- Macroplastique(R) year-over-year U.S. Sales Double -
- SUmiT Trial Nears Completion -
- Conference Call to be Held Today at 3:30 pm Central Time -
MINNEAPOLIS, Aug. 3 /PRNewswire-FirstCall/ -- Uroplasty, Inc. (NYSE Amex: 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, 2009.
"Our team is successfully executing the strategy we communicated at the beginning of the fiscal year of growing U.S. Macroplastique sales and accumulating the clinical data for seeking a unique CPT code for Urgent PC((R)) treatments," said David Kaysen, President & CEO. "While our fiscal first quarter financial performance is below year-ago results, we are encouraged by our U.S. Macroplastique sales that have doubled from last year's fiscal first quarter. Our European Macroplastique sales were impacted by a recently resolved distributor over-stock issue, change in a distributor in a key market, and a new competitive product entry we noted earlier this year. At the same time, we have been managing expenses to conserve cash while investing in R&D, namely the SUmiT clinical study."
Fiscal First Quarter Results for the Period Ended June 30, 2009
Net sales for the three months ended June 30, 2009 were $2.8 million versus $4.5 million for the same period a year ago.
Sales to customers in the U.S. during the three months ended June 30, 2009 totaled $1.5 million, representing a 34% decrease, over net sales of $2.2 million for the three months ended June 30, 2008. Sales of our Urgent PC of $1.0 million declined from $2.0 million in the year-ago quarter. The trend in decline of our Urgent PC sales over corresponding year-ago periods began in the second half of fiscal 2009 due to reimbursement related issues. Partially offsetting this decline was an increase in Macroplastique sales to $0.4 million from $0.2 million in the year-ago quarter. Sales of Macroplastique product have steadily increased because of increased sales and marketing focus.
Sales to customers outside of the U.S. for the three months ended June 30, 2009 were $1.4 million, down 41% from $2.3 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 31%. The sales decrease is mainly attributed to the strengthening of the U.S. dollar against the Euro and the British pound, increased competition from a newly-introduced product against the Macroplastique product, inventory buildup in the previous quarters at one of the European distributors, a change in distributor in another European country and discontinuation of our I-Stop urethral sling product in the United Kingdom.
Net loss for the first fiscal quarter ended June 30, 2009 was $1.4 million, or $0.09 per diluted share, versus a net loss of $0.4 million, or $0.03 per diluted share for the first quarter of last year.
At June 30, 2009, cash and cash equivalents, and short-term investments were $6.3 million compared with $7.8 million at March 31, 2009 and $8.6 million at December 31, 2008.
"Our first quarter Urgent PC results reflect the continued challenging environment for our Urgent PC system due to the ongoing reimbursement uncertainties in the U.S. market," continued Mr. Kaysen. "As we have noted in the past, we expect these uncertainties to continue until after the Urgent PC is assigned a new listed CPT code by the American Medical Association (AMA) and payors create coverage policies that provide adequate reimbursement. 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. The study is designed to directly compare the effectiveness of Urgent PC treatment to a non-active sham treatment with 219 enrolled subjects at 22 urology and urogynecology centers across the United States. The study is evaluating reductions in urinary urgency, urge incontinence, and frequency of urinary voids, as well as patient quality of life measures. Currently, study data are being analyzed and a manuscript for publication is under development. We expect the manuscript will be submitted for publication by the early fall, slightly ahead of our original plan," Mr. Kaysen added.
"Macroplastique continues to build sales momentum in the U.S.," said Mr. Kaysen. "In the U.S., we are benefiting from our sales and marketing strategy that highlights the clinical and competitive advantages of Macroplastique and the sales force is doing a good job of adding customers. At the same time, our European sales momentum with Macroplastique has been challenged by the launch of a competitive product, the strengthening of the U.S. dollar against the Euro and the British pound, and, as previously noted, distributor issues in a few key markets. We have now resolved the distributor issues, expect the competitive product impact on sales to stabilize and, overall, we remain optimistic the Macroplastique line will continue to be viewed as the 'gold standard' for bulking agents," said Mr. Kaysen.
"Looking ahead, we expect sales of our Macroplastique product in the U.S. to continue to grow during the remainder of the year as we expect to benefit from our increased sales and marketing effort," continued Mr. Kaysen. "However, we do not expect that we will be able to return to significant sales growth or return to the historic sales level of Urgent PC in the U.S. until a new listed CPT code is assigned and payors create coverage policies that provide adequate reimbursement.
"For the past three quarters we have been implementing a comprehensive program designed to educate Medicare carriers and private payer medical directors around the country about the benefits and clinical study results of Urgent PC. During the quarter no Medicare or private payer carrier changed or eliminated Urgent PC coverage. We continue to generate additional peer-reviewed publications on percutaneous tibial nerve stimulation (PTNS) treatments, and, to date, 12 articles have been published in U.S. peer-reviewed medical and nursing journals. And, we understand that the 12-week results of our earlier OrBIT clinical study have been accepted for publication in the September issue of the Journal of Urology, and the 12-month follow-up results from the same study have been accepted for publication in the January 2010 issue of the same journal. We are hopeful these publications will lead the medical directors to reaffirm or reinstate reimbursement, as well as aid us in our application to the AMA for the CPT code. Our overall goal remains to receive a listed CPT code that will encourage broader use of our Urgent PC. We are confident that we are continuing to move toward that objective," 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 of 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 877-941-1466 (domestic) or 480-629-9644 (international).
