BioDelivery Sciences International Inc. (BDSI) filed Quarterly Report for the period ended 2009-09-30.
BioDelivery Sciences International is a development-stage biotechnology company that is developing and seeking to commercialize a drug delivery technology designed for a potentially broad base of pharmaceuticals vaccines and over-the-counter drugs. In general a drug delivery technology refers to any process substance or combination thereof that delivers drugs into the body. Biodelivery Sciences International Inc. has a market cap of $83 million; its shares were traded at around $3.95 with and P/S ratio of 315.4.
Highlight of Business Operations:
Income Taxes. During the three months ended September 30, 2009, the Company recognized a $0.2 million deferred tax benefit based upon the loss incurred and temporary timing differences through September 30, 2009. During the three months ended September 30, 2008, the Company recognized a $2.0 million deferred tax benefit based upon the expectation that it was more likely than not that there would be taxable income for the year ended December 31, 2008 because, notwithstanding the Company’s financial accounting with regard to this item, approximately $30.0 million of revenue which was deferred for financial reporting purposes became taxable in 2008. Deferred revenues that will be recognized and taxable in the fourth quarter of 2009 will be substantially offset by the Company’s net operating loss carry-forward.
Income Taxes. During the nine months ended September 30, 2009, the Company recognized a $0.2 million deferred tax benefit based upon the loss incurred and temporary timing differences through September 30, 2009. During the nine months ended September 30, 2008, the Company recognized a $2.0 million deferred tax benefit based upon the expectation that it was more likely than not that there would be taxable income for the year ended December 31, 2008 because, notwithstanding the Company’s financial accounting with regard to this item, approximately $30.0 million of revenue which was deferred for financial reporting purposes became taxable in 2008. Deferred revenue that will be recognized and taxable in the fourth quarter of 2009 will be substantially offset by the Company’s net operating loss carry-forward.
In July 2009, we received $26.8 million from Meda, which consisted of $11.8 million for the approval of ONSOLIS™ and $15.0 million for the production of launch supplies.
In August 2006 and September 2007, we received up-front non-refundable payments in connection with our license, development and supply agreements with Meda of $2.5 million and $30.0 million, respectively. In March 2008 we received a milestone payment of $2.5 million in connection with our Meda EU Agreements. In January 2009 we received $6.0 million from Meda, which consisted of a $3.0 million advance against the $15.0 million approval milestone and $3.0 million for expansion of the Meda EU license.
licensing and milestone payments, and additional equity or debt financing opportunities that we are able to negotiate in the coming year. We generated $22.3 million of cash from operations in the nine-months ended September 30, 2009. This principally resulted from: (1) a net loss of $21.8 million, which included and was offset by net non-cash charges of $9.7 million ($7.4 million derivative loss associated with fair value of outstanding warrants; $1.7 million stock based compensation; $0.6 million of depreciation and amortization); (2) aforementioned milestone payments from Meda, along with reimbursements for research and development expenses totaling $35.0 million; and (3) reduction of our accounts payable and accrued liabilities of $2.2 million. In accordance with our revenue recognition policy, costs associated with non-cancer breakthrough pain and BREAKYL™ are expensed in the accompanying financial statements, while the associated reimbursement from Meda is treated as deferred revenue until the products are approved and we have the first commercial sale.
We invested $2.2 million in 2008 in special equipment we will require for packaging ONSOLIS™, which together with $0.7 million expended in 2007 and final payments of $0.6 million in 2009 has resulted in total cost of the equipment of $3.5 million, which we may seek to finance in the future.
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