RADFORD, Va., Nov. 14 /PRNewswire-FirstCall/ -- New River Pharmaceuticals Inc. today announced its financial results for the quarter ended October 2, 2005. New River recognized a net loss of $9.1 million, or $0.50 per basic and diluted share, for the fiscal quarter ended October 2, 2005 compared to a net loss of $4.4 million, or $0.28 per basic and diluted share, for the fiscal quarter ended September 26, 2004.
Cash and short-term investment balances were $56.6 million at October 2, 2005.
General and administrative expenses were $4.3 million for the fiscal quarter ended October 2, 2005 compared to $1.4 million for the fiscal quarter ended September 26, 2004. The increase in these costs is primarily due to an increase in compensation-related costs, including stock-based compensation, and a general increase in various other administrative costs associated with New River’s operating as a public company, such as directors’ and officers’ insurance costs and legal expenses.
Research and development expenses were $5.2 million for the fiscal quarter ended October 2, 2005 compared to $3.1 million for the fiscal quarter ended September 26, 2004. This increase was primarily the result of the continued expansion of New River’s research and development programs and clinical trials associated with NRP104 and increases in compensation-related costs, including stock-based compensation.
“During the third quarter, our efforts resulted in significant progress in clinical trials on our lead product candidate, NRP104, and our second clinical candidate, NRP290,” said Krish Krishnan, Chief Financial Officer and Chief Operating Officer of New River. “We expect to file an NDA on NRP104 in the fourth quarter of this year and anticipate IND filings on NRP388 and NRP409 in the first half of 2006.”
New River Pharmaceuticals Inc. is a specialty pharmaceutical company focused on developing novel pharmaceuticals that are generational improvements of widely prescribed drugs in large and growing markets.
For further information on New River, please visit the company’s website at http://www.nrpharma.com.
“SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This press release contains certain forward-looking information that is intended to be covered by the safe harbor for “forward-looking statements” provided by the Private Securities Litigation Reform Act of 1995. Forward- looking statements are statements that are not historical facts. Words such as “expect(s),” “feel(s),” “believe(s),” “will,” “may,” “anticipate(s)” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, financial projections and estimates and their underlying assumptions; statements regarding plans, objectives and expectations with respect to future operations, products and services; and statements regarding future performance. Such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of New River Pharmaceuticals, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include: those discussed and identified in the New River Pharmaceuticals Inc. annual report on Form 10-K, filed with the SEC on April 1, 2005; the timing, progress and likelihood of success of our product research and development programs; the timing and status of our preclinical and clinical development of potential drugs; the likelihood of success of our drug products in clinical trials and the regulatory approval process; our drug products’ efficacy, abuse and tamper resistance, onset and duration of drug action, ability to provide protection from overdose, ability to improve patients’ symptoms, incidence of adverse events, ability to reduce opioid tolerance, ability to reduce therapeutic variability, and ability to reduce the risks associated with certain therapies; the ability to develop, manufacture, launch and market our drug products; our projections for future revenues, profitability and ability to achieve certain sales targets; our estimates regarding our capital requirements and our needs for additional financing; the likelihood of obtaining favorable scheduling and labeling of our drug products; the likelihood of regulatory approval under Section 505(b)(2) under the Federal Food, Drug, and Cosmetic Act; our ability to develop safer and improved versions of widely-prescribed drugs using our Carrierwave (TM) technology; and our ability to obtain favorable patent claims. Readers are cautioned not to place undue reliance on these forward- looking statements that speak only as of the date hereof. New River Pharmaceuticals does not undertake any obligation to republish revised forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Readers are also urged to carefully review and consider the various disclosures in New River Pharmaceuticals’ annual report on Form 10-K, filed with the SEC on April 1, 2005, as well as other public filings with the SEC.
Contacts: The Ruth Group John Quirk (investors) 646-536-7029 jquirk@theruthgroup.com Zack Kubow (media) 646-536-7020 zkubow@theruthgroup.com NEW RIVER PHARMACEUTICALS INC. AND SUBSIDIARY CONSOLIDATED BALANCE SHEETS Assets October 2, 2005 January 2, 2005 Current assets: (Unaudited) Cash and cash equivalents $ 1,723,592 $ 4,018,556 Short-term investments 54,843,804 21,174,747 Prepaid expenses 1,180,610 315,644 Total current assets 57,748,006 25,508,947 Property and equipment: Leasehold improvements 94,609 76,860 Machinery and equipment 811,545 686,895 906,154 763,755 Less accumulated depreciation and amortization 617,169 502,890 Property and equipment, net 288,985 260,865 Total assets $58,036,991 $25,769,812 Liabilities and Shareholders’ Equity Current liabilities: Capital lease obligation - current $ 21,681 $ - Accounts payable 1,218,377 701,175 Unpaid and accrued research and development expenses 1,968,323 2,100,421 Accrued compensation 1,825,533 1,506,413 Due to affiliates 111,838 76,920 Total current liabilities 5,145,752 4,384,929 Capital lease obligation - noncurrent 32,959 - Accrued stock-based compensation 2,071,558 - Deferred revenue 50,000,000 - Total liabilities 57,250,269 4,384,929 Shareholders’ Equity: Preferred stock, par value $0.001 per share. Authorized 25,000,000 shares; none issued and outstanding - - Common stock, par value $0.001 per share. Authorized 150,000,000 shares; issued and outstanding 18,127,201 shares at October 2, 2005 and 17,774,554 shares at January 2, 2005 18,127 17,775 Additional paid-in capital 62,875,645 61,346,030 Accumulated deficit (62,107,050) (39,978,922) Total shareholders’ equity 786,722 21,384,883 Commitments and contingencies Total liabilities and shareholders’ equity $58,036,991 $25,769,812 NEW RIVER PHARMACEUTICALS INC. AND SUBSIDIARY CONSOLIDATED STATEMENTS OF OPERATIONS Three months ended Nine months ended October 2, September 26, October 2, September 26, 2005 2004 2005 2004 (Unaudited) (Unaudited) Sales, net $ - $ - $ - $ - Operating costs and expenses: Selling, general, and administrative 4,327,045 1,374,455 9,272,568 3,609,265 Research and development 5,247,036 3,072,912 14,072,247 5,493,858 Depreciation and amortization of property and equipment 41,562 30,254 116,378 89,966 Total operating expenses 9,615,643 4,477,621 23,461,193 9,193,089 Operating loss (9,615,643) (4,477,621) (23,461,193) (9,193,089) Other income (expense): Gain on settlement of litigation - - - 1,764,043 Interest expense (1,633) - (3,487) (11,422) Interest income 515,814 61,357 1,336,552 63,600 Total other income, net 514,181 61,357 1,333,065 1,816,221 Net loss $(9,101,462) $(4,416,264) $(22,128,128) $(7,376,868) Net loss per share: Basic and diluted $ (0.50) $ (0.28) $ (1.24) $ (0.53)
New River Pharmaceuticals Inc.
CONTACT: John Quirk, investors, of The Ruth Group, +1-646-536-7029,jquirk@theruthgroup.com; or Zack Kubow, media, +1-646-536-7020,zkubow@theruthgroup.com
Web site: http://www.nrpharma.com/