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ISTA Pharmaceuticals Inc. Reports Operating Results (10-Q)

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Nov. 05, 2009 | Filed Under: ISTA


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10qk

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ISTA Pharmaceuticals Inc. (ISTA) filed Quarterly Report for the period ended 2009-09-30.

Ista Pharmaceuticals discovers and develops new remedies for diseases and conditions of the eye. The company's product development efforts involve mixtures of a natural enzyme called hyaluronidase. The company targets serious conditions of the eye such as vitreous hemorrhage diabetic retinopathy corneal opacification and keratoconus. Each of these conditions affects a significant number of patients and has limited treatment options. Ista Pharmaceuticals Inc. has a market cap of $143.5 million; its shares were traded at around $4.32 with and P/S ratio of 1.7.

Highlight of Business Operations:

Research and development expenses. Research and development expenses vary due to timing of initiation and completion of clinical trials. Research and development expenses were $6.3 million for the three months ended September 30, 2009, as compared to $7.8 million for the three months ended September 30, 2008. The decrease in research and development expenses for the three months ended September 30, 2009 was primarily the result of a decrease in clinical development costs, which include clinical investigator fees, study monitoring costs, and data management costs, offset by a $2.0 million milestone payment upon the FDA approval of our Bepreve New Drug Application, or NDA. Stock-based compensation costs included in research and development expenses were $0.3 million for the three months ended September 30, 2009, as compared to $0.2 million for the three months ended September 30, 2008.


Interest expense. Interest expense was $2.4 million for the three months ended September 30, 2009, as compared to $4.1 million for the three months ended September 30, 2008. Interest expense included interest on our Facility Agreement ($1.1 million), interest on our borrowings under our Revolving Credit Facility ($0.1 million), and amortization of the discount on the Facility Agreement ($1.2 million). Included in the three months ended September 30, 2008 is the impact of the adoption of ASC 470-20, which required retrospective application as if ASC 470-20 had been in effect in prior periods. This retrospective application required us to record additional non-cash interest expense of $2.3 million, or $0.07 per share, in our financial results for the three months ended September 30, 2008. This additional non-cash interest expense represents the amortization of a debt discount recorded against our principal debt obligation on our balance sheet. Because our convertible debt was repaid in September 2008, there was no impact to our third quarter ended September 30, 2009.


Research and development expenses. Research and development expenses were $19.6 million for the nine months ended September 30, 2009, as compared to $25.1 million for the nine months ended September 30, 2008. The decrease in research and development expenses for the nine months ended September 30, 2009 was primarily the result of a decrease in clinical development costs, which include clinical investigator fees, study monitoring costs, and data management costs, offset by $3.0 million in milestone payments. Stock-based compensation costs included in research and development expenses were $0.9 million for the nine months ended September 30, 2009, as compared to $0.5 million for the nine months ended September 30, 2008.


Selling, general and administrative expenses. Selling, general and administrative expenses were $38.9 million for the nine months ended September 30, 2009, as compared to $40.2 million for the nine months ended September 30, 2008. The $1.3 million decrease primarily results from an overall improvement in expense management. Stock-based compensation costs included in selling, general and administrative expenses were $1.9 million for the nine months ended September 30, 2009, as compared to $2.8 million for the nine months period ended September 30, 2008. Selling, general and administrative expenses are expected to increase as we incur costs associated with launching Bepreve and expanding our sales force.


Stock-based compensation. For the nine months ended September 30, 2009 and 2008, we granted stock options to employees to purchase 812,288 shares of common stock (at a weighted average exercise price of $1.64 per share) and 917,247 shares of common stock (at a weighted average exercise price of $4.34 per share), respectively, equal to the fair market value of our common stock at the time of grant. We also issued 148,101 and 123,055 restricted stock awards for the nine months ended September 30, 2009 and 2008, respectively. Included in stock-based compensation costs were $0.4 million and $0.5 million for the nine months ended September 30, 2009 and 2008, respectively, related to restricted stock awards.


Interest expense. Interest expense was $5.6 million for the nine months ended September 30, 2009, as compared to $7.7 million for the nine months ended September 30, 2008. Interest expense incurred included interest on our Facility Agreement ($3.1 million), interest on our borrowings under our Revolving Credit Facility ($0.2 million), and amortization of the discount on the Facility Agreement ($2.3 million). Included in the nine months ended September 30, 2008 is the impact of the adoption of ASC 470-20 as discussed above, which required us to record additional non-cash interest expense of $4.0 million, or $0.12 per share. This additional non-cash interest expense represents the amortization of a debt discount recorded against our principal debt obligation on our balance sheet. Because our convertible debt was repaid in September 2008, there was no impact to the nine months ended September 30, 2009.


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