UPI Uroplasty Common Stock

- Macroplastique(R) FY 2009 U.S. Sales Up 191% - MINNEAPOLIS, June 4 /PRNewswire-FirstCall/ -- Uroplasty, Inc. (AMEX:UPI), a medical device company that develops, manufactures and markets innovative proprietary products to treat voiding dysfunctions, today reported financial results for the fourth quarter and full year ended March 31, 2009. Net sales of $2.9 million in the fourth fiscal quarter and $14.7 million for the fiscal year were in line with management's previous guidance. "Our fourth quarter and full year results reflect the challenging environment for our Urgent PC(R) system due to insurance reimbursement uncertainties in the U.S. market," said David Kaysen, President and CEO. "While we experienced a significant decline in our fourth quarter net sales, as compared to last year, and expect our operating environment for Urgent PC sales in the U.S. to remain difficult during fiscal 2010, we are beginning to see signs that reinforce our optimism about our long-term future. For example, in April at the American Urology Association Annual Meeting we generated a large number of high-quality leads. At the same time, several doctors who were previous Urgent PC customers told us they were slowly taking steps to rebuild their Urgent PC business. Additionally, we've learned Aetna recently renewed coverage of Urgent PC procedures. Finally, results for the first two months of the new fiscal year suggest Urgent PC sales in certain geographies here in the U.S. may be stabilizing. "A major part of our strategy to expand and support third-party reimbursement coverage of Urgent PC treatment is the SUmiT clinical study, which we announced in October 2008," added Mr. Kaysen. "The study is designed to directly compare the effectiveness of Urgent PC treatment to non-active treatment with the 219 enrolled subjects close to completing their final assessments. The study is evaluating reductions in urinary urgency, urge incontinence and frequency of urinary voids, as well as patient quality of life measures. This study, expected to be completed by early summer of 2009, is being conducted at 23 urology and urogynecology centers across the United States." "We continue to be encouraged by Macroplastique's momentum in the U.S., and the recent Ghoniem et al. publication reporting on its efficacy compared to collagen in the January 2009 issue of the Journal of Urology," added Mr. Kaysen. "Our U.S. Macroplastique sales grew by 191%, as compared to fiscal 2008. In the U.S., we continue to execute our sales and marketing strategy that highlights the clinical and competitive advantages of Macroplastique and we are pleased to report that Aetna has recently initiated coverage for Macroplastique procedures. While our European momentum with Macroplastique was tested by competitive activities and the strengthening of the U.S. dollar against the Euro and the British pound, overall we are optimistic the Macroplastique product line will continue to generate growth," said Mr. Kaysen. Fiscal Fourth Quarter and Full Year Results for the Periods Ended March 31, 2009 Net sales for the three months ended March 31, 2009 were $2.9 million versus $4.1 million for the same period a year ago. Net sales for the year ended March 31, 2009 were $14.7 million, up 6% from $13.9 million for fiscal 2008. Sales to customers in the U.S. for the three months ended March 31, 2009 were $1.6 million, down 24%, compared with $2.1 million in the same period a year ago. This decrease was due to the reimbursement uncertainty for Urgent PC treatments that has developed in the second half of fiscal 2009 in the U.S. market. Sales to customers outside of the U.S. for the three months ended March 31, 2009 were $1.3 million, down 36% from $2.0 million in the year ago period. Excluding the translation impact of fluctuations in foreign currency exchange rates, sales to customers outside of the U.S. declined approximately 22%. Fiscal 2009 sales to customers in the U.S. were $8.0 million, an increase of 27% from $6.3 million in fiscal 2008. First half fiscal 2009 sales of Urgent PC systems drove this growth. Sales of the Macroplastique product line, which was launched in late 2007, increased 191% to $1.1 million compared to sales of $0.4 million in fiscal 2008. Sales of Urgent PC increased 17% to $6.8 million compared to $5.8 million in fiscal 2008. All of this increase occurred during the first half of the year. Due to the previously mentioned reimbursement issues, Urgent PC sales declined in the second half of the fiscal year. Fiscal 2009 sales to customers outside of the U.S. were $6.8 million, a decline of 11%, compared with $7.6 million in fiscal 2008. Excluding the translation impact of fluctuations in foreign currency exchange rates, sales to customers outside of the U.S. declined approximately 8%. In fiscal 2009, the U.S. dollar against the Company's foreign currency denominated sales was weaker in the first half, creating a favorable benefit on translated sales, and was stronger in the second half, creating an unfavorable benefit on translated sales, over corresponding year-ago periods. Net loss for the fourth fiscal quarter ended March 31, 2009 was $1.7 million, or $0.11 per diluted share, versus a net loss of $699,000, or $0.05 per diluted share for the fourth quarter of last year. Fiscal 2009 net loss was $3.6 million, or $0.24 per diluted share compared with a net loss of $3.8 million, or $0.28 per diluted share in fiscal 2008. At March 31, 2009, cash and cash equivalents, and short-term investments were $7.8 million compared with $8.6 million at December 31, 2008 and $10.1 million at March 31, 2008. "We anticipate sales of our Macroplastique product in the U.S. to continue to grow in fiscal 2010 as we expect to benefit from our increased sales and marketing effort," continued Mr. Kaysen. "At the same time, we expect that Urgent PC sales will not return to recent historical sales levels in the U.S. until after a new listed CPT code is assigned and adequate reimbursement provided. We continue to implement a comprehensive program designed to educate Medicare carrier and private payer medical directors around the country about the benefits and clinical study results of Urgent PC. The medical directors have asked for additional peer-reviewed publications in medical journals on percutaneous tibial nerve stimulation (PTNS) treatments, and to date, three new articles have been published. We understand that the 12-week results of our earlier OrBIT clinical study will be published in the September issue of the Journal of Urology. We are hopeful that these publications, along with an anticipated three to four additional articles we will provide to the medical directors, will lead them to either reaffirm or reinstate reimbursement. "In addition to this publications strategy, we have at least four abstracts that have been accepted for presentation by medical professionals at upcoming medical conferences here in the U.S. Our overall goal is to receive a listed CPT code in February 2010 which would become effective in January 2011 that we believe will encourage broader use of our Urgent PC. We are confident that we are moving toward that objective." 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 fourth 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 877-941-8609 (domestic) or 480-629-9818 (international). An audio replay will be available for 30 days following the call at 800-406-7325 (domestic) or 303-590-3030 (international), with the passcode 4081844#. 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 on sales growth in the U.S. market. We offer the 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. 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. Further, we cannot assure you that our SUmiT clinical trial will produce favorable results, that even if it does produce favorable results 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, or 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 2010 results. For Further Information: Uroplasty, Inc. EVC Group David Kaysen, President and CEO, or Doug Sherk (Investors) Medi Jiwani, Vice President, CFO, and Treasurer 415.896.6820 952.426.6140 Chris Gale (Media) 646.201.5431 UROPLASTY, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS Three Months Ended Fiscal Year Ended March 31, March 31, (unaudited) 2009 2008 2009 2008 Net sales 2,908,759 $4,138,280 $14,742,182 $13,855,811 Cost of goods sold 492,821 881,927 2,283,975 2,935,135 Gross profit 2,415,938 3,256,353 12,458,207 10,920,676 Operating expenses General and administrative 758,305 937,678 3,428,959 3,692,678 Research and development 1,093,905 404,566 2,551,075 1,798,062 Selling and marketing 2,004,119 2,509,000 9,255,025 8,515,598 Amortization of intangibles 211,957 210,668 845,524 843,533 4,068,286 4,061,912 16,080,583 14,849,871 Operating loss (1,652,348) (805,559) (3,622,376) (3,929,195) Other income (expense) Interest income 34,056 95,612 196,714 312,162 Interest expense (1,788) (8,125) (17,160) (35,266) Foreign currency exchange loss (13,111) (64,452) (13,843) (117,990) Other, net (2,060) (2,501) (6,747) 1,513 17,097 20,534 158,964 160,419 Loss before income taxes (1,635,251) (785,025) (3,463,412) (3,768,776) Income tax expense (benefit) 81,335 (86,480) 114,708 55,464 Net loss (1,716,586) $(698,545) $(3,578,120) $(3,824,240) Basic and diluted loss per common share $(0.11) $(0.05) $(0.24) $(0.28) Weighted average common shares outstanding: Basic and diluted 14,932,540 14,916,540 14,922,502 13,839,371 UROPLASTY, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS March 31, 2009 2008 Assets Current assets: Cash and cash equivalents & short-term investments $7,776,299 $10,146,081 Accounts receivable, net 1,214,049 2,318,604 Income tax receivable - 50,841 Inventories 495,751 558,657 Other 279,898 244,517 Total current assets 9,765,997 13,318,700 Property, plant, and equipment, net 1,401,229 1,638,953 Intangible assets, net 3,378,648 4,200,890 Prepaid pension asset 66,130 26,482 Deferred tax assets 68,793 105,298 Total assets $14,680,797 $19,290,323 Liabilities and Shareholders' Equity Total current liabilities 1,927,998 2,739,933 Long-term debt - less current maturities - 413,279 Deferred rent - less current portion 147,576 180,979 Accrued pension liability 296,646 353,411 Total liabilities 2,372,220 3,687,602 Total shareholders' equity 12,308,577 15,602,721 Total liabilities and shareholders' equity $14,680,797 $19,290,323 UROPLASTY, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS Years ended March 31, 2009 2008 Cash flows from operating activities: Net loss $(3,578,120) $(3,824,240) Adjustments to reconcile net loss to net cash used in operations: Depreciation and amortization 1,135,800 1,072,552 Loss on disposal of equipment 6,757 27 Share-based consulting expense 60,093 49,749 Share-based compensation expense 689,513 989,144 Deferred income taxes 17,594 5,262 Deferred rent (35,000) (35,000) Changes in operating assets and liabilities: Accounts receivable 918,959 (947,869) Inventories (19,512) 346,598 Other current assets and income tax receivable 50,086 107,204 Accounts payable (25,781) 86,190 Accrued liabilities (655,186) 553,757 Accrued pension liability, net 13,111 (248,160) Net cash used in operating activities (1,421,686) (1,844,786) Cash flows from investing activities: Proceeds from sale of short-term investments 14,157,410 6,648,447 Purchase of short-term investments (12,391,373) (9,914,484) Purchases of property, plant and equipment (199,704) (302,457) Proceeds from sales of equipment - 1,847 Payments for intangible assets (23,282) (77,469) Net cash provided by (used in) investing activities 1,543,051 (3,644,116) Cash flows from financing activities: Proceeds from financing obligations - 178,374 Repayment of debt obligations (455,913) (259,650) Net proceeds from issuance of common stock, warrants and option exercise - 5,352,762 Net cash (used in) provided by financing activities (455,913) 5,271,486 Effect of exchange rates on cash and cash equivalents (269,197) 333,758 Net (decrease) increase in cash and cash equivalents (603,745) 116,342 Cash and cash equivalents at beginning of year 3,880,044 3,763,702 Cash and cash equivalents at end of year $3,276,299 $3,880,044 Supplemental disclosure of cash flow information: Cash paid during the year for interest $13,612 $32,479 Cash paid during the year for income tax $18,335 $- Supplemental disclosure of non-cash financing and investing activities: Purchase of intellectual property funded by issuance of stock - 4,658,861 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, 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. We use these 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 loss for fiscal 2009 and 2008 was approximately $1.7 million and $1.8 million, respectively. Years ended March 31, 2009 2008 Non-GAAP Gross Profit GAAP gross profit $12,458,207 $10,920,676 % of sales 85% 79% Share-based compensation 42,818 22,531 Depreciation expenses 52,432 54,635 Non-GAAP gross profit 12,553,457 10,997,842 Non-GAAP Operating Expenses GAAP operating expenses 16,080,583 14,849,871 Share-based compensation 706,788 1,016,362 Depreciation expenses 237,844 174,384 Amortization expenses 845,524 843,533 Non-GAAP operating expenses 14,290,427 12,815,592 Non-GAAP Operating Loss GAAP operating loss (3,622,376) (3,929,195) Share-based compensation 749,606 1,038,893 Depreciation expenses 290,276 229,019 Amortization expenses 845,524 843,533 Non-GAAP operating loss $(1,736,970) $(1,817,750) DATASOURCE: Uroplasty, Inc. 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, +1-415-896-6820, or Media, Chris Gale, +1-646-201-5431, both of EVC Group, for Uroplasty, Inc. Web Site: http://www.uroplasty.com/

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