Uroplasty, Inc. - Newswireextras.newswire.ca/canaccordgenuity/20111206/uroplasty.pdf · 06-12-2011 · ~16 Million lives (3 regional carriers) with negative policy A number of private-pay

Uroplasty, Inc.

Investor Update

Canaccord Genuity Conference

December 6, 2011

Forward Looking Statement

This presentation includes forward-looking statements, including

financial projections, relating to our business plan and growth

strategies. For many reasons we may not achieve our financial

objectives or successfully grow our business.

Our reports filed with the U.S. Securities and Exchange Commission

describe risks of our business and of an investment in us. We urge

you to read our reports and carefully consider whether our securities

are an appropriate investment for you.

Confidential – Do not copy

Company Profile

NASDAQ Listing: UPI

Closing Price1: $4.03

Shares Outstanding1: 20.8 million common

2.1 million options

Market Cap1: $84 million

Operations: Headquartered in Minnetonka, MN Subsidiaries – Uroplasty, LTD - UK

– Uroplasty, BV - The Netherlands

Employees: US – 95 (53 Field People)

Netherlands – 10

UK – 4

Total – 109


1 As of November 30, 2011

Company Overview/Highlights

Market Opportunity

Products


Urgent® PC (Overactive Bladder)

Macroplastique® (Stress Incontinence)

Uses percutaneous tibial nerve stimulation (PTNS) to deliver an electrical pulse that travels to the sacral nerve plexus, a control center for bladder function

Launched in 2006

Injectable soft-tissue bulking agent used to treat adult female SUI primarily due to intrinsic sphincter deficiency

Launched in 2007

Urgent® PC - Neurostimulation

Provides percutaneous tibial nerve stimulation (PTNS) for the treatment of

urinary urgency, urinary frequency and urge incontinence.

Initial treatment course of 12 weekly office-based 30 minute treatments

Strong published clinical data

Minimally invasive

Urgent® PC


U.S. Urgent PC – Expanded business

Code Category 1 code in effect

Strong clinical data

Payment Medicare payment for 2011

Base ~$130

As high as ~$170

Private Payers higher

Coverage - Ongoing


Initial focus on Medicare Coverage ~31 Million lives (10 regional carriers) with positive

coverage policy

~16 Million lives (3 regional carriers) with negative policy

A number of private-pay carriers have positive coverage policy (Approximately 84 million

covered lives.) Aetna

HCSC (BC/BS)

BC/BS Locals

Scripps California

Local HMO’s/PPO’s

United Healthcare

Kaiser California

U.S. Execution to Expand Business – Expanded Insurance Coverage for Urgent PC Treatments


PTNS Medicare Coverage

65% Positive Coverage

As of 9/12/2011

LEGEND

Positive Coverage

WPS

NGS

Highmark

WA

OR

CA

ID

MT

NV

AK

HI

WY

UT

AZ

ND

SD

NE

KS

CO

NM

TX

OK

AR

LA

MO

IA

MN

WI

IL

MS AL

TN

KY

IN

MI

OH

GA

FL

SC

NC

VA WV

PA

NY

VT

MD

NJ

DE

CT

MA

RI

NH

ME

Market Opportunity


~ 33 million persons in the U.S. grapple with OAB (16% of population)

~ 11 Million (33%) of these persons bothered enough to seek treatment

~ 6 Million (55%) of these patients CANNOT tolerate OAB drug therapy

Our Opportunity

OAB Treatment Options


Behavioral Therapy

Dietary Modification

• This class of drugs has annual US sales of $1.7 Billion

Anticholinergic Drugs

• Urgent PC® Neuromodulation, non-surgical therapy

Minimally-Invasive

• Interstim® Therapy ($200M+) Surgery

Competitive Landscape

•Botox –Neurogenic bladder approved

–Study ongoing for idiopathic bladder

•Two neuromodulation systems in early stage pivotal studies.


Barriers to Entry

•Uroplasty patents

•Time frames and completion of competitive study −Late 2012 to 2014

•Regulatory approval − 6-12+ months

•Reimbursement clarity −12+ months after FDA approval

•2-4 years to commercialization

U.S. Execution – Increase Market

Penetrations

Target Market: ~10,500 physicians (~7,000 offices)


Market Penetration Today

~6 - 7%

Target Market Penetration 3 Years from Today

~35 - 40%

5,000 Urologists

3,500 Urogynecologist

2,000 Gynecologists

Urgent® PC – U.S. Active Customers

(Doctors Offices)


-50

50

150

250

350

450

550

Q3 '11 Q4 '11 Q1 '12 Q2 '12

236

346

401

509

Urgent® PC – U.S. Boxes of Leads


0

500

1000

1500

2000

2500

3000

Q3 '11 Q4 '11 Q1 '12 Q2 '12

1,379

1,668

1,985

2,579

# o

f B

oxe

s

U.S. usage of Urgent PC is growing very quickly

U.S. Execution – Expanded Market Coverage 43 Direct Employed Reps

Rep Tenure

17 Reps/Greater Than 1 Year

16 Reps/Less Than 6 Months

10 Reps/No Medicare Coverage

VT

NH

MA

RI

CT

NJ

DE

MD


Other Opportunities

Explore regulatory path for Urgent® PC in U.S. for

fecal incontinence Already approved in Europe

Work closely with European KOL’s on Urgent® PC

for OAB and fecal incontinence reimbursement


Financial Overview

Historic Revenue

0

2

4

6

8

10

12

14

16

FY 3/31/2006 FY 3/31/2007 FY 3/31/2008 FY 3/31/2009 FY 3/31/2010 FY 3/31/2011

$0.1 $1.4

$6.3

$8.0

$6.1

$7.9

$6.1

$8.3

$13.9 $14.7

$11.9

$13.8 Annual Uroplasty Revenue

$ in

mill

ion

s

U.S.

Consolidated

Fiscal years Ending in March 31


Income Statement (non-GAAP)*

Sales $8,311 $13,856 $14,742 $11,863 $13,787

Adjusted Gross Profit $5,774 $10,998 $12,553 $9,890 $11,470

Adjusted Operating Exp.

G & A R & D S & M

Total

$2,390 $2,244 $5,066 $9,700

$2,905 $1,703 $8,181

$12,816

$2,970 $2,885 $8,835

$14,290

$2,453 $1,723 $7,364

$11,540

$3,023 $1,683 $9,908

$14,614

Adjusted Operating (loss/gain)* ($3,926) ($1,818) ($1,737) ($1,650) ($3,144)

*Excludes non cash charges for Stock Options,

Depreciation & Amortization of $1046, $2,111 and $1,885

and $1,553, respectively, in FY 2007, 2008, 2009 & 2010. In Thousands

Fiscal Years Ending March 31


FY2007 FY2009 FY2008 FY2010 FY2011

$0.0

$1.0

$2.0

$3.0

$4.0

$5.0

6/30/2010 9/30/2010 12/31/2010 3/31/2011 6/30/2011 9/30/2011

$0.9 $1.0 $1.0 $1.3 $1.5

$2.0

$3.0 $3.2

$3.5

$4.0

$4.7

$5.0

FY 2011 FY 2012

$ in

millio

ns

Quarterly Revenue U.S. Urgent PC

Income Statement (non-GAAP)*

Sales $4,653 $4,967

Adjusted Gross Profit $3,956 $4,222


G & A R & D S & M

Total

$ 909 $ 425 $3,537 $4,891

$ 812 $ 443 $3,804 $5,059

Adjusted Operating (loss/gain)* ($ 937) ($ 837)

*Excludes non cash charges for Stock Options,

Depreciation & Amortization of $406 and $438, respectively,

in Q1 and Q2. In Thousands

Fiscal Year 2012


Q2 Q1

Financial Model (non-GAAP)

Margin Analysis

FY ‘08 FY ‘09 FY ‘10 FY ‘11 Target $45 Million Revenue

Adjusted Gross Profit 79% 85% 83% 83% 82% - 86%


General & Administration

Research & Development

Sales & Marketing

21%

12%

59%

20%

17%

60%

21%

14%

62%

22%

12%

72%

9 - 10%

10 - 13%

31 - 35%

Total Adjusted Operating Expenses 92% 97% 97% 106% 48 – 56%

Adjusted Operating (loss/gain)* -13% -12% -14% -23% 26% - 36% *Excludes non cash charges for Stock Options,

Depreciation & Amortization of $252, $1046, $2111 and

$1,885 respectively, in FY 2006, 2007, 2008 & 2009. In Thousands

Fiscal Years Ending March 31

Operating Profit, excluding non cash charges, breakeven at $25 Million in Revenue

Balance Sheet

9/30/11 3/31/11

Cash, Equivalents & Investments $17,323 $19,593

Working Capital (exc. ash, equivalents & investments)

$995 $566

Total Assets $23,419 $26,438

Long Term Debt $0 $0

Shareholders’ Equity $20,475 $22,629

In Thousands


Capital Structure (9/30/11) In Millions

20.8 Common Shares

2.1 Outstanding Options (weighted average exercise price=$3.64)

22.9 Fully Diluted Total

Summary

In Summary

Multi-billion dollar market for OAB patients who cannot

tolerate drug therapy

Clinical data confirms efficacy

OrBIT study vs. #1 pharmaceutical showed clear efficacy

SUmiT study vs. validated sham

New CPT Category 1 code for PTNS is 64566

Reimbursement amount provides economic incentive to

physicians

Ramping up US field organization

Strong balance sheet and cash position

Barriers to entry gives runway to growth


Urgent® PC Macroplastique®

Essential Incontinence Solutions


THANK YOU!

Documents

Uroplasty, Inc. - Newswireextras.newswire.ca/canaccordgenuity/20111206/uroplasty.pdf · 06-12-2011 · ~16 Million lives (3 regional carriers) with negative policy A number of private-pay