Good morning, everyone. I'd like to welcome you to Pear's 2022 Investor Day. Next slide. Some of the statements we make in today's call may constitute forward-looking statements. This includes statements concerning our future business, operating results, management's intentions, beliefs, and expectations about future results, events, strategies, operating plans, and performance or financial condition, all of which are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Actual results may differ materially from those indicated by these forward-looking statements due to a variety of important factors. Additional information regarding these factors is included in our annual report on Form 10-K and quarterly report on Form 10-Q filed with the SEC. Except as required by law, Pear assumes no obligation to update or revise these forward-looking statements, even if actual results or future expectations change materially. Next slide. Today I'll kick us off. I'm here joined by our Chief Medical Officer, Yuri, our Chief Commercial Officer, Julia, our VP of Market Access, Mark, and our VP of Government Affairs, Beth. For our agenda, we'll begin with an introduction. This will include a very brief reminder of Pear's business and the opportunity before us. We'll then move into a deep dive on Pear's clinical evidence. As you will hear, we believe that this data is highly differentiated and is poised to ultimately drive adoption of our products. We expect questions here, and so we will end this session with Q&A. Then we'll move into a discussion of market access. You'll hear about the work that Pear is doing to help establish a payment infrastructure for reimbursement of our PDTs and how clinicians may obtain reimbursement for certain services provided via our PDT backend. We'll also have a dedicated Q&A here. Finally, we'll wrap up the call with a few comments. Without further delay, I'd love to kick us off. Many of you are highly familiar with our business, but for those who are still getting up to speed, Pear is the category creator and leader in the development and commercialization of software-based medicines called prescription digital therapeutics or PDTs. Pear is a pioneer and first mover in this space with three of the first three FDA-authorized prescription digital therapeutics. Those products are in major markets with our reSET and reSET-O products for different addiction conditions, and Somryst for the treatment of chronic insomnia. All told, these three commercial products have the opportunity to address more than 70 million patients in the U.S. Behind those three commercial products, we have a deep and broad pipeline with the next 14 product candidates in different stages of development. All of those product candidates and all of those commercial products sit on the same end-to-end platform, which is a scalable infrastructure to discover, develop, and deliver PDTs to patients. We're a company that's focused on scale and focused on moving from three to 17 to hundreds of prescription digital therapeutics. We've demonstrated adoption by patients, clinicians, and payers, and we are now applying data playbook across additional assets and geographies. On the next slide. In our last earnings call, we walked you through a set of functional metrics. Those are total prescriptions, fulfillment rate, payment rate, and ASP. Today, we aim to highlight a number of our activities that are related to these metrics. You can see here things like CPT codes and EHR integration. We've discussed both of these previously, but you can think about these initiatives as impacting total prescriptions and fulfillment rate by making our products easier to use and potentially providing reimbursement for prescribing clinicians. Then, data. We'll discuss our real-world data extensively today. We believe that this data can help drive payment rate and ASP as it supports our value proposition to payers across government and our commercial businesses. We'll also discuss some initiatives that are tightly focused on payment rate. You have things like state and federal legislation for coverage of PDTs, HCPCS codes for reimbursement via a durable medical equipment benefit, and the access agreements we've been executing directly with payers. We haven't included EHR integration into this presentation, but we're happy to take questions on the topic. This remains an important aspect of provider ease of use, and we believe that integration into clinical workflows is critical to PDT adoption. On the next slide, I'd like to briefly double-click on our data. This data helps to support our value proposition across healthcare stakeholders. For patients, data helps them identify safe and effective products. For clinicians, data helps them understand the clinical benefit of prescribing our products to their patients. For payers, that data helps them to understand the potential cost savings from our product use. On slide eight, building briefly on this framework, here's an example of our data-centric value proposition for reSET and reSET-O, our products covering substance use disorder and opioid use disorder, respectively. For patients and clinicians, our data shows strong patient engagement, reduced substance use, enhanced retention in therapy, and high patient and clinician satisfaction. For payers, our data shows reduced inpatient hospitalizations, reduced emergency department use, durable clinical effect, and overall cost savings. On the next slide, from an external perspective, I'd like to share a video from Dr. Scott Whittle, a Former Medical Director for Intermountain Healthcare. Scott has worked in the payer and addiction space for more than 20 years. Team, please start the video. I'm Dr. Scott Whittle, child psychiatrist, adult psychiatrist, boarded in neurology as well, served as medical director and executive leadership within the payer system for over two decades. I'm very excited to talk today about reSET-O and Pear Therapeutics in general. I have been connected to Pear Therapeutics for a number of years, watching the product grow, mature, watching the offering become, you know, in my opinion, frankly, quite compelling. It's my pleasure to outline a couple of reasons why I believe reSET-O and Pear Therapeutics in general are just standouts in the industry. Number one, the digital therapeutic space is really complicated and not to get into too much detail on this, but the prescription digital therapeutic space, in particular, is compelling. You know, there'll be a lot of detail that and I'm sure that'll be discussed. From a payer point of view, having a product that very specifically targets a significant illness within our industry and with very clear evidence-based care, efficacy towards one of our most, let's just say, challenging headaches in the healthcare space, being opioid use disorder. You know, there are other areas obviously for applying prescription digital therapeutics, but this one in particular was very compelling to a payer. The cost of that product is heavily outweighed by the benefit to me in terms of other services that might be provided in a complicated journey of providing treatment for opioid use disorder. Next slide, please. Zooming out from evidence and payment, all of these efforts are in the service of creating a category-defining company in an entirely new industry. This is an opportunity where many disease conditions can be treated by software. Where Pear has the opportunity over time to develop and commercialize hundreds of PDTs, all from one shared platform. Where each of these products is able to demonstrate robust health economic value, and where we are able to rapidly and efficiently develop new PDTs. We believe in a vision for this space where there's a winner-take-most dynamic, like in the EMR space, where most clinicians use one and only one platform instead of simultaneously engaging with tens of solutions. We believe that because of our first-mover advantage, our data, as described later, our platforms called PearCreate and PearConnect, and our regulatory position that we are poised to be that company. We move to the next slide. With that backdrop, I'd like to turn it over to Yuri, our Chief Medical Officer. Yuri will spend the next approximately 45 minutes discussing the data and evidence for our products. We will also end this section with specific time for Q&A related to data and evidence. For those of you in the audience, you can submit a question by clicking on Ask Question in the top right portion of your screen. Without further delay, Yuri. Great. Thank you, Corey. Before we— why we are all here. reSET is the first PDT authorized by FDA. This product is indicated to treat substance use disorder. SUD affects at a minimum 40 million people in the U.S. reSET is the only FDA-authorized product for addiction to cannabis, cocaine, and stimulants. reSET-O is the first PDT to receive breakthrough designation by FDA, and this product treats opioid use disorder using the same mechanisms as reSET. Opioid addiction impacts about 3 million people nationwide. Other studies that look at overdose rates on top of self-reported OUD estimate that this number can be as high as 7 million. Somryst is the first PDT to treat chronic insomnia. It offers drug-free and guideline-recommended treatment. Insomnia impacts about 30 million people in the country. Next slide. The goal of Pear's evidence generation strategy is to demonstrate that our products work, improve outcomes, they deliver value, and they increase access. That's the most important part of what Pear does. Our products have to be proven to work. In an emerging class of treatments, especially behavioral health, often the biggest concern is that a clinical trial is conducted in a highly controlled environment. What we aim to do is show that products work similarly in this controlled setting in the real world, and that it drives impact for the ecosystem as a whole. RCTs are considered the gold standard for evidence, as you can do an apples-to-apples comparison of a therapy versus control. For our products, the control has been the standard of care, so we can see how PDTs compare to the care people receive today. Outcomes are analyzed as endpoints that are commonly accepted as indicators of a disease impact on a patient. Real-world clinical evidence is similar but in a controlled setting. They analyze clinical endpoints like abstinence and addiction, and patients are not randomly selected. Rather, this decision is made by the patient and provider. The benefit of these studies is seeing how therapies work in the wild. In many cases, payers will question the generalizability of RCT data because of how controlled the settings are. Especially in addiction, real-world evidence can be an important factor in showing that products show consistency to the RCT. Finally, real-world health economic evidence is similar to real-world clinical evidence, but instead it looks at claims data to determine how therapies impact patient utilization of other healthcare services. For example, does reSET-O utilization help to reduce hospitalizations and emergency department visits, which are both costly and indicators of poor health outcomes for patients? Let me emphasize that these are not modeled outcomes such as comparative effectiveness or budget impact but instead are actual measures of health economic outcomes from patients treated in the real world. By combining these all together helps us show that, A, products work versus standard of care. B, these outcomes can be replicated and are consistent at scale across multiple care settings and populations, and C, these outcomes drive broader health impact for payers and the ecosystem overall. We believe the combination of these, and the continuum of evidence creates a compelling argument to provide broad access to PDTs. Next slide. Pear's products are designed to collect robust real-world data while they create safe and effective outcomes for patients. Data and data security are thus critical to PDTs. Part of why regulation is important is it's a third-party independent scientific body which validates the safety, effectiveness, as well as reliability of the therapeutic. This ensures claims are real and not self-attested. Second, the requirements around data security and patient management are met. Third, that the organization continues to meet FDA's strict standards through regular audits and monitors for adverse events and complaints. With PDTs, data is integral to both the therapy and the broader impact of the class. For patients, PDTs help to create a more comprehensive picture of their care. What this translates to is engagement outside of clinic interactions. Objective endpoints, clinician-reported and patient-reported outcomes are captured. Our PDTs also can capture clinical outcomes that support our real-world studies to facilitate rapid evidence generation. To underscore the value here, you can think about the sheer investment that pharma companies make in digital tools to support data collection. These companies are always looking for ways to capture patient-reported outcomes or PROs that support their product efficacy in the real world. This is intrinsic to our products. For example, Somryst captures PROs against the Insomnia Severity Index scale such that we can see how the product is impacting patients regularly without additional investment. For providers, these data are critical just as much as patients. Pear MD, as you can see in the middle, collates and presents this data for providers to make more informed care decisions and can also aggregate data to support population management. It also collects clinician input and lab data that abuts next to patient inputs. As an example, by combining these together, you can understand abstinence addiction using both drug screen data and PROs to gain richer insights. For payers, this de-identified and aggregated data can be put next to claims data to determine the health economic impact of therapy. Similar to providers, these outcomes can be utilized by payers to support management of their patient population. Next slide. You can see here a summary of our clinical data across the products, but the more impressive aspect is the consistency across our RCTs and real-world outcomes. We have now created a continuum of evidence for each of our commercial products. As we move forward, we will cover each product specifically. At a high level, the patient volumes in these studies speak to the significance of our evidence across RCTs, real-world clinical data, and real-world health economic data. What's even more interesting here is the duration of these studies. Addiction and insomnia today are chronic diseases. Insomnia is treated largely by unsustainable solutions such as sleeping pills. What we aim to do with behavioral therapy is to have a durable effect on patients to help them potentially reduce or remove a disease from their life. In the case of insomnia, our RCTs followed up the patients 18 months after therapy and the outcomes were consistent. Therefore, one can begin to think that nine weeks of Somryst has read through to 18 months later. This is further supported by other studies which have gone out to three years and real-world evidence showing value through 24 months. When the environment is not controlled, nine weeks of Somryst use had a durable effect three years later. We will discuss this product to product, but you can see that our focus is larger datasets, targeted populations which help unlock markets and care settings, and longer durations of analysis. Next slide. Beyond longer and larger data sets, we also want to make sure that PDTs are proven to work across a variety of populations. We believe that PDTs are critical to improving health disparities across the country, and it is important to ensure that our PDTs are not biased, but rather generalizable. On that point, our products have been tested across ethnicities and race, socioeconomic status, educational levels, geographical locations, including rural and care settings such as incarcerated individuals. These are topics that are top of mind for both providers and payers as they assess whether PDTs can close gaps in care. Next slide. The importance of prescription digital therapeutics and the criticality of data have been supported by multiple patient advocacy groups. Here is Ann Herbst from Young People in Recovery to provide her organization's perspective. My organization believes that digital therapeutics would be a great help to our community. I think it's really important that people have access to products they can use in the privacy of their own home any time of day or night, whether they live close to a treatment provider or very far away. It's also important that people have the option to use a product that feels comfortable to them and something that they actually enjoy engaging with. I think it's also really critical that any product be FDA approved so that there is an evidence base behind it. Anybody can create a video game or some kind of technology, but you need to know that it works if you're going to invest time and resources in it. I also have to say that there really hasn't been any breakthroughs, you know, medically. The most recent medication-assisted treatment are not terribly new, and that's part of the reason why we're so excited about prescription digital therapeutics. We think that our audience would really enjoy them. We believe that they're effective. We know that they're safe because they're FDA approved. As a parent, it's something that I wish that my family had had access to for our son when he was in treatment. I'm really excited about this product, and I think it's part of the reason why YPR is a champion. Our constituents are excited about it, and we'd like to see them more widely available for everybody to use and benefit from. Thanks. Thanks, Ann. Next slide, please. I would like to now do a deep dive on our first product, reSET. As many of you may be aware, reSET is FDA authorized to treat patients with SUD related to alcohol, cannabis, cocaine and stimulants. The product is intended to increase abstinence and retention. Next slide. reSET is supported by two large randomized controlled trials with over 1,000 patients. This morning we share details of health economic data comparing the six months before and after therapy onset that has been accepted for publication and made available via preprint. The RCTs demonstrated meaningful impact on both substance use and retention and treatment. Real-world use shows consistency in these outcomes, and this translated to a meaningful reduction in healthcare resource utilization that was seen even after therapy ended. We will double click on the health economic data shortly, but at a top line the outcomes are very promising. This is the first step toward a continuum of evidence in this population. As we have seen methamphetamine use become more and more common, this data set only becomes more important. This morning, we will run through a few of the studies for each of our commercial assets. Next, I will discuss the pivotal study that supported reSET's FDA authorization. Next slide. This is reSET's pivotal study. It was a 399-patient study showing that the product doubled rates of abstinence for patients with substance use disorder. reSET's clinical trial focused on comparing the use of reSET versus standard face-to-face therapy. The reSET arm contained some face-to-face therapy, but about half of that in the control arm. The primary endpoints here were abstinence in the last month of treatment and retention in treatment. reSET was successful on both endpoints. Notably, reSET more than doubles abstinence rates for all patients and more than quintupled rates in patients who are using drugs when they entered the trial. Next slide. This new data is now publicly available, and we think the results are impressive. Up to now, we did not have real-world healthcare resource utilization data or claims evaluating the population with substance use disorder due to alcohol, cannabis, cocaine or stimulants. Our analysis here looked at the six months before and after treatment initiation to see the net impact of reSET on resource utilization. Adding everything together, reSET reduced costs by approximately $3,600 per patient when the cost of therapy is about half of that. In other words, this data supports a 100% ROI for a payer within six months after a patient starts therapy. For a payer, this is a rapid ROI realization, which is very important information as they may have one to two years at most with the patient before they may switch payers. Diving into specific line items here on the slide, there was a 50% reduction in overall hospital encounters. There was a 46% reduction in inpatient stays and a 54% reduction in emergency department visits. More so than the cost, we are extremely happy with the impact reSET has had on patients going to the hospital. Whether from overdoses or broader SUD complications, reSET helps to stabilize patients and keep them from using drugs. We are excited to roll this data out to the market and see more and more patients obtain access to reSET. Next slide. Next, I would like to highlight data from reSET-O. reSET-O is FDA authorized to treat patients with opioid use disorder. The product is intended to be used in combination with the pharmaceutical medication buprenorphine. Next slide. reSET-O also features a continuum of evidence. There are three RCTs with over 450 people, two real-world clinical studies in over 6,000 people collectively, and three real-world health economic studies, the largest with over 1,800 people. Our RCT data is consistent with the real-world data. Our health economic outcomes now go out to 12 months to demonstrate durability of the clinical effect. For opioid use disorder, Medicaid is the major payer involved. In commercial populations, about 20% of patients churn year-on-year, whereas in Medicaid only about 6% of patients churn year-on-year. Our experience thus far shows Medicaid payers caring about 12-month durable effect to justify the upfront spend. Especially in opioid use disorder, where patients can have very costly events that come up if a relapse occurs, these 12-month outcomes can be very impactful for Medicaid organizations. In our subpopulation analysis of Medicaid patients over 12 months, reSET-O had an even greater cost savings given the higher incidence of facility events. Next slide. For reSET-O, we have published multiple real-world clinical outcomes datasets, the largest for over 3,000 patients with opioid use disorder. We have also published similar data on over 600 patients who have used more than one prescription. Here we can collect product engagement, retention and therapy and abstinence, as well as other patient and clinician-reported outcomes. This is the cleanest set of data to compare RCTs to real-world outcomes directly. When doing this analysis, you can see that our real-world evidence performs equally or better than our RCTs. Showing 91% abstinence in the final months of treatment and a 91% response rate is very promising. Next slide. Adherence and engagement with any treatment is a critical issue across healthcare delivery and medicines. The same dataset shows engagement data across the population. Adherence is a challenge for many medications, and engagement can be the most elusive component of many digital health products and digital therapeutics. Generally speaking, you will see engagement for digital therapeutics drop significantly after the first month or so. In a meta-analysis of digital therapeutics hosted on Microsoft SilverCloud, 17% of patients were engaging the 12th week of treatment. In a similar analysis of treatment offered by an IDN, the engagement dropped down to near 1% in the fourth week and was not tracked beyond that. Interestingly, when we compare to buprenorphine, we are matching a similar disease area and patient population for reSET-O, and this patient population is challenging to reach and treat. That patient population, we observe a 37% retention rate, as you can see on the slide. Compare these numbers to our reSET-O engagement. In the final month of treatment of reSET-O, 74% of patients are engaged. When you compare this to what is broadly available on the market, it is clear patients are using our treatment with better engagement than both the standard of care and medication as well as other digital products. Next slide. reSET-O is also supported by real-world health economic data. This dataset now goes out to 12 months after treatment. We just recently presented this data at ISPOR, or the International Society for Pharmacoeconomics and Outcomes Research, to demonstrate durability of outcomes. To underscore this point, what we're seeing across over 1,800 patients, roughly half treated and half in control, is that not only does reSET-O work, it sustains a positive impact for up to 12 months. This data is also put up against a control group, so the data is normalized against a similar population. What you see here is the impact across Medicaid patients, which are the majority of those using reSET-O in the real world. As we discussed earlier, this 12-month landmark data is important to Medicaid payers who are looking for sustainable solutions that help people graduate from Medicaid to gainful employment and commercial coverage. This population is very expensive for payers, especially in the year before people begin engaging with treatment. Our data here shows a meaningful reduction in hospital encounters which translated to a greater than 100% ROI for reSET-O. Next slide. Looking across the various real-world health economic publications we have put out, we see a scaling and durable effect. To properly set up this graph, the co-cost differentials are compared to the same reference point before initiation of treatment. We would not always expect this curve to have a positive slope as some patients may have had their first healthcare encounter associated with OUD six months before therapy, and the previous six months may have not had hospital facility services. To see the value increasing consistently is really great to see. Across each of these publications, reSET-O demonstrated a positive ROI ranging from around 25% to around 100% over 12 months for Medicaid patients. An important note here is also about when these results were published. Our six-month data came out in the back half of 2020. Our nine-month data came out in 2021, and now our 12-month data is available in 2022. When you overlay this on our market access progress, it paints a positive picture. We believe this 12-month data will have a catalytic impact on patient access. Next slide. Finally, I would like to highlight the clinical data for Somryst. Somryst remains the only FDA-authorized prescription digital therapeutic to treat chronic insomnia. Next slide. Somryst has the most data of our products. In fact, Somryst has 44 completed or ongoing studies. The pivotal outcomes for RCTs go out to 18 months. The real-world health economic data goes out to 24 months, and additional evaluations and clinical studies go out to 36 months. Somryst has demonstrated immediate impact in patients, sustained clinical impact, and significant health economic impact. Chronic insomnia has significant impact on both mental health and physical health and similarly impacts critical workforce productivity and health criteria critical to employers. We can demonstrate to employers that nine weeks of Somryst treatment equates to at least a year and a half of reduced insomnia severity. We can demonstrate to their payers that over two years after treatment, Somryst has a greater than 100% ROI. We will go over this data in some detail over the next few slides. Next slide. We will discuss our two pivotal trials in two slides. This one focuses on insomnia severity, and the next focuses on responder remitter rate. ISI, or Insomnia Severity Index, is a measure of impact on sleep as well as daytime impairment and functioning. As we noted earlier, the neat thing about Somryst is that it captures the ISI score within the therapeutic itself. In two studies, including over 1,400 patients, there was a greater than 50% reduction in insomnia symptoms over 18 months. The pivotal studies have also shown that after treatment, patients actually sustain or get better over the subsequent year. Nine weeks of treatment leads to 18 months of over 50% reduction in insomnia symptoms. Next slide. In chronic insomnia, a reduction below 8 points is considered a remitter. The proportion of patients meeting the remitter definition is highly clinically meaningful. Response above and beyond the responder definition of a change of 7 points on the ISI. In this analysis, the proportion of patients in the intervention group, which is in purple, who met the remitter definition, were compared to the proportion of patients in the control group, which is in the light gray. Across both studies, we can visualize that the proportion of patients who met the remitter rate of clinically meaningful reduction in insomnia severity was statistically significant at end of treatment, as well as at six-month and 12-month follow-up. While not presented here, this similar analysis was performed across ISI responder as well as sleep onset latency, which is the time it takes to fall asleep, and wakefulness after sleep onset, which is the amount of time a person spends awake while trying to sleep. For both of those, a responder is defined as less than 30 minutes by the American Academy of Sleep Medicine. In both studies across both endpoints, a similar positive pattern was observed. Next slide. Somryst has been tested in the real world as well. This study includes over 7,000 patients. The engagement at the end of treatment is similar to the reSET data set, and ISI score showed a 50% reduction. Additional outcomes in the bottom two nomograms of sleep onset latency and wakefulness after sleep onset were also collected, and these showed a greater than 50% reduction as well. This is a critical demonstration of the continuum of evidence, where we observe consistency in the outcomes in the real world as well as in the prior RCTs we just reviewed. Of note here as well, was that nearly 350,000 sleep diaries were collected in this data set. Over 7,000 patients, people are using this 5x greater on average over the course of treatment. In addition to the outcomes, this engagement with patient-reported outcomes and insights is critical for improving care. Next slide. Another newly published data set is two-year health economic outcomes associated with Somryst. Two-year durability is something unmatched in the sleep space across therapeutics, and the results are impressive. In comparing the health services in the post-period after treatment compared to the pre-period, it was found that there was a 53% reduction in ER visits, a 21% reduction in inpatient admissions, a 19% reduction in sleep medication use, and a 13% reduction in hospital outpatient services. Interestingly, we see a 2% increase in office visits, which could be interpreted as patients engaging with less acute, less expensive, and more appropriate outpatient treatment. Overall, estimated cost savings over two years is $2,059, which is a greater than 100% ROI for the payer. Next slide. As we noted earlier, Somryst has one of the most comprehensive data sets in this space of chronic insomnia and sleep therapeutics. There are over 44 studies which include a population of greater than 10,000 patients across these evidence generation activities. Studies and real-world evaluations included patients across the variety of care settings and patient populations, and the outcomes go out to 36 months. Importantly, we are demonstrating that this product works across a broad set of patient populations. Next slide. To bring us together and back, we are very happy to present our continuum of evidence across our three commercial products. Not only do our PDTs work in clinical trials, data show they work just as well in the real world and may have a significant positive economic impact on our healthcare system. We believe these products can provide value to patients, clinicians, and payers over the therapy duration and the subsequent six to 24 months. Taking another step back, data includes generation before as well as during an unprecedented pandemic, which may change the nature of many people's lives. It is both humbling and exciting to imagine the benefit Pear Therapeutics can have on patients, providers, and our health ecosystem. As Pear continues our journey, we look forward to generating more evidence that shows just how impactful PDTs are for the treatment landscape. I'm now going to pass back to Corey for Q&A. Thanks, Yuri. For those joining our session, we'll now open for question and answer. We have a fair amount of time here, and so we'll try to take all of the questions that we possibly can. But we'll focus specifically on questions related to clinical and real-world data, where we have the opportunity. As a reminder, you can submit a question by clicking on Ask a Question in the top right portion of your screen. I'd just like to thank all of you who have already submitted questions. I'll just take a moment and just order the questions, really briefly. As I look at what's coming in, I see a couple of questions on specific data sets for Yuri. Yuri, the first question that I have here is: What is the significance of the data you presented on underserved populations? I think that's specifically slide number 16. You bet. Thanks, Corey. If it's possible to go back to slide 16, great, if not. What we've heard as a recurring refrain from payers is their focus on removing or reducing disparities in care across underserved and minority populations. There are very real gaps and inequities in care amongst underserved and minority populations. In addition to this being an inequity, this has many negative consequences for the payers as well as the population. We've heard that addressing health equity and care disparities is critical for payers right now, and doing so in the real world is even better. Our data set continues to show that our products are effective across not only different disease states, as we reviewed together, but also we wanted to look at different geographies, different socioeconomic statuses, and different ethnicities and race. We find that as payers come to understand this data, it elevates the importance of covering our products, and we are excited for the opportunity to share this data with more payers to highlight how payers can actually partner with them to help solve the payers' problems. Thanks, Yuri. The next question is on clinical data as well. The question is: Can you explain the potential commercial impact of your new reSET six-month data? Sure. Really excited about this one. While we cannot yet speak to the impact of our new reSET data, we can speak to the impact that our reSET-O six-month data had on our commercial efforts. When we released reSET-O's six-month data, we saw a large increase in payer interest and correspondingly in organizations providing coverage. It is not uncommon for a new category of therapeutic that payers will require real-world health economic data to confirm that it's not going to result in a runaway expense without both clinical and the economic benefit. In addition, the potential of a near term greater than 100% ROI seems attractive based on prior payer feedback. Putting all this together, while we can't exactly say what impact reSET six-month data will have, we are very excited to be able to have a continuum of evidence, RCT, real-world clinical, and now real-world health economic for all of our commercial therapeutics. Yuri, we have a related question here which is regarding the real-world healthcare resource utilization study on reSET, the one that you just spoke on. Is there a specific threshold in cost reduction payers would like to see? Can you put that $3,591 reduction in context and potentially extrapolate beyond six months post-treatment? Certainly. I think to that question in particular, what we are seeing is that, as I mentioned, when we look at the pre-period before compared to the post-period, payers are now seeing this reduction. It's meaningful in terms of the fact that it's greater than the cost of the product. Patients are experiencing a cost reduction that the payer benefits from that is greater than 100% ROI. As I shared with our experience with reSET-O, we see that this threshold is important. While I can't speculate on reSET data, as I've mentioned and reviewed in the slides before, the reSET-O data, we now have durability out to 12 months. For Somryst, we now have durability out to 24 months. Our focus is gonna be on continuing to generate larger and longer datasets to help support our payer partners in evaluating and covering our products. Great. Yuri, you did a nice job of foreshadowing the 12-month data, and I have some questions on the 12-month data here. Specifically, and I quote, you mentioned two cost savings around $2,700 and around $3,800. Can you explain the difference between those two numbers? Sure. Thanks for the question. As was pointed out, there are now two cost-saving numbers in that reSET-O 12-month comparison study. That was a study that was compared to a control population in 1,800 patients. The first value is $2,791, and that is the cost savings observed across the 12 months for all the 901 patients who are in the treated group on reSET-O compared to the control patients not treated with reSET-O. This includes, importantly, all payer mixes, so Medicaid, Medicare, commercial, and uninsured. The second number that I mentioned is $3,832. If you recall, we saw that on the slide that showed the graph over time, and then it was elevated up in the top right. This is a 12-month cost savings observed across 12 months for all 666 Medicaid patients on reSET-O versus Medicaid control patients. This is essentially the Medicaid subpopulation analysis in that health economic analysis. In this dataset, it was a little over 70% of the patients who were insured by Medicaid. While a Medicaid fee schedule may in fact be lower than a commercial fee schedule, we see that the Medicaid patients are often more complex and have higher rates of healthcare utilization than commercial patients. Earlier during the video by Scott Whittle, you may have heard a similar message from him. These different cost savings numbers illustrate a really important nuance, which is that our cost savings are not coming from a resource utilization model. It's not speculation or modeling of a forecasted cost savings given a particular RCT. These are all direct measurement of costs in real-world patients, as well as looking at all types of utilization by payer mix. As we've mentioned, we believe that this sort of data analysis will be a huge advantage of PDTs across conditions. Looking forward, it's an opportunity for provider organizations as well as payer organizations to think of real-world clinical and health economics data as a tool for population management as well as evidence. Great. Thanks, Yuri, for those couple of answers. The next question that I have moves a bit broader, and the question is, what kind of data are payers looking for? I think maybe for this question, if it's okay, I'd love to tag in Mark Hopman from our Market Access team. Yeah. Thanks, Corey. We believe payers want products which are safe, effective, secure, usable, and deliver value. Our products are designed to meet those standards. An advantage of a PDT versus a traditional drug is the ability to collect, analyze, and utilize this evidence to support evaluation and coverage by payers. Yuri's highlighted much of that during his presentation. In many instances, traditional drugs have a few RCTs to tout and a limited amount of real-world clinical and health economic data. We have RCTs, which are critical to validating the clinical outcomes, but we also have a tremendous amount of real-world clinical and health economic data, which is continually growing. To ground these statements in our real-world payer discussions, as we formulated the Medicaid deals with SoonerCare in Oklahoma and MassHealth in Massachusetts, our six- and nine-month data was very critical. Fast-forwarding to our current conversations with other states now, we can show 12-month data, which is a critical milestone because we're showing the potential of both a cost offset at six months and a durable and increasing cost offset at one year. An additional point, and I'll double down on what Yuri was just saying, is the importance of accessibility and parity within the mental health space. This is a hot topic in the industry and is also being fueled by the Biden administration through CMS and Medicaid. I believe payers are beginning to realize both the scalability and ability of PDTs to close the last mile when it comes to underserved and minority populations. Awesome. Thanks, Mark. So the next question we have here is, how important to payers is it for 12-month reSET data, 12-month reSET health economic data to demonstrate sustainable benefits seen at six months? Apologies if a little bit of this is duplicative of some of the previous answers. I'm happy to take this one on myself. I think as we think about really data and data that faces payers, I think they're generally speaking looking for two things. One is evidence of a near-term cost offset. You can think about that as being six-month data. Two is evidence of a durable clinical effect. You can think about that as being 12-month data. I think as we just described, we've seen what are increasing clinical effects and increasing health economic savings for reSET-O in particular, and that is from six months through to nine months through to 12 months. We believe that those datasets do a nice job of satisfying those two requirements, near-term cost offset and long-term clinical durability. I think it would be beyond the scope, just a bit, of this call for us to pontificate on what might happen in reSET at 12 months. Suffice to say, we're, you know, very heartened by where the reSET six-month data stands, and you can imagine that since PDTs are data collecting products, that we'll have the opportunity to continue to build on that story with longer data points, with larger patient populations, and then with particular clinical care settings. I think we just have one more question before we move, and that is: as more candidates come to market, how much real-world evidence will become the gold standard in terms of what timeframe you want to measure? If I can just ask the presenters to maybe just move us back to slide number 13, and this is a slide that you may see more of, as Pear is presenting on its data. Yuri did a great job of describing what we would refer to as our continuum of evidence. What I would communicate is that there's no one of these pillars which is inherently sufficient to drive coverage, but yet all three of these pillars are necessary to drive coverage. We believe that data in randomized controlled trials certainly is required for a product authorization and certainly is required for payer evaluations. We support that data with real-world evidence that shows things like the engagement data that we showed for reSET-O. It also shows things like the abstinence data that we showed for reSET-O. I think all payers want to know that products work in the real world and that products work in their particular patient population. I think lastly, we're showing real-world health economic evidence for every single one of our products. You saw it for reSET, you saw it for reSET-O, you saw it for Somryst. Because of the stack that we've been able to build, we're able to look at real world outcomes for every single one of our patients who moves through the products. We're able to quantify the impact of those real-world outcomes in terms of dollars and cents. I think that's a lot of words to say that we believe that all three of the pillars on this slide are what drives products toward reimbursability. We think it's critical to have RCTs, we think it's critical to have RWE, and we think it's critical to have health economic evidence. It's not necessarily that HEOR evidence becomes the standard of care. I think it's that a continuum of evidence becomes the standard at play here. That moves us through the balance of our questions for session number one. Remarkably, we're doing pretty well on timing here. What we'd love to do is to transition just a bit. Whereas in the last session, you heard us talk about how we believe our clinical data is unlocking market access for our products, it's important to note that in order to realize the potential of that data, we need to create a generalizable reimbursement framework for our commercial products. Note that that framework applies also to our pipeline of products, creating what we believe is a truly scalable opportunity. We'd like to now dig into that payment infrastructure. To begin that transition, I'd like to first share a video by Dr. Trey Causey, who is the Chief Medical Officer of Crossroads Treatment Centers. Crossroads is a national leader in the treatment of opioid use disorder. Trey will talk about his organization's decision to provide patients access to reSET-O. Following that video, Julia, Mark, and Beth from our commercial team will lead the discussion. Hi, I'm Trey Causey. I'm the Chief Medical Officer for Crossroads Treatment Centers. We provide medication-assisted treatment services across 10 states, seeing in the neighborhood of 20,000 patients a month. It's extremely important to Crossroads that we provide high-quality, evidence-based treatment and that that treatment is convenient to our patients because we're really invested in removing barriers to people seeking treatment. When we were approached regarding reSET-O, it really seemed like a great opportunity and a good tool for us to partner with. One, the evidence base, the evidence that got the FDA to approve it as a digital therapeutic was very compelling to us. Two, the convenience of the app-based digital therapeutic in a world where psychotherapy resources are either unavailable or very difficult to access for most of our patients. We feel like using reSET-O has enhanced the services we're able to provide for our patients and moves us in the direction of better outcomes. As Yuri communicated, Pear focuses on making a positive impact on patients, and there's two elements to this. First, demonstrating that our products work, and second, that our products can get in the hands of patients. Patients need our help. We are in the midst of a growing public crisis where one in five U.S. adults experience mental illness each year, and over 40 million people suffer from SUD and OUD, with less than 10% of those people in treatment. Data proves that our product works. It also establishes trust in patients, credibility with providers, and burden of proof for payers. PDTs meet patients where they are to facilitate access. Pear meets clinicians and payers where they are to facilitate availability. Next slide. We engage across multiple payer channels to support the diversity of our portfolio. You can see here a framework for a breakdown of payer coverage across the U.S. Importantly, Pear's products can impact all of these populations. Patients that could utilize our reSET product span across all channels. reSET-O serves patients predominantly in Medicaid. Chronic insomnia patients are served under both commercial plans and Medicare. All of these payers prefer flexibility in how they pay for PDTs, and Pear has been enabling that. Next slide. To support a deeper dive on how we partner with clinicians and payers to enable access to our products, I'd like to start with a few simple definitions of the payment infrastructure. First, two sets of codes are affirmed upon FDA approval or authorization. Unique Device Identifier, or UDI, is utilized for medical devices. National Drug Codes, or NDCs, are codes that can be utilized directly to bill through pharmacy benefits. In addition, two sets of codes are granted upon application to CMS. Healthcare Common Procedure Coding System, or HCPCS, is a code to enable submission of healthcare claims to Medicare and other health insurers for medical devices, supplies, medications, transportation services, and other items and services. Earlier this year, CMS established new Level II HCPCS code for prescription digital behavioral therapy FDA cleared for course of treatment to describe prescription digital therapeutics, including Pear's PDTs. Further, Current Procedural Terminology, or CPT codes, support payment for clinicians for certain services they provide to patients. Beth will provide a deeper dive on these codes later, but it is important to note that Pear's products are not billed for using CPT codes. Rather, the CPT codes allow clinicians to bill for the time they spend interacting with the PDTs. Next slide. A key component of the payment infrastructure is coding infrastructure. This is about collaborating to build the PDT coding framework and category to enable both product and clinician reimbursement. The goal is to support clinicians as they traverse a new product category and to enable payers to provide access for treatment. Reflecting on both the infusion and drug delivery as well as the continuous glucose monitoring markets, which are very large markets. We understood that meeting payers where they are and clinicians where they are is just as critical as meeting patients where they are. Next, Mark and Beth will discuss the payment infrastructure in more depth as they have leveraged their experience with Dexcom to help build the payment infrastructure for the CGM category. As Julia mentioned, NDC codes are assigned by the FDA for drugs. NDC codes are specific to exactly one product. Drug manufacturers list their product information, including the NDC code, with compendia, which publishes the information out to all pharmacy systems. These systems then work together to adjudicate pharmacy claims with the NDC as the foundation. For a device like a Dexcom G6, an Abbott Libre or Pear's PDTs, the process I just described works exactly the same except for one notable difference. The FDA does not assign NDCs for medical devices. Instead, UDIs are linked to each medical device. Pear then creates an NDC-like code from the UDI code using an industry-accepted conversion formula and submits the code to the compendia. This manufacturer-assigned NDC code drives adjudication. Conversely, should a payer want to use the medical benefit, then the HCPCS code A9291 drives the medical billing process. Both methods, pharmacy and medical benefit, have been instrumental in facilitating CGM's ability to scale, and we believe both will be the foundation of how Pear scales PDTs. Beth will cover CPT codes in a moment. Next slide. By establishing this coding framework, Pear's market access team is engaged with all facets of a payer's business. Said simply, we provide payers with defined turnkey optionality, and the payer chooses the option which suits them best. However, we do recommend access agreements and pharmacy coverage as those two pathways are most efficient for the patient and provider. For example, access agreements and pharmacy billing takes minutes to process a claim which can quicken patient access. These agreements can also be value-based, which help payers as they navigate complex economic modeling. DME, while slower, is a pathway which a portion of payers will require. As Julia mentioned, we have to meet the payer where they are. For payers who require the DME pathway, Pear is working with several established DME suppliers who are submitting the claims. Next slide. Looking at the same concepts in a different way, this slide represents a high-level framework for how the large national payers are set up. Because Pear's products can be adjudicated via access agreements, NDCs or a HCPCS code, there is a viable pathway into each segment. Equally important, and I really want these three points to crystallize. Point one, the conversations with each of these payer verticals can be had in a language they understand. Point two, the implementation of claim processing within each of the segments can naturally occur through the payer's legacy processes. Point three, the contract framework, whether rebate agreements, value-based agreements, or medical policy and associated fee schedules, are familiar to the payer. One additional business unit we would like to mention that many of the payers have established are behavioral health organizations. These behavioral health organizations are creating solutions to address mental health access and parity problems, and Pear believes 24/7 access to PDTs is a part of the solution. These behavioral health organizations are proving to be a very valuable access point. With that, I will turn it over to Beth Keyt, our VP of Government Affairs. Thanks, Mark. PDTs have momentum in being recognized and called out as therapy by federal agencies as well as federal and state governments. Our strategy is to leverage this momentum with the current administration and the focus on the mental health crisis to create patient access for technology like ours. Some of the examples of this are President Biden calls out the opioid crisis in his State of the Union. Biden calls out CMS to enable Medicare coverage of evidence-based digital therapies and platforms that facilitate the delivery of mental health services. Most recently, in the National Drug Control Strategy released by the White House, it calls out contingency management and PDTs as therapies that should be more widely available. Medicare access is critical to building a new class, and we're leveraging momentum to gain that access for our patients. Excuse me. Fee-for-service Medicare cannot cover PDTs right now. They cannot cover PDTs right now because PDTs do not fit into an existing benefit category. A benefit category isn't required for Medicaid or commercial coverage, but it is for F ee-for-Service Medicare. To accomplish this on the federal level, we worked with 12 other PDT companies and sponsors on both sides of the aisle in the House and Senate to draft bipartisan legislation to create a benefit category for PDTs. In parallel, we're speaking to CMS directly to make the argument that we can fit into an existing benefit category such as DME. This is the continuation of our HCPCS application from last year. Frankly, we believe that CMS can and should move quickly to provide access to PDTs, especially SUD, as over 1 million Medicare beneficiaries have SUD, and only 10% of those recipients find treatment. As I mentioned earlier, state coverage is not contingent upon federal coverage, and we are pursuing several pathways for state access while driving towards Medicare coverage. To date, five states have passed legislation that have led to or can lead to coverage for PDTs. We've also partnered with states to drive legislation that allocates state budget funds for broad access. An example of that is the state of Michigan. On the next slide, let's discuss the large amount of financial support that states are receiving to address this epidemic. Next slide, please. There's an unprecedented amount of federal financial support flowing into states to support SUD and OUD treatment. Many of the states we're working with are utilizing these funding sources as significant drivers for access for technology like ours. SAMHSA, the Substance Abuse and Mental Health Services Administration, has committed over $20 billion in grants for SUD and OUD and treatments to the states. SAMHSA has given guidance to use a portion of these funds for products like ours. Specifically, they state, "Develop and expand the use of FDA-approved medications and digital therapeutics as part of addiction treatment." The federal funds aren't the only source of funding for the states, as various settlements are being made by the states with drug manufacturers, suppliers, pharmacies, wholesalers around the opioid epidemic. To date, around $4.5 billion have been allocated to states through these settlements, but this is just the beginning. We're seeing states use innovative approaches with these funds that include coverage and access for innovative therapies like ours. As Yuri mentioned earlier, reSET is the only FDA-approved medication or digital therapeutic to treat addiction to stimulants, cocaine, cannabis. Further, reSET-O is the only FDA-approved digital therapeutic for treatment for opioid addiction. This is further validation on top of the president's policies that FDA-authorized digital therapeutics have a clear place in addiction treatment with government payers. Next slide, please. Mark spoke earlier about product reimbursement codes. We hope that you have a good feel for the mechanisms that underlie the reimbursement of our products, but I'd like to take a moment to similarly take a brief run through the mechanisms that allow for clinicians to be reimbursed when they interact with our patients utilizing our products, and dive in a little more on the CPT codes. An important part of creating a new category is supporting the physicians for the time they spend on training and setup, administering and managing these innovative treatments. Recently, the American Medical Association added Cognitive Behavioral Therapy services to an existing set of codes for remote therapeutic monitoring. We're in the early stages of the rollout of this coding set, and providers are still learning how to appropriately document and bill for these codes. It's important to note that RTM codes are new and apply to respiratory and musculoskeletal services in addition to cognitive behavioral therapy services. Pear is not alone in driving this education and awareness of these new code sets, as large organizations in the musculoskeletal and respiratory markets are also driving awareness. Our goal is always to support our clinicians through education and awareness and do so in a way that's always best for the patients that we serve. CPT codes help to support that process. Julia? Next slide, please. We're gonna transition to the video. Besides the clear compelling engagement and member experience pieces that the ability for a payer to put the reSET-O product into the right bucket of payment is really compelling to us too. There's the ability to put it into the pharmacy benefit, into CPT codes, into HCPCS codes. You know, I can make sure that that expense falls in the medical benefit category and not into administrative costs that could be harmful to a payer in terms of how we're reviewed and how our oversight works. So for us, that's incredibly important. You know what? I probably would just finish by saying that when you have a solution to a compelling problem like opiate use disorder, it's not if, it's and. You know, that we need to include all solutions on deck, and to leave an evidence-based solution outside of one solution in the opioid use disorder space just makes no sense to me. Very much appreciate my experience with Pear, my members' ability to have a positive experience with Pear and what looks like a very bright future. Great. Today, we've highlighted our access payment data and infrastructure initiatives that map to our key functional metrics. These include CPT codes and EMR integration, our real-world engagement and healthcare economic evidence, our state and federal legislation drivers to drive coverage for PDTs, HCPCS codes for reimbursement via durable medical equipment, and our access agreements that we are executing directly with payers. All these drivers build the PDT category by supporting patients and addressing the national health crisis. I'd love to transition now to Q&A of the second section. Great. Thanks, Julia. For those joining our session, we'll open for Q&A. We have a significant amount of time left, so we should be in a position to take most of the questions. We're gonna first try to focus on questions that are related to our payment infrastructure, and like we did for the last session, we'll try to coordinate these questions in terms of broad topic. Just as a quick reminder, you can submit a question by clicking Ask a Question in the top right portion of your screen. I'm seeing first a couple of general questions about our conversations with payers. The first question, just to kick us off is, can you characterize how your conversations are going with payers? Maybe Mark, would you be able to address this question? Sure, Corey. The conversations we are having with payers are very similar to the conversations we had with payers when we were building the CGM space. It's a new category to them and a new modality of treatment, so they are being very cautious. We have to educate them on PDTs and how they're different than non-PDTs, like health and wellness apps. We have to educate them on the clinical and real-world data, as well as the payment mechanism. We also have to educate them on the FDA authorization process and communicate the rigors associated with it. We've demonstrated the roadmap with commercial organizations like Prime and Optum, and with states like Michigan, Indiana, Ohio, Kentucky, Massachusetts, and Oklahoma. Thanks to those wins and the infrastructure we described early, we believe we are in a position to replicate those successes instead of reinventing the payment pathway within each of the discussions. Great. Thanks, Mark. We have a related high-level question on payers. The question is, and I quote, "What are the key questions that payers are asking, and how does Pear answer them?" Julia, would you mind speaking to this question? Sure. Thanks, Corey. Payers are really interested in asking three questions. First is, do patients use your product? Two, does your product save me money? And three, how does my organization implement coverage for these products? First, on engagement. You saw our data today for both reSET-O, and Somryst, and we are able now to show payers engagement and outcomes of their own patients and their own members. We can structure our contracts appropriately with either value-based agreements on engagement or outcomes. When we think about the next question, which is, can your product save me money? On the savings side, as Yuri discussed earlier, one of the advantages of PDT is that they're able to collect robust datasets within commercial patients. We share with payers our data demonstrating the durable treatment effects, a near-term breakeven, a reduction in inpatient hospital utilization and emergency department visits, and a cost savings in access to product price per treated patient. This is the type of data that we're gonna continue to publish for all of our products to, again, demonstrate the question, do your products save me money? Lastly, on the implementation of coverage question, you heard us discuss the optionality that we've created both, with pharmacy and the medical benefit, and we have to meet the payers where they are. Agnostic to their own current position, we have scalable solutions that allow claims processing within their current infrastructure. That answers the three questions. Corey? Thanks, Julia. I think we have another related question, which is, can you speak to how you work with payers on value-based agreements or VBAs? Sure. VBAs are just an absolute great way to manage risk for payers. They're also a great way for payer to unlock the economic opportunity by utilizing the real-world data that we described earlier. We believe value-based arrangements use the data transparency of PDTs, and it really then translates to our real-world publications. We've quantified multiple outcomes in the real world through these publications, including patient-reported outcomes, clinician input and data at the payer and DV level, which is our clinical dashboard level, our EMR input data, and we can even get the level of cost per individual patient. Today there's really two levels or two elements that payers included in value-based arrangements and contracts. First, engagement metrics and second, healthcare resource and outcome metrics. With engagement metrics, it is working with payers to rebate for non-use during the defined period of time or prescription period. With healthcare resource and outcome metrics, it's the reduction of real world facility utilization with claims and retention and treatment or overall total cost of care. Across both arrangements, again, we still have really great transparency into the historical trends, and in many cases have the data for the payer's own patient or membership population as they've engaged during this treatment period. Again, already, an approach that allows us to really de-risk coverage for the payers. I hope that Yuri's presentation today helped you understand this in more detail, and it allows us to really set up this strong engagement with value-based engagements or arrangements with payers. Great. Thanks, Julia. So we have next a couple of questions that are related to some of the government affairs work that we're doing. I'm gonna bucket two questions together. So we have the question: Why are you asking CMS to make you DME? Then we have a corresponding question, which is: Could you elaborate on your efforts related to the HCPCS meeting this week and falling under DME for Medicaid fee for service? Beth, would you be able to address these questions? Sure. Actually, we didn't request directly that the HCPCS committee categorizes us as DME. This is an automatic part of the HCPCS process. When we submitted our HCPCS application last year and were granted our code, it put us into the process for requesting a benefit category. We believe DME is the most appropriate existing benefit category within CMS. We communicate our thinking to CMS. We will be communicating our thinking to CMS in this upcoming meeting next week to discuss the fact that this is the best existing benefit category. However, we also understand that the legislation would give us a new benefit category. You can think of the legislation and a benefit category designation as both addressing the same issue. I, as I just mentioned, this would allow Fee-for-Service Medicare to cover PDTs. Great. Thank you so much, Beth. We have a related question on HCPCS and legislation, and this might just be a good opportunity for a little bit of clarification. The question is: If you have a HCPCS code enabling medical reimbursement, why do you need legislation? Yeah, that's a good question. A HCPCS code enables billing through most payer medical systems. It also allows organizations like Medicare Advantage, the VA, DoD to cover. For products like reSET in particular, this is sufficient to unlock most of the market. The current HCPCS codes do not allow for Fee-for-Service Medicare to cover. For Fee-for-Service Medicare to cover, we require a new benefit category, or we would need to fit into an existing benefit category. When we move to products like Somryst, which provide care for many patients within Fee-for-Service, we need CMS to make this benefit category determination. CMS has to make their own coverage determination within the framework of their available benefit categories. We have legislation that would create a new benefit category for PDTs. We're lobbying CMS to consider placing us under an existing category of DME, and we will be at the HCPCS meeting next week, asking for a category of DME in order to fit into the existing benefit categories. Thanks so much, Beth. A lot of questions on the legislation, so I have a couple of related questions here. One is your views on timing or potential vehicles for the legislation. The second very related question is: Can you describe timing or potential vehicles for the legislation that would create a new Medicare benefit category for PDTs? Just to save you the breath, we certainly can't comment on timing. That's something which is a bit beyond the scope of what we're able to in any way speculate on. Beth, maybe could you just speak to some of the potential vehicles? Yeah. I can. Of course, Corey, you're right. We can't really speculate on the timing. What I would say is there's probably a few shots on goal between now and the end of the year of what we would look at for 2022 in terms of attachment to a specific vehicle. We talked earlier about the fact that there's a large focus on mental health and a mental health package. There are a couple other vehicles that the PDT Coalition, we're all working together to work towards attachment. Great. Thanks so much, Beth. I see some questions here around access agreements next. I think the first of those, Julia, I'd love to throw your way. The question is, can you walk me through billing for access agreements? Sure. Thanks, Corey. The contractual framework for access agreements is simple and usually comes in two forms. First, we can be paid upfront and provide the payer with a monthly update of the enrollments. Or second, the payments are made as pay-as-you-go basis, and we invoice on a monthly basis. Both cases, they are direct billed, and we can quickly adjudicate the prescriptions that have been dispensed through the PearConnect infrastructure that we have. Again, these access agreements really drive our goal and aim to meet patients and payers where they are. We find that in many states, addiction care is largely being provided by these funding mechanisms, which are outside of the traditional coverage zone. Access agreements create a quick and simple opportunity for us to extend our reach and offer products to a population that's at risk. Thanks, Corey. Great. Thanks, Julia. I see two related questions here, and I might take a first crack. Julia, if you wanna chime in thereafter, please feel free to. The related questions are what's your split right now between access, pharmacy and medical benefit, and how do you envision this changing? I see a very related question here, which is how do you balance asking states for access agreements versus traditional coverage? I think with regard to the split of different payment structures, that's not something that we've disclosed to date, and it's probably not something that we will disclose in the near-term future. I think, as we put out our functional metric of payment rate, we think about not so much balance, but our ability to get paid as reflective of that payment rate metric. I think for folks who are asking questions like this, I would point you to payment rate in the future. I think on the question of balancing access agreements versus traditional coverage, Julia, is there anything qualitatively there that you might wanna add? Yeah, just that our primary goal is making sure that we can bring PDTs to patients. Depending on the engagement with the state and/or the payer, some payers engage in traditional coverage because it uses their existing coding infrastructure. Others focus on access agreements given the funding sources that are coming into the state. Fair balance between the two. Again, it's all in the spirit and aim of delivering access to patients and demonstrating the robust economic value and clinical value for the state and the payer. Great. Thanks so much, Julia. Just to shift gears a little bit, we have some questions on CPT. Here, we have a question: What pain points remain for the clinicians who are trying to use RTM CPT codes? Then we have a related question, which is: On the physician CPT codes, do you have a sense of utilization of RTM codes amongst providers prescribing Pear products? I'm happy to take this one directly. What we stated during the presentation itself was that we see the RTM codes being reimbursed in about 50% of the states in which we're commercializing. As I think about RTM, really the biggest thing that we're working through is awareness. I think if you were to look at the remote patient monitoring codes or RPM codes, those are codes with which clinicians are much more familiar, but it's taken some time in order to get to that familiarity and hence utilization. This is a place where really we are working for clinicians to be aware of the codes. When we look at the degree of payment and uptake qualitatively after a relatively short amount of time with the codes being in clinical practice, I think we're quite heartened with the progress that's been made. At the risk of giving the audience whiplash, we had a question come in that was back on the HCPCS and the legislation. I might throw that one back to Beth. How important is a distinct HCPCS code instead of A9291 for all PDTs? Yeah. I mean, we believe it's important. We can certainly work within the parameters of our existing HCPCS code. However, in our original HCPCS application, we requested multiple HCPCS codes. I will let you know that next week during the HCPCS hearing, we have signed up to be a five-minute speaker as the original applicant for A9291 to support Akili. As Akili goes in and requests a distinct HCPCS code for their product. It is important. We're supportive of it. It's a request that is embedded within the federal legislation as well, and we'll work towards supporting the PDT Coalition and other PDT companies to make that happen. Great. Thanks so much, Beth. Have a question here. Can you elaborate on which payers are requiring DME/medical benefit pathway? And do you see a significant difference in reimbursement rates negotiated under pharmacy versus medical benefit pathways? I think this is one that I'm happy to speak to. So just for the folks asking the question, it's a great question. It's one that we hope to have more visibility on in the coming quarters. Just as a reminder, the HCPCS codes only came on board April 1st. You can imagine that it's very early days for the HCPCS codes. Bring on top of that the notion that DME traditionally takes a number of weeks on which to adjudicate a claim. You can imagine that the number of data points that we might have around DME reimbursement for prescription digital therapeutics is relatively low. I think given that dearth of data, we probably wouldn't be able to speak to things like specific reimbursement rates. What we can speak to is the importance of offering what we would call benefit type optionality. You heard this come through loud and clear in Mark's comments. Just in the same way that we aim to meet patients where they are, we aim to meet payers where they are. We know that some payers will prefer to provide reimbursement via a pharmacy benefit. It's quicker, it's simpler, it's easier to contract, and it's easier to adjudicate. We are more than happy to meet those payers where they are and provide reimbursement via a pharmacy benefit. We know that other payers will choose to provide reimbursement via a medical benefit, i.e. DME, and that's where the HCPCS codes come in, and we're thrilled to be able to offer products to those payers for the first time as of April the 1st. As Julia mentioned, in some places, there are large pools of capital that provide coverage for things like addiction care, and this really sits outside of a traditional medical or pharmacy benefit structure. That's where we use the access agreements, and that's really designed to be able to leverage the capital that is providing care for many of those patients in those given regions. Again, maybe just to close here, from our perspective, it's much more important to be able to provide this sort of benefit type optionality to be able to bring the products to as many patients as we possibly can. We have a couple of disparate questions here. One is on the question: Over time, will there be any economic difference to payer about how HCPCS versus CPT codes are utilized? I think here, again, what we've set up is the payment framework for the product, and that is access agreements, it is HCPCS codes, and it is pharmacy reimbursement. We've set up the reimbursement for clinician time or potential reimbursement for clinician time. That is the CPT codes. I guess the expectation that I would set is that that framework remains relatively constant, but you may see individual codes come up that support that framework. For example, Beth mentions the possibility of product-specific HCPCS codes. That's something that we're pushing toward and I think would be useful for the space. That's an example of something that would fit very nicely into the framework and would only add to the framework. I think on the CPT code side, you may see a supply code come up in the CPT code world. I think that's similarly something that adds to the framework, provides clinicians another way to be able to provide the products, but it doesn't necessarily change the framework. I think all that said, I'd like to just bring us back to what is most important to the business and most important to the space, which is generating access, full stop. I would view all of these things not so much as which one is best, but I would view them insofar as the aggregate of all of these different methods is best for providing access to as many patients as we possibly can. We have a couple of questions which are maybe off the beaten path, just a bit. One is on EMR integration, and I'm wondering, Julia, if you're able to provide a couple of comments on EMR integration. The question here is, you've previously mentioned EMR integration, but you didn't speak about it here. It may be outside of the scope of what's to be discussed today, but would you mind speaking briefly about the work you're doing around EMR integration? Sure. Thanks, Corey. We continue to facilitate access and fulfillment for our customers who elect to use an enterprise and integrated approach to our platform. Integration into a digital provider infrastructure truly provides a simpler prescribing experience and ultimately an optimized patient access and fulfillment journey. One example of this integration for our commercial platform of PearConnect is in the Epic App Orchard Gallery. The intent is that providers can access the platform within Epic's EMR. Of course, some of our customers continue to elect prescribing and processing claims via fax. However, at this point, this is becoming a smaller component of our business moving forward, and people are really opting to create integration, not only front-end e-prescribing, but digitally enabled through the EMR. In addition, as we continue to set a really strong foundation for direct integration into larger health systems, not only EMR integration is important, but data security and privacy is incredibly important and meeting the assessment of that system. Most IDN health systems have pretty stringent requirements to bring in a new system to really enable this workflow and this optimized workflow. To that end, Pear has really focused on privacy and security as a valuable contributor to our overall platform. We are ISO certified, SOC 2 Type 2 and Type 3 certified, HIPAA compliant with an attestation, 42 CFR Part 2 compliant, and of course, compliant with the FDA. Again, have really made privacy and security as well as EMR integration really this foundation for our continued engagement into health systems. This really marries or brings us really back to the long-term strategy that we had previously discussed in these calls to build an infrastructure that can ultimately serve not only the three commercialized or marketed Pear's PDT products today through PearConnect, but ultimately bring more PDTs and solutions across many disease states. This allows for, you know, clinician cross-prescribing, ease of optimal patient journey, and efficient prescribing not only for access but also fulfillment of our solutions. Thanks, Corey. Awesome. Thanks, Julia. I'll apologize to the audience. We got some questions that are coming in. They're not in keeping with the flow that we had just established, but we'll try to answer a couple of them. One is, can you talk specifically about progress on coverage for Somryst given the different payer mix, lack of available access agreements? This is one where we have not to date, and we won't provide any sort of coverage guidance or financials on a product-by-product level. I think you rightly point out that the payer mix is different for Somryst than it is for reSET and reSET-O. Somryst is less focused on Medicaid while there are access agreements, there's less of a focus on access agreements. The way that I would encourage you to think about Somryst is that as Pear is really building up what is the payment infrastructure for our products and for the space, which is what Julia, Mark, and Beth spoke to this morning, you can think about that as having direct read-through to Somryst. While we have not really issued guidance on revenue mix, I think what we have said is that as we move into 2023, 2024, and 2025, that in those years, we would expect products like Somryst as well as other products in Pear's portfolio to make up a larger fraction of the revenue mix. I think we have one last question here. I'll try to paraphrase just a little bit. We have, as people become more familiar with Pear's story and the broader digital therapeutic space, we're hearing more questions about competing players, specifically, non-prescription digital therapeutics or NPDTs that are studied in randomized controlled trials. Has the presence of these NPDTs affected the tone of payer conversations? It's a good question, and it's one where we might just speculate just a little bit. We view FDA authorization really as table stakes. We view it as being required for the creation of market access. We also view the only way to be able to treat a disease with a piece of software is via FDA oversight. Certainly it's possible, and there are companies that make spurious claims, but we don't believe that that's a way to be reviewed by payers, and we don't believe that that is a scalable business model. We also don't believe in companies interpreting their own datasets. This is really where having an independent third party, a regulator like FDA to review and validate datasets becomes incredibly important. It's also important from the perspective of the quality and security standards that the company is really required to abide by. What I might do is just read from a payer's coverage policy so that you can hear it in their words, not mine. This is a set of conditions that must be met in order for a digital therapeutic to be covered. Number one, approved or cleared by the FDA. Number two, there is credible scientific evidence which permits reasonable conclusions regarding the impact of the digital therapeutic on health outcomes. Number three, the product has been proven materially to improve net health outcomes or be as beneficial as any established alternatives. Number four, the product has been prescribed by a healthcare provider, and there is documentation that it was ordered for a covered purpose, such as preventing, evaluating, diagnosing, or treating an illness. I think that says it probably better than we possibly could, and I hope that ties everything together. It gives you a sense for why we are bullish on the data that we're collecting, why we are putting forth a continuum of evidence that show health economic benefit in the near term as well as a durable clinical treatment effect, and why we've gone through an FDA process, in order to put ourselves in a position where payers are able to review the products. I think with that said, I might just transition to the next slide, which I believe is the last slide. What we'll do is we'll give folks just a little bit of time back here. If we can move to the next slide, please. We spent a good deal of time talking about our continuum of data and the evidence that demonstrate value of our commercial products to patients, clinicians, and payers. You heard us also lay out how we're building the payment infrastructure that we believe can convert the data that we've collected into commercial success. We believe that evidence and payment support broad access to prescription digital therapeutics for patients and also unlock significant economic value for payer. We believe that because of our first-mover advantage, our data, our platforms, and our regulatory position that we're poised to transform healthcare by making software a mainstream medical treatment. Wanted to thank you for your time today. As always, I'd ask you to please reach out to Meara Murphy, our Head of Corporate Communications, and let her know if you have any questions. That concludes today's call. Thank you, everyone.
Loading workspace