- 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 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). 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 4119644#. 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 http://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. 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) 646.201.5431
UROPLASTY, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS
OF OPERATIONS (Unaudited) Three Months Ended June 30, -------- 2009
2008 ---- ---- Net sales $2,825,929 $4,525,622 Cost of goods sold
551,970 707,967 ------- ------- Gross profit 2,273,959 3,817,655
--------- --------- Operating expenses General and administrative
848,551 1,038,714 Research and development 527,815 405,519 Selling
and marketing 2,057,288 2,620,035 Amortization 211,813 210,975
------- ------- 3,645,467 4,275,243 --------- --------- Operating
loss (1,371,508) (457,588) ---------- --------- Other income
(expense) Interest income 31,399 75,115 Interest expense (7,907)
(6,834) Foreign currency exchange loss (7,330) (5,770) Other, net
(2,183) - ------ --- 13,979 62,511 ------ ------ Loss before income
taxes (1,357,529) (395,077) Income tax expense 8,245 11,571 -----
------ Net loss $(1,365,774) $(406,648) =========== ========= Basic
and diluted loss per common share $(0.09) $(0.03) Weighted average
common shares outstanding: Basic and diluted 14,937,771 14,916,540
UROPLASTY, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE
SHEETS June 30, 2009 March 31, (unaudited) 2009 -----------
--------- Assets Current assets: Cash, cash equivalents &
Short-term investments $6,263,649 $7,776,299 Accounts receivable,
net 1,327,112 1,214,049 Inventories 491,252 495,751 Other 392,241
279,898 ------- ------- Total current assets 8,474,254 9,765,997
Property, plant, and equipment, net 1,388,109 1,401,229 Intangible
assets, net 3,166,835 3,378,648 Prepaid pension asset 83,405 66,130
Deferred tax assets 74,172 68,793 ------ ------ Total assets
$13,186,775 $14,680,797 =========== =========== Liabilities and
Shareholders' Equity Current liabilities: Current portion -
deferred rent $35,000 $35,000 Accounts payable 527,655 604,593
Income tax payable 61,776 56,785 Accrued liabilities 834,324
1,231,620 ------- --------- Total current liabilities 1,458,755
1,927,998 Deferred rent - less current portion 138,921 147,576
Accrued pension liability 358,268 296,646 ------- ------- Total
liabilities 1,955,944 2,372,220 --------- --------- Total
shareholders' equity 11,230,831 12,308,577 ---------- ----------
Total liabilities and shareholders' equity $13,186,775 $14,680,797
=========== =========== UROPLASTY, INC. AND SUBSIDIARIES CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS Three Months Ended June 30,
2009 and 2008 (Unaudited) Three Months Ended June 30, -------- 2009
2008 ---- ---- Cash flows from operating activities: Net loss
$(1,365,774) $(406,648) Adjustments to reconcile net loss to net
cash used in operating activities: Depreciation and amortization
284,040 280,822 Loss on disposal of equipment 2,186 - Share-based
consulting expense - 16,029 Share-based compensation expense
172,649 266,962 Deferred income taxes (969) (2,637) Deferred rent
(8,750) (8,750) Changes in operating assets and liabilities:
Accounts receivable (54,213) 129,863 Inventories 30,618 32,627
Other current assets (106,949) (167,223) Accounts payable (87,783)
(208,510) Accrued liabilities (414,828) (784,377) Accrued pension
liability, net and income tax payable 35,291 48,922 ------ ------
Net cash used in operating activities (1,514,482) (802,920)
---------- -------- Cash flows from investing activities: Proceeds
from sale of short-term investments - 4,500,000 Purchase of
short-term investments (1,000,000) (2,542,267) Purchases of
property, plant and equipment (16,487) (50,750) ------- ------- Net
cash (used in) provided by investing activities (1,016,487)
1,906,983 ---------- --------- Cash flows from financing
activities: Repayment of debt obligations - (58,187) --- -------
Net cash used in financing activities - (58,187) --- ------- Effect
of exchange rates on cash and cash equivalents 18,319 6,314 ------
----- Net (decrease) increase in cash and cash equivalents
(2,512,650) 1,052,190 Cash and cash equivalents at beginning of
period 3,276,299 3,880,044 --------- --------- Cash and cash
equivalents at end of period $763,649 $4,932,234 ========
========== Supplemental disclosure of cash flow information: Cash
paid during the period for interest $- $6,850 Cash paid during the
period for income taxes 7,908 19,759 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 $(915,000) for the three months
ended June 30, 2009 decreased from a $106,000 operating gain in
same period fiscal 2009. We attribute the fiscal 2010 non-GAAP
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 June 30, -------- 2009 2008 ---- ----
Gross Profit GAAP gross profit $2,273,959 $3,817,655 % of sales 80%
84% SFAS 123 (R) share-based compensation 13,544 16,375
Depreciation expense 14,150 12,790 ------ ------ Non-GAAP gross
profit 2,301,653 3,846,820 --------- --------- Operating Expenses
GAAP operating expenses 3,645,467 4,275,243 SFAS 123 (R)
share-based compensation 159,105 266,616 Depreciation expense
58,077 57,057 Amortization expense 211,813 210,975 ------- -------
Non-GAAP operating expenses 3,216,472 3,740,595 --------- ---------
Operating Loss GAAP operating loss (1,371,508) (457,588) SFAS 123
(R) share-based compensation 172,649 282,991 Depreciation expense
72,227 69,847 Amortization expense 211,813 210,975 ------- -------
Non-GAAP operating income (loss) $(914,819) $106,225 ---------
-------- DATASOURCE: Uroplasty, Inc. CONTACT: David Kaysen,
President and CEO, or Medi Jiwani, Vice President, CFO, and
Treasurer, both of Uroplasty, Inc., +1-952-426-6140; or Investors,
Doug Sherk, +1-415-896-6820, or Media, Chris Gale, +1-646-201-5431,
both of EVC Group for Uroplasty, Inc. Web Site:
http://www.uroplasty.com/
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