May 13, 2021
Operator
Good afternoon, and welcome to the Viveve First Quarter 2021 Financial Results and Corporate Update Conference Call. All participants will be in listen-only mode.
[Operator Instructions] After the today's prepared remarks, there will be a brief question-and-answer session. Please note, this event is being recorded.
I will now turn the call over to Jeannie Swindle, Viveve's Senior Director of Corporate Communications. Please go ahead.
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. 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. 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.
Jim Robbins
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 2021 financial results. I will then turn the call over to Scott, who will provide a corporate update.
And afterwards, we'll open the call to questions. Today, we reported total revenue for the first quarter of $1.5 million from the global sale of 8 Viveve Systems and approximately 2,450 consumable treatment tips.
As of the end of the first quarter 2021, the Company had an installed base of 860 Viveve Systems worldwide. Total operating expenses for the first quarter decreased to $5.5 million, a reduction from $6 million for the same period last year.
The decrease is a result of the Company's organizational realignment to focus on our current SUI clinical development program. We ended the quarter in a strong cash position due to the success of our public offering in January and our lowered operating cash burn of $3.3 million in Q1.
Cash and cash equivalents as of March 31 were $28.4 million. Before handing the call to Scott, I will remind Viveve's shareholders on our call this afternoon that Viveve's recent 2021 Annual Stockholders' Meeting was adjourned to June 2 due to a lack of quorum.
We would like to encourage all shareholders of record to please vote. Thanks.
I'll now turn the conference call over to Scott.
Scott Durbin
Thanks, Jim. Good afternoon, everyone.
And again, thank you for listening to today's call. I will begin my remarks today to give perspective on the positive financial results and capital position of the Company that Jim just reported.
Today, we are in a strong financial position as a result of the dedicated efforts of the entire Viveve organization, achievement of critical milestones in our stress urinary incontinence or SUI clinical development program and confidence in our ability to execute our SUI strategy to achieve a potential new indication in the United States. With the capital resources to support operations through the end of 2022, we plan to continue our strategic focus in the following core areas: number one, advancing our currently underway PURSUIT trial and achieving a positive data readout in the middle of next year; thereafter, if positive, commercially launching the first FDA-approved, patent-protected endovaginal office-based treatment for urethral hypermobility to improve SUI in women; secondly, focusing on our commercial and market development efforts in the United States and Asia Pacific regions through the expansion of our installed base targeting urogynecology, urology and gynecology core specialties; and finally, third, supporting our customers with successful initiatives to continue to drive increased consumable treatment tip utilization and sales.
The entire Viveve organization is committed to these core areas of strategic focus and successfully achieving critical milestones as we advance our SUI clinical development program toward a potential new indication in the U.S. I'd now like to direct my remarks to our pivotal SUI PURSUIT trial.
PURSUIT is a randomized, double-blinded, sham-controlled trial with an intended enrollment of 390 subjects with moderate SUI. This is defined as greater than 10 mls and up to 50 mls of urine leakage on the 1-hour pad weight test at up to 30 study sites in the United States.
Randomized in a 2:1 ratio, subjects in the active treatment are receiving our cryogen-cooled, monopolar radiofrequency, or CMRF treatment, while subjects in the control arm are receiving an inert or energy-less sham treatment. The primary efficacy end point of the PURSUIT trial is a comparison of the proportion of patients who experienced greater than 50% reduction in urine linkage compared to baseline on the standardized and objective 1-hour pad weight test at 12 months posttreatment versus the inert sham procedure.
The study also includes several secondary end points also assessed using the 1-hour pad weight test, the 3-day bladder voiding diary and other behavioral and quality-of-life questionnaires. Subject safety will also be monitored throughout the study.
Launched in late January, PURSUIT enrollment is ongoing at nearly all 30 study sites. Although a bit slower than we anticipated, enrollment is now accelerating, and we expect completion in the third quarter of this year.
Importantly, positive 12-month data results from PURSUIT may support a marketing application for a new SUI label in the United States. 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 with few effective noninvasive treatments that exist today to reduce leakage associated with SUI. As a result, a positive PURSUIT outcome and FDA approval opens a multibillion-dollar commercial opportunity for Viveve.
On the commercial and market development front, we continued to see steady improvement from the COVID-19-caused challenges endured during the past year by medical practitioners and clinics worldwide. In the U.S.
and Asia Pacific, our targeted regions of focus, progress is gradually returning to full operations, patient flow and elective procedure volumes. We continue to provide high-quality service and support to increase Viveve procedures and treatment tip utilization through our dedicated customer care team in the U.S.
and distribution partners internationally. As I previously stated, our market development efforts in the U.S.
and Asia Pacific are directed towards core specialties of urogynecology, urology and gynecology. We're pleased to report that receptivity for our innovative dual-energy technology is strong and growing.
Two successful key opinion leader physician events were recently conducted: One in Beijing, China, with Paragon Meditech, our exclusive distribution partner in that country; and another in the United States. The U.S.
event included a select group of female, uro and urogyn physicians who, with Viveve, will launch and grow an influencer network entitled [EmpowHer Network]. Several of these influencer programs are planned in the coming months, in addition to our relationship-building efforts with key opinion leaders in urology, urogynecology and incontinence medical societies and associations.
Our goal is to increase awareness of and build upon our tradition of scientific rigor and the body of clinical evidence that supports the safety and efficacy of the Viveve treatment as we advance our clinical program towards a potential new SUI indication in the U.S. In the first quarter of this year, Viveve continued to make significant strides.
Our focus through 2021 is to complete PURSUIT enrollment; expand our installed base of Viveve Systems in the U.S. and Asia Pacific, targeting core medical specialties; supporting existing customers to drive increased treatment tip utilization and sales; and to continue the operational efficiencies we have achieved, which has lowered our cash burn rate considerably over the past year.
Finally, I'd like to thank the tremendous team at Viveve for their extraordinary efforts this quarter as well as everyone for participating in our conference call today. Operator, this concludes our prepared remarks, and we can open the call to any questions.
Thank you.
Operator
[Operator Instructions] Our first question comes from Ben Haynor with AGP.
Ben Haynor
First off, congrats on getting ramped up to nearly all the 30 sites. You mentioned that you expect completion in the third quarter.
I think on the Q4 call, you talked about early Q3. I mean, is that still kind of the sense given the recent acceleration?
Or should we expect mid-Q3 or late Q3? Any color there would be helpful.
Scott Durbin
Ben, thanks for joining the call today. Appreciate it.
Yes, just with respect to the trial, enrollment never goes as fast as anybody hopes it does. I think we expected to see enrollment be a little bit greater through February and March, but sort of the COVID-19 impact on clinics and sort of the logistics of clinical trial execution played a part.
And so we're very encouraged by where we are. A little bit more color I can tell you is that we've got -- a lot of patients have been screened.
And as you know, we have fairly strict inclusion criteria to make sure that we are enrolling in a pivotal trial the most appropriate patient population who is going to have strong outcomes from the treatment. So generally speaking, we're sitting in a good spot today.
We see enrollment accelerating now that almost nearly all the 30 sites are fully operational and enrolling and randomizing patients. And so it's a little difficult to predict whether it's going to be early in the third quarter, mid-third quarter.
But our hope is certainly in the first half of the third quarter, we can complete enrollment.
Ben Haynor
Okay. That's definitely helpful.
And then just looking at kind of the revenue breakdown, it looks like U.S. revenue was a bit better than we expected.
It was up 30-odd percent. I suppose, arguably, you could say that there may have been more of a COVID impact in Q1 this year than last year even.
So I mean, is there anything specific on that, that you can kind of attribute the performance to? I mean, is it certain regions that are performing well?
Is it kind of across the board? What's the right way to think about that?
Scott Durbin
Yes. I think, remember that last year, we were -- it was prior to the readout of our sexual function trial.
That was still a part of the -- our clinical development program and potential commercial opportunity. We were continuing to target a broad group of specialties, I think, as we went through 2020 and began to focus and shift our focus to the clinical development program for SUI and the commercial opportunity around SUI.
I think the focus of targeting urogyn and urology and gynecology has paid dividends, particularly following the positive preclinical and clinical data we achieved in SUI last August. And I think that's really what's driving the positive impact in the U.S.
As well, we've got a tremendous customer care team who has really developed best practices for helping clinics and physicians be successful in recruiting patients for treatments. And so I think that's an element that contributed to the difference in Q1 this year as well.
Ben Haynor
Okay. That's helpful.
And then lastly for me on the [EmpowHer] program that you guys are going to initiate here. To the extent that you can kind of talk about it in the kind of current political environment, do you see that female physicians are, on average, more engaged or more receptive to the technology?
Or is it something that is just a good thing for the business overall?
Scott Durbin
I don't want to sort of make gender characterizations for the physicians.
Ben Haynor
I figured it might be a little bit problematic.
Scott Durbin
But -- yes. But let me just say this.
I think the concept was derived by our sales team, certain individuals in our sales team, and it was a tremendous idea. And I can tell you that it's in its infancy right now.
We have had our first event. It was very well attended, and enthusiasm for the opportunity to participate in a sort of female-only physician network, which is focused on stress urinary incontinence for a female population, was incredibly overwhelmingly positive.
And so we had our first event. Again, it's in its infancy right now.
We have several more events planned. We think it could gain a lot of momentum, and it's certainly good for business.
But it's also -- we are a women's health company and try to do what we can to advocate in that area, and this is a step forward in that regard.
Operator
Our next question comes from Jeffrey Cohen with Ladenburg Thalmann.
Jeffrey Cohen
I'm going to skip any questions on what the current political environment is, and we'll go straight to the few that I had. So firstly, can you talk about the -- give us a better sense of the pace of the trial.
You gave us some sense about the number of sites and how it looks. Will that kind of accelerate linearly throughout the second and third quarter?
Or will that accelerate more swiftly?
Scott Durbin
We think it's going to accelerate sort of linearly. Let me give you some perspective there.
We've screened 280 subjects across 25 centers, roughly. And obviously, these numbers change on a daily basis.
We have some strict -- as I mentioned in the previous response, we have some strict inclusion criteria really aimed at making sure that we have a predominant stress incontinence patient population in this trial, incredibly important for the ultimate outcome of measuring responders from a pad weight reduction perspective. We don't want a bunch of patients who are predominantly urge incontinence patients.
And so a proportion of those 280 have been randomized and treated today, but now we've got all 30 centers up and enrolling. I'll tell you that just from an interest-level perspective, we are doing local social media advertising around all of our sites.
And we've seen 3,500 forms be submitted by women who are interested in participating in the trial. So we're confident that the numbers are there.
I think it took, in the COVID environment, a bit longer than we had anticipated early in the first quarter to get up and rolling. But I think we're there now, and I think we'll continue to see sort of randomizations and treatments accelerate as we move through the next couple of months.
Jeffrey Cohen
Okay. Got it.
Could you talk about with and if an approval, how that data may play out outside the U.S.? Would it be something that you would -- with the clearance here, go for CE and others directly?
Scott Durbin
Yes. We will certainly do everything we can to best leverage a positive clinical outcome from PURSUIT in the United's States.
And we -- I don't want to speculate about the possibilities there. But Health Canada, CE Mark and other countries may be willing to accept that data, particularly on an FDA clearance to allow for an approval in that country.
So we believe there's an opportunity to significantly leverage it, but we'll have to go through that process at that time.
Jeffrey Cohen
Okay. Could you give us a sense of demographic age as far as the current trial and then maybe compare that or contrast that with how you think about the TAM and what that may look like in the U.S.
and abroad?
Scott Durbin
Well, we're focused -- from a trial perspective, I think the single biggest differentiator there between the TAM and our enrolled population is we are focused on a premenopausal patient population for the trial. We did that because it has been our history.
That's been part of the inclusion criteria of historical effort in SUI, and we didn't want to introduce new variables going into our pivotal. I think that is the single biggest factor from a type of patient perspective between the trial and the total available market.
That being said, I don't believe that's going to limit our opportunity if we have a positive trial outcome and get an FDA clearance for stress incontinence indication. There's nothing to suggest that our treatment can't be used in a postmenopausal patient who has similar SUI characteristics and severity.
So that's the biggest difference.
Jeffrey Cohen
Okay. Got it.
And then lastly for me, Jim, on the income statement, can you give us a sense of the R&D line? Does it seem like that's going to kind of peak out in the second quarter or the third quarter?
I think we had previously thought it would be towards the latter part of the year. Is that going to come a little bit earlier for us?
Jim Robbins
Yes. I mean, it's -- we expect that it's going to pick up a little bit more in the second quarter, and then it's going to level back down after that.
I mean, but -- so it's not going to be anything too dramatic, but it will peak in the second quarter and then start to level back down in the third quarter and then come back down later in the fourth quarter and then through the next year.
Operator
This concludes our question-and-answer session, and the conference has also now concluded. Thank you for attending today's presentation.
You may now disconnect.