Published:
Nuvelo Reports First Quarter 2008 Financial Results and Updated Outlook for 2008
SAN CARLOS, Calif., May 8 /PRNewswire-FirstCall/ -- Nuvelo, Inc.
(Nasdaq: NUVO) today announced first quarter 2008 financial results and
provided an updated outlook for 2008.
For the first quarter ended March 31, 2008, Nuvelo reported a net loss of
$18.4 million, or $0.34 per share, compared with a net loss of $15.3 million,
or $0.29 per share, for the same period in 2007. The increase in net loss was
primarily due to $4.0 million in restructuring and facility exit charges taken
in the first quarter of 2008, which are discussed below. Net cash used in
operating activities was $16.4 million for the 2008 quarter, and as of March
31, 2008, the company had $87.2 million in cash and cash equivalents,
marketable securities and restricted cash.
Revenues for the first quarter of 2008 were $0.1 million, compared with
$0.9 million for the same period in 2007. In May 2008, we expect to recognize
the $15.0 million received from Bayer in connection with the termination of
the collaboration agreement in June 2007. The $15.0 million, which had been
recorded as deferred revenue, will be recognized as revenue upon the
expiration of the notice period, as defined in the termination agreement with
Bayer.
Operating expenses for the first quarter of 2008, including $4.0 million
in restructuring and facility exit charges, were $19.5 million, compared with
$18.1 million for the same period in 2007.
Research and development expenses were $11.5 million for the first quarter
2008, compared with $12.7 million for the same period in 2007. Non-cash
employee stock-based compensation included in R&D expenses totaled
$0.2 million and $1.0 million in the 2008 and 2007 periods, respectively. The
decrease in R&D expenses in 2008 was primarily attributed to a reduction in
headcount, partially offset by increases in development expenses related to
NU172 and NU206.
General and administrative expenses were $4.0 million for the first
quarter of 2008, compared with $5.4 million for the same period in 2007. Non-
cash employee stock-based compensation included in general and administrative
expenses totaled $0.8 million and $1.2 million in the 2008 and 2007 periods,
respectively. The decrease in general and administrative expenses in 2008 was
primarily related to a $1.4 million decrease in personnel-related expenses as
a result of a reduction in headcount.
Restructuring expenses were $2.5 million for the first quarter 2008, which
resulted from a reduction in workforce intended to realign the Company's
organization. Included in the restructuring expenses were $1.3 million of
termination benefits and $1.2 million of non-cash stock-based compensation.
The facility exit charge was $1.5 million for the first quarter of 2008.
This non-cash charge resulted from management's conclusion that the likelihood
of subleasing the facility has become remote.
Net interest income was $1.0 million for the first quarter of 2008,
compared with $1.8 million for the same period in 2007.
"We are focused on building shareholder value through the aggressive
advancement of our pipeline and R&D programs. We just announced positive
proof-of-concept data demonstrating NU172's potential for rapid onset and
offset of anticoagulation, have put programs in place to accelerate the
development of NU206 and plan to designate a candidate from one of our two
research programs this year," said Dr. Ted W. Love, chairman and chief
executive officer of Nuvelo. "We are also seeking partnership and in-licensing
opportunities to accelerate research and development, expand our pipeline and
enhance our already solid financial position."
2008 Guidance and Key Milestones
Nuvelo is reiterating its guidance and expects 2008 net cash used in
operating activities to be in the range of $43.0 to $48.0 million and
operating expenses, including $4.0 million in restructuring and facility exit
charges taken in the first quarter, to be in the range of $47.0 to
$52.0 million.
Nuvelo anticipates accomplishing the following near-term milestones:
-- Initiation of a Phase 1b bolus plus infusion trial with NU172 in
healthy volunteers in the second quarter of 2008;
-- Trial completion and top-line data from the Phase 1b bolus plus
infusion trial with NU172 in the third quarter of 2008;
-- Initiation of a Phase 2 trial with NU172 in medical or surgical
procedures in the fourth quarter of 2008 or first quarter of 2009;
-- Initiation of a Phase 1 trial with NU206 in mucositis in the second
quarter of 2008;
-- Initiation of a Phase 1 single ascending dose trial with NU206 in
healthy volunteers in the third quarter of 2008;
-- Trial completion and top-line data from the Phase 1 single ascending
dose trial with NU206 in healthy volunteers in the second half of 2008;
-- Initiation of a Phase 1b multiple ascending dose trial with NU206 in
healthy volunteers in the fourth quarter of 2008 or first quarter of
2009; and
-- Advancement of a new candidate from either the Wnt Therapeutics or the
Leukemia Therapeutics Program in 2008.
Conference Call Information
Nuvelo will hold a conference call and virtual webcast today at 4:30 p.m.
Eastern Time (1:30 p.m. Pacific Time) to discuss this announcement. To
participate in the conference call, please dial 866-854-8095 for domestic
callers and 706-634-8567 for international callers and reference conference
passcode 43639045. A telephone replay of the conference call will be available
through Thursday, May 22, 2008. To access the replay, please dial 800-642-1687
for domestic callers and 706-645-9291 for international callers and reference
conference passcode 43639045.
This call is being webcast by Thomson/CCBN and will include a virtual
slide presentation. The webcast can be accessed via Nuvelo's website at
http://www.nuvelo.com and is also being distributed through the Thomson
StreetEvents Network. Individual investors can listen to the call at
http://www.earnings.com, Thomson's individual investor portal, powered by
StreetEvents. Institutional investors can access the call via Thomson
StreetEvents (http://www.streetevents.com), a password-protected event
management site.
About Nuvelo
Nuvelo, Inc. is dedicated to improving the lives of patients through the
discovery, development and commercialization of novel drugs for acute
cardiovascular disease, cancer and other debilitating medical conditions.
Nuvelo's development pipeline includes NU172, a direct thrombin inhibitor in
Phase 1 development for use as a potential short-acting anticoagulant during
medical or surgical procedures; and preclinical candidate NU206, a Wnt pathway
modulator for the potential treatment of chemotherapy/radiation
therapy-induced mucositis and inflammatory bowel disease. In addition, Nuvelo
is pursuing research programs in leukemia and lymphoma therapeutic antibodies
and Wnt signaling pathway therapeutics to further expand its pipeline and
create additional partnering and licensing opportunities.
Information about Nuvelo is available at our website at
http://www.nuvelo.com or by phoning 650-517-8000.
This press release contains "forward-looking statements," which include
statements regarding the timing, progress and anticipated completion of
Nuvelo's clinical stage and research programs, the anticipated availability of
top line data, projected operating expenses and cash usage and the potential
benefits that patients may experience from the use of our clinical stage
compounds, which statements are hereby identified as "forward-looking
statements" for purposes of the safe harbor provided by the Private Securities
Litigation Reform Act of 1995. Such statements are based on our management's
current expectations and involve risks and uncertainties. Actual results and
performance could differ materially from those projected in the
forward-looking statements as a result of many factors, including, without
limitation, uncertainties relating to drug discovery and the regulatory
approval process; clinical development processes; enrollment rates for
patients in our clinical trials; changes in relationships with strategic
partners and dependence upon strategic partners for the performance of
critical activities under collaborative agreements; stock market conditions;
the impact of competitive products and technological changes; and
uncertainties relating to our ability to obtain funding. These and other
factors are identified and described in more detail in Nuvelo's filings with
the SEC, including without limitation Nuvelo's annual report on Form 10-K for
the year ended December 31, 2007 and subsequent filings. We disclaim any
intent or obligation to update these forward-looking statements.
NUVELO, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
Three Months Ended
March 31,
2008 2007
Contract revenues $63 $910
Operating expenses:
Research and development 11,518 12,725
General and administrative 4,009 5,366
Restructuring 2,470 -
Facility exit charge 1,472 -
Total operating expenses 19,469 18,091
Operating loss (19,406) (17,181)
Interest income, net 998 1,832
Net loss $(18,408) $(15,349)
Basic and diluted net loss per share $(0.34) $(0.29)
Weighted average shares used in computing
basic and diluted net loss per share 53,456 53,252
CONSOLIDATED BALANCE SHEET DATA
(in thousands)
(unaudited)
March 31, 2008 December 31, 2007*
Cash and cash equivalents,
marketable securities and
restricted cash $87,168 $103,567
Working capital 51,271 81,799
Total assets 103,686 120,683
Non-current liabilities 19,874 34,837
Accumulated deficit (488,921) (470,513)
Total stockholders' equity 51,623 67,659
* The consolidated balance sheet data as of December 31, 2007 have been
derived from the audited financial statements.
SOURCE Nuvelo, Inc.
Copyright © 2009, PRNewswire
Copyright © 2009, NewsBlaze,
Daily NewsTags: ,HEA,BIO,MTC,ERN,CCA,ERP,CA-NUVO-1Q-08-Earnngs
Search News
Daily News
