Click here to close now.


News Feed Item

BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of its 2013 Annual Report

BUNAVAIL PDUFA date June 7, 2014; Plans underway for potential Q3 2014 launch

RALEIGH, N.C., March 14, 2014 /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, 2013 with the U.S. Securities and Exchange Commission and, in connection therewith, is providing a review of BDSI's 2013 financials and achievements as well as an update on business operations and upcoming milestones for 2014.

In 2013, BDSI made important progress in significantly advancing and building its product portfolio in pain and addiction treatment and made meaningful strides in its continuing evolution from a development stage entity to a commercial enterprise. This included significant progress in the development of BDSI's two buprenorphine-containing products, BUNAVAIL for the maintenance treatment of opioid dependence and BEMA Buprenorphine, in partnership with Endo Pharmaceuticals, for the treatment of moderate to severe chronic pain. 

A New Drug Application (NDA) for BUNAVAIL was submitted to the U.S. Food and Drug Administration (FDA) in mid-2013 and has a Prescription Drug User Fee Act (PDUFA) date of June 7, 2014. In January 2014, BDSI and Endo announced positive top-line results from the Phase 3 clinical trial of BEMA Buprenorphine in opioid naive patients. The trial successfully met its primary efficacy endpoint in demonstrating that BEMA Buprenorphine resulted in significantly (p<0.005) improved pain relief compared to placebo. Additional secondary endpoints supported the efficacy of BEMA Buprenorphine while the most commonly reported adverse events in patients treated with BEMA Buprenorphine compared to placebo in the double blind phase of the study were nausea (10% vs. 8%), vomiting (4% vs. 2%) and constipation (4% vs. 2%). A second Phase 3 pivotal study for BEMA Buprenorphine, which is ongoing and being conducted in opioid experienced patients, is expected to report top-line results in mid-2014. 

In addition to the progress on its two buprenorphine containing products, BDSI expanded its product portfolio in 2013 by in-licensing Clonidine Topical Gel, a proposed treatment for painful diabetic neuropathy. Following a positive end of Phase 2 meeting with FDA in November, BDSI will begin this quarter enrolling patients in the first of two Phase 3 studies. 

BDSI's financials reflect the company's investment in these late-stage clinical programs during 2013.  The concurrent execution of Phase 3 studies for both BUNAVAIL and BEMA Buprenorphine increased BDSI's research and development expenditures from $35.4 million in 2012 to $53.3 million in 2013. The majority of the research and development expense was incurred in the BEMA Buprenorphine chronic pain program ($41.8 million) and the remainder was incurred primarily from BUNAVAIL-related activities ($7.1 million).  In 2013, BDSI recognized $11.4 million in revenue, including $9.1 million from Endo, $6.3 of which was recognition of previously deferred revenue associated with a 2012 signing milestone and $2.8 million was for reimbursements of certain contractual research and development expenses.

BDSI reported a net loss of ($57.4) million or ($1.51) per share for the twelve months ending December 31, 2013. That compares to net income of $1.7 million, or $0.05 per share in 2012. This difference came from the increase in research and development spending in 2013, as previously noted. In addition, 2012 revenue included $53.4 million from one-time sources, including $35.8 million from two Endo milestones (upon signing and patent approval) and $17.5 million of deferred revenue recognized upon launch of BREAKYL (BEMA Fentanyl) in Europe. This deferred revenue was originally generated from various contractual milestones from Meda, BDSI's commercial partner for its approved product ONSOLIS.

At the end of 2013, BDSI had $23.2 million in cash compared to $63.2 million at December 31, 2012.  BDSI's cash balance was increased significantly in several early 2014 transactions, including proceeds from the $60 million registered direct financing which closed in February 2014, a database lock milestone payment from Endo for $10 million related to the BEMA Buprenorphine opioid naive study, the sale of 658,459 shares of common stock through the "at-the-market" offering program during January 2014, which totaled $3.9 million dollars, and the exercise of certain outstanding warrants totaling another $2.6 million. As a result of the foregoing, BDSI's February 28, 2014 cash balance was approximately $89.8 million, which it plans to utilize toward the execution of its corporate goals in 2014 and beyond.

"I am exceptionally pleased by the progress made by BDSI in the past year and excited about the prospects for 2014," said Dr. Mark A. Sirgo, President and Chief Executive Officer. "In 2013, we significantly progressed our product portfolio while adding to it with the licensing of Clonidine Topical Gel. In addition, we have strengthened our management team with several key additions in research and development, finance and commercial organization. Also, with the completion of our $60 million dollar offering in February of this year, we solidified our balance sheet while strengthening our shareholder base."

"From a research and development perspective, we now have two programs in Phase 3 and a third awaiting FDA approval," continued Dr. Sirgo. "The accomplishment of BDSI's key business objectives during the past year is a tribute to the focus and dedication of our employees. In 2014, we are looking forward to an extremely exciting year as we make plans to transition from a development focused organization to a commercial enterprise following our potential approval and subsequent launch of BUNAVAIL. As it relates to the potential launch of BUNAVAIL, we will be providing more details on our launch plan as we approach our June 7 PDUFA date. Overall, this will be a very busy year for BDSI and one that has the potential to continue to create substantial value for our shareholders."

Corporate Update and Recent Accomplishments

BDSI had multiple clinical, regulatory, business development and corporate accomplishments over the past 15 months, including:

  • BEMA Buprenorphine for Chronic Pain. In conjunction with partner Endo, BDSI recently announced positive top-line results from its pivotal Phase 3 efficacy study of BEMA Buprenorphine in opioid "naive" subjects.
  • BUNAVAIL for Opioid Dependence. Clinical development work was completed and the NDA was submitted to the FDA and subsequently assigned a PDUFA date of June 7, 2014. 
  • Clonidine Topical Gel – Painful Diabetic Neuropathy.  Clonidine Topical Gel was in-licensed from Arcion Therapeutics for $2.5 million in BDSI stock, and BDSI confirmed with FDA the Phase 3 regulatory pathway. The first of two Phase 3 studies for the treatment of painful diabetic neuropathy is anticipated to begin shortly.  
  • $60 Million Registered Financing. In February 2014, BDSI closed a non-brokered registered direct financing (near market price and no warrants) which yielded gross proceeds of $60 million. The lead investor was Federated Kaufmann, along with three current institutional investors. 
  • Strengthened Management Team. BDSI improved the depth and breadth of its management as the company moves toward commercialization of BUNAVAIL as well as further business development opportunities. Appointed were Ernest R. De Paolantonio as Chief Financial Officer, Adrian Hepner, MD, as Vice President of Clinical Research and Regulatory Affairs, and David Acheson as Vice President of Sales and Managed Markets. 

Anticipated 2014 Milestones

BDSI is focusing its resources on achievement of the following key milestones:

  • BUNAVAIL for Opioid Dependence. Given the  FDA action date of June 7, 2014, BDSI is currently working on the execution of the sales, marketing and other commercialization and product supply chain activities to support the anticipated third quarter 2014 launch of BUNAVAIL. Additionally, data from clinical studies of BUNAVAIL will be presented at the American Society of Addiction Medicine (ASAM) 45th Annual Medical-Scientific Conference, April 10-13, 2014 in Orlando, Florida. 
  • BEMA Buprenorphine for Chronic Pain. BDSI anticipates the second database lock from the Phase 3 trial for opioid experienced patients and subsequent $10 million milestone payment from Endo, to occur in mid-year 2014, and the potential filing of the NDA in late 2014 or early 2015.
  • Clonidine Topical Gel for Painful Diabetic Neuropathy. A Phase 3 study will be initiated by the end of first quarter 2014 with the potential for interim data by year-end. 

About BioDelivery Sciences International

BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction. 

BDSI's pain franchise consists of three products, two of which utilize the patented BioErodible MucoAdhesive (BEMA) drug delivery technology.  ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, E.U. (where it is marketed as BREAKYL) and Taiwan (where it is marketed as PAINKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). 

BEMA Buprenorphine is in Phase 3 clinical trials for the treatment of moderate to severe chronic pain and is licensed on a worldwide basis to Endo. Clonidine Topical Gel for the treatment of painful diabetic neuropathy is currently in Phase 3 development.

An NDA for BUNAVAIL, a BEMA formulation of buprenorphine used in combination with naloxone, is currently under review for the maintenance treatment of opioid dependence and has a PDUFA date of June 7, 2014.

BDSI's headquarters is located in Raleigh, North Carolina. For more information visit

Cautionary Note on Forward-Looking Statements

This press release, the presentation referred to herein, and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto 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 and those that relate to the Company's ability to leverage the expertise of employees and partners to assist the Company in the execution of its strategy. Actual results (including, without limitation, the timing for and results of the clinical trials and proposed NDA submissions for, and FDA review of, the Company's products in development, as well as the outcomes of the Company's commercial plans) 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 events or otherwise, except as required by applicable law. 

BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. The BioDelivery Sciences logo and BUNAVAIL™ are trademarks owned by BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL™ is a trademark owned by Meda Pharma GmbH & Co. KG. PAINKYLTM is a trademark owned by TTY Biopharm.  All other trademarks and tradenames are owned by their respective owners.

© BioDelivery Sciences International, Inc. All rights reserved

SOURCE BioDelivery Sciences International, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Docker is hot. However, as Docker container use spreads into more mature production pipelines, there can be issues about control of Docker images to ensure they are production-ready. Is a promotion-based model appropriate to control and track the flow of Docker images from development to production? In his session at DevOps Summit, Fred Simon, Co-founder and Chief Architect of JFrog, will demonstrate how to implement a promotion model for Docker images using a binary repository, and then show h...
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome,” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
Achim Weiss is Chief Executive Officer and co-founder of ProfitBricks. In 1995, he broke off his studies to co-found the web hosting company "Schlund+Partner." The company "Schlund+Partner" later became the 1&1 web hosting product line. From 1995 to 2008, he was the technical director for several important projects: the largest web hosting platform in the world, the second largest DSL platform, a video on-demand delivery network, the largest eMail backend in Europe, and a universal billing syste...
There are many considerations when moving applications from on-premise to cloud. It is critical to understand the benefits and also challenges of this migration. A successful migration will result in lower Total Cost of Ownership, yet offer the same or higher level of robustness. Migration to cloud shifts computing resources from your data center, which can yield significant advantages provided that the cloud vendor an offer enterprise-grade quality for your application.
The IoT is upon us, but today’s databases, built on 30-year-old math, require multiple platforms to create a single solution. Data demands of the IoT require Big Data systems that can handle ingest, transactions and analytics concurrently adapting to varied situations as they occur, with speed at scale. In his session at @ThingsExpo, Chad Jones, chief strategy officer at Deep Information Sciences, will look differently at IoT data so enterprises can fully leverage their IoT potential. He’ll sha...
Today air travel is a minefield of delays, hassles and customer disappointment. Airlines struggle to revitalize the experience. GE and M2Mi will demonstrate practical examples of how IoT solutions are helping airlines bring back personalization, reduce trip time and improve reliability. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Dr. Sarah Cooper, M2Mi's VP Business Development and Engineering, will explore the IoT cloud-based platform technologies driv...
The modern software development landscape consists of best practices and tools that allow teams to deliver software in a near-continuous manner. By adopting a culture of automation, measurement and sharing, the time to ship code has been greatly reduced, allowing for shorter release cycles and quicker feedback from customers and users. Still, with all of these tools and methods, how can teams stay on top of what is taking place across their infrastructure and codebase? Hopping between services a...
In today's digital world, change is the one constant. Disruptive innovations like cloud, mobility, social media, and the Internet of Things have reshaped the market and set new standards in customer expectations. To remain competitive, businesses must tap the potential of emerging technologies and markets through the rapid release of new products and services. However, the rigid and siloed structures of traditional IT platforms and processes are slowing them down – resulting in lengthy delivery ...
As a CIO, are your direct reports IT managers or are they IT leaders? The hard truth is that many IT managers have risen through the ranks based on their technical skills, not their leadership ability. Many are unable to effectively engage and inspire, creating forward momentum in the direction of desired change. Renowned for its approach to leadership and emphasis on their people, organizations increasingly look to our military for insight into these challenges.
Containers have changed the mind of IT in DevOps. They enable developers to work with dev, test, stage and production environments identically. Containers provide the right abstraction for microservices and many cloud platforms have integrated them into deployment pipelines. DevOps and Containers together help companies to achieve their business goals faster and more effectively.
DevOps and Continuous Delivery software provider XebiaLabs has announced it has been selected to join the Amazon Web Services (AWS) DevOps Competency partner program. The program is designed to highlight software vendors like XebiaLabs who have demonstrated technical expertise and proven customer success in DevOps and specialized solution areas like Continuous Delivery. DevOps Competency Partners provide solutions to, or have deep experience working with AWS users and other businesses to help t...
The buzz continues for cloud, data analytics and the Internet of Things (IoT) and their collective impact across all industries. But a new conversation is emerging - how do companies use industry disruption and technology enablers to lead in markets undergoing change, uncertainty and ambiguity? Organizations of all sizes need to evolve and transform, often under massive pressure, as industry lines blur and merge and traditional business models are assaulted and turned upside down. In this new da...
The broad selection of hardware, the rapid evolution of operating systems and the time-to-market for mobile apps has been so rapid that new challenges for developers and engineers arise every day. Security, testing, hosting, and other metrics have to be considered through the process. In his session at Big Data Expo, Walter Maguire, Chief Field Technologist, HP Big Data Group, at Hewlett-Packard, will discuss the challenges faced by developers and a composite Big Data applications builder, foc...
Nowadays, a large number of sensors and devices are connected to the network. Leading-edge IoT technologies integrate various types of sensor data to create a new value for several business decision scenarios. The transparent cloud is a model of a new IoT emergence service platform. Many service providers store and access various types of sensor data in order to create and find out new business values by integrating such data.
Overgrown applications have given way to modular applications, driven by the need to break larger problems into smaller problems. Similarly large monolithic development processes have been forced to be broken into smaller agile development cycles. Looking at trends in software development, microservices architectures meet the same demands. Additional benefits of microservices architectures are compartmentalization and a limited impact of service failure versus a complete software malfunction....