- Strong Macroplastique(R) Year-over-Year U.S. Sales Growth - -
Significant Publication & Presentation Schedule for Uroplasty
Products - - Conference Call to be Held Today at 3:30 pm Central
Time - MINNEAPOLIS, Feb. 1 /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
third fiscal quarter ended December 31, 2009. "We continue to
successfully 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. "We submitted our application in
November to The American Medical Association (AMA) for a unique CPT
code for percutaneous tibial nerve stimulation. The AMA will
evaluate our application at their February 11-13 meeting. We are
encouraged by the support we are receiving for our application from
leading urologists and the American Urology Association. We are not
permitted to discuss the results from the meeting as we are bound
by a confidentiality agreement with the AMA. In October the new CPT
codes will be published in the Federal Register by the Centers for
Medicare and Medicaid Services (CMS). "Our fiscal third quarter
sales illustrate the continued strong growth of Macroplastique in
the U.S.," continued Mr. Kaysen. "Sales of our Macroplastique
product in the U.S. through nine months of our current fiscal year
have about doubled over the corresponding year-ago period. However,
our European sales of Macroplastique continue to be impacted by a
competitive product launch. Urgent PC sales in the U.S. remain
challenged by the uncertain insurance reimbursement environment,
but have remained relatively stable in recent quarters. At the same
time, with our vigilant efforts to control expenses, we have
maintained our December 31, 2009 cash position at about the same
level as at September 30, 2009. We believe we have adequate
liquidity to meet our needs for the next 12 months." Fiscal Third
Quarter and Nine Month Results for the Periods Ended December 31,
2009 Net sales for the three months ended December 31, 2009 were
$3.1 million versus $3.4 million for the year-ago quarter. Net
sales for the nine months ended December 31, 2009 were $8.9 million
versus $11.8 million for same period a year ago. Net sales to
customers in the U.S. during the three months ended December 31,
2009 totaled $1.5 million, as compared to net sales of $1.9 million
for the three months ended December 31, 2008. Sales of Urgent PC of
$934,000 declined from $1.6 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. Sales of Urgent PC have stabilized at
around $900,000 to $1 million per quarter in each of the last three
quarters. Partially offsetting the decline in Urgent PC sales was
an increase in sales of Macroplastique to $565,000 from $321,000 in
the year-ago quarter. Sales of Macroplastique to customers in the
U.S. for the first nine months of fiscal 2010 about doubled to $1.5
million from $762,000 for the first nine months of fiscal 2009.
Sales of Macroplastique have increased over the year-ago periods
because of increased sales and marketing focus. Sales to customers
outside of the U.S. for the three months ended December 31, 2009
were $1.6 million, compared to $1.4 million in the year-ago period.
Excluding the translation impact of fluctuations in foreign
currency exchange rates, sales decreased by approximately 2%. Sales
for the nine months ended December 31, 2009 were $4.4 million, a
decrease of 19% from $5.5 million for the nine months ended
December 31, 2008. Excluding the translation impact of fluctuations
in foreign currency exchange rates, sales decreased by
approximately 15%. The sales decrease for the nine months is mainly
attributed to increased competition for Macroplastique from a
newly-introduced product. In addition, in fiscal year 2010 the
Company discontinued sales in the United Kingdom of the I-Stop
mid-urethral sling product, which accounted for sales of
approximately $135,000 for the nine months ended December 31, 2008
and $191,000 in fiscal 2009. Net loss for the third fiscal quarter
ended December 31, 2009 was $387,000, or $0.03 per diluted share,
versus a net loss of $894,000, or $0.06 per diluted share for the
third quarter of last year. For the first nine months of fiscal
2010, the net loss was $2.6 million, or $0.18 per diluted share as
compared with a net loss for the first nine months of fiscal 2009
of $1.9 million, or $0.12 per diluted share. At December 31, 2009,
cash and cash equivalents, and short-term investments were $5.9
million compared with $5.8 million at September 30, 2009 and $7.8
million as of March 31, 2009. "Looking ahead, we expect the current
sales trends to continue for the remainder of fiscal 2010," said
Mr. Kaysen. "U.S. sales of Macroplastique should continue to grow
during the remainder of the fiscal year as we expect to benefit
from our increased sales and marketing effort, while Urgent PC
sales continue to stabilize. As we've stated in the past, 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 payers create coverage
policies that provide adequate reimbursement. "For the past five
quarters we have implemented a comprehensive program designed to
educate Medicare carriers and private payer medical directors about
the clinical efficacy of Urgent PC. As a result, we remain well
ahead of our planned publication and presentation schedule for
Urgent PC. The data demonstrating sustained symptom improvement at
one year from Phase 2 of the OrBIT study of Urgent PC was published
in the January 2010 edition of The Journal of Urology®. The SUmiT
study results are expected to be published in the April 2010
edition of The Journal of Urology, and, at the upcoming Society for
Urodynamics and Female Urology annual meeting in late February,
both Urgent PC and Macroplastique will be featured in several
clinician presentations. We believe these publications and
presentations, 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 third 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 877-941-8610. 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 4203310#. 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 Nine Months Ended ------------------ -----------------
December 31, December 31, ------------ ------------ 2009 2008 2009
2008 ---- ---- ---- ---- Net sales $3,068,142 $3,387,285 $8,880,546
$11,833,422 Cost of goods sold 505,399 533,987 1,592,443 1,791,153
------- ------- --------- --------- Gross profit 2,562,743
2,853,298 7,288,103 10,042,269 --------- --------- ---------
---------- Operating expenses General and administrative 639,608
713,545 2,201,199 2,670,653 Research and development 401,481
723,673 1,365,194 1,457,170 Selling and marketing 1,702,900
2,125,274 5,728,242 7,250,906 Amortization 211,189 211,626 634,505
633,567 ------- ------- ------- ------- 2,955,178 3,774,118
9,929,140 12,012,296 --------- --------- --------- ----------
Operating loss (392,435) (920,820) (2,641,037) (1,970,027) --------
-------- ---------- ---------- Other income (expense) Interest
income 21,468 24,001 77,097 162,657 Interest expense (1,291)
(1,787) (10,986) (15,372) Foreign currency exchange loss (8,335) -
(23,030) (731) Other, net - - (183) (4,687) --- --- ---- ------
11,842 22,214 42,898 141,867 ------ ------ ------ ------- Loss
before income taxes (380,593) (898,606) (2,598,139) (1,828,160)
Income tax expense (benefit) 6,143 (4,684) 29,030 33,374 -----
------ ------ ------ Net loss $(386,736) $(893,922) $(2,627,169)
$(1,861,534) ========= ========= =========== =========== Basic and
diluted loss per common share $(0.03) $(0.06) $(0.18) $(0.12)
Weighted average common shares outstanding: Basic and diluted
14,946,540 14,924,540 14,943,638 14,919,216 UROPLASTY, INC. AND
SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS December 31,
March 31, 2009 2009 ------------ --------- (unaudited) -----------
--------- Assets Current assets: Cash and cash equivalents &
short-term investments $5,903,132 $7,776,299 Accounts receivable,
net 1,204,466 1,214,049 Inventories 416,632 495,751 Other 266,901
279,898 ------- ------- Total current assets 7,791,131 9,765,997
Property, plant, and equipment, net 1,311,307 1,401,229 Intangible
assets, net 2,744,143 3,378,648 Prepaid pension asset 93,040 66,130
Deferred tax assets 79,946 68,793 ------ ------ Total assets
$12,019,567 $14,680,797 =========== =========== Liabilities and
Shareholders' Equity Current liabilities: Current portion -
deferred rent $35,000 $35,000 Accounts payable 292,087 604,593
Income tax payable - 56,785 Accrued liabilities: Compensation
888,083 983,052 Other 181,611 248,568 ------- ------- Total current
liabilities 1,396,781 1,927,998 Deferred rent - less current
portion 121,307 147,576 Accrued pension liability 321,471 296,646
------- ------- Total liabilities 1,839,559 2,372,220 ---------
--------- Total shareholders' equity 10,180,008 12,308,577
---------- ---------- Total liabilities and shareholders' equity
$12,019,567 $14,680,797 =========== =========== UROPLASTY, INC. AND
SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited) Nine Months Ended ----------------- December 31,
------------ 2009 2008 ---- ---- Cash flows from operating
activities: Net loss $(2,627,169) $(1,861,534) Adjustments to
reconcile net loss to net cash used in operating activities:
Depreciation and amortization 852,370 849,933 Loss on disposal of
equipment 183 4,687 Share-based consulting expense - 52,567
Share-based compensation expense 356,583 583,013 Deferred income
taxes (5,299) (11,531) Deferred rent (26,250) (26,250) Changes in
operating assets and liabilities: Accounts receivable 71,404
668,510 Inventories 112,460 (34,427) Other current assets and
income tax receivable (44,238) 8,173 Accounts payable (324,094)
(91,686) Accrued liabilities (221,266) (802,027) Accrued pension
liability, net and income tax payable (20,141) (7,585) -------
------ Net cash used in operating activities (1,875,457) (668,157)
---------- -------- Cash flows from investing activities: Proceeds
from sale of short-term investments 3,000,000 14,157,410 Purchase
of short-term investments (2,000,000) (7,891,373) Purchases of
property, plant and equipment (70,354) (181,354) Proceeds from sale
of property, plant and equipment 2,000 - Payments for intangible
assets - (23,282) --- ------- Net cash provided by investing
activities 931,646 6,061,401 ------- --------- 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
70,644 (255,095) ------ -------- Net increase (decrease) in cash
and cash equivalents (873,167) 4,682,236 Cash and cash equivalents
at beginning of period 3,276,299 3,880,044 --------- --------- Cash
and cash equivalents at end of period $2,403,132 $8,562,280
========== ========== 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 121,655 53,739
Non-GAAP Financial Measures: The following table reconciles our
operating loss 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 described 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 and incentive compensation for senior
management because we believe such measures are one important
indicator of the strength and the operating performance of our
business. Analysts and investors frequently ask us for this
information. We believe that they 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 $42,000 for the three
months ended December 31, 2009 was less than the $492,000 operating
loss in same period in fiscal 2009. Our non-GAAP operating loss was
approximately $1.4 million for the nine months ended December 31,
2009 compared to an operating loss of $485,000 in same period
fiscal in 2009. We attribute the increased operating loss during
the nine months ended December 31, 2009 primarily to the decrease
in sales and a lower gross margin rate, offset partially by a
decrease in cash operating expenses. With continued focus on
spending reductions, we reduced the operating loss for the three
months ended December 31, 2009. Three Months Ended Nine Months
Ended ------------------ ----------------- December 31, December
31, ------------ ------------ 2009 2008 2009 2008 ---- ---- ----
---- Gross Profit GAAP gross profit $2,562,743 $2,853,298
$7,288,103 $10,042,269 % of sales 84% 84% 82% 85% Share-based
compensation 4,771 8,879 23,218 34,132 Depreciation expense 14,481
12,436 42,780 38,283 ------ ------ ------ ------ Non-GAAP gross
profit 2,581,995 2,874,613 7,354,101 10,114,684 --------- ---------
--------- ---------- Operating Expenses GAAP operating expenses
2,955,178 3,774,118 9,929,140 12,012,296 Share-based compensation
60,351 136,701 333,365 601,448 Depreciation expense 59,462 58,922
175,085 178,083 Amortization expense 211,189 211,626 634,505
633,567 ------- ------- ------- ------- Non-GAAP operating expenses
2,624,176 3,366,869 8,786,185 10,599,198 --------- ---------
--------- ---------- Operating Loss GAAP operating loss (392,435)
(920,820) (2,641,037) (1,970,027) Share-based compensation 65,122
145,580 356,583 635,580 Depreciation expense 73,943 71,358 217,865
216,366 Amortization expense 211,189 211,626 634,505 633,567
------- ------- ------- ------- Non-GAAP operating loss $(42,181)
$(492,256) $(1,432,084) $(484,514) -------- --------- -----------
--------- DATASOURCE: Uroplasty, Inc. CONTACT: David Kaysen,
President and CEO, or Medi Jiwani, Vice President, CFO, and
Treasurer, +1-952-426-6140, both of Uroplasty, Inc.; 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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