Q4 2020 Cardiovascular Systems Inc Earnings Call
[music].
Ladies and welcome to the Cardiovert.
Oh, yes, 2024th quarter earnings Conference call at this time, all participants are enough listen only mode. After the speakers presentation. There will be a question answer session to ask a question during the session you'll need to press star.
You require any further assistance. Please press star zero I would now like to hand, the conference over to your Speaker today, Jack Nielsen Vice President Investor Relations and corporate communications. Thank you. Please go ahead Sir.
Thank you Christine good afternoon, and welcome to our fiscal 2024th quarter Conference call with me today, Our Scott Ward see aside chairman, President and Chief Executive Officer, Rhonda, Rob operating officer.
Points, Chief Financial Officer, and Dr., Ryanair Gladden, Chief Medical Officer, approximately 30 minutes ago, We issued a press release announcing our full year in fiscal 2024th quarter results. You may find a copy of this release on our investor really.
You May also find and earnings presentation that includes additional details on our performance and outlook in a few moments you assign management will discuss results.
For a fourth quarter, which ended on June 20 June Thirtyth 2020. After our prepared remarks, we will entertain your questions. During today's call. We will make forward looking statements. These forward looking statements are covered under the safe Harbor provisions of the private Security Litigation Reform Act of 1995 and includes statements regarding see assaf.
Future financial and operating results or other statements that are not historical facts actual results could differ materially from those stated or implied by our forward looking statements due to certain risks and uncertainties, including those described in our most recent form 10-K and stuff.
The covert 19 pandemic has created.
It risks and uncertainties for our business tradition, and prospects, which we will discuss on this call see us I disclaims any duty to update or revise our for that.
Future events and developments or otherwise.
We will also refer to non-GAAP measures because we believe they provide useful information for our investors. Today's press release contains a reconciliation to GAAP results I will now turn the call over to Scott Ward.
Thank you Jack.
Good afternoon, everyone and thank you for joining us today I hope that you and your families are healthy and are continuing to successfully navigate this pandemic.
Today, we reported Q4 revenue of 42.5 million a decline of 38% compared to last year.
The quarter came in better than expected and we are encouraged that our revenue steadily improved throughout the quarter of how our company has responded to the Corona virus crisis, our customers will never forget how we engage them and how we continued to support cases.
How we took action to protect their safety.
How we offered.
The occasion programs to help them optimum vice chair and financially so five during a pandemic.
Our customers, new we stood with them throughout this crisis.
We enhanced our brand during Q4.
Seemingly grateful for our support.
Worldwide peripheral revenue days decreased 36% to 30.6 million.
Hospital based critical limb ischemia and limb salvage.
Which programs remained active throughout the quarter and the treatment of Clauda can patients is rebounding as hospitals are performing more in addition office space labs have helped lead the recall.
Sales and we believe that they will play an increasingly important role.
Full in the treatment of peripheral artery disease going forward.
Fourth quarter worldwide coronary.
At the outset of the Pan.
Abate coronary procedures will steadily improve throughout the remainder of the calendar year.
The recovery has been asymmetric across the United States with a stronger improvement in the south and Retlin west regions of the country.
Although there has been a recent surgeon Corona virus.
Care facilities around the country.
Have adapted and our success in emergent procedures well.
Simultaneously caring for patients teen.
So the chaos, we experienced in March and April has.
Has begun to subside and the recovery due to the steady improvement in our procedure volumes in made.
His confidence in our ability to forecast sales and we have issued guidance for Q1 revenue in the range of 55 to 50.
The 8 million.
In in a number of favorable and unfavorable factors that will in.
And in total we think our revenue will rebound to approximately.
Scent of prior year sales.
We'll provide additional information regarding our R&D pipeline and come up.
I will ask Jeff to provide you with additional details regarding our financial results and our first quarter.
Revenue guidance Jeff.
Pensions fourth quarter revenue of 42.5 million represented 38% decrease compared to last year.
And Tim.
Thousand 500, atherectomy devices during the quarter, representing a 37% decrease.
Compared to last year.
Worldwide peripheral revenue decreased 36%.
Yes.
30.6 million.
Worldwide coronary revenue decreased 41% to 11.9 million.
The revenue generated in the us and international markets total us revenue decreased 38% to 40 plus.
Ethically.
Overall unit volumes decreased 35%.
Domestic coronary revenues declined 44% from last year, primarily driven by lower atherectomy unit volumes.
International revenue decreased 17% to 2.1 million.
Travel restrictions and our inability to support new accounts has slowed our progress in international markets.
In Q4.
6% as a result of lower volumes.
Operating expenses, a 47.1 million decreased 6.4 million or 12% compared to last year.
Compared to last year due to lower core sales and other incentive compensation as well as actions taken to reduce variable spending.
R&D expenses increased approximately 2.4 million versus last year.
And includes a noncash charge of 3.3 million related to patents within our product portfolio and pipeline that are no longer tied to current or future commercial activities.
As you know we have a growing 20 patents for orbital atherectomy and products in development.
Was partially offset by lower expenses related to the positive of our eclipse clinical trial.
Fourth quarter net loss was 15.2 million.
Adjusted EBITDA was a negative 10.6 million.
On the balance sheet, we ended the quarter with over 200.
Turning 32 million in cash and marketable securities and no long term debt.
The increase in our cash position compared to Q3 was related to an equity issuance in June where we see is.
This issuance further strengthened strengthens our balance sheet and ensures we remain well capitalized throughout the recovery of a pandemic.
For the fiscal year ended June Thirtyth 2020 revenues declined 4.6% to 236 point.
Gross margin remained strong but.
But decreased slightly to 79.4% compared to 80.8% in the prior year, primarily driven by growth in lower margins segments, such as office space Labs, interventional support devices and international along with lower volumes caused by the pandemic.
Operating expenses increased 13.4 billion EUR, 6.7%.
The 214.6 million.
Net loss was 27.2 million or 79 cents per basic and diluted share.
For the full year compared to a net loss of 0.3 million or one cents.
Per year.
That concludes my review of Q4 and full year financial results.
I will now provide some commentary on what.
Fiscal 21.
As we discussed our expectations for Q1. Please note that we remain in a very dynamic environment.
Can you to monitor the many models that predict various scenarios for the severity on duration of the covenants.
As Scott mentioned.
Proceed with your volume steadily improved throughout Q4 and even into July.
As hospitals resume emergent and elective procedures.
We believe this trend will continue and we are forecasting a strong sequential increase in revenues for Q1 compared to Q4.
Our first quarter revenue guidance of 55 to 58 million.
Represents sequential revenue growth of 29% to 36% compared to Q4.
This range also represents approximately 85% to 90% of our Q1 revenue.
One year ago.
In addition, our international business, especially operations outside of Japan are expected to continue to be negatively impacted by the pandemic.
As a result, we expect international revenue may slightly decline over the next two quarters.
Similar to Q4, our anticipated reduction of volumes in Q1 compared to the prior year, we'll have a modestly negative impact on gross margin.
Recall that a significant portion of our cost of goods sold is related to burden.
A fewer devices manufactured as expected, resulting gross margins approximately equal to Q4 at 76% to 77%.
In total we expect operating expenses in Q1 to range between 50 and 52 million.
This represents a decline of approximately 10% to 13% from the prior year.
So procedure volumes returned to normal levels, we intend to maintain several of the business continuity plans, we implemented in March which reduced operating expenses and capital expenditures across the business.
Active management of operating expenses combined with a strong balance sheet position see aside a managed through this challenging time and remain poised to resume our double digit growth trajectory as elective and urgent procedures returned to previous levels.
Roger will now discuss our commercial developments Rhonda great. Thank you Jack and good afternoon, everyone.
Scott mentioned, we have increased our efforts to serve our customers and support our patient throughout the pandemic, we supported cases and consistently delivering high quality products and services to our customers.
We expanded our digital footprint in all communication.
And increased customer engagement, our updated take a stand website launched a physician finer sit at patients can locate physicians and their community performing limb salvage procedures throughout the print pandemic in Q4 3200 patients click through to identify addition.
Our field sales Rep. and Cfive executives have remained in close contact with each of our customers to understand their need. These frequent conversations enable CFO I can meet each one of our customers where they need us.
During the quarter, we took action to assure the safety of our employees customers and their team.
Sure procedure volumes due to the pandemic reduced cash flow at many facilities. We responded by offering expanded pricing and contracting programs to help facilities face with near term financial constraints.
Our field sales Representatives are also increasingly supporting cases in person and virtually flexing to the needs of each individual physician that we serve.
Demand for professional education programs increased dramatically during the fourth quarter over 1200 physicians attended our virtual program nearly three times, our normal course attendance.
In many cases, we partnered with societies to develop specialized content content, we knew our customers desired. For example, we partnered with we are yet to deliver educational programming to help our custom understand the financial resources available through co bad and the operating of an outpatient lab in the wake of a pandemic.
With I ask CBS, we developed a program specific to managing limb salvage during a pandemic.
With Sci we produced a new coronary program and in total we are encouraged by the level of engagement and interest in our professional education program.
We look to expand these efforts and continue to leverage virtual education programs going forward.
Each of these actions strengthened our brand and demonstrated to our customers that cxi remains a key partner in the care of their patient.
In Q4, we also demonstrated how innovation can help physicians effectively treat their patients.
And peripheral are low profile devices that allow for a variety of access points are resonating with physicians seeking to treat peripheral lesion, while reducing procedure time and bleeding comp complication related to traditional femoral access.
As a result, we are seeing increased interest in the use of radio access and other alternate sites have access that reduce bleeding complications and accelerate time to ambulation.
We anticipate further adoption to have enhanced the consistent flow of patients from intake through discharge.
Last week at the new cardiovascular horizons or any PVH conference data from our reach peripheral study with shared virtually as a late breaker reach demonstrated that the use of orbital atherectomy in radio peripheral vascular intervention has a high rate of procedural and treatment success and is effective and reducing residuals.
No thats across all lesion.
98% of patients achieved procedural and treatment success and were no reports of serious trans radio access related events.
Additionally, the study demonstrators sort of recovery time and length of stay which are key factors in patient satisfaction faction at a particular interest during his pandemic.
During the quarter. We also found that physicians are increasingly interested in performing full lag revascularization in one procedure.
Our exchangeable platform with glide assessed offers a low profile device to Soc design to access the vasculature through multiple access points. This platform is designed to serve up to 50% of the peripheral patients that have multi vessel disease throughout the lag.
Exchangeable enables the use of up to three crown so that physician can treat legions above and below the knee and provide full laggard revascularization in an efficient single procedure. This product is being well received by physicians and their patients will be motivated to complete treatment in a single session as opposed to schedules.
Thanks multiple intervention.
Exchangeable is sold at a premium and helped drive an increase in our hospital peripheral ASP during the fourth quarter.
We also made progress and whenever longer term innovation projects in Q4 weeks successfully completed a pre submission meeting with FDA on our P. Bad Fs study protocol, we remain remain cognizant of the ha data presented last fall in the high risk PCI supports base and believe this may increase the number of patients.
Lengthen the follow up requirements and our pivotal I'd study. Nevertheless, we are pleased with the alignment and the process that is developing with FDA and we continue to target first in human late in fiscal <unk> 21.
Turning to our patent effort.
One year ago, we set out to invalidate three key patents related to the development of an Ivy health system.
In July the patent trial and appeal Board issued its final rulings and invalidated 50 out of the 51 challenged claims across three key Ivy L. patents.
Our successful IP challenge provide see aside optionality to pursue development of an ideal system at our discretion.
In some we've strengthened our business and brand in a number of important areas that efficiency aside to resume double double digit revenue growth and expand our market leadership position during fiscal 2021 and beyond.
Turning to our key revenue drivers in the first half of fiscal 21.
I previously mentioned, our innovation and peripheral with our radio and exchangeable platform. We will continue to demonstrate this fall. We will also begin offering peripheral support devices. When we launched the wire on embolic protection device.
We like the filter because it is the only to fill up.
Alex filter that can be used with any commercially available peripheral atherectomy system to capture all forms of embolic debris, including from.
We used with anyone for wire, making it an incredibly versatile where the risk of to fill embolization could be hot air.
During the second half.
Fiscal 21, we plan to introduce full line of peripheral support.
Products, including angioplasty balloon catheters, and a full complement of radio access support devices.
Represents.
Peripheral away asphalt now we noticed strategy works in the back six months of fiscal 2020, we sold over $500 of support products for every coronary.
Paul Atherectomy represents 80% of our unit sold so leveraging our large domestic sales channel by selling a growing number of.
Peripheral products is expected to accelerate revenue growth.
Of course, the timing of our product development, our best estimates at this time now could result in changes to the timing of these events.
[laughter] ruling in Japan, now allows facilities without surgical backup to conduct coronary atherectomy procedures this dramatically expand.
Where we can train and educate from 400 to over 700.
Our coronary atherectomy device during the first with most of our onsite training professionals.
New expectations are modest.
We look forward to updating you on our plans once approved also.
Oh, yes for approval in Canada.
Overall, we continue to execute on our international expansion strategy. However, we do anticipate.
Well reduce international revenues during the first half of fiscal 21.
And clinical we will resume.
Brian leader in fiscal 21.
20 to claim on when the disruption caused by the pandemic for further SCADA and renewal of research.
Pivotal phase and semi urgent procedures across the country and we'll engage with our principal investigators to assured our data this will certainly push out the timing.
Okay of the read outs on eclipse enrolled to date and it's important study we will remain patient and we don't make sure. We can definitively answered a quite severely calcified coronary lesions.
With the lower extreme.
Many revascularization Rep code Fats under review starting in October it's important to note that peripheral atherectomy ASIC.
Category has both proven safety and outcomes with decreased adverse events short lengths of stay lower major amputation rates and lower mortality rate and surgical by bypass the leadership role and generated unprecedented peripheral medical evidence that Pepsi OSI apart from.
All competitors more than 48000 lesions treated in clinical studies.
These have proven that Oh, yes.
As a safe durable like cost effective solution.
60, the largest real world stuff.
Study of Endovascular device interventions, we will continue to leverage on largest real world study.
Endovascular device interventions to drive the use of peripheral Oh, yes.
In the fall timeframe, you will that will provide further evidence just.
For the economics for treating more complex patients as well calcium below the knee lesion.
It will show important data.
Reflecting the addition of away asked to a procedure lowers costs at one and two years compared to the overall study. This positions are way up very well for pairs focused on more term long term longer term outcomes.
Although the CPT editorial panel pig process, we will do our best to keep everyone apprised of updates.
We continue to anticipate but that it on <unk>.
Element of a new codes that may require a work group, which could push the introduction of new codes into 2023 or later societies will advocate to protect atherectomy reimbursement and may see differentiation based on.
Laxity, which may favor our technology that is used to treat long.
And below the knee.
Concludes my prepared remarks, I will now turn the call back that for his closing comments. Thank you Rhonda.
Well the information that we've shared with you today should.
Illustrate that we are managing this crisis exceptionally well our previous growth trajectory when this pandemics subsides.
Although the pandemic has changed many aspects of how we do bill.
Strategic intent to become an innovate.
Global medical device company.
Focused on treating the most complex patients living with per.
Pearl and coronary artery disease.
We continue to invest in sustaining our market leadership and growth in our core business by expanding our product portfolio Bill.
Delivering higher rep.
Revenue per procedure and accelerating the growth of our core business through a steady cadence of comfort.
Actual launches globally.
Despite the Corona virus, we are making strong progress on the position to emerge from this crisis as a stronger and broader company.
For example over the past two years, we have launched 12 new products.
We have expanded our evidenced based significantly with greater than 70 manuscripts published our products have been highlighted in over one.
Tons delivered at major medical conferences, and we have expanded internationally with the presence now in 13 countries, including Japan, where we have rapidly.
Gained market share.
In addition.
We completed an equity financing in June that generated additional.
This additional.
Sources required to and newer through the Corona virus crisis and provides flexibility to adding new products to our portfolio.
Nothing is imminent, we may consider adding products that will enhance the quality of care for our patients.
Leverage our commercial footprint.
And expand our core technologies.
In closing I want to assure you that the strengths capacity and key growth drivers for our business remain vibrant and robust.
We look forward to the day, when we can focus solely on our mission.
Called cardiovascular disease.
Which still today remains the number one causative mortality in the United States.
I would like to thank all of our see OSI employees for their perseverance dedication and compassion and delivering exceptional support to our.
This extraordinary time.
I would also like to thank all of you for your continued interest in Cxi.
Christine if you would please.
Repeat the instructions that'd be great. Thank you.
Thank you as a reminder to ask a question you will need to press star one on your cell phone to withdraw your question press the pound or hash key please standby, we compile the Q and a roster.
Your first question comes from the line as Chris Pass Pasquale from Guggenheim. Your line is up.
Okay.
Thanks, I appreciate taking the questions.
Scott just start with I'd be curious you can shed any light on how June and July sales compared to a year for the incremental improvement assumed in guidance relative to where things stand today.
Yeah, I can comment on June Christian and I think you have been issuing.
Reports based upon it and advisory committee that you've assembled and I think actually they have sort of do well.
I think you've been estimating recovery and that 80% to 90% range versus prior year and I would say in June that says that we had climbed to about that range.
Okay. So fair to say that the guidance for the first quarter assumes that the pace of recovery slow.
Month by month.
Yeah, I think Thats fair I I think we we actually see we don't really believe it will slow, but we think it will flow.
But now.
HM Okay.
And then the decline in STEMI admissions was one of them more surprising aspects what we saw in the early days.
Pandemic it still seems like Coronaries lagging a bit how much has that particular STEMI dynamic changed or improved.
Yes, so the STEMI dynamic has has improved a bit but.
I think the fundamental issue we still have is in.
The coronary referral channel and I think I'd I'd like.
Dr. Hagglund, our Chief Medical Officer, just to address that briefly Brian do you want to talk about what are you had no. Thanks for the your question, Chris I think part of the issue is outside of the CF patients there is a.
Reduction obviously in the diagnostic resources as a result to the pandemic and that of course reduces the number of patients that ultimately are diagnosed with non merchant disease and then I think the second thing that has become more apparent is that these patients that are advanced in disease. They have significant.
Symptoms as complex disease, but may not necessarily present with an urgent inciting incident that creates an emergent procedure and so some of those patients may elect although there.
Not managed effectively with medications they may elect not to come in in the course of the pandemic and so thats. Another contributing effect, we expect both of those really too to become less pronounced overtime.
Thanks.
Your next question comes from line of Kristen Stewart from Barclays. Your line is open.
Hi, Thanks for taking my question.
What kind of go back to the the reimbursement.
Decisions I kind of open the codes here in October.
The common for helpful. Just in terms of this taking a long time I was just wondering if you could maybe just share some of your thoughts on opening the number codes and whether or not you feel like that could be more positive in terms of.
Changing the never codes from 16 to 32, if you feel like that opens the door to maybe reflecting.
And the type of procedures that are being treated and peripheral and maybe that being a good thing for you guys. Just as you treat more complex lesions as well.
Yes, Thanks, Chris and I really appreciate you.
You know quite honestly, we're really pleased that.
The lower extremity codes are now on the agenda in October we have been shadow boxing against an unknown opponent here for for a while so we look forward to gaining clarity I should say in regards to your question when when you've indicated the increased number of codes. We don't at this time have land this is clear.
Only a very.
A lot of different procedures in a lot of different products.
That are used in the care of these patients so it's difficult to comment on that specific please.
I would point out however that we have a really unique case mix.
At Sea OSI, and we have been focused on treating patients that generally have a much higher burden of disease. So we focus on treating patients that have longer lesions and we focus on treating patients that have severely calcified lesions. These are usually really complex cases. So these are.
We have a high focus on pace.
Patients that have below the knee lesions and of course, many of our patients have critical limb ischemia and average procedures. So we we do think that based on this large number of.
Codes that.
By lesion complexity and by lengths and if they do that.
As we think this will be an advantage foresee it it's reducing reimbursement in my view foresee a lion limb salvage and some of these other complex cases with real hot.
Just doesn't seem to make sense. So we're confident that any.
On would be small and.
And probably would not reduce utilization and would not affect our price.
This.
This is this is where we're at right now it's about as much as we can say based upon.
We'll certainly keep you up.
David as we know more as we have.
Filed as an inch or more in a few weeks, but.
At this time, that's that's about as much as you can address this topic.
Your next.
Your next question comes from line of Mike Matson from Needham Your line is open.
Hi, Good afternoon. This is David Saxon on for Mike. Thanks for taking your questions.
You called out Obiols as leading the recovery from if you could put some numbers behind that.
And you know as you see that shift to obiols implications are for pricing and margin if that mix.
Yes, the rpls I'm going to have.
Jeff addresses question in a moment, but recovery in peripheral we we've seen.
Bills in certain places.
Like Texas, and Florida, where healthcare community, though.
Hospitals have been more.
The office based labs continues so.
In that context.
Say the Obiols have continued to.
And.
Hi.
Certainly we've benefited from that so Jeff you want to address the yes, Dave factors, just a follow up on that 36% year over year.
Sure, but if you just break that out in the and you'll be all space, We act and the purple space we saw in there.
Can you hear as we go into Q1.
Okay. Thank you and then.
And.
On.
I mean, it sounds like this is final so can you confirm that and keep I mean, it sounds like you're you're maybe planning on developing your own device, so and I.
That would be very helpful. Thank you.
Yes. The PTAB decision is is open for appeal, we don't know if it will be appealed at this time.
This time we.
Are not really commenting on the nature of our R&D pipeline as it relates to the Ivy Hill.
So we'll we'll ask you to stay tuned on that.
Okay. Thank you.
Thank you thanks, David.
Of Danielle.
Hi, Toffee from SVB.
Hi, good afternoon, everyone. Thanks, so much for taking.
A question just if you would on reimbursement.
I mean, there's there's a lot of debate around that but at the end of the day like how much do fit.
How much.
Uh-huh moneymaker from a volume perspective is this for the hospital and or the Ob out your view, how much does not really even impact the actual adoption of these devices. That's that's my first question I have one follow up.
Sure Danielle Thank you for that.
Yes, I think actually is the when you consider atherectomy and the utilization of et cetera.
It is it is not a.
A large contributor to the revenue if you just simply look at the the overall spending in this call.
Bode side, it's a it's a smaller percentage of the total.
There are site search and who focus on C. ally and I think in those hospitals and in those Obiols you would find that.
As a higher percentage of.
Their overall revenue streams.
But generally.
A major contributor.
To the revenue streams for these hospitals or or for many obiols.
Yes, I know that isn't I guess another way so.
It's just sort of asked a question I mean, if reimbursement were to come down would it be so.
So just track so much from revenues I guess, that's what I'm trying to get out here.
No as I said at a reimbursement first of all I don't think reimbursement for atherectomy is going to come down that much and in particular as it relates to our.
Company were longer lesions, where we believe.
The societies are advocating.
For actually.
Just takes longer and is more complex.
Okay. So so we really don't think expense that you would reduce reimbursement for the care of these more complex patients.
Are the utilization of our product I think it would have come down a lot to affected because our product like I said, we treat a very unique set.
Set of patients and really we have a very sells a device for the treatment of these severe.
Severely calcified and long lesions many alternatives in the marketplace for the care of these patients frankly, there's none and so as a result of that.
We will continue to have a very strong place in the treatment.
Continue on for the care patients that have CLA.
Got it thanks, so much.
Daniel.
Your next question comes from the line of Surajit Pal.
Okay.
Good afternoon, everyone.
Scott can you hear me all right.
Perfect, Okay, everyone, let's say from healthy.
So Scott forgive me I was just jumping between calls.
I do my question is good.
Inventory in the field specifically related yeah. This is more for broader question, whether it's are you just given hospital.
Actual situation.
We should we be concerned paying attention to that specific aspects at this stage.
Well as Raj, Yes, I think over.
Beginning in March hospitals, really began to conserve their cash and they have not replenished inventories and and I would say as you look at our current revenue streams advice.
And what you're really seeing now is a revenue run rate that very much correlates to.
Our case loads.
Got it is Scott did you talk about eclipse and Goldman status.
Yes that did you have a specific question.
Hi, just curious the number last we had was around houses in patients enrolled I wasn't sure. If you will give an updated number or.
Sure we actually made the decision you know when code Red hat.
To suspend enrollment.
Our customers really wanted to focus there.
Capital resources on caring for covered patients.
During the pandemic and so we are working with our P. ice to restart eclipse.
So the enrollment rate has remained stable since our last update.
And we'll look at the best timing to resume when hospitals and physicians and investigators are comfortable doing so but anticipate it sometime in F. Why 21 likely just not in our Q1 and we currently are out about 1364 page Yep Yep, Thank out and if I could squeeze one more in rondo maybe.
And I appreciate the element of secrecy and you don't want to give too much information right.
So any color would be great sure. Thanks, everyone.
The FDA on that Fs protocol and as I mentioned in my comments, we have alignment to that so that's a really exciting stop.
[music].
And just kind of focused on that pathway moving forward and as we get through Fs and then subsequently move into pivotal that may be the time at which we would begin to.
Plus more information and put more information out there with regard to the performance of our device.
Your next question comes from line of Brandon Vasquez from.
Hi from William Blair. Your line is open.
Hi, Thanks for taking your question.
First just in terms of.
Patient pipeline and diagnoses during the the ongoing pandemic.
You guys noted that patients are kind of coming back into your customer accounts and do you feel comfortable that.
The pipeline of patients is coming back so that there is not maybe some pockets of volatility as we move through the next few quarters.