Celsion Corporation Reports Second Quarter 2006 Financial Results.COLUMBIA Columbia, cities, United States Columbia (kəlŭm`bēə). 1 City (1990 pop. 75,883), Howard co., central Md., between Washington, D.C., and Baltimore. , Md. -- CELSION CORPORATION (AMEX AMEX See: American Stock Exchange :CLN CLN Clean CLN Community Learning Network CLN Colon CLN Celsion Corporation CLN Class Library for Numbers CLN Credit Linked Note CLN Comitato di Liberazione Nazionale (Committee of National Liberation) CLN Corn Lethal Necrosis ) today announced financial results for its second quarter ended June 30, 2006. The Company reported revenue of $0.3 million for the quarter, compared to $2.9 million for the second quarter of 2005. The Company recorded a net loss for the second quarter of $3.7 million or $0.35 per share, compared to a net loss of $2.4 million or $0.22 per share for the comparable quarter in 2005. The decrease in revenues and increase in the net loss for the quarter and six months to date was primarily due to a production interruption INTERRUPTION. The effect of some act or circumstance which stops the course of a prescription or act of limitation's. 2. Interruption of the use of a thing is natural or civil. during the transition to a new manufacturer for our Prolieve(R) catheter catheter /cath·e·ter/ (kath´e-ter) 1. a tubular, flexible surgical instrument that is inserted into a cavity of the body to withdraw or introduce fluid. 2. urethral c. kit which resulted in a product recall and suspension of shipments for the duration of the second quarter. Revenue for the six months ended June 30, 2006 was $2.7 million compared to revenue of $4.8 million in the comparable period in 2005. Net loss for six months ended June 30, 2006 was $5.5 million, or $0.51 per share, compared to a net loss of $4.6 million, or $0.43 per share for the six months ended June 30, 2005. The adoption of FAS 123R, as of January 1, 2006, resulted in non-cash employee compensation expense of $0.2 million and $0.6 million or $0.02 and $0.05 per share respectively for the three and six month periods ended June 30, 2006. Dr. Lawrence Olanoff, Celsion's Chief Executive Officer, commented, "Although these results are in line with our earlier guidance they are nonetheless very disappointing. We are currently in discussions with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. concerning the supplement we filed covering the changes in the manufacturing process at our new supplier and hope to resume Prolieve shipments shortly. Due to the fact that the product has now been off the market for almost four months we are reducing our revenue guidance for the year to approximately $10 million. We are continuing to make good progress in our liver and breast cancer clinical studies. We believe we have established the dose to go forward into our planned Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA liver cancer Liver Cancer Definition Liver cancer is a relatively rare form of cancer but has a high mortality rate. Liver cancers can be classified into two types. program next year and expect to confirm this result over the next one to two months. We have also enrolled and initiated treatment for each of the three patients in the first cohort cohort /co·hort/ (ko´hort) 1. in epidemiology, a group of individuals sharing a common characteristic and observed over time in the group. 2. of the recurrent recurrent /re·cur·rent/ (re-kur´ent) [L. recurrens returning] 1. running back, or toward the source. 2. returning after remissions. re·cur·rent adj. 1. chest wall breast cancer study at Duke University and hope to begin enrollment of the second cohort in September. We are encouraged by the progress we have made to date in the development of ThermoDox(TM) and are optimistic op·ti·mist n. 1. One who usually expects a favorable outcome. 2. A believer in philosophical optimism. op that we will be able to initiate an expanded program in 2006 including a registration program for liver cancer." The Company is holding a shareholders' conference call at 11:00 a.m. Eastern Time today, Thursday, August 10, 2006. To participate in the call, interested parties can dial 866-558-6338 to register ten minutes before the call is scheduled to begin. The call will be archived for replay August 10, 2006 at 2:00 p.m. until Thursday, August 17, 2006. The replay can be accessed at 719-457-0820 or 888-203-1112, access code: 8947453. The call will also be available on the Company's website, http://www.celsion.com for 90 days after 2:00 p.m. on Thursday, August 10, 2006. ABOUT CELSION: Celsion Corporation, based in Columbia, Maryland Columbia is a census-designated place and planned community in Howard County, Maryland, United States. It is a suburb of Baltimore, and, to a lesser degree, Washington, DC. It began with the idea that a city could enhance its residents' quality of life. , is a biotechnology company dedicated to the development and commercialization of heat activated activated a state of being more than usually active. In biological systems this is usually brought about by chemical or electrical means. Commonly said of pharmaceutical and chemical products. treatment systems for cancer. Celsion has research, license or commercialization agreements with leading institutions such as the National Institute of Health, Duke University Medical Center, Massachusetts Institute of Technology Massachusetts Institute of Technology, at Cambridge; coeducational; chartered 1861, opened 1865 in Boston, moved 1916. It has long been recognized as an outstanding technological institute and its Sloan School of Management has notable programs in business, , Harbor UCLA Medical Center UCLA Medical Center is a hospital located on the campus of the University of California, Los Angeles in Los Angeles, California. It is rated as one of the top three hospitals in the United States and is the top hospital on the West Coast according to US News & World Report. , Montefiore Medical Center Montefiore Medical Center, in the Bronx, New York, is the university hospital of the Albert Einstein College of Medicine. The hospital, named after Moses Montefiore, is one of the 50 largest employers in New York State [1]. and Memorial Sloan-Kettering Cancer Center The Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City is a cancer treatment and research institution founded in 1884 as the New York Cancer Hospital. The main campus is located at 1275 York Avenue, between 67th and 68th Streets, with other locations in New in New York City New York City: see New York, city. New York City City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S. , Roswell Park Cancer Institute The Roswell Park Cancer Institute is a cancer research and treatment center located in Buffalo, New York. Founded in 1898 by Dr. Roswell Park, it was the first dedicated medical facility for cancer treatment and research in the United States. in Buffalo, New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of , and Duke University. For more information on Celsion, visit our website: www.celsion.com. Celsion wishes to inform readers that forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. in this release are made pursuant to the "safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. " provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, unforeseen changes in the course of research and development activities and in clinical trials by others; possible acquisitions of other technologies, assets or businesses; possible actions by customers, suppliers, competitors, regulatory authorities Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest regulatory agency administrative body, administrative unit - a unit with administrative responsibilities ; and other risks detailed from time to time in the Company's periodic reports filed with the Securities and Exchange Commission.
Celsion Corporation
Consolidated Condensed Statements of Operations
(in thousands, except per share amounts)
Three Months Ended Six Months Ended
June 30, June 30,
------------------------ -----------------------
2005 2006 2005 2006
------------ ----------- ----------- -----------
(Unaudited) (Unaudited) (Unaudited) (Unaudited)
Revenues $ 2,896 306 4,766 2,652
Cost of Sales 1,926 652 3,198 2,406
------------ ----------- ----------- -----------
Gross Margin 970 (346) 1,568 246
------------ ----------- ----------- -----------
Operating Expenses
Research &
development 2,485 2,087 4,704 4,570
General and
administrative 1,072 1,020 1,838 2,093
------------ ----------- ----------- -----------
Total Operating
Expenses 3,557 3,107 6,542 6,663
------------ ----------- ----------- -----------
Loss from Operations (2,587) (3,453) (4,974) (6,417)
Other Income/(Expense)
License fee
amortization 143 143 286 286
Interest income
(expense), net 64 (84) 125 (129)
Loss from investment
in Celsion China
Ltd. (24) (186) (44) (251)
(Loss)/Gain on sale
of Celsion (Canada)
Ltd. -- (134) -- 1,012
Other income/
(expense) -- (9) -- (7)
------------ ----------- ----------- -----------
Net loss before income
taxes (2,404) (3,723) (4,607) (5,506)
Income taxes -- -- -- --
------------ ----------- ----------- -----------
Net loss $ (2,404) (3,723) (4,607) (5,506)
============ =========== =========== ===========
Net loss per common
share (basic and
diluted) $ (0.22) (0.35) (0.43) (0.51)
============ =========== =========== ===========
Weighted average
shares outstanding
('000's) 10,726,547 10,733,156 10,730,193 10,732,390
============ =========== =========== ===========
Celsion Corporation
Consolidated Condensed Balance Sheets
(in thousands)
December 31, June 30,
2005 2006
------------ -----------
ASSETS (Audited) (Unaudited)
Current assets
Cash and cash equivalents $ 2,313 285
Short term investments 6,000 6,500
Accounts receivable 765 178
Inventory 3,326 2,937
Prepaid expenses 437 371
Escrow account - license fee -- 2,095
------------ -----------
Total current assets 12,841 12,366
Property and equipment, net 571 622
Investment in Celsion China, Ltd. 12 --
Escrow account - license fee 2,053 --
Notes and loans receivable -- 1,602
Other assets 432 451
------------ -----------
Total assets $ 15,909 15,041
============ ===========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable $ 1,996 1,264
Accrued expenses 1,348 1,418
Deferred income 571 571
------------ -----------
Total current liabilities 3,915 3,253
Loans Payable - principal and accrued
interest 6,178 11,101
Deferred revenue 2,381 2,095
------------ -----------
Total liabilities 12,474 16,449
------------ -----------
Stockholders' equity (deficit)
Common stock 107 107
Additional paid-in capital 86,230 86,896
Treasury stock -- (2)
Accumulated deficit (82,902) (88,409)
------------ -----------
Total stockholders' equity (deficit) 3,435 (1,408)
------------ -----------
Total liabilities and stockholders'
equity (deficit) $ 15,909 15,041
============ ===========
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