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Titan Pharmaceuticals Announces Second Quarter 2014 Financial Results

Companies mentioned in this article: Titan Pharmaceuticals, Inc.

SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 08/13/14 -- 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 second quarter ended June 30, 2014.

Titan generated total revenue in the second quarter of 2014 of approximately $0.9 million, compared with approximately $2.2 million in the second quarter of 2013. Revenue earned during the quarters ended June 30, 2014 and 2013 reflects the amortization of the upfront license fee received from development and commercialization partner Braeburn Pharmaceuticals in December 2012.

Total operating expenses for the quarter ended June 30, 2014 were approximately $1.5 million, compared with approximately $2.5 million in the same quarter in 2013. These expenses consisted primarily of research and development (R&D) expenses of approximately $0.7 million, compared with approximately $1.8 million in the second quarter of 2013, a decrease of approximately $1.1 million or 61 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 second quarter of 2014 remained relatively flat compared with the same period in 2013, with Titan reporting approximately $0.7 million in G&A expenses in both periods.

Net other expense for the second quarter of 2014 was approximately $0.3 million, which was primarily related to non-cash losses on changes in the fair value of warrants. This compared with net other income of approximately $5.4 million in the same quarter of 2013, which was primarily related to non-cash gains on the changes in the fair value of warrants. Net loss for the second quarter of 2014 was approximately $0.8 million, or approximately $0.01 per share, compared with net income of approximately $5.1 million, or approximately $0.06 per share in the same quarter in 2013.

At June 30, 2014, Titan had cash of approximately $8.9 million, which is expected to be sufficient to fund planned operations into June 2015.

"Titan made significant progress in all areas of our business during the second quarter. Our partner Braeburn Pharmaceuticals completed the preparations necessary to begin the Phase 3 trial of Probuphine and last month we announced first patient enrollment in that trial, which we expect will pave the way for resubmission of our New Drug Application in late 2015," said Titan Pharmaceuticals President Sunil Bhonsle. "We have also made good progress towards developing an optimal product formulation from our long-term delivery system ProNeura for the treatment of Parkinson's disease, and continue to have substantive discussions with our scientific advisors to solidify the development plans. Importantly, this quarter we secured additional intellectual property protection for that program. We plan to file an investigational new drug application for ProNeura for Parkinson's in 2015."

Recent highlights include:

  • On July 21, Titan announced first patient enrollment in the Phase 3 clinical trial of Probuphine, the company's investigational subdermal implant for the maintenance treatment of opioid dependence. The study, which is expected to be completed by the middle of 2015, is designed to address key questions posed by the U.S. Food and Drug Administration (FDA) in its complete response letter last year after review of the original NDA.
  • On June 9, Titan announced that it received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent application covering the sustained release of dopamine agonists utilizing ProNeura, the company's proprietary long-term drug delivery technology. The patent provides intellectual property protection for the company's development program of ProNeura for Parkinson's disease and carries a patent term to at least 2024.

"With the Phase 3 trial of Probuphine enrolling on schedule and plans under way for the development of ProNeura for Parkinson's disease, Titan is well positioned for future growth," said Marc Rubin, M.D., executive chairman of Titan. "The board is extremely encouraged by the progress Titan is making, and we look forward to developing treatments using ProNeura, our proprietary long-term delivery technology, for select chronic diseases for which steady state delivery of a drug provides an efficacy and/or safety benefit."

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). Probuphine is currently being tested in an additional Phase 3 study sponsored by our partner Braeburn Pharmaceuticals, and upon completion in mid-2015 the data from this study is expected to support the resubmission of the New Drug Application later that year.

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 and received notice of allowance in the U.S., while prosecution of patent applications continues in 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, Aug. 14, 2014 to discuss the company's financial results as of June 30, 2014. The call will be hosted by Sunil Bhonsle, president; 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 888-637-7707, participant code 8273007, 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, around-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     Six Months Ended
                                       June 30,              June 30,
                                 --------------------  --------------------
                                    2014       2013       2014       2013
                                 ---------  ---------  ---------  ---------
Revenue:
  License revenue                $     911  $   2,198  $   1,823  $   5,948
  Royalty revenue                        -          -          -      1,424
                                 ---------  ---------  ---------  ---------
    Total revenue                      911      2,198      1,823      7,372

Operating expense:
  Research and development             748      1,789      1,698      5,701
  General and administrative           713        701      1,609      1,792
                                 ---------  ---------  ---------  ---------
    Total operating expense          1,461      2,490      3,307      7,493
                                 ---------  ---------  ---------  ---------
Loss from operations                  (550)      (292)    (1,484)      (121)

    Other income (expense), net       (292)     5,356     (1,162)    11,186
                                 ---------  ---------  ---------  ---------
Net income (loss) and
 comprehensive income (loss)     $    (842) $   5,064  $  (2,646) $  11,065
                                 =========  =========  =========  =========

Basic net income (loss) per
 share                           $   (0.01) $    0.06  $   (0.03) $    0.14
                                 =========  =========  =========  =========

Diluted net income (loss) per
 share                           $   (0.01) $       -  $   (0.03) $    0.10
                                 =========  =========  =========  =========

Weighted average shares used in
 computing basic net income
 (loss) per share                   88,998     82,527     88,964     80,403
                                 =========  =========  =========  =========

Weighted average shares used in
 computing diluted net income
 (loss) per share                   88,998     82,559     88,964     86,271
                                 =========  =========  =========  =========





                          CONDENSED BALANCE SHEETS
                               (in thousands)
                                 (unaudited)

                                                     June 30,   December 31,
                                                       2014         2013
                                                   ------------ ------------

Assets
  Cash                                             $      8,853 $     11,798
  Receivables                                             3,743        4,818
  Prepaid expenses and other current assets                 216          204
                                                   ------------ ------------
    Total current assets                                 12,812       16,820
  Furniture and equipment, net                            1,437        1,603
                                                   ------------ ------------
                                                   $     14,249 $     18,423
                                                   ============ ============
Liabilities and Stockholders' Equity
  Current liabilities                              $      7,821 $     10,846
  Warrant liabilities                                     2,965        1,817
  Stockholders' equity                                    3,463        5,760
                                                   ------------ ------------
                                                   $     14,249 $     18,423
                                                   ============ ============


Contact:

CONTACT:
Titan Pharmaceuticals, Inc.
Sunil Bhonsle
650-244-4990
President

Media
Susan Thomas
619-540-9195
stcommunications@aol.com