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March 18, 2013 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that it has filed its Annual Report on Form 10-K for the year ended
December 31, 2012 with the U.S. Securities and Exchange Commission and, in connection therewith, is providing a review of BDSI's 2012 achievements and an update on business operations and upcoming milestones for 2013.
In 2012, significant progress was made in the development of BDSI's two buprenorphine-containing products with the initiation, in partnership with Endo Health Solutions (Endo), of two Phase 3 pivotal trials with BEMA Buprenorphine for the treatment of chronic pain. BDSI also completed key bioavailability and safety studies with BUNAVAIL (formerly BEMA Buprenorphine/Naloxone or BNX) for the treatment of opioid dependence.
These extensive development activities increased BDSI's research and development expenditures from
$20.8 million in 2011 to
$35.4 million in 2012. Revenues recognized in 2012 were
$54.5 million, including
$35.8 million from Endo and
$17.5 million previously deferred revenue associated with the BDSI commercialization agreement with Meda for BDSI's FDA approved product ONSOLIS. At the end of 2012, BDSI had
$9.2 million in deferred revenue associated with Endo, which will be recognized through 2013 and into early 2014 as clinical trials progress. BDSI reported net income of
$1.7 million or
$0.05 per share for the twelve months ending
December 31, 2012. That compares to a net loss of
$23.3 million, or
$(0.82) per share in 2011.
At the end of 2012, BDSI had
$63.2 million in cash compared to
$10.8 million at
December 31, 2011.
"Over the past year, we have made remarkable progress, executing a timely and very productive partnership with Endo worth up to
$180 million for BEMA Buprenorphine and initiating two Phase 3 studies for chronic pain, as well as reporting positive data from our key bioequivalence and safety studies for BUNAVAIL for the treatment of opioid dependence," said Dr.
Mark A. Sirgo, President and Chief Executive Officer of BDSI.
"Additionally, we completed a
$40 million registered financing which will assist in funding the clinical trial programs for both BEMA Buprenorphine and BUNAVAIL, while also providing a strong balance sheet as we continue BUNAVAIL licensing discussions in the U.S. and abroad and consider commercializing BUNAVAIL ourselves. We look forward to an exciting 2013 and working to achieve a number of key milestones, including the anticipated mid-year filing of our NDA for BUNAVAIL and moving the Phase 3 studies for BEMA Buprenorphine for chronic pain toward completion. We will also be determining whether to move forward with commercializing BUNAVAIL on our own or through a commercial partnership here in the U.S.," concluded Dr. Sirgo.
Concurrently with the filing of its 2012 10-K, BDSI also took steps to complete its previously announced restatement of its 2012 quarter financial statements to properly account for the
$30 million non-refundable upfront license fee received by BDSI in
January 2012 under its license and development agreement with Endo. To this end, BDSI has filed three amended Form 10-Q reports for 2012 to reflect the deferral of recognition as revenue of approximately
$14.4 million of such
$30 million payment over the period during which BDSI is expected to perform clinical development services under its Endo agreement. Approximately
$5.2 million of such deferred amount was actually recognized as revenue during 2012, leaving approximately
$9.2 million of deferred revenue related to Endo on BDSI's balance sheet as of
December 31, 2012. As previously reported, this deferral of revenue had no impact (and will have no impact) on BDSI's cash position or its ability to use these funds in connection with its business plans. Further details regarding this restatement can be found in such amended Form 10-Q reports and BDSI's 2012 Form 10-K, all of which were filed with the SEC on
March 18, 2013.
2012 Corporate Update