________________________________________________________________________________ SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K [X] Annual Report pursuant to Section 13 or 15(d) of the Securities and Exchange Act of 1934 For the fiscal year ended October 31, 1997 or [ ] Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from ___ to ____ Commission file number: 0-13907 ________________________________________________________________________________ BIO-VASCULAR, INC. (Exact name of Registrant as specified in its charter) ________________________________________________________________________________ Minnesota 41-1526554 ------------------------ ----------------------------------- (State of Incorporation) (I.R.S. Employer Identification No.) 2575 UNIVERSITY AVENUE, ST. PAUL, MINNESOTA 55114-1024 (Address of principal executive offices) TELEPHONE NUMBER: (612) 603-3700 -------------------------- Securities Registered Pursuant to Section 12(b) of the Act: None Securities Registered Pursuant to Section 12(g) of the Act: Common Stock, $.01 par value Common Stock Purchase Rights -------------------------- 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 Registrant's 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. [ ] As of November 30, 1997, 9,583,399 shares of Common Stock of the Registrant were outstanding, and the aggregate market value of the Common Stock of the Registrant (based upon the last reported sale price of the Common Stock on that date by the Nasdaq National Market), excluding shares owned beneficially by executive officers and directors, was approximately $ 30,896,394. Part III of this Annual Report on Form 10-K incorporates documents incorporated by reference (to the extent specific sections are referred to herein) from the Registrant's Proxy Statement for its Annual Meeting of Shareholders to be held February 24, 1998 (the "1998 Proxy Statement"). Tissue-Guard(TM), Supple Tissue-Guard(TM), Peri-Strips(R), Peri-Strips Dry(R), PSD Gel(TM), Dura-Guard(R) ,Vascu-Guard(R), Supple Peri-Guard(R), Peri- Guard(R), CV Peri-Guard(TM), Ocu-Guard(TM), Biograft(R), Flo-Rester(R), and Bio-Vascular Probe(R), are trademarks of the Company. FORWARD-LOOKING STATEMENTS - -------------------------- This Annual Report on Form 10-K contains certain forward-looking statements. For this purpose, any statements contained in this Form 10-K that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, words such as "may," "will," "expect," "believe," "anticipate," "estimate" or "continue" or the negative or other variations thereof or comparable terminology are intended to identify forward- looking statements. These statements by their nature involve substantial risks and uncertainties, and actual results may differ materially depending on a variety of factors, including those set forth in the section below entitled "Important Factors." PART I ITEM 1 - BUSINESS - ----------------- Bio-Vascular, Inc. ("Bio-Vascular" or "the Company") was incorporated in Minnesota in July of 1985. The Company's principal executive offices are located at 2575 University Avenue, St. Paul, Minnesota 55114-1024. The Company can also be contacted by telephone at (612) 603-3700, facsimile at (612) 642- 9018, or by electronic mail at info@biovascular.com. SPIN-OFF OF VITAL IMAGES, INC. - ------------------------------ On May 12, 1997, the Company completed the spin-off distribution of all the shares of Vital Images, Inc. ("Vital Images") to the shareholders of Bio- Vascular, with Vital Images thereafter operating as an independent company, with its own publicly traded securities. All Bio-Vascular shareholders received one share of Vital Images common stock for each two shares of Bio-Vascular stock held, with cash issued in lieu of fractional shares. The Company attempted to structure the transaction as tax free, but since no revenue ruling was sought from the Internal Revenue Service, no assurance can be made about the final tax treatment of the transaction. The Company recorded the distribution of Vital Images common stock to its shareholders as of March 19, 1997, the date the Board of Directors of the Company gave final approval for the transaction. The distribution was recorded by reducing shareholders' equity by $10,124,000, which represents $10,000,000 of cash and investments, plus the carrying value of Vital Images' net assets. The Company's financial statements and notes thereto (see list of documents filed as part of this Report on Page 31) report the business of Vital Images as discontinued operations. Prior years' financial statements and notes have been restated accordingly. GENERAL DEVELOPMENT OF BUSINESS - ------------------------------- Bio-Vascular develops, manufactures and markets proprietary and patented specialty medical products for use in thoracic, cardiac, neuro, vascular and ophthalmic surgery. The Company's products include the Tissue-Guard product line and the Biograft peripheral vascular graft. The Tissue-Guard product line includes Peri-Strips, Peri-Strips Dry, Dura-Guard, Vascu-Guard, Supple Peri- Guard, Peri-Guard, Tissue-Guard and Supple Tissue-Guard. Tissue-Guard products are made from bovine pericardium (the thin membrane surrounding the heart of cattle) processed using proprietary tissue-fixation technology. The Tissue- Guard products, made in various configurations, are used in a wide variety of surgical procedures and are designed to reinforce, reconstruct and repair tissue and prevent leaks of air, blood and other body fluids. Biograft is used to bypass occluded blood vessels and is produced from modified human umbilical veins. The Company also markets and sells two surgical 2 productivity tools used in cardiac and vascular surgery, Flo-Rester vessel occluders and the Bio-Vascular Probe. The Company was incorporated in Minnesota in July of 1985. Through 1985 and 1986 the Company acquired the rights to certain cardio-vascular products, including Peri-Guard and Flo-Rester, and was spun-off to the shareholders of its then parent company. In fiscal 1990 the Company acquired Biograft peripheral vascular graft from Meadox Medicals, Inc. In fiscal 1991 the Company developed the Bio-Vascular Probe to further compliment its cardio-vascular product line. Additionally, in fiscal 1991 the Company introduced Supple Peri-Guard in response to surgeons' requirements for a flexible soft tissue patching material. Peri-Strips staple-line buttress was introduced in 1994 for use in lung surgical procedures, primarily lung volume reduction surgery ("LVRS" or "LVR surgery"). Peri-Strips represented the Company's first non-cardio-vascular product as the Company began to expand its product development strategy to meet the needs of the broader surgical community. LVRS is performed principally on patients with late-stage emphysema who have significantly reduced respiratory function. During the procedure, a portion of each diseased lung is removed from the patient allowing an improved expansion and contraction movement of the remaining lung tissue within the chest cavity, providing relief from the symptoms of emphysema. Peri-Strips are designed to prevent air leakage at the surgical staple line which is essential to a successful LVRS procedure. Sales from Peri-Strips fueled significant revenue growth for the Company from late 1994 through fiscal 1995, increasing from $685,000 in fiscal 1994 to $5,500,000 in fiscal 1995. Domestic revenue from Peri-Strips continues to be affected by the Health Care Financing Administration's non-coverage decision in January 1996 regarding LVRS (see Business - Third Party Reimbursement and Cost Containment on Page 15 of this Report). Dura-Guard, which was introduced in 1995, is a dural patch used in cranial surgery designed to prevent fluid leakage and reduce post-surgical adhesions. Vascu-Guard, also introduced in 1995, is a vascular patch used primarily in carotid endarterectomy procedures designed to improve tissue integration and reduce suture line bleeding. Dura-Guard and Vascu-Guard both are made from Supple Peri-Guard. Peri-Strips Dry, an advanced version of Peri-Strips, was launched in July 1997. The Company believes the Peri-Strips Dry design provides significant advantages for thorascopic surgical procedures over the original Peri-Strip "sleeve" design. Peri-Strips Dry eliminates the need to extract the sutured sleeve backing, that was part of the original design, through the thorascope after the surgical stapler is fired. R&D efforts have recently resulted in new product opportunities and the Company has two products nearing the end of the product development phase, CV Peri-Guard and Ocu-Guard. The Company filed a 510(k) application with the FDA in May for CV Peri-Guard. The intended uses for CV Peri-Guard include intra-cardiac patching and vessel repair. The Company currently expects FDA clearance for CV Peri-Guard during the first quarter of 1998. CV Peri-Guard will be an addition to the Tissue Guard product line. Ocu-Guard, filed with the FDA in September for marketing clearance, will have indications for use in enucleation surgery. Enucleation removes a patient's damaged eye and supporting tissue and replaces it with an implant. The Company's tissue would be used in the procedure as an orbital implant wrap instead of using cadaver sclera to encase the orbital prosthesis. The Company currently expects FDA clearance for Ocu-Guard during the first quarter of 1998. Ocu-Guard uses the Company's Supple tissue and will also be a Tissue Guard product line extension. The Company estimates that 25,000 to 30,000 enucleation procedures are performed worldwide each year. The Company's forward-looking statements regarding FDA clearance for CV Peri- Guard and Ocu-Guard are dependent on the timing of FDA review and the need for additional clinical data regarding such products, among other factors. There can be no assurance that marketing clearance for CV Peri-Guard and Ocu-Guard will be received on a timely basis, if at all, or if received, that either device will become commercially successful. 3 Narrative Description of Business - --------------------------------- MARKETS AND MEDICAL NEED While the trend in medicine is toward less invasive surgical procedures, substantially all surgical procedures, whether invasive or not, involve the cutting of tissue to access, repair or remove tissue at or from the surgical site. Tissue which has been cut must either be repaired or replaced so that it can heal properly. Proper repair of incised tissue is dependent upon a number of variables, including whether (i) the repair must be leakproof, either for air, blood or other body fluids, (ii) the incised tissue is under tension or subject to shrinkage such that additional tissue is needed to bridge the two tissue surfaces to be repaired, and (iii) the tissue subject to the repair must be strengthened to accommodate the natural stresses of the human body. In certain instances, suturing of two tissue surfaces will be effective. In other instances, however, a patching material, whether autologous (from the body of the patient), synthetic (from man-made materials) or tissue-based (from processed biologically based tissue), may be needed. The Company's tissue-based products are designed to fulfill the medical need for repairing human tissue and preventing leaks at the surgical site in certain existing surgical procedures, as well as offering a potential medium for techniques and procedures currently being developed. The Company's core competency is the development and manufacture of tissue-based implantable medical products for use by surgeons in various surgical procedures where reinforcing, reconstructing and repairing tissue and preventing leaks of air, blood or other body fluids is necessary for the achievement of a favorable outcome. Historically, surgeons primarily used autologous tissue in situations where tissue repair was necessary. Harvesting the autologous material, which is still performed in many circumstances, necessarily requires the surgeon to excise the tissue from another part of the patient's body. The second surgical site increases the cost of the procedure and lengthens the time the patient is under anesthesia, thereby increasing the risk of complication and resulting in additional pain and recovery time for the patient. To the extent a surgeon is confident that the performance of a readily available medical product, whether tissue-based or synthetic, is equal to or better than the patient's own tissue, the Company believes the surgeon will choose the tissue-based or synthetic product to avoid a second surgical site as a means of reducing surgical costs and improving patient outcomes. Lung Volume Reduction Surgery ("LVRS"). Emphysema, most often caused by cigarette smoking, is a progressive disease of the lungs characterized by air- filled expansions or pocket-like blisters in the tissue of the lungs. Because the air in the lungs cannot be fully expelled, the effort to inhale fresh air becomes increasingly difficult, pushing the lung walls farther out and causing the lungs to expand and lose their elasticity. The diaphragm, the major muscle used for breathing, becomes flattened and loses its ability to function. As the disease advances and patient health is progressively compromised, breathing becomes more difficult. Persons with late-stage emphysema eventually become incapable of even minor physical activity and often become dependent upon continuous supplemental oxygen even when at rest. As a result, late-stage emphysema can significantly reduce mobility, leaving individuals with late-stage emphysema unable to care for themselves or engage in normal daily activities. Because of the weakened respiratory condition of these patients, common illnesses involving pulmonary functions can result in emergency room visits and hospitalization. Non-surgical therapies for patients suffering from emphysema include (i) bronchodilators (pills and inhalers), to open up airways to temporarily relieve wheezing or shortness of breath, (ii) steroids, to reduce inflammation in the airways, (iii) pulmonary rehabilitation to increase endurance, and (iv) oxygen supplements to help decrease the feeling of shortness of breath. Each of these non-surgical therapies, however, offers only temporary relief and each becomes less effective as the disease progresses. Data gathered by the Company indicates that the cost of medication and oxygen supplements for late-stage emphysema patients can range from $5,000 to $8,000 annually. In addition, visits to the doctor, in-home health care and equipment, and the need for periodic emergency room care for persons suffering the effects of late-stage emphysema, can increase costs substantially. Lung transplantation is the only known cure for emphysema. A lung transplant surgical procedure, however, costs 4 up to $250,000 and is typically used only as a last resort because of the high degree of risk associated with the procedure, an inadequate supply of donor lungs, and the requirement that the patient receive anti-rejection drugs for the remainder of his or her lifetime. Only 688 lung transplants were performed in the United States in 1994. In the 1950's, a surgical procedure was developed to treat the symptoms of late- stage emphysema by removing damaged lung tissue. Due to air leaks around the suture lines, these experimental LVRS procedures resulted in a high mortality rate and long, painful post-surgical recovery periods. As a result, the LVRS procedure was abandoned. In the late 1980's, various surgeons began to develop specialized techniques for accessing and resecting the lung. The use of surgical staples was introduced to perform LVRS more quickly, a particularly important consideration in light of the debilitated condition of the patients requiring the surgery. Despite many advances in LVRS, multiple small air leaks caused by the staples in the lung continued to limit the effectiveness of the procedure. In 1994, Dr. Joel Cooper, a pioneer in lung transplant surgery, modified LVRS using strips of Supple Peri-Guard to reinforce the staple line to prevent air leakage around the staples. During LVRS, the surgeon collapses one lung, while allowing the patient to continue breathing with the other lung with supplemental oxygen. Using a stapling device, the surgeon removes sections of damaged tissue, typically 20% to 30% of each lung. The Company's Peri-Strips or Peri-Strips Dry are used to strengthen these staple lines and prevent air leakage. By removing the most diseased tissue, the remaining lung tissue has room to expand, improving breathing capacity by, among other things, enabling the muscles used in breathing to regain their function and allowing the rib cage and diaphragm to return to their normal size and state. The Company estimates that the current cost of LVRS ranges from $25,000 to $45,000 per procedure. The American Lung Association estimates that in 1992 there were approximately 1.9 million Americans suffering from emphysema. LVRS, however, is currently only being performed on a small portion of these patients who have late-stage emphysema and who meet certain criteria established by the attending surgeons. Currently, most surgeons require that an LVRS candidate be less than 75 years old, quit smoking at least six months prior to LVRS, have no documented history of heart disease or previous lung surgery and have no other major diseases. In addition, most surgeons performing LVRS require that candidates have documented lung function testing and chest x-rays detailing the severity of the condition. The Company believes that the patient selection criteria will continue to be refined as surgeons become more familiar with LVRS and as long-term clinical results become available. While LVRS is not a cure for emphysema, the results from the procedure to date are encouraging based on peer-reviewed published literature. Generally, the literature shows that patients undergoing the procedure have reduced shortness of breath, improved exercise tolerance and improved quality of life. However, LVRS was only re-introduced into the United States in late calendar 1993. While it is estimated that over 3,000 surgeons have been trained and over 6,000 procedures have been performed, not enough time has elapsed to provide a statistically significant body of clinical data from which to draw conclusions concerning the long-term efficacy and long-term outcomes associated with LVRS. Craniotomy. Craniotomies (surgical operations involving the brain and skull) are typically performed to treat various brain conditions, such as tumors, aneurysms, blood clots, head injuries and abscesses. To access the brain, the surgeon is required to cut through several of the protective layers surrounding the brain. The dura, the fibrous protective layer below the skull, protects the brain and spinal cord from bacterial infection and trauma and provides a fluid tight seal. Once the surgeon has cut through the scalp and the skull, the dura must be cut with a scalpel or scissors and resected to expose the brain. After the specific brain condition has been treated by the surgeon, the dura often must be closed to prevent cerebral spinal fluid leakage. While the dura is often closed with direct suture, surgeons who consider the prevention of fluid leakage to be critical to the success of the operation will use a dural patch. The primary patching materials include autologous tissue, synthetic patches, processed cadaver tissue or bovine pericardium. The Company's Dura- Guard Dural Repair Patch is designed to be sewn to the dura to close the incision by fusing to the native dura with little or no adhesion (an abnormal union between two tissue surfaces not intended to be joined) to the underlying 5 brain cortex. The Company estimates that in the United States approximately 140,000 cranial operations are performed annually. Whether a dural patch is used in such operations is subject to surgical conditions and surgeon discretion. Dural patching is most often used when the dura shrinks after incision such that sutures alone may not provide adequate closure. Carotid Endarterectomy. Stroke is the third leading cause of death in the United States with an estimated 500,000 new cases per year. The build-up of atherosclerotic plaque (fat deposits with a proliferation of fibrous connective cells along the artery walls) in the carotid arteries (the principal arteries located in the neck that supply blood to the brain) increases the risk of stroke. A substantial portion of strokes is caused by a fragment of atherosclerotic plaque breaking away from the inner wall of the carotid artery and becoming lodged in an artery in the brain. Drug therapy is often prescribed to treat the early indications of atherosclerotic plaque build-up. If the condition progresses to a point where drug therapy is not effective, surgical intervention may be required. Carotid endarterectomy is a surgical procedure used to remove atherosclerotic plaque build-up in the carotid artery. The endarterectomy procedure begins with an incision in the internal carotid artery. A temporary shunt may be inserted to maintain blood flow to the brain during the surgery. Once the artery is opened, the plaque and inner layer of the artery are carefully removed, and the incised artery must be repaired. Although the artery often can be closed without a patch, use of an autologous or prosthetic patch is often suggested to expand the artery, encouraging greater blood flow. In addition, certain patients require patching due to the small size of their carotid arteries, or in some patients with a normal carotid artery diameter, a patch is used to decrease the incidence of post-operative stenosis or occlusion. While the Company estimates that in the United States approximately 115,000 carotid endarterectomy procedures are performed annually, the use of a patching material in such procedures is subject to surgeon discretion. Once a surgeon determines a vascular patch is necessary or desirable, the surgeon has additional discretion in determining the type of patching material to use. Characteristics of an effective vascular patch include the ability to imitate human tissue, to exhibit good blood flow characteristics and to reapproximate around sutures to prevent blood leaks. The primary patching materials include autologous tissue, synthetic patches made out of polytetraflurothylene ("PTFE"), silicone fabric or tissue-based patches made out of bovine pericardium, such as Vascu-Guard. Lower Limb Vascular Reconstruction. Certain diseases, such as diabetes, can cause a restriction or occlusion in the arteries which provide blood to the legs. If left untreated, insufficient blood flow can ultimately result in the need for amputation. If drug therapy is not deemed an effective treatment based upon the severity of the restriction or blockage, the use of a graft in peripheral vascular reconstructive surgery may be needed. In this type of surgical procedure, the surgeon can bypass the blocked artery to regain blood circulation, thereby saving the affected limb. Diabetics, in particular, are often at risk for amputation of a lower limb due to insufficient blood flow in the femoral artery in the thigh. By implanting a graft from the upper portion of the femoral artery to either the lower femoral artery or to the popliteal artery blow the knee, the surgeon is able to increase blood flow below the site of the restriction or blockage. Long-term patency (openness), and a thrombo- resistant surface that provides smooth blood flow are essential qualities of an effective graft. Saphenous veins (autologous veins from the leg) typically provide the most effective grafting material. In many instances, however, a suitable saphenous vein may be unavailable in sufficient quantity or quality, and a substitute graft must be used. The primary alternative substitute grafts involve synthetic grafts made from PTFE or bio-synthetic materials or tissue-based grafts, such as Biograft. The Company estimates that in the United States approximately 55,000 lower limb vascular reconstructions are performed annually. 6 PRODUCTS The following table summarizes the Company's product lines and primary products, the procedures in which such products are used and the type of regulatory clearance obtained for such products: REGULATORY PRODUCT LINE PRODUCT APPLICATION REPRESENTATIVE PROCEDURE CLEARANCE - -------------------- --------------- ------------------------- --------------------------- ------------- Tissue-Guard Peri-Strips Soft tissue stapling Lung volume reduction/lung buttress resection 510(k) Peri-Strips Dry Soft tissue stapling Lung volume reduction/lung buttress resection 510(k) Dura-Guard Dural repair patch Craniotomy 510(k) Vascu-Guard Peripheral vascular patch Carotid Endarterectomy 510(k) Supple Peri- General soft tissue patch Various surgical procedures 510(k) Guard Peri-Guard Pericardial patch Various cardiovascular procedures 510(k) Biograft Biograft Peripheral vascular Lower limb vascular bypass graft reconstruction PMA Surgical Bio-Vascular Locator of arterial Various surgical bypass Productivity Tools Probe blockages procedures 510(k) Flo-Rester Internal vessel occluder Coronary artery bypass graft surgery 510(k) The following table summarizes the net revenue contributed by the Company's products and various product lines for the periods indicated: YEARS ENDED OCTOBER 31, PRODUCT/PRODUCT LINE 1997 1996 1995 - -------------------- -------- -------- -------- (IN THOUSANDS) Tissue-Guard Products: Peri-Strips and Peri-Strips Dry.. $2,915 $4,336 $5,550 Other Tissue-Guard Products...... 3,852 2,944 1,845 Biograft........................... 800 938 1,198 Surgical Productivity Tools........ 2,127 1,902 1,825 TISSUE-GUARD PRODUCT LINE. The Company's Tissue-Guard products are all produced from bovine pericardium. Many of the product characteristics and competitive advantages of this product line are derived from the collagen 7 configuration of the bovine pericardium. Collagen, which is a fibrous protein found in all multi-cellular animals, makes the pericardium durable and provides superior fluid interface properties, similar to autologous tissue. These characteristics allow for effective host tissue incorporation. Host cells deposit a collagen matrix on the surface of the pericardial product, which helps the Tissue-Guard product integrate into the host tissue and which the Company believes enhances the long-term tensile strength (the maximum stress a material subjected to a stretching load can withstand without tearing) of all the products in the Tissue-Guard product line. The Company processes the bovine pericardium using proprietary and patented tissue-fixation technologies. The tissue is treated with glutaraldehyde and other proprietary chemical treatments to prevent degradation of the tissue and to render it biologically compatible with the host tissue. In addition, according to studies commissioned by the Company, the tissue-fixation technologies used by the Company reduce the level of residual glutaraldehyde remaining in the processed tissue to less than six parts per million, resulting in a lower incidence of host tissue inflammatory response and promoting host tissue incorporation similar to the body's natural healing process. Tissue- Guard has in excess of a 15 year history of successful clinical performance as a surgical patch in a wide variety of clinical applications. Surgeons have indicated that different pericardial patch characteristics are useful in different surgical procedures. Accordingly, depending on the particular tissue-fixation technology used by the Company, the bovine pericardium is processed into either Supple Peri-Guard or Peri-Guard. While the raw material used is the same, Supple Peri-Guard has greater elasticity and flexibility than Peri-Guard, which allows for greater conformity to the surgical site. The Company's Peri-Guard and Supple Peri-Guard products are produced in square or rectangular sheets of different sizes, ranging from 4 cm x 4 cm to 12 cm x 25 cm. Supple Peri-Guard is produced for use as a multi-purpose material designed for reinforcing, reconstructing and repairing tissue and preventing leaks of air, blood and other body fluids. Each of such products has received 510(k) clearance from the FDA as a general soft-tissue patch. The products in the Tissue-Guard product line described below are special configurations of Supple Peri-Guard designed to enable specific surgical procedures. Peri-Strips and Peri-Strips Dry Peri-Strips and Peri-Strips Dry, soft tissue stapling buttress, are currently used primarily in LVRS but are also used for lobectomy (removal of a lobe), excision/destruction of a lesion and segmental resection of the lung. The key competitive features of Peri-Strips and Peri-Strips Dry include the following: - - Reapproximation. Due to the elastic-like nature of the collagen fibers in the tissue, Peri-Strips and Peri-Strip Dry reapproximate (close around) surgical staples to prevent pulmonary air leaks at the staple site. - - Prevents Enlargement. The elasticity of Peri-Strips and Peri-Strip Dry prevents staple holes from enlarging, which could lead to additional air leaks and require additional surgery. - - Reinforcement. The use of Peri-Strips and Peri-Strip Dry strengthens the entire staple line, which makes it more durable and less likely to tear. Also, Peri-Strips and Peri-Strips Dry are thin enough to allow for staple lines to be overlapped, which is often required during LVRS. - - Configuration. The sleeve configuration of Peri-Strips is customized to fit disposable, reusable and endoscopic staplers of varying sizes and produced by different manufacturers. The Peri-Strip Dry design provides even greater ease of use for thorascopic surgical procedures over the sleeve configuration. The Peri-Strip Dry design eliminates the need to extract the sutured sleeve through the thorascope. 8 Dura-Guard Dura-Guard, a dural repair patch, is primarily used in craniotomy procedures when the dura must be repaired and suturing without a patch is not deemed sufficient. Dura-Guard offers advantages over competitive dural patches produced from autologous or cadaver tissue. Harvesting autologous tissue necessarily involves a second surgical site, thereby increasing costs and recovery time. Cadaver tissue is subject to rigorous tissue bank regulations, which could impact upon the availability of such tissue. Certain other competitive advantages of Dura-Guard relate to the specific benefits produced by the physical properties of Dura-Guard in connection with the craniotomy procedure. Observations in the course of subsequent surgical procedures on patients receiving Dura-Guard patches have shown that there is little or no adhesion formation on the Dura-Guard surface that faces the cerebral cortex, a complicating factor following any cranial surgery. In addition, Company commissioned studies have shown that fibrous bone cells invade the Dura-Guard surface facing the cranium, as they do the human dura, inviting good host tissue incorporation. The collagen configuration of the processed bovine pericardium in Dura-Guard reapproximates around the sutures used to affix the patch, thereby providing a barrier between the skull and the tissue layers underlying the dura and preventing the leakage of cerebrospinal fluid. Studies have shown synthetic materials have been unable to perform as effective dura substitutes and have been associated with late subdural hematoma formation (bleeding between the dura and the brain). Vascu-Guard Vascu-Guard, a vascular repair patch, is primarily used in carotid endarterectomy and other peripheral vascular procedures when the artery must be repaired and closing the vessel without a patch is not deemed sufficient. Vascu- Guard offers advantages over competitive carotid artery repair patches produced from autologous tissue or synthetics. The use of autologous tissue necessarily involves a second surgical site and results in increased costs and additional recovery time. Synthetic patches, which lack the collagen configuration of tissue, do not reapproximate around sutures as does the Vascu-Guard product, thereby increasing the risk of suture line bleeding and resulting in longer operating times. In addition, unlike synthetic patches, the physical attributes of Vascu-Guard imitate human tissue and certain characteristics associated with human tissue. Specifically, Company commissioned studies have shown that, once healed, Vascu-Guard supports endothelialization (growth of a cell layer normally lining the interior of blood vessels) and its non-thrombogenic blood flow surface imitates the blood flow characteristics of autologous vessels. In addition, its pulsatility (ability to reflect movement signifying the rhythmic pumping of the heart) allows the surgeon to readily verify normal blood flow after implantation. BIOGRAFT. Biograft, a peripheral vascular graft manufactured from human umbilical veins, is indicated for use in lower limb vascular reconstructions when a saphenous vein is not available. Biograft offers advantages over competitive vein grafts produced from synthetics, like PTFE, due to its thrombo- resistant surface which provides smooth blood flow and minimizes turbulence and risk of occlusion. Other competitive advantages of Biograft include its long- term patency and its similarity to an autologous blood vessel, minimizing intimal hyperplasia (a build up of cells on the interior of the blood vessel which results in restricted blood flow). In addition, a knitted and supportive Dacron mesh is placed around the graft, which allows for easier handling and promotes tissue integration for strength and stability. SURGICAL PRODUCTIVITY TOOLS. Flo-Rester and Bio-Vascular Probe. The Company's Flo-Rester products are vessel occluders manufactured from medical grade silicone. The Flo-Rester products are designed to interrupt blood flow in arteries and to stent them (hold them open) during surgery, thereby facilitating the suturing together of vessels. These products are primarily used during coronary artery bypass graft surgeries in which blood is routed past the heart through a heart-lung bypass machine in order to keep the heart free of blood during surgery. During such procedures, incidental blood flow obstructs the surgeon's view of the operative site and interferes with precise suturing. Flo-Rester consists of a flexible shaft with small bulbs at each end that are inserted into the blood vessel to stop the blood flow at the point where the artery bypass is sutured to the artery. Competitive procedures involve external occlusion through the use of clamps, snares or tapes. The Bio-Vascular Probe is a flexible shaft with 9 varying sizes of bulbous tips on either end. Surgeons use the Bio-Vascular Probe to locate occlusions or blockages in arteries and to ascertain the blood flow characteristics of arteries. The Bio-Vascular Probe is inserted and fed into an artery. When the tip of the probe meets resistance, the surgeon is able to identify the exact location of the occlusion. The Bio-Vascular Probe is then extracted and a bypass is completed below the occlusion. In addition, the Probe can be used to atraumatically lift the edge of the incision to assist the surgeon in accurately placing sutures, which can improve the functioning of bypass grafts. RESEARCH AND DEVELOPMENT The Company generally allocates its research and development resources among three broad functions: research and development support of current products through training of Company personnel and writing and publishing research papers on these products; development of product line extensions by improving current products or developing new applications for current products; and the development of new products for medical applications that utilize the Company's proprietary technologies and core competencies in tissue processing and bio- materials. As an integral part of both its research and development and sales and marketing strategies, the Company strives to involve its surgeon-customers in its product development activities. The Company consults with selected surgeons frequently as to market needs and assessments of products under development. The Company believes that this practice allows it to receive early stage assessments of products in development. The Company's research and development staff, including engineering, currently consists of five scientists, four engineers, and three technicians. The Company also expands its research and development activities through the use of external consultants and research staff and facilities at research centers and hospitals on an as-needed basis. The Company spent approximately $1,258,000, $909,000 and $643,000 on research and development in fiscal 1997, 1996 and 1995, respectively. MARKETING The Company's sales and marketing strategy is designed to ensure that the Company has an innovative "first in the mind of the customer" focus that results in timely and effective marketing programs and new product introductions. These programs include surgical trade shows, support of the presentation of clinical data and new product information by key physicians, limited direct-mail campaigns, journal ads and the development of strategic physician alliances and utilization of the Company's scientific advisory boards. The Company believes these efforts to be cost-effective in producing awareness of, and loyalty to, the Company's products. The sales and marketing strategy of the Company also includes developing and maintaining a close working relationship with the hospitals and surgeons who purchase and use the Company's products in order to assess and satisfy their needs. The Company continues to assist in the education of surgeons in the use of Peri-Strips in LVRS through sponsorship of workshops and training programs. These workshops and training sessions have been conducted in the United States, Canada and certain European and Far Eastern countries. The Company estimates that over 3,000 surgeons have been trained in LVRS as of the end of fiscal 1997. The Company has also sponsored "focus group" meetings as a forum for discussion and the exchange of information for surgeons performing LVRS. In addition, the Company sponsors surgeon workshops and training programs in the use of Biograft and Vascu-Guard. The Company's products are sold to hospitals and surgeons worldwide. For the fiscal years ended October 31, 1997, 1996 and 1995, approximately 24%, 22%, and 17% of the Company's revenue, respectively, were from sales in international markets. The lower percent of net revenue attributed to international markets during fiscal 1995 was primarily due to increases of sales of Peri-Strips in the United States. The majority of the Company's international sales are in Europe. In the United States, the Company sells its products through a combination of distributors and independent sales 10 representatives managed by regional sales managers. To further strengthen the direct relationship between the Company and the end users of its products, the Company requires distributors to provide the Company with the names and addresses of such end users. The Company also ships products directly to end users for a limited period of time when there is a new product introduction. In addition to strengthening customer relationships, this practice provides the Company with some protection in the event a distributor is terminated and resists providing the Company with customer lists. Internationally, the Company's products are sold through distributors. In some situations, sales in a country may occur through more than one distributor due to distributors' varying market strengths and focus. The Company currently has written agreements with 43 of its domestic and international independent sales representatives and distributors. These agreements generally impose limited geographic exclusivity and minimum purchase obligations on the Company's independent sales representatives and distributors. However, significant overlap occurs in many of the Company's international distribution agreements. These agreements are typically terminable upon breach of the agreement by the distributor, including breach of the minimum sales obligations imposed by the agreement, as well as certain extraordinary events. The Company's marketing and sales department and its national and international distribution network is managed by the Vice President of Marketing and Sales. The Company's marketing and sales department currently consists of 15 employees. These employees include domestic and international sales managers, domestic regional sales managers, product managers, administrative and customer service personnel. In fiscal 1997, three domestic distributors accounted for a total of 44% of the Company's gross revenues, each in excess of 10%. In fiscal 1996 and 1995, the same three domestic distributors each accounted for more than 10% of the Company's gross revenue. COMPETITION The Company competes primarily on the basis of product performance, service and price. The Company believes that product performance is the single most important factor in selling any of its products and develops and produces its products accordingly. The surgical products market in which the Company competes is characterized by intense competition. This market is dominated by established manufacturers that have broader product lines, greater distribution capabilities, substantially greater capital resources and larger marketing, research and development staffs and facilities than the Company. Many of these competitors offer broader product lines within the Company's specific product market, particularly in the Company's surgical tool product markets and/or in the general field of medical devices and supplies. Broad product lines give many of the Company's competitors the ability to negotiate exclusive, long-term medical device supply contracts and, consequently, the ability to offer comprehensive pricing for their products, including those that compete with the Company's products. By offering a broader product line in the general field of medical devices and supplies, competitors may also have a significant advantage in marketing competing products to group purchasing organizations, health maintenance organizations and other managed care organizations that increasingly seek to reduce costs through centralization of purchasing functions. In 1996, the FDA cleared for marketing a synthetic product made from PTFE, configured for use with surgical staplers in LVRS, and intended to compete with Peri-Strips. Pictures taken with electron microscopes indicate that PTFE, unlike Peri-Strips, does not fully reapproximate around surgical staplers. Additionally, the Company is aware of two tissue products that may be potentially competitive with Peri-Strips. The Company, however, has three patents related to the use of Peri-Strips as a soft tissue stapling buttress (see Intellectual Property on page 16) which the Company intends to vigorously enforce. To the Company's knowledge, there are dural patches currently available that compete with Dura-Guard. These are either autologous tissue or processed cadaver tissue, including Tutoplast/TM/, a processed cadaver product manufactured by Biodynamics International, Inc., and synthetic patches. In addition to specifically configured patches, there are multi-purpose patches made from bovine and other types of animal tissue that compete with the Company's Supple Peri-Guard, Peri-Guard, and Vascu-Guard products, including bovine pericardium products produced by Medtronic, Inc. and Baxter International Inc. The Company does not believe that these alternative bovine pericardium products have specific FDA marketing clearance for use 11 in the lung, although such products are FDA cleared for pericardial closure and soft tissue repair. In addition, synthetic multi-purpose patches made out of PTFE or silicone fabric are currently available. W. L. Gore & Associates, Inc., manufacturer of Gore-Tex(R), is believed to have a prominent position in the synthetic patch market. Synthetic patches are generally cheaper to produce and to the extent that comparable synthetic patches are available and effective in procedures, the Company faces significant price competition for its Tissue-Guard products. The Company believes, however, that the collagen characteristics exclusive to tissue, the special configuration of its Tissue-Guard products and the proprietary tissue-fixation technology (Supple Peri-Guard, Peri-Strips, Dura-Guard and Vascu-Guard) and patented (Peri-Guard) tissue-fixation technology employed by the Company offer significant product performance advantages over competing products. Alternative treatments and competitive products to Biograft include drug therapies and surgical procedures that use autologous or synthetic grafts. Once the decision has been made to use surgical intervention, surgeons generally prefer the patient's own vessels for lower limb vascular reconstruction. When the patient's own vessels are not available in sufficient quality or quantity, surgeons choose a prosthesis graft such as Biograft or synthetic grafts made from expanded PTFE produced by W. L. Gore & Associates, Inc., IMPRA, Inc. or other grafts made of bio-synthetic materials. There can be no assurance that competing products will not achieve greater acceptance or that future products developed by competitors will not offer similar or enhanced performance advantages relative to the Company's product. MANUFACTURING The Company manufactures all of its products at its 36,000 square foot facility occupied since July 1995 in St. Paul, Minnesota. Previously, the Bio-Vascular Probe was manufactured to the Company's specifications by a contract manufacturer, with certain final cleaning, packaging and sterilization testing procedures performed by the Company at its St. Paul facility. During fiscal 1997, the Company brought the manufacture of this product in-house. The Company acquires bovine pericardium for use in the Tissue-Guard product line from a private independent contractor who obtains the tissue from local United States Department of Agriculture ("USDA") inspected meat packing facilities. The Company acquires human umbilical cords for use in Biograft from various hospitals throughout the United States. The Company has not experienced any product shortages arising from interruptions in the supply of any raw materials or components, and has identified alternative sources of supply for such raw materials and components. GOVERNMENTAL REGULATION The manufacture and sale of the Company's products are subject to regulation by numerous governmental authorities, principally the FDA and corresponding foreign agencies. In the United States, the FDA administers the Federal Food, Drug and Cosmetics Act and amendments thereto. The Company is subject to the standards and procedures respecting manufacture and marketing of medical devices contained in the Federal Food, Drug and Cosmetics Act and the regulations promulgated thereunder and is subject to inspection by the FDA for compliance with such standards and procedures. These regulations classify medical devices as either Class I, II or III devices, which are subject to general controls, special controls or premarket approval ("PMA") requirements, respectively. All Class I and II devices, as well as some Class III devices marketed prior to the effective date of the Medical Device Amendments of 1976, can be cleared for marketing pursuant to a 510(k) pre-market notification, establishing that the device is "substantially equivalent" to a device that was legally marketed prior to May 28, 1976, the date on which the Medical Device Amendments of 1976 became effective. The 510(k) pre-market notification must be supported by data establishing the claim of substantial equivalence to the satisfaction of the FDA. The process of obtaining a 510(k) clearance typically can take several months to a year or longer. If substantial equivalence cannot be established, or if the FDA 12 determines that the device or the particular application for the device requires a more rigorous review, the FDA will require that the manufacturer submit a PMA application that must be carefully reviewed and approved by the FDA prior to sale and marketing of the device in the United States. The PMA application must contain the results of clinical trials, the results of all relevant prototype tests, laboratory and animal studies, a complete description of the device and its components, and a detailed description of the methods, facilities and controls used for manufacturing, including the method of sterilization and its assurance. In addition, the submission must include the proposed labeling, advertising literature and training methods, if applicable. Most Class III devices are subject to the PMA requirements rather than the 510(k) pre-market notification procedure. The process of obtaining a PMA can be expensive, uncertain and lengthy, frequently requiring anywhere from one to several years from the date of FDA submission, if approval is obtained at all. Moreover, a PMA, if granted, may include significant limitations on the indicated uses for which a product may be marketed. FDA enforcement policy strictly prohibits the marketing of approved medical devices for unapproved uses. In addition, product approvals can be withdrawn for failure to comply with regulatory standards or the occurrence of unforeseen problems following initial marketing. Of the Company's current products, Biograft and Peri-Guard (when marketed as a pericardial patch) are Class III devices. Biograft received marketing clearance from the FDA pursuant to a PMA, while Peri-Guard received clearance for use as a pericardial patch as the result of a 510(k) submission. Peri-Strips (as marketed in both strip and sleeve configurations), Peri-Strips Dry, Vascu-Guard, Dura-Guard, Peri-Guard (when marketed as a patch for soft tissue deficiency), Supple Peri-Guard (when marketed as a patch for soft tissue deficiency and as a pericardial patch) and both the disposable and reusable Flo-Rester and the Bio- Vascular Probe have all been classified as Class II medical devices and have received 510(k) marketing clearance from the FDA. The United States and Europe have focused attention on the safety of tissue banks, spurred by incidents of the transmission of human disease during tissue transplantation. In the United States, FDA draft regulations have outlined requirements for tissue banks. These regulations have specifically excluded medical devices subject to FDA review, including preserved umbilical cord vein grafts such as Biograft. As a result, the Company does not expect Biograft to be subject to tissue bank regulations in the United States, including the expensive donor screening and donor testing procedures. In response to the increased scrutiny of umbilical cord vein grafts, the Company commissioned an independent virology laboratory to test Biograft for viral inactivation. The results of the testing demonstrated that Biograft's chemical manufacturing processes inactivate a variety of viruses, resulting in a sterile product. The Company has informed the FDA of these test results and does not anticipate that the FDA will impose additional regulatory requirements on Biograft. There can be no assurance, however, that the FDA will not impose additional regulatory requirements on Biograft at some later date or that Biograft would be able to meet any such new requirements. The Company is also subject to regulation in most of the foreign countries in which it sells its products with regard to product standards, packaging requirements, labeling requirements, import restrictions, tariff regulations, duties and tax requirements. Many of the regulations applicable to the Company's products in such countries are similar to those of the FDA. The national health or social security organizations of certain such countries require the Company's products to be qualified before they can be marketed in those countries. In Japan, a potentially significant market for the Company's products, clinical trials of certain of the Company's products are required before such products can be cleared for sale in the Japanese market. To date, this has delayed the Company's market entry in some cases, but has not ultimately prevented sales in Japan of any of the Company's devices sold in the United States. The Company relies on its independent distributors to comply with the majority of the foreign regulatory requirements, including registration of the Company's products with the appropriate governmental authorities. To date, the Company has been successful in complying with the regulatory requirements in most foreign countries in which its products are marketed. Bovine Spongiform Encephalopathy ("BSE") has been endemic in cattle in the United Kingdom (UK) and has received much publicity in Europe regarding beef for dietary consumption. Under the direction of the USDA, the U.S. government has had an active program of surveillance and import controls since the late 1980's, designed to prevent the introduction of BSE into U.S. cattle. To date, all evidence indicates that U.S. cattle are free of BSE. 13 The Company obtains all of its raw pericardium from USDA slaughterhouses. The Company cannot predict whether or not a case of BSE may someday be reported in the U.S. If a case of BSE were reported in the U.S. cattle, it could have a material adverse effect on the Company's business, financial condition and results of operations. The Company's notified body, the British Standards Institute ("BSI"), and French authorities have specifically reviewed Tissue- Guard sourcing and manufacturing processes and have then accepted the Company's bovine pericardium products. Although the Company does not anticipate that countries will prohibit the sale of Tissue-Guard products as a result of concerns related to BSE, such prohibition by certain countries could have a material adverse effect on the Company's business, financial condition and results of operation. The Company is subject to periodic inspections by the FDA, whose primary purpose is to audit the Company's compliance with Good Manufacturing Practices ("GMP") established by the FDA and other applicable government standards. Strict regulatory action may be initiated in response to audit deficiencies or to product performance problems. The Company believes that its manufacturing and quality control procedures are in compliance with the requirements of the FDA regulations. The Company's manufacturing facilities and processes were inspected and audited by the BSI to verify the Company's compliance with the requirements of the Medical Device Directive ("MDD") issued by the European Union ("EU"). They have also verified that the Company's quality system conforms with the ISO 9001 international quality standard and that its products conform with the "essential requirements" set forth by the MDD for the class of products produced by the Company. In June of 1996, BSI certified the Company's conformity with both the ISO 9001 standard and the MDD essential requirements, entitling the Company to place the "CE" mark on the Company's Tissue-Guard products. The CE mark enables the Company's products to be marketed, sold and used throughout the EU, subject to limited "safeguard" powers of member states. Presently, the CE mark is not required to be affixed to the Company's products (or those of its competitors) sold in the EU, but may be affixed during a transition period currently in effect and which began January 1, 1995. This transition period will end on June 15, 1998, when all of the Company's current products (and those of its competitors) will be required to comply with the essential requirements in order to be marketed in the EU. The long-term future regulatory environment for Biograft in Europe is uncertain. The MDD explicitly excludes medical devices from human tissue; however, there is an effort developing to include such devices under a comprehensive regulatory program. This effort is in the early stages; the Company understands that a consensus on such a directive would take approximately four to five years. In addition, if extensive donor screening and donor testing requirements are imposed, such requirements could make it uneconomical to sell Biograft in Europe even under a regulatory program. As a result of significant problems with their blood supply, France has passed national laws and regulations requiring extensive donor screening and testing on products derived from human tissue. Accordingly, Biograft is not being sold in France. It is not known whether a comprehensive regulatory program for Biograft would override such national requirements or whether other countries in the EU will adopt regulations similar to those of France. The Company is seeking Biograft registration in Germany, but cannot predict when or if it will achieve such registration. Biograft is not marketed generally in Germany, but rather is prescribed by physicians on a prescription-by-prescription basis only. If the CE mark or other regulatory program requirements are unavailable for Biograft or if the requirements for obtaining such designation are too burdensome, the Company intends to seek country-by-country registration of the product where such registration requirements exist for as long as it continues to market the Biograft. The Company cannot predict when or if it would obtain such registrations. The financial arrangements through which the Company markets, sells and distributes its products may be subject to certain federal and state laws and regulations in the United States with respect to the provision of services or products to patients who are Medicare or Medicaid beneficiaries. The "fraud and abuse" laws and regulations prohibit the knowing and willful offer, payment or receipt of anything of value to induce the referral of Medicare or Medicaid patients for services or goods. In addition, the physician anti-referral laws prohibit the referral of Medicare or Medicaid patients for certain "Designated Health Services" to entities in which the referring physician has an ownership or compensation interest. Violations of these laws and regulations may result in civil and criminal penalties, including substantial fines and imprisonment. In a number of states, the scope of fraud and abuse or 14 physician anti-referral laws and regulations, or both, have been extended to include the provision of services or products to all patients, regardless of the source of payment, although there is variation from state to state as to the exact provisions of such laws or regulations. In other states, and, on a national level, several health care reform initiatives have been proposed which would have a similar impact. The Company believes that its operations and its marketing, sales and distribution practices currently comply in all respects with all current fraud and abuse and physician anti-referral laws and regulations, to the extent they are applicable. Although the Company does not believe that it will need to undertake any significant expense or modification to its operations or its marketing, sales and distribution practices to comply with federal and state fraud and abuse and physician anti-referral regulations currently in effect or proposed, financial arrangements between manufacturers of medical devices and other health care providers may be subject to increasing regulation in the future. Compliance with such regulation could adversely affect the Company's marketing, sales and distribution practices, and may affect the Company in other respects not presently foreseeable, but which could have an adverse impact on the Company's business, financial condition and results of operations. THIRD PARTY REIMBURSEMENT AND COST CONTAINMENT The Company's products are purchased primarily by hospitals and other users which then bill various third-party payers for the services provided to the patients. These payers, which include Medicare, Medicaid, private health insurance plans and managed care organizations, reimburse part or all of the costs and fees associated with the procedures utilizing the Company's products. The availability and level of reimbursement from third-party payers is significant to the Company's business. For Medicare carriers, HCFA may establish a national coverage policy, including the amount to be reimbursed, for coverage of claims submitted for reimbursement related to a specific procedure. Private health insurance plans and managed care organizations make their own determinations regarding coverage and reimbursement based either upon "usual and customary" fees or, increasingly, upon a similar prospective payment system. During the past several years, the major third party payers have substantially revised their reimbursement methodologies in an attempt to contain their healthcare reimbursement costs. Medicare and Medicaid reimbursement for inpatient hospital services is based on a fixed amount per admission based on the patient's specific diagnosis. As a result, any illness to be treated or procedure to be performed will be reimbursed only at a prescribed rate set by the government that is known in advance to the healthcare provider. If the treatment costs less, the provider keeps the difference. If it costs more, the provider cannot bill the patient for the rest. Frequently, reimbursement is reduced to reflect the availability of a new procedure or technique, and as a result hospitals are generally willing to implement new cost saving technologies before these downward adjustments take effect. No separate payment is made in most cases for products such as the Company's when they are furnished or used in connection with inpatient care. Any amendments to existing rules and regulations which restrict or terminate the reimbursement eligibility (or the extent or amount of coverage) of medical procedures using the Company's products or the eligibility (or the extent or amount of coverage) of the Company's products could have an adverse impact on the Company's business, financial condition and results of operations. In response to the focus of national attention on rising health care costs, a number of changes to reduce costs have been proposed or have begun to emerge. There have been, and may continue to be, proposals by legislators and regulators and third-party payers to curb these costs. There has also been a significant increase in the number of Americans enrolling in some form of managed care plan, and over 80% of hospitals participate in or have agreements with HMOs. It has become a typical practice for hospitals to affiliate themselves with as many managed care plans as possible. Higher managed care penetration typically drives down the prices of health care procedures, which in turn places pressure on medical supply prices. This causes hospitals to implement tighter vendor selection and certification processes, by reducing the number of vendors used, purchasing more products from fewer vendors and trading discounts on price for guaranteed higher volumes to vendors. Hospitals have also sought to control and reduce costs over the last decade by joining group purchasing organizations or purchasing alliances. The Company cannot predict what continuing or future impact these practices, the existing or proposed legislation, or such third- 15 party payer measures may have on its future business, financial condition or results of operations. Because the Company's surgical products are primarily used in thoracic, cardiac, neuro and vascular surgeries, changes in reimbursement policies and practices of third party payers with respect to these surgeries could have a substantial and material impact on sales of the Company's products. The development or increased use of more cost effective treatments for diseases requiring these surgeries could cause such payers to decrease or deny reimbursement for such surgeries or to favor these other treatments over surgical treatment. In January of 1996, HCFA, the agency of the federal government that administers Medicare, made a national policy decision not to reimburse LVRS. These surgeries had been reimbursed nationwide on a regional basis during fiscal 1994 and 1995. The Company estimates that approximately 70% of the patients undergoing LVRS in fiscal 1995 were Medicare patients. In April of 1996, the National Institute of Health ("NIH") announced a collaborative study of LVRS with HCFA. The National Emphysema Treatment Trial ("NETT"), as it is currently structured, is limited to a small number of patients relative to the number of Medicare dependent patients who would otherwise be eligible for the procedure. HCFA and NIH have estimated it will take approximately five years if the study goes to completion and will include 4,700 Medicare patients, with a little more than half of those receiving LVRS done bilaterally by open median sternotomy or thoracoscopic. This represents less than 2% of those currently estimated to benefit from LVRS. The Company understands that many private insurance companies and managed care organizations are continuing to reimburse LVRS based on their own evaluation of the procedure and its outcomes. It is unknown whether these private payers will change their reimbursement practices in the future. If these private payers change their reimbursement practices, it could have an adverse impact on the Company's business, financial condition and results of operations. INTELLECTUAL PROPERTY The Company's success will depend in large part on its ability to preserve its trade secrets, to obtain patent protection for its products and to operate without infringing the proprietary rights of third parties. While the Company has obtained or acquired a license to certain patents and applied for additional United States and foreign patents covering certain aspects of its products, no assurance can be given that any additional patents will be issued, that the scope of any patent protection will exclude competitors or that any of the Company's rights under such patents will be held valid if subsequently challenged. The validity and breadth of claims covered in medical technology patents involve complex legal and factual questions and, therefore, may be highly uncertain. Whether or not the Company's patent applications are granted, others may receive patents which contain claims having a scope that covers products developed by the Company. The Company has been granted three United States patents relating to the use of tissue on a removable backing which cover the sleeve configuration of Peri- Strips, the combination of tissue with a surgical stapling gun, and methods of performing a surgical procedure to remove diseased tissue. The Company has been granted one United States patent relating to Peri-Strips Dry covering the application of buttressing material (tissue or other synthetic material) onto a surgical stapler for purposes of reinforcing a surgical fastener suture line utilizing an adhesive substance and a positional and pressure equalization device to accomplish the adherence of the tissue to the surgical suturing device. A patent is pending regarding the method of manufacturing the Peri- Strips Dry tissue. In December 1994, the Company entered into an agreement with Surgical Research, Inc., which obligates the Company to pay royalties of five percent (5%) on revenue from sales of Peri-Strips and Peri-Strips Dry for the life of the patents. In December 1995, the Company purchased the patent for Peri-Guard. Previously, the Company had an exclusive, worldwide, perpetual license to make, use and sell its Peri-Guard product for use in connection with the cardiovascular system. The Company holds no patents and pays no royalties on Supple Peri-Guard or the configurations of Supple Peri-Guard marketed as Dura-Guard or Vascu-Guard. The Company also has an exclusive, worldwide, perpetual license to make, use and sell its Flo-Rester product. The last of the patents related to the Company's Biograft product expired in November 1993. 16 The Company also relies on trade secrets and proprietary know-how which it seeks to protect, in part, through confidentiality agreements with employees, consultants and other parties. Supple Peri-Guard, which is used in the manufacture of the majority of the Company's Tissue-Guard products, is protected exclusively by trade secrets. There can be no assurance that these agreements will not be breached, that the Company will have adequate remedies for any breach, or that the Company's trade secrets will not otherwise become known to or independently developed by competitors. The surgical products industry is characterized by frequent and substantial intellectual property litigation, and competitors may resort to intellectual property litigation as a means of competition. The surgical products markets are characterized by extensive patent and other intellectual property claims that can create greater potential than in less developed markets for possible allegations of infringement, particularly with respect to newly developed technology. Intellectual property litigation is complex and expensive, and the outcome of such litigation is difficult to predict. Any future litigation, regardless of outcome, could result in substantial expense to the Company and significant diversion of the efforts of the Company's technical and management personnel. Litigation may also be necessary to enforce patents issued to and licenses held by the Company, to protect trade secrets or know-how owned by the Company or to determine the enforcement, scope and validity of the proprietary rights of others. It is the Company's intention to vigorously enforce and defend these intellectual property rights. An adverse determination in any such proceeding could subject the Company to significant liabilities to third parties, or require the Company to seek licenses from third parties or pay royalties that may be substantial. Furthermore, there can be no assurance that necessary licenses would be available to the Company on satisfactory terms, if at all. Accordingly, an adverse determination in a judicial or administrative proceeding or failure to obtain necessary licenses could prevent the Company from manufacturing or selling certain of its products which in turn would have a material adverse effect on the Company's business, financial condition or results of operations. The Company has registered United States trademarks, including Peri-Strips(R), Peri-Strips Dry(R), Dura-Guard(R), Vascu-Guard(R), Supple Peri-Guard(R), Peri- Guard(R), Biograft(R), Flo-Rester(R) and Bio-Vascular Probe(R). EMPLOYEES At October 31, 1997, the Company employed 92 full-time and 2 part-time individuals, including 12 in research and development, 47 in manufacturing, quality control and quality assurance, 15 in sales and marketing, 14 in general and administrative functions and 6 in regulatory affairs and clinical affairs. The Company's employees are not represented by a union, and the Company considers its relationship with its employees to be good. FINANCIAL INFORMATION ABOUT FOREIGN AND DOMESTIC OPERATIONS AND EXPORT SALES - ---------------------------------------------------------------------------- For information with respect to the Company's revenue attributable to international markets, see page 49 of this Annual Report on Form 10-K. ITEM 1A - IMPORTANT FACTORS - --------------------------- The following factors are important and should be considered carefully in connection with any evaluation of the Company's business, financial condition, results of operations and prospects. Additionally, the following factors could cause the Company's actual results to materially differ from those reflected in any forward-looking statements of the Company. LIMITATIONS ON THIRD-PARTY REIMBURSEMENT The Company's products are purchased primarily by hospitals and other users, which bill various third-party payers, such as government health programs, private health insurance plans, managed care organizations and other similar programs, for the health care goods and services provided to their patients. Payers may deny reimbursement if they determine that a product used in a procedure was not used in accordance with established payer protocol regarding 17 cost-effective treatment methods or was used for an unapproved indication. Third-party payers are also increasingly challenging the prices charged for medical products and services and, in some instances, have put pressure on medical device suppliers to lower their prices. The Company is unable to predict what changes will be made in the reimbursement methods used by third- party health care payers. There can be no assurance that the surgical procedures in which the Company's products are used will continue to be considered cost-effective by third-party payers, that reimbursement for such surgeries will be available or, if available will continue, or that payers' reimbursement levels will not adversely affect the Company's ability to sell its products on a profitable basis. The cost of health care has risen significantly over the past decade, and there have been and may continue to be proposals by legislators, regulators and third-party payers to curb these costs. Failure by hospitals and other users of the Company's products to obtain reimbursement from third-party payers, changes in third-party payers' policies towards reimbursement for procedures using the Company's products or legislative action could have a material adverse effect on the Company's business, financial condition and results of operations. In January of 1996, HCFA, the agency of the federal government that administers Medicare, made a national policy decision not to reimburse LVRS. These surgeries had been reimbursed nationwide on a regional basis during fiscal 1994 and 1995. The Company estimates that approximately 70% of the patients undergoing LVRS in fiscal 1995 were Medicare patients. In April of 1996, the National Institute of Health ("NIH") announced a collaborative study of LVRS with HCFA. The National Emphysema Treatment Trial ("NETT"), as it is currently structured, is limited to a small number of patients relative to the number of Medicare dependent patients who would otherwise be eligible for the procedure. HCFA and NIH have estimated it will take approximately five years if the study goes to completion and will include 4,700 Medicare patients, with a little more than half of those receiving LVRS done bilaterally by open median sternotomy or thoracoscopic. This represents less than 2% of those currently estimated to benefit from LVRS. The Company understands that many private insurance companies and managed care organizations are continuing to reimburse LVRS based on their own evaluation of the procedure and its outcomes. It is unknown whether these private payers will change their reimbursement practices in the future. If these private payers change their reimbursement practices, it could have an adverse impact on the Company's business, financial condition and results of operations. HIGHLY COMPETITIVE INDUSTRIES AND RISK OF TECHNOLOGICAL OBSOLESCENCE The Company faces intense competition. The medical products industry is highly competitive and characterized by rapid innovation and technological change. The Company expects technology to continue to develop rapidly, and the Company's success will depend to a large extent on its ability to maintain a competitive position with its technology. There can be no assurance that the Company will be able to compete effectively in the marketplace or that products developed by its competitors will not render its products obsolete or non-competitive. Similarly, there can be no assurance that the Company's competitors will not succeed in developing or marketing products that are viewed by physicians as providing superior clinical performance or are less expensive relative to the Company's products currently marketed or to be developed. Several established companies manufacture and sell surgical products which compete with all of the Company's surgical products. The companies with which the Company competes have greater distribution capabilities, substantially greater capital resources and larger marketing, research and development staffs and facilities than the Company. In addition, many of the Company's competitors offer broader product lines within the Company's specific product markets. Broad product lines may give the Company's competitors the ability to negotiate exclusive, long-term medical product supply contracts and the ability to offer comprehensive pricing for their products, including those that compete with the Company's products. By offering a broader product line in the general field of medical products and supplies, competitors may also have a significant advantage in marketing competing products to group purchasing organizations and managed care organizations that increasingly seek to reduce costs. There can be no assurance that the Company will be able to compete effectively with such manufacturers. 18 RISKS ASSOCIATED WITH INTELLECTUAL PROPERTY The Company protects its technology through trade secrets and proprietary know- how and through patents, both owned and licensed. The Company seeks to protect its trade secrets and proprietary know-how through confidentiality agreements with employees, consultants and other parties. Supple Peri-Guard, which is used in the manufacture of the majority of the Company's Tissue-Guard products, is protected exclusively by trade secrets. There can be no assurance that the Company's trade secrets or confidentiality agreements will provide meaningful protection of the Company's proprietary information or, in the event of a breach of any confidentiality agreement, that the Company will have adequate remedies. There can be no assurance that any pending or future patent applications will result in issued patents, or that any current or future patent, regardless of whether the Company is an owner or licensee of such patent, will not be challenged, invalidated or circumvented or that the rights granted thereunder or under its licensing agreements will provide a competitive advantage to the Company. Furthermore, there can be no assurance that others will not independently develop similar technologies or duplicate any technology developed by the Company or that the Company's technology does not or will not infringe patents or other rights owned by others. The medical product industry is characterized by frequent and substantial intellectual property litigation, and competitors may resort to intellectual property litigation as a means of competition. Intellectual property litigation is complex and expensive, and the outcome of such litigation is difficult to predict. Any future litigation, regardless of the outcome, could result in substantial expense to the Company and significant diversion of the efforts of the Company's technical and management personnel. Litigation may also be necessary to enforce patents issued to the Company and license agreements entered into by the Company, to protect trade secrets or know-how owned by the Company or to determine the enforcement, scope and validity of the proprietary rights of others. An adverse determination in any such proceeding could subject the Company to significant liabilities to third parties, or require the Company to seek licenses from third parties or pay royalties that may be substantial. Furthermore, there can be no assurance that necessary licenses would be available to the Company on satisfactory terms, if at all. Accordingly, an adverse determination in a judicial or administrative proceeding or failure to obtain necessary licenses could prevent the Company from manufacturing or selling certain of its products which, in turn, would have a material adverse effect on the Company's business, financial condition and results of operations. See "Intellectual Property" on page 16 of this Report. RISKS ASSOCIATED WITH HUMAN TISSUE PRODUCTS Both the United States and Europe have recently focused attention on the safety of tissue banks, spurred by incidents of the transmission of human disease during tissue transplantation. In the United States, regulations drafted by the FDA have outlined requirements for tissue banks. The regulations have specifically excluded from regulation medical devices subject to FDA review, including preserved umbilical cord vein grafts such as Biograft. As a result, the Company does not expect Biograft to be subject to tissue bank regulations in the United States and the related expensive donor screening and donor testing procedures. There can be no assurance, however, that the FDA will not impose additional regulatory requirements on Biograft at some later date or that Biograft would be able to meet any such new requirements. The long-term future regulatory environment for Biograft in Europe is uncertain. The MDD explicitly excludes medical devices from human tissue; however, there is an effort developing to include such devices under a comprehensive regulatory program. This effort is in the early stages; the Company understands that a consensus on such a directive would take approximately four to five years. In addition, if extensive donor screening and donor testing requirements are imposed, such requirements could make it uneconomical to sell Biograft in Europe even under a regulatory program. Biograft accounted for 8% and 16% of the Company's net revenue and international net revenue, respectively, for the year ended October 31, 1997. Bovine Spongiform Encephalopathy ("BSE") has been endemic in cattle in the United Kingdom (UK) and has received much publicity in Europe regarding beef for dietary consumption. Under the direction of the USDA, the 19 U.S. government has had an active program of surveillance and import controls since the late 1980's, designed to prevent the introduction of BSE into U.S. cattle. To date all evidence indicates that U.S. cattle are free of BSE. The Company obtains all of its raw pericardium from USDA slaughterhouses. The Company cannot predict whether or not a case of BSE may someday be reported in the U.S. If a case of BSE were reported in the U.S. cattle, it could have a material adverse effect on the Company's business, financial condition and results of operations. The Company's notified body, the British Standards Institute, and French authorities have specifically reviewed Tissue-Guard sourcing and manufacturing processes and have then accepted the Company's bovine pericardium products. Although the Company does not anticipate that countries will prohibit the sale of Tissue-Guard products as a result of concerns related to BSE, such prohibition by certain countries could have a material adverse effect on the Company's business, financial condition and results of operation. GOVERNMENTAL REGULATION The Company's products, development activities and manufacturing processes are subject to extensive and rigorous regulation by the FDA and by comparable agencies in foreign countries. In the United States, the FDA regulates the introduction, manufacturing, labeling and record keeping procedures for medical devices. The process of obtaining marketing clearance from the FDA for new products and new applications for existing products can be time-consuming and expensive, and there is no assurance that such clearances will be granted or that FDA review will not involve delays that would adversely affect the Company's ability to commercialize additional products or additional applications for existing products. In addition, certain of the Company's products that are in the research and development stage may be subject to a lengthy and expensive pre-market approval ("PMA") process with the FDA. Even if regulatory approvals to market a product are obtained from the FDA, these approvals may entail limitations on the indicated uses of the product. Product approvals by the FDA can also be withdrawn due to failure to comply with regulatory standards or the occurrence of unforeseen problems following initial approval. The FDA could also limit or prevent the manufacture or distribution of the Company's products and has the power to require the recall of such products. FDA regulations depend heavily on administrative interpretation, and there can be no assurance that future interpretations made by the FDA or other regulatory bodies, with possible retroactive effect, will not adversely affect the Company. The FDA, various state agencies and foreign regulatory agencies inspect the Company and its facilities from time to time to determine whether the Company is in compliance with various regulations relating to manufacturing practices, validation, testing, quality control and product labeling. A determination that the Company is in violation of such regulations could lead to imposition of civil penalties, including fines, product recalls or product seizures and, in extreme cases, criminal sanctions. Approximately 24% of the Company's revenue in fiscal 1997 resulted from sales of its products outside the United States through independent distributors. International regulatory bodies have established varying regulations governing product standards, packaging requirements, labeling requirements, import restrictions, tariff regulations, duties and tax requirements. The Company relies on independent distributors to comply with foreign regulatory requirements. As a result, communication between foreign regulatory agencies and the Company is indirect as it occurs through the foreign distributor. The inability or failure of independent distributors to comply with the varying regulations or the imposition of new regulations could restrict such distributors' ability to sell the Company's products internationally and thereby adversely affect the Company's business, financial condition and results of operations. The registration scheme in the EU requires that the Company's quality system conform with the ISO 9001 international quality standard and that its products conform with the "essential requirements" set forth by the MDD for the class of products produced by the Company. Compliance with these requirements will allow the Company to issue a "Declaration of Conformity" and apply the CE mark to products, allowing free sale in the EU. While the Company has obtained the "CE" mark for its Tissue-Guard products, there can be no assurance that the Company will be able to maintain compliance with the regulations to retain the CE mark. In addition, it is uncertain whether the Company will be successful in obtaining the CE mark for its other products or new product introductions. Failure to obtain the CE mark authority for the Company's other products by June 15, 1998 would limit the Company's ability to sell such products in Europe and would have a material adverse effect on the Company's 20 business, financial condition and results of operations. See "Governmental Regulation" on page 12 of this Report. EXPOSURE TO PRODUCT LIABILITY CLAIMS; RISK OF PRODUCT RECALL The medical product industry historically has been litigious, and the manufacture and sale of the Company's products inherently entails a risk of product liability claims. Since the Company's principal products are designed to be permanently placed in the human body, production errors could result in an unsafe product and injury to the patient. Although the Company maintains product liability insurance in amounts believed to be adequate based upon the nature and risks of its business in general and its actual experience to date, there can be no assurance that one or more liability claims will not exceed the coverage limits of such policies or that such insurance will continue to be available on commercially reasonable terms, if at all. Furthermore, the Company does not expect to be able to obtain insurance covering its costs and losses as the result of any recall of its products due to alleged defects, whether such a recall is instituted by the Company or required by a regulatory agency. In September 1996, the Company voluntarily issued a Safety Alert regarding the usage of its bovine pericardium as a urethral sling and removed "urethral sling" from the "indications" statement in its instructions for use. The Company issued the Safety Alert as a prudent course of action. The deletion of "urethral sling" from the labeling caused the action to fall into the category of a "field correction". In November 1996, the FDA acknowledged this field correction and reported it in the "FDA Weekly Enforcement Report" of November 11, 1996 as a "recall", as the definition of a recall encompasses field corrections. No product units were physically recalled and none were returned to the Company. Although Peri-Guard and Supple Peri-Guard have included the urethral sling indication in their labeling for several years, the products were rarely used in this application until late 1995. At that time a handful of urological surgeons began using the products in place of autologous fascia slings to treat female urinary incontinence. Approximately 65 transvaginal implants were done, resulting in 16 explants due to vaginal discharge, opening of the vaginal incision, and localized inflammation without fever. These results were similar to those which have been reported for synthetic urethral slings. A product liability claim, recall or other claim with respect to uninsured liabilities or in excess of insured liabilities could have a material adverse effect on the business, financial condition and results of operations of the Company. DEPENDENCE ON DISTRIBUTOR SALES Sales to distributors constitute a significant portion of the Company's current business. In the year ended October 31, 1997, three domestic distributors accounted for an aggregate of 44% of gross revenue, with each of such distributors accounting for in excess of 10% of the Company's gross revenue for the period. There can be no assurance that the Company will be able to maintain its relationships with these significant distributors, or, in the event of termination of any of such relationships, that a new replacement distributor will be found. The loss of a significant distributor could materially adversely affect the Company's business, financial condition and results of operations if a new distributor or other suitable sales organization could not be found on a timely basis in the relevant geographic market. See Business - "Marketing" on page 10 of this Report. ITEM 2 - PROPERTIES - ------------------- The Company leases approximately 36,000 square feet of office and manufacturing space at 2575 University Avenue, St. Paul, Minnesota. The base rent of this lease, which commenced August 1, 1995 and expires July 31, 2005, is approximately $255,000 annually. The Company also pays apportioned real estate taxes and common costs on this lease. The Company believes that its current space is adequate for the foreseeable future. ITEM 3 - LEGAL PROCEEDINGS - -------------------------- During the first quarter of fiscal 1997, the Company received notice of a suit brought against it in Tokyo District Court in Japan by Jostra, Japan, K.K., a former Japanese distributor, claiming wrongful termination and economic 21 damage of $500,000. The Company settled this matter out of court during the fourth quarter of fiscal 1997 at an amount considerably less than the original claim. ITEM 4 - SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS - ------------------------------------------------------------ No matter was submitted to a vote of security holders during the fourth quarter of the fiscal year covered by this Report. ITEM 4A - EXECUTIVE OFFICERS OF THE REGISTRANT - ---------------------------------------------- The Company's executive officers, their ages, and their offices held as of November 30, 1997 are as follows: NAME AGE TITLE - -------------------------- --- ------------------------------------------------------- M. Karen Gilles........... 55 President, Chief Executive Officer, Corporate Secretary and Director Connie L. Magnuson........ 36 Vice President of Finance and Chief Financial Officer Donald E. Gardner, Ph.D... 63 Vice President of Regulatory Affairs and Quality Assurance Kemal Schankereli......... 45 Vice President of Research and Development Frank A. Stephenson....... 44 Vice President of Marketing and Sales M. Karen Gilles. Ms. Gilles has served as President and Chief Executive Officer of the Company since July 1997 and as a Director of the Company since August 1997. Ms. Gilles has also served as Secretary of the Company since November 1991. Prior to July 1997, Ms. Gilles held the positions of Chief Financial Officer of the Company from December 1990, Vice President of Finance from April 1989 to December 1990 and Director of Finance and Administration of the Company from April 1989 to December 1989. From 1985 to 1989, Ms. Gilles served as Controller for VEE Corporation, a production company, and Colin Companies, a related concession company. From 1983 to 1985, Ms. Gilles was an accountant with McGladrey & Pullen, a public accounting firm. Connie L. Magnuson. Ms. Magnuson joined the Company as Chief Financial Officer and Vice-President of Finance in November 1997. From March 1997 to November 1997, Ms. Magnuson served as Treasurer of Northern Technologies International Corporation. From 1996 to March 1997, Ms. Magnuson served as a private financial consultant. From 1983 to 1996, Ms. Magnuson held a series of positions with Deloitte and Touche, LLP, a public accounting firm, including Audit Senior Manager and Director of Human Resources for their Minneapolis office. Donald E. Gardner. Ph.D. Dr. Gardner has served as Vice President of Regulatory Affairs and Quality Assurance since September 1997. From June 1995 to September 1997, Dr. Gardner served as a senior associate with Regulatory Strategies Consultants, Inc., a consulting firm serving clients in the medical device, diagnostics, pharmaceutical and biologics industries. From June 1993 to June 1995, Dr. Gardner served as Vice-President of Regulatory Affairs and Quality Assurance with Cryolife, Inc. From August 1984 to May 1993, Dr. Gardner held quality management and regulatory affairs positions with Alcon Laboratories. From 1975 to 1984, Dr. Gardner held quality management and regulatory affairs positions with Abbott Laboratories and Pharmaseal Division of American Hospital Supply Corp. Kemal Schankereli. Mr. Schankereli has served as Vice President of Research and Development since December 22 1993 after serving as Director of Research and Development from January 1993 to December 1993. From 1991 to December 1992, Mr. Schankereli served as a private consultant to the bio-medical device industry. From 1983 to 1991, Mr. Schankereli held the position of Manager of Vascular Product Research at St. Jude Medical, Inc., a medical device company. From 1978 to 1983, Mr. Schankereli served as a Senior Research Scientist at Meadox Medicals, Inc., a medical device company. Frank A. Stephenson. Mr. Stephenson has served as Vice President of Marketing and Sales since December 1994. From 1989 to August 1994, Mr. Stephenson served as Vice President of Marketing and Sales for Spectranetics Corporation, a medical laser company. From 1985 to 1989, Mr. Stephenson held a series of marketing management positions with Boston Scientific Corporation, a manufacturer of medical devices, and served as a senior sales representative and trainer from 1982 to 1985 with Codman & Shurtleff, a distributor of neurosurgical products, which is a division of Johnson and Johnson, Inc. PART II ITEM 5 - MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS - ------------------------------------------------------------------------------ The Company's Common Stock is currently traded on the Nasdaq National Market under the symbol "BVAS". The following table sets forth, for each of the fiscal periods indicated, the range of high and low closing sale prices per share as reported by the Nasdaq National Market. These prices do not include adjustments for retail mark-ups, mark-downs or commissions. HIGH LOW ------- ------ FISCAL 1997 First Quarter......... $ 7.750 $6.000 Second Quarter........ 6.000 5.000 Third Quarter......... 5.875 3.875 Fourth Quarter........ 5.000 3.750 FISCAL 1996 First Quarter......... $15.000 $7.500 Second Quarter........ 13.125 8.000 Third Quarter......... 9.875 6.125 Fourth Quarter........ 8.375 5.250 The Company has not declared or paid any cash dividends on its Common Stock since its inception, and the Board of Directors presently intends to retain all earnings for use in the business for the foreseeable future. As of November 30, 1997, there were approximately 6,600 beneficial owners of the Company's Common Stock. 23 ITEM 6 - SELECTED FINANCIAL DATA - -------------------------------- YEAR ENDED OCTOBER 31 1997 1996 1995 1994 1993 =================================================================================================== Net revenue $ 9,694,047 $10,124,709 $10,426,076 $4,951,743 $4,422,775 Gross margin 5,726,587 6,681,611 6,964,259 3,027,708 2,586,354 Operating income (loss) (1,305,235) 571,013 2,121,096 (255,951) 333,058 Income (loss) from continuing (603,613) operations 1,218,501 1,659,162 (697,025) 650,634 Income (loss) per share from continuing operations (.06) .13 .20 (.10) .09 Weighted average shares outstanding 9,531,000 9,433,000 8,172,000 7,277,000 7,055,000 The above information excludes discontinued operations; see Note 2 to the financial statements AT OCTOBER 31: 1997 1996 1995 1994 1993 =================================================================================================== Working capital $16,905,823 $22,106,990 $24,059,746 $6,261,521 $6,636,651 Total assets 25,134,451 37,881,279 37,303,375 7,431,793 8,807,445 Long-term debt - - - - 40,016 Shareholders' equity 23,952,235 35,220,535 35,355,336 6,785,539 8,476,742 In connection with the spin-off of Vital Images, Inc. on the distribution date, Shareholders' Equity was reduced by $10,124,000, which represents the contribution of cash equivalents and marketable securities plus the carrying value of Vital Images' net assets. 24 ITEM 7 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS - -------------------------------------------------------------------------------- OF OPERATIONS - ------------- OVERVIEW Although net revenue for the year was down $431,000 or 4% over fiscal 1996 levels, reflecting the $1,421,000 decline in Peri-Strips revenue, fiscal 1997 has many successes to report. The Company continues to see impressive growth from its core Tissue Guard product line, excluding Peri-Strips. In particular within the Tissue Guard product line, Dura-Guard, Vascu-Guard, Peri-Guard and Supple Peri-Guard had significant revenue increases in the year, increasing $908,000 or 31% over fiscal 1996 revenues. In the Surgical Productivity Tools product line, Flo-Rester experienced excellent revenue growth, increasing $153,000 or 12% over fiscal 1996. Previous Flo-Rester annual revenue increases have been in the 5-7% range. Fourth quarter fiscal 1997 net revenues exceeded fiscal 1996 fourth quarter revenue by $212,000. This is the first quarter in which net revenues increased over the comparable prior year quarter since the HCFA non-coverage decision in January of 1996. Fourth quarter revenue growth was again led by Dura-Guard, Vascu-Guard and Supple Peri-Guard. During fiscal 1997 the Company launched Peri-Strips Dry, an advanced version of Peri-Strips initially targeted for the European market, and is close to final development on two new products in the Tissue Guard product line. The Company also brought the manufacture of the Bio-Vascular Probe in-house which will allow the Company greater control over the manufacture of this growing product. The Company continues to expend significant time and resources in the research and development of new applications using its core tissue products and tissue processing technology. Domestic revenue from Peri-Strips continued to be significantly affected by the HCFA decision in January of 1996 for LVRS. Domestic revenue from Peri-Strips was down 38% from fiscal 1996. The Company believes that some hospitals in the U.S. are no longer promoting LVRS cases. However, the Company is encouraged that surgeons and other medical professionals continue to seek training on the LVR surgical procedure. Peri-Strips fiscal 1997 revenue was also down from the Company's original expectations due to a delay in the start date for a study of LVRS, the National Emphysema Treatment Trial ("NETT") sponsored jointly by HCFA and NIH. (See "Medicare Non-Coverage Decision" on Page 26 for a more in-depth discussion). The start date is subject to the completion of organizational and procedural activities. The Company had orginally received indications that the study would commence in June 1997. The Company accordingly anticipated demand for the Peri-Strips product associated with the HCFA study and corresponding Peri-Strips revenue in the second half of fiscal 1997. The Company now believes that the earliest surgeries under the study will begin is January 1998. There can be no assurance, however, that further delays will not impact the commencement of surgeries under the study, or that the study will proceed on the basis anticipated by the Company, if at all, as the study is subject to determinations made by HCFA and NIH and is beyond the control of the Company. Peri-Strips Dry was launched in July 1997. The Company believes that the Peri- Strips Dry design provides significant advantages for thorascopic surgical procedures over the original Peri-Strips "sleeve" design. Peri-Strips Dry eliminates the need to extract through the thorascope the sutured sleeve backing that was part of the original design. A specially formulated PSD Gel enables the Peri-Strip Dry strip to adhere to the surgical stapler. Thorascopic procedures are currently estimated to comprise 75% of the total LVR surgeries performed in Europe. The majority of surgeons in Europe have performed LVRS without benefit of a staple-line buttress. The Company was successful in convincing a leading European thoracic surgeon to evaluate Peri-Strips Dry. This surgeon is now the lead investigator for the Company's marketing clinical trials currently underway at three European sites. The Company expects European revenue growth from Peri-Strips Dry and Peri-Strips will be gradual as reimbursement is obtained on a country-by-country basis. However, this forward- looking statement is dependent upon the receipt of reimbursement approval from European countries, and will be negatively impacted by any failure or delay in receiving such reimbursement approvals. Currently, European patients pay directly for the product. In the U.S., Peri-Strips Dry is expected to replace the original Peri-Strips sleeve configuration for thorascopic procedures. 25 THE SPIN-OFF OF VITAL IMAGES On May 12, 1997, the Company completed the spin-off distribution of all the shares of Vital Images to the shareholders of Bio-Vascular, with Vital Images thereafter operating as an independent public company. Vital Images is currently traded on the OTC Bulletin Board under the symbol VTAL. All Bio- Vascular shareholders received one share of Vital Images common stock for each two shares of Bio-Vascular stock held, with cash issued in lieu of fractional shares. The Company attempted to structure the transaction as tax free, but since no advance ruling was sought from the Internal Revenue Service, no assurance can be made about the final tax treatment of the transaction. Both organizations should benefit from a tighter focus on their respective markets, be able to invest in research and development at levels appropriate to their respective stages of development and be able to evolve unique organizational and marketing structures to better serve their substantially different markets. As a result of the Company's spin-off of Vital Images, the Company's financial statements and notes thereto report the business of Vital Images as discontinued operations. MEDICARE NON-COVERAGE DECISION Effective January 1, 1996, HCFA made a non-coverage decision with respect to LVRS, a surgical treatment for late-stage emphysema. This decision significantly impacted the Company's revenues from sales of Peri-Strips. At the time that this non-coverage decision was put into effect, the Company estimates that approximately 70% of the patients undergoing LVRS were Medicare patients. While the Company understands that several private insurance companies and managed care organizations continue to reimburse LVRS based on their own evaluation of the procedure and its outcomes, it is unknown whether these private payers will change their reimbursement practices in the future or if more private payers will begin to cover the procedure. NIH, in collaboration with HCFA, has outlined and is in the process of organizing a prospective, randomized study of LVRS, the NETT study, to determine whether it is safe and efficacious. The NETT study, as it is currently structured, is limited to a small number of patients relative to the number of Medicare dependent patients who would be otherwise eligible for the procedure. Congress, responding to the concerns of their constituents and in light of a significant number of favorable peer-reviewed published medical articles bearing out the safety and efficacy of LVRS, requested HCFA to present to Congress updated information on the LVRS procedure by January 1997. HCFA requested an extension until April 1997 and as of the date of this report had not yet complied with Congress' request. Because HCFA and NIH appear intent on proceeding with the study, no assumptions can be made as to whether the efforts of Congress or the mounting evidence regarding the benefits of this procedure will cause them to alter the study. The Company continues to work for restoration of coverage of LVRS for Medicare dependent patients. RESULTS OF CONTINUING OPERATIONS COMPARISON OF THE YEAR ENDED OCTOBER 31, 1997 WITH THE YEAR ENDED OCTOBER 31, 1996 Revenue decreased to $9,694,000 from $10,125,000, primarily due to the decrease in Peri-Strips revenue. Peri-Strips revenue decreased $1,421,000 to $2,915,000 from $4,336,000. Revenue from sales of other Tissue-Guard products, Dura-Guard, Vascu-Guard, Peri-Guard and Supple Peri-Guard increased $908,000 to $3,852,000 from $2,944,000. All Tissue Guard products showed significant increases over the prior year. Increased revenues from Tissue Guard products in the fourth quarter of fiscal 1997 over the same quarter in fiscal 1996 more than offset the decreased revenue from Peri-Strips for the first time since the HCFA decision in January of 1996. Biograft revenue decreased $138,000, or 15%, to $800,000 from $938,000, continuing a trend representative of the late stage of this product's life cycle. Revenue from sales of surgical productivity tools (Flo-Rester and the Bio-Vascular Probe) increased 12% to $2,127,000 from $1,907,000. 26 The gross margin percentage was 59% for 1997 and 66% for 1996. During fiscal 1996 and 1997 the gross margin percentages declined through the quarters, primarily due to decreases in production volume in response to decreases in demand for Peri-Strips.. The gross margin percentage was 62% by the fourth quarter of 1996 and continued to decrease through the third quarter of 1997. Gross margin improvements in the fourth quarter of 1997 were primarily due to increased production volume. The Company expects the gross margin percentage for 1998 to be slightly higher than the 1997 level. This forward looking statement is influenced primarily by the Company's current estimate of standard costs and would be impacted by significant increases or decreases in production volumes of the Company's products, by material changes in the Company's product mix and by the accuracy of the Company's estimates of standard costs and other manufacturing costs. Selling, general and administrative expense increased $573,000 or 11% between 1997 and 1996. General and administrative expenses increased $348,000, or 13%, and was due in part to increases in regulatory personnel and related market clearance costs. Selling expense increased $224,000, or 9%. Increases in selling costs originated from the launch of Peri-Strips Dry in the third quarter of 1997, increased marketing efforts in Europe including the addition of a European Sales Manager and renewed focus in the domestic marketplace of the Company's strong line of tissue products. The Company has maintained and judiciously added to the basic corporate infrastructure which was developed during 1995 to support the Company's rapid growth at that time. Although the rapid growth, which was fueled by Peri-Strips was interrupted, the infrastructure that was built to support that growth is vital to moving the Company forward to the next level of its corporate strategy. The Company continued to incur expenses related to efforts to inform Congress and other interested parties of the devastating effect of the HCFA decision on patients in the late-stages of emphysema and to seek consideration of a modification or reversal of that decision. Research and development expense increased $349,000 or 38% between 1997 and 1996, with the increase primarily due to the cost of moving projects forward in the research and development pipeline, including an increase in the number of animal studies. The Company has several projects under development including the Company's small diameter graft. R&D efforts have included two new product opportunities, CV Peri-Guard and Ocu-Guard, which are expected to generate revenues in fiscal 1998. R&D expense is expected to increase as these and other projects continue to progress. This forward-looking statement will be influenced primarily by the number of projects, the related R&D personnel requirements, the development path and success of each project, the expected costs, and the timing of these costs. Primarily due to the continued decrease in revenue from Peri-Strips, componded by lower gross margins earlier in the year and increased spending on research and development, regulatory and selling costs, continuing operations had an operating loss in 1997 of $1,305,000 as compared to operating income of $571,000 for 1996. Other income, primarily interest income, was $1,067,000 and $1,161,000 in 1997 and 1996, respectively. As a result, continuing operations had a loss before income taxes in 1997 of $238,0000 as compared to income from continuing operations before income tax of $1,732,000 in 1996. The Company's provision for income taxes in 1997 is $365,000 including a $421,000 write-off of an income tax asset in the third quarter. The Company expected to utilize a significant portion of Vital Images' net operating loss carryforwards against the Company's anticipated fiscal 1997 taxable income. These net operating losses were generated by Vital Images prior to its spin-off and are only available to the Company in the 1997 fiscal year, reverting solely to Vital Images thereafter. When the Company realized its fiscal 1997 taxable income would fall short of original expectations, the deferred tax asset had no further value to Bio-Vascular and was written-off in the third quarter. In 1996, the Company allocated its provision for income taxes to continuing and discontinuing operations based on their respective pretax income contributions and tax attributes. As a result, the amount of the provision allocated to continuing operations in 1996 was $514,000, representing an effective tax rate of approximately 30%. Continuing operations' effective tax rate for 1996 reflected the benefit of recognizing a deferred tax asset associated with capital loss and research and experimentation credit carryforwards created in prior years. 27 Loss from continuing operations was $604,000, or $0.06 per share in 1997, compared to income of $1,219,000, or $0.13 per share in 1996. COMPARISON OF THE YEAR ENDED OCTOBER 31, 1996 WITH THE YEAR ENDED OCTOBER 31, 1995 Revenue decreased to $10,125,000 from $10,426,000, primarily due to the decrease in Peri-Strips revenue resulting from the HCFA decision, offset substantially by an increase in revenue from sales of other Tissue Guard products. Peri-Strips revenue decreased $1,214,000 to $4,336,000 from $5,550,000. Revenue from sales of other Tissue-Guard products, Dura-Guard, Vascu-Guard, Peri-Guard and Supple Peri-Guard, increased by $1,099,000 to $2,944,000 from $1,845,000, primarily due to the increase in revenue from Dura-Guard, which was cleared to market by the FDA in June 1995. Revenue from sales of Biograft decreased to $938,000 from $1,198,000. Revenues from the sales of Biograft have been decreasing since late 1993 as new competitive treatments reached the market. Revenue from sales of surgical productivity tools (Flo-Rester and the Bio-Vascular Probe) increased 4% to $1,907,000 from $1,818,000. The gross margin percentage was 66% for 1996 and 67% for 1995. While the annual gross margin percentages appeared stable, they were not on a quarter-to-quarter basis during 1996. In 1995, the gross margin percentage was increasing, primarily due to rapidly increasing production volume associated with rising Peri-Strips sales, while in 1996, the gross margin percentages declined, primarily due to decreases in the production volume in response to decreases in expected demand for Peri-Strips as a result of the HCFA decision. Selling, general and administrative expense increased $1,002,000 or 24% between 1995 and 1996. Increases were generally across all functions and due in large part to the presence during much of 1996 of a complete basic corporate infrastructure, expenses related to the development of a quality system under ISO 9001and expenses related to efforts to inform Congress and other interested parties of the devastating effect of the HCFA decision on patients in the late- stages of emphysema and to seek consideration of a modification or reversal of that decision. Research and development expense increased 41% between 1995 and 1996, with the increase primarily due to the cost of moving projects forward in the research and development pipeline and including an increase in animal studies. The increase in infrastructure, the increased level of business activities and the acceleration and expansion of research and development efforts, resulted in operating income of $571,000 compared to $2,121,000 for 1995. Other income was $1,161,000 and $265,000 in 1996 and 1995, respectively and consisted primarily of interest income. A secondary public offering which the Company completed in September of 1995 provided approximately $26,000,000 net of offering costs. This comprised the basis for the increase in interest income in 1996 over 1995. The Company allocated its provision for income taxes to continuing and discontinued operations based on their respective pretax income contribution and tax attributes. As a result, continuing operations recorded a tax provision of $514,000 for 1996 and $727,000 for 1995, representing an effective tax rate of approximately 30% in both years. Continuing operations' effective tax rate in 1995 reflected the benefit of utilizing remaining net operating loss carry forwards to offset 1995 income. Continuing operations' effective tax rate for 1996 reflected the benefit of recognizing a deferred tax asset associated with capital loss and research and experimentation credit carryforwards created in prior years. Income from continuing operations was $1,219,000, or $0.13 per share, compared to $1,659,000, or $0.20 per share for 1995. LIQUIDITY AND CAPITAL RESOURCES For the year ended October 31, 1997, activities from continuing operations provided cash of $1,051,000 (excluding 28 $1,860,920 used by discontinued operations) as compared to $343,000 (excluding $70,046 used by discontinued operations) of net cash provided by operating activities in fiscal 1996. Cash was provided by continuing operations in fiscal 1997 through non-cash expenses, increases in accrued liabilities, decreases in inventories and non-trade receivables in excess of the loss from continuing operations. These increases in cash were partially offset by an increase in trade accounts receivable. The Company invested $654,000 in equipment and leasehold improvements primarily related to new manufacturing processes related to Peri-Strips Dry and the Bio- Vascular Probe. Financing activities included $265,000 provided from stock option exercises and a related tax benefit, net of restricted stock repurchased from employees. In addition, the Company used $150,000 to repurchase shares of its own Common Stock in the open market in accordance with the Company's ongoing stock repurchase program. This program was announced in August 1997 whereby the Company stated its intention to repurchase up to 500,000 shares of its Common Stock. Such purchases will be made in the open market from time-to-time as price opportunities arise. The Company believes existing cash and investments will be sufficient to satisfy its cash requirements for the foreseeable future. At October 31, 1997, the Company has cash and investments totaling $17,987,000. At October 31, 1996, the Company's cash and investments totaled $29,671,000. The net decrease in cash and investments was largely attributable to the $11,800,000 funded to Vital Images. THE YEAR 2000 ISSUE Computer designs that use microprocessors have consistently abbreviated dates by eliminating the first two digits of the year under the assumption that these two digits would always be 19. As the year 2000 approaches, such systems will be unable to accurately process certain date-based information. This problem is commonly referred to as "the Year 2000 Issue". The Company has not yet determined if it will be necessary to modify or replace significant portions of its software so that its computer systems will properly utilize dates beyond December 31, 1999. The Company presently believes that with modifications to existing software and conversions to new software, the Year 2000 Issue can be mitigated. However, if such modifications and conversions are not made, or are not completed timely, the Year 2000 Issue could have a material impact on the operations of the Company. INFLATION Management believes inflation has not had a material effect on the Company's operations or on its financial condition. FOREIGN CURRENCY TRANSACTIONS Substantially all of the Company's foreign transactions are negotiated, invoiced and paid in U.S. dollars. Fluctuations in currency exchange rates in other countries may therefore reduce the demand for the Company's products by increasing the price of the Company's products in the currency of the countries in which the products are sold. NEW ACCOUNTING STANDARDS In February 1997, SFAS No. 128, Earnings per Share (EPS), was issued by the Financial Accounting Standards Board. This standard, which the Company must adopt effective with its first quarter of fiscal 1998, requires dual presentation of basic and diluted EPS on the face of the statement of operations. Net income per common share currently presented by the Company for 1997 and 1996 is comparable to the basic EPS required under SFAS 128. 29 Diluted EPS for the Company would be calculated based on both common shares outstanding and consideration of the dilutive effects of common stock equivalents. In June 1997, SFAS No. 130 (SFAS 130), Comprehensive Income, was issued by the Financial Accounting Standards Board. SFAS 130 establishes standards for reporting and displaying comprehensive income and its components (revenues, expenses, gains and losses) in the financial statements. Also issued in June 1997 was SFAS No. 131 (SFAS 131), Disclosures about Segments of an Enterprise and Related Information, which establishes new standards for the way public business enterprises report information about operating segments. The Company must adopt SFAS 130 and SFAS 131 in fiscal year 1999. ITEM 7A - QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK - -------------------------------------------------------------------- Not applicable. ITEM 8 - FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA - ---------------------------------------------------- The Company's Financial Statements and the reports of its independent accountants are included herein on pages 33 through 49 of this Annual Report on Form 10-K. The index to such items is included on Page 31 in Item 14 (a)(1). ITEM 9 - CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND - ------------------------------------------------------------------------ FINANCIAL DISCLOSURE - -------------------- None. PART III ITEM 10 - DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT - ------------------------------------------------------------ (a) Directors of the Registrant --------------------------- The information under the caption "Election of Directors" in the Registrant's 1998 Proxy Statement is incorporated by reference herein. (b) Executive Officers of the Registrant ------------------------------------ Information concerning Executive Officers of the Company is included in this Report on page 22 under Item 4 A, "Executive Officers of the Registrant". (c) Compliance with Section 16(a) of the Exchange Act ------------------------------------------------- The information under the caption "Section 16(a) Beneficial Ownership Reporting Compliance" in the Registrant's 1998 Proxy Statement is incorporated by reference herein. ITEM 11 - EXECUTIVE COMPENSATION - -------------------------------- The information under the caption "Executive Compensation" and "Election of Directors--Directors' Compensation" in the Registrant's 1998 Proxy Statement is incorporated by reference herein. ITEM 12 - SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT - ------------------------------------------------------------------------ The information under the caption "Principal Shareholders and Beneficial Ownership of Management" in the Registrant's 1998 Proxy Statement is incorporated by reference herein. 30 ITEM 13 - CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS - -------------------------------------------------------- In October 1997, the Company entered into a distribution agreement with Scanlan International, Inc., a medical and surgical products distributor. A Director of the Company is President and Chief Executive Officer of the Scanlan Group of Companies, the parent company of Scanlan International. The agreement grants Scanlan International the exclusive right, acting as a sales representative of Bio-Vascular, to solicit orders, work with distributors and market listed products within Latin America until October 31, 2000 subject to annual renewal thereafter. Scanlan International will receive a commission of 20% on net sales to Latin America during the term of the agreement. For the year ended October 31, 1997, there was no sales activity resulting from this agreement. PART IV ITEM 14 - EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K - ------------------------------------------------------------------------- (a) List of documents filed as part of this Report 1) Financial Statements: The following financial statements are included herein (page numbers refer to pages in this Annual Report on Form 10-K): Page ----- - Report of Independent Accountants 33 - Balance Sheets as of October 31, 1997 and 1996 34 - Statements of Operations for the Years Ended October 31, 1997, 1996 and 1995 35 - Statements of Shareholders' Equity for the Years Ended October 31, 1997, 1996 and 1995 36 - Statements of Cash Flows for the Years Ended October 31, 1997, 1996 and 199 37 - Notes to Financial Statements 38-49 2) Financial Statement Schedules The following financial statement schedules and independent accountants' report thereon are included herein and should be read in conjunction with the Financial Statements referred to above (page numbers refer to pages in this Annual Report on Form 10-K): Page ----- - Report of Independent Accountants' on Financial Statement Schedule 50 - Schedule II - Valuation and Qualifying Accounts 51 All other financial statement schedules not listed have been omitted because the required information is included in the Financial Statements or the Notes thereto, or is not applicable. 3) Exhibits The exhibits to this Annual Report on Form 10-K are listed in the Exhibit Index hereinafter contained on pages E-1 through E-3 of this Report. The Company will furnish a copy of any exhibit to a shareholder who requests a copy in writing upon payment to the Company of a fee of $5.00 per exhibit. Requests should be 31 sent to: Connie L. Magnuson, Vice President of Finance and Chief Financial Officer; Bio-Vascular, Inc.; 2575 University Avenue; St. Paul, Minnesota 55114-1024. The following is a list of each management contract or compensatory plan or arrangement required to be filed as an exhibit to this Annual Report on Form 10-K pursuant to Item 14 (c): A. 1988 Stock Option Plan, as amended, (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the quarter ended April 30, 1997 (File No. 0-13907)). B. 1990 Management Incentive Stock Option Adjustment Plan (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 1997 (File No. 0-13907)). C. 1992 Stock Option Adjustment Plan (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 1997 (File No. 0-13907)). D. 1995 Stock Incentive Plan, as amended (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q for the period ended April 30, 1997 (File No. 0-139070)). E. Employee Stock Purchase Plan, as amended (filed herewith electronically). F. Employment letter dated November 28, 1994, as amended January 2, 1995, between the Company and Mr. Stephenson (incorporated by reference to Exhibit 10.20 to the Company's Annual Report on Form 10-K for the year ended October 31, 1995 (File No. 0-13907)). G. Severance agreement dated June 30, 1997, between the Company and Mr. Karcanes (filed herewith electronically). H. Form of Change in Control Agreement entered into between the Company and each of Ms. Gilles, Mr. Schankereli and Mr. Stephenson (incorporated by reference to Exhibit 10.28 to the Company's Annual Report on Form 10-K for the year ended October 31, 1994 (File No. 0-13907)). (b) Reports on Form 8-K None. (c) Exhibits: The response to this portion of Item 14 is included as a separate section of this Annual Report on Form 10-K. (d) Financial Statement Schedules: The response to this portion of Item 14 is included as a separate section of this Annual Report on Form 10-K. 32 REPORT OF INDEPENDENT ACCOUNTANTS To the Board of Directors and Shareholders of Bio-Vascular, Inc.: We have audited the accompanying balance sheets of Bio-Vascular, Inc. as of October 31, 1997 and 1996, and the related statements of operations, shareholders' equity and cash flows for each of the three years in the period ended October 31, 1997. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with generally accepted auditing standards. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes 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 Bio-Vascular, Inc. as of October 31, 1997 and 1996, and the results of its operations and its cash flows for each of the three years in the period ended October 31, 1997, in conformity with generally accepted accounting principles. COOPERS & LYBRAND L.L.P. Minneapolis, Minnesota December 9, 1997 33 BIO-VASCULAR, INC. BALANCE SHEETS OCTOBER 31, 1997 AND 1996 - -------------------------------------------------------------------------------- ASSETS 1997 1996 - ------------------------------------------------------------------ ------------ ------------ Current assets: Cash and cash equivalents......................................... $ 6,766,687 $ 5,736,650 Marketable securities, short-term................................. 7,229,934 13,761,050 Accounts receivable, net.......................................... 1,846,519 1,465,809 Inventories....................................................... 1,619,395 1,972,728 Deferred income taxes............................................. 144,549 914,300 Other............................................................. 480,955 917,197 ----------- ----------- Total current assets........................................... 18,088,039 24,767,734 Equipment and leasehold improvements, net......................... 1,670,446 1,370,256 Intangible assets, net............................................ 1,003,251 1,213,600 Marketable securities, long-term.................................. 3,989,896 10,173,086 Deferred income taxes............................................. 382,819 182,200 Net assets of discontinued operations............................. - 174,403 ----------- ----------- TOTAL ASSETS................................................... $25,134,451 $37,881,279 =========== =========== LIABILITIES AND SHAREHOLDERS' EQUITY - ------------------------------------ Current liabilities: Accounts payable.................................................. $ 616,941 $ 306,376 Accrued expenses.................................................. 565,275 554,368 Accrued loss on disposal of discontinued operations............... - 1,800,000 ----------- ----------- Total current liabilities...................................... 1,182,216 2,660,744 ----------- ----------- Commitments (Note 6) Shareholders' equity: Preferred stock: authorized 5,000,000 shares of $.01 par value; None issued or outstanding in 1997 and 1996..................... - - Common stock: authorized 20,000,000 shares of $.01 par value; issued and outstanding, 9,563,609 in 1997 and 9,484,898 shares in 1996......................................................... 95,636 94,849 Additional paid-in capital........................................ 29,664,715 39,500,239 Unearned compensation............................................. (447,254) (484,909) Unrealized marketable securities holding gain (loss).............. 1,288 (51,107) Accumulated deficit............................................... (5,362,150) (3,838,537) ----------- ----------- Total shareholders' equity..................................... 23,952,235 35,220,535 ----------- ----------- TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY..................... $25,134,451 $37,881,279 =========== =========== The accompanying notes are an integral part of the financial statements. 34 BIO-VASCULAR, INC. STATEMENTS OF OPERATIONS FOR THE YEARS ENDED OCTOBER 31, 1997, 1996 AND 1995 - -------------------------------------------------------------------------------- 1997 1996 1995 ------------- ------------- ------------ Net revenue....................................... $ 9,694,047 $10,124,709 $10,426,076 Cost of revenue................................... 3,967,460 3,443,098 3,461,817 ----------- ----------- ----------- Gross margin...................................... 5,726,587 6,681,611 6,964,259 Operating expenses: Selling, general and administrative............... 5,773,918 5,201,236 4,199,673 Research and development.......................... 1,257,904 909,362 643,490 ----------- ----------- ----------- Operating income (loss)........................... (1,305,235) 571,013 2,121,096 Other income, net................................. 1,066,822 1,161,488 264,898 ----------- ----------- ----------- Income (loss) from continuing operations before provision for income taxes...................... (238,413) 1,732,501 2,385,994 Provision for income taxes........................ 365,200 514,000 726,832 ----------- ----------- ----------- Income (loss) from continuing operations.......... (603,613) 1,218,501 1,659,162 Discontinued operations: Income (loss) from operations of discontinued business, net of income taxes................... - (1,048,142) 527,304 Loss on disposal of discontinued business, net of income taxes............................. (920,000) (1,348,000) - ----------- ----------- ----------- NET INCOME (LOSS)................................. $(1,523,613) $(1,177,641) $ 2,186,466 =========== =========== =========== Net income (loss) per share: Continuing operations............................. $ (.06) $ .13 $ .20 Discontinued operations........................... (.10) (.25) .06 ----------- ----------- ----------- Net income (loss) per share....................... $ (.16) $ (.12) $ .27 =========== =========== =========== Weighted average shares outstanding............... 9,531,000 9,433,000 8,172,000 =========== =========== =========== The accompanying notes are an integral part of the financial statements. 35 BIO-VASCULAR, INC. STATEMENTS OF SHAREHOLDERS' EQUITY FOR THE YEARS ENDED OCTOBER 31, 1997, 1996 AND 1995 - -------------------------------------------------------------------------------- UNREALIZED MARKETABLE ADDITIONAL SECURITIES PAID-IN UNEARNED HOLDING ACCUMULATED COMMON STOCK CAPITAL COMPENSATION GAIN (LOSS) DEFICIT ----------------------- ------------- -------------- ------------- ------------ PAR SHARES VALUE ---------- ----------- BALANCE AT OCTOBER 31, 1994................. 7,318,125 $73,181 $ 11,685,163 $(125,443) - $(4,847,362) Stock option activity....................... 197,400 1,974 424,819 4,250 Restricted stock activity................... 41,138 412 78,629 (269,908) Stock compensation, net..................... 23,105 231 109,519 (39,125) Issuance of stock, net of offering costs of $2,277,460...................... 1,800,000 18,000 26,054,530 Net income.................................. 2,186,466 --------- ------- ------------ --------- ------------ ----------- BALANCE AT OCTOBER 31, 1995................. 9,379,768 93,798 38,352,660 (430,226) - (2,660,896) Stock option activity, net of tax benefit... 82,744 827 1,099,719 (150,387) Warrant activity............................ 28,929 289 115,427 Employee Stock Purchase Plan activity.................................. 5,715 57 36,376 Restricted stock activity................... (12,258) (123) (16,616) 71,954 Stock compensation, net..................... 23,750 Offering costs.............................. (87,327) Unrealized marketable securities holding loss, net......................... $(51,107) Net loss.................................... (1,177,641) --------- ------- ------------ --------- ------------ ----------- BALANCE AT OCTOBER 31, 1996................. 9,484,898 94,849 39,500,239 (484,909) (51,107) (3,838,537) Stock option activity, net of tax benefit................................... 48,236 482 654,522 (332,462) Employee Stock Purchase Plan activity.................................. 9,190 92 37,217 Restricted stock activity................... 22,185 222 62,998 22,954 Stock compensation, net..................... 36,000 360 143,640 (112,837) Stock repurchased by the Company............ (36,900) (369) (149,560) Distribution of net investment in Vital Images.............................. (10,584,341) 460,000 Unrealized marketable securities holding gain, net......................... 52,395 Net loss.................................... (1,523,613) --------- ------- ------------ --------- ------------ ----------- BALANCE AT OCTOBER 31, 1997................. 9,563,609 $95,636 $ 29,664,715 $(447,254) $ 1,288 $(5,362,150) ========= ======= ============ ========= ============ =========== The accompanying notes are an integral part of the financial statements. 36 BIO-VASCULAR, INC. STATEMENT OF CASH FLOWS FOR THE YEARS ENDED OCTOBER 31, 1997, 1996 AND 1995 - -------------------------------------------------------------------------------- 1997 1996 1995 ------------- ------------- ------------ CASH FLOWS FROM OPERATING ACTIVITIES: Net income (loss)........................................................... $(1,523,613) $ (1,177,641) $ 2,186,466 Less income (loss) from discontinued operations............................. (920,000) (2,396,142) 527,304 ----------- ------------ ------------ Income (loss) from continuing operations.................................... (603,613) 1,218,501 1,659,162 Adjustments to reconcile income from continuing operations to net cash provided by (used in) operating activities: Depreciation and amortization............................................... 619,769 591,410 376,423 Provision for inventory obsolescence........................................ 116,031 354,822 176,568 Non-cash compensation....................................................... 212,367 286,018 232,839 Deferred income taxes....................................................... 239,132 (1,096,500) - Changes in operating assets and liabilities: Accounts receivable......................................................... (380,710) 704,417 (1,142,845) Inventories................................................................. 237,302 (359,324) (1,012,125) Other assets................................................................ 313,365 (268,753) (527,547) Current liabilities......................................................... 297,247 (1,087,297) 1,331,783 ----------- ------------ ------------ Net cash provided by continuing operations............................... 1,050,889 343,294 1,094,258 Net cash provided by (used in) discontinued operations................... (1,860,920) (70,046) 818,283 ----------- ------------ ------------ Net cash provided by (used in) operating activities...................... (810,031) (273,248) 1,912,541 ----------- ------------ ------------ CASH FLOWS FROM INVESTING ACTIVITIES: Purchase of equipment and improvements...................................... (654,153) (402,290) (1,035,537) Purchase of intangibles..................................................... (43,310) (803,272) (42,799) Investments in marketable securities........................................ (9,000,000) (25,980,000) (14,872,509) Maturities of marketable securities......................................... 13,750,000 16,795,920 1,270,841 Discontinued operations, net................................................ (2,327,360) (379,855) (306,014) ----------- ------------ ------------ Net cash (used in) investing activities.................................. 1,725,177 (10,769,497) (14,986,018) ----------- ------------ ------------ CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds related to the sale of common stock, net........................... - (87,327) 26,072,530 Proceeds related to stock options, employee stock purchase plan and restricted stock................................................ 264,821 895,257 77,962 Purchase of common stock.................................................... (149,930) - - ----------- ------------ ------------ Net cash provided by financing activities................................ 114,891 807,930 26,150,492 ----------- ------------ ------------ NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS.............................................................. 1,030,037 (9,688,319) 13,077,015 CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR..................................................................... 5,736,650 15,424,969 2,347,954 ----------- ------------ ------------ CASH AND CASH EQUIVALENTS AT END OF YEAR.................................... $ 6,766,687 $ 5,736,650 $ 15,424,969 =========== ============ ============ The accompanying notes are an integral part of the financial statements. 37 BIO-VASCULAR, INC. NOTES TO FINANCIAL STATEMENTS - ------------------------------------------------------------------------------- (1) BUSINESS DESCRIPTION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES: Business Description: Bio-Vascular, Inc. ("the Company") develops, manufactures and markets proprietary specialty medical products used in thoracic, cardiac, neuro and vascular surgery. The Company markets its products through a worldwide network of distributors and independent sales representatives. Use of Estimates: The preparation of financial statements in conformity with generally accepting accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from those estimates. The most significant areas which require the use of management's estimates relate to the determination of the allowance for obsolete inventory, the evaluation of realizability of intangible and deferred tax assets, and the loss on disposal of discontinued operations. Cash and Cash Equivalents: Cash and cash equivalents consist of cash and highly liquid investments purchased with an original maturity of three months or less. Cash at October 31, 1997 is primarily concentrated in one money market fund. Marketable Securities: Investments having original maturities in excess of three months are classified as marketable securities and generally consist of U.S. Government or U.S. Government-backed obligations. Investments are classified as short-term or long-term in the balance sheet based on their maturity date. At October 31, 1997 and 1996, all of the Company's marketable securities are classified as available-for-sale and all mature in two years or less. Available-for-sale investments are recorded at market value with unrealized holding gains and losses included as a separate component of shareholders' equity. Inventories: Inventories are valued at the lower of cost or market, with costs generally determined on a first-in, first-out method. Equipment and Leasehold Improvements: Equipment and leasehold improvements are stated at cost. Depreciation and amortization are computed using accelerated and straight-line methods over the shorter of the estimated useful lives (generally three to seven years) or lease life. Major replacements and improvements are capitalized and maintenance and repairs which do not improve or extend the useful lives of the respective assets are charged to operations. The asset and related accumulated depreciation or amortization accounts are adjusted for asset retirements and disposals with the resulting gain or loss, if any, is recorded in other income, net, on the Statement of Operations. Long-Lived Assets: The Company adopted the Statement of Financial Accounting Standard (SFAS) No. 121, Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to be Disposed of, in fiscal 1997. The Company 38 BIO-VASCULAR, INC. NOTES TO FINANCIAL STATEMENTS--(Continued) - ------------------------------------------------------------------------ reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset in question may not be recoverable. Impairment losses are recorded whenever indicators of impairment are present. The adoption of SFAS No. 121 did not have a material effect on the Company's results of operations, cash flows or financial position. Goodwill, Patents and Other Intangibles: Goodwill, patents and other intangibles are recorded at cost and are amortized using the straight-line method over the estimated useful lives, generally ten to seventeen years. The Company evaluates the net realizability of goodwill and other intangibles on an ongoing basis, based on current and anticipated undiscounted cash flows. Revenue Recognition: Revenue is recognized upon shipment of goods to customers. Research and Development: Research and development costs are expensed as incurred. Stock-Based Compensation: The Company has adopted the disclosure-only provisions of SFAS No. 123, Accounting for Stock-Based Compensation, effective for fiscal 1997, which disclosures are presented in Note 5 "Shareholders' Equity". The Company continues to account for stock-based compensation using the intrinsic value method as prescribed under Accounting Principles Board Opinion (APB) No. 25, Accounting for Stock Issued to Employees, and related Interpretations. Income Taxes: The Company accounts for income taxes using the liability method. The liability method provides that deferred tax assets and liabilities are recorded based on the differences between the tax basis of assets and liabilities and their carrying amounts for financial reporting purposes ("temporary differences"). Temporary differences relate primarily to operating and capital loss carryforwards, research and experimentation tax credit carryforwards, and obsolete inventory reserves. Deferred tax assets are reduced by a valuation allowance to reflect the realizable value, when necessary. Net Income (Loss) Per Common Share: Net income (loss) per common share is computed by dividing net income (loss) by the weighted average number of common and common equivalent shares outstanding. Common equivalent shares relate to common stock options and warrants, when their effect is dilutive. In February 1997, SFAS No. 128, Earnings per Share (EPS), was issued by the Financial Accounting Standards Board. This standard, which the Company must adopt effective with its first quarter of fiscal 1998, requires dual presentation of basic and diluted EPS on the face of the statement of operations. Net loss per common share currently presented by the Company for 1997 and 1996 is comparable to the basic EPS required under SFAS 128. Diluted EPS for the Company would be calculated based on both common shares outstanding and consideration of the dilutive effects of common equivalent shares. 39 BIO-VASCULAR, INC. NOTES TO FINANCIAL STATEMENTS--(Continued) - ------------------------------------------------------------------------ (2) DISCONTINUED OPERATIONS: On May 12, 1997, the Company completed the spin-off distribution of all shares of Vital Images, Inc. ("Vital Images") to shareholders of Bio-Vascular, with Vital Images thereafter operating as an independent company with its own publicly-traded securities. All Bio-Vascular shareholders of record received one share of Vital Images common stock for every two shares of Bio-Vascular common stock held, with cash issued in lieu of fractional shares. The Company attempted to structure the transaction as tax free, but since no revenue ruling was sought from the Internal Revenue Service, no assurance can be made about the final tax treatment of the transaction. The Company recorded the distribution of Vital Images common stock to its shareholders as of March 19, 1997, the date the Board of Directors of the Company gave final approval for the transaction. The distribution was recorded by reducing shareholders' equity by $10,124,000, which represents $10,000,000 of cash and investments, plus the carrying value of Vital Images' net assets. The accompanying financial statements of the Company for the year ended October 31, 1997 reflect these transactions. The Company's financial statements and notes report Vital Images as discontinued operations. Prior years' financial statements and notes have been restated accordingly. The 1996 loss from operations of the discontinued business included an allocation of interest income (based on the ratio of net investment assets contributed to the discontinued business over total investment assets) of $547,000. Interest income for the year ended October 31, 1995 was determined to be attributable solely to income from continuing operations. The 1997 loss on disposal reflects amounts exceeding that previously estimated and recorded as of October 31, 1996, in part a result of the spin-off taking longer to complete in 1997 than originally anticipated. The 1996 loss on disposal of discontinued business of $1,348,000 included the estimated future operating losses of Vital Images through the estimated date of spin-off. In addition to the estimate of future results of operations, major components of the loss on disposal include $400,000 of transaction costs, interest income of $200,000 and deferred income tax benefits of $452,000. Net cash used by discontinued operations in 1996 differs from the 1996 loss from discontinued operations principally due to the loss on disposal for which no cash had been expended at October 31, 1996, deferred revenues and depreciation. The 1996 discontinued operations cashflow amounts have been reclassified to conform with the 1997 presentation. DISCONTINUED OPERATIONS 1997 1996 1995 ----------- ------------ ----------- Net revenue - $ 882,126 $2,893,654 Gross margin........................................ - 719,840 2,488,480 Operating income (loss)............................. - (2,357,065) 318,205 Income (loss) from discontinued operations.......... - (1,048,142) 527,304 Loss on disposal, net of income taxes............... $(920,000) (1,348,000) - Total discontinued operations, net of income taxes.. (920,000) (2,396,142) 527,304 A one-time license fee recorded in the fourth quarter of fiscal 1995 contributed $1,500,000 to net revenue and $1,322,000 to operating income. The net assets of discontinued operations were approximately $174,000 at October 31, 1996, comprised primarily of equipment totaling approximately $650,000, offset by deferred revenues of $510,000. All net assets associated with the discontinued operations were distributed as part of the May 1997 spin-off. 40 BIO-VASCULAR, INC. NOTES TO FINANCIAL STATEMENTS--(Continued) - ------------------------------------------------------------------------ (3) SUPPLEMENTAL FINANCIAL STATEMENT INFORMATION: 1997 1996 ------------ ------------ Accounts receivable: Trade receivables................................... $ 1,867,919 $1,487,209 Less allowance for doubtful accounts................ (21,400) (21,400) ----------- ---------- $ 1,846,519 $1,465,809 =========== ========== Inventories: Raw materials and supplies.......................... $ 580,354 $ 514,478 Work-in-process..................................... 405,736 541,483 Finished goods...................................... 1,006,305 1,284,767 Less reserve for inventory obsolescence............. (373,000) (368,000) ----------- ---------- $ 1,619,395 $1,972,728 =========== ========== Equipment and leasehold improvements: Furniture, fixtures and computer equipment.......... $ 826,360 $ 903,162 Laboratory equipment................................ 210,273 168,463 Manufacturing equipment............................. 780,854 536,688 Leasehold improvements.............................. 874,887 628,949 Less accumulated depreciation and amortization...... (1,021,928) (867,006) ----------- ---------- $ 1,670,446 $1,370,256 =========== ========== Intangible assets: Goodwill............................................ $ 1,538,374 $1,538,374 Less accumulated amortization....................... (1,047,024) (889,300) Patents and other intangibles....................... 708,880 665,570 Less accumulated amortization....................... (196,979) (101,044) ----------- ---------- $ 1,003,251 $1,213,600 =========== ========== Accrued expenses: Payroll, other employee benefits and related taxes.. $ 275,015 $ 263,423 Royalties........................................... 52,587 56,185 Other............................................... 237,673 234,760 ----------- ---------- $ 565,275 $ 554,368 =========== ========== 41 BIO-VASCULAR, INC. NOTES TO FINANCIAL STATEMENTS--(Continued) - ------------------------------------------------------------------------ (4) INCOME TAXES: PROVISION FOR INCOME TAXES 1997 1996 1995 ----------- ------------ ------------ Current: Federal.......................................... $ 95,893 $ 834,720 $ 724,999 State............................................ 43,750 34,606 1,833 --------- ---------- ---------- 139,643 869,326 726,832 --------- ---------- ---------- Deferred: Federal.......................................... 286,159 (345,518) - State............................................ (60,602) (9,808) - --------- ---------- ---------- 225,557 (355,326) - --------- ---------- ---------- Total............................................ $ 365,200 $ 514,000 $ 726,832 ========= ========== ========== RECONCILIATION OF EFFECTIVE INCOME TAX RATE 1997 1996 1995 --------- ---------- ---------- Income (loss) from continuing operations......... $(238,413) $1,732,501 $2,385,994 ========= ========== ========== Statutory federal rate........................... $ (81,060) $ 606,375 $ 835,098 Benefit from marginal rate....................... - (17,325) (23,860) State taxes, net of federal benefit.............. (11,122) 24,798 1,833 Permanent differences............................ (20,269) 36,206 2,047 Write-off of deferred tax asset associated with discontinued operations......................... 421,000 - - Increase (decrease) in valuation reserve......... 61,390 (203,058) (239,316) Other, net....................................... (4,739) 67,004 151,030 --------- ---------- ---------- Total............................................ $ 365,200 $ 514,000 $ 726,832 ========= ========== ========== COMPONENTS OF DEFERRED TAX ASSETS 1997 1996 --------- ---------- Operating and capital loss carryforwards......... $ 318,862 $ 890,900 Credit carryforwards............................. 269,005 128,300 Other............................................ 83,028 151,800 Less: valuation allowance........................ (143,527) (74,500) --------- ---------- Total............................................ $ 527,368 $1,096,500 ========= ========== Income tax payments included in the Statement of Cash Flows totaled $5,850, $410,769 and $77,152 for the years ended October 31, 1997, 1996 and 1995. 42 BIO-VASCULAR, INC. NOTES TO FINANCIAL STATEMENTS--(Continued) - ------------------------------------------------------------------------ The operating loss carryforwards included as a component of deferred tax assets were generated by continuing operations in the current year and are expected to be fully utilized in the future. A tax benefit of $119,738 and $682,200 related to the exercise of stock options was allocated to additional paid-in capital in 1997 and 1996, respectively. (5) SHAREHOLDERS' EQUITY: Increase in Authorized Shares and Designation of Preferred Class of Stock: In March 1997, the shareholders approved an increase in authorized shares of capital stock from 20,000,000 shares to 25,000,000 shares and reservation of 5,000,000 of such shares as undesignated shares of preferred stock, having such rights, preferences and designations as determined by the Board of Directors. As a result, the Company's authorized capital stock consists of 20,000,000 shares of common stock and 5,000,000 shares of undesignated preferred stock. Stock Repurchase Plan: In August 1997, the Company's Board of Directors adopted a stock repurchase plan and authorized the purchase of up to 500,000 shares of its common stock. In the year ended October 31, 1997, the Company repurchased 36,900 shares of common stock. Warrants: During 1995, in connection with a public offering of its common shares, the Company issued the underwriter of the offering warrants to purchase 90,000 shares of common stock at an exercise price of $16.375 per share. These warrants became exercisable in September 1996 and will remain exercisable until 1999. Under the agreement governing the Company's spin-off of Vital Images, Vital Images is required to assume its respective obligations represented by such underwriter warrants and to issue 45,000 shares of its common stock upon the exercise thereof, based upon the spin-off distribution ratio of one share of Vital Images common stock for each two shares of Bio-Vascular common stock. In exchange, the spin-off agreement provides that Vital Images will receive a proportionate share of the exercise price set by the terms of the agreement. Accordingly, upon exercise of the warrants, Bio-Vascular will receive proceeds of $13.0823 per share and Vital Images will receive proceeds of $3.2927 per share. Shareholder Rights Plan: In June 1996, the Company's Board of Directors declared a dividend distribution of one Common Stock purchase right (a Right) for each outstanding share of the Company's common stock on July 15, 1996. The Company also entered into a Rights Agreement governing the terms of the Rights, and each share of Common Stock issued subsequent to July 15, 1996, has been issued with an attached Right pursuant to the terms of the Rights Agreement. Upon exercise, each Right entitles the holder thereof to purchase one-tenth of a share of Common Stock at a purchase price currently set at $6.00 per share, subject to adjustment to reflect the value of the Company following the spin-off of Vital Images, Inc. Upon the occurrence of certain events in connection with: (i) a person or group acquiring 15% or more of the Company's outstanding Common Stock; (ii) a third party announcing an offer to purchase a 15% or greater stake in the Company; or (iii) the Board of Directors declaring a person to be an "adverse person" based upon such person being a holder of 10% or more of the Company's outstanding stock and the 43 BIO-VASCULAR, INC. NOTES TO FINANCIAL STATEMENTS--(Continued) - ------------------------------------------------------------------------ Board's belief that such person's shares were acquired for short-term financial gain or that the shareholder might otherwise adversely affect the Company's business or prospects, the Rights become exercisable and entitle each holder thereof (other than the acquiring person or "adverse person") to purchase, for a price equal to ten times the then-current purchase price of the Right, shares of Common Stock (or other securities of the Company) or equity securities of the acquiring company, as the case may be, having a market value equal to twenty times the then-current purchase price of the Right. In general, the Company is entitled to redeem the Rights in whole at a price of $.001 per Right (payable in cash, stock or other consideration deemed appropriate by the Board of Directors) prior to the first to occur of any such set of events. Each Right will expire on June 11, 2006, if not previously redeemed or exercised. Restricted Stock: Under certain compensation agreements, an arrangement which provides for awards of restricted common stock to key management was adopted in 1992. These awards of restricted common stock are subject to forfeiture if employment terminates prior to the end of the prescribed periods. Vesting periods range from three to four years. The market value of the shares at the time of grant is recorded as unearned restricted stock. The unearned amount is amortized to compensation expense over the periods during which the restrictions lapse. As part of these same compensation agreements, the Company agreed to buy back the number of shares which would allow the employees to meet their income tax obligations arising from the non-cash compensation related to the earned restricted shares. Unearned restricted stock granted to employees is summarized as follows: UNEARNED RESTRICTED STOCK MARKET VALUE BALANCE SHARES AT GRANT ---------- -------- -------------- Balance October 31, 1994... $ 112,818 35,204 $3.25 -- $3.44 Granted.................... 430,809 78,748 4.75 -- 14.50 Earned..................... (144,101) (33,887) 3.25 -- 14.50 Canceled/Forfeited......... (16,800) (3,537) 4.75 ---------- ------- Balance October 31, 1995... 382,726 76,528 3.25 -- 14.50 Granted.................... 131,414 11,868 8.63 -- 14.00 Earned..................... (172,463) (35,061) 8.25 -- 14.50 Canceled/Forfeited......... (30,905) (4,002) 4.75 -- 14.00 ---------- ------- Balance October 31, 1996... 310,772 49,333 3.25 -- 14.50 Granted.................... 220,064 46,545 4.25 -- 6.50 Earned..................... (134,021) (27,101) 3.25 -- 14.50 Canceled/Forfeited......... (108,997) (13,705) 4.75 -- 14.50 ---------- ------- Balance October 31, 1997... $ 287,818 55,072 $4.25 --$14.00 ========== ======= Shares of common stock have also been awarded to certain medical professionals as compensation for services provided in the Company's product development activities. These awards vest in accordance with the service agreement and totaled 36,000, 1,000, and 21,000 shares in 1997, 1996, and 1995, respectively. The weighted average market value at grant date for restricted stock awards was $ 4.41, $ 11.02 and $ 5.21 for 1997, 1996 and 1995, respectively. 44 BIO-VASCULAR, INC. NOTES TO FINANCIAL STATEMENTS--(Continued) - ------------------------------------------------------------------------ Stock Option Plans: The Company has two stock option plans: the 1995 Stock Incentive Plan (the "1995 Plan") and a Directors' Stock Option ("DSO") Plan. Options have been granted pursuant to the two stock option plans as well as certain non-plan options granted to consultants, officers and directors of the Company. Plan options are exercisable over periods of up to ten years from the date of grant. Common shares of 190,796 remain available for issuance under the Company's stock option plans. Plan options outstanding at October 31, 1997 include performance option awards for up to 25,000 shares, assuming maximum performance payout. The actual number of performance options awarded may vary depending on the degree to which the performance objectives are met. The Company has reserved and granted 371,720 shares of common stock for issuance in connection with non-plan options, which are exercisable over periods of up to seven years from the date of grant. The difference between the estimated market value and the exercise price for certain option grants was recorded as unearned compensation and is being amortized on a straight-line basis over the vesting period of the related options. A summary of the status of the Company's stock options for the years ended October 31is as follows: 1997 1996 1995 ---------------------- -------------------- ---------------------- WEIGHTED WEIGHTED WEIGHTED AVERAGE AVERAGE AVERAGE EXERCISE EXERCISE EXERCISE SHARES PRICE SHARES PRICE SHARES PRICE ---------- --------- ---------- -------- ---------- --------- Outstanding at beginning of year................................ 1,148,764 $5.60 1,014,263 $ 3.97 889,850 $2.78 Granted............................... 419,262 5.16 267,108 10.44 485,297 5.34 Exercised............................. (48,236) 3.23 (82,744) 2.59 (197,400) 2.01 Canceled.............................. (214,684) 5.20 (49,863) 8.38 (163,484) 3.23 --------- --------- --------- Outstanding at end of year............ 1,305,106 5.43 1,148,764 5.60 1,014,263 3.97 ========= ========= ========= Options exercisable at end of year................................ 794,743 $4.98 692,623 $ 4.26 589,803 $3.21 ========= ========= ========= 45 BIO-VASCULAR, INC. NOTES TO FINANCIAL STATEMENTS--(Continued) - ------------------------------------------------------------------------ The following table summarizes information about stock options outstanding at October 31, 1997: OPTIONS OUTSTANDING OPTIONS EXERCISABLE -------------------------------------------- ----------------------- Weighted Average Weighted Number of Weighted Remaining Number of Average Options Average Contractual Options Exercise Range of Prices Outstanding Exercise Price Life (Years) Exercisable Price --------------- ----------- -------------- ------------ ----------- -------- $ 1.87--$4.25 394,450 $ 3.28 4.49 315,981 $ 3.06 $ 4.38--$6.24 556,399 4.78 5.43 310,698 4.85 $ 6.64--$9.03 310,198 8.51 6.90 143,576 8.47 $9.53--$12.21 44,059 11.04 5.34 24,488 10.96 --------- ------- $1.87--$12.21 1,305,106 $ 5.43 5.49 794,743 $ 4.98 ========= ======= New Accounting Standard: In 1997, the Company adopted Statement of Financial Accounting Standard (SFAS) No. 123, Accounting for Stock-Based Compensation, which encourages, but does not require companies to recognize compensation cost for stock-based compensation plans over the vesting period based upon the fair value of awards at the date of grant. SFAS No. 123 allows the alternative use of the intrinsic value method as prescribed in Accounting Principles Board Opinion (APB) No. 25, Accounting for Stock Issued to Employees. As permitted, the Company will continue to apply APB No. 25, and related Interpretations in accounting for its employee stock-based compensation. For the year ended October 31, compensation expense recorded for stock based compensation awards (restricted stock and stock options) was as follows: 1997 1996 1995 -------- -------- -------- Employee................................. $149,608 $210,836 $186,226 Non-employee............................. 62,759 49,125 28,500 -------- -------- -------- Total stock-based compensation expense... $212,367 $259,961 $214,726 ======== ======== ======== 46 BIO-VASCULAR, INC. NOTES TO FINANCIAL STATEMENTS--(Continued) - ------------------------------------------------------------------------ Had compensation expense for the Company's stock-based compensation plans been determined based on the fair value at the grant dates consistent with SFAS No. 123, the Company's net income and earnings per share would have been reduced to the pro forma amounts indicated below: 1997 1996 ------------ ------------ Net Loss................. As Reported $(1,523,613) $(1,177,641) ................. Pro forma (4,634,523) (2,252,420) Loss Per Share........... As Reported (.16) (.12) ........... Pro forma (.49) (.24) The pro forma information includes stock options granted and purchases under the Employee Stock Purchase Plan (ESPP) in 1997 and 1996. Additionally, the 1997 pro forma information reflects the impact of the modification, occurring as part of the spin-off of Vital Images, of stock options and other stock based awards granted in years prior to 1997. The 1997 pro forma loss would have been significantly lower had the Company recorded in years prior to 1997, pro forma compensation costs associated with stock options and other stock based awards in the year of grant. Such pro forma compensation costs were not required prior to the implementation of SFAS No. 123. The weighted average fair value per option granted during 1997 and 1996 was $2.18 and $3.60 for the ESPP and $2.99 and $8.38 for all other options, respectively. The weighted average fair value was calculated by using the fair value of each option on the date of grant. The fair value of the ESPP options was based on the 15 percent purchase discount. The fair value of all other options was estimated using the Black-Scholes option pricing model with the following weighted average assumptions for 1997 and 1996: 1997 1996 ---------- ---------- Expected Option Term......... 4.2 years 6.6 years Expected Volatility Factor... 72% 69% Expected Dividend Yield...... 0% 0% Risk-Free Interest Rate...... 6.33% 6.02% (6) COMMITMENTS: Operating Lease: The Company has a noncancellable operating lease related to its office and production facility which expires in July 2005. Total annual base rent expense for this lease is $255,441. The Company also pays apportioned real estate taxes and common costs on its leased facilities. Total rent expense was $293,059, $296,486 and $154,622 for the years ended October 31, 1997, 1996 and 1995, respectively. Future minimum payments at October 31, 1997 are payable in the amount of $255,441 each year for 1998 through 2002 and total $702,480 thereafter. 47 BIO-VASCULAR, INC. NOTES TO FINANCIAL STATEMENTS--(Continued) - ------------------------------------------------------------------------ Royalties: In connection with the acquisition of product licenses and product manufacturing rights, the Company is obligated for the payment of royalties as follows: - 5% on net sales of Peri-Strips and Peri-Strips Dry until the expiration of the related patents. - 2.5% of net sales of the Biograft through 1998. - 3% of net sales of the Bio-Vascular Probe through 2001. Royalty expense was approximately $191,000, $291,000 and $393,000 for the years ended October 31, 1997, 1996, and 1995, respectively, and is included in cost of revenue. (7) RELATED PARTY TRANSACTIONS: In October 1997, the Company entered into a distribution agreement with Scanlan International, Inc., a medical and surgical products distributor. A Director of the Company is President and Chief Executive Officer of the Scanlan Group of Companies, the parent company of Scanlan International. The agreement grants Scanlan International the exclusive right, acting as a sales representative of Bio-Vascular, to solicit orders, work with distributors and market listed products within Latin America until October 31, 2000 subject to annual renewal thereafter. Scanlan International will receive a commission of 20% on net sales to Latin America during the term of the agreement. For the year ended October 31, 1997, there was no sales activity resulting from this agreement. (8) EMPLOYEE BENEFIT PLANS: Salary Reduction Plan: The Company sponsors a salary reduction plan established on January 1, 1991, which qualifies under Section 401(k) of the Internal Revenue Code. Employee contributions are limited to 15% of their annual compensation, subject to annual limitations. At the discretion of the Board of Directors, the Company may make matching contributions equal to a percentage of the salary reduction or other discretionary amount. The Company has made no contributions to the plan since its inception. Employee Stock Purchase Plan: The Company sponsors an Employee Stock Purchase Plan under which 300,000 shares of common stock were reserved for future issuance. The Plan was established to enable employees of the Company to invest in Company stock through payroll deduction. Options are granted to employees to purchase shares of stock at 85 percent of market value. There were 9,190 and 5,715 shares purchased through the Plan in 1997 and 1996, respectively. 48 BIO-VASCULAR, INC. NOTES TO FINANCIAL STATEMENTS--(Continued) - ------------------------------------------------------------------------ (9) MAJOR CUSTOMERS AND GEOGRAPHIC DATA: PERCENTAGE ------------------------- SIGNIFICANT ACCOUNTS CUSTOMER GROSS SALES RECEIVABLE -------------- ------------ ----------- Year ended October 31, 1997...... Futuretech 19% 20% Life Systems 14% 13% Cardio Medical 11% 10% Year ended October 31, 1996...... Futuretech 18% 21% Life Systems 15% 16% Cardio Medical 12% 14% Year ended October 31, 1995...... Futuretech 19% 20% Life Systems 16% 19% Cardio Medical 11% 14% International net revenues amounted to 24%, 22%, and 17% of total revenues for 1997, 1996 and 1995, respectively. Substantially all of the Company's international revenues are negotiated, invoiced and paid in U.S. dollars. Gross export revenues by significant geographic area are summarized as follows: 1997 1996 1995 ---------- ---------- ---------- Europe and Middle East... $1,412,675 $1,371,867 $1,102,720 Asia and Pacific Region.. 666,201 623,884 521,642 49 REPORT OF INDEPENDENT ACCOUNTANTS ON FINANCIAL STATEMENT SCHEDULE Our report on the financial statements of Bio-Vascular, Inc. is included on page 35 of this Form 10-K. In connection with our audits of such financial statements, we have also audited the related financial statement schedule listed in the index on page 30 of this Form 10-K. In our opinion, the financial statement schedule referred to above, when considered in relation to the basic financial statements taken as a whole, presents fairly, in all material respects, the information required to be included therein. COOPERS & LYBRAND L.L.P. Minneapolis, Minnesota December 9, 1997 50 SCHEDULE II - ------------------------------------------------------------------------------------------ BIO-VASCULAR, INC. VALUATION AND QUALIFYING ACCOUNTS - ------------------------------------------------------------------------------------------ Balance at Charged to Balance beginning cost and at end of Description of period expenses Deductions period - ------------------------------------------------------------------------------------------ Allowance for doubtful accounts: Year ended October 31, 1997 $21,400 - - $21,400 Year ended October 31, 1996 20,000 36,592 35,192 21,400 Year ended October 31, 1995 30,000 (1,901) 8,099 20,000 - ------------------------------------------------------------------------------------------ Balance at Charged to Balance beginning cost and at end of Description of period expenses Deductions period - ------------------------------------------------------------------------------------------ Reserve for obsolete inventories: Year ended October 31, 1997 $368,000 $116,031 $111,031 $373,000 Year ended October 31, 1996 46,000 354,822 32,822 368,000 Year ended October 31, 1995 10,000 176,568 140,568 46,000 - ------------------------------------------------------------------------------------------ 51 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. BIO-VASCULAR, INC. By /s/ M. Karen Gilles -------------------------------- M. Karen Gilles, President and Chief Executive Officer (Principal Executive Officer) Dated: December 23, 1997 Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below on December 23, 1997 by the following persons on behalf of the registrant and in the capacities indicated. /s/ M. Karen Gilles - ---------------------------------- M. Karen Gilles President, Chief Executive Officer and Director /s/ Connie L. Magnuson - ---------------------------------- Connie L. Magnuson Vice President of Finance and Chief Financial Officer (Principal Financial and Accounting Officer) /s/ James F. Lyons - ---------------------------------- James F. Lyons Chairman, Board of Directors /s/ Richard W. Perkins - ---------------------------------- Richard W. Perkins, Director /s/ Anton R. Potami - ---------------------------------- Anton R. Potami, Director /s/ Timothy M. Scanlan - ---------------------------------- Timothy M. Scanlan, Director /s/ Edward E. Strickland - ---------------------------------- Edward E. Strickland, Director 52 BI0-VASCULAR, INC. EXHIBIT INDEX TO ANNUAL REPORT ON FORM 10-K FOR THE YEAR ENDED OCTOBER 31, 1997 - ------------------------------------------------------------------------------- 3.1 Restated Articles of Incorporation of the Company, as amended, (incorporated by reference to Exhibit 3.1 to the Company's Quarterly Report on Form 10-Q for the quarter ended April 30, 1997 (File No. 0-13907)). 3.2 Amended and Restated Bylaws of the Company (incorporated by reference to Exhibit 3.2 to the Company's Registration Statement on Form S-4 (File No.33-74750)). 4.1 Form of common stock Certificate of the Company (incorporated by reference to Exhibit 4.1 to the Company's registration statement on Form 10 (File No. 0-13907)). 4.2 Form of Rights Agreement, dated as of June 12, 1996, between Bio- Vascular, Inc. and American Stock Transfer & Trust Company, which includes as Exhibit A the form of Rights Certificate (incorporated by reference to Exhibit 4.1 to the Company's Current Report on Form 8-K dated June 12, 1996 (File No. 0-13907)). 4.3 Restated Articles of Incorporation of the Company, as amended (see Exhibit 3.1). 4.4 Amended and Restated Bylaws of the Company (see Exhibit 3.2). 10.1 Agreement dated as of July 31, 1985 among Genetic Laboratories, Inc., Vascular Services Diversified, Inc., and the Company, including first amendment thereto, dated September 25, 1985 (incorporated by reference to Exhibit 2.1 to the Company's registration statement on Form 10 (File No. 0-13907)). 10.2 Amendment No. 2 to the Agreement referred to in Exhibit 10.1, effective July 31, 1985 (incorporated by reference to Exhibit 19.1 to the Company's Quarterly Report on Form 10-Q for the period ended April 30, 1986 (File No. 0-13907)). 10.3 License Agreement dated September 25, 1985 between the Company and Genetic Laboratories, Inc. (incorporated by reference to Exhibit 10.1 to the Company's registration statement on Form 10 (File No. 0-13907)). 10.4 Amendment to License Agreement dated June 13, 1986 between the Company and Genetic Laboratories, Inc. (incorporated by reference to Exhibit 10.4 to the Company's Current Report on Form 8-K dated June 15, 1986 (File No. 0-13907)). 10.5 Debt and Royalty Restatement Agreement dated June 16, 1986 among Genetic Laboratories, Inc., Vascular Services Diversified, Inc. and the Company (incorporated by reference to Exhibit 19.3 to the Company's Quarterly Report on Form 10-Q for the period ended April 30, 1986 (File No. 0-13907)). 10.6 Purchase Agreement dated February 17, 1986, between the Company and Genetic Laboratories, Inc. including Bill of Sale and Assignment (incorporated by reference to Exhibit 19.4 to the Company's Quarterly Report on Form 10-Q (File No. 0-13907)). E-1 BI0-VASCULAR, INC. EXHIBIT INDEX TO ANNUAL REPORT ON FORM 10-K FOR THE YEAR ENDED OCTOBER 31, 1997 - ------------------------------------------------------------------------------- 10.7 Purchase and sale agreement dated October 30, 1989 and closed December 28, 1989 between the Company and Meadox Medicals, Inc. (incorporated by reference to Exhibit 2.1 to the Company's Current Report on Form 8-K dated January 11, 1990 (File No. 0-13907)). 10.8 Assignment and Assumption Agreement dated July 31, 1985 between the Company and Genetic Laboratories, Inc., including the Purchase Agreement dated June 4, 1984 between Genetic Laboratories, Inc. and Xomed, Inc. (incorporated by reference to Exhibit 19.5 to the Company's Quarterly Report on Form 10-Q for the period ended April 30, 1986 (File No. 0- 13907)). 10.9 Assignment dated June 13, 1986 by Genetic Laboratories, Inc. to the Company (incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K dated June 15, 1986 (File No. 0-13907)). 10.10 Confirmatory Assignment dated June 13, 1986 by Genetic Laboratories, Inc., to the Company (incorporated by reference to Exhibit 10.2 to the Company's Current Report on Form 8-K dated June 15, 1986 (File No. 0-13907)). 10.11 Confirmatory Assignment dated June 13, 1986 by Genetic Laboratories, Inc., to the Company (incorporated by reference to Exhibit 10.3 to the Company's Current Report on Form 8-K dated June 15, 1986 (File No. 0-13907)). 10.12 Trademark Assignment Agreement dated June 19, 1986 between the Company and Genetic Laboratories, Inc. (incorporated by reference to Exhibit 19.10 to the Company's Quarterly Report on Form 10-Q for the period ended April 30, 1986 (File No. 0-13907)). 10.13 Assignment dated June 26, 1986 between the Company and Genetic Laboratories, Inc. (incorporated by reference to Exhibit 19.11 to the Company's Quarterly Report on Form 10-Q for the period ended April 30, 1986 (File No. 0-13907)). 10.14 1988 Stock Option Plan, as amended, (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the quarter ended April 30, 1997 (File No. 0-13907)). 10.15 1990 Management Incentive Stock Option Adjustment Plan (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 1997 (File No. 0-13907)). 10.16 1992 Stock Option Adjustment Plan (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 1997 (File No. 0-13907)). 10.17 1995 Stock Incentive Plan, as amended (incorporated by reference to Exhibit 10.2 to the Company's Quarterly Report on Form 10-Q for the period ended April 30, 1997 (File No. 0-139070)). 10.18 Employee Stock Purchase Plan, as amended (filed herewith electronically). E-2 BIO-VASCULAR, INC. EXHIBIT INDEX TO ANNUAL REPORT ON FORM 10-K FOR THE YEAR ENDED OCTOBER 31, 1997 - ------------------------------------------------------------------------------- 10.19 Employment letter dated November 28, 1994, as amended January 2, 1995, between the Company and Mr. Stephenson (incorporated by reference to Exhibit 10.20 to the Company's Annual Report on Form 10-K for the year ended October 31, 1995 (File No. 0-13907)). 10.20 Severance agreement dated June 30, 1997 between the Company and Mr. Karcanes (filed herewith electronically). 10.21 Form of Change in Control Agreement entered into between the Company and each of Ms. Gilles, Mr. Schankereli and Mr. Stephenson (incorporated by reference to Exhibit 10.28 to the Company's Annual Report on Form 10-K for the year ended October 31, 1994 (File No. 0-13907)). 10.22 Lease Agreement effective August 1, 1995 between the Company and CMS Investors, Inc. (incorporated by reference to Exhibit 10.25 to the Company's Annual Report on Form 10-K for the year ended October 31, 1995 (File No. 0-13907)). 10.23 Purchase and Sale Agreement dated December 1, 1995 among the Company, Bioplasty, Inc. and Uroplasty, Inc. (incorporated by reference to Exhibit 10.27 to the Company's Annual Report on Form 10-K for the year ended October 31, 1995 (File No. 0-13907)). 10.24 License Agreement dated December 1, 1995 between the Company and Uroplasty, Inc. (incorporated by reference to Exhibit 10.28 to the Company's Annual Report on Form 10-K for the year ended October 31, 1995 (File No. 0-13907)). 10.25 Assignment of U.S. Patent dated December 1, 1995 among the Company, Bioplasty, Inc. and Uroplasty, Inc. (incorporated by reference to Exhibit 10.29 to the Company's Annual Report on Form 10-K for the year ended October 31, 1995 (File No. 0-13907)). 21.1 List of Subsidiaries of the Company (filed herewith electronically). 23.1 Consent of Coopers & Lybrand L.L.P. (filed herewith electronically). 27.1 Financial Data Schedule for the year ended October 31, 1997 (filed herewith electronically). E-3