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Edited Transcript of VIVE.OQ earnings conference call or presentation 12-Nov-20 10:00pm GMT

·9 min read

Q3 2020 Viveve Medical Inc Earnings Call FRANKLIN Nov 13, 2020 (Thomson StreetEvents) -- Edited Transcript of Viveve Medical Inc earnings conference call or presentation Thursday, November 12, 2020 at 10:00:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Jeannie Swindle Viveve Medical, Inc. - Senior Director of Corporate Communications * Scott C. Durbin Viveve Medical, Inc. - CEO & Director ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Good afternoon, and welcome to the Viveve Third Quarter 2020 Financial Results Conference Call. (Operator Instructions) Speaking today are Viveve's Chief Executive Officer, Scott Durbin; and Jeannie Swindle, Senior Director of Corporate Communications. Please note, this event is being recorded. I will now turn the call over to Jeannie Swindle. Please go ahead. -------------------------------------------------------------------------------- Jeannie Swindle, Viveve Medical, Inc. - Senior Director of Corporate Communications [2] -------------------------------------------------------------------------------- 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 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. I would like to now turn the conference call over to Scott Durbin, Chief Executive Officer. -------------------------------------------------------------------------------- Scott C. Durbin, Viveve Medical, Inc. - CEO & Director [3] -------------------------------------------------------------------------------- Thank you, Jeannie. Good afternoon, everyone. We really appreciate you joining us today. I'd like to begin the call this afternoon with a short business summary, then review our third quarter financial results and highlight certain milestones as well as summarize our forthcoming pivotal U.S. clinical trial, PURSUIT, in the context of the multibillion-dollar market opportunity it may afford us in the future. As a result of positive preclinical and clinical SUI results released during the third quarter, Viveve has transitioned to a urogynecology company with a core focus on stress urinary incontinence, or SUI. As a result, we pivoted the focus of the entire organization in the third quarter to 3 core areas: First, to continue to grow our installed base through our recurring revenue model into our core specialties of urogynecology, urology and gynecology. Second, to continue to support our customers through our novel internal customer care team efforts, which drive increased consumable treatment tip utilization and sales. And third, to rapidly advance our pivotal clinical program in SUI to achieve an FDA label and to commercially launch the first patented, protected, endovaginal, office-based treatment for urethral hypermobility to improve SUI in women. Further, like most companies in the third quarter, Viveve continued to experience the negative impact of the COVID-19 crisis on business operations, particularly in the United States. While we plan to continue to operate at a significantly reduced cash burn rate as we execute and complete our pivotal PURSUIT trial towards a new FDA approval in the U.S., the commercial environment, overall, is improving. Today, we reported total revenue for the third quarter of $1.5 million with a global installed base of 865 systems as of September 30. Through our new recurring revenue model, we've placed nearly 100 systems in the United States since June of last year. This commercial model continues to be met with great enthusiasm from practitioners, and we anticipate increasing its success in the future due to its scalability, lower selling costs and the potential to rapidly improve profitability. Internationally, third quarter was also a strong quarter. We grew our installed base to 386 systems and continue a high rate of consumable utilization throughout the Asia Pacific region, where we continue our focus on key markets like South Korea, China, Taiwan, Thailand and others. Total operating expenses for the third quarter decreased substantially to $3.6 million, down from $6.5 million for the same period last year. The decrease resulted from the company's organizational realignments and efforts implemented in response to the impact of the COVID-19 crisis. Finally, cash and cash equivalents as of September 30 were $9.2 million, and we expect a cash burn rate of $3 million to $4 million per quarter going forward until our pivotal PURSUIT trial is completed. I'd now like to shift the focus to our stress urinary incontinence program. As I mentioned a few moments ago, the recent milestones we achieved have enhanced our long-term commercial opportunity in SUI. Specifically, these include positive results from both the 3-arm SUI feasibility and in-vivo preclinical studies; issuance of a U.S. SUI method patent covering the use of both radiofrequency and cryogen to treat SUI; formation of a world-class clinical advisory board in urinary incontinence; and FDA approval of our IDE to conduct the PURSUIT trial. Before I summarize these and their importance, I'd like to provide a brief overview of SUI for those on the call who may be new to Viveve. SUI is a condition that affects an estimated 25 million to 30 million women worldwide. And based on our estimates, represents a $10 billion to $12 billion total available consumable market opportunity. Today, few effective noninvasive treatments exist that reduce leakage associated with SUI. In fact, the current spectrum of therapeutic options for women is limited to physiotherapy, at one end of the spectrum, such as Kegels or electrical muscle stimulation designed to strengthen the pelvic floor musculature; to surgical approaches at the highly invasive end of the spectrum, such as bulking agents or sling procedures. We believe that our endovaginal, office-based, cryogen-cooled, monopolar radiofrequency treatment, which can be done in approximately 45 minutes, can safely and effectively improve urethral hypermobility and thereby, significantly reduce leakage for women with SUI. Following the inconclusive clinical results of last year's LIBERATE-International trial, whereby our control arm performed equally as well as our treatment arm across 6 different end points, we developed and validated a new sham tip, conducted a preclinical tissue study to make sure the new tip was not causing any temperature or cellular changes in tissue, and conducted a small clinical feasibility study to demonstrate that the new sham tip would not result in a meaningful clinical outcome versus our CMRF treatment. The combined results from each of these efforts is of significant importance. We believe these results support our thesis that the cryogen cooling treatment tip, used as a sham treatment in our prior LIBERATE-International SUI trial, likely produced the positive therapeutic effect we saw. And the fact that we now have a true inert sham tip provides us with confidence that our upcoming PURSUIT trial can achieve its primary end point, positioning us for a potential SUI indication in the United States. With respect to the U.S. PURSUIT trial, I cannot overstate the importance of this trial, its design and implications for our future. Positive results from PURSUIT may enable a new label in SUI from the FDA and open a multibillion-dollar commercial opportunity. The current FDA-approved IDE trial is designed as a randomized, double-blind, sham-controlled study intended to enroll approximately 240 subjects at up to 24 study sites in the United States, randomized in a 2:1 ratio. The primary efficacy end point is the proportion of patients who experienced more than a 50% reduction in leakage as measured using the standardized 1-hour pad weight test at 12 months post treatment. In the treated group, and as a reminder, this is using our CMRF active tip, versus the control group, which is now a virtually energy-less sham tip. Again, I want to highlight that unlike our previously completed LIBERATE-International SUI study, the sham treatment that would be administered to the control group in PURSUIT will be a clinically inert or a true sham treatment. The minimal RF energy and cryogen cooling delivered by the sham treatment tip will be at a subtherapeutic level. Again, we have demonstrated that it should not induce a meaningful cellular nor clinical response within subjects in the control group. Initiation of the U.S. PURSUIT trial is targeted for the end of this year. The tremendous milestones accomplished in the third quarter have now set the course for Viveve towards a commercial label in SUI and a multibillion-dollar market opportunity. Our focus is to provide a clinically proven, safe and effective, noninvasive treatment option to the millions of women worldwide who suffer from stress urinary incontinence. In this effort, we are extremely fortunate to have strategically assembled an elite group of preeminent urology and urogynecology experts to help guide and advance our SUI program. Equally important, the issuance of our new SUI methods patent during the third quarter strengthens our intellectual property portfolio, and we believe will protect our technology and this market in the future. As we have transformed our strategy to focus on SUI, we have solidified the path of our clinical development program and enhanced our long-term commercial opportunity. I am extremely pleased with the significant milestones that were achieved this quarter and equally proud of the talented and dedicated effort of the entire Viveve team. As a result of our collective focus and dedication, I'm confident that we can continue to successfully navigate the current commercial conditions and know that the perseverance demonstrated by the entire organization will position Viveve in the future as a global leader in stress urinary incontinence. Again, I'd like to thank everyone for participating in our third quarter conference call today. Operator, this is the end of our prepared remarks. Thank you. ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- The conference has now concluded. Thank you for attending today's presentation, and you may now disconnect.