Q2 2022 Global Blood Therapeutics Inc Earnings Call
Efficient and effective procedure at a more attractive associated cost.
Our center of Excellence partnership and the 200 plus hospitals. They comprise play an important role in our overall development and commercial strategy and we are sincerely grateful for each of these hospitals choosing to open their doors to us I.
Im confident that by working together with our unique strategy, leading technology and our talented team vicarious surgical will provide hospital systems across the world our platform optimized to meet hospital needs and the needs of their surgeons and patients and as a result that she's widespread commercial adoption.
Concurrent with our center of Excellence partnerships. We are also leveraging further input from our surgeon Luminary group as.
As we announced last quarter. This is a group of 20 of the most talented experienced an innovative surgeons in robotics led by Dr. Igor Lansky and expands our access to leaders across an additional 10 hospital systems, providing ongoing development feedback we continue to receive strong enthused.
Out of them toward our platform from the surgeon.
In that regard.
We continue to make great strides in the development of our beta to robotic platform.
It to the previous beta one system focus on ergonomic changes per surgeon comfort improved visualization enhanced sensing and motion capabilities, which enable the surgeon to move freely within the abdominal cavity further expanding their access and ability to operate.
With significant and very positive feedback on the initial beta two ergonomic prototypes, we have completed the beta two design and we are beginning the integration phase of the belt business. Our next step towards bringing our robotics platform to market and ultimately demonstrating its capabilities through a cat or their eventual hernia.
<unk> in a hospital setting, which we plan to share greater detail around later this year.
I would also like to take a moment to acknowledge the business environment in which we're operating.
As we ramp up our operation we.
We increasingly see the same challenges that many of our peers have noted.
More specifically, we've experienced limited semiconductor supply and shortages of chips and other hardware in recent months.
If these challenges continue they can present a risk to our timeline.
That said I am tremendously proud of our team's ability to respond to and mitigate most of these challenges and supply chain delays to date.
We continue to evaluate the details of our supply chain for opportunities to build internal redundancies multi source key components and enhanced our product designed to address constrained supply chain risk.
Given these factors we believe we are well positioned in this environment.
This has been an exciting quarter for vicarious surgical.
We have significantly expanded our hospital and surgeon outreach first with the surgeon Luminary group as well as the more recently announced centre of excellence partnerships.
These relationships will help optimize the development of the vicarious surgical platform and will serve as the foundation for strong commercial traction.
In addition, leveraging our unique hospital and surgeon assets, we continue to enhance our differentiated technology make meaningful progress towards delivering a disruptive by carrier surgical ecosystem, which we believe will be uniquely position for swift and effective integration into <unk>.
Hospital setting.
I will now turn the call over to Bill for a discussion of our second quarter financial results.
Thank you Adam and thank you all for joining us today.
Total operating expenses for the second quarter of 2022 were $19 $1 million.
Inclusive of R&D expenses of $10 1 million general and administrative expenses of seven $8 million and another $123 million in sales and marketing expenses.
Operating expenses in the second quarter were up from $6 6 million in the prior year, primarily due to continued investment in the development of our beta two platform.
And necessary expansion within our internal teams.
Adjusted net loss, which excludes $17 $6 million adjustment for changes in the fair value of our warrant liabilities was $19 1 million for the second quarter.
Equating to an adjusted net loss of <unk> 16 per share as opposed to an adjusted net loss of $6 $6 million or an adjusted loss of eight <unk> per share for the same period in the prior year.
GAAP net loss for the second quarter was $1 5 million equating.
Equating to a basic and diluted net loss of one per share respectively as compared to a net loss of $6 6 million or basic and net loss of <unk> <unk> per share for the same period of the prior year.
For additional detail regarding our second quarter 2022 financial results and a reconciliation of all non-GAAP measures to GAAP. Please review our earnings press release.
Our cash burn for the quarter sort of the second quarter of 2022 was $15 7 million.
And we ended the quarter with $141 million of cash and cash equivalents.
As we advanced our development clinical and regulatory processes. We continue to expect full year 2022 cash burn of approximately $65 million to $75 million.
As such we also continue to anticipate ending the year with approximately $100 million in cash and cash equivalents on our balance sheet.
We are excited by the progress we've made to date and we look forward to sharing further progress in the quarters to come.
And with that I'll turn the call back to Adam Adam.
Thank you Bill.
I'd like to close by highlighting our recent experience at the 2020 to society of robotic surgery annual meeting and the stages surgical disruptive technology summit.
Both events provide important opportunities each year, but health care community to coalesce and examine the direction of robotic surgery for years to come.
With the landscape of robotic surgery more extensive than it's ever been it's become clear differentiation in the market is paramount to long term success and adoption the appetite for differentiated next generation robotics is large.
We were pleased to hear panelists and thought leader to emphasize the importance of a single port system to expand surgical access and capability and more than anything we appreciated the enthusiastic reception of our technology from the participating <unk> community.
Our attendance at these conferences as well as our continued surgeon feedback and support has made us all the more confident in our ability to transform the landscape of robotic surgery.
Thank you again for joining today's call operator would you. Please open the line for questions.
Thank you as a reminder, if you would like to ask a question. Please press star followed by one on your telephone keypad.
Have you changed your mind anytime Keith for Scotty.
Please standby plus the order today's Q&A.
Our first question comes from Josh Jennings of Cowen Your line is open Josh.
Hi, This is Eric on for Josh Thanks for taking the question was.
Was hoping to hear any updates you can provide on recent discussions with the FDA around trial design and plans to finalize the study for the ventral hernia indication.
If the trial design is still hasnt been finalized just wondering if we get a.
Any timing on when that may be in place just thinking maybe.
Early first half of next year, maybe a good timeline, but any detail there would be great. Thank you.
Thanks, so much for the question. So it's a really good question I'll say right off the bat that the conversations that we're having with the FDA continue to be very positive and very collaborative.
We're going back and forth around the details of everything around not just the trial design, but actually starting with the pieces that go in before the specific trial design to finalize those.
Everything that we've seen thus far would indicate that will be in line with again with our peers.
A relatively small trial.
Very short follow up note the technical significance required again this has not been locked in.
I think the timeline, specifically, though I would like to hold off on commenting specifically around that simply because at the end of the day. It really is the agency's discretion on when they sign off on our trial design.
Okay understood, Yes, that's totally fair.
We do think of this as being a smaller trials say, maybe 50 patients or less I know youre not blessing of patient numbers, but if I'm, just assuming 50 patients or less is that a number you think you'd be at one investigation side or do you think you'll need a few sites is complete the trial.
I think that typically you probably don't want to put all your eggs in one basket both for variation of geography as well as.
Simply risk mitigation on our part as well that being said I'd look at given that we have the resources to support multiple trials and we have these incredible relationships that have actually been lined up explicitly in the agreements with with University hospitals in an HCA healthcare to her.
Have support and use them to support us through the clinical trial process, we're really enthusiastic about doing multiple type because it frankly.
It de risks from a clinical standpoint, and provide better data for a filing so that we can actually derisk that filing and it helped set us up well for a better and broader commercial launch.
Yeah.
Excellent. Thank you so much for taking the questions.
Of course.
Thank you we now have the next question on the line from.
And the leader of Piper Sandler you May proceed with your question.
Hey, Adam and Bill This is Phil on for Adam can you hear me all right.
Yeah.
Yes, great great. Thanks for taking my questions and good to hear the progress in this quarter I guess just to start from a macro level.
I understand you've been able to navigate the supply chain headwinds, but could you go into more detail there, especially as it relates to the beta two units it hasnt impacted the design in any way.
If you give it has I would say could you describe.
How exactly it hasn't and how you've been able to kind of overcome these challenges.
So most of the challenges that we're facing today.
Our around sourcing capabilities. So the way, there's a few ways that it impacts us, but the biggest is it simply design.
Development effort as well as as some amount of timeline, especially looking towards the future.
As you know I wish I could better predict things, but we're in a world where when parts and components are delivered becomes highly unpredictable, which is really quite a drastic change from where we were a year or two ago.
So if youre looking for a specific example, I think just.
The Best example off the top of my mind is probably around the chip shortage and particular component that in our robotic arms that.
Critical we were easily able to swap it for a different component that we're able to source, but that involves some amount of PCE redesign and ordering and some software rewriting as well. So we've ended up with just as good a product and at just has been a point, but with significant additional time and effort as a result.
No. Thank you for that color, that's great and just to kind of stick on beta two here I understand that it's early but can you kind of go into detail in terms of feedback if you've been able to garner any.
And it's one in beta to I know you were going after those ergonomic and and visualization changes, but any feedback there would be great.
Yes, the feedback has been overwhelmingly positive.
It really is a night and day from an ergonomic standpoint to just back up a little bit.
Two beta one the feedback on the robot itself and the patient cart or phenomenal, but the feedback on frankly, the surgeon console left a silicon opportunity for improvement and I think we've really seen that opportunity incredibly well.
And developed a system that surgeons tell.
Tell us they really loved and has resolved a lot of the problems not just.
That work with our beta one but actually existing in the field at large.
Awesome. Thank you.
Thank you we now have skyway is kind of code.
You May proceed with your question.
Okay.
Hello, This is Kevin on for Bob.
A couple of questions have you made the simulators available to a broader set of hospitals and are these hospitals testing out other use cases, yet besides hernia repair.
And then just on the centre of excellence agreements have you been able to already engaged these systems to test your baby units.
Yes.
Great questions so to start with the simulator for now the simulator is available.
Internally for testing and with our with our close partner.
As we get to the end of the era, we're going to be looking at the opportunity to show this off more and we'll be really without that including to a broader audience within the incredible network of hospitals and partners that we have today.
To the question of.
Of indications that we're testing.
And the data too as well so the early iterations of beta two have been tested by handful of our hospital partners, including Opex.
In.
With our partners that I mentioned and some other partners as well.
And we're going to be looking of course to greatly expand that over the next few months as we fully integrate the final data to design. So we're really excited about that we're excited about the opportunity to show at all to get broader feedback beyond that and I believe last question indications specifically the testing that we're doing is is for.
It's on our early indications so mostly focused on ventral hernia repair, but we are of course testing other indications as well, including some that we've mentioned some that we haven't that believe the ones that we've mentioned include choline.
Down a number of those hysterectomy in England.
Okay.
Yeah.
Thank you.
We now have another question on the line from.
Matt.
From Barclays. You May proceed with your question.
Hey, great. Thanks for taking the question.
So congrats on the centre of excellence agreements of course, Stephen team Adam.
You had talked and as you mentioned sort of as promised you know about these are coming together.
Can you talk maybe a little bit about.
Any surprises or.
Things that came through a little bit differently than you expected them to hear how that positions you going forward.
Maybe and maybe sketch out you know from a practical standpoint, what this could look like I know I'm sure yourself with any other plans to physically how this works, but maybe just for folks who may not understand what this means.
Sketch out something like a scenario of how this could work over the next 12 to 24 months say and I have one follow up if I could.
Yeah, absolutely. Thanks, Thanks for the question Matt.
So the two.
The surprises I'll start with that.
I'll say, a always incredibly pleasantly surprised that the really positive reception that we've received overall and how deep our level of engagement. These hospitals are looking for.
Both both hospital system that we're working with are incredibly excited about not just.
The potential to use our system down the road, but actually the potential to work really closely with us and collaborate over the next 12 to 24 months and then and beyond that we're looking at these as really long term partnerships for us that really worked together to build a system that provides better.
Patient care.
Overall, what we're focused on right now is beta to feedback refining that design getting to the next stage, which is verification or validation of our device will.
We will be making some design changes after beta two based on the feedback that we received again all with the goal of making sure that the device that we're launching is exactly what surgeons need in hospitals need in order to provide better care for their patients.
And then the step after that will be support through clinical trials and then finally commercialization, where we're optimistic that we'll have delivered on exactly what both these hospital systems need as well as hospital systems all across the world.
That's great and just a simple follow up on sort of timelines I think.
There was a time when you had talked about the prospect of putting.
One of these data systems in front of investors.
Just curious if you have.
If you've been more specific about that or do you have any timing in mind.
When you might be able to host an event like that.
Yeah going forward.
So yeah, we're really excited about the opportunity to show it off in a hospital setting still looking at out around the end of this year and we'll be having.
Probably more details to follow on the exact date of that.
Terrific. Thanks, so much.
Thank you, Matt as a reminder.
If you'd like to ask any further questions. Please press star followed by one on your telephone keypad now.
As that has not had nice ask questions registered I will now close the call.
Thank you for joining you may now disconnect your lines.
Yeah.
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Okay.
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