UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 9, 2005
Celsion Corporation
(Exact Name of Registrant as Specified in Charter)
| Delaware | 000-14242 | 52-1256615 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) | (IRS Employer Identification No.) |
| 10220-L Old Columbia Road, Columbia, Maryland |
21046-2364 | |
| (Address of principal executive office) | (Zip Code) |
Registrant’s telephone number, including area code: (410) 290-5390
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions (see General Instruction A.2. below):
| ¨ | Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.135-4(c)) |
Potential persons who are to respond to the collection of information contained in this form are not required to respond unless the form displays a currently valid OMB control number.
Item 2.02 Results of Operations and Financial Condition
On November 9, 2005, Celsion Corporation (the “Company”) issued a press release reporting its financial results for the three- and nine-month periods ended September 30, 2005 (the “Earnings Release”). The Earnings Release is being filed as exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits
| Exhibit No. |
Description | |
| 99.1 | Earnings Release dated November 9, 2005, furnished pursuant to Item 2.02 of Form 8-K. |
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| CELSION CORPORATION | ||||
| Date: November 9, 2005 | By: | /s/ Anthony P. Deasey | ||
| Executive Vice President, Chief Financial Officer and Chief Operating Officer | ||||
3
Exhibit 99.1
| For Further Information Contact: | ||
| Tony Deasey Celsion Corporation 410.290.5390 tony@celsion.com |
General Info: Marilynn Meek Financial Relations Board 212-827-3773 mmeek@financialrelationsboard.com Investor Info: Susan Garland 212-827-3775 sgarland@financialrelationsboard.com | |
CELSION CORPORATION REPORTS THIRD QUARTER
2005 FINANCIAL RESULTS
Company Reports Revenue of $3.2 Million for Quarter. Net Loss reduced by 41%.
Columbia, MD – November 9, 2005: CELSION CORPORATION (AMEX: CLN) today announced financial results for its third quarter ended September 30, 2005. The Company reported revenue of $3.2 million for the quarter, compared to $0.5 million for the third quarter of 2004.
The Company recorded a net loss for the third quarter of $2.0 million, or $0.01 per basic and diluted share, compared to a net loss of $3.3 million, or $0.02 per basic and diluted share for the comparable quarter in 2004. The increase in revenues and reduction in the net loss for the quarter and year to date was primarily due to income generated from the sale of Prolieve™ control units and catheters.
Revenue for the nine months ended September 30, 2005 was $8.0 million, compared to $1.1 million in the comparable period in 2004. Net loss for the nine months was $6.6 million, or $0.04 per basic and diluted share, compared to $10.9 million, or $0.07 per basic and diluted share in the first nine months of 2004
Dr. Lawrence Olanoff, Celsion’s Chief Executive Officer, commented, “We are very encouraged by these results. Prolieve sales continue to be strong. We expect to see this progress continue and as a result we are increasing our guidance for 2005 annual sales from our current estimate of $10 million to $12 million. We are making good progress in our ThermoDox liver cancer Phase I trial, having recently completed the third cohort of patients. Additionally, we have agreed to fund a Phase I dose escalation study in recurrent chest wall breast cancer at Duke University Medical Center and we expect to start enrolling patients in this study early in 2006.”
About Celsion: The Prolieve Thermodilatation system is a minimally invasive transurethral microwave system which combines a transurethral microwave thermotherapy device with pressure applied by a balloon catheter.
Prolieve is marketed, in the United States under an exclusive distribution agreement, with Boston Scientific Corporation.
Celsion has research, license or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, Massachusetts Institute of Technology, Harbor UCLA Medical Center, Montefiore Medical Center and Memorial Sloan-Kettering Cancer Center in New York City, Roswell Park Cancer Institute in Buffalo, New York, and Duke University. For more information on Celsion, visit our website: http://www.celsion.com.
Celsion wishes to inform readers that forward-looking statements in this release are made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act 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; and other risks detailed from time to time in the Company’s periodic reports filed with the Securities and Exchange Commission.
-Financial Tables Follow-
Celsion Corporation
Condensed Statements of Operations
(in thousands, except per share amounts)
(Unaudited)
| Three Months Ended September 30 |
Nine Months Ended September 30 |
|||||||||||||||
| 2004 |
2005 |
2004 |
2005 |
|||||||||||||
| Revenues |
$ | 540 | $ | 3,206 | $ | 1,083 | $ | 7,972 | ||||||||
| Cost of sales |
473 | 2,187 | 897 | 5,385 | ||||||||||||
| Gross margin |
67 | 1,019 | 186 | 2,587 | ||||||||||||
| Operating expenses |
||||||||||||||||
| Research & development |
2,974 | 2,294 | 8,946 | 6,998 | ||||||||||||
| General & administrative |
602 | 810 | 2,538 | 2,648 | ||||||||||||
| Total Operating expenses |
3,576 | 3,104 | 11,484 | 9,646 | ||||||||||||
| Loss from operations |
(3,509 | ) | (2,085 | ) | (11,298 | ) | (7,059 | ) | ||||||||
| Other income/(expense) |
||||||||||||||||
| License fee amortization |
143 | 143 | 333 | 429 | ||||||||||||
| Interest income, net |
66 | 10 | 165 | 136 | ||||||||||||
| Loss from investment in Celsion China Ltd |
11 | 22 | 48 | 67 | ||||||||||||
| Net loss before income taxes |
(3,311 | ) | (1,954 | ) | (10,848 | ) | (6,561 | ) | ||||||||
| Income taxes |
— | — | — | — | ||||||||||||
| Net loss |
$ | (3,311 | ) | $ | (1,954 | ) | $ | (10,848 | ) | $ | (6,561 | ) | ||||
| Net loss per common share (basic and diluted) |
$ | (0.02 | ) | $ | (0.01 | ) | $ | (0.07 | ) | $ | (0.04 | ) | ||||
| Weighted average shares outstanding |
160,639,842 | 160,601,600 | 158,062,867 | 160,897,950 | ||||||||||||
Celsion Corporation
Condensed Balance Sheets
(in thousands)
| December 31 2004 |
September 30 2005 |
|||||||
| (Unaudited) | (Unaudited) | |||||||
| ASSETS | ||||||||
| Current assets |
||||||||
| Cash and cash equivalents |
$ | 10,484 | $ | 9,255 | ||||
| Accounts receivable |
783 | 876 | ||||||
| Inventory |
2,202 | 4,008 | ||||||
| Prepaid expenses |
679 | 510 | ||||||
| Total current assets |
14,148 | 14,648 | ||||||
| Property and equipment, net |
682 | 593 | ||||||
| Investment in Celsion China, Ltd. |
108 | 41 | ||||||
| Escrow account - license fee |
2,007 | 2,036 | ||||||
| Other assets |
107 | 60 | ||||||
| Total assets |
$ | 17052 | $ | 17,379 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities |
||||||||
| Accounts payable |
$ | 819 | $ | 1,622 | ||||
| Accrued expenses |
738 | 1,128 | ||||||
| Deferred income |
571 | 571 | ||||||
| Total current liabilities |
2,128 | 3,321 | ||||||
| Loan Payable |
6,056 | |||||||
| Deferred revenue |
2,952 | 2,524 | ||||||
| Total liabilities |
5,080 | 11,901 | ||||||
| Stockholders’ equity |
||||||||
| Common stock |
1,608 | 1,609 | ||||||
| Additional paid-in capital |
84,581 | 84,648 | ||||||
| Accumulated deficit |
(74,217 | ) | (80,779 | ) | ||||
| Total stockholders’ equity |
11,972 | 5,478 | ||||||
| Total liabilities and stockholders’ equity |
$ | 17,052 | $ | 17,379 | ||||
####