SOURCE: Titan Pharmaceuticals, Inc.

Titan Pharmaceuticals, Inc.

March 24, 2011 19:47 ET

Titan Pharmaceuticals Reports Fourth Quarter and Full Year 2010 Financial Results

Conference Call to Be Held March 29 at 10:00 a.m. PDT

SOUTH SAN FRANCISCO, CA--(Marketwire - March 24, 2011) - Titan Pharmaceuticals, Inc. (OTCBB: TTNP) today reported financial results for the fourth quarter and full year ended December 31, 2010.

Total revenues for the year 2010 were approximately $10.1 million, consisting primarily of grant and royalty revenues. Grant revenue from the National Institutes of Health (NIH) in support of the confirmatory Phase 3 clinical study of Probuphine™, and the Small Business Innovation Research (SBIR) grant in support of non-clinical studies with dopamine agonists, was approximately $7.6 million, while royalty revenue received from Novartis on net sales of Fanapt® was approximately $2.5 million. Total revenues for the year 2009 were approximately $79,000 generated solely from licensing agreements.

Total operating expenses for the year 2010 were approximately $16.1 million, compared with $5.9 million for the full year of 2009. The year over year increase was primarily a result of the expenses associated with the Phase 3 clinical development of Probuphine.

Net loss applicable to common shareholders for 2010 was approximately $5.6 million, or $0.09 per share, compared to our net loss of approximately $5.9 million, or $0.10 per share, for 2009. Net loss for 2010 includes a non-cash gain of approximately $1.2 million, or $0.02 per share, related to the retirement of preferred stock in Ingenex, Inc., a subsidiary of Titan that was dissolved in the fourth quarter.

At December 31, 2010, we had approximately $3.2 million of cash compared to approximately $3.3 million at December 31, 2009. We believe that our working capital at year end 2010, together with the recently announced $20 million debt financing, remaining proceeds from the NIH grants and the royalty revenue expected from sales of Fanapt will be sufficient to sustain our planned operations into the first quarter of 2012.

"2010 has been a year with many key accomplishments for Titan. In terms of corporate growth and milestones, we are now receiving the royalty revenue from the sales of Fanapt. We also continue to make important research and development progress. Thanks to our clinical and operations teams and the support from the NIH grant, we were successful in rapidly commencing the confirmatory Phase 3 study of Probuphine and even completing full enrollment three months ahead of schedule," said Sunil Bhonsle, President of Titan Pharmaceuticals. "We achieved an important milestone for the Probuphine program with the publication of results from our first Phase 3 study in the prestigious Journal of the American Medical Association (JAMA) in October. The ongoing clinical studies of Probuphine are progressing smoothly and we anticipate having the results from our confirmatory Phase 3 study in late second quarter, followed by an important meeting with the FDA targeted for late summer," he noted.

"2010 was a year of building on Titan's strengths, and the board is very pleased by the continued progress in the development of Probuphine, and fully supports the ongoing efforts," said Marc Rubin, M.D., Executive Chairman of Titan Pharmaceuticals. "The recent financing also emphasizes our commitment to the Probuphine program and our goal of enhancing value while minimizing shareholder dilution. This year, we are also focusing on the potential commercialization of Probuphine, working towards establishing appropriate partnerships to maximize Probuphine's promise in the treatment of opioid addiction."

Additional Financial Results

Full Year 2010

Research and development expenses for 2010 were approximately $12.9 million compared to approximately $2.5 million in 2009, an increase of approximately $10.4 million, or 416%. This increase was primarily associated with an increase in external research and development expenses related to the initiation and ongoing expenses of the Phase 3 clinical trials related to our Probuphine product, specifically, a confirmatory controlled efficacy study and a retreatment safety study. External research and development expenses include direct expenses such as clinical research organization charges, investigator and review board fees, patient expense reimbursements and contract manufacturing expenses.

General and administrative expenses for 2010 were approximately $3.3 million, compared to approximately $3.4 million in 2009, a decrease of approximately $0.1 million, or 3%. The decrease in general and administrative expenses was primarily related to decreases in non-cash stock compensation costs and facilities related costs which was offset in part by increases in employee-related costs, legal fees and consulting and professional fees.

Net other expense for 2010 was approximately $809,000 compared to approximately $71,000 in 2009. Net other expense in 2010 consisted primarily of interest expense of approximately $678,000 and loan fees of approximately $125,000 resulting from our loans with Oxford Capital Financing.

Fourth Quarter 2010

Total revenues for the fourth quarter of 2010 were approximately $2.7 million, consisting primarily of grant revenue of $2.3 million from the NIH in support of the confirmatory Phase 3 clinical study of Probuphine and the SBIR grant in support of non-clinical studies with dopamine agonists, while royalty revenue received from Novartis on net sales of Fanapt was approximately $0.4 million. Total revenues for the fourth quarter of 2009 were approximately $27,000 generated solely from licensing agreements.

Total operating expenses for the fourth quarter of 2010 were approximately $6.7 million, comprising primarily research and development expense of $6.1 million and general and administrative expense of $0.6 million. Operating expense for the comparable period in the fourth quarter of 2009 was $1.4 million which included $0.7 million in research and development expenses and the remaining $0.7 million in general and administrative expenses. The year over year increase was primarily a result of the expenses associated with the Phase 3 clinical development of Probuphine.

Net loss applicable to common shareholders for the fourth quarter of 2010 was approximately $3.1 million, or $0.05 per share which included the adjustment for the gain on retirement of preferred stock upon dissolution of our majority owned subsidiary Ingenex, Inc. Net loss for the comparable period in 2009 was approximately $1.5 million, or $0.02 per share.

Probuphine: Recent and Upcoming Events

Probuphine is a novel formulation of buprenorphine designed to provide six months of continuous drug delivery with a single administration. It is in Phase 3 development by Titan for the treatment of opioid addiction and we are currently conducting a confirmatory Phase 3 clinical study in the U.S. which is partially funded through a two year $7.6 million National Institutes of Health (NIH) grant being administered by the National Institute on Drug Abuse (NIDA). Recent and upcoming events include the following:

--  Patient enrollment commenced in the fourth quarter for the Phase 3 open
    label safety study of Probuphine for the retreatment of patients who
    complete the controlled confirmatory study. Results of this study will
    be available in fourth quarter of 2011.

--  Scientific data presentations of Probuphine during fourth quarter 2010:
    --  Society for Neuroscience (SfN), November 2010, San Diego
        (Therapeutic area symposium)
    --  American College of Neuropsychopharmacology (ACNP), December 2010,
        Miami (Poster presentation)

--  Results of the confirmatory Phase 3 safety and efficacy study of
    Probuphine for the treatment of opioid addiction expected in June 2011

--  Pre-NDA meeting with the Food and Drug Administration to review
    clinical and other support data targeted for August 2011

--  Upcoming scientific presentations:
    --  The 2011 NIDA International Forum: Building International
        Collaborative Research on Drug Abuse - June 2011
    --  American Academy of Addiction Psychiatry - December 2011

Conference Call

Titan management will host a live call and webcast on Tuesday, March 29, at 10:00 a.m. PDT (1:00 p.m. EDT) to discuss our fourth quarter and full year 2010 results and current corporate developments. The live webcast of the call may be accessed by visiting our website at www.titanpharm.com. The call can also be accessed by dialing 1-877-879-6174 Participant code: 5681362 five minutes prior to the start time. A replay of the call will be available on our website approximately two hours after completion of the call and will be archived for two weeks.

About Titan Pharmaceuticals

For information concerning Titan Pharmaceuticals, Inc., please visit the Company's website at www.titanpharm.com.

The 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 the Company's development program and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company's drug candidates, adverse side effects or inadequate therapeutic efficacy of the Company's drug candidates that could slow or prevent product development or commercialization, the uncertainty of patent protection for the Company's intellectual property or trade secrets, and the Company's ability to obtain additional financing. Such statements are based on management's current expectations, but actual results may differ materially due to various factors, including those risks and uncertainties mentioned or referred to in this press release.

                        TITAN PHARMACEUTICALS, INC.
              CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
                  (in thousands, except per share amount)
                                (unaudited)

                                    Three Months Ended      Years Ended
                                       December 31,        December 31,
                                    ------------------  ------------------
                                      2010      2009      2010      2009
                                    --------  --------  --------  --------

Revenue:
  Grant revenue                     $  2,306  $      -  $  7,557  $      -
  Royalty revenue                        408         -     2,512         -
  License revenue                         12        27        24        79
                                    --------  --------  --------  --------
     Total revenue                     2,726        27    10,093        79

Operating expense:
  Research and development             6,085       715    12,855     2,456
  General and administrative             625       715     3,263     3,438
                                    --------  --------  --------  --------
     Total operating expense           6,710     1,430    16,118     5,894
                                    --------  --------  --------  --------
Loss from operations                  (3,984)   (1,403)   (6,025)   (5,815)

     Other expense, net                 (315)      (65)     (809)      (71)
                                    --------  --------  --------  --------
Net loss                              (4,299)   (1,468)   (6,834)   (5,886)

  Gain on retirement of preferred
   stock upon dissolution of
   subsidiary                          1,241         -     1,241         -
                                    --------  --------  --------  --------
Net loss applicable to common
 stockholders                       $ (3,058) $ (1,468) $ (5,593) $ (5,886)
                                    ========  ========  ========  ========
Basic and diluted net loss per
 share                              $  (0.05) $  (0.02) $  (0.09) $  (0.10)
                                    ========  ========  ========  ========
Weighted average shares used in
 computing basic and diluted
 net loss per share                   59,248    59,014    59,248    58,473
                                    ========  ========  ========  ========





                  CONDENSED CONSOLIDATED BALANCE SHEETS
                              (in thousands)
                                (unaudited)

                                                           December 31,
                                                       -------------------
                                                         2010       2009
                                                       --------   --------
Assets
  Cash                                                 $  3,180   $  3,300
  Accounts receivable                                     1,225         66
  Prepaid expenses and other current assets                 294        250
                                                       --------   -------- 
     Total current assets                                 4,699      3,616
  Furniture and equipment, net                               53        110
                                                       --------   --------
                                                       $  4,752   $  3,726
                                                       ========   ========
Liabilities and Stockholders' Equity
  Current liabilities                                  $  5,405   $  1,547
  Long-term debt                                          5,400      2,386
  Non-controlling interest                                    -      1,241
  Stockholders' deficit                                  (6,053)    (1,448)
                                                       --------   --------
                                                       $  4,752   $  3,726
                                                       ========   ========

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