Good day and thank you for standing by, and welcome to the Better Therapeutics' Second Quarter 2023 Update Call. At this time all participants are in a listen-only mode. After the speakers' presentation, there’ll be a question-and-answer session. [Operator Instructions]. And please be advised today's conference is being recorded.
I would now like to hand the conference over to your speaker today, Mark Heinen, Chief Financial Officer..
Thank you, operator. Good morning, everyone, and welcome to the Better Therapeutics conference call. Our press release was issued this morning and can be found in the Investors section of our corporate website, bettertx.com. Joining me on the call today is Frank Karbe, our President and Chief Executive Officer; Dr.
Mark Berman, our Chief Medical Officer; and Diane Gomez-Thinnes, our Chief Commercial Officer. During today's call, we will provide a business update and a financial overview of the second quarter of 2023. A Q&A session will follow our prepared remarks.
Before we begin, I'd like to remind everyone that any statements we make or information presented on this call that are not historical facts are forward-looking statements that are based on our current beliefs, plans, and expectations that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.
Actual events and results may differ materially from those expressed or implied by any forward-looking statement. With that, I'll pass the call over Frank Karbe.
Frank?.
Thank you, Mark, and good morning, everyone. Thanks for joining us on the call today. I will begin with a brief recap of the exciting news we shared recently regarding FDA authorization. In July, AspyreRx, formerly known as BT-001, received FDA authorization as a Class 2 medical device indicated to treat adults with Type 2 diabetes.
This marks the culmination of eight years of development involving more than 6,000 participants in studies of increasing rigor.
And with this FDA authorization, a new regulatory class of digital therapeutics has been established with AspyreRx being the first prescription-only digital therapeutic treatment to provide cognitive behavioral therapy, or CBT, to adult patients with Type 2 diabetes.
AspyreRx is based on a proprietary form of CBT developed by Better Therapeutics, specifically for treating cardiometabolic diseases and designed to overcome many of the limitations of traditional in-person CBT.
AspyreRx was granted marketing authorization based on efficacy and safety data from our randomized controlled trial involving 668 participants, demonstrating clinically meaningful and statistically significant reduction in HbA1c, as well as improvements in other health outcome measures, which were published in peer-reviewed journals and presented at various conferences.
As a prescription digital therapeutic, AspyreRx is differentiated from general health apps due to its rigorous clinical testing, FDA authorization as a Class 2 medical device, and its indication for treatment rather than just monitoring and data tracking.
It requires a healthcare provider's prescription and is designed to be integrated into patients'overall care management, ensuring expert oversight and coordination. Additionally, AspyreRx adheres to strict security and data privacy standards to protect patient information and medical devices from cyber threats.
FDA authorization of AspyreRx is significant on multiple levels. It is an important advancement in the diabetes treatment landscape, providing clinicians with a standardized, evidence-based, and prescribable form of CBT to empower patients in making sustainable behavior changes.
It facilitates the implementation of current Type 2 diabetes treatment guidelines and lowers access to care hurdles, as it can be used by any patient with a smartphone. The establishment of a new class of FDA-authorized devices to treat diabetes with CBT also opens possibilities for future expansion into related cardiometabolic diseases.
And lastly, the authorization has broadened our business development discussions. I'll now recap other accomplishments in the second quarter and July of this year. We've advanced our preparations for the commercialization of AspyreRx, including the completion of a quantitative pricing study and a decision on price.
We've also made significant progress in our launch readiness efforts with Phil, our pharmacy and hub partner. Furthermore, FDA authorization has accelerated conversations with payers and we're encouraged by the meetings we're having.
The awareness of PDTs continues to grow amongst payers, in part because there are now over 10 PDTs on the market, and in part because of the ongoing efforts to provide coverage for Medicare and Medicaid patients. For example, in June, the Academy of Managed Care Pharmacy sponsored an event in Washington, D.C.
to advocate for the Access to Prescription Digital Therapeutics Act, a policy priority for them.
This followed our own recent advocacy efforts, in which we participated alongside other members of the Digital Therapeutics Alliance to advocate for the bill, which, if passed, will provide a Medicare benefit category for prescription digital therapeutics and would facilitate coverage for millions of patients.
We further strengthened our financial position by completing multiple financings throughout the second quarter and into July, raising $12.5 million in net proceeds. We intend to use the proceeds to support the commercial launch of AspyreRx in Q4 of this year.
We're pleased to report, we've enrolled approximately 90% of the target participants in our real-world evidence studies and are on track to complete enrollment by the end of Q3 of this year. And lastly, our abstract describing our LivVita study results was presented at the European Association for the Study of the Liver, or EASL annual congress.
EASL is a leading professional society, and their clinical practice guidelines inform the standard of care for NAFLD and NASH around the world. We've delivered on multiple critical milestones through the first half of this year and have exciting opportunities ahead of us. The commercial potential for AspyreRx is significant.
We continue to get very encouraging feedback from providers, payers, and patients, and we're exploring multiple business development and royalty options to get our product to as many patients as possible, as quickly as possible. I will now hand it over to Diane to share more detail around the commercial strategy.
Diane?.
Thanks, Frank. This is exciting progress. I will start with a payer update. Immediately upon the announcement of FDA authorization for AspyreRx, we shared this milestone with payers on our target list and have completed six post-authorization meetings with key senior decision-makers to review our label and review the clinical data in more detail.
Several of these have now advanced to follow-on conversations with broader team members at these payer organizations, and additional meetings have been scheduled for the coming weeks. We are encouraged by payers' willingness to meet with us so quickly after the FDA authorization.
And feedback has been encouraging as payers recognize the unmet needs that exist in Type 2 diabetes and are looking for ways to control the escalating costs associated with this patient population. We continue to get positive reactions from them related to our trial design. That is, it is very drug-like with a clinical endpoint of A1C reduction.
It's inclusive of a diverse Type 2 diabetes population, and the fact that it is a sizable randomized control trial. We are finalizing our National Association of Managed Care Physicians, or NAMCP, dossier, which we will use to facilitate even broader communication about AspyreRx to payers.
I will now move on to price, which is a key factor for payer economic and coverage analysis. After just completing our latest pricing research, we decided to set the wholesale acquisition cost, or list price, for AspyreRx for a 90-day treatment at $750.
We anticipate most patients will get at least one refill for a minimum treatment period of six months. Unlike many drugs that are meant to be used indefinitely, AspyreRx has a predefined duration. At $1,500 per patient for a six-month treatment experience, we believe it is well-priced when considering the costs associated with chronic medication.
We are confident we provide a compelling value proposition to payers, offering cost predictability for a defined period of time, unlike other treatments.
In the most recent quantitative pricing research, which included pharmacy directors, medical directors, and PBM directors, payers view AspyreRx favorably, with greater than 72% of payers finding AspyreRx valuable, and 64% of payers anticipating covering it. And this is consistent with prior studies and payer meetings, both pre and post authorization.
We are acutely aware of the challenges that people with diabetes face due to out-of-pocket costs associated with managing their condition, and our commitment to ensuring the broad access to AspyreRx at an affordable price has been central to our mission at Better Therapeutics.
To achieve this, we've been actively working to get AspyreRx covered by insurance plans and aim to reduce the financial burden on people with diabetes while enabling them to access the high-quality care they deserve. And our list price was set with this in mind. We know that we won't have broad insurance coverage at launch.
However, it is vitally important that we provide patients and providers a good experience. Through our distribution pharmacy partner, claims will be processed to demonstrate demand for payers.
For patients who may have claims rejected by insurance, we will offer, for a limited time, a reasonably priced cash pay option with a focus of maintaining low patient out-of-pocket costs.
We expect this to yield several benefits, including doctors gaining experience and confidence in prescribing AspyreRx, patients being able to access the treatment, and Better Therapeutics generating initial revenue.
Moving to our go-to-market update, we are pleased by the broad label enabling us to offer AspyreRx to the vast majority of the currently diagnosed 29 million adults living with Type 2 diabetes in the U.S.
As previously outlined, our initial focus is to reach the patients considered most urgent by payers and providers who are not yet at A1c target, roughly 14 million people. We have identified these patients and their prescribers and health system affiliations.
Together with our target list of innovative, regionally dominant payers, our analysis points us to five to six priority geographies for initial focus and where we'd sequence in sales personnel and health system account leads as we gain traction.
And with virtual resources, we build in flexibility to support any prescribing doctor who is an early adopter. With regards to the VA, we are working diligently to provide access for AspyreRx, finalizing our SAM registration, the System for Award Management, which is a government-wide registry for vendors doing business with the federal government.
Registration is followed by negotiation for access via the federal supply schedule. We plan to have dedicated resources to drive awareness and penetration of AspyreRx in the VA. And as mentioned previously, the Durham VA site is part of our ongoing clinical study program. We are dedicated to providing veterans access to this innovation.
To further inform our initial provider-level targeting, we just completed a segmentation study that has identified innovative providers who show high interest and willingness to prescribe AspyreRx very quickly upon commercial release of the product.
This group is comprised of approximately 1,100 providers from the top two deciles of providers mapped from our patient claims analysis, 74% of whom are endocrinologists and diabetologists with a high volume of patients.
On average, they have seen over 500 patients with Type 2 diabetes in the last six months and are actively using diabetes technology in their practice. 61% of this group is already familiar with digital therapeutics and on average have recommended various app-based solutions 38 times in the last month.
Our goal is to ensure AspyreRx becomes their preferred digital treatment to prescribe. These providers indicate that on average they would prescribe AspyreRx to half of their patients. Top drivers for these tech-savvy providers are patient engagement in the app, ease of use, and low out-of-pocket costs.
Given AspyreRx's strong patient engagement data from the pivotal trial with 81% of patients still engaging with treatment at six months, combined with our plans for gaining payer coverage and an affordable cash pay option, we are eager to connect with this targeted group of HCPs.
There is another equally large group of early adopters who are just as aware of digital therapeutics and are also likely to prescribe AspyreRx to almost half of their patients, provided coverage is in place.
As we have shared previously, there is a lot we have learned from prior PDT launches and in the first two quarters after launch, we will be closely monitoring and reporting on the following leading indicators.
The number of prescriptions, both scripts and refills, the number of healthcare providers who are prescribing AspyreRx, both new prescribers and repeat prescribers, payer coverage, both the number of lives covered and the percent of prescriptions that are reimbursed.
In summary, we are at a pivotal juncture in our journey of Better Therapeutics as we transform into a commercial organization.
With FDA authorization coming through last month as planned, we are standing up a number of critical functions, including our commercial infrastructure build, activating recruitment for our field team, advancing commercial strategies such as the cash pay program, and continuing to engage with payers across the country.
I'm enthusiastic and confident in the potential we have with AspyreRx. Mark Heinen, our Chief Financial Officer, will now review our second quarter 2023 financial results.
Mark?.
Thank you, Diane. I will start by discussing our operating expenses for the second quarter of 2023. R&D expenses were $2.2 million for the quarter compared to $4.2 million for the same period in 2022.
The decrease was primarily due to a $1 million decline in clinical study costs as we completed the pivotal trial last year, and a $700,000 decline in personnel related costs as a result of savings for the restructuring in the first quarter of 2023. Sales and marketing expenses were $1.7 million, which was flat year-over-year.
Personnel related costs increased $300,000 as we continue to advance our preparations for commercial launch of AspyreRx. This was offset by a $300,000 severance charge in the second quarter of last year. G&A expenses for the quarter were $3.1 million compared to $3.7 million for the same period in 2022.
The decrease was primarily related to lower business insurance costs. Interest expense for the quarter was $600,000 compared to $300,000 for the same period last year. The increase was primarily the result of higher interest rates and an additional $5 million borrowed under the company's secured term loan agreement in the second quarter of last year.
Net loss was $7.6 million compared to $9.9 million in Q2 last year. On a per share basis, net loss was $0.24 for the quarter compared to $0.41 last year. The decline in loss per share is related to lower net loss as a result of savings from a restructuring in the first quarter of 2023 and an increase in weighted average shares outstanding.
Moving to our balance sheet, cash and cash equivalents were $6.2 million on June 30th, 2023 compared to $15.7 million on December 31st, 2022. In July 2023, we completed equity financings for gross proceeds of $6.7 million.
So, on a pro forma basis, taking into account the financings, cash and cash equivalents was $12.9 million at the end of the second quarter. Our cash burn in the second quarter was $6 million, a decline from Q1 primarily as a result of the restructuring and other cost savings initiatives.
The lower cash burn and the recent equity financings are expected to extend our cash runway toward the end of Q4, allowing us to potentially meet several key milestones, including commercial launch. I will now hand back over to Frank for some closing remarks..
Thank you, Mark. Before we wrap up, I want to address where we stand in the evolution of Better Therapeutics overall. Now, there are three key areas we've been focused on de-risking over the past few months. The FDA authorization of AspyreRx with a favorable label resolved the regulatory risk and has cleared the way for commercial launch.
We now need to demonstrate commercial traction. To do that, we need adoption from providers, payers, and patients, and we believe we're in a good position to achieve this. We have a great product, as demonstrated by the strong results of our pivotal trial.
We continue to receive positive feedback from providers, and our approach to treating Type 2 diabetes through behavior change is already included in the treatment guidelines.
Furthermore, the encouraging feedback from payers, the findings from our payer research, and the quickly evolving landscape of PDTs in general give us confidence payer coverage will be successfully obtained. However, because PDTs are still a relatively new category, obtaining broad coverage will take some time.
As Diane shared, our research suggests that there's a sufficiently large number of providers that are likely to be early prescribers of AspyreRx to give us meaningful commercial traction. And the feedback from patients to date suggests that being on AspyreRx can be life-changing.
To ensure providers and patients have a good experience with AspyreRx at the outset, and while we are building coverage, the cash pay option Diane mentioned will be priced appropriately to enable broad patient access.
We believe this will not only drive early provider and patient adoption, but also accelerate our efforts to broaden payer coverage, and as coverage broadens, we expect an increasing number of scripts to switch from cash pay to covered scripts, which in turn will drive our revenue.
So this is broadly how we expect the dynamics of our launch to play out. In parallel, we need to ensure we have adequate financial resources. With the latest financings, we've extended our cash runway through the end of the year, allowing us to potentially meet multiple important milestones and secure further funding.
We're focused on the following key milestones for the remainder of the year. With regards to the commercial launch of AspyreRx, we expect to make AspyreRx commercially available in Q4 of this year.
Ideally, we announce initial payer coverage around the same time and continue to broaden coverage before the end of the year, along with getting on the federal supply schedule. Second, complete the enrollment in BT-001 real world evidence programs.
We expect to complete enrollment by the end of the third quarter, and pending sufficient power, we expect to share the first data set from these long-term effectiveness studies in the fourth quarter of this year. Third, request breakthrough device designation.
Following the successful completion of the LivVita Liver Study, we intend to submit a request to the FDA for breakthrough device designation for non-alcoholic fatty liver disease, NAFLD, and non-alcoholic steatohepatitis, or NASH, by the end of 2023. And fourth, further strengthen our financial position.
We expect to complete a business development partnership or structured financing transaction, such as a royalty monetization, before the end of the year. In closing, we envision AspyreRx becoming part of the standard of care for most adults living with Type 2 diabetes.
The unique combination of AspyreRx's mechanism of action, safety and efficacy profile, broad utility and accessibility, and potential health economic benefits truly set it apart and position it to succeed. And with that, we're now ready to take your questions. Thank you..
[Operator Instructions] Our first question comes from Charles Rhyee with TD Cohen. Your line is open..
Hi. This is Lucas on for Charles. I wanted to ask, I understand it's obviously early days here and we haven't launched, but I wanted to see if you guys can point us directionally to what OpEx could look like once we hit commercialization.
And then also what, if you guys have any sales projections for the first year of commercial launch?.
Hey, Lucas. Thanks for your question and good afternoon. So regarding your operating expense question, I think as you know, we have substantially curtailed our operating expense in the early part of this year through a restructuring.
And through the early innings of the launch, we expect our operating expense to remain roughly flat, maybe increase slightly. And the goal here is to first demonstrate early commercial traction before we expand our operating expense beyond sort of the current levels in a meaningful way.
We think that is the most prudent approach to take, and that's the path that we're going to pursue. So you can expect over the next, let's say at least two quarters of operating expense to not change in any significant way. And then it really depends how commercial traction evolves.
And of course, if we see good commercial traction, we would then want to expand our commercial footprint. And with that, you would then see a commensurate increase in expense. With regards to your second question about revenue, we are not providing revenue guidance at this point.
I think generally, it is wise to wait until we have at least two to three quarters of launch experience under our belt and we have a better understanding of the launch dynamics..
Okay. Thanks. Understood. And then I guess a question around NASH and NAFLD.
In terms of going to the market, pending receiving a breakthrough designation, would there be any changes to make to your commercial strategy for diabetes, or will you be able to plug and play into the same targeted payer and physician population? Just trying to think about that dynamic..
Yes, so there's actually several points to make here.
The first one relates to the product itself where you haven't really asked about this, but I want to address it nevertheless because it's one of the unique aspects of AspyreRx and the platform that we have built in that the underlying behaviors that are driving the progression of type 2 diabetes are largely the same that are driving the progression of NASH, NAFLD and other cardiometabolic diseases.
And so we believe we can use the platform with very modest modifications to easily be then applied to other cardiometabolic indications. So that's point number one. The second point with regards to what type of providers we would target.
It depends a little bit from indication to indication, but we would expect there to be a large overlap to the providers that we're targeting with our type two diabetes launch..
Okay, great, thanks..
One moment for our next question. Our next question comes from Thomas Flaten with Lake Street Capital Markets. Your line is open..
Hey, good afternoon, everyone. I appreciate you taking the questions.
Frank, for the real-world evidence study, how many patients will you have enrolled, assuming the powering is still there or that you'll report out on?.
Yes, thanks for your question. I'll actually let Mark Berman answer that question..
Hey, Thomas. Good afternoon. So, the study is going to enroll approximately 1,000 a thousand patients, and our estimates would point to roughly around half of those having interim data by the end of the year.
But as mentioned, we're going to be taking a look at the power for the results that we have to make sure that we're adequately powered before releasing results. We wouldn't want to be premature about releasing results that we didn't think were likely to be representative of the final sample..
Excellent. Thank you.
I'm not sure if you're willing to share what your cash pay price will be, but I'm just curious if you could at least share what comparables you use to come up with what you think is a reasonable price for pure out-of-pocket?.
Yes. So I think you've picked up on the fact we have not yet finalized the decision on the cash pay price. But our objective is to price it at a level that will minimize patient drop off and maximize adoption.
And I can tell you from the latest pricing research that we have done, when asked directly on price and out-of-pocket costs for patients, providers indicate a range of $25 to $50 per month as a reasonable max out-of-pocket expense for patients.
And when asked patients directly, they indicate a range of $40 to $55 per month as a reasonable max price range for out-of-pocket costs. So it is going to be somewhere in that vicinity because that is what I think the latest market research indicates to be the sweet spot and to achieve our objective of maximizing adoption..
Got it. And Diane, from your comments, you mentioned five to six geographies that you targeted, but also 1100 providers. I was curious if I should read five to six geographies as five to six reps, which makes that seem like a pretty heavy physician burden for those reps to carry. I was wondering if you could help me reconcile those two numbers..
Yes. Hey, Thomas. Nice to hear from you.
So, with regards to the five to six geographies, we've been able to identify these priority geographies based on several data sets and inputs, which include our patient claims analyses, the associated prescribing physicians and their connection to health system profiles, as well as the analyses that we've conducted with regards to regionally dominant payers that overlap with the large health system.
When we went about conducting our segmentation data or segmentation study, it's important to note that the healthcare providers were sourced from the patient claims analysis and this mapping to the top two deciles. And from those cohorts of physicians, we were able to identify these early innovators or 1,100.
These do stand to be clear nationwide and so as you can understand certainly a small team, that is a burden and so for us we're looking at maintaining flexibility depending on how our momentum ramps as we release the product into market.
And so our team, we're estimating of about 10, will include sales, payer leads, medical science liaisons, as well as VA specialists. And for us, we will be focused on where we have that early adoption from both provider levels at the health system level and where we're able to access coverage early.
So we are really focused on being extremely flexible. And as I had previously stated, the health system approach is one that allows for efficiency. If we can get to these early adopters who tend to be endocrinologists who are influences within the health system, we expect to have a faster and broader reach with that approach..
Got it.
And then one I know I've asked you before, but any stronger sense today on whether this will ultimately funnel into pharmacy versus medical benefit?.
It's a good question. And even through our most recent conversations post-announcement and authorization of AspyreRx, we still get mixed feedback from payers. And I'll just emphasize that we do have a partner here with Phil or Online Pharmacy that allows for optionality whether payers choose to cover via pharmacy benefit or medical benefit..
Got it. I appreciate you taking the question. Thank you..
Thanks, Tom..
One moment for our next question. Our next question comes from Keay Nakae with Chardan. Your line is open..
Yes, thank you. I'm wondering if you can give us some qualitative thoughts on how the early discussions with payers are going post the authorization.
I guess, maybe specifically as it might pertain to value-based pricing agreements?.
Yes, Keay. Nice to have you on the call and thanks for your question. Yes, we can comment on that a little bit. I will hand it over to Diane in just a second. Just as an intro remark, we have actually been quite encouraged by the latest rounds of discussions that we have had since the announcement of FDA authorization.
Clearly once we announced FDA authorization, it acted as a catalyst for accelerating and broadening our payer discussions. And, yes, the feedback that we've gotten so far is encouraging. Diane, maybe you want to comment a bit more on what we've heard..
Yes, thanks, Frank. I will say that we are very encouraged by these multiple post-authorization meetings that have taken place since the announcement.
We are getting to the senior decision-makers, which I'm really happy to see their interest, while we've also advanced conversations with other regional payers, PBMs and national payers who are showing interest in AspyreRx beyond our targeted list. The meetings are very focused on reviewing our updated label.
As we mentioned during our announcement call, we're very happy to have the broad label and to be able to share that with payers has been important. And we are reviewing in more depth our clinical data. And this is now leading on to follow-on conversations with broader team members, at these payer organizations.
And consistent with what we've heard even pre-authorization, the positives really are around our trial size, the fact that we have very compelling and clinically meaningful endpoints of our study, the diversity of our population, the sizable study, and also, the fact that there's an acknowledgement that we see some reduction in medications for the intervention arm in our study.
So all of that is very compelling. You asked specifically to the value-based agreements. These certainly do come up in our conversations. And as a reminder, we conducted research earlier this year to understand the role BBAs might play in coverage discussions. And we do know that they will be important for some of these payer negotiations.
And as we move on to these, secondary meetings with the broader team members at the payer organizations, I'm sure that we will engage in more detail around these BBAs, which will likely be structured around engagement metrics or clinical outcomes as consistent with the research we did earlier this year..
And is it fair to assume if you go down the path of a BBA with a payer, since they're more interested in the durability, that might lead to more six-month prescriptions?.
For sure, one of the outstanding questions that continues to come up in conversations with payers is the durability of response beyond six months. What I can say is that throughout all of our conversations pre and post our expectation is that a AspyreRx will likely be a treatment to have both an index and a refill -- 90 day script.
And beyond that, there's a question of the durability and that's where our current real-world evidence program will be able to provide some more insight into that. But at this point, that is an outstanding question. And BBAs, for sure, these value-based agreements are an opportunity to address this question with payers..
Okay, great. Thank you..
Yes, I would just add there are a number of different variables beyond what you just mentioned that are important to payers. We've talked about some of them in the past and one of them that we are encouraged by actually is engagement, which is something that we believe we can well. We've gotten good feedback on that from payers..
Okay. Thank you..
One moment for our next question. Our next question comes from Rahul Rakhit with LifeSci Capital. Your line is open..
Hey, guys. Thanks for taking the question. Diane, you mentioned that there's like 1,100 potential early prescribers. They said that I think roughly 48% of their patients, they'd likely prescribe this to.
Was there any follow-up on the profile or characteristics of that cohort of patients? Or is there any sense of who or what patient profile these docs thought of as ideal for the PDT early on?.
Yes. Hey, Rahul. Nice to hear from you. Yes, we were very encouraged with this data, keeping in mind that this research was a quantitative study, so did not have the opportunity to engage in deep conversations with this cohort.
But what I can tell you is that the top drivers for prescribing to these patients include patient engagement, ease of use, and low out-of-pocket. So specific to this innovator group, this patient engagement comes up and this ease of use.
And so they really are looking at patients who are likely familiar with technologies and are able to use, apps today. But there is no additional color from this quantitative study in detail there..
Got it. And I appreciate you guys highlighting kind of the top three drivers there.
Were you also able to identify any, potential barriers that lead to some potential hesitation among prescribers that you guys see as an opportunity to further educate prescribers that you guys see as an opportunity to further educate prescribers and kind of drive adoption early on?.
Yes. I actually, with the -- it's varied by the group, and specific to this innovator group, a barrier would be, for example, lack of insurance, or if it appears complicated for patients, and it may not be good for less tech-savvy patients. And that's specific to this innovator group that I've highlighted. And so, obviously, insurance comes up here.
But also, again, the ease of use. And so, they're thinking about their patients and who would be more or less tech-savvy..
Got it. That's helpful. Thanks for taking the questions..
Yep..
This concludes today's conference call. Thank you for participating. You may all disconnect..