BioDelivery Sciences International Inc. Reports Operating Results (10-K/A)
Biodelivery Sciences International Inc. has a market cap of $70.8 million; its shares were traded at around $2.95 with and P/S ratio of 1.1.
Highlight of Business Operations: The aggregate market value of the voting and non-voting common equity held by non-affiliates as of June 30, 2009 was approximately $101,998,704 based on the closing sale price of the companys common stock on such date of $6.68 per share, as reported by the NASDAQ Capital Market.
On July 16, 2009, we announced the FDAs approval of ONSOLIS®. ONSOLIS® will be marketed in Europe under the name BREAKYL if regulatory approvals are obtained. The FDA approval of ONSOLIS®, together with our satisfactory preparation of launch supplies of ONSOLIS®, triggered the payment to us by our ONSOLIS® commercial partner Meda AB (which we refer to herein as Meda) of approval milestones aggregating $26.8 million. The FDA approval of ONSOLIS® also caused the termination of a security interest in the ONSOLIS® product and related assets which was held by CDC IV, LLC, or CDC, pursuant to a funding arrangement that we previously entered into with CDC in connection with the development of ONSOLIS®. Additionally, the FDA approval triggered a requirement by us to pay an approval milestone of $2.0 million to QLT USA Inc., which we refer to herein as QLT, from which we purchased the BEMA® delivery technology, which payment was made in August 2009.
Datamonitor estimates the global market for branded medications to treat breakthrough pain will reach $1.3 billion by 2017, with the U.S. being the single largest market and likely to account for well over half of global sales. In 2009, the leading fentanyl product for the treatment of breakthrough cancer pain in the U.S. market was Actiq® which is marketed by Cephalon, Inc. (NASDAQ:CEPH) and available as a generic from Barr Laboratories and Watson Pharmaceuticals. Cephalon introduced a second fast dissolving fentanyl product, Fentora® in late 2006. The reported combined retail sales of these products in 2009 were $633 million. We believe that ONSOLIS® may offer advantages over the marketed and pipeline fentanyl products in terms of ease of use and other attributes.
The pain market is well established, with many pharmaceutical companies marketing innovative products as well as generic versions of older, non-patent protected products. According to Datamonitor, the opioid market is estimated to total in excess of $10 billion in sales. Due to the ability of BEMA® Buprenorphine to potentially participate in the chronic pain market, we estimate that BEMA® Buprenorphine (low dose) has the potential to exceed $500 million in annual peak sales.
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