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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

 

Commission file number 000-14242

 

 

CELSION CORPORATION

(Exact Name of Registrant as Specified in its Charter)

 

 

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   o

 

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “accelerated filer”, “large accelerated filer”, and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large Accelerated Filer  o    Accelerated Filer  o    Non-accelerated Filer  o Smaller Reporting Company x

 

Indicate by checkmark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).   Yes  o   No  x

 

As of November 1, 2008 the Registrant had 10,149,850 shares outstanding of Common Stock, $.01 par value per share.

 

 

Table of Contents

 

TABLE OF CONTENTS

 

PART I:	FINANCIAL INFORMATION
	Item 1.		Financial Statements and Notes (Unaudited)
				Balance Sheets
				Statements of Operations
				Statement of Changes in Stockholders’ Equity
				Statements of Cash Flows
				Notes to Financial Statements
	Item 2.		Management’s Discussion and Analysis of Financial Condition and Results of Operations
	Item 3.		Quantitative and Qualitative Disclosures about Market Risk
	Item 4.		Controls and Procedures
PART II:	OTHER INFORMATION
	Item 1.		Legal Proceedings
	Item 1A.		Risk Factors
	Item 2.		Unregistered Sales of Equity Securities and Use of Proceeds
	Item 3.		Defaults Upon Senior Securities
	Item 4.		Submission of Matters to a vote of Security Holders
	Item 5.		Other Information
	Item 6.		Exhibits
	SIGNATURES
	EXHIBITS
	11	Statement Re: Computation of Earnings Per Share. (Filed herewith)
	31.1	Certification of Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. (Filed herewith)
	31.2	Certification of Principal Financial Officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. (Filed herewith)
	32.1	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. (Furnished herewith)
	32.2	Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. (Furnished herewith)

 

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PART I

FINANCIAL INFORMATION

 

Item 1.     Financial Statements.

 

Index to Financial Statements

 

	Page
Balance Sheets as of September 30, 2008 (Unaudited) and December 31, 2007	4 - 5
Statements of Operations (Unaudited) for the Three and Nine Month Periods Ended September 30, 2008 and 2007	6
Statement of Changes in Stockholders’ Equity (Unaudited) for the Nine Months Ended September 30, 2008	7
Statements of Cash Flows (Unaudited) for the Nine Months Ended September 30, 2008 and 2007	8
Notes to Financial Statements (Unaudited)	9 - 16

 

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CELSION CORPORATION

BALANCE SHEETS

September 30, 2008 and December 31, 2007

 

		September 30,			December 31,
		2008			2007
		(Unaudited)
ASSETS
Current assets
Cash and cash equivalents		$	818,256		$	2,937,373
Short term investments available for sale, at fair value		8,151,090			3,000,000
Accounts receivable - trade		13,182			183,043
Other receivables		54,657			47,110
Due from Boston Scientific Corporation		15,000,000			15,000,000
Prepaid expenses		141,069			256,874
Total current assets		24,178,254			21,424,400
Property and equipment - at cost
Furniture and office equipment		198,434			194,200
Computer hardware and software		314,096			338,349
Laboratory and shop equipment		324,501			305,340
Leasehold improvements		132,148			132,148
		969,179			970,037
Less: Accumulated depreciation		744,324			702,156
Net value of property and equipment		224,855			267,881
Other assets
Advances under Celsion (Canada), Ltd.
Transition Services Agreement (net of allowance of $649,891 and $442,225 respectively)		—			200,000
Note receivable (net of discount of $147,154 and $168,473, respectively, and an allowance of $882,136 and $0, respectively)		320,710			1,181,527
Due from Boston Scientific Corporation - Non Current		—			15,000,000
Deposits with CROs and other assets		1,118,402			899,268
Patent licensing fees (net of accumulated amortization of $15,000 and $9,375, respectively)		60,000			65,625
Total other assets		1,499,112			17,346,420
Total assets		$	25,902,221		$	39,038,701

 

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CELSION CORPORATION

BALANCE SHEETS (Continued)

September 30, 2008 and December 31, 2007

 

		September 30,			December 31,
		2008			2007
		(Unaudited)
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable - trade		$	2,237,168		$	1,830,457
Other accrued liabilities		2,745,848			5,056,380
Income taxes payable		—			546,000
Accrued non-cash compensation		8,910			8,910
Note payable - current portion		407,761			676,859
Total current liabilities		5,399,687			8,118,606
Long-term liabilities
Note payable		—			234,742
Other liabilities		30,051			34,238
Total long-term liabilities		30,051			268,980
Total liabilities		5,429,738			8,387,586
Stockholders’ equity
Common stock - $0.01 par value per share (250,000,000 shares authorized; 10,809,588 and 10,783,922 shares issued as of September 30, 2008 and December 31, 2007, respectively.)		108,096			107,839
Additional paid-in capital		89,014,495			88,319,985
Accumulated other comprehensive loss		(21,322		)	—
Accumulated deficit		(65,989,834		)	(55,137,757		)
Subtotal		23,111,435			33,290,067
Less: 659,738 shares of treasury stock - at cost		(2,638,952		)	(2,638,952		)
Total stockholders’ equity		20,472,483			30,651,115
Total liabilities and stockholders’ equity		$	25,902,221		$	39,038,701

 

See accompanying notes.

 

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CELSION CORPORATION

STATEMENTS OF OPERATIONS

(Unaudited)

 

		Three Months Ended						Nine Months Ended
		September 30,						September 30,
		2008			2007			2008			2007
Operating expenses:
Research and development		$	3,839,951		$	1,958,671		$	8,422,143		$	6,078,520
General and administrative		509,794			1,860,531			1,586,322			4,826,087
Total operating expenses		4,349,745			3,819,202			10,008,465			10,904,607
Loss from operations		(4,349,745		)	(3,819,202		)	(10,008,465		)	(10,904,607		)
Other (expense) / income:
Other expense		(57,287		)	(23,754		)	(896,377		)	(439,211		)
Interest income		81,419			204,143			185,543			505,174
Interest expense		(14,457		)	(11,899		)	(132,778		)	(677,324		)
Loss from continuing operations		$	(4,340,070	)	$	(3,650,712	)	$	(10,852,077	)	$	(11,515,968	)
Discontinued Operations (Note 12)
Income from discontinued operations		—			33,054			—			50,029,211
Income tax expense		—			—			—			(274,000		)
Income from discontinued operations		—			33,054			—			49,755,211
Net (loss) / income		$	(4,340,070	)	$	(3,617,658	)	$	(10,852,077	)	$	38,239,243
Net loss from continuing operations per common share - basic		$	(0.43	)	$	(0.34	)	$	(1.07	)	$	(1.07	)
Net loss from continuing operations per common share - diluted		$	(0.43	)	$	(0.34	)	$	(1.07	)	$	(1.07	)
Net income from discontinued operations per common share - basic		$	—		$	0.00		$	—		$	4.62
Net income from discontinued operations per common share - diluted		$	—		$	0.00		$	—		$	4.32
Net (loss) / income per common share - basic		$	(0.43	)	$	(0.34	)	$	(1.07	)	$	3.55
Net (loss) / income per common share - diluted		$	(0.43	)	$	(0.34	)	$	(1.07	)	$	3.32
Weighted average shares outstanding - basic		10,149,055			10,774,497			10,146,339			10,764,878
Weighted average shares outstanding - diluted (1)		10,149,055			10,774,497			10,146,339			11,526,717

 

(1) Potentially dilutive securities are excluded from the computation of earnings per share for periods in which there is a loss as their effect would be anti-dilutive.

 

See accompanying notes.

 

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CELSION CORPORATION

STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2008

(Unaudited)

 

		Nine Months Ended September 30, 2008
															Accumulated
							Additional								Other
		Common Stock					Paid-in			Treasury Stock					Comprehensive			Accumulated
		Shares		Total			Capital			Shares		Total			Loss			Deficit			Total
Balance at January 1, 2008		10,783,922		$	107,839		$	88,319,985		659,738		$	(2,638,952	)	$	—		$	(55,137,757	)	$	30,651,115
Stock-based compensation expense related to employee stock options		—		—			612,930			—		—			—			—			612,930
Stock based compensation - restricted stock		—		—			39,217			—		—			—			—			39,217
Issuance of restricted stock upon vesting		16,666		167			(167		)	—		—			—			—			—
Shares issued to employees		9,000		90			42,130			—		—			—			—			42,220
Extension of warrants		—		—			400			—		—			—			—			400
Change in fair value of investments		—		—			—			—		—			(21,322		)	—			(21,322		)
Net loss		—		—			—			—		—			—			(10,852,077		)	(10,852,077		)
Balance at September 30, 2008		10,809,588		$	108,096		$	89,014,495		659,738		$	(2,638,952	)	$	(21,322	)	$	(65,989,834	)	$	20,472,483

 

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CELSION CORPORATION

STATEMENTS OF CASH FLOWS

(Unaudited)

 

		Nine Months Ended
		September 30,
		2008			2007
Cash flows from operating activities
Net (loss) / income for the year		$	(10,852,077	)	$	38,239,243
Non-cash items included in net loss:
Depreciation and amortization		90,038			136,463
Accretion of discount on note receivable		(21,319		)	(78,979		)
Gain on the sale of Prolieve		—			(48,029,793		)
Loss on disposal of fixed assets		523			10,488
Stock based compensation - Options		612,930			714,053
Stock based compensation - Stock grants		66,717			58,560
Amortization of deferred license fee		—			(269,840		)
Exercise of common stock options		—			2,718
Shares issued in exchange for services		14,720			56,255
Amortization of patent license		5,625			59,731
Allowance for bad debts		895,854			428,722
Net changes in:
Accounts receivable-trade		169,861			1,653,023
Other receivables		(13,599		)	17,873
Due from Boston Scientific Corporation		15,000,000			—
Inventories		—			5,792
Prepaid expenses		115,805			170,351
Escrow account-license fee		—			1,824,740
Deposits and other assets		(219,134		)	(607,586		)
Accounts payable - trade and accrued interest		606,711			(295,846		)
Income taxes payable		(546,000		)	68,500
Other accrued liabilities		(2,314,719		)	(1,212,541		)
Net cash provided by / (used in) operating activities		3,611,936			(7,048,073		)
Cash flows from investing activities
Purchase of short term investments		(11,640,470		)	(5,000,000		)
Sale of short-term investments		6,507,355			4,100,000
Proceeds from the sale of the Prolieve assets		—			9,958,615
Advances under Celsion Canada transition services agreement		(7,666		)	(45,400		)
Amortization of premium on investments		7,871			—
Accretion of discount on investments		(12,499		)	—
Accrued interest on investments		(34,669		)	—
Payment of licensing fee		—			(1,600,000		)
Purchase of property and equipment		(47,535		)	(87,043		)
Net cash (used in) / provided by investing activities		(5,227,613		)	7,326,172
Cash flows from financing activities
Extension of warrants		400			—
Draws on line of credit		3,000,000			—
Repayment of line of credit		(3,000,000		)	—
Proceeds from note payable		—			1,181,925
Payments on note payable		(503,840		)	(107,324		)
Net cash (used in) / provided by financing activities		(503,440		)	1,074,601
Net (decrease) / increase in cash and cash equivalents		(2,119,117		)	1,352,700
Cash and cash equivalents at beginning of period		2,937,373			1,032,674
Cash and cash equivalents at end of period		$	818,256		$	2,385,374
Cash paid for:
Interest		$	45,882		$	13,637
Income taxes		$	546,000		$	205,500

 

See accompanying notes.

 

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CELSION CORPORATION

 

NOTES TO FINANCIAL STATEMENTS (UNAUDITED)

 

For the Three and Nine Month Periods Ended September 30, 2008 and 2007

 

Note 1.   Basis of Presentation

 

The accompanying unaudited financial statements of Celsion Corporation (which we sometimes refer to as “Celsion”, the “Company”, “we” or “us”) have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of management, all adjustments, consisting only of normal recurring accruals considered necessary for a fair presentation, have been included in the accompanying unaudited financial statements. Operating results for the three and nine month periods ended September 30, 2008 are not necessarily indicative of the results that may be expected for any other interim period(s) or for any full year. For further information, refer to the financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2007 filed with the Securities and Exchange Commission on March 28, 2008.

 

Note 2.   Common Stock Outstanding and Per Share Information

 

Basic earnings per share is computed by dividing net income by the weighted average number of common shares outstanding. Diluted earnings per share is computed after adjusting the denominator of the basic earnings per share computation for the effects of all dilutive potential common shares outstanding during the period. The dilutive effects of options, warrants and their equivalents are computed using the treasury stock method.

 

For the quarter ended September 30, 2008, the 2,097,913 options and warrants that were convertible into shares of the Company’s common stock were excluded from the calculation of diluted earnings per share as their effect would have been anti-dilutive. For the quarter ended September 30, 2007, 844,791 options and warrants that were convertible into shares of the Company’s common stock were excluded from the calculation of diluted earnings per share as their effect would have been anti-dilutive. The total number of outstanding warrants and options for the periods ended September 30, 2008 and 2007 were 2,057,080 and 2,062,467 respectively. Additionally, shares of unvested restricted stock were excluded from the calculation. The total number of shares of unvested stock as of September 30, 2008 and 2007 was 40,833 and 56,400, respectively.

 

Information relating to the calculation of earnings per share is summarized as follows:

 

		Three Months Ended						Nine Months Ended
		September 30,						September 30,
		2008			2007			2008			2007
Net loss from continuing operatons - basic and diluted		$	(4,340,070	)	$	(3,650,712	)	$	(10,852,077	)	$	(11,515,968	)
Net income from discontinued operations - basic and diluted		$	—		$	33,054		$	—		$	49,755,211
Net (loss) / income - basic and diluted		$	(4,340,070	)	$	(3,617,658	)	$	(10,852,077	)	$	38,239,243
Weighted average shares outstanding - basic		10,149,055			10,774,497			10,146,399			10,764,878
Dilutive securities - options and warrants		—			—			—			761,839
Adjusted weighted average shares outstanding - dilutive		10,149,055			10,774,497			10,146,399			11,526,717
Net loss from continuing operations per common share - basic		$	(0.43	)	$	(0.34	)	$	(1.07	)	$	(1.07	)
Net loss from continuing operations per common share - diluted		$	(0.43	)	$	(0.34	)	$	(1.07	)	$	(1.07	)
Net income from discontinued operations per common share - basic		$	—		$	0.00		$	—		$	4.62
Net income from discontinued operations per common share - diluted		$	—		$	0.00		$	—		$	4.32
Net (loss) / income per common share - basic		$	(0.43	)	$	(0.34	)	$	(1.07	)	$	3.55
Net (loss) / income per common share - diluted		$	(0.43	)	$	(0.34	)	$	(1.07	)	$	3.32

 

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Note 3.  New Accounting Pronouncements

 

In September 2006, the Financial Accounting Standards Board issued SFAS No. 157 “Fair Value Measurements”, which defines fair value, establishes a framework for consistently measuring fair value under generally accepted accounting principles, and expands disclosures about fair value measurements. SFAS No. 157 became effective for the Company on January 1, 2008 and did not have an impact on the Company’s financial statements.

 

In November 2007, the Emerging Issues Task Force (“EITF”) issued Issue No. 07-1 (“EITF 07-1”), Accounting for Collaborative Arrangements Related to the Development and Commercialization of Intellectual Property. Companies may enter into arrangements with other companies to jointly develop, manufacture, distribute, and market a product. Often the activities associated with these arrangements are conducted by the collaborators without the creation of a separate legal entity (that is, the arrangement is operated as a “virtual joint venture”). The arrangements generally provide that the collaborators will share, based on contractually defined calculations, the profits or losses from the associated activities. Periodically, the collaborators share financial information related to product revenues generated (if any) and costs incurred that may trigger a sharing payment for the combined profits or losses. EITF 07-1 requires collaborators in such an arrangement to present the result of activities for which they act as the principal on a gross basis and report any payments received from (made to) other collaborators based on other applicable GAAP or, in the absence of other applicable GAAP, based on analogy to authoritative accounting literature or a reasonable, rational, and consistently applied accounting policy election. EITF 07-1 is effective for collaborative arrangements in place at the beginning of the annual period beginning after December 15, 2008. The Company does not currently expect the adoption of EITF 07-1 to have a material impact on its financial statements.

 

In February 2007, the Financial Accounting Standards Board issued SFAS No. 159 “The Fair Value Option for Financial Assets and Financial Liabilities – including an amendment of FASB Statement No. 115”. SFAS No. 159 permits entities to choose to measure eligible items at fair value at specified election dates and report unrealized gains and losses on items for which the fair value option has been elected in earnings at each subsequent reporting date. SFAS No. 159 became effective for the Company on January 1, 2008 and did not have an impact on the Company’s financial statements.

 

In March 2008, the FASB issued SFAS No. 161, “Disclosures about Derivative Instruments and Hedging Activities –an amendment of FASB Statement No. 133” (“SFAS 161”), which requires enhanced disclosures about an entity’s derivative and hedging activities and thereby improves the transparency of financial reporting. SFAS 161 is effective for fiscal years beginning after November 15, 2008. The Company does not expect that the adoption of SFAS 160 will have a significant impact on its financial statements.

 

In April 2008, the FASB issued FASB Staff Position No. 142-3, “Determination of the Useful Life of Intangible Assets” (“FSP No. 142-3”) to improve the consistency between the useful life of a recognized intangible asset (under SFAS No. 142) and the period of expected cash flows used to measure the fair value of the intangible asset (under SFAS No. 141(R)). FSP No. 142-3 amends the factors to be considered when developing renewal or extension assumptions that are used to estimate an intangible asset’s useful life under SFAS No. 142. The guidance in the new staff position is to be applied prospectively to intangible assets acquired after December 31, 2008. In addition, FSP No. 142-3 increases the disclosure requirements related to renewal or extension assumptions. The Company is currently assessing the impact of the adoption of FSP No. 142-3 on its financial statements.

 

In May 2008, the FASB issued SFAS No. 162, “The Hierarchy of Generally Accepted Accounting Principles” (“SFAS 162”). SFAS 162 is intended to improve financial reporting by identifying a consistent framework, or hierarchy, for selecting accounting principles to be used in preparing financial statements in conformity with GAAP for nongovernmental entities. The statement establishes that the GAAP hierarchy should be directed to entities because it is the entity (not its auditor) that is responsible for selecting accounting principles for financial statements that are presented in conformity with GAAP.  This statement is effective 60 days following the SEC’s approval of the Public Company Accounting Oversight Board’s amendments to AU Section 411, The Meaning of Present Fairly in Conformity with Generally Accepted Accounting Principles.  The Company does not believe implementation of SFAS 162 will have a material impact on its financial statements.

 

In June 2008, the FASB issued FASB Staff Position EITF No. 03-6-1, “Determining Whether Instruments Granted in Share-Based Payment Transactions Are Participating Securities” (“FSP EITF No. 03-6-1”).  Under FSP EITF No. 03-6-1, unvested share-based payment awards that contain rights to receive non-forfeitable dividends (whether paid or unpaid) are participating securities, and should be included in the two-class method of computing earnings per share (“EPS”). FSP EITF No. 03-6-1 is

 

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effective for fiscal years beginning after December 15, 2008, and the Company does not expect it to have a material impact on the Company’s financial statements.

 

Note 4.   Stock Based Compensation

 

Employee Stock Options

 

The Company has long-term compensation plans that permit the granting of incentive awards in the form of stock options. Generally, the terms of these plans require that the exercise price of the options may not be less than the fair market value of Celsion’s Common Stock on the date the options are granted. Options generally vest over various time frames or upon milestone accomplishments. Some vest immediately. Others vest over a period between one and five years. The Company’s options generally expire ten years from the date of the grant.

 

2001 Stock Option Plan

 

The purpose of the 2001 Plan is to promote the long-term growth and profitability of Celsion by providing key associates with incentives to improve stockholder value and to contribute to the growth and financial success of Celsion and to enable the Company to attract, retain and reward the best available persons for positions of substantial responsibility. The 2001 Plan permitted the granting of stock options (including nonqualified stock options and incentive stock options qualifying under Section 422 of the Internal Revenue Code) and stock appreciation rights or any combination of the foregoing. During the year that ended December 31, 2007, 195,043 options were canceled or expired. During the nine months ended September 30, 2008, 13,333 options expired.  All of the 208,376 canceled and expired options under the 2001 Plan became available for issue under the 2007 Plan.

 

2004 Stock Incentive Plan

 

The purpose of the 2004 Plan is to promote the long-term growth and financial success of the Company and enable the Company to attract, retain and reward the best available persons for positions of substantial responsibility. The 2004 Plan permits the granting of awards in the form of incentive stock options, restricted stock, restricted stock units, stock appreciation rights, phantom stock, and performance awards, or in any combination of the foregoing. During the year that ended December 31, 2007, 90,379 options were canceled or expired. During the nine months ended September 30, 2008,  24,333 options were canceled or expired. All of the 114,712 canceled and expired options under the 2004 Plan became available for issue under the 2007 Plan.

 

2007 Stock Incentive Plan

 

The purpose of the 2007 Plan is to promote the long-term growth and profitability of the Company by providing incentives to improve stockholder value and enable the Company to attract, retain and reward the best available persons for positions of substantial responsibility. The 2007 Plan permitted the granting of awards in the form of incentive stock options, nonqualified stock options, restricted stock, restricted stock units, stock appreciation rights, phantom stock, and performance awards, or in any combination of the foregoing. During the year ended December 31, 2007, 103,500  options were issued. No options were canceled or expired under the plan for the year ended December 31, 2007. During the nine months ended September 30, 2008, 345,000 options were issued and 24,000 options were canceled. Additionally, 9,000 shares of stock were issued under the plan as performance awards during the quarter ended September 30, 2008. On September 30, 2008, there were 566,500 shares available out of 1,000,000 shares authorized and available under the 2007 Plan. All canceled and expired options under the 2001 Plan and the 2004 Plan became available for issue under the 2007 Plan.

 

Options and Restricted Stock Issued to Consultants for Services

 

The Company enters into agreements with consultants in which the consultants receive restricted stock and stock options in exchange for services. Generally, the terms of these plans require that the exercise price of the options may not be less than the fair market value of Celsion’s Common Stock on the date the options are granted. Options and restricted stock generally vest over various time frames or upon milestone accomplishments. Some vest immediately. Others vest over a period between one and five years. The Company’s options generally expire ten years from the date of the grant. During the nine months ended September 30, 2008, 5,000 shares of restricted stock were issued to a consultant as part of a consulting agreement. There were no options granted to non-employees for the nine months ended September 30, 2008.

 

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A summary of the Company’s Common Stock option and warrant activity and related information is as follows:

 

Stock Options		Options Outstanding		Weighted Average Exercise Price			Weighted Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value
Outstanding at December 31, 2007		1,498,841		$	6.17
Granted		345,000		5.44
Exercised		—		—
Canceled or expired		(61,667	)	(7.72		)
Outstanding at September 30, 2008		1,782,174		$	5.97		7.2		$	336,625
Exercisable at September 30, 2008		998,550		$	7.21		5.9		$	87,167

 

Warrants		Warrants Outstanding		Weighted Average Exercise Price			Weighted Average Remaining Contractual Term (in years)		Aggregate Intrinsic Value
Outstanding at December 31, 2007		568,461		$	15.59
Granted		—		—
Exercised		—		—
Canceled or expired		(293,555	)	(14.17		)
Outstanding at September 30, 2008		274,906		$	17.12		0.6		$	—
Exercisable at September 30, 2008		274,906		$	17.12		0.6		$	—

 

A summary of the Company’s Restricted Stock activity and related information is as follows:

 

Restricted Stock		Outstanding		Weighted Average Exercise Price
Non-vested stock awards at December 31, 2007		50,000		$	2.42
Granted		7,500		4.89
Vested		(16,667	)	2.42
Forfeited		—		—
Non-vested stock awards at September 30, 2008		40,833		$	2.87

 

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The following is additional information with respect to options granted during the nine months ended September 30, 2008:

 

 

For all of the Company’s stock-based compensation plans, the fair value of each grant was estimated at the date of grant using the Black-Scholes option pricing model.  Black-Scholes utilizes assumptions related to volatility, the risk-free interest rate, the dividend yield and employee exercise behavior.  Expected volatilities utilized in the model are based on historical volatility of the Company’s stock price.  The risk free interest rate is derived from values assigned to U.S. Treasury strips as published in the Wall Street Journal in effect at the time of grant.  The model incorporates exercise, pre-vesting and post-vesting forfeiture assumptions based on analysis of historical data.  The expected life of the fiscal 2008 grants was generated using the simplified method as allowed under Securities and Exchange Commission Staff Accounting Bulletin No. 107.

 

Stock based compensation expense totaled $148,240 and $694,276 during the three and nine months ended September 30, 2008 and $345,326 and $772,613 during the three and nine months ended September 30, 2007. Stock based compensation is recognized ratably over the requisite service period for all awards. Unrecognized stock based compensation expense related to stock options totaled $1,799,674 at September 30, 2008 while the unrecognized stock based compensation expense related to non-vested restricted stock awards was $78,150 at September 30, 2008. These unrecognized expenses will be recognized in the income statement at various rates up to the next four years.

 

Note 5.   Short Term Investments Available for Sale

 

Short term investments available for sale of $8,151,090 as of September 30, 2008 and $3,000,000 as of December 31, 2007 consist of money market funds, commercial paper, corporate debt securities, and government agency debt securities. They are valued at estimated fair value, with unrealized gains and losses reported as a separate component of stockholders’ equity in Accumulated Other Comprehensive Loss.

 

Securities available for sale are evaluated periodically to determine whether a decline in their value is other than temporary.  The term “other than temporary” is not intended to indicate a permanent decline in value.  Rather, it means that the prospects for near term recovery of value are not necessarily favorable, or that there is a lack of evidence to support fair values equal to, or greater than, the carrying value of the security.  Management reviews criteria such as the magnitude and duration of the decline, as well as the reasons for the decline, to predict whether the loss in value is other than temporary.  Once a decline in value is determined to be other than temporary, the value of the security is reduced and a corresponding charge to earnings is recognized.

 

		September 30			December 31,
Short term investments - at fair value		2008			2007
Money market funds and commercial paper		$	3,441,082		$	3,000,000
Bonds - government agencies		2,423,707			—
Bonds - corporate issuances		2,286,301			—
Total		$	8,151,090		$	3,000,000

 

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Note 6.   Fair Values of Financial Instruments

 

FASB Statement No. 157 establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The standard describes three levels of inputs that may be used to measure fair value:

 

Level 1: Quoted prices (unadjusted) or identical assets or liabilities in active markets that the entity has the ability to access as of the measurement date.

 

Level 2: Significant other observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data.

 

Level 3: Significant unobservable inputs that reflect a reporting entity’s own assumptions that market participants would use in pricing an asset or liability.

 

The fair values of securities available for sale are determined by obtaining quoted prices on nationally recognized exchanges (Level 1 inputs) or matrix pricing, which is a mathematical technique widely used in the industry to value debt securities without relying exclusively on quoted prices for the specific securities but rather by relying on the securities’ relationship to other benchmark quoted securities (Level 2 inputs).

 

Assets measured at fair value on a recurring basis are summarized below:

 

Fair value measurements at September 30, 2008 using

Significant

Quoted prices in

other

Significant

active markets for

observable

unobservable

identical assets

inputs

inputs

September 30, 2008

(Level 1)

(Level 2)

(Level 3)

Short term investments available for sale

$

8,151,090

$

—

$

8,151,090

$

—

 

Note 7.   Note Receivable

 

On January 16, 2006, Celsion contributed to its wholly-owned subsidiary, Celsion (Canada) Limited (“Canada”), all of the Company’s assets relating to its Adaptive Phased Array (“APA”) technology for the treatment of breast cancer. Also on that date, the Company entered into a Stock Purchase Agreement with the Company’s founder and former officer and director, Dr. Augustine Y. Cheung, whereby the Company sold to Dr. Cheung all of the issued and outstanding shares of capital stock of Canada. The Company also agreed to provide certain services to Canada pursuant to a Transition Services Agreement between the Company and Canada.

 

Under the Stock Purchase Agreement, all of the capital stock of Canada was transferred to Dr. Cheung in exchange for a promissory note made by Dr. Cheung in favor of the Company in the principal amount of $1,500,000 to be paid over a period of up to 78 months and secured by a pledge of 100,536 shares of Celsion common stock owned by Dr. Cheung and his wife and the commitment of Canada to pay a 5 % royalty on the net sales of certain products sold by, and patent royalties received by, Canada and its successors and assigns, of up to $18,500,000.

 

The terms of the note receivable only specify an interest charge in the event that scheduled payments are in arrears.  The $1,500,000 note was therefore discounted at the prime rate in effect January 16, 2006 (7.25%) plus 1.0%, or 8.25%, and the balance, net of discount, of $1,146,428 was recorded in the financial statements above.  Interest income of $21,319 and $60,624 was recorded in the nine months ended September 30, 2008 and 2007, respectively.

 

During the month of May 2008, the borrower approached the Company and requested that the terms of the note be extended and/or restructured. As of the filing of this Form 10-Q, an agreement between the parties had not been reached. As a result, the collectibility of the note receivable became doubtful. Accordingly, an allowance was placed against the note to reduce the balance to the estimated net realizable value of the collateral underlying the note. As noted above, 100,536 shares of Celsion common stock are pledged as collateral to the note. The closing price of Celsion’s common stock on September 30, 2008 was $3.19, which results in a total collateral value of $320,710. Therefore, the carrying value of the note was reduced to $320,710 as of September 30, 2008.

 

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Note 8.  Advances under Celsion (Canada) Limited Transition Services Agreement

 

In conjunction with the sale of Canada, a Transition Services Agreement was entered into whereby (i) Celsion sublet space in the Company’s offices for use by Canada to carry on its business, for a period of up to six (6) months from the date of the agreement; (ii) Celsion provided administrative support services as needed in the operation of Canada’s business for the period of the sublease; and (iii) Celsion advanced funds to pay salary and health and dental insurance of each of certain employees of Canada and the expenses reasonably incurred in connection with the operation of Canada’s business up to $100,000 for the shorter of the period ending June 30, 2006 or the date of closing by Canada of a transaction involving the merger of Canada into a newly created Canadian Capital Pool Company and a simultaneous funding through a private placement of shares under terms approved by the Toronto Stock Exchange (the “Canada Transaction”). Within ten days after the closing of the Canada Transaction, Canada is obligated to pay the Company all amounts due under the Transition Services Agreement.

 

The Transition Services Agreement was amended on March 28, 2006 to advance Canada an additional $200,000 to fund reasonable operating expenses. This additional advance is repayable under the same terms as the Transition Services Agreement.  The cumulative balance advanced under the Transition Services Agreement, as amended, at September 30, 2008 was $649,891.

 

When the Canada Transaction did not close by December 31, 2006, Celsion management established, based on discussions with Canada management, that diligent efforts were being made by Canada management to close the Canada Transaction on a timely basis and agreed to extend the due date for repayment of the loan to the earlier of the closing of the Canada Transaction or June 30, 2007. Canada did not close the transaction nor had it paid the amounts due as of the June 30, 2007 due date. Accordingly, during the quarter ended June 30, 2007, the Company placed an allowance against this receivable and recorded the estimated net realizable value of the receivable as $200,000, which was guaranteed by Dr. Cheung. Given the collectibility concern of Dr. Cheung’s note described in Note 7 above, the Company has increased its allowance to $649,891 as of September 30, 2008 and recorded the estimated net realizable value of the receivable as zero.

 

Note 9. Licensing Agreement

 

Celsion entered into a Distribution Agreement with Boston Scientific Corporation (“Boston Scientific” or “BSC”) on January 20, 2003 pursuant to which the Company granted Boston Scientific exclusive rights to market and distribute the Prolieve Thermodilatation^® system and its component parts for the treatment of BPH in all territories other than China, Taiwan, Hong Kong, Macao, Mexico and Central and South America. The agreement was terminated upon the sale of the Prolieve assets to Boston Scientific on June 21, 2007 (as more fully described in Note 12). The Distribution Agreement had a seven-year term commencing on February 21, 2004. The parties previously shared gross sales (less costs and expenses) attributable to the product.

 

Celsion received a $4,000,000 licensing fee under the Distribution Agreement, $2,000,000 of which was placed in an interest bearing escrow account for a period of 36 months ending February 21, 2007 for payment of any legal expenses, settlements, license fees, royalties, damages or judgments incurred by Celsion or Boston Scientific in connection with any patent litigation related to alleged infringement of third party patents.   Interest on the funds was retained in the escrow account and accrued to the benefit of Celsion. The balance remaining in the escrow was released to Celsion on February 20, 2007 and applied to settlement of a patent infringement lawsuit with American Medical Systems, Inc. and AMS Research Corporation (together referred to as “AMS”).

 

The Company recognized the licensing fee at a rate of $47,619 per month over the seven-year term of the Distribution Agreement which began February 21, 2004. Upon the sale of the Prolieve assets on June 21, 2007, the remaining balance of the fee was recorded as income and included in the gain on the sale of the Prolieve assets during the quarter ended June 30, 2007.

 

Note 10. Secured Line of Credit

 

On November 9, 2007, the Company entered into a Loan and Security Agreement (the “Agreement”) with Manufacturers and Traders Trust Company (“M&T”) pursuant to which M&T agreed to provide a draw-down credit facility to the Company (the “Credit Facility”).  The Company was able to request advances under the Credit Facility at a rate not to exceed $1.5 million per month, up to a maximum principal amount under the Credit Facility of $6.5 million.  Each

 

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advance was subject to, among other customary conditions, a determination by M&T in its good faith discretion that the Company owned less than $0.5 million in cash and other property readily convertible into cash, excluding a $1.0 million cash collateral account held at M&T.  Amounts borrowed by the Company under the Credit Facility and repaid could not be re-advanced to the Company.

 

The Credit Facility was secured by (i) the $1.0 million cash collateral account and (ii) substantially all of the Company’s assets.  The Credit Facility bore interest on the outstanding balance at a rate of the London Interbank Offered Rate plus 2.75%.  Accrued interest on the outstanding balance was payable monthly.  The total outstanding principal and accrued interest balance on the Credit Facility was fully repaid on June 6, 2008.

 

Upon receipt of the second $15 million installment due from Boston Scientific under the Asset Purchase Agreement (disussed below in Note 12) on June 6, 2008, the credit facility was closed.

 

Note 11. Note Payable

 

On July 23, 2007, the Company entered into a Premium Finance Agreement with Flatiron Capital Corporation (“Flatiron”) whereby Flatiron funded certain insurance premiums in the amount of $1,313,250 on behalf of the Company. In exchange, the Company will make 21 monthly installments of $59,418 beginning on August 23, 2007. Interest accrues at a rate of 5.98% on outstanding balances.

 

Note 12. Discontinued Operations

 

On April 17, 2007, the Company and Boston Scientific entered into an asset purchase agreement to reflect the exercise by Boston Scientific of its option to purchase all of the Prolieve assets of the Company (the “Asset Purchase Agreement”). The Board of Directors of the Company approved the Asset Purchase Agreement and the transactions contemplated thereby, and the Company’s stockholders ratified the sale at the annual meeting on June 13, 2007.  Pursuant to the Asset Purchase Agreement, Boston Scientific purchased the Prolieve assets for an aggregate purchase price of $60 million, subject to reduction in accordance with the terms and conditions of the Asset Purchase Agreement. The transaction closed on June 21, 2007, and the Company recorded a gain on the sale in the amount of $48 million.

 

The gain on the sale of Prolieve was calculated as follows:

 

Sales Price		$	60,000,000
Transaction fees and legal costs		(1,460,165		)
Indemnity guarantee costs		(5,000,000		)
Licensing fee		(3,100,000		)
Adjusted Sales Price		50,439,835
Net assets sold
Inventories		(2,824,757		)
Laboratory and shop equipment		(150,503		)
AMS License Fee		(1,545,893		)
Liabilities Transferred
Amortization of License Fee		2,111,111
Gain on Sale		$	48,029,793

 

As previously disclosed, the Company and Boston Scientific entered into a Transaction Agreement effective January 20, 2003 (the “Transaction Agreement”). As part of the consideration in the Transaction Agreement, the Company granted Boston Scientific an exclusive option to purchase the Prolieve assets for a price equal to the greater of $60 million or a multiple of sales, exercisable for a period of five years and expiring in February 2009. As previously disclosed, on August 8, 2005, the Company and Boston Scientific entered into the First Amendment pursuant to which Boston Scientific agreed to lend the Company up to $15 million to be evidenced by one or more convertible secured promissory notes (the “Notes”). The first installment of $6 million was disbursed on August 17, 2005, the second and third installments, each of $4.5 million, were disbursed on February 2, 2006, and  July 28, 2006, respectively. The First Amendment also fixed the purchase option price at $60 million (eliminating the multiple of sales).

 

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