Praecis (NASDAQ:PRCS)
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PRAECIS PHARMACEUTICALS INCORPORATED (NASDAQ: PRCS) today announced
consolidated financial results for the three and nine months ended
September 30, 2006.
Third Quarter 2006 Results
The Company’s net loss for the three months
ended September 30, 2006 was approximately $6,753,000, or $0.63 per
diluted share, compared to a net loss of approximately $5,168,000, or
$0.49 per diluted share, for the three months ended September 30, 2005.
The increased net loss for the third quarter of 2006 was due primarily
to a decrease in product sales and licensing revenues related to Plenaxis®.
Also contributing to the increased net loss for the third quarter was
incremental non-cash compensation expense associated with the Company’s
adoption commencing in 2006 of Financial Accounting Standards Board
Statement No. 123R, Share-Based Payment (SFAS No. 123R). For the
three months ended September 30, 2006, approximately $785,000 of expense
associated with equity-based compensation plans was included in the
Company’s financial results under SFAS No.
123R, of which approximately $591,000 was allocated to research and
development expense, and approximately $194,000 was allocated to general
and administrative expense. There was also a reduction in sales and
marketing expenses from the prior year quarter due to the voluntary
discontinuation of promotional activities for Plenaxis®
in the United States. Expenses incurred during the third quarter
of 2006 related primarily to the Company’s
preclinical and clinical development efforts, advancement of existing
drug discovery programs to support the Company’s
pilot agreements and ongoing partnering efforts, continued technology
enhancement, and general and administrative expenses.
For the nine months ended September 30, 2006, the net loss was
approximately $28,878,000, or $2.73 per diluted share, compared to a net
loss of approximately $59,883,000, or $5.71 per diluted share, for the
nine months ended September 30, 2005. The reduced net loss for the nine
months ended September 30, 2006 was principally the result of the
$32,173,000 of restructuring and asset impairment expenses recorded
during the second quarter of 2005. At September 30, 2006, the Company
had cash and cash equivalents of $40,370,000, compared to cash, cash
equivalents and marketable securities of approximately $62,580,000 at
December 31, 2005.
Commenting on the activities for the quarter, Kevin F. McLaughlin,
President and Chief Executive Officer stated, “During
the third quarter, we continued to make significant progress in our
PPI-2458 clinical development program, our DirectSelect™
pilot drug discovery programs and our S1P-1 research and development
program. Yesterday we presented interim data from our Phase 1 clinical
trial of PPI-2458 in non-Hodgkin’s lymphoma
and solid tumors at the 18th EORTC-NCI-AACR
Symposium held in Prague. We are very encouraged by the preliminary
information from this clinical trial and are utilizing the growing
clinical and preclinical data on this compound to establish a focused
Phase 2 clinical development plan in oncology. In addition, we are
further evaluating the potential initiation of clinical studies of
PPI-2458 in rheumatoid arthritis. We recently presented the scientific
rationale for studying PPI-2458 as a targeted molecular therapy for this
disease at the 14th International Inflammation
Research Association Conference, where we received the Cerep Award for
Research with the greatest therapeutic potential. As previously
disclosed, our goal is to partner this program in one or more
indications as clinical development advances. With respect to
DirectSelect™, the
majority of our recent efforts in this area have been devoted to
advancing our partnered pilot programs and seeking to enter into broader
pharmaceutical partnerships for drug discovery and development
utilizing, or possibly other transactions with respect to, this
technology that will provide cash and/or cost reduction benefits to us.
We are pleased with our progress to date under our existing pilot study
agreements and we continue to initiate and advance discussions with
other potential partners.
“In parallel with the development of our
DirectSelect™ technology, we have also been
conducting a highly focused discovery research effort to identify small
molecules that interact with sphingosine-1-phosphate receptor-1 (S1P-1).
S1P-1 is a G-protein coupled receptor that is implicated in
immunomodulation, making it an attractive therapeutic target for
treating autoimmune disorders such as multiple sclerosis and for
preventing rejection in solid organ transplants. Utilizing conventional
medicinal chemistry lead optimization techniques, we have identified a
number of selective S1P-1 agonist compounds. We are currently evaluating
several preclinical candidates with a goal of identifying one or more
lead compounds to advance into clinical testing. It is our goal to enter
into a collaborative arrangement for the development and
commercialization of such lead compound(s).”
Concluding his comments, Mr. McLaughlin stated, “As
previously announced, we are actively exploring strategic options which
may be available to the Company. No decision has been made as to whether
we will engage in a strategic transaction, and there can be no assurance
as to whether or when this process will result in a successful
transaction. We do not currently intend to disclose developments or
anticipated timing regarding the status or outcome of this process
unless and until our board of directors has approved a specific
transaction.”
There will be a conference call to discuss this press release today
beginning at 9:00 a.m. (EST). This call will be broadcast live over the
Internet at www.praecis.com under “Investor
Relations.” A telephonic replay of this call
will be available beginning at 12:00 Noon (EST), until midnight
Thursday, November 16, 2006, by calling 888-203-1112 (domestic
toll-free) or 719-457-0820, and entering the passcode 6471068. This
press release, including the financial results relating to PRAECIS’
third quarter ended September 30, 2006, is also available on PRAECIS’
web site under “News Center.”
About PRAECIS
PRAECIS PHARMACEUTICALS INCORPORATED is a biopharmaceutical company
focused on utilizing its proprietary technologies for the discovery and
development of novel compounds that have the potential to address unmet
medical needs or improve existing therapies. PRAECIS has a novel MetAP-2
inhibitor, PPI-2458, in clinical development for cancer indications,
including non-Hodgkin’s lymphoma and solid
tumors, an innovative drug discovery technology, DirectSelect™,
which enables the generation and practical use of ultra-large libraries
for the discovery of orally active compounds for drug development, and a
research and development program aimed at identifying one or more
selective S1P-1 agonist compounds to advance into clinical testing.
This news release contains forward-looking statements, including
statements regarding the Company’s plans to
actively explore strategic options which may be available to the
Company, its plans for the continued clinical development of PPI-2458
and the advancement of its program to identify selective S1P-1 agonist
compounds to advance into clinical testing, and seeking partnerships
relating to, as well as the internal use in certain programs of, the
Company’s DirectSelect™
technology. These statements are based on the Company’s
current beliefs and expectations as to future outcomes and are not
guarantees of such outcomes or of future performance. These statements
are subject to numerous risks, uncertainties and assumptions that could
cause actual events and results to differ from those expected or
anticipated, including, but not limited to, the Company’s
ability to successfully consummate, in a timely manner and on favorable
terms, a strategic transaction, the Company’s
ability to continue to manage operating expenses and to retain key
employees, unexpected expenditures, the Company’s
ability to continue development of and successfully partner or enter
into other transactions with respect to its DirectSelect™
technology, the Company's ability to continue development of PPI-2458
and successfully partner this program, the Company’s
ability to identify one or more lead selective S1P-1 agonist compounds
and successfully partner its S1P-1 program, the Company’s
ability to successfully perform under its DirectSelect™
pilot study agreements, unexpected results in ongoing and future
clinical or preclinical trials, and the need for additional research and
testing, including as a result of unanticipated determinations by
regulatory authorities, as well as the risks set forth from time to time
in the Company’s filings with the Securities
and Exchange Commission, including but not limited to the various risks
discussed in the Company’s Quarterly Report
on Form 10-Q for the quarter ended September 30, 2006. The
Company undertakes no obligation to update any forward-looking statement
made in this press release to reflect new information, events or
circumstances after the date of this release.
Plenaxis® is a
registered trademark of PRAECIS PHARMACEUTICALS INCORPORATED.
PRAECIS PHARMACEUTICALS INCORPORATED
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2005
2006
2005
2006
Revenues:
Product sales
$
282
$
-
$
1,437
$
209
Licensing and other revenues
1,806
-
1,924
35
Total revenues
2,088
-
3,361
244
Costs and expenses:
Cost of goods sold
97
45
3,889
5,615
Research and development
5,333
5,610
18,892
18,157
Sales and marketing
203
-
5,988
-
General and administrative
1,489
1,560
5,456
5,433
Restructuring and asset impairment
-
110
28,680
1,688
Total costs and expenses
7,122
7,325
62,905
30,893
Operating loss
(5,034)
(7,325)
(59,544)
(30,649)
Interest (expense) income, net
(134)
572
(339)
1,771
Net loss
$
(5,168)
$
(6,753)
$
(59,883)
$
(28,878)
Basic and diluted net loss per common share
$
(0.49)
$
(0.63)
$
(5.71)
$
(2.73)
Weighted average number of basic and diluted common shares
outstanding
10,494
10,687
10,488
10,594
PRAECIS PHARMACEUTICALS INCORPORATED
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
December 31, 2005
September 30, 2006
Cash and cash equivalents
$
57,088
$
40,370
Marketable securities
5,492
-
Accounts receivable and other current assets
1,080
1,013
Net fixed assets
3,559
1,595
Inventory and other long-term assets
2,325
793
Total assets
$
69,544
$
43,771
Current liabilities
$
9,579
$
9,402
Long-term liabilities
8,802
8,757
Total stockholders' equity
51,163
25,612
Total liabilities and stockholders' equity
$
69,544
$
43,771
PRAECIS PHARMACEUTICALS INCORPORATED (NASDAQ: PRCS) today
announced consolidated financial results for the three and nine months
ended September 30, 2006.
Third Quarter 2006 Results
The Company's net loss for the three months ended September 30,
2006 was approximately $6,753,000, or $0.63 per diluted share,
compared to a net loss of approximately $5,168,000, or $0.49 per
diluted share, for the three months ended September 30, 2005.
The increased net loss for the third quarter of 2006 was due
primarily to a decrease in product sales and licensing revenues
related to Plenaxis(R). Also contributing to the increased net loss
for the third quarter was incremental non-cash compensation expense
associated with the Company's adoption commencing in 2006 of Financial
Accounting Standards Board Statement No. 123R, Share-Based Payment
(SFAS No. 123R). For the three months ended September 30, 2006,
approximately $785,000 of expense associated with equity-based
compensation plans was included in the Company's financial results
under SFAS No. 123R, of which approximately $591,000 was allocated to
research and development expense, and approximately $194,000 was
allocated to general and administrative expense. There was also a
reduction in sales and marketing expenses from the prior year quarter
due to the voluntary discontinuation of promotional activities for
Plenaxis(R) in the United States. Expenses incurred during the third
quarter of 2006 related primarily to the Company's preclinical and
clinical development efforts, advancement of existing drug discovery
programs to support the Company's pilot agreements and ongoing
partnering efforts, continued technology enhancement, and general and
administrative expenses.
For the nine months ended September 30, 2006, the net loss was
approximately $28,878,000, or $2.73 per diluted share, compared to a
net loss of approximately $59,883,000, or $5.71 per diluted share, for
the nine months ended September 30, 2005. The reduced net loss for the
nine months ended September 30, 2006 was principally the result of the
$32,173,000 of restructuring and asset impairment expenses recorded
during the second quarter of 2005. At September 30, 2006, the Company
had cash and cash equivalents of $40,370,000, compared to cash, cash
equivalents and marketable securities of approximately $62,580,000 at
December 31, 2005.
Commenting on the activities for the quarter, Kevin F. McLaughlin,
President and Chief Executive Officer stated, "During the third
quarter, we continued to make significant progress in our PPI-2458
clinical development program, our DirectSelect(TM) pilot drug
discovery programs and our S1P-1 research and development program.
Yesterday we presented interim data from our Phase 1 clinical trial of
PPI-2458 in non-Hodgkin's lymphoma and solid tumors at the 18th
EORTC-NCI-AACR Symposium held in Prague. We are very encouraged by the
preliminary information from this clinical trial and are utilizing the
growing clinical and preclinical data on this compound to establish a
focused Phase 2 clinical development plan in oncology. In addition, we
are further evaluating the potential initiation of clinical studies of
PPI-2458 in rheumatoid arthritis. We recently presented the scientific
rationale for studying PPI-2458 as a targeted molecular therapy for
this disease at the 14th International Inflammation Research
Association Conference, where we received the Cerep Award for Research
with the greatest therapeutic potential. As previously disclosed, our
goal is to partner this program in one or more indications as clinical
development advances. With respect to DirectSelect(TM), the majority
of our recent efforts in this area have been devoted to advancing our
partnered pilot programs and seeking to enter into broader
pharmaceutical partnerships for drug discovery and development
utilizing, or possibly other transactions with respect to, this
technology that will provide cash and/or cost reduction benefits to
us. We are pleased with our progress to date under our existing pilot
study agreements and we continue to initiate and advance discussions
with other potential partners.
"In parallel with the development of our DirectSelect(TM)
technology, we have also been conducting a highly focused discovery
research effort to identify small molecules that interact with
sphingosine-1-phosphate receptor-1 (S1P-1). S1P-1 is a G-protein
coupled receptor that is implicated in immunomodulation, making it an
attractive therapeutic target for treating autoimmune disorders such
as multiple sclerosis and for preventing rejection in solid organ
transplants. Utilizing conventional medicinal chemistry lead
optimization techniques, we have identified a number of selective
S1P-1 agonist compounds. We are currently evaluating several
preclinical candidates with a goal of identifying one or more lead
compounds to advance into clinical testing. It is our goal to enter
into a collaborative arrangement for the development and
commercialization of such lead compound(s)."
Concluding his comments, Mr. McLaughlin stated, "As previously
announced, we are actively exploring strategic options which may be
available to the Company. No decision has been made as to whether we
will engage in a strategic transaction, and there can be no assurance
as to whether or when this process will result in a successful
transaction. We do not currently intend to disclose developments or
anticipated timing regarding the status or outcome of this process
unless and until our board of directors has approved a specific
transaction."
There will be a conference call to discuss this press release
today beginning at 9:00 a.m. (EST). This call will be broadcast live
over the Internet at www.praecis.com under "Investor Relations." A
telephonic replay of this call will be available beginning at 12:00
Noon (EST), until midnight Thursday, November 16, 2006, by calling
888-203-1112 (domestic toll-free) or 719-457-0820, and entering the
passcode 6471068. This press release, including the financial results
relating to PRAECIS' third quarter ended September 30, 2006, is also
available on PRAECIS' web site under "News Center."
About PRAECIS
PRAECIS PHARMACEUTICALS INCORPORATED is a biopharmaceutical
company focused on utilizing its proprietary technologies for the
discovery and development of novel compounds that have the potential
to address unmet medical needs or improve existing therapies. PRAECIS
has a novel MetAP-2 inhibitor, PPI-2458, in clinical development for
cancer indications, including non-Hodgkin's lymphoma and solid tumors,
an innovative drug discovery technology, DirectSelect(TM), which
enables the generation and practical use of ultra-large libraries for
the discovery of orally active compounds for drug development, and a
research and development program aimed at identifying one or more
selective S1P-1 agonist compounds to advance into clinical testing.
This news release contains forward-looking statements, including
statements regarding the Company's plans to actively explore strategic
options which may be available to the Company, its plans for the
continued clinical development of PPI-2458 and the advancement of its
program to identify selective S1P-1 agonist compounds to advance into
clinical testing, and seeking partnerships relating to, as well as the
internal use in certain programs of, the Company's DirectSelect(TM)
technology. These statements are based on the Company's current
beliefs and expectations as to future outcomes and are not guarantees
of such outcomes or of future performance. These statements are
subject to numerous risks, uncertainties and assumptions that could
cause actual events and results to differ from those expected or
anticipated, including, but not limited to, the Company's ability to
successfully consummate, in a timely manner and on favorable terms, a
strategic transaction, the Company's ability to continue to manage
operating expenses and to retain key employees, unexpected
expenditures, the Company's ability to continue development of and
successfully partner or enter into other transactions with respect to
its DirectSelect(TM) technology, the Company's ability to continue
development of PPI-2458 and successfully partner this program, the
Company's ability to identify one or more lead selective S1P-1 agonist
compounds and successfully partner its S1P-1 program, the Company's
ability to successfully perform under its DirectSelect(TM) pilot study
agreements, unexpected results in ongoing and future clinical or
preclinical trials, and the need for additional research and testing,
including as a result of unanticipated determinations by regulatory
authorities, as well as the risks set forth from time to time in the
Company's filings with the Securities and Exchange Commission,
including but not limited to the various risks discussed in the
Company's Quarterly Report on Form 10-Q for the quarter ended
September 30, 2006. The Company undertakes no obligation to update any
forward-looking statement made in this press release to reflect new
information, events or circumstances after the date of this release.
Plenaxis(R) is a registered trademark of PRAECIS PHARMACEUTICALS
INCORPORATED.
-0-
*T
PRAECIS PHARMACEUTICALS INCORPORATED
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
------------------- -------------------
2005 2006 2005 2006
--------- --------- --------- ---------
Revenues:
Product sales $ 282 $ - $ 1,437 $ 209
Licensing and other
revenues 1,806 - 1,924 35
--------- --------- --------- ---------
Total revenues 2,088 - 3,361 244
Costs and expenses:
Cost of goods sold 97 45 3,889 5,615
Research and development 5,333 5,610 18,892 18,157
Sales and marketing 203 - 5,988 -
General and administrative 1,489 1,560 5,456 5,433
Restructuring and asset
impairment - 110 28,680 1,688
--------- --------- --------- ---------
Total costs and
expenses 7,122 7,325 62,905 30,893
--------- --------- --------- ---------
Operating loss (5,034) (7,325) (59,544) (30,649)
Interest (expense) income,
net (134) 572 (339) 1,771
--------- --------- --------- ---------
Net loss $(5,168) $(6,753) $(59,883) $(28,878)
========= ========= ========= =========
Basic and diluted net loss per
common share $ (0.49) $ (0.63) $ (5.71) $ (2.73)
========= ========= ========= =========
Weighted average number of
basic and diluted common
shares outstanding 10,494 10,687 10,488 10,594
*T
-0-
*T
PRAECIS PHARMACEUTICALS INCORPORATED
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
December 31, September 30,
2005 2006
-------------- -------------
Cash and cash equivalents $ 57,088 $ 40,370
Marketable securities 5,492 -
Accounts receivable and other current
assets 1,080 1,013
Net fixed assets 3,559 1,595
Inventory and other long-term assets 2,325 793
-------------- -------------
Total assets $ 69,544 $ 43,771
============== =============
Current liabilities $ 9,579 $ 9,402
Long-term liabilities 8,802 8,757
Total stockholders' equity 51,163 25,612
-------------- -------------
Total liabilities and stockholders'
equity $ 69,544 $ 43,771
============== =============
*T