Viveve Medical, Inc.

Welcome to the Vavid Third Quarter 2022 Financial Results in Corporate Update Conference Call. All participants will be in listening mode. If you need assistance, please signal a conference specialist by pressing the star key followed by zero. Please note that this event is recorded. I'll turn the call over to Ms. Jeanne Sundell of Vavid, Senior Director of Corporate Communications. Please go ahead.

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 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, which 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 the call today will be Scott Durbin, the VEEDS Chief Executive Officer, and Jim Robbins, Senior Vice President of Finance and Administration. I will now turn the call over to Jim.

Thank you, Jeanne. Good afternoon, everyone, and thank you for joining the call today. I will begin today's call with a brief review of our third 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 third quarter of $1.7 million from the global sale of 11 systems and approximately 3,100 disposable treatment kits. As of the end of the third quarter 2022, the company had an installed base of 915 PV systems worldwide. Third quarter total operating expenses were $5.2 million compared to $5.6 million for the same period last year. The decrease is primarily due to reduced clinical study costs during the period as we advanced our fully enrolled pursuit trial. Operating expense reductions were partially offset by costs associated with increased engineering and development work related to our next generation products and strategic planning efforts in anticipation of the pursuit clinical trial completion. As of September 30th, 2022, we reported cash and cash equivalents of $5.9 million. Thanks. I'll now turn the conference call over to Scott.

Thanks, Jim. Good afternoon, everyone, and thanks again for listening to our conference call today. 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 SUI indication. Follow-up visits from our landmark US PURSUIT clinical trial are expected to be completed by the end of this year. Our confidence level continues to remain high 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. As we move forward, towards the readout of top-line results, our strategic efforts continue to be focused on the following core areas. First, to complete patient follow-up visits by the end of the year and report 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 female SUI. Secondly, continuing to focus our commercial and market development efforts on the U.S. and Asia-Pacific regions through the expansion of our install base, targeting urogynecology, urology, and gynecology core specialties. And 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. With that, I'd now like to discuss some specifics around our fully enrolled U.S. Pivotal PURSUIT trial for female SUI. As a reminder, PURSUIT is a randomized, double-blinded, sham-controlled trial which enrolled 415 subjects with moderate SUI. This is defined as greater than 10 mLs up to 50 mLs of urine leakage on the standardized one-hour Padway test. We did this at approximately 30 study sites in the United States. Randomized in a two-to-one ratio, subjects in the active treatment arm received our cryogen-cooled monopolar radiofrequency, or CMRF, treatment, while subjects in the control arm received a true sham treatment. The primary efficacy endpoint of the PURSUIT trial is a comparison of the proportion of patients who experience greater 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 inert sham procedure. Importantly, the trial is powered at 90% to detect an absolute 17% responder rate difference between the two groups. The study also includes several secondary endpoints assessed using one-hour pad weight test, the three-day bladder voiding diary, and other behavioral and quality of life questionnaires. Post-treatment follow-up visits were scheduled for three, six, nine, and 12 months. And subject safety is also being monitored throughout the study. As mentioned, 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-, six-, and nine-month post-treatment visits, and 80% of those subjects have completed their final 12-month post-treatment visit. The next short seven weeks 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 top-line results shortly thereafter. I want to emphasize that the need for a clinically proven, safe, non-invasive office-based endovaginal procedure for women with SUI is considerable. SUI is a condition that affects an estimated 25 to 30 million women in the United States alone. And based on our estimates, this represents a $10 to $12 billion total available consumable market opportunity. As a result, a positive pursued outcome and FDA approval would open a multi-billion dollar commercial opportunity for Vaviv. On the market development front, Our commercial team in the U.S. and distribution partners internationally continue to expand our install base and provide high-quality service and support to drive increased procedure volumes and disposable treatment tip utilization. Our efforts today and through the end of the year remain focused on the U.S. and Asia Pacific regions, directed towards the core specialties of urogynecology, urology, and gynecology. Although we currently have a limited commercial organization, their efforts continue to reveal strong physician receptivity for our novel endovaginal SUI procedure. Our recent rebranding initiative reflecting our focus on the treatment of female SUI has also been well received and continues to generate new interest in Viviv. 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 VIV treatment as we advance our program towards a potential new SUI indication in the U.S. During the third quarter of this year, the focus of our entire organization was to continue to advance our SUI clinical development program and successfully execute our core initiatives. Through the remainder of 2022, we intend to successfully complete our landmark pursuit trial, expand our install base in the U.S. and Asia Pacific regions with core medical specialties, support 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. In closing, I'd like to thank the incredibly talented and dedicated team at Viviv for their efforts over the last three years. As we transition to a urogynecology company focused on the treatment of female SUI with our novel endovaginal treatment, we look forward to reporting our top line results from pursuit and appreciate everyone listening to our conference call today. Operator, this concludes our prepared remarks. Thank you.

Thank you. Thank you for attending today's presentation.