Viveve Medical, Inc.

Good afternoon and welcome to the Vaviv first quarter 2022 financial results and corporate update conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing star, then zero. Please also note this event is being recorded. And now I'll turn the call over to Jeannie Swindle, Vaviv's Senior Director of Corporate Communications.

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 the novel coronavirus 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 today will be Scott Durbin, the V'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 first 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 $1.6 million from the global placement of 11 systems and approximately 2,750 consumable treatment tips. As of the end of the first quarter 2022, the company had an installed base of 895 of these systems worldwide. First quarter, total operating expenses were $5.8 million, compared to $5.5 million for the same period last year. The increase is mainly a result of the company's efforts to advance our Stress Urinary Incontinence, or SUI, development program and support our currently underway pursuit clinical trial in the U.S., as well as engineering and development work related to our next-generation products and product line improvements. As of March 31, 2022, we reported cash and cash equivalents of $14 million. Thanks. I'll now turn the conference call over to Scott.

Thanks, Jim. Good afternoon, everyone, and thank you again for listening to our call today. I'd like to begin today by underscoring the positive financial results and capital position of the company that Jim just reported on. Povee's financial position this quarter is a result of the efforts of our entire organization, which maintains its focus on advancing our Stress Urinary Incontinence Program towards a potential future new indication. Our pivotal U.S. Pursuit clinical trial continues to be our focus 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 operations through the end of 2022, including the planned completion of the Pursuit trial, Our strategic focus and efforts in the following core areas will continue to be, first, successfully executing the currently underway pursuit trial for SUI and achieving positive top line data by the end of the year. If positive, preparing to commercially launch the first FDA approved, patent protected, endovaginal dual energy office based treatment for urethral hypermobility to improve SUI in women. Secondly, focusing 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, supporting our customers with successful initiatives to continue to drive increased consumable treatment tip utilization and sales. As I previously stated, our entire organization is committed to these core areas of focus as we advance our SUI clinical development program towards a potential new indication in the U.S. I'd now like to direct my remarks to our currently underway U.S. pivotal PURSUIT trial for SUI. PURSUIT is a randomized, double-blinded, sham-controlled trial which enrolled 415 subjects with moderate SUI. defined as greater than 10 milliliters up to 15 milliliters of urine leakage on the one-hour pathway test 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 an inert or energy-less 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 compared to baseline on the standardized and objective one-hour pad weight test at 12 months post-treatment versus the inert sham procedure. The study also includes several secondary endpoints assessed using one-hour pad weight, the three-day bladder voiding diary, and other behavioral and quality of life questionnaires. Post-treatment follow-up visits occur at 3, 6, 9, and 12 months. 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 advancing. Importantly, the PURSUIT trial 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 have completed their three-month post-treatment visit. 76% of subjects have completed their six-month post-treatment visit. Approximately 44% have completed their nine-month follow-up visit. And with 14% of subjects having completed their 12-month final post-treatment visit, the VAE's clinical and medical affairs team continues to track, monitor, and support all our investigational sites. The months ahead in 2022 are, in essence, a countdown as we diligently execute our pursuit trial. And I'm pleased to state that we remain on track to complete all patient follow-up visits by the end of the year with announcement of top-line results shortly thereafter. Again, 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 strategy to achieve a potential SUI indication in the United States. The need for a clinically proven, safe, non-invasive, office-based individual 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. Based on our estimates, this represents a $10 to $12 billion total available consumable market opportunity. As a result, a positive pursuit outcome and subsequent FDA approval opens a multi-billion dollar commercial opportunity for Vaviv. On the market development front, our dedicated commercial team in the U.S. and distribution partners internationally continue to provide high-quality sales and service and support to drive increased Vaviv procedure volumes and treatment tip utilization. These efforts are focused on the U.S. and Asia Pacific regions and directed towards the core specialties of urogynecology, urology, and gynecology. Although we have a very small commercial organization today, their efforts continue to reveal growing physician receptivity for our innovative dual energy technology. 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 Vaviv treatment. as we advance our clinical program towards a potential new SUI indication in the U.S. In closing, during the first 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 pursuit trial expand our install base in the U.S. and Asia Pacific regions with core medical specialties, support our existing customers to drive increased treatment tip utilization and sales, and to continue the financial efficiencies we have achieved. In closing, I'd like to thank the dedicated team at Vaviv for their continuing efforts this quarter, as well as everyone for participating in our conference call today. Operator, this concludes our prepared remarks. Thank you so much.

The conference is now concluded. Thank you for attending today's presentation, and you may now disconnect.