Celsion Corporation Reports Fourth Quarter 2007 Results
Celsion Corporation Reports Fourth Quarter 2007 Results
February 21, 2008
Celsion Corporation Reports Fourth Quarter 2007 ResultsDriven by Two Milestone events Celsion to commence Pivotal Studies
for ThermoDox for two indications in 2008
COLUMBIA, Md., Feb 21, 2008 (BUSINESS WIRE) -- Subsequent to the end of the year, CELSION CORPORATION (NASDAQ: CLN) reported two important milestones in the development of its lead drug ThermoDox®, and in its transformation to a company totally focused on the development and commercialization of oncology drugs. On January 18th, the FDA notified the company that its Special Protocol Assessment (SPA) submission for Phase III liver cancer had been agreed to. On January 15th the FDA provided supportive notification regarding Celsion's proposal for an open label phase II study for the treatment of patients with recurrent breast cancer at the chest wall.
Concurrent with FDA's review and agreement of the SPA submission for the company's Phase III primary liver cancer study, Celsion completed a number of operational tasks critical to the start up of the trial. Accordingly, the company expects to treat the first patient in the study by the end of the first quarter of 2008.
For the 4th quarter ended December 31, 2007 Celsion reported a net loss of $2.3 million, or $0.22 per share, compared to a net loss of $1.1 million, or $0.10 per share, for the fourth quarter of 2006. The Company recorded a loss from continuing operations of $2.6 million, or $0.24 per share for the fourth quarter of 2007 compared to $2.5 million or $0.23 per share for the fourth quarter of 2006.
For the year ended December 31, 2007 the Company reported net income of $35.9 million, or $3.34 per share, compared to a net loss of $7.6 million, or $0.71 per share, in 2006. Excluding income from discontinued operations, the Company recorded a loss for the year ended December 31, 2007 of $14.1 million, or $1.31 per share, compared to a loss of $9.8 million, or $0.92 per share, for the year ended December 31, 2006.
Mr. Michael H. Tardugno, Celsion's president and chief executive officer, commented, "We have the necessary financial resources to advance our current programs, including funding of our Phase III primary liver cancer study to a point where we have sufficient results to determine if there is support for an NDA filing, as well as demonstrating feasibility for additional formulations. Additionally, we continue to make progress in accelerating our Recurrent Chest Wall cancer trial and anticipate initiating our pivotal Phase II study before the end of this year."
"2007 has been a transformational year for Celsion," concluded Mr. Tardugno. "Now as a pure play oncology focused company, Celsion is well positioned to deliver results consistent with the early promise that we've seen in our Phase I ThermoDox® studies."
The Company is holding a shareholders' conference call on Thursday, February 21, 2008 at 11:00 a.m. Eastern Time. To participate in the call, interested parties can dial 877-604-2080 (U.S./Canada) or 706-902-1383 (International), Conference ID: #35634307 to register ten minutes before the call is scheduled to begin.
The call will be archived for replay February 21, 2008 at 2:00 p.m. until Thursday, February 28, 2008. The replay can be accessed at 800-642-1687 or 706-645-9291, Conference ID: # 35634307. The call will also be available on the Company's website, http://www.celsion.com for 90 days.
About ThermoDox®: ThermoDox® is Celsion's proprietary heat-sensitive liposomal encapsulation of doxorubicin, an approved and frequently used anti-cancer drug used in the treatment of various cancers including breast cancer. Localized mild hyperthermia (40-42 degrees Celsius) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
About Celsion: Celsion is dedicated to the development and commercialization of oncology drugs including tumor-targeting treatments using focused heat energy in combination with heat activated drug delivery systems.
Celsion has research, license or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, University of Hong Kong, Cleveland Clinic, and the North Shore Long Island Jewish Health System.
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.
Driven by Two Milestone events Celsion to commence Pivotal Studies
for ThermoDox for two indications in 2008
Financial Resources Sufficient to Advance Current Projects
COLUMBIA, Md., Feb 21, 2008 (BUSINESS WIRE) -- Subsequent to the end of the year, CELSION CORPORATION (NASDAQ: CLN) reported two important milestones in the development of its lead drug ThermoDox®, and in its transformation to a company totally focused on the development and commercialization of oncology drugs. On January 18th, the FDA notified the company that its Special Protocol Assessment (SPA) submission for Phase III liver cancer had been agreed to. On January 15th the FDA provided supportive notification regarding Celsion's proposal for an open label phase II study for the treatment of patients with recurrent breast cancer at the chest wall. Concurrent with FDA's review and agreement of the SPA submission for the company's Phase III primary liver cancer study, Celsion completed a number of operational tasks critical to the start up of the trial. Accordingly, the company expects to treat the first patient in the study by the end of the first quarter of 2008.
For the 4th quarter ended December 31, 2007 Celsion reported a net loss of $2.3 million, or $0.22 per share, compared to a net loss of $1.1 million, or $0.10 per share, for the fourth quarter of 2006. The Company recorded a loss from continuing operations of $2.6 million, or $0.24 per share for the fourth quarter of 2007 compared to $2.5 million or $0.23 per share for the fourth quarter of 2006.
For the year ended December 31, 2007 the Company reported net income of $35.9 million, or $3.34 per share, compared to a net loss of $7.6 million, or $0.71 per share, in 2006. Excluding income from discontinued operations, the Company recorded a loss for the year ended December 31, 2007 of $14.1 million, or $1.31 per share, compared to a loss of $9.8 million, or $0.92 per share, for the year ended December 31, 2006.
Mr. Michael H. Tardugno, Celsion's president and chief executive officer, commented, "We have the necessary financial resources to advance our current programs, including funding of our Phase III primary liver cancer study to a point where we have sufficient results to determine if there is support for an NDA filing, as well as demonstrating feasibility for additional formulations. Additionally, we continue to make progress in accelerating our Recurrent Chest Wall cancer trial and anticipate initiating our pivotal Phase II study before the end of this year."
"2007 has been a transformational year for Celsion," concluded Mr. Tardugno. "Now as a pure play oncology focused company, Celsion is well positioned to deliver results consistent with the early promise that we've seen in our Phase I ThermoDox® studies."
The Company is holding a shareholders' conference call on Thursday, February 21, 2008 at 11:00 a.m. Eastern Time. To participate in the call, interested parties can dial 877-604-2080 (U.S./Canada) or 706-902-1383 (International), Conference ID: #35634307 to register ten minutes before the call is scheduled to begin.
The call will be archived for replay February 21, 2008 at 2:00 p.m. until Thursday, February 28, 2008. The replay can be accessed at 800-642-1687 or 706-645-9291, Conference ID: # 35634307. The call will also be available on the Company's website, http://www.celsion.com for 90 days.
About ThermoDox®: ThermoDox® is Celsion's proprietary heat-sensitive liposomal encapsulation of doxorubicin, an approved and frequently used anti-cancer drug used in the treatment of various cancers including breast cancer. Localized mild hyperthermia (40-42 degrees Celsius) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
About Celsion: Celsion is dedicated to the development and commercialization of oncology drugs including tumor-targeting treatments using focused heat energy in combination with heat activated drug delivery systems.
Celsion has research, license or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, University of Hong Kong, Cleveland Clinic, and the North Shore Long Island Jewish Health System.
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.
Celsion Corporation
Condensed Statements of Operations
(in thousands except per share amounts)
(Unaudited)
Three Months Ended Years Ended
December 31, December 31,
------------------------ -----------------------
(unaudited) (unaudited) (unaudited) (unaudited)
2007 2006 2007 2006
----------- ----------- ----------- -----------
Revenues $ - $ - $ - $ -
Operating expenses:
Research and
development $ 2,153 $ 1,458 $ 8,231 $ 6,096
General and
administrative 528 902 5,354 4,057
----------- ----------- ----------- -----------
Total operating
expenses 2,681 2,360 13,585 10,153
----------- ----------- ----------- -----------
Loss from
operations 2,681 2,360 13,585 10,153
Other (expense)
income:
Gain on the sale of
Celsion (Canada),
Ltd. - - - 1,012
Other (expense) /
income, net (18) 43 (457) (215)
Interest income 163 186 668 637
Interest expense (17) (356) (695) (1,104)
----------- ----------- ----------- -----------
Loss from continuing
operations before
income taxes (2,553) (2,487) (14,069) (9,823)
Income taxes - - - -
----------- ----------- ----------- -----------
Loss from continuing
operations $(2,553) $(2,487) $(14,069) $(9,823)
Discontinued
Operations
Income from
discontinued
operations
(including gain on
sale of $48,029,793) 209 1,400 50,237 2,239
Income tax expense - - (273) -
----------- ----------- ----------- -----------
Income from
discontinued
operations 209 1,400 49,964 2,239
----------- ----------- ----------- -----------
Net (loss) / income $(2,344) $(1,087) $ 35,895 $(7,584)
=========== =========== =========== ===========
Net loss from
continuing
operations per
common share - basic $ (0.24) $ (0.23) $ (1.31) $ (0.92)
=========== =========== =========== ===========
Net loss from
continuing
operations per
common share -
diluted $ (0.24) $ (0.23) $ (1.31) $ (0.92)
=========== =========== =========== ===========
Net income from
discontinued
operations per
common share - basic $ 0.02 $ 0.13 $ 4.66 $ 0.21
=========== =========== =========== ===========
Net income from
discontinued
operations per
common share -
diluted $ 0.02 $ 0.13 $ 4.34 $ 0.21
=========== =========== =========== ===========
Net (loss) / income
per common share -
basic $ (0.22) $ (0.10) $ 3.34 $ (0.71)
=========== =========== =========== ===========
Net (loss) / income
per common share -
diluted $ (0.22) $ (0.10) $ 3.12 $ (0.71)
=========== =========== =========== ===========
Weighted average
shares outstanding -
basic 10,637 10,728 10,732 10,728
=========== =========== =========== ===========
Weighted average
shares outstanding -
diluted 11,433 10,753 11,514 10,742
=========== =========== =========== ===========
Celsion Corporation
Condensed Balance Sheets
(in thousands)
December 31,
2007 December 31,
(Unaudited) 2006
------------ ------------
Current assets
Cash and short term investments $ 5,937 $ 9,033
Accounts receivable 230 1,904
Due from Boston Scientific Corporation 15,000 -
Inventories - 2,831
Prepaid expenses 257 430
Escrow account - license fee - 1,825
------------ ------------
Total current assets 21,424 16,023
------------ ------------
Other assets
Property and equipment, net 268 515
Notes and loans receivable 1,382 1,665
Due from Boston Scientific Corporation -
Non Current 15,000 -
Other assets 965 727
------------ ------------
Total other assets 17,615 2,907
------------ ------------
Total assets $ 39,039 $ 18,930
============ ============
Current liabilities
Accounts payable $ 1,830 $ 2,136
Accrued expenses 5,066 1,301
Note payable - current portion 677 -
Current portion of deferred revenue - 571
------------ ------------
Total current liabilities 7,573 4,008
------------ ------------
Long-term liabilities
Deferred revenue - 1,810
Notes and loans payable - principal and
interest 235 16,278
Other liabilities 34 35
------------ ------------
Total long-term liabilities 269 18,123
------------ ------------
Total liabilities 7,842 22,131
------------ ------------
Stockholders' equity / (deficit)
Common stock 108 107
Additional paid-in capital 85,681 87,179
Accumulated deficit (54,592) (90,487)
------------ ------------
Total stockholders' equity / (deficit) 31,197 (3,201)
------------ ------------
Total liabilities and stockholders' equity $ 39,039 $ 18,930
============ ============
SOURCE: Celsion Corporation
Cameron Associates
Paul G. Henning, 212-554-5462
phenning@cameronassoc.com
Copyright Business Wire 2008
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