UPI (MM)

MINNEAPOLIS, Aug. 10 /PRNewswire-FirstCall/ -- Uroplasty, Inc. (Nasdaq: UPI), a medical device company that develops, manufactures and markets innovative proprietary products to treat voiding dysfunctions, today reported financial results for the first fiscal quarter ended June 30, 2010.  The results were highlighted by a 7% global sales growth driven by a 69% growth in U.S. Macroplastique product sales and the return to overall sales growth in Europe.  

"We generated improved financial performance during our fiscal first quarter as our team began the preparations for the relaunch of the Urgent PC system with the January 2011 availability of the new CPT code," said David Kaysen, President & CEO of Uroplasty, Inc.  "While reimbursement rates for the Urgent PC procedure have not yet been established and a specific new CPT code number has not yet been assigned, we continue to expect both to be published in the Federal Register by the Centers for Medical and Medicare Services (CMS) sometime in October or early November 2010.  Meanwhile, our sales team continued to generate strong sales growth for Macroplastique products in the U.S., and we increased overall sales in Europe by 3% and in local currency by approximately 10%.  In anticipation of increased sales and marketing and working capital requirements resulting from the relaunch, we raised approximately $14.9 million through a public offering after quarter end," Mr. Kaysen added.

Fiscal First Quarter Results for the Period Ended June 30, 2010

Net sales for the three months ended June 30, 2010 were $3,036,000, an increase of 7% versus $2,826,000 for the same quarter of fiscal 2010.  Excluding the translation impact of fluctuations in foreign currency exchange rates, sales increased by approximately 10%.

Sales to customers in the U.S. for the three months ended June 30, 2010 were $1,622,000, an 11% increase, compared to $1,460,000 for the year-ago quarter.  Urgent PC sales of $897,000 declined slightly from $1,028,000 for the year-ago quarter.  The slight decline in Urgent PC sales was offset by an increase in sales of Macroplastique.  Macroplastique sales of $712,000 increased 69% from $421,000 for the year-ago quarter.

Net sales to customers outside of the U.S. for the three months ended June 30, 2010 were $1,413,000, an increase of 3%, compared to $1,366,000 for the same period ending June 30, 2009. Excluding the translation impact of fluctuations in foreign currency exchange rates, sales increased by approximately 10%.

Operating loss for the first fiscal quarter ended June 30, 2010 was $925,000 compared to an operating loss of $1,372,000 for the year-ago quarter. Net loss for the first fiscal quarter ended June 30, 2010 was $929,000, or $0.06 per diluted share, versus a net loss of $1,366,000, or $0.09 per diluted share for the year-ago quarter.

At June 30, 2010, cash and cash equivalents, and short-term investments were $7.3 million, which includes approximately $2.2 million of net proceeds from the exercise of warrants to purchase 886,000 shares of the Company's common stock.  Subsequent to the quarter end, in a public offering of common shares, the Company issued an additional 4.6 million shares at $3.50 per share, for net proceeds of approximately $14.9 million.  The proceeds are expected to be used to expand the U.S. sales and marketing organizations to support the Urgent PC business, and for clinical studies, working capital and general corporate purposes.  Including the shares offered in the public offering, the company now has 20.5 million common shares outstanding.

"The first component of our plan for relaunch of the Urgent PC system in the U.S. was to raise funds for investing in expanded sales and marketing resources," continued Mr. Kaysen.  "This step was completed in mid July with the public offering of our common shares.  Today we have in excess of $20 million of cash and cash equivalents on hand.  To educate the market about Urgent PC and the CPT code, we are beginning to implement plans to nearly double our U.S. sales force from the current 16 field reps and four managers to 31 field reps, four field reimbursement specialists and four managers by November.

"If reimbursement rates are adequate, our goal is to capture some portion of the market for patients who cannot tolerate, and discontinue, the drug regimens commonly used to treat symptoms of overactive bladder. We also intend to explore the emerging opportunity in the U.S. to treat fecal incontinence using the Urgent PC.  The Urgent PC is already CE-marked for treatment of fecal incontinence and our increased OUS sales during the fiscal first quarter can be partially attributed to increased Urgent PC business in Europe for the treatment of fecal incontinence.  In summary, we remain quite excited about the opportunities ahead for our company, and are focused on executing plans that fully capitalize on those opportunities," 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 ended June 30, 2010. 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 888-549-7750. 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 4337016#.

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 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 Implants, an injectable urethral bulking agent for the treatment of adult female stress urinary incontinence primarily due to intrinsic sphincter deficiency. For more information on the company and its products, please visit Uroplasty, Inc. at www.uroplasty.com.

Forward-Looking Information

This press release contains forward-looking statements, that 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 affect the achievement of our forward-looking statements in our Annual Report on Form 10-K filed with the SEC. In particular, we cannot be certain that the CPT Code for the PTNS procedures in which Urgent PC is used will be timely published, that the rate of reimbursement for such procedures will be adequate to justify the cost of our product, that the amount and rate at which we apply funds to expand our sales force will be justified by increased sales, that larger competitors will not introduce products or pharmaceuticals that target the portion of the market for which Urgent PC is designed, that sales of our Macroplastique product will continue to increase, that percutaneous nerve stimulation will ever be an accepted, and FDA cleared, procedure for the treatment of fecal incontinence, or that if it is, it will be reimbursed by private and governmental payers, or that any of the other risks identified in our 10-K will not adversely effect our expectations as described in these forward-looking statements .

Non-GAAP Financial Measures:  The following table reconciles our operating loss 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 described 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 and incentive compensation for senior management because we believe such measures are one important indicator of the strength and the operating performance of our business.  Analysts and investors frequently ask us for this information.  We believe that they 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 during the three months ended June 30, 2010 and 2009 was approximately $565,000 and $915,000, respectively.  The decline in the non-GAAP operating loss is attributed primarily to an increase in sales and gross margin rate.   

SOURCE Uroplasty, Inc.