MINNEAPOLIS, July 31 /PRNewswire-FirstCall/ -- Uroplasty, Inc. , a medical device company that develops, manufactures and markets innovative proprietary products for the treatment of voiding dysfunctions, today reported financial results for the first quarter of fiscal 2009 ended June 30, 2008. Net sales for the first quarter of fiscal 2009 were $4.5 million, up 53% from $2.9 million in the first quarter of fiscal 2008. Excluding the translation impact of fluctuations in foreign currency exchange rates, sales during the fiscal quarter increased by approximately 46%. U.S. sales were $2.2 million, an increase of 118% from $1.0 million in the first quarter of fiscal 2008.
“During the first quarter, we continued to grow our active U.S. customer base for the Urgent PC system and we generated positive non-GAAP operating income, excluding certain non-cash items,” said David Kaysen, President and Chief Executive Officer. “We generated strong international sales and continued to build momentum in the U.S. market for our Urgent PC system, which we believe is the only FDA-approved minimally invasive nerve stimulation device designed for office-based treatment of urinary frequency, urinary urgency and urge incontinence -- symptoms often associated with overactive bladder. The increasing productivity of our domestic sales team enabled us to expand our active Urgent PC customer base in the U.S. to 339, an increase from 166 customers during the comparable period a year ago. As doctors and their patients experience positive results with the Urgent PC, we are confident about our team’s ability to continue to expand the active U.S. customer base as the fiscal year progresses.”
“Uroplasty is about to embark on a new, multicenter clinical study with our Urgent PC system for patients afflicted with urinary urgency, urinary frequency, and urge incontinence. The preparations are progressing well with an anticipated start this fall and we believe the study will further enhance the marketing of our Urgent PC,” Mr. Kaysen added.
“Our strong financial results reflect our drive to achieve profitable and sustainable growth, a key factor in determining long-term success. Getting our business to generate non-GAAP breakeven operating income, excluding certain non-cash charges has been an important focus of management. We continue to believe we can grow fiscal 2009 sales in excess of 30% over fiscal 2008, and U.S. sales by more than 70% based on our expectations for continued market adoption of our Urgent PC system. At the same time, we do expect to experience the normal seasonality in our non-U.S. sales during the second fiscal quarter. In addition, we expect to increase spending over fiscal first quarter levels for a clinical study and to support our full-year revenue growth. We continue to expect consistent operating income breakeven on a non-GAAP basis, which excludes non-cash and unusual charges, to occur between revenues of $19 million to $20 million,” Mr. Kaysen concluded.
Conference Call
Uroplasty will host an audio conference call today at 3:30 pm Central, 4:30 pm Eastern, to review the financial results for the first fiscal quarter of 2009. David Kaysen, President and Chief Executive Officer and Medi Jiwani, Vice President, Chief Financial Officer and Treasurer will host the call. Individuals wishing to participate in the conference call should dial (866) 249-5225 (domestic) or (303) 262-2131 (international). An audio replay will be available two hours after the call for 30 days by dialing (800) 405-2236 (domestic) or (303) 590-3000 (international), with the passcode 11117192#.
About Uroplasty, Inc.
Uroplasty, Inc., headquartered in Minnetonka, Minnesota, with wholly-owned subsidiaries in The Netherlands and the United Kingdom, is a medical device company that develops, manufactures and markets innovative proprietary products for the treatment of voiding dysfunctions. Our primary focus is the commercialization of our Urgent PC system, which we believe is the only FDA-approved minimally invasive nerve stimulation device designed for office-based treatment of urinary urgency, urinary frequency and urge incontinence -- symptoms often associated with overactive bladder. We also offer Macroplastique(R) Implants, an injectable bulking agent for the treatment of adult female stress urinary incontinence primarily due to intrinsic sphincter deficiency. Please visit Uroplasty, Inc. at http://www.uroplasty.com.
Safe Harbor
The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for certain forward-looking statements. This press release contains forward-looking statements, which reflect our views regarding future events and financial performance. These forward-looking statements are subject to certain risks and uncertainties, including those identified below, which could cause actual results to differ materially from historical results or those anticipated. The words “aim,” “believe,” “expect,” “anticipate,” “intend,” “estimate” and other expressions, which indicate future events and trends, identify forward-looking statements. Actual future results and trends may differ materially from historical results or those anticipated depending upon a variety of factors, including, but not limited to: the ability to receive third party reimbursement for our products; the impact of international currency fluctuations on our cash flows and operating results; the impact of technological innovation and competition; acceptance of our products by physicians and patients, our historical reliance on a single product for most of our current sales; our ability to commercialize our recently licensed product lines; our intellectual property and the ability to prevent competitors from infringing our rights; effect of government regulation, including when and if we receive approval for marketing products in the United States; the results of clinical trials; our continued losses and the possible need to raise additional capital in the future; our ability to manage our international operations; our ability to hire and retain key technical and sales personnel; our dependence on key suppliers; future changes in applicable accounting rules; and volatility in our stock price. We cannot assure that we can successfully expand our U.S. field sales force, that our active Urgent PC customer base will continue to grow or that we will be successful in helping our active customers introduce, and our existing customers will continue to market, our Urgent PC technology. Our first quarter fiscal 2009 financial performance is not indicative of future performance. We also cannot assure that (i) our sales representatives will continue to grow their sales productivity, (ii) future additions to our sales force will increase our sales or profitability, (iii) we can conduct our planned clinical study on budget or achieve the desired objectives from the study, (iv) we will achieve our projected revenue target range for fiscal 2009 or (v) we can achieve our fiscal 2009 non-GAAP operating income objective at our targeted revenue level. Uroplasty undertakes no obligation to update or revise these forward-looking statements to reflect new events or uncertainties.
Non-GAAP Financial Measures: The following table reconciles our financial results calculated in accordance with accounting principles generally accepted in the U.S. (GAAP) to non-GAAP financial measures that exclude non-cash charges for stock options under SFAS 123 (R), and depreciation and amortization expenses from gross profit, operating expenses and operating loss. The non-GAAP financial measures used by management and disclosed by us are not a substitute for, or superior to, financial measures and consolidated financial results calculated in accordance with GAAP, and you should carefully evaluate our reconciliations to non-GAAP. We may calculate our non-GAAP financial measures differently from similarly titled measures used by other companies. Therefore, our non-GAAP financial measures may not be comparable to those used by other companies. We have described the reconciliations of each of our non-GAAP financial measures above to the most directly comparable GAAP financial measures.
Management uses our non-GAAP financial measures, and in particular non-GAAP operating loss, for internal managerial purposes because we believe such measures are one important indicator of the strength and the performance of our business as they provide a link to operating cash flow. We also believe that analysts and investors use such measures to evaluate the overall operating performance of companies in our industry, including as a means of comparing period-to-period results and as a means of evaluating our results with those of other companies.
CONTACT: David Kaysen, President and CEO, or Medi Jiwani, Vice President,
CFO, and Treasurer, both of Uroplasty, Inc., +1-952-426-6140; or Investors,
Doug Sherk or Dahlia Bailey, +1-415-896-6820, or Media, Steve DiMattia or
Chris Gale, +1-646-201-5445, all of the EVC Group, for Uroplasty, Inc.
Web site: http://www.uroplasty.com/