- Macroplastique(R) Year-over-Year U.S. Sales Continue Strong
Growth - - SUmiT Trial Results Recommended for Publication in
Journal of Urology - - Conference Call to be Held Today at 3:30 pm
Central Time - 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 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. 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 --------- --------
----------- ------ 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 Doug Sherk,
Investors, +1-415-896-6820, or Chris Gale, Media, +1-646-201-5431,
both of EVC Group for Uroplasty Web Site: http://uroplasty.com/
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