SOUTH SAN FRANCISCO, Calif.,
May 15, 2018 /PRNewswire/ -- Titan
Pharmaceuticals, Inc. (NASDAQ: TTNP), a company developing
proprietary therapeutics for the treatment of select chronic
diseases utilizing its ProNeura™ long-term, continuous drug
delivery technology, today reported financial results for the first
quarter ended March 31, 2018, and
provided an update on its business.
First Quarter 2018 Business Highlights
- In January 2018, Titan confirmed
that it was in preliminary discussions with Braeburn for the return
of U.S. commercialization rights to Probuphine. This followed a
substantial sales and marketing staff reduction at Braeburn, and
consistently lower than expected sales of Probuphine during 2017.
The Company has been reviewing pertinent documents and contracts as
part of the due diligence process, and, in preparation for
potential participation in commercial activities, has also been
conducting preliminary research in select market segments where
Probuphine® may be used for the treatment of opioid use
disorder.
- In February 2018, Titan entered
into an amendment to its July 2017
loan agreement with Horizon Technology Finance Corporation,
pursuant to which it prepaid $3.0
million of the outstanding $7.0
million loan balance.
- In March 2018, Titan entered into
a definitive asset purchase, supply and support agreement with
Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A.
through which Molteni acquired the European intellectual property
related to Probuphine, including the Marketing Authorization
Application under review by the European Medicines Agency, and
gained the exclusive right to commercialize the Titan supplied
Probuphine product in Europe, as
well as certain countries of the Commonwealth of Independent
States, the Middle East and
North Africa ('the "Molteni
Territory"). Titan received an initial payment of approx.
$2.4 million for the purchased assets
and will receive potential additional payments totaling up to
approx. $5.5 million upon the
achievement of certain regulatory and product label milestones.
Additionally, Titan is entitled to receive earn-out payments for up
to 15 years on net sales of Probuphine in the Molteni Territory
ranging in percentage from the low-teens to the mid-twenties.
- In March 2018, Molteni also made
an indirect strategic investment in Titan by purchasing
$2.4 million of the outstanding
$4.0 million principal balance owed
under the July 2017 loan agreement
with Horizon, and assumed majority and administrative control of
the debt. Molteni has the right and, under certain circumstances,
the obligation to convert its portion of the debt into shares of
Titan's common stock at a conversion price of $1.20 per share.
- Over the past several months, Titan has been working closely
with Molteni to address all questions pertaining to the Marketing
Authorization Application for Probuphine under review by the
European Medicines Agency, and will continue to fully support
Molteni in the product review and approval process through to its
completion.
"We believe that entering into our strategic partnership with
Molteni marked a potential important inflection point for both
Probuphine and Titan," said Titan's President and CEO, Sunil Bhonsle. "There is a significant and
growing potential U.S. market for Probuphine that, at this stage,
remains largely untapped. There is also an attractive
international commercial opportunity for the product. We hope
to make significant strides in driving Probuphine's commercial
success in both the United States
and internationally this year, and look forward to updating our
stakeholders as we progress."
Titan's Executive Chairman, Dr. Marc
Rubin, commented, "We remain confident that Probuphine can
play a prominent role in combatting what has become a truly global
opioid addiction epidemic. Accordingly, while continuing the
process to regain control of Probuphine in the U.S., we are working
with our partner Molteni to position the product for commercial
success both here in the United
States and in select international markets."
First Quarter 2018 Financial Results
For the three months ended March 31,
2018, Titan reported approximately $1.1 million in revenue, compared with
approximately $40,000 in the same
period in 2017. Revenues for the 2018 period reflect
approximately $1.0 million related to
the sale to Molteni of the European intellectual property rights to
Probuphine and $25,000 related to the
recognition of royalties earned on net sales of Probuphine by
Braeburn. Revenue for the 2017 period reflects the
recognition of royalties earned on net sales of our Probuphine
product by Braeburn.
Total operating expenses for the first quarter of 2018 were
approximately $3.5 million, unchanged
from the same quarter in 2017, and consisted primarily of research
and development (R&D) and general and administrative (G&A)
expenses. R&D expenses for the quarter ended March 31, 2018 were approximately $1.9 million, compared with approximately
$2.1 million for the same quarter in
2017. G&A expenses for the 2018 first quarter were
approximately $1.6 million, compared
with approximately $1.4 million in
the same quarter a year ago.
Net other expense, consisting primarily of interest expenses
related to outstanding debt, was approximately $0.2 million in the first quarter of 2018,
compared with net other income of approximately $0.4 million, consisting primarily of non-cash
gains on changes in the fair value of warrant liabilities and
interest income, in the same quarter in 2017.
Net loss applicable to common shareholders in the first quarter
of 2018 was approximately $2.6
million, or approximately $0.12 per share, compared with a net loss
applicable to common shareholders of approximately $3.0 million, or approximately $0.14 per share, in the same quarter in 2017.
At March 31, 2018, Titan had cash
of approximately $3.5 million, which
the company believes is sufficient to fund its planned operations
into the third quarter of 2018. While Titan is exploring
several financing alternatives to fund its operations beyond that
period, there can be no assurance that those efforts will be
successful.
Conference Call Scheduled for Tomorrow, May 16, 2018
Titan is pleased to invite all interested parties to participate
in a conference call on May 16, 2018
at 4:15 p.m. EST / 1:15 p.m. PST, during which management will
discuss the financial results and provide an update on Titan's
corporate developments. The call will be hosted by Sunil Bhonsle, President and CEO; Katherine Beebe, Ph.D., Executive Vice President
and Chief Scientific Officer; Brian
Crowley, Vice President of Finance; and Marc Rubin, M.D., Executive Chairman. To
participate in this conference call, please dial 1-855-940-9476
(U.S.) or 1-412-317-5223 (international) approximately 10 minutes
prior to the start time. Alternatively, a live webcast and
replay of the call may accessed by visiting
http://www.titanpharm.com/news/events.
About Titan Pharmaceuticals
Titan Pharmaceuticals, Inc. (NASDAQ:TTNP), based in South San Francisco, CA, is developing
proprietary therapeutics primarily for the treatment of select
chronic diseases. The company's lead product 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 three months or longer. Approved by the U.S. Food and Drug
Administration in May 2016,
Probuphine is 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 and hypothyroidism, where maintaining consistent,
around-the-clock blood levels of medication may benefit the patient
and improve medical outcomes. For more information about Titan,
please visit www.titanpharm.com.
Forward-Looking Statements
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
commercialization of Probuphine, 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.
CONTACTS:
Sunil Bhonsle,
President & CEO
(650) 244-4990
Stephen Kilmer
Investor Relations
(650) 989-2215
skilmer@titanpharm.com
TITAN
PHARMACEUTICALS, INC.
|
CONDENSED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
(in thousands,
except per share amount)
|
(unaudited)
|
|
|
|
|
Three Months
Ended
March 31,
|
|
|
|
|
2018
|
|
2017
|
Revenue:
|
|
|
|
|
|
License
revenue
|
|
$
1,064
|
|
$
40
|
|
|
Total
revenue
|
|
1,064
|
|
40
|
|
|
|
|
|
|
|
Operating
expense:
|
|
|
|
|
|
Research and
development
|
|
1,856
|
|
2,126
|
|
General and
administrative
|
|
1,615
|
|
1,351
|
|
|
Total operating
expense
|
|
3,471
|
|
3,477
|
Loss from
operations
|
|
(2,407)
|
|
(3,437)
|
|
|
|
|
|
|
|
|
|
Other income
(expense), net
|
|
(198)
|
|
432
|
|
|
|
|
|
|
|
Net loss and
comprehensive loss
|
|
$
(2,605)
|
|
$
(3,005)
|
|
|
|
|
|
|
|
Basic net loss per
share
|
|
$
(0.12)
|
|
$
(0.14)
|
|
|
|
|
|
|
|
Diluted net loss per
share
|
|
$
(0.12)
|
|
$
(0.16)
|
|
|
|
|
|
|
|
Weighted average
shares used in computing
|
|
|
|
|
|
basic net loss per
share
|
|
21,204
|
|
21,199
|
|
|
|
|
|
|
|
Weighted average
shares used in computing
|
|
|
|
|
|
diluted net loss per
share
|
|
21,204
|
|
21,376
|
|
|
|
|
|
|
|
|
|
CONDENSED BALANCE
SHEETS
|
(in
thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
March
31,
|
|
December
31,
|
|
|
|
|
2018
|
|
2017
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
3,465
|
|
$
7,522
|
|
Restricted
cash
|
|
361
|
|
361
|
|
Receivables
|
|
27
|
|
65
|
|
Contract
assets
|
|
291
|
|
-
|
|
Prepaid expenses and
other current assets
|
|
605
|
|
362
|
|
|
Total current
assets
|
|
4,749
|
|
8,310
|
|
Furniture and
equipment, net
|
|
541
|
|
595
|
|
|
Total
assets
|
|
$
5,290
|
|
$
8,905
|
Liabilities and
Stockholders' Equity (Deficit)
|
|
|
|
|
|
Current
liabilities
|
|
$
2,718
|
|
$
4,464
|
|
Long-term
debt
|
|
3,418
|
|
3,584
|
|
Stockholders' equity
(deficit)
|
|
(846)
|
|
857
|
|
|
Total liabilities and
stockholders' equity (deficit)
|
$
5,290
|
|
$
8,905
|
|
|
|
|
|
|
|
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SOURCE Titan Pharmaceuticals, Inc.