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ISTA > SEC Filings for ISTA > Form 10-Q on 12-May-2009All Recent SEC Filings

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Form 10-Q for ISTA PHARMACEUTICALS INC


12-May-2009

Quarterly Report


Item 2 Management's Discussion and Analysis of Financial Condition and Results of Operations

This Quarterly Report on Form 10-Q contains forward-looking statements that have been made pursuant to the provisions of the Private Securities Litigation Reform Act of 1995 and concern matters that involve risks and uncertainties that could cause actual results to differ materially from those projected in the forward-looking statements. Discussions containing forward-looking statements may be found in the material set forth under "Management's Discussion and Analysis of Financial Condition and Results of Operations," "Risk Factors" and in other sections of this Quarterly Report on Form 10-Q. Words such as "may," "will," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" or similar words are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Although we believe that our opinions and expectations reflected in the


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forward- looking statements are reasonable as of the date of this Quarterly Report on Form 10-Q, we cannot guarantee future results, levels of activity, performance or achievements, and our actual results may differ substantially from the views and expectations set forth in this Quarterly Report on Form 10-Q. We expressly disclaim any intent or obligation to update any forward-looking statements after the date hereof to conform such statements to actual results or to changes in our opinions or expectations. Readers are urged to carefully review and consider the various disclosures made by us, which attempt to advise interested parties of the risks, uncertainties, and other factors that affect our business, including without limitation the disclosures made under the captions "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Risk Factors" in this Quarterly Report on Form 10-Q and the audited financial statements and the notes thereto and disclosures made under the captions "Management Discussion and Analysis of Financial Condition and Results of Operations", "Risk Factors", "Condensed Consolidated Financial Statements" and "Notes to Condensed Consolidated Financial Statements" included in our Annual Report on Form 10-K for the year ended December 31, 2008. We obtained the market data and industry information contained in this Quarterly Report on Form 10-Q from internal surveys, estimates, reports and studies, as appropriate, as well as from market research, publicly available information and industry publications. Although we believe our internal surveys, estimates, reports, studies and market research, as well as industry publications, are reliable, we have not independently verified such information, and, as such, we do not make any representation as to its accuracy.

Overview

We are an ophthalmic pharmaceutical company. Our products and product candidates address the $5.1 billion U.S. prescription ophthalmic market and include therapies for inflammation, ocular pain, glaucoma, allergy, dry eye, vitreous hemorrhage, and diabetic retinopathy. In addition, we plan to compete in a $2.3 billion U.S. allergic rhinitis market with our nasal formulation of bepotastine. We currently have three products for sale in the U.S.: Xibrom® (bromfenac sodium ophthalmic solution) for the treatment of inflammation and pain following cataract surgery, Istalol® (timolol maleate ophthalmic solution) for the treatment of glaucoma, and Vitrase®(hyaluronidase for injection) for use as a spreading agent. We also have several product candidates in various stages of development. We have incurred losses since inception and had an accumulated deficit of $358.7 million through March 31, 2009.

Results of Operations

Three Months Ended March 31, 2009 and 2008

Revenue. Net product sales were approximately $20.3 million for the three months ended March 31, 2009, as compared to $15.4 million for the three months ended March 31, 2008. The increase in revenue is primarily the result of increased growth in prescription levels and market share, particularly for Xibrom, our highest gross margin product.

In addition to product revenues for the three months ended March 31, 2009 and 2008, we recorded license revenue of $69,000 in each of the three month periods ended March 31, 2009 and 2008, reflecting the amortization of deferred revenue recorded in December 2001 for the license fee payment made by Otsuka Pharmaceuticals Co., Ltd. in connection with the license of Vitrase in Japan for ophthalmic uses in the posterior region of the eye.

The following table sets forth our net revenue for each of our products for each of the three month periods ended March 31, 2009 and 2008 and the corresponding percentage change.

                                  Net Revenue



                               Quarter Ended      Quarter Ended
          $ millions           March 31, 2009     March 31, 2008    % Change
          Xibrom              $           15.7   $           11.8         33 %
          Istalol                          3.6                2.7         33 %
          Vitrase                          1.0                0.9         11 %
          Other                            0.1                0.1          0 %

          Total Net Revenue   $           20.4   $           15.5         32 %

Gross margin and cost of products sold. Gross margin for the three months ended March 31, 2009 was 75% of net revenue, or $15.3 million, as compared to 73% of net revenue, or $11.3 million, for the three months ended March 31, 2008.


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Cost of products sold was $5.1 million for the three months ended March 31, 2009, as compared to $4.2 million for the three months ended March 31, 2008. Cost of products sold for the three months ended March 31, 2009 and 2008 consisted primarily of standard costs for each of our commercial products, distribution costs, royalties, inventory reserves for short dating of certain lots of products and other costs of products sold. The increase in cost of products sold is primarily the result of increased net product sales year over year. The increase in gross margin for the three months ended March 31, 2009 as compared to the three months ended March 31, 2008 is primarily due to higher sales of Xibrom, our highest gross margin product, price increases taken during the quarter and other factors such as changes in our manufacturing costs, wholesaler fees and reserves for returns and rebates, as compared to the same period in 2008.

Research and development expenses. Research and development expenses were $6.7 million for the three months ended March 31, 2009, as compared to $9.8 million for the three months ended March 31, 2008. The decrease in research and development expenses of $3.1 million is due primarily to an overall reduction in outside service costs, offset by higher costs incurred during the first quarter ended March 31, 2008 which included clinical development costs associated with the Bepreve NDA costs and support of the filing and other studies, additional clinical costs for the Xibrom QD once-daily product and additional clinical costs for the ecabet sodium product. Stock compensation costs included in research and development expenses were $0.3 million for the three months ended March 31, 2009, as compared to $0.2 million for the three months ended March 31, 2008.

Generally, our research and development resources are not dedicated to a single project but are applied to multiple product candidates in our portfolio. As a result, we manage and evaluate our research and development expenditures generally by the type of costs incurred. We generally classify and separate research and development expenditures into amounts related to clinical development costs, regulatory costs, pharmaceutical development costs, manufacturing development costs, and medical affairs costs. In addition, we also record as research and development expenses any up front and milestone payments that have accrued to third parties prior to regulatory approval of a product candidate under our licensing agreements unless there is an alternative future use. For the three months ended March 31, 2009, approximately 31% of our research and development expenditures were for clinical development costs, 16% were for regulatory costs, 5% were for pharmaceutical development costs, 13% were for manufacturing development costs, 16% were for medical affairs costs, 15% was for a one time milestone payment upon the FDA acceptance of our Bepreve NDA and 4% for stock-based compensation expense.

Changes in our research and development expenses are primarily due to the following:

• Clinical Development Costs - Overall clinical costs, which include clinical investigator fees, study monitoring costs and data management, for the three months ended March 31, 2009 were $2.1 million as compared to $6.8 million for the three months ended March 31, 2008, or a decrease of $4.7 million. The decrease in clinical costs during the first quarter ended March 31, 2009 as compared to the first quarter ended March 31, 2008 is primarily due to the timing of initiation and completion of clinical trials.

• Regulatory Costs - Regulatory costs, which include compliance expense for existing products and other activity for pipeline projects, were $1.0 million for the three months ended March 31, 2009 as compared to $0.2 million for the three months ended March 31, 2008. The increase of $800,000 was due primarily to a receivable recorded at March 31, 2008 in the amount of $0.9 million representing a partial refund of our NDA filing fee paid in December 2007 for Xibrom QD.

• Pharmaceutical Development Costs - Pharmaceutical development costs, which include costs related to the testing and development of our pipeline products, for both the three months ended March 31, 2009 and the three months ended March 31, 2008 were $0.3 million.

• Manufacturing Development Costs - Manufacturing development costs, which include costs related to production scale-up and validation, raw material qualification, and stability studies, for the three months ended March 31, 2009 were $0.9 million as compared to $1.5 million for the three months ended March 31, 2008, or a decrease of $600,000. The decrease is primarily attributable to a reduction in research activities, specifically clinical supply costs.

• Medical Affairs Costs - Medical affairs costs, which include activities that relate to medical information in support of our products, for the three months ended March 31, 2009 were $1.1 million as compared to $0.8 million for the three months ended March 31, 2008, or an increase of $300,000. The increase is primarily attributable to an increase in continuing medical education costs.

Our research and development activities reflect our efforts to advance our product candidates through the various stages of product development. The expenditures that will be necessary to execute our development plans are subject to numerous uncertainties, which may affect our research and development expenditures and capital resources. For instance, the duration and the cost of clinical trials may vary significantly depending on a variety of factors including a trial's protocol, the number of patients in the trial, the duration of patient follow-up, the number of clinical sites in the trial, and the length of time


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required to enroll suitable patient subjects. Even if earlier results are positive, we may obtain different results in later stages of development, including failure to show the desired safety or efficacy, which could impact our development expenditures for a particular product candidate. Although we spend a considerable amount of time planning our development activities, we may be required to deviate from our plan based on new circumstances or events or our assessment from time to time of a product candidate's market potential, other product opportunities and our corporate priorities. Any deviation from our plan may require us to incur additional expenditures or accelerate or delay the timing of our development spending. Furthermore, as we obtain results from trials and review the path toward regulatory approval, we may elect to discontinue development of certain product candidates in certain indications, in order to focus our resources on more promising candidates or indications. As a result, the amount or ranges of estimable cost and timing to complete our product development programs and each future product development program is not estimable.

Selling, general and administrative expenses. Selling, general and administrative expenses were $13.0 million for the three months ended March 31, 2009, as compared to $13.7 million for the three months ended March 31, 2008. The $0.7 million decrease in selling, general and administrative expenses during the first quarter ended March 31, 2009 as compared to the first quarter ended March 31, 2008 primarily results from lower sales and marketing expenses of approximately $0.7 million. Stock compensation costs included in selling, general and administrative expenses were $0.7 million for both the three months ended March 31, 2009 and the three months ended March 31, 2008.

Stock-based compensation. Compensation for stock options granted to non-employees has been determined in accordance with SFAS 123R, and EITF Consensus No. 96-18, "Accounting for Equity Instruments that are Issued to Other Than Employees for Acquiring or in Conjunction with Selling Goods or Services". The fair value of the equity instrument issued is periodically re-measured as the underlying options vest. Stock option compensation for non-employees is recorded as the related services are rendered and the value of compensation is periodically re-measured as the underlying options vest. These amounts are not significant.

We account for equity awards to employees and non-employee directors under the fair value measurement and recognition method in accordance with SFAS 123R effective January 1, 2006 and under the intrinsic value method under Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees," or APB 25, for periods prior to January 1, 2006. For the three months ended March 31, 2009 and 2008, we granted stock options to employees to purchase 651,688 shares of common stock (at a weighted average exercise price of $1.11 per share) and 823,477 shares of common stock (at a weighted average exercise price of $4.61 per share), respectively, equal to the fair market value of our common stock at the time of grant. We also issued 135,702 restricted stock awards and 121,205 restricted stock awards for the three months ended March 31, 2009 and 2008, respectively, and included in stock compensation expense was $111,000 and $133,000 for the three months ended March 31, 2009 and 2008, respectively, related to these restricted stock awards.

Interest income. Interest income was zero for the three months ended March 31, 2009, as compared to $0.4 million for the three months ended March 31, 2008. The decrease in interest income was primarily attributable to the reclassification of our short term investments to our fully insured direct deposit account which is a non-interest bearing account.

Interest expense. Interest expense was $1.8 million for the three months ended March 31, 2009, as compared to $2.1 million for the three months ended March 31, 2008. Interest expense incurred included interest on our borrowings under our Revolving Credit Facility, interest payments on our $65.0 million Facility Agreement, amortization of the related deferred financing costs, the amortization of the discount on the Facility Agreement and the change in the value of a derivative associated with the Facility Agreement. Included in our first quarter results for 2008 is the impact of the adoption of FASB Staff Position No. APB 14-1, "Accounting for Convertible Debt Instruments That May be Settled in Cash upon Conversion (Including Partial Cash Settlement)", or FSP APB 14-1. The adoption of FSP APB 14-1 required retrospective application as if FSB APB 14-1 had been in effect in prior periods. This retrospective application required us to record additional non-cash interest expense of $0.9 million, or $0.03 per share, in our financial results for the first quarter ended March 31, 2008. This additional non-cash interest expense represents the amortization of a debt discount recorded against our principal debt obligation on our balance sheet as required under FSB APB 14-1. Because our convertible debt was repaid in September 2008, there was no impact to our first quarter ended March 31, 2009.

Warrant valuation expense. Included in our first quarter results for 2009 is the impact of the adoption of EITF Issue No. 07-05, "Determining Whether an Instrument (or Embedded Feature) Is Indexed to an Entity's Own Stock", or EITF 07-05. The adoption of EITF 07-05 required us to analyze the accounting for warrants under our Credit Facility issued in September 2008. During 2008, the warrants were classified as equity under EITF Issue No. 01-6, "The Meaning of 'Indexed to a Company's Own Stock'". With the adoption of EITF 07-05 on January 1, 2009, we were required, due to certain provisions in the Facility Agreement, to reclassify the warrants as a liability and mark the value of the warrants to market at March 31, 2009. As a result, we recorded a non-cash valuation adjustment for an additional $13.3 million, or $0.40 per share, in our financial results for the quarter ended March 31, 2009. The change in the valuation of the warrants was primarily driven by an increase of almost 150% in our stock price plus an increase in related volatility during the first quarter 2009. If the stock price and volatility had remained unchanged from the fourth quarter 2008, we would not have recorded an adjustment to the valuation of our warrants.


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Reaffirming 2009 Financial Outlook

• We continue to expect our full-year 2009 net revenue will be approximately $92 to $97 million. We do not expect a generic to Xibrom in 2009.

• We continue to expect our full-year 2009 gross margin will be approximately 70% to 73%, subject to quarterly fluctuations based on revenue mix. We expect our gross margin to be lower in the second quarter of 2009, as compared to the first quarter of 2009, due to changes in other manufacturing expenses, wholesaler fees and reserves for returns and rebates.

• We continue to expect to be approximately operating income breakeven in 2009.

• Depending upon the progress of our clinical and pre-clinical programs, we continue to expect our research and development expenses for the full year of 2009 will be approximately $20 to $25 million.

• We continue to expect our net loss for 2009 (excluding any "mark-to-market" valuation adjustments relating to our warrants issued in 2008) will be approximately ($7 to $10) million. We have excluded warrant valuation expense from our net loss guidance because we are not able to predict this expense accurately due to the difficulty of forecasting our future stock price and volatility.

• We expect to end 2009 with a cash balance of $35 to $45 million, including cash drawn on our Silicon Valley Bank Revolving Credit Facility.

Liquidity and Capital Resources

As of March 31, 2009, we had approximately $52.0 million in cash, including $13 million borrowed under our Revolving Credit Facility with Silicon Valley Bank, and working capital of $26.8 million. Historically, we have financed our operations primarily through sales of our debt and equity securities and cash receipts from product sales. Since March 2000, we have received gross proceeds of approximately $346.7 million from sales of our common stock and the issuance of promissory notes and convertible debt.

Under our Revolving Credit Facility we may borrow up to the lesser of $25.0 million or 80% of eligible accounts receivable, plus the lesser of 25% of net cash or $5.0 million. As of March 31, 2009, we borrowed $13.0 million from our Revolving Credit Facility and as of April 30, 2009, we had no borrowings outstanding on our Revolving Credit Facility. All outstanding amounts under the Revolving Credit Facility bear interest at a variable rate equal to the lender's prime rate plus a margin of either (i) 0.50% for such periods that our adjusted quick ratio is greater than 1.50:1.00, or (ii) 0.875% for such periods that our adjusted quick ratio is less than or equal to 1.50:1.00. In no event will the interest rate on outstanding borrowings be less than 4.50%, which is payable on a monthly basis. The Revolving Credit Facility also contains customary covenants regarding operations of our business and financial covenants relating to ratios of current assets to current liabilities and is collateralized by all of our assets. An event of default under the Revolving Credit Facility will occur if, among other things, (i) we are delinquent in making payments of principal or interest on the Revolving Credit Facility; (ii) we fail to cure a breach of a covenant or term of the Revolving Credit Facility; (iii) we make a representation or warranty under the Revolving Credit Facility that is materially inaccurate; (iv) we are unable to pay our debts as they become due, certain bankruptcy proceedings are commenced or certain orders are granted against us, or we otherwise become insolvent; (v) an acceleration event occurred under certain types of other indebtedness outstanding from time to time. If an event of default occurs, the indebtedness to Silicon Valley Bank could be accelerated, such that it becomes immediately due and payable. As of March 31, 2009, we were in compliance with all of the covenants under the Revolving Credit Facility. Unless repaid earlier, all amounts owing under the Revolving Credit Facility will become due and payable on December 31, 2009. While we believe we will be able extend our agreement with Silicon Valley Bank upon its maturity or refinance outstanding amounts with another lender, we may not be able to do so due to general economic conditions surrounding the current crisis. If we are unable to renew our Revolving Credit Facility or obtain suitable alternative debt financing, it may adversely affect our ability to execute on our business plan.

In September 2008, we entered into a facility agreement, or the Facility Agreement, with certain institutional accredited investors, which we refer to as the Lenders, to loan us up to $65.0 million. We borrowed the entire $65.0 million available under the Facility Agreement and issued warrants to purchase 15 million shares of common stock at an exercise price of $1.41 per share. Outstanding amounts under the Facility Agreement accrue interest at a fixed rate of 6.5% per annum, payable quarterly in cash in


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arrears beginning on January 1, 2009. We are required to repay the Lenders 33% of any principal amount outstanding under the Facility Agreement on each of September 26, 2011 and 2012, and 34% of such principal amount outstanding on September 26, 2013. Additionally, any amounts drawn under the Facility Agreement may become immediately due and payable upon (i) an "event of default," as defined in the Facility Agreement, in which case the Lenders would have the right to require us to re-pay 100% of the principal amount of the loan, plus any accrued and unpaid interest thereon, or (ii) the consummation of certain change of control transactions, in which case the Lenders would have the right to require us to re-pay 110% of the outstanding principal amount of the loan, plus any accrued and unpaid interest thereon. An event of default under the Facility Agreement will occur if, among other things, (i) we fail to make payment when due; (ii) we fail to comply in any material respect with any covenant of the Facility Agreement, and such failure is not cured; (iii) any representation or warranty made by us in any transaction document was incorrect, false, or misleading in any material respect as of the date it was made; (iv) we are generally unable to pay our debts as they become due or a bankruptcy or similar proceeding has commenced by or against us; and (v) cash and cash equivalents on the last day of each calendar quarter are less than $10,000,000. The Facility Agreement also contains customary covenants regarding operations of our business.

For the three months ended March 31, 2009, we received $1.2 million of cash for operations principally as a result of the net loss of $19.6 million, offset by the net change in operating assets and liabilities of $5.6 million, the recording of $13.3 million in warrant valuation expense, the recording of $0.9 million in stock-based compensation, the recording of $0.3 million in depreciation and amortization, the recording of $0.5 million in debt discount write off and the recording of $0.2 million in amortization of deferred financing costs associated with the Facility Agreement. For the three months ended March 31, 2008, we used $14.8 million of cash for operations principally as a result of the net loss of $13.9 million, the net change in operating assets and liabilities of ($3.1) million, offset by the recording of $0.9 million in stock based compensation, the recording of $0.9 million in discount amortization expense on the convertible notes, the recording of $0.2 million in depreciation and amortization and the recording of $0.2 million for the change in the value of the derivative associated with the subordinated convertible notes.

For the three months ended March 31, 2009, we received $4.5 million of cash from investing activities, primarily due to the maturities of our short-term investment securities. For the three months ended March 31, 2008, we received $9.2 million of cash from investing activities, primarily due to the maturities of our short-term investment securities.

For the three months ended March 31, 2009, we used $2.1 million of cash in financing activities, primarily as a result of net proceeds from our Revolving Credit Facility ($2.0 million). For the three months ended March 31, 2008, we received $2.5 million from financing activities, primarily as a result of net proceeds from our revolving line of credit.

We believe that current cash and cash equivalents, together with amounts available for borrowing under our Revolving Credit Facility and cash receipts generated from product sales, will be sufficient to meet anticipated cash needs for operating and capital expenditures for at least the next 12 months.

However, our actual future capital requirements will depend on many factors, including the following:

• the success of the commercialization of our products;

• sales and marketing activities, and expansion of our commercial infrastructure, related to our approved products and product candidates;

• the results of our clinical trials and requirements to conduct additional clinical trials;

• the introduction of generic products;

• the rate of progress of our research and development programs;

• the time and expense necessary to obtain regulatory approvals;

• activities and payments in connection with potential acquisitions of companies, products or technology;

• the results of inquiries from the subpoena received in April 2008 from the United States District Attorney's office;

• competitive, technological, market and other developments; and

• our ability to establish and maintain collaborative relationships.

These factors may cause us to seek to raise additional funds through additional . . .

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