Viveve Medical, Inc.
Q4 2020 Earnings Call Transcript

Published: 18 Mar 2021

[Company Representatives:]

Scott Durbin - Chief Executive Officer Jeannie Swindle - Senior Director of Corporate Communications

[Operator:]

Good afternoon, and welcome to the Viveve Full Year 2020 Financial Results Conference Call and Corporate Update Conference Call. All participants will be in listen-only mode. . Speaking today are Viveve's Chief Executive Officer, Scott Durbin; and Jeannie Swindle, Senior Director of Corporate Communications. After today’s prepared remarks there will be a brief question-and-answer session. Please note that this event is being recorded. I will now turn the call over to Jeannie Swindle.

[Jeannie Swindle:]

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.

[Scott Durbin:]

Thank you, Jeannie. Good afternoon everyone. We really appreciate you joining us today. I'd like to start the call this afternoon with a short strategic business summary, followed by a high level review of our 2020 full year financial results. I'll then remark on our Stress Urinary Incontinence clinical development program and the pivotal PURSUIT trial that is underway in the United States. Before opening the call to questions, I will close with our plans to achieve an SUI indication and the enormous commercial opportunity it represents. 2020 was a challenging, yet transformational year for Viveve as a result of the dedicated efforts of the entire company and the achievement of critical milestones for our SUI program. Viveve successfully pivoted in 2020 becoming a euro gynecology company with a focus on SUI and launched our pivotal U.S. PURSUIT trial. As we move forward over the next 18 to 24 months our core areas of strategic focus will be to first continue to advance the clinical development program in SUI, by successfully executing the currently underway PURSUIT trial and achieving a positive data read out. Thereafter, if positive to commercially launch the first FDA approved, patent protected, endovaginal office-based treatment for urethral hypermobility to improve SUI in women. Secondly, continue to focus our commercial efforts on the United States and Asia Pacific regions and expand the installed base of systems throughout the world, additionally targeting core specialties of urogynecology, urology and gynecology. And finally third, continue to support our customers, to our internal customer care team and successful initiatives, which continue to drive increased consumable treatment tip utilization and sales.

[Operator:]

Our first question today will come from Jeffrey Cohen with Ladenburg Thalmann.

[Jeffrey Cohen:]

Hi Scott! How are you?

[Scott Durbin:]

Hi Jeff, how are you? Thanks for joining today.

[Jeffrey Cohen:]

No problem, it’s a pleasure to be here. So, a couple of questions on the enrollment. You expect that, how has that occurred throughout the centers, number of centers that are enrolling now are how many?

[Scott Durbin:]

Yeah, we are up to I’d say a little over 20 centers right now who are currently enrolling. We've got a handful that are in the IRB process or going through site initiation visits and training, but we expect them to be up to speed in the next couple of weeks.

[Jeffrey Cohen:]

Okay, and there's no type of eminent looks or the Pad Weight measurement is at month 12 or you are taking looks at earlier months?

[Scott Durbin:]

So we are taking both three and six months looks on Pad Weight from a responder perspective and also from a mean change and baseline perspective, as well as 3-day voiding diary, you know collecting those at those time points as well. But we won't have, we won't have an unblinded look at any of those time points, but we will have them at the end of the 12 month study.

[Jeffrey Cohen:]

Okay, got it. And then back to your base business currently, could you talk about that a little more. It feels like there's some upside that this had on the utilization in the revenues. Could you call that out as far as geographies that you're seeing recently and obviously we don't expect any guidance, but it feels like at the moment ‘21 could be guided into ‘20 on the top line, at least from how we are looking at it?

[Scott Durbin:]

Yeah, we certain expect it to Jeff. You know 2020 was obviously difficult, particularly in the United States where the Asia Pacific region recovered far more quickly in 2020 and actually contributed quite strongly to the 2020 results. But here at the beginning, as I mentioned in the prepared remarks and 2021, I think it's – we are certain the market is improving, we're certainly seeing clinics that had to close down in 2020, re-open up, order tips, start to treat patients, see and improve patient flow. So we're optimistic that we're on the up-tick here and that should translate into a better year for us from a financial perspective.

[Jeffrey Cohen:]

Okay and then as far as OpEx going forward, it sounds like the baseline from 2020 carries through to 2021, plus I don’t know, 10% to 30% based upon on the clinical work as well as perhaps additional resources needed for the higher trajectory on revenues.

[Scott Durbin:]

Yeah, I think 10% to 30% is probably a good range in terms of increasing OpEx for 2021. We’ve worked hard as you know over the last 18 months or so to sort of reduce the cash burn and start to level set the financial statements and improve just operational efficiency. And so we're going to continue to improve that as we go into 2021 and while we’ll see an uptick in 2021 on the R&D line due to the trial being mostly conducted this year, you know these are tremendously expensive trials and so it won't be significant.

[Jeffrey Cohen:]

Got it, and then lastly for us is just walk us through share count as of current inclusive of the additional shares from our end-of-year or beginning of the year.

[Scott Durbin:]

Yes, so we ended, we ended 2020 with 10.3 or we filed the 10-K with 10.3 million common shares outstanding which reflects the shares issued - common shares issued in the January financing.

[Jeffrey Cohen:]

Okay, got it, perfect. That does it for us. Thanks for taking the questions.

[Scott Durbin:]

Okay, thanks so much for joining Jeff. I appreciate it.

[Operator:]

And our next question will come from Ben Haynor with AGP.

[Ben Haynor:]

Good afternoon, guys. Thanks for taking the questions and congrats on the transformation and progress over the last year or so.

[Scott Durbin:]

Thanks so much Ben. Welcome, and thanks for joining.

[Ben Haynor:]

Yeah, no problem. So you said you’re at 20 or so sites, a handful more kind of going through the process. It sounds like the way you're characterizing the enrollment, its effectively on track with what you expected there. Is that the right read and then also is there a chance that you ultimately don't get to the 30 sites, just to maybe some of these sites that are more impacted from COVID or other matters, just ultimately don't get ramped up before you roll the thing.

[Scott Durbin:]

Yeah, I think it's fair to say, you know we're at where we expect it to be. It's always a ramp up when you begin and we began – we announced enrollment on January ’21, so it's been a little less than two months here. And then it tends to accelerate as you get all the sites up and screening and treating patients and dealing with the flow through of the various advertising campaigns that are going on locally around each of our clinic sites. And so you know right now we feel like we're on track to hit our enrollment target of the end of the second quarter or you know very early in July.

[Ben Haynor:]

Okay, so by the 4th of July you’ll have it all enrolled, right?

[Scott Durbin:]

Well, we certainly hope so, and we're certainly on track for that right now. You know we obviously always wanted to go quicker. We knew we were going to face certain challenges coming into the execution of the trial from enrollment and follow-up perspective in this environment, but I think we learned a lot in 2020 having run the feasibility study and you know try to incorporate those learning’s into this very important study for us and I think we're on track and I expect we'll get you know right up to or at or very near to the 30 site at the end of the day.

[Ben Haynor:]

Okay. That’s defiantly helpful. And then just looking at some of these secondary endpoints and it looks like you've kind of altered them or at least a couple few on them since the original trial design came out before you boosted the patient count. Can you maybe talk about some of these secondary end points and you know why you add some, or simple ones that are chosen. I mean it seems like there are few that maybe could help us kind of get the patient guidance on when they could expect the results, or was that a consideration. What went into some of these changes?

[Scott Durbin:]

Yeah, I think the most important change is really the addition of the three month time point and that was really done for precisely the reason you just highlighted, which is you know if as we expect sort of to get to a positive outcome from this trial, it will be important from there as we achieve an FDA clearance and begin to be able to finally market on-label in the United States and elsewhere for SUI. That you know physicians have a sense for the on-set of improvement in symptoms or leakage and by adding the three month end-point it really gives a nice time history of improvement, because we can look back at voiding episodes, we can look at mean change from baseline on the Pad Weight Test in addition to responder rates, and really get a sense of the time sequence of outcome and that can be communicated to patients once we're on a label from the physician in terms of setting expectations. Because as you know, ours is a tissue mechanism of action that based on our history in the many clinical trials we've run and the sort of vast commercial experience we have today, we know that it takes 30 to 90 days for the tissues to remodel and for women to start seeing clinical improvement in their symptoms. And so that's the main change to – is really adding the three month time point to the pad Weight Tests and to the voiding diary.

[Ben Haynor:]

Got it. That makes a lot of sense and then, obviously SUI is an embracement conditions. So it makes sense that people are suffering from it or are kind of reluctant to discuss and that's why you get that kind of broad spectrum of estimates in terms of you know what's the number of women in the U.S. that have it. But I did notice, it sounds like you're looking more at 25 million to 30 million based upon some of the prepared remarks, where you said in the press release, whereas like we caught you previously talking more or less kind of the 11 million range. Is that maybe including a little bit more of a mixed UI or why the higher figure now.

[Scott Durbin:]

Yeah so, it’s a great question and thanks for asking it, because I think it's important to clarify that when we talk about you know 25 million to 30 million women in the U.S. with you know with stress incontinence, its was some form of stress incontinence and as you know there's pure stress incontinence, there is pure urge incontinence and then there is this enormous population of patients who have a little bit of both, which they refer to as mixed. And so when we talk about 25 million to 30 million women in the United States have some form of stress urinary incontinence, it's including pure SUI and most of the mix patience. But as you drill down on that and really what we're focused on, you know with stress in particular is making sure we're identifying patients who have predominant SUI, and so when we talk about 10 million or 11 million 12 million of those patients who would be candidates for as of the procedure, we're really honing in on those patients who are predominantly SUI and there are a variety of clinical mechanisms to differentiate whether a patient has more stress incontinence or more urge incontinence. And so that's the difference in those two numbers Ben.

[Ben Haynor:]

Okay, that masks sense. You know obviously, either way it’s a fairly massive market.

[Scott Durbin:]

It certainly is.

[Ben Haynor:]

Good deal. Well, I think that’s all I have for this afternoon. Good luck with the enrolment and thanks for taking the question again.

[A - Scott Durbin:]

I really appreciate it. Thanks Ben, thanks for joining and I appreciate everybody joining the conference call today. Thanks so much.

[Operator:]

as well as today’s conference call. Thank you for attending today's presentation. You may now disconnect.