BioDelivery Sciences Reports Second Quarter 2017 Financial Results and Provides Corporate Update

RALEIGH, N.C., Aug. 9, 2017 /PRNewswire/ -- BioDelivery Sciences International, Inc. (BDSI) today reported financial results for the three and six months ended June 30, 2017, and provided an update on recent business highlights and upcoming milestones.

"The U.S. currently faces a very serious crisis with regard to prescription opioid abuse, addiction and overdose.  Our two buprenorphine-containing products provide important options to address the needs of those with chronic pain and opioid dependence, and we believe this is becoming increasingly recognized by healthcare providers, and that these dynamics are likely aiding our commercial performance with BELBUCA^®," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI.  "Our strong start with our focused commercial effort behind BELBUCA continued in the second quarter, with solid 44% growth in BELBUCA net sales to $6.6 million compared to net sales of $4.6 million in the first quarter.  This is accentuated by sales from May onward that exceeded the previous sales peak reached by our former commercial partner Endo in December 2016.  The increasing number of both prescriptions and number of BELBUCA prescribers provide us with the confidence that our commercial strategy is working, and we anticipate continued growth.  We also believe that the addition of government payers, such as Medicare Part D, which represents nearly 40% of the total prescriptions for long-acting opioids, provides further opportunity for growth as we look ahead to 2018."

Dr. Sirgo continued, "We also achieved important progress with our BELBUCA licensing efforts outside the U.S.  Our second quarter marketing approval for BELBUCA by Health Canada was followed shortly thereafter by our licensing agreement with Purdue (Canada) for the licensing, distribution, marketing, and sale of BELBUCA in Canada.  We anticipate the launch will take place early next year.  Beyond this agreement, we are focused on advancing toward additional commercial transactions for ex-U.S. rights to BELBUCA this year, which will further support sustained future growth and our expansion strategy for this important product."

"Our cash on hand, in combination with expected BELBUCA and BUNAVAIL^® revenue, provide us the capital runway to support our current operating plan into the second half of 2018.  In addition, this runway does not include our ability to access up to an additional $30 million from our current CRG loan, the availability of which is dependent upon BDSI achieving certain funding conditions."

Second Quarter 2017 Financial Highlights

Net revenue for the second quarter ended June 30, 2017, was approximately $8.7 million compared to $29.5 million in the first quarter of 2017, and $5.0 million in the second quarter of last year.  First quarter 2017 revenue included $20.0 million of non-cash deferred revenue recognized as part of the reacquisition of BELBUCA and termination of the Endo license in January 2017.  This deferred revenue was part of the $50 million NDA approval milestone payment received by BDSI from Endo.

Total net revenue of BELBUCA and BUNAVAIL in the second quarter were $6.6 million and $1.3 million, respectively, versus $4.6 million and $3.2 million in the first quarter of 2017.  BUNAVAIL sales of $3.2 million in the first quarter included $1.7 million in sales shipped to wholesalers prior to January 1, 2017, and recognized during the first quarter as we adopted the sell-in method, which records sales based on product sold to wholesalers, versus the previously utilized sell-through method.

Total operating expenses for the second quarter ended June 30, 2017, were $17.6 million, compared to $16.5 million in the second quarter of 2016, with the increase due to increased general and administrative costs due to the amortization of $1.1 million of the $45.0 million intangible from the favorable valuation of the BELBUCA reacquisition.

Net loss for the second quarter ended June 30, 2017, was $14.9 million, or ($0.27) per basic and diluted share, compared to a net loss of $16.5 million, or ($0.31) per basic and diluted share, in the same period of 2016.  The decrease in net loss was attributable principally to net sales from the reacquisition of BELBUCA in January 2017.

BDSI had cash and cash equivalents of approximately $27.5 million at June 30, 2017. This compares to cash and cash equivalents of approximately $35.2 million at March 31, 2017.

Six Months Ended June 30, 2017 Financial Highlights

Net revenue for the six months ended June 30, 2017, was approximately $38.2 million, compared to $8.0 million in the same period of 2016.  Total net sales of BELBUCA and BUNAVAIL in the first six months of 2017 were $11.1 million and $4.6 million, respectively.  This compares to BUNAVAIL total net revenue of $4.2 million in the six months ended June 30, 2016.  Also recognized in net revenue for the six months ended June 30, 2017, was $20 million of deferred revenue for BELBUCA upon termination of the license with Endo.  

Total operating expenses for the six months ended June 30, 2017, were $33.5 million, compared to $34.9 million in the same period of 2016.  The reduction in operating expenses was primarily attributable to a decrease in research and development spending, offset somewhat by the amortization of $2.2 million of the $45.0 million intangible from the favorable valuation of the BELBUCA reacquisition. 

Net income for the six months ended June 30, 2017, was $33.4 million, or $0.61 per basic and $0.60 per diluted share, compared to a net loss of $35.2 million, or ($0.66) per basic and diluted share, in the same period of 2016.  The increase in net income was attributable principally to BELBUCA net sales, favorable valuation of the licensing and distribution agreement for BELBUCA and recognition of deferred revenue associated with the license termination and reacquisition of BELBUCA.

Recent Company Milestones

Commercial

• BELBUCA (buprenorphine) buccal film (CIII) generated net revenue of $6.6 million in the second quarter of 2017, an increase of 44% over the first quarter of 2017. The June annualized net revenue run rate for BELBUCA exceeds $33 million.
• Signed an exclusive agreement with Purdue Pharma (Canada) for the licensing, distribution, marketing, and sale of BELBUCA in Canada. BDSI is eligible to receive upfront and potential milestones of up to CAD $4.5 million, as well as royalties on net sales. BDSI expects Purdue to launch BELBUCA in Canada in early 2018.

Regulatory

• Approval for BELBUCA received from Health Canada in June.
• Received approval from the U.S. Food and Drug Administration (FDA) for a Supplemental New Drug Application (sNDA) expanding the indication for BUNAVAIL (buprenorphine and naloxone) buccal film (CIII) to include induction of buprenorphine treatment for opioid dependence. Induction is the first step to assist a patient in discontinuing or markedly reducing their use of opioids.

Managed Care

• BELBUCA prescriptions increased 19% from the first to second quarter of 2017 within United Healthcare commercial book of business. This follows implementation of a contract on January 1, 2017, providing preferred access to BELBUCA over Butrans.
• Additional significant managed care contract secured and announced in the second quarter with a January 1, 2018, effective date.

Intellectual Property

• Two new Orange Book listed patents further extend and strengthen patent protection on BELBUCA, BUNAVAIL and ONSOLIS^® (fentanyl buccal soluble film) (CII).
• Patent issued extending patent protection on ONSOLIS from January 2020 to July 2027; issued patent is associated with a $3 million milestone payment to BDSI from Collegium Pharmaceutical, payment of which is due upon FDA approval of the supplemental application supporting the new manufacturer for ONSOLIS.

Key Anticipated Milestones

• Continued prescription and revenue growth of BELBUCA
• Opportunity for additional managed care contracts, particularly Medicare for BELBUCA
• BELBUCA launch in Canada in early 2018 by Purdue (Canada)
• Opportunity to execute additional commercial transaction for ex-U.S. rights to BELBUCA
• Planned regulatory submission later this year to qualify the new manufacturer for ONSOLIS, facilitating a potential return of the product to market in the first half of 2018

Conference Call & Webcast

About BioDelivery Sciences International

BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a specialty pharmaceutical company with a focus in the areas of pain management and addiction medicine.  BDSI is utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA^®) technology and other drug delivery technologies to develop and commercialize, either on its own or in partnership with third parties, new applications of proven therapies aimed at addressing important unmet medical needs.  BDSI's marketed products and those in development address serious and debilitating conditions such as breakthrough cancer pain, chronic pain and opioid dependence.  BDSI's headquarters is in Raleigh, North Carolina.  

BUNAVAIL^® (buprenorphine and naloxone) buccal film (CIII) and BELBUCA^® (buprenorphine) buccal film (CIII) are marketed in the U.S. by BioDelivery Sciences.   ONSOLIS® (fentanyl buccal soluble film) (CII) is licensed in the U.S. to Collegium Pharmaceutical pursuant to the U.S. licensing and development agreement between BDSI and Collegium. For full prescribing information and important safety information on BDSI products, including BOXED WARNINGS for ONSOLIS, please visit www.bdsi.com where the Company promptly posts press releases, SEC filings and other important information or contact the Company at (800) 469-0261.  For full prescribing and safety information on BELBUCA, please visit www.belbuca.com and for full prescribing and safety information on BUNAVAIL, please visit www.bunavail.com.

Cautionary Note on Forward-Looking Statements

This press release and any statements of employees, representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto (including, without limitation, the presentation described herein) contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995.  Such forward-looking statements involve significant risks and uncertainties.  Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions.  These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission.  Actual results (including, without limitation, the results of commercialization efforts for the Company's approved products and the clinical trials for, and regulatory review of, the Company's products in development) may differ significantly from those set forth in the forward-looking statements.  These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control).  The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.

BDSI^®, BEMA^®, ONSOLIS^®, BUNAVAIL^® and BELBUCA^® are registered trademarks of BioDelivery Sciences International, Inc.  The BioDelivery Sciences, BUNAVAIL and BELBUCA logos are trademarks owned by BioDelivery Sciences International, Inc.  All other trademarks and tradenames are owned by their respective owners.

© 2017 BioDelivery Sciences International, Inc.  All rights reserved.

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