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10-Q - FORM 10-Q - UROPLASTY INCc62679e10vq.htm
EX-32.1 - EX-32.1 - UROPLASTY INCc62679exv32w1.htm
EX-31.1 - EX-31.1 - UROPLASTY INCc62679exv31w1.htm
Exhibit 99.1
(UROPLASTY LOGO)
UROPLASTY REPORTS FINANCIAL RESULTS FOR THE THIRD QUARTER FY2011
Global sales increase 14%
Sales to U.S. customers up 33% driven by 64% growth in Macroplastique®
Urgent® PC customers increase to 236 in the third quarter from 185
in the second quarter of the fiscal year
Two Additional Regional Medicare Carriers Begin Payment for PTNS
Conference call today at 4:30 p.m. ET
MINNEAPOLIS, MN, January 27, 2011 — Uroplasty, Inc. (NASDAQ: 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, 2010.
Global sales grew 14% to $3.5 million, compared with $3.1 million in the same quarter a year ago. The growth was driven by strength in U.S. sales, up 33% from the third quarter a year ago. The increase in U.S. sales reflected a 64% increase in sales of the Macroplastique product line, where the Company has had a focused marketing effort. Sales of the Urgent PC Neuromodulation System in the U.S. for the recent third fiscal quarter totaled $1.0 million, an increase of 10% from the prior year’s third quarter. The number of customers in the U.S. purchasing the Urgent PC Neuromodulation System during the quarter increased to 236 from 185 in the second quarter ended September 30, 2010.
The Company also announced that two additional Medicare carriers, Cahaba Government Benefit Administrators®, LLC and First Coast Service Options, Inc. (FCSO), have begun to pay for Percutaneous Tibial Nerve Stimulation (PTNS) treatments, using the Urgent PC Neuromodulation System. Cahaba administers Medicare health insurance for the states of Alabama, Georgia, Mississippi and Tennessee. FCSO is the Medicare carrier for Florida, Puerto Rico and the U.S. Virgin Islands.
With the addition of these two carriers, there are now nine regional Medicare carriers providing coverage for PTNS, using Urgent PC, for the treatment of symptoms of overactive bladder syndrome in 29 states and two territories. Coverage of PTNS using the Urgent PC Neuromodulation System, currently extends to approximately 28 million lives of the 46 million total lives covered under Medicare.
“We were very encouraged by the growth in Urgent PC customers in the U.S. We believe the availability of a Category I CPT® code for PTNS, a favorable reimbursement amount under Medicare coverage and recent decisions by several Medicare carriers to cover the treatment when the CPT code became effective on January 1, 2011 are creating renewed interest in PTNS,” said David Kaysen, President & CEO of Uroplasty, Inc. “The number of customers grew in the third quarter as physicians began to ramp up their practices in light of the positive Medicare reimbursement decisions. We saw a

 


 

surge in new and reengaged customers in December and expect to see continued growth in the adoption of Urgent PC. However, it is important to note that the exceptional rate of adoption we experienced in the third quarter reflected some pent up demand from physicians, who were waiting for implementation of the CPT code and confirmation of positive reimbursement rates.”
“The coverage of PTNS using Urgent PC, by Cahaba and FCSO continues to show the strength of the clinical data that supports the effectiveness and safety of Urgent PC for treating the symptoms of overactive bladder,” Mr. Kaysen added. “In addition to the nine regional Medicare carriers that today provide reimbursement for PTNS, there is now one carrier, representing five states with approximately two million covered lives that has indicated it will cover on a case-by-case basis. An additional three Medicare carriers, representing 16 states with approximately 17 million covered lives, continue to decline reimbursement coverage for PTNS.”
“Our reimbursement team is working to move the case-by-case coverage to routine coverage and to have the negative coverage decisions reversed,” continued Mr. Kaysen. “We are also working with select private health insurers to educate them on the benefits and results of clinical studies that demonstrate the success of PTNS in the treatment of overactive bladder. In anticipation of increased interest in Urgent PC, we have expanded our U.S. field sales and support organization. At December 31, 2010, we had 31 sales representatives compared with 19 sales reps at September 30, 2010.”
“As we look ahead, we anticipate continued demand for our Urgent PC Neuromodulation System, as physicians become more comfortable with the treatment and gather additional patient feedback and reimbursement experience. We are focused on execution, driving adoption and sales of Urgent PC and Macroplastique in the U.S., and maintaining our presence in international markets. With the capital raise in July, we have sufficient cash to pursue these growth initiatives,” Mr. Kaysen concluded.
Fiscal Third Quarter and First Nine Months Results for the Period Ended December 31, 2010
Net sales for the three months ended December 31, 2010 totaled $3.5 million, an increase of 14% over net sales of $3.1 million for the third quarter of the prior fiscal year. Excluding the translation impact of foreign currency exchange rates, sales increased by approximately 17%. For the nine months ended December 31, 2010, net sales were $9.8 million, a 10% increase above net sales for the comparable period of 2009 of $8.9 million. Excluding the impact of foreign exchange translation, sales grew by 14%.
Sales to customers in the U.S. for the three months ended December 31, 2010 were $2.0 million, a 33% increase compared to $1.5 million in net sales for the year-ago quarter. During the first nine months of fiscal 2011, sales to customers in the U.S. totaled $5.5 million, representing a 22% increase over net sales of $4.5 million for the comparable nine month period of fiscal 2010.
Sales in the U.S. of the Urgent PC product for the three months ended December 31, 2010 increased 10% to $1.0 million compared with $934,000 for the same period last year. For the recent nine month period, sales from Urgent PC totaled approximately $3.0 million, an increase of 1% over sales in the comparable period last year.
Sales in the U.S. of Macroplastique increased 64% to $925,000 for the three months ended December 31, 2010, from $565,000 for the same period last year. For the nine months of fiscal 2011, sales of Macroplastique increased 60% to $2.4 million compared with $1.5 million in the same period a year ago, reflecting the increased sales and marketing focus on this product line.

 


 

Net sales to customers outside of the U.S. for the third quarter ended December 31, 2010 were $1.5 million, a decrease of 5% from $1.6 million in the same quarter last year. Excluding the impact of foreign exchange translation, sales increased by approximately 2%. For the nine months ended December 31, 2010, sales were $4.3 million, a decrease of 2% compared with $4.4 million in the comparable period of the prior year. Excluding the impact of foreign exchange translation, sales increased by approximately 5%.
The operating loss for the fiscal 2011 third quarter was $1.5 million compared with $392,000 in the prior year. The operating loss, excluding non-cash charges for share-based compensation and depreciation and amortization, of $1.1 million in the recent third quarter increased from approximately $42,000 in the year-ago quarter, primarily due to increased spending attributable to higher bonuses, commissions, travel expenses and increase in headcount. The net loss for the three months ended December 31, 2010 was $1.5 million, or $0.07 per share, as compared to a net loss of $387,000, or $0.03 per share, for the quarter ended December 31, 2009.
Cash, cash equivalents and cash investments at December 31, 2010 totaled $20.8 million. Reflected in the total was the contribution from the proceeds of a public offering of common shares in July 2010. The Company issued 4.6 million shares at $3.50 per share, for net proceeds of approximately $14.9 million. The Company plans to use the proceeds to expand the U.S. sales and marketing organizations to support the Urgent PC business, and for clinical studies, working capital and general corporate purposes.
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 ended December 31, 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 877-941-8609. 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 4402505.
CPT is a registered trademark of the American Medical Association.
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-cleared 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 that 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. In particular, we cannot be certain that we will ever achieve sustained profitability, that the rate of reimbursement for PTNS treatments will be adequate to justify the cost of our product, that other Medicare carriers or private payers will provide coverage for this treatment or that existing carriers and payers will not change their coverage decisions, or that any of the other risks identified in our 10-K will not adversely affect our expectations as described in these forward-looking statements.
     
For Further Information:
   
 
Uroplasty, Inc.
  EVC Group
David Kaysen, President and CEO, or
  Doug Sherk/Jenifer Kirtland (Investors)
Medi Jiwani, Vice President, CFO, and
  415.896.6820
Treasurer
  Chris Gale (Media)
952.426.6140
  646.201.5431

 


 

UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
                                 
    Three Months Ended     Nine Months Ended  
    December 31,     December 31,  
    2010     2009     2010     2009  
Net sales
  $ 3,492,067     $ 3,068,142     $ 9,772,389     $ 8,880,546  
Cost of goods sold
    604,566       505,399       1,709,731       1,592,443  
 
                       
 
                               
Gross profit
    2,887,501       2,562,743       8,062,658       7,288,103  
 
                       
 
                               
Operating expenses
                               
General and administrative
    861,183       639,608       2,608,868       2,201,199  
Research and development
    423,794       401,481       1,296,431       1,365,194  
Selling and marketing
    2,871,456       1,702,900       6,877,402       5,728,242  
Amortization
    211,058       211,189       632,508       634,505  
 
                       
 
    4,367,491       2,955,178       11,415,209       9,929,140  
 
                       
 
                               
Operating loss
    (1,479,990 )     (392,435 )     (3,352,551 )     (2,641,037 )
 
                       
 
                               
Other income (expense)
                               
Interest income
    21,135       21,468       52,762       77,097  
Interest expense
    (652 )     (1,291 )     (4,537 )     (10,986 )
Foreign currency exchange gain (loss)
    503       (8,335 )     12,867       (23,030 )
Other, net
                (192 )     (183 )
 
                       
 
    20,986       11,842       60,900       42,898  
 
                       
 
                               
Loss before income taxes
    (1,459,004 )     (380,593 )     (3,291,651 )     (2,598,139 )
 
                               
Income tax expense
    8,927       6,143       28,260       29,030  
 
                       
 
                               
Net loss
  $ (1,467,931 )   $ (386,736 )   $ (3,319,911 )   $ (2,627,169 )
 
                       
 
                               
Basic and diluted loss per common share
  $ (0.07 )   $ (0.03 )   $ (0.18 )   $ (0.18 )
 
Weighted average common shares outstanding:
                               
Basic and diluted
    20,514,530       14,946,540       18,314,157       14,943,638  

 


 

UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
                 
    December 31, 2010     March 31, 2010  
Assets
               
Current assets:
               
Cash and cash equivalents & short-term investments
  $ 14,822,635     $ 5,811,269  
Accounts receivable, net
    1,547,665       1,287,440  
Inventories
    592,181       341,497  
Income tax receivable
          23,820  
Other
    308,137       237,321  
 
           
Total current assets
    17,270,618       7,701,347  
 
               
Property, plant, and equipment, net
    1,133,179       1,230,771  
Intangible assets, net
    1,911,887       2,533,095  
Long-term investments
    6,009,337        
Deferred tax assets
    112,907       108,530  
 
           
Total assets
  $ 26,437,928     $ 11,573,743  
 
           
 
               
Liabilities and Shareholders’ Equity
               
Current liabilities:
               
Accounts payable
  $ 489,093     $ 485,594  
Current portion — deferred rent
    35,000       35,000  
Income tax payable
    12,487       10,000  
Accrued liabilities:
               
Compensation
    1,476,238       903,057  
Other
    251,455       212,028  
 
           
 
               
Total current liabilities
    2,264,273       1,645,679  
 
               
Deferred rent — less current portion
    86,079       112,500  
Accrued pension liability
    578,262       601,037  
 
           
 
               
Total liabilities
    2,928,614       2,359,216  
 
           
 
Total shareholders’ equity
    23,509,314       9,214,527  
 
           
 
               
Total liabilities and shareholders’ equity
  $ 26,437,928     $ 11,573,743  
 
           

 


 

UROPLASTY, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
                 
    Nine Months Ended  
    December 31,  
    2010     2009  
Cash flows from operating activities:
               
Net loss
  $ (3,319,911 )   $ (2,240,434 )
Adjustments to reconcile net loss to net cash used in operating activities:
               
Depreciation and amortization
    848,385       567,238  
Loss on disposal of equipment
    192       186  
Amortization of premium on marketable securities
    7,226          
Share-based consulting expense
    9,739        
Share-based compensation expense
    279,083       291,462  
Deferred income taxes
    (5,863 )     (3,249 )
Deferred rent
    (26,421 )     (17,500 )
Changes in operating assets and liabilities:
               
Accounts receivable
    (261,136 )     91,206  
Inventories
    (248,656 )     47,499  
Other current assets and income tax receivable
    (48,492 )     (102,998 )
Accounts payable
    4,474       (185,406 )
Accrued liabilities
    610,710       (348,381 )
Accrued pension liability, net and income tax payable
    (10,783 )     (58,492 )
 
           
Net cash used in operating activities
    (2,161,453 )     (1,958,869 )
 
           
 
               
Cash flows from investing activities:
               
Proceeds from maturity of marketable securities
    4,000,000       2,500,000  
Purchases of marketable securities
    (16,311,352 )     (2,000,000 )
Purchases of property, plant and equipment
    (128,935 )     (61,334 )
Purchase of intangible assets
    (11,300 )      
Proceeds from sale of property, plant and equipment
          2,000  
 
           
Net cash (used in) provided by investing activities
    (12,451,587 )     440,666  
 
           
 
               
Cash flows from financing activities:
               
Net proceeds from public offering of common stock
    14,917,059        
Net proceeds from exercise of warrants and options
    2,467,007        
 
           
Net cash provided by financing activities
    17,384,066        
 
           
 
               
Effect of exchange rates on cash and cash equivalents
    (37,554 )     34,771  
 
           
 
               
Net increase (decrease) in cash and cash equivalents
    2,733,472       (1,483,432 )
 
               
Cash and cash equivalents at beginning of period
    2,311,269       3,276,299  
 
           
 
               
Cash and cash equivalents at end of period
  $ 5,044,741     $ 1,792,867  
 
           
 
               
Supplemental disclosure of cash flow information:
               
Cash paid during the period for interest
  $     $ 6,145  
Cash received(paid) during the period for income taxes
    9,633       (105,877 )

 


 

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 these 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 during the three months ended December 31, 2010 and 2009 was approximately $1,059,000 and $42,000, respectively. Our non-GAAP operating loss during the nine months ended December 31, 2010 and 2009 was approximately $2.2 million and $1.4 million, respectively.
                                 
    Three Months Ended     Nine Months Ended  
    December 31,     December 31,  
    2010     2009     2010     2009  
Gross Profit
                               
GAAP gross profit
  $ 2,887,501     $ 2,562,743     $ 8,062,658     $ 7,288,103  
% of sales
    83 %     84 %     83 %     82 %
Share-based compensation
    4,184       4,771       12,851       23,218  
Depreciation expense
    12,007       14,481       43,470       42,780  
 
                       
Non-GAAP gross profit
    2,903,692       2,581,995       8,118,979       7,354,101  
 
                       
 
                               
Operating Expenses
                               
GAAP operating expenses
    4,367,491       2,955,178       11,415,209       9,929,140  
Share-based compensation
    135,947       60,351       275,971       333,365  
Depreciation expense
    57,745       59,462       172,407       175,085  
Amortization expense
    211,057       211,189       632,508       634,505  
 
                       
Non-GAAP operating expenses
    3,962,742       2,624,176       10,334,323       8,786,185  
 
                       
 
                               
Operating Loss
                               
GAAP operating loss
    (1,479,990 )     (392,435 )     (3,352,551 )     (2,641,037 )
Share-based compensation
    140,131       65,122       288,822       356,583  
Depreciation expense
    69,752       73,943       215,877       217,865  
Amortization expense
    211,057       211,189       632,508       634,505  
 
                       
Non-GAAP operating loss
  $ (1,059,050 )   $ (42,181 )   $ (2,215,344 )   $ (1,432,084 )