Uroplasty (UPI) Reports Fiscal Fourth Quarter And Full Year 2013 Financial Results

~U.S. Sales of Urgent® PC increase 11% in Fourth Quarter and 35% for Full Fiscal Year onference call today at 4:30 p.m. ET

MINNEAPOLIS, May 30, 2013 /PRNewswire/ — 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 fourth quarter and fiscal year 2013 ended March 31, 2013.

Fiscal Fourth Quarter 2013 Financial Results

Fiscal fourth quarter 2013 sales in the U.S. increased 2%, driven by an 11% increase in sales of the Urgent^® PC Neuromodulation System, compared with fiscal fourth quarter a year ago.  Global sales declined 1% to $5.5 million in the fourth quarter of fiscal 2013, compared with $5.6 million in the fiscal fourth quarter a year ago.

U.S. Urgent PC Sales in the fiscal fourth quarter of 2013 were $2.6 million.  Macroplastique sales in the U.S. totaled $1.4 million in the recent fiscal fourth quarter, a decrease of 13% over the same quarter last year.

The Company sold 3,365 lead set boxes to 581 active Urgent PC customers in the U.S. in the fiscal fourth quarter compared with 3,501 lead set boxes to 620 active customers during the fiscal third quarter.

“While sales of Urgent PC in the U.S. increased year over year, we were disappointed with our progress,” said Rob Kill, Interim Chief Executive Officer of Uroplasty. “We are executing our strategy to reinvigorate and regain the momentum of Urgent PC sales, especially in the U.S.  By mid-May, under our new sales leadership, we had replaced sales representatives in six territories. We are focused on finding sales representatives with experience in medical device sales, a solid understanding of their regional markets and strong relationships with physician groups in their territories. By end of June we expect to have 45 total sales representatives in place.”

Net sales to customers outside the U.S. for the fiscal fourth quarter totaled $1.5 million, compared to $1.6 million in the fiscal fourth quarter last year.  Excluding the impact of fluctuations in foreign currency exchange rates, sales outside the U.S. were down 7%.

The Company reported a gross margin of 86.5% in the recent fiscal fourth quarter compared with 85.9% in the same quarter a year ago.  The operating loss of $968,000 in the fiscal fourth quarter compares with a $589,000 operating loss in the same quarter last year. Excluding non-cash charges for share-based compensation and depreciation and amortization expense, the non-GAAP operating loss was $477,000 in the fourth quarter of fiscal 2013, compared with a $122,000 non-GAAP operating loss in the fourth quarter a year ago.  The increase in operating loss was primarily attributable to the decrease in sales and an increase in operating expenses.

Full Year Fiscal 2013 Financial Results

For the full year ended March 31, 2013, sales grew $1.9 million to $22.4 million, reflecting an 18% increase in U.S. sales and a 10% decrease in sales outside the U.S.  In the U.S., sales of Urgent PC increased 35% to $10.5 million, and Macroplastique sales decreased 2% to $5.7 million.  At March 31, 2013, cash, cash equivalents and investments totaled $14.9 million compared to $15.6 million at December 31, 2012.

R&D Initiatives

The Company continues to make progress on two R&D initiatives – an implantable tibial nerve stimulator for in-home treatments for OAB for the markets outside of the U.S. and an indication for use of Urgent PC to treat bowel incontinence for the U.S. market.  Both products have the potential to expand Uroplasty’s addressable market.

The implantable tibial nerve stimulator will allow patients to receive the benefits of PTNS treatments at home with the patient controlling the treatment interval.  The Company continues to make progress on prototypes for this new product.

The Company has identified two U.S. centers to conduct a pilot clinical trial for the treatment of bowel incontinence using the Urgent PC Neuromodulation System.  The investigators at those centers are currently in the screening process for potential candidates for treatment.  The pilot trial, for the initial treatments, is scheduled for completion late next year.  Urgent PC has CE Mark approval for the treatment of bowel incontinence and has been used in Europe for this indication for several years.

Outlook

“Our focus in the near term will be on driving sales of Urgent PC through additional investments in sales and marketing. We made progress in the quarter in hiring experienced sales reps with strong relationships in their markets and have also revised our sales incentives to be better aligned with our financial objectives.  We are also adding clinical representatives to the team who will focus on working with our customers to expand patient access to Urgent PC.  We anticipate it will take a few months for our new reps to become productive.

“In addition, we have commenced a search for a new CEO.  Working with an outside search firm, we are seeking a senior executive with experience in leading the commercial expansion of new medical device therapies and scaling an organization in the $25 to $200 million range of revenue for sustained top and bottom line growth.  We remain optimistic about the opportunities ahead for Uroplasty through this transition and our ability to return to sales growth and improved operating results during the second half of the fiscal year,” concluded Mr. Kill.

Conference Call

Uroplasty will host a conference call and webcast today at 3:30 pm Central, 4:30 pm Eastern, to review the financial results for the fiscal fourth quarter and full year of 2013.  Rob Kill, Interim Chief Executive Officer, and Medi Jiwani, Vice President, Chief Financial Officer and Treasurer, will host. 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 with the passcode 4618943#.

To access the live webcast of the call, go to Uroplasty’s website at www.uroplasty.com and click on the Investor Relations section. An archived webcast will also be available at http://investor.uroplasty.com.

About Uroplasty, Inc.

Uroplasty, Inc., headquartered in Minnetonka, Minnesota, with wholly-owned subsidiaries in The Netherlands and the United Kingdom, is a global medical company committed to offering transformative treatment options to specialty physicians. Our products are designed to help providers change the lives of their voiding dysfunction patients and strengthen the efficiency of their practices. Our focus is the continued commercialization of our Urgent® PC Neuromodulation System, the only FDA-cleared system that delivers percutaneous tibial nerve stimulation (PTNS) for the office-based treatment of overactive bladder and associated symptoms of urgency, frequency and urge incontinence. We also offer Macroplastique®, 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 we will ever achieve sustained profitability, that the rate of reimbursement for PTNS treatments will be adequate to justify the cost of our product, that other Medicare carriers or private payers will provide coverage for this treatment or that existing carriers and payers will not change their coverage decisions, that the rate of adoption of our products by new customers will continue, or that any of the other risks identified in our 10-K will not adversely affect 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 these 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 the three months ended March 31, 2013 and 2012 was approximately $477,000 and $122,000, respectively.  Our non-GAAP operating loss for fiscal 2013 and 2012 was approximately $1.3 million and $2.5 million, respectively.  The fiscal 2013 decrease in non-GAAP operating loss is attributed primarily to an increase in Net sales which more than offset the increase in non-GAAP spending.