MINNEAPOLIS, Jan. 24, 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 third quarter of fiscal 2013 ended December 31, 2012. The Company also announced the completion of a purchase agreement for both Urgent PC and Macroplastique with KP Select, Inc., which provides contract management services for all Kaiser Permanente and affiliated health care facilities.
Fiscal Third Quarter 2013 Financial Results
Global sales grew 5% to $5.6 million for the third quarter of fiscal 2013, compared with $5.3 million in the fiscal third quarter a year ago. Sales in the U.S. increased 15%, driven by a 37% increase in sales of the Urgent® PC Neuromodulation System.
The Company sold 3,501 lead set boxes to 620 active Urgent PC customers in the U.S. in the fiscal third quarter compared with 648 active customers and 3,576 lead set boxes sold during the fiscal second quarter. This is the second consecutive year the Company has experienced a sequential quarterly flattening in these metrics, and management believes the decrease reflects the seasonal slowdown in initiation of treatments by new patients.
“Sales of Urgent PC in the fiscal third quarter ended December were affected by a slowdown in new patient volume during the holiday season that began in mid-November and persisted through the end of the calendar year,” said David Kaysen, President and CEO of Uroplasty. “However, we are optimistic about the product’s continued growth and expect the sales momentum to pick up in the fiscal fourth quarter, as new patients commit to the procedure and as we continue to make inroads into penetrating existing accounts and bringing in new customers.”
U.S. Urgent PC Sales in the fiscal third quarter of 2013 totaled $2.7 million, up from $2.0 million in the fiscal 2012 third quarter. Macroplastique sales in the U.S. totaled $1.4 million in the recent fiscal third quarter, a decrease of 12% over the same quarter last year, reflecting the emphasis of sales representatives on driving sales of Urgent PC.
Net sales to customers outside of the U.S. for the fiscal third quarter totaled $1.5 million, a decrease of 16% from the fiscal third quarter last year. Excluding the impact of fluctuations in foreign currency exchange rates, total sales outside the U.S. were down 14%. Urgent PC sales outside of the U.S. were $556,000 compared with $581,000 in the prior fiscal year’s third quarter.
The Company reported a gross margin of 86.9% in the recent fiscal third quarter compared with 85.5% in the same quarter a year ago. The operating loss of $677,000 in the fiscal third quarter compares with a $1.1 million 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 $135,000 in the third quarter of fiscal 2013, compared with a $570,000 non-GAAP operating loss in the third quarter a year ago. The decrease in operating loss was primarily attributable to the increase in sales, an improved gross margin, and a decrease in operating expenses.
Fiscal Nine Months 2013 Financial Results
For the nine-month period ended December 31, 2012, sales grew 13% to $16.9 million, reflecting a 25% increase in U.S. sales and an 11% decrease in sales outside the U.S. In the U.S., sales of Urgent PC increased 45% to $8.0 million and Macroplastique sales increased 1% to $4.3 million. At December 31, 2012, cash, cash equivalents and cash investments totaled $15.6 million
KP Select Purchase Agreement and Additional Expanded Coverage
The recently-completed purchase agreement with KP Select, Inc. for sales of Urgent PC and Macroplastique to Kaiser Permanente is a three-year contract and begins on March 1, 2013. Kaiser Permanente provides services to more than nine million members in 10 states through 37 hospitals and 611 medical offices and clinics, though not all locations treat urinary incontinence.
“We are extremely excited about the new contract with Kaiser Permanente, which opens the door for us to provide both Urgent PC and Macroplastique to this world class organization, its physicians and members,” Mr. Kaysen continued. “We are looking forward to presenting both of our products to Kaiser Permanente locations that treat patients with urinary stress incontinence and overactive bladder.
“During the fiscal third quarter, we also received new or enhanced coverage decisions from several private payers and Medicare administrators. Health Net, one of the largest insurance payers in California; Medica®, a Minnesota-based private payer with coverage in the northern Midwest region of the country; and Health First of Florida began to cover percutaneous tibial nerve stimulation (PTNS) treatments. Additionally, two Medicare administrators – Noridian Administrative Services and Palmetto - have expanded coverage to two years based on recently published clinical studies that confirm the sustained therapeutic effects from continued PTNS treatments. These recent new agreements and treatment time expansions give us confidence in the outlook for continued strong growth of Urgent PC.”
R&D Initiatives
“We have made significant progress in our efforts to secure CE Mark approval for an implantable tibial nerve stimulator for the treatment of overactive bladder,” continued Mr. Kaysen. “This product is designed for patients who have successfully completed 12 weekly treatments using Urgent PC and can continue to receive the benefits of PTNS treatments in the comfort and privacy of their homes. We expect to submit an application for a CE Mark in late spring/early summer, which, if approved, would allow us to commercialize this product in Europe in the fall.”
General Outlook
“Looking forward, we anticipate a strong finish to fiscal 2013 and healthy momentum from Urgent PC sales going into the new fiscal year. While early in its implementation, our practice enhancement program, designed to help our physician customers find and treat patients with OAB, is demonstrating good potential. We continue to aggressively call on new urologists and related physicians in our coverage areas to educate them on the safety and efficacy benefits of Urgent PC. With our large base of positive payer coverage policies, experienced sales team and potential for increased penetration at existing accounts, we are well-positioned to grow. Finally, the outlook for two new additional products - our implantable tibial nerve stimulator as well as an indication for use of Urgent PC in treating fecal incontinence in the United States – is very promising and offers potential for incremental future revenues. We are optimistic about the opportunities ahead for Uroplasty and our ability to drive revenue growth and improved operating results,” 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 fiscal third quarter of 2013. 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 877-941-9205. An audio replay will be available for 30 days following the call at 800-406-7325 with the passcode 4589816#.
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.
For Further Information:
Uroplasty, Inc.
David Kaysen, President and CEO, or
Medi Jiwani, Vice President, CFO, and Treasurer
952.426.6140
EVC Group
Jenifer Kirtland (Investors)
415.568.4887
Chris Gale (Media)
646.201.5431
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