LOUISVILLE, Colo., Feb. 26 /PRNewswire-FirstCall/ -- Replidyne,
Inc. (NASDAQ:RDYN) today announced its financial results for the
fourth quarter and full year ended December 31, 2007. Replidyne
reported a net loss of $16.9 million for the fourth quarter ended
December 31, 2007, or a net loss per basic and diluted common share
of $0.63 per share, compared to a net loss of $9.6 million, or
$0.36 per basic and diluted common share, for the quarter ended
December 31, 2006. For the year ended December 31, 2007, Replidyne
reported net income of $7.7 million, or $0.29 per share basic
common share and $0.28 per diluted common share, compared to a net
loss of $29.2 million, or $2.49 per basic and diluted common share,
for the year ended December 31, 2006. Net income for the current
year was due to revenue recognized upon termination of the
company's commercialization and development agreement for faropenem
medoxomil (faropenem) with Forest Laboratories (Forest) in May
2007. Cash, cash equivalents and short-term investments at December
31, 2007 totaled $90.3 million. "At the end of 2007, we streamlined
our operations by restructuring the organization and
re-prioritizing our research and development pipeline. In 2008, we
continue to focus on our main objectives," said Kenneth J. Collins,
Replidyne's President and CEO. "Securing a partner for the
faropenem program remains a top priority. We intend to advance our
Clostridium difficile program and file an IND by the end of the
year. Also by the end of the year, we expect to identify an IND
candidate from our DNA replication inhibition program. Finally, we
will continue to seek strategic alternatives that augment our
pipeline and add value." Revenue for the year ended December 31,
2007 was $58.6 million. Upon termination of the commercialization
and development agreement with Forest, all unamortized upfront and
milestone payments as well as contract revenue for funded
activities were fully recognized as revenue in the period ended May
7, 2007. Replidyne will not report any revenue under this agreement
for future reporting periods. Research and development expenses in
the fourth quarter of 2007 were $14.9 million compared to $13
million in the corresponding quarter of 2006. Faropenem related
expense represented approximately 77% of total research and
development expense in the quarter, primarily for costs to prepare
for patient enrollment in three planned Phase III clinical trials
of faropenem, one for treatment of acute bacterial sinusitis and
two for treatment of community acquired pneumonia, as well as costs
to support the ongoing placebo-controlled Phase III clinical trial
of faropenem for treatment of acute exacerbation of chronic
bronchitis. Fourth quarter 2007 expense also included $1.7 million
related to contingent supply agreement costs related to the delayed
development program for faropenem. Additionally, research and
development expense included increased costs for preclinical
activities targeted to Replidyne's discovery research programs,
primarily its C. difficile and inhibition of DNA replication
programs offset by decreased expense related to the REP8839 program
that was suspended in December 2007. Research and development
expense was $43.3 million for the full year 2007 compared to $38.3
million in 2006. The increase in full year research and development
expense reflected increased costs to prepare for future clinical
trials of faropenem and ongoing execution of the placebo-controlled
Phase III clinical trial for treatment of acute exacerbations of
chronic bronchitis as well as increased preclinical activities
within the C. difficile and inhibition of DNA replication programs.
These increases were partially offset by lower full year contingent
supply agreement costs related to the faropenem program and $1.5
million of product acquisition cost in 2006 to complete the
purchase of tRNA synthetase technology from GlaxoSmithKline which
includes Replidyne's C. difficile program and REP8839. Sales,
general and administrative expenses for the fourth quarter of 2007
were $3.2 million compared to $3.5 million in the fourth quarter of
2006 reflecting lower marketing study expenses in the 2007 quarter.
Included in the 2007 quarter result was $0.6 million related to the
organizational restructuring implemented on December 10, 2007. Full
year 2007 selling, general and administrative expenses were $13
million compared to $12.2 million in 2006 reflecting increased full
year compensation costs, restructuring expense, and increased
professional fees related to public company compliance. Investment
income for the fourth quarter of 2007 was $1.2 million compared to
$1.7 million for the fourth quarter of 2006, primarily reflecting
lower cash balances available for investment in the 2007 period.
Full year 2007 investment income was $5.5 million compared to $6.0
million 2006. As reported in its 2006 results, through July 3, 2006
Replidyne recorded dividends due to preferred shareholders of $5.4
million. All outstanding preferred stock and accumulated dividends
were converted into common stock upon closing of the initial public
offering on July 3, 2006 and no preferred stock or accrued
dividends were outstanding after that date. Conference Call
Information Replidyne will host a conference call and webcast
today, February 26, 2008, at 4:45 P.M. EST to discuss 2007 fourth
quarter and full year financial results and update the Company's
expectations. Callers may participate in the conference call by
dialing 866-510-0707 (domestic) or 617-597-5376 (international),
and providing the passcode 33794809. To access the live webcast,
log on to the Company's website at http://www.replidyne.com/ and go
to the Investor Relations section. A replay of the conference call
will be available approximately one hour after the completion of
the call through Tuesday, March 11, 2008 at midnight. Callers may
access the replay by dialing 888-286-8010 (U.S. participants) or
617-801-6888 (international participants). The audio replay
passcode is 92464480. To access a replay of the webcast, visit the
Investor Relations section of the Company's website at
http://www.replidyne.com/. About Replidyne, Inc. Replidyne is a
biopharmaceutical company focused on discovering, developing,
in-licensing and commercializing innovative anti-infective
products. Replidyne's lead product, faropenem medoxomil, is a novel
oral community antibiotic, expected to be appropriate for use as a
first-line antibiotic for treatment of respiratory and skin
infections in adult and pediatric patients. Replidyne's
investigational antibacterial agent REP3123 targets Gram-positive
C. difficile bacteria and C. difficile-associated disease (CDAD).
Replidyne is pursuing the development of other novel anti-infective
programs based on its DNA replication inhibition technology and its
in-house discovery research. Safe Harbor This press release
contains plans, intentions, objectives, estimates and expectations
that constitute forward-looking statements about Replidyne, Inc.
that involve significant risks and uncertainties. Actual results
could differ materially from those discussed due to a number of
factors including, the success and timing of pre-clinical studies
and clinical trials; the Company's ability to obtain a new partner
for faropenem on acceptable terms; the Company's ability to obtain
and maintain regulatory approval of product candidates and the
labeling under any approval that may be obtained; plans to develop
and commercialize product candidates; the loss of key scientific or
management personnel; the size and growth of the potential markets
for the Company's product candidates and the Company's ability to
serve those markets; regulatory developments in the U.S. and
foreign countries; the rate and degree of market acceptance of any
future products; the accuracy of Company estimates regarding
expenses, future revenues and capital requirements; the Company's
ability to obtain and maintain intellectual property protection for
our product candidates; the successful development of the Company's
sales and marketing capabilities; the success of competing drugs
that are or become available; and the performance of third party
manufacturers. These and additional risks and uncertainties are
described more fully in the Company's most recent Form 10-Q filed
with the SEC under the Securities Exchange Act of 1934. Copies of
filings made with the SEC are available through the SEC's
electronic data gather analysis and retrieval system (EDGAR) at
http://www.sec.gov/. All forward-looking statements made in the
press release are made as of the date hereof and the Company
assumes no obligation to update the forward-looking statements in
the document. REPLIDYNE, INC. CONDENSED BALANCE SHEETS (in
thousands) (unaudited) December 31, December 31, 2007 2006 ASSETS
Current assets: Cash and cash equivalents $43,969 $24,091
Short-term investments 46,297 101,476 Receivable from Forest
Laboratories - 4,634 Prepaid expenses and other current assets
2,429 2,079 Total current assets 92,695 132,280 Property and
equipment, net 1,905 3,170 Other assets 90 111 Total assets $94,690
$135,561 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities:
Accounts payable and accrued expenses $12,255 $7,957 Deferred
revenue - 56,176 Total current liabilities 12,255 64,133 Other
long-term liabilities 31 56 Total liabilities 12,286 64,189
Commitments and contingencies Stockholders' equity 82,404 71,372
Total liabilities and stockholders' equity $94,690 $135,561
REPLIDYNE, INC. CONDENSED STATEMENTS OF OPERATIONS (In thousands,
except per share amounts) (unaudited) Three Months Ended December
31, Year Ended December 31, 2007 2006 2007 2006 Revenue - $5,387
$58,571 $15,988 Costs and expenses: Research and development 14,851
13,008 43,313 38,295 Sales, general and administrative 3,217 3,511
13,020 12,187 Total costs and expenses 18,068 16,519 56,333 50,482
Net income (loss) from operations (18,068) (11,132) 2,238 (34,494)
Investment income and other, net 1,125 1,515 5,454 5,245 Net income
(loss) (16,943) (9,617) 7,692 (29,249) Preferred stock dividends
and accretion - - - (5,391) Net income (loss) attributable to
common stockholders $(16,943) $(9,617) $7,692 $(34,640) Net loss
attributable to common stockholders per share - basic $(0.63)
$(0.36) $0.29 $(2.49) Net loss attributable to common stockholders
per share - diluted $(0.63) $(0.36) $0.28 $(2.49) Weighted average
common shares outstanding - basic 26,828 26,520 26,730 13,908
Weighted average common shares outstanding - diluted 26,828 26,520
27,666 13,908 DATASOURCE: Replidyne, Inc. CONTACT: Sabrina B. Oei,
Dir. Investor & Public Relations of Replidyne, Inc.,
+1-303-996-5535 Web site: http://www.replidyne.com/
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