Titan Pharmaceuticals Announces Third Quarter 2010 Financial Results
Conference Call to be Held November 16 at 10:00 a.m. PST
SOUTH SAN FRANCISCO, Calif., Nov. 15, 2010 /PRNewswire-FirstCall/ -- Titan Pharmaceuticals, Inc. (OTC Bulletin Board: TTNP) today reported financial results for the third quarter ended September 30, 2010.
Total revenues for the third quarter of 2010 were approximately $3.6 million, consisting primarily of grant and royalty revenues. Grant revenue from the National Institutes of Health (NIH) in support of the Phase 3 clinical study of Probuphine® was approximately $3.2 million, while royalty revenue received from Novartis on net sales of Fanapt® was approximately $ 0.4 million.
Total operating expenses for the third quarter of 2010 were approximately $3.7 million, compared with $1.6 million for the third quarter of 2009. The year-over-year increase in expenses resulted primarily from an increase of approximately $2.3 million in research and development (R&D) expense related to the Phase 3 clinical study of Probuphine currently in progress, which was offset in part by a decrease in general and administrative (G&A) expenses during the 2010 quarter of $0.2 million due primarily to lower non-cash stock compensation and facility related expenses.
Net loss for the third quarter of 2010 was approximately $0.4 million or $0.01 per share compared with a net loss of $1.6 million or $0.03 per share for the third quarter of 2009.
At September 30, 2010, we had cash and cash equivalents of $6.4 million. We believe that our working capital at September 30, 2010, together with proceeds from the NIH grants and the royalty revenue expected from sales of Fanapt® will be sufficient to sustain our planned operations into the second quarter of 2011.
"We have continued to make excellent progress with the confirmatory Phase 3 study of Probuphine with full enrollment completed in late September, and qualified patients completing this study will have the opportunity for an additional six months of treatment with Probuphine in an open label safety study" said Sunil Bhonsle, President of Titan Pharmaceuticals. "We are also very pleased with the publication of the results from the first Phase 3 study in the Journal of the American Medical Association (JAMA) in October," he noted.
"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 publication of the clinical results in JAMA recognize the innovative nature of Probuphine, and its potential to offer a meaningful therapeutic alternative to patients in the future," he added.
Third Quarter 2010 Additional Financial Results
R&D expenses for the third quarter of 2010 were approximately $3.0 million, compared with approximately $0.7 million in the third quarter of 2009. The increase in R&D expense reflects the costs of conducting the Phase 3 clinical study of Probuphine and includes $2.5 million of external expenses such as clinical research organization charges, investigator and patient related clinical site expenses, and other associated costs. The remaining R&D expenses reflect internal operating costs such as personnel related expenses, meeting and travel expenses and allocation of facility and corporate costs.
G&A expenses for the third quarter of 2010 decreased to approximately $0.7 million from approximately $0.9 million in the comparable period of 2009 primarily due to decreases in non-cash stock compensation costs of approximately $0.1 million, and consulting fees and facility expenses of $0.1 million.
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 in the confirmatory Phase 3 study was completed in late September, with study results expected in mid second quarter 2011. -- A symposium on Probuphine was conducted at the International Society of Addiction Medicine annual meeting on October 6, 2010 in Milan, Italy. This symposium was co-sponsored by NIDA. -- Upcoming scientific presentations of Probuphine data: o Society for Neuroscience (SfN), November 2010, San Diego (Therapeutic area symposium) o American College of Neuropsychopharmacology (ACNP), December 2010, Miami (Poster presentation)
Titan management will host a live call and webcast tomorrow, Tuesday, November 16, at 10:00 a.m. PST (1:00 p.m. EST) to discuss our third quarter 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 1-800-860-2442, International Dial-In: +1 412-858-4600, Canadian Toll Free: +1-866-605-3852 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.
CONTACT: Titan Pharmaceuticals, Inc. Pure Communications Sunil Bhonsle, 650-244-4990 Dan Budwick, 973-271-6085 President email@example.com
TITAN PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amount) Three Months Ended Nine Months Ended September 30, September 30, 2010 2009 2010 2009 (unaudited) (unaudited) Revenue: Grant revenue $ 3,203 $ - $ 5,251 $ - Royalty revenue 396 - 2,104 - License revenue 1 - 12 52 Total revenue 3,600 - 7,367 52 Operating expense: Research and development 3,044 709 6,770 1,741 General and administrative 691 876 2,638 2,723 Total operating expense 3,735 1,585 9,408 4,464 Loss from operations (135) (1,585) (2,041) (4,412) Other expense, net (249) (8) (494) (6) Net loss $ (384) $ (1,593) $ (2,535) $ (4,418) Basic and diluted net loss per share $ (0.01) $ (0.03) $ (0.04) $ (0.08) Weighted average shares used in computing basic and diluted net loss per share 59,248 58,297 59,248 58,291
CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) September 30, December 31, 2010 2009 (unaudited) (Note A) Assets Cash and cash equivalents $ 6,401 $ 3,300 Accounts receivable 1,904 66 Prepaid expenses and other current assets 181 250 Total current assets 8,486 3,616 Furniture and equipment, net 61 110 $ 8,547 $ 3,726 Liabilities and Stockholders' Equity Current liabilities $ 4,586 $ 1,547 Long-term debt 6,113 2,386 Non-controlling interest 1,241 1,241 Stockholders' deficit (3,393) (1,448) $ 8,547 $ 3,726 Note A: The year end condensed balance sheet data was derived from audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the United States of America.
SOURCE Titan Pharmaceuticals, Inc.
Released November 15, 2010