UNITED STATES SECURITIES AND EXCHANGE COMMISSION
FORM 10-K
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(Mark One)
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ANNUAL REPORT PURSUANT TO SECTION 13 OR
15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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| For the fiscal year ended September 30, 2003 | ||
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TRANSITION REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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Commission File Number: 000-49867
CTI Molecular Imaging, Inc.
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Delaware
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62-1377363 | |
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(State of Incorporation)
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(I.R.S. Employer Identification No.) | |
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810 Innovation Drive, Knoxville,
Tennessee
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37932 | |
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(Address of Principal Executive
Offices)
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(Zip Code) |
Registrants Telephone Number, Including Area Code: (865) 218-2000
Securities registered pursuant to Section 12(b) of the Act: None
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, $0.01 par value
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrants knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this form 10-K. þ
Indicate by check mark whether the registrant is an accelerated filer (as defined in Exchange Act Rule 12b-2). Yes þ No þ
The aggregate market value of common stock held by non-affiliates of the registrant was $468,191,923 as of March 31, 2003, based upon the last sale price of such stock as reported on the Nasdaq National Market on that day (assuming for purposes of this calculation, without conceding, that all executive officers and directors are affiliates).
There were 45,164,233 shares of common stock outstanding at December 1, 2003.
DOCUMENTS INCORPORATED BY REFERENCE
Parts of the registrants proxy statement for its 2004 Annual Meeting of Stockholders are incorporated by reference in Part III of this Form 10-K.
CTI MOLECULAR IMAGING, INC.
TABLE OF CONTENTS
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| CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS | 1 | |||||
| PART I | ||||||
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Item 1.
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Business | 2 | ||||
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Item 2.
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Properties | 28 | ||||
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Item 3.
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Legal Proceedings | 28 | ||||
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Item 4.
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Submission of Matters to a Vote of Security Holders | 29 | ||||
| PART II | ||||||
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Item 5.
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Market for Registrants Common Equity and Related Stockholder Matters | 29 | ||||
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Item 6.
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Selected Financial Data | 31 | ||||
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Item 7.
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Managements Discussion and Analysis of Financial Condition and Results of Operations | 31 | ||||
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Item 7A.
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Quantitative and Qualitative Disclosures About Market Risk | 65 | ||||
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Item 8.
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Financial Statements and Supplementary Data | 66 | ||||
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Item 9.
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Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 66 | ||||
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Item 9A.
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Controls and Procedures | 66 | ||||
| PART III | ||||||
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Item 10.
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Directors and Executive Officers of the Registrant | 66 | ||||
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Item 11.
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Executive Compensation | 66 | ||||
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Item 12.
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Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 66 | ||||
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Item 13.
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Certain Relationships and Related Transactions | 66 | ||||
| PART IV | ||||||
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Item 14.
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Exhibits, Consolidated Financial Statement Schedules, and Reports on Form 8-K | 67 | ||||
| SIGNATURES | 68 | |||||
CAUTIONARY NOTICE REGARDING FORWARD-LOOKING STATEMENTS
This report contains forward-looking statements. Forward-looking statements relate to expectations, beliefs, future plans and strategies, anticipated events or trends and similar expressions concerning matters that are not historical facts or that necessarily depend upon future events. In some cases, you can identify forward-looking statements by terms such as may, will, should, could, would, expect, plan, anticipate, believe, estimate, project, predict, potential, and similar expressions. Specifically, this report contains, among others, forward-looking statements about:
| | our expectations regarding financial condition or results of operations for periods after September 30, 2003; | |
| | our critical accounting policies; | |
| | the timing of the exercisability of the Siemens option to purchase an additional ownership interest in CTI PET Systems and the effect of the Siemens option, or its exercise, on our business; | |
| | our expectations regarding the size and growth of the market for our products and services and the market acceptance of CTIs products and services; | |
| | our business strategies and our ability to grow our business; | |
| | competition, pricing, the seasonality of capital equipment sales, the timing of orders from and shipments to distribution partners and customers, and the availability of financing services for customers; | |
| | our ability to enhance existing, or develop new, products and services and the impact of any such enhancements or developments; | |
| | the development and timing of new applications for PET and the impact of any such new applications; | |
| | the implementation or interpretation of current or future regulations and legislation; | |
| | the number and scope of procedures involving our products and services for which third-party reimbursement is available, and the reimbursement levels of third-party payors; | |
| | our ability to maintain contracts and relationships with key suppliers, customers, distributors or research and development collaboration partners; | |
| | our ability to maintain our existing, or to develop additional, valuable intellectual property rights; and | |
| | our future sources of and needs for liquidity and capital resources. |
The forward-looking statements contained in this report reflect our current views about future events, are based on assumptions and are subject to known and unknown risks and uncertainties. Many important factors could cause actual results or achievements to differ materially from any future results or achievements expressed in or implied by our forward-looking statements. Many of the factors that will determine future events or achievements are beyond our ability to control or predict. Important factors that could cause actual results or achievements to differ materially from the results or achievements reflected in our forward-looking statements include, among other things, the factors discussed in Part II, Item 7 of this report under the sub-heading Risk Factors.
You should read this report, the information incorporated by reference into this report and the documents filed as exhibits to this report completely and with the understanding that our actual future results or achievements may be materially different from what we expect or anticipate.
The forward-looking statements contained in this report reflect our views and assumptions only as of the date this report is signed. Except as required by law, we assume no responsibility for updating any forward-looking statements.
We qualify all of our forward-looking statements by these cautionary statements. In addition, with respect to all of our forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
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PART I
For convenience in this annual report, CTI, we, us, and the Company refer to CTI Molecular Imaging, Inc. and our consolidated subsidiaries, taken as a whole.
| Item 1. | Business |
Overview
We are a leading manufacturer of positron emission tomography imaging equipment and related products used in the detection and treatment of cancer, cardiac disease and neurological disorders. Positron emission tomography, or PET, is a medical imaging technology that images the biology of disorders at the molecular level before anatomical changes are visible. This allows physicians to diagnose and treat a broad range of diseases earlier and more accurately than other imaging technologies that focus on anatomic abnormalities. We provide the most complete and integrated product line for PET, including scanners, cyclotrons, radiopharmaceuticals, detector materials and support services. Our business model emphasizes our exclusive focus on PET, our ability to provide a total solution for our customers, our proprietary technology rights and our proven track record of technological innovation.
PET scans allow physicians to view metabolic activity on a non-invasive basis using minute quantities of injected radioactive molecules. Procedures conducted with PET technology provide information that is not available from traditional imaging technologies such as X-ray, computed tomography (CT), ultrasound and magnetic resonance imaging (MRI), where changes in body structure or anatomy must occur before an abnormality can be detected. Unlike X-ray, CT, ultrasound and MRI, PET evaluates biological and biochemical processes that precede anatomical changes or lesions from disease, thereby enabling earlier detection of diseases such as cancer and neurological disorders. PET also offers advantages in the treatment of disease due to its ability to monitor the effects of therapy at the molecular level. Our combined PET/CT scanner, which we introduced commercially in November 2001, was selected by TIME Magazine as the medical science Invention of the Year in 2000. This scanner combines PET and CT technologies into one device that reveals both metabolic processes and anatomical details within the body to improve image quality and localization of abnormalities as well as to guide biopsies, radiation therapy and surgical treatments.
The market for PET products and services has recently experienced rapid growth, and we believe it will continue to grow rapidly, for the following reasons:
| | the increasing number of PET procedures for which Medicare and private insurance reimbursement is available; | |
| | increasing recognition by physicians of the clinical advantages of PET and an increasing number of PET providers; | |
| | the expansion of PET applications beyond the diagnosis of disease and into the monitoring of disease therapy; | |
| | the discovery of additional clinical applications for PET; | |
| | the aging of the population and the growing number of patients with cancer, cardiac disease, neurological disorders and other diseases for which PET scans are performed; | |
| | technological innovations involving PET that shorten scan times and improve imaging capabilities, such as the current generation of LSO-based scanners and the combined PET/CT scanner; and | |
| | the increasing availability of the radiopharmaceuticals used in PET, as well as the development of new radiopharmaceuticals that extend PET technology to new applications. |
We believe we are well positioned to benefit from the anticipated growth in the PET market due to our total solution approach of offering health care providers a comprehensive line of the products and services necessary to incorporate the benefits of PET into their clinical settings. We manufacture and
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Industry Background
| The Science of PET |
The basis of PET imaging is the labeling of small, biologically important molecules, such as glucose, amino acids, pharmaceuticals or even water, with positron-emitting radionuclides that are injected into patients. These injected materials are referred to as radiopharmaceuticals. The radionuclides undergo radioactive decay, whereby their nuclei emit positrons that travel a very short distance in tissue before colliding with electrons, converting their total mass into detectable forms of energy. In the modern PET scanner, thousands of small detectors are oriented in a ring configuration surrounding the patients body. Computer reconstruction of the data acquired by these detectors permits a visual depiction of a metabolic process within cells of the organ systems of the body.
In common applications relating to cancer, a few milliliters of a water-based solution containing a minute amount of sugar tagged with the radionuclide fluorine-18, known as F-18-fluorodeoxyglucose, or FDG, is injected into a patient. FDG is delivered throughout the body via the blood stream, and like natural sugar in the blood, FDG is taken into normal cells of organs as well as cancerous cells. Because many types of cancer cells use sugar and grow faster than normal cells, they consume FDG at a much higher rate than normal cells. The PET scanner produces an image of the consumption of FDG in cells of the organs and tissues throughout the body. Like many diseases, cancer is a metabolic abnormality. PETs ability to image the metabolic process enables an earlier and more accurate diagnosis of the disease and monitoring of the effectiveness of therapy.
Other promising applications for PET include cardiac disease and neurological disorders. In cardiology, PET images can be used to assess coronary artery disease (CAD) and left ventricular dysfunction. Physicians can use PET images to determine the presence and extent of heart disease and to assist in determining whether invasive procedures are necessary and will benefit the patient. In addition to examining blood flow to the heart, PET is used for patients with heart disease to determine whether cells of the heart are dead or alive. The use of PET prior to angioplasty and bypass surgery to assess the viability of heart tissue and the likelihood of a successful outcome could have significant cost advantages to payors by eliminating expensive, unnecessary revascularization procedures. PET has been useful scientifically with respect to neurological disorders such as Alzheimers disease, Parkinsons disease, and epilepsy.
The effective use of a PET scanner depends on a readily available supply of radiopharmaceuticals, which are very short lived, making local availability essential. Most clinically important radiopharmaceuticals are produced using a sophisticated piece of electronic equipment called a cyclotron, which requires specially trained technicians and a licensed special purpose facility. Historically, institutions performing PET scans required an on-site cyclotron to produce radiopharmaceuticals on demand. PET customers now have an alternative to installing and operating cyclotrons on-site by obtaining local distribution of radiopharmaceuticals from specialized pharmacy providers. We expect the market for radiopharmaceuticals to grow as the adoption and utilization of PET continues to grow and as new and more effective radiopharmaceuticals are developed for additional applications of PET technology.
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The most common medical imaging technologies in the U.S. today are X-ray, CT and MRI. These imaging technologies have several advantages over PET, namely they represent the current standard of patient care, provide clear anatomical images, generally are reimbursed, are fast (in the case of X-ray and CT) and todays radiologists are very competent in reading these types of images. In comparison to CT and MRI, PET has some disadvantages including the lack of exact anatomical images to help pinpoint the location of disease, the poor sensitivity of FDG in certain cancers such as prostate cancer, the lack of reimbursement for several types of cancer, and the steep physician learning curve associated with PET. However, we do not believe that PET and MRI compete with one another as MRI is primarily used for diagnosing musco-skeletal injuries. Furthermore, we believe that PET and CT are complementary, as evidenced by the development of the combined PET/CT scanner.
PET is fundamentally different from X-rays, MRI, ultrasound and CT technologies. With X-rays, CT, ultrasound and MRI, an abnormality must manifest itself as a change in body structure or anatomy, such as the development of a sizeable tumor, before it can be detected. PET, on the other hand, can, in many cases, identify diseases earlier and more specifically than X-rays, CT, ultrasound or MRI by detecting abnormalities in cellular activity that precede anatomical changes. In addition, unlike other imaging technologies, which merely confirm the presence of a mass, PET often enables physicians to distinguish between benign and malignant disorders or between living and dead tissue. PET can also be more effective in monitoring the treatment of disease. For example, treating cancer with chemotherapy leads to changes in cellular activity, including a decline in the consumption of sugar and FDG, that are observable by PET long before structural changes can be measured by X-rays, CT, MRI or ultrasound. Accordingly, PET can enable a physician to evaluate the efficacy of a prescribed treatment regimen, perhaps leading to a modification in treatment, before such an evaluation could be made using X-rays, CT, MRI or ultrasound.
| The Growth of PET |
Sales of PET imaging equipment and related products and services have grown rapidly and are expected to continue to grow rapidly. Based on 2001 and 2003 market analyses prepared by Frost & Sullivan, a marketing consulting firm, the estimated installed base of PET scanners in the U.S. grew from 107 in 1997 to 849 in 2002, and the estimated number of units shipped annually in the U.S. grew from 12 in 1997 to 299 in 2002. The Frost & Sullivan analysis forecasts that from 2002 through 2009 the U.S. installed base of PET scanners will grow at an estimated compound annual growth rate of 27.4%, and the number of units shipped in the U.S. will grow at an estimated compound annual growth rate of 19.0%.
One of the principal reasons for growth in the PET market is the increasing number of PET applications being approved for reimbursement by third-party payors, such as Medicare, national and local private insurers and HMOs. Reimbursement is critical to increasing the adoption rate of PET by clinicians. Through active educational efforts, industry participants and associations, such as the Academy for Molecular Imaging, the Society of Nuclear Medicine and the Radiological Society of North America as well as the National Institutes of Health, have been successful in increasing the awareness of PETs benefits to patients, physicians and members of the payor community and in increasing the number of PET applications for which reimbursement is available. On July 1, 2001, the Centers for Medicare and Medicaid Services (CMS), which administers Medicare and Medicaid, expanded its policy to cover PET scanning in six oncology applications, two cardiac applications and one neurological application. Effective October 1, 2002, CMS expanded coverage for breast cancer and heart disease. Most recently, on April 16, 2003, and effective as of October 1, 2003, CMS announced expansion of Medicare coverage for PET to include thyroid cancer and patients with potential cardiac disease.
The following table summarizes the PET applications that have been approved for reimbursement by CMS. As used in the following table, the term staging generally refers to the use of PET in the initial diagnosis process to verify the existence and status of the disease. The term restaging generally refers to
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| Effective Date | Clinical Condition | Coverage | ||
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March 14, 1995
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Perfusion of the heart (Rubidium 82 tracer) | Non-invasive imaging of the perfusion of the heart | ||
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January 1, 1998
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Lung cancer (non-small cell) | Initial staging | ||
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January 1, 1998
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Solitary pulmonary nodules (SPNs) | Characterization | ||
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July 1, 1999
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Colorectal cancer | Determining location of tumors if rising carcinoembryonic antigen (CEA) level suggests Recurrence | ||
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July 1, 1999
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Lymphoma | Staging and restaging only when used as an alternative to gallium scan | ||
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July 1, 1999
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Melanoma | Evaluating recurrence prior to surgery as an alternative to a gallium scan | ||
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July 1, 2001
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Colorectal cancer | Diagnosis, staging and restaging | ||
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July 1, 2001
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Esophageal cancer | Diagnosis, staging and restaging | ||
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July 1, 2001
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Head and neck cancers (excluding central nervous system and thyroid) | Diagnosis, staging and restaging | ||
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July 1, 2001
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Lung cancer (non-small cell) | Diagnosis, staging and restaging | ||
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July 1, 2001
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Lymphoma | Diagnosis, staging and restaging | ||
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July 1, 2001
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Melanoma | Diagnosis, staging and restaging; not covered for evaluating regional nodes | ||
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July 1, 2001
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Myocardial viability | Covered only following inconclusive single photon emission computed tomography (SPECT) | ||
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July 1, 2001
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Refractory seizures | Pre-surgical evaluation | ||
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October 1, 2002
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Myocardial viability | Primary evaluation or initial study to determine myocardial Viability prior to Revascularization | ||
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October 1, 2002
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Breast cancer | Staging for metastasis/restaging for regional and/or distant metastasis and monitoring response to therapy | ||
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October 1, 2003
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Thyroid cancer | Restaging of recurrent or residual thyroid cancers of follicular cell origin that have been previously treated by thyroidectomy and radioiodine ablation and have a serum thyroglobulin> 10 ng/ml and negative I-131 whole body scan performed | ||
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October 1, 2003
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Perfusion of the heart | Noninvasive imaging of the perfusion of the heart or using ammonia N-13 (non-FDG) tracer. |
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Source: Section 50-36 of the CMS Coverage Manual and CMS Decision Memoranda #CAG-00094A and #CAG-00098N
As the foregoing table suggests, the majority of PET scans today are performed for oncology procedures. According to the U.S. Centers for Disease Control, cancer is the second leading cause of death in the U.S., with one in four deaths in the U.S. related to cancer. Incidence of cancer increases with age. The number of Americans age 45-64 who will reach 65 over the next two decades increased by 34% during the past decade. We believe the utilization of PET in the oncology market will continue to grow due to the aging of the population, a corresponding increase in the number of patients with cancer and discoveries involving the use of PET in additional oncology applications as well as the expansion of reimbursement to additional cancer indications.
We also expect new innovations involving PET. Research and development activities in the industry are focused on decreasing scan times, thereby increasing patient throughput capacity and improving patient comfort and image quality. For example, by using detectors made from lutetium oxyorthosilicate, or LSO, rather than the traditional detector material, bismuth germanate, or BGO, scan times for certain routine procedures have decreased from approximately thirty minutes to approximately ten minutes. Other research and development activities focused on improving image quality resulted in the commercial introduction of a combined PET/CT scanner. The combination of PET and CT technologies in a single scanner results in better diagnostic and therapy monitoring capability than either technology alone and allows physicians to identify the location of biologic abnormality with more precision. By pinpointing the location of malignant tumors and providing clearer images, we believe the combined PET/CT has the potential to revolutionize both the practice and business of cancer treatment by, for example, facilitating concurrent tumor ablation or resection.
We also believe that research and development activities focused on the development of new radiopharmaceuticals may allow PET scanners to detect and monitor additional diseases which, in turn, could increase the number of recognized indications for PET.
Business Strategy
Our business focuses on enabling diagnosis and therapy management for cancer, cardiac disease and neurological disorders using molecular imaging technology. Our overall goal is to expand and integrate PET into standard clinical practice by delivering innovative total solutions that support adoption and use of PET technology. We intend to enhance our position as the leading provider of integrated PET products and services in order to capitalize on the rapidly growing molecular imaging market. To achieve this objective, we intend to pursue the following strategies:
Increase Overall Utilization of PET Technology. We intend to stimulate increased utilization of PET procedures by:
| | supporting efforts to increase the number and scope of PET procedures that are approved for reimbursement; | |
| | educating physicians, patients, pharmaceutical companies and payors regarding the clinical advantages of PET; | |
| | expanding the utilization of our PET scanners beyond diagnosis to a broader management of the treatment of disease; and | |
| | developing new applications for PET technology by developing new radiopharmaceuticals, by supporting clinical trials that involve PET and by collaborating with pharmaceutical companies. |
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Continue Offering Customers a Comprehensive Line of Integrated PET Products and Services. We intend to emphasize our total solutions approach by offering a broad range of integrated products and services that complement our sophisticated PET imaging equipment in order to:
| | better compete with larger imaging equipment companies that have a captive finance company and a broader imaging product line but lack the full array of PET products and services a customer needs to operate a PET imaging business; | |
| | offer products and services that are comprehensive yet individually tailored to meet the differing needs of a variety of customers in a variety of clinical settings; | |
| | facilitate entry into the PET imaging business by offering new providers an integrated total solution of all products and services necessary to incorporate the benefits of PET into a clinical setting; and | |
| | capture a greater share of PET-related expenditures as the market for PET imaging products and services continues to grow. |
Expand Our Direct Sales Force and Distribution Network. In order to capture a large portion of the anticipated growth in demand for PET scanners, we intend to enhance our sales and distribution capacity by:
| | expanding our direct sales force, including the addition of CTI sales representatives in major U.S. metropolitan markets and adding a direct sales force and distributors in key international markets; and | |
| | pursuing a multiple distributor strategy for our PET scanner products through CPS. |
Continue to Build Our Production and Distribution Network for Radiopharmaceuticals. We intend to further expand our existing PETNET network of radiopharmaceutical production and distribution facilities in order to:
| | seize first mover advantage by being the first PET radiopharmacy in targeted markets and leveraging our access to lower cost, self-manufactured cyclotrons; | |
| | continue to grow our recurring revenue streams; and | |
| | extend the reach of the PETNET radiopharmacy network and leverage this greater scale to achieve operating efficiencies and improve delivery time and quality of service. |
Maintain Our Technological Leadership Through Focused Research and Development. We have been a leading innovator of PET technology, and through CPS are dedicated to the continued development of PET scanners in order to:
| | take advantage of our exclusive right to use LSO in molecular imaging products to advance the state-of-the-art in PET scanners; | |
| | improve image quality for better diagnosis and treatment of patients; | |
| | shorten scan times for increased patient comfort and throughput capacity; and | |
| | expand clinical applications of PET technology; and | |
| | lead the application of PET in brain research and clinical development. |
Develop New Proprietary Radiopharmaceuticals. We intend to focus significant research and development efforts on our radiopharmaceuticals business, including efforts to:
| | develop new varieties of radiopharmaceuticals to be used as biomarkers to characterize the varied pathways of diseases and extend the use of PET imaging to additional diseases; | |
| | collaborate with leading pharmaceutical companies and academic institutions to, among other things, improve their process for conducting research and clinical trials; and |
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| | explore new therapeutic applications for PET. |
Our Products and Services
Our products and services can be broadly classified into four principal categories:
| | PET and PET/CT scanners; | |
| | detector material products; | |
| | radiopharmaceuticals; and | |
| | other PET products and services. |
| PET and PET/CT Scanners |
Our subsidiary, CPS, manages the development, manufacturing, distribution and sale of the ECAT® line of PET scanners. This line of scanners consists of stand-alone PET scanners and the combined PET/CT scanner. The scanner system consists of a scanner frame known as the gantry, a patient bed, an acquisition computer and a high-speed operators workstation. The ECAT® scanner line performs simultaneous acquisition, image reconstruction, processing, and data analysis, which enhances patient throughput and generates prompt results. The scanners produced by CPS range in price from $800,000 to $2.4 million and offer customers a range of throughput times, resolution and image quality. With the variety in pricing and function, we are able to meet the needs of small and mid-sized imaging centers, as well as larger facilities that require more extensive equipment for clinical research purposes. For a discussion of segment financial information, see Segments in note 13 of the notes to our consolidated financial statements appearing elsewhere in this annual report.
| Detector Material Products |
We are the only manufacturer of lutetium oxyorthosilicate, or LSO, as a detector material for use in our PET scanners. LSO is a lutetium based scintillator material the chemical compound of which was patented by Schlumberger Technology Corporation. By using LSO as a detector material in our products, our scanners provide improved performance and diagnostic accuracy by decreasing patient scan times and increasing image quality. We have exclusive rights to the development and manufacturing of LSO as a detector material. We acquired these exclusive rights from Schlumberger in February 1995. The exclusive rights terminate upon the expiration of Schlumbergers patents for LSO, which are currently scheduled to expire in October 2008. While LSO is the only lutetium based scintillator material currently used in the PET industry, it may be possible for others to produce a lutetium based detector that does not contain LSO without violating the Schlumberger patent and, therefore, our exclusive license. Previously we manufactured bismuth germanate, or BGO, a detector material, which is still used in competitive scanners.
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The following table highlights the benefits of LSO versus BGO as a detector material in PET scanners:
| LSO | ||||||
| Feature | LSO | BGO | Advantage | |||
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Scan Time
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| The shorter the decay constant for the detector material, the shorter the patient scan time | Decay constant of 40 nanoseconds, or more than seven times faster than BGO. | Decay constant of 300 nanoseconds. | LSO-based scanners generally exhibit a shorter patient scan time than BGO-based scanners. This shorter scan time increases the number of patient scans that can be performed each day, thereby reducing the likelihood of image distortion due to patient movement. | |||
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Image Quality
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| Detector materials that provide a higher light output allow for higher image resolution and higher sensitivity | LSO has a light output of 75 on a scale of 100, or five times greater light output than BGO. | BGO has a light output of 15 on a scale of 100. | The increased light output results in higher image resolution for LSO-based scanners and allows the detection of smaller lesions. | |||
| Proprietary Technology | We have an exclusive license to use LSO in the molecular imaging market. | We do not have an exclusive right to use BGO and it is commonly used by our competitors. | We believe the combination of our exclusive license to use LSO and the performance benefits of LSO provide us with a significant competitive advantage. | |||
| Radiopharmaceuticals |
Through our PETNET subsidiary, we currently operate 39 radiopharmaceutical production and distribution centers, referred to as PETNET radiopharmacies, located in major metropolitan areas across the U.S. and one radiopharmaceutical production and distribution center in the United Kingdom. Of our 40 radiopharmacies, we operate 13 cyclotrons owned by others, or hosts, pursuant to contracts. Our PETNET radiopharmacies principally produce and distribute FDG, which is used in oncology, cardiology and neurology applications, but these radiopharmacies can also manufacture and distribute research radiopharmaceuticals. Our PETNET radiopharmacies allow customers to obtain a cost effective source of radiopharmaceuticals without having to purchase and operate their own cyclotron. In addition, our nationwide network of distribution centers provides our customers with assurance that their radiopharmaceutical requirements will be satisfied in a timely manner that reduces scanner downtime and facilitates patient scheduling. We also provide various PET-related services through PETNET, including reimbursement education, radiation safety consulting, licensure assistance and marketing assistance. We believe that the demand for radiopharmaceuticals will expand with the future growth of the PET market and the growing demand for PET services. To meet this demand, we expect to continue the expansion of our PETNET network.
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| Other PET Products and Services |
Cyclotron Systems. We produce cyclotrons for the production of radiopharmaceuticals at our PETNET radiopharmacies and for sale to hospitals and imaging centers that choose to manufacture radiopharmaceuticals for themselves. Our cyclotrons provide a cost-effective, easy-to-operate, self-shielded, and automated system that produces positron-emitting radionuclides and compounds used in making radiopharmaceuticals such as FDG. We developed these systems to improve efficiency and lower cost while maintaining high levels of performance, improved production capacity, automated operation, and a complete line of automated chemistry modules. Our cyclotrons combine high beam quality and shielding with efficiencies in space requirements, building modifications and operating costs. In 2001, we introduced a new high performance cyclotron with 100% more production capacity than our previous model, while maintaining its cost-effective, self-shielded design. Currently, we offer three cyclotron models: the ECLIPSE ST, which is designed for hospital use, ECLIPSE RD, which is configured for research use, and the ECLIPSE HP, which is built for high-yield commercial use. Each of our cyclotron systems can be upgraded to meet the needs of our customers as their business develops.
Reveal Network Solutions. We have introduced an Internet-based product called Reveal Network Solutions to connect physicians, PETNET radiopharmacies and patients to PET providers. Reveal Network Solutions will facilitate the sharing of relevant information among users, thereby improving efficiency by automating some aspects of the PET process. Reveal Network Solutions can be used to schedule imaging procedures and to obtain information regarding reimbursement. We expect this network to increase the efficiency of our PETNET radiopharmacies by allowing PET facilities or hospitals to order radiopharmaceuticals on line as opposed to ordering by facsimile or phone. Further, Reveal Network Solutions will provide us with an on-line method to educate physicians regarding the clinical advantages of PET.
Mirada Workstations. Through our subsidiary, Mirada Solutions Limited, we produce Mirada workstations with Reveal-MVS. Reveal-MVS is software designed to improve the patient care delivered by our customers with innovative, unique and productive tools for the creation, display and analysis of molecular images.
Concorde MicroPET. We have, through PETNET, an exclusive, royalty-free license agreement to distribute products of Concorde Microsystems, Inc., a related party, within certain territories, including high-resolution animal PET tomography scanners (MicroPET). MicroPET provides researchers in the biomedical sciences with a compact and very high performance PET system that can be used non-invasively to image a wide range of small animals in a routine laboratory setting. PETNET is responsible for sales, marketing and education activities, while Concorde is responsible for all product warranty, installation, training, service and technical support.
Additional Products and Services. Establishing, operating and maintaining a facility to conduct molecular imaging procedures requires more than purchasing a molecular imaging scanner. Our customers face challenges ranging from designing their facility to educating referring physicians and imaging technologists in the operation of the scanner. Our extensive experience in the molecular imaging industry allows us to help our customers through this process by offering a broad range of services. These include:
| Repair and Maintenance Services. We offer our customers the opportunity to enter into long term service contracts with us pursuant to which we agree to provide repair and maintenance services, including scheduled preventive maintenance, troubleshooting and problem diagnosis, service and repair procedures and replacement parts installation. Approximately 150 PET scanners are under contract for repair and maintenance services at an average price of $119,000 per year. Equipment maintenance service contracts are recognized ratably over the respective contract periods as the services are performed. | |
| Site Planning and Installation Services. Prior to installing a PET scanner, we assist our customers with the development of their sites by providing pre-installation site inspections, consultation with facility architects, construction management services, system requirement and |
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| specification development and development of site planning documentation. Once a site is completed, we will then provide installation services including transporting the system to the facility, connecting all subsystems, completing the system start-up and safety check and conducting the initial performance testing. | |
| Radioactive Materials Licensing. A radioactive materials license is required to operate a molecular imaging center. Gathering the forms and information needed for the license application is a lengthy and cumbersome process. We work with our customers to collect the necessary information and then prepare the license application for submission. Once submitted, we track the progress of the application until it is received from the applicable state agency. | |
| Technologist Recruiting and Training. The day-to-day responsibilities for operating a molecular imaging scanner and interacting with patients are generally handled by a molecular imaging technologist. As a result of our extensive contacts in the molecular imaging industry, we have the capability to help our customers recruit and hire these technologists. Once hired, we can also provide them with additional training. | |
| Physician Training. We have a preceptorship program in operation at several facilities to train physicians in the details of PET imaging. We arrange for the physician to attend these courses. This training allows the physician to gain hands-on experience in an operational molecular imaging facility. The preceptorships typically last five days and include continuing medical education credits. | |
| Telephone Support. We also provide our customers access to a telephone support, or help desk, hotline where we have service personnel standing by to assist our customers with questions related the operation of our products. This hotline can also be used to order spare parts and request emergency on site assistance. | |
| Calibration Sources. Through our subsidiary, CTI Services, Inc., we produce the radioactive sources used to calibrate our ECAT® scanners. All dedicated PET scanners require transmission sources as well as calibration sources. These sources are used by CPS to evaluate newly manufactured scanners and we also sell replacement sources to the end users, generally through the scanner distributors. |
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Research & Development
Our founders and directors are recognized leaders in the development of PET technology. For example, our President and Chief Executive Officer and director, Ronald Nutt, Ph.D., has been credited with co-developing the combined PET/CT and our director, Michael Phelps, Ph.D., one of the original inventors of the PET scanner, is a leading academic figure in PET. As a result of their leadership, we have been responsible for the development of many of the major commercial innovations in PET since our formation in 1983. The following table highlights some of these innovations:
| Date | Innovation | |
|
1985
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Invented the block detector which assisted in the commercial introduction of PET by lowering the cost and increasing the performance of PET equipment | |
|
1990
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Developed the first three dimensional high resolution PET that images human organs in a single frame | |
|
1992
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First to develop whole body imaging capability | |
|
1995
|
Developed the first whole body three dimensional PET scanner for cancer | |
|
1997
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Commercially introduced the RDS 111 cyclotron which incorporated proprietary technology that lowered the cost, target volumes and power requirements for our cyclotrons and provided electronic automated preparation of radiopharmaceuticals | |
|
1998
|
Developed the first 2mm multi-slice brain scanner for research | |
|
1998
|
Invented the combined PET/CT and demonstrated the first clinical image using a PET/CT | |
|
2001
|
Introduced LSO scanners on a commercial basis | |
|
2003
|
Introduced high resolution (Hi-Rez) PET/CT |
Our research and development team focuses on developing the next generation of PET scanners, cyclotrons and radiopharmaceuticals. In addition to our internal ideas, our research and development department collaborates with a network of leading physicians, academic imaging experts and, in the case of CPS, with Siemens. We actively involve scientists and physicians during the research and development process in order to produce products that are truly customer driven and customer focused. We incurred $31.3 million in 2003, $21.7 million in 2002 and $19.0 million in 2001 in research and development expenses, including clinical and regulatory expenses.
In order to enhance our research capabilities, we have also entered into collaboration arrangements with a number of universities and research institutions. For example, in 1994 we entered into a collaboration agreement with UCLA for the development of new molecular imaging technology. This relationship has led to a number of breakthrough developments in molecular imaging, from imaging the expression of genes to the development of new experimental radiopharmaceuticals. For example, our image of Alzheimers-related plaques using a new radiopharmaceutical was selected as the image of the year in 2001 by the Society of Nuclear Medicine. CPS also worked with Dr. David Townsend at the University of Geneva, who was named the Distinguished Clinical Scientist of the Year for 2004 by the Academy of Molecular Imaging, to develop the PET/CT, which was recognized by TIME Magazine as the medical science Invention of the Year in 2000. Further, CPS worked with the Max Planck Institute in Germany to develop the first large field of view clinical scanner in 1990 and, more recently, a 2mm brain scanner used for neurological research. These collaboration arrangements have increased our access to world-class physicians and scientists and have given us a platform to expand our name recognition in the scientific and medical communities and to increase understanding among physicians of the benefits of PET.
Our role as a leader in the area of research and development is exemplified by the academic and research institutions that use our products. Today, our products are used by many of the leading medical
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Products Under Development
CPS develops dedicated PET scanners that use our advanced LSO-based detector materials. These scanners provide substantially higher patient throughput while providing improved image quality and upgradeable performance. CPS also develops PET/CT scanners that incorporate advanced LSO-based detector systems. Future PET/CT scanners are expected to better integrate PET and CT technologies and are anticipated to substantially decrease body scan time to be consistent with the scan times of a CT while improving image quality.
We are also expending significant resources in the development of the next generation of commercially available radiopharmaceuticals. Through this development process, we hope to expand the number of PET indications by, among other things, creating new proprietary radiopharmaceuticals that will allow PET to diagnose and manage an increasing number of diseases and to produce a closer alignment between molecular imaging of disease with PET radiopharmaceuticals and the treatment of disease with pharmaceuticals. Currently, we are working on the development of new radiopharmaceuticals to enhance the ability of PET to detect disorders such as inflammation, breast cancer, prostate cancer, Parkinsons disease and Alzheimers disease.
In order to further enhance our role as a leader in developing new PET technology and radiopharmaceuticals, PETNET has established a collaborative research and development facility with the UCLA School of Medicine. We refer to this facility as the LA Tech Center. One of the goals of the LA Tech Centers research is to establish new biomarkers that will eventually allow medical personnel to probe the various pathways of disease, using methods similar to those used today by in vitro laboratory techniques. Another primary goal of the LA Tech Center is to expand the use of PET technology to accelerate the drug development process. We believe PET has a number of advantages over other imaging modalities that will allow pharmaceutical companies to use PET to more quickly identify whether their developmental drugs are reaching their intended targets and achieving the desired therapeutic results. We anticipate that the use of PET by pharmaceutical companies could help to improve their success rate in clinical trials and speed up the drug development process. In addition, by increasing the labeled pharmaceuticals available in the PET imaging modality, we expect the process will result in increasing the number of radiopharmaceuticals for use in PET imaging.
Our Relationship with Siemens
| Ownership of CPS |
In 1987 we entered into a joint venture agreement with Siemens Medical Solutions USA, Inc., a wholly owned subsidiary of Siemens AG, pursuant to which Siemens acquired 49.9% of the outstanding capital stock of our subsidiary, CPS. The cash consideration paid by Siemens for its 49.9% interest was paid directly to the individual shareholders of CPS. The amount of the consideration, and the determination of the ownership percentage acquired by Siemens, was negotiated at arms length between Siemens and the shareholders of CPS. Neither Siemens nor any of its affiliates has any ongoing financial obligations, commitments or guarantees with respect to CPS related to the formation or operation of the joint venture. We entered into the joint venture agreement in order to provide us with access to Siemens global distribution network and to include our scanners in its product line.
Put/Call Provision. The joint venture agreement contains, among other things, a put/call provision pursuant to which Siemens has the right to acquire from us for cash up to that number of shares of CPS common stock necessary to bring Siemens aggregate ownership interest in CPS to 80%. We refer to this as the call right. The call right becomes exercisable upon CPS exceeding certain PET scanner unit sales volumes, as described below. Upon an exercise by Siemens of the call right, we have a one-time right to
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The exercisability of the put/call right is contingent upon CPS selling, during the year preceding exercise, in excess of the cumulative total number of units specified in the Siemens minima plus 20% plan attached to the joint venture agreement. The Siemens minima plus 20% plan provides for annual increases in the cumulative total number of units sold by CPS beginning on December 9, 1987. As of September 30, 2003, the cumulative total number of units sold by CPS was 697 and CPS would need to have sold a cumulative total of 981 units to achieve the required cumulative sales level for the put/call right to be exercisable. The cumulative unit sales requirement increases by 74 units each year. It is impossible to definitively state when the put/call right will become exercisable by either party. However, based upon our current forecasts, we believe it is unlikely that the minimum sales volumes will be met in 2005. Assuming that sales volumes are met in 2005 and further assuming the exercise of the one-year deferral right, the sale of CPS is not expected to occur before 2006.
Upon exercise of either the put or the call, the joint venture agreement provides that the parties will attempt to negotiate the price to be paid for the CPS shares. In the event the parties are unable to agree upon the price within 60 days, the price will be determined through an appraisal process with each party obtaining a valuation of the CPS shares by an independent professional experienced in the valuation of closely held corporations similar to CPS. If the valuations that are obtained are within 20% of each other, the price to be paid for the CPS shares will be the average of the two valuations. If the difference between the valuations is more than 20%, the two appraisers will select another independent appraiser to provide a third valuation. In this case, the price to be paid for the CPS shares will be the average of the two valuations that are the closest to each other.
If the put/call right is exercised and Siemens aggregate ownership interest in CPS increases to 80%, Siemens will then be able to effect a merger of CPS with another Siemens-controlled entity and acquire the remaining 20% from us. Siemens will only be required to pay us either a negotiated price for the remaining 20% or, if we and Siemens are unable to agree, the fair value of the shares as determined in accordance with applicable provisions of the Tennessee Business Corporation Act. In the event Siemens acquires a controlling interest in CPS, CTI will no longer include CPS in its consolidated financial statements.
Use of Proceeds from Sale. If the put/call right is exercised, we will have broad discretion with respect to the use of the proceeds received from Siemens in connection with our sale of the shares of CPS. We anticipate that we will evaluate appropriate alternatives as we approach the cumulative totals. Possible uses of the proceeds include the repayment of debt, strategic acquisitions, investment in product development and repurchase of a portion of our outstanding shares.
Distributions. The joint venture agreement does not provide for any mandatory dividends or distributions by CPS to us or to Siemens. Since the formation of the joint venture, CPS has not paid any dividends or made any distributions on its capital stock. Payment of future dividends or distributions, if any, on the capital stock of CPS would be at the discretion of the CPS board of directors.
Non-Competition Agreement. The joint venture agreement contains covenants not to compete which will prohibit us from participating in or owning an interest in any business that develops, sells or manufactures products that compete with the products offered by CPS. This non-compete provision will remain in effect for a period of three years following the sale of our shares of CPS pursuant to the exercise of the put/call right. Siemens is subject to a substantially similar covenant not to compete, which will also remain in effect following the exercise of the put/call right.
Ownership of Intellectual Property and Other Assets. Following an exercise of the put/call right, Siemens will acquire control of CPS and will therefore control the rights to the patents and other intellectual property then held by CPS. These patents cover various electronics, detector technologies and
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LSO Supply Arrangements. During the term of an existing sublicense agreement between us and CPS, we are obligated to sell LSO-based products to CPS on terms more favorable than we sell such products to any other party. However, we are not restricted from selling LSO to a competitor of CPS. This sublicense automatically terminates upon the termination of our current LSO license, which expires in October 2008.
Governance of CPS and CTI. The joint venture agreement grants various rights to Siemens regarding the governance of CPS, including the right to:
| | designate two members of the five member board of directors of CPS (we also have the right to designate two members of the CPS board); | |
| | select the fifth director of CPS from a list of candidates that we submit to Siemens; and | |
| | nominate one individual to serve as either the chairman of the board of directors or the president of CPS with the appointment to the specific office to be at the discretion of the board. |
We have also agreed that for so long as we and Siemens each own more than 20% of the outstanding shares of CPS, our board of directors will nominate a representative of Siemens, chosen by Siemens, to serve as a member of our board of directors. Several of our stockholders, who collectively own an aggregate of 38.8% of the outstanding shares of our common stock, have agreed to vote in favor of the Siemens nominee. Currently, Bernd Haetzel is the nominee selected by Siemens to serve on our board of directors.
The joint venture agreement also contains provisions for the orderly and prompt resolution of disputes among the parties. In the fifteen years since the formation of the joint venture, the parties have only elected to avail themselves of the dispute resolution procedures twice. Most recently, the process was used to address a contract interpretation issue with respect to the implementation of the multiple distributor strategy. A favorable resolution was reached that has led to the expansion of our sales and marketing force for the distribution of products manufactured by CPS. Additionally, this process resulted in the signing of a number of new long-term contracts with Siemens and increased joint projects with Siemens on several new initiatives, including the development of more advanced PET/CT capabilities.
Intercompany Services between CPS and CTI. We have entered into an administrative services agreement with CPS pursuant to which we provide certain administrative services to CPS. Currently we provide CPS with human resources services, information technology services, facilities support and maintenance services, regulatory services and various other corporate services. We also allow employees of CPS to participate in our employee benefit programs, including our stock option plan.
| Distribution Agreements |
Siemens served as our exclusive distributor of ECAT® scanners from 1987 to 1997. From 1997 until 2001, Siemens and CPS served as the only distributors of ECAT® scanners. In 2001, CPS adopted a multiple distributor strategy in order to expand its distribution channels. In November 2001 we added Hitachi Medical Systems America, Inc. as a third-party distributor of CPS products and in October 2003 we added Toshiba Medical Systems Corporation as a third-party distributor of CPS products in Japan. As a result, we are now serving as a direct distributor of the products manufactured by CPS. Our distribution agreement with CPS grants us a non-exclusive worldwide right to distribute PET scanners manufactured by CPS. Pursuant to the terms of our distribution agreement, CPS has an obligation to sell scanners to us at a price that is no less favorable than the price offered by CPS to any of its other distributors based on
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As a result of our distribution agreement with CPS, following the exercise of the put/call right we will continue to have a right to distribute PET products manufactured by CPS through at least 2010. During the term of our distribution agreement, we will have access to new products developed by CPS on the same terms and conditions that CPS grants distribution rights to Siemens.
| Credit Facility |
Pursuant to the terms of our revolving credit facility with SunTrust Bank, CPS is allowed to borrow up to $55.0 million under the credit facility to finance its operations. At September 30, 2003, CPS had no outstanding balance under the credit facility. CPS pays its pro rata portion of all fees and commissions under this credit facility. Our subsidiaries guarantee all obligations under the credit facility, except that the guarantee by CPS is limited to $55.0 million and does not include any advances under the credit facility that are loaned (on an intercompany basis) to our PETNET subsidiary. The credit facility and the obligations of our subsidiary guarantors under the credit facility are secured by a lien on substantially all of our assets (including the capital stock or other forms of ownership interests we hold in our subsidiaries) and the assets of our subsidiary guarantors, except that the lien securing the guarantee of CPS is principally limited to the accounts receivable and inventory of CPS.
| Other Relationships |
In addition to the relationships previously discussed, we have entered into various other commercial arrangements with Siemens. For example, Siemens and CPS have an agreement pursuant to which Siemens supplies CPS with CT scanners for the purpose of manufacturing a combined PET/CT scanner. Siemens also provides us with replacement parts, training and other support for the CT scanners incorporated into the combined PET/CT systems. CPS also has a license to use Siemens syngo® software which is an important component of the operating system for the PET/CT.
Competition
The primary competitive factors in the PET equipment market are quality, technical capability, breadth of product line, distribution capabilities, price, the ability to offer vendor financing, and the ability to provide quality service and support. Our principal competition in the market for PET scanners comes from divisions or subsidiaries of much larger corporations such as GE Medical Systems and Philips Medical Systems. GE Medical Systems markets and sells a combined PET/CT, which is the main competitor to the PET/CT manufactured by CPS. We also compete with Siemens in connection with the sale and distribution of the PET scanners manufactured by CPS, as well as for service and support business. Our competitors also include academic institutions and other public and private research organizations that conduct research, seek patent protection and establish arrangements for commercializing products that compete with our products. We are a relatively modest-sized company compared to our primary competitors in the PET equipment market, GE Medical Systems and Philips Medical Systems. These two competitors have substantially greater access to capital and the ability to bundle PET sales with the sale of other medical devices in their respective product lines. However, they both have more limited PET product lines than CTI. Because we offer a comprehensive, integrated line of PET related products and services that complement our PET scanners, we believe we have some competitive advantages over these and other competitors with more limited PET product lines. We also believe that our position as a technological leader in the PET industry helps us to compete in the market for PET scanners.
We believe the primary competitive factors in the radiopharmaceutical market are national distribution capabilities, reliability of delivery, price, the ability to develop new radiopharmaceuticals and the ability to obtain proprietary rights to any newly developed radiopharmaceuticals and cyclotron technology. In the radiopharmaceutical market, we have three principal groups of competitors. The first
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In the cyclotron business, the primary competitive factors are distribution capabilities, effective shielding design, quality, production capacity and automated production capability. We believe our position as a leader in developing cyclotron technology combined with our integrated product line will help us to compete in the cyclotron market.
Sales and Marketing
Our sales and marketing efforts are focused on two primary segments of the PET market. The first segment includes hospitals, universities and other research institutions. The second segment includes customers such as freestanding imaging centers and cancer treatment centers, often owned by physicians and other entrepreneurs, who we believe are particularly well suited to benefit from our ability to offer a complete, integrated line of PET products and services. In order to effectively target each of these segments, CPS has a multiple distributor strategy for scanners. Through a distribution arrangement with Siemens, we are able to leverage Siemens large sales and marketing force to sell dedicated PET scanners and combined PET/CT scanners to hospitals and research institutions. As an additional direct distributor of ECAT® scanners sold as REVEAL scanners through CTI Services, CTI targets customers whom we believe would particularly benefit from our integrated line of PET products and services. As a direct distributor of CPS products, we have also entered into sub-distribution agreements in certain international markets in an effort to sell more ECAT® and (by CTI Services) REVEAL scanners abroad and in order to provide us access to new markets in which to sell our other PET products and services.
Our marketing and sales strategy emphasizes our complete and integrated line of PET related products and services, including PET scanners, radiopharmaceuticals, cyclotrons and services such as physician training and facility planning and design. Unlike many of our competitors who focus on limited aspects of the PET market, our sales and marketing team is able to present CTI as a single source for all PET related needs. In order to implement this strategy, which we call the total solutions approach, sales personnel from each of our business segments work together with prospective customers to develop a customized package of products and services.
Our success in assisting the Thompson Cancer Center, a Knoxville, Tennessee based cancer center, offers a good example of our total solutions approach. Through the combined efforts of a multi-disciplinary team, we designed and implemented a comprehensive, customized solution for the development and operation of the Thompson Cancer Centers new PET center. Our service organization assisted the center with the design and installation of the facility. Upon completion of the design and construction phase, the center acquired an ECAT® scanner manufactured by CPS and today PETNET provides the center with all of its PET related radiopharmaceutical requirements.
For fiscal years 2003, 2002 and 2001, our revenues from U.S. sales were $278.0 million, $197.7 million and $144.7 million, respectively. For fiscal years 2003, 2002 and 2001, our revenues from sales outside the U.S. were $84.3 million, $60.7 million and $44.2 million, respectively, and substantially all of our long-lived assets, were located in the U.S. Sales through Siemens represented approximately
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Firm backlog orders at September 30, 2003 and September 30, 2002 were $190.6 million and $112.2 million, respectively. A majority of this backlog is expected to be realized as revenues by the end of the 2004 fiscal year.
Customer Service and Support