(Source: PRNewswire)

- Macroplastique(R) FY 2009 U.S. Sales Up 191% -
- Total Net Sales in Line with Previous Guidance -
- Conference Call to be Held Today at 3:30 pm Central Time -
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.