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Uroplasty Reports Fourth Quarter and Full Year Fiscal 2009 Results

- 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. The medical directors have asked for additional peer-reviewed publications in medical journals on percutaneous tibial nerve stimulation (PTNS) treatments, and to date, three new articles have been published. We understand that the 12-week results of our earlier OrBIT clinical study will be published in the September issue of the Journal of Urology. We are hopeful that these publications, along with an anticipated three to four additional articles we will provide to the medical directors, will lead them to either reaffirm or reinstate reimbursement.

"In addition to this publications strategy, we have at least four abstracts that have been accepted for presentation by medical professionals at upcoming medical conferences here in the U.S. Our overall goal is to receive a listed CPT code in February 2010 which would become effective in January 2011 that we believe will encourage broader use of our Urgent PC. We are confident that we are moving toward that objective."

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 fourth fiscal quarter of 2009. 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 877-941-8609 (domestic) or 480-629-9818 (international). 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 4081844#.

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 primary focus is on sales growth in the U.S. market. We offer the 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(R) Implants, an injectable bulking agent for the treatment of adult female stress urinary incontinence. Please visit Uroplasty, Inc. at

Forward-Looking Information

This press release contains forward-looking statements, which 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 effect the achievement of our forward-looking statements in our Annual Report on Form 10-K filed with the SEC. Further, we cannot assure you that our SUmiT clinical trial will produce favorable results, that even if it does produce favorable results third-party payors will provide or continue to provide coverage and reimbursement, or reimburse the providers an amount sufficient to cover their costs and expenses, or that we will timely obtain, or even succeed at all at obtaining, a specific "listed" CPT reimbursement code from the AMA for Urgent PC treatments. We further cannot assure that reimbursement or other issues will not further impact our fiscal 2010 results.

    For Further Information: Uroplasty, Inc.          EVC Group
    David Kaysen, President and CEO, or               Doug Sherk (Investors)
    Medi Jiwani, Vice President, CFO, and Treasurer   415.896.6820
    952.426.6140                                      Chris Gale (Media)
                        UROPLASTY, INC. AND SUBSIDIARIES

                           Three Months Ended         Fiscal Year Ended
                                March 31,                 March 31,
                             2009        2008         2009         2008

    Net sales             2,908,759  $4,138,280  $14,742,182  $13,855,811
    Cost of goods sold      492,821     881,927    2,283,975    2,935,135

    Gross profit          2,415,938   3,256,353   12,458,207   10,920,676

    Operating expenses
       General and
        administrative      758,305     937,678    3,428,959    3,692,678
       Research and
        development       1,093,905     404,566    2,551,075    1,798,062
       Selling and
        marketing         2,004,119   2,509,000    9,255,025    8,515,598
       Amortization of
        intangibles         211,957     210,668      845,524      843,533
                          4,068,286   4,061,912   16,080,583   14,849,871

    Operating loss       (1,652,348)   (805,559)  (3,622,376)  (3,929,195)

    Other income (expense)
       Interest income       34,056      95,612      196,714      312,162
       Interest expense      (1,788)     (8,125)     (17,160)     (35,266)
       Foreign currency
        exchange loss       (13,111)    (64,452)     (13,843)    (117,990)
       Other, net            (2,060)     (2,501)      (6,747)       1,513
                             17,097      20,534      158,964      160,419

    Loss before income
     taxes               (1,635,251)   (785,025)  (3,463,412)  (3,768,776)

    Income tax expense
     (benefit)               81,335     (86,480)     114,708       55,464

    Net loss             (1,716,586)  $(698,545) $(3,578,120) $(3,824,240)

    Basic and diluted
     loss per common
     share                   $(0.11)     $(0.05)      $(0.24)      $(0.28)

    Weighted average
     common shares
       Basic and
        diluted          14,932,540  14,916,540   14,922,502   13,839,371

                        UROPLASTY, INC. AND SUBSIDIARIES
                                    March 31,

                                                   2009        2008
      Current assets:
       Cash and cash equivalents & short-term
        investments                             $7,776,299 $10,146,081
       Accounts receivable, net                  1,214,049   2,318,604
       Income tax receivable                             -      50,841
       Inventories                                 495,751     558,657
       Other                                       279,898     244,517
           Total current assets                  9,765,997  13,318,700

      Property, plant, and equipment, net        1,401,229   1,638,953
      Intangible assets, net                     3,378,648   4,200,890
      Prepaid pension asset                         66,130      26,482
      Deferred tax assets                           68,793     105,298

       Total assets                            $14,680,797 $19,290,323

    Liabilities and Shareholders' Equity
      Total current liabilities                  1,927,998   2,739,933
      Long-term debt - less current maturities           -     413,279
      Deferred rent - less current portion         147,576     180,979
      Accrued pension liability                    296,646     353,411

       Total liabilities                         2,372,220   3,687,602

       Total shareholders' equity               12,308,577  15,602,721

       Total liabilities and shareholders'
        equity                                 $14,680,797 $19,290,323

                        UROPLASTY, INC. AND SUBSIDIARIES
                              Years ended March 31,

                                                       2009         2008
    Cash flows from operating activities:
       Net loss                                   $(3,578,120) $(3,824,240)
         Adjustments to reconcile net loss to net
          cash used in operations:
            Depreciation and amortization           1,135,800    1,072,552
            Loss  on disposal of equipment              6,757           27
            Share-based consulting expense             60,093       49,749
            Share-based compensation expense          689,513      989,144
            Deferred income taxes                      17,594        5,262
            Deferred rent                             (35,000)     (35,000)
         Changes in operating assets and liabilities:
            Accounts receivable                       918,959     (947,869)
            Inventories                               (19,512)     346,598
            Other current assets and income tax
             receivable                                50,086      107,204
            Accounts payable                          (25,781)      86,190
            Accrued liabilities                      (655,186)     553,757
            Accrued pension liability, net             13,111     (248,160)

    Net cash used in operating activities          (1,421,686)  (1,844,786)

    Cash flows from investing activities:
       Proceeds from sale of short-term
        investments                                14,157,410    6,648,447
       Purchase of short-term investments         (12,391,373)  (9,914,484)
       Purchases of property, plant and equipment    (199,704)    (302,457)
       Proceeds from sales of equipment                     -        1,847
       Payments for intangible assets                 (23,282)     (77,469)

    Net cash provided by (used in) investing
     activities                                     1,543,051   (3,644,116)

    Cash flows from financing activities:
       Proceeds from financing obligations                  -      178,374
       Repayment of debt obligations                 (455,913)    (259,650)
       Net proceeds from issuance of common
        stock, warrants and option exercise                 -    5,352,762

    Net cash (used in) provided by financing
     activities                                      (455,913)   5,271,486

    Effect of exchange rates on cash and cash
     equivalents                                     (269,197)     333,758

    Net (decrease) increase in cash and cash
     equivalents                                     (603,745)     116,342

    Cash and cash equivalents at beginning of
     year                                           3,880,044    3,763,702
    Cash and cash equivalents at end of year       $3,276,299   $3,880,044

    Supplemental disclosure of cash flow
       Cash paid during the year for interest         $13,612      $32,479
       Cash paid during the year for income tax       $18,335           $-

    Supplemental disclosure of non-cash
     financing and investing activities:

       Purchase of intellectual property funded
        by issuance of stock                                -    4,658,861

    Non-GAAP Financial Measures.  The following table reconciles our
    financial results 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 above to the most directly comparable GAAP financial

    We use these non-GAAP financial measures, and in particular non-GAAP
    operating loss, for internal managerial purposes because we believe such
    measures are one important indicator of the strength and the performance
    of our business as they provide a link to operating cash flow.  We also
    believe that analysts and investors 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 for fiscal 2009 and 2008 was approximately
    $1.7 million and $1.8 million, respectively.

                                                     Years ended
                                                      March 31,
                                                  2009          2008

    Non-GAAP Gross Profit
          GAAP gross profit                  $12,458,207   $10,920,676
                % of sales                            85%           79%
          Share-based compensation                42,818        22,531
          Depreciation expenses                   52,432        54,635

          Non-GAAP gross profit               12,553,457    10,997,842

    Non-GAAP Operating Expenses
          GAAP operating expenses             16,080,583    14,849,871
          Share-based compensation               706,788     1,016,362
          Depreciation expenses                  237,844       174,384
          Amortization expenses                  845,524       843,533

          Non-GAAP operating expenses         14,290,427    12,815,592

    Non-GAAP Operating Loss
          GAAP operating loss                 (3,622,376)   (3,929,195)
          Share-based compensation               749,606     1,038,893
          Depreciation expenses                  290,276       229,019
          Amortization expenses                  845,524       843,533

          Non-GAAP operating loss            $(1,736,970)  $(1,817,750)

SOURCE Uroplasty, Inc.
Copyright©2009 PR Newswire.
All rights reserved

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