Q2 2020 Viveve Medical Inc Earnings Call
<unk> conference call all participants will be in listen only mode. So do you need assistance. Please signally conference specialist by pressing the star key followed by zero.
Speaking today, our beliefs, Chief Executive Officer, Scott Durbin, and Genies Wendell senior director of corporate Communications.
Please note this event is being recorded.
Now I'll turn the call over to Genies Wendell.
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.
These statements that is not a statement of historical fact is a forward looking statement.
This includes remarks about the corporations projections expectations plans beliefs and prospects.
These statements are based on judgment and analysis as if 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.
Another filings made with the FCC, which are also available on the company's website.
So any forward looking statements represent management's views only as of the data This conference call and should not be relied upon as representing management's views as of any subsequent date.
I would now like to turn the conference call over to Scott Durban Our CEO.
Thank you Jeanie good afternoon, everyone and thanks for joining us today.
I'd like to begin the call this afternoon and with a summary of our second quarter results and milestones.
Finally, I'd like to highlight the trajectory of our asked you why clinical development program discuss important upcoming milestones and provide our perspective for our business going forward.
To begin during the second quarter. This year the beats business operations were significantly impacted by the covered 19 crisis, particularly in the United States.
In response, the significant organizational realignment and operational efficiencies designed to reduce cash burn that were initiated late in the first quarter have continued throughout the second quarter.
These measures were required in response to the unprecedented health an economic challenges caused by the cobot 19 crisis.
Health safety and well being of our employees customers distribution partners. Another contacts took priority.
Like most companies across all industries. The majority of our employees continue to work remotely and it here to strict health and safety protocols when they are in our offices or contract or facilities.
Additionally, due to an estimated 70% to 80% of our customers temporarily closing were dramatically reducing services and staff and their medical practices. The beeps U.S. commercial team was significantly reduced and the entire organization refocused to support current customers and advance.
Our pivotal stress urinary incontinence or actually why clinical development program.
I am pleased to report that these deliberate yet dramatic measure said proven effective in their intent to support customers significantly reduce cost and preserve cash and I'm equally pleased to report that despite the challenges caused by the Kobe 19 crisis during the second quarter our organization achieved.
Nipigon regulatory and clinical milestones I.
I will expand further on the importance of these milestones in my upcoming remarks, but to highlight them. They are after FDA clearance of our I'd. He to conduct a pivotal pursue trial for improvement of Bashi why in women.
The continued advancement of our as she why three arm feasibility trial targeted for read out in the coming weeks.
And regulatory approval of our 2.0 system in Thailand.
Achievement of these milestones was previously announced via press releases and filings.
Today, We also reported total revenue for the second quarter of 2020 of $704000 as of June Thirtyth 2020. The company has a growing installed base of 855 that these systems.
Nearly 100 of the total 481, but these systems in the U.S. had been placed under the new recurring revenue model that was implemented in the United States in June of 2019.
The number of system placements within the inaugural 12 month period, notwithstanding the significant five months commercial disruption caused by the covert 19 crisis, including a greatly reduce the these sales team is evidence of the models traction as physicians more readily adopt RCM RF technology.
Hey into their practices.
We anticipate increasing success of the recurring revenue model in the future due to the model scalability, lower selling costs and potential to improve profitability dramatically.
Internationally, our installed base has grown to 374 of these systems sold through the company's distribution partners without significant change or impact to the international International business model.
As a cobot 19 crisis evolves and as clinic practices reopen elective procedures, increasing conditions continue to improve the d. this well position to re scale its operational and commercial activities as warranted.
Additionally, through several financing efforts, we strengthened the these balance sheet into second quarter to bride, the resources necessary to maintain our business strategy and continue to advance our critical asked you I clinical development program.
The ultimate goal. These actions has been to create long term value by supporting our existing customers and aspiring to achieve a U.S. label for US you lie.
Our S. You I program is now the focus of the entire of a deep organization Ashley wise a condition that affects an estimated 25 to 30 million women worldwide and represents a massive 10 to 12 billion dollar total available consumable market opportunity.
Today, there are few affective noninvasive treatments like that exists to reduce leakage as a result, the best you I in fact, the current spectrum of therapeutic options for women is limited to physiotherapy at one end of the spectrum, such as key goals or electrical muscle stimulation design to strengthen the pulled the.
Sculpsure.
To surgical approaches at the highly invasive ended the spectrum, such as bulking agent pass razor sling procedures.
The Visvis demonstrated in three previous clinical studies that are single noninvasive and durable see MRF treatment, which can be done in approximately 45 minutes safely improves as to why symptoms and significantly reduces linkage for women with US you why.
The recently announced after <unk> I D E clearance to conduct our U.S. pursuit trial represents a significant regulatory milestone achievement for the company.
Completion and read out of our three arm as she why feasibility study targeted in the next few weeks also represents a major near term catalysts that we believe will set the course for the company going forward.
The current three arm as she why feasibility study compares our cryogenic cooled monopolar radio frequency treatment and a cryogenic only sham treatment to a totally in our Cham treatment for the Approvement I've asked you lie in women.
This prospective randomized single Blind study is being conducted at three clinical sites with the planned enrollment of approximately 36 subjects randomized on a one to one to one ratio to each of the three study arms.
The primary efficacy endpoint is the mean change from baseline in the standardized and objective one hour pad weight test at five months post treatment.
The primary goal this trials to demonstrate directional separation between the treatment arms and the inner Chan more true placebo arm of the study.
A positive data read out from this short term feasibility study in the next few weeks will strongly support initiation of our pivotal pursue trial in the United States.
The importance of the U.S. pursue trial, its design and implications for our future cannot be overstated.
Initiation of this pivotal U.S. trial pending a positive read out from the S. You I'd feasibility study will enable the company to continue its strategic pursuit for U.S. label expansion of RCM RF technology for industry why indication.
The FDA approved pursued trial will be a multi center randomized double blind and Sham controlled study.
The primary efficacy endpoint you.
He's the one hour pad way test at 12 months post treatment.
Enrollment is intended to be approximately 240 subjects at up to 24 study sites in the United States.
Randomized in a two to one ratio subjects in the active arm will receive our see MRF treatment.
Subjects in the control arm will receive a clinically entered cham treatment.
And it's incredibly important for me to emphasize the comparative treatments in the active in <unk> and control groups and the pursue trial.
Like previously completed I see why trials, specifically, our liberate international study the sham treatment that will be administered to the control group will be a clinically in or or a true sham treatment.
The minimal RF or radio frequency energy and the cries and cooling delivered by our new Sham treatment TEP will be at some clinical and therapeutic levels and thereby should not in do say true treatment response in subjects in the control group.
Initiation of the pursuit trial is targeted in the fall of this year pending the read out of the S. You I feasibility study in a few weeks.
As the Cobot 19 crisis continues to evolve and present challenges to our commercial and business operations. It is the talent and dedication of all members of the Viiv organization and our dedication to our customers that has effectively enabled us to meet and address these challenges.
In spite of the uncertain duration of the pandemic and the severe cost cutting actions executed during the second quarter. The entire organization is resolute in its focus to support our customers and advance our asked you I clinical program through important upcoming steps and milestones.
A positive read out from the assay why feasibility study in the next few weeks will provide tremendous confidence and the ability of the pursuit trial to achieve positive results and position for the <unk> potential U.S.S. you like indication in the future.
In a market opportunity that is several billion dollars large.
As a result of our focus and dedication I remain confident that the company can continue to successfully navigate the changing commercial conditions and know that the professionalism and perseverance demonstrated by the entire believe organization will position our company in the future as a global.
Leader in stress urinary incontinence.
I'd like to thank everyone today for participating in our second quarter Conference call. Operator. This is the end of our prepared remarks. Thank you so much.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.