UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO. 1 ON FORM 10-K/A (Mark One) [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED SEPTEMBER 30, 2002 or [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________to _________ Commission file number 000-14242 CELSION CORPORATION ------------------------------------------------------ (Exact Name of Registrant as Specified in Its Charter) DELAWARE 52-1256615 --------------------------------- ------------------------ State or Other Jurisdiction (I.R.S. Employer of Incorporation or Organization Identification No.) 10220-I OLD COLUMBIA ROAD COLUMBIA, MARYLAND 21046-1705 ---------------------------------------- ----------------------- (Address of Principal Executive Offices) (Zip Code) (410) 290-5390 ------------------------------------------------------------------- Registrant's telephone number, including area code ecurities registered pursuant to Section 12(b) of the Act: Name of Each Exchange Title of Each Class on Which Registered -------------------------------------- --------------------------- COMMON STOCK, PAR VALUE $.01 PER SHARE AMERICAN STOCK EXCHANGE -------------------------------------- --------------------------- Securities registered pursuant to Section 12(g) of the Act: Not Applicable ------------------------------------------------------------------------- Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [ ] Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of Registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K/A or any further amendment to this Form 10-K/A. [X] Indicate by check mark whether the registrant is an accelerated filer (as defined in Exchange Act Rule 12b-2). Yes [ ] No [X] As of December 26, 2002, 96,492,556 shares of the Registrant's Common Stock were issued and outstanding. As of December 26, 2002, the aggregate market value of voting stock held by non-affiliates of the Registrant was approximately $38,188,207, based on the closing price for the Registrant's Common Stock on that date as quoted on the American Stock Exchange. DOCUMENTS INCORPORATED BY REFERENCE Portions of the Registrant's Definitive Proxy Statement in connection with its Annual Meeting of Stockholders, scheduled for February 18, 2003, filed with the Securities and Exchange Commission on January 10, 200, are incorporated by this reference into Part III hereof, as indicated herein. PART I ITEM 1. BUSINESS GENERAL We develop medical treatment systems primarily to treat breast cancer and a chronic prostate enlargement condition, common in older males, known as benign prostatic hyperplasia, or BPH, using minimally invasive focused heat technology. We also are working with Duke University on the development of heat-sensitive liposome compounds for use in the delivery of chemotherapy drugs to tumor sites, and with the Memorial Sloan-Kettering Cancer Center, or Sloan-Kettering, on the development of heat-activated gene therapy compounds. BPH TREATMENT SYSTEM Benign Prostatic Hyperplasia Millions of aging men experience symptoms resulting from BPH, a non-cancerous urological disease in which the prostate enlarges and constricts the urethra. The prostate is a walnut-sized gland surrounding the male urethra that produces seminal fluid and plays a key role in sperm preservation and transportation. The prostate frequently enlarges with age. As the prostate expands, it compresses or constricts the urethra, thereby restricting the normal passage of urine. This restriction of the urethra may require a patient to exert excessive bladder pressure to urinate. Because the urination process is one of the body's primary means of cleansing impurities, the inability to urinate adequately increases the possibility of infection and bladder and kidney damage. Prevalence of BPH As BPH is an age-related disorder, its incidence increases with maturation of the population. Industry estimates suggest that more than 9 million men in the United States experience BPH symptoms and that more than 26 million men are affected by BPH worldwide. As the population continues to age, the prevalence of BPH can be expected to continue to increase. It is generally estimated that approximately 50% of men over the age of 55 and 90% of men over 75 will have BPH symptoms at various times. Industry studies estimate the overall costs of BPH therapy for those patients currently seeking treatment to be approximately $2.5 to $3.0 billion annually in the United States and $8.0 to $10.0 billion worldwide. Current Treatment Alternatives for BPH Like cancerous tumors, BPH historically has been treated by surgical intervention or by drug therapy. The primary treatment for BPH currently is transurethral resection of the prostate, or TURP, a surgical procedure in which the prostatic urethra and surrounding diseased tissue in the prostate are trimmed with a telescopic knife, thereby widening the urethral channel for urine flow. While the TURP procedure typically has been considered the most effective treatment available for the relief of BPH symptoms, the procedure has shortcomings. In the first instance, TURP generally requires from one to three days of post-operative hospitalization. In addition, a significant percentage of patients who undergo TURP encounter significant complications, which can include painful urination, infection, retrograde ejaculation, impotence, incontinence and excessive bleeding. Furthermore, the cost of the TURP procedure and the related hospitalization is high, ranging from $8,000 to $12,000. This cost does not take into account the costs of lost work time, which could amount to several weeks, or the costs related to adverse effects on patients' quality of life. Other, less radical, surgical procedures, generally categorized as "minimally invasive," or MI, therapies, are available as alternatives to the TURP procedure. The primary MI treatments use microwave heating (transurethral microwave thermotherapy of the prostate, or TUMT) to treat BPH by incinerating the obstructing portion of the prostate. TUMT involves sedation, catheterization and high levels of heat to incinerate a portion of the prostate. Two other MI therapies--interstitial RF therapy and laser therapy--employ, respectively, concentrated radio frequency, or RF, waves or laser radiation to reduce prostate swelling by cauterizing tissue instead of removing it with a surgical knife. However, these procedures require puncture incisions in order to insert cauterizing RF or laser probes into the affected tissue and, therefore, also involve the use of a full operating facility and anesthesia, as well as the burning of prostate tissue by the probes. Although these procedures result in less internal bleeding and damage to the urethra than the TURP procedure and may decrease the adverse effects and costs associated with surgery, anesthesia and post-operative tissue recovery, they do not entirely eliminate these adverse consequences. 2 Finally, drug therapy has emerged as an alternative to surgery in the last several years. There currently are several drugs available for BPH treatment, the two most widely prescribed being Hytrin and Proscar. Hytrin works by relaxing certain involuntary muscles surrounding the urethra, thereby easing urinary flow and Proscar is intended to shrink the enlarged gland. However, industry studies have asserted that drug therapy costs $500 to $800 per year or more, must be maintained for life and does not offer consistent relief to a large number of BPH patients. In fact, studies have shown that 45% of patients who begin drug therapy for BPH drop out within the first year, primarily due to the ineffectiveness of currently available drug therapies. Also, all of the currently available BPH drugs have appreciable side effects. Accordingly, neither the medicinal treatments nor the surgical alternatives presently available appear to provide fully satisfactory, cost-effective treatment solutions for BPH sufferers. Celsion BPH Treatment System We have developed a BPH treatment system--"Microwave Uretheroplasty(TM)"--that combines our microwave thermotherapy capability with a proprietary balloon compression technology licensed from MMTC, Inc. The system consists of a microwave generator and conductors and a computer and computer software programs that control the focusing and application of heat, plus a specially designed balloon catheter. Treatment using this system consists of two fundamental elements: - Celsion's proprietary catheter, incorporating a balloon enlargement device, delivers computer-controlled transurethral microwave heating directly to the prostate at temperatures greater than 44 degrees C (111 degrees F). - Simultaneously, the balloon inflates the device and expands to press the walls of the urethra from the inside outward as the surrounding prostate tissue is heated. The combined effect of this "heat plus compression" therapy is twofold: first, the heat denatures the proteins in the wall of the urethra, causing a stiffening of the opening created by the inflated balloon. Second, the heat effectively kills off prostate cells outside the wall of the urethra, thereby creating sufficient space for the enlarged natural opening. Pre-clinical animal studies have demonstrated that a natural "stent," or reinforced opening, in the urethra forms after the combined heat plus compression treatment. Also, the BPH system's relatively low temperature (43 degrees C to 45 degrees C) (109 degrees F to 113 degrees F) appears to be sufficient to kill prostatic cells surrounding the urethra wall, thereby creating space for the enlargement of the urethra opening. However, the temperature is not high enough to cause swelling in the urethra. Celsion's investigational, minimally invasive Microwave Uretheroplasty(TM) treatment system is designed to overcome the limitations of all three of the current treatment systems. It is designed to be a relatively painless, rapid procedure that delivers the efficacy of surgical treatments without significant risks and the potential for life-altering side effects. The potential benefits of the Microwave Uretheroplasty(TM) system include walk-in, outpatient treatment that can be completed in less than an hour; no required sedation; generally no post-operative catheterization; and rapid symptomatic relief from BPH. Ultimate Food and Drug Administration, or FDA, approval for a device such as our equipment typically requires two phases of clinical testing. The purpose of Phase I testing is to show feasibility and safety and involves a small group of patients. Phase II testing is designed to show safety and efficacy. The FDA approved an Investigational Device Exemption, or IDE, to allow clinical testing of our BPH system in June 1998 and we completed initial Phase I clinical feasibility human trials of the BPH system at Montefiore Medical Center in May 1999. In the Phase I trials, the combination of computer-controlled microwave heat and balloon catheter expansion was able to increase peak flow rates and to provide immediate relief of symptoms caused by BPH. In addition, we undertook an expanded Phase I study to test an accelerated treatment protocol, which was completed in May 2000, at Montefiore Medical Center. In July 2000, the FDA approved the commencement of multiple-site Phase II studies to collect the safety and efficacy data necessary for FDA premarketing approval ("PMA") for commercialization. All 160 patients required to be treated under the Phase II trial had been treated as of November 29, 2001 and, as of that date, we submitted the first two of three required modules to the FDA in support of the PMA. We expect to submit the last module, consisting of clinical data, early in 2003. If Phase II testing produces anticipated results and if our BPH system meets all other requirements for FDA approval and receives such approval, we intend to begin marketing the BPH system during the second calendar quarter of 2003. Based on the information we have collected to date, we believe that our BPH system has the potential to deliver a treatment that is performed in one hour or less on an outpatient basis, generally would not require post-treatment catheterization, and would deliver symptomatic relief and an increase in urinary flow rates promptly after the procedure is completed. 3 BREAST CANCER TREATMENT SYSTEM Prevalence of Breast Cancer Breast cancer is one of the leading causes of death among women in the United States. According to statistics published in the American Cancer Society's A Cancer Journal for Clinicians, there were an average of 183,000 newly diagnosed breast cancer cases in the United States in each of the years from 1995 through 1999. Current Treatment for Breast Cancer Breast cancer is presently generally treated by mastectomy, the surgical removal of the entire breast, or by lumpectomy, the surgical removal of the tumor and surrounding tissue. Both procedures are often followed by radiation therapy or chemotherapy. The more severe forms of surgical intervention can result in disfigurement and a need for extended prosthetic and rehabilitation therapy. In addition, heat therapy (also known as hyperthermia or thermotherapy) is a historically recognized method of treatment of various medical conditions, and heat therapy has been used in the past to treat malignant tumors in conjunction with radiation and chemotherapy. As summarized in the Fourth Edition of Radiobiology for the Radiologist, published in 1994 by J.B. Lippincott Company, in 24 independent studies on an aggregate of 2,234 tumors, treatment consisting of heat plus radiation resulted in an average doubling of the complete response rate of tumors, compared to the use of radiation alone. The complete response rate for this purpose means the total absence of a treated tumor for a minimum of two years. Comparable increases in the complete response rate were reported with the use of heat combined with chemotherapy. In addition, it has been demonstrated on numerous occasions that properly applied heat, alone and without the concurrent use of radiation, can also kill cancer cells. Heat Therapy in Conjunction with Radiation; First Generation Celsion Equipment In 1989, we obtained FDA premarketing approval for our microwave-based Microfocus 1000 heat therapy equipment for use on surface and subsurface tumors in conjunction with radiation therapy. Until 1995, we marketed our Microfocus equipment for this use in 23 countries, but microwave heat therapy was not widely accepted in the United States medical community as an effective cancer treatment. Moreover, due to the limitations of microwave technology available at the time, it was difficult to deliver a controlled amount of heat to subsurface tumors without overheating surrounding healthy tissue. New Microwave Technology from MIT In 1993, we began working with researchers at the Massachusetts Institute of Technology, or MIT, who had developed, originally for the United States Defense Department, the microwave control technology known as "Adaptive Phased Array", or APA. This technology permits properly designed microwave equipment to focus and concentrate energy targeted at diseased tissue areas deep within the body and to heat them selectively, without adverse impact on surrounding healthy tissue. In 1996, MIT granted us an exclusive worldwide license to use this technology for medical applications and, since that time, we have concentrated on developing a second generation of Microfocus equipment capable of focusing microwave energy on specific tissue areas. We have now incorporated the APA technology in our second-generation microwave therapy equipment. Second Generation Celsion Breast Cancer Treatment System Using the APA technology, we have developed a prototype breast cancer treatment system intended to destroy localized breast tumors through the application of heat alone. The system consists of a microwave generator and conductors, a computer and computer software programs that control the focusing, application and duration of the thermotherapy, and a specially designed patient treatment table. 4 In 1998, we completed pre-clinical animal testing of our prototype system at the Massachusetts General Hospital, a teaching hospital for Harvard Medical School in Boston, Massachusetts. Using breast tissue-equivalent phantoms and tumors in live animals, these studies demonstrated that our system is capable of selectively heating tumors at temperatures up to 46 degrees C (115 degrees F) without damage to surrounding healthy tissues. High temperatures maintained for eight to ten minutes can cause complete tumor necrosis (death), leading to the death of viable cancer cells within the tumor and in its immediate vicinity. A second prototype clinical breast cancer treatment system at Oxford University in England was used to demonstrate successfully the ability of our equipment to focus heat deep into animal tissue at precise locations and in small target areas. In our view, these animal tests demonstrate that it is possible to eliminate tumors by heat alone and without the use of radiation. Using the pre-clinical data from Massachusetts General, the FDA granted Celsion a supplemental premarketing approval to incorporate the APA technology with Celsion's already approved Microfocus 1000 system. The APA technology enhances the ability of the Microfocus 1000 system to focus energy. In January 1999, we received an IDE from the FDA to permit clinical testing of our breast cancer treatment system, and also received FDA approval to proceed with Phase I human clinical studies. In August 2000, we completed the treatment of ten patients in the Phase I study using our breast cancer equipment at Columbia Hospital in West Palm Beach, Florida, and at Harbor UCLA Medical Center in Torrance, California. In the study, our equipment was clinically tested on female breast tumors on a minimally invasive basis through a single application of precisely controlled and targeted heat. In December 2000, we received approval from the FDA to commence Phase II trials for our breast cancer system. The Phase II trials consist of two protocols--the first (IIA) is designed to ablate (kill) small breast tumors using heat alone and the second (IIB) is designed to downsize large breast cancer tumors using a combination of heat and chemotherapy, thus allowing a surgeon to perform a lumpectomy rather than a mastectomy, thereby preserving the affected breast. These trials are currently under way at The Center for Breast Surgery (Columbia/HCA) in Florida, Comprehensive Breast Center in Florida, Harbor UCLA in California, Mroz-Baier Breast Care Center in Memphis, Tennessee, Halle Martin Luther Breast Center in Halle, Germany, and with Dr. Lynne Clarke in Tacoma, Washington. We expect to add a total of four additional sites, in the United States and in Europe, early in 2003. In July 2002, we reached the endpoint for the IIB protocol by determining the maximum heat dosage required to optimize the treatment. We have learned from our current and potential clinical investigators that our breast cancer treatment system has the potential to meet a significant unmet need in the realm of breast cancer treatment. Currently 25% to 30% of all lumpectomy patients are recalled for a second surgery (commonly referred to as a second incision) when, through pathological examinations, the surgeon discovers that viable cancer cells remain in the margins surrounding the area from which the tumor has been removed. This additional procedure is costly for the surgeon and other medical providers and traumatic for the patient. We believe that studies will demonstrate that our treatment system, in conjunction with lumpectomy, would lead to a reduction in the rate of second incisions. Based on our Phase II trial results to date and our new learning, we decided to revise our IIB protocol to provide a clinical endpoint demonstrating that the incidence of second incision could be significantly reduced if a patient underwent treatment with our system prior to lumpectomy. We submitted the revision of our IIB protocol to the FDA in July 2002 and, in August 2002, the FDA approved our revised protocol on condition that the IIB trials be expanded from 43 to 222 patients, with half the patients being treated with Celsion's system followed by lumpectomy and the remainder undergoing conventional lumpectomies alone. At the same time, we reviewed and revised our IIA protocol to clarify the clinical endpoints. As revised, the IIA trials will now be fully randomized against patients receiving preoperative chemotherapy alone and the study size has been increased from 130 to 312 patients. Treatments under both protocols were halted while the revisions were in process. We anticipate that both the IIA and IIB trials will be completed by the end of calendar year 2003 and, if successful, that we will file for the addition of new indications of use to the existing FDA premarketing approval for our Microfocus 1000 equipment early in 2004. THERMO-LIPOSOMES--DUKE UNIVERSITY TECHNOLOGY Background Liposomes are man-made microscopic spheres with a liquid membrane, developed in the 1980's to encapsulate drugs for targeted delivery. Commercial liposomes can now encapsulate chemotherapeutic drugs, enabling them to avoid destruction by the body's immune system, and allowing them to accumulate in tumors. However, with presently available technology, it often takes two to four hours for commercial liposomes to release their drug contents to a tumor, severely limiting the clinical efficacy of liposome chemotherapy treatments. 5 Development of Thermo-Sensitive Liposomes A team of Duke University scientists has developed heat-sensitive liposomes comprised of materials that rapidly change porosity when heated to a specific point. As the heat-sensitive liposomes circulate within the small arteries, arterioles, and capillaries, the drug contents of the liposomes are released at significantly higher levels in those tissue areas which have been heated for 30 to 60 minutes than in areas that do not receive heat. In animal trials, it has been determined that heat-sensitive liposomes deposited 50 times the amount of drugs at a specific heated tissue site, when compared to conventional liposomes. We have been a sponsor of this research, which is part of a larger Duke University project to develop new temperature-sensitive liposomes, temperature-sensitive gene promoters and related compounds, and we are the exclusive licensee of Duke University's heat-activated liposome technology. Celsion's focused microwave equipment is used to provide minimally invasive heating of cancerous tumors to trigger heat-activated liposomes within the tumors. The heat-activated liposomes, which encapsulate chemotherapeutic agents, are injected into the bloodstream, where they remain encapsulated until they release their drug payload inside the heated tumor. In preliminary tumor growth delay studies conducted at Duke University, tumor-bearing mice received a single intravenous injection of the liposome with a 5mg per kilogram Doxorubicin concentration. This was immediately followed by heating of the tumor to 42 degrees C (108 degrees F) for one hour. The result of the study was a complete disappearance of the tumors in 11 out of 11 mice. These animals remained disease free through the 60 days of the study. In November 2001, we completed large animal toxicity studies involving our Doxorubicin-laden thermo-liposome at the Roswell Park Cancer Institute, a cancer research organization in Buffalo, New York. In March 2002, we filed an Investigational New Drug, or IND, application with the FDA for the use of this liposome in the treatment of prostate cancer using our Microfocus equipment as the means of heat activation. In June 2002, the IND became effective, allowing us to proceed with human clinical trials. We expect to start the Phase I clinical trials at Roswell Park Cancer Institute early in 2003. In addition, in January 2001, we entered into a Material Transfer Agreement, or MTA, with the National Cancer Institute, or NCI, under which we are supplying heat-activated liposomes to enable the NCI to conduct clinical trials on liver cancer. NCI will use an RF heating device to isolate the tumors and to heat the liver, activating Celsion's heat-activated liposomes to kill peripheral cancer cells. Liver cancer has yet to be successfully treated with existing treatment modalities. NCI expects to complete the animal toxicity studies and submit an IND application to the FDA for approval early in 2003. Celsion and Duke University are pursuing further development work and pre-clinical studies aimed at using the new thermo-liposome technology in conjunction with our APA focused heat technology for a variety of applications, including cancer chemotherapy. We view the Duke thermo-liposome technology as a highly promising improvement in the delivery of medicines used to combat serious diseases. For example, the drugs used to fight cancer in chemotherapy regimens are often toxic when administered in large quantities, and produce nausea, vomiting, and exhaustion--all side effects of the body being poisoned. However, if such a drug can be delivered directly to a tissue area where it is needed, as opposed to being distributed through the entire circulatory system, the local concentration of the drug could be increased without the side effects that accompany large systemic dosing. In addition, in the July 1, 2000 issue of Cancer Research, a Duke University research scientist reported on his initial use of heat to activate gene therapy and to increase the production in animals of Interleukin-12, a genetic protein, in order to delay tumor growth. On August 8, 2000, we entered into an agreement with Duke University, subsequently renewed for six-month periods, under which Celsion has the right, for a period of six months thereafter, to negotiate an exclusive license for this technology. Production of Heat-Sensitive Liposomes We have established a relationship with British Columbia Cancer Authority, or BCCA, of Vancouver, Canada to provide Quality System Regulation, or QSR (formerly Good Manufacturing Practices, or GMP), production of our heat-activated liposome for our large animal toxicity studies under our Material Transfer Agreement with the National Cancer Institute and for our planned Phase I clinical study in humans. BCCA is a leading drug formulation and discovery company that specializes in liposome drug development. Celsion will require a large-scale liposome manufacturer at such time, if any, as it reaches Phase II clinical trials and beyond. Toward that end, we are in the process of identifying a large-scale producer of the Doxorubicin-based heat-activated liposome. 6 HEAT-ACTIVATED GENE THERAPY COMPOUNDS--SLOAN-KETTERING TECHNOLOGY Background Cancer cells have the ability to repair themselves after radiation or chemotherapy. Thus, patients require repeated treatments to destroy substantially all of the cancer cells. Celsion has licensed from Memorial Sloan-Kettering Cancer Center a biomedical innovation that we believe has significant potential to improve cancer therapy. Sloan-Kettering has developed a biological modifier that inhibits cancer cells' ability to repair themselves. Activated by focused heat, this Cancer Repair Inhibitor, or CRI, temporarily disables the repair mechanism of cancer cells, making it possible to reduce significantly the number of radiation/chemotherapy treatments and/or lower the treatment dosage. A standard approach to treating cancer is radiation therapy combined with chemotherapy. High doses of radiation kill cancer cells or keep them from dividing, but produce chronic or acute side effects, including fatigue, neutropenia, anemia and leukopenia. Also, depending on the location of the tumor, other acute side effects may occur, including diarrhea, allopecia and various foreign ulcers. Chemotherapy presents comparable or more serious side effects. Oncologists are seeking methods to mitigate these side effects. In radiation therapy, such methods include hyperfractionated radiation, intra-operative radiation, three-dimensional radiation, stereotactic radiosurgery and the use of radio-labeled monoclonal antibodies and radio sensitizers. CRI falls into this latter category because it "sensitizes" a cancer cell for treatment by making it more susceptible to DNA-damaging agents such as heat, chemicals or radiation. A product of advances in the understanding of the biology of cancer, CRI is one of a new class of "biologics" that are expected to become part of the cancer treatment protocol. The Celsion Technology--CRI Plus Focused Heat CRI can be activated in tumors by minimally invasive focused heat in the range of 41 degrees C (106 degrees F). This focused heat may be generated by Celsion's Adaptive Phased Array microwave technology, which provides deep heating without damage to surrounding healthy tissue. Having increased the susceptibility of cancer cells to DNA-damaging agents, radiation and chemotherapy treatment may then be administered with less frequency and/or at lower doses than currently is possible. CRI would then deactivate and the patient would resume normal post-treatment care. In September 2001, scientists at Sloan-Kettering successfully completed pre-clinical laboratory feasibility demonstrations to assess the safety and biological activity of CRI. In December 2001, a small animal feasibility study was completed at Sloan-Kettering's Good Laboratory Practice facility to assist in drug formulation. Further studies with large animals to assess toxicity effects are being conducted and are expected to continue into 2003. Based on the current development timeline, we expect to file an IND application with the Food and Drug Administration by the end of calendar year 2003 and anticipate that we will be in a position to commence Phase I clinical (human) trials before the end of calendar year 2004. At such time as we determine safety and dosage in our preliminary studies, we expect to form partnership(s) with one or more drug companies to scale-up manufacturing and marketing for larger pivotal studies. In May 2000, we entered into an exclusive worldwide agreement for the commercial rights to the CRI, heat-activated gene therapy technology developed by Sloan-Kettering. DEVELOPMENT, MARKETING AND SALES STRATEGY OVERVIEW AND GOALS We are not currently engaged in marketing and sales, and are focusing our activities on the development and testing of our products. Our strategic plan is based upon our expertise and experience in the medical application of focused microwave heat and our relationships with and license rights from our institutional research partners. Our goal has been to employ these resources to develop minimally invasive or non-invasive treatment technologies with efficacy significantly exceeding that available from other sources. Using our management and staff, scientific advisory personnel and available financial resources, we are focusing our efforts on the following goals: o Short-Term Goals: 12 to 24 Months - complete the clinical testing and commercialization of our BPH treatment system; - complete the development, clinical testing, and commercialization of our second generation technology for the eradication of cancerous breast tumors; and 7 - pursue the development and testing of targeted drug delivery via heat-sensitive liposomes for the purpose of concentrating chemotherapeutic drugs at tumor sites. o Longer-Term Goals: 18 Months and Beyond - continue the development of gene therapy to significantly improve the effectiveness of radiation and chemotherapy on tumors; and - initiate, either alone or with partners, the development of cost-effective enhancements and variations of our technology, including a version of our Microfocus equipment for treating prostate and other cancers, and additional potential applications for heat-sensitive liposome therapy and heat-activated gene therapy in the treatment of inflammatory, infectious and genetic diseases. We anticipate that, in the near term (up to 24 months), the source of our revenues will be from our proprietary technology for BPH and for treatment of breast cancer and deep-seated tumors through the use of focused microwave heat therapy equipment, if the necessary testing and regulatory approval processes are completed. We intend to generate initial sales through the development of marketing alliances. In the longer term (from 18 months to 36 months and beyond), we will seek to develop new revenue streams from our current work with Duke University in targeted drug delivery systems and with Sloan-Kettering in gene therapy. We anticipate that revenues will come from the licensing of this technology to pharmaceutical manufacturers and major institutional health care providers who would employ these technologies to deliver drug regimens or gene therapy throughout the body. Also, because this technology is designed to be used in conjunction with our APA-improved microwave equipment, we expect that the acceptance of the technology will generate demand for our equipment which, in turn, is expected to create equipment sales revenues. To prepare for future marketing of our heat-sensitive drug delivery systems, we intend to explore the possibilities of forming alliances with pharmaceutical companies, major hospitals and health maintenance organizations. BPH TREATMENT SYSTEM Our BPH treatment system is expected to be marketed to the constituencies critical to its success. Particularly, towards the approximately two million readily identified BPH sufferers currently employing drug therapies, as well as the estimated seven million United States men afflicted with BPH who are not currently being treated--the "watchful waiters"--with a focused message designed to encourage these BPH sufferers to take advantage of a solution that will relieve their symptoms and help to restore the quality of their lives. We expect that this marketing effort will include the following elements: o Reimbursement - We have established reimbursement under the TUMT reimbursement code for Medicare patients participating in our Phase II clinical trials. Based on this precedent, we expect that our BPH treatment will be covered in a like manner by private insurers. o Targeting Key Constituencies: - Urology Practices. We expect first to target large urology practices, starting with the large practices participating in our Phase II trial. We expect that our Microwave Uretheroplasty(TM) equipment will be placed in urologists' offices with no up-front capital cost to the physicians. The urologists will purchase a unique disposable catheter from Celsion or its marketing partner for each treatment. We believe that urology practices have experienced a loss of revenue to primary care physicians as a result of new drug therapies introduced to treat BPH and other urological disorders and that urologists will be favorably disposed toward our Microwave Uretheroplasty(TM) system, which could offer them a significant new revenue source. - Consumers. We also expect BPH sufferers will be targeted through aggressive use of promotional and advertising media. Due to the specificity of our target patient audience (males 50 years and older) and the geographic concentration of retirees, we expect that specific media in well defined and discrete markets will generate a high level of awareness of the availability of, and interest in, our treatment system. We also expect that the Internet and other electronic methods will be utilized to direct prospective patients to urology offices equipped to perform our Microwave Uretheroplasty(TM) procedure. 8 - Primary Care Physicians. The marketing approach has been designed to bypass primary care physicians, whom we believe to be the most significant barrier to the success of our BPH treatment system. Generally, under current managed care protocols, a patient must first visit his primary care physician who, after reviewing the patient's symptoms, may either treat him or refer him to a specialist. With increasing availability of drug therapies to treat urological disorders, the number of referrals to urologists has been declining. We intend to ensure that BPH sufferers are aware of our Microwave Uretheroplasty(TM) treatment system so that they are in a position to insist that they be referred to a urologist to obtain treatment. Celsion does not plan to develop an internal sales and marketing capability for its BPH business. Rather, Celsion intends to enter into a strategic alliance with a larger medical products company regarding the sales, supply and distribution of its Microwave Uretheroplasty(TM) treatment system. Such a strategic relationship should allow Celsion to maintain its focus on its core development activities while leveraging its sales force infrastructure and marketing expertise. To this end, effective January 21, 2003, Celsion entered in to a Distribution Agreement with Boston Scientific Corporation, pursuant to which Celsion has granted Boston Scientific exclusive rights to market and distribute the Microwave BPH 800 Urethroplasty(TM) System and its component parts for the treatment BPH in all territories other than China, Taiwan, Hong Kong, Macao, Mexico and Central and South America. Additional information relating to Celsion's strategic partnership with Boston Scientific appears in our Current Report on Form8-K filed with the Securities and Exchange Commission on January 22, 2003. LICENSE AGREEMENTS AND PROPRIETARY RIGHTS We do not own any patents, although we do have three United States patents pending, two of which have been filed internationally. Two of our pending United States patent applications are directed to our BPH treatment system, with the third directed to our breast cancer treatment. Through our license agreements with MIT, MMTC, Duke and Sloan-Kettering, we have exclusive rights, within defined fields of use, to nine United States patents. Three of these patents relate to the treatment of BPH, four relate to thermotherapy for cancer, including the APA technology, one relates to heat-sensitive liposomes and one relates to gene therapy. The MIT, MMTC, Duke University and Sloan-Kettering license agreements each contain license fee, royalty and/or research support provisions, testing and regulatory milestones, and other performance requirements that we must meet by certain deadlines with respect to the use of the licensed technologies. In conjunction with the patent holders, we intend to file international applications for certain of the United States patents. In 1996, we entered into a patent license agreement with MIT, pursuant to which we obtained exclusive rights to use of MIT's patented APA technology in conjunction with application of heat to breast tumor conditions, the application of heat to prostate conditions and all other medical uses. MIT has retained certain rights in the licensed technology for non-commercial research purposes. MIT's technology has been patented in the United States and MIT has patents pending for its technology in China, Europe, Canada and Japan. The term of our exclusive rights under the MIT license agreement expires on the earlier of ten years after the first commercial sale of a product using the licensed technology or October 24, 2009, but our rights continue on a non-exclusive basis for the life of the MIT patents. We entered into license agreements with MMTC in 1996 and 2002, by which we currently have exclusive worldwide rights to MMTC's patents related to its balloon compression technology for the treatment of prostatic disease in humans. Our exclusive rights under the MMTC license agreements extend for the life of MMTC's patents. MMTC currently has patents in the United States and Canada. The terms of these patents expire at various times from April 2008 to November 2014. In addition, MMTC also has patent applications pending in Japan and Europe. On November 10, 1999, we entered into a license agreement with Duke University under which we received exclusive rights (subject to certain exceptions) to commercialize and use Duke's thermo-liposome technology. The license agreement contains annual royalty and minimum payment provisions and also requires us to make milestone-based royalty payments measured by various events, including product development stages, FDA applications and approvals, foreign marketing approvals and achievement of significant sales. However, in lieu of such milestone-based cash payments, Duke has agreed to accept shares of our Common Stock to be issued in installments at the time each milestone payment is due, with each installment of shares to be calculated at the average closing price of the Common Stock during the 20 trading days prior to issuance. The total number of shares issuable to Duke under these provisions is subject to adjustment in certain cases, and Duke has "piggyback" registration rights for public offerings taking place more than one year after the effective date of the license agreement. We are currently renegotiating certain terms of our contractual arrangements with Duke. Our rights under our license agreement with Duke University extend for the longer of 20 years or the end of any term for which any relevant patents are issued by the United States Patent and Trademark Office. Currently, we have 9 rights to Duke's patent for its thermo-liposome technology in the United States, which expires in 2018, and to future patents received by Duke in Canada, Europe, Japan and Australia, where it has patent applications pending. The European application can result in coverage in the United Kingdom, France and Germany. For this technology, our license rights are worldwide, with various patent rights covering the United States, Canada, the United Kingdom, France, Germany and Japan. We entered into a license agreement with Sloan-Kettering in November 2000 by which we obtained exclusive rights to Sloan-Kettering's United States patent and to patents that Sloan-Kettering may receive in the future for its heat-sensitive gene therapy in Japan, Canada and Europe, where it has patent applications pending. Our rights under the agreement with Sloan-Kettering will terminate at the later of 20 years after the date of the agreement or the last expiration date of any patent rights covered by the agreement. In addition to the rights available to us under completed or pending license agreements, we rely on our own proprietary know-how and experience in the development and use of microwave thermotherapy equipment, which we seek to protect, in part, through proprietary information agreements with employees, consultants and others. We cannot offer assurances that these information agreements will not be breached, that we will have adequate remedies for any breach or that these agreements, even if fully enforced, will be adequate to prevent third-party use of our proprietary technology. Similarly, we cannot guarantee that technology rights licensed to us by others will not be successfully challenged or circumvented by third parties, or that the rights granted will provide us with adequate protection. We are aware of published patent applications filed after November 29, 2001 and issued patents belonging to other companies, and it is uncertain whether any of those patent documents, or patent applications filed before November 29, 2001 of which we may not have any knowledge, will require us to alter our potential products or processes, pay licensing fees, or cease certain activities. MANUFACTURING Celsion presently manufactures its BPH equipment in-house and anticipates that it will continue to do so for the immediate future. However, as the market develops, we expect that we will outsource some or all of our BPH equipment manufacturing. We believe we are best suited to conduct basic research and development activities, to pursue a prototype product through clinical testing and regulatory approval, to engage in initial manufacturing activities during product launch and to market the final product. Accordingly, we do not intend to engage in large-scale manufacturing with respect to our breast cancer treatment system or any other possible future products, but instead intend generally to outsource the manufacture of final commercial products, components and disposables. Based on past experience, we do not anticipate any significant obstacles in identifying and contracting with qualified suppliers and manufacturers. THIRD-PARTY REIMBURSEMENT Third-party reimbursement arrangements will likely be essential to commercial acceptance of our new devices, and overall cost-effectiveness and physician advocacy will be keys to obtaining such reimbursement. We believe that our equipment can be used to deliver treatment at substantially lower total cost than surgical treatments for BPH or cancer or than continuous drug therapy. Consequently, we believe that third-party payors seeking procedures that provide quality clinical outcomes at relatively lower cost will help drive acceptance of our products. For BPH, our strategy is to use reimbursement codes currently approved for TUMT in the United States and which have been approved for Medicare patients in connection with BPH treatment in our Phase II clinical trials. For breast cancer, we expect that our strategy for obtaining new reimbursement authorizations in the United States will be to obtain appropriate reimbursement codes and to perform studies in conjunction with clinical trials to establish the efficacy and cost-effectiveness of the procedures as compared to surgical and drug treatments for BPH and cancerous breast tumors. We plan to use this information when approaching health care payors to obtain new reimbursement authorizations. With the increasing use of managed care and capitation as means to control health care costs in the United States, we believe that physicians may view our products as a tool to treat BPH and breast cancer patients at a lower total cost, thus providing them with a competitive advantage when negotiating managed care contracts. This is especially important in the United States, where a significant portion of the aging, Medicare-eligible population is moving into a managed care system. Subject to regulatory approval for the use of our equipment to treat BPH and breast cancer, we anticipate that physicians will submit insurance claims for reimbursement for such procedures to third-party payors, such as Medicare carriers, Medicaid carriers, health maintenance organizations and 10 private insurers. In the United States and in international markets, third-party reimbursement is generally available for existing therapies used to treat cancer and BPH. The availability and level of reimbursement from such payors for the use of our new products will be a significant factor in our ability to commercialize these systems. We expect that new regulations regarding third-party reimbursement for certain investigational devices in the United States will allow us to pursue early reimbursement from Medicare with individual clinical sites prior to receiving FDA approval. However, FDA approval likely will be necessary to obtain a national coverage determination from Medicare. The national coverage determination for third-party reimbursement will depend on the determination of the Centers for Medicare and Medicaid Service, or CMS (formerly known as the United States Health Care Financing Administration, or HCFA), which establishes national coverage policies for Medicare carriers, including the amount to be reimbursed, for coverage of claims submitted for reimbursement related to specific procedures. Private insurance companies and health maintenance organizations make their own determinations regarding coverage and reimbursement based upon "usual and customary" fees. Reimbursement experience with a particular third-party payor does not reflect a formal reimbursement determination by the third-party payor. New outpatient procedure codes were instituted on August 1, 2000. Our ability to petition successfully for these new reimbursement codes will ultimately determine the degree of success we achieve in implementing our business model. Internationally, we expect to seek reimbursement approvals for procedures utilizing our new products on an individual country basis. Some countries currently have established reimbursement authorizations for transurethral microwave therapy. We expect to use clinical studies and physician advocacy to support reimbursement requests in countries in which there is currently no reimbursement for such procedures. REGULATION OF SALES IN THE UNITED STATES FDA REGULATION--RESEARCH AND APPROVAL Our research and development activities, pre-clinical tests and clinical trials and, ultimately, the manufacturing, marketing and labeling of our products, are subject to extensive regulation by the FDA. The Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or PHSA and the regulations promulgated by the FDA govern, among other things, the testing, manufacture, safety, efficacy, labeling, storage, record keeping, approval, advertising, promotion, import and export of our products. Under these statutes, our Microwave Uretheroplasty(TM) treatment system is regulated as a class III medical device, our heat-activated liposomes may be regulated as a new drug and our CRI may be regulated as a biological product. The steps ordinarily required before such products can be marketed in the U.S. include; (a) pre-clinical and clinical studies; (b) the submission to the FDA of an IDE or an IND which must become effective before human clinical trials may commence; (c) adequate and well-controlled human clinical trials to establish the safety and efficacy of the product; (d) the submission to the FDA of an application for premarketing approval (PMA), a New Drug Application (NDA), or a Biological License Application (BLA); and (e) FDA approval of the application, including approval of all product labeling. Pre-clinical tests include laboratory evaluation of product chemistry, formulation and stability, as well as animal studies to assess the potential safety and efficacy of the product. Pre-clinical safety tests must be conducted by laboratories that comply with FDA regulations regarding Good Laboratory Practice. The results of pre-clinical tests are submitted to the FDA as part of an IDE or IND and are reviewed by the FDA before the commencement of human clinical trials. Submission of an IDE or IND will not necessarily result in FDA authorization to commence clinical trials or and the absence of FDA objection to an IDE or IND does not necessarily mean that the FDA will ultimately approve a PMA or that a product candidate otherwise will come to market. Clinical trials involve the administration of therapy to humans under the supervision of a qualified principal investigator. Clinical trials must be conducted in accordance with good clinical practices under protocols submitted to the FDA as part of an IDE or IND. Also, each clinical trial must be approved and conducted under the auspices of an internal review board, or IRB, and with patient informed consent. The IRB will consider, among other things, ethical factors, the safety of human subjects and the possible liability of the institution conducting the clinical trials. Clinical trials are typically conducted in two or three sequential phases, but the phases may overlap. Phase I clinical trials involve the initial introduction of the therapy to a small number of subjects. Phase II trials are generally larger trials conducted in the target population. For devices such as our Microwave Uretheroplasty(TM) treatment system, Phase II studies may serve as the pivotal trials demonstrating safety and effectiveness required for approval. In the case of drugs and biological products, Phase II clinical trials generally are conducted in a target patient population to gather evidence about the pharmacokinetics, safety and biological or clinical efficacy of the drug for specific indications, to determine dosage tolerance and optimal dosage and to 11 identify possible adverse effects and safety risks. When a drug or biological compound has shown evidence of efficacy and an acceptable safety profile in Phase II evaluations, Phase III clinical trials are undertaken to serve as the pivotal trials to demonstrate clinical efficacy and safety in an expanded patient population. There can be no assurance that any of our clinical trials will be completed successfully, within any specified time period or at all. Either the FDA or we may suspend clinical trials at any time, if either the FDA or we conclude that clinical subjects are being exposed to an unacceptable health risk or for other reasons. The FDA inspects and reviews clinical trial sites, informed consent forms, data from the clinical trial sites (including case report forms and record keeping procedures) and the performance of the protocols by clinical trial personnel to determine compliance with good clinical practices. The FDA also examines whether there was bias in the conduct of clinical trials. The conduct of clinical trials is complex and difficult, especially in pivotal Phase II or Phase III trials. There can be no assurance that the design or the performance of the pivotal clinical trial protocols or any of our current or future product candidates will be successful. The results of pre-clinical studies and clinical trials, if successful, are submitted in an application for FDA approval to market the device, drug or biological product for a specified use. The testing and approval process requires substantial time and effort, and there can be no assurance that any approval will be granted for any product at any time, according to any schedule, or at all. The FDA may refuse to approve an application if it believes that applicable regulatory criteria are not satisfied. The FDA may also require additional testing for safety and efficacy. Moreover, if regulatory approval is granted, the approval will be limited to specific indications. There can be no assurance that any of our product candidates will receive regulatory approvals for marketing or, if approved, that approval will be for any or all of the indications that we request. The FDA is authorized to require user fees for submission of NDAs and BLAs. The current user fee for such applications is $267,606 and may increase from year to year. The FDA is also authorized to require annual user fees for approved products and for companies with establishments at which finished products are manufactured, which fees may increase from year to year. The FDA may waive or reduce such user fees under special circumstances. We intend to seek waivers or reductions of user fees where possible, but we cannot be assured that we will be eligible for any such waiver or reduction. FDA REGULATION--POST-APPROVAL REQUIREMENTS Even if we receive necessary regulatory approvals for one or more of our product candidates, our manufacturing facilities and products are subject to ongoing review and periodic inspection. Each U.S. device, drug and biologic manufacturing establishment must be registered with the FDA. Manufacturing establishments in the U.S. and abroad are subject to inspections by the FDA and must comply with the FDA's QSR regulations. Medical devices also must comply with the FDA's QSR regulations. In order to ensure full technical compliance with such regulations, manufacturers must expend funds, time and effort in the areas of production and quality control. FDA REGULATION--MANUFACTURING STANDARDS We are also subject to record keeping and reporting regulations, including the FDA's mandatory Medical Device Reporting, or MDR, regulations. These regulations require, among other things, the reporting to FDA of adverse events alleged to have been associated with the use of a product or in connection with certain product failures. Labeling and promotional activities also are regulated by the FDA and, in certain instances, by the Federal Trade Commission (FTC). We must also comply with record keeping requirements as well as requirements to report certain adverse events involving our products. The FDA can impose other post-marketing controls on us as well as our products including, but not limited to, restrictions on sale and use, through the approval process regulations and otherwise. Failure to comply with applicable regulatory requirements can result in, among other things, warning letters, fines, injunctions and other equitable remedies, civil penalties, recall or seizure of products, total or partial suspension of production, refusal of the government to grant approvals, pre-market clearance or pre-market approval, withdrawal of approvals and criminal prosecution. OTHER FEDERAL REGULATION The Federal Communications Commission (FCC) regulates the frequencies of microwave and radio-frequency emissions from medical and other types of equipment to prevent interference with commercial and governmental 12 communications networks. The FCC has approved the frequency of 915 MHZ for medical applications, and machines utilizing that frequency do not require shielding to prevent interference with communications. Our Microfocus and BPH treatment products utilize the 915 MHZ frequency. In December 1984, the Health Care Financing Administration (now known as the Centers for Medicare and Medicaid Service (CMS)) approved reimbursement under Medicare and Medicaid for thermotherapy treatment when used in conjunction with radiation therapy for the treatment of surface and subsurface tumors. At this time, most of the large medical insurance carriers in the U.S. have approved reimbursement for this type of thermotherapy treatment under their health policies. Thermotherapy treatment administered using equipment that has received a PMA is eligible for such reimbursement. REGULATION OF FOREIGN SALES Sales of domestically produced drugs, biologics and medical devices outside of the U.S. are subject to United States export requirements and foreign regulatory controls. Drugs, biologics, and devices that are subject to PMA requirements and have not received FDA marketing approval cannot be exported unless they are approved in the European Union (EU), in a country in the EU or the European Free Trade Association, or in certain other countries specified in the Federal Food, Drug and Cosmetic Act. Products approved in these countries may be exported to other countries in which they are legal for marketing. Such products must bear labeling that complies with both the country of approval and the country to which the product is exported. In the case of drugs and biologics, there must also be a valid marketing authorization by a responsible authority and FDA must make detailed determinations regarding the adequacy of the statutory or regulatory requirements of the importing country. Exported products that are not approved in the U.S. are subject to other FDA regulatory requirements as well, including substantial compliance with good manufacturing practice requirements. The FDA may prohibit export if there is a determination that the exportation of the product presents an imminent hazard to the public health of the importing country or to the U.S. if reimported. Upon exportation, our products would be subject to regulation by national governments and supranational agencies as well as by local agencies affecting, among other things, product standards, packaging requirements, labeling requirements, import restrictions, tariff regulations, duties and tax requirements. There can be no assurance that one or more countries or agencies will not impose regulations or requirements that could have a material adverse effect on our ability to sell our products. In the EU, the harmonization of standards has caused a shift from a country-by-country regulatory system towards an EU-wide single regulatory system. However, many members of the EU have imposed additional country-specific regulations/requirements. The approval procedure varies from member state to member state, and the time required may be longer or shorter than that required for FDA approval. There can be no assurance that the changes in the regulatory schemes imposed either by the EU, supranational agencies or individual countries affecting our products will not have a material adverse effect on the our ability to sell our products in countries other than the U.S. Failure to comply with foreign regulatory requirements can result in, among other things, warning letters, fines, injunctions and other equitable remedies, civil penalties, recall orders or seizure of products, total or partial suspension of production, refusal of the health authorities to grant desired approvals, the withdrawal of approvals and criminal prosecution. We sold our original products in 23 countries in Asia, Europe and South America. Meeting the registration requirements within these countries was the responsibility of our distributors in each of these countries. Legal restrictions on the sale of imported medical devices vary from country to country. The time required to obtain approval by a foreign country may be longer or shorter than that required for FDA approval, and the requirements may differ. We expect to receive approvals for marketing in a number of countries outside the U.S. prior to the time that we will be able to market our products in the U.S. However, the timing for such approvals currently is not known. COMPETITION Many companies and institutions are engaged in research and development of thermotherapy technologies for both cancer and prostate disease products that seek treatment outcomes similar to those we are pursuing. In addition, a number of companies and institutions are pursuing alternative treatment strategies through the use of RF, laser and ultrasound energy sources, all of which appear to be in the early stages of development and testing. Potential competitors engaged in all areas of cancer and prostate treatment research in the U.S. and other countries include, among others, major pharmaceutical and chemical companies, specialized technology companies, universities and other research institutions. See "Risk Factors." 13 There currently are three principal competitors in the MI market for BPH treatment systems: Medtronic (NYSE:MDT), Urologix (NASDAQ:ULGX) and TherMatrx (private). In addition to Celsion, one other company, ACMI (a privately held company selling Prostalund technology from Sweden), is in the process of FDA review of a minimally invasive BPH treatment system. These companies utilize one of two major approaches to BPH treatment: o Transurethral needle ablation, or TUNA, which uses radio frequency ablation and is offered by Medtronic; and o TUMT, which uses microwave heating to ablate tissue within the prostate and is offered by the remaining companies. Medtronic acquired its TUNA business as part of its acquisition of Vidamed, Inc. for $329 million in April 2002. TUNA technology is labor intensive for the physician and requires a significant learning curve prior to perfecting the technique. Patients require post-treatment catheterization and significant pre-medication is common. TUMT technology is currently the dominant MI alternative. Urologix is the market leader in TUMT systems. Its machines currently list for approximately $90,000 and its single use catheters cost between $1,000 and $1,200. Urologix's technology uses a "water cooled" catheter, which is designed to use high microwave energy without damaging the urethral lining. TherMatrx takes a simpler approach, offering a low power machine that does not require cooling. The sales price of the TherMatrx equipment is approximately $25,000, due to its relatively less complex design. The catheter used in conjunction with this equipment sells in the same range as the Urologix catheter. Both Urologix's and TherMatrx's products (and ACMI's Prostalund, which has not been approved) require pre-medication, are more difficult for the physician to administer than is the Celsion Microwave Urethroplasty(TM) system and require post-treatment catheterization of the patient. We believe that our technology is a leap forward in the advancement of microwave therapy. Celsion relies on Microwave Urethroplasty(TM) in addition to traditional microwave energy. The addition of balloon compression within the prostatic portion of the urethra allows for immediate relief to the patient and in most cases can avoid post treatment catheterization. Thus, Celsion's technology allows for the type of rapid relief for the patient normally associated with drug therapies while avoiding the side effects and significant delays in patient symptomatic relief associated with other minimally invasive therapies. PRODUCT LIABILITY AND INSURANCE Our business exposes us to potential product liability risks that are inherent in the testing, manufacturing and marketing of human therapeutic products. We presently have product liability insurance limited to $5,000,000 per incident, and, if we were to be subject to a claim in excess of this coverage or to a claim not covered by our insurance and the claim succeeded, we would be required to pay the claim out of our own limited resources. EMPLOYEES We presently employ 23 full-time employees and one part-time employee and also utilize the services of part-time consultants from time to time. In addition, our Scientific Advisory Board actively assists our management with advice on various projects. None of our employees are represented by a collective bargaining organization, and we consider our relations with our employees to be good. ITEM 2. PROPERTIES We lease premises consisting of approximately 22,451 square feet of administrative office, laboratory and workshop space at 10220-I Old Columbia Road, Columbia, Maryland 21046-1705 from an unaffiliated party under a five-year lease (7,056 square feet) that expires on June 30, 2005 and a sublease (15,395 square feet), which expires on October 31, 2005. Rent expense for the year ended September 30, 2002 was $359,206. Future minimum lease obligations are as follows: 2003 $ 302,779 2004 $311,789 2005 $239,018 14 ITEM 3. LEGAL PROCEEDINGS The following information was reported by Celsion under Item 5 in a Current Report on Form 8-K dated January 25, 2002 filed with the Securities and Exchange Commission (SEC) on January 29, 2002: As previously reported, on April 27, 2000, Celsion commenced an action (the "Original Suit") in the United States District Court for the District of Maryland (the "Maryland Court") against Warren C. Stearns, a former director of the Company ("W.C. Stearns"), Mr. Stearns' management company and a number of his affiliates, family members and colleagues (collectively, the "Original Defendants"), who held warrants (the "Original Warrants") for the purchase of approximately 4.1 million shares of Celsion's Common Stock at $0.41 per share. On January 18, 2001, the Maryland Court transferred the case to the United States District Court for the Northern District of Illinois, in Chicago (the "Chicago Court"). On July 17, 2001, Celsion filed a motion to amend its complaint to add a second count, alleging that Mr. Stearns, on behalf of himself and the other Original Defendants, had executed a Mutual Release which released any right the Original Defendants had to exercise the warrants ("Count II"). The motion was granted on July 19, 2001. On August 9, 2001, the Original Defendants filed a counterclaim (the "Counterclaim") against the Celsion, certain of its officers and directors, and an attorney and law firm that previously had represented Celsion. On September 10, 2001, the Chicago Court dismissed, with prejudice, Count I of the Complaint. On November 23, 2001, Celsion and certain of its officers and directors filed a motion to dismiss the Counterclaim. On January 25, 2002, Celsion and Augustine Y. Cheung, Spencer J. Volk, Walter B. Herbst, LaSalle D. Leffall, Claude Tihon, John Mon, Max E. Link (all of whom are present or former officers and/or directors of the Company), George Bresler, Bresler, Goodman & Unterman LLP and The George Bresler Trust on the one hand (collectively, the "Company Parties"), and Stearns Management Company, Anthony Riker, Ltd., John T. Horton, The George T. Horton Trust, Warren R. Stearns, Charles A. Stearns, and W.C. Stearns (collectively, the "Stearns Parties"), on the other hand, entered into a settlement agreement (the "Settlement Agreement"). Pursuant to the Settlement Agreement, Celsion, among other things, has agreed (a) to pay to W.C. Stearns the lesser of (i) the Stearns Parties' actual legal fees, costs and expenses incurred in connection with the Original Suit, the Counterclaim and the Settlement Agreement or (ii) $265,000; (b) to issue to the Stearns Parties warrants (the "Settlement Warrants") to purchase a total of 6,325,821 shares of Celsion's Common Stock, at an exercise price of $0.01 per share; and (c) to register for resale the shares underlying the Settlement Warrants. The Settlement Warrants are in replacement of the Original Warrants, the validity of which was at issue in the Original Suit. However, while the Original Warrants, among other things, contained antidilution provisions ensuring the Stearns Parties the right to purchase 4.6875% of Celsion's Common Stock, on a fully diluted basis, until completion of the Celsion's next public offering (as defined) and a renewal right at the election of the holder, the Settlement Warrants contain no such provisions. In addition, pursuant to the Settlement Agreement, the Company Parties, on the one hand, and the Stearns Parties, on the other, unconditionally released one another from any and all claims arising prior to the effective date of the Settlement Agreement and agreed to dismiss, with prejudice, the Original Suit, including the Counterclaim. The Settlement Agreement has the effect of fully and finally resolving the matters in dispute in the Original Suit and the Counterclaim between the Company Parties, on the one hand, and the Stearns Parties, on the other hand. ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS Not applicable. 15 PART II ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS MARKET PRICE FOR OUR COMMON STOCK Our Common Stock trades on The American Stock Exchange. The following table sets forth the high and low sales prices for our Common Stock reported by The American Stock Exchange. The quotations set forth below do not include retail markups, markdowns or commissions. High Low FISCAL YEAR ENDED SEPTEMBER 30, 2001 First Quarter (October 1 - December 31, 2000) $ 2.19 $ 0.75 Second Quarter (January 1 - March 31, 2001) $ 3.75 $ 0.94 Third Quarter (April 1 - June 30, 2001) $ 1.25 $ 0.60 Fourth Quarter (July 1 - September 30, 2001) $ 0.85 $ 0.40 FISCAL YEAR ENDED SEPTEMBER 30, 2002 First Quarter (October 1 - December 31, 2001) $ 0.68 $ 0.40 Second Quarter (January 1 - March 31, 2002) $ 0.98 $ 0.59 Third Quarter (April 1 - June 30, 2002) $ 0.80 $ 0.40 Fourth Quarter (July 1 - September 30, 2002) $ 0.53 $ 0.34 On December 23, 2002, the last reported sale price for our Common Stock on The American Stock Exchange was $0.41 As of December 23, 2002, there were approximately 1,300 holders of record of our Common Stock. DIVIDEND POLICY We have never declared or paid any cash dividends on our Common Stock or other securities and do not currently anticipate paying cash dividends in the foreseeable future. ISSUANCE OF SHARES WITHOUT REGISTRATION During the fiscal quarter ended September 30, 2002, we issued the following securities without registration under the Securities Act of 1933, as amended (the "Securities Act"): - On August 1, 2002, Celsion issued a total of 200,000 shares of its Common Stock for cash consideration of $2,000 upon exercise of stock purchase warrants. On September 4, 2002, Celsion issued a total of 150,000 shares of its Common Stock for cash consideration of $1,500 upon exercise of stock purchase warrants. On September 12, 2002, Celsion issued a total of 200,000 shares of its Common Stock for cash consideration of $2,000 upon exercise of stock purchase warrants. On September 24, 2002, Celsion issued a total of 250,000 shares of its Common Stock for cash consideration of $2,500 upon exercise of stock purchase warrants. On September 26, 2002, Celsion issued a total of 200,000 shares of its Common Stock for cash consideration of $2,000 upon exercise of stock purchase warrants. These shares are restricted stock, and the certificates representing such shares are endorsed with Celsion's standard restrictive legend, with a stop transfer instruction recorded by the transfer agent. Accordingly, Celsion views the shares issued as exempt from registration under Sections 4(2) and/or 4(6) of the Securities Act. - On July 1, 2002, Celsion also issued 14,709 shares of its Common Stock to a consultant for services valued at $7,500. These shares are restricted stock, and the certificates representing such shares are endorsed with the Celsion's standard restricted stock legend, with a stop transfer instruction recorded by the transfer agent. Accordingly, Celsion views the shares issued as exempt from registration under Sections 4(2) and/or 4(6) of the Securities Act. - On September 4, 2002, Celsion issued 918,000 shares of its Common Stock upon conversion of 459 shares of its Series B 8% Convertible Preferred Stock. These shares are restricted stock, and the certificates representing such shares are endorsed with Celsion's standard restricted stock legend, with a stop transfer instruction recorded by the transfer agent. Accordingly, Celsion views the shares issued as exempt from registration under Sections 4(2) and/or 4(6) of the Securities Act. 16 Celsion views these issuances as transactions by an issuer not involving any public offering and therefore as exempt from registration under Sections 4(2) and/or 4(6) of the Securities Act. See also "Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters." ITEM 6. SELECTED FINANCIAL DATA The following table contains certain financial data for Celsion for the five fiscal years ended September 30, 2002 is qualified in its entirety by, and should be read in conjunction with, the "Item 8. Financial Statements and Supplementary Data and Financial Disclosure" and "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations." YEAR ENDED SEPTEMBER 30, 1998 1999 2000 2001 2002 ------------ ------------ ------------ ------------ ------------ STATEMENT OF OPERATIONS DATA: Revenues: Product Sales (Net) $ 174,182 $ -- $ 3,420 $ -- $ -- Research and development contracts -- -- -- -- -- ------------ ------------ ------------ ------------ ------------ Total revenues 174,182 3,420 Cost of sales 136,500 -- 246 -- -- ------------ ------------ ------------ ------------ ------------ Gross profit on product sales 37,682 -- 3,174 -- -- ------------ ------------ ------------ ------------ ------------ Other costs and expenses: Selling, general and administrative 2,515,822 1,371,161 2,662,623 3,211,625 4,833,005 Research and development 1,534,872 1,019,941 2,238,292 4,075,249 5,004,687 ------------ ------------ ------------ ------------ ------------ Total operating expenses 4,050,694 2,391,102 4,900,915 7,286,874 9,837,692 ------------ ------------ ------------ ------------ ------------ (Loss) from operations (4,013,012) (2,391,102) (4,897,741) (7,286,874) (9,837,692) ------------ ------------ ------------ ------------ ------------ Other income (expense) 11,870 15,744 -- 45,609 38,289 Interest income (expense) (199,346) (60,834) 350,526 318,038 48,321 ------------ ------------ ------------ ------------ ------------ Net (loss) $ (4,200,488) $ (2,436,192) $ (4,547,215) $ (6,923,227) $ (9,751,082) ============ ============ ============ ============ ============ Net loss per share $ (0.12) $ (0.05) $ (0.08) $ (0.10) $ (0.12) ============ ============ ============ ============ ============ Weighted average shares outstanding 34,867,001 45,900,424 59,406,921 72,249,920 87,257,672 AS OF SEPTEMBER 30, 1998 1999 2000 2001 2002 ------------ ------------ ------------ ------------ ------------ BALANCE SHEET DATA: Cash and cash equivalents $ 54,920 $ 1,357,464 $ 8,820,196 $ 2,510,136 $ 928,819 Working Capital (2,000,351) 906,926 8,509,173 2,388,900 735,216 Total Assets 330,738 1,558,684 9,117,821 2,956,861 2,291,449 Long-term debt, less current maturities -- -- -- 15,203 -- Redeemable preferred stock: Series A 10% Convertible Preferred Stock -- -- 5,176,000 1,099,584 1,130,500 Series B 8% Convertible Preferred Stock -- -- -- -- 1,396,285 Accumulated deficit (19,464,010) (21,900,202) (26,770,917) (33,928,781) (43,820,081) Total stockholders' equity (deficit) (1,851,067) 1,037,125 8,726,429 2,669,217 1,516,490 17 ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FORWARD-LOOKING STATEMENTS Certain of the statements contained in this Annual Report on Form 10-K/A, including certain in this section, are forward-looking. In addition, from time to time we may publish forward-looking statements relating to such matters as anticipated financial performance, business prospects, technological developments, new products, research and development activities and similar matters. These statements involve known and unknown risks, uncertainties, and other factors that may cause our or our industry's actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance, or achievements expressed or implied by such forward-looking statements. Such factors include, among other things, unforeseen changes in the course of research and development activities and in clinical trials; possible changes in cost and timing of development and testing, capital structure, and other financial items; changes in approaches to medical treatment; introduction of new products by others; possible acquisitions of other technologies, assets or businesses; possible actions by customers, suppliers, strategic partners, potential strategic partners, competitors and regulatory authorities, as well as those listed under "Risk Factors" below and elsewhere in this Annual Report on Form 10-K/A. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential" or "continue" or the negative of such terms or other comparable terminology. Forward-looking statements are only predictions. Actual events or results may differ materially. In evaluating these statements, you should specifically consider various factors, including the risks outlined under "Risk Factors." Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of such statements, or for updating such statements after the date hereof. BASIS OF PRESENTATION Since inception, the Company has incurred substantial operating losses, principally from expenses associated with our research and development programs, the clinical trials conducted in connection with our thermotherapy systems and applications for submission to the Food and Drug Administration. We believe these expenditures are essential for the commercialization of our technologies. As a result of these expenditures, as well as related general and administrative expenses Celsion had an accumulated deficit of $43,820,081 as of September 30, 2002. We expect such operating losses to continue in the near term and for the foreseeable future as we continue our product development efforts, and undertake marketing and sales activities. Celsion's ability to achieve profitability is dependent upon its ability to successfully obtain governmental approvals, produce, market and sell its new technology and integrate such technology into its thermotherapy systems. There can be no assurance that we will be able to commercialize our technology successfully or that we ever will achieve profitability. Our operating results have fluctuated significantly in the past and we expect that such results will fluctuate significantly from quarter to quarter in the future and will depend on a number of factors, many of which are outside Celsion's control. We will need substantial additional funding in order to complete the development, testing and commercialization of our cancer treatment and BPH products and of potential new products. It is our current intention both to increase the pace of development work on our present products and to make a significant commitment to thermo-sensitive liposome and gene therapy research and development projects. The increase in the scope of present development work and such new projects will require additional funding, at least until we are able to begin marketing our products. If adequate funding is not available in the future, Celsion may be required to delay, scale-back or eliminate certain aspects of its operations or to attempt to obtain funds through onerous arrangements with partners or others that may force us to relinquish rights to certain of our technologies, products or potential markers. Furthermore, if we cannot fund its ongoing development and other operating requirements, and particularly those associated with our obligation to conduct clinical trials under our licensing agreements, Celsion will be in breach of its commitments under such licensing agreements and could therefore lose its license rights, with material adverse effects Celsion. Management is continuing its efforts to obtain additional funds so that Celsion can meet its obligations and sustain operations. 18 RESULTS OF OPERATIONS Comparison of Fiscal Year Ended September 30, 2002 and Fiscal Year Ended September 30, 2001 We generated no revenues during the fiscal year ended September 30, 2002 or the fiscal year ended September 30, 2001. Research and development expenditures in the year ended September 30, 2002 were $5,004,687, an increase of $929,438, or 23%, compared to the fiscal year ended September 30, 2001. The increase was attributable to costs incurred in undertaking pivotal Phase II clinical trials for both our BPH and breast cancer treatment systems. These costs included increased personnel costs as well as costs related to the acquisition of equipment and materials necessary to complete the trials. Additionally, during the year we completed the large animal toxicity studies using our heat-activated liposomes. Selling, general and administrative expense increased by 52%, to $4,833,005 for the fiscal year ended September 30, 2002 compared to $3,211,625 for the fiscal year ended September 30, 2002. The increase was due primarily to increased staffing and legal costs associated with private placements and various SEC filings. Celsion also incurred costs associated with settlement of its ongoing lawsuit with Warren C. Stearns and his associates. Under the terms of the settlement, Celsion issued to the Stearns group certain Common Stock purchase warrants that were at issue in the litigation, together with additional warrants as compensation for relinquishment of certain anti-dilution rights under the disputed warrants and up to $265,000 in cash to reimburse Stearns for costs incurred up to the settlement date. Celsion accrued the remaining amounts due to Spencer J. Volk, its former President and Chief Executive Officer, under the terms of the agreement governing his retirement. Finally, Celsion incurred consulting costs related to the exploration of the feasibility of setting up a business in China (including Hong Kong, Taiwan and Macao). The increase in research and development, selling, general and administrative expenses described above, together with the absence of revenues during the relevant periods, resulted in a loss from operations of $9,837,692 for the year ending September 30, 2002 compared to a loss $7,286,874 for the year ended September 30, 2001, representing an increase of $2,550,818. Interest income net of interest expense decreased by $269,717 to $48,321 for the fiscal year ended September 30, 2002 compared to $318,038 for the fiscal year ended September 30, 2001. This decrease is the result of a combination of lower average funds available for investment and lower interest rates in fiscal 2002. Comparison of Fiscal Year Ended September 30, 2001 and Fiscal Year Ended September 30, 2000 We generated no revenues during the fiscal year ended September 30, 2001, compared to revenues on the sale of parts and equipment in the amount of $3,240 during the fiscal year ended September 30, 2000. Research and development expenditures in the year ended September 30, 2001 were $4,075,249, an increase of $1,836,957, or 82%, compared to the fiscal year ended September 30, 2000. The increase was attributable to costs incurred in undertaking pivotal Phase II clinical trials for both our BPH and breast cancer treatment systems. These costs included increased personnel costs as well as costs related to the acquisition of equipment and materials necessary to complete the trials. Additionally, during the year we initiated development of our heat-activated liposomes by formulating the drug and undertaking large animal toxicity studies. Selling, general and administrative expense increased by 21%, to $3,211,625 for the fiscal year ended September 30, 2001 compared to $2,662,623 for the fiscal year ended September 30, 2000. The increase was due primarily to increased staffing, principally our newly retained Chief Financial Officer, and legal costs associated with the conversion of the Series A 10% Convertible Preferred Stock, various SEC filings and settlement of a long-standing trade dispute with a former distributor in Hong Kong. The increase in research and development, selling, general and administrative expenses described above, together with the absence of revenues, resulted in a loss from operations of $7,286,874 for the year ending September 30, 2001 compared to a loss $4,897,741 for the year ended September 30, 2000, representing an increase of $2,389,133. Interest income net of interest expense decreased by $32,488, to $318,038 for the fiscal year ended September 30, 2001 compared to $350,526 for the fiscal year ended September 30, 2000. This decrease reflects the fact that, as Celsion has no revenues, all expenditures are met from cash reserves. As cash reserves declined, interest income is likewise reduced. 19 LIQUIDITY AND CAPITAL RESOURCES Since inception, our expenses have significantly exceeded our revenues, resulting in an accumulated deficit of $43,820,081 at September 30, 2002. We have incurred negative cash flows from operations since our inception and have funded our operations primarily through the sale of equity securities. As of September 30, 2002, we had cash of $928,819 and total current assets of $1,510,175, compared with current liabilities of $774,959, resulting in a working capital surplus of $735,216. As of September 30, 2001, we had $2,510,136 in cash and total current assets of $2,661,341, compared with current liabilities of $272,441, which resulted in a working capital surplus of $2,388,900 at fiscal year end. The decrease in working capital at September 30, 2002 as compared to September 30, 2001 was due to the fact that, during the past fiscal year, we drew on our cash reserves to pay for our ongoing operations. We do not have any bank financing arrangements and have funded our operations primarily through private placement offerings of equity securities. On October 15, 2002, Celsion completed a private placement resulting in net proceeds of approximately $748,000 and, on November 12, 2002, Celsion completed a private placement generating approximately $300,000 in net proceeds. For all of fiscal year 2003, we expect to expend a total of approximately $8,500,000 for clinical testing of our breast cancer and BPH treatment systems, as well as corporate overhead, which we expect to fund from our current resources. The foregoing amounts are estimates based upon assumptions as to the availability of funding, the scheduling of institutional clinical research and testing personnel, the timing of clinical trials and other factors, not all of which are fully predictable. Accordingly, estimates and timing concerning projected expenditures and programs are subject to change. We expect to fund our operations through the 2003 fiscal year though a combination of private placements of equity and up-front and other funding contributed by one or more strategic partners for the BPH business. Additionally, if as currently anticipated our BPH system is approved for marketing during the course of fiscal 2003 funding could be generated from the sale of catheters. Our available cash on hand is sufficient to fund our activities through December 31, 2002. Subsequent to December 30, 2002, we received further funding through a private placement of $425,000 and issuance of a note in the amount of $500,000 which funds will be sufficient to fund operations through February 2003. On January 21, 2003, Celsion reached an agreement with Boston Scientific Corporation under which Boston Scientific will market and distribute the Company's BPH treatment system. In connection with this agreement Boston Scientifc purchased $5 million of Celsion Common Stock and agreed to invest a further $10 million in a combination equity and licensing fees upon Celsion meeting certain milestones. The initial investment will be sufficient to repay the $500,000 note and to fund the Company's operations through the end of fiscal year 2003 and further investments will contribute to Celsion's funding requirements for the future. Our dependence on raising additional capital will continue at least until we are able to begin marketing our new technologies. Our future capital requirements and the adequacy of our financing depend upon numerous factors, including the successful commercialization of our Microwave Uretheroplasty(TM) and breast cancer treatment systems, progress in product development efforts, progress with pre-clinical studies and clinical trials, the cost and timing of production arrangements, the development of effective sales and marketing activities, the cost of filing, prosecuting, defending and enforcing intellectual property rights, competing technological and market developments and the development of strategic alliances for the marketing of our products. We will be required to obtain such funding through equity or debt financing, strategic alliances with corporate partners and others, or through other sources not yet identified. We do not have any committed sources of financing, and cannot guarantee that additional funding will be available in a timely manner, on acceptable terms, or at all. If adequate funds are not available, we may be required to delay, scale back or eliminate certain aspects of our operations or attempt to obtain funds through unfavorable arrangements with partners or others that may require us to relinquish rights to certain of our technologies, product candidates, products or potential markets or which otherwise may be materially unfavorable to us. Furthermore, if we cannot fund our ongoing development and other operating requirements, particularly those associated with our obligation to conduct clinical trials under our licensing agreements, we will be in breach of our commitments under these licensing agreements and could therefore lose our license rights, which could have material adverse effects on our business. 20 RISK FACTORS Among numerous risk factors that may affect our future performance and our ability to achieve profitable operations are the following: WE HAVE A HISTORY OF SIGNIFICANT LOSSES AND EXPECT TO CONTINUE SUCH LOSSES FOR THE FORESEEABLE FUTURE. -------------------------------------------------------------------------------- Since Celsion's inception in 1982, our expenses have substantially exceeded our revenues, resulting in continuing losses and an accumulated deficit of $43,820,081 at September 30, 2002, including losses of $6,923,227 for the fiscal year ended September 30, 2001 and $9,751,082 for the fiscal year ended September 30, 2002. Because we presently have no revenues and are committed to continuing our product research, development and commercialization programs, we will continue to experience significant operating losses unless and until we complete the development of new products and these products have been clinically tested, approved by the FDA and successfully marketed. We have funded our operations primarily through the sale of Celsion's securities and have limited working capital for our product research, development, commercialization and other activities. WE DO NOT EXPECT TO GENERATE SIGNIFICANT REVENUE FOR THE FORESEEABLE FUTURE. -------------------------------------------------------------------------------- We marketed and sold our original microwave thermotherapy products, which produced modest revenues from 1990 to 1994, but ceased marketing these products in 1995. We have devoted our resources in ensuing years to developing a new generation of thermotherapy and other products, but cannot market these products unless and until we have completed clinical testing and obtained all necessary governmental approvals. Accordingly, we have no current source of revenues, much less profits, to sustain our present operations, and no revenues will be available unless and until our new products are clinically tested, approved by the FDA and successfully marketed. We cannot guarantee that any or all of our products will be successfully tested, approved by the FDA or marketed, successfully or otherwise, at any time in the foreseeable future or at all. OUR MICROWAVE HEAT THERAPY TECHNOLOGY IS STILL UNDERGOING CLINICAL TESTING AND MAY NOT ACHIEVE SUFFICIENT ACCEPTANCE BY THE MEDICAL COMMUNITY TO SUSTAIN OUR BUSINESS. -------------------------------------------------------------------------------- To date, microwave heat therapy has not been widely accepted in the United States medical community as an effective treatment for BPH or for cancer treatment, with or without the concurrent use of radiation. We believe that this is primarily due to the inability of earlier technology adequately to focus and control heat directed at specific tissue locations and to conclusions that were drawn from a widely publicized study by the Radiation Oncology Therapy Group that purported to show that thermotherapy in conjunction with radiation was only marginally effective. Subsequent to the publication of that study, the Health Care Financing Administration, a HCFA (now known as the Centers for Medicare and Medicaid Services, or CMS) established a low medical reimbursement rate for all thermotherapy equipment designed to be used in conjunction with radiation. While management believes that our new technology is capable of overcoming the limitations of the earlier technology, the medical community may not embrace the perceived advantages of our "adaptive phased array," or APA, focused heat therapy without more extensive testing and clinical experience than we will be able to provide. To date, we have completed and submitted to the FDA only Phase I clinical trials of our Microwave Uretheroplasty(TM) treatment system, although we have completed patient treatments in our Phase II trials. Our PMA application is being submitted on a modular basis, consisting of three separate filings: a manufacturing module, a pre-clinical module and a module consisting of 12-month patient follow-up data. The first two out of three modules were submitted in November 2001 and we expect to submit the remaining module after the 12-month patient follow-up data has been collected and the first two modules have been cleared by the FDA. The manufacturing module has been cleared, we anticipate that the FDA will clear the pre-clinical module in the near future and we have completed collection of the 12-month patient follow-up data. Therefore, we presently anticipate that we will submit the third module early in 2003. Our new breast cancer treatment technology is currently in Phase II trials. Our technology may not prove as effective in practice as we anticipate based on testing to date. If further testing and clinical practice do not confirm the safety and efficacy of our technology or, even if further testing and practice produce positive results but the medical community does not view this new form of heat therapy as effective and desirable, our efforts to market our new products may fail, with material adverse consequences to our business. We intend to petition CMS for a new reimbursement code for our breast cancer treatment. The success of our business model depends significantly upon our ability to petition successfully for favorable reimbursement codes. However, we cannot offer any assurances as to when, if ever, CMS may act on our request to establish a reimbursement code for our breast cancer treatment system. In addition, there can be no assurance that the reimbursement level established for our breast cancer treatment system, if established, will be sufficient for us to carry out our business plan effectively. IF WE ARE NOT ABLE TO OBTAIN NECESSARY FUNDING, WE WILL NOT BE ABLE TO COMPLETE THE DEVELOPMENT, TESTING AND COMMERCIALIZATION OF OUR TREATMENTS AND PRODUCTS. -------------------------------------------------------------------------------- We will need substantial additional funding in order to complete the development, testing and commercialization of our BPH and breast cancer treatment systems and heat-activated liposome and cancer repair inhibitor products, as well as other potential new products. We expended approximately $9,359,311 in the 12 months ending September 30, 2002. As of that date, we had 21 available a total of approximately $928,900 to fund additional expenditures. On October 15, 2002, Celsion completed a private placement resulting in net proceeds of approximately $748,000 and, on November 12, 2002, Celsion completed a private placement generating approximately $300,000 in net proceeds. Our available cash on hand is sufficient to fund our activities through December 31, 2002, although since December 30, 2002 we received further funding through a private placement of $425,000 and issuance of a note in the amount of $500,000, which funds will be sufficient to fund operations through February 2003. On January 21, 2003, Celsion reached an agreement with Boston Scientific Corporation under which Boston Scientific will market and distribute the Company's BPH treatment system. In connection with this agreement Boston Scientifc purchased $5 million of Celsion Common Stock and agreed to invest a further $10 million in a combination of equity and licensing fees upon Celsion meeting certain milestones. The initial investment will be sufficient to repay the $500,000 note and fund operations through the end of fiscal year 2003 and further investments will contribute to Celsion's funding requirements for the future. In addition, it is our current intention both to increase the pace of development work on our present products and to make a significant commitment to our heat-activated liposome and cancer repair inhibitor research and development projects. The increase in the scope of present development work and the commitment to these new projects, as well as our ongoing activities, will require additional external funding, at least until we are able to begin marketing our products and to generate sufficient cash flow from the sale of those products to support our continued operations. We do not have any committed sources of financing and cannot offer any assurances that additional funding will be available in a timely manner, on acceptable terms or at all. If adequate funding is not available, we may be required to delay, scale back or eliminate certain aspects of our operations or attempt to obtain funds through unfavorable arrangements with partners or others that may force us to relinquish rights to certain of our technologies, products or potential markets or that could impose onerous financial or other terms. Furthermore, if we cannot fund our ongoing development and other operating requirements, particularly those associated with our obligations to conduct clinical trials under our licensing agreements, we will be in breach of these licensing agreements and could therefore lose our license rights, which could have material adverse effects on our business. OUR BUSINESS IS SUBJECT TO NUMEROUS AND EVOLVING STATE, FEDERAL AND FOREIGN REGULATIONS AND WE MAY NOT BE ABLE TO SECURE THE GOVERNMENT APPROVALS NEEDED TO DEVELOP AND MARKET OUR PRODUCTS. -------------------------------------------------------------------------------- Our research and development activities, pre-clinical tests and clinical trials, and ultimately the manufacturing, marketing and labeling of our products, all are subject to extensive regulation by the FDA and foreign regulatory agencies. Pre-clinical testing and clinical trial requirements and the regulatory approval process typically take years and require the expenditure of substantial resources. Additional government regulation may be established that could prevent or delay regulatory approval of our product candidates. Delays or rejections in obtaining regulatory approvals would adversely affect our ability to commercialize any product candidates and our ability to generate product revenues or royalties. The FDA and foreign regulatory agencies require that the safety and efficacy of product candidates be supported through adequate and well-controlled clinical trials. If the results of pivotal clinical trials do not establish the safety and efficacy of our product candidates to the satisfaction of the FDA and other foreign regulatory agencies, we will not receive the approvals necessary to market such product candidates. Even if regulatory approval of a product candidate is granted, the approval may include significant limitations on the indicated uses for which the product may be marketed. Also, manufacturing establishments in the United States and abroad are subject to inspections and regulations by the FDA. Medical devices must also continue to comply with the FDA's Quality System Regulation, or QSR. Compliance with such regulations requires significant expenditures of time and effort to ensure full technical compliance. The FDA stringently applies regulatory standards for manufacturing. We are also subject to record keeping and reporting regulations, including FDA's mandatory Medical Device Reporting, or MDR regulation. Labeling and promotional activities are regulated by the FDA and, in certain instances, by the Federal Trade Commission. Many states in which we do or in the future may do business or in which our products may be sold impose licensing, labeling or certification requirements that are in addition to those imposed by the FDA. There can be no assurance that one or more states will not impose regulations or requirements that have a material adverse effect on our ability to sell our products. In many of the foreign countries in which we may do business or in which our products may be sold, we will be subject to regulation by national governments and supranational agencies as well as by local agencies affecting, among other things, product standards, packaging requirements, labeling requirements, import restrictions, tariff regulations, duties and tax 22 requirements. There can be no assurance that one or more countries or agencies will not impose regulations or requirements that could have a material adverse effect on our ability to sell our products. The European Union, or EU, has a registration process that includes registration of manufacturing facilities (known as "ISO certification") and product certification (known as a "CE Mark"). We have obtained ISO certification for our existing facilities. However, there is no guarantee that we will be successful in obtaining EU certifications for any new facilities or for our products, or that we will be able to maintain our existing certifications in the future. Foreign government regulation may delay marketing of our new products for a considerable period of time, impose costly procedures upon our activities or provide an advantage to larger companies that compete with us. There can be no assurance that we will be able to obtain necessary regulatory approvals, on a timely basis or at all, for any products that we develop. Any delay in obtaining, or failure to obtain, necessary approvals would materially and adversely affect the marketing of our contemplated products subject to such approvals and, therefore, our ability to generate revenue from such products. Even if regulatory authorities approve our product candidates, such products and our facilities, including facilities located outside the EU, may be subject to ongoing testing, review and inspections by the European health regulatory authorities. After receiving premarketing approval, in order to manufacture and market any of its products, we will have to comply with regulations and requirements governing manufacture, labeling and advertising on an ongoing basis. Failure to comply with applicable domestic and foreign regulatory requirements, can result in, among other things, warning letters, fines, injunctions and other equitable remedies, civil penalties, recall or seizure of products, total or partial suspension of production, refusal of the government to grant approvals, pre-market clearance or pre-market approval, withdrawal of approvals and criminal prosecution of Celsion and its employees, all of which would have a material adverse effect on our business. OUR BUSINESS DEPENDS ON LICENSE AGREEMENTS WITH THIRD PARTIES TO PERMIT US TO USE PATENTED TECHNOLOGIES. THE LOSS OF ANY OF OUR RIGHTS UNDER THESE AGREEMENTS COULD IMPAIR OUR ABILITY TO DEVELOP AND MARKET OUR PRODUCTS. -------------------------------------------------------------------------------- Currently, we have nine utility patents pending in the United States Patent & Trademark Office. One application directed to our breast cancer treatment and another application directed to our Microwave Uretheroplasty(TM) treatment for BPH have been allowed and should issue as United States patents within the next few months. We have filed international applications with respect to the above technologies in various countries including Japan, China, Europe, and Canada. Three additional U.S. utility applications are on file directed to various features of our breast cancer treatment and three additional applications are on file directed to different features of our thermotherapy treatment of BPH. The ninth application on file is directed to our deep tumor therapy treatment. However, even when our pending applications mature into United States patents, our business will still depend on license agreements that we have entered into with third parties until the third parties' patents expire. We intend to file applications for international patent protections for inventions covered by our U.S. applications. However, there can be no assurance when, if ever, we will receive such international patent protection. Our success will depend, in substantial part, on our ability to maintain our rights under license agreements granting us rights to use patented technologies. We have entered into exclusive license agreements with MIT, for APA technology, and with MMTC, a privately owned developer of medical devices, for microwave balloon catheter technology. We have also entered into a license agreement with Duke University, under which we have exclusive rights to commercialize medical treatment products and procedures based on Duke University's thermo-liposome technology and a license agreement with Memorial Sloan-Kettering Cancer Center under which we have rights to commercialize certain cancer repair inhibitor products. The MIT, MMTC, Duke University and Sloan-Kettering agreements each contain license fee, royalty and/or research support provisions, testing and regulatory milestones, and other performance requirements that we must meet by certain deadlines. If we were to breach these or other provisions of the license and research agreements, we could lose our ability to use the subject technology, as well as compensation for our efforts in developing or exploiting the technology. Also, loss of our rights under the MIT license agreement would prevent us from proceeding with our most current product development efforts, which are dependent on licensed APA technology. Any such loss of rights and access to technology would have a material adverse effect on our business. Further, we cannot guarantee that any patent or other technology rights licensed to us by others will not be challenged or circumvented successfully by third parties, or that the rights granted will provide adequate protection. We are aware of published patent applications and issued patents belonging to others, and it is not clear whether any of these patents or applications, or 23 other patent applications of which we may not have any knowledge, will require us to alter any of our potential products or processes, pay licensing fees to others or cease certain activities. Litigation, which could result in substantial costs, may also be necessary to enforce any patents issued to or licensed by us or to determine the scope and validity of others' claimed proprietary rights. We also rely on trade secrets and confidential information that we seek to protect, in part, by confidentiality agreements with our corporate partners, collaborators, employees and consultants. We cannot guarantee that these agreements will not be breached, that, even if not breached, they are adequate to protect our trade secrets, that we will have adequate remedies for any breach or that our trade secrets will not otherwise become known to, or will not be discovered independently by, competitors. TECHNOLOGIES FOR THE TREATMENT OF CANCER ARE SUBJECT TO RAPID CHANGE AND THE DEVELOPMENT OF TREATMENT STRATEGIES THAT ARE MORE EFFECTIVE THAN OUR THERMOTHERAPY TECHNOLOGY COULD RENDER OUR TECHNOLOGY OBSOLETE. -------------------------------------------------------------------------------- Various methods for treating cancer currently are, and in the future may be expected to be, the subject of extensive research and development. Many possible treatments that are being researched, if successfully developed, may not require, or may supplant, the use of our thermotherapy technology. These alternate treatment strategies include the use of radio frequency (RF), laser and ultrasound energy sources. The successful development and acceptance of any one or more of these alternative forms of treatment could render our technology obsolete as a cancer treatment method. WE MAY NOT BE ABLE TO HIRE OR RETAIN KEY OFFICERS OR EMPLOYEES THAT WE NEED TO IMPLEMENT OUR BUSINESS STRATEGY AND DEVELOP OUR PRODUCTS AND BUSINESSES. -------------------------------------------------------------------------------- Our success depends significantly on the continued contributions of our executive officers, scientific and technical personnel and consultants, and on our ability to attract additional personnel as we seek to implement our business strategy and develop our products and businesses. During our operating history, we have assigned many essential responsibilities to a relatively small number of individuals. However, as our business and the demands on our key employees expand, we have been, and will continue to be, required to recruit additional qualified employees. The competition for such qualified personnel is intense, and the loss of services of certain key personnel or our inability to attract additional personnel to fill critical positions as we implement our business strategy could adversely affect our business. Effective October 4, 2001, Spencer J. Volk, formerly the President, Chief Executive Officer and a director of Celsion, resigned from all of these positions. Our Board has appointed Dr. Augustine Y. Cheung, formerly the Chairman and Chief Scientific Officer, to serve as Celsion's President and Chief Executive Officer and Dr. Max Link, a director since 1997, has assumed the position of Chairman of the Board. Effective September 20, 2002, Dr. LaSalle Leffall resigned as a member of our Board of Directors. At its meeting on December 27, 2002, the Board appointed Dr. Gary Pace to fill the remainder of Dr. Leffall's term and to reduce the number of directors constituting the whole Board from seven to six. OUR SUCCESS WILL DEPEND IN PART ON OUR ABILITY TO GROW AND DIVERSIFY, WHICH IN TURN WILL REQUIRE THAT WE MANAGE AND CONTROL OUR GROWTH EFFECTIVELY. -------------------------------------------------------------------------------- Our business strategy contemplates growth and diversification. As we add to our manufacturing, marketing, sales, research and development and other capabilities, our operating expenses and capital requirements will increase. Our ability to manage growth effectively will require that we continue to expend funds to improve our operational, financial and management controls, reporting systems and procedures. In addition, we must effectively expand, train and manage our employees. We will be unable to manage our business effectively if we are unable to alleviate the strain on resources caused by growth in a timely and successful manner. There can be no assurance that we will be able to manage our growth and a failure to do so could have a material adverse effect on our business. THE SUCCESS OF OUR PRODUCTS MAY BE HARMED IF THE GOVERNMENT, PRIVATE HEALTH INSURERS AND OTHER THIRD-PARTY PAYORS DO NOT PROVIDE SUFFICIENT COVERAGE OR REIMBURSEMENT. -------------------------------------------------------------------------------- Our ability to commercialize our thermotherapy technology successfully will depend in part on the extent to which reimbursement for the costs of such products and related treatments will be available from government health administration authorities, private health insurers and other third-party payors. The reimbursement status of newly approved medical products is subject to significant uncertainty. We cannot guarantee that adequate third-party insurance coverage will be available for us to establish and maintain price levels sufficient for us to realize an appropriate return on our investment in developing new therapies. Government, private health insurers and other third-party payors are increasingly attempting to contain health care costs by limiting both coverage and the level of reimbursement for new therapeutic 24 products approved for marketing by the FDA. Accordingly, even if coverage and reimbursement are provided by government, private health insurers and third-party payors for uses of our products, market acceptance of these products would be adversely affected if the reimbursement available proves to be unprofitable for health care providers. WE FACE INTENSE COMPETITION AND THE FAILURE TO COMPETE EFFECTIVELY COULD ADVERSELY AFFECT OUR ABILITY TO DEVELOP AND MARKET OUR PRODUCTS. -------------------------------------------------------------------------------- There are many companies and other institutions engaged in research and development of thermotherapy technologies, both for prostate disease and cancer treatment products, which seek treatment outcomes similar to those that we are pursuing. In addition, a number of companies and other institutions are pursuing alternative treatment strategies through the use of microwave, infrared, radio frequency, laser and ultrasound energy sources, all of which appear to be in the early stages of development and testing. We believe that the level of interest by others in investigating the potential of thermotherapy and alternative technologies will continue and may increase. Potential competitors engaged in all areas of prostate and cancer treatment research in the United States and other countries include, among others, major pharmaceutical and chemical companies, specialized technology companies, universities and other research institutions. Substantially all of our competitors and potential competitors have significantly greater financial, technical, human and other resources, and may also have far greater experience, than do we, both in pre-clinical testing and human clinical trials of new products and in obtaining FDA and other regulatory approvals. One or more of these companies or institutions could succeed in developing products or other technologies that are more effective than the products and technologies that we have been or are developing, or which would render our technology and products obsolete and non-competitive. Furthermore, if we are permitted to commence commercial sales of any of our products, we will also be competing, with respect to manufacturing efficiency and marketing, with companies having substantially greater resources and experience in these areas. LEGISLATIVE AND REGULATORY CHANGES AFFECTING THE HEALTH CARE INDUSTRY COULD ADVERSELY AFFECT OUR BUSINESS. -------------------------------------------------------------------------------- There have been a number of federal and state proposals during the last few years to subject the pricing of health care goods and services to government control and to make other changes to the United States health care system. It is uncertain which legislative proposals, if any, will be adopted (or when) or what actions federal, state, or private payors for health care treatment and services may take in response to any health care reform proposals or legislation. We cannot predict the effect health care reforms may have on our business and we can offer no assurances that any of these reforms will not have a material adverse effect on that business. WE MAY BE SUBJECT TO SIGNIFICANT PRODUCT LIABILITY CLAIMS AND LITIGATION. -------------------------------------------------------------------------------- Our business exposes us to potential product liability risks inherent in the testing, manufacturing and marketing of human therapeutic products. We presently have product liability insurance limited to $5,000,000 per incident. If we were to be subject to a claim in excess of this coverage or to a claim not covered by our insurance and the claim succeeded, we would be required to pay the claim with our own limited resources, which could have a material adverse effect on our business. In addition, liability or alleged liability could harm the business by diverting the attention and resources of our management and by damaging our reputation. WE PRESENTLY HAVE LIMITED MARKETING AND SALES CAPABILITY AND WILL BE REQUIRED TO DEVELOP SUCH CAPABILITIES AND TO ENTER INTO ALLIANCES WITH OTHERS POSSESSING SUCH CAPABILITIES IN ORDER TO COMMERCIALIZE OUR PRODUCTS SUCCESSFULLY. -------------------------------------------------------------------------------- We intend to market our Microwave Uretheroplasty(TM) treatment system through a strategic alliances with a third party at such time, if any, as it is approved for commercialization by the FDA, and to market our breast cancer treatment system, if and when so approved, through such third parties. There can be no assurance that we will be able to establish sales and marketing capabilities successfully or successfully enter into third-party marketing or distribution arrangements. In addition, we have limited experience and capabilities in marketing, distribution and direct sales, although we intend to develop an effective sales and marketing capability as we pursue commercialization. We expect to incur significant additional expense in attracting, establishing and maintaining a marketing and sales force or entering into third-party marketing or distribution arrangements. Effective January 21, 2003 we entered in to a Distribution Agreement with Boston Scientific Corporation, pursuant to which Celsion has granted Boston Scientific exclusive rights to market and distribute the Microwave BPH 800 Urethroplasty(TM) System in all territories other than China, Taiwan, Hong Kong, Macao, Mexico and Central and South America. However, there can be no assurance that Boston Scientific or other third parties with which me may enter into commercialization arrangements will establish adequate sales and distribution capabilities or be successful in gaining market acceptance for our products and services. There can 25 be no assurance that our direct sales, marketing, licensing and distribution efforts would be successful or that revenue from such efforts would exceed expenses. WE DEPEND ON THIRD-PARTY SUPPLIERS TO PROVIDE US WITH COMPONENTS REQUIRED FOR OUR PRODUCTS AND MAY NOT BE ABLE TO OBTAIN THESE COMPONENTS ON FAVORABLE TERMS OR AT ALL. -------------------------------------------------------------------------------- We are not currently manufacturing any products, but are using our facilities to assemble prototypes of the equipment for research and development purposes. We currently purchase certain specialized microwave and thermometry components and applicator materials and the catheter unit used for our Microwave Uretheroplasty(TM) equipment from single or limited source suppliers because of the small quantities involved. While we have not experienced any significant difficulties in obtaining these components, the loss of an important current supplier could require that we obtain a replacement supplier, which might result in delays and additional expense in being able to make prototype equipment available for clinical trials and other research purposes. In addition, inasmuch as we expect to manufacture our Microwave Uretheroplasty(TM) equipment at least for some period subsequent to FDA approval and the commencement of commercialization, such manufacturing and commercialization also could be delayed. In addition, in the event that we succeed in marketing our products, we intend to use outside contractors to supply components and the Microwave Uretheroplasty(TM) catheter, and may use such contractors to assemble finished equipment in the future, which could cause us to become increasingly dependent on key vendors. WE HAVE NOT PAID DIVIDENDS IN THE PAST AND DO NOT INTEND TO DO SO FOR THE FORESEEABLE FUTURE. -------------------------------------------------------------------------------- We have never paid cash dividends and do not anticipate paying cash dividends on our Common Stock or Preferred Stock in the foreseeable future. Therefore, our stockholders cannot achieve any degree of liquidity with respect to their shares of Common Stock except by selling such shares. THE EXERCISE OR CONVERSION OF OUR OUTSTANDING OPTIONS, WARRANTS AND CONVERTIBLE PREFERRED STOCK COULD RESULT IN SIGNIFICANT DILUTION OF OWNERSHIP INTERESTS IN OUR COMMON STOCK OR OTHER CONVERTIBLE SECURITIES. -------------------------------------------------------------------------------- Options and Warrants. As of September 30, 2002, we had outstanding and exercisable warrants and options to purchase a total of 30,288,795 shares of our Common Stock at exercise prices ranging from $0.01 to $5.00 per share (and a weighted average exercise price of approximately $0.60 per share). We also had outstanding but unexercisable and unvested options to purchase a total of 4,394,998 shares of our Common Stock at exercise prices ranging from $0.50 to $1.36 per share. Some of the exercise prices are below the current market price of our Common Stock, which has ranged from a low of $0.36 to a high of $0.46 over the 20 trading days ending September 30, 2002. If holders choose to exercise such warrants and options at prices below the prevailing market price for the Common Stock, the resulting purchase of a substantial number of shares of our Common Stock would have a dilutive effect on our stockholders and could adversely affect the market price of our issued and outstanding Common Stock and convertible securities. In addition, holders of these options and warrants who have the right to require registration of the Common Stock under certain circumstances and who elect to require such registration, or who exercise their options or warrants and then satisfy the one-year holding period and other requirements of Rule 144 of the Securities Act, will be able to sell in the public market some or all of their shares of Common Stock purchased upon such exercise. Preferred Stock. As of September 30, 2002, we had outstanding a total of 893 shares of Series A 10% Convertible Preferred Stock, with an additional 238 shares of such preferred stock representing accrued dividends, and 1,591 shares of Series B 8% Convertible Preferred Stock (collectively, the "Preferred Stock"). The shares of Series A 10% Convertible Preferred Stock are subject to exchange and conversion privileges upon the occurrence of major events, including a public offering of our securities or a merger of our subsidiary with a public company. The shares of Series B 8% Convertible Preferred Stock are entitled to convert their shares at any time after September 3, 2002. In addition, the holders of the Series A and B Preferred Stock are entitled to convert their preferred shares into shares of Common Stock at a conversion price of $0.41 and $0.50 per share of Common Stock, respectively, subject to certain adjustments. The conversion of the Preferred Stock could have a dilutive effect on our stockholders and could adversely affect the market price of our issued and outstanding Common Stock and convertible securities. The holders of the Series A 10% Convertible Preferred Stock have registration rights at such time, if any, as we undertake a registered public offering of securities. The holders of the Series B 8% Convertible Preferred Stock became entitled to registration of the shares of Common Stock underlying their shares of Series B Preferred Stock as of September 3, 2002, the date on which the shares of Series B Preferred Stock first became convertible. Even without such registration, holders of the Preferred Stock who satisfy the requirements of Rule 144 of the Securities Act will be able to sell in the public market shares of Common Stock acquired upon the conversion of Preferred Stock. 26 In addition, future sales of our Common Stock, including shares issued upon the exercise of outstanding options and warrants or other derivative transactions with respect to our stock, could have a significant negative effect on the market price of our Common Stock. These sales might make it more difficult for us to sell equity securities or equity-linked securities in the future at a time and price that we would deem appropriate. IF THE PRICE OF OUR SHARES REMAINS LOW OR OUR FINANCIAL CONDITION CONTINUES TO DETERIORATE, WE MAY BE DELISTED BY THE AMERICAN STOCK EXCHANGE AND BECOME SUBJECT TO SPECIAL RULES APPLICABLE TO LOW PRICED STOCKS. -------------------------------------------------------------------------------- Our Common Stock currently trades on The American Stock Exchange (Amex). The Amex, as a matter of policy, will consider the suspension of trading in, or removal from listing of, any stock when, in the opinion of the Amex, (i) the financial condition and/or operating results of an issuer appear to be unsatisfactory; (ii) it appears that the extent of public distribution or the aggregate market value of the stock has become so reduced as to make further dealings on the Amex inadvisable; (iii) the issuer has sold or otherwise disposed of its principal operating assets; or (iv) the issuer has sustained losses which are so substantial in relation to its overall operations or its existing financial condition has become so impaired that it appears questionable, in the opinion of the Amex, whether the issuer will be able to continue operations and/or meet its obligations as they mature. For example, the Amex will consider suspending dealings in or delisting the stock of an issuer if the issuer has sustained losses from continuing operations and/or net losses in its five most recent fiscal years or for other reasons. Another instance where the Amex would consider suspension or delisting of a stock is if the stock has been selling for a substantial period of time at a low price per share and the issuer fails to effect a reverse split of such stock within a reasonable time after being notified that the Amex deems such action to be appropriate. We have sustained net losses for our last five fiscal years (and beyond) and our Common Stock has been trading at relatively low prices. Therefore, our Common Stock could be at risk for delisting by the Amex. Upon any such delisting, the Common Stock would become subject to the penny stock rules of the SEC, which generally are applicable to equity securities with a price of less than $5.00 per share (other than securities registered on certain national securities exchanges or quoted on the Nasdaq system, provided that current price and volume information with respect to transactions in such securities is provided by the exchange or system). The penny stock rules require a broker-dealer, prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document prepared by the SEC that provides information about penny stocks and the nature and level of risks in the penny stock market. The broker-dealer also must provide the customer with bid and ask quotations for the penny stock, the compensation of the broker-dealer and its salesperson in the transaction and monthly account statements showing the market value of each penny stock held in the customer's account. In addition, the penny stock rules require that, prior to a transaction in a penny stock that is not otherwise exempt from such rules, the broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser's written agreement to the transaction. These disclosure requirements are likely to have a material and adverse effect on price and the level of trading activity in the secondary market for a stock that becomes subject to the penny stock rules. If our Common Stock were to become subject to the penny stock rules it is likely that the price of the Common Stock would decline and that our stockholders would find it more difficult to sell their shares. OUR STOCK IS THINLY TRADED. THEREFORE INVESTORS MAY FIND IT DIFFICULT TO SELL THEIR SHARES. -------------------------------------------------------------------------------- While our Common Stock is listed on The American Stock Exchange, the volume of trading historically has been relatively light. Further, there can be no assurance that the market in our shares will be sustained in the future. Therefore, there can be no assurances that stockholders will be able to sell their shares at the time or price that they desire or at all or that stockholders will be able to achieve liquidity as desired. OUR STOCK PRICE COULD BE VOLATILE. -------------------------------------------------------------------------------- Market prices for our Common Stock and the securities of other medical, high technology companies have been volatile. Factors such as announcements of technological innovations or new products by us or by our competitors, government regulatory action, litigation, patent or proprietary rights developments and market conditions for medical and high technology stocks in general can have a significant impact on the market for our Common Stock. ANTI-TAKEOVER PROVISIONS IN OUR CHARTER DOCUMENTS AND DELAWARE LAW COULD PREVENT OR DELAY A CHANGE IN CONTROL. -------------------------------------------------------------------------------- Our Certificate of Incorporation and Bylaws may discourage, delay or prevent a merger or acquisition that a stockholder may consider favorable by authorizing the issuance of "blank check" preferred stock. In addition, our 27 classified Board of Directors may discourage such transactions by increasing the amount of time necessary to obtain majority representation on the Board. Certain other provisions of our Bylaws and of Delaware law may also discourage, delay or prevent a third party from acquiring or merging with us, even if such action were beneficial to some, or even a majority, of our stockholders. We also have adopted a stockholder rights plan and declared a dividend distribution of one right for each outstanding share of Common Stock to stockholders of record as of August 6, 2002. When it becomes exercisable, each right entitles the registered holder to purchase from Celsion one ten-thousandth of a share of Series C Junior Participating Preferred Stock, par value $0.01 per share, or Series C Preferred Stock, at a price of $4.46 per one ten-thousandth (1/10,000) of a share of Series C Preferred Stock, subject to adjustment. Under certain circumstances, if a person or group acquires 15% or more of our outstanding Common Stock, holders of the rights (other than the person or group triggering their exercise) will be able to purchase, in exchange for the $4.46 exercise price, shares of our Common Stock or of any company into which we are merged having a value of $8.92. The rights expire on August 15, 2012, unless earlier redeemed by our Board of Directors. Because the rights may substantially dilute the stock ownership of a person or group attempting to take us over without the approval of our Board of Directors, our rights plan also could make it more difficult for a third party to acquire us (or a significant percentage of our outstanding capital stock) without first negotiating with our Board of Directors regarding such acquisition. ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK We do not currently hold any derivative instruments and do not engage in hedging activities and currently do not enter into any transactions denominated in a foreign currency. Thus, our exposure to interest rate and foreign exchange fluctuations is minimal. ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA AND FINANCIAL DISCLOSURE The financial statements, supplementary data and report of independent public accountants are filed as part of this report on pages F-1 through F-14. ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE Not applicable. PART III ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS The information required by this item is incorporated by reference to the information set forth under the captions "Directors and Executive Officers" and "Compliance with Section 16(a) of the Securities Exchange At of 1934, as Amended" in Celsion's Definitive Proxy Statement in connection with the Annual Meeting of Stockholders to be held on February 18, 2003, filed with the Securities and Exchange Commission on January 10, 2003. ITEM 11. EXECUTIVE COMPENSATION The information required by this item is incorporated herein by reference to the information set forth under the caption "Executive Compensation" in Celsion's Definitive Proxy Statement in connection with the Annual Meeting of Stockholders to be held on February 18, 2003, filed with the Securities and Exchange Commission on January 10, 2003. ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS Equity Compensation Plan Information Number of securities remaining available for Number of securities to Weighted-average future issuance under be issued upon exercise exercise price of equity compensation plans of outstanding options, outstanding options, (excluding securities warrants and rights warrants and rights reflected in column (a)) Plan category (a) (b) (c) --------------------------- ---------------------------- -------------------------------------------------------- Equity compensation plans 7,952,125(1) $0.71 2,439,375 approved by security holders Equity compensation plans 12,381,601 $0.58 - (2) not approved by security holders --------------------------- ------------------------- ----------------------------- Total 20,333,726 $0.63 2,439,375 (2) =========================== ========================= ============================= 28 (1) Includes both vested and unvested options to purchase Common Stock issued to employees, officers, directors and outside consultants under the Company's 2001 Stock Option Plan (the "Plan"). Certain of these options to purchase Common Stock were issued under the Plan in connection with employment agreements. An aggregate of 391,500 of these options were issued pursuant to the Company's previous stock option plan. (2) Certain of the securities exercisable to purchase Common Stock set forth in column (a) of this row have price protection or antidilution rights that entitle the holders to reduce the exercise price of such securities if the Company issues additional stock, options, warrants or other convertible securities below the exercise price of the subject securities. Certain of the information required by this item is incorporated herein by reference to the information set forth under the caption "Security Ownership of Certain Beneficial Owners and Management" in Celsion's Definitive Proxy Statement in connection with the Annual Meeting of Stockholders to be held on February 18, 2003, filed with the Securities and Exchange Commission on January 10, 2003. ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS The information required by this item is incorporated herein by reference to the information set forth under the caption "Certain Transactions" in Celsion's Definitive Proxy Statement in connection with the Annual Meeting of Stockholders to be held on February 18, 2003, filed with the Securities and Exchange Commission on January 10, 2003. ITEM 14. CONTROLS AND PROCEDURES Our Chief Executive Officer and Chief Financial Officer have evaluated the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-14(c) and 15d-14(c) under the Securities Exchange Act of 1934) as of an evaluation date within 90 days prior to the filing date of this Annual Report on Form 10-K/A. Based on this evaluation, they have concluded that, as of the evaluation date, our disclosure controls and procedures are effective to ensure that information required to be disclosed in reports that Celsion files or submits under the Exchange Act is recorded, processed, summarized and reported in a timely manner. Since the evaluation date referred to above, there have not been any significant changes in our internal controls or in other factors that could significantly affect such controls. ITEM 15. EXHIBITS, FINANCIAL STATEMENTS, SCHEDULES AND REPORTS ON FORM 8-K 1. FINANCIAL STATEMENTS The following is a list of the financial statements of Celsion Corporation filed with this Annual Report on Form 10-K/A, together with the report of our independent public accountants. TITLE OF DOCUMENTS PAGE NO. ------------------------------------------------- ---------- Independent Auditors' Report F-1 Balance Sheet F-2 Statements of Operations F-4 Statements of Changes in Stockholders' Equity F-5 Statements of Cash Flows F-6 Notes to Financial Statements F-7 2. FINANCIAL STATEMENT SCHEDULES No schedules are provided because of the absence of conditions under which they are required. 29 3. EXHIBITS .The following documents are included as exhibits to this report: EXHIBIT NO. DESCRIPTION 3.1.1 Certificate of Incorporation of Celsion (the "Company"), as amended, incorporated herein by reference to Exhibit 3.1.1 to the Annual Report on Form 10-K of the Company for the Year Ended September 30, 2002. 3.1.2 Certificate of Designations regarding the Series A 10% Preferred Stock of the Company, incorporated herein by reference to Exhibit 3.1.2 to the Annual Report on Form 10-K of the Company for the Year Ended September 30, 2001. 3.1.3 Certificate of Ownership and Merger of Celsion Corporation (a Maryland Corporation) into Celsion (Delaware) Corporation (inter alia, changing the Company's name to "Celsion Corporation" from "Celsion (Delaware) Corporation), incorporated herein by reference to Exhibit 3.1.3 to the Annual Report on Form 10-K of the Company for the Year Ended September 30, 2000. 3.1.4 Certificate of the Designations, Powers, Preferences and Rights of the Series B 8% Convertible Preferred Stock of Celsion Corporation, incorporated herein by reference to Exhibit 4.3 to the Form S-3 Registration Statement (File No. 333-100638) filed October 18, 2002. 3.1.5 Certificate of Designations of Series C Junior Participating Preferred Stock of Celsion Corporation, incorporated herein by reference to Exhibit 4.4 to the Form S-3 Registration Statement (File No. 333-100638) filed October 18, 2002. 3.2 By-laws of the Company, as amended, incorporated herein by reference to Exhibit 3.2 to the Quarterly Report on Form 10-Q of the Company for the Quarter Ended June 30, 2001. 4.1 Form of Common Stock Certificate, par value $0.01, incorporated herein by reference to Exhibit 4.1 to the Annual Report on Form 10-K of the Company for the Year Ended September 30, 2001. 4.2 Celsion Corporation and American Stock Transfer & Trust Company Rights Agreement dated as of August 15, 2002, incorporated by reference to Exhibit 99.1 to the Current Report on Form 8-K filed August 21, 2002. 10.1 Patent License Agreement between the Company and Massachusetts Institute of Technology dated June 1 1996, incorporated herein by reference to Exhibit 10.1 to the Annual Report on Form 10-K of the Company for the year ended September 30, 1996 (Confidential Treatment Requested). 10.2 License Agreement between the Company and MMTC, Inc. dated August 23, 1996, incorporated herein by reference to Exhibit 10.2 to the Annual Report on Form 10-K of the Company for the year ended September 30, 1996 (Confidential Treatment Requested). 10.3 Patent License Agreement between the Company and Massachusetts Institute of Technology dated October 17, 1997, incorporated herein by reference to Exhibit 10.7 to the Annual Report on Form 10-K (amended) of the Company for the year ended September 30, 1998. (Confidential Treatment Requested). 10.4 Amendment dated November 25, 1997 to the License Agreement between the Company and MMTC, Inc. dated August 23, 1996, incorporated herein by reference to Exhibit 10.8 to the Annual Report on Form 10-K (amended) of the Company for the year ended September 30, 1998. (Confidential Treatment Requested). 10.5 Patent License Agreement between the Company and Duke University dated November 10, 1999, incorporated herein by reference to Exhibit 10.9 to the Annual Report on Form 10-K of the Company for the year ended September 30, 1999 (Confidential Treatment Requested). 10.6 Amendment dated March 23, 1999 to the License Agreement between the Company and MMTC, Inc. dated August 23, 1996, incorporated herein by reference to Exhibit 10.10 to the Annual Report on Form 10-K of the Company for the year ended September 30, 1999. (Confidential Treatment Requested). 10.7 * Celsion Corporation 2001 Stock Option Plan. Incorporated herein by reference to Exhibit 10.23 to the Annual Report on Form 10-K of the Company for the year ended September 30, 2001. 10.8 * Form of Series 200 Warrant issued to certain employees, directors and consultants to Purchase Common Stock of the Company, Incorporated herein by reference to Exhibit 10.11 to the Annual Report on Form 10-K of the Company for the year ended September 30, 1998. 30 10.9 Form of Series 250 Warrant issued to DunnHughes Holding, Inc. to Purchase Common Stock of the Company, incorporated herein by reference to Exhibit 10.12 to the Annual Report on Form 10-K of the Company for the year ended September 30, 1998. 10.10 Form of Series 300 Warrant issued to Nace Resources, Inc. to purchase Common Stock of the Company, incorporated herein by reference to Exhibit 10.13 to the Annual Report on Form 10-K of the Company for the year ended September 30, 1998. 10.11 Form of Series 400 Settlement Warrant issued to Stearns Management Company, incorporated herein by reference to Exhibit 4.7 to the Registration Statement of Form S-3 of the Company (File No. 333-82450) filed February 8, 2002. 10.12 Form of Series 500 Warrant to Purchase Common Stock of the Company pursuant to the Private Placement Memorandum dated January 6, 1997, as amended, incorporated herein by reference to Exhibit 10.15 to the Annual Report on Form 10-K of the Company for the year ended September 30, 1998. 10.13 Intentionally omitted. 10.14 * Form of Series 600 Warrant issued to Certain Employees and Directors on May 16, 1996 to Purchase Common Stock of the Company, incorporated herein by reference to Exhibit 10.17 to the Annual Report on Form 10-K of the Company for the year ended September 30, 1998. 10.15 License Agreement between the Company and Sloan-Kettering Institute for Cancer Research dated May 19, 2000, incorporated herein by reference to Exhibit 10.18 to the Annual Report on Form 10-K of the Company for the year ended September 30, 2000. 10.16 * Employment Agreement between the Company and Anthony P. Deasey dated November 27, 2000, incorporated herein by reference to Exhibit 10.1 to the Quarterly Report on Form 10-K of the Company for the quarter ended June 30, 2001. 10.17 * Amended and Restated Executive Employment Agreement between the Company and Augustine Y. Cheung, effective January 1, 2000, incorporated herein by reference to Exhibit 10.17 to the Annual Report on Form 10-K of the Company for the Year Ended September 30, 2002. 10.18 * Amended and Restated Executive Employment Agreement between the Company and John Mon, effective June 8, 2000, incorporated herein by reference to Exhibit 10.18 to the Annual Report on Form 10-K of the Company for the Year Ended September 30, 2002. 10.19 * Amended and Restated Executive Employment Agreement between the Company and Dennis Smith, dated effective May 19, 2000, incorporated herein by reference to Exhibit 10.19 to the Annual Report on Form 10-K of the Company for the Year Ended September 30, 2002. 10.20 Option Agreement between the Company and Duke University dated August 8, 2000, incorporated herein by reference to Exhibit 10.23 to the Annual Report on Form 10-K of the Company for the year ended September 30, 2000. 10.21 * Employment Agreement between the Company and Daniel S. Reale dated April 9, 2001, incorporated herein by reference to the Annual Report on Form 10-K of the Company for the year ended September 30, 2001. 10.22 Service Agreement between the British Columbia Cancer Agency, Division of Medical Oncology, Investigational Drug Section, Propharma Pharmaceutical Clean Room and the Company dated September 20, 2000, incorporated herein by reference to Exhibit 10.24 to the Annual Report on Form 10-K of the Company for the year ended September 30, 2000 (Confidential Treatment Requested). 10.23 Form of Warrant to Purchase Common Stock of the Company pursuant to the Private Placement Memorandum dated October 11, 2001, incorporated herein by reference to Exhibit 10.23 to the Annual Report on Form 10-K of the Company for the year ended September 30, 2001. 10.24 * Advisory Agreement between the Company and Dr. Kris Venkat dated August 1, 2001, incorporated herein by reference to Exhibit 10.24 to the Annual Report on Form 10-K of the Company for the Year Ended September 30, 2001. 10.25 Amendment dated May 23, 2002 to the Patent License Agreement between the Company and Massachusetts Institute of Technology dated October 17, 1997, incorporated herein by reference to Exhibit 10.25 to the Annual Report on Form 10-K of the Company for the Year Ended September 30, 2002. (Confidential Treatment Requested). 31 10.26 Amendment dated September 17, 2002 to the License Agreement between the Company and MMTC, Inc. dated August 23, 1996, incorporated herein by reference to Exhibit 10.26 to the Annual Report on Form 10-K of the Company for the Year Ended September 30, 2002. 10.27 * Employment Agreement between the Company and William W. Gannon, Jr. dated January 15, 2002, incorporated herein by reference to Exhibit 10.27 to the Annual Report on Form 10-K of the Company for the Year Ended September 30, 2002. 10.28 Form of Warrant to Purchase Common Stock Units of the Company issued to Placement Agents pursuant to the Private Placement Memorandum dated October 18, 2001, incorporated herein by reference to Exhibit 4.4 to the Registration Statement on Form S-3 of the Company (File No. 333-82450) filed February 8, 2002. 10.29 Form of Warrant to Purchase Common Stock of the Company pursuant to private placement by the Company which closed on June 3, 2002, incorporated herein by reference to Exhibit 4.6 to the Form S-3 Registration Statement of the Company (File No. 333-100638) filed October 18, 2002. 10.30 Letter dated May 8, 2002, from Legg Mason Wood Walker, Incorporated ("Legg Mason") to the Company regarding retention of Legg Mason as financial advisor, incorporated herein by reference to Exhibit 10.30 to the Annual Report on Form 10-K of the Company for the Year Ended September 30, 2002. 10.31 Letter Agreement with Goldpac Investment Partners dated October 17, 2001, incorporated herein by reference to Exhibit 4.5 to the Form S-3 Registration Statement (File No. 333-82450) filed February 8, 2002. 10.32 Letter Agreement with Equity Communications, dated November 5, 2001, incorporated herein by reference to Exhibit 4.6 to the Form S-3 Registration Statement (File No. 333-82450) filed February 8, 2002. 23.1+ Consent of Stegman & Company, independent public accountants of the Company. 99.1+ Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 99.2+ Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. + Filed herewith. *Management contract or compensatory plan, contract or arrangement. (b) REPORTS ON FORM 8-K. Celsion filed a report on Form 8-K on August 21, 2002 disclosing the adoption of its stockholder rights plan and declaration of a dividend distribution related to such plan. 32 SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused its annual report on Form 10-K/A to be signed on its behalf by the undersigned, thereunto duly authorized. CELSION CORPORATION January 28, 2003 By: /s/ Anthony P. Deasey ------------------------- Anthony P. Deasey Chief Financial Officer (Principal Financial and Accounting Officer) 33 CERTIFICATIONS I, Augustine Y. Cheung, certify that: 1. I have reviewed this amended annual report on Form 10-K/A of Celsion Corporation; 2. Based on my knowledge, this amended annual report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this amended annual report; 3. Based on my knowledge, the financial statements, and other financial information included in this amended annual report, fairly present in all material respects the financial condition, results of operation and cash flows of the registrant as of, and for, the periods presented in this amended annual report; 4. The registrant's other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14, for the registrant and have: a. Designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this amended annual report is being prepared; b. Evaluated the effectiveness of the registrant's disclosure controls and procedures as of a date within 90 days prior to the filing date of this amended annual report (the "Evaluation Date"); and c. Presented in this amended annual report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; 5. The registrant's other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant's auditors and the audit committee of registrant's board of directors (or persons performing the equivalent functions): a. All significant deficiencies in the design or operation of internal controls which could adversely affect the registrant's ability to record, process, summarize and report financial data and have identified for the registrant's auditors any material weaknesses in internal controls; and b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal controls; and 6. The registrant's other certifying officers and I have indicated in this amended annual report whether there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. Date: January 28, 2003 By: /s/ Augustine Y. Cheung -------------------------------------- President and Chief Executive Officer 34 I, Anthony P. Deasey, certify that: 1. I have reviewed this amended annual report on Form 10-K/A of Celsion Corporation; 2. Based on my knowledge, this amended annual report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this amended annual report; 3. Based on my knowledge, the financial statements, and other financial information included in this amended annual report, fairly present in all material respects the financial condition, results of operation and cash flows of the registrant as of, and for, the periods presented in this amended annual report; 4. The registrant's other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14, for the registrant and have: a. Designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this amended annual report is being prepared; b. Evaluated the effectiveness of the registrant's disclosure controls and procedures as of a date within 90 days prior to the filing date of this amended annual report (the "Evaluation Date"); and c. Presented in this amended annual report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; 5. The registrant's other certifying officers and I have disclosed, based on our most recent evaluation, to the registrant's auditors and the audit committee of registrant's board of directors (or persons performing the equivalent functions): a. All significant deficiencies in the design or operation of internal controls which could adversely affect the registrant's ability to record, process, summarize and report financial data and have identified for the registrant's auditors any material weaknesses in internal controls; and b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal controls; and 6. The registrant's other certifying officers and I have indicated in this amended annual report whether there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. Date: January 28, 2003 By: /s/ Anthony P. Deasey ----------------------------------------------------- Executive Vice President--Finance and Administration and Chief Financial Officer 35 CELSION CORPORATION REPORT ON AUDITS OF FINANCIAL STATEMENTS FOR THE YEARS ENDED SEPTEMBER 30, 2002, 2001 AND 2000 No extracts from this report may be published without our written consent. Stegman & Company CELSION CORPORATION REPORT ON AUDITS OF FINANCIAL STATEMENTS FOR THE YEARS ENDED SEPTEMBER 30, 2002, 2001 AND 2000 CONTENTS Page ---- INDEPENDENT AUDITORS' REPORT F-1 FINANCIAL STATEMENTS Balance Sheets F-2 Statements of Operations F-4 Statements of Changes in Stockholders' Equity F-5 Statements of Cash Flows F-6 NOTES TO FINANCIAL STATEMENTS F-7 INDEPENDENT AUDITORS' REPORT The Board of Directors and Stockholders Celsion Corporation Columbia, Maryland We have audited the accompanying balance sheets of Celsion Corporation (the "Company") as of September 30, 2002 and 2001, and the related statements of operations, changes in stockholders' equity, and cash flows for each of the three years in the period ended September 30, 2002. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Celsion Corporation as of September 30, 2002 and 2001, and the results of its operations and its cash flows for each of the three years in the period ended September 30, 2002 in conformity with accounting principles generally accepted in the United States of America. /s/Stegman & Company -------------------- Baltimore, Maryland November 18, 2002, except as to Notes 2 and 13, which are dated January 24, 2003 F-1 CELSION CORPORATION BALANCE SHEETS SEPTEMBER 30, 2002 AND 2001 ASSETS 2002 2001 ---------- ---------- CURRENT ASSETS: Cash $ 928,819 $2,510,136 Accounts receivable - trade -- 1,205 Other receivables 84,493 -- Inventories 449,608 -- Prepaid expenses 47,255 -- Other current assets -- 150,000 ---------- ---------- Total current assets 1,510,175 2,661,341 ---------- ---------- PROPERTY AND EQUIPMENT - at cost: Furniture and office equipment 311,481 229,643 Laboratory and shop equipment 89,354 87,193 ---------- ---------- 400,835 316,836 Less accumulated depreciation 190,658 127,556 ---------- ---------- Net value of property and equipment 210,177 189,280 ---------- ---------- OTHER ASSETS: Deposits23,622 29,537 Prepaid inventory development costs 486,602 -- Patent licenses (net of accumulated amortization of $129,077 and $113,247 in 2002 and 2001, respectively) 60,873 76,703 ---------- ---------- Total other assets 571,097 106,240 ---------- ---------- TOTAL ASSETS $2,291,449 $2,956,861 ========== ========== See accompanying notes. F-2 LIABILITIES AND STOCKHOLDERS' EQUITY 2002 2001 ------------ ------------ CURRENT LIABILITIES: Accounts payable - trade $ 494,650 $ 145,520 Other accrued liabilities 280,309 126,921 ------------ ------------ Total current liabilities 774,959 272,441 LONG-TERM LIABILITIES - Security deposit -- 15,203 ------------ ------------ Total liabilities 774,959 287,644 ------------ ------------ STOCKHOLDERS' EQUITY: Common stock - $.01 par value; 150,000,000 shares authorized, 92,417,556 and 76,876,761 shares issued and outstanding for 2002 and 2001, respectively 924,176 768,768 Series A 10% Convertible Preferred Stock, $1,000 par value, 7,000 shares authorized, 1,131 and 1,099 shares issued and outstanding for 2002 and 2001, respectively 1,130,500 1,099,584 Series B 8% Convertible Preferred Stock, $1,000 par value; 5,000 shares authorized, 1,591 and zero shares issued and outstanding for 2002 and 2001, respectively 1,396,285 -- Additional paid-in capital 41,885,610 34,729,646 Accumulated deficit (43,820,081) (33,928,781) ------------ ------------ Total stockholders' equity 1,516,490 2,669,217 ------------ ------------ TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 2,291,449 $ 2,956,861 ============ ============ See accompanying notes. F-3 CELSION CORPORATION STATEMENTS OF OPERATIONS FOR THE YEARS ENDED SEPTEMBER 30, 2002, 2001 AND 2000 2002 2001 2000 ------------ ------------ ------------ REVENUES: Equipment sales and parts $ -- $ -- $ 3,420 Returns and allowances -- -- -- ------------ ------------ ------------ Total revenues -- -- 3,420 COST OF SALES -- -- 246 ------------ ------------ ------------ GROSS PROFIT -- -- 3,174 ------------ ------------ ------------ OPERATING EXPENSES: Selling, general and administrative 4,833,005 3,211,625 2,662,623 Research and development 5,004,687 4,075,249 2,238,292 ------------ ------------ ------------ Total operating expenses (9,837,692) (7,286,874) (4,900,915) ------------ ------------ ------------ INTEREST INCOME 48,321 318,038 350,526 RENTAL INCOME 38,289 45,609 -- ------------ ------------ ------------ NET LOSS (9,751,082) (6,923,227) (4,547,215) BENEFICIAL CONVERSION FEATURE AND DIVIDENDS ON PREFERRED STOCK (391,888) (234,513) (323,500) ------------ ------------ ------------ NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS $(10,142,970) $ (7,157,740) $ (4,870,715) ============ ============ ============ BASIC AND DILUTED NET LOSS PER COMMON SHARE $ (0.12) $ (0.10) $ (0.08) ============ ============ ============ BASIC AND DILUTED WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING 87,257,672 72,249,920 59,406,921 ============ ============ ============ See accompanying notes. F-4 CELSION CORPORATION STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY FOR THE YEARS ENDED SEPTEMBER 30, 2002, 2001 AND 2000 Series A 10% Convertible Common Stock Preferred Stock ------------------------- -------------------- Shares Amount Shares Amount ----------- ----------- ----------- ----------- Balances at October 1, 1999 53,370,498 $ 533,705 -- $ -- Sale of common stock 10,248,544 102,485 -- -- Issuance of warrants/options and common stock for payment of indebtedness and expenses 753,025 7,531 -- -- Issuance of shares of Series A 10% convertible, preferred stock (net of issuance costs) -- -- 4,853 4,852,500 Preferred stock dividend -- -- 323 323,500 Net loss -- -- -- -- ----------- ----------- ----------- ----------- Balances at September 30, 2000 64,372,067 643,721 5,176 5,176,000 Sale of common stock 510,000 5,100 -- -- Issuance of warrants/options and common stock for payment of expenses 319,174 3,192 -- -- Conversion of shares of Series A 10% convertible, preferred stock plus accrued dividends 10,514,763 105,148 (4,311) (4,311,053) Exercise of common stock warrants and options 1,160,757 11,607 -- -- Preferred stock dividend -- -- 234 234,637 Stock compensation -- -- -- -- Net loss -- -- -- -- ----------- ----------- ----------- ----------- Balances at September 30, 2001 76,876,761 768,768 1,099 1,099,584 Sale of preferred and common stock 12,500,000 125,000 -- -- Issuance of warrants/options and common stock for payment of expenses 507,709 5,077 -- -- Conversion of shares of Series A 10% convertible, preferred stock plus accrued dividends 143,836 1,438 (58) (58,972) Conversion of shares of Series B 8% convertible, preferred stock plus accrued dividends 918,000 9,180 -- -- Exercise of common stock warrants and options 1,471,250 14,713 -- -- Preferred stock dividend -- -- 90 89,888 Beneficial conversion -- -- -- -- Stock compensation -- -- -- -- Net loss -- -- -- -- ----------- ----------- ----------- ----------- Balances at September 30, 2002 92,417,556 $ 924,176 1,131 $ 1,130,500 =========== =========== =========== =========== See accompanying notes. F-5 Series B 8% Convertible Preferred Stock Additional ---------------------------- Paid-in Accumulated Shares Amount Capital Deficit Total ------------ ------------ ------------ ------------ ------------ -- $ -- $ 22,403,622 $(21,900,202) $ 1,037,125 -- -- 7,122,893 -- 7,225,378 -- -- 771,965 -- 779,496 -- -- (620,855) -- 4,231,645 -- -- -- (323,500) -- -- -- -- (4,547,215) (4,547,215) ------------ ------------ ------------ ------------ ------------ -- -- 29,677,625 (26,770,917) 8,726,429 -- -- 147,400 -- 152,500 -- -- 337,690 -- 340,882 -- -- 4,205,905 -- -- -- -- (11,607) -- -- -- -- -- (234,637) -- -- -- 372,633 -- 372,633 -- -- -- (6,923,227) (6,923,227) ------------ ------------ ------------ ------------ ------------ -- -- 34,729,646 (33,928,781) 2,669,217 2,000 2,000,000 5,454,532 -- 7,579,532 -- -- 705,048 -- 710,125 -- -- 57,534 -- -- (459) (402,375) 393,195 -- -- -- -- 34,814 -- 49,527 50 50,330 -- (140,218) -- -- (251,670) 251,670 -- -- -- -- 259,171 -- 259,171 -- -- -- (9,751,082) (9,751,082) ------------ ------------ ------------ ------------ ------------ 1,591 $ 1,396,285 $ 41,885,610 $(43,820,081) $ 1,516,490 ============ ============ ============ ============ ============ See accompanying notes. F-6 CELSION CORPORATION STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED SEPTEMBER 30, 2002, 2001 AND 2000 2002 2001 2000 ------------ ------------ ------------ CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $ (9,751,082) $ (6,923,227) $ (4,547,215) Noncash items included in net loss: Depreciation and amortization 82,437 68,845 39,478 Inventory valuation -- 13,538 17,000 Stock option compensation 259,172 372,633 -- Warrants issued for legal settlement 476,724 -- -- Common stock issued for operating expenses 233,401 340,758 542,745 Loss from disposal of property and equipment 1,825 -- -- Net changes in: Accounts receivable and other receivables (83,288) 1,102 (495) Inventories (449,608) -- (8,479) Accrued interest receivable - related parties -- 7,751 (7,751) Prepaid expenses (47,255) 14,832 197,103 Other current assets 150,000 (115,644) 4,847 Investment in prepaid inventory development costs (486,602) -- -- Accounts payable and accrued interest payable 349,130 (70,324) (73,370) Accrued compensation -- -- (91,009) Other accrued liabilities 153,388 66,275 60,681 ------------ ------------ ------------ Net cash used in operating activities (9,111,758) (6,223,461) (3,866,465) ------------ ------------ ------------ CASH FLOWS FROM INVESTING ACTIVITIES: Decrease (increase) in deposits 5,915 (21,952) -- (Decrease) increase in security deposit liability (15,203) 15,203 -- Purchase of property and equipment (89,329) (117,572) (122,108) ------------ ------------ ------------ Net cash used in investing activities (98,617) (124,321) (122,108) ------------ ------------ ------------ CASH FLOWS FROM FINANCING ACTIVITIES: Payment on notes payable - other -- (114,778) -- Payment on capital lease obligation -- -- (5,719) Proceeds of stock issuances 7,629,058 152,500 11,457,024 ------------ ------------ ------------ Net cash provided by financing activities 7,629,058 37,722 11,451,305 ------------ ------------ ------------ NET (DECREASE) INCREASE IN CASH (1,581,317) (6,310,060) 7,462,732 CASH AT BEGINNING OF YEAR 2,510,136 8,820,196 1,357,464 ------------ ------------ ------------ CASH AT END OF YEAR $ 928,819 $ 2,510,136 $ 8,820,196 ============ ============ ============ See accompanying notes. F-7 Celsion Corporation Statements of Cash Flows (Continued) For the Years Ended September 30, 2002, 2001 and 2000 2002 2001 2000 ------------ ------------ ------------ Conversion of accounts payable, debt and accrued interest payable through issuance of common stock $ -- $ -- $ 20,750 Prepaid expenses funded through issuance of common stock $ -- $ -- $216,000 Cash paid during the year for interest $ -- $ -- $ 1,290 See accompanying notes. F-8 CELSION CORPORATION NOTES TO FINANCIAL STATEMENTS FOR THE YEARS ENDED SEPTEMBER 30, 2002, 2001 AND 2000 1. DESCRIPTION OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Description of Business ----------------------- Celsion Corporation ("Celsion" or the "Company"), a Delaware corporation, is a research and development company dedicated to the development of medical treatment systems primarily to treat breast cancer and a chronic prostate enlargement condition, common in older males, known as benign prostatic hyperplasia, or BPH, using minimally invasive focused heat technology. The Company is also working with Duke University on the development of heat-sensitive liposome compounds for use in the delivery of chemotherapy drugs to tumor sites, and with the Memorial Sloan-Kettering Cancer Center, or Sloan-Kettering on the development of heat-activated gene therapy compounds. Inventories ----------- Inventories are stated at the lower of cost or market. Cost is determined using the average cost method. Property and Equipment ---------------------- Property and equipment is stated at cost. Depreciation is provided over the estimated useful lives of the related assets of three to seven years using the straight-line method. Major renewals and improvements are capitalized at cost and ordinary repairs and maintenance are charged against operations as incurred. Depreciation expense was $66,608, $53,016 and $23,648 for the years ended September 30, 2002, 2001 and 2000, respectively. Prepaid Inventory Development Costs ----------------------------------- The balance in prepaid development costs represents research/development costs paid to a vendor for the design and development of catheters which are to be used with the Company's BPH machines. Patent Licenses --------------- The Company has purchased several licenses to use the rights to patented technologies. Patent license costs are amortized straight-line over the remaining patent life. F-9 CELSION CORPORATION NOTES TO FINANCIAL STATEMENTS FOR THE YEARS ENDED SEPTEMBER 30, 2002, 2001 AND 2000 Research and Development ------------------------ Research and development costs are expensed as incurred. Equipment and facilities acquired for research and development activities which have alternative future uses are capitalized and charged to expense over their estimated useful lives. Net Loss Per Common Share ------------------------- Basic and diluted net loss per common share was computed by dividing net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding during each period. The impact of common stock equivalents has been excluded from the computation of weighted average common shares outstanding, as the effect would be antidilutive. Nonmonetary Transactions ------------------------ Nonmonetary transactions are accounted for in accordance with Accounting Principles Board Opinion No. 29 "Accounting for Nonmonetary Transactions" which requires that the transfer or distribution of a nonmonetary asset or liability generally is based on the fair value of the asset or liability that is received or surrendered whichever is more clearly evident. Use of Estimates ---------------- The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Financial Instruments --------------------- For most financial instruments, including cash, accounts payable and accruals, management believes that the carrying amount approximates fair value, as the majority of these instruments are short-term in nature. 2. FINANCIAL CONDITION Since inception, the Company has incurred substantial operating losses, principally from expenses associated with the Company's research and development programs, the clinical trials conducted in connection with the Company's thermotherapy systems and applications for submission to the Food and Drug Administration. The Company believes these expenditures are essential for the commercialization of its technologies. As a result of these expenditures, as well as related general and administrative expenses the Company had an accumulated deficit of $44 million as of September 30, 2002. The Company expects such operating losses to continue in the near term and for the foreseeable future as it continues its product development efforts, and undertakes marketing and sales activities. The Company's ability to achieve profitability is dependent upon its ability to successfully obtain governmental approvals, produce, market and sell its new technology and integrate such technology into its thermotherapy systems. There can be no assurance that the Company will be able to commercialize its technology successfully or that profitability will ever be achieved. The operating results of the Company have fluctuated significantly in the past. The Company expects that its operating results will fluctuate significantly from quarter to quarter in the future and will depend on a number of factors, many of which are outside the Company's control. F-10 CELSION CORPORATION NOTES TO FINANCIAL STATEMENTS FOR THE YEARS ENDED SEPTEMBER 30, 2002, 2001 AND 2000 The Company will need substantial additional funding in order to complete the development, testing and commercialization of its cancer treatment and BPH products and of potential new products. It is the Company's current intention both to increase the pace of development work on its present products and to make a significant commitment to thermo-sensitive liposome and gene therapy research and development projects. The increase in the scope of present development work and such new projects will require additional funding, at least until the Company is able to begin marketing its products. If adequate funding is not available in the future, the Company may be required to delay, scale-back or eliminate certain aspects of its operations or to attempt to obtain funds through onerous arrangements with partners or others that may force the Company to relinquish rights to certain of its technologies, products or potential markets. Furthermore, if the Company cannot fund its ongoing development and other operating requirements, and particularly those associated with its obligation to conduct clinical trials under its licensing agreements, it will be in breach of its commitments under such licensing agreements and could therefore lose its license rights, with material adverse effects on the Company. As a result of the Company's agreement with Boston Scientific Corporation dated January 21, 2003 (Note 13), the Company received an initial equity investment of $5,000,000. Management believes that this investment will be adequate to fund operations through September 30, 2003. 3. INVENTORIES Inventories are stated at the lower of cost or market and consist of the following: 2002 2001 --------- ---------- Materials $373,786 $ -- Work-in-process 75,822 -- --------- ---------- $449,608 $ -- ========= ========== F-11 CELSION CORPORATION NOTES TO FINANCIAL STATEMENTS FOR THE YEARS ENDED SEPTEMBER 30, 2002, 2001 AND 2000 4. INCOME TAXES A reconciliation of the Company's statutory tax rate to the effective rate for the years ended September 30 is as follows: 2002 2001 2000 ------- ------- ------- Federal statutory rate 34.0% 34.0% 34.0% State taxes, net of federal tax benefit 4.6 4.6 4.6 Valuation allowance (38.6) (38.6) (38.6) ------- ------- ------- .0% .0% .0% ======= ======= ======= As of September 30, 2002, the Company had net operating loss carryforwards of approximately $37 million for federal income tax purposes that are available to offset future taxable income through the year 2021. The components of the Company's deferred tax asset for the years ended September 30 is as follows: 2002 2001 ------------ ------------ Net operating loss carryforwards $ 14,300,000 $ 11,400,000 Valuation allowance (14,300,000) (11,400,000) ------------ ------------ $ -- $ $ -- ============ ============ The evaluation of the realizability of such deferred tax assets in future periods is made based upon a variety of factors for generating future taxable income, such as intent and ability to sell assets and historical and projected operating performance. At this time, the Company has established a valuation reserve for all of its deferred tax assets. Such tax assets are available to be recognized and benefit future periods. 5. RETIREMENT PLAN The Company provides a SAR-SEP savings plan to which eligible employees may make pretax payroll contributions up to 15% of compensation. The Company does not make contributions to the plan. 6. PREFERRED STOCK The Company has preferred stock known as Series A 10% convertible preferred stock. Holders of shares of preferred stock are entitled to receive, as and if declared by the Company's Board of Directors, dividends at the annual rate of 10% per share payable semi-annually on March 31 and September 30. Such dividends are payable in shares and fractional shares of preferred stock, valued for this purpose at the rate of $1,000 per share. There are 1,131 and 1,099 (including accrued dividends) shares of this stock issued and outstanding at September 30, 2002 and 2001, respectively. The shares of Series A preferred stock are subject to exchange and conversion privileges upon the occurrence of major events, including a public offering of the Company's securities or the Company's merger into another public company. In addition, the holders of the Series A preferred stock are entitled to convert their preferred shares into shares of common stock at a conversion price of $0.41 per share of common stock, subject to certain adjustments. There are outstanding warrants to purchase 36 shares of Series A preferred stock (convertible into an additional 87,805 shares of common stock) as of September 30, 2002. F-12 CELSION CORPORATION NOTES TO FINANCIAL STATEMENTS FOR THE YEARS ENDED SEPTEMBER 30, 2002, 2001 AND 2000 During the year ended September 30, 2002 the Company issued 2,000 shares of Series B 8% convertible preferred stock on a private placement basis. Holders of shares of preferred stock are entitled to receive, as and if declared by the Company's Board of Directors, dividends at the annual rate of 8% per share payable semi-annually on June 30 and December 31. Such dividends are payable in shares and fractional shares of preferred stock, valued for this purpose at the rate of $1,000 per share. There are 1,591 and -0- (including accrued dividends) shares of this stock issued and outstanding at September 30, 2002 and 2001, respectively. The shares of Series B preferred stock are subject to exchange and conversion privileges at any time after September 3, 2002 at a conversion price of $0.50 per share of common stock. As of September 30, 2002, 1,591.33 (including accrued dividends) shares of Series B 8% preferred stock was outstanding. 7. STOCK OPTIONS AND WARRANTS The Company has issued stock options and warrants to employees, directors, vendors and debt holders. Options and warrants are generally granted at market value at the date of the grant. A summary of the Company's stock option and warrant activity and related information for the years ended September 30, 2002, 2001 and 2000 is as follows: Weighted Options/ Average Warrants Exercise Outstanding Price ------------ ----------- Outstanding at October 1, 1999 16,653,770 .59 Granted 1,125,214 .94 Exercised (10,247,074) .70 Expired/cancelled -- -- ------------ ----------- Outstanding at September 30, 2000 7,531,910 .44 Granted 8,158,308 1.36 Exercised (585,000) .35 Expired/cancelled -- -- ------------ ----------- Outstanding at September 30, 2001 15,105,218 .94 Granted 31,307,874 .52 Exercised (1,471,250) .03 Expired/cancelled (10,258,049) .91 ------------ ----------- Outstanding at September 30, 2002 34,683,793 .61 ============ =========== F-13 CELSION CORPORATION NOTES TO FINANCIAL STATEMENTS FOR THE YEARS ENDED SEPTEMBER 30, 2002, 2001 AND 2000 Following is additional information with respect to options and warrants outstanding at September 30, 2002: Exercise Exercise Exercise Exercise Price from Price from Price from Price from $.01 to $.25 $.41 to $.70 $.71 to $1.50 $1.50 to $5.00 ------------ ------------ ------------- -------------- Outstanding at September 30, 2002: Number of options/warrants 6,279,226 22,500,497 5,058,070 846,000 Weighted average exercise price $ .06$ $ .60$ $ .94$ $ 3.12 Weighted average remaining contractual life in years 3.72 5.01 6.36 3.44 Exercisable at September 30, 2002: Number of options/warrants 6,279,226 20,118,832 3,044,737 846,000 Weighted average exercise price $ .06 $ .60$ $1.01$ $ 3.12 Option Repricing ---------------- On March 25, 2002, in order to provide meaningful continuing stock-based incentives for members of management, and in recognition of the decline in the market price of the Company's Common Stock, the Compensation Committee of the Board of Directors approved the cancellation of options to purchase a total of 3,625,000 shares of Common Stock held by certain key executives and issued new options to purchase a total of 3,150,000 shares, resulting in a net decrease of options to purchase 475,000 shares. The cancelled options had been issued to the Company's executives pursuant to their respective employment contracts at exercise prices in excess of the current market price of the Company's Common Stock. These options consisted of certain options vested at the time of cancellation, as well as options with vesting dates through April of 2003, and with expiration dates through April of 2011. The new options consist of currently vested compensatory options, bonus options, one-third of which are currently vested and the remainder of which vest on March 31, 2003 and 2004, and performance-based awards that vest, if at all, upon achievement, by the Company, of certain specified milestones, all of which expire in May of 2012. All of the new options were issued pursuant to the Company's 2001 Stock Option Plan, at exercise prices at or in excess of the market price for the common stock on the date of grant. The Company will account for the repriced options using variable accounting under FASB Interpretation No. 44, Accounting for Certain Transactions Involving Stock Compensation-An Interpretation of APB Opinion No. 25. Consequently, during each reporting period the Company will record compensation expense relating to the vested portion of the repriced options to the extent that the fair market value of the Company's Common Stock exceeds the exercise price of such options. During the year ended September 30, 2002 the Company did not record any compensation expense of this kind. During the year ended September 30, 2002, the Company entered into agreements with consultants in which the consultants received stock options in exchange for services. The fair value of these options was estimated at the date of the grant using a Black-Scholes option pricing model with the following weighted average assumptions: risk-free interest rate of 5.0%, expected volatility of 50%; expected option life 5 years from vesting and an expected dividend yield of 0%. As a result of these agreements expense of $259,171 was recognized in the year ended September 30, 2002. The Company has adopted the disclosure-only provisions of Statement of Financial Accounting Standards No. 123, Accounting for Stock-Based Compensation (SFAS No. 123), but applies Accounting Principles Board Opinion No. 25 and related interpretations. No compensation expense related to the granting of stock options to employees or directors was recorded during the three years ended September 30, 2002. The fair value of these equity awards was estimated at the date of grant using a Black-Scholes option pricing model with the following weighted average assumptions for 2002, 2001 and 2000: risk-free interest rate of 5.27%, 4.77% and 6.54% for 2002, 2001 and 2000, respectively; expected volatility of 78%; expected option life of 3 to 5 years from vesting and an expected dividend yield of 0%. If the Company had elected to recognize expense based on the fair value at the grant dates consistent with the method prescribed by SFAS No. 123, net loss and loss per share would have been changed to the pro forma amounts as follows: F-14 CELSION CORPORATION NOTES TO FINANCIAL STATEMENTS FOR THE YEARS ENDED SEPTEMBER 30, 2002, 2001 AND 2000 Year Ended September 30, ------------------------------------------------------- 2002 2001 2000 --------------- -------------- ------------- Net loss attributable to common stockholders $(11,123,932) $(7,834,189) $(5,356,215) Net loss per common share - basic (.13) (.11) (.09) 8. LICENSE AGREEMENTS AND PROPRIETARY RIGHTS The Company does not own any patents but has three United States patents pending, two of which have been filed internationally. Two of the three pending United States patent applications are directed to the BPH treatment system with the third directed to our breast cancer treatment. Through the Company's license agreements with Massachusetts Institute of Technology ("MIT") MMTC, Inc., Duke University ("Duke") and Sloan-Kettering, the Company has exclusive rights, within defined fields of use of nine United States patents. Three of these patents relate to the treatment of BPH, four relate to thermotherapy for cancer, one relates to heat-sensitive liposomes and one relates to gene therapy. The MIT, MMTC, Duke and Sloan-Kettering license agreements each contains license fee, royalty and/or research support provisions, testing and regulatory milestones, and other performance requirements that the Company must meet by certain deadlines with respect to the use of the licensed technologies. In conjunction with the patent holders, the Company intends to file international applications for certain of the United States patents. In 1996, the Company entered into a patent license agreement with MIT, pursuant to which the Company obtained exclusive rights to use of MIT's patented APA technology in conjunction with application of heat to breast tumor conditions, the application of heat to prostate conditions and all other medical uses. MIT has retained certain rights in the licensed technology for non-commercial research purposes. MIT's technology has been patented in the United States and MIT has patents pending for its technology in China and Europe. The term of the Company's exclusive rights under the MIT license agreement expires on the earlier of ten years after the first commercial sale of a product using the licensed technology or October 24, 2009, but the rights continue on a non-exclusive basis for the life of the MIT patents. The Company entered into a license agreement with MMTC in 1996, for exclusive worldwide rights to MMTC's patents related to its balloon compression technology for the treatment of prostatic disease in humans. The exclusive rights under the MMTC license agreements extend for the life of MMTC's patents. MMTC currently has patents in the United States and Canada. The terms of these patents expire at various times from April 2008 to November 2014. In addition, MMTC also has patent applications pending in Japan and Europe. On November 10, 1999, the Company entered into a license agreement with Duke under which the Company received exclusive rights (subject to certain exceptions) to commercialize and use Duke's thermo-liposome technology. The license agreement contains annual royalty and minimum payment provisions and also requires milestone-based royalty payments measured by various events, including product development stages, FDA applications and approvals, foreign marketing approvals and achievement of significant sales. However, in lieu of such milestone-based cash payments, Duke has agreed to accept shares of the Company common stock to be issued in installments at the time each milestone payment is due, with each installment of shares to be calculated at the average closing price of the common stock during the 20 trading days prior to issuance. The total number of shares issuable to Duke under these provisions is subject to adjustment in certain cases, and Duke has "piggyback" registration rights for public offerings taking place more than one year after the effective date of the license agreement. F-15 CELSION CORPORATION NOTES TO FINANCIAL STATEMENTS FOR THE YEARS ENDED SEPTEMBER 30, 2002, 2001 AND 2000 The rights under the license agreement with Duke extend for the longer of 20 years or the end of any term for which any relevant patents are issued by the United States Patent and Trademark Office. Currently, the Company has rights to Duke's patent for its thermo-liposome technology in the United States, which expires in 2018, and to future patents received by Duke in Canada, Europe, Japan and Australia, where it has patent applications pending. The Company entered into a license agreement with Sloan-Kettering in 2000 by which we obtained exclusive rights to Sloan-Kettering's United States patent and to patents that Sloan-Kettering may receive in the future for its heat-sensitive gene therapy in Japan, Canada and Europe, where it has patent applications pending. Rights under the agreement with Sloan-Kettering will terminate at the later of 20 years after the date of the agreement or the last expiration date of any patent rights covered by the agreement. 9. LITIGATION SETTLEMENT During the year ended September 30, 2002, the Company settled litigation with a former director and a related investment group (the "Group") related to the issuance of common stock warrants. In settlement of this litigation the Company agreed to pay the lesser of certain legal costs or $265,000 and to adjust the exercise price of 6,325,821 warrants originally issued to the Group. Expense related to this settlement totaled $741,724 and is included in selling, general and administrative expenses for the year ended September 30, 2002. 10. COMMITMENTS AND CONTINGENCIES Lease Commitments ----------------- The Company has entered into a lease for their facilities located in Columbia, Maryland. Future minimum lease obligations are as follows: 2003 $ 302,779 2004 311,789 2005 239,018 Thereafter - Rent expense for the years ended September 30, 2002, 2001 and 2000 was $359,206, $227,961 and $70,848, respectively. F-16 CELSION CORPORATION NOTES TO FINANCIAL STATEMENTS FOR THE YEARS ENDED SEPTEMBER 30, 2002, 2001 AND 2000 Rental Income ------------- In July 2001, the Company began subleasing some of its office/warehouse space to an unrelated party. The Company rented this space for three months in each of the years ended September 30, 2002 and 2001, generating $38,289 and $45,609, respectively. The sublease ended January 1, 2002 and since that time no other sublease has been signed. Product Liability Insurance --------------------------- The Company's business exposes it to potential product liability risks which are inherent in the testing, manufacturing, and marketing of human therapeutic products. The Company presently has product liability insurance limited to $5,000,000 per incident, and, if the Company was to be subject to a claim in excess of such coverage and such claim succeeded, the Company would be required to pay such claim out of its own limited resources. 11. CONCENTRATIONS OF CREDIT RISK As of September 30, 2002, the Company has a concentration of credit represented by cash balances in one large commercial bank in amounts which exceed current federal deposit insurance limits. The financial stability of this institution is continually reviewed by senior management. 12. SELECTED QUARTERLY FINANCIAL INFORMATION (UNAUDITED) First Second Third Fourth Quarter Quarter Quarter Quarter ------------- ------------ ------------ ------------ Gross profit on sales $ -- $ -- $ -- $ -- General and administrative expenses (541,247) (1,521,682) (987,306) (1,304,221) Research and development expenses (1,123,221) (1,759,775) (1,646,710) (474,981) Other income/expense 11,060 (459,800) 11,154 45,647 ------------- ------------ ------------ ------------ Net loss $(1,653,408) $(3,741,257) $(2,622,862) $(1,733,555) ============= ============ ============ ============ Net loss per share - basic and diluted $(.02) $(.04) $(.03) $(.03) ============= ============ ============ ============ 13. AGREEMENT WITH BOSTON SCIENTIFIC CORPORATION On January 21, 2003 the Company and Boston Scientific Corporation ("BSC") entered into a distribution agreement pursuant to which the Company has granted BSC certain rights to market and distribute the Company's BPH technology. The Company and BSC also entered into a transaction agreement on January 21, 2003. Pursuant to this agreement, upon attainment of specified milestones by Celsion, BSC will make equity investments in Celsion through the purchase of the Company's common stock. On January 21, 2003 BSC purchased 9,375,354 shares of the Company's common stock for $5,000,000. The Company has also granted BSC the exclusive right to purchase the assets and technology relating to the manufacture, marketing sale, distribution and/or research and development of products using thermal therapy for the treatment of BPH. F-17