MINNEAPOLIS, Oct. 29 /PRNewswire-FirstCall/ -- Uroplasty, Inc. , a medical device company that develops, manufactures and markets innovative proprietary products to treat voiding dysfunctions, today reported financial results for the second quarter of fiscal 2009 ended September 30, 2008. Net sales for the second quarter of fiscal 2009 were $3.9 million, up 29% from $3.0 million in the second quarter of fiscal 2008. U.S. sales were $2.2 million, an increase of 83% from $1.2 million in the second quarter of fiscal 2008.
"During our second fiscal quarter, our team continued to execute our strategies and we generated solid growth," said David Kaysen, President and CEO. "In the U.S., support for the Urgent PC(R) system is continuing to build after the release of the initial results of the OrBIT study in May which demonstrated Urgent PC's efficacy to be comparable to the number-one prescribed pharmaceutical for overactive bladder. In addition, we continued to make progress in building sales of Macroplastique(R), which we introduced in the U.S. market in mid-2007," added Mr. Kaysen.
The Urgent PC system 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 system is an office-based, nonsurgical, percutaneous tibial nerve stimulation (PTNS) device that treats these symptoms. Macroplastique is an injectable urethral bulking agent for the treatment of adult-female stress-urinary incontinence primarily due to intrinsic sphincter deficiency.
Fiscal Second Quarter and Six Month Results for the Periods Ended September 30, 2008
"Earlier this month, we announced the first patient enrollment in a new, multicenter clinical study that will support our U.S. reimbursement efforts, and is part of a very focused strategy to solidify reimbursement coverage for PTNS," continued Mr. Kaysen. "We are making impressive progress with center and patient enrollment in the new study which compares the Urgent PC system treatment against non-active treatment (placebo or sham treatment). This study design was suggested by professional associations that help to educate third party insurance carriers establish reimbursement for procedures. We anticipate applying to the American Medical Association for a specific "listed" CPT reimbursement code for Urgent PC treatments once the data is compiled and analyzed.
"Meanwhile, we have implemented a comprehensive program designed to educate medical directors of insurance carriers around the country. Physicians using Urgent PC are communicating their successes to these medical directors. In addition, we are in active communication with professional associations who are involved with reimbursement and believe we have the right people and the right resources to proactively address various reimbursement related issues. It is important to remember that reimbursement uncertainties are common with practically every new medical technology. We have been successfully educating the market on the benefits of Urgent PC since we received FDA approval and believe that our strategies to solidify reimbursement coverage are generating positive responses from the market," added Mr. Kaysen.
"As we look to the remainder of fiscal 2009, we still anticipate solid revenue growth over the prior fiscal year, albeit at a lower rate than we previously forecasted. In this challenging market environment we have maintained more than 330 active customers through the end of the second fiscal quarter. We now believe that overall sales in the current fiscal year will grow by approximately 20% over fiscal 2008, and we expect U.S. sales to grow between 30% and 40%. As we have previously discussed, we anticipate spending between $1.1 million and $1.4 million for the new clinical study, substantially all of it in the second half of fiscal 2009. 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 second 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 (800) 218-0204 (domestic) or (303) 262-2161 (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 11121202#.
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 continued 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.
Forward Looking Information
This press release contains forward-looking statements, which reflect our best estimates regarding future events and financial performance. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our anticipated results. We discuss in detail the factors that may effect the achievement of our forward-looking statements in our Annual Report on Form 10-K filed with the SEC. These factors include:
We cannot assure you that our clinical trial will produce favorable results, that third-party payors will provide or continue to provide coverage and reimbursement, or reimburse the providers an amount sufficient to cover their costs and expenses, nor can we assure you that we will timely obtain, or even succeed at all at obtaining, a specific "listed" CPT reimbursement code from the AMA for Urgent PC treatments. We further cannot assure that reimbursement or other issues will not further impact our fiscal 2009 results.
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 share-based compensation 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.
Our non-GAAP operating performance improved from a loss of approximately $0.6 million and $1 million, respectively, for the three and six months ended September 30, 2007 to a (loss) gain of approximately ($98,000) and $8,000, respectively, for the three and six months ended September 30, 2008. We attribute this improvement in non-GAAP operating performance to the increase in sales and an improvement in gross margin rate, offset partially by an increase in cash operating expenses.
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, Chris Gale, or
Steve DiMattia, +1-646-201-5431, all of EVC Group, for Uroplasty, Inc.
Web site: http://www.uroplasty.com/
