Mar 20 2010
BioDelivery Sciences International, Inc. (Nasdaq:BDSI) has filed its
Annual Report with the U.S. Securities and Exchange Commission on Form
10-K for the fiscal year ended December 31, 2009. Such Form 10-K is
available on the SEC’s website at www.sec.gov.
“We believe that the going concern opinion is driven more by the
requirements of the accounting rules as opposed to what we believe are
the promising prospects for our company”
In addition, and in compliance with Nasdaq Marketplace Rule 5250(b)(2),
the company disclosed a going concern qualification from its independent
registered public accounting firm, Cherry, Bekaert & Holland, L.L.P.
Nasdaq Rule 5250(b)(2) requires the separate disclosure of an audit
opinion that contains a going concern qualification. Under current
guidance, a going concern qualification means that, in the opinion of
the auditing firm on the day they render their opinion, the company may
not have sufficient cash and other resources available to run the
business for the next twelve to fifteen months. Although BDSI had more
than $23 million in cash on hand as of December 31, 2009, the going
concern qualification was anticipated by the company given the company’s
strategic plan that calls for more aggressive spending in support of its
product pipeline in 2010 and beyond.
“We believe that the going concern opinion is driven more by the
requirements of the accounting rules as opposed to what we believe are
the promising prospects for our company,” stated Dr. Mark A. Sirgo,
President and Chief Executive Officer of BDSI. “Although we now have a
product on the market and significantly more cash on hand than we did a
year ago, similar to last year, the going concern opinion was
anticipated and not uncommon for maturing companies like ours with
products in development. As a result of our efforts, we are hopeful to
have three product candidates entering Phase 3 trials in early 2011,
including: (1) BEMA Buprenorphine (low dose) for chronic pain; (2) BEMA
Buprenorphine (high dose) for the treatment of opioid dependence; and
(3) BEMA Granisetron for the prevention of cancer therapy induced nausea
and vomiting. At this time, our main recurring revenue source is from
royalties we receive on our marketed product ONSOLIS, which only
recently launched in the U.S. It is still too early in the launch cycle
to allow for a consistent or precise forecasting of our revenue,
especially given the current regulatory landscape which we have
previously outlined. Regardless, we have always maintained that our
ONSOLIS royalties will not alone fund our strategic plan for developing
our pipeline of products and growing our company; rather we believe that
ONSOLIS will allow for a sound foundation around which we can grow the
company.”
Dr. Sirgo continued, “From a revenue perspective, in addition to
royalties from sales of ONSOLIS in the U.S. in 2010 and into 2011, we
also anticipate a $5 million milestone from our commercial partner Meda
in conjunction with the approval and launch of ONSOLIS in Europe,
royalties from sales of ONSOLIS that we expect to commence following
launches in the E.U. and Canada, and the potential for a significant
upfront payment related to a BEMA Buprenorphine commercial partnership.
We believe that the achievement of these milestones will allow us to
continue to build value for our stockholders.”
Source BioDelivery Sciences International