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, 2009 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: 000-17272 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 55413-2610 (Address of principal executive offices) (Zip Code) Registrant's telephone number: (612) 379-8854 Securities registered pursuant to Section 12(b) of the Act: Common Stock, $0.01 par value Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes (X) No ( ) Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ( ) No (X) Indicate by check mark whether the registrant (1) has filed all reports required to be filed by section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days: Yes (X) No ( ) Indicate by check mark whether the registrants has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ( ) 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. (X) Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of "accelerated filer and large accelerated filer" in Rule 12b-2 of the Securities Exchange Act. Large accelerated filer (X) Accelerated filer ( ) Non-accelerated filer ( ) Small reporting company ( ) Indicate by check mark whether the Registrant is a shell company (as defined in Exchange Act Rule 12b-2). ( ) Yes (X) No The aggregate market value of the Common Stock held by non-affiliates of the Registrant, based upon the closing sale price on August 27, 2009 as reported on The Nasdaq Stock Market was approximately $1.6 billion. 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 $0.01 par value Common Stock outstanding at August 27, 2009: 37,244,629. DOCUMENTS INCORPORATED BY REFERENCE Portion of the Company's Proxy Statement for its 2009 Annual Meeting of Shareholders are incorporated by reference into Part III. TABLE OF CONTENTS Page PART I Item 1. Business 3 Item 1A. Risk Factors 10 Item 1B. Unresolved Staff Comments 12 Item 2. Properties 12 Item 3. Legal Proceedings 12 Item 4. Submission of Matters to a Vote of Security Holders 13 Supplemental Item - Executive Officers of the Company 13 PART II Item 5. Market for the Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 13 Item 6. Selected Financial Data 15 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 16 Item 7A. Quantitative and Qualitative Disclosures about Market Risk 23 Item 8. Financial Statements and Supplementary Data 24 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 39 Item 9A. Controls and Procedures 39 Item 9B. Other Information 39 PART III Item 10. Directors, Executive Officers and Corporate Governance 39 Item 11. Executive Compensation 39 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 40 Item 13. Certain Relationships and Related Transactions, and Director Independence 40 Item 14. Principal Accounting Fees and Services 40 PART IV Item 15. Exhibits and Financial Statement Schedules 40 SIGNATURES 41 2 PART I ITEM 1. BUSINESS OVERVIEW TECHNE Corporation was incorporated on July 17, 1981 in the state of Minnesota. TECHNE Corporation and Subsidiaries (the Company) are engaged in the development, manufacture and sale of biotechnology products and hematology calibrators and controls. These activities are conducted domestically through its wholly-owned subsidiaries, Research and Diagnostic Systems, Inc. (R&D Systems) and BiosPacific, Inc. (BiosPacific). The Company distributes biotechnology products in Europe through its wholly-owned U.K. subsidiary, R&D Systems Europe Ltd. (R&D Europe). R&D Europe has a sales subsidiary, R&D Systems GmbH, in Germany and a sales office in France. The Company distributes biotechnology products in China through its wholly-owned subsidiary, R&D Systems China, Co. Ltd. (R&D China). The Company has three reportable operating segments based on the nature of products and geographic location: biotechnology, R&D Europe and hematology. The biotechnology segment consists of R&D Systems' Biotechnology Division, BiosPacific and R&D China, which develop, manufacture and sell biotechnology research and diagnostic products world-wide. R&D Europe distributes Biotechnology Division products throughout Europe. The hematology segment develops and manufactures hematology controls and calibrators for sale world- wide. THE MARKET The Company manufactures and sells products for the biotechnology research and clinical diagnostics market (cytokines, assays and related products) and the clinical diagnostics market (hematology controls and calibrators). In fiscal 2009, 2008 and 2007, net sales from the Company's biotechnology segment were 66%, 64% and 66%, respectively, of consolidated net sales. Net sales from the Company's R&D Europe segment were 27%, 30% and 27%, respectively, of consolidated net sales for same periods. The Company's hematology segment net sales were 7%, 6% and 7% of consolidated net sales for fiscal 2009, 2008 and 2007, respectively. Financial information relating to the Company's operating segments is incorporated herein by reference to Note L to the Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K. Biotechnology and R&D Europe Segments The Company, through its biotechnology and R&D Europe segments, is the world's leading supplier of cytokines and cytokine-related reagents to the biotechnology research community. These valuable proteins are produced in minute amounts by different types of cells and can be isolated from these cells or synthesized through recombinant DNA technology. Currently nearly all of the Company's cytokines are produced by recombinant DNA technology. The growing interest by academic and commercial researchers in cytokines is largely due to the profound effect that a tiny amount of a cytokine can have on cells and tissues of the body. Cytokines are intercellular messengers. They act as signals by interacting with specific receptors on the affected cells and trigger events that can lead to significant changes in a cell, tissue or organism. For example, cytokines can signal a cell to acquire the features necessary for it to take on a more specialized task. Another example of cytokine action is the key role played in stimulating cells surrounding a wound to grow and divide, to attract migratory cells to the injury site and mediate the healing process. The Company also has enzymes and intracellular cell signaling reagents in its product portfolio. Enzymes are biological catalysts that accelerate a variety of chemical reactions in cells. Most enzymes, including proteases, kinases and phosphatases, are proteins that modify the structure and function of other proteins. Many enzymes have the potential to serve as predictive biomarkers and therapeutic targets for a variety of diseases including cancer, Alzheimer's, arthritis, autoimmunity, diabetes, hypertension, obesity, AIDS and SARS. 3 The Company markets cytokine assay kits under the tradename Quantikine. These kits are used by researchers to quantify the level of a specific cytokine in biological fluids, such as serum, plasma, or urine. Cytokine quantification is an integral component of basic research as well as in the pharmaceutical discovery and development process. The Company currently manufactures and sells nearly 14,000 biotechnology products. Biotechnology Products Cytokines and Enzymes. Cytokines, extracted from natural sources or produced using recombinant DNA technology, are manufactured to the highest purity. Enzymes and related factors including enzyme substrates and inhibitors are highly purified and characterized to ensure the highest biological activity. Antibodies. Antibodies are proteins produced by the immune system of an animal that specifically recognize and bind to target molecules. The Company's polyclonal antibodies are produced in animals (primarily goats and sheep) and purified from the animals' blood. Monoclonal antibodies are made by immortalized cell lines derived from the antibody producing cells of a rodent. Monoclonal antibodies are secreted from these cell lines during cell culture and purified from the cell culture medium. Assay Kits. This product line includes human and animal Quantikine kits which allow research scientists to quantify the amount of a specific analyte (cytokine, adhesion molecule, enzyme, etc.) in a sample of serum or other biological fluids. Clinical Diagnostic Kits. The Company has received Food and Drug Administration (FDA) marketing clearance for its erythropoietin (EPO), transferrin receptor (TfR) and Beta2-microglobulin immunoassays for use as in vitro diagnostic kits. Flow Cytometry Products. This product line includes fluorochrome labeled antibodies and Fluorokine kits, which are used to measure the presence or absence of cell surface receptors for specific cytokines by flow cytometry. Intracellular Cell Signaling Products. This diverse product line provides reagents to study apoptosis (programmed cell death) and to elucidate signal transduction pathways within cells. Products include antibodies, phospho-specific antibodies, antibody protein arrays, active caspases, kinases, and phosphatases, and ELISA assays to quantitate and measure the activity of apoptotic and signaling molecules. Hematology Segment Hematology controls and calibrators are products composed of the various cellular components of blood which have been stabilized. Proper diagnosis of many illnesses requires a thorough and accurate analysis of a patient's blood cells, which is usually done with automated or semi-automated 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. Hemoglobin in red cells transports oxygen from the lungs throughout the body. 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. These fundamental blood components (red cells, white cells and platelets) differ widely in size and concentration. As noted above, hematology controls are used in automated and semi-automated cell counting analyzers to make sure these instruments are counting blood cells in patient samples accurately. One of the most frequently performed laboratory tests on a blood sample is a complete blood count (CBC). Doctors use this test in disease screening and diagnosis. More than one billion of these tests are done world-wide 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 (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. 4 These and other characteristics or "parameters" of a blood sample can be measured by automated or semi-automated cell counters. 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. In addition, most instruments need to be calibrated periodically. Hematology calibrators are similar to controls, but go through additional testing to ensure that the calibration values assigned are within tight specifications and can be used to calibrate the instrument. The Company offers a wide range of hematology controls and calibrators for both impedance and laser type cell counters. The Company believes its products have improved stability and versatility and a longer shelf life than most of those of its competitors. Hematology control products are also supplied for use as proficiency testing materials by laboratory certifying authorities of a number of states and countries. Hematology Products Whole Blood CBC Controls/Calibrators. The Company currently produces controls and calibrators for the following major brands of analyzers: Abbott Diagnostics, Beckman Coulter, Siemens Healthcare Diagnostics, HORIBA Medical and Sysmex. Linearity and Reportable Range Controls. These products provide a means of assessing the linearity of hematology analyzers for white blood cells, red blood cells, platelets and reticulocytes (immature red blood cells). Because hematology analyzers are single-point calibrated, these products allow users to determine and validate the reportable range of an instrument. Whole Blood Reticulocyte Controls. These controls are designed for manual and automated counting of reticulocytes (immature red blood cells). Whole Blood Flow Cytometry Controls. These products are controls for flow cytometry instruments. These instruments are used to identify and quantify white blood cells by their surface markers. Whole Blood Glucose/Hemoglobin Control. This product is designed to monitor instruments which measure glucose and hemoglobin in whole blood. Erythrocyte Sedimentation Rate Control. This product is designed to monitor erythrocyte (red blood cell) sedimentation rate tests. Multi-Purpose Platelet Reference Controls. These products, Platelet-Trol II and Platelet-Trol Extended, are designed for use by automated and semi- automated analyzers which monitor platelet levels. Original Equipment Manufacturer (OEM) agreements represent the largest market for hematology controls and calibrators made by the Company. In fiscal 2009, 2008 and 2007, OEM contracts accounted for $7.6 million, $7.0 million and $6.0 million, respectively, or 3% of total consolidated net sales in each fiscal year. PRODUCTS UNDER DEVELOPMENT The Company is engaged in ongoing research and development in all of its major product lines: controls and calibrators (hematology) and cytokines, antibodies, assays and related products (biotechnology). The Company believes that its future success depends, to a large extent, on its 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 efficiency. 5 In fiscal 2009, the Company introduced over 1,400 new biotechnology products. The Company 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. The Company also developed several new hematology control products in fiscal 2009 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 successfully completed or, if completed, can be successfully introduced into the marketplace. Year Ended June 30, 2009 2008 2007 ------- ------- ------- Research expense (in thousands): Biotechnology expenses $22,792 $21,632 $19,333 Hematology expenses 772 762 749 ------- ------- ------- $23,564 $22,394 $20,082 ======= ======= ======= Percent of net sales 8.9% 8.7% 9.0% INVESTMENTS Since fiscal 1998, the Company has invested in the preferred stock of ChemoCentryx, Inc. (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 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. The Company holds a 16.8% ownership percentage in CCX. The Company has evaluated the cost versus equity method of accounting for its investment in CCX and determined that it does not have the ability to exercise significant influence over the operating and financial policies of CCX and therefore, accounts for its investment on a cost basis. The Company's net investment in CCX at both June 30, 2009 and 2008 was $14.3 million. In fiscal 2004, the Company purchased a 10% interest in Hemerus Medical, LLC (Hemerus) for $3.0 million. In fiscal years 2006 through 2008, the Company invested an additional $1.8 million in Hemerus, increasing its ownership percentage to 19%. In fiscal 2009, as a result of Hemerus repurchasing and retiring a third party's membership units, the Company's ownership percentage increased to 22%. Hemerus was formed in March 2001 and has acquired and is developing technology for the separation of leukocytes from blood and blood components. Hemerus owns two patents, has several patent applications pending and has received FDA clearance to market its products in the U.S. In parallel with this investment, R&D Systems entered into a Joint Research Agreement with Hemerus. The research involves joint projects to explore the use of Hemerus' filter technology to applications within R&D Systems' Hematology and Biotechnology Divisions. Such applications, if any, may have commercial potential in other laboratory environments. The Company accounts for its investment in Hemerus under the equity method of accounting as Hemerus is a limited liability company. The Company's net investment in Hemerus was $2.2 million and $2.9 million at June 30, 2009 and 2008, respectively. In fiscal 2007, the Company invested $7.2 million for an 18% equity interest in Nephromics LLC (Nephromics). Nephromics has licensed technology related to the diagnosis of preeclampsia and has sublicensed the technology to several major diagnostic companies for the development of diagnostic assays. In fiscal 2008, Nephromics issued additional membership units which reduced the Company's ownership percentage to 16.8%. In fiscal 2009, the Company received a $1.3 million distribution from Nephromics. The Company accounts for its investment in Nephromics under the equity method of accounting as Nephromics is a limited liability company. Its net investment in Nephromics was $4.5 million and $6.2 million at June 30, 2009 and 2008, respectively. In fiscal 2008, the Company invested $1.4 million for a 19% interest in ACTGen, a development stage biotechnology company located in Japan. ACTGen has intellectual property related to the identification and expression of molecules. The technology covers techniques to identify cellular molecules which are destined to be secreted into tissue fluids or shuttled to the cell membrane. Such molecules represent an ideal target as disease biomarkers. The Company's net investment in ACTGen was $1.2 million and $1.3 million at June 30, 2009 and 2008, respectively. 6 GOVERNMENT REGULATION All manufacturers of hematology controls and calibrators are regulated under the Federal Food, Drug and Cosmetic Act, as amended. All of the Company's 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 Company's hematology control operations and facilities. Hematology control manufacturing must comply with Quality System Regulations (QSR) as set forth in the FDA's regulations governing medical devices. Three of the Company's immunoassay kits, EPO, TfR and Beta2-microglobulin, have FDA clearance to be sold for clinical diagnostic use. The Company must comply with QSR 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 the Company's research groups use small amounts of radioactive materials in the form of radioisotopes in their product development activities. Thus, the Company is subject to regulation and inspection by the Minnesota Department of Health and has been granted a license through August 2010. The license is renewable annually. The Company has had no difficulties in renewing this license in prior years and has no reason to believe it will not be renewed in the future. If, however, the license was not renewed, it would have minimal effect on the Company's business since there are other technologies the research groups could use to replace the use of 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 while 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 due to the requirement that it be tested for certain diseases and pathogens, the higher cost of these materials has not had a serious adverse effect on the Company's business. The Company does not perform its own pathogen testing 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 which extend for various periods depending on the date of the patent application or patent grant. 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. See Item 3. "Legal Proceedings" in this Annual Report on Form 10-K. 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 use patented technology or the non-exclusive right to manufacture and sell certain patented cytokine and cytokine related products to the research market. For fiscal 2009, 2008 and 2007, total royalties expensed under these licenses were approximately $3.2 million, $3.0 million and $2.6 million, respectively. R&D Systems has obtained federal trademark registration for certain of its hematology controls and biotechnology product groups which extend for various periods depending upon the date of the trademark grant. R&D Systems believes it has common law trademark rights to certain marks in addition to those which it has registered. 7 SEASONALITY OF BUSINESS Products marketed by R&D Systems and, particularly R&D Europe, historically experience a slowing of sales or of the rate of sales growth during the summer months. R&D Systems also usually experiences a slowing of sales during the Thanksgiving to New Year holiday period. The Company believes this slowing is a result of vacation schedules in Europe and Japan and of academic schedules in the United States. SIGNIFICANT CUSTOMERS No single customer accounted for more than 10% of total revenues during fiscal 2009, 2008 or 2007. BACKLOG There was no significant backlog of orders for the Company's products as of the date of this Annual Report on Form 10-K or as of a comparable date for fiscal 2008. The majority of the Company's biotechnology products are shipped within one day of receipt of the customers' orders. The majority of hematology products are shipped based on a preset, recurring schedule. COMPETITION The worldwide market for cytokines and research diagnostic assay kits is being supplied by a number of biotechnology companies, including GE Healthcare Life Sciences, BD Biosciences, EMD Biosciences, Inc., Life Technologies Corporation, Millipore Corporation, PeproTech, Inc., Santa Cruz Biotechnology, Inc., Abcam plc., Sigma-Aldrich Corporation and Thermo Fisher Scientific, Inc.. 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 Abbott Diagnostics, Beckman Coulter, Inc., Bio-Rad Laboratories, Inc., Streck Laboratories, Inc., Siemens Healthcare Diagnostics Inc. and Sysmex Corporation. R&D Systems believes it is the third largest supplier of hematology controls in the marketplace behind Beckman Coulter, Inc. and Streck Laboratories, Inc. EMPLOYEES Through its subsidiaries, the Company employed 687 full-time and 59 part-time employees as of June 30, 2009, as follows: Full-time Part-time --------- --------- R&D Systems 615 36 R&D Europe 53 20 BiosPacific 7 0 R&D China 12 3 --- --- 687 59 === === Included in R&D Europe employees are 8 full-time and 4 part-time employees at R&D Europe's sales subsidiary in Germany. 8 ENVIRONMENT Compliance with federal, state and local environmental protection laws in the United States, United Kingdom, Germany and China had no material effect on the Company in fiscal 2009. GEOGRAPHIC AREA FINANICAL INFORMATION Following is financial information relating to geographic areas (in thousands): Year Ended June 30, 2009 2008 2007 -------- -------- -------- Net sales United States $147,271 $141,443 $127,695 Europe 79,381 81,628 66,492 Other areas 37,304 34,349 29,295 -------- -------- -------- Total net sales $263,956 $257,420 $223,482 ======== ======== ======== As of June 30, 2009 2008 2007 -------- -------- -------- Long-lived assets United States $ 93,571 $ 93,612 $ 90,965 Europe 7,214 8,992 867 Other areas 98 112 47 -------- -------- -------- Total long-lived assets $100,883 $102,716 $ 91,879 ======== ======== ======== Net sales are attributed to countries based on the location of the customer/distributor. Long-lived assets are comprised of land, buildings and improvements equipment, and other assets, net of depreciation and amortization. See the description of risks associated with the Company's foreign subsidiaries in Item 1A of this Annual Report on Form 10-K. INVESTOR INFORMATION The Company is subject to the information requirements of the Securities Exchange Act of 1934. Therefore, the Company files periodic reports, proxy statements, and other information with the Securities and Exchange Commission (SEC). Such reports, proxy statements, and other information may be obtained by visiting the Public Reference Room of the SEC at 100 F Street, N.E., Room 1580, Washington, DC 20549 or by calling the SEC at 1-800-SEC-0330. In addition, the SEC maintains an internet site (http://www.sec.gov) that contains reports, proxy and information statements, and other information regarding issuers that file electronically. Financial and other information about the Company is available on its internet site (http://www.techne-corp.com). The Company makes available on its internet site, copies of its annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after filing such material electronically or otherwise furnishing it to the SEC. 9 ITEM 1A. RISK FACTORS Statements in this Annual Report on Form 10-K, 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 Company undertakes no obligation to update or revise any forward-looking statements made due to new information or future events. Investors are cautioned not to place undue emphasis on these statements. The following risk factors should be read carefully in connection with evaluation of the Company's business and any forward-looking statements made in this Annual Report on Form 10-K and elsewhere. Any of the following risks could materially adversely affect the Company's business, operating results and financial condition. The Company's revenues are significantly dependent on sales to research scientists in the private and public sector, and a decrease in research spending could negatively impact the Company's revenues. The Company's biotechnology products are sold primarily to research scientists at pharmaceutical and biotechnology companies and at university and government research institutions. Changes in spending on research by such companies and in the funding that such universities and institutions receive from government agencies, including the National Institutes of Health, affects the revenues and earnings of the Company. The Company carries essentially no backlog of orders and changes in the level of orders received and filled daily can cause fluctuations in quarterly revenues and earnings. The Company operates in rapidly changing and intensely competitive industries, and may not be able to keep pace with its competitors. The biotechnology industry is subject to rapid and significant technological change. While the hematology controls industry historically has been less subject to rapid change, it too is evolving and is impacted significantly by changes in the automated testing equipment offered by instrument 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 is significantly dependent on sales made through foreign subsidiaries, and revenues and earnings could be negatively impacted by changes in exchange rates. Approximately 29% of the Company's sales are made through its foreign subsidiaries, which make their sales in foreign currencies. The Company's revenues and earnings are, therefore, affected by fluctuations in currency exchange rates. Any adverse movement in foreign currency rates could negatively affect the CompanY's revenues and earnings. The Company's business is subject to governmental regulation, which may have the effect of delaying or impeding the release of certain of its products. Ongoing research and development activities and the production and marketing of certain 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 may take a year or more. Delays in obtaining approvals could adversely affect the marketing of new products developed by the Company, and negatively affect the Company's revenues. 10 The Company is dependent on maintaining our intellectual property rights, and cannot guarantee that it will not be subject to intellectual property litigation in the future. 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 success will be dependent on recruiting and retaining highly qualified personnel, the loss of whom could adversely affect its operations. 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. The Company may incur losses as a result of its investments in other companies, the success of which is largely out of the Company's control. 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, technologies and additional customer base, carry risks that objectives will not be achieved and future earnings will be adversely affected. Development stage companies of the type the Company has invested in are dependent on their ability to raise additional funds to continue research and development efforts and on receiving patent protection and/or FDA clearance to market their products. The Company uses the equity method of accounting for certain of these investments and records a percentage of the losses of these companies as losses of the Company. The Company may not have control of the expense levels of such companies and their losses may be greater than those anticipated by the Company. Additionally, if funding were unavailable or inadequate to fund operations of these companies or if patent protection or FDA clearance were not received by them, the Company may determine that its investment in one or more of these unconsolidated companies is "other than temporarily" impaired, and the Company could write off all or a portion of its investment. The Company may be unsuccessful in expanding into China and establishing adequate distribution channels for our products in China. The Company established a subsidiary in China in late fiscal 2007, to provide warehousing, marketing, sales and technical services for the growing Chinese market. The Company's ability to recover its investment is dependent upon its ability to retain current third-party distributors in China and expand its market share in the region. 11 ITEM 1B. UNRESOLVED STAFF COMMENTS There are no unresolved staff comments as of the date of this report. ITEM 2. PROPERTIES The Company owns the facilities that its headquarters and R&D Systems subsidiary occupy in Minneapolis, Minnesota. The R&D Systems main complex includes approximately 500,000 square feet of administrative, research and manufacturing space in several adjoining buildings. The Company owns two additional properties adjacent to its main complex. The Company has renovated the first property and is currently leasing or plans to lease approximately 70% of the 176,000 square foot building as retail and office space and use the remainder as warehouse and storage space. A portion of the second property is currently leased to third parties and the Company plans to continue to lease out the building until the space is needed for its own operations. The Company owns approximately 649 acres of farmland, including buildings, in southeast Minnesota. A portion of the land and buildings are being leased to third parties as cropland and for a dairy operation. The remaining property is used by the Company to house goats and sheep for polyclonal antibody production. Rental income from the above properties was $481,000, $404,000 and $686,000 in fiscal 2009, 2008 and 2007, respectively. In fiscal 2008, the Company purchased the 17,000 square foot facility it had been leasing for its R&D Europe operations in Abingdon, England for $8.3 million. The Company leases the following facilities: Company Location Type Square Feet - ----------- ------------------------------- --------------- ----------- R&D GmbH Wiesbaden-Nordenstadt, Germany Office space 2,300 BiosPacific Emeryville, California Office space 3,500 R&D China Shanghai, China Office/warehouse 4,500 The Company believes the owned and leased property discussed above, are adequate to meet its occupancy needs in the foreseeable future. ITEM 3. LEGAL PROCEEDINGS On June 29, 2006, Streck Laboratories, Inc. (Streck) filed a Complaint against the Company and its subsidiary, R&D Systems, in the United States District Court for the District of Nebraska. The Complaint alleges patent infringement involving certain patents issued to Streck relating to the addition of reticulocytes to hematology controls. Streck is seeking a reasonable royalty on sales of integrated hematology controls containing reticulocytes. The Company has reason to believe that R&D Systems and not Streck, first invented the inventions claimed in these patents and several other patents issued to Streck. An interference was declared by the U.S. Patent and Trademark Office on March 21, 2007 to determine priority of invention between a patent application filed by R&D and the Streck patents, including each of the patents involved in the lawsuit. The Company does not believe the resolution of the above proceedings will have a material impact on the Company's consolidated financial statements. 12 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 2009 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 68 Chairman of the Board, 1985 President, Treasurer, Chief Executive and Director Marcel Veronneau 55 Vice President, Hematology Operations 1995 Gregory J. Melsen 57 Vice President of Finance and Chief 2004 Financial Officer The term of office of each executive officer is annual 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, Treasurer and Chief Executive Officer of the Company since December 1985. Mr. Oland also served as Chief Financial Officer of the Company from December 1985 to December 2004. Marcel Veronneau was appointed 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. Gregory J. Melsen joined the Company in December 2004 as Vice President of Finance and Chief Financial Officer. From 2002 to 2004, he served as Vice President and Chief Financial Officer of PLATO Learning, Inc., a publicly held provider of computer-based and e-learning educational software. From 1999 to 2001, he held the position of Vice President of Finance, Treasurer and Chief Financial Officer of American Medical Systems Holdings, Inc., a publicly traded medical device manufacturer. Previously, Mr. Melsen was employed by a public accounting firm for 19 years, including nine years as an audit partner. PART II ITEM 5. MARKET FOR THE REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES The following table sets forth the repurchases of Company Common Stock for the quarter ended June 30, 2009. Maximum Approximate Dollar Value Total Number of of Shares Shares Purchased that May Yet Total Number Average as Part of Be Purchased Of Shares Price Paid Publicly Announced Under the Plans Period Purchased Per Share Plans or Programs of Programs - -------------- ------------ ---------- ------------------ ------------------- 4/1/09-4/30/09 33,183 53.33 33,183 $67.5 million 5/1/09-5/31/09 0 0 0 $67.5 million 6/1/09-6/30/09 0 0 0 $67.5 million In November 2007, the Company authorized a plan for the repurchase and retirement of up to $150 million of its common stock. In April 2009, the Company authorized an additional $60 million for its stock repurchase plan. The plan does not have an expiration date. 13 The Company's common stock trades on The NASDAQ Stock Market 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 National Market. Fiscal 2009 Price Fiscal 2008 Price ----------------- ----------------- High Low High Low ------ ------ ------ ------ 1st Quarter $81.90 $71.38 $66.38 $56.20 2nd Quarter 74.34 60.54 69.90 61.66 3rd Quarter 64.84 45.64 71.12 59.49 4th Quarter 64.45 51.71 79.73 64.84 As of August 27, 2009, there were approximately 230 shareholders of record. As of August 27, 2009, there were over 50,000 beneficial shareholders of the Company's common stock. TECHNE Corporation paid three quarterly cash dividends of $0.25 per share per quarter totaling $28.2 million in fiscal 2009. Its Board of Directors periodically considers the payment of cash dividends. The following chart compares the cumulative total shareholder return on the Company's Common Stock with the S&P Midcap 400 Index and the S&P 400 Biotechnology Index. The comparison assumes $100 was invested on the last trading day before July 1, 2004 in the Company's Common Stock and in each of the foregoing indices and assumes reinvestment of dividends. COMPARISION OF CUMULATIVE FIVE YEAR TOTAL RETURNS INDEXED RETURNS Year Ending Company/Index June 2005 June 2006 June 2007 June 2008 June 2009 - --------------------- --------- --------- --------- --------- --------- Techne Corporation 105.66 117.19 131.67 178.11 148.76 S&P Midcap 400 Index 114.03 128.83 152.67 141.48 101.83 S&P 400 Biotechnology 93.86 95.63 100.32 130.03 126.35 14 ITEM 6. SELECTED FINANCIAL DATA (dollars in thousands, except share and per share data) 2009 2008 2007 2006 (1) 2005 -------- -------- -------- -------- -------- Income and Share Data: Net sales $263,956 $257,420 $223,482 $202,617 $178,652 Gross margin(2) 79.0% 79.5% 79.1% 77.4% 79.4% Selling, general and administrative expenses(2) 12.6% 14.3% 13.9% 13.6% 13.7% Research and development expenses(2) 8.9% 8.7% 9.0% 9.3% 10.3% Operating income(2) 57.1% 56.1% 55.6% 53.6% 54.7% Earnings before income taxes(2) 58.9% 59.8% 57.7% 54.9% 55.9% Net earnings(2) 39.9% 40.2% 38.1% 36.2% 37.0% Net earnings $105,242 $103,558 $ 85,111 $ 73,351 $ 66,132 Diluted earnings per share $ 2.78 $ 2.64 $ 2.15 $ 1.85 $ 1.62 Average common and common equivalent shares - diluted (in thousands) 37,900 39,247 39,513 39,594 40,920 Share price: High $ 81.90 $ 79.73 $ 61.87 $ 60.14 $ 47.25 Low $ 45.64 $ 56.20 $ 45.63 $ 46.40 $ 33.11 Balance Sheet Data as of June 30: Cash, cash equivalents and short-term available- for-sale investments $202,887 $206,345 $164,774 $108,846 $ 97,134 Receivables 31,153 33,332 30,966 25,078 23,722 Inventories 11,269 9,515 8,757 9,024 7,758 Working capital 239,944 238,194 195,645 131,856 120,965 Total assets 472,005 507,369 454,844 370,512 295,263 Long-term debt, less current portion -- -- -- 12,198 13,378 Cash Flow Data: Net cash provided by operating activities $111,321 $115,317 $ 90,503 $ 85,589 $ 74,433 Capital expenditures 6,556 16,365 8,076 4,603 11,410 Cash dividends declared per common share(4) 0.75 -- -- -- -- Financial Ratios: Return on average equity 22.3% 22.4% 21.9% 24.1% 23.4% Return on average assets 21.5% 21.5% 20.6% 22.0% 21.3% Current ratio 16.5 12.8 12.4 8.3 9.6 Price to earnings ratio(3) 23 29 27 28 28 Employee Data as of June 30: Full-time employees 687 666 628 577 538 (1) The Company acquired Fortron Bio Science, Inc. and BiosPacific, Inc. on July 1, 2005. Fortron Bio Science, Inc. was merged into R&D Systems on July 1, 2007. (2) As a percent of net sales. (3) Common share price at end of fiscal year (June 30) divided by the diluted earnings per share for the respective fiscal year. (4) The Company's Board of Directors periodically considers the payment of cash dividends. 15 ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Overview TECHNE Corporation and Subsidiaries (the Company) are engaged in the development, manufacture and sale of biotechnology products and hematology calibrators and controls. These activities are conducted domestically through its wholly-owned subsidiaries, Research and Diagnostic Systems, Inc. (R&D Systems) and BiosPacific, Inc. (BiosPacific). The Company distributes biotechnology products in Europe through its wholly-owned U.K. subsidiary, R&D Systems Europe Ltd. (R&D Europe). R&D Europe has a sales subsidiary, R&D Systems GmbH, in Germany and a sales office in France. The Company distributes biotechnology products in China through its wholly-owned subsidiary, R&D Systems China Co. Ltd. (R&D China). The Company has three reportable operating segments based on the nature of products and geographic location: biotechnology, R&D Europe and hematology. The biotechnology segment consists of R&D Systems' Biotechnology Division, BiosPacific and R&D China, which develop, manufacture and sell biotechnology research and diagnostic products world-wide. R&D Europe distributes Biotechnology Division products throughout Europe. The hematology segment develops and manufactures hematology controls and calibrators for sale world- wide. Overall Results Consolidated net sales and consolidated net earnings increased 2.5% and 1.6%, respectively, for fiscal 2009 as compared to fiscal 2008. Consolidated net sales and consolidated net earnings in fiscal 2009 were unfavorably affected by the strengthening of the U.S. dollar as compared to foreign currencies. The unfavorable impact on consolidated net sales in fiscal 2009 of the change from the prior year in exchange rates used to convert sales in foreign currencies (primarily British pounds sterling and euros) into U.S. dollars was $8.6 million. The unfavorable impact on consolidated net earnings in fiscal 2009 of the change from the prior year in exchange rates used to convert foreign currency financial statements to U. S. dollars was $4.5 million. Consolidated net sales and consolidated net earnings increased 15.2% and 21.7%, respectively, for fiscal 2008 as compared to fiscal 2007. The favorable impact on consolidated net sales of the change from the prior year in exchange rates used to convert sales in foreign currencies into U.S. dollars was $6.4 million for fiscal 2008. The favorable impact on fiscal 2008 consolidated net earnings, as compared to fiscal 2007, from changes in exchange rates used to convert foreign currency financial statements to U.S. dollars was $1.3 million. Results of Operations Net sales (in thousands): Year Ended June 30, 2009 2008 2007 -------- -------- -------- Biotechnology $173,913 $165,663 $146,614 R&D Europe 72,541 75,735 61,766 Hematology 17,502 16,022 15,102 -------- -------- -------- $263,956 $257,420 $223,482 ======== ======== ======== Consolidated net sales for fiscal 2009 were $264.0 million, an increase of $6.5 million (2.5%) from fiscal 2008. Consolidated net sales were unfavorably affected by the strength of the U.S. dollar as compared to foreign currencies. Excluding the effect of changes in foreign currency exchange rates, consolidated net sales increased 5.9% in fiscal 2009 from fiscal 2008. Included in consolidated net sales in fiscal 2009 were $3.4 million of sales of new biotechnology products, which had their first sale in fiscal 2009. Biotechnology net sales in fiscal 2009 increased $8.3 million (5.0%) from fiscal 2008. The majority of the biotechnology net sales increase was from increased sales volume. Biotechnology net sales to international distributors, pharmaceutical/biotechnology customers and academic customers increased 6.2%, 4.7% and 3.9%, respectively, in fiscal 2009 from fiscal 2008. R&D Europe net sales decreased $3.2 million (4.2%) in fiscal 2009. R&D Europe net sales increased 7.2% for fiscal 2009 when measured at currency rates in effect in fiscal 2008, mainly as a result of increased sales volume. Hematology net sales in fiscal 2009 increased $1.5 million (9.2%) mainly due to increased sales volume. Consolidated net sales for fiscal 2008 were $257.4 million, an increase of $33.9 million (15.2%) from fiscal 2007. Consolidated net sales were favorably affected by the strength of foreign currencies as compared to the U.S. dollar. Excluding the effect of changes in foreign currency exchange rates, consolidated net sales increased 12.3% for fiscal 2008. 16 Biotechnology net sales in fiscal 2008 increased $19.0 million (13.0%) from fiscal 2007. The majority of the biotechnology net sales increase was from increased sales volume, including shipments to diagnostic customers. Increased sales to diagnostic customers positively affected biotechnology net sales in fiscal 2008. Excluding sales to diagnostic customers, biotechnology net sales increased 12.4% for fiscal 2008 as compared to the prior fiscal year. Biotechnology net sales to international distributors, pharmaceutical/biotechnology customers and academic customers increased 14.5%, 10.0% and 7.7%, respectively, in fiscal 2008 from fiscal 2007. R&D Europe net sales increased $14.0 million (22.6%) in fiscal 2008. R&D Europe net sales increased 12.2% for fiscal 2008 when measured at currency rates in effect in fiscal 2007, mainly as a result of increased sales volume. Hematology net sales in fiscal 2008 increased $920,000 (6.1%) mainly due to increased sales volume. Gross margins, as a percentage of net sales, were as follows: Year Ended June 30, 2009 2008 2007 -------- -------- -------- Biotechnology 79.3% 79.7% 79.9% R&D Europe 51.7% 56.5% 52.9% Hematology 45.9% 41.0% 43.1% Consolidated 79.0% 79.5% 79.1% The decline in consolidated gross margins for fiscal 2009 was mainly the result of lower gross margins at R&D Europe due to unfavorable exchange rates between a stronger U.S. dollar and weaker euro and British pound sterling. The improvement in consolidated gross margins for fiscal 2008 was the result of higher gross margins at R&D Europe due to favorable exchange rates between a weaker U.S. dollar and stronger euro and British pound sterling and the result of higher sales growth in the Biotechnology Division as compared to the sales growth in the lower margin Hematology Division. Selling, general and administrative expenses decreased $3.6 million (9.7%) and increased $5.8 million (18.6%) in fiscal 2009 and 2008, respectively. Selling, general and administrative expenses were as follows (in thousands): Year Ended June 30, 2009 2008 2007 -------- -------- -------- Biotechnology $ 19,035 $ 20,981 $ 17,460 R&D Europe 7,967 9,667 8,756 Hematology 1,463 2,003 1,690 Corporate 4,699 4,064 3,059 -------- -------- -------- $ 33,164 $ 36,715 $ 30,965 ======== ======== ======== The change from the comparable fiscal year was primarily the result of the following (in thousands): Increase/(Decrease) 2009 2008 -------- -------- Profit sharing and bonus expense $ (3,759) $ 1,997 Change in exchange rates to convert British pounds to U.S dollars (2,024) 311 Legal fees 786 837 Stock-based compensation expense (249) 151 China selling, general and administrative expense 91 552 Other, including annual wage, salary and benefit increases 1,604 1,902 -------- -------- $ (3,551) $ 5,750 ======== ======== The increase in legal fees in both fiscal years was due to ongoing patent interference and infringement litigation. The decrease in stock-based compensation expense in fiscal 2009 was mainly the result of decreased stock volatility and interest rates used to calculate the fair value of options granted. The increase in stock-based compensation expense in fiscal 2008 was due to an increase in the number of stock options granted in fiscal 2008 compared to fiscal 2007 as a result of expanding the Board of Directors by one member. Operations in China were established in late fiscal 2007, resulting in increased expenses in fiscal 2008. The remainder of the change in selling, general and administrative expenses for both fiscal years was mainly the result of annual wage, salary and benefit increases. Research and development expenses increased $1.2 million (5.2%) and $2.3 million (11.5%) in fiscal 2009 and 2008, respectively, as compared to prior- year periods. The increases were primarily the result of the development of new cytokines, antibodies and assay kits by R&D Systems' Biotechnology Division. The Company introduced over 1,400 new biotechnology products in both fiscal 2009 and 2008, respectively. Research and development expenses are composed of the following (in thousands): Year Ended June 30, 2009 2008 2007 -------- -------- -------- Biotechnology $ 22,792 $ 21,632 $ 19,333 Hematology 772 762 749 -------- -------- -------- $ 23,564 $ 22,394 $ 20,082 ======== ======== ======== Amortization of intangible assets. Amortization expense was $1.0 million, $1.1 million and $1.6 million in fiscal 2009, 2008 and 2007, respectively, related mainly to technologies, trade names and customer relationships acquired as a result of acquisitions in fiscal 2006. Intangible assets are being amortized over lives of two to eight years. 17 Interest income and expense. Interest income for fiscal 2009, 2008 and 2007 was $7.6 million, $12.2 million and $8.4 million, respectively. The decrease in fiscal 2009 from the prior fiscal year was primarily the result of lower rates of return on cash and available-for-sale investments. The increase in fiscal 2008 from the prior year was due to higher cash and investment balances and increased interest rates. Interest expense in fiscal 2007 was $1.1 million. Through October 2006, the Company had a floating interest rate mortgage note outstanding. Fiscal 2007 interest expense included $651,000 of prepayment penalty and $78,000 of unamortized loan origination fees. Other non-operating (expense) income consists mainly of foreign currency transaction gains and losses, rental income, building expenses related to rental property, the Company's share of losses by equity method investees as follows (in thousands): Year Ended June 30, 2009 2008 2007 ------- ------- ------- Foreign currency (losses) gains $ (34) $ 807 $ (82) Rental income 481 404 686 Real estate taxes, depreciation and utilities (2,208) (2,315) (2,212) Losses by equity method investees (1,290) (1,140) (966) Impairment loss on marketable equity security -- (400) -- ------- ------- ------- $(3,051) $(2,644) $(2,574) ======= ======= ======= The Company has two equity method of accounting investments in limited liability companies, Hemerus Medical, LLC (Hemerus) and Nephromics, LLC (Nephromics). See Cash flows from investing activities following. The Company has an investment in the common stock of Immunicon Corporation (IMMC), a publicly-held company primarily focused on the development and sale of cancer diagnostic and research products and services. In June 2008, IMMC filed for relief under Chapter 11 of the U.S. Bankruptcy Code and announced the sale of substantially all of its assets. The Company determined that the reduction in market value of its investment in IMMC was other-than-temporary and wrote off its investment in fiscal 2008. Income taxes for fiscal 2009, 2008 and 2007 were provided at rates of approximately 32.3%, 32.7% and 34.0%, respectively, of consolidated earnings before income taxes. The fiscal 2009 consolidated tax rate was positively impacted by the renewal of the U.S. research and development credit. The fiscal 2009 credit included $354,000 of credit for the January to June 2008 period. The fiscal 2008 consolidated tax rate was positively impacted by changes in state apportionment percentages partially offset by the reduction of the credit for research and development expenditures as a result of the delayed renewal of the credit. U.S. federal taxes have been reduced by the benefit for extraterritorial income through December 2006 and the manufacturer's deduction provided for under the American Jobs Creation Act of 2004. Foreign income taxes have been provided at rates which approximate the tax rates in the countries in which R&D Europe and R&D China operate. The Company expects income tax rates for fiscal 2010 to range from 32% to 33%. QUARTERLY FINANCIAL INFORMATION (Unaudited) (in thousands, except per share data) Fiscal 2009 Fiscal 2008 First Second Third Fourth First Second Third Fourth Qtr. Qtr. Qtr. Qtr. Qtr. Qtr. Qtr. Qtr. ------- ------- ------- ------- ------- ------- ------- ------- Net sales $69,324 $61,876 $67,866 $64,890 $57,987 $62,142 $69,522 $67,769 Gross margin 56,238 48,446 53,550 50,234 45,883 49,391 55,376 53,881 Earnings before taxes 42,948 34,150 40,841 37,424 34,753 35,581 42,992 40,505 Income taxes 14,355 10,528 13,200 12,038 11,681 11,942 13,402 13,248 Net earnings 28,593 23,622 27,641 25,386 23,072 23,639 29,590 27,257 Basic earnings per share 0.74 0.62 0.74 0.68 0.58 0.60 0.76 0.70 Diluted earnings per share 0.74 0.62 0.74 0.68 0.58 0.60 0.76 0.70 Liquidity and Capital Resources Cash, cash equivalents and available-for-sale investments at June 30, 2009 were $264.8 million compared to $293.7 million at June 30, 2008. The Company has an unsecured line of credit of $750,000 available at June 30, 2009 which expires on October 31, 2009. The interest rate charged on the line of credit is a floating rate at the one month London interbank offered rate (Libor) plus 1.75%. There were no borrowings on the line in the current or prior fiscal year. Management of the Company expects to be able to meet its foreseeable future cash and working capital requirements for operations, facility expansion and capital additions through currently available funds, cash generated from operations and maturities of available-for-sale investments. Cash flows from operating activities The Company generated cash from operations of $111.3 million, $115.3 million and $90.5 million in fiscal 2009, 2008 and 2007, respectively. The decrease in cash generated from operating activities in fiscal 2009 as compared to fiscal 2008 was mainly the result of changes in operating assets and liabilities offset by increased net earnings of $1.7 million. In fiscal 2009, changes in operating assets and liabilities negatively impacted net cash from operating activities by $4.1 million compared to a positive impact in fiscal 2008 of $2.2 million as a result of changes in the timing of cash payments and receipts. 18 The increase in cash generated from operating activities in fiscal 2008 as compared to fiscal 2007 was mainly the result of increased net earnings of $18.4 million. In addition, changes in operating assets and liabilities in fiscal 2008 positively impacted net cash from operating activities by $2.2 million compared to a negative impact in fiscal 2007 of $3.0 million as a result of changes in the timing of cash payments and receipts. Cash flows from investing activities Capital additions consist of the following (in thousands): Year Ended June 30, 2009 2008 2007 -------- -------- -------- Laboratory, manufacturing, and computer equipment $ 2,573 $ 3,010 $ 2,484 Construction/renovation 1,810 5,012 5,592 Property purchases 2,173 8,343 -- -------- -------- -------- $ 6,556 $ 16,365 $ 8,076 ======== ======== ======== Included in fiscal 2009, 2008 and 2007 capital additions were approximately $1.8 million, $4.3 million and $5.6 million, respectively, related to the construction and renovation of laboratory space at the Company's Minneapolis facility. The additional construction in fiscal 2008 was for the build out of rental space for tenants. Construction was financed through available cash. In fiscal 2009, the Company purchased two parking lots adjacent to its Minneapolis facility for $2.2 million. In fiscal 2008, the Company purchased the facility it had been leasing for its R&D Europe operations in Abingdon, England for $8.3 million. The property purchases were financed through available cash. Capital additions for laboratory, manufacturing and computer equipment and space renovations planned for fiscal 2010 are expected to be approximately $6.1 million and are expected to be financed through currently available cash and cash generated from operations. The Company's net (sales) purchases of available-for-sale investments in fiscal 2009, 2008 and 2007 were ($26.5) million, $8.6 million and $23.8 million, respectively. The Company's investment policy is to place excess cash in municipal and corporate bonds with the objective of obtaining the highest possible return while minimizing risk and keeping the funds accessible. Additional investments in unconsolidated entities were as follows (in thousands): Year Ended June 30, 2009 2008 2007 -------- -------- -------- ACTGen, Inc. $ -- $ 1,423 $ -- Hemerus -- 300 700 Nephromics -- -- 7,200 -------- -------- -------- $ -- $ 1,723 $ 7,900 ======== ======== ======== In fiscal 2008, the Company invested $1.4 million for a 19% interest in ACTGen, Inc. (ACTGen), a development stage biotechnology company located in Japan. The Company's net investment in ACTGen at June 30, 2009 and 2008 was $1.2 million and $1.3 million, respectively. In fiscal 2004, the Company purchased a 10% interest in Hemerus for $3 million. In fiscal years 2006 through 2008, the Company invested an additional $1.75 million in Hemerus, increasing its ownership percentage to 19%. In fiscal 2009, as a result of Hemerus repurchasing and retiring a third party's membership units, the Company's ownership percentage increased to 22%. The Company's net investment in Hemerus at June 30, 2009 and 2008 was $2.2 million and $2.9 million, respectively. Hemerus' success is dependent on its ability to market its products and to obtain adequate financing. The Company has financial exposure to any losses of Hemerus to the extent of its net investment. In fiscal 2007, the Company invested $7.2 million for an 18% equity interest in Nephromics. In fiscal 2008, Nephromics issued additional membership units which reduced the Company's ownership percentage to 16.8%. In fiscal 2009, the Company received a $1.3 million distribution from Nephromics. At June 30, 2009 and 2008, the Company's net investment in Nephromics was $4.5 million and $6.2 million, respectively. The Company has financial exposure to any losses of Nephromics to the extent of its net investment. All of the above investments were financed through cash and equivalents on hand. Cash flows from financing activities The Company received $953,000, $3.1 million and $2.7 million for the exercise of options for 21,000, 86,000 and 78,000 shares of common stock in fiscal 2009, 2008 and 2007, respectively. The Company recognized excess tax benefits from stock option exercises of $107,000, $524,000 and $534,000 in fiscal 2009, 2008 and 2007, respectively. 19 In fiscal 2009, 2008 and 2007, the Company purchased 22,637, 23,641 and 24,400 shares of common stock, respectively, for its employee Stock Bonus Plans at a cost of $1.7 million, $1.5 million and $1.2 million, respectively. In fiscal 2008, the Board of Directors authorized the Company to purchase up to $150 million of its common stock and in fiscal 2009 increased the authorization by $60 million. In fiscal 2009 and 2008, the Company purchased and retired 1.4 million and 899,000 shares of common stock at market values of $90.6 million and $58.7 million, respectively. Approximately $67.5 million remained available for purchase under these authorizations at June 30, 2009. In fiscal 2009, the Company paid three quarterly cash dividends of $0.25 per share per quarter totaling $28.2 million. The Board of Directors plans to periodically consider the payment of cash dividends. In fiscal 2007, the Company paid off its mortgage debt. The total payment of $13.8 million included a prepayment penalty of $651,000 which is included in interest expense in the consolidated statement of earnings for fiscal 2007. Contractual Obligations The following table summarizes the Company's contractual obligations and commercial commitments as of June 30, 2009 (in thousands): Payments Due by Period Less than 1-3 3-5 After Total 1 Year Years Years 5 Years ------- --------- ----- ----- ------- Operating leases $ 867 $ 332 $ 344 $ 174 $ 17 Minimum royalty payments 166 166 -- -- -- ------- --------- ----- ----- ------- $ 1,033 $ 498 $ 344 $ 174 $ 17 ======= ========= ===== ===== ======= The above table does not include any reserves for income taxes under the Financial Accounting Standards Board (FASB) Interpretation No. 48, Accounting for Uncertainty in Income Taxes - an interpretation of FASB Statement No. 109, as the Company is unable to reasonably predict the ultimate amount or timing of settlement of any reserve for income taxes. Off-balance Sheet Arrangements The Company is not a party to any off-balance sheet transactions, arrangements or obligations that have, or are reasonably likely to have, a current or future material effect on the Company's financial condition, changes in the financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources. Critical Accounting Policies Management's discussion and analysis of the Company's financial condition and results of operations are based upon the Company's consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP). The preparation of these financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. The Company has identified the policies outlined below as critical to its business operations and an understanding of results of operations. The listing is not intended to be a comprehensive list of all accounting policies. Valuation of available-for-sale investments. The Company considers all of its marketable securities available-for-sale and reports them at fair market value. Fair market values are based on quoted market prices. Unrealized gains and losses on available-for-sale investments are excluded from income, but are included, net of taxes, in other comprehensive income. If an "other-than- temporary" impairment is determined to exist, the difference between the value of the investment recorded in the financial statements and the Company's current estimate of fair value is recognized as a charge to earnings in the period in which the impairment is determined. Net unrealized gains on available-for-sale investments at June 30, 2009 were $874,000. Valuation of inventory. Inventories are stated at the lower of cost (first- in, first-out method) or market. The Company regularly reviews inventory on hand for slow-moving and obsolete inventory, inventory not meeting quality control standards and inventory subject to expiration. 20 To meet strict customer quality standards, the Company has established a highly controlled manufacturing process for proteins and antibodies. New protein and antibody products require the initial manufacture of multiple batches to determine if quality standards can be consistently met. In addition, the Company will produce larger batches of established products than current sales requirements due to economies of scale. The manufacturing process for proteins and antibodies, therefore, has and will continue to produce quantities in excess of forecasted usage. The Company values its manufactured protein and antibody inventory based on a two-year forecast. The establishment of a two-year forecast requires considerable judgment. Protein and antibody quantities in excess of the two-year usage forecast are considered impaired and not included in the inventory value. The value of protein and antibody inventory reserved at June 30, 2009 was $17.7 million. Valuation of goodwill. The Company is required to perform an annual review for impairment of goodwill in accordance with FASB Statement of Financial Accounting Standards (SFAS) No. 142, Goodwill and Other Intangible Assets. Goodwill is considered to be impaired if it is determined that the carrying amount of the reporting unit exceeds its fair value. Assessing the impairment of goodwill requires the Company to make judgments regarding the fair value of the net assets of its reporting units and the allocation of the carrying amount of shared assets to the reporting units. The Company's annual assessment included comparison of the carrying amount of the net assets of a reporting unit, including goodwill, to the fair value of the reporting unit. A significant change in the Company's market capitalization or in the carrying amount of net assets of a reporting unit could result in an impairment charge in future periods. Goodwill at June 30, 2009 was $25.1 million. Valuation of intangible and other long-lived assets. The Company reviews the carrying amount of intangible and other long-lived assets for impairment whenever events or changes in circumstances indicate the carrying amount of an asset may not be recoverable. This assessment requires the Company to make assumptions and judgments regarding the fair value of these asset groups. Asset groups are considered to be impaired if their carrying amount exceeds the asset groups' ability to continue to generate income from operations and positive cash flow in future periods. If asset groups are considered impaired, the amount by which the carrying amount exceeds its fair value would be expensed as an impairment loss. The net carrying amount of intangible assets at June 30, 2009 was $3.0 million. The net carrying amount of property and equipment was $100.1 million at June 30, 2009. Valuation of investments. The Company has made equity investments in several start-up and early development stage companies, among them ChemoCentryx, Inc. (CCX), Hemerus, Nephromics and ACTGen. The accounting treatment of each investment (cost method or equity method) is dependent upon a number of factors, including, but not limited to, the Company's share in the equity of the investee and the Company's ability to exercise significant influence over the operating and financial policies of the investee. In determining which accounting treatment to apply, the Company must make judgments based upon the quantitative and qualitative aspects of the investment. The Company periodically assesses its equity investments for impairment. Development stage companies of the type the Company has invested in are dependent on their ability to raise additional funds to continue research and development efforts and on receiving patent protection and/or U.S. Food and Drug Administration (FDA) clearance to market their products. If such funding were unavailable or inadequate to fund operations or if patent protection or FDA clearance were not received, the Company would potentially recognize an impairment loss to the extent of its remaining net investment. The Company's net investments at June 30, 2009 in CCX, Hemerus, Nephromics and ACTGen were $14.3 million, $2.2 million, $4.5 million and $1.2 million, respectively. Recent Accounting Pronouncements In June 2009, the FASB issued SFAS No. 168, The FASB Accounting Standards Codification and the Hierarchy of Generally Accepted Accounting Principles. SFAS No. 168 will become the single source of authoritative nongovernmental U.S. GAAP, superseding existing FASB and other related accounting literature. SFAS No. 168 will be effective for the Company for the quarter ending September 30, 2009. The Company does not expect the adoption of the Codification to have an impact on the consolidated financial statements. 21 In June 2009, the FASB issued SFAS No. 167, Amendments to FASB Interpretation No. 46(R), which is effective for the Company beginning July 1, 2010. This Statement amends FIN 46(R), Consolidation of Variable Interest Entities an interpretation of ARB No. 51, to require revised evaluations of whether entities represent variable interest entities, ongoing assessments of control over such entities, and additional disclosures for variable interests. The Company believes the adoption of this pronouncement will not have an impact on the Company's consolidated financial statements. In February 2008, the FASB amended SFAS No. 157, Fair Value Measurements, to defer the effective date of SFAS No. 157 for all nonfinancial assets and liabilities that are not remeasured at fair value on a recurring basis. As disclosed in Note A to the Consolidated Financial Statements following, the Company partially adopted the provisions of SFAS No. 157 effective in the first quarter of fiscal 2009. The Company expects to adopt the remaining provisions of SFAS No. 157 beginning in the first quarter of fiscal 2010. The adoption of the provisions of SFAS No. 157 related to other nonfinancial assets and liabilities is not expected to have a material impact on the Company's consolidated financial statement disclosures. Market Risk At the end of fiscal 2009, the Company had an independently managed investment portfolio of fixed income securities, excluding those classified as cash and cash equivalents, of $103.8 million (see Note B 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, because the Company's fixed income securities are classified as available-for-sale, no gains or losses are recognized by the Company in its Consolidated Statement of Earnings due to changes in interest rates unless such securities are sold prior to maturity. The Company generally holds its fixed income securities until maturity and, historically, has not recorded any material gains or losses on any sale prior to maturity. The Company operates internationally, and thus is subject to potentially adverse movements in foreign currency rates. Approximately 29% of consolidated net sales are made in foreign currencies including 15% in euro, 6% in British pound sterling, 2% in Chinese yuan and the remaining 6% in other European currencies. As a result, the Company is exposed to market risk mainly from foreign exchange rate fluctuations of the euro, British pound sterling, and the Chinese yuan as compared to the U.S. dollar as the financial position and operating results of the Company's foreign operations are translated into U.S. dollars for consolidation. Exchange rates between the British pound sterling, euro and Chinese yuan and the U.S. dollar were as follows based on month-end ratios: Year Ended June 30, 2009 2008 2007 -------- -------- -------- British pound: High $ 1.98 $ 2.08 $ 2.00 Low 1.43 1.98 1.87 Average 1.60 2.01 1.95 Euro: High $ 1.56 $ 1.58 $ 1.36 Low 1.27 1.36 1.27 Average 1.37 1.48 1.31 Chinese yuan: High $ .147 $ .146 N/A Low .146 .132 N/A Average .146 .138 N/A The Company's exposure to foreign exchange rate fluctuations also arises from trade receivables and intercompany payables denominated in one currency in the financial statements, but receivable or payable in another currency. At June 30, 2009, the Company had the following trade receivable and intercompany payables denominated in one currency but receivable or payable in another currency (in thousands): Denominated U.S. Dollar Currency Equivalent ----------- ----------- Accounts receivable in: Euros 641 Br. pound $ 1,055 Other European currencies 857 Br. pound $ 1,410 Intercompany payable in: Euros 221 Br. pound $ 364 U.S. dollars 2,234 Br. pound $ 3,676 U.S. dollars 3,483 Ch. Yuan $ 510 All of the above balances are revolving in nature and are not deemed to be long-term balances. The Company does not enter into foreign exchange forward contracts to reduce its exposure to foreign currency rate changes on forecasted intercompany sales transactions or on intercompany foreign currency denominated balance sheet positions. Foreign currency transaction gains and losses are included in "Other non-operating expense" in the Consolidated Statement of Earnings. The effect of translating net assets of foreign subsidiaries into U.S. dollars are recorded on the Consolidated Balance Sheet as part of "Accumulated other comprehensive income." 22 The effects of a hypothetical simultaneous 10% appreciation in the U.S. dollar from June 30, 2009 levels against the euro, British pound sterling and Chinese yuan are as follows (in thousands): Hypothetical Effect Increase (Decrease) ------------------- Translation of 2009 earnings into U.S. dollars $ (2,225) Transaction losses 380 Translation of net assets of foreign subsidiaries (12,165) Forward-looking Information This report contains forward-looking statements, which are based on the Company's current assumptions and expectations. The principal forward-looking statements in this report include: the Company's expectations regarding future tax rates, capital expenditures, future dividend declarations, and sufficiency of capital resources to meet the Company's foreseeable future cash and working capital requirements. All such forward-looking statements are intended to enjoy the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995, as amended. Although the Company believes there is a reasonable basis for the forward-looking statements, the Company's actual results could be materially different. The most important factors which could cause the Company's actual results to differ from forward-looking statements are set forth in the Company's description of risk factors in Item 1A to the Company's Annual Report on Form 10-K, which should be read in conjunction with the forward looking statements in this report, and include the following: - The Company's revenues are significantly dependent on sales to research scientists in the private and public sector, and a decrease in research spending could negatively impact the Company's revenues. - The Company operates in rapidly changing and intensely competitive industries, and may not be able to keep pace with its competitors. - The Company is significantly dependent on sales made through foreign subsidiaries, and revenues and earnings could be negatively impacted by changes in exchange rates. - The Company's business is subject to governmental regulation, which may have the effect of delaying or impeding the release of certain of its products. - The Company is dependent on maintaining its intellectual property rights, and cannot guarantee that it will not be subject to intellectual property litigation in the future. - The Company's success will be dependent on recruiting and retaining highly qualified personnel, the loss of whom could adversely affect its operations. - The Company may incur losses as a result of its investments in other companies, the success of which is largely out of the Company's control. - The Company may be unsuccessful in expanding into China and establishing adequate distribution channels for its products in China. Forward-looking statements speak only as of the date they are made, and the Company does not undertake any obligation to update any forward-looking statements. ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK See discussion under "Market Risk" in Item 7. Management's Discussion and Analysis of Financial Conditions and Results of Operations. 23 ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA CONSOLIDATED STATEMENTS OF EARNINGS TECHNE Corporation and Subsidiaries (in thousands, except per share data) Year Ended June 30, 2009 2008 2007 -------- -------- -------- Net sales $263,956 $257,420 $223,482 Cost of sales 55,488 52,889 46,667 -------- -------- -------- Gross margin 208,468 204,531 176,815 -------- -------- -------- Operating expenses: Selling, general and administrative 33,164 36,715 30,965 Research and development 23,564 22,394 20,082 Amortization of intangible assets 960 1,135 1,614 -------- -------- -------- Total operating expenses 57,688 60,244 52,661 -------- -------- -------- Operating income 150,780 144,287 124,154 -------- -------- -------- Other (expense) income: Interest expense -- -- (1,083) Interest income 7,634 12,188 8,434 Other non-operating expense, net (3,051) (2,644) (2,574) -------- -------- -------- Total other income 4,583 9,544 4,777 -------- -------- -------- Earnings before income taxes 155,363 153,831 128,931 Income taxes 50,121 50,273 43,820 -------- -------- -------- Net earnings $105,242 $103,558 $ 85,111 ======== ======== ======== Earnings per share: Basic $ 2.78 $ 2.65 $ 2.16 Diluted $ 2.78 $ 2.64 $ 2.15 Cash dividends per common share: $ 0.75 -- -- Weighted average common shares outstanding: Basic 37,802 39,139 39,406 Diluted 37,900 39,247 39,513 See Notes to Consolidated Financial Statements. 24 CONSOLIDATED BALANCE SHEETS TECHNE Corporation and Subsidiaries (in thousands, except per share data) June 30, 2009 2008 -------- -------- Assets Current assets: Cash and cash equivalents $160,940 $166,992 Short-term available-for-sale investments 41,947 39,353 Trade accounts receivable, less allowance for doubtful accounts of $357 and $153, respectively 29,516 31,747 Other receivables 1,637 1,585 Inventories 11,269 9,515 Deferred income taxes 9,345 8,433 Prepaid expenses 813 808 -------- -------- Total current assets 255,467 258,433 Available-for-sale investments 61,863 87,384 Property and equipment, net 100,133 101,722 Goodwill 25,068 25,068 Intangible assets, net 3,004 3,964 Deferred income taxes 3,601 5,055 Investments in unconsolidated entities 22,119 24,749 Other assets 750 994 -------- -------- $472,005 $507,369 ======== ======== Liabilities and Stockholders' Equity Current liabilities: Trade accounts payable $ 5,156 $ 4,343 Salaries, wages and related accruals 4,010 8,584 Other accounts payable and accrued expenses 2,311 1,768 Income taxes payable 4,046 5,544 -------- -------- Total current liabilities 15,523 20,239 -------- -------- Commitments and contingencies (Note H) Stockholders' equity: 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 37,244,029 and 38,643,480 shares, respectively 372 386 Additional paid-in capital 117,946 115,408 Retained earnings 345,641 359,208 Accumulated other comprehensive (loss) income (7,477) 12,128 -------- -------- Total stockholders' equity 456,482 487,130 -------- -------- $472,005 $507,369 ======== ======== See Notes to Consolidated Financial Statements. 25 CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY AND COMPREHENSIVE INCOME (LOSS) TECHNE Corporation and Subsidiaries (in thousands)