Welcome!

News Feed Item

Titan Pharmaceuticals Announces First Quarter 2014 Financial Results

Titan Management Team to Host Conference Call May 15 at 10 a.m. PT/ 1 p.m. ET

SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 05/14/14 -- Titan Pharmaceuticals, Inc. (OTCBB: TTNP), a specialty pharmaceutical company developing proprietary therapeutics for the treatment of opioid dependence and other serious medical disorders, today reported financial results for the first quarter ended March 31, 2014.

Titan generated total revenue in the first quarter of 2014 of approximately $0.9 million, compared with approximately $5.2 million in the first quarter of 2013. First quarter 2014 revenues consisted of license revenue of approximately $0.9 million, compared with license revenue of approximately $3.8 million for first quarter 2013. License revenue in the quarters ended March 31, 2014 and 2013 reflects the amortization of the upfront license fee received from development and commercialization partner Braeburn Pharmaceuticals in December 2012. Titan did not recognize any Fanapt® royalty revenues during the quarter ended March 31, 2014, compared with net royalty revenue of $1.4 million during the first quarter in 2013. Beginning in April 2013, Titan discontinued recognizing Fanapt royalty revenues, as all royalties are being paid to third parties.

Total operating expenses for the quarter ended March 31, 2014 were approximately $1.8 million, compared with approximately $5.0 million in the same quarter in 2013. These expenses consisted primarily of research and development (R&D) expenses of approximately $1.0 million, compared with approximately $3.9 million in the first quarter of 2013, a decrease of approximately $2.9 million or 74 percent. The decrease in R&D costs was due to lower external R&D expenses related to the Probuphine® product development program and preparation and review of the new drug application (NDA) for Probuphine with the U.S. Food and Drug Administration. General and administrative (G&A) expenses for the first quarter of 2014 were approximately $0.9 million, compared with approximately $1.1 million for the same period in 2013, a small decrease of approximately $0.2 million, or 18 percent.

Net other expense for the first quarter of 2014 was approximately $0.9 million, which was primarily related to non-cash losses on changes in the fair value of warrants. Net other income for the first quarter of 2013 was approximately $5.8 million, consisting primarily of approximately $9.0 million in other income generated by the termination of Titan's royalty repurchase agreement with Deerfield and an approximately $1.9 million gain resulting from the settlement of indebtedness to Deerfield as a result of the exercise of all of the Deerfield warrants, which were offset in part by interest expense of approximately $1.6 million related to the Deerfield loans, non-cash losses on changes in the fair value of warrants of approximately $3.0 million and approximately $0.5 million in other expenses related to unamortized transaction fees related to the initial Deerfield debt transaction.

Net loss for the first quarter 2014 was approximately $1.8 million, or approximately $0.02 per share, compared with net income of approximately $6.0 million, or approximately $0.08 per share in the same quarter in 2013.

At March 31, 2014, Titan had cash of approximately $10.2 million. Titan believes that its working capital at present is sufficient to fund planned operations into April 2015.

During the first quarter of 2014, Titan's primary focus remained on securing a path forward for Probuphine®, the company's investigational subdermal implant for the long-term maintenance treatment of opioid dependence developed using Titan's ProNeura™ drug delivery system. After reaching an agreement in principle with the FDA on the design of a clinical study to support the resubmission of the Probuphine NDA, Titan and Braeburn announced on April 30, 2014 that the FDA had provided clear guidance on the full clinical study protocol of Probuphine, paving the way to commence the new clinical study. As a result, preparations are now under way to qualify investigator sites, obtain Institutional Review Board Approval and train clinicians in study procedure. The study is expected to begin enrollment around mid-year, and study completion is anticipated by the middle of 2015.

"We have made significant progress moving Probuphine forward since the beginning of 2014. Our discussions with the FDA in the first quarter were productive and insightful, and resulted in clear guidance from the FDA on a new study," Titan President and CEO Sunil Bhonsle said. "As we work with our partner, Braeburn, to prepare for commencing patient enrollment around mid-year and to complete the study next year, we remain optimistic that we will be able to resubmit our NDA for Probuphine in 2015. We will continue to provide progress reports periodically. If approved, Probuphine has the potential to be the first long-term maintenance treatment of opioid dependence to provide continuous, round-the-clock blood levels of buprenorphine for six months."

"The board is pleased with the progress Titan has made this quarter, and we are confident that Probuphine is now on a solid path forward," said Marc Rubin, M.D., executive chairman of Titan. "As we continue to advance Probuphine, we are also looking to further deliver on the value of the ProNeura drug delivery system. In the coming months we will be consulting with scientific advisors and key opinion leaders and seeking regulatory guidance on the submission of an investigational new drug application for ProNeura for Parkinson's disease by late next year."

About Opioid Dependence
According to recent estimates, there are approximately 2.7 million people with opioid dependence in the U.S. Approximately 20 percent of this population is addicted to illicit opioids, such as heroin, and the other 80 percent to prescription opioids, such as oxycodone, hydrocodone, methadone, hydromorphone and codeine. Before the year 2000, medication-assisted therapies for opioid dependence had been sanctioned to a limited number of facilities in the U.S. The Drug Addiction Treatment Act of 2000 (DATA 2000) allowed medical office-based treatment of opioid dependence and greatly expanded patient access to medication-assisted treatments. As a result, an estimated 1.2 million people in the U.S. sought treatment for opioid dependence in 2011.

About Probuphine®
Probuphine is an investigational subdermal implant designed to deliver continuous, around-the-clock blood levels of buprenorphine for six months following a single treatment, and to simplify patient compliance and retention. Buprenorphine, an approved agent for the treatment of opioid dependence, is currently available in the form of daily dosed sublingual tablets and film formulations, with reported 2012 sales of approximately $1.5 billion in the United States.

Probuphine was developed using ProNeura™, Titan's continuous drug delivery system that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate (EVA) and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper arm in a simple office procedure, and removed in a similar manner at the end of the treatment period. The drug substance is released slowly and continuously through the process of dissolution resulting at a steady rate of release.

The efficacy and safety of Probuphine has been studied in several clinical trials, including a 163-patient, placebo-controlled study over a 24-week period (published in the Journal of the American Medical Association (JAMA)), and a follow-on study of 287 patients (published in the journal Addiction).

ProNeura™ Technology
Probuphine is the first product to utilize Titan's proprietary, long-term drug delivery technology, ProNeura, which has the potential to be used in developing products for the treatment of other chronic conditions. In July 2012, Titan announced that it had successfully completed preclinical investigation into the feasibility of a long-term, around-the-clock, non-fluctuating dopamine agonist treatment for Parkinson's disease, where maintaining stable, around-the-clock blood levels of dopamine agonists may benefit the patient and improve medical outcomes. Titan has been issued patents covering certain dopamine agonist implants in Europe, Japan, Australia, Canada, South Korea, Mexico, New Zealand, South Africa, and Hong Kong, while prosecution of patent applications continues in the U.S., Israel, India and China.

Conference Call
Titan Pharmaceuticals, Inc. (OTCBB: TTNP) will host a live conference call at 10 a.m. PT / 1 p.m. ET on Thursday, May 15, 2014 to discuss the company's financial results as of March 31, 2014. The call will be hosted by Sunil Bhonsle, president and CEO; Katherine Glassman-Beebe, Ph.D., executive vice president and chief development officer; Brian Crowley, vice president of finance, and Marc Rubin, M.D., executive chairman.

The live webcast of the call may be accessed by visiting the Titan website at www.titanpharm.com. The call can also be accessed by dialing 888-438-5491, participant code 2873375, five minutes prior to the start time. A replay of the call will be available on the company website approximately two hours after completion of the call and will be archived for two weeks.

About Titan Pharmaceuticals
Titan Pharmaceuticals Inc. (OTCBB: TTNP), based in South San Francisco, CA, is a specialty pharmaceutical company developing proprietary therapeutics primarily for the treatment of serious medical disorders. The company's lead product candidate is Probuphine®, a novel and long-acting formulation of buprenorphine for the long-term maintenance treatment of opioid dependence. Probuphine employs Titan's proprietary drug delivery system ProNeura™, which is capable of delivering sustained, consistent levels of medication for six months or longer. Titan has granted North American commercial rights for Probuphine to Braeburn Pharmaceuticals. If approved, Probuphine would be the first and only commercialized treatment of opioid dependence to provide continuous, round-the-clock blood levels of buprenorphine for six months following a single procedure. The ProNeura technology has the potential to be used in developing products for treating other chronic conditions, such as Parkinson's disease, where maintaining consistent blood levels of a dopamine agonist may benefit the patient and improve medical outcomes. For more information about Titan, please visit www.titanpharm.com.

This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from management's current expectations include those risks and uncertainties relating to the regulatory approval process, the development, testing, production and marketing of our drug candidates, patent and intellectual property matters and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.




                         TITAN PHARMACEUTICALS, INC.
     CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
                   (in thousands, except per share amount)
                                 (unaudited)
                                                    Three Months Ended
                                                        March 31,
                                             -------------------------------
                                                  2014             2013
                                             --------------   --------------
Revenue:
  License revenue                            $          911   $        3,750
  Royalty revenue                                         -            1,424
                                             --------------   --------------
    Total revenue                                       911            5,174

Operating expenses:
  Research and development                              949            3,912
  General and administrative                            896            1,091
                                             --------------   --------------
    Total operating expense                           1,845            5,003
                                             --------------   --------------
Income (loss) from operations                          (934)             171

Other income (expense), net                            (870)           5,830
                                             --------------   --------------
Net income (loss) and comprehensive
income (loss)                                $       (1,804)  $        6,001
                                             ==============   ==============

Basic net income (loss) per share            $        (0.02)  $         0.08
                                             ==============   ==============

Diluted net income (loss) per share          $        (0.02)  $         0.07
                                             ==============   ==============

Weighted average shares used in computing
basic net income (loss) per share                    88,929           78,256
                                             ==============   ==============

Weighted average shares used in computing
diluted net income (loss) per share                  88,929           86,762
                                             ==============   ==============



                          CONDENSED BALANCE SHEETS
                               (in thousands)
                                 (unaudited)

                                                March 31,      December 31,
                                                  2014             2013
                                             --------------   --------------

Assets
  Cash                                       $       10,239   $       11,798
  Receivables                                         4,080            4,818
  Prepaid expenses and other current assets             286              204
                                             --------------   --------------
    Total current assets                             14,605           16,820
  Furniture and equipment, net                        1,518            1,603
                                             --------------   --------------
    Total assets                             $       16,123   $       18,423
                                             ==============   ==============
Liabilities and Stockholders' Equity
  Current liabilities                        $        9,160   $       10,846
  Warrant liabilities                                 2,681            1,817
  Stockholders' equity                                4,282            5,760
                                             --------------   --------------
    Total liabilities and stockholders'
     equity                                  $       16,123   $       18,423
                                             ==============   ==============


More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
Adobe is changing the world though digital experiences. Adobe helps customers develop and deliver high-impact experiences that differentiate brands, build loyalty, and drive revenue across every screen, including smartphones, computers, tablets and TVs. Adobe content solutions are used daily by millions of companies worldwide-from publishers and broadcasters, to enterprises, marketing agencies and household-name brands. Building on its established design leadership, Adobe enables customers not o...
If you’re responsible for an application that depends on the data or functionality of various IoT endpoints – either sensors or devices – your brand reputation depends on the security, reliability, and compliance of its many integrated parts. If your application fails to deliver the expected business results, your customers and partners won't care if that failure stems from the code you developed or from a component that you integrated. What can you do to ensure that the endpoints work as expect...
WebRTC adoption has generated a wave of creative uses of communications and collaboration through websites, sales apps, customer care and business applications. As WebRTC has become more mainstream it has evolved to use cases beyond the original peer-to-peer case, which has led to a repeating requirement for interoperability with existing infrastructures. In his session at @ThingsExpo, Graham Holt, Executive Vice President of Daitan Group, will cover implementation examples that have enabled ea...
Just over a week ago I received a long and loud sustained applause for a presentation I delivered at this year’s Cloud Expo in Santa Clara. I was extremely pleased with the turnout and had some very good conversations with many of the attendees. Over the next few days I had many more meaningful conversations and was not only happy with the results but also learned a few new things. Here is everything I learned in those three days distilled into three short points.
SYS-CON Events announced today that ReadyTalk, a leading provider of online conferencing and webinar services, has been named Vendor Presentation Sponsor at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. ReadyTalk delivers audio and web conferencing services that inspire collaboration and enable the Future of Work for today’s increasingly digital and mobile workforce. By combining intuitive, innovative tec...
Apache Hadoop is a key technology for gaining business insights from your Big Data, but the penetration into enterprises is shockingly low. In fact, Apache Hadoop and Big Data proponents recognize that this technology has not yet achieved its game-changing business potential. In his session at 19th Cloud Expo, John Mertic, director of program management for ODPi at The Linux Foundation, will explain why this is, how we can work together as an open data community to increase adoption, and the i...
There is growing need for data-driven applications and the need for digital platforms to build these apps. In his session at 19th Cloud Expo, Muddu Sudhakar, VP and GM of Security & IoT at Splunk, will cover different PaaS solutions and Big Data platforms that are available to build applications. In addition, AI and machine learning are creating new requirements that developers need in the building of next-gen apps. The next-generation digital platforms have some of the past platform needs a...
Fifty billion connected devices and still no winning protocols standards. HTTP, WebSockets, MQTT, and CoAP seem to be leading in the IoT protocol race at the moment but many more protocols are getting introduced on a regular basis. Each protocol has its pros and cons depending on the nature of the communications. Does there really need to be only one protocol to rule them all? Of course not. In his session at @ThingsExpo, Chris Matthieu, co-founder and CTO of Octoblu, walk you through how Oct...
Smart Cities are here to stay, but for their promise to be delivered, the data they produce must not be put in new siloes. In his session at @ThingsExpo, Mathias Herberts, Co-founder and CTO of Cityzen Data, will deep dive into best practices that will ensure a successful smart city journey.
Businesses are struggling to manage the information flow and interactions between all of these new devices and things jumping on their network, and the apps and IT systems they control. The data businesses gather is only helpful if they can do something with it. In his session at @ThingsExpo, Chris Witeck, Principal Technology Strategist at Citrix, will discuss how different the impact of IoT will be for large businesses, expanding how IoT will allow large organizations to make their legacy ap...
SYS-CON Events announced today that Tintri Inc., a leading producer of VM-aware storage (VAS) for virtualization and cloud environments, will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Tintri VM-aware storage is the simplest for virtualized applications and cloud. Organizations including GE, Toyota, United Healthcare, NASA and 6 of the Fortune 15 have said “No to LUNs.” With Tintri they mana...
24Notion is full-service global creative digital marketing, technology and lifestyle agency that combines strategic ideas with customized tactical execution. With a broad understand of the art of traditional marketing, new media, communications and social influence, 24Notion uniquely understands how to connect your brand strategy with the right consumer. 24Notion ranked #12 on Corporate Social Responsibility - Book of List.
Major trends and emerging technologies – from virtual reality and IoT, to Big Data and algorithms – are helping organizations innovate in the digital era. However, to create real business value, IT must think beyond the ‘what’ of digital transformation to the ‘how’ to harness emerging trends, innovation and disruption. Architecture is the key that underpins and ties all these efforts together. In the digital age, it’s important to invest in architecture, extend the enterprise footprint to the cl...
SYS-CON Events announced today that Numerex Corp, a leading provider of managed enterprise solutions enabling the Internet of Things (IoT), will exhibit at the 19th International Cloud Expo | @ThingsExpo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Numerex Corp. (NASDAQ:NMRX) is a leading provider of managed enterprise solutions enabling the Internet of Things (IoT). The Company's solutions produce new revenue streams or create operating...
Why do your mobile transformations need to happen today? Mobile is the strategy that enterprise transformation centers on to drive customer engagement. In his general session at @ThingsExpo, Roger Woods, Director, Mobile Product & Strategy – Adobe Marketing Cloud, covered key IoT and mobile trends that are forcing mobile transformation, key components of a solid mobile strategy and explored how brands are effectively driving mobile change throughout the enterprise.