SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K (X) ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2001 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: 0-17272 TECHNE CORPORATION (Exact name of Registrant as specified in its charter) Minnesota 41-1427402 (State of Incorporation) (IRS Employer Identification No.) 614 McKinley Place N.E., Minneapolis, MN 55413 (Address of principal executive offices) (Zip Code) Registrant's telephone number: (612) 379-8854 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. Indicate by check mark whether the Company (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. ( ) The aggregate market value of the Common Stock held by non-affiliates of the Registrant, based upon the closing sale price on September 11, 2001 as reported on The Nasdaq Stock Market was approximately $1,166,747,000. Shares of Common Stock held by each officer and director and by each person who owns 5% or more of the outstanding Common Stock have been excluded. Shares of $.01 par value Common Stock outstanding at September 11, 2001: 41,443,688 DOCUMENTS INCORPORATED BY REFERENCE Portions of the Company's Proxy Statement for its 2001 Annual Meeting of Shareholders are incorporated by reference into Part III. PART I ITEM 1. BUSINESS OVERVIEW Techne Corporation (the Company) is a holding company which has two wholly- owned operating subsidiaries: Research and Diagnostic Systems, Inc. (R&D Systems) located in Minneapolis, Minnesota and R&D Systems Europe Ltd. (R&D Europe) located in Abingdon, England. R&D Systems is a specialty manufacturer of biological products. Its two major operating segments are hematology controls, which are used in hospital and clinical laboratories to check the accuracy of blood analysis instruments, and biotechnology products, including purified proteins (cytokines) and antibodies which are sold exclusively to the research market and assay kits which are sold to the research and clinical diagnostic markets. R&D Europe distributes R&D Systems' biotechnology products in Europe. R&D Europe has a German sales subsidiary, R&D Systems GmbH (R&D GmbH). The Company also has a foreign sales corporation, Techne Export Inc. R&D Systems was founded and incorporated in 1976 in Minneapolis, Minnesota and was acquired by the Company in 1985. In 1977 R&D Systems introduced its first product, a Platelet-Rich-Plasma control. In 1981 R&D Systems was the second manufacturer in the world to release a Whole Blood Control with Platelets, thereby establishing itself as one of the leaders in the field of hematology control products manufacturing. Subsequently, R&D Systems has developed several types of hematology controls designed to keep pace with the technology of the newest models of hematology instruments. These products are sold throughout the United States directly by R&D Systems and in many foreign countries through distributors. In 1985 R&D Systems entered the research reagent market with its first cytokine, TGF-beta. Cytokines are specialized protein molecules that stimulate or suppress various cell functions in the body. Cytokines are in demand by biomedical researchers who want to learn more about their diverse effects. Encouraged by its success in the cytokine market, R&D Systems formed a biotechnology division in 1986 with the goal of producing and marketing a wide range of human cytokines through genetic engineering. Recombinant DNA technology offers several advantages over extraction of these proteins from natural sources, including lower production cost and potentially unlimited supply. In 1991 R&D Systems purchased Amgen Inc.'s research reagent and diagnostic assay kit business. With this purchase, R&D Systems obtained Amgen's Erythropoietin (EPO) kit, the Company's first enzyme-linked immunosorbent assay kit for a cytokine that had been cleared by the U.S. Food and Drug Administration (FDA) for clinical diagnostic use. In 1993 the Company acquired its European biotechnology distributor, British Bio-technology Products Ltd. (renamed R&D Systems Europe Ltd.) from British Bio-technology Group plc. R&D Europe distributes biotechnology products developed by R&D Systems. During fiscal 1998, 1999, and 2000, the Company made equity investments in the preferred stock of ChemoCentryx, Inc. (CCX), a technology and drug development company. The Company currently holds approximately 26% of the outstanding stock of CCX. In addition to the equity investment and joint research efforts, the Company obtained research and diagnostic market rights to all products discovered or developed by CCX. On July 1, 1998, R&D Systems purchased Genzyme Corporation's research products business. This acquisition established R&D Systems as the world's leading supplier of research and diagnostic cytokine products. On August 2, 2001, the Company made an equity investment of $3 million and entered into a research and license agreement with Discovery Genomics, Inc. (DGI). DGI holds licenses from the University of Minnesota to develop technologies used for functional genomics and the discovery of druggable targets. The Company currently holds a 39% equity interest in DGI and also received the rights to develop antibodies and immunoassay kits for proteins discovered by DGI and the rights to sell such products to the research market. THE MARKET The Company, through its two operating subsidiaries, manufactures and sells products for the clinical diagnostics market (hematology controls and calibrators) and the biotechnology research and clinical diagnostics market (cytokines, assays and related products). In fiscal 2001, R&D Systems' Hematology Division revenues accounted for approximately 13% of consolidated revenues of $115,356,562. Revenues from R&D Systems' Biotechnology Division and R&D Europe were 64% and 23% of consolidated revenues, respectively. Biotechnology Products R&D Systems is the world's leading supplier of cytokines and cytokine-related reagents to the biotechnology research community. These valuable proteins exist in minute amounts in different types of cells and can be extracted from these cells or made through recombinant DNA technology. In 1985, R&D Systems introduced its first cytokine and continues to add to this product line. The first cytokines were extracted from natural sources (human and porcine platelets and bovine brain). Currently almost all of cytokines are produced by recombinant DNA technology. R&D Systems also sells antibodies for specific cytokines, cytokine assay kits, clinical diagnostic kits, kits for cytokine receptor binding studies, and related research reagents. The growing interest by researchers in cytokines exists because of the profound effect a tiny amount of a cytokine can have on the cells and tissues of the body. Cytokines are intercellular messengers. They act as signals by interacting with specific receptors on the effected cells. They carry vital signals to the cell's genetic machinery that can trigger events that can lead to significant changes in a cell, tissue or organism. For example, cytokines can signal a cell to differentiate, i.e., to acquire the features necessary for it to take on a more specialized task. Another example of cytokine action is the key role they play in stimulating cells surrounding a wound to grow and divide and to attract migratory cells to the injury site. R&D Systems' Biotechnology Division was formed in response to a growing need for highly purified biologically active proteins. R&D Systems believes that its cytokines are addressing the growing demand for these products within the scientific research community. During fiscal 1990, the Biotechnology Division released its first cytokine assay kits under the tradename Quantikine. These kits are used by researchers to quantify the level of a specific cytokine in a sample of blood, serum, or other biological fluid. In fiscal 1996, the Biotechnology Division expanded its Quantikine line by introducing a line of assay kits for mouse cytokines. These kits are used extensively by research scientists doing cytokine studies using animal models, such as those used in pharmaceutical discovery and development programs. Current Biotechnology Products Cytokines and Related Antibodies. Cytokines, extracted from natural sources or produced using recombinant DNA technology, are manufactured to the highest purity. Polyclonal antibodies are produced by injecting purified cytokines into animals (primarily goats and rabbits). The animals' immune systems recognize the cytokines as foreign and develop antibodies to these cytokines. The polyclonal antibodies are then extracted from the animals' blood and purified. Monoclonal antibodies are produced by injecting purified cytokines into mice. The B cells of a mouse's immune system are then isolated and fused with immortalized mouse cells that will produce the desired antibody. Purified cytokines and antibodies are made available both as research reagents and as parts of assay kits (below). Assay Kits. This product line includes R&D Systems' human and murine (mouse and rat) Quantikine kits which allow research scientists to quantify the amount of a specific cytokine in a sample of blood or tissue. Also included in this product line are assay kits, developed by R&D Europe, to quantify adhesion molecules. These kits are used by research scientists to measure cellular adhesion molecules in serum, plasma, or cell culture media. Cellular adhesion molecules facilitate the movement of infection fighting cells out of the blood stream to the site of infections. Clinical Diagnostic Kits. The EPO kit, acquired from Amgen Inc. in fiscal 1992, was the first diagnostic assay for which R&D Systems had FDA marketing clearance. R&D Systems also has received FDA marketing clearance for its transferrin receptor (TfR) and Beta2-microglobulin kits. Flow Cytometry Products. This product line includes R&D Systems' Fluorokine kits which are used to measure the presence or absence of receptors for specific cytokines on the surface of cells. DNA and Related Products. Designer genes and designer probes are synthetic DNAs used in the study of gene function. Hematology Controls and Calibrators Hematology controls and calibrators, manufactured and marketed through the Hematology Division of R&D Systems, are products made up of the various cellular components of blood. Proper diagnosis of many illnesses requires a thorough and accurate analysis of the patient's blood cells, which is usually done with automatic or semiautomatic hematology instruments. Controls and calibrators ensure that these instruments are performing accurately and reliably. Blood is composed of plasma, the fluid portion of which is mainly water, and blood cells, which are suspended in the plasma. There are three basic types of blood cells: red cells, white cells and platelets. Red cells transport oxygen from the lungs throughout the body, which they do by being rich in hemoglobin. White cells defend the body against foreign invaders. Platelets serve as a "plug" to stem blood flow at the site of an injury by initiating a complex series of biochemical reactions that lead to the formation of a clot. The formed elements of blood (red cells, white cells and platelets) differ a great deal in size and concentration. The white cells are the largest in size and platelets the smallest. The red cells are the most numerous and constitute 95 percent of all blood cells. The average adult has from 20 to 30 trillion red cells. For every 500 red cells there are approximately one white cell and about 20 platelets. As noted above, hematology controls are used in automatic and semiautomatic cell counting analyzers to make sure these instruments are counting blood cells accurately. One of the most frequently performed laboratory tests on a blood sample is called a complete blood count, or CBC for short. Doctors use this test in disease screening and diagnosis. More than a billion of these tests are done every year, the great majority with cell counting instruments. In most laboratories the CBC consists of the white cell count, the red cell count, the hemoglobin reading, and the hematocrit reading or the percent of red cells in a volume of whole blood after it has been centrifuged. Also included in a CBC test is the differential which numbers and classifies the different types of white cells. These and other characteristics or "parameters" of a blood sample can be measured by automatic or semiautomatic cell counters. Cell counters can read the parameters of blood either by impedance, in which a cell interrupts an electrical current and is counted, or by a laser, in which a cell interrupts a laser beam and is counted. The number of parameters measurable in a blood control product depends on the type and sophistication of the instrument for which the control is designed. Ordinarily, a hematology control is used once to several times a day to make sure the instrument is reading accurately. Some instruments need to be calibrated periodically. Hematology calibrators are similar to controls but go through additional processing and testing to ensure that the calibration values assigned are extremely accurate and can be used to adjust the instrument. The Hematology Division of R&D Systems offers a complete line of hematology controls and calibrators for both impedance and laser type cell counters. R&D Systems believes its products have improved stability and versatility and a longer shelf life than most of those of its competitors. The Hematology Division supplies hematology control products for use as proficiency testing materials by laboratory certifying authorities of a number of states and countries. All products are priced competitively and come with an unconditional money back guarantee. R&D Systems recognizes that developing technologies for cell counting instruments will require increasingly sophisticated and high-quality controls and is prepared to meet this challenge. Current Retail Hematology Products Impedance-Type Whole Blood Controls/Calibrators. The Hematology Division of R&D Systems currently produces controls and calibrators for the following impedance-type instruments: Abbott Cell-Dyn, ABX, Beckman Coulter, Danam, Hycel, Roche and TOA Sysmex instruments. Laser-Type Whole Blood Controls/Calibrators. Currently produced controls and calibrators for laser-type instruments include products for the following: Beckman Coulter MAXM, STKS and GENS; Abbott Cell-Dyn 3000, 3200, 3500 and 4000 instruments; ABX instruments; Bayer Technicon ADVIA and H series instruments; and the TOA Sysmex NE-8000 and NE-5500 instruments. Linearity Control. This product provides a means of assessing the linearity of hematology analyzers for white blood cells, red blood cells, hemoglobin and platelets. Whole Blood Reticulocyte Control. This control is designed for manual and automated counting of reticulocytes (immature red blood cells). Whole Blood Flow Cytometry Control. This product is a control for flow cytometry instruments. These instruments are used to identify and quantify white blood cells by their surface antigens. Whole Blood Glucose/Hemoglobin Control. This product is designed to monitor instruments for measuring glucose and hemaglobin. Erythrocyte Sedimentation Rate Control. This product is designed to monitor erythrocyte sedimentation rate tests. Multi-Purpose Platelet Reference Control. This product, Platelet-Trol II, is designed for use by automatic and semi-automatic impedance and laser instruments and is the successor to Platelet-Rich-Plasma which R&D Systems introduced in 1977. PRODUCTS UNDER DEVELOPMENT R&D Systems is engaged in ongoing research and development in all of its major product lines: hematology controls and calibrators, biotechnology cytokines, antibodies, assays and related products. The Company believes that its future success depends, to a large extent, on the ability to keep pace with changing technologies and markets. At the same time, the Company continues to examine its production processes to ensure high quality and maximum economy. R&D Systems' Biotechnology Division is planning to release new cytokines, antibodies and cytokine assay kits in the coming year. All of these products will be for research purposes only and therefore do not require FDA clearance. R&D Systems' Hematology Division has developed several new control products in fiscal 2001 and is continuously working on product improvements and enhancements. However, there is no assurance that any of the products in the research and development phase can be developed or, if developed, can be successfully introduced into the marketplace. Expenditures for research and development activities were $14,522,233, $11,198,309 and $12,004,798 for fiscal years 2001, 2000 and 1999, respectively. BUSINESS RELATIONSHIPS During fiscal 1998, 1999, and 2000, the Company purchased a total of $5 million of convertible preferred stock of ChemoCentryx, Inc. (CCX), which gave the Company a 49% interest in CCX through January 2001. In February 2001, CCX obtained $23 million in financing through the issuance of 8,846,154 shares of additional preferred stock. The Company currently holds approximately 26% of the outstanding voting stock of CCX. CCX is a technology and drug development company working in the area of chemokines. Chemokines are cytokines which regulate the trafficking patterns of leukocytes, the effector cells of the human immune system. In conjunction with the equity investment and joint research efforts, the Company obtained exclusive worldwide research and diagnostic marketing rights to chemokine proteins, antibodies and receptors discovered or developed by CCX or R&D Systems. The Company accounts for the investment under the equity method of accounting and, through January 2001, recognized 100% of the losses of CCX due to the limited amount of cash consideration provided by the holders of the common shares of CCX. Subsequent to January 2001, the Company is including CCX operating results in its consolidated financial statements based on its ownership percentage. The Company's net investment in CCX was $6,441,481 and $3,553,516 at June 30, 2001 and 2000, respectively. On August 2, 2001, the Company made an equity investment of $3 million and entered into a research and license agreement with Discovery Genomics, Inc. (DGI) of Minneapolis, Minnesota. DGI was recently organized and holds licenses from the University of Minnesota to develop technologies used for functional genomics and the discovery of druggable targets. The Company acquired a 39% equity interest in DGI and warrants to acquire additional equity. The Company also received the rights to develop antibodies and immunoassay kits for proteins discovered by DGI and an exclusive, royalty free license to sell such products in the research market. The Company's investment will be accounted for under the equity method of accounting. Original Equipment Manufacturers (OEM) agreements represent the largest market for hematology controls and calibrators made by R&D Systems. In fiscal year 2001, OEM contracts accounted for $7,096,901 or 48% of Hematology Division revenues and 6% of total consolidated revenues. GOVERNMENT REGULATION All manufacturers of hematology controls and calibrators are regulated under the Federal Food, Drug and Cosmetic Act, as amended. All of R&D Systems' hematology control products are classified as "In Vitro Diagnostic Products" by the FDA. The entire hematology control manufacturing process, from receipt of raw materials to the monitoring of control products through their expiration date, is strictly regulated and documented. FDA inspectors make periodic site inspections of the Hematology Division's control operations and facilities. Hematology control manufacturing must comply with Good Manufacturing Practices (GMP) as set forth in the FDA's regulations governing medical devices. Three of R&D Systems' immunoassay kits, EPO, TfR and Beta2-microglobulin, have FDA clearance to be sold for clinical diagnostic use. R&D Systems must comply with GMP for the manufacture of these kits. Biotechnology products manufactured in the United States and sold for use in the research market do not require FDA clearance. Some of R&D Systems' research groups use small amounts of radioactive materials in the form of radioisotopes in their product development activities. Thus, R&D Systems is subject to regulation by the US Nuclear Regulatory Commission (NRC) and has been granted an NRC license due to expire in April 2002. The license is renewable annually. R&D Systems is also subject to regulation and inspection by the Department of Health of the State of Minnesota for its use of radioactive materials. It has been granted a certificate of registration, which is renewable annually, by the Minnesota Department of Health. The current certificate expires April 1, 2002. R&D Systems has had no difficulties in renewing these licenses in prior years and has no reason to believe they will not be renewed in the future. If, however, the licenses were not renewed, it would have minimal effect on R&D Systems' business since there are other technologies the research groups could use to replace radioisotopes. AVAILABILITY OF RAW MATERIALS The primary raw material for the Company's hematology controls is whole blood. Human blood is purchased from commercial blood banks and porcine and bovine blood is purchased from nearby meat processing plants. After raw blood is received, it is separated into its components, processed and stabilized. Although the cost of human blood has increased owing largely to the requirement that it be tested for HIV (AIDS) antibodies and hepatitis, the higher cost of these materials has not had a serious adverse effect on the Company's business. R&D Systems does not perform its own testing for the AIDS antibodies as the supplier tests all human blood purchased. R&D Systems' Biotechnology Division develops and manufactures the majority of its cytokines from synthetic genes developed in-house, thus significantly reducing its reliance on outside resources. R&D Systems typically has several outside sources for all critical raw materials necessary for the manufacture of products. PATENTS AND TRADEMARKS R&D Systems owns patent protection for certain hematology controls. R&D Systems may seek patent protection for new or existing products it manufactures. No assurance can be given that any such patent protection will be obtained. No assurance can be given that R&D Systems' products do not infringe upon patents or proprietary rights owned or claimed by others, particularly for genetically engineered products. R&D Systems has not conducted a patent infringement study for each of its products. R&D Systems and R&D Europe have a number of licensing agreements with patent holders under which they have the non-exclusive right to patented technology or the non-exclusive right to manufacture and sell certain patented cytokine and cytokine related products to the research market. For fiscal 2001, total royalties expensed under these licenses were approximately $1,563,000. R&D Systems has obtained federal trademark registration for certain of its hematology controls and biotechnology product groups. R&D Systems believes it has common law trademark rights to certain marks in addition to those which it has registered. SEASONALITY OF BUSINESS Sales of the products manufactured by R&D Systems and R&D Europe are not seasonal, although R&D Europe historically experiences a slowing of sales during the summer months. SIGNIFICANT CUSTOMERS No single customer accounted for more than 10% of total revenues during fiscal 2001, 2000 or 1999. BACKLOG There was no significant backlog of orders for the Company's products as of the date of this report or as of a comparable date for fiscal 2000. COMPETITION The worldwide market for cytokines and research diagnostic assay kits is being supplied by a number of biotechnology companies, including BD Biosciences, BioSource International, Sigma Chemical Co., Amersham Pharmacia and CN Biosciences. R&D Systems believes that it is the leading worldwide supplier of cytokine related products in the research marketplace. R&D Systems believes that the expanding line of its products, their recognized quality, and the growing demand for these rare and versatile proteins, antibodies and assay kits, will allow the Company to remain competitive in the growing biotechnology research and diagnostic market. Competition is intense in the hematology control business. The first control products were developed in response to the rapid advances in electronic instrumentation used in hospital and clinical laboratories for blood cell counting. Historically, most of the instrument manufacturing companies made controls for use in their own instruments. With rapid expansion of the instrument market, however, a need for more versatile controls enabled non- instrument manufacturers to gain a foothold. Today the market is comprised of manufacturers of laboratory reagents, chemicals and coagulation products and independent control manufacturers in addition to instrument manufacturers. The principal hematology control competitors of R&D Systems' retail products are Beckman Coulter, Inc., TOA Sysmex, Streck Laboratories, Abbott Diagnostics and Hematronix, Inc. R&D Systems believes it is the third largest supplier of hematology controls in the marketplace behind Beckman Coulter and Streck Laboratories. EMPLOYEES R&D Systems had 447 full-time and 47 part-time employees as of June 30, 2001. R&D Europe had 47 full-time and 10 part-time employees as of June 30, 2001, including 9 full-time and 1 part-time at R&D Europe's sales subsidiary in Germany. ENVIRONMENT Compliance with federal, state and local environmental protection laws in the United States, England and Germany had no material effect on R&D Systems or R&D Europe in fiscal 2001. FOREIGN AND DOMESTIC OPERATIONS The following table represents certain financial information relating to foreign and domestic operations for the fiscal years ended June 30 (all amounts are in thousands of US dollars): 2001 2000 1999 -------- -------- -------- Net Sales to External Customers Hematology Division: US $ 12,357 $ 11,140 $ 10,549 Other 2,353 2,435 2,125 Biotechnology Division: US 58,661 51,788 43,712 Other 14,995 12,443 11,249 R&D Europe: Other 26,990 26,032 23,266 Gross Margin R&D Systems (US) 76,578 66,125 52,791 R&D Europe (England) 8,731 9,373 9,490 R&D GmbH (Germany) 1,623 1,590 1,296 Net Earnings (Loss) Parent and R&D Systems (US) 31,006 22,418 15,230 R&D Europe (England) 3,310 3,269 2,835 R&D GmbH (Germany) 229 253 8 ChemoCentryx (US) (500) 643 (1,417) Identifiable Assets Parent and R&D Systems (US) 194,355 165,834 112,327 R&D Europe (England) 17,029 13,546 10,213 R&D GmbH (Germany) 753 1,030 1,261 CAUTIONARY STATEMENTS The Company wishes to caution investors that the following important factors, among others, in some cases have affected and in the future could affect the Company's actual results of operations and cause such results to differ materially from those anticipated in forward-looking statements made in this document and elsewhere by or on behalf of the Company: Risk of Technological Obsolescence and Competition The biotechnology industry is subject to rapid and significant technological change. While the hematology controls industry historically has been subject to less rapid change, it too is evolving and is impacted significantly by changes in the automated testing equipment offered by hardware manufacturers. Competitors of the Company in the United States and abroad are numerous and include, among others, specialized biotechnology firms, medical laboratory instrument and equipment manufacturers and disposables suppliers, major pharmaceutical companies, universities and other research institutions. There can be no assurance that the Company's competitors will not succeed in developing technologies and products that are more effective than any which have been or are being developed by the Company or that would render the Company's technologies and products obsolete or noncompetitive. Many of these competitors have substantially greater resources and product development, production and marketing capabilities than the Company. With regard to diagnostic kits, which constitute a relatively minor portion of the Company's business, many of the Company's competitors have significantly greater experience than the Company in undertaking preclinical testing and clinical trials of new or improved diagnostic kits and obtaining FDA and other regulatory approvals of such products. Patents and Proprietary Rights The Company's success will depend, in part, on its ability to obtain licenses and patents, maintain trade secret protection and operate without infringing the proprietary rights of others. The Company has filed a very limited number of United States and foreign patent applications for products in which it believes it has a proprietary interest. The Company has obtained and is negotiating licenses to produce a number of cytokines and related products claimed to be owned by others. The Company has not conducted a patent infringement study for each of its products. It is possible that products of the Company may unintentionally infringe patents of third parties or that the Company may have to alter its products or processes, pay licensing fees or cease certain activities because of patent rights of third parties, thereby causing additional unexpected costs and delays which may have a material adverse effect on the Company. The patenting of hematology and biotechnology processes and products involves complex legal and factual questions and, to date, there has emerged no consistent policy regarding the breadth of claims in biotechnology patents. Protracted and costly litigation may be necessary to enforce rights of the Company and defend against claims of infringement of rights of others. Financial Impact of Expansion Strategy The Company engages in an expansion strategy which includes internal development of new products, collaboration with manufacturers of automated instruments which may use the Company's products, investment in joint ventures and companies developing new products related to the Company's business and acquisition of companies for new products or additional customer base. Each of the strategies carries risks that objectives will not be achieved and future earnings will be adversely affected. During the early development stage, a percentage of the operating losses of certain companies in which the Company may invest will be reported as losses of the Company, as is the case with ChemoCentryx, Inc. and Discovery Genomics, Inc. Government Regulation Ongoing research and development activities, including preclinical and clinical testing, and the production and marketing of the Company's products are subject to regulation by numerous governmental authorities in the United States and other countries. Some of the Company's products and manufacturing processes and facilities require governmental approval prior to commercial use. The approval process applicable to clinical diagnostic products of the type which may be developed by the Company usually takes a number of years and typically requires substantial expenditures. Delays in obtaining regulatory approvals would adversely affect the marketing of products developed by the Company and the Company's ability to receive product revenues or royalties. There can be no assurance that regulatory approvals for such products will be obtained without lengthy delays, if at all. Attraction and Retention of Key Employees Recruiting and retaining qualified scientific and production personnel to perform research and development work and product manufacturing is critical to the Company's success. Although the Company believes it has been and will be able to attract and retain such personnel, there can be no assurance that the Company will be successful. In addition, the Company's anticipated growth and expansion into areas and activities requiring additional expertise, such as clinical testing, government approvals, production and marketing, will require the addition of new management personnel and the development of additional expertise by existing management personnel. The failure to attract and retain such personnel or to develop such expertise would adversely affect the Company's business. Litigation On September 19, 2000, the Company brought a declaratory judgement action in United States District Court for the District of Minnesota (the Court) seeking to have the Court declare that no amount is owed by the Company to Amgen, Inc. (Amgen) in connection with invoices in the amount of $31.9 million rendered by Amgen in June 2000 for materials provided to the Company in past years. The Company also claimed damages for breach of contract and unfair business practices in violation of applicable statutes. Amgen subsequently acknowledged error and reduced the amount of its invoices by $3.9 million to $28 million. Amgen filed a counterclaim seeking the $28 million plus interest and attorneys fees. The Company believes that it has strong defenses to Amgen's claims and that it owes no material amount. The ultimate outcome of litigation, however, cannot be predicted with certainty. An unfavorable outcome to the litigation with Amgen would not adversely impair the operations of the Company or its financial condition, but would have a material effect on net income for the period in which realized. See "Financial Statements, Note E. Commitments and contingencies." ITEM 2. PROPERTIES On July 1, 1999, the Company purchased, for approximately $28 million, the facilities R&D Systems had been leasing in Minneapolis, Minnesota. The R&D complex currently includes 365,000 square feet of administrative, research and manufacturing space. The Hematology Division manufacturing and shipping operations are located at 640 McKinley Place N.E. (47,000 square feet). Biotechnology Division manufacturing and research operations are located at 600 McKinley Place NE (85,000 square feet) and 2201 Kennedy Street (200,000 square feet). Administrative, sales and marketing functions are also located at the 2201 Kennnedy Street building. The Company also occupies an additional 20,000 square feet in space connecting the three buildings. This area houses a lunchroom, a library and additional warehouse space. In addition, the Company constructed a 13,000 square foot entrance to the facility. The Company has entered into two option agreements for real estate adjacent to the current facility. The options are exercisable through November 2001 and January 2005 on the two properties, respectively. The Company plans to exercise its option on the first property during fiscal 2002 and plans to build an infill to connect this property with its current facility. R&D Europe sub-leased approximately 12,500 square feet in one building in Abingdon, England. The lease on the building expired in June 2001. In May 2001 R&D Europe began leasing approximately 17,000 square feet in a building less than one mile from its previous location. Rental rates for the new facility are expected to be slightly higher than rates under the previous sub-lease. Base rent was $195,000 in fiscal 2001. R&D GmbH leases approximately 2,300 square feet as a sales office in Wiesbaden-Nordenstadt, Germany. Base rent was $32,000 in fiscal 2001. The Company believes the acquired property, purchase options and leased property discussed above are adequate to meet its occupancy needs in the foreseeable future. ITEM 3. LEGAL PROCEEDINGS On September 19, 2000, the Company brought a declaratory judgement action in United States District Court for the District of Minnesota (the Court) seeking to have the Court declare that no amount is owed by the Company to Amgen, Inc. (Amgen) in connection with invoices in the amount of $31.9 million rendered by Amgen in June 2000 for materials provided to the Company in past years. The Company also claimed damages for breach of contract and unfair business practices in violation of applicable statutes. Amgen subsequently acknowledged error and reduced the amount of its invoices by $3.9 million to $28 million. Amgen filed a counterclaim seeking the $28 million plus interest and attorneys fees. The Company believes that it has strong defenses to Amgen's claims and that it owes no material amount. The ultimate outcome of litigation, however, cannot be predicted with certainty. An unfavorable outcome to the litigation with Amgen would not adversely impair the operations of the Company or its financial condition, but would have a material effect on net income for the period in which realized. See "Financial Statements, Note E. Commitments and contingencies." ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS No matter was submitted to a vote of the Company's security holders during the fourth quarter of the Company's 2001 fiscal year. EXECUTIVE OFFICERS OF THE COMPANY (a) The names, ages and positions of each executive officer of the Company are as follows: Name Age Position Officer Since ---- --- --------- ------------- Thomas E. Oland 60 Chairman of the Board, President, 1985 Treasurer and Director Dr. Monica Tsang 56 Vice President, Research 1995 Marcel Veronneau 46 Vice President, Hematology Operations 1995 Timothy M. Heaney 55 Vice President, Secretary, General 1999 Counsel and Director The term of office of each executive officer is from one annual meeting of directors until the next annual meeting of directors or until a successor is elected. There are no arrangements or understandings among any of the executive officers and any other person (not an officer or director acting as such) pursuant to which any of the executive officers was selected as an officer of the Company. (b) The business experience of the executive officers during the past five years is as follows: Thomas E. Oland has been Chairman of the Board, President and Treasurer of the Company since December 1985. Dr. Monica Tsang was elected a Vice President of the Company in March 1995. Prior thereto, she served as Executive Director of Cell Biology for R&D Systems' Biotechnology Division and has been an employee of R&D Systems since 1985. Marcel Veronneau was elected a Vice President of the Company in March 1995. Prior thereto, he served as Director of Operations for R&D Systems' Hematology Division since joining the Company in 1993. Timothy M. Heaney was elected a Vice President of the Company in October 1999. Prior thereto, he was a partner at Fredrikson and Byron, P.A., the Company's outside legal counsel and had served as the managing partner on the Company's account. An additional officer, Dr. James A. Weatherbee, who served as Vice President and Chief Scientific Officer since 1995, is on medical leave. Dr. Weatherbee and Dr. Tsang are husband and wife. Dr. Thomas Detwiler, Vice President of the Company since March 1995, retired from the Company in July 2000. PART II ITEM 5. MARKET FOR THE COMPANY'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS The Company's common stock trades on The NASDAQ Stock Exchange under the symbol "TECH." The following table sets forth for the periods indicated the range of the closing price per share for the Company as reported by NASDAQ. FISCAL 2001 PRICE FISCAL 2000 PRICE HIGH LOW HIGH LOW -------- ------- -------- -------- 1st Quarter $ 74.00 $ 36.50 $ 16.38 $ 12.38 2nd Quarter 62.66 32.00 27.53 15.88 3rd Quarter 33.69 22.50 44.19 25.99 4th Quarter 38.41 24.81 70.00 30.00 As of September 11, 2001, there were approximately 300 shareholders of record. As of September 11, 2001, there were over 14,000 beneficial shareholders of the Company's common stock. TECHNE Corporation has never paid cash dividends on its common stock. Payment of dividends is within the discretion of TECHNE's Board of Directors, although the Board of Directors plans to retain earnings for the foreseeable future for operating the Company's business. ITEM 6. SELECTED FINANCIAL DATA (DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA) REVENUE, EARNINGS AND CASH FLOW DATA FOR THE YEARS ENDED JUNE 30 2001 2000 1999(1) 1998 1997 ----------------------------- -------- -------- ------- ------- ------- Net sales $115,357 $103,838 $ 90,901 $67,291 $60,924 Gross margin 75.4% 74.2% 69.9% 70.3% 68.7% Selling, general and administrative expense 15.4% 16.7% 18.6% 22.8% 23.9% Research and development expenses 12.6% 10.8% 13.2% 15.8% 19.2% Interest expense 1,381 1,441 -- -- 29 Earnings before income taxes 47,808 39,412 26,054 22,411 15,988 Net earnings 34,045 26,583 16,656 15,183 10,882 Diluted earnings per share(3) 0.80 0.63 0.40 0.39 0.28 Capital expenditures 6,815 30,368 5,564 2,780 4,243 Depreciation and amortization 12,737 12,651 11,890 2,303 2,322 Change in net working capital 34,560 36,352 (12,544) 15,033 6,639 Net cash provided by operating activities 46,372 38,739 28,422 20,875 12,477 Return on sales 29.5% 25.6% 18.3% 22.6% 17.9% Return on average equity 21.4% 22.3% 20.7% 27.1% 25.0% BALANCE SHEET, COMMON STOCK AND EMPLOYEE DATA AS OF JUNE 30 2001 2000 1999(1) 1998 1997 ----------------------------- -------- -------- ------- ------- ------- Cash, cash equivalents and short-term investments $ 97,072 $ 59,824 $ 29,114 $41,436 $24,752 Receivables 18,322 15,601 13,520 10,002 9,114 Inventories 5,438 4,652 5,715 3,811 4,087 Working capital 108,300 73,740 37,388 49,932 34,899 Total assets 215,525 180,410 123,801 72,785 53,922 Long-term debt, less current portion 18,050 18,935 -- -- -- Stockholders' equity 177,660 141,145 96,838 63,831 48,081 Average common and common Equivalent shares (in thousands)(3) 42,668 42,206 41,373 39,215 38,925 Book value per share(2)(3) 4.29 3.41 2.41 1.67 1.27 Share price:(3) High 74.00 70.00 14.75 10.00 7.63 Low 22.50 12.38 6.13 6.72 5.06 Price to earnings ratio 41 103 31 25 27 Current ratio 7.81 6.87 3.78 7.84 8.12 Quick ratio 7.26 6.00 3.17 7.05 6.91 Full-time employees 494 440 402 356 326 (1) The Company acquired the research products business of Genzyme Corporation on July 1, 1998. (2) Total stockholders' equity divided by total shares outstanding at June 30. (3) The Company declared a two-for-one stock split with a record date of November 24, 2000. All prior year share and per share amounts have been restated to reflect the stock split. The Company has not declared any cash dividends in the past, and it is not anticipated that it will declare any dividends in the foreseeable future. ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS COMPANY STRUCTURE TECHNE (the Company) has two operating subsidiaries: Research and Diagnostic Systems, Inc. (R&D Systems) and R&D Systems Europe Ltd. (R&D Europe). R&D Systems, located in Minneapolis, Minnesota, has two operating segments: its Biotechnology Division and its Hematology Division. The Biotechnology Division develops and manufactures purified cytokines (proteins), antibodies and assay kits which are sold to biomedical researchers and clinical research laboratories. The Hematology Division develops and manufactures whole blood hematology controls and calibrators which are sold to hospitals and clinical laboratories to check the performance of hematology instruments to assure the accuracy of hematology test results. R&D Europe, the Company's third operating segment, located in Abingdon, England, is the European distributor of R&D Systems' biotechnology products. R&D Europe has a German sales subsidiary, R&D Systems GmbH. The Company also has a foreign sales corporation, Techne Export Inc. RESULTS OF OPERATIONS Net sales for fiscal 2001 were $115,356,562, an increase of $11,518,407 (11%) from fiscal 2000. Net sales by R&D Systems' Biotechnology Division for the period increased $9,426,085 (15%). Net sales by R&D Systems' Hematology Division increased $1,135,001 (8%) and net sales by R&D Europe increased $957,321 (4%). The increase in consolidated net sales for the fiscal year was due largely to increased sales of proteins and antibodies. R&D Europe's net sales for fiscal 2001 were affected by changes in foreign currency exchange rates. In British pounds, R&D Europe's net sales increased 14% from the prior year and, adjusted for all changes in exchange rates, R&D Europe's net sales for fiscal 2001 would have been approximately $2.9 million higher than reported. Net sales for fiscal 2000 were $103,838,155, an increase of $12,937,458 (14%) from fiscal 1999. Net sales by R&D Systems' Biotechnology Division for the period increased $9,269,504 (17%). Net sales by R&D Systems' Hematology Division increased $901,919 (7%) and net sales by R&D Europe increased $2,766,035 (12%). The increase in consolidated net sales for the fiscal year was due largely to increased sales of proteins and antibodies. Net sales for fiscal 1999 were $90,900,697, an increase of $23,609,259 (35%) from fiscal 1998. Net sales by R&D Systems' Biotechnology Division for the period increased $17,247,069 (46%). Net sales by R&D Systems' Hematology Division increased $889,451 (8%) and net sales by R&D Europe increased $5,472,739 (31%). The increase in consolidated net sales for the fiscal year was due, in part, to the acquisition of Genzyme Corporation's research products business on July 1, 1998. In addition, the increase in consolidated net sales was due to increased sales of R&D Systems products to both R&D Systems customers and to former Genzyme customers as they were converted from Genzyme products to R&D Systems products. Gross margins, as a percentage of sales, increased from 74.2% in fiscal 2000 to 75.4% in fiscal 2001. Biotechnology Division gross margins increased from 76.9% in fiscal 2000 to 78.6% in fiscal 2001. Margins in the first half of fiscal 2000 were affected by higher cost inventory acquired from Genzyme. R&D Europe gross margins decreased from 41.9% in fiscal 2000 to 38.3% in fiscal 2001 mainly as a result of changes in exchange rates. Hematology Division gross margins decreased from 48.4% in fiscal 2000 to 46.7% in fiscal 2001 as a result of changes in product mix. Gross margins, as a percentage of sales, increased from 69.9% in fiscal 1999 to 74.2% in fiscal 2000. Biotechnology Division gross margins increased from 70.8% in fiscal 1999 to 76.9% in fiscal 2000. Margins in fiscal 1999 were affected by higher cost inventory acquired from Genzyme. R&D Europe gross margins decreased from 46.0% in fiscal 1999 to 41.9% in fiscal 2000 mainly as a result of changes in exchange rates. Hematology Division gross margins did not change significantly from the prior year. Gross margins, as a percentage of sales, decreased slightly from 70.3% in fiscal 1998 to 69.9% in fiscal 1999. Biotechnology Division gross margins decreased from 72.9% in fiscal 1998 to 70.8% in fiscal 1999 as a result of lower gross profit levels on inventory acquired from Genzyme and the write- off of obsolete Genzyme packaging and kit components due to conversion of customers to R&D Systems labeled product. R&D Europe and Hematology Division gross margins did not change significantly from the prior year. Selling, general and administrative expenses increased $399,084 (2%) in fiscal 2001. The increase was the result of increased wages and benefits partially offset by exchange rate changes. Selling, general and administrative expenses increased $452,914 (3%) in fiscal 2000. The increase was the result of increased wages and benefits and exchange rate losses partially offset by decreased rent expense due to the purchase of R&D Systems' Minneapolis facilities on July 1, 1999. Selling, general and administrative expenses increased $1,494,457 (10%) in fiscal 1999. The majority of the increase in consolidated selling, general and administrative expenses was due to additional sales personnel added in the U.S. and Europe as a result of the Genzyme acquisition and associated advertising and promotion activities. Research and development expenses increased $3,323,924 in fiscal 2001, decreased $806,489 in fiscal 2000 and increased $1,366,994 in fiscal 1999. The decrease in consolidated research and development expenses in fiscal 2000 was a result of research grant money received in fiscal 2000 by ChemoCentryx, Inc. (CCX), which offset CCX's research expenses. CCX is a technology and drug development company in which the Company has invested. Research and development expenses by R&D Systems increased $2.4, $1.6 and $.6 million in fiscal 2001, 2000 and 1999, respectively. These increases were primarily the result of the development and release of new cytokines, antibodies and assay kits by R&D Systems' Biotechnology Division and the development and release of several new Hematology Division control products. Management of the Company believes that R&D Systems will continue to develop new products. Earnings before taxes increased from $39,411,797 in fiscal 2000 to $47,808,376 in fiscal 2001. The increase in earnings was primarily the result of a $8,543,176 increase in R&D Systems' Biotechnology Division earnings, a $573,280 increase in R&D Systems' Hematology Division earnings and a $270,873 increase in R&D Europe earnings. The increases were due mainly to increased sales and improved Biotechnology Division gross margins. The increases in consolidated earnings were partially offset by a $1,142,272 increase in operating losses by CCX as a result of increased research spending. Earnings before taxes increased from $26,054,010 in fiscal 1999 to $39,411,797 in fiscal 2000. The increase in earnings was primarily the result of a $10,803,845 increase in R&D Systems' Biotechnology Division earnings, a $777,379 increase in R&D Systems' Hematology Division earnings and a $804,885 increase in R&D Europe earnings. The increases were due mainly to increased sales and improved Biotechnology Division gross margins. In addition, as a result of the research grant money received by CCX in fiscal 2000, CCX's losses decreased $2,059,224 from fiscal 1999. The above were partially offset by increased interest expense related to financing of the building acquisition. Earnings before taxes increased from $22,410,961 in fiscal 1998 to $26,054,010 in fiscal 1999, despite $9.54 million in intangible asset amortization in fiscal 1999 related to the Genzyme acquisition. The increase in earnings was primarily the result of a $3,073,439 increase in R&D Systems' Biotechnology Division earnings, a $583,237 increase in R&D Systems' Hematology Division earnings and a $942,983 increase in R&D Europe earnings, all as a result of increased sales. These increases were offset by increased net losses by CCX of $744,209. Income taxes for fiscal 2001, 2000 and 1999 were provided at rates of approximately 29%, 33% and 36%, respectively. The decrease in the tax rate in fiscal 2001 is due primarily to increased tax exempt interest income and a one-time $1.2 million credit as a result of the close-out of pending issues related to a state income tax examination for fiscal years 1996 through 1999. In fiscal 2000, CCX losses were offset by grant money received, resulting in a decrease in the tax rate from fiscal 1999. The higher tax rate in fiscal 1999 was due to the net losses of CCX for which no tax benefit was provided. U.S. federal and state taxes have been reduced as a result of tax-exempt interest income, the benefit of the foreign sales corporation, and the federal and state credit for research and development expenditures. Foreign income taxes have been provided at rates which approximate the tax rates in the United Kingdom and Germany. LIQUIDITY AND CAPITAL RESOURCES Cash, cash equivalents and short-term investments at June 30, 2001, were $97,071,868, an increase of 62% from the prior year. At June 30, 2000, cash, equivalents and short-term investments were $59,824,291 compared to $29,114,124 at June 30, 1999, an increase of 105%. The Company has an unsecured line of credit of $750,000 available at June 30, 2001. The interest rate on the line of credit is at the prime rate of 6.75% at June 30, 2001. There were no borrowings on the line outstanding as of June 30, 2001 and 2000. Management of the Company expects to be able to meet its future cash and working capital requirements for operations, debt repayment, facility expansion and capital additions through currently available funds, cash generated from operations and maturities of short-term investments. Cash flows from operating activities The Company generated cash from operations of $46,371,711, $38,739,403 and $28,421,859 in fiscal 2001, 2000 and 1999, respectively. The majority of cash generated from operating activities in all three years resulted from an increase in net earnings after adjustment for noncash expenses. Cash flows from investing activities The Company's net investment in short-term investments in fiscal 2001, 2000 and 1999 was $33,335,894, $26,123,527 and $1,022,721, respectively. The Company's investment policy is to place excess cash in tax-exempt bonds with the objective of obtaining the highest possible return with the lowest risk, while keeping funds accessible. Capital additions (excluding the building purchase discussed below) were $6,814,953, $8,505,709 and $5,564,033 in fiscal 2001, 2000 and 1999, respectively. Included in fiscal 2001 capital additions is $1.9 million for the construction of a $7.9 million parking ramp. The ramp is currently under construction and is expected to be completed in fiscal 2002. Also included in fiscal 2001, 2000 and 1999 capital additions are building improvements of $2.3, $5.1 and $3.5 million related to R&D Systems' remodeling and expansion. The remaining capital additions were for laboratory, manufacturing and computer equipment. Total capital additions planned for fiscal 2002 for equipment, building improvements and the completion of the parking ramp are expected to be approximately $8.8 million. All capital additions are expected to be financed through currently available cash, cash generated from operations and maturities of short-term investments. On July 1, 1999, the Company purchased the facilities it occupies in Minneapolis, Minnesota for approximately $28 million. Cash of $4 million and 200,000 shares of common stock valued at $2.16 million were placed in escrow during fiscal 1999. The remainder of the purchase price was financed through cash on hand and a $20.4 million 15-year mortgage. On July 1, 1999, the Company paid $2 million and issued warrants to purchase 120,000 shares of common stock as a deposit on an option to purchase additional property adjacent to its Minneapolis facility. The balance due on the purchase is approximately $6 million. The Company plans to exercise its option to purchase this property during fiscal 2002. Costs to renovate the buildings are estimated at approximately $12 million, with renovation expected to be completed early in fiscal 2003. The Company also plans to build an infill to connect this property with its current facility. The construction of the infill is expected to begin in the spring of 2002 with completion in late fall 2002 and costs are estimated at approximately $5.5 million. On July 1, 1998 the Company acquired the research products business of Genzyme Corporation for $24.76 million cash, $17 million common stock and royalties on the Company's biotechnology sales for five years. Cash and equivalents at June 30, 1998 and maturities of short-term investments were used to finance the cash portion of the acquisition. Cash flows from financing activities The Company received $814,892, $6,470,910 and $1,136,633 for the exercise of options for 89,616, 1,052,046 and 385,704 shares of common stock in fiscal 2001, 2000 and 1999, respectively. In fiscal 2001 and 1999, the Company purchased and retired 40,000 and 427,200 shares of Company common stock at a market value of $1,163,768 and $3,941,950, respectively. In May 1995, the Company announced a plan to purchase and retire up to $5 million of its common stock. In April 1997 and January 2001 this was increased an additional $5 and $10 million, respectively. Through June 30, 2001, $9,917,882 of common stock had been purchased under the plan. Any additional purchases will be funded from currently available cash. The Company has never paid cash dividends and has no plans to do so in fiscal 2002. The Company's earnings will be retained for reinvestment in the business. NEW ACCOUNTING PRONOUNCEMENTS In December 1999, the Securities and Exchange Commission issued Staff Accounting Bulletin (SAB) No. 101, "REVENUE RECOGNITION IN FINANCIAL STATEMENTS," which provides guidance in applying generally accepted accounting principles to revenue recognition in financial statements. The application of this SAB did not have a material impact on the Company's operating results or financial position. On July 1, 2000, the Company adopted Statement of Financial Accounting Standards (SFAS) No. 133, "ACCOUNTING FOR DERIVATIVE INSTRUMENTS AND HEDGING ACTIVITIES", as amended by SFAS No. 138, "ACCOUNTING FOR CERTAIN DERIVATIVE INSTRUMENTS AND CERTAIN HEDGING ACTIVITIES". SFAS No. 133 establishes accounting and reporting standards for derivative instruments and for hedging activities. It requires that all derivatives, including those embedded in other contracts, be recognized as either assets or liabilities and that those financial instruments be measured at fair value. The accounting for changes in the fair value of derivatives depends on their intended use and designation. Management has reviewed the requirements of SFAS No. 133 and has determined that they have no free-standing or embedded derivatives. All contracts that contain provisions meeting the definition of a derivative also meet the requirements of, and have been designated as, normal purchases or sales. The Company's policy is to not use free-standing derivatives and to not enter into contracts with terms that cannot be designated as normal purchases or sales. In July 2001, the Financial Accounting Standards Board issued SFAS No. 141, "BUSINESS COMBINATIONS" and SFAS No. 142, "GOODWILL AND OTHER INTANGIBLE ASSETS". SFAS No. 141 applies to all business combinations initiated after June 30, 2001 and prohibits the use of the pooling-of-interests method of accounting. There are also transition provisions provided that apply to business combinations completed before July 1, 2001 that were accounted for using the purchase method. Under SFAS No. 142, goodwill as well as other intangibles determined to have an infinite life will no longer be amortized; however, these assets will be reviewed for impairment on a periodic basis. SFAS No. 142 also includes provisions for the reclassification of certain existing recognized intangibles as goodwill, reclassification of certain intangibles out of previously reported goodwill and the identification of reporting units for purposes of assessing potential future impairments of goodwill. The Company plans to adopt SFAS No. 142 on July 1, 2002. The Company is currently assessing, but has not yet determined, the impact of these statements on its financial position and results of operations. As of June 30, 2001, the Company had net goodwill and other intangibles assets of approximately $18.8 million and $8.6 million, respectively. Amortization expense recorded during fiscal 2001, 2000, and 1999 was approximately $8.9 million, $9.2 million and $9.6 million, respectively. FORWARD-LOOKING INFORMATION Statements in this Annual Report, and elsewhere, that are forward-looking involve risks and uncertainties which may affect the Company's actual results of operations. Certain of these risks and uncertainties which have affected and, in the future, could affect the Company's actual results are discussed below. The biotechnology industry is subject to rapid and significant technological change. While the hematology controls industry historically has been subject to less rapid change, it too is evolving and is impacted significantly by changes in the automated testing equipment offered by hardware manufacturers. Competitors of the Company are numerous and include, among others, specialized biotechnology firms, medical laboratory instrument and equipment manufacturers and disposables suppliers, major pharmaceutical companies, universities and other research institutions. There can be no assurance that the Company's competitors will not succeed in developing technologies and products that are more effective than any which have been or are being developed by the Company or that would render the Company's technologies and products obsolete or noncompetitive. The Company's success will depend, in part, on its ability to obtain licenses and patents, maintain trade secret protection and operate without infringing the proprietary rights of others. The Company has obtained and is negotiating licenses to produce a number of cytokines and related products claimed to be owned by others. Since the Company has not conducted a patent infringement study for each of its products, it is possible that products of the Company may unintentionally infringe patents of third parties or that the Company may have to alter its products or processes, pay licensing fees or cease certain activities because of patent rights of third parties, thereby causing additional unexpected costs and delays which may have a material adverse effect on the Company. The Company's expansion strategies, which include internal development of new products, collaborations, investments in joint ventures and companies developing new products related to the Company's business, and the acquisition of companies for new products and additional customer base, carry risks that objectives will not be achieved and future earnings will be adversely affected. Ongoing research and development activities, including preclinical and clinical testing, and the production and marketing of the Company's products are subject to regulation by numerous governmental authorities in the United States and other countries. The approval process applicable to clinical diagnostic products of the type that may be developed by the Company usually takes a number of years and typically requires substantial expenditures. Delays in obtaining approvals could adversely affect the marketing of new products developed by the Company. Recruiting and retaining qualified scientific and production personnel to perform research and development work and product manufacturing are critical to the Company's success. The Company's anticipated growth and its expected expansion into areas and activities requiring additional expertise will require the addition of new personnel and the development of additional expertise by existing personnel. The failure to attract and retain such personnel could adversely affect the Company's business. On September 19, 2000, the Company brought a declaratory judgement action in United States District Court for the District of Minnesota (the Court) seeking to have the Court declare that no amount is owed by the Company to Amgen, Inc. (Amgen) in connection with invoices in the amount of $31.9 million rendered by Amgen in June 2000 for materials provided to the Company in past years. The Company also claimed damages for breach of contract and unfair business practices in violation of applicable statutes. Amgen subsequently acknowledged error and reduced the amount of its invoices by $3.9 million to $28 million. Amgen filed a counterclaim seeking the $28 million plus interest and attorneys fees. The Company believes that it has strong defenses to Amgen's claims and that it owes no material amount. The ultimate outcome of litigation, however, cannot be predicted with certainty. An unfavorable outcome to the litigation with Amgen would not adversely impair the operations of the Company or its financial condition, but would have a material effect on net income for the period in which realized. See "Financial Statements, Note E. Commitments and contingencies." ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK At the end of fiscal 2001, the Company had an investment portfolio of fixed income securities, excluding those classified as cash and cash equivalents, of $75,804,077 (see Note A of Notes to Consolidated Financial Statements). These securities, like all fixed income instruments, are subject to interest rate risk and will decline in value if market interest rates increase. However, the Company has the ability to hold its fixed income investments until maturity and therefore the Company would not expect to recognize an adverse impact in income or cash flows. The Company operates internationally, and thus is subject to potentially adverse movements in foreign currency rate changes. The Company does not enter into foreign exchange forward contracts to reduce its exposure to foreign currency rate changes on intercompany foreign currency denominated balance sheet positions. ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA CONSOLIDATED STATEMENTS OF EARNINGS TECHNE CORPORATION AND SUBSIDIARIES YEAR ENDED JUNE 30, 2001 2000 1999 ------------ ------------ ----------- Net sales $115,356,562 $103,838,155 $90,900,697 Cost of sales 28,424,906 26,750,650 27,323,211 ------------ ------------ ----------- Gross margin 86,931,656 77,087,505 63,577,486 Operating expenses: Selling, general and administrative 17,714,215 17,315,131 16,862,217 Research and development 14,522,233 11,198,309 12,004,798 Amortization of intangible assets (Note A) 8,889,254 9,229,250 9,578,646 Interest expense 1,381,276 1,441,272 -- Interest income (3,383,698) (1,508,254) (922,185) ------------ ------------ ----------- 39,123,280 37,675,708 37,523,476 ------------ ------------ ----------- Earnings before income taxes 47,808,376 39,411,797 26,054,010 Income taxes (Note G) 13,763,000 12,829,000 9,398,000 ------------ ------------ ----------- Net earnings $ 34,045,376 $ 26,582,797 $16,656,010 ============ ============ =========== Earnings per share:(1) Basic $ 0.82 $ 0.65 $ 0.41 Diluted $ 0.80 $ 0.63 $ 0.40 Weighted average common shares outstanding:(1) Basic 41,438,670 40,625,482 40,234,734 Diluted 42,668,236 42,206,042 41,373,350 (1) All earnings per share and share amounts for the periods presented have been restated for the two-for-one stock split declared on November 9, 2000 and paid December 1, 2000. See Notes to Consolidated Financial Statements. CONSOLIDATED BALANCE SHEETS TECHNE CORPORATION AND SUBSIDIARIES JUNE 30, 2001 2000 ------------ ------------ ASSETS Current assets: Cash and cash equivalents $ 21,267,791 $ 17,356,108 Short-term available-for-sale investments (Note A) 75,804,077 42,468,183 Trade accounts receivable, less allowance for doubtful accounts of $126,000 and $162,000, respectively 15,894,048 14,056,481 Interest receivable 2,428,240 1,544,387 Inventories (Note B) 5,437,594 4,651,615 Deferred income taxes (Note G) 2,720,000 2,440,000 Prepaid expenses 639,759 494,117 Income taxes receivable -- 3,290,314 ------------ ------------ Total current assets 124,191,509 86,301,205 Property and equipment (Note C) 49,193,972 46,266,177 Intangible assets (Note A) 27,446,246 36,335,500 Deferred income taxes (Note G) 4,128,000 3,938,000 Other long-term assets (Note E) 10,565,386 7,568,699 ------------ ------------ $215,525,113 $180,409,581 ============ ============ LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Trade accounts payable $ 3,477,072 $ 2,630,164 Salaries, wages and related accounts 2,302,553 2,998,696 Other accounts payable and accrued expenses 6,155,189 6,107,979 Income taxes payable 3,071,982 -- Current portion of long-term debt (Note D) 884,760 824,315 ------------ ------------ Total current liabilities 15,891,556 12,561,154 Royalty payable 3,923,000 7,768,000 Long-term debt, less current portion (Note D) 18,050,289 18,935,049 Commitments and contingencies (Note E) -- -- Stockholders' equity (Note F): Undesignated capital stock, no par; authorized 5,000,000 shares; none issued or outstanding -- -- Common stock, par value $.01 a share; authorized 100,000,000 shares; issued and outstanding 41,432,390 and 41,381,998 shares, respectively 414,324 413,820 Additional paid-in capital 57,382,636 52,857,444 Retained earnings 121,209,686 88,336,230 Accumulated other comprehensive loss (1,346,378) (462,116) ------------ ------------ Total stockholders' equity 177,660,268 141,145,378 ------------ ------------ $215,525,113 $180,409,581 ============ ============ See Notes to Consolidated Financial Statements. CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY TECHNE CORPORATION AND SUBSIDIARIES