BioDelivery Sciences International Provides Corporate Update And Reports Second Quarter 2015 Financial Results

RALEIGH, N.C., Aug. 10, 2015 /PRNewswire/ -- BioDelivery Sciences International, Inc. (BDSI) today reported financial results for the second quarter ended June 30, 2015, and reviewed its most significant recent accomplishments and upcoming milestones.

Net revenue for the second quarter ended June 30, 2015, was $1.7 million compared to $13.9 million in the corresponding period of 2014.  Revenue for the second quarter versus 2014 is less due to 2014 containing the database lock for one of the BELBUCA Phase 3 trials.  Net revenue for BUNAVAIL increased 23% versus first quarter while operating expenses decreased by 10% over the same time period. 

Net revenue for the six months ended June 30, 2015, was $14.8 million, compared to $34.6 million in the corresponding period of 2014.  While six month revenue for 2015 includes the milestone payment for the FDA acceptance of the NDA for BELBUCA in the first quarter, 2014 revenue includes two milestone payments, one each quarter, totaling $20 million for database locks for the two BELBUCA Phase 3 studies and $10.8 million of R&D reimbursable expenses for BELBUCA.

"We are on target with both operating expenses and cash burn both for the quarter and year to date.  In addition, we have further strengthened our balance sheet as our cash balance reflects the addition of $20 million in debt financing," said Ernest DePaolantonio, Chief Financial Officer for BDSI.  "This additional cash will give us runway into mid-2016 to fund operations as currently planned."

Financial Highlights

Second Quarter 2015 Financial Results Overview

• Net revenue for the second quarter ended June 30, 2015, was $1.7 million, compared to $13.9 million in the corresponding period of 2014
• Total operating expenses for the second quarter ended June 30, 2015, were $17.8 million, compared to $15.2 million in the corresponding period of 2014
• Net loss for the second quarter ended June 30, 2015, was $19.2 million, or $0.37 per diluted share, compared to $6.7 million, or $0.14 per diluted share, in the corresponding period of 2014

Six Months Ended June 30, 2015 Financial Results Overview

• Net revenue for the six months ended June 30, 2015, was $14.8 million, compared to $34.6 million in the corresponding period of 2014
• Total operating expenses for the six months ended June 30, 2015, were $37.5 million, compared to $34.5 million in the corresponding period of 2014
• Net loss for the six months ended June 30, 2015, was $27.4 million, or $0.53 per diluted share, compared to $11.3 million, or $0.24 per diluted share, in the corresponding period of 2014
• As of June 30, 2015, BDSI had $67.7 million in cash and cash equivalents, as compared to $70.5 million as of December 31, 2014

Corporate Update and Recent Accomplishments

BUNAVAIL (buprenorphine and naloxone) buccal film for the maintenance treatment of opioid dependence:

• Nearly 14,000 prescriptions dispensed for BUNAVAIL during second quarter 2015; 27% increase over first quarter

Photo - http://photos.prnewswire.com/prnh/20150809/257099
Source: Symphony Health; July estimated based on weekly sales

• BUNAVAIL prescriber base expanded to 1,728 physicians, with 684 new prescribers added during the second quarter
• Market access continues to improve with multiple managed care wins in the second quarter and through July. During the second quarter, 6 additional state Medicaid fee-for-service programs added BUNAVAIL to their preferred drug list. In total, BUNAVAIL now has parity access to other branded products in the category in 19 states
• BUNAVAIL available with 3^rd tier, unrestricted access in >75% of commercial managed care lives; multiple additional contracts in process
• Resources aligned to areas with good managed care access including Tennessee and Massachusetts resulted in prescription growth from first quarter to second quarter of 125% and 57% respectively

BELBUCA (buprenorphine HCl) buccal film for treatment of chronic pain:

• PDUFA date of October 23rd
• Upon FDA approval, eligible to receive up to a $50 million milestone payment from partner Endo Pharmaceuticals
• Phase 3 pivotal trial data presented during second quarter at the American Pain Society 2015 Annual Scientific Conference and the International Conference on Opioids

Clonidine Topical Gel for treatment of painful diabetic neuropathy:

• Data analysis completed, resulting in identification of opportunities to strengthen patient screening criteria that will be employed in a smaller scale pivotal study
• New study planned to commence in the fourth quarter of this year with a budget of $3-5 million

Buprenorphine Depot Injection for the maintenance treatment of opioid dependence and chronic pain:

• Preclinical study yields favorable results supporting development of a formulation capable of providing 30 days of continuous therapy for pain and opioid dependence
• On track for year-end 2015 IND filing and first human trial first quarter of 2016

Patent Litigation Update:

• On June 30^th, in an Inter Partes Review (IPR) proceeding filed by BDSI, the U.S. Patent and Trademark Office rejected and rendered unpatentable all challenged claims of RB Pharmaceuticals Limited's United States Patent No. 8,475,832 ('832 patent)
• In another IPR proceeding, on August 5^th the U.S. Patent and Trademark Office again ruled in favor of BDSI and issued a decision upholding all claims of U.S. Patent No. 7,579,019 ('019 patent), which is Orange Book listed for BUNAVAIL

"We made substantial progress in the last quarter behind the BUNAVAIL launch relating to improved managed care access, particularly Medicaid, expanded pharmacy stocking and enhanced physician targeting.  Progress was also made through shifting our sales force resources to areas where physicians have the best access to BUNAVAIL and strengthening of the sales management team with some key hires, all of which are all helping us to move beyond some of the greater than anticipated challenges we faced during the early launch phase," said Dr. Mark A. Sirgo, President and Chief Executive Officer. 

To read full press release, please click here.

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