Viveve Medical, Inc.

Thank you, operator, and welcome, everyone. Before we begin, we would like to remind you that this conference call may contain forward-looking statements regarding future events or the future financial performance of the company.

Any statement that is not a statement of historical fact is a forward-looking statement. This includes remarks about the corporation's cost, timing, progress and results of its clinical trials, including the initiation, progress of and results from our PURSUIT trial and whether the clinical trial will support the intended uses for treatment of stress urinary incontinence, or SUI, in the United States, fluctuation of global market economic conditions impact of COVID-19 on clinical development, regulatory review and clearances, manufacturing, system placements and utilization projections, expectations, plans, beliefs and prospects.

These statements are based on judgments and analysis as of the date of this conference call and are subject to numerous important risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties are described more fully in the company's annual report on Form 10-K and other filings made with the SEC, which are also available on the company's website.

Also, any forward-looking statements represent management's view only as of the date of this conference call and should not be relied upon as representing management's views as of any subsequent date. Speaking on today's call will be Scott Durbin, Viveve's Chief Executive Officer; and Jim Robbins, Senior Vice President of Finance and Administration.

I will now turn the call over to Jim.

Thank you, Jeannie. Good afternoon, everyone, and thank you for joining the call today.

I will begin today's call with a brief review of our second quarter 2022 financial results. I will then turn the call over to Scott, who will provide a corporate update.

Today, we reported total revenue for the first quarter of $1.8 million from the global sale of 14 systems and approximately 2,850 disposable treatment kits. As of the end of the second quarter 2022, the company had an installed base of 905 Viveve Systems worldwide.

Second quarter total operating expenses were $5.3 million compared to $5.1 million for the same period last year. The increase is mainly a result of the company's efforts to advance our stressed urinary comments, our SUI development program and support our fully enrolled PURSUIT clinical trial in the U.S.

as well as engineering and development work related to our next-generation products and product line improvement. As of June 30, 2022, we reported cash and cash equivalents of $9.4 million.

Thanks I'll now turn the conference call over to Scott.

Thanks, Jim. Good afternoon, everyone, and thank you for listening to our conference call.

I'd like to begin today by stating that our positive financial results this quarter are the result of the efforts of our entire organization, which continues its focus on our core initiatives as we rapidly advance our stress urinary incontinence program towards a potential future new indication. Our landmark U.S.

PURSUIT clinical trial continues to progress as we execute the trial towards completion of subject follow-up visits by the end of the year. We have a high level of confidence in the strength of the PURSUIT study design and in our ability to execute our strategy to achieve a potential SUI indication in the United States.

With the capital resources to support our operations through Q1 2023, including the completion of the PURSUIT trial, our strategic efforts continue to be focused on the following core areas. First, continuing to successfully execute the fully enrolled pursuit trial for SUI by completing patient follow-up visits by the end of the year and reporting top line results shortly thereafter.

If the trial results are positive, preparing to quickly submit our de novo application to FDA for approval and preparing to commercially launch what could be the first FDA-approved patent-protected endovaginal dual-energy office-based treatment for urethral hypermobility to improve SUI in women. Secondly, continuing to focus our commercial and market development efforts on the U.S.

and Asia Pacific regions through the expansion of our installed base targeting urogynecology, urology and gynecology core specialties. And finally, third, continuing to support our current and future customers with successful initiatives to drive increased disposable treatment tip utilization and sales.

As I've stated previously, our entire organization is committed to these core areas of strategic focus as we continue to advance our SUI clinical development program towards a potential new indication in the U.S. I'd now like to discuss some of the specifics around our fully enrolled U.S.

pivotal PURSUIT trial for SUI. As a reminder, PURSUIT is a randomized double-blinded sham-controlled trial that enrolled 415 subjects with moderate SUI.

Moderate SUI is defined as greater than 10 ml up to 50 ml of urine leakage on the one-hour pad weight test. We enrolled patients at approximately 30 study sites in the United States.

Randomized in a 2:1 ratio, subjects in the active treatment arm received the cryogen-cooled monopolar radio frequency or CMRF treatment, while subjects in the control arm received an inert or energy list true sham treatment. The primary efficacy endpoint of the PURSUIT trial is a comparison of the proportion of patients who experienced more than a 50% reduction in urine leakage as compared to baseline, using the standardized and objective one-hour pad weight test at 12 months post treatment versus the procedure.

The study also includes several secondary endpoints assessed using the one-hour pad weight test, the three-day bladder voiding diary and other behavioral and quality of life questionnaires. Post-treatment follow-up visits are occurring at three, six, nine and 12 months and subject safety is also being monitored throughout the study.

Initiated in January of 2021, full enrollment is complete and post-treatment follow-up visits are rapidly advancing. Importantly, PURSUIT is highly powered with strict inclusion criteria for the proper diagnosis of moderate SUI.

The trial was intentionally designed to better assess the primary efficacy endpoint and potentially increase the probability of a positive outcome. As of today, 100% of subjects who have not withdrawn from the study have completed their three and six and 6-month post-treatment visits.

80% of those subjects have completed their 9-month posttreatment visit, and 41% of those subjects have completed their final 12-month post-treatment visit. The next five months represent the final phase of the PURSUIT study as we count down to last patient last visit.

Again, we plan to complete all patient follow-up visits by the end of the year and anticipate announcement of the top line results shortly thereafter. We have a high level of confidence in the power and strength of the PURSUIT trial design and in our ability to execute our clinical and regulatory strategy to achieve a potential SUI indication in the United States.

Importantly, the need for a clinically proven and safe noninvasive, office space endovaginal procedure for women with SUI as considerable. SUI is a condition that affects an estimated 25 million to 30 million women in the United States alone.

Based on our estimates, this represents a $10 billion to $12 billion total available consumable market opportunity. As a result, a positive pursuit outcome and FDA approval opens a multibillion-dollar commercial opportunity for Viveve.

On the market development front, our dedicated commercial team in the U.S. and distribution partners internationally continue to expand our installed base and provide high-quality service and support to drive increased procedure volumes and disposable treatment tip utilization.

Our efforts today remain focused on the U.S. and Asia Pacific regions directed towards the core specialties of urogynecology, urology and gynecology.

Although, we have a limited sized commercial organization, their efforts continue to reveal strong physician receptivity for our innovative SUI procedure. Our goal is to continue to increase awareness of and build upon our body of clinical evidence that supports the safety and efficacy of the Viveve treatment as we advance our program towards a potential new SUI indication in the U.S.

During the second quarter of this year, the focus of our entire organization was to continue to advance our SUI clinical development program and to successfully execute our core initiatives. Through the remainder of 2022, we intend to successfully complete our landmark PURSUIT trial, expand our installed base in the United States and Asia Pacific regions with core medical specialties, support our existing and new customers to drive increased treatment tip utilization and sales and to continue the financial efficiencies we have achieved over the last two years.

Finally, in closing, I'd like to thank the incredibly talented and dedicated team at Viveve for their continuing efforts this quarter as well as to everyone for listening to our conference call today. Operator, this concludes our prepared remarks.

Thank you so much.