Inspire Pharmaceuticals Inc. (ISPH) filed Quarterly Report for the period ended 2009-09-30.
Inspire Pharmaceuticals Inc. discovers and develops new drugs to treat diseases characterized by deficiencies in the body's innate defense mechanisms of mucosal hydration and mucociliary clearance. These mechanisms are the natural way that the body defends its mucosal surfaces against dust pollutants bacteria and viruses. Inspire Pharmaceuticals Inc. has a market cap of $436 million; its shares were traded at around $5.3 with and P/S ratio of 6.2. Inspire Pharmaceuticals Inc. had an annual average earning growth of 2.9% over the past 5 years.
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Estimated subsequent costs necessary to amend our NDA submission for Prolacria and resubmit the application for commercial approval in the United States are projected to be in the range of $4 million to $8 million. This range includes costs for completing Trial 03-113, regulatory and consulting activities, salaries for development personnel, and other unallocated development costs, but excludes the cost of pre-launch inventory which is Allergan’s responsibility. If we are required to do, and if we elect to do any additional clinical work, our costs will be higher than the projected range. The projected costs associated with Prolacria are difficult to determine due to the uncertainty of the FDA’s scientific review and interpretation of what is required to demonstrate safety and efficacy sufficient for approval. Actual costs could be materially different from our estimate.
Estimated subsequent costs necessary to submit an NDA for denufosol for the treatment of cystic fibrosis are projected to be in the range of $23 million to $32 million. This estimate includes completing TIGER-2, the subsequent open-label trial and the carcinogenicity study, as well as conducting any additionally required toxicology studies and other ancillary studies, manufacturing denufosol for clinical trials, producing qualification lots consistent with current Good Manufacturing Practices, or cGMP, standards, salaries for development personnel, other unallocated development costs and regulatory preparation and filing costs, but excludes any additional clinical trials, costs to secure a secondary supplier for denufosol, including the approximate $11 million total milestone payments under our technology license agreement with Yamasa Corporation, the cost of pre-launch inventory and any product approval milestones payable to Cystic Fibrosis Foundation Therapeutics, Inc. These costs are difficult to project and actual costs could be materially different from our estimate. For example, clinical trials, toxicology and carcinogenicity studies
Total revenues were approximately $25.2 million for the three months ended September 30, 2009, as compared to approximately $20.0 million for the same period in 2008. The increase in 2009 revenue of approximately $5.2 million, or 26%, as compared to the same period in 2008, was primarily due to an increase in product revenue from net sales of AzaSite.
Product sales of AzaSite, net of rebates and discounts, for the three months ended September 30, 2009 were approximately $9.0 million, as compared to approximately $4.7 million for the same period in 2008. The increase in 2009 revenue for AzaSite of approximately $4.3 million, or 92%, as compared to the same period in 2008, was primarily due to increased patient and physician usage of AzaSite, evidenced by an increase of prescriptions year-over-year, as well as price increases for the product between the periods. Approximately $1.0 million to $1.5 million of revenue from sales of AzaSite for the three months ended September 30, 2009 was associated with hospital usage of AzaSite as a substitute therapy during a temporary supply shortage of erythromycin ophthalmic ointment (0.5%), as discussed below.
Total co-promotion and royalty revenue was approximately $16.1 million for the three months ended September 30, 2009, as compared to approximately $15.2 million for the same period in 2008, representing an increase of approximately $896,000, or 6%.
Allergan recorded revenue from net sales of Restasis of approximately $129 million and $107 million, respectively. In October 2009, Allergan revised its 2009 guidance and expects net sales of Restasis to be in the range of $500-$510 million.
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