POINT RICHMOND, Calif.,
Nov. 12, 2012 /PRNewswire/ --
Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT), a specialty
pharmaceutical company focused on the development and
commercialization of proprietary products that address important
therapeutic needs in the field of neuroscience, today announced
financial results for the three and nine months ended September 30, 2012.
Intermezzo® (zolpidem tartrate) sublingual tablet
C-IV is the first FDA approved Transcept product and is
being marketed in the United
States by Purdue Pharmaceutical Products L.P. (Purdue) under the terms of a collaboration
agreement between Transcept and Purdue.
Transcept reported cash, cash equivalents and marketable
securities of $98.7 million at
September 30, 2012, which included
the receipt of a $10.0 million
milestone payment from Purdue.
"As the Intermezzo launch advances, Purdue continues to refine their understanding of
the insomnia landscape and reshape the substantial Intermezzo
promotional effort now underway," stated Glenn A. Oclassen, President and Chief Executive
Officer of Transcept. "It is clear that further effort is needed to
educate physicians and patients about middle of the night
awakenings as an important manifestation of insomnia. We are
working closely with Purdue to address
this need and to support the future success of Intermezzo."
Three months ended September 30,
2012 financial results
Transcept recorded
$10.4 million in revenue for the
quarter ended September 30, 2012
compared to $0.6 million for the
quarter ended September 30, 2011.
Revenue during the quarter ended September
30, 2012 included a $10.0
million milestone payment from Purdue for the listing of a Transcept method of use
patent in the FDA's Orange Book, $0.2
million of royalties based on Purdue net sales of Intermezzo to wholesalers, and
$0.2 million from Purdue for a non-refundable option to negotiate for
the commercialization of Intermezzo in Mexico and Canada. Revenue for the same period in 2011
consisted of $0.6 million of license
fees for recognition of a portion of the $25.0 million up-front license fee received from
Purdue in connection with the
collaboration agreement for commercialization of Intermezzo in
the United States. All revenue
from this up-front license fee was recognized by year-end 2011.
Research and development expense for the quarter ended
September 30, 2012 was $3.1 million, compared to $2.7 million for the same period in 2011.
Research and development expense in both periods was primarily
attributable to expense associated with our Phase 2 study for the
TO-2061 development program. Research and development expense for
the quarter ended September 30, 2011
included $0.5 million of severance
and benefit continuation expense related to the reduction in force
announced in July 2011. Research and
development expense included non-cash stock compensation expense of
$0.2 million for each of the quarters
ended September 30, 2012 and
2011.
General and administrative expense for the quarter ended
September 30, 2012 was $2.5 million, compared to $2.9 million for the same period in 2011. The
decrease in general and administrative expense was primarily
attributable to $0.5 million of
severance and benefit continuation expense recorded in the quarter
ended September 30, 2011 related to
the reduction in force announced in July
2011. General and administrative expense included non-cash
stock compensation expense of $0.5
million for each of the quarters ended September 30, 2012 and 2011.
Net income for the quarter ended September 30, 2012 was $4.9 million, or $0.26 per share (basic) and $0.25 per share (diluted), compared to a net loss
of $5.0 million, or $0.37 per share (basic and diluted), for the same
period in 2011. This increase in net income was primarily
attributable to the $10.0 million
method of use patent milestone payment related to the Purdue collaboration agreement. The weighted
average shares used to calculate basic and diluted net income per
share were 18,567,833 and 19,231,656, respectively, for the quarter
ended September 30, 2012. The
weighted average shares used to calculate basic and diluted net
loss per share for the quarter ended September 30, 2011 were 13,521,965. At
September 30, 2012, there were
18,578,159 common shares outstanding and 3,313,751 common shares
underlying outstanding options and warrants.
Nine months ended September 30,
2012 financial results
Transcept recorded
$10.9 million in revenue for the nine
month period ended September 30, 2012
compared to $6.9 million for the nine
month period ended September 30,
2011. Revenue during the nine month period ended
September 30, 2012 included a
$10.0 million milestone payment from
Purdue for the listing of a Transcept
method of use patent in the FDA's Orange Book, $0.7 million of royalties based on Purdue net sales of Intermezzo to wholesalers, and
$0.2 million from Purdue for a non-refundable option to negotiate for
the commercialization of Intermezzo in Mexico and Canada. Revenue for the same period in 2011
consisted of $6.9 million of license
fees for recognition of a portion of the $25.0 million up-front license fee received from
Purdue in connection with the
collaboration agreement for commercialization of Intermezzo in
the United States. All revenue
from this up-front license fee was recognized by year-end 2011.
Research and development expense for the nine months ended
September 30, 2012 was $8.3 million, compared to $7.9 million for the same period in 2011.
Research and development expense in both periods was primarily
attributable to expense associated with our Phase 2 study for the
TO-2061 development program. Research and development expense for
the nine months ended September 30,
2011 included severance and benefit continuation expense of
$0.5 million related to our
July 2011 reduction-in-force.
Research and development expense included non-cash stock
compensation expense of $0.7 million
for the nine months ended September 30,
2012 and $0.5 million for the
nine months ended September 30,
2011.
General and administrative expense for the each of the nine
months ended September 30, 2012 and
2011 was $8.0 million. General and
administrative expense during the nine months ended September 30, 2011 included $0.5 million severance and benefit continuation
expense related to our July 2011
reduction-in-force as well as non-cash stock compensation expense
of $0.2 million for stock option
modifications to two members of our Board of Directors. General and
administrative expense during the nine months ended September 30, 2012 included increased expense for
external professional fees, including third-party consulting, and
market research. General and administrative expense included
non-cash stock compensation expense of $1.5
million and $1.6 million for
the nine months ended September 30,
2012 and 2011, respectively.
Net loss for the nine months ended September 30, 2012 was $5.5 million, or $0.33 per share (basic and diluted), compared to
a net loss of $9.2 million, or
$0.68 per share (basic and diluted),
for the nine months ended September 30,
2011. The decrease in net loss was primarily attributable to
the $10.0 million method of use
patent milestone payment related to the Purdue collaboration agreement. The weighted
average shares used to calculate basic and diluted net loss per
share were 16,523,037 and 13,490,588 for the nine months ended
September 30, 2012 and September 30, 2011, respectively.
FINANCIAL TABLES FOLLOW
Conference call and webcast information
Transcept will
host a conference call and webcast on Monday, November 12, 2012, at 4:30 p.m. ET to discuss third quarter 2012
financial results. Telephone numbers for the live conference call
are 877-638-4558 (U.S.) or 914-495-8537 (International). The
webcast can be accessed on the Investors page of the Transcept
website at www.transcept.com and will be available for replay until
close of business on January 30,
2013.
About Transcept
Transcept Pharmaceuticals,
Inc. is a specialty pharmaceutical company focused on the
development and commercialization of proprietary products that
address important therapeutic needs in the field of neuroscience.
Intermezzo® (zolpidem tartrate) sublingual tablet C-IV
is the first FDA approved Transcept product. Purdue
holds commercialization and development rights for Intermezzo in
the United States. Transcept is
currently conducting a Phase 2 study of an investigational product,
TO-2061, in patients with obsessive-compulsive disorder. For
further information about Transcept, please visit
www.transcept.com. For information about Intermezzo, please visit
www.IntermezzoRx.com.
Forward looking statements
This press release
contains forward-looking statements that involve substantial risks
and uncertainties. All statements, other than statements of
historical facts, included in this press release regarding our
strategy, future operations, future financial position, future
revenues, projected expenses, prospects, plans and objectives of
management are forward-looking statements. Examples of such
statements include, but are not limited to, statements relating to
the following: Purdue refining their
understanding of the insomnia landscape; Purdue reshaping the current Intermezzo promotional
effort; the need to educate the medical community about
middle-of-the-night sleep problems, and our collaboration with
Purdue to educate physicians and payers
accordingly; and the progression of the commercialization of
Intermezzo, including our collaboration with Purdue to support any future success of Intermezzo.
Transcept may not actually achieve the plans, carry out the
intentions or meet the expectations or projections disclosed in our
forward-looking statements and you should not place undue reliance
on these forward-looking statements. Actual results or events could
differ materially from the plans, intentions, expectations and
projections disclosed in the forward-looking statements. Various
important factors could cause actual results or events to differ
materially from the forward-looking statements that Transcept
makes, including the following: achieving acceptance of Intermezzo
by physicians, patients and third party payers; supplying
sufficient quantities of Intermezzo from third party manufacturers
and suppliers to meet anticipated market demand; the impact of
competitive products and the market for Intermezzo generally; our
dependence on our collaboration with Purdue; and obtaining, maintaining and protecting
regulatory exclusivity and intellectual property protection for
Intermezzo; and the ability of Transcept to obtain additional
funding, if needed, to support its business activities. These and
other risks are described in greater detail in the "Risk Factors"
section of Transcept periodic reports filed with the SEC.
Forward-looking statements do not reflect the potential impact of
any future in-licensing, collaborations, acquisitions, mergers,
dispositions, joint ventures, or investments Transcept may enter
into or make. Transcept does not assume any obligation to update
any forward-looking statements, except as required by law.
Contact:
Transcept Pharmaceuticals, Inc.
Greg Mann
Senior Director, Corporate Communications
(510) 215-3567
gmann@transcept.com
Transcept
Pharmaceuticals, Inc.
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
(in
thousands, except per share data)
(Unaudited)
|
|
|
Three
Months Ended September 30,
|
|
Nine
Months Ended September 30,
|
|
2012
|
|
2011
|
|
2012
|
|
2011
|
Revenue:
|
|
|
|
|
|
|
|
|
Royalty
revenue
|
$
190
|
|
$
-
|
|
$
683
|
|
$
-
|
|
License
fee revenue
|
-
|
|
625
|
|
-
|
|
6,875
|
|
Milestone
revenue
|
10,000
|
|
-
|
|
10,000
|
|
-
|
|
Other
revenue
|
250
|
|
-
|
|
250
|
|
-
|
Total
revenue
|
10,440
|
|
625
|
|
10,933
|
|
6,875
|
|
|
|
|
|
|
|
|
Operating
expense:
|
|
|
|
|
|
|
|
|
Research
and development
|
3,057
|
|
2,668
|
|
8,273
|
|
7,922
|
|
General
and administrative
|
2,483
|
|
2,919
|
|
7,998
|
|
8,045
|
Total
operating expense
|
5,540
|
|
5,587
|
|
16,271
|
|
15,967
|
Income
(loss) from operations
|
4,900
|
|
(4,962)
|
|
(5,338)
|
|
(9,092)
|
Interest
and other income (expense), net
|
(45)
|
|
(29)
|
|
(124)
|
|
(84)
|
Net income
(loss)
|
$
4,855
|
|
$
(4,991)
|
|
$
(5,462)
|
|
$
(9,176)
|
|
|
|
|
|
|
|
|
Net income
(loss) per share:
|
|
|
|
|
|
|
|
Basic
|
$
0.26
|
|
$
(0.37)
|
|
$
(0.33)
|
|
$
(0.68)
|
Diluted
|
$
0.25
|
|
$
(0.37)
|
|
$
(0.33)
|
|
$
(0.68)
|
|
|
|
|
|
|
|
|
Weighted
average shares outstanding
|
|
|
|
|
|
|
|
Basic
|
18,568
|
|
13,522
|
|
16,523
|
|
13,491
|
Diluted
|
19,232
|
|
13,522
|
|
16,523
|
|
13,491
|
|
|
|
|
|
|
|
|
Comprehensive income (loss)
|
$
4,862
|
|
$
(4,996)
|
|
$
(5,485)
|
|
$
(9,142)
|
Transcept
Pharmaceuticals, Inc.
Condensed
Consolidated Balance Sheets
(unaudited, in thousands)
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
|
|
2012
|
|
2011
|
Assets
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and
cash equivalents
|
$
70,037
|
|
$
10,659
|
|
Marketable
securities
|
28,634
|
|
51,703
|
|
Other
current assets
|
2,548
|
|
3,475
|
Total
current assets
|
101,219
|
|
65,837
|
Property
and equipment, net
|
166
|
|
314
|
Goodwill
|
2,962
|
|
2,962
|
Other
assets
|
-
|
|
38
|
Total
assets
|
$
104,347
|
|
$
69,151
|
|
|
|
|
|
Liabilities and stockholders'
equity
|
|
|
|
Total
current liabilities
|
$
3,369
|
|
$
3,339
|
Total
non-current liabilities
|
-
|
|
60
|
Total
liabilities
|
3,369
|
|
3,399
|
Stockholders' equity:
|
|
|
|
|
Common
stock and additional paid-in capital
|
206,528
|
|
165,817
|
|
Accumulated deficit
|
(105,556)
|
|
(100,094)
|
|
Accumulated other comprehensive
income
|
6
|
|
29
|
|
Total
stockholders' equity
|
100,978
|
|
65,752
|
Total
liabilities and stockholders' equity
|
$
104,347
|
|
$
69,151
|
SOURCE Transcept Pharmaceuticals, Inc.