A Women’s Health and Wellness Company - Jefferies Group › CMSFiles › Jefferies.com › files › Viveve M… · A women’s health and wellness company commercializing a clinically

© 2017 Viveve, Inc. Confidential and Proprietary.0

Advancing the Science of Satisfaction

A Women’s Health and Wellness Company

Corporate Presentation(NASDAQ: VIVE)


Safe Harbor Statement

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 currentexpectations, the information on which such expectations were based may change. These forward lookingstatements 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 resultsto materially differ from such statements.

Such risks, uncertainties, and other factors include, but are not limited to: (i) we currently do not have theability to market our system in the U.S.; (ii) we will need to obtain FDA clearance or approval, which maynot be granted; (iii) our business is not profitable, and we may not be able to achieve profitability; (iv) wedepend on distributors to market and sell our products and they may not be successful; (v) we currentlyhave limited sales and marketing resources; (vi) the fluctuation of global economic conditions; (vii) theperformance of management and our employees; (viii) our ability to obtain financing; (ix) competition andgeneral economic conditions; and (x) other factors that are to be detailed in our periodic and currentreports available for review at www.sec.gov. Furthermore, we operate in a highly competitive and rapidlychanging environment where new and unanticipated risks may arise. Accordingly, investors should notplace any reliance on forward-looking statements as a prediction of actual results. We disclaim anyintention to, and undertake no obligation to, update or revise forward-looking statements.

.

http://www.sec.gov/


A women’s health and wellness company commercializing a clinically proven cryogen-cooled monopolar radiofrequency (CMRF)

technology that generates new collagen and restores tissue

The GENEVEVE™ Treatment is indicated for the treatment of vaginal laxity or improvement of sexual function in 51

countries around the world*

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


Company Highlights

• Completed largest clinical trial for vaginal laxity and sexual function ever conducted – JSM publication

• Pending IDE for sexual function label expansion – Data expected 2H 2018

• Q4 2016 FDA Clearance – general indication

• Regulatory approval/indications to sell in 54 countries

• Vaginal laxity/sexual function indication in 51 countries

• Over $7M in first full year of sales

• Double digit sales growth seven consecutive quarters

• 2017 revenue guidance: $14M – $16M

Rapid Commercial

Growth

Demonstrated Clinical

Evidence

Significant Regulatory Momentum


Experienced Leadership Team

Patricia Scheller Chief Executive Officer

> 25 / 5

Scott Durbin Chief Financial Officer

> 20 / 4

James Atkinson President andChief Business Officer

> 30 / 2

Daniel Janney Debora Jorn Jon Plexico Arlene Morris Lori Bush

Managing Director, Alta Partners

Former EVP and Company Chair, Valeant

Founder and Managing Member, Stonepine Capital

Former President and CEO of SyndaxPharmaceuticals

Former President and CEO, Rodan + Fields

Key Management & Previous Experience

Independent Board of Directors

Years Experience: Industry / Viveve

MEDICALSTIMULATIONCORPORATION


Significant Unmet Need

• Vaginal childbirth overstretches the vaginal introitus (opening)

Feeling of “Looseness”

Diminished sensation during intercourse

Reduction in sexual function and quality of life

Vaginal Laxity - a significant concern for millions of women

Data sources - available upon request.

Impacts ~50% of Women Post-Partum

#1 Reported ChangePost-Partum

• UroGYNs recognize it is underreported, yet bothersome, medical condition that impacts personal happiness and sexual function

• Vaginal laxity causes include: pregnancy, childbirth, aging, genetic predisposition, lifestyle, and/or trauma


Enormous Global Market Opportunity

Significant Additional Market Opportunities

• Stress Incontinence• Vaginal Atrophy• External applications

$7 Billion Consumable Post-Partum Market

EXCLUDES:

• Equipment sales

• Repeat procedures

• Additional indications

13 Million Women

Worldwide Potential

Early Adopters

• 3 million in US• 10 million OUS

$


Vaginal Rejuvenation – Competitive Landscape

Treatment Paradigm

GENEVEVE™ Coolant (CMRF) allows depth of penetration

while maintaining patient comfort & safety

Reproducible procedure

Demonstrated large scale clinical evidence

Significant patent coverage

Pelvic floor exercises (Kegels)

Highly invasive, costly, painful and lengthy recovery yet nearly 115,000 annual procedures worldwide

BehavioralModifications

Energy-basedDevices

SurgicalIntervention


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


The GENEVEVE Treatment

• Treatment tip delivers pulses to the tissue

• Each pulse lasts ~8 seconds

• Total procedures consists of ~110 pulses

• Total procedure lasts only 30 minutes

Only clinically proven and effective, non-surgical procedure

for vaginal tissue*

* Journal of Sexual Medicine 2017;14:215-225. In the United States the Viveve System is indicated for general surgical procedures for electrocoagulation and hemostasis.

Treatment Technique


Physician and Patient Benefits

• Clinically proven to improve sexual function

• 30 minute comfortable in-office procedure

• No anesthesia; non-ablative and non-surgical

• Little or no downtime / recovery period

• Lasting results up to 12 months

• Significant in-office revenue

55% of surveyed women agreed “this vaginal tightening

procedure is for me”

84% of surveyed physicians interested in performing the procedure


“It works! Sex is enjoyable and satisfying again – for me and my

husband!”

“The sensation just kept getting better months following the

treatment. It lasts!”


Successful Results in Multiple Trials


Demonstrated scientific rigor establishing efficacy and safety

CMRF Technology based on proven Thermage technology

Animal Studies: Documented fibroblast activation, collagen remodeling, no cellular or tissue damage

VIVEVE II IDE approval pending

Multi-center, double-blind, sham controlled study to improve sexual function at 12 months

VIVEVE I Study: Multi-center, blinded, sham-controlled trial - active treatment group 3X more likely to report NOvaginal laxity and sustained improvement in sexual function at 6 months with NO related adverse events

Continued commitment to providing clinically proven solutions

US and Japan Studies: 88% of women reported increased vaginal tightness at 12 months with NO serious adverse events


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 – US Sexual Function Indication

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

FDA Clearance1H 2019

• Clinically proven path to approval

• IDE submission under FDA review

• VIVEVE II study start – Q4 2017


Track Record of Success

Attainment of key commercial milestones at a rapid pace

Year-End 2015 Year-End 2016 Q1 2017

Reported Revenue

$1.4M $7.1M $3.04M

Installed Base 42 217 259

Distribution Coverage

46 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 reviewin process

Regulatory Approvals

20 Countries51 Countries

US, Brazil, and Korea approvals

54 CountriesKorea Expanded-

Vaginal Laxity


Strong Global Commercial Footprint – 69 Countries

EUROPE29 countries

MIDDLE EAST 10 countries

ASIA PACIFIC13 countries

LATIN AMERICA15 countries

N. AMERICA2 countries


International Commercialization

Extensive global distribution network

• 26 distributors covering 67 countries

• Approvals & indications to sell in 53 countries

• 4 Regional Sales Directors managing Asia Pacific, Europe, Middle East, and Latin America

Pending regulatory submissions in 14 additional countries


US Commercialization

Commercial Organization:

Vice President of Sales Two Regional Directors

Twelve Territory Managers(4 Territory Managers added Q2 2017)

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 sexual health and

wellness

* 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 259 Viveve Systems globally with double digit sales growth – quarter-over-quarter – since Q3 2015


2017 - Building on a Track Record of Success

• Drive GENEVEVE™ adoption

• Implement innovative education and awareness campaigns to educate and motivate

• Improve gross margins

Grow Global Revenue Commitment to Scientific Rigor An Eye to the Future

• Fund External Research Programs to explore potential new applications

• Conduct rigorous clinical trials to secure new regulatory indications

• Expand product portfolio

• Broaden indications

• Secure additional regulatory clearances

Documents

A Women’s Health and Wellness Company - Jefferies Group › CMSFiles › Jefferies.com › files › Viveve M… · A women’s health and wellness company commercializing a clinically