SOUTH SAN FRANCISCO, Calif.,
Aug. 14, 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
second quarter ended June 30, 2018,
and provided an update on its business.
Second Quarter 2018 Business Highlights
- In May 2018, Titan announced the
appointment of accomplished global pharmaceuticals executive,
Federico Seghi Recli, to its Board of Directors.
- In May 2018, Titan and Braeburn
Pharmaceuticals, Inc. reached an agreement pursuant to which Titan
regained all rights to the commercialization and clinical
development of Probuphine® (buprenorphine) implant in
the United States and Canada.
"We are making good progress in transitioning to a commercial
company," said Titan's President and CEO, Sunil Bhonsle. "Moving forward, we will be
focusing on four key market segments: high Probuphine-prescribing
physicians with long-term recovery oriented treatment programs;
residential facilities that utilize medication-assisted treatment;
academic institutions with addiction residency and fellowships
programs; and the criminal justice system."
Titan's Executive Chairman, Dr. Marc
Rubin, commented, "We are encouraged by the early progress
we have made in the relaunch of Probuphine in the U.S., and
continue to work closely with Molteni and the team of addiction
medicine experts that we have assembled to help position Probuphine
for global success."
Second Quarter 2018 Financial Results
For the three months ended June 30,
2018, Titan reported approximately $2.7 million in revenue, compared with
approximately $77,000 in the same
period in 2017. Revenues for the second quarter of 2018
reflect approximately $0.5 million
related to the amortization of deferred revenue related to the sale
to L. Molteni & C. Dei Frattelli Alitti Società Di Esercizio
S.P.A. ("Molteni") of the European intellectual property rights to
Probuphine in March 2018,
$7,000 related to the recognition of
royalties earned on net sales of Probuphine by Braeburn prior to
the termination of the Braeburn license, approximately $2.1 million related to terms of the license
termination agreement, and $75,000
generated from Titan's own sales of Probuphine after the return of
the Braeburn license. Revenue for the 2017 period reflects
the recognition of royalties earned on net sales of Probuphine by
Braeburn.
Total operating expenses for the second quarter of 2018 were
approximately $3.3 million, compared
with approximately $3.7 million 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 June 30, 2018 were approximately $1.9 million, compared with approximately
$2.5 million for the same quarter in
2017. G&A expenses for the 2018 second quarter were
approximately $1.4 million, compared
with approximately $1.2 million in
the same quarter a year ago.
Net other expense, consisting primarily of interest expense, was
approximately $0.2 million in the
second quarter of 2018, compared with net other income of
approximately $0.2 million,
consisting primarily of non-cash gains on changes in the fair value
of warrants, in the same quarter in 2017.
Net loss applicable to common shareholders in the second quarter
of 2018 was approximately $0.9
million, or approximately $0.04 per share, compared with a net loss
applicable to common shareholders of approximately $3.5 million, or approximately $0.16 per share, in the same quarter in 2017.
As at June 30, 2018, Titan had
cash of approximately $1.6
million. Subsequent to the end of the second quarter,
Titan entered into an amendment to its purchase agreement with
Molteni, pursuant to which Molteni paid €950,000 (approximately
$1.1 million) to Titan, and has
committed to make a convertible loan to Titan of €550,000
(approximately $0.6 million) in
mid-September 2018, subject to
Titan's submission of a response to questions posed by the European
Medicines Agency (EMA), in exchange for the elimination of an
aggregate of €2.0 million (approximately $2.3 million) of regulatory milestones provided
for in the purchase agreement. Assuming the convertible loan
is made to Titan, the Company believes it will have sufficient cash
to fund its operating activities through the end of the third
quarter of 2018, beyond which it will require additional funds to
finance its operations, including the commercialization of
Probuphine in the U.S., completion of the Probuphine Phase IV
clinical trials mandated by the FDA and advancement of our current
ProNeura development programs to later stage clinical studies.
No Conference Call Scheduled
Due to a scheduling conflict, Titan has elected not to host a
conference call to discuss its second quarter 2018 financial
results.
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
June 30,
|
|
Six Months
Ended
June 30,
|
|
|
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Revenue:
|
|
|
|
|
|
|
|
|
|
License
revenue
|
|
$ 2,593
|
|
$
77
|
|
$
3,657
|
|
$
117
|
|
Product
revenue
|
|
75
|
|
-
|
|
75
|
|
-
|
|
|
Total
revenue
|
|
2,668
|
|
77
|
|
3,732
|
|
117
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expense:
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
70
|
|
-
|
|
70
|
|
-
|
|
Research and
development
|
|
1,857
|
|
2,501
|
|
3,713
|
|
4,627
|
|
General and
administrative
|
|
1,380
|
|
1,197
|
|
2,995
|
|
2,548
|
|
|
Total operating
expense
|
|
3,307
|
|
3,698
|
|
6,778
|
|
7,175
|
Loss from
operations
|
|
(639)
|
|
(3,621)
|
|
(3,046)
|
|
(7,058)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expense), net
|
|
(230)
|
|
170
|
|
(428)
|
|
602
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss and
comprehensive loss
|
|
$
(869)
|
|
$ (3,451)
|
|
$
(3,474)
|
|
$ (6,456)
|
|
|
|
|
|
|
|
|
|
|
|
Basic net loss per
share
|
|
$ (0.04)
|
|
$
(0.16)
|
|
$
(0.16)
|
|
$
(0.30)
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net loss per
share
|
|
$ (0.04)
|
|
$
(0.17)
|
|
$
(0.16)
|
|
$
(0.33)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares used in computing basic net loss per share
|
|
21,204
|
|
21,204
|
|
21,204
|
|
21,199
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
shares used in computing diluted net loss per share
|
|
21,204
|
|
21,204
|
|
21,204
|
|
21,201
|
CONDENSED BALANCE
SHEETS
|
(in
thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
|
|
2018
|
|
2017
|
|
|
|
|
|
|
Assets
|
|
|
|
|
Cash and cash
equivalents
|
$
1,614
|
|
$
7,522
|
|
Restricted
cash
|
361
|
|
361
|
|
Receivables
|
189
|
|
65
|
|
Inventory
|
1,317
|
|
-
|
|
Contract
assets
|
291
|
|
-
|
|
Prepaid expenses and
other current assets
|
421
|
|
362
|
|
|
Total current
assets
|
4,193
|
|
8,310
|
|
Furniture and
equipment, net
|
424
|
|
595
|
|
|
Total
assets
|
$
4,617
|
|
$
8,905
|
Liabilities and
Stockholders' Equity (Deficit)
|
|
|
|
|
Current
liabilities
|
$
2,389
|
|
$
4,464
|
|
Long-term
debt
|
3,541
|
|
3,584
|
|
Stockholders' equity
(deficit)
|
(1,313)
|
|
857
|
|
|
Total liabilities and
stockholders' equity (deficit)
|
$
4,617
|
|
$
8,905
|
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SOURCE Titan Pharmaceuticals, Inc.