advancing the science · • primary efficacy endpoint –fsfi total score at 6 months •...

Advancing the Science

of Women’s Intimate Health

Investor Presentation(NASDAQ: VIVE)

© 2018 Viveve, Inc. Confidential and Proprietary.1

Forward Looking Statements

All statements in this presentation that are not based on historical fact are “forward looking statements”. While

management has based any forward looking statements included in this release on its current expectations, the

information on which such expectations were based may change. These forward looking statements rely on a

number of assumptions concerning future events and are subject to a number of risks, uncertainties and other

factors, many of which are outside of our control, which could cause actual results to materially differ from such

statements.

Such risks, uncertainties, and other factors include, but are not limited to: (i) we currently do not have the ability to

market our system in the U.S.; (ii) we will need to obtain FDA clearance or approval, which may not be granted; (iii)

our business is not profitable, and we may not be able to achieve profitability; (iv) we depend on distributors to

market and sell our products and they may not be successful; (v) we currently have limited sales and marketing

resources; (vi) the fluctuation of global economic conditions; (vii) the performance of management and our

employees; (viii) our ability to obtain financing; (ix) competition and general economic conditions; and (x) other

factors that are to be detailed in our periodic and current reports available for review at www.sec.gov. Furthermore,

we operate in a highly competitive and rapidly changing environment where new and unanticipated risks may arise.

Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual

results. We disclaim any intention to, and undertake no obligation to, update or revise forward-looking statements.

http://www.sec.gov/


A women’s intimate health company

commercializing innovative, clinically-proven,

proprietary platform technologies to address

multiple unmet medical needs and improve

patients’ well-being and quality of life.


Company Highlights

• Significant preclinical animal and tissue study data

• Two positive pilot studies in vaginal laxity/sexual function - U.S.

and Japan

• Positive OUS vaginal laxity/sexual function trial – JSM and JWH

publications

• Positive Canadian pilot study results recently announced in

Stress Urinary Incontinence

• 114% YoY revenue growth - $15.3M in 2017 sales

• Global installed base expansion – 444 Systems worldwide

• Global disposable treatment tip utilization 3/system/month

• Expanding N.A. sales organization to 27 regional sales reps

Rapid

Commercial

Growth

Clinically

Proven

CMRF

Platform


Experienced Leadership Team

Patricia Scheller Chief Executive Officer

> 25 / 6

Scott Durbin Chief Financial Officer

> 20 / 5

James Atkinson President andChief Business Officer

> 30 / 3

Key Management & Previous Experience

Years Experience: Industry / Viveve

MEDICAL

STIMULATION

CORPORATION


Proven Track Record of Success

Year-End 2015 Year-End 2016 Year-End 2017

Revenue $1.4M $7.1M $15.3M

Installed

Base42 217 444

Distribution

Coverage46 Countries 67 Countries - 2 Direct 67 Countries – 2 Direct

Clinical

Milestones

Completed VIVEVE I

study

IDE submission –

VIVEVE II

JSM Publication –

VIVEVE I

VIVEVE II IDE review

in process

Regulatory

Approvals20 Countries

51 Countries

US, Brazil, and Korea

approvals

62 Countries

(2018 YTD)


The Viveve Solution

Viveve® System utilizes internationally patented,

cryogen-cooled monopolar RF energy (CMRF) technology

2Physician operated table-top device

Single-use consumable treatment tip

1


Competitive Advantages

Treatment

Paradigm

CMRF PLATFORM

• Allows depth of penetration while maintaining patient comfort and safety

• Reproducible procedures

• Demonstrated clinical evidence

• Robust patent coveragePelvic floor exercises (Kegels)

Behavioral

Modifications

Energy-based

Devices

Surgical

Interventions


Significant Unmet Medical Needs

Vaginal childbirth overstretches the vaginal introitus (opening)

• Feeling of “Looseness” - diminished sensation during intercourse

• Reduction in sexual function and quality of life

13 million women worldwide

$7 billion global consumable market opportunity

Stress Urinary Incontinence

(Mild to Moderate)

Vaginal Laxity

(Sexual Function)

Vaginal childbirth damages tissues of the pelvic floor

• Urine leakage associated with hypermobility

• Need to wear pads -reduction in certain activities & quality of life

25-30 million women worldwide

$10-$12 billion global consumable market opportunity


VIVEVE I – Demonstrated Improvement in Sexual Function

Largest controlled study ever conducted to assess treatment of vaginal laxity

Significant and

sustained

improvement

after a SINGLE

treatment

Adjusted Mean

Difference of 3.2

at

6 Months

p-value = 0.009

FSFI – Female Sexual Function Index: a validated patient reported outcome questionnaire FSFI analysis conducted on 103 per protocol patients with baseline scores less than 26.5.


VIVEVE II – Sexual Function Indication in U.S.

VIveve Treatment of the Vaginal Introitus to EValuate Efficacy

• Randomized (1:1), double-blinded and sham-controlled

• Enrollment ~250 patients at up to 25 clinical sites in the U.S. and Canada

• Primary efficacy endpoint – FSFI total score at 6 months

• Secondary efficacy endpoints – Various domain scores at 6 months

• Safety and efficacy at 12 months

Sexual Function…treatment of

vaginal tissue to

improve sexual

function

Study

Completion …expected 2H

2019

• Clinically proven path to approval

• IDE submission under FDA review

• VIVEVE II study start – 1H 2018


Pilot Study – Demonstrated Improvement in SUI

Positive outcomes from two validated SUI outcome measures at 12 months

UDI-6 (n=9) ICIQ-UI (n=9)

Baseline Score 1567 9.4

4 Mos 517 3.2

6 Mos 383 2.4

9 Mos 733 5.6

12 Mos 767 5.7

% Reduction from Baseline 51% 40%

Responder Rate 100% 89%


LIBERATE - Stress Urinary Incontinence Indication

• Enrollment ~100 patients at up to 10 clinical sites in Canada

• Primary efficacy endpoint: mean change in 1 hour pad weight test at 6 months

• 12 months of safety follow-up

• Study to support Health Canada and CE Mark approval

Two multi-center, randomized, sham-controlled studies to be conducted following positive Pilot Study Results

LIBERATE (U.S.)LIBERATE (International)

• Enrollment ~200 patients at up to 25 clinical sites in U.S.

• Primary efficacy endpoint: mean change in 1 hour pad weight test at 12 months

• 12 months of safety follow-up

• Study to support FDA clearance


Label Expansion Across Multiple Indications

Several Significant Near-Term Clinical & Regulatory Milestones

Today

Q1 Q2 Q3 Q4Q12019

Q2 Q3 Q4Q12020

Q2 Q3

IDE Approval 12 Mo. Data FDA CLEARANCE

6 Mo. Data CHA / CE MARK

12 Mo. Data FDA CLEARANCE

Enroll Follow-upSub-

mission

Enroll Follow-up Sub-

mission

Enroll Follow-upSub-

mission

VIVEVE IISexual

Function

LIBERATE

INT’LSUI

LIBERATE

U.S.SUI


Global Commercial Footprint – 69 Countries

EUROPE

29 countries

MIDDLE EAST

10 countries

ASIA PACIFIC

13 countries

LATIN

AMERICA

15 countries

N. AMERICA

2 countries


International Commercialization

Extensive international distribution network

• Distribution Partners covering 67 countries

• 2 countries direct (U.S. and Canada)

• Approvals & indications to sell in 62 countries

• 3 Regional Sales Directors & Global Director of Strategic Partnerships

Pending regulatory submissions in 7 additional countries


North American Commercialization

2017 YE Commercial Organization

• 17 Regional Sales Reps

• 5 Associate Sales Reps

• 27 Total Sales Organization

2018 Growth Strategy

• 27 Regional Sales Reps

• 14 Associate Sales Reps

• 10 Practice Development Managers

• 58 Total Sales Organization

Physician Specialties

Gynecologists

Urogynecologists

Plastic Surgeons

Dermatologists

P R O M O T I O N A L C A M P A I G N S

Branded Campaign

FEEL SENSATIONAL

Unbranded Campaign

Educational and empowerment initiative focused on women’s intimate health

* In the United States the Viveve System is indicated for general surgical procedures for electrocoagulation and hemostasis


Commercial Success & Rapid Adoption

Current installed base of 444 systems and significant sales growth

RECORD 4th QUARTER 2017 - 80 Systems and 2,600 treatment tips114% YoY $ Growth (2017-2018)

Syste

ms S

old T

ips S

old


Building on a Track Record of Success

Grow Revenue & Profitability Commitment to Scientific Rigor An Eye to the Future

• Fund external research programs to explore potential new applications

• Conduct rigorous clinical trials to differentiate our technology from the competition

• Drive installed base adoption and consumable utilization

• Implement innovative education and awareness campaigns

• Improve gross margins

• Successful label expansion: Sexual function, SUI and Atrophy

• Secure additional regulatory clearances


Advancing the Science of Women’s Intimate Health

(NASDAQ: VIVE)

Thank You

advancing the science · • primary efficacy endpoint –fsfi total score at 6 months •...

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