Uroplasty Reports Results for Second Quarter FY2010

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Mon Nov 2, 2009 4:05pm EST

- Macroplastique(R) Year-over-Year U.S. Sales Continue Strong Growth -







MINNEAPOLIS, Nov. 2 /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 second fiscal quarter ended September 30, 2009.   

"Our team continues to execute our strategy for the current fiscal year by
growing U.S. Macroplastique sales and maximizing the potential for gaining a
unique CPT code for Urgent PC® treatments," said David Kaysen, President &
CEO.  "During the quarter, we learned that a manuscript of the results from
the SUmiT Trial has been recommended for publication in The Journal of
Urology® and is tentatively scheduled to appear in the April 2010 issue.  This
study reports on a 220-subject, multicenter, randomized, controlled clinical
trial designed to directly compare the effectiveness of PTNS using Urgent PC
to a validated sham intervention over a 12-week period and is a major
component of our strategy to expand and support third-party reimbursement
coverage of Urgent PC treatments.  The investigators' submission of this
manuscript was ahead of the original timetable. We fully anticipate submitting
an application to the American Medical Association (AMA) for a unique CPT code
for PTNS prior to the November 11, 2009 deadline. 

"While our fiscal second quarter and first half financial performance is below
year-ago results, we are encouraged by the continued strong growth of our U.S.
Macroplastique product sales," continued Mr. Kaysen.  "Sales of our
Macroplastique product in the U.S. through six months of our current fiscal
year have about doubled in each quarter over the corresponding year-ago
quarter.  At the same time, Urgent PC sales in the U.S., while continuing to
be challenged by the uncertain insurance reimbursement environment, have
stabilized at about $1 million per quarter in each of the last two quarters. 
While European sales continue to be impacted by a competitive product launch,
we saw growth in sales in the second fiscal quarter from distributors in two
major European markets which had recorded a decline in the first fiscal
quarter.  At the same time, with the SUmiT clinical study expenses largely
behind us, and our vigilant efforts to manage expenses to conserve cash, we
have adequate liquidity to meet our needs for the next 12 months."

Fiscal Second Quarter and First Half Results for the Period Ended September
30, 2009

Net sales for the three months ended September 30, 2009 were $3.0 million
versus $3.9 million for the second quarter of fiscal 2009.  Net sales for the
six months ended September 30, 2009 were $5.8 million versus $8.4 million for
same period a year ago.

Net sales to customers in the U.S. during the three months ended September 30,
2009 totaled $1.5 million, as compared to net sales of $2.2 million for the
three months ended September 30, 2008.  Sales of Urgent PC of $960,000
declined from $2.0 million in the year-ago quarter.  The trend in decline of
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 product sales to $528,000 from
$254,000 in the year-ago quarter.  Sales of Macroplastique have steadily
increased because of increased sales and marketing focus.  Net sales of
Macroplastique to customers in the U.S. for the first half of fiscal 2010
totaled $949,000 versus $441,000 for the first six months of fiscal 2009. 

Sales to customers outside of the U.S. for the three months ended September,
2009 were $1.5 million, down from $1.7 million in the year-ago period. 
Excluding the translation impact of fluctuations in foreign currency exchange
rates, sales decreased by approximately 5%.  The second fiscal quarter is
normally the weakest of the year for the Company's international business. 
The sales decrease as compared to last year is mainly attributed to increased
competition from a newly-introduced product competitive with Uroplasty's
Macroplastique.  

Sales to customers outside of the U.S. for the first half of fiscal 2010 were
$2.8 million as compared to $4.0 million, a decrease of 29%, for the six
months ended September 30, 2008.  Excluding the translation impact of
fluctuations in foreign currency exchange rates, sales decreased by
approximately 20%.  Also contributing to the decline in sales is the
discontinuation in the current fiscal year in the U.K. of our I-Stop urethral
sling product which accounted for approximately $101,000 in sales for the six
months ended September 30, 2009 and $191,000 in sales in fiscal 2009.

Net loss for the second fiscal quarter ended September 30, 2009 was $875,000,
or $0.06 per diluted share, versus a net loss of $561,000, or $0.04 per
diluted share for the second quarter of last year.  For the first half of
fiscal 2010, the net loss was $2.2 million, or $0.15 per diluted share as
compared with a net loss for the first half of fiscal 2009 of $968,000, or
$0.06 per diluted share.  

At September 30, 2009, cash and cash equivalents, and short-term investments
were $5.8 million compared with $6.3 million at June 30, 2009 and $7.8 million
as of March 31, 2009. 

"Looking ahead, we expect U.S. sales of Macroplastique to continue to grow
during the remainder of the fiscal 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 four quarters we have implemented a comprehensive program
designed to educate Medicare carriers and private payer medical directors
about the clinical efficacy of Urgent PC.  I am pleased with how we have
executed this strategy, and we are well ahead of our planned publication and
presentation schedule.  Phase I OrBIT data, published in September 2009
demonstrated that PTNS had comparable efficacy to the leading anticholinergic
drug prescribed for overactive bladder. The data demonstrating sustained
symptom improvement at one year from Phase 2 of the OrBIT study has been
accepted for publication in the January 2010 edition of The Journal of
Urology.  With SUmiT study results available in spring 2010, we believe these
publications, as well as others, will lead the medical directors to reaffirm
or reinstate reimbursement, as well as aid us in our CPT Code application. Our
overall goal remains to obtain a unique CPT code that will encourage broader
use of Urgent PC.  We are confident that we are moving closer toward attaining
that goal," 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 second 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
866-561-1721 (domestic) or 480-629-9868 (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 4171526#.

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, 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 affect 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.
    David Kaysen, President and CEO, or
    Medi Jiwani, Vice President, CFO, and Treasurer
    952.426.6140

    EVC Group
    Doug Sherk (Investors)
    415.896.6820
    Chris Gale (Media)
    646.201.5431

                           UROPLASTY, INC. AND SUBSIDIARIES

                   CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
                                     (Unaudited)

                                Three Months Ended      Six Months Ended
                                   September 30,         September 30,
                                   -------------         -------------
                                 2009        2008        2009       2008
                                 ----        ----        ----       ----


    Net sales                $2,986,475  $3,920,516   $5,812,404   $8,446,138
    Cost of goods sold          535,074     549,199    1,087,044    1,257,166
                                -------     -------    ---------    ---------

    Gross profit              2,451,401   3,371,317    4,725,360    7,188,972
                              ---------   ---------    ---------    ---------

    Operating expenses
       General and
        administrative          713,040     918,394    1,561,591    1,957,108
       Research and
        development             435,898     327,978      963,713      733,498
       Selling and marketing  1,968,054   2,505,598    4,025,342    5,125,632
       Amortization             211,503     210,966      423,316      421,941
                                -------     -------      -------      -------
                              3,328,495   3,962,936    6,973,962    8,238,179
                              ---------   ---------    ---------    ---------

    Operating loss             (877,094)   (591,619)  (2,248,602)  (1,049,207)
                               --------    --------   ----------  -----------

    Other income
     (expense)
       Interest income           24,230      63,542       55,629      138,656
       Interest expense          (1,788)     (6,750)      (9,694)     (13,585)
       Foreign currency
        exchange gain (loss)     (7,365)      5,038      (14,697)        (732)
       Other, net                 2,000      (4,687)        (183)      (4,687)
                                  -----      ------         ----       ------
                                 17,077      57,143       31,055      119,652
                                 ------      ------       ------      -------

    Loss before income
     taxes                     (860,017)   (534,476)  (2,217,547)    (929,555)

    Income tax expense           14,642      26,487       22,887       38,057
                                 ------      ------       ------       ------

    Net loss                  $(874,659)  $(560,963) $(2,240,434)   $(967,612)
                              =========  ==========  ===========    =========

    Basic and diluted
     loss per common
     share                       $(0.06)     $(0.04)      $(0.15)      $(0.06)

    Weighted average
     common shares
     outstanding:
       Basic and diluted     14,946,540  14,916,540   14,942,179   14,916,540




                           UROPLASTY, INC. AND SUBSIDIARIES

                        CONDENSED CONSOLIDATED BALANCE SHEETS

                                                   September 30,  March 31,
                                                       2009         2009
                                                    (unaudited)
                                                     ----------  ----------
    Assets
       Current assets:
           Cash and cash equivalents & Short-term
            investments                              $5,792,867  $7,776,299
           Accounts receivable, net                   1,196,518   1,214,049
           Inventories                                  486,269     495,751
           Other                                        326,278     279,898
                                                        -------     -------
                  Total current assets                7,801,932   9,765,997

       Property, plant, and equipment, net            1,389,493   1,401,229
       Intangible assets, net                         2,955,332   3,378,648
       Prepaid pension asset                             86,687      66,130
       Deferred tax assets                               79,367      68,793
                                                         ------      ------
             Total assets                           $12,312,811 $14,680,797
                                                    =========== ===========
    Liabilities and Shareholders' Equity
       Current liabilities:
               Current portion - deferred rent          $35,000     $35,000
           Accounts payable                             431,016     604,593
               Income tax payable                             -      56,785
           Accrued liabilities                          902,718   1,231,620
                                                        -------   ---------
                Total current liabilities             1,368,734   1,927,998

       Deferred rent - less current portion             130,114     147,576
       Accrued pension liability                        283,008     296,646
                                                        -------     -------

       Total liabilities                              1,781,856   2,372,220
                                                      ---------   ---------

       Total shareholders' equity                    10,530,955  12,308,577
                                                     ----------  ----------

       Total liabilities and shareholders' equity   $12,312,811 $14,680,797
                                                    =========== ===========





                           UROPLASTY, INC. AND SUBSIDIARIES

                    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
                                      (Unaudited)

                                                      Six Months Ended
                                                        September 30,
                                                        -------------
                                                   2009                2008
                                                   ----                ----
    Cash flows from operating
     activities:
       Net loss                             $(2,240,434)          $(967,612)
            Adjustments to reconcile
             net loss to net cash used
             in operating activities:
            Depreciation and
             amortization                       567,238             566,949
            Loss on disposal of
              equipment                             186               4,687
            Share-based consulting
             expense                                  -              36,409
            Share-based compensation
             expense                            291,462             453,592
            Deferred income taxes                (3,249)            (10,164)
                             Deferred rent      (17,500)            (17,500)
            Changes in operating assets
             and liabilities:
                Accounts receivable              91,206             537,959
                Inventories                      47,499             (11,128)
                Other current assets and
                 income tax receivable         (102,998)           (108,041)
                Accounts payable               (185,406)           (145,610)
                Accrued liabilities            (348,381)           (634,851)
                Accrued pension liability,
                 net and income tax payable     (58,492)            (44,772)
                                                -------             -------
    Net cash used in operating
     activities                              (1,958,869)           (340,082)
                                             ----------            --------

    Cash flows from investing
     activities:
       Proceeds from sale of
        short-term investments                2,500,000           8,808,304
       Purchase of short-term
        investments                          (2,000,000)         (7,891,373)
       Purchases of property,
        plant and equipment                     (61,334)           (130,421)
       Proceeds from sale of
        property, plant and
        equipment                                 2,000                   -
                                                  -----                 ---
    Net cash provided by
     investing activities                       440,666             786,510
                                                -------             -------

    Cash flows from financing
     activities:
       Repayment of debt
        obligations                                   -            (455,913)
                                                    ---            --------
    Net cash used in financing
     activities                                       -            (455,913)
                                                    ---            --------

    Effect of exchange rates on
     cash and cash equivalents                   34,771            (194,967)
                                                 ------            --------

    Net decrease  in cash and
      cash equivalents                       (1,483,432)           (204,452)

    Cash and cash equivalents
     at beginning of period                   3,276,299           3,880,044
                                              ---------           ---------

    Cash and cash equivalents
     at end of period                        $1,792,867          $3,675,592
                                             ==========          ==========

    Supplemental disclosure of
     cash flow information:
       Cash paid during the period
        for interest                             $6,145             $13,612
       Cash paid during the period
        for income taxes                        105,877              35,474





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 measures.

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 of approximately $475,000 for the three months
ended September 30, 2009 was greater than the $98,000 operating loss in same
period in fiscal 2009.  Our non-GAAP operating loss was approximately
$1,390,000 for the six months ended September 30, 2009 compared to an
operating income of $8,000 in same period fiscal in 2009.  We attribute the
increased operating loss primarily to the decrease in sales and a lower gross
margin rate, offset partially by a decrease in cash operating expenses.

                            Three Months Ended             Six Months Ended
                               September 30,                 September 30,
                               -------------                 -------------
                             2009              2008         2009         2008
                             ----              ----         ----         ----
    Gross Profit
       GAAP gross
        profit         $2,451,401        $3,371,317   $4,725,360   $7,188,972
            % of sales         82%               86%          81%          85%
       Share-based
        compensation        4,903             8,879       18,448       25,253
       Depreciation
        expense            14,150            13,057       28,299       25,847
                           ------            ------       ------       ------
       Non-GAAP
        gross profit    2,470,454         3,393,253    4,772,107    7,240,072
                        ---------         ---------    ---------    ---------

    Operating
     Expenses
       GAAP
        operating
        expenses        3,328,495         3,962,936    6,973,962    8,238,179
       Share-based
        compensation      113,909           198,131      273,014      464,748
       Depreciation
        expense            57,546            62,104      115,623      119,161
       Amortization
        expense           211,503           210,966      423,316      421,941
                          -------           -------      -------      -------
       Non-GAAP
        operating
        expenses        2,945,537         3,491,735    6,162,009    7,232,329
                        ---------         ---------    ---------    ---------

    Operating
     Loss
       GAAP
        operating
        loss             (877,094)         (591,619)  (2,248,602)  (1,049,207)
       Share-based
        compensation      118,812           207,010      291,462      490,001
       Depreciation
        expense            71,696            75,161      143,922      145,008
       Amortization
        expense           211,503           210,966      423,316      421,941
                          -------           -------      -------      -------
       Non-GAAP
        operating
        income
        (loss)          $(475,083)         $(98,482) $(1,389,902)      $7,743
                        ---------          --------  -----------       ------






SOURCE  Uroplasty, Inc.

David Kaysen, President and CEO, or Medi Jiwani, Vice President, CFO, and
Treasurer, both of Uroplasty, Inc., +1-952-426-6140; or Doug Sherk, Investors,
+1-415-896-6820, or Chris Gale, Media, +1-646-201-5431, both of EVC Group for
Uroplasty
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