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| ICGN > SEC Filings for ICGN > Form 10-Q on 7-May-2009 | All Recent SEC Filings |
7-May-2009
Quarterly Report
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, asthma, 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 two clinical development programs, 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 March 31, 2009, we had an accumulated deficit of $130.1 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. In particular, as we advance ICA-105665 and the other lead compounds that we are developing for the treatment of epilepsy and neuropathic pain and as we pursue the development of senicapoc, formerly ICA-17043, for the treatment of asthma, we expect that our research and development expenses will increase significantly. 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 $3.0 million over the course of the next year for the planned proof-of-concept trials for ICA-105665 in epilepsy and in pain. The actual amount of expenses is subject to a number of variables, including the lifting of the partial clinical hold related to epilepsy and the approval by the FDA of a proposed proof-of-concept study in epilepsy. Additionally, we expect to incur at least approximately $3.0 million over the course of the next year to complete the two ongoing proof-of-concept trials of senicapoc for the treatment of asthma. The conduct of these programs 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 March 2009, we initiated a Phase II proof-of-concept study of senicapoc, a novel orally available small molecule inhibitor of the KCa3.1 potassium ion channel, in patients with exercise-induced asthma. This study complements an ongoing proof-of-concept study in patients with allergic asthma which we initiated during the fourth quarter of 2008 and for which we completed enrollment in April 2009.
In March 2009, we received notification from the U.S. Food and Drug Administration, or FDA, that ICA-105665, a novel orally administered opener of KCNQ channel subtypes under development for the treatment of epilepsy and neuropathic pain, had been placed on partial clinical hold for epilepsy due to findings in certain high dose preclinical studies. We are in the process of conducting additional preclinical studies to address the issues raised by the FDA, and expect to submit additional data to the FDA along with the protocol for a planned proof-of-concept study in patients with photosensitive epilepsy. If the FDA lifts the clinical hold and approves the protocol, we expect to initiate the proof-of-concept study in epilepsy patients during the second half of this year. The partial clinical hold does not apply to the development of ICA-105665 for pain, and we expect to initiate a proof-of-concept pain trial during the third quarter of this year.
In April 2009, we reported the results of the Phase I program for ICA-105665. The Phase I program consisted of two studies, a single ascending dose study conducted in healthy volunteers and a multiple ascending dose study conducted in both healthy volunteers and epilepsy patients. In both studies, ICA-105665 was well tolerated at all dose levels, with no serious adverse events, no dose limiting toxicities, and no dropouts. Adverse events related to the central nervous system were mild and consistent with those of other anti-epileptic drugs. Pharmacokinetics were linear, dose proportional, and consistent with the potential for twice daily dosing.
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 March 31, 2009 and 2008
Collaborative Research and Development Revenues
Collaborative research and development revenues were $3.0 million for the three months ended March 31, 2009 and 2008, and consisted primarily of research and development funding and amortization of the initial upfront payment related to our collaboration with Pfizer for both periods.
Research and Development Expense
Research and development expense decreased by $120,000, or 2%, to $5.4 million for the three months ended March 31, 2009 from $5.5 million for the three months ended March 31, 2008. The decrease was due primarily to a decrease of $418,000 in expenses associated with our epilepsy and neuropathic pain program, a decrease of $122,000 in equity compensation expense, a decrease of $90,000 in patent expense, a decrease of $64,000 in laboratory supplies expense, a decrease of $62,000 in pharmacology study expenses and a decrease of $60,000 in outsourced chemistry expense, partially offset by an increase of $640,000 in expenses related to the development of senicapoc for asthma and an increase of $121,000 in salary and benefits expense.
Senicapoc for asthma, and formerly senicapoc for sickle cell disease, and ICA-105665 and our other lead compounds for epilepsy and neuropathic 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 March 31, Cumulative
from
Development Program 2009 2008 Inception
(in thousands) (in thousands)
Senicapoc $ 930 $ 284 $ 49,899
ICA-105665 and other lead compounds for
epilepsy and neuropathic pain 746 1,168 18,777
Total $ 1,676 $ 1,452 $ 68,676
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General and Administrative Expense
General and administrative expense decreased by $277,000, or 18%, to $1.2 million for the three months ended March 31, 2009 from $1.5 million for the three months ended March 31, 2008. The decrease was due primarily to a decrease of $110,000 in equity compensation expense, a decrease of $86,000 in salary and benefits expense, a decrease of $54,000 in corporate development expense and a decrease of $52,000 in accounting expense, partially offset by an increase of $53,000 in legal expense.
Interest Income and Interest Expense
Interest income decreased by $400,000, or 97%, to $13,000 for the three months ended March 31, 2009, from $413,000 for the three months ended March 31, 2008. The decrease in interest income was attributable to decreased interest rates and a lower average balance of cash and cash equivalents during the period.
Interest expense increased by $10,000, or 23%, to $54,000 for the three months ended March 31, 2009 from $44,000 for the three months ended March 31, 2008. The increase in interest expense was attributable to increased weighted average borrowings outstanding under our equipment debt financing.
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 March 31, 2009, our cash and cash equivalents were $29.3 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.
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 is providing us with research and development funding over a 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 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 $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 $10.0
million.
Cash Flows
Net cash used in operating activities was $4.7 million for the three months ended March 31, 2009. This reflects a net loss of approximately $3.6 million, a decrease of $1.6 million in deferred revenue and an increase of $1.2 million in prepaid expenses and other current and non-current assets. These amounts were partially offset by an increase of $1.0 million in accounts payable and accrued expenses, $446,000 of non-cash expenses related to stock-based compensation and $205,000 of non-cash expenses related to depreciation and amortization of property and equipment.
Net cash used in investing activities in the three months ended March 31, 2009 was $44,000 related to the purchase of property and equipment.
Net cash used in financing activities during the three months ended March 31, 2009 was $225,000 and consisted of principal repayments related to our equipment debt financing.
Net cash used in operating activities was $7.2 million for the three months ended March 31, 2008. This reflects a net loss of $3.6 million, a decrease of $2.9 million in deferred revenue, an increase of $1.0 million in prepaid expenses and other current and non-current assets and a decrease of $772,000 in accounts payable and accrued expenses. These amounts were partially offset by $679,000 of non-cash expenses related to stock-based compensation, an increase in other liabilities of $284,000 and $168,000 of non-cash expenses related to depreciation and amortization of property and equipment.
Net cash used in investing activities in the three months ended March 31, 2008 was $478,000 related to the purchase of property and equipment.
Net cash generated by financing activities during the three months ended March 31, 2008 was $10.2 million and consisted primarily of $10.0 million in net proceeds from the Pfizer equity investment completed in February 2008 and $343,000 in proceeds related to our equipment debt financing, partially offset by $176,000 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. In particular, as described above, we expect to incur increasing research and development expense and general and administrative expense in the future. We believe our existing cash and cash equivalents, including the $12.0 million up front license fee from Pfizer 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 through the second quarter of 2010. 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. In the absence of additional funding, we expect our continuing operating losses to result in increases in our cash used in operations over the next several quarters and 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. Except for collaboration revenue we expect to receive from Pfizer as funding for research and development activities through August 2009, we do 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 December 2007, the Financial Accounting Standards Board, or FASB, issued Statement of Financial Accounting Standards, or SFAS, No. 141 (revised 2007), Business Combinations, or SFAS No. 141(R). SFAS No. 141(R) 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. SFAS No. 141(R) 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 SFAS No. 141(R) did not have a material impact on our financial statements.
In November 2007, the EITF of the FASB reached consensus on Issue No. 07-1, Accounting for Collaborative Arrangements, or EITF Issue No. 07-1. EITF Issue No. 07-1 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. EITF Issue No. 07-1 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. EITF Issue No. 07-1 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 EITF Issue No. 07-1 did not have a material impact on our financial statements.
In June 2007, the FASB ratified the consensus reached by the Emerging Issues Task Force, or EITF, on EITF Issue No. 07-3, Accounting for Advance Payments for Goods or Services to Be Used in Future Research and Development Activities, or EITF 07-3. EITF 07-3 requires companies to defer and capitalize prepaid, nonrefundable research and development payments to third parties and amortize them over the period that the research and development activities are performed or the services are provided, subject to an assessment of recoverability. EITF 07-3 was effective for new contracts entered into during fiscal years beginning after December 15, 2007, including interim periods within those fiscal years. The adoption of EITF 07-3, effective January 1, 2008, did not have a material impact on our financial statements.
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and Financial Liabilities, or SFAS No. 159. SFAS No. 159 permits an entity to measure certain financial assets and financial liabilities at fair value. Entities that elect the fair value option will report unrealized gains and losses in earnings at each subsequent reporting date. The provisions of SFAS No. 159 were effective for fiscal years beginning after November 15, 2007. The adoption of SFAS No. 159, effective January 1, 2008, did not have a material impact on our financial statements.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements, or SFAS No. 157. SFAS No. 157 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. SFAS No. 157 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. SFAS No. 157 is to be applied prospectively. The adoption of the requirements of SFAS No. 157 that were effective January 1, 2008 and January 1, 2009 did not have a material impact on our financial statements.
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