(Nasdaq: VIVE) Advancing the Science of Women s Intimate Health. December 2018

Transcription

1 (Nasdaq: VIVE) Advancing the Science of Women s Intimate Health December 2018

2 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 presentation 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. for sexual function, vaginal laxity or stress urinary incontinence; (ii) we will need to obtain FDA clearance or approval for other indications, 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 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 Viveve, Inc. In the United States the Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

3 A women s intimate health company commercializing an innovative, clinically-proven, proprietary platform technology (CMRF) to address multiple unmet medical needs Viveve, Inc. In the United States the Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

4 Company Highlights Continued Commercial Growth Global installed base expansion 646 Viveve Systems worldwide (Q3 2018) Over 28,000 treatment tips sold globally since inception (Q3 2018) Anticipated U.S. commercial sales organizational shift commencing in Q expected to result in a significant reduction in operating expenses through 2019 and 2020 CMRF Platform w/ongoing Label Expansion Opportunity Three studies in vaginal laxity/sexual function with positive results Enrollment in VIVEVE II study for improved sexual function underway Positive Pilot and Feasibility study results in Stress Urinary Incontinence (SUI) International SUI study enrollment complete LIBERATE-INT U.S. SUI study planned pending resubmission of IDE to FDA LIBERATE-US Viveve, Inc. In the United States the Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

5 The Viveve Solution Utilizes internationally patented, cryogen-cooled monopolar RF energy (CMRF) technology Viveve, Inc. In the United States the Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

6 Current Global Commercial Footprint Spans 60 Countries NORTH AMERICA 2 countries EUROPE 17 countries MIDDLE EAST 12 countries ASIA PACIFIC 14 countries LATIN AMERICA 15 countries Distribution partners covering 58 countries Current direct salesforce in 2 countries (U.S. and Canada) Viveve, Inc. In the United States the Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

7 Anticipated US Sales Organizational Shift Aesthetic Practices AMP Partnership Network Independent Partnership Reps Regional Distribution Partners OBGYNs UroGyns Urologists Direct Capital Sales Practice Management Medical Affairs Mkt Development U.S. sales organizational shift anticipated to commence in Q Expected to result in significantly reduced operating expenses through 2019 and 2020 Expected to allow for a focused market development effort on core physicians International distribution network expected to remain unchanged Viveve, Inc. In the United States the Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

8 Unmet Medical Needs Sexual Function (Vaginal Laxity) Vaginal childbirth overstretches the vaginal introitus (opening) Feeling of looseness - diminished sensation during intercourse Reduction in sexual function and quality of life Stress Urinary Incontinence (Mild-to-Moderate SUI) Pregnancy can damage soft tissues and musculature of pelvic floor Urine leakage associated with Urethral Hypermobility Need to wear pads - reduction in physical activities & quality of life million women worldwide* $6-$8 billion global consumable market* million women worldwide* $10-$12 billion global consumable market* * Estimated based on 2017 Company derived research and data analysis Viveve, Inc. In the United States the Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

9 VIVEVE I Demonstrated Improvement in Sexual Function Significant and sustained improvement after a SINGLE treatment Adjusted mean difference of 3.2 in FSFI score at 6 months p-value = FSFI Female Sexual Function Index: a validated patient reported outcome questionnaire FSFI analysis conducted on 103 per protocol patients with baseline scores less than Viveve, Inc. In the United States the Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

10 Currently enrolling 19 active clinical sites 100 patients FDA clearance to continue full enrollment of 250 patients at 1:1 randomization Primary efficacy endpoint: mean change from baseline in total Female Sexual Function Index (FSFI) score at 12 months Study to support FDA clearance - may lead to the first ever overall sexual function claim for women in the U.S. Expecting Q readout of final 12-month data* Q3 Q4 Q Q2 Q3 Q4 Q Q2 Q3 Q4 IDE Approval Today 12 Mo. Data VIVEVE II Sexual Function Enroll Follow-up * Timelines based on current company estimates Viveve, Inc. In the United States the Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

11 SUI Feasibility Study 12-month Results 1-Hr Pad Weight Test Daily Incontinence Episodes UDI-6 IIQ-7 ICIQ-UI-SF MEAN BASELINE SCORES (N=35) MEAN SCORES AT 12 MONTHS (N=25) % REDUCTION FROM BASELINE AT 12 MONTHS (N=25) IMPROVEMENT FROM BASELINE AT 12 MONTHS (N=25) 56.1% 63.5% 37.4% 48.7% 30.7% 72.0% 64.0% 68.0% 72.0% 76.0% 72% of patients treated experienced an improvement from baseline in the 1-hour Pad Weight Test A clinically meaningful benefit (n=25) was achieved across all patient-reported outcome measures (SUI symptoms and quality of life) No device-related safety issues were reported for any of the patients Studies conducted by Dr. Bruce Allan, Founder and Medical Director of the Allan Centre in Calgary, Alberta. UDI-6 (Urogenital Distress Inventory-Short Form), IIQ-7 (Incontinence Impact Questionnaire) and ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form) Viveve, Inc. In the United States the Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

12 SUI Feasibility Study 12-month Results Group Baseline Pad Weight % of Subjects with a >50% Reduction in Pad Weight from Baseline Cure Rate* ( 1 g leak) 1 mo 4 mos 6 mos 12 mos 6 mos 12 mos All Subjects 7.29 g (n=35) 56% 2.15 g (n=34) 73% 1.27 g (n=33) 69% 1.69 g (n=29) 52% 3.20 g (n=25) 66% 60% >50% reduction in the 1-hour Pad Weight Test was achieved by 52% of patients 60% of patients experienced significant benefit as they had one gram of urine leakage in the 1-hour Pad Weight Test * Cure Rate is defined by the U.S. Food and Drug Administration Viveve, Inc. In the United States the Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

13 Enrollment complete at 9 clinical sites; 99 patients at 2:1 randomization Primary efficacy endpoint: MCFB 1hr Pad Weight Test at 6- months SAP: 50% MCFB in treated group vs 30% MCFB in control group (sham) 20% Difference Expecting early Q readout of final 6-month data* Study to support various international SUI clearances Q3 Q4 Q Q2 Q3 Q4 Q Q2 Q3 Q4 Health Canada Approval Today 6 Mo. Data LIBERATE INT L SUI Enroll Follow-up * Timelines based on current company estimates Viveve, Inc. In the United States the Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

14 IDE submitted in mid-september 2 rounds questions - All protocol, SAP and other issues resolved Require short acute animal tissue study to demonstrate safety of SUI protocol conduct in 1H 2019 Total 250 patients; 2:1 randomization SAP: 50% of patients > 50% reduction 1hr Pad Weight Test treated group vs 27% of patients > 50% reduction 1hr Pad Weight Test in control (sham) at 12-months 23% Difference Expecting end of 2020 / early 2021 readout of final 12- month data* Q3 Q4 Q Q2 Q3 Q4 Q Q2 Q3 Q4 Today IDE Approval 12 Mo. Data LIBERATE U.S. SUI Preclinical Enroll Follow-up Viveve, Inc. In the United States the Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis. * Timelines based on current company estimates.

15 Milestones 4Q18 SUI Feasibility Study 12-month Data FDA clearance to continue VIVEVE II (FSFI) enrollment LIBERATE-INT (SUI) enrollment completed 2019 H1 - VIVEVE II completion of enrollment MID-YEAR - LIBERATE-INT (SUI) Final 6- month data available Q3 - LIBERATE-US (SUI) IDE approval from FDA and clinical trial initiated YEAR-END - LIBERATE-US (SUI) enrollment complete Viveve, Inc. In the United States the Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

16 Core Areas of Strategic Focus I. Continue commercial growth Expand current system installed base Drive increased consumable treatment tip utilization II. Commercial & operational efficiency Realignment of sales force resulting in significant cost savings Physician specialty market development III. Label expansion for multiple indications U.S. for sexual function VIVEVE II trial U.S. & International for SUI LIBERATE trials Viveve, Inc. In the United States the Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

17 Advancing the Science of Women s Intimate Health (Nasdaq: VIVE) Viveve, Inc. In the United States the Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.