-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, D9tn/A5YGro9bQUthluYC3pxHprmDDDKZyePovFtnZnOu3pK/hKDAalDZOKW+n3k NIid7n0aqqzlvZ4nEGZSEA== 0001012870-99-000968.txt : 19990403 0001012870-99-000968.hdr.sgml : 19990403 ACCESSION NUMBER: 0001012870-99-000968 CONFORMED SUBMISSION TYPE: 10-K405 PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 19981231 FILED AS OF DATE: 19990331 FILER: COMPANY DATA: COMPANY CONFORMED NAME: APPLIED IMAGING CORP CENTRAL INDEX KEY: 0000816066 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 770120490 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K405 SEC ACT: SEC FILE NUMBER: 000-21371 FILM NUMBER: 99583505 BUSINESS ADDRESS: STREET 1: 2380 WALSH AVE BLDG B CITY: SANTA CLARA STATE: CA ZIP: 95051 BUSINESS PHONE: 4085620250 MAIL ADDRESS: STREET 1: 2380 WALSH AVE STREET 2: BUILDING B CITY: SANTA CLARA STATE: CA ZIP: 95051 10-K405 1 FORM 10-K - ------------------------------------------------------------------------------- - ------------------------------------------------------------------------------- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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 December 31, 1998 or [_]Transition Report Pursuant to Section 13 or 15 (d) of the Securities Exchange Act of 1934 Commission File Number: 0-21371 APPLIED IMAGING CORP. (Exact name of registrant as specified in its charter)
Delaware 77-0120490 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) (Identification No.) 2380 Walsh Avenue, Building B, Santa Clara, California 95051 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (408) 562-0250 Securities registered pursuant to Section 12 (b) of the Act: Name of each exchange Title of each class on which registered None N/A
Securities registered pursuant to Section 12 (g) of the Act: Common Stock, $0.001 par value (Title of Class) 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 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. [X] The aggregate market value of voting stock held by non-affiliates of the registrant, based upon the closing sale price of the Common Stock on March 8, 1999, as reported on the NASDAQ National Market, was approximately $11,529,537. The number of shares of Common Stock outstanding as of March 8, 1999: 11,529,537 shares. DOCUMENTS INCORPORATED BY REFERENCE Part III of this Form 10-K incorporates information by reference from the Registrant's definitive proxy statement to be filed with the Securities and Exchange Commission within 120 days after the close of the fiscal year. - ------------------------------------------------------------------------------- - ------------------------------------------------------------------------------- PART I Item 1. BUSINESS This Report on Form 10-K contains certain forward looking statements regarding future events with respect to Applied Imaging Corp. Actual events or results may differ materially as a result of the factors described herein and in the documents incorporated herein by reference, including, in particular, those factors described under "Additional Risk Factors." The Company Applied Imaging Corp ("Applied Imaging" or the "Company") was incorporated in California in July 1986, and reincorporated in Delaware in October 1996. Applied Imaging designs, develops, manufactures and markets automated image analysis systems used by cytogenetic laboratories for prenatal, cancer and other genetic testing applications. The Company's cytogenetic instrumentation and reagent business, which has sold systems to over 650 sites in more than 35 countries since its inception, markets computer-based microscopic image analysis systems that enable laboratories to automate the analysis of chromosomal abnormalities associated with conditions such as Down Syndrome. The Company is also developing a proprietary genetic screening technology designed to facilitate prenatal screening for genetic abnormalities by isolating "fetal blood cells" from a routine maternal blood sample. This new technology is designed to improve current prenatal testing methods by providing a timely and cost-effective screening procedure without the risks of miscarriage or fetal damage associated with invasive prenatal tests such as amniocentesis or chorionic villus sampling. In addition, the company has under development a system to detect micrometastatic cells from bone marrow, lymph node and blood samples from cancer patients as a means to better determine the initial staging of the cancer and then detect relapses after treatment earlier than is currently possible. According to the Company's own analysis of its primary competitors' publicly available financial data, Applied Imaging is a leading provider of automated chromosomal image analysis systems to clinical and research laboratories worldwide. The Company's CytoVisionTM systems are utilized because of their ability to analyze standard human chromosome preparations using powerful software classification algorithms along with a specialized cytogenetic user interface. The CytoVision systems also incorporate the capability to analyze and record images derived from advanced genetic research assays employing fluorescent in situ hybridization ("FISH") or comparative genomic hybridization ("CGH") methods. The Company has introduced its first proprietary assay for color chromosome analysis (called RxFISHTM), a rapidly developing area of research interest. Based upon a novel method developed by scientists at The University of Cambridge, the Company's RxFISHTM assay develops a unique fluorescent color banding pattern for human chromosomes that is then analyzed by the CytoVisionTM system. The future development of specialized reagent products that can be optimized for use on the Company's installed base of over 1100 chromosome analysis workstations worldwide is one aspect of the Company's business strategy. The Company's prenatal genetic screening development program is focused on the isolation of specific fetal cells from a blood sample taken from the expectant mother using normal venipuncture techniques. This allows prenatal genetic testing to be performed without the need to obtain a fetal tissue sample by an invasive procedure, such as amniocentesis, which can pose a physical risk to the fetus. The Company's proprietary screening technology incorporates (i) a hematological procedure to enrich the concentration of fetal blood cells found in maternal blood, (ii) a fetal hemoglobin test kit, (iii) automated image analysis instrumentation to identify fetal blood cells and (iv) third-party DNA probes to identify certain chromosomal abnormalities present in these fetal blood cells. This prenatal screening system is expected to be both safe and accurate because it evaluates actual fetal cells while posing no direct risk to the fetus. The Company's prenatal screening products are currently under development. The Company has received notice from the U.S. Food and Drug Administration, ("FDA"), that it may market either of two components utilized in its prenatal screening method (the ENRICH Kit and its WinScan Automated Image Analysis System). The Company has chosen not to market these components on a stand-alone basis at the present time. The Company believes that certain of its new cell enrichment, identification and image 1 analysis products may also have utility for cancer testing as in the case of the detection of micrometastatic disease at the time of initial patient diagnosis and treatment. Genetic Disorders All genetic information in an organism is contained in its chromosomes, made up of strands of DNA and associated protein molecules. DNA is comprised of paired nucleotide bases and genetic information is encoded by the specific order of the nucleotide bases within units called genes. Genes are organized linearly along the chromosomes and carry the required information for the synthesis of the proteins that provide the structural components of cells and tissues, as well as the enzymes needed for the basic biochemical and physiological functions of the cells. Chromosomal Disorders The nuclei of normal human cells (except sperm and egg cells) contain two sets of 23 different chromosomes, one set provided by each parent. Sperm and egg cells are formed in a special cell division process called meiosis, and they each contain only one set of the 23 individual chromosomes. When these cells unite during fertilization, each contributes its set of 23 chromosomes to the genetic information for a new human fetus, and the fertilized egg then has the two sets of 23 chromosomes. Chromosomal disorders may occur when genes or portions of genes move between chromosomes (chromosomal translocations), when portions of chromosomes and the genes they contain are missing, or when an abnormal number of chromosomes are present in the cell. Certain chromosomal disorders are thought to occur during meiosis when the division of the chromosomes to form the egg cell or the sperm cell takes place. During this process the chromosomes may not divide properly resulting in an extra chromosome being present in the cell, an extra piece of genetic material being attached to a chromosome, or a piece of chromosome being broken. Chromosomes can be seen under a microscope and, when stained with certain dyes, reveal light and dark bands reflecting regional variations in the DNA of the cell. Differences in size and banding pattern allow the chromosomes to be distinguished from each other or may identify a chromosomal disorder. The most common chromosomal disorder, Down Syndrome, also known as trisomy 21, occurs when there are three copies of chromosome 21 in the human cell. Syndromes caused by the most common chromosomal abnormalities may result in mental retardation, impaired physical development and abnormal sexual development. There are approximately four million births in the United States annually. Of these, approximately 90% are to women under the age of 35. The Company estimates that there are approximately 11 million births in industrialized countries where prenatal screening and diagnostic testing is routine. Approximately 2% of newborns have birth defects, approximately 12% of which are caused by chromosomal genetic disorders. The risk of bearing a child with a chromosomal abnormality increases with maternal age and more than doubles from one in 526 births for mothers of age 20 to more than one in 192 births for mothers of age 35. Single Gene Disorders In addition to chromosomal disorders caused by an abnormal number of chromosomes, single gene disorders may occur when the DNA sequences of individual genes are altered, resulting in the disruption of the normal balance or function of essential human proteins. Single gene disorders are responsible for many inherited diseases such as cystic fibrosis, sickle cell anemia and Tay-Sachs disease. Cancer Cytogenetics Chromosomal analysis is also performed for clinical research purposes for the precise characterization of certain types of cancers. Cancerous cells frequently demonstrate complex chromosomal abnormalities. The patterns of these chromosomal abnormalities may be associated with certain well-defined cancers. The chromosomal analysis of leukemia and lymphomas, for example, may provide researchers with supplementary 2 information useful in the staging or classification of the disease and may also provide useful prognostic indicators. Similarly, advanced chromosomal analysis may allow a researcher to assess the sources of new disease in a patient to determine if this is a recurrence of a previous cancer or an entirely different neoplasm. Prenatal Testing Prenatal testing is the process of detecting certain types of chromosomal disorders in a fetus at an early stage of pregnancy. Prenatal testing is currently performed either invasively, by extracting fetal cells and inspecting the chromosomes within such cells to diagnose specific disorders or non-invasively, by an analysis of a maternal blood sample. The invasive diagnostic procedures yield accurate results on a broad range of chromosomal disorders because actual fetal cells are obtained and analyzed. However, these procedures involve the risk of spontaneous miscarriage and other complications. Due to the risk of spontaneous miscarriage, invasive diagnostic procedures are usually recommended only to those women who are age 35 or older (at which ages the risk of having a child with a chromosomal disorder is greater than the risk of spontaneous miscarriage due to the procedure) or who have another specific risk factor for fetal abnormalities. Those women younger than 35 are typically screened initially using non- invasive techniques. For this group, an invasive diagnostic procedure is generally recommended to confirm the result of a non-invasive blood test if such test indicates a heightened risk of a chromosomal disorder. The blood test presents no risk to the fetus, but is less accurate since it does not diagnose chromosomal genetic disorders by direct analysis of fetal cells. These non-invasive tests are known to produce relatively high levels of false negative and false positive test results. A false negative test result is seen as a failure to identify a chromosomal disorder when it is actually present, while a false positive test result occurs when a test result indicates the presence of a chromosomal disorder that is actually not present. Women under the age of 35 have a lower statistical risk of giving birth to an infant with a chromosomal disorder than do women age 35 or older. However, because the majority of all births are among women under the age of 35, the total number of newborns with chromosomal disorders born to women in this age group is much higher than that among women age 35 and older. Consequently, women younger than 35 bear over 75% of all infants with Down Syndrome. Invasive Diagnostic Procedures Amniocentesis. Amniocentesis, usually performed between the 14th and 20th weeks of pregnancy, is the most common procedure used to obtain fetal cell samples for prenatal genetic testing. In an amniocentesis procedure a small amount of amniotic fluid is withdrawn from the amniotic sac via a long needle inserted through the mother's abdominal wall. During the procedure, the physician typically uses ultrasound instrumentation to guide the needle in order to minimize potential harm to the unborn child. Once the amniotic sample is extracted, it is forwarded to a cytogenetic laboratory, where the cells are cultured and deposited on a microscope slide. The slide is then examined under a microscope in order to locate and analyze a number of fetal cells in metaphase (undergoing cell division). During metaphase, a cell's chromosomes are individually visible under the microscope. Chromosome analysis without the advantage of an automated imaging system is both tedious and time consuming. Typically, a laboratory technologist scans the slide manually to locate cells in metaphase. Once metaphase cells are found, they are photographed using a camera attached to the microscope. This photograph is then printed and each photographed chromosome is manually cut out of the photograph, arranged in order and pasted on a sheet to show the two sets of 23 chromosomes present in the cell. This visual presentation of the chromosomes is called a karyotype. Alternatively, laboratories may eliminate many of these steps by using an automated image analysis system to scan the slides for cells in metaphase, to automatically classify the chromosomes, to present them on a video display for review and acceptance and to print final karyotype copies. 3 Once the karyotype is completed it is then visually analyzed by a trained geneticist or genetic counselor to determine if any chromosomal abnormalities are present. The processing and analysis of prenatal genetic samples obtained by amniocentesis generally requires seven to 14 days. A significant portion of this time is required to culture the fetal cells for use in the visual karyotype. In the United States, amniocentesis generally costs more than $1,000 for the procedure itself, tissue culture and karyotypic assessment. With an estimated fetal loss rate of approximately 0.5% (one in every 200 procedures) one normal fetus will be lost by spontaneous miscarriage resulting from amniocentesis for every one or two fetuses with chromosomal disorders detected by this procedure for women at age 35. Amniocentesis is the most common and accurate of all prenatal screening procedures. All principal chromosomal disorders can be detected and the Down Syndrome detection rate is greater than 99%. Chorionic Villus Sampling (CVS). CVS, typically performed between the 9th and 12th weeks of pregnancy, involves the extraction of placental tissue samples, generally through the pregnant woman's cervix. The tissue, which is genetically representative of the fetus, is analyzed in the same manner as the fetal cells obtained by amniocentesis to determine if chromosomal disorders are present. CVS is an alternative to amniocentesis and can be performed earlier in the pregnancy, but poses a risk of miscarriage that is one in every 100 CVS procedures, double that of amniocentesis. CVS is generally as accurate as amniocentesis for detecting chromosomal abnormalities. With an estimated fetal loss rate of approximately 1% (one in every 100 procedures), two normal fetuses will be lost by spontaneous miscarriage resulting from CVS for every one or two fetuses with chromosomal disorders detected by this procedure for women at age 35. Due to its higher associated risk and procedural complexity CVS is used less frequently than amniocentesis for prenatal diagnostic purposes. Non-invasive Screening Procedures In the United States, approximately 2,000,000 pregnant women under the age of 35 are screened each year for chromosomal disorders and other birth defects. Of those screened, a majority are tested using the non-invasive serum tests described below. Alpha-Fetoprotein Test. A common serum prenatal screening test for certain chromosomal disorders involves the analysis of alpha-fetoprotein ("AFP") in the maternal blood. This test is performed on a standard blood sample taken from the mother that is tested for levels of serum AFP. Down Syndrome and other similar chromosomal disorders are associated with low levels of AFP. Although this serum test is relatively accurate in detecting open neural tube defects (such as spina bifida), studies indicate that the AFP test can detect only 20-30% of fetuses with Down Syndrome. Triple Test. In recent years, the accuracy of the AFP test has been improved by combining it with additional blood chemistry tests. This combination is commonly referred to as "triple marker screening" or the "triple test." This test identifies Down Syndrome in 60% of the pregnancies where Down Syndrome is present. In 40% of the cases where Down Syndrome is present, this test inaccurately concludes that Down Syndrome is not present (a false negative result). In approximately 5% of the cases, the triple test suggests the presence of a chromosomal disorder where it is not present (a false positive result). Women whose triple test screening results indicate a heightened risk of chromosomal disorder are usually recommended to have an amniocentesis procedure to confirm these results. Due to the high false positive rate associated with the triple test, clinically unnecessary amniocentesis procedures are performed in many cases where no chromosomal disorder exists. Assuming two million serum screening tests per year and a 5% false positive rate, as many as 100,000 unnecessary amniocentesis procedures may be performed on women with healthy fetuses each year in the U.S. In addition, assuming an average cost of $1,500 per amniocentesis, the unnecessary cost to the health care system associated with these false positive triple test results could be as high as $150 million per year. With an estimated fetal loss rate of 0.5%, approximately 500 normal fetuses may be lost each year as a direct result of such unnecessary amniocentesis procedures. 4 New Serum Markers In order to improve the specificity and sensitivity of the serum screening tests, new markers are being identified and tested on an ongoing basis. These new markers can be substitutes for one of the triple marker tests or additions to the testing panel. No general consensus has yet been reported in scientific literature regarding which new markers may offer the most cost-effective improvements to current screening procedures. Summary The most accurate prenatal testing involves direct analysis of fetal cells, which contain the chromosomes of the fetus. The only routinely available procedures to extract fetal cells in order to examine the fetal chromosomes are invasive and pose risks of injury to the fetus and/or spontaneous miscarriage. The non-invasive serum screening procedures, which do not pose such risks, are much less accurate because they do not allow for the direct examination of fetal chromosomes. The Company believes that there is a significant need for a prenatal testing procedure which would allow direct analysis of the fetal cells without the risks associated with the currently available invasive procedures. Fetal blood cells exist in minute quantities in samples of maternal blood. In contrast to adult red blood cells, many of these fetal red blood cells are nucleated. That is, they contain a nucleus with fetal chromosomes. A number of companies and research groups are attempting to isolate these fetal blood cells for testing through a variety of methods, including immunologically- based separation techniques using monoclonal antibodies, flow cytometry, or magnetic separation techniques. Although the feasibility of genetic analysis of fetal blood cells isolated from maternal blood has been demonstrated, obtaining a sufficient number of fetal blood cells for analysis has been difficult and must be adapted further for routine clinical applications. Applied Imaging's Prenatal Screening Products The Company is developing a prenatal screening test to detect chromosomal abnormalities by identifying fetal blood cells from a routine maternal blood sample. The Company's proprietary screening technology incorporates: (i) a hematological procedure to enrich the concentration of fetal blood cells utilizing the Company's consumable enrichment kit, (ii) a fetal hemoglobin identification kit, (iii) automated image analysis instrumentation to identify the fetal blood cells and (iv) the use of third-party DNA probes to identify certain chromosomal disorders present in fetal blood cells. This new approach is designed to improve current prenatal screening procedures by providing an accurate, timely and cost-effective technique without the risks of miscarriage or fetal damage associated with invasive prenatal screening techniques. In contrast to immunologically based procedures to isolate fetal blood cells from maternal blood, the Company is developing a hematologically based procedure for enriching the concentration of fetal blood cells from maternal blood samples. The Company's enrichment process is designed to increase the concentration of fetal blood cells in a maternal sample approximately 10,000 times. The fetal cell enriched sample is then harvested and deposited on a microscope slide. The fetal hemoglobin in the cell is stained using the identification kit to facilitate examination through image analysis. The Company has developed a semi-automated system to automatically identify fetal cells on the slide based on adaptations of the image analysis, pattern recognition, and slide-scanning technologies incorporated in the Company's current cytogenetic products. Once fetal cells are stained by the fetal hemoglobin identification kit, fluorescent DNA probes are added that specifically bind to certain DNA sequences within the fetal cells indicating the presence or absence of chromosomal disorders. DNA probes can be designed to locate specific chromosomal changes, additions, or deletions that result in genetic disorders. The results of the DNA probe analysis are captured and processed using the Company's automated visualization technology for the detection, analysis, and documentation of the DNA probe results. Clinical/Regulatory Matters In December 1996, the Company submitted two 510(k) medical device applications to the FDA. The first submission is for a product that isolates mononuclear cells with the use of a gel gradient separation medium. 5 The product is based on the Company's patented hematological techniques. The Company received notification from the FDA on December 15, 1997 that this product may be marketed in the US and, as labeled, is exempt from further 510(k) premarket notification regulatory requirements. The second submission is for an automated image analysis instrument, (WinScan) which is a general laboratory tool able to automatically detect and locate nucleated red blood cells on a microscope slide. The instrument presents these cells for operator review, further analysis, and eventual use in a diagnostic or screening procedure. On June 15, 1998, the Company received notification from the FDA that it received 510(k) clearance to market WinScanTM for the identification and enumeration of nucleated red blood cells from peripheral blood. In June of 1997, the Company submitted an additional 510(k) notification for the fetal hemoglobin identification kit. This submission has been withdrawn in anticipation of being combined with a later DNA probe submission. The DNA probe components of the Company's products will require either FDA clearance of a 510(k) with a tier III level of review or FDA approval of a pre-market approval application ("PMA"). The Company plans to market its prenatal screening products internationally upon receipt of required regulatory clearances or approvals. Commercialization Strategy The Company's prenatal screening techniques under development are currently expected to be introduced first in Europe and subsequently in the United States and the Pacific Rim, subject to receipt of required clearances or approvals in such jurisdictions. The technology is being designed to initially screen for chromosomal abnormalities resulting in conditions such as Down Syndrome and certain sex chromosome abnormalities such as Turner Syndrome, Klinefelter Syndrome, Triple X Syndrome and certain other conditions. These abnormalities account for a vast majority of the incidence of all birth defects which result from chromosome-based genetic disorders. The proprietary prenatal screening products under development will consist of: (i) a prepackaged kit to enrich the concentration of nucleated fetal red blood cells in the maternal blood sample; (ii) a reagent kit to identify the hemoglobins in fetal cells; (iii) the Company's instrumentation to automate the identification of fetal blood cells and the acquisition and presentation of the DNA probe analysis; and (iv) a DNA probe kit that is comprised of DNA probes that may or may not be provided by third parties. Future Applications of the Prenatal Screening Products The Company's prenatal screening products are being designed to accommodate various chromosome-specific DNA probes, which are currently commercially available. The Company believes that its cell identification and enrichment technology developed for prenatal screening could have future applications for cancer diagnosis and monitoring via the isolation of tumor cells from bone marrow or peripheral blood and the genetic analysis of such cells. Because evaluations of future applications are at an early stage, no assurance can be given when, if ever, the Company's fetal cell identification and enrichment technology may facilitate the early detection of other disorders. Micrometastases Detection The Company is developing a micrometastases detection system designed to provide researchers and clinicians with the ability to identify micrometastatic cells in bone marrow, lymph nodes or blood specimens. The Company is currently involved in a collaborative study with a leading European cancer center to determine the prognostic significance of micrometastatic staging in a population of nine hundred cancer patients.. The micrometastasis system incorporates (i) an automated image analysis system, (ii) monoclonal primary antibodies specific to micrometastatic cells and (iii) a colorimetric detection reagent. Micrometastasis is the spread of cancer away from the primary tumor that is not detectable on routine screening tests. Typically, the metastases are too 6 limited to have created enough mass to be observed using routine examination techniques. The majority of cancers with micrometastases are attributable to a subset of cancer known as carcinomas, a malignant growth that arises from epithelial cells, found in skin or, more commonly, the lining of body organs (i.e., breast, prostate, stomach or bowel). Carcinomas tend to infiltrate into adjacent tissue and then spread (metastasize) to distant organs such as bone, liver, lung or the brain. The initial application for micrometastases testing will be performed on patients at the time of initial diagnosis for breast, prostate, colorectal and gastric carcinomas. This testing will be an adjunct to normal staging parameters and will aid in the appropriate diagnosis and treatment of these patients. Current Cytogenetic Products In the United States, approximately 500,000 total cytogenetic test procedures are performed annually. Cytogenetic testing includes prenatal screening for genetic disorders using amniotic fluid obtained through amniocentesis or fetal tissue samples obtained through CVS. Other cytogenetic testing includes tests for the diagnosis and prognosis of cancerous conditions using bone marrow, blood and tumor samples. The Company currently manufactures, markets and sells its CytoVision family of automated instruments for cytogenetic applications. The Company's primary cytogenetic products are described below. The Company has sold systems to over 650 sites worldwide in more than 35 countries. The Company's primary cytogenetic products currently sell for prices ranging from $25,000 to $125,000, depending upon the instrument's capabilities and final configurations. CV ChromoScan(TM) System The Cyto Vision ChromoScan is the Company's most comprehensive system for automated chromosome analysis. The ChromoScan integrates many of the key features of the Company's earlier products into one system capable of automated microscope slide scanning, advanced chromosome analysis, and fluorescent image processing. The ChromoScan allows laboratories to automatically scan slides in either brightfield or fluorescent modes to locate specific cells for chromosome analysis. This eliminates one of the most tedious and time-consuming aspects of cytogenetic analysis: that of manual slide scanning. The system accomplishes this in the background while simultaneously allowing the technologist to process and analyze images previously identified. The Company believes that no other commercially available system for cytogenetic analysis incorporates this same range of features in one integrated and automated package. CV ChromoFluor(TM) System The CytoVision ChromoFluor is a comprehensive chromosome analysis system that integrates standard karyotyping capability with advanced FISH imaging technologies including color chromosome analysis techniques. The system is based on computerized image capture and analysis capabilities incorporating pattern recognition and automated chromosome classification algorithms. The system provides automated karyotyping capabilities, automatic separation of touching or overlapping chromosomes (a common occurrence), a variety of user- defined image enhancement features, report annotation capabilities and full screen display options. The DNA probe imaging capability of the CytoVision ChromoFluor utilizes the same imaging equipment to detect and analyze signals from DNA probes that have been applied to cell nuclei. CytoVision Chromofluor systems enhance images of often-faint fluorescent DNA probes and provide the operator with a range of optimized analytical tools. The system may also be upgraded to detect genetic amplifications and deletions in tumor cells utilizing a research technique known as comparative genomic hybridization ("CGH"). CytoVision(TM) System The CytoVision System incorporates the most commonly-required chromosome analysis tools and FISH imaging capabilities into a standard workstation suitable for widespread laboratory usage. The system provides automated karotyping capabilities, automatic separation of touching or overlapping chromosomes (a common occurrence), a variety of user-defined image enhancement features, report annotation capabilities and full screen 7 display options. This system entirely replaces the manual processing of photographic images that previously included photographing individual cells in metaphase, photographic development, the manual "cut-and-paste" of each chromosome, identifying the individual chromosomes, arranging them in order and preparation of the final karyotype report. This manual process may take 30 minutes to one hour of a technologist's time to process an individual sample. The comparable CytoVision process requires only 10 minutes or less of the same technologist's time. The DNA probe imaging capability of the Cyto VisionTM system detects and analyzes signals from DNA probes that have been applied to cell nuclei. RxFISH(TM) DNA Probe Reagents The first reagent product offered by the Company allows laboratories to process color banded chromosome images using the Company's RxFISH research reagent system. This system takes advantage of a novel DNA probe technique for identifying each human chromosome with a unique color bar code that allows the Company's proprietary image analysis software to rapidly and accurately identify specific chromosomes, even in cases containing complex or cryptic rearrangements. All of the products in the CytoVision family are compatible with one another and can be integrated into a network with common data management protocols. In addition to its analysis systems, the Company also sells a number of peripherals including a range of high quality printers. A typical installation will include a number of interconnected CytoVision systems and components. Sales, Distribution and Marketing The Company currently sells its cytogenetic products to government and private clinical cytogenetic laboratories, hospital laboratories, research institutions, universities and pharmaceutical companies. The Company has sold such systems to over 650 customers in more than 35 countries. These customers utilize the Company's cytogenetic products for prenatal genetic screening as well as for certain cancer research studies. If regulatory clearance or approval is received, the Company initially plans to sell and distribute its prenatal screening products directly and through its established worldwide network of distributors and agents through which it sells and distributes its current products. In North America, the Company sells its cytogenetic products directly to its customers. The North American sales team is comprised of six sales and application support specialists. Outside of North America, the Company sells its products either directly through local agents who are remunerated on a commission basis or through independent distributors. The Company manages its international sales and distribution activities from Applied Imaging International Ltd., the Company's wholly owned subsidiary located in the United Kingdom. The international sales team is comprised of ten sales and application support individuals, based in the United Kingdom and France. The Applied Imaging International Ltd. sales team supports all distributors and agents upon request. The Company's distributors are located in Australia, Hong Kong, Japan, Italy and South Korea. In addition, the Company has agents selling its cytogenetic products in a number of other countries primarily within Europe, the Middle East and the Pacific Rim. Because the Company's products are technically sophisticated, the Company's sales staff is supported by scientifically qualified and highly trained product specialists. The Company offers an annual maintenance program to its customers through its own support organization. The Company's marketing activities include telemarketing, product advertising and participation in trade shows and product seminars. Manufacturing The Company assembles and tests components and subassemblies made by outside vendors to the Company's specifications and manufactures only when it believes significant value can be added. The Company's current products are assembled from a combination of (i) commodity technology components such as computers and monitors, (ii) custom subassemblies, such as automated filter wheels, and (iii) operating 8 systems and application software. Any disruption or delay in the supply of components or custom subassemblies will have a material adverse effect on the Company. While the Company typically uses components and subassemblies that are available from alternate sources, any unanticipated interruption of the supply of these components or subassemblies could require the Company to redesign its products. The Company orders components and subassemblies to forecast and assembles specific configurations on receipt of firm orders. The Company's research, investigational and clinical products are subject to regulation by the FDA and all products are subject to regulation by the U.S. Department of Commerce export controls, primarily as they relate to the associated computers and peripherals. The Company has experienced no material difficulties in obtaining necessary export licenses to date. The Company plans to initially subcontract third parties to manufacture the consumable enrichment kit components of its fetal cell screening technology under development and may ultimately manufacture such components on its own. For clinical trials, the Company intends to purchase the consumable enrichment kit from a third party contracted to manufacture the kit. The Company has no experience manufacturing such components. The Company may encounter difficulties in scaling up production of the consumable component of its fetal cell screening technology under development or in hiring and training additional personnel to manufacture its consumable enrichment kit products in commercial quantities. Under current law, if the Company manufactures finished devices in the United States, it will be required to comply with the FDA's Quality System Regulation and the State of California's current Good Manufacturing Practice ("GMP") regulations. In addition, the FDA and/or the California authorities will inspect the Company's manufacturing facilities on a regular basis to determine such compliance. Failure to comply with applicable FDA or other regulatory requirements can result in fines, injunctions, civil penalties, recalls or seizures of products, total or partial suspensions of production or criminal prosecutions. Research and Development The Company's research and development efforts include various research, product development, clinical evaluation and testing, quality assurance, regulatory and process development activities. The current focus of the Company's research and development efforts is the continued development of the Company's prenatal screening products and particularly the initiation of clinical trials. In addition, the Company is analyzing different methods for facilitating image analysis of fetal cell enriched samples. The Company's future research and development efforts are expected to include development of additional applications of the Company's current cytogenetic products and additional applications of the fetal cell screening technology under development. These potential additional applications may include the use of technology developed for fetal cell analysis for the characterization and monitoring of certain cancers and the diagnosis of certain single gene disorders. Development of these applications would require substantial additional funds and will be subject to technological, clinical, regulatory and other risks associated with new medical technologies. There can be no assurance that the Company will develop its prenatal screening products or any other future applications of such technology. Research and development expenses were approximately $6.7 million, $7.4 million and $3.7 million in 1998, 1997 and 1996 respectively. Patents and Proprietary Rights The Company actively seeks, when appropriate, protection for its products and proprietary information by means of United States and foreign patents and trademarks. The Company has one issued United States patent relating to its CytoVision System and has corresponding issued patents in certain European countries. The Company also has one United States patent relating to Multicolor Fluorescent in situ Hybridization ("M-FISH") imaging techniques. In addition, the Company has three United States patents concerning its technology for enriching the concentration of fetal nucleated red blood cells from maternal blood samples. Corresponding applications were filed through the Patent Cooperation Treaty and preserve for the Company the right to file 9 applications in various countries. The Company relies upon trade secrets, know-how and contractual arrangements to protect certain of its proprietary information and products. The fields of life science instrumentation and genetic screening processes are covered by many issued patents and patent applications. The Company has been notified that it may be infringing on certain patents pertaining to specialized cytogenetic applications and the Company is currently reviewing the merits of this claim. The Company is not aware of any other patents which it may be infringing; however, patent applications in the United States remain confidential until a patent is issued, and, therefore, the Company's products could infringe patents to be issued in the future. If the Company's technology is determined to use products, processes or other subject matter that is claimed under other existing U.S. or foreign patents, or if other patents claiming subject matter utilized by the Company are issued, such companies may bring infringement actions against the Company. The Company may be required to obtain licenses to patents or proprietary rights of others. There can be no assurance that any such license would be made available or, if available, would be available on commercially acceptable terms. Failure to obtain a required license could prevent the Company from commercializing its products resulting in a material adverse affect on the Company's business, financial condition and results of operations. The Company generally enters into confidentiality agreements with its employees and consultants designed to both protect the Company's confidential information and prevent the disclosure of confidential information of prior employers and other parties. There can, however, be no assurance that the Company's trade secrets or proprietary technology will not become known or be independently developed by competitors in such a manner that the Company has no practical recourse. Certain employees of and consultants to the Company are subject to the terms of confidentiality agreements with respect to proprietary information of their former employers. The failure of these persons to comply with the terms of their agreements could result in assertion of claims against the Company and such persons which, if successful, might restrict their roles within the Company. In 1996, the Company entered into a collaborative research agreement with Leiden University ("Leiden") in the field of enrichment, isolation and analysis of fetal cells derived from maternal blood. Under the terms of the agreement, the Company has sole ownership of any jointly developed inventions and has an exclusive license to any issued patents owned solely by Leiden. The royalty rate for the exclusive license shall not be more than 5% of associated sales. In 1996, the Company entered into an agreement to acquire an invention for the use of certain antibodies in the identification of fetal cells from maternal blood. The agreement provides for the Company to pay certain expenses associated with obtaining a U.S. patent for the invention and a royalty of not more than 2% of net sales. In 1998, the Company entered in an option agreement to acquire ownership of patents for the enrichment of fetal cells. The agreement provides for payments of $1.1 million if the option is exercised and products using the technology are successful in clinical trials. In October 1997, the Company entered into an exclusive worldwide licensing agreement with the University of Cambridge for the commercialization of DNA- probe technology developed by Cambridge researchers. The technology, known as Cross Species Color Banding, is being utilized by the Company in an effort to develop research test reagents to detect and analyze chromosomal aberrations. The Company has developed an initial test kit for color banding analysis of human chromosomes that will be made available for research use. The agreement requires minimum annual royalty payments of $30,000 and the payment for specific research related projects. The agreement will remain in full force and effect until the expiration of the last patent right or ten years whichever is later. In January 1998, the Company entered into a non-exclusive worldwide agreement with Vysis, Inc. for the right to use certain CGH software products. The agreement requires an initial payment of $5,000 and a royalty payment of $500 for each CGH software product sold. In March 1998, the Company entered into a non-exclusive worldwide agreement with Amersham Pharmacia Biotech Inc for the right to use certain technologies in conjunction with its DNA probe technology. The 10 agreement requires minimum annual royalty payments of $10,000. The agreement will remain in full force and effect until the expiration of all patents or eight years; which ever is the later. The Company also relies upon trademarks to protect certain of its products, and holds a United States trademark registration for the mark "CYTOSCAN." Registration for this mark and the mark "CYTOVISION" are held by the Company in certain foreign jurisdictions. The Company also has certain other trademark rights in the United States and other foreign countries. It is possible that third parties may allege superior rights to one or more of the Company's trademarks, or close variations, for those countries in which the Company is presently conducting business or may do so in the future. The Company's rights to use and register its marks in a given jurisdiction may depend on its rights relative to a third party's rights as governed by the laws of the pertinent country. Factors utilized to determine the relevant rights between parties include priority of the use or registration of the mark, how close the respective marks are in appearance, sound and/or meaning, as well as the goods to which they are applied. It is possible that the Company could be prevented from using or registering its trademarks in certain countries due to a superior third party right. Competition The market for the Company's current cytogenetic products is highly competitive. The Company believes that its primary competitors in this market include Perceptive Scientific Instruments, Inc. (a subsidiary of International Remote Imaging Systems, Inc.), and Vysis Inc. The principal competitive factors in this market are product features offered, ease of use, clarity of output, customer service capabilities, price and installed base. The Company believes it competes favorably with regard to these factors. With respect to its prenatal screening products under development, the Company is aware of other companies that are in the process of developing genetic screening products based on competing technologies designed to specifically isolate fetal blood cells in maternal blood samples. Certain of these companies have greater research and development, marketing and financial resources than the Company. These companies include Genzyme Inc. and Bioseparations Inc. Genzyme, through its Genetics subsidiary, specializes in providing genetic testing services and Bioseparations is a research-stage company focusing on fetal cell isolation methods. The medical diagnostic and biotechnology industries are subject to intense competition. The Company's fetal cell screening technology, if commercially marketed, will also be subject to intense competition from existing procedures such as the triple test. There can be no assurance that the Company's fetal cell screening technology under development will replace any existing procedures. The Company expects the principal competitive factors in the fetal cell screening market to be risk to the fetus, reliability, accuracy, range of disorders detected, cost savings to health care systems and payers and the price of testing. Certain of the Company's competitors have greater financial and technical resources and production and marketing capabilities than the Company. There can be no assurance that these competitors will not succeed in developing technologies and products that are more effective, easier to use or less expensive than those which are currently offered or being developed by the Company or that would render the Company's technology and products obsolete and noncompetitive. In addition, some of the Company's competitors have significantly greater experience than the Company in conducting clinical investigations of new diagnostic products and in obtaining FDA and other regulatory clearances and approvals of products. Accordingly, the Company's competitors may succeed in developing and obtaining regulatory approvals for such products more rapidly than the Company. Government Regulation The testing, manufacturing, labeling, distribution, sales, and marketing of the Company's products are subject to government regulation in the United States and in other countries. The Company believes that its future success will be significantly dependent upon commercial sales of its prenatal screening products under 11 development. The Company will not be able to market these products for commercial use in the United States until the Company obtains clearance or approval from the FDA and will not be able to market such products overseas until it meets the safety and quality regulations of each foreign jurisdiction in which the Company seeks to sell such products. In the United States, the Company's products are also subject to regulation by state authorities. The State of California's requirements in this area require registration with the state and compliance with state GMP regulations. Noncompliance with applicable FDA requirements can result in, among other things, fines, injunctions, civil penalties, recall or seizure of products, total or partial suspension of production, distribution, sales, and marketing, refusal of the government to grant approval of a PMA or clearance of a 510(k), withdrawal of marketing approvals or clearances, a recommendation by the FDA that the manufacturer or distributor not be permitted to enter into government contracts, and criminal prosecution. In certain circumstances, the FDA also has the authority to order the manufacturer or distributor of a device to repair, replace or refund the cost of the device. Failure to comply with regulatory requirements in the United States or abroad could have a material adverse effect on the Company's business, financial condition and results of operations. Before a new medical device can be introduced into the market, the manufacturer must obtain FDA clearance of a 510(k) or approval of a PMA, unless the device is exempt from the requirement of such clearance or approval. A 510(k) clearance will be granted if the submitted information establishes that the device is substantially equivalent to a legally marketed Class I or II medical device or to a legally marketed Class III device that does not itself require an approved PMA prior to marketing ("predicate device"). A 510(k) must contain information to support a claim of substantial equivalence, which may include laboratory test results or the results of clinical studies of the device in humans. Commercial distribution of a device for which a 510(k) is required may begin only after the FDA issues a finding that the device is "substantially equivalent" to a predicate device. A 510(k) for a device incorporating new technology may be given a tier III level of review, which requires the submission of data from human clinical trials. The FDA is required to review 510(k) submissions within 90 days, but it generally takes from five to twelve months from the date of submission to obtain 510(k) clearance from the FDA; it may take longer and 510(k) clearance may never be obtained. The FDA may determine that a device is not "substantially equivalent" to a predicate device, or that additional information is needed before a substantial equivalence determination can be made. If a device is not found by the FDA to be substantially equivalent to a predicate device, the Company may be required to submit a PMA application. A PMA must be supported by valid scientific evidence that typically includes data from preclinical testing and human clinical trials to demonstrate the safety and effectiveness of the device. Upon submission of a PMA, the FDA makes a threshold determination regarding whether the application is sufficiently complete to permit filing for a substantive review. An FDA review of a PMA generally takes one to two years from the date the PMA is accepted for filing, but may take significantly longer if the FDA requires the Company to file any major amendment to the PMA. The review time is often significantly extended by the FDA's asking for additional information. An Advisory Panel, primarily composed of clinicians, is convened to review and evaluate the application and provide recommendations to the FDA regarding whether the PMA should be approved. The FDA is not bound by the recommendations of the Advisory Panel. The FDA also conducts an inspection of the manufacturer's facilities to ensure that the facilities are in compliance with GMP requirements. The Company submitted a protocol for clinical trials of the DNA probe product to the FDA in November of 1996. The Company intends to initiate a multisite, United States and international, clinical trial of the DNA probe component of its prenatal testing technology to detect chromosomal disorders in isolated fetal cells. There can be no assurance regarding the timing or nature of the FDA response regarding the DNA probe related protocol or the timing for the commencement of clinical trials. There can be no assurance that 510(k) clearance for any of the prenatal screening products under development or any other future product or modification of an existing product will be granted or that the clearance process will not be unduly lengthy and subjected to a thorough FDA review. The FDA has stated that the DNA probe product will require at least a 510(k) tier III level of review. Further, in its draft guidance for in vitro diagnostic devices utilizing cytogenetic in situ 12 hybridization technology for the detection of genetic mutations, the FDA states that when such devices are intended for use as a "stand-alone" for test reporting based on interphase analysis, they will require a PMA that must be reviewed and approved by the FDA prior to sales, distribution and marketing of these products in the United States. The PMA process is typically more complex, expensive and time consuming than the 510(k) process. While the Company has made determinations regarding the appropriate form of approval, if any, required for its products, there can be no assurance that such determinations are correct, that the FDA will concur with such determinations or that such determinations may not be altered due to new interpretations or new data that may become available or changes in the FDA's policies. Export sales of investigational devices that are subject to PMA or investigational device exemption application requirements and have not received FDA marketing approval generally may be subject to FDA export permit requirements depending upon, among other things, the purpose of the export (investigational or commercial), the country to which the device is intended for export, and on whether the device has valid marketing authorization in a country listed in the FDA Export Reform and Enhancement Act of 1996. In order to obtain such a permit, when one is required, the Company must provide the FDA with documentation from the medical device regulatory authority of the country in which the purchaser is located, stating that the device has the approval of the country. In addition, the FDA must find that exportation of the device is not contrary to the public health and safety of the country in order for the Company to obtain the permit. In addition to domestic regulation of medical devices, the Company's current products and its products under development are subject to corresponding regulations governing safety processes, manufacturing processes and quality in foreign jurisdictions in which it operates or such products are sold. The sale of the fetal cell screening products under development may be materially affected by the policies of regulatory bodies or the domestic politics of the countries involved. There can be no assurance that an early prenatal screening test for genetic disorders will not be prohibited or restricted in some jurisdictions. In addition, FDA export permits may be required for shipment of the Company's fetal cell screening products under development to certain foreign countries. Failure to comply with applicable regulatory requirements can, among other consequences, result in fines, injunctions, civil penalties, suspensions or loss of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution. In addition, future governmental regulations may be established that could prevent or delay regulatory approval of the Company's products. The regulation of medical devices in a number of such jurisdictions continues to develop and there can be no assurance that new laws or regulations will not have a material adverse effect on the Company's business. Upon the adoption of the "In Vitro Diagnostic Medial Device Directive of October 27, 1998, the European Community and its member countries currently are imposing more substantial regulation on in vitro diagnostic devices and equipment-like medical devices, and such regulation may affect the Company's current products and products under development. Delays in receipt of clearances or approvals to market its products, failure to receive these clearances or approvals, the loss of previously received clearances or approvals or the determination that 510(k) clearance, pre-market approval or other approval is required for a product being marketed without such clearance or approval could have a material adverse effect on the Company's business, financial condition and results of operations. In addition, laboratories who purchase the Company's current products and/or the prenatal screening products under development could be subject to the Clinical Laboratory Improvement Amendments of 1988 ("CLIA"), which are intended to ensure the quality and reliability of medical testing conducted in laboratories in the United States. The Company's products should comply with CLIA regulations or the Company's ability to market its products could be negatively affected. Marketed devices are subject to pervasive and continuing regulatory oversight by the FDA and other agencies, including record-keeping requirements and reporting of adverse experiences with the use of the device. Device manufacturers are required to register their establishments and list their devices with the FDA and certain state agencies. The Federal Food, Drug and Cosmetic Act and certain state laws require that medical devices be manufactured in accordance with the Quality System Regulations ("QSregs"). Manufacturing facilities are 13 subject to periodic inspection by the FDA and certain state agencies on a periodic basis to monitor compliance with GMP, QSregs and other requirements. If violations of the applicable regulations are noted during such inspections of manufacturing facilities, the Company can be prohibited from conducting further manufacturing, distribution and sale of the devices until the violations are cured. The Company is also subject to other federal, state, local and foreign laws, regulations and recommendations relating to safe working conditions and good laboratory practices. The extent of government regulation that might result from any future legislation or administrative action cannot be accurately predicted. Failure to comply with any federal or state regulatory requirements could have a material adverse effect on the Company's business, financial condition and results of operations. Third-Party Reimbursement and Health Care Reform In the United States, the Company's products are purchased primarily by medical institutions which then bill various third-party payors, such as private insurance plans, Medicare, Medicaid, and other government programs ("Third-Party Payors") for the health care services provided to their patients. Third-Party Payors may deny reimbursement if they determine that the device used in a treatment was unnecessary, inappropriate, experimental or investigational, used for a non-approved indication, or not cost-effective and typically do not reimburse for devices used for research and investigational purposes. Accordingly, physicians must determine that the new clinical benefits of genetic screening procedures justify the additional cost. The market for the Company's current cytogenetic products could be adversely affected by changes in governmental and private third-party payors' policies and the market for the Company's fetal cell screening technology under development could be materially adversely effected by the failure of governmental and Third-Party Payors adopting policies to reimburse health care providers for the use of the Company's fetal cell screening technology under development. The unavailability of third-party coverage or the inadequacy of the reimbursement for medical procedures using the Company's products would adversely affect the Company's business, financial condition and results of operations. In both the United States and internationally, Third-Party Payors are increasingly challenging the prices charged for medical products and services. There can be no assurance that reimbursement for the procedures using the Company's products will be available or, if currently available, will continue to be available, or that future reimbursement policies of payors will not adversely affect the Company's ability to sell its products on a profitable basis. In addition, there can be no assurance that third-party reimbursement will be available for diagnostic procedures based on the Company's prenatal screening products under development. The levels of revenues and profitability of medical device companies may be affected by the continuing efforts of governmental and Third-Party Payors to contain or reduce the costs of health care through various means. In the United States, there have been, and the Company expects that there will continue to be, a number of federal and state proposals to implement government regulation of health care costs. It is uncertain what legislative proposals will be adopted or what actions federal, state or private payers for health care goods and services may take in response to any health care reform proposals or legislation. The Company cannot predict the effect health care reforms may have on its business, and no assurance can be given that any such reforms will not have a material adverse effect on the Company's business, financial condition and results of operations. Further, to the extent that such proposals or reforms have a material adverse effect on the business, financial condition and profitability of the clinical and research laboratories, hospitals and other institutions that comprise the Company's customer base, the Company's business, financial condition and results of operations could be adversely affected. Product Liability and Insurance The Company's business may involve the risk of product liability claims, including those relating to inaccurate results from its screening products. Although the Company has not experienced any product liability claims to date, any such claims could have a material adverse impact on the Company. The Company maintains product liability insurance at coverage levels which it deems commercially reasonable; however, there can be no assurance that product liability or other claims will not exceed such insurance coverage limits or that such 14 insurance will continue to be available on commercially acceptable terms, or at all. The Company intends to evaluate, depending on the circumstances that exist at the time, whether or not to obtain any additional product liability insurance coverage prior to the time that the Company engages in any extensive marketing of its fetal cell screening technology under development. Even if the Company obtains additional product liability insurance, there can be no assurance that it would prove adequate or that a product liability claim, insured or uninsured, would not have a material adverse effect on the Company's business, financial condition and results of operations. Even if a product liability claim is not successful, the time and expense of defending against such a claim may adversely affect the Company's business, financial condition and results of operations. Employees As of December 31, 1998, the Company had 92 employees, of whom 33 were involved in research and development, 9 in manufacturing and manufacturing engineering, 37 in sales, marketing and customer service and 13 in finance and administration. As of December 31, 1998, 40 of the employees were based in the United Kingdom, 49 in the United States, 1 in Israel, and 2 in France. A total of 5 employees hold Ph.Ds, and 1 employee is an M.D. The Company's employees include a number of professional cytogeneticists who support and sell its product range. The Company believes its relationship with its employees to be good. Additional Risk Factors Prenatal Screening Products in Early Stage of Development; No Assurance of Successful Development or Commercialization The Company's prenatal screening products are in an early stage of development and testing. The isolation, identification, enrichment and analysis of fetal cells from a maternal blood sample is difficult and poses a significant technical challenge due to their rarity in maternal blood. The Company has not yet determined how many fetal cells, if any, can be routinely obtained using its process. In addition, fetal cells that circulate in maternal blood are not yet completely understood in terms of their variety and characteristics, such as longevity in maternal blood and fragility when exposed to various processes to enrich their concentration in a maternal blood sample. The Company has refined, and continues to refine, its processes and test reformulated enrichment media to determine if concentrations of fetal cells can be increased, but there can be no assurance that these efforts will prove successful. In addition, there can be no assurance that the Company's prenatal screening products will be able to detect fetal cells in amounts sufficient to allow for the detection and analysis of chromosomal abnormalities. There can be no assurance that the Company's prenatal screening products will be able to effectively and accurately detect Down Syndrome or other chromosomal abnormalities. The development and potential commercialization of the Company's prenatal screening products will require significant research and development, substantial investment and clinical testing and regulatory clearances or approvals. The Company plans to continue to conduct preclinical testing in order to analyze the feasibility of its prenatal screening products. Such efforts may disclose significant technical obstacles that need to be overcome prior to pursuing clinical trials and seeking necessary regulatory approvals. Such obstacles could have the effect of delaying or preventing the successful development of the Company's prenatal screening products. There can be no assurance that the Company will be able to develop this technology into reliable and effective prenatal screening products, that required regulatory clearances or approvals for commercialization will be obtained in a timely manner, or at all, or that the Company's prenatal screening products or other products under development, if introduced commercially, will be successful. If the Company is unable to successfully develop and market its prenatal screening products, the Company's business, financial condition and results of operations would be materially and adversely affected. Lack of Clinical Data The Company has conducted no clinical trials of its prenatal screening products pursuant to FDA reviewed protocols. There can be no assurance that the Company will commence such clinical testing, or once commenced, that such testing can be completed successfully within the Company's expected time frame and budget, if at all, 15 or that the Company's products will prove to be reliable and effective in clinical trials. If clinical trials are initiated, such trials may disclose significant technical obstacles having the effect of delaying or preventing the development, testing, regulatory approval and commercialization of the Company's prenatal screening products. There can be no assurance that the results of such clinical trials will be consistent with the Company's limited preclinical results to date or would be sufficient to obtain regulatory clearance or approval or clinical acceptance. If the Company is unable to initiate and conclude successfully clinical trials of its prenatal screening products, the Company's business, financial condition and results of operations would be materially and adversely affected. No Assurance of Clinical Acceptance The isolation of fetal cells from maternal blood is a new and novel development. The clinical acceptance of the Company's prenatal screening products will depend upon its acceptance by the medical community and third- party payors as clinically useful, reliable, accurate, and cost-effective compared to existing and future procedures. Clinical acceptance will depend on numerous factors, including the establishment of the product's ability to isolate sufficient numbers of fetal cells during the early stages of pregnancy, to adequately enrich the concentration of nucleated fetal cells, and to reliably analyze and detect the presence of chromosomal abnormalities. Clinical acceptance will also depend on the receipt of regulatory clearances in the United States and internationally, the availability of third-party reimbursement and the Company's ability to adequately train laboratory technicians and cytogeneticists on how to use the prenatal screening products. In addition, there can be no assurance that the Company's prenatal screening products will be a preferable alternative to existing procedures such as the maternal AFP test or the triple test which detect neural tube defects in addition to chromosomal abnormalities, or that the prenatal screening products will not be rendered obsolete or noncompetitive by products under development by other companies. The Company's products are intended to initially screen for Down Syndrome and may not compete favorably with widely accepted methodologies such as amniocentesis or CVS that are highly accurate and diagnose a broader range of abnormalities from one sample of fetal cells. Patient acceptance of the Company's prenatal testing products will depend in part upon physician recommendations as well as other factors, including the effectiveness and reliability of the procedure as compared to amniocentesis, CVS and serum marker procedures. Even if the Company's prenatal screening products are clinically adopted, physicians may elect not to recommend the procedure unless acceptable reimbursement from health care payors is available. There can be no assurance that the Company's prenatal screening products under development will be accepted by the medical community or that market demand for such products will be sufficient to allow the Company to achieve profitable operations. Failure of the Company's prenatal screening procedure, for whatever reason, to achieve significant clinical adoption or failure of the Company's products to achieve any significant market acceptance would have a material adverse effect on the Company's business, financial condition and results of operations. Accumulated Deficit; Future Losses From its inception in July 1986 through the end of 1998, the Company has generated an accumulated deficit of approximately $28.0 million. The Company expects its operating losses to continue to increase as it continues its efforts to develop and test its prenatal screening products. There can be no assurance that its prenatal screening products under development will be commercially marketed or, if commercially marketed, that the Company will ever receive sufficient revenue to achieve profitability and failure to do so would have a material adverse effect on the Company's business, financial condition and results of operations. Quarterly Fluctuations The Company has experienced and expects to continue to experience significant fluctuations in its quarterly operating results. Factors which may have an influence on the Company's operating results in a particular quarter include (i) demand for the Company's products, new product introductions by the Company or its competitors or transitions to new products, (ii) the results of preclinical or planned clinical trials and, if ever received, the timing of regulatory and third-party reimbursement approvals; (iii) the timing of orders and shipments; (iv) the mix of sales between distributors and the Company's direct sales force; (iv) competition, including pricing pressures; 16 (v) the timing and amount of research and development expenses, including clinical trial-related expenditures; (vi) seasonal factors; (vii) foreign currency fluctuation; and (viii) the delay between incurrence of expenses to develop new products, including related marketing and service capabilities, and realization of benefits from such efforts. The Company believes the pattern of fluctuating revenues is influenced by the budgetary spending practices of the Company's customer base which consists primarily of public and private cytogenetic laboratories, research organizations and hospitals operating on annual budgets. In addition, currency devaluations and lower economic growth in Asia has decreased and are expected to continue to decrease demand for the Company's products in Asian markets. Due to all the foregoing factors, it is likely that in some future quarter the Company's operating results will be below the expectations of public market analysts and investors. In such event, the price of the Company's Common Stock would likely be materially adversely affected. Additional Capital Requirements; No Assurance Future Capital will be Available The Company has expended and will continue to expend substantial funds for research and development, preclinical testing, planned clinical investigations, capital expenditures and manufacturing and marketing of its products. The timing and amount of spending of such capital resources cannot be accurately determined at this time and will depend upon several factors, including the progress of its research and development efforts and planned clinical investigations, competing technological and market developments, commercialization of products currently under development, and market acceptance and demand for the Company's products. To the extent required, the Company may seek to obtain additional funds through equity or debt financing, collaborative or other arrangements with other companies and from other sources. If additional funds are raised by issuing equity securities, further dilution to stockholders would occur. There can be no assurance that additional financing will be available when needed or on terms acceptable to the Company. If adequate funds are not available, the Company could be required to delay development or commercialization of certain of its products, to license to third parties the rights to commercialize certain products or technologies that the Company would otherwise seek to commercialize for itself, or to reduce the marketing, customer support or other resources devoted to certain of its products each of which could have a material adverse effect on the Company's business, financial condition and results of operations. Dependence on Prenatal Screening Products; Rapid Technological Change and Risk of Technological Obsolescence The Company is dependent on the successful development and commercialization of the Company's prenatal screening products. Unfavorable preclinical or clinical results, failure to obtain regulatory clearances or approvals in a timely manner, or at all, or failure to gain widespread market acceptance for the products would have a material adverse effect on the Company's business, financial condition and results of operations. The medical device industry, particularly the prenatal testing, diagnostic, and screening markets, is characterized by rapid and significant technological change. The sale of the Company's current products is largely dependent upon the continued use of prenatal testing methodologies that require the location of fetal cells in metaphase and the karyotyping of chromosomes identified in the metaphase cells. In addition, the Company's current products require a testing laboratory to make a large one-time investment, and the availability of less expensive automated cytogenetic equipment could have a material adverse effect on the Company's business financial condition, and results of operations. The Company's future success will depend in large part on the Company's ability to continue to respond to such changes. There can be no assurance that the Company will be able to respond to such changes or that new or improved competing products will not be developed that render the Company's products obsolete. Product research and development will require substantial expenditures and will be subject to inherent risks, and there can be no assurance that the Company will be successful in developing products that have the characteristics necessary to screen or diagnose particular indications or that any new product introduced will receive regulatory clearance or approval or will be successfully commercialized. Uncertainty of FDA or Other Regulatory Clearances or Approvals The testing, manufacturing, labeling, distribution, sale, and marketing, of the Company's products are subject to government regulation in the United States and other countries. The Company's future success will be 17 significantly dependent upon commercial sales of its prenatal screening products under development. The Company will not be able to market these prenatal screening products for commercial use in the United States until the Company obtains clearance or approval from the United States Food and Drug Administration ("FDA") for each device and will not be able to market such products overseas until it meets the safety and quality regulations of each foreign jurisdiction in which the Company seeks to sell such products. Noncompliance with applicable FDA requirements can result in severe administrative, civil and criminal sanctions. The Company's Cytoscan products were marketed until 1994 in the United States pursuant to pre-market notifications to the FDA under Section 510(k) of the Federal Food, Drug and Cosmetic Act ("510(k)"). A 510(k) pre-market notification must be supported by appropriate data establishing, to the satisfaction of the FDA, that a newly developed device is "substantially equivalent" to a legally marketed device that does not itself require FDA approval of a PMA. The Company's CytoVision product is the current model of the Cytoscan product, marketed pursuant to the original 510(k) filing. The Company has applied for three separate 510(k) clearances for the enrichment product, automated scanning product and the Fetal Hemoglobin Identification Kit. The Company has been notified by the FDA that the Enrich Kit and WinScan Automated Image Analysis System may be marketed in the U.S. The DNA probe product will require either FDA clearance of a 510(k) with a tier III level of review or a PMA. The Company submitted a protocol for clinical trials of the DNA probe product to the FDA in November of 1996. The Company intends to initiate a multisite, U.S. and international clinical trial of the DNA probe product to detect chromosomal disorders in isolated fetal cells, based upon the review of the protocol by the FDA. There can be no assurance regarding the timing or nature of the FDA response regarding the DNA probe related protocol or the timing for the commencement of clinical trials. There can be no assurance that 510(k) clearance for any of the Company's products under development or any other future product or modification of an existing product will be granted or that the clearance process will not be unduly lengthy and subjected to a thorough FDA review. The FDA has stated that the DNA probe product will require at least a 510(k) tier III level of review. Further, in its draft guidance for in vitro diagnostic devices utilizing cytogenetic in situ hybridization technology for the detection of genetic mutations, the FDA states that when such devices are intended for use as a "stand-alone" for test reporting based on interphase analysis, they will require a PMA that must be reviewed and approved by the FDA prior to sales, distribution and marketing of these products in the United States. The regulation of medical devices continues to develop and there can be no assurance that new laws or regulations will not have a material adverse effect on the Company's business, financial condition and results of operations. Delays in receipt of clearance or approvals to market its products, failure to receive these clearances or approvals, the loss of previously received clearances or approvals, the determination that 510(k) clearance, pre-market approval or other approval is required for a product being marketed without such clearance or approval, or failure to comply with existing or future regulatory requirements could have a material adverse effect on the Company's business, financial condition and results of operations. Need to Comply with International Government Regulation The regulatory review process varies from country to country. Currently, the Company's products are subject to pre-market approval in several of the countries that are members of the European Union ("EU") and subject to other regulatory requirements in those and other countries. In addition, the regulation of in vitro diagnostic devices ("IVDs") and other medical devices continues to change. The Company may rely, in some circumstances, on its international distributors for compliance with regulatory requirements in those countries where the Company intends to use distributors. Any enforcement action by regulatory authorities with respect to regulatory noncompliance may have a material adverse effect on the Company's business, financial condition and results of operations. 18 The time required to obtain approval for sale in foreign countries may be longer or shorter than that required for FDA clearance and the requirements may differ. In addition, there may be foreign regulatory barriers other than approval for sale. The Company has brought its currently sold instruments, as required, into compliance with the European Parliament's Electromagnetic Compatibility Directive (89/336/EEC) (the "ECD") and is entitled to apply the CE mark, with respect to the ECD, to such instruments. The European Parliament has made a distinction between Medical Devices ("MDs") and IVDs. The Company's instruments are subject to the requirements or advantages of the In Vitro Diagnostic Medical Device Directive (98/79/ec). There can be no assurance, however, that some or all of the Company's products will not be redefined as M.D.'s and made subject to this Directive by the EU or its member states, which may have a material adverse effect on the Company's business, financial condition, and results of operations. There can be no assurance, moreover, that member states, or any other European country, will not adopt other statutes or regulations that could require approval to sale the Company products, or that will otherwise have a material adverse effect on the Company's business, financial condition, or results of operations. As required by the In Vitro Diagnostics medical Device Directive, the Company's medical device products have the right to affix the CE mark approved, and the Company is entitled to apply the CE mark. Depending on the complexity of the electromagnetic compatibility of each product, the testing and certification process may take a day to months and cost from the several hundred to several thousand dollars. Dependence upon Patents and Proprietary Technology; Risk of Infringement The Company holds two issued U.S. patents that materially relate to the prenatal screening system, patent no. 5,432,054, issued July 11, 1995 and entitled "Method for Separating Rare Cells from a Population of Cells," and patent no. 5,731,156, issued March 24, 1998 and entitled "Use of Anti- Embryonic Hemoglobin Antibodies to Identify Fetal Cells." These patents expire in July 2012 and March 2015, respectively. Additionally, the Company relies on trade secret protection and on its unpatented proprietary know-how in the development and manufacturing of its products. There can be no assurance that the Company's trade secrets or proprietary technology will not become known or be independently developed by competitors in such a manner that the Company has no practical recourse. Nor can there be any assurance that others will not develop or acquire equivalent expertise or develop products that render the Company's current or future products noncompetitive or obsolete. There can be no assurance that the claims allowed under its patents will be sufficiently broad to protect what the Company believes to be its proprietary rights. In addition, there can be no assurance that issued patents will not be disallowed or circumvented by competitors, or that the rights granted thereunder will provide competitive advantages to the Company. Companies have filed applications for, or have been issued patents relating to, products or processes that may be competitive with certain of the Company's products or processes. The Company is unable to predict how the courts would resolve issues relating to the validity and scope of such patents. The validity and breadth of claims in medical technology patents involve complex legal and factual questions and, therefore, may be highly uncertain. No assurance can be given that any issued patent or patents based on pending patent applications or any future patent application will exclude competitors, that any of the Company's patents in which it has licensed rights will be held valid if subsequently challenged or that others will not claim rights in or ownership of the patents and other proprietary rights held or licensed by the Company. Furthermore, no assurance can be given that others have not developed or will not develop similar products, duplicate any of the Company's products or design around any patents issued to or licensed by the Company or that may be issued in the future to the Company. Since patent applications in the United States are maintained in secrecy until patents issue, the Company also cannot be certain that others did not first file applications for inventions covered by the Company's pending patent applications, nor can the Company be certain that it will not infringe any patents that may issue to others on such applications. 19 In addition, patent applications in foreign countries are maintained in secrecy for a period after filing. Publication of discoveries in the scientific or patent literature tends to lag behind actual discoveries and the filing of related patent applications. The Company has not conducted an extensive search of patents issued to other companies, research or academic institutions, or others, and no assurances can be given that such patents do not exist, have not been filed, or could not be filed or issued, which contain claims relating to the Company's technology, products or processes. Patents issued and patent applications filed in the United States or internationally relating to medical devices are numerous and there can be no assurance that current and potential competitors and other third parties have not filed or in the future will not file applications for, or have not received or in the future will not receive, patents or obtain additional proprietary rights relating to products or processes used or proposed to be used by the Company. There are pending applications, which if issued with claims in their present form, might provide proprietary rights to third parties relating to products or processes used or proposed to be used by the Company. The Company may be required to obtain licenses to patents or proprietary rights of others. The medical device industry in general, and the industry segment that includes products for prenatal diagnostic screening in particular, have been characterized by substantial competition. Litigation regarding patent and other intellectual property rights, whether with or without merit, could be time consuming and expensive to respond to and could divert the Company's technical and management personnel. The Company may be involved in litigation to defend against claims of infringement by the Company, to enforce patents issued to the Company, or to protect trade secrets of the Company. If any relevant claims of third-party patents are held as infringed and not invalid in any litigation or administrative proceeding, the Company could be prevented from practicing the subject matter claimed in such patents, or would be required to obtain licenses from the patent owners of each such patent, or to redesign its products or processes to avoid infringement. In addition, in the event of any possible infringement, there can be no assurance that the Company would be successful in any attempt to redesign its products or processes to avoid such infringement. Accordingly, an adverse determination in a judicial or administrative proceeding or failure to obtain necessary licenses could prevent the Company from manufacturing and selling its products, which would have a material adverse effect on the Company's business, financial condition and results of operations. Costly and time-consuming litigation brought by the Company may be necessary to enforce patents issued to the Company, to protect trade secrets or know-how owned by the Company, or to determine the enforceability, scope and validity of the proprietary rights of others. Limited Manufacturing Experience; No Manufacturing Experience for the Consumable Enrichment Kit To date, the Company's manufacturing activities have consisted primarily of the assembly and testing of its cytogenetic products. If the Company obtains necessary regulatory clearances, registrations and approvals for its prenatal screening products and such technology is successfully introduced, the Company will be required to increase its manufacturing capacity. The Company has no experience in manufacturing the Enrichment Kit, WinscanTM or fetal hemoglobin identification kit portions of its prenatal screening products. Manufacturers often encounter difficulties in commencing and increasing production, including problems involving production yields, adequate supplies of components, quality control and assurance (including failure to comply with the FDA's and State of California's GMP regulations, international quality standards and other regulatory requirements) and shortages of qualified personnel. Difficulties experienced by the Company in manufacturing could have a material adverse effect on its business, financial condition and results of operations. There can be no assurance that the Company will be successful in commencing manufacture of the prenatal screening products in commercial quantities, increasing manufacturing capacity or that it will not experience manufacturing difficulties or product recalls in the future. Need to Manage Growth Significant future growth in the Company's sales and expansion in the scope of its operations, should they occur, may place considerable strain on the Company's management, financial, manufacturing and other capabilities, procedures and controls. There can be no assurance that any existing or additional capabilities, 20 procedures or controls will be adequate to support the Company's operations or that its capabilities, procedures or controls will be designed, implemented or improved in a timely and cost-effective manner. Failure to implement, improve and expand such capabilities, procedures and controls in an efficient manner at an appropriate pace could have a material adverse effect on the Company's business, financial condition and results of operations. Single Source Components; Dependence on Key Distributors Certain components of the Company's prenatal screening products under development are expected to be in consumable enrichment kit form. The Company intends to initially subcontract the manufacture of such consumable enrichment kits; however, given the stage of the product's development, neither internal nor third party manufacturing processes have been established. The Company currently relies on a sole supplier for the DNA probe component of its consumable enrichment kit. There can be no assurance that reliable, high volume commercial supplies of such component can be established at commercially reasonable costs or that a new supplier could be qualified in a timely manner if the supply of such component were interrupted. There can be no assurance that reliable high volume manufacturing of such gradients can be established at commercially reasonable costs or that a new supplier could be qualified in a timely manner if the supply of such gradients were interrupted. In addition, the Company proposes to use DNA probes in a prenatal screening kit under development, which are currently provided by a limited number of vendors. The Company purchases certain types of DNA probes from a particular supplier subject to such supplier meeting various performance standards. Such probes require FDA clearance or approval for marketing for clinical diagnostic procedures in the United States and may require FDA approval for export. The DNA probe market is characterized by extensive patent litigation and any court order with respect to infringement of intellectual property could adversely affect the supply of available and cost-effective DNA probes. While the Company believes that other sources for such DNA probes are available, if there were to be interruptions in obtaining supplies from its present source, the Company would have to qualify new sources of approved supply. Dependence on Key Distributors Outside of North America and the United Kingdom, the Company relies substantially on independent distributors and sales agents to market and sell its products. There can be no assurance that distributors and agents will devote adequate resources to support sales of the Company's products. Moreover, agreements with a number of its distributors require that the Company indemnify such distributors against costs, expenses and liabilities relating to litigation regarding the Company's products and, despite these obligations of the Company, distributors may decide to reduce or end their selling efforts until an infringement dispute is resolved or settled. Reliance on International Sales and Operations The Company has significant international operations based in the United Kingdom, employing at December 31, 1998, approximately 40 employees. In 1998, 1997 and 1996, approximately 63%, 59% and 60% respectively, of the Company's total revenues were derived from customers and distributors outside of the United States and Canada. Until such time, if ever, as the FDA clears or approves the Company's fetal cell screening technology for marketing in the United States, the Company expects that international sales of cytogenetic products will continue to account for a significant portion of its revenues. Changes in overseas economic conditions, currency exchange rates, foreign tax laws, or tariffs or other trade regulations could have a material adverse effect on the Company's business, financial condition and results of operations. The international nature of the Company's business subjects it and its representatives, agents and distributors to laws and regulations of the foreign jurisdictions in which it operates or in which its products are sold. The regulation of medical devices in a number of such jurisdictions, particularly in the European Community, continues to develop and there can be no assurance that new laws or regulations will not have a material adverse effect on the Company's business. The laws of certain foreign countries may not protect the Company's intellectual property rights to the same extent, as do the laws of the United States. 21 Currently, most of the Company's international sales are denominated in U.S. dollars or the U.K. pound sterling. The Company has significant operations in the U.K., and therefore, incurs significant operating expenses denominated in U.K. pounds. Accordingly, the Company has not historically attempted to reduce the risk of currency fluctuations by hedging, as changes in exchange rates between the U.S. dollar and the U.K. pound sterling immaterially affect the Company's results of operations. However, there can be no assurance that the Company will not be disadvantaged with respect to its competitors operating in a foreign country by foreign currency exchange rate fluctuations that make the Company's products more expensive relative to those of local competitors. Asian countries, particularly Japan and Korea, continue to experience banking, currency and other difficulties that are contributing to economic slowdowns or recessions in those countries. The region does not appear to be responding quickly to significant efforts to stimulate its economies. If Asian economies remain stagnant or continue to deteriorate, capital investment by Asian customers could decrease from current levels. Customers in Japan and Korea have already canceled or delayed a significant amount of orders for the Company's products and may cancel or delay additional orders in the future. For 1998, net sales to customers located in Asian countries decreased 4% from 1997 to 15%, of the Company's total revenues. For 1998, net sales to customers located in European countries accounted for 45% of the Company's total sales. The unification of the European countries, including the standardization of European currencies, as well as other factors, could contribute to certain countries in the region experiencing banking, currency and other difficulties that could, ultimately, impact the Company's sales in Europe. International Availability of Third-Party Reimbursement; Health Care Reform and Related Matters In the United States, hospitals, physicians and other health care providers that purchase medical devices generally rely on Third-Party Payors, and other sources of reimbursement for health care costs to reimburse all or part of the cost of the procedure in which the medical device is being used. Certain Third-Party Payors are moving toward a managed care system in which they contract to provide comprehensive health care for a fixed cost per person. The fixed cost per person established by these Third-Party Payors may be independent of the hospital's cost incurred for the specific case and the specific devices used. Medicare and other Third-Party Payors are increasingly scrutinizing whether to cover new products and the level of reimbursement for covered products. Because the Company's fetal cell screening technology is currently under development and has not received FDA clearance or approval, uncertainty exists regarding the availability of third-party reimbursement for procedures that would use the Company's fetal cell screening technology. Failure by physicians, hospitals and other potential users of the Company's products or products currently under development to obtain sufficient reimbursement from Third-Party Payors for the procedures in which the Company's products or products currently under the development are intended to be used could have a material adverse effect on the Company's business, financial condition and results of operations. Third-Party Payors that do not use prospectively fixed payments increasingly use other cost-containment processes that may pose administrative hurdles to the use of the Company's products and products currently under development. In addition, Third-Party Payors may deny reimbursement if they determine that the device used in a treatment is unnecessary, inappropriate, experimental, used for a non-approved indication or is not cost-effective. Potential purchasers must determine that the clinical benefits of the Company's products justify the additional cost or the additional effort required to obtain prior authorization or coverage and the uncertainty of actually obtaining such authorization or coverage. If the Company obtains the necessary foreign regulatory registrations or approvals, market acceptance of the Company's products and products currently under development in international markets would be dependent, in part, upon the availability of reimbursement within prevailing health care payment systems. Reimbursement and health care payment systems in international markets vary significantly by country, and include both government-sponsored health care and private insurance. There can be no assurance that any international reimbursement approvals will be obtained in a timely manner, if at all. Failure to receive international 22 reimbursement approvals could have a material adverse effect on market acceptance of the Company's products in the international markets in which such approvals are sought. The Company believes that in the future, reimbursement will be subject to increased restrictions both in the United States and in international markets. The Company believes that the overall escalating cost of medical products and services will continue to lead to increased pressures on the health care industry, both foreign and domestic, to reduce the cost of products and services, including the Company's products and products currently under development. There can be no assurance in either United States or international markets that third-party reimbursement and coverage will be available or adequate, that future legislation, regulation or reimbursement policies of Third-Party Payors will not otherwise adversely affect the demand for the Company's products or products currently under development or its ability to sell its products on a profitable basis. The unavailability of Third-Party Payor coverage or the inadequacy of reimbursement could have a material adverse effect on the Company's business, financial condition and results of operations. In addition, fundamental reforms in the health care industry in the United States and Europe continue to be considered, and there can be no assurance that such reform will not materially adversely affect the Company's business, financial condition and results of operations. Risk of Removal From the NASDAQ National Market The shares of the Company's Common Stock are quoted on the NASDAQ National Market. If the Company should continue to experience losses from operations, it may be unable to maintain the standards for continued quotation on the NASDAQ National Market, and the shares of Common Stock could be subject to removal from the NASDAQ National Market. Trading, if any, in the Common Stock would therefore be conducted on the NASDAQ SmallCap Market, which is a significantly less liquid market than the NASDAQ National Market. As a result, an investor could find it more difficult to dispose of the Company's Common Stock. NASDAQ has recently promulgated new rules which make continued listing of companies on both the NASDAQ National Market and the NASDAQ SmallCap Market more difficult and has significantly increased its enforcement efforts with regard to the standards for such listing. In addition, if the Company's Common Stock were removed from the NASDAQ National Market and not qualify for listing on the NASDAQ SmallCap Market, the Company's Common Stock could be subject to the so-called "penny stock" rules that impose additional sales practice and market making requirements on broker-dealers who sell and/or make a market in such securities. Consequently, failure to qualify for listing on, or removal from, the NASDAQ SmallCap Market, if it were to occur, could affect the ability or willingness of broker-dealers to sell and/or make a market on the Company's Common Stock and the ability of purchasers of the Company's Common Stock to sell their securities in the secondary market. In addition, if the market price of the Company's Common Stock is less than $5.00 per share, the Company may become subject to certain penny stock rules even if still quoted on the NASDAQ SmallCap Market. Such rules may further limit the market liquidity of the Common Stock and the ability of investors to sell such Common Stock in the secondary market. Dependence Upon Key Personnel The Company's future success depends in significant part upon the continued service of certain key scientific, technical and management personnel, and its continuing ability to attract and retain highly qualified scientific, technical and managerial personnel. Competition for such personnel is intense and there can be assurance that the Company can retain its key scientific, technical and managerial personnel or that it can attract, assimilate or retain other highly qualified scientific, technical and managerial personnel in the future. Key employees of the Company include Jack Goldstein, Ph.D., its Chief Executive Officer, Michael Zoccoli, Ph.D., Vice President of Research and Development, Leslie G. Grant, Ph.D., Executive Vice President, and Carl Hull, Vice President Sales and Marketing. The Company has no key man insurance. The Company has taken steps to retain its key employees, including the granting of stock options that vest over time. Additionally, the Company has entered into employment agreements with Dr. Goldstein, Dr. Grant and Mr. Hull. The loss of key personnel especially if without advanced notice, or the inability to hire or retain qualified personnel could have a material adverse effect upon the Company's business, results of operations and financial condition. 23 Risk of Software Defects The Company's cytogenetic and prenatal screening products currently under development involve a software component that facilitates the detection of chromosomal and genetic abnormalities through the interaction of certain imaging algorithms with the genetic sample under examination. The software, including any new versions that may be released, may contain undetected errors or failures. There can be no assurance that, despite testing by the Company and current and potential customers, errors will not be found in the software components of the Company's cytogenetic or prenatal screening products, resulting in loss or delay in market acceptance, which could have a material adverse effect on the Company's business, financial condition and results of operations. Product Liability Risk; Possible Insufficiency of Insurance The manufacture and sale of the Company's products involves the risk of product liability claims. There can be no assurance that the coverage limits of the Company's insurance policies will be adequate. The Company intends to evaluate its coverage on a regular basis and in connection with the introduction of products currently under development. Such insurance is expensive and may not be available on acceptable terms, in sufficient amount of coverage, or at all. A successful claim brought against the Company in excess of its insurance coverage would have a material adverse effect on the Company's business, results of operations and financial condition. Control by Certain Stockholders Certain stockholders, including certain executive officers and directors of the Company and their affiliates, own approximately 65% of the outstanding Common Stock. As a result, these stockholders will, to the extent they act together, continue to have the ability to exert significant influence and control over matters requiring the approval of the Company's stockholders, including the election of a majority of the Company's Board of Directors. Possible Volatility of Stock The market prices for securities of medical diagnostic instrument companies have historically been highly volatile. Announcements of technological innovations or new products by the Company or its competitors, developments concerning proprietary rights, including patents and litigation matters, publicity regarding actual or potential results with respect to products under development by the Company or others, regulatory developments in both the United States and foreign countries and public concern as to the safety of new technologies, changes in financial estimates by securities analysts or failure of the Company to meet such estimates and other factors, may have a significant impact on the market price of the Common Stock. In addition, the Company believes that fluctuations in its operating results may cause the market price of its Common Stock to fluctuate, perhaps substantially. Potential Adverse Effect of Shares Eligible for Future Sale According to Forms 13D and 13G filed by the Company's stockholders, approximately 3,048,305 shares of the Company's Common Stock (representing approximately 26% of the total shares outstanding) are held by affiliates and are therefore subject to volume limitations pursuant to Rule 144. In the event any of such stockholders cease to be affiliates (for example, by resigning from the Board of Directors and holding less than 10% of the shares outstanding), (i) certain of the shares held by such stockholders will be eligible for immediate resale in the public market and (ii) pursuant to Rule 144(k), certain of such shares will no longer be subject to the manner of sale and volume limitations of Rule 144 and will be eligible for resale in the public market after 90 days from the date such stockholder ceases to be an affiliate. Any sale of a substantial number of shares may have the effect of depressing the trading price of the Company's publicly traded stock, which would lower the Company's value and make it more difficult for the Company to raise capital. 24 Significant Restrictions on Change in Control Certain provisions of the Company's current Certificate of Incorporation and Bylaws may have the effect of making it more difficult for a third party to acquire, or discouraging a third party from attempting to acquire, control of the Company. Such provisions could limit the price that certain investors might be willing to pay in the future for shares of the Company's Common Stock. Certain of these provisions provide for the elimination of the right of stockholders to act by written consent without a meeting and specify procedures for director nominations by stockholders and submission of other proposals for consideration at stockholder meetings. In addition, the Company has adopted a Preferred Shares Rights Agreement, sometimes referred to as a poison pill, designed to prevent hostile takeovers not approved by the Board of Directors. Also, the Company is authorized to issue 6,000,000 shares of undesignated Preferred Stock. Such shares of Preferred Stock may be issued by the Company without stockholder approval upon such terms as the Company's Board of Directors may determine. The issuance of Preferred Stock may have the effect of delaying, deferring or preventing a change of control of the Company, may discourage bids for the Company's Common Stock at a premium over the market price of the Common Stock and may adversely affect the market price of the voting and other rights of, the holders of Common Stock. At present, the Company has no plans to issue any of the Preferred Stock. The rights of the holders of Common Stock will be subject to, and may be adversely affected by, the rights of the holders of any Preferred Stock that may be issued in the future. The issuance of Preferred Stock, while providing desirable flexibility in connection with possible acquisitions and other corporate purposes, could have the effect of making it more difficult for a third party to acquire a majority of the outstanding voting stock of the Company. Certain provisions of Delaware law applicable to the Company could also delay or make more difficult a merger, tender offer or proxy contest involving the Company, including Section 203 of the Delaware General Corporation Law, which prohibits a Delaware corporation from engaging in any business combination with any interested stockholder for a period of three years unless certain conditions are met. Item 2. PROPERTIES In the United States, Applied Imaging leases an approximately 14,000 square foot facility in Santa Clara, California, under a lease, which terminates in November 30, 2000. The Company also leases approximately 2,700 square foot facility in Pittsburgh, Pennsylvania, under a lease that terminates in March 1999. In the United Kingdom, Applied Imaging International Ltd. ("AII") leases approximately 12,500 square foot facility in Newcastle , which lease terminates in July 2008. The Company believes that its facilities are adequate to meet its requirements through 2000. Item 3. LEGAL PROCEEDINGS The Company is not party to any legal proceedings. Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS Not applicable. 25 PART II Item 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS The Company's Common Stock is traded on the NASDAQ National Market under the symbol "AICX." The following table sets forth the range of the high and low sale prices by quarter as reported on the NASDAQ National Market from November 1996, when the Company's Common Stock commenced trading.
High Low ------ ------- 1998 First Quarter............................................. 4 1/4 1 7/8 Second Quarter............................................ 3 9/16 1 7/8 Third Quarter............................................. 3 2 Fourth Quarter............................................ 3 1/8 1 1/4 1997 First Quarter............................................. 9 1/2 5 Second Quarter............................................ 6 7/8 3 3/8 Third Quarter............................................. 6 7/8 4 1/8 Fourth Quarter............................................ 6 1/8 1 13/16
As of March 8, 1999, the number of common stockholders of record was 177. The Company currently intends to retain any earnings for use in its business and does not anticipate paying any cash dividends in the foreseeable future. 26 Item 6. SELECTED FINANCIAL DATA
Year Ended December 31, --------------------------------------------------- 1998 1997 1996 1995 1994 --------- --------- --------- --------- ------- (In thousands, except per share data) Statement of Operations Data: Revenues: Product sales............ $ 9,034 $ 10,457 $ 9,259 $ 8,106 $ 7,021 Software maintenance and service................. 2,650 2,677 2,663 2,692 2,550 --------- --------- --------- --------- ------- Total revenues.......... 11,684 13,134 11,922 10,798 9,571 Cost of revenues.......... 6,010 6,284 5,974 5,484 5,350 --------- --------- --------- --------- ------- Gross profit............ 5,674 6,850 5,948 5,314 4,221 Operating Expenses: Research and development............. 6,662 7,381 3,667 2,919 2,821 Sales and marketing...... 4,950 3,740 3,088 2,918 2,524 General and administrative.......... 2,721 3,639 2,088 2,094 1,898 Restructuring costs...... 353 -- -- -- -- --------- --------- --------- --------- ------- Total operating expenses............... 14,686 14,760 8,843 7,931 7,243 --------- --------- --------- --------- ------- Operating loss.......... (9,012) (7,910) (2,895) (2,617) (3,022) Other income, net......... 541 398 14 71 52 --------- --------- --------- --------- ------- Net loss.................. $ (8,471) $ (7,512) $ (2,881) $ (2,546) $(2,970) ========= ========= ========= ========= ======= Net loss per share--Basic and diluted.............. $ (0.86) $ (1.03) $ (1.43) $ (2.46) $ (3.07) ========= ========= ========= ========= ======= Shares used to calculate Basic and diluted net loss per share........... 9,850,293 7,324,194 2,020,369 1,033,020 967,686 ========= ========= ========= ========= ======= December 31, --------------------------------------------------- 1998 1997 1996 1995 1994 --------- --------- --------- --------- ------- (In thousands) Balance Sheet Data: Cash, cash equivalents and short-term investments............. $ 11,728 $ 8,378 $ 12,318 $ 5,156 $ 2,503 Working capital.......... 10,753 7,171 10,700 3,249 1,712 Total assets............. 18,808 14,714 16,473 9,373 7,441 Non-current portion of long-term debt and capital lease obligations............. 64 89 229 231 336 Accumulated deficit...... (28,004) (19,533) (12,021) (9,140) (6,594) Total stockholders' equity(1)............... 12,343 8,943 12,005 4,714 2,811
- -------- (1) No cash dividends have been declared with respect to the Company's Common and Preferred Stock. 27 Item 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The information set forth in this Item 7 below contains forward-looking statements, (designated by an *), and the Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including those set forth below under "Factors That May Affect Future Results," and those set forth under Item One on this document, including "Additional Risk Factors". Overview Since its inception in 1986, the Company has principally been engaged in the design, development, manufacture and marketing of automated clinical analysis systems used by cytogenetic laboratories for prenatal and other genetic screening. The Company's cytogenetic instrumentation products include systems that enable laboratories to automate aspects of the detection of chromosomal abnormalities associated with conditions such as Down Syndrome. The Company sells its cytogenetic systems to government and private clinical cytogenetic laboratories, research institutions, universities and pharmaceutical companies, and has sold such systems to approximately 650 sites in over 35 countries. In 1993, the Company established a research project to develop proprietary prenatal screening products to detect chromosomal genetic disorders through the enrichment and analysis of fetal blood cells from a routine maternal blood sample. Since that time, the Company has devoted substantial resources to the development of these prenatal screening products. The Company's prenatal screening products, which the Company is developing, incorporate (i) a hematological procedure to enrich the concentration of the fetal blood cells found in maternal blood, (ii) a fetal hemoglobin test kit, (iii) automated image analysis instrumentation to identify the fetal blood cells and (iv) third-party DNA probes to identify certain chromosomal abnormalities present in these fetal cells. The Company intends that preclinical and clinical evaluations of the products be done in such a way so as to establish them as a broadly applicable prenatal screening procedure. The Company anticipates that sales of the products, if cleared or approved by the FDA, will include a consumable enrichment kit used to separate fetal blood cells from maternal blood, a consumable hemoglobin identification kit and imaging instrumentation used to analyze these cells. The implementation of the Company's strategy is dependent upon the successful development and commercialization of the Company's prenatal screening products. In addition, the company has under development a system to detect micrometastatic cells from bone marrow, lymph node and blood samples from cancer patients as a means to better determine the initial staging of the cancer and then detect relapses after treatment earlier than is currently possible. The operating results of the Company have fluctuated significantly in the past on an annual and quarterly basis. The Company expects that its operating results will fluctuate significantly from quarter to quarter and year to year in the future and will depend on a number of factors, some of which may affect future sales of the Company's cytogenetic products. These factors include, but are not limited to, demand for the Company's products, timing of orders and shipments, competition and its related pricing pressures, and seasonal factors, many of which are outside the Company's control. If FDA clearance or approval is received, the Company intends to increase the amount of expenditures for research and development and sales and marketing activities, principally for the commercial launch of its prenatal screening system. If additional funding is obtained, the Company intends to increase its research and development expenses related to follow-on products and additional applications of its prenatal screening technology. The Company markets its products worldwide from its operations in the United States and the United Kingdom and performs research and development in the United States. Sales from the United States are primarily to customers within the United States. Revenues in the United Kingdom result from drop shipments of products from the United States directly to customers and from direct shipments from the United Kingdom. Results of Operations Fiscal 1998 Compared With Fiscal 1997 Revenues. Revenues decreased to $11.7 million in 1998 from $13.1 million in 1997. The decrease in revenues is principally due to the economic crisis in Asia, particularly Japan, as well as lower sales in North 28 America. Software and service contract pricing is derived from product pricing, and with unit selling prices of the Company's CytoVision systems, sold since 1994, significantly lower than earlier generation products, software and service contract pricing has decreased accordingly. In 1998 the Company recorded $287,000 of grant proceeds as revenues. For 1998 and 1997 revenues derived outside of North America were approximately 63% and 59% of total revenues, respectively. Cost of Revenues. Cost of revenues as a percent to total sales increased to 51% in 1998, from 48% in 1997. The increase in cost of revenues as a percentage of total revenues is attributable to lower selling prices, as a result of increased price competition for the cytogenetic instrumentation products, lower service revenues and increases to inventory reserves for certain discontinued products. Research and Development Expenses. Research and development expenses of $6.7 million decreased $719,000 over 1997. The decrease is primarily due to cost saving programs implemented throughout the year Research and development costs were 57% and 56% of total revenues for 1998 and 1997, respectively. Sales and Marketing Expenses. Sales and marketing expenses increased to $5.0 million in 1998 from $3.7 million in 1997. In 1998 and 1997 sales and marketing expenses as a percentage of total revenues were 42% and 28%, respectively. The increase in 1998 is primarily attributable to investment spending for additional marketing and sales personnel to support the launch of the new instrumentation systems and RxFISH. General and Administrative Expense. General and administrative expenses in 1998 amounted to $2.7 million, decreasing $918,000 over 1997. The decrease is primarily due to lower corporate staffing levels and lower costs for recruiting and relocation. Restructuring. During the quarter ended June 30, 1998, plans were developed to reduce operating costs by eliminating thirteen positions in the Company. The reductions were made at both the United States and United Kingdom facilities. The consolidated statement of operations for 1998 includes a $353,000 charge relating to the severance costs of these terminated employees. Substantially all of the costs have been paid. Fiscal 1997 Compared With Fiscal 1996 Revenues. Revenues increased to $13.1 million in 1997 from $11.9 million in 1996. The increase in revenues is primarily attributable to demand by cytogenetic laboratories to automate aspects of otherwise labor-intensive analyses, to increase capacity of existing systems, or to replace older generation systems with the Company's CytoVision products. Software and service contract revenues remained relatively flat at $2.7 million for 1997 and 1996 and as a percentage of total revenues, decreased to 20% in 1997 from 22% in 1996. For 1997 and 1996 revenues derived outside of North America remained relatively consistent at approximately 59% and 60% of total revenues, respectively. Cost of Revenues. Cost of revenues increased $6.3 million in 1997, from $6.0 million in 1996, or 48% and 50% as a percentage of total revenues, respectively. This decrease in cost of revenues as a percentage of total revenues from year to year was attributable to increased product shipment volume and engineering design changes to reduce direct material and production costs. The decrease in cost of software maintenance and service is primarily due to lower staffing and material costs as a result of improved components which reduced the number of service calls. Research and Development Expenses. Research and development expenses increased to approximately $7.4 million in 1997 from $3.7 million in 1996. The increase was due to increasing expenditures on the development of the prenatal screening products. Sales and Marketing Expenses. Sales and marketing expenses increased to $3.7 million in 1997 from $3.1 million in 1996. In 1997 and 1996 sales and marketing expenses as a percentage of total revenues were 28% and 26% respectively. The increase in 1997 is primarily attributable to additional marketing and sales management personnel and the associated recruitment and relocation costs. 29 General and Administrative Expenses. General and administrative expenses in 1997 amounted to $3.6 million, increasing $1.6 million over 1996. The increase is primarily due to increased administrative and management staff and associated costs related to public company reporting requirements and management infrastructure changes in anticipation of future growth. In addition, the Company incurred a charge of $480,000 in 1997 associated with executive management changes. In 1997 and 1996 general and administrative expenses were 28% and 18% of total revenue, respectively. Factors That May Affect Future Results The Company's operating results may vary significantly depending on certain factors, including the effect of delays in its research and development program, adverse results in its clinical studies, delay in the introduction or shipment of new products, increased competition, adverse changes in the economic conditions in any of the several countries in which the Company does business, a slower growth rate in the Company's target markets, order deferrals in anticipation of new product releases, lack of market acceptance of new products, the uncertainty of FDA or other domestic and international regulatory clearances or approvals. Due to the factors noted above, the Company's future earnings and stock price may be subject to significant volatility, particularly on a quarterly basis. Any shortfall in revenues or earnings from levels expected by security analysts could have an immediate and significant adverse effect on the trading price of the Company's common stock. Liquidity and Capital Resources The Company strengthened in financial position in 1998 by raising $11.4 million of equity net of issuance costs, via private placements of its common stock. As of December 31, 1998, the Company had cash, cash equivalents and short-term investments of $11.7 million and working capital of $10.8 million, compared to $8.4 million and $7.2 million, respectively, at December 31, 1997. For the year ended December 31, 1998, cash used by operations totaled $8.2 million, compared to $7.1 million for the corresponding prior year. The increase in cash used by operations was primarily attributable to an increased loss, and increases in accounts receivable and inventories of $463,000 and $320,000 respectively. In addition, the Company consumed $744,000 in 1998 for purchases of capital equipment compared to $1.1 million for the comparable prior year. Since its inception in July 1986 through December 1998, the Company has generated an accumulated deficit of approximately $28 million. The Company expects negative cash flow from operations to continue into at least 2000, as it continues the development of its fetal cell and micrometastasis programs, conducts clinical trials required for FDA clearance of the DNA probe portion of the fetal cell technology, expands its marketing, sales and customer support capabilities, and adds administrative infrastructure .* The Company currently estimates that its capital resources will enable it to meet its short-term capital needs and sustain it through the middle of 2000 .* Long- term capital needs of the Company will require it to raise additional debt or equity financing . If adequate funds are not available, the Company could be required to delay development or commercialization of certain products, to license to third parties the rights to commercialize certain products or technologies that the Company would otherwise seek to commercialize itself, or to reduce the marketing, customer support, or other resources devoted to certain products .* There can be no assurance, however, that the Company will not be required to seek capital at an earlier date. The timing and amount of spending of such capital resources cannot be accurately determined at this time and will depend on several factors, including but not limited to, the progress of its research and development efforts and clinical investigation, the timing of regulatory approvals or clearances, competing technological and market developments, commercialization of products currently under development and market acceptance and demand for the Company's products. In addition, as opportunities arise, proceeds may also be used to acquire businesses, technologies or products that complement any such acquisitions . * The Company may seek to obtain additional funds through equity or debt financing, collaborative or other arrangements with other companies, and from other sources.* No assurance can be given that additional financing will be available when needed or on terms acceptable to the Company. 30 In 1998, the Company entered into an Option Agreement to acquire ownership of patents for the enrichment of fetal cells. The agreement provides for a series of payments of approximately $1.1 million if the option is exercised and products using the technology are successful in clinical trials. The final payment of $250,000 would be paid in common stock based on the market value of the common stock as of the date the clinical trials are successfully completed. Year 2000 Compliance The Company is knowledgeable of the issues associated with the programming code in existing computer systems as the year 2000 approaches. The Company began in 1997 and 1998 with a Year 2000 problem assessment, establishing Year 2000 Company Policy, and initiating the product upgrade solution. The Company is using a four phase approach to address the Year 2000 compliance and issues. The first phase consisted of the inventorying of all potential business interruption problems, including those with products and systems, as well as potential disruption from suppliers and other third parties. The second phase consists of prioritization of potential problems and allocating the appropriate level of resources to the most critical areas. The third phase addresses the remediation programs to solve or mitigate any identified Year 2000 problems. The fourth phase, if necessary, will be to develop and implement contingency plans if there are significant Year 2000 problems from the Company or its key suppliers. The Company has completed an assessment of its internal Year 2000 risks. The assessment included a review of products the Company produces and sells to third parties, its telecommunication systems and its internal computer and management information systems. The Company has determined that its current products are Year 2000 compliant. The Company has recently upgraded its telecommunication equipment and accounting systems to be Year 2000 compliant. In February 1999, the Company released Year 2000 Upgrades to bring Pentium- based systems currently installed at customer sites into Year 2000 compliance. * Should unanticipated Year 2000 problems occur, the Company is prepared to develop and execute contingency plans to satisfy customers on an as needed basis. The Company has commenced its external assessment of Year 2000 risks. In early 1998, the Company contacted its key third party manufacturing suppliers to assess exposure to Year 2000 problems. The initial assessment was that the key supplier products were Year 2000 complaint. Currently, the Company is contacting its key suppliers, vendors, financial service organizations (third party suppliers) to confirm their continuing Year 2000 compliance of their products and business programs to ensure the Company will not incur any Year 2000 business disruptions. Additionally, new key suppliers are also being contacted. The Company expects to complete its 1999 external assessment on or before the end of June 1999. At present, the Company is not aware of any issues with any of its third party suppliers. * However, uncertainty exists and significant Year 2000 compliance problems from its third party supplies, partners, or customers that could materially have adverse affect on the Company's business, results of operation, financial condition and prospects. The Company has and will continue to expend resources to continue to monitor and upgrade its products and services and for the upgrade to its telecommunication and management information systems. * To date the Company estimates that its has expended approximately $90,000 for costs associated with its year 2000 compliance and estimates it will spend an additional $75,000 to $110,000 inclusive of non-incremental costs that will be incurred by reallocation of existing resources in bringing the Company into Year 2000 compliance.* However, there may be unforeseeable issues with unseen costs that are outside of the Company's control that could have a negative impact. New Accounting Pronouncements The Financial Accounting Standards Board recently issued Statement of Financial Accounting Standards (SFAS) No. 133, Accounting for Derivative Instruments and Hedging Activities. SFAS No. 133 establishes accounting and reporting standards for derivative instruments, including certain derivative instruments embedded in other contracts (collectively referred to as derivatives), and for hedging activities. It requires that an entity 31 recognize all derivatives as either assets or liabilities in the balance sheet and measure those instruments at fair value. For a derivative not designated as a hedging instrument, changes in the fair value of the derivative are recognized in earnings in the period of change. The Company must adopt SFAS No. 133 by January 1, 2000. Management does not believe that the adoption of SFAS No. 133 will have a material effect on the financial position or results of operations of the Company. Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK DERIVATIVES AND FINANCIAL INSTRUMENTS Foreign currency hedging instruments The Company transacts business in various foreign currencies. Accordingly, the Company is subject to exposure from adverse movements in foreign currency exchange rates. This exposure is primarily related to revenues and operating expenses in the U.K. denominated in the respective local currency. The Company currently does not use financial instruments to hedge operating expenses in the U. K. denominated in the respective local currency. Instead, the Company believes that a natural partial hedge exits, because local currency revenues will substantially offset the operating expenses denominated in the respective local currency. The company assesses the need to utilize financial instruments to hedge currency exposure on a ongoing basis. As of December 31, 1998 the Company had no hedging contracts outstanding. The Company does not use derivative financial instruments for speculative trading purposes, nor does the Company hedge its foreign currency exposure in a manner that entirely offsets the effects of changes in foreign exchange rates. The Company regularly reviews its hedging program and may as a part of this review determine at any time to change its hedging program. See "Risk Factors--Reliance on International Sales and Operations Fixed income investments The Company's exposure to market risks for changes in interest rates relates primarily to investments in debt securities issued by U.S. government agencies and corporate debt securities. The Company places its investments with high credit quality issuers and, by policy, limits the amount of the credit exposure to any one issuer. The company's general policy is to limit the risk of principal loss and ensure the safety of invested funds by limiting market and credit risk. All highly liquid investments with a maturity of three months or less at the date of purchase are considered to be cash equivalents; investments with maturities over three months are considered to be short-term investments. The weighted average pre-tax interest rate on the investment portfolio is approximately 5.7%. 32 Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA Report of Independent Certified Public Accountants The Board of Directors Applied Imaging Corp.: We have audited the accompanying consolidated balance sheets of Applied Imaging Corp. and subsidiaries as of December 31, 1998 and 1997, and the related consolidated statements of operations, stockholders' equity, and cash flows for each of the years in the three-year period ended December 31, 1998. In connection with our audits of the consolidated financial statements for the periods indicated above, we have also audited the consolidated financial statement schedule as listed in the Index at Item 14(a)(2) . These consolidated financial statements and financial statement schedule are the responsibility of the Company's management. Our responsibility is to express an opinion on these consolidated financial statements and financial statement schedule based on our audits. We conducted our audits in accordance with generally accepted auditing standards. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Applied Imaging Corp. and subsidiaries as of December 31, 1998 and 1997, and the results of their operations and their cash flows for each of the years in the three-year period ended December 31, 1998, in conformity with generally accepted accounting principles. Also in our opinion, the related consolidated financial statement schedule, when considered in relation to the basic consolidated financial statements taken as a whole, presents fairly, in all material respects, the information set forth therein. KPMG LLP Mountain View, California February 5, 1999 33 APPLIED IMAGING CORP. AND SUBSIDIARIES Consolidated Balance Sheets
December 31, ------------------------ 1998 1997 ----------- ----------- Assets Current assets: Cash and cash equivalents.......................... $ 5,480,000 $ 2,918,000 Short-term investments............................. 6,248,000 5,460,000 Trade accounts receivable (less allowance for doubtful accounts of $162,000 and $191,000 at December 31, 1998 and 1997, respectively)......... 3,821,000 3,358,000 Inventories........................................ 1,169,000 849,000 Prepaid expenses and other assets.................. 436,000 268,000 ----------- ----------- Total current assets............................. 17,154,000 12,853,000 Property and equipment............................... 1,569,000 1,793,000 Other assets......................................... 85,000 68,000 ----------- ----------- $18,808,000 $14,714,000 =========== =========== Liabilities and Stockholders' Equity Current liabilities: Bank debt.......................................... $ 1,045,000 $ 299,000 Current portion of capital lease obligation........ 34,000 34,000 Accounts payable................................... 1,572,000 1,754,000 Accrued expenses................................... 2,519,000 2,434,000 Deferred revenue................................... 1,231,000 1,161,000 ----------- ----------- Total current liabilities........................ 6,401,000 5,682,000 Capital lease obligation, less current portion....... 64,000 89,000 Commitments Stockholders' equity: Common stock; $0.001 par value; 20,000,000 shares authorized; 11,529,537 and 7,667,956 shares issued and outstanding at December 31, 1998 and 1997, respectively...................................... 12,000 8,000 Additional paid-in capital......................... 41,121,000 29,636,000 Accumulated deficit................................ (28,004,000) (19,533,000) Deferred stock compensation........................ (419,000) (801,000) Accumulated other comprehensive income............. (367,000) (367,000) ----------- ----------- Total stockholders' equity....................... 12,343,000 8,943,000 ----------- ----------- $18,808,000 $14,714,000 =========== ===========
See accompanying notes to consolidated financial statements. 34 APPLIED IMAGING CORP. AND SUBSIDIARIES Consolidated Statements of Operations
Year ended December 31, ------------------------------------- 1998 1997 1996 ----------- ----------- ----------- Revenues: Product sales........................ $ 9,034,000 $10,457,000 $ 9,259,000 Software maintenance and other....... 2,650,000 2,677,000 2,663,000 ----------- ----------- ----------- Total revenues..................... 11,684,000 13,134,000 11,922,000 ----------- ----------- ----------- Cost of revenues: Product sales........................ 4,953,000 5,188,000 4,501,000 Software maintenance and service..... 1,057,000 1,096,000 1,473,000 ----------- ----------- ----------- Total cost of revenues............... 6,010,000 6,284,000 5,974,000 ----------- ----------- ----------- Gross profit......................... 5,674,000 6,850,000 5,948,000 ----------- ----------- ----------- Operating expenses: Research and development............. 6,662,000 7,381,000 3,667,000 Sales and marketing.................. 4,950,000 3,740,000 3,088,000 General and administrative........... 2,721,000 3,639,000 2,088,000 Restructuring costs.................. 353,000 -- -- ----------- ----------- ----------- Total operating expenses............. 14,686,000 14,760,000 8,843,000 ----------- ----------- ----------- Operating loss....................... (9,012,000) (7,910,000) (2,895,000) Other income, net...................... 541,000 398,000 14,000 ----------- ----------- ----------- Net loss............................. $(8,471,000) $(7,512,000) $(2,881,000) =========== =========== =========== Net loss per share--basic and diluted.. $ (0.86) $ (1.03) $ (1.43) =========== =========== =========== Shares used to calculate basic and diluted net loss per share............ 9,850,293 7,324,194 2,020,369 =========== =========== ===========
See accompanying notes to consolidated financial statements. 35 APPLIED IMAGING CORP. AND SUBSIDIARIES Consolidated Statements of Stockholders' Equity
Accumulated Preferred stock Common stock Additional Deferred other Total ------------------ ------------------ paid-in Accumulated stock comprehensive stockholder Shares Amount Shares Amount capital deficit compensation income equity ---------- ------ ---------- ------- ----------- ------------ ------------ ------------- ----------- Balances as of December 31, 1995............ 3,919,179 $4,000 1,067,785 $ 1,000 $14,216,000 $ (9,140,000) -- $(367,000) $ 4,714,000 Exercise of common stock options........ -- -- 89,250 -- 161,000 -- -- -- 161,000 Initial public offering (IPO) of common stock, net of $1,829,000 offering costs.......... -- -- 1,650,000 2,000 9,719,000 -- -- -- 9,721,000 Preferred stock converted to common stock in connection with IPO............ (3,919,179) (4,000) 3,960,017 4,000 -- -- -- -- -- Net exercise of 110,416 Series F preferred stock warrants in connection with IPO....... -- -- 56,783 -- -- -- -- -- -- Deferred employee stock option compensation... -- -- -- -- 1,473,000 -- (1,.473,000) -- -- Amortized of deferred stock compensation... -- -- -- -- -- -- 290,000 -- 290,000 Net Loss........ -- -- -- -- -- (2,881,000) -- -- (2,881,000) ---------- ------ ---------- ------- ----------- ------------ ----------- --------- ----------- Balances as of December 31, 1996............ -- -- 6,823,835 7,000 25,569,000 (12,021,000) (1,183,000) (367,000) 12,005,000 Exercise of common stock options........ -- -- 34,003 -- 72,000 -- -- -- 72,000 Private placement of common stock, net of $59,000 offering costs.......... -- -- 796,020 1,000 3,940,000 -- -- -- 3,941,000 Stock issued in connection with employee stock purchase plan.. -- -- 14,098 -- 55,000 -- -- -- 55,000 Amortization of deferred stock compensation... -- -- -- -- -- -- 382,000 -- 382,000 Net Loss........ -- -- -- -- -- (7,512,000) -- -- (7,512,000) ---------- ------ ---------- ------- ----------- ------------ ----------- --------- ----------- Balances as of December 31, 1997............ -- -- 7,667,956 8,000 29,636,000 (19,533,000) (801,000) (367,000) 8,943,000 Exercise of common stock options........ -- -- 8,247 -- 17,000 -- -- -- 17,000 Private placement of common stock net of $100,000 offering costs.......... -- -- 3,833,330 4,000 11,396,000 -- -- -- 11,400,000 Stock issued in connection with employee stock purchase plan.. -- -- 20,004 -- 48,000 -- -- -- 48,000 Stock warrants extended....... -- -- -- -- 24,000 -- -- -- 24,000 Amortized of deferred stock compensation... -- -- -- -- -- -- 382,000 -- 382,000 Net loss........ -- -- -- -- -- (8,471,000) -- -- (8,471,000) ---------- ------ ---------- ------- ----------- ------------ ----------- --------- ----------- Balances as of December 31, 1998............ -- -- 11,529,537 $12,000 $41,121,000 $(28,004,000) $ (419,000) $(367,000) $12,343,000 ========== ====== ========== ======= =========== ============ =========== ========= ===========
See accompanying notes to consolidated financial statements. 36 APPLIED IMAGING CORP. AND SUBSIDIARIES Consolidated Statements of Cash Flows
Year ended December 31, ------------------------------------- 1998 1997 1996 ----------- ----------- ----------- Cash flows from operating activities: Net loss............................... $(8,471,000) $(7,512,000) $(2,881,000) Adjustments to reconcile net loss to net cash used for operating activities: Depreciation and amortization......... 939,000 695,000 583,000 Unrealized exchange (gain) loss....... -- -- 33,000 Compensation expense related to employee stock options............... 382,000 382,000 290,000 Loss on sale of other assets.......... 5,000 29,000 -- Changes in operating assets and liabilities: Trade accounts receivable............ (463,000) (1,904,000) 47,000 Inventories.......................... (320,000) (18,000) 49,000 Prepaid expenses and other assets.... (168,000) 68,000 (196,000) Accounts payable..................... (182,000) 75,000 538,000 Accrued expenses..................... (15,000) 1,130,000 (126,000) Deferred revenue..................... 70,000 (62,000) (163,000) ----------- ----------- ----------- Net cash used for operating activities.......................... (8,223,000) (7,117,000) (1,826,000) ----------- ----------- ----------- Cash flows from investing activities: Purchase of short-term investments.... (4,997,000) (7,456,000) -- Proceeds from sales and maturities of short term investments............... 4,209,000 1,996,000 2,997,000 Proceeds from sales of fixed assets... 24,000 -- -- Purchase of equipment................. (744,000) (1,119,000) (498,000) Other assets.......................... (17,000) 203,000 71,000 ----------- ----------- ----------- Net cash provided by (used for) investing activities................ (1,525,000) (6,376,000) 2,570,000 ----------- ----------- ----------- Cash flows from financing activities: Net proceeds from issuance of common stock................................ 11,565,000 4,068,000 9,882,000 Proceeds from stock warrants extended............................. 24,000 -- -- Bank loan proceeds/(payments)--net.... 746,000 38,000 (467,000) Capital lease payments................ (25,000) (13,000) -- ----------- ----------- ----------- Net cash provided by financing activities.......................... 12,310,000 4,093,000 9,415,000 ----------- ----------- ----------- Net increase (decrease) in cash and cash equivalents............................ 2,562,000 (9,400,000) 10,159,000 Cash and cash equivalents at beginning of year................................ 2,918,000 12,318,000 2,159,000 ----------- ----------- ----------- Cash and cash equivalents at end of year................................... 5,480,000 $ 2,918,000 $12,318,000 =========== =========== =========== Supplemental disclosure of cash paid for interest............................... $ 92,000 $ 39,000 $ 86,000 =========== =========== =========== Supplemental disclosure of non-cash investing and financing activities: Equipment acquired through capital leases............................... -- $ 135,000 -- =========== =========== =========== Deferred compensation relating to employee stock options............... -- -- $ 1,473,000 =========== =========== =========== Conversion of preferred stock and preferred stock warrants into common stock................................ -- -- $ 4,000 =========== =========== ===========
See accompanying notes to consolidated financial statements. 37 APPLIED IMAGING CORP. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (1) Summary of the Company and Significant Accounting Policies The Company Applied Imaging Corp. (the Company) was incorporated in 1986 to develop, manufacture, and market automated clinical analysis systems used by cytogenetic laboratories in prenatal genetic screening. The Company sells its products to government and private clinical cytogenetic laboratories, research institutions, universities, and pharmaceutical companies located primarily in the United States, Canada, Europe, and the Pacific Rim. The Company is currently devoting significant resources to the development of a new prenatal screening designed to enable the detection of prenatal chromosomal disorders through the analysis of fetal blood cells drawn from maternal blood. There have been no revenues earned in relation to this new prenatal screening system. Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Applied Imaging International, Limited (United Kingdom) and Applied Imaging, Limited (Israel). All significant intercompany accounts and transactions have been eliminated in consolidation. Foreign Exchange The Company accounts for its foreign operations in accordance with Statement of Financial Accounting Standards (SFAS) No. 52, Foreign Currency Translation. Prior to April 1994, the functional currency for Applied Imaging International, Limited was the British pound and, accordingly, translation adjustments resulting from the conversion of the subsidiary's financial statements into U.S. dollars were accumulated and reported as a separate component of stockholders' equity. Beginning in April 1994, certain operational and organizational changes within the Company caused the functional currency for the Company's subsidiary to become the U.S. dollar. Therefore, monetary assets and liabilities of the subsidiary are remeasured to the U.S. dollar at year-end exchange rates while nonmonetary items are remeasured at historical rates. Revenue and expense accounts related to monetary assets and liabilities are remeasured at the average rates in effect during the year. Revenue and expenses related to non-monetary assets and liabilities are translated at historical rates. Foreign currency gains and losses resulting from the conversion of the subsidiary's financial statements into U.S. dollars are currently recognized in the consolidated statement of operations. The functional currency of Applied Imaging, Limited is also the U.S. dollar. Use of Estimates The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Comprehensive Income In accordance with Statement of Financial Accounting Standards (SFAS) No.130 Reporting Comprehensive Income, the Company is required to classify items of other comprehensive income, by their nature (e.g. unrealized gains or losses on securities) in a financial statement. There were no components of other comprehensive income for the years ended December 31, 1998, 1997 and 1996. The accumulated balance of other comprehensive income from periods prior to 1996 are reported as Accumulated other comprehensive 38 APPLIED IMAGING CORP. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued) income' and displayed separately from retained earnings and additional paid-in capital in the equity section of the balance sheet. Revenue Recognition The company recognizes revenue on product sales upon shipment and concurrently accrues for expected hardware warranty expenses and establishes reserves for product returns. Revenue attributable to software maintenance and support, is deferred and recognized ratably over the term of the maintenance agreement, generally one year. In October 1997, the American Institute of Certified Public Accountants ("AICPA") issued Statement of Position ("SOP") 97-2, Software Revenue Recognition. SOP 97-2 applies to the sales of products that contain software elements that are more than incidental to the product as a whole. The Company adopted SOP 97-2 effective January 1, 1998. SOP 97-2 generally requires revenue attributable to software elements to be allocated to the elements based on their fair values. The fair value of an element must be based on the evidence which is specific to the vendor. The revenue allocated to software products is recognized upon shipment of the product. The revenue attributable to maintenance and support is recognized ratably over the term of the maintenance agreement. There was no change to the Company's accounting for revenues as a result of the adoption of SOP 97-2. In February 1998, the AICPA issued SOP 98-4, Deferral of the Effective Date of SOP 97-2. The SOP defers the effective date for applying the provisions regarding vendor-specific objective evidence of fair value ("VSOE") until the AICPA can reconsider what constitutes such VSOE. There was no change to the Company's accounting for revenues as a result of the adoption of SOP 98-4. In December 1998, the AICPA issued SOP 98-9, Software Revenue Recognition, with Respect to Certain Arrangements, which requires recognition of revenue using the "residual method" in a multiple-element arrangement when fair value does not exist for one of more of the delivered elements in the arrangement. Under the residual method, the total fair value of the undelivered elements is deferred and subsequently recognized in accordance with SOP 97-2. The Company does not expect a change to its accounting for revenues as a result of the provisions of SOP 98-9. Research and Development Expenditures Research and development expenditures are charged to expense as incurred. Earnings (loss) per Share Basic and diluted net loss per share are computed using the weighted average number of outstanding shares of common stock. There were no reconciling items of the numerators and denominators of the basic and diluted EPS computation. Shares excluded from the computation of EPS because their effect on EPS was antidilutive, but could dilute basic EPS in future periods are as follows:
1998 1997 1996 ------------------------ ------------------------ ---------------------- Weighted Weighted Weighted average average average Shares exercise price Shares exercise price Shares exercise price --------- -------------- --------- -------------- ------- -------------- Options................. 1,787,405 $2.32 1,199,272 $4.04 481,250 $2.48 Warrants................ 577,909 5.17 681,744 5.18 508,734 4.97 --------- --------- ------- Total................. 2,365,314 1,881,016 989,984 ========= ========= =======
39 APPLIED IMAGING CORP. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued) Cash Equivalents and Short-Term Investments All investments with original maturities at date of purchase of three months or less are considered by the Company to be cash equivalents. Inventories Inventories are stated at the lower of cost (first in, first out) or market. Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation is provided using the straight-line method over the estimated useful lives of the respective assets, generally three to five years. Recoverability of property and equipment is measured by comparison of its carrying amount to future net cash flows the property and equipment are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the property and equipment exceeds its fair market value. To date, the Company has made no adjustments to the carrying values of its long-lived assets. Short-Term Investments Short-term investments consist of investments acquired with maturities exceeding three months. While the Company's intent is to hold debt securities to maturity, consistent with SFAS No. 115, Accounting for Certain Investments in Debt and Equity Securities, the Company has classified all securities as available-for-sale, as the sale of such securities may be required prior to maturity to implement management strategies. Such securities are reported at fair value with unrealized gains or losses excluded from earnings and reported as a separate component of shareholder's equity, net of applicable taxes. As of December 31, 1998, the difference between the fair value and the amortized cost of available-for-sale securities was not significant, therefore, no unrealized gains or losses have been recorded in shareholders equity. As of December 31, 1998 and 1997, the Company's short-term investments consisted of certificates of deposit and corporate bonds with the following contractual maturities::
1998 1997 ------ ------ Corporate bonds.............................................. $6,248 $2,191 Certificates of deposit...................................... -- 3,269 ------ ------ Total...................................................... $6,248 $5,460 ====== ======
As of December 31, 1998, the maturities of the short-term investments are as follows: $3,166 within one year and $3,082 more than one year. Capitalized Software Costs Computer software development costs incurred subsequent to the determination of product technological feasibility are capitalized in accordance with the provisions of SFAS No. 86, Accounting for the Cost of Computer Software to be Sold, Leased or Otherwise Marketed. Amortization of these capitalized costs is provided using the greater of the ratio of revenues generated in the period over total future revenues of the product, or the straight-line method over the estimated market life of the related products, generally three years, commencing when the product becomes generally available to customers. For the years ended December 31, 40 APPLIED IMAGING CORP. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued) 1998, 1997 and 1996, software development costs incurred subsequent to the establishment of technological feasibility have not been material. The net book value of capitalized costs is not significant and is included in other assets in the consolidated balance sheets. Stock Based Compensation The Company uses the intrinsic-value method to account for its stock-based compensation arrangements. Income Taxes The Company uses the asset and liability method of accounting for income taxes. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amount of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. A valuation allowance is provided to reduce the deferred tax assets when it is more likely than not that all or a portion of the deferred tax assets will not be realized. Fair Value of Financial Instruments Financial instruments consist principally of cash equivalents, short-term investments, trade receivables, notes receivable, accounts payable, and bank debt. The carrying amounts of these financial instruments approximate fair value. Financial instruments that potentially subject the Company to concentrations of credit risk are accounts receivable, cash equivalents and short-term investments which the Company places with high-credit qualified financial institutions and, by policy, limits the amount of credit exposure to any one financial institution. The Company sells its products to government and private clinical cytogenetic laboratories, research institutions, universities, and pharmaceutical companies located primarily in the United States, Canada, Europe, and the Pacific Rim. The Company's credit risk is concentrated primarily in the United States and Europe. The Company does not have a significant concentration of credit risk with any single customer. The Company performs on-going credit evaluations of its customer's financial condition and, generally requires no collateral from its customers. The Company maintains an allowance for doubtful accounts to cover potential credit losses. (2) Inventories A summary of inventories follows:
December 31, ------------------- 1998 1997 ---------- -------- Raw materials.......................................... $ 999,000 $721,000 Work in process........................................ 96,000 85,000 Finished goods......................................... 74,000 43,000 ---------- -------- $1,169,000 $849,000 ========== ========
41 APPLIED IMAGING CORP. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued) (3) Property and Equipment A summary of property and equipment follows:
December 31, --------------------- 1998 1997 ---------- ---------- Equipment........................................... $2,726,000 $2,793,000 Demonstration equipment............................. 1,173,000 1,275,000 Furniture and fixtures.............................. 626,000 489,000 ---------- ---------- 4,525,000 4,557,000 Less accumulated depreciation....................... 2,956,000 2,764,000 ---------- ---------- $1,569,000 $1,793,000 ========== ==========
In 1998, the Company reduced the carrying amount of property and equipment and the related accumulated depreciation by $569,000 related to fully depreciated property and equipment that is no longer in use. (4) Accrued Expenses A summary of accrued expenses follows:
December 31, --------------------- 1998 1997 ---------- ---------- Compensation and related costs...................... $ 523,000 $ 649,000 Royalties .......................................... 367,000 267,000 Severance .......................................... 226,000 480,000 Other .............................................. 1,403,000 1,038,000 ---------- ---------- $2,519,000 $2,434,000 ========== ==========
(5) Bank Debt Applied Imaging International, Limited has a (Pounds)750,000 gross and (Pounds)500,000 net unsecured line of credit with an international bank which is guaranteed by the Company. Under the line of credit the Company also has the ability to borrow additional amounts based on cash deposits held by the bank up to a maximum additional amount of (Pounds)250,000. The line of credit is available until April 30, 1999, and bears interest at 3% above the bank's base rate, for borrowings up to (Pounds)500,000 and 6% for borrowings over (Pounds)500,000. The base rate was 6.25% as of December 31, 1998. As of December 31, 1998 amounts outstanding under this facility amounted to $1,045,000. (6) Stockholders' Equity Common Stock The Company is authorized to issue 20,000,000 shares of common stock. As of December 31, 1998, there were warrants outstanding to purchase 173,010 shares of common stock at $5.78 per share, 264,899 shares at $5.25 per share and 140,000 shares at $4.25 per share. These warrants expire in 2000, 1999 and 2000, respectively. During 1998, the Company extended the exercise period of warrants to purchase 264,899 shares of common stock at $5.05 per share originally scheduled to expire in 1998 such that the warrants now expire in 1999. The Company received proceeds of $24,000 from the warrant holders equal to the fair value of the extended warrants using the Black-Scholes option pricing model. 42 APPLIED IMAGING CORP. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued) As of December 31, 1998, 950,000 shares of common stock were reserved for issuance under the Company's 1998 Stock Plan. Under the 1998 Stock Plan, stock options may be granted to Board members, officers, key employees, and consultants at the fair market value of the common stock at the date of the grant, as determined by the Board. Options are exercisable over 5 to 10 years from the date of grant, and typically vest ratably over 4 years. In October 1998, the Company's 1988 Amended and Restated Incentive Stock Option Plan expired. In 1994, the Company enacted a Directors Option Plan designed to encourage participation on the Company's Board. Under this plan, 5,000 shares per year are automatically granted to non-employee directors. The terms of the plan allow the granting of stock options upon initial election to the Board and for each subsequent term on the Board. As of December 31, 1998 there were 60,000 shares reserved for issuance under this plan and a total of 60,000 options have been granted. On June 19, 1996, the Board adopted, effective upon the closing of the IPO, the Company's Employee Stock Purchase Plan (the Plan) whereby eligible employees may purchase common stock through payroll deductions of up to 10% of compensation, at a per share price of 85% of the fair market value of the Company's common stock on the enrollment date or the exercise date six months later, whichever is lower. As of December 31, 1998 there were 165,898 shares reserved for issuance under the Plan. The compensation expense measured for the difference between the fair value of the Company's common stock on the enrollment date and the date of purchase is not material for the years ended December 31, 1998, 1997 and 1996. Accounting for Stock-Based Compensation As of December 31, 1998, there were 351,250 options available for grant under the 1998 Stock Plan. In 1996, the Company recorded a deferred charge of $1,473,000, representing the difference between the exercise price and the deemed fair value of the Company's common stock for 246,750 shares subject to common stock options granted in the 12-month period preceding the IPO. The deferred stock compensation is being amortized to compensation expense over the period during which the options become exercisable, generally four years. The Company has adopted the pro forma disclosure provisions of SFAS No. 123 for the 1998 Stock Plan and Employee Stock Purchase Plan. Had compensation cost for the Company's stock-based compensation plans been determined in a manner consistent with the fair value approach described in SFAS No. 123 'Accounting for Stock-Based Compensation', the Company's net loss and pro forma net loss per share as reported would have been increased to the pro forma amounts indicated below.
Year ended December 31, ------------------------- 1998 1997 1996 ------- ------- ------- Net loss: As reported................................... $(8,471) $(7,512) $(2,881) Pro forma..................................... $(9,206) $(8,218) $(2,965) Net loss per share: As reported: Basic and diluted........................... $ (.86) $ (1.03) $ (1.43) Pro forma: Basic and diluted........................... $ (.93) $ (1.12) $ (1.47)
On February 2, 1998, the Company's board of directors approved an amendment to reprice options outstanding under the Company's 1988 Stock Option Plan with exercise prices over $3.00 per share. On February 2, 1998, holders of such options were offered the choice of retaining their existing options without amendment or accepting the amendment of their stock options. The exercise price of the amended options is $2.44 per share, which equals the fair market value of the Company's common stock on February 2, 1998. 43 APPLIED IMAGING CORP. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued) Vesting of the amended options occurs over four years and begins on February 2, 1998. Holders of the options had until March 30, 1998 to make an irrevocable decision to either retain their existing options without amendment or accept the amendment to their options. The amendment of the options is treated for accounting purposes as if the Company cancelled the existing options and issued new options with the lower exercise price and new vesting schedule. The compensation expense measured for the difference between the fair value of the Company's common stock on the date employees elected to accept new repriced options and the exercise price of the repriced options ($2.44 per share) was not significant. The fair value of each option is estimated on the date of grant using the fair value method with the following weighted-average assumptions: volatility of 60%, no dividends, an expected life of three years, and risk-free interest rates of 4.66 %, 6.16% and 5.71% for the years ended December 31, 1998, 1997 and 1996 respectively. All of the above assumptions were used for the Employee Stock Purchase Plan except the expected life is six months. A summary of the status of the Company's stock option activity for the years ended December 31, 1998, 1997 and 1996, is as follows:
Weighted- Weighted- average average exercise fair Shares price value --------- --------- --------- Outstanding at December 31, 1995............ 356,250 $2.24 Granted--Exercise price equals market value...................................... 238,750 2.66 $7.38 Granted--Exercise prices less than market value...................................... 53,750 2.66 2.90 Canceled.................................... (78,250) 2.80 Exercised................................... (89,250) 1.80 --------- Outstanding at December 31, 1996............ 481,250 2.48 Granted--Exercise price equals market value...................................... 443,750 5.67 2.93 Granted--Exercise prices greater than market value...................................... 269,400 3.87 1.88 Granted--Exercise prices less than market value...................................... 60,250 4.05 2.15 Canceled.................................... (21,375) 3.90 Exercised................................... (34,003) 2.15 --------- Outstanding at December 31, 1997............ 1,199,272 4.04 Granted--Exercise price equals market value...................................... 714,750 2.43 1.05 Granted--Exercise price greater than market value...................................... 520,250 1.91 .83 Granted--Exercise price less than market value...................................... 16,000 3.19 $1.44 Canceled.................................... (654,016) 5.30 Exercised................................... (8,851) 1.82 --------- ----- Outstanding at December 31, 1998............ 1,787,405 $2.32 =========
Approimately 604 shares that were exercised in 1998 were issued in 1999. 44 APPLIED IMAGING CORP. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued) The following table summarizes information about fixed stock options outstanding as of December 31, 1998:
Options Options outstanding exercisable ------------------------------------------- ---------------- Weighted Weighted average Weighted average Number remaining average exercise Range of exercise prices outstanding contractual life exercise price Number price ------------------------ ----------- ---------------- -------------- ------- -------- From $1.80 to $2.50..... 1,463,005 8.74 years $2.09 313,281 $2.03 From $2.75 to $3.25..... 271,400 8.35 years 2.87 94,446 2.85 From $4.88 to $6.30..... 53,000 7.95 years 5.99 43,250 6.20 --------- ------- 1,787,405 8.66 years 2.32 450,977 2.60 ========= =======
(7) Income Taxes The Company has not recorded an income tax benefit in 1998, 1997, and 1996 due to the recording of a valuation allowance as an offset to net deferred tax assets. A valuation allowance is provided due to uncertainties surrounding the realization of deferred tax assets due to the history of operating losses incurred by the Company. The tax effects of temporary differences that give rise to significant portions of deferred tax assets are presented below:
December 31, --------------------------------- 1998 1997 1996 ----------- ---------- ---------- Deferred tax assets: Accounts receivable, principally due to the allowance for doubtful accounts...... $ 31,000 $ 43,000 $ 43,000 Inventories, principally due to the allowance for obsolete inventory, and additional costs inventoried for tax purposes................................. 162,000 146,000 131,000 Tangible and intangible assets, principally due to differences in depreciation and amortization............ 100,000 -- -- Revenue deferred for financial statement purposes, not for tax reporting purposes................................. -- -- 220,000 Deferred compensation not currently deductible............................... 122,000 122,000 101,000 Accrued expenses, not currently deductible............................... 237,000 415,000 90,000 Net operating loss carryforwards.......... 8,740,000 6,109,000 4,055,000 Business credit carryforwards............. 1,186,000 540,000 386,000 ----------- ---------- ---------- Total gross deferred tax assets........... 10,578,000 7,375,000 5,026,000 Less valuation allowance.................. 10,578,000 7,368,000 4,967,000 ----------- ---------- ---------- Net deferred tax assets................... $ -- $ 7,000 $ 59,000 Deferred tax liabilities: Tangible and intangible assets, principally due to differences in depreciation and amortization............ -- 7,000 59,000 ----------- ---------- ---------- Total gross deferred tax liability........ -- 7,000 59,000 ----------- ---------- ---------- Net deferred tax assets................... $ -- $ -- $ -- =========== ========== ==========
As of December 31, 1998, the Company had net operating loss carryforwards for U.S. federal, U.K., and California state tax return purposes of approximately $22,166,000, $2,803,000, and $4,765,000, respectively. The 45 APPLIED IMAGING CORP. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued) federal and California net operating loss carryforwards expire in the years between 2004 and 2018 and between 1998 and 2004, respectively. The Company's U.K. net operating loss carryforward is available indefinitely to offset its U.K. trading profits arising from distribution operations. The difference between the tax loss carryforwards and the accumulated deficit primarily relates to timing differences in the recognition of deferred revenue, accrued compensation, and certain reserves. The Internal Revenue Code of 1986 and the California Conformity Act of 1987 substantially restrict the ability of a corporation to utilize existing net operating losses and credits in the event of an "ownership change". The several issuances of preferred stock and the initial public offering have resulted in multiple ownership changes since inception of the Company. Approximately $10,300,000 of the federal net operating loss carryforward will be subject to an annual limitation in the aggregate of $800,000. Any unused annual limitation can be carried over and added to the succeeding year's annual limitation within the allowable carryforward period. (8) Commitments The Company has various noncancelable operating leases for equipment, vehicles, and facilities expiring through 2008. The facility leases generally contain renewal options for periods ranging from two to five years and require the Company to pay all executory costs such as maintenance, property taxes, and insurance. Rent expense under operating leases aggregated $481,000, $351,000 and $264,000 during 1998, 1997 and 1996, respectively. The Company's primary lease commitments are for its facilities in the United Kingdom, which aggregate approximately (Pounds)119,000 per year through 2003, with a five- year renewal option held by the Company, and for its facilities in the United States, which aggregate approximately $291,000 and $267,000 for 1999 and 2000, respectively. The Company has a capital lease commitment of $116,000, including interest of $17,000 at 10%, which calls for annual payments of $34,000 through the year 2001 and a payment of $15,000 in 2002. In October 1997, the Company entered into an exclusive worldwide licensing agreement with the University of Cambridge for the commercialization of DNA- probe technology recently developed by the Cambridge researchers. The agreement requires minimum annual royalty payments of $30,000 and the payment for specific research related projects. The agreement will remain in full force and effect until the expiration of the last patent right or ten years whichever is later. In March 1998, the Company entered into a non-exclusive world-wide agreement with Amersham Pharmacia Biotech Inc. for the right to use certain technologies in conjunction with its DNA probe technology. The agreement requires minimum annual royalty payments of $10,000. The agreement will remain in full force and effect until the expiration of all patents or eight years, whichever is later. In December 1998, the Company entered into an option agreement to acquire ownership of patents for the enrichment of fetal cells. The agreement provides for payments of $1.1 million if the option is exercised and products using the technology are successful in clinical trials. The final payment of $250,000 would be paid in common stock based on the market value of the common stock as of the date the clinical trials are successfully completed. (9) Employee Benefit Plans In January 1994, the Company implemented a retirement savings and investment plan that is intended to qualify under Section 401(k) of the Internal Revenue Code (the 401(k) Plan) covering all of the Company's United States-based employees. An employee may elect to defer, in the form of contributions to the 401(k) Plan 46 APPLIED IMAGING CORP. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued) on his or her behalf, up to 15% of the total compensation that would otherwise be paid to the employee, not to exceed the amount allowed by applicable Internal Revenue Service guidelines. The Company matches 100% of the amounts deferred by the employee participants up to 3% of such employee's total compensation and such matching amounts vest over a three-year period from the initial participation date. The Company contributed, $90,000, $85,000 and $69,000 in 1998, 1997 and 1996, respectively. The Company's United Kingdom-based employees are covered by retirement savings plans (the International Retirement Plans). Under such plans, an employee may elect to make contributions of 3.5% of such employee's earnings. Amounts contributed by the Company range from 5.5% to 10.5% of such employee's earnings. During 1998, 1997 and 1996, respectively, the Company made contributions to the Internal Retirement Plans totaling $66,000, $60,000, $47,000, respectively. (10) Other Income, Net The components of other income, net are as follows:
December 31, ------------------------------ 1998 1997 1996 -------- --------- --------- Interest income............................ $579,000 $ 595,000 $ 208,000 Interest expense........................... (92,000) (49,000) (86,000) Gain (loss) on foreign exchange............ 58,000 (163,000) (112,000) Miscellaneous income (expense)............. (4,000) 15,000 4,000 -------- --------- --------- $541,000 $ 398,000 $ 14,000 ======== ========= =========
(11) Foreign Operations The Company has adopted the provision of SFAS No. 131, Disclosure About Segments of an Enterprise and Related Information. SFAS No 131 establishes standards for the reporting by public business enterprises of information about operating segments, products and services, geographic areas, and major customers. The method for determining what information to report is based on the way management organizes the operating segments within the Company for making operating decision and assessing financial performance. The Company's chief operating decision maker is considered to be the Company's Chief Executive Officer (CEO"). The CEO reviews financial information presented on a consolidated basis for purposes of making operating decisions and assessing financial performance. The consolidated financial information is identical to the information presented in the accompanying consolidated statements of operations. Therefore, the Company operates in a single operating segment: prenatal instrumentation and screening.
United States United Kingdom Israel Consolidated ------------- -------------- ------- ------------ Revenues: 1998.................... $ 4,304,000 $7,380,000 -- $11,684,000 1997.................... 5,328,000 7,806,000 -- 13,134,000 1996.................... 4,797,000 7,125,000 -- 11,922,000 Identifiable assets: 1998.................... $13,762,000 $4,498,000 $48,000 $18,808,000 1997.................... 11,051,000 3,438,000 225,000 14,714,000
No single customer accounted for greater than 10% of revenues in any period reported. 47 APPLIED IMAGING CORP. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS--(Continued) (12) Research and Development Arrangement During 1995, the Company was awarded a grant by the Israel-United States Binational Industrial Research and Development (BIRD) Foundation. With the funding received from the grant, the Company began research operations in its Israel subsidiary relating to its fetal cell program. All funds received by the Company in advance of performing the related research and development are recorded as a deferred credit in the accompanying consolidated balance sheets and, as expenses are incurred, the deferred credit is depleted. Over the life of the grant, the Company could receive up to $543,000 in matching funds. These funds, as well as any accrued interest, will be required to be paid back to the BIRD Foundation if future revenues are realized from the related research and development activities, at the rate of 2 1/2 % of such future revenues generated in the first year such revenues occur, and 5% of revenues in succeeding years, over a six-year period, up to a maximum of 150% of the funds received. As of December 31, 1997, the Company has received a total of $492,000 in funding and no further funding is expected. The Company recognized credits to research and development expenses of approximately $34,000 during 1997 and $361,000 during 1996. (13) Restructuring During the quarter ended June 30, 1998, the Company developed plans to reduce operating costs by eliminating thirteen employee positions in the Company. The employee reductions were made at both the United States and United Kingdom facilities. The consolidated statement of operations for the year ended December 31, 1998 includes a $353,000 charge related to the severance costs for these terminated employees. Substantially all of the severance costs had been paid as of December 31, 1998. (14) Private Placement Transaction On June 3, 1998, the Company consummated a private sale of 3,333,331 shares of its common stock to certain accredited investors at $3.00 per share. The price exceeded the closing price of the Company's common stock as reported on the NASDAQ National Market System. Included in the sale was 1,000,000 shares sold to New Enterprise Associates, a principal owner of the Company. Thomas C. McConnell, a director of the company, is an affiliate of New Enterprise Associates. On July 7, 1998 and July 15, 1998, the Company consummated private sales of collectively 499,999 shares of its common stock to certain accredited investors at $3.00 per share. The price exceeded the closing price of the Company's common stock as reported on the NASDAQ National Market System. On May 22, 1997, the Company consummated a private sale of 796,020 shares of its common stock to certain partnerships affiliated with New Enterprise Associates, at $5.025 per share. The price per share was calculated as the average of the closing prices of the Company's common stock as reported on the NASDAQ National Market System for the previous five trading days prior to the day of the transaction closing date. In connection with this transaction, the Company also issued warrants, which may be exercised within a three-year period ending May 21, 2000 to acquire an aggregate of 173,010 shares of the Company's common stock at a purchase price of $5.78 per share. The Company allocated a portion of the proceeds to the warrants based on the fair value using the Black-Scholes pricing model and such amount is included within common stock. Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None. 48 PART III Certain information required by Part III is omitted from this Report on Form 10-K in that the Registrant will file a definitive proxy statement within 120 days after the end of its fiscal year pursuant to Regulation 14A with respect to the 1998 Annual Meeting of Stockholders (the "Proxy Statement") and certain information included therein is incorporated herein by reference. Item 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT Certain of the information required by this item relating to directors is incorporated by reference to the information under the caption "Proposal No. 1 - -- Election of Directors" in the Proxy Statement. The executive officers of the Registrant, who are elected by the board of directors, are as follows:
Name Age Position ---- --- -------- Jack Goldstein, Ph.D.......... 51 Chief Executive Officer and President Michael A. Zoccoli, Ph.D...... 48 Vice President Research and Development Leslie G. Grant, Ph.D......... 45 Executive Vice President Carl Hull..................... 40 Vice President Sales and Marketing
Jack Goldstein, Ph.D. joined the Company as Chief Executive Officer and President in April 1997. Dr. Goldstein has 23 years of management experience at leading healthcare companies. From 1986 to 1997, Dr. Goldstein worked for Johnson & Johnson in various executive management positions including President of Ortho Diagnostic Systems and Executive Vice President of Professional Diagnostics at Johnson & Johnson World Headquarters. Prior to his tenure at Johnson & Johnson, Dr. Goldstein served in management positions at Baxter Healthcare Corporation and American Home Products Corporation. Dr. Goldstein holds a B.A. degree in Biology from Rider University, an M.S. in Immunology and a Ph.D. in Microbiology from St. John's University. Michael A. Zoccoli, Ph.D. has been Vice President of Research and Development since July 1998. He joined the Company in October 1997 as Vice President of Product Development. From 1991 to 1997, Dr. Zoccoli held various senior management positions with Roche Molecular Systems. Dr. Zoccoli has over 16 years of experience in research and development of immunoassay and P C R reagent products for the clinical and research markets and is a co-inventor on three US Patents. Dr. Zoccoli holds a B.A. in Chemistry from the University of Connecticut and a Ph.D. in Chemistry from Dartmouth College. Leslie G. Grant Ph.D., has been President and Chief Operating Officer of the Company's Cytogenetics Division since February 1992. In 1997 he became an Executive Vice President of the Company. He joined the Company in October 1991 as Managing Director of Applied Imaging International Ltd. From 1980 to 1991, Dr. Grant held various general management and senior engineering positions with GEC-Marconi. Dr. Grant has 20 years experience in the instrumentation and medical industry, including 11 years in senior management positions. Dr. Grant holds a B.S. in Mathematics and a Ph.D. in Mathematics and Electronic Engineering from the University of Hull, United Kingdom. Carl Hull joined the Company as Vice President of Worldwide Marketing in August 1997. In January 1999 he also became Vice President of Sales. Prior to joining the Company, Mr. Hull served as Vice President of Marketing and Business Development for Ventana Medical Systems. From 1982 to 1996, he served in various marketing and sales management positions at Abbott Laboratories, including Vice President and General Manager of Abbott Laboratories, Puerto Rico. He also served as Marketing Manager Far-East, Marketing manager for Hematology Products, District Sales Manager as well as Product Manager for several diagnostic product lines. Mr. Hull received his MBA from University of Chicago and a B.A. in Political Science and International Relations at Johns Hopkins University. 49 Item 11. EXECUTIVE COMPENSATION The information required by this item is incorporated by reference to the information under the caption "Executive Compensation" in the Proxy Statement. Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT The information required by this item is incorporated by reference to the information under the caption "Record Date and Stock Ownership" in the Proxy Statement. Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS The information required by this item is incorporated by reference to the information under the caption "Certain Transactions" in the Proxy Statement. 50 PART IV Item 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K (a) 1. Financial Statements The following Financial Statements of Applied Imaging Corp. and Report of KPMG LLP, have been provided as Item 8, above: Report of KPMG LLP Consolidated Balance Sheets, 1998 and 1997 Consolidated Statements of Operations, Years Ended December 31, 1998, 1997 and 1996 Consolidated Statements of Stockholders' Equity, Years Ended December 31, 1998, 1997 and 1996 Consolidated Statements of Cash Flows, Years Ended December 31, 1998, 1997 and 1996 Notes to Consolidated Financial Statements 2. Financial Statement Schedules The financial statement schedule entitled "Valuation and Qualifying Accounts" is included at page 54 of this Form 10-K. All other schedules are omitted because they are not applicable or the required information is shown in the Financial Statements or the notes thereto. 3. Exhibits Refer to (c) below. (b) Reports on Form 8-K The Company was not required to and did not file any reports on Form 8-K during the three months ended December 31, 1998. (c) Exhibits
Exhibit No. Description ----------- ----------- 3.1(1) Restated Certificate of Incorporation of the Registrant. 3.2(2) Bylaws of the Registrant as amended. 4.1(1) Specimen Common Stock Certificate. 4.2(3) Preferred Shares Rights Agreement dated as of May 29, 1998 between Applied Imaging Corp. and Norwest Bank Minnesota, N.A., including the form of Rights Certicate and the Certificate of Designation, the summary of Rights Attached thereto as Exhibits A, B and C, respectively. Form 8-A, 6/5/98. 4.3(5) Preferred Shares Rights Agreement dated as of May 29, 1998, between the Registrant and Norwest Bank Minnesota, N.A. including the form of Rights Certificate, the Certificate of Designation and the summary of Rights attached thereto as Exhibits A, B, and C, respectively. 10.1(1) Form of Indemnification Agreement for directors and officers. 10.2(a)(1) Amended and Restated 1988 Incentive Stock Option Plan and form of agreement thereunder. 10.2(b)(4) 1998 Incentive Stock Option Plan and form of Stock Option Agreement thereunder. 10.3(1) 1994 Director Option Plan and form of subsequent agreement thereunder. 10.4(1) Employee Stock Purchase Plan. 10.5(1) Amended and Restated Registration Rights Agreements. 10.6(1) License Agreement dated December 1, 1993 between the Registrant and Chronomed, Inc.
51
Exhibit No. Description ----------- ----------- 10.7(1) Assignment dated December 1, 1993 by and between the Registrant and Alex Saunders, M.D. 10.8(a)(1) Lease dated February 15, 1994 for the Registrant's headquarters in Santa Clara, CA. 10.8(b) Lease renewal dated December 8, 1998 for the Registrants headquarters in Santa Clara, CA. 10.9 Lease dated July 1998 between Bio Science Center and Applied Imaging International Ltd. 10.10(1) Employment Letter Agreement dated August 12, 1991 between the Registrant and Leslie G. Grant. 10.11(1) Amendment to Employment Letter Agreement between the Registrant and Leslie G. Grant, dated February 12, 1996. 10.12(1) Know-How License Agreement dated November 1989 between Medical Research Council and Shandon Scientific Limited (assigned to the Registrant in November 1989), as amended, July 5, 1994. 10.13(1) Cooperative Research and Development Agreement, dated June 10, 1995 between Registrant and the National Institute of Health. 10.14(1) Supply & Distribution Agreement dated March 3, 1994 between Cytocell Ltd. and Registrant. 10.15(1) Research Purchase Agreement dated March 26, 1996 between Pharmacia Biotech AB and Registrant. 10.16(1) Development Agreement dated February 5, 1996 between EM Industries and Registrant. 10.17(1) Security and Loan Agreement dated September 5, 1995 between Registrant and Imperial Bank. 10.18(1) Extension to Security and Loan Agreement dated September 16, 1996 between Registrant and Imperial Bank. 10.19(2) License Agreement dated October 24, 1997 between Cambridge University and the Registrant. 10.20(2) Employment Letter Agreement dated July 21, 1997 between the Company and Carl Hull. 10.21(2) Employment Letter Agreement dated April 2, 1997 between the Company and Jack Goldstein, Ph.D. and amendment dated April 4, 1997. 10.22(6) Stock and Warrant Purchase Agreement dated May 22, 1997 between the Registrant and partnership affiliates of New Enterprise Associates and exhibits thereto. 10.23(7) Stock and Warrant Purchase Agreement dated May 22, 1997 between the registrant and certain investors 10.24(8) Form of Stock Purchase Agreement between the Registrant and certain investors used in connection with sales of Common Stock on July 7 and July 15, 1998. 21.1(1) List of Subsidiaries of the Registrant. 23.1 Consent of KPMG LLP. 24.1 Power of Attorney (included at page 53 below). 27.1 Financial Data Schedule.
- -------- (1) Filed as an Exhibit to the Company's Registration Statement on Form S-1 (File No. 333-06703) and incorporated herein by reference. (2) Filed as an exhibit to the Company's Form 10-K for the year ending December 31, 1997 and incorporated herein by reference. (3) Filed as exhibit 3 to the Registrant's Report on Form 8-A with the Commission on June 5, 1998 and incorporated herein by reference. (4) Filed as exhibit 4.1 to the registrant's Report on Form S-8 filed with the Commission on June 26,1998 and incorporated herein by reference. (5) Filed as an Exhibit to the Registrant's Registration Statement on form 8-A filed with the Commission on June 5, 1998 and incorporated herein by reference. (6) Filed as exhibit 10.1 to the Registrant's Report on form 8-K filed with the Commission on June 4, 1997 and incorporated herein by reference. (7) Filed as exhibit 10.1 to the registrant's Report on form 8-K filed with the Commission on June 16, 1998 and incorporated herein by reference. (8) Filed as exhibit 10.1 to the Registrant's Report on form 8-K filed with the Commission on July 28, 1998 and incorporated herein by reference. 52 SIGNATURES Pursuant to the requirements of the Securities Act, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. Applied Imaging Corp. By: /s/ Jack Goldstein ----------------------------------- Jack Goldstein Chief Executive Officer Date: March 25, 1999 POWER OF ATTORNEY Know All Men And Women by these Presents, that each person whose signature appears below constitutes and appoints Jack Goldstein and Thomas Klein his or her attorney-in-fact, with the power of substitution, for him or her in any and all capacities, to sign any amendments to this Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that said attorneys-in-fact, or his or her substitute or substitutes, may do or cause to be done by virtue thereof. Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the date indicated.
Signature Title Date --------- ----- ---- /s/ Jack Goldstein Chief Executive Officer and March 25, 1999 ____________________________________ Director (Principal (Jack Goldstein) Executive Officer) /s/ Michael J. Braden Corporate Controller March 25, 1999 ____________________________________ (Principal Accounting (Michael J. Braden) Officer) /s/ John F. Blakemore, Jr. Director March 25, 1999 ____________________________________ (John F. Blakemore, Jr.) /s/ Gilbert J.R. McCabe Director March 25, 1999 ____________________________________ (Gilbert J.R. McCabe) /s/ Thomas C. McConnell Director March 25, 1999 ____________________________________ (Thomas C. McConnell) /s/ Andre F. Marion Director March 25, 1999 ____________________________________ (Andre F. Marion) /s/ Robert C. Miller Director March 25, 1999 ____________________________________ (Robert C. Miller) /s/ G. Kirk Raab Director March 25 , 1999 ____________________________________ (G. Kirk Raab)
53 APPLIED IMAGING CORP. SCHEDULE II-VALUATION AND QUALIFYING ACCOUNTS (In thousands)
Balance at Charged to Balance at Beginning of Costs and (Deductions)/ End of Year Expenses Recoveries Year ------------ ---------- ------------- ---------- Allowance for doubtful accounts: Year ended December 31, 1998...................... $191 $-- $(29) $162 Year ended December 31, 1997...................... $228 $10 $(47) $191 Year ended December 31, 1996...................... $166 $76 $(14) $228
54
EX-10.8(B) 2 LEASE RENEWAL DATED 12/08/1998 EXHIBIT 10.8(b) [Commerce Communities Letterhead] December 08, 1998 Mike Braden c/o Applied Imaging 2380 Walsh Avenue Santa Clara, CA 95051 Re: Lease renewal 2380 Walsh Ave., Santa Clara, CA Dear Mike: This letter will serve as our written agreement to extend your Lease two (2) years. The Lease Extension is for that certain Lease dated April 17, 1997 by and between San Tomas Investors II, Landlord, and Applied Imaging Corp., Tenant, covering those certain premises known and numbered as stated above, which Lease was to terminate November 30, 1998. Landlord and Tenant hereby agree: 1. The term of said Lease shall be extended through November 30, 2000. 2. The base rent, as provided in paragraph 3, shall be increased to twenty four thousand two hundred fifty dollars ($24,250.00) per month beginning December 1, 1998 and continuing to November 30, 2000. 3. The security deposit shall be increased from $18,541.00 to $24,250.00. 4. Tenant acknowledges that there exists a license from the Principal Mutual Life Insurance Company which permits the Tenant to pay rent to San Tomas Investors II. Tenant further acknowledges that the Principal Mutual Life Insurance Company has the right to revoke such license and that upon such revocation the Tenant will pay rent at such address as the Principal Mutual Life Insurance Company may direct by written notice to Tenant. 5. Landlord will provide the following improvements at Landlord's expense: a. new restroom floor tile b. repaint restroom walls and toilet partitions c. install new building standard light fixtures in restrooms d. repair or replace carpet as shown on "Exhibit 1" to this renewal 6. All other terms and conditions of said Lease shall remain the same and in full force and effect. If the foregoing is acceptable, please have the appropriate party sign and return both copies to me at your earliest convenience. A fully executed copy will be returned to you. Sincerely, AGREED & ACCEPTED: /s/ Richard Gatley COMMERCE COMMUNITIES CORP. By: /s/ Peggy Lafferty, Trustees ------------------------------ San Tomas Investors II, Landlord /s/ Richard V. Treakle Date: Richard V. Treakle President By: /s/ Michael Braden ------------------------------ Applied Imaging Corp., Tenant Date: 12/3/98 ---------------------------- EX-10.9 3 LEASE DATED JULY OF 1998 EXHIBIT 10.9 DATED JULY 1,1998 ----------------- INTERNATIONAL CENTRE FOR LIFE (PROPERTY) LIMITED to APPLIED IMAGING INTERNATIONAL LIMITED L E A S E --------- relating to first floor premises within Bio Science Centre comprising part of the International Centre for Life Newcastle upon Tyne in the County of Tyne and Wear EVERSHEDS Sun Alliance House 35 Mosley Street Newcastle upon Tyne NE1 1XX (RJN.LK : 31.03.1998) THIS LEASE is made the day of 1998 - ---------- BETWEEN the Landlord (hereinafter called "the Landlord") specified in Schedule 1 - ------- of the one part and the Tenant (hereinafter called "the Tenant") specified in Schedule 2 of the other part WITNESSETH as follows: - ---------- 1. In this Lease except as otherwise provided or where the context otherwise requires: "Accessways" all unadopted roads driveways service areas forecourts paths entrances exits lifts corridors lobbies landings stairways and other accessways which form part of the Centre at any time during the Term "Advance Payments" the quarterly advance payments of Service Charge payable by the Tenant under clause 7.4.1 "Authorised Person" anyone deriving title from the Tenant and anyone at the Premises with the express or implied authority of the Tenant or of such person so deriving title "Buyer's Works" the works carried out by the Tenant prior to completion of the Lease and more particularly described in the Agreement for Lease between the Landlord (1) and the Tenant (2) "Cattle Market Car Park" the car parking area neighbouring the Centre and known as the Cattle Market Car Park "Cattle Market Parking Fee" ten thousand pounds ((Pounds)10,000.00) per annum "Centre" means the property known as the Bio Science Centre forming part of the International Centre for Life Newcastle upon Tyne "Centre Parking Fee" the fee for parking two (2) cars or light vehicles in the basement of the Centre to be notified by the Landlord to the Tenant not less than six (6) months before the fifth anniversary of the commencement of the Term "Common Parts" means those parts of the Centre not comprised in any lease tenancy or licence of the Centre and provided for common use of the users of the Centre "Expenditure" (1) the aggregate of all costs fees expenses and outgoings incurred by the Landlord in providing the Landlord's Services including bank charges interest and VAT (2) such sums as the Landlord in its reasonable discretion considers reasonably desirable to set aside from time to time for the purpose of providing for periodically recurring items of expenditure in connection with the Landlord's Services whether recurring at regular or irregular intervals and (3) such provisions for anticipated expenditure in connection with the Landlord's Services as the Landlord in its reasonable discretion considers fair and reasonable in the circumstances "Financial Year" the annual accounting period beginning on 1 January in each year or on such alternative date as the Landlord may at any time stipulate "Independent Surveyor" an independent chartered surveyor who has practised in the United Kingdom for at least the previous five years and who has recent substantial experience of the letting and valuation of premises of similar character quality and general location to the Premises and who is appointed as prescribed in clause 8.5.2 "Insurance Rent" the amount attributable to the Premises (conclusively determined by the Landlord acting reasonably) which the Landlord from time to time incurs or expends in insuring the Centre in accordance with its covenants at clause 4.2 "Insured Risks" The insurance risks referred to at clause 4.3 "Landlord" includes the person from time to time entitled to the reversion immediately expectant on the determination of the term hereby granted "Landlord's Services" the services which the Landlord covenants to provide in clause 7 and the services listed in Schedule 2 which the Landlord may provide in its absolute discretion "Landlord's Surveyor" means such surveyor appointed by the Landlord from time to time -2- "Perpetuity Period" shall be the period of eighty years from the date hereof and shall be the perpetuity period applicable in this Lease "Pipes" means pipes sewers drains mains ducts conduits gutters watercourses wires cables channels flues and other conducting media and includes any fixings louvres cowls and any other ancillary apparatus "Planning Acts" means the Town and Country Planning Act 1990 the Planning (Listed Building and Conservation Areas) Act 1990 the Planning (Hazardous Substances) Act 1990 the Planning (Consequential Provisions) Act 1990 and the Planning and Compensation Act 1991 and any Act or Acts for the time being, in force amending or replacing the same and any directions regulations plans permissions consents licences or orders made thereunder or under any enactment repealed thereby "Permitted Part" such part or parts of the Premises as the Landlord acting reasonably shall specify in writing as being capable of being underlet "Premises" means the premises hereby demised and includes (without prejudice to the generality of the foregoing) all additions and improvements which during the Term may be made to the Premises hereby demised and all equipment plant machinery materials and items (including the Landlord's fixtures and fittings) which may at any time during the Term be therein "Permitted Hours" means between the hours of 8 .a.m. and 6 p.m. and such other times as shall be agreed by the parties (acting reasonably) PROVIDED THAT the Tenant shall reimburse the Landlord its reasonable costs in respect of services provided at such other times "Prescribed Rate" means the rate of interest which is from time to time 3% above the base rate for the time being of Royal Bank of Scotland Plc or in the event of the said base rate ceasing to exist such other reasonable rate of interest as the Landlord may from time to time specify in writing "Rent Commencement Date" means -3- "Review Date" means "Rent" means the rents reserved by Clause 2 hereof or any sum substituted for the rent on Rent Review "Service Charge" the Service Charge Proportion of the Expenditure or such other proportion of the Expenditure as the Landlord or the Landlord's Surveyor may from time to time acting reasonably determine to be fair and reasonable in all circumstances Provided That for the first five years of the Term the annual Service Charge payable in respect of the Premises shall not exceed (Pounds)2.50 per square foot of the Premises "Service Charge Proportion" means % "Tenant" includes the persons deriving, title under the Tenant hereinbefore named "Term" means the term hereby created "the 1954 Act" means the Landlord and Tenant Act 1954 (as amended) "the 1995 Act" means the Landlord and Tenant (Covenants) Act 1995 "Title Matters" means the matters affecting or relating to the Landlord's reversionary interest specified in Schedule 1 "VAT" means value added tax as defined by the Value Added Tax Act 1994 and any new tax of a similar nature 1.1 Where the expression "the Tenant" at any time comprises two or more persons firms or companies the obligations of the Tenant shall be construed as joint and several and the Landlord shall not be prejudiced by any agreement bankruptcy composition dealing death dissolution indulgence liquidation or security in relation to some one or more of such persons firms or companies 1.2 Any reference to an Act of Parliament shall include any modification extension or re-enactment thereof for the time being in force and shall also include all instruments orders plans regulations permissions and directions for the time being made issued or given thereunder or deriving validity therefrom 1.3 Any reference to the masculine gender only shall include the feminine and neuter genders and vice versa and any reference to the similar shall include the plural and vice versa and any reference to persons shall include corporations and vice versa -4- 2. In consideration of the rent and of the Tenant's covenants hereinafter contained the Landlord hereby demises unto the Tenant ALL THAT the Premises described in Schedule 1 TO HOLD the same unto the Tenant for the Term specified in Schedule 1 YIELDING AND PAYING therefor yearly during the Term on and with effect from the Rent Commencement Date to the Landlord: 2.1 the rent specified in Schedule 1 by equal quarterly payments in advance on the usual quarter days in every year the first such payments or a due proportion thereof being made on the Rent Commencement Date 2.2 Charge in accordance with the provisions of clause 7 2.3 on demand those costs which the Landlord incurs in insuring the Premises in accordance with the provisions of clause 4 2.4 the Centre Parking Fee and the Cattle Market Parking Fee by equal quarterly payments in advance on the usual quarter days in every year the Centre Parking Fee only to be payable from the fifth anniversary of the date hereof and the Cattle Market Parking Fee only to be payable from the third anniversary of the date hereof 2.5 VAT at the standard rate for the time being in force upon such sums 3. The Tenant hereby covenants with the Landlord throughout the Term as follows:- 3.1 To pay to the Landlord without any deduction or set-off: 3.1.1 the Rent Service Charge Centre Parking Fee Cattle Market Parking Fee and Insurance Rent reserved in clause 2 at the times and in the manner stated and 3.1.2 on demand all VAT properly chargeable on every VAT supply made by the Landlord to the Tenant under this Lease 3.1.3 all other sums due from the Tenant under this Lease 3.2 Without prejudice to any other right remedy or power herein contained or otherwise available to the Landlord if any rent or any other sum of money payable to the Landlord or by the Tenant under these presents shall have become due but remain unpaid for fourteen days after demand to pay on demand to the Landlord (if the Landlord shall so require) interest thereon at the Prescribed Rate from the date when the same became due and until payment thereof (as well after as before any judgement) 3.3 At the expense of the Tenant to insure forthwith and throughout the term with an insurance office of repute against public liability claims arising out of or as a result of -5- its occupation of the Premises in the sum of at least (Pounds)2,000,000.00 (two hundred thousand pounds) for any one incident in any one year and the produce to the Landlord on demand such insurance policy receipt proving payment of the premium for the relevant period 3.4 From time to time and at all times during the Term to keep the Premises in good and substantial repair condition and decoration and to decorate the Premises in colours approved by the Landlord in every third year of the Term and in the last year of the Term (whenever it ends) in a good and workmanlike manner using good quality materials (damage by Insured Risks excepted unless the insurance is vitiated by the Tenant) PROVIDED THAT this Clause 3.4 shall be null and void to the extent that any want of repair relates to a matter which would otherwise have given rise to an actionable claim by the Tenant under the warranties described below) in the event that the Tenant has not by the date hereof received from Building Design Partnership Limited and John Laing Construction Limited in each case an enforceable deed of collateral warranty in favour of the Tenant in terms no less onerous than the latest edition of the British Property Federation standard form warranty for purchasers and tenants (CoWa/P&T) 3.5 At the expiration or sooner determination of the Term quietly to yield up the Premises in a good and tenantable repair and in a clean and tidy condition in accordance in all respects with the covenants herein contained 3.6 To indemnify and keep indemnified the Landlord from and against its liability (if any) for injury (whether fatal or not) to persons (including officers and employees of the Landlord) the infringement disturbance or destruction by the Tenant or his agents or licensees of any right easement or privilege and for damage to property (movable or immovable) caused by or in any way arising out of the condition of the Premises (other than the structure thereof) or any fixtures fittings equipment machinery or chattels therein or the use and occupation of the Premises during the Term or any fixtures fittings equipment machinery and chattels therein or the act or default of the Tenant its employees or visitors and from all proceedings costs claims and demands of whatsoever nature in respect of any such liability or alleged liability 3.7 Not to do anything or suffer anything to be done on the Premises which would remove support from any adjoining land buildings or structures or endanger such land buildings or structures in any way whatsoever 3.8 Not at any time during the Term without the consent in writing of the Landlord 3.8.1 to make any alterations or additions whatsoever in or to the Premises or any part thereof or cut maim injure or remove any of the walls beams, columns or other structural parts thereof provided that the Tenant may without the Landlord's prior consent install internal demountable -6- partitioning at the Premises provided that the Premises are re- instated at the end or sooner determination of the Term to the Landlord's reasonable satisfaction or 3.8.2 to make any alteration or addition to the electrical installation or mechanical installation in the Premises save in accordance with the regulations of the electricity supply or gas supply authorities 3.9 To permit the Landlord or its agents with or without workmen and others authorised by the Landlord at all reasonable times during the Term at convenient hours in the day time upon reasonable prior written notice (or at any time in an emergency without notice) as often as occasion shall require to enter into and upon the Premises or any part thereof for the purpose of carrying out any work to adjoining property of the Landlord or for the purpose of connecting services necessary therefor into the services in the Premises provided that the same shall not be overloaded and also for the purpose of carrying, out any work required in relation to the provisions of Schedule 2 the person or persons so entering causing as little damage and inconvenience to the Tenant's business and use as possible and making good all damage caused by the exercise of such rights 3.10 To permit the Landlord or its agents with or without workmen and others authorised by the Landlord at all reasonable times during the Term at convenient hours in the day time upon reasonable prior written notice (or at any time in an emergency without notice) as often as occasion shall require to enter into and upon the Premises or any part thereof for the purpose of taking inventories of the Landlord's fixtures and fittings therein or of viewing and examining the state and condition of the Premises and equipment and on notice in writing of any want of cleansing or repair or decoration or defect in the order or condition of the Premises or equipment for which the Tenant is liable hereunder being given to the Tenant or left at or upon the Premises for the Tenant by or on behalf of the Landlord to repair, cleanse, decorate, amend, maintain and (where necessary) renew the same accordingly within two months after the date of such notice and so that in case of default by the Tenant the Landlord may carry out all necessary or proper cleansing reparation decoration amendment maintenance and renewal thereof and any money expended by the Landlord for that purpose shall be repayable by the Tenant on demand and if not so repaid shall be recoverable by the Landlord as rent in arrear 3.11 3.11.1 Not at anytime either to use or permit or suffer the Premises nor any part thereof to be used for any illegal nor immoral purpose nor the sale of ale, beer, wine or spiritous liquors nor any noisy or offensive or dangerous trade or business nor any sale by auction nor to do or permit or suffer to be done in the Premises or any part thereof any act or thing, which may be or grow to be in any way an annoyance disturbance or nuisance or -7- detrimental to the neighbourhood or to the adjoining or neighbouring property or to the Landlord 3.11.2 Not at any time either to use or permit or suffer the Premises nor any part thereof to be used for any testing or experimentation on or involving animals and not to bring onto or suffer or allow or permit to be kept on the Premises any animal or animals 3.12 3.12.1 Subject to the Tenant obtaining all requisite consents under the Planning Acts to use the Premises at all times for the purpose specified in Schedule 1 and not at any time to use or permit or suffer the Premises or any part thereof to be used for any other purpose 3.12.2 To ensure that all waste and refuse of a specialist or toxic nature is stored and disposed of safely and in accordance with the reasonable requirements of the Landlord and with any requirements of the local authority or other relevant authority as to the storage collection and disposal of all such waste or refuse 3.13 Not without the consent in writing of the Landlord to bring on to the Premises any safe or other heavy object and not to take any goods upon the Premises so as to cause any undue stress or strain to the floors main girders or structure of the Centre in any manner whatsoever 3.14 Not to store any explosive or inflammable materials at the Premises nor to allow any grit, noxious or offensive effluvia to be emitted from the Premises or any part thereof nor to allow any oil grease or other deleterious materials or substances to enter the Pipes 3.15 3.15.1 Not at any time during the Term to do or omit or permit or suffer to be done or omitted anything on the Premises or any part thereof the doing or omission of which shall be a contravention of the Planning Acts and to indemnify the Landlord against all actions proceedings, damages, penalties, costs, charges, claims and demands in respect of such acts or omissions or any of them 3.15.2 To give notice as soon as practicable to the Landlord of any notice order or proposal for a notice or order served on the Tenant under the Planning Acts and if so required by the Landlord to produce the same and at the request and cost of the Landlord to make or join in making, such objections or representations in respect of any proposal as the Landlord may require -8- 3.15.3 To comply at the cost of the Tenant with any notice or order served on the Tenant under the provisions of the Planning Acts which relates to the Tenant's use of the Premises and to keep the Landlord effectually indemnified against all actions, proceedings, damages, penalties, costs charges and demands in respect thereof 3.16 Not to place or affix any aerial signboard, fascia, placard, bill, notice or other notification whatsoever to or upon the outside of the Premises or in or upon the windows thereof without the prior written consent of the Landlord (such consent not to be unreasonably withheld or delayed) 3.17 Not to use the Common Parts except in accordance with any reasonable rules or regulations which the Landlord shall impose in relation thereto and without prejudice to the generality of the foregoing not to obstruct any part or parts of the Common Parts nor store any materials or refuse thereon nor allow any vehicles or machinery to be repaired or maintained thereon 3.18 At all times during, the Term at the expense of the Tenant to do and execute or cause to be done and executed all such works and to do all such things as under or by virtue of any Act or Acts of Parliament now or hereafter to be passed and orders by-laws rules and regulations thereunder are or shall be directed or necessary to be done or executed upon or in respect of the Premises or any part thereof by the owner lessee tenant or occupier thereof and at all times to save harmless and to keep indemnified the Landlord against all actions costs claims demand costs expenses and liabilities in respect thereof and to pay all costs charges and expenses properly incurred by the Landlord in abating a nuisance or for remedying any other matter in connection with the Premises in obedience to a notice served by a local or any other authority 3.19 To inform the Landlord immediately of the receipt by the Tenant of any bankruptcy notice or order or (as the case may be) any winding-up petition in connection with any insolvency proceedings in which the Tenant is involved 3.20 Within fourteen days of the receipt of notice of the same to give full particulars to the Landlord of any permission notice order or proposal for a notice or order made given or issued to the Tenant by any government department local or public authority under or by virtue of any statutory powers and if so required by the Landlord to produce such permission notice order or proposal for a notice or order to the Landlord and also without delay to take all reasonable or necessary steps to comply with any such notice or order and at all times to save harmless and to keep indemnified the Landlord and the Landlord's estate and effects against all actions claims demands costs expenses and liability in respect thereof and also at the request and cost of the Landlord to make or join with the Landlord in making such objections or representations against -9- or in respect of any such notice order or proposal as aforesaid as the Landlord shall deem expedient 3.21 To pay to the Landlord all reasonable and proper costs charges and expenses including legal costs and charges payable to a surveyor (together with (in any such case) any value added tax or similar tax which may be chargeable thereon) which may be incurred by the Landlord in or in contemplation of any application to the Landlord for any consent pursuant to the covenants herein contained or relating to or in contemplation of any proceedings relating to the Premises or any part thereof under Section 146 or 147 of the Law of Property Act 1925 notwithstanding forfeiture is avoided otherwise than by relief granted by the Court 3.22 Not to stop or darken or obstruct any windows or lights belonging to the premises without the prior written consent of the Landlord provided that the Tenant shall be entitled to darken 2 (two) windows in respect of room in the east wing 3.23 By way of indemnity only to observe and perform the Title matters so far as the same relate to or affect the Premises 3.24 3.24.1 not in relation to either the whole or to any part of the Premises to hold the tenancy on trust to assign underlet part with or share possession or occupation or to grant licences or franchises to use and occupy except as expressly contemplated in the following provisions of Clause 3.21 3.24.2 not to assign the whole of the Premises without having obtained the Landlord's prior consent and for the purposes of s.19(1A) of the Landlord and Tenant Act 1927 and subject to the proviso in Clause 3.24.3 the Landlord is entitled to refuse consent in any of the circumstances specified in Clauses 3.24.4 and 3.24.5 and to impose any of the conditions specified in Clause 3.24.6 3.24.3 whether or not any of the specified circumstances have arisen or any of the imposed conditions have been complied with the Landlord shall be entitled to refuse consent or to impose any further condition or conditions where it would be reasonable to do so 3.24.4 the Landlord is entitled to refuse consent where the proposed assignee or its proposed guarantor (a) is a member of the same group of companies (within the meaning of s.42(l) of the 1954 Act) as the person who is the Tenant at the time of the application or -10- (b) is a limited company which is not registered in the United Kingdom or (c) has or will have immunity from suit or legal process in relation to any breach of any covenant or condition of this Lease 3.24.5 the Landlord is entitled to refuse consent where in the Landlords reasonable opinion (a) the effect of the proposed assignment would be to diminish the value of the Landlords reversionary interest in the Premises or his interest in any Landlord's property (b) either the use to which the assignee intends to put the Premises or the trading profile of the assignee is either unsuitable on grounds of good estate management or does not comply with the Landlords policy of tenant mix 3.24.6 the Landlord is entitled as a condition of granting consent to assign to require: (a) that whether or not any further surety is required the Tenant enters into an authorised guarantee of the assignees liability under this Lease pursuant to s.16 of the 1995 Act in such reasonable form as the Landlord shall require including provisions requiring the former tenant to take up a new lease in the event of disclaimer (b) in addition to any authorised guarantee agreement for the purposes of s.16 of the 1995 Act but only if this further requirement is reasonable that one or more third party guarantor approved by the Landlord (acting reasonably) covenants with the Landlord 3.24.7 not to underlet the whole or a Permitted Part of the Premises, without having, obtained the Landlord's prior consent which consent will not be unreasonably withheld where the provisions of Clauses 3.24.8 to 3.24.10 (inclusive) are first either actually complied with or agreed to be complied with (as appropriate) 3.24.8 in relation to every underlease: (a) to procure that the undertenant covenants directly with the Landlord to perform and observe the covenants and conditions in this Lease (other than the covenant to pay the Yearly Rent) so far as they relate to the underlet premises -11- (b) to obtain a guarantor or guarantors of the undertenant to be approved by the Landlord who must covenant by deed with the Landlord in such reasonable form as the Landlord shall require including provisions requiring the former tenant to take up a new Lease in the event of disclaimer (c) to enforce observance of the provisions of the underlease by every undertenant and not at any time to waive any breach of the covenants or conditions on the part of the undertenant (d) to grant the underlease without any premium or other consideration and at a rent which is approved by the Landlord and which is no lower than the then open market rent of the underlet premises or in the case of an underletting of the whole at a rent equal to the higher of the Rent then payable under this Lease and the then open market rent of the Premises 3.24.9 any permitted underlease must be in a form approved by the Landlord and must in addition provide that the undertenant enters into an authorised guarantee agreement pursuant to s.16 of the 1995 Act on assignment of the underlease 3.24.10 in the case of the grant of an underlease of a Permitted Part the Landlord may require the following as a pre-condition of giving its consent (a) that the underlease is excluded from the provisions of ss.24 28 (inclusive) of the 1954 Act and that the Tenant covenants to take all requisite steps to ensure that the undertenant does not acquire protection of Part II of the 1954 Act (b) that the underlease provides that the undertenant will pay a fair proportion of the Insurance Rent and of the costs and expenses incurred by the Tenant in maintaining repairing and decorating and renewing the Premises such proportion in each case to be determined by the underlandlord (acting reasonably) 3.24.11 notwithstanding Clause 3.24.1, where the Tenant is a company incorporated under the Companies Acts 1948 to 1985 the Tenant may share occupation of the Premises with any other company which is a member of the same group of companies as the Tenant (within the meaning of s.42(l) of the 1954 Act) PROVIDED that no tenancy is created or allowed to arise that the Tenant gives the Landlord at least one months prior notice of such proposed occupation and notifies the Landlord when the occupation ends and that any such occupation ends immediately if the -12- company ceases to be a member of the same group of companies as the Tenant 4. The Landlord hereby covenants with the Tenant that 4.1 The Tenant paving the Rent and observing and performing the Tenant's covenants herein contained shall and may peaceably hold and enjoy the Premises during the Term without any interruption or disturbance from or by the Landlord or any person lawfully claiming through under or in trust for the Landlord 4.2 The Landlord will keep the Centre (including the Premises) (except any plate glass and except any fixtures fittings and contents belonging to the Tenant) insured with reputable insurers against the risks and for the cover stated in clause 43 so far as cover is available at normal insurance rates for the locality and subject to reasonable excesses and exclusions 4.3 The Landlord's insurance will cover full rebuilding site clearance professional fees, VAT and three years, loss of rent against the risks of fire, lightning, explosion, earthquake, landslip, subsidence, riot, civil commotion, aircraft, aerial devices, storm, flood water, theft, impact by vehicles, malicious damage and third party liability and any other risks reasonably required by the Landlord 4.4 On request (but not more than once in any 12 month period) the Landlord will give to the Tenant particulars of the policy and evidence from the insurer that it is in force 4.5 The Landlord will make good damage to the Premises and their means of access caused by any Insured Risk as soon as possible after the insurance money is paid to the Landlord 4.6 The Tenant will not do or omit anything, which would have the effect of causing the insurance of the Centre to become void and the Tenant will comply with all the insurer's reasonable requirements 4.7 The Landlord is not liable to reinstate any part of the Centre if the insurance money is wholly or partly unpaid owing to the act or default of the Tenant or persons under its control 4.8 If the Premises become unusable owing to damage caused by an Insured Risk then unless the insurance money is wholly or partly unpaid owing to the act or default of the Tenant or persons under its control the Rent and Service Charge or a fair proportion of them are to be suspended until the expiry of a period three years from the date of the damage or until the Premises are fully restored (whichever is the earlier) -13- 4.9 If because of the act or default of the Tenant or persons under its control the insurance money is wholly or partly unpaid or if it appears impractical or uneconomical to reinstate the Centre within the three year period then the Landlord is entitled to terminate this Lease by notice to the Tenant at any time before the end of that period and is entitled to keep any insurance money 4.10 The Landlord shall ensure that the goods lift security access system incorporates a mechanism which prevents unauthorised access to the Premises 4.11 The Landlord shall affix to the Common Parts direction signage for the benefit of the Tenant and any other users of the Premises 5. IT IS HEREBY AGREED AND DECLARED as follows:- 5.1 Nothing herein contained shall by implication of law or otherwise operate to confer on the Tenant any easement rig t or privilege whatsoever over or against the Premises or any adjoining or other property belonging, to the Landlord which might restrict or prejudicially affect the future rebuilding, alteration or development of the Premises or such adjoining or other property nor shall the Tenant be entitled to compensation for any damage or disturbance caused by or suffered through any such rebuilding alteration or development 5.2 The Tenant may not less than six (6) months before the expiry of the fifth anniversary of the Term or (if later) within one (1) month of the Landlord advising the Tenant in writing of the Landlord's proposal for the Rent to apply from the Review Date give notice to the Landlord of its intention to determine this Lease on the later of the Review Date and the date six (6) months after the giving of such notice on expiry of which notice if the Tenant shall have throughout the Term up until such date have reasonably observed and performed the covenants terms and obligations on its part contained in this Lease the Term shall thereupon determine but without prejudice to the rights of either party against the other in respect of any antecedent breach of the terms hereof 5.3 In the event of the Premises being damaged or destroyed for any reason whatsoever the Landlord as an alternative to reinstatement shall be entitled to determine this tenancy by one months written notice to the Tenant 5.4 Except as herein expressly provided to the contrary all disputes or differences which may arise touching the provisions hereof or the operation or construction hereof or the rights or liabilities of the Landlord and the Tenant shall be referred to arbitration by a single arbitrator under the provisions of the Arbitration Act 1996 or any Act amending or replacing the same -14- 5.5 No receipt of rents or other payments paid by standing order or otherwise inadvertently accepted by the Landlord or the Landlord's personnel of any breach of any of the Tenant's covenants shall operate as a waiver wholly or partially of such breach and the Tenant shall not be entitled to set up such demand or receipt as a defence in any act or proceeding by the Landlord 5.6 All rents and sums due from the Tenant hereunder shall be deemed to be exclusive of Value Added Tax and the Landlord or other the person to whom the Tenant is making payment shall be entitled to charge such Value Added Tax on such rents and sums as may be required or be permitted by law to be charged from time to time on production of a valid VAT invoice addressed to the Tenant 5.7 Nothing contained in this Lease or done thereunder and no consents given by the Landlord or any other person acting on behalf of the Landlord hereunder shall affect the power of the Landlord in any other capacity whatsoever (other than as a landowner) under or by virtue of any public private or local act, order, instrument, regulation or bye- law in operation from time to time nor relieve the Tenant from the necessity of obtaining all such approvals or consents (in respect of plans or otherwise) as may from time to time be requisite from the Landlord in any such capacity as aforesaid under or by virtue of any such act order instrument, regulation or bye-law in operation from time to time notwithstanding that consent may have been given by the Landlord hereunder 6. FORFEITURE 6.1 The Landlord is entitled to forfeit this Lease by entering any part of the Premises whenever full payment of any of the sums reserved as rent is overdue more than 14 days (whether or not formally demanded) and in any of the circumstances specified in clause 6.2 but re-entry does not prejudice any rights of the Landlord in respect of previous breaches of covenant by the Tenant 6.2 The circumstances referred to in clause 6.1 are whenever the Tenant 6.2.1 is in breach of a material covenant or 6.2.2 ceases to carry on its business or suffers distress or execution to be levied on its goods or 6.2.3 becomes insolvent or unable to pay its debts as they fall due or 6.2.4 enters into any deed or scheme of arrangement or composition with its creditors or any application or proposal is made for a voluntary arrangement in respect of it under the Insolvency Act 1986 or the Insolvent Partnerships Order 1994 or -15- 6.2.5 (if an individual and if more than one any of them) is adjudicated bankrupt or an interim receiver of his property is appointed or he dies or 6.2.6 (if a company and if more than one any of them) has a receiver or manager appointed (including an administrative receiver) or goes into liquidation (unless the liquidation has the Landlord's approval and is solely for the purpose of amalgamation or reconstruction when solvent) or has an administration order made in respect of it 7. SERVICE CHARGE 7.1 Landlord's covenant The Landlord covenants with the Tenant that subject to the Tenant paying the Service Charge the Landlord will keep the Common Parts and the roof foundations structural parts and exterior of the Centre in good and substantial repair and condition throughout the Term provided that: 7.1.1 this covenant does not apply to any works or repairs which the Tenant is liable to carry out under the provisions of this Lease or which are necessary as a result of the default or neglect of the Tenant 7.1.2 in supplying the Landlord's Services the Landlord may employ managing, agents contractors or such other suitably qualified persons as the Landlord may from time to time think fit and whose proper and reasonable fees salaries charges and expenses (including VAT) will form part of the Expenditure 7.2 Breakdown in Landlord's Services 7.2.1 The Landlord will not be liable for any injury to or loss or damage suffered by the Tenant caused by: 7.2.1.1 any breakdown, absence, failure or insufficiency of any of the Landlord's Services or 7.2.1.2 any defect in any of the Conduits or any boiler lift machinery appliance or apparatus used in connection with the provision of the Landlord's Services or 7.2.1.3 any defect in any part of the Centre unless either:- 7.2.1.4 the injury loss or damage is covered by and the Landlord receives payment under a policy of insurance effected by it in respect of that risk or -16- 7.2.1.5 such injury loss or damage arises out of the wilful neglect or refusal of the Landlord to comply with the provisions of clause 7.2.2 provided to the extent that any such failure or interruption could not readily have been prevented or shortened by the exercise of proper care, attention, diligence and skill by the Landlord or those undertaking the services on behalf of the Landlord or the Landlord uses and continues to use its reasonable endeavours to restore the services in question 7.2.2 The Landlord will use all reasonable endeavours to remedy or make good any breakdown absence failure insufficiency or defect in the provision of the Landlord's services for which the Landlord is responsible under this Lease within a reasonable time after the Tenant notifies the Landlord in writing of such matter but the Landlord will not be liable under this covenant: 7.2.2.1 for anything, which the Tenant covenants to repair or make good under this Lease or 7.2.2.2 if the policy money due to the Landlord under any relevant insurance policy effected by the Landlord in respect of that matter has been wholly or partly refused or withheld in consequence of some act, neglect or default of the Tenant 7.3 Service Charge Accounts As soon as convenient after the end of each Financial Year the Landlord will prepare accounts certified by a properly qualified accountant showing the Expenditure for that Financial Year and containing a fair summary of the various items comprising the Expenditure and a copy of such accounts will be supplied to the Tenant 7.4 Payment of Service Charge 7.4.1 The Tenant covenants with the Landlord that on each of the usual quarter days in every year during, the Term the Tenant will pay the Landlord such a sum in advance and on account of the Service Charge for the Financial Year then current as the Landlord may from time to time specify as being in its reasonable discretion a fair and reasonable assessment of one quarter of the likely Service Charge for that particular Financial Year the first advance payment of which (apportioned if necessary on a daily basis) will be made on the date of this Lease -17- 7.4.2 If the Service Charge for any Financial Year: 7.4.2.1 exceeds the Advance Payments for that Financial Year the excess will be paid by the Tenant to the Landlord on demand or 7.4.2.2 is less than the Advance Payments for that Financial Year the overpayment will be credited to the Tenant against the next quarterly payment of the Service Charge 7.5 Omission of item of Expenditure in any Financial Year If the Landlord does not seek to recover any sum expended or liability incurred by it in connection with the Landlord's Services in any Financial Year the Landlord may nevertheless in its reasonable discretion recover such sum or liability in any subsequent Financial Year 7.6 Variation of Landlord's Services The Landlord may at its reasonable discretion withhold add to extend, vary or make any alterations to any of the Landlord's Services from time to time if the Landlord reasonably deems it desirable to do so for the more efficient management security and operation of the Centre or for the comfort of the tenants in the Centre 7.7 Variation of the Centre If at any time during the Term the total property vested in the Landlord which enjoys or is capable of enjoying the benefit of any of the Landlord's Services is extended to Adjoining Premises or is increased or decreased on a permanent basis the Service Charge Proportion will be varied with immediate effect and the variation will be determined reasonably by the Landlord's Surveyor (acting as an expert and not as an arbitrator) and his decision will be final and binding on the parties 7.8 End of the Term The provisions of this clause will continue to apply notwithstanding the end of the Term but only in respect of the period to the end of the Term and the Service Charge for that Financial Year will be apportioned for such period on a daily basis 7.9 Sinking Fund 7.9.1 in accordance with paragraph 14 of Schedule 2 a reasonable provision (to be determined by the Landlord) may be made towards the Landlord's anticipated expenditure during the Term in respect of periodically recurring items whether recurring, at regular or irregular intervals and such of the Landlord's services as relate to the renewal or replacement of the -18- items referred to provided that such reasonable provision in relation to this sub-clause and paragraph 14 of Schedule 2 shall be determined on the assumption that the cost of replacement of such items is calculated on such life expectancy as the Landlord may reasonably determine and that each year the Tenant will be required to pay a reasonable proportion toward the anticipated costs of renewal or replacement to the intent that a fund or funds be accumulated sufficient to cover the cost of renewal or replacement by the end of the anticipated life of each such item 7.9.2 any expenditure by the Landlord in respect of a recurring item referred to in this sub-clause or pursuant to paragraph 14 of Schedule 2 in connection with the renewal or replacement of an item referred to where either (a) a fund has been established in connection with such recurring item or the renewal or replacement of that item ("the Specific Fund") (b) a part of a fund ("the General Fund") has been allocated by the Landlord for such recurring, item or the renewal or replacement of that item shall first be met out of the Specific Fund or as appropriate out of the General Fund to the extent of the credit allocated for that item by the Landlord in the General Fund 7.9.3 the General Fund statement shall indicate whether or not the Landlord has established and is monitoring any fund or funds pursuant to this paragraph and shall provide full details of any such fund or funds 7.9.4 all sums received by the Landlord pursuant to this sub-clause shall be credited to an account separate from the Landlord's own money and shall be held by the Landlord upon trust during the Term for the persons who from time to time shall be tenants of the Centre to apply the same and any interest accruing, for the purposes set out in this sub-clause and at the expiry of such period any such sums unexpended shall be paid to the Tenant in proportion to the area of the property occupied by them 8. RENT REVIEW 8.1 Requirement for Review The amount of the Rent is to be reviewed on the Review Date and the sum payable as the Rent on and following the Review Date will be the greater of 8.1.1 the amount of the Rent immediately before such Review Date and -19- 8.1.2 the best annual rent at which the Premises might reasonably be expected to be let in the open market at the Review Date ascertained as if to be let on the terms of the hypothetical lease described in clause 8.2 and on the assumptions set out in clause 8.3 but disregarding the matters set out in clause 8.4 ("the open market rent") 8.2 The Hypothetical Lease The hypothetical lease by reference to which each review of the Rent is to take place is a lease 8.2.1 on the same terms as this Lease (including but not limited to the review provisions and with review of rent on the same dates as are specified in this Lease) except for the amount of the Rent and for anything which is inconsistent with the express assumptions and disregards set out in clauses 8.3 and 8.4 and 8.2.2 granted without any premium by a willing lessor to a willing lessee with vacant possession and for whichever is longer of a term equal to the residue of the Term unexpired at the Review Date and a term of 10 years starting on the Review Date 8.3 Assumptions The assumptions to be made in ascertaining the open market rent are 8.3.1 that no work has been carried out to the Premises which has diminished their rental value 8.3.2 that the Premises are fit for immediate occupation and use with all requisite services connected and available and that if the Premises have been damaged or destroyed they have been fully restored 8.3.3 that at the Review Date the Tenant has already had the benefit of a rent free period for fitting out 8.3.4 that the covenants in this Lease have been fully performed and observed 8.3.5 that the Premises are let as a whole or if the aggregate of rents for such sublettings would produce a higher rental value of the Premises that each separately lettable part of the Premises is separately let 8.4 Matters to be disregarded In assessing the open market rent the following are to be disregarded -20- 8.4.1 any effect on rent of the fact that the Tenant or any predecessors of the Tenant or any authorised underlessee of either of them have been in occupation of the Premises 8.4.2 any goodwill attached to the Premises by reason of the carrying on there of the Tenants business or that of any predecessors of the Tenant or of any authorised underlessee of either of them 8.4.3 any increase in value attributable to tenant's fixtures and fittings 8.4.4 subject to the assumptions at clause 8.3.2 arid 8.3.3 any increase in rental value attributable to any improvement to the Premises carried out with the Landlord's written permission by the Tenant or any predecessors of the Tenant or any authorised underlessee during the Term and the Buyer's Works except for any improvement which has been carried out pursuant to an obligation to the Landlord or its predecessors or which has been carried out wholly or partly at the Landlords expense 8.5 Settlement of open market rent 8.5.1 the Landlord and the Tenant will endeavour to agree the open market rent prior to the Review Date but if agreement has not then been reached either party may at any time thereafter refer the determination of the open market rent to the Independent Surveyor 8.5.2 the appointment of the Independent Surveyor is to be made by agreement between the parties but in default of agreement then either party may request the President of the Royal Institution of Chartered Surveyors to nominate or arrange the nomination of the Independent Surveyor and the person so nominated is to be appointed by the parties jointly but if for any reason notice of his determination is not given within a reasonable period the parties may appoint a replacement Independent Surveyor using the procedures in this sub-clause 8.5.3 the Independent Surveyor is at the Landlords option to act as an expert and the parties may make representations to him but he is not bound to take them into account in reaching his decision which (including his decision as to the payment of his costs) is to be final and binding on the parties but if he fails to make a decision as to payment of his costs they are to be shared equally between the parties -21- 8.6 Arrears of increased rent and interest 8.6.1 where and for so long, as settlement of any Rent Review remains uncompleted the Rent will continue to be payable on and following the Review Date at the rate applying immediately before such Review Date 8.6.2 immediately after the parties have agreed the amount of the open market rent or where the determination was referred to the Independent Surveyor immediately after he has notified the parties of his decision the Tenant will forthwith pay to the Landlord the full amount of the difference (if any) between: (a) the total of the sums in respect of the Rent actually paid by the Tenant to the Landlord for the period starting on the Review Date and ending, on the day before the quarter day which immediately follows the date of such agreement or notification and (b) the total of the sums in respect of the Rent which would have been payable in respect of that period had the agreement or notification been made on or prior to such Review Date 8.6.3 where any payment falls to be made by the Tenant to the Landlord pursuant to clause 8.622 the Tenant will at the same time pay to the Landlord interest at 3% below the Prescribed Rate on that payment in respect of the period beginning on the day on which each instalment was due and ending on the date of the payment made by the Tenant under clause 8.6.2 8.7 Time not of the essence Time is not to be of the essence of any of the Review Provisions 8.8 Memorandum After the open market rent has been ascertained in respect of a Review Date a memorandum signed by the Landlord and the Tenant recording the amount of the Rent so ascertained is to be endorsed on or annexed to this Lease and its counterpart (each party bearing its own costs)] 9. Having been authorised to do so by an Order of the Newcastle upon Tyne County Court made on the day of , 199 under the provisions of Section 38(4) of the Landlord and Tenant Act 19-54 (as amended by Section 5 of the Law of Property Act 1969) the parties hereto agree that the provisions of Section 24-28 (inclusive) of that Act shall be excluded in relation to the Lease hereby created -22- 10. The parties hereto certify that this is a new tenancy under the 1995 Act This document is executed as a deed on the date at the beginning of the document -23- SCHEDULE 1 ---------- The Landlord - ------------ Name : International Centre for Life (Property) Limited Company Number : 3261320 Registered Office : Scotswood House Newcastle Business Park Newcastle upon Tyne NE4 7YL The Tenant - ---------- Name : Applied Imaging International Limited Company Number : 1984637 Registered Office : Hylton Park Wessington Way Sunderland SR5 3HD The Term - -------- 10 years from 1998 subject to clause 5 The Rent - -------- (Pounds)119,372.56 per annum exclusive of VAT and of all rates and all other outgoings whatsoever Rent Commencement Date - ---------------------- Permitted User - -------------- The manufacture of medical devices related equipment and test services together with office use ancillary thereto Title Matters - ------------- All rights easements covenants agreements and declarations exceptions reservations and other matters contained or referred to in the Property and Charges Registers of title number TY239836 so far as they subsist and are capable of being enforced and relate to the Premises or the Centre The Premises - ------------ ALL THAT property being, part of the Centre and shown for the purposes of identification only -24- 8. The right to use any lifts in the Centre PROVIDED THAT the Tenant shall only have the right to use the goods lift to access the first floor and the basement 9. The right to use the meeting conference rooms at the Centre at a rent or licence fee and on terms to be agreed between the Landlord and the Tenant from time to time during the Term in the Centre and such other communal facilities as are provided by the Landlord in the Centre for the common use of the tenants of the International Centre for Life 10. The right to use the dedicated loading bays at the Centre 11. The right until the date immediately preceding the third anniversary of the date hereof to park without charge twenty five (25) cars or light vehicles in the spaces in the Cattle Market Car Park from time to time designated by the Landlord and a right thereafter to park such vehicles in such spaces until the date immediately preceding the fifth anniversary of the date hereof subject to payment of the Cattle Market Parking Fee Provided That such right to park in the Cattle Market Car Park shall be extended for a period ending at the expiry or sooner determination of the Term (howsoever determined) subject to prior agreement between the Landlord and the Tenant of the fee payable for such right which shall be not less than the Cattle Market Parking Fee EXCEPT AND RESERVING to the Landlord and all persons authorised by the Landlord or otherwise entitled the following rights:- 1. Full and free right to enter the Premises at all reasonable times after reasonable notice (or at any tune in an emergency) with or without surveyors agents workmen materials and appliances to exercise any of the rights excepted reserved or contained in this Lease or to comply with any obligation of the Landlord under this Lease or to carry out the Landlord's Services the person or persons exercising such rights causing as little inconvenience as reasonably practicable and making good all damage to the Premises caused in the exercise of the rights but the Landlord will not be liable to the Tenant in respect of any loss damage or claim arising from noise, dust, vibration, noxious fumes, odours, loss of trade, nuisance or annoyance caused to the Tenant or any other person in connection with the exercise of those rights 2. Full right and liberty to build on alter add to redevelop or extend in height or otherwise the Centre or any adjoining premises notwithstanding that the access of light and air to the Premises and its lights windows and openings may be affected 3. The free and uninterrupted use of the Conduits and the right to enter the Premises at all reasonable times after reasonable notice (or at any time in an emergency) to install make connection with clean alter renew remove replace or inspect the Conduits or any of them as -25- the Landlord may require and during the Perpetuity Period to build additional Conduits or relay any existing Conduits the person or persons exercising such rights causing as little inconvenience as reasonably practicable and making good all damage to the Premises caused in the exercise of the rights but the Landlord will not be liable to the Tenant in respect of any loss damage or claim arising from noise, dust, vibration, noxious fumes, odours, loss of trade, nuisance or annoyance caused to the Tenant or any other person in connection with the exercise of these rights 4. Full right and liberty to enter the Premises at all reasonable times after reasonable notice as often as may be necessary to inspect repair maintain cleanse decorate or renew the Centre or any adjoining premises (including the right if necessary to erect and maintain scaffolding for the purpose of repairing or cleaning the exterior of the Centre or any adjoining premises notwithstanding that such scaffolding may temporarily interfere with the access to or enjoyment and use of the Premises) the person or persons exercising such rights causing, as little inconvenience as reasonably practicable and making good all damage to the Premises caused in the exercise of the rights but the Landlord will not be liable to the Tenant in respect of any loss damage or claim arising from noise dust vibration noxious fumes odours loss of trade nuisance or annoyance caused to the Tenant or any other person in connection with the exercise of those rights 5. Full rights of lateral and subjacent support and protection from the Premises for the remainder of the Centre and any adjoining premises 6. The right in emergency only to pass on foot through the Premises via any fire escape door or Corridor leading through the Premises 7. Full rights of light and air and all other easements and rights now or at any time during the Term belonging to or enjoyed by the Centre and any adjoining premises SCHEDULE 2 ---------- Landlord's Services ------------------- 1. Maintenance of the Centre ------------------------- The maintenance repair rebuilding replacement and renewal of: 1.1 the main structure and exterior of the Centre including (without limitation) all structural or load-bearing walls and columns the structural parts of the floors and columns and the timbers stanchions girders roof and foundations of the Centre 1.2 the boundary walls fences and other structures of the Centre 1.3 the party walls within the Centre -26- 1.4 the Conduits 1.5 the Common Parts 1.6 any rooms occupied and used by any staff employed by the Landlord 1.7 all other parts of the Centre not included in the above paragraphs but excluding, in each case any such which are included in this Lease or the Lease tenancy or licence of any other part of the Centre or the repair of which are the responsibility of the Tenant or any other tenant licensee or occupier of the Centre 2. Decoration ---------- 2.1 The painting cleaning and decorating of: 2.2 the exterior of the Centre 2.3 the Common Parts 2.4 any rooms occupied or used by any staff employed by the Landlord such painting cleaning and decorating to be carried out by the Landlord at such intervals as it may decide 3. Plant and Machinery ------------------- Operating, inspecting, servicing, overhauling, repairing, maintaining, cleaning, lighting and renewing or replacing all landlord's fixtures fittings plant machinery apparatus and equipment in the Centre from time to time during the Term including (without limitation) the lifts, lift shafts and lift motor room and the boilers and all items relating to the heating, air conditioning and the natural and carbon gas supply, the compressed air supply and the vacuum system and any fibre optic cabling ventilation and hot and cold and de-ionised water systems serving the Centre including the provision of all fuel and electricity for them and maintenance contracts and insurance in respect of them (but excluding all landlord's fixtures, fittings, plant machinery apparatus and equipment which are included in this Lease or the lease tenancy or licence of any other part of the Centre or the repair of which are the responsibility of the Tenant or any other tenant licensee or occupier of the Centre) 4. Common Parts ------------ 4.1 The furnishing, alteration and reinstatement of the Common Parts 4.2 The purchase or hire (as appropriate) maintenance and renewal of plants and any planters and any other landscaping features in the Common Parts and the cultivation of all landscaped areas within the Common Parts -27- 4.3 The operation repair maintenance renewal replacement and cleaning of all signs and notices and lighting systems in the Common Parts 4.4 The provision of fire extinguishers and other fire fighting equipment in the Common Parts and the payment of all charges in connection with their rental installation and maintenance 5. Heating and hot water --------------------- The provision of:- 5.1 an adequate supply of hot water during the Permitted Hours for domestic use to the basins which are in the Centre at any time during the Term and 5.2 reasonably adequate heat to the radiators which are in the Centre at any time during the Term during the Permitted Hours and during the period from 1 October to the following 1 May (or such other period as the Landlord may determine from time to time having regard to weather conditions) 5.3 a hot and cold water shower facility in the Common. Parts for domestic use during the Permitted Hours 6. Staff ----- The provision of cleaning and other staff for the day to day running of the Centre and for the provision of cleaning security and other services and for the general management, operation and security of the Centre (including such direct or indirect labour as the Landlord deems appropriate) and all other related expenditure including but not limited to: 6.1 the payment of wages salaries and expenses together with such statutory and other insurance health pension and welfare severance and other payments contributions and premiums as the Landlord may deem reasonably necessary in relation to such staff 6.2 the provision of uniforms working clothes tools appliances materials and equipment including telephones for the proper performance of the duties of any such staff 7. Refuse ------ The provision repair maintenance and renewal of any litter bins, bin liners, paladin units, refuse trolleys or other receptacles for the storing or packaging of refuse for the Centre and the cost of storing collecting and disposing of all refuse from the Centre -28- 8. Window Cleaning --------------- The cleaning of the outside of all the windows in the Centre (including those of the Premises) and the cleaning of the inside of all the windows in the Common Parts 9. Staff accommodation ------------------- The payment of rent for any accommodation occupied or used by any staff employed by the Landlord within other property belonging to the Landlord (a notional rent equivalent to the rent at which the Landlord's Surveyor considers such accommodation might be let from time to time in the open market with vacant possession) 10. Management Costs ---------------- 10.1 The employment of managing agents, contractors, surveyors, valuers, architects, engineers accountants, solicitors and other professional persons in connection with the management and/or maintenance of the Centre and the payment of all proper fees, charges, salaries, expenses and commissions payable to them including the payment of the fees and expenses incurred by the Landlord in preparing accounts of the Expenditure for each Financial Year and having such accounts certified by the Accountant in accordance with clause 7 10.2 The payment of a proper management charge in respect of the provision of Services for the Centre during each Financial Year 10.3 The payment of all proper costs and expenses including bank charges interest and VAT incurred by the Landlord incidental to the provision of services for the Centre 11. Statutory Requirements ---------------------- The costs to the Landlord of carrying out any works to the Centre required to comply with any statute (other than works for which any tenant or occupier is responsible) and the cost to the Landlord of taking any steps deemed desirable or expedient by the Landlord for complying with making representations against or otherwise contesting the incidence of the provisions of any statute including those concerning town planning, public health, fire precautions, highways, streets, drainage or other matters which may affect the Centre (other than such matters which relate only to one tenant or occupier of the Centre) 12. Outgoings --------- The payment of all existing and future rates (including water rates) taxes assessments charges and outgoings whether parliamentary local or otherwise whether of the nature of capital or revenue and even though of a wholly novel character which may now or at any time be rated taxed assessed charged or imposed upon the Common Parts or any part of them or upon the -29- Centre as a whole or upon any accommodation occupied or used by any staff employed by the Landlord 13. General ------- The provision of such other services and works as the Landlord may reasonably deem desirable or necessary for the benefit of the Centre or the tenants or occupiers of it or in the interests of good estate management 14. Sinking Fund ------------ Such provision of anticipated future expenditure in relation to the Common Parts as may in the Landlord's reasonable opinion be appropriate in accordance with the provisions outlined in clause 7 of this Lease -30- EXECUTED AS A DEED by affixing the Common Seal of [SEAL] APPLIED IMAGING INTERNATIONAL LIMITED in the presence of:- Director /s/ L.G. Grant Secretary /s/ ILLEGIBLE -31- EX-23.1 4 CONSENT OF INDEPENDENT AUDITORS Exhibit 23.1 Consent of Independent Auditors The Board of Directors Applied Imaging Corp.: We consent to incorporation by reference in the registration statements (Nos. 333-26127 and 333-57835) on Form S-8 and registration statement (No. 333-60345) on form S-3 of Applied Imaging Corp. of our report dated February 5, 1999, relating to the consolidated balance sheets of Applied Imaging Corp. and subsidiaries as of December 31, 1998 and 1997, and the related consolidated statements of operations, stockholders' equity, and cash flows for each of the years in the three-year period ended December 31, 1998, and the related consolidated financial statement schedule, which report appears in the December 31, 1998, annual report on Form 10-K of Applied Imaging Corp. /s/ KPMG LLP Mountain View, California March 29, 1999 EX-27.1 5 FINANCIAL DATE SCHEDULE
5 YEAR YEAR DEC-31-1997 DEC-31-1998 JAN-01-1997 JAN-31-1998 DEC-31-1997 DEC-31-1998 2,918 5,480 5,460 6,248 3,549 3,983 (191) (162) 849 1,169 12,853 17,154 4,557 4,525 (2,764) (2,956) 14,714 18,808 5,682 6,401 0 0 0 0 0 0 29,644 41,133 (20,701) (28,790) 14,714 18,808 10,457 9,034 13,134 11,684 5,188 4,953 6,284 6,010 14,760 14,686 (37) (29) 39 92 (7,910) (9,012) 34 13 (7,512) (8,471) 0 0 0 0 0 0 (7,512) (8,471) (1.03) (.86) (1.03) (.86)
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