http://www.titanpharm.com/ () —
Titan Pharmaceuticals, Inc. (OTCBB: TTNP) today reported financial
results for the first quarter ended March 31, 2011.
Total revenues for the first quarter of 2011 were $0.9 million,
consisting of $0.7 million in royalties on net sales of Fanapt@ and
$0.2 million in grant revenues from the National Institutes of Health
(NIH) in support of the ongoing confirmatory Phase 3 clinical study of
Probuphine and the SBIR grant for Titan's proprietary ProNeura drug
delivery technology.
Total operating expenses for the first quarter of 2011 were $4.5
million, compared with $2.6 million for the first quarter of 2010. The
year-over-year increase in expenses resulted primarily from an
increase of approximately $2.0 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 of $0.1 million.
Net loss for the first quarter of 2011 was $4.5 million or $0.08 per
share compared with a net loss of $0.3 million or $0.01 per share for
the first quarter of 2010.
At March 31, 2011, we had cash and cash equivalents of approximately
$0.8 million. On April 5, 2011, we completed our transactions with
entities affiliated with Deerfield Management for a loan of $20.0
million to the company. We used a portion of the proceeds received to
repay the outstanding debt of $7.7 million to Oxford Finance
Corporation and also paid a facility fee to Deerfield of $0.5 million.
With the recently completed financing and the royalty revenues
expected from the sales of Fanapt, we believe that we have sufficient
cash resources to fund operations into the first quarter of 2012.
"We have continued to make excellent progress with the confirmatory
Phase 3 study of Probuphine and are on target to announce top-line
results before the end of the second quarter," said Sunil Bhonsle,
President of Titan Pharmaceuticals. "Completion of the recent
financing with Deerfield provides the resources to continue the
clinical and manufacturing development of Probuphine, and the six
month patient re-treatment study is progressing smoothly and will
provide important safety data on patients treated for up to one year
by the end of this year," he noted.
"This has been an important time period for the Company as we prepare
for the upcoming events, and the board is in full support of the
ongoing efforts," said Marc Rubin, M.D., Executive Chairman of Titan
Pharmaceuticals. "Dr. Kate Beebe has provided outstanding leadership
for the Probuphine clinical development program, and is highly
respected by both the physician and patient communities. In
recognition of Dr. Beebe's many important contributions, the board
recently appointed her to the position of Executive Vice President and
Chief Development Officer. We congratulate her as we continue with the
important task of seeking partners for the future commercialization of
Probuphine, and the possible opportunity to offer a meaningful
therapeutic alternative to patients with the disease of opioid
addiction," he added.
First Quarter 2011 Additional Financial Results
R&D expenses for the first quarter of 2011 were $3.7 million, compared
with $1.7 million in the comparable period of 2010. The increase in
R&D expense reflects the costs of conducting the Phase 3 clinical
study of Probuphine and includes approximately $2.9 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 first quarter of 2011 decreased to $0.8 million
from $0.9 million in the comparable period of 2010 primarily due to
decreases in consulting and professional fees.
Probuphine: Recent and Upcoming Events
Probuphine is a novel formulation of buprenorphine that is capable of
maintaining a stable, round the clock level of medicine in patients
for six months following a single treatment. It is in Phase 3
development for the treatment of opioid addiction and Titan is
currently conducting a confirmatory Phase 3 clinical study in the U.S.
that is partially funded through a two-year $7.6 million NIH grant
being administered by the National Institute on Drug Abuse (NIDA).
Recent and upcoming events include the following:
-- Last patient treatment and follow-up in the confirmatory Phase 3
efficacy and safety study of Probuphine for the treatment of opioid
addiction is complete, and top-line results are expected before the
end of June 2011.
-- Patient enrollment is complete in the Phase 3 open label study for
the re-treatment of patients who completed the controlled
confirmatory study, and results of this study will be available
before year end 2011.
-- A pre-NDA meeting with the Food and Drug Administration to review
clinical and other support data is targeted for late in the third
quarter of this year.
-- Upcoming scientific presentations:
- NIDA International Forum: Building International Collaborative
Research on Drug Abuse, Hollywood, FL, June 2011
- International Society of Addiction Medicine annual meeting, Oslo,
Norway, September 2011
- American Academy of Addiction Psychiatry, Scottsdale, AZ,
December 2011
Conference Call
Titan management will host a live call and webcast on Thursday, May
19, 2011 at 10:00 a.m. PDT (1:00 p.m. EDT) to discuss our first
quarter 2011 results and current corporate developments. The live
webcast of the call may be accessed by visiting our website at
www.titanpharm.com (http://www.titanpharm.com) . The call can also be
accessed by dialing 1-800-289-0508 Participant code: 1991632 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
(http://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)
Three Months Ended
March 31,
------------------------
2011 2010
----------- -----------
(unaudited)
Revenue:
Royalty revenues $ 716 $ 1,653
Grant revenue 232 761
License revenue - 11
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Total revenue 948 2,425
Operating expenses:
Research and development 3,738 1,670
General and administrative 793 935
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Total operating expenses 4,531 2,605
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Loss from operations (3,583) (180)
Other expense (929) (125)
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Net loss $ (4,512) $ (305)
Basic and diluted net loss per share $ (0.08) $ (0.01)
Weighted average shares used in computing
basic and diluted net loss per share 59,248 59,248
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
March 31, December 31,
2011 2010
----------- -----------
(unaudited) (Note A)
Assets
Cash and cash equivalents $ 800 $ 3,180
Receivables 2,155 1,225
Prepaid expenses and other current assets 220 294
----------- -----------
Total current assets 3,175 4,699
Furniture and equipment, net 43 53
----------- -----------
$ 3,218 $ 4,752
Liabilities and Stockholders' Equity
Current liabilities $ 8,714 $ 5,405
Long-term debt 4,930 5,400
Stockholders' deficit (10,426) (6,053)
----------- -----------
$ 3,218 $ 4,752
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.