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ICGN > SEC Filings for ICGN > Form 10-Q on 9-Nov-2009All Recent SEC Filings

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Form 10-Q for ICAGEN INC


9-Nov-2009

Quarterly Report


ITEM 2 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. You should review the section entitled "Risk Factors" of this Quarterly Report on Form 10-Q for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.

Overview

We are a biopharmaceutical company focused on the discovery, development and commercialization of novel orally-administered small molecule drugs that modulate ion channel targets. Utilizing our proprietary know-how and integrated scientific and drug development capabilities, we have identified multiple drug candidates that modulate ion channels. We are conducting research and development activities in a number of disease areas, including epilepsy, pain and inflammation.

Since our incorporation in November 1992, we have devoted substantially all of our resources to the discovery and development of drug candidates with activity at ion channels. We currently have one clinical development program, as well as other drug discovery programs addressing specific ion channel targets. We have not received approval to market any product and, to date, have received no product revenues.

Since our inception, we have incurred substantial losses and, as of September 30, 2009, we had an accumulated deficit of $135.9 million. These losses and accumulated deficit have resulted from the significant costs incurred in the research and development of our compounds and technologies and general and administrative costs. We expect that our operating losses will continue and likely increase substantially for at least the next several quarters and years as we continue to expand our research, development and clinical trial activities and infrastructure.

A substantial portion of our revenue for at least the next several years will depend on our achieving development and regulatory milestones in our existing collaborative research and development program and entering into new collaborations. Our revenue may vary substantially from quarter to quarter and year to year. Our operating expenses may also vary substantially from quarter to quarter and year to year based on the timing of clinical trial patient enrollment and our research activities. We believe that period-to-period comparisons of our results of operations are not meaningful and should not be relied on as indicative of our future performance.

The successful development of our product candidates is highly uncertain. We estimate that we will incur at least approximately $2.0 million over the course of the next nine months for the planned proof-of-concept trials for ICA-105665 in epilepsy and in pain. The conduct of this program beyond these proof-of-concept studies will be dependent upon the availability of additional capital or the formation of one or more new collaborations.

Recent Developments

In July 2009, the U.S. Food and Drug Administration, or the FDA, lifted the partial clinical hold related to the development of ICA-105665, our novel orally available small molecule KCNQ potassium channel agonist, for the treatment of epilepsy. Accordingly, in September 2009, we initiated a proof-of-concept study of ICA-105665 in patients with photosensitive epilepsy. In addition, in September 2009 we initiated a proof-of-concept pain study in healthy volunteers.

In September 2009, we reported top line results of a Phase IIa proof-of-concept study of senicapoc in allergic asthma. In this study, senicapoc demonstrated a modest reduction in the late asthmatic response (LAR) to a challenge of inhaled allergen. In October 2009, we reported top line results of a Phase IIa proof-of-concept study of senicapoc in exercise induced asthma. In this study, senicapoc failed to demonstrate an effect on the primary study endpoints. We are completing the analysis of both data sets from these two proof-of-concept studies, but do not plan to pursue the further clinical development of senicapoc for asthma.

In September 2009, we announced a one year extension through September 2010 of the research term of our worldwide collaboration and licensing agreement with Pfizer for the discovery, development, and commercialization of compounds that modulate three specific sodium ion channel targets as potential new treatments for pain and related disorders.


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Critical Accounting Policies and Estimates

Our discussion and analysis of our financial condition and results of operations are based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amount of assets and liabilities at the date of the financial statements and revenues and expenses during the reporting period. Actual results may differ materially from these estimates. Critical accounting policies are those policies that are reflective of significant judgments and uncertainties and could potentially result in materially different results under different assumptions and conditions. Our most critical accounting policies involve: revenue recognition, accrued expenses, research and development, stock-based compensation and accounting for income taxes. For a more detailed explanation of our critical accounting policies, refer to our Annual Report on Form 10-K for the fiscal year ended December 31, 2008, as filed with the Securities and Exchange Commission, or SEC, on March 16, 2009.

Results of Operations

Comparison of Three Months Ended September 30, 2009 and September 30, 2008

Collaborative Research and Development Revenues

Collaborative research and development revenues decreased by $893,000, or 29%, to $2.2 million for the three months ended September 30, 2009 from $3.1 million for the three months ended September 30, 2008 and consisted of research and development funding related to our collaboration with Pfizer for both periods. The decrease was due primarily to a $790,000 decrease in amortization of the initial upfront payment from Pfizer which became fully amortized during the third quarter of 2009.

Research and Development Expense

Research and development expense decreased by $1.1 million, or 19%, to $4.6 million for the three months ended September 30, 2009 from $5.6 million for the three months ended September 30, 2008. The decrease was due primarily to the implementation of a variety of cost reduction measures, including a decrease of $287,000 in patent expense, a decrease of $206,000 in salary and benefits expense, and a decrease in the aggregate of $171,000 related to laboratory supplies expense and outsourced chemistry expense; a decrease of $600,000 in expenses associated with our epilepsy and pain program due to the timing of the conduct of the studies in this program; and a decrease of $121,000 in equity compensation expense. This decrease was partially offset by an increase of $319,000 in expenses related to the development of senicapoc for asthma and $197,000 of restructuring charges.

Senicapoc, which we had previously studied as a potential treatment for both sickle cell disease and asthma, and ICA-105665 and our other lead compounds for epilepsy and pain represent a substantial majority of the total research and development payments by us to third parties. The following table shows, for the periods presented, the total out-of-pocket payments made by us to third parties for preclinical study support, clinical supplies and clinical trials associated with these programs:

                                                   Three months ended
                                                      September 30,           Cumulative from
Development Program                                 2009          2008           Inception
                                                                (in thousands)
Senicapoc                                        $      861     $    555     $          51,578
ICA-105665 and other lead compounds for
epilepsy and pain                                       513        1,112                19,414

Total                                            $    1,374     $  1,667     $          70,992

General and Administrative Expense

General and administrative expense decreased by $120,000, or 10%, to $1.1 million for the three months ended September 30, 2009 from $1.3 million for the three months ended September 30, 2008. The decrease was due primarily to the implementation of a variety of cost control measures, including a decrease of $184,000 related to business development expense, and a decrease of $104,000 in equity compensation expense, partially offset by $182,000 of restructuring charges.

Interest Income and Interest Expense

Interest income decreased $218,000, or 96%, to $8,000 for the three months ended September 30, 2009, from $226,000 for the three months ended September 30, 2008. The decrease in interest income was attributable to decreased interest rates and decreased cash balances.


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Interest expense decreased $9,000, or 18%, to $40,000 for the three months ended September 30, 2009 from $49,000 for the three months ended September 30, 2008. The decrease in interest expense was attributable to decreased average borrowings under our equipment debt financing.

Comparison of Nine Months Ended September 30, 2009 and September 30, 2008

Collaborative Research and Development Revenues

Collaborative research and development revenues decreased by $1.0 million, or 11%, to $8.3 million for the nine months ended September 30, 2009 from $9.3 million for the nine months ended September 30, 2008 and consisted of research and development funding related to our collaboration with Pfizer for both periods. The decrease was due primarily to a $790,000 decrease in amortization of the initial upfront payment from Pfizer which became fully amortized during the third quarter of 2009.

Research and Development Expense

Research and development expense decreased by $2.6 million, or 15%, to $14.2 million for the nine months ended September 30, 2009 from $16.7 million for the nine months ended September 30, 2008. The decrease was due primarily to a decrease of $2.2 million in expenses associated with our epilepsy and pain program due to the timing of the conduct of the studies in this program; the implementation of a variety of cost control measures, including a decrease in patent expense of $702,000, a decrease in outsourced chemistry expense of $210,000, a decrease of $189,000 in expenses associated with our pharmacology studies, a decrease of $146,000 in laboratory supplies expense, a decrease of $114,000 in license fee expense and a decrease in the aggregate of $232,000 related to travel and seminar expenses, consulting expenses and software license expenses; and a decrease of $379,000 in equity compensation expense. This decrease was partially offset by an increase of $1.5 million in expense related to the development of senicapoc for the treatment of asthma and $197,000 in restructuring charges.

Senicapoc, which we had previously studied as a potential treatment for both sickle cell disease and asthma, and ICA-105665 and our other lead compounds for epilepsy and pain represent a substantial majority of the total research and development payments by us to third parties. The following table shows, for the periods presented, the total out-of-pocket payments made by us to third parties for preclinical study support, clinical supplies and clinical trials associated with these programs:

                                                    Nine months ended
                                                      September 30,           Cumulative from
Development Program                                  2009         2008           Inception
                                                                 (in thousands)
Senicapoc                                         $    2,608     $ 1,107     $          51,578
ICA-105665 and other lead compounds for
epilepsy and pain                                      1,383       3,628                19,414

Total                                             $    3,991     $ 4,735     $          70,992

General and Administrative Expense

General and administrative expense decreased by $816,000, or 19%, to $3.5 million for the nine months ended September 30, 2009 from $4.3 million for the nine months ended September 30, 2008. The decrease was due primarily to the implementation of a variety of cost control measures, including a decrease of $312,000 in business development expense, a decrease of $203,000 in salary and benefits expense, and a decrease in the aggregate of $163,000 related to board of director expenses and auditing and tax expense; and a decrease of $392,000 in equity compensation expense. This decrease was partially offset by $182,000 of restructuring expenses and an increase of $105,000 in insurance expense.

Interest Income and Interest Expense

Interest income decreased $910,000, or 97%, to $27,000 for the nine months ended September 30, 2009 from $937,000 for the nine months ended September 30, 2008. The decrease in interest income was attributable to lower interest rates and decreased cash balances during the period.

Interest expense remained stable at $142,000 for the nine months ended September 30, 2009 and 2008.

Liquidity and Capital Resources

We have financed our operations since inception through the issuance of equity securities, payments received under our collaboration agreements, proceeds from equipment debt financing and capital leases and interest income. At September 30, 2009, our cash and cash equivalents were $21.1 million as compared to $34.2 million at December 31, 2008. Our cash and cash equivalents are highly liquid investments with a maturity of 90 days or less at date of purchase and consist of time deposits and investments in money market funds with commercial banks and financial institutions and United States government obligations.


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In August 2007, we entered into a collaborative research and license agreement with Pfizer for the discovery, development, manufacture and commercialization of compounds and products that modulate three specific sodium ion channels as new potential treatments for pain and related disorders. Pursuant to the collaboration arrangement, Pfizer paid us an initial upfront license fee of $12.0 million. In addition to the upfront license fee, Pfizer provided us with research and development funding over the initial two-year research period pursuant to the agreement. Pfizer is obligated to make payments to us upon achievement of specified research, development, regulatory and commercialization milestones of up to $359.0 million for each drug candidate developed. We are also eligible to receive tiered royalties, against which Pfizer may credit any commercialization milestones, based on specified percentages of net product sales. In September 2009, the research term of the collaborative research and license agreement with Pfizer was extended for a one-year period through September 2010.

In August 2007, in connection with the collaborative research and license agreement with Pfizer, we also entered into a purchase agreement with Pfizer to sell to Pfizer up to $15.0 million of our common stock. In a first closing of the transaction on August 20, 2007, we sold 2,688,172 shares of common stock to Pfizer at a price of $1.86 per share, which was the closing bid price of our common stock as reported on the Nasdaq Global Market as of 4:00 p.m. Eastern time on the business day preceding the execution of the purchase agreement, resulting in gross proceeds to us of approximately $5.0 million. In a subsequent closing of the transaction on February 13, 2008, we sold an additional 5,847,953 shares of common stock to Pfizer at a price of $1.71 per share, which was the closing bid price of our common stock as reported on the Nasdaq Global Market as of 4:00 p.m. Eastern time on the business day preceding the date of our exercise of our put option to sell the shares, resulting in gross proceeds to us of approximately $10.0 million.

Cash Flows

Net cash used in operating activities was $12.6 million for the nine months ended September 30, 2009. This reflects a net loss of approximately $9.5 million, a decrease of approximately $4.0 million in deferred revenue, an increase of approximately $379,000 in prepaid expenses and other current and non-current assets and a decrease of approximately $366,000 in accounts payable and accrued expenses. These amounts were partially offset by $1.0 million of non-cash expenses related to stock-based compensation and $612,000 of non-cash expenses for depreciation and amortization of property and equipment.

Net cash used in investing activities in the nine months ended September 30, 2009 was $47,000, consisting of the purchase of property and equipment.

Net cash used in financing activities during the nine months ended September 30, 2009 was $477,000 and consisted primarily of $564,000 in principal repayments related to our equipment debt financing.

Net cash used in operating activities was $13.7 million for the nine months ended September 30, 2008. This reflects a net loss of approximately $10.9 million, a decrease of approximately $4.1 million in deferred revenue, a decrease of approximately $1.1 million in accounts payable and accrued expenses and an increase of approximately $168,000 in prepaid expenses and other current and non-current assets. These amounts were partially offset by $1.8 million of non-cash expenses related to stock-based compensation, $586,000 of non-cash expenses for depreciation and amortization of property and equipment and an increase of approximately $278,000 in other liabilities.

Net cash used in investing activities in the nine months ended September 30, 2008 was $1.6 million, consisting of the purchase of property and equipment.

Net cash provided by financing activities during the nine months ended September 30, 2008 was $10.5 million and consisted of $10.0 million in net proceeds from the Pfizer equity investment completed in February 2008 and $1.0 million in proceeds from equipment debt financing, partially offset by $570,000 in principal repayments related to our equipment debt financing.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements.

Contractual Obligations

Our contractual obligations as of December 31, 2008 are described in our Annual Report on Form 10-K.

Funding Requirements

We expect to incur losses from operations for at least the next several years. We believe, based upon our current operating plan, that our existing cash and cash equivalents, which were provided primarily from the $12.0 million up front license fee from Pfizer


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received in August 2007 and the gross proceeds of approximately $15.0 million from the Pfizer equity investments completed in August 2007 and February 2008, will be sufficient to enable us to fund our operating expenses, obligations under our equipment debt financing and capital expenditure requirements at least for the next twelve months. We will need additional funds to meet our obligations and fund our operations beyond that time. Our future capital requirements will depend on many factors, including:

• the scope and results of our research, preclinical and clinical development activities;

• the timing of, and the costs involved in, obtaining regulatory approvals;

• the cost of commercialization activities, including product marketing, sales and distribution;

• the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims and other patent-related costs, including litigation costs and the results of such litigation;

• the extent to which we acquire or invest in businesses, products and technologies;

• the success of our collaboration with Pfizer; and

• our ability to establish and maintain additional collaborations.

We do not anticipate that we will generate product revenue for at least the next several years. To the extent our capital resources are insufficient to meet future capital requirements, we will need to finance future cash needs through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements. The Company has renewed the research term of its collaboration with Pfizer for a one year period through September 2010. Except for collaboration revenue it expects to receive from Pfizer as funding for research and development activities, the Company does not currently have any commitments for future external funding.

Additional equity or debt financing, or corporate collaboration and licensing arrangements, may not be available on acceptable terms, if at all, particularly in the current economic environment. If adequate funds are not available, we may be required to delay, reduce the scope of or eliminate our research and development programs, reduce our planned commercialization efforts, or obtain funds through arrangements with collaborators or others that may require us to relinquish rights to certain drug candidates that we might otherwise seek to develop or commercialize independently. Additionally, any future equity funding may dilute the ownership of our equity investors.

Recent Accounting Pronouncements

In June 2009, the Financial Accounting Standards Board , or FASB, issued Accounting Standards Codification, or ASC, 105 (formerly Statement of Financial Accounting Standards, or SFAS, No. 168), "The FASB Accounting Standards Codification and the Hierarchy of Generally Accepted Accounting Principles-a replacement of FASB Statement No. 162," or ASC 105. ASC 105 establishes the ASC as the single source of authoritative U.S. accounting and reporting standards applicable for all non-governmental entities, with the exception of guidance issued by the SEC and its staff. ASC 105 was effective July 1, 2009 and applies to all interim periods ending after September 15, 2009. Therefore, we adopted ASC 105 for the reporting in our 2009 third quarter. The adoption of ASC 105 did not have a material impact on our financial statements.

In May 2009, the FASB issued ASC 855 (formerly SFAS No. 165), "Subsequent Events," or ASC 855. ASC 855 establishes general standards of accounting for and disclosure of events that occur after the balance sheet date but before financial statements are issued or are available to be issued. It requires the disclosure of the date through which an entity has evaluated subsequent events and the basis for that date. ASC 855 was effective for us for the quarter ended June 30, 2009. The adoption of ASC 855 did not have a significant impact upon our accounting for and disclosure of subsequent events.

In December 2007, the FASB issued ASC 805 (formerly SFAS No. 141R), "Business Combinations," or ASC 805. ASC 805 establishes principles and requirements for how an acquirer in a business combination recognizes and measures the assets acquired, liabilities assumed and any noncontrolling interest in the acquiree. This statement also provides guidance for recognizing and measuring the goodwill acquired in the business combination and determines what information to disclose to enable users of the financial statements to evaluate the nature and financial effects of the business combination. ASC 805 applies prospectively to business combinations for which the acquisition date is on or after the beginning of the first fiscal year beginning on or after December 15, 2008. The adoption of ASC 805 did not have a material impact on our financial statements.

In November 2007, the Emerging Issues Task Force, or EITF, of the FASB reached consensus on ASC 808 (formerly EITF Issue No. 07-1), "Accounting for Collaborative Arrangements," or ASC 808. ASC 808 addresses the issue of how costs incurred and revenue generated on sales to third parties should be reported by participants in a collaborative arrangement in each of their respective income statements. ASC 808 also provides guidance on how an entity should characterize payments made between participants in a collaborative arrangement in the income statement and what participants should disclose in the notes to the financial statements about collaborative arrangements. ASC 808 was effective for fiscal years beginning after December 15, 2008 and has been applied retrospectively to all periods presented for all collaborative arrangements existing as of the effective date. The adoption of ASC 808 did not have a material impact on our financial statements.


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In September 2006, the FASB issued ASC 820 (formerly SFAS No. 157), "Fair Value Measurements," or ASC 820. ASC 820 defines fair value, establishes a framework for measuring fair value in accordance with accounting principles generally accepted in the United States, and expands disclosures about fair value measurements. This pronouncement applies under the other accounting standards that require or permit fair value measurements. Accordingly, this statement does not require any new fair value measurements. ASC 820 was effective for fiscal years beginning after November 15, 2007 and interim periods within those fiscal years, for all financial assets and liabilities and for nonfinancial assets and liabilities that are recognized or disclosed at fair value at least annually. It is effective for fiscal years beginning after November 15, 2008 for all other nonfinancial assets and liabilities. ASC 820 is to be applied prospectively. The adoption of the requirements of ASC 820 that were effective January 1, 2008 and January 1, 2009 did not have a material impact on our financial statements.

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