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.
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.
CONDENSED BALANCE SHEETS
December 31, December 31,
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
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
CONDENSED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
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)
common stockholders $(16,943) $(9,617) $7,692 $(34,640)
Net loss attributable to
per share - basic $(0.63) $(0.36) $0.29 $(2.49)
Net loss attributable to
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
|SOURCE Replidyne, Inc.|
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