Titan Pharmaceuticals Announces Third Quarter 2013 Financial
Results
Management Team to Host Conference Call November 15 at 1:00 p.m.
ET / 10:00 a.m. PT
SOUTH SAN FRANCISCO, CA--(Marketwired - Nov 14, 2013) - Titan
Pharmaceuticals, Inc. (OTCBB: TTNP) today reported financial
results for the third quarter ended September 30, 2013.
Net loss for the quarter ended September 30, 2013 was
approximately $1.1 million, or approximately $0.01 per share,
compared to a net loss of approximately $8.0 million, or
approximately $0.12 per share, for the comparable period in 2012.
License revenues of approximately $2.2 million for the three months
ended September 30, 2013 reflect the amortization of the upfront
license fee received from Braeburn in December 2012 for its license
agreement for the U.S. and Canadian rights to commercialize
Probuphine®, the company's investigational subdermal implant
designed to deliver continuous, blood levels of buprenorphine for
six months following a single treatment. Titan generated no grant
or royalty revenue during the three months ended September 30,
2013.
Total operating expenses for the third quarter ended September
30, 2013 were approximately $2.3 million, compared with
approximately $3.9 million for the comparable period in 2012, and
consisted largely of research and development (R&D) expenses of
approximately $1.7 million, compared to approximately $3.0 million
of R&D expenses for the comparable period in 2012. This
decrease in R&D costs was primarily associated with a decrease
in external R&D expenses related to the preparation and review
of the New Drug Application (NDA) for Probuphine by the U.S. Food
and Drug Administration (FDA). General and administrative (G&A)
expenses for the quarter were approximately $0.6 million, compared
to approximately $0.9 million for the comparable period in 2012.
The decrease in G&A expenses was primarily related to decreases
in non-cash stock compensation of approximately $0.2 million and
legal fees of approximately $0.1 million.
At September 30, 2013, Titan had approximately $9.0 million of
cash compared to approximately $18.1 million at December 31, 2012.
Titan believes that its working capital at September 30, 2013,
together with the $5.0 million in proceeds from the recently
announced sale of common stock to Braeburn, is sufficient to fund
its planned operations into January 2015.
Key recent updates include:
- On November 12, Titan announced a $5 million equity investment
by Braeburn Pharmaceuticals as well as adjusted terms to its
license agreement for the U.S. and Canadian commercialization
rights for Probuphine. Under the terms of the license agreement
amendment, there will be a reduction in the milestone payment upon
approval by the FDA of the Probuphine NDA from $45 million to $15
million, and an increase in the total amount of potential sales
milestones payments to Titan from $130 million to $165 million. The
sales threshold to achieve the highest royalty tier has been
lowered. Braeburn also agreed to assume responsibility for all
third-party expenses related to the Probuphine regulatory process.
The collaboration amendment also contains a provision entitling
Titan to receive a low single-digit royalty on sales by Braeburn of
other mid or long-term continuous delivery treatments for opioid
dependence, up to a maximum of $50 million. In addition, Titan has
the right to elect to participate in sales by Braeburn of other
products in the addiction market in exchange for a similar
reduction in Titan's royalties on Probuphine. The amendment will be
effective upon the closing of the sale of shares.
- In September, Titan announced that the FDA had granted its
request for a meeting to discuss Probuphine. The goal of this
meeting is to understand more fully the issues raised in the April
2013 Complete Response Letter (CRL) to the NDA for Probuphine for
the maintenance treatment of opioid dependence in adults, review
and discuss the available data from the Probuphine studies
conducted to date and gain further clarity regarding the regulatory
path forward for Probuphine. Comprehensive briefing materials
addressing the issues raised in the CRL have been submitted to the
FDA and the meeting is scheduled for November 19, 2013.
- In August, Titan announced the publication of data from
its positive confirmatory Phase 3 clinical trial of Probuphine
in the journal Addiction.
"As you know, the focus for the third quarter was on the
preparation of the briefing material for the upcoming FDA meeting
which was provided to the FDA in early October," said Sunil
Bhonsle, president of Titan Pharmaceuticals. "The goal of this FDA
meeting is to understand more fully the issues raised in the CRL,
review and discuss the information in the briefing book and gain
further clarity regarding the regulatory path forward. The
financial results for the quarter were as expected, and the
recently announced investment in Titan by Braeburn Pharmaceuticals
should help support our operations into the beginning of 2015."
"The board is pleased with the progress made by Titan and
Braeburn in preparation for the upcoming meeting with the FDA,"
said Marc Rubin, M.D., executive chairman of Titan Pharmaceuticals.
"Given the generally uncertain nature of the regulatory process
with respect to timing and outcome, the board felt it was prudent
to raise additional capital, and is very pleased with the at market
transaction without warrants concluded with Braeburn this week.
Braeburn's investment in Titan strengthens our partnership and
brings the companies in alignment to continue advancing the
Probuphine program toward our ultimate goal -- to make Probuphine
available to those clinicians, patients and families that need
it."
About Opioid Dependence According to recent estimates, there are
2.2 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 $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 in 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
confirmatory study of 287 patients (published in the journal
Addiction).
Conference Call Titan management will host a live conference
call at 1 p.m. ET / 10 a.m. PT on Friday, November 15, 2013 to
provide the Company's financial results as of September 30, 2013.
Participating on the call will be Mr. Bhonsle, Dr. Rubin, Brian
Crowley, vice president of finance and Katherine Glassman-Beebe,
Ph.D. executive vice president and chief development officer.
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 888-504-7963,
participant code: 9627990 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 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 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.
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TITAN PHARMACEUTICALS, INC. |
|
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
INCOME (LOSS) |
|
(in thousands, except per share amount) |
|
(unaudited) |
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2013 |
|
|
2012 |
|
|
2013 |
|
|
2012 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License revenue |
|
$ |
2,198 |
|
|
$ |
- |
|
|
$ |
8,146 |
|
|
$ |
- |
|
|
Royalty revenue |
|
|
- |
|
|
|
1,228 |
|
|
|
1,424 |
|
|
|
3,816 |
|
|
Grant revenue |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
42 |
|
|
|
Total revenue |
|
|
2,198 |
|
|
|
1,228 |
|
|
|
9,570 |
|
|
|
3,858 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expense: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
1,679 |
|
|
|
2,995 |
|
|
|
7,380 |
|
|
|
8,037 |
|
|
General and administrative |
|
|
647 |
|
|
|
890 |
|
|
|
2,439 |
|
|
|
3,750 |
|
|
|
Total operating expense |
|
|
2,326 |
|
|
|
3,885 |
|
|
|
9,819 |
|
|
|
11,787 |
|
Loss from operations |
|
|
(128 |
) |
|
|
(2,657 |
) |
|
|
(249 |
) |
|
|
(7,929 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
(1,017 |
) |
|
|
(5,356 |
) |
|
|
10,169 |
|
|
|
(6,972 |
) |
Net income (loss) and comprehensive income (loss) |
|
$ |
(1,145 |
) |
|
$ |
(8,013 |
) |
|
$ |
9,920 |
|
|
$ |
(14,901 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss) per share |
|
$ |
(0.01 |
) |
|
$ |
(0.12 |
) |
|
$ |
0.12 |
|
|
$ |
(0.23 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income (loss) per share |
|
$ |
- |
|
|
$ |
(0.07 |
) |
|
$ |
0.11 |
|
|
$ |
(0.19 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used in computing basic net
income (loss) per share |
|
|
82,544 |
|
|
|
66,839 |
|
|
|
81,125 |
|
|
|
63,748 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares used in computing diluted net
income (loss) per share |
|
|
82,544 |
|
|
|
66,839 |
|
|
|
81,832 |
|
|
|
70,189 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
CONDENSED BALANCE SHEETS |
|
(in thousands) |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
2013 |
|
2012 |
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Cash |
|
$ |
8,998 |
|
$ |
18,102 |
|
|
Receivables |
|
|
4,590 |
|
|
4,646 |
|
|
Prepaid expenses and other current assets |
|
|
262 |
|
|
687 |
|
|
|
Total current assets |
|
|
13,850 |
|
|
23,435 |
|
|
Furniture and equipment, net |
|
|
1,670 |
|
|
1,392 |
|
|
|
$ |
15,520 |
|
$ |
24,827 |
|
Liabilities and Stockholders' Equity (Deficit) |
|
|
|
|
|
|
|
|
Current liabilities |
|
$ |
12,250 |
|
$ |
21,393 |
|
|
Warrant liabilities |
|
|
2,248 |
|
|
8,240 |
|
|
Royalty liability |
|
|
- |
|
|
8,962 |
|
|
Long-term debt |
|
|
- |
|
|
9,360 |
|
|
Stockholders' equity (deficit) |
|
|
1,022 |
|
|
(23,128 |
) |
|
|
$ |
15,520 |
|
$ |
24,827 |
|
|
|
|
|
|
|
|
|
|
|
|
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CONTACT: Titan Pharmaceuticals, Inc. Sunil Bhonsle 650-244-4990
President Pure Communications Susan Heins 864-286-9597
sjheins@purecommunicationsinc.com
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