Good morning. My name is Jason and I will be your Conference Operator today. At this time, I would like to welcome everyone to the Provention Bio call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. Please be advised that this call is being recorded at the company's request. Now I would like to turn the conference over to Heidy Abreu King-Jones, Chief Legal Officer of Provention Bio. Please go ahead. Thank you, operator and thank you all for joining us today. Ashleigh Palmer, Chief Executive Officer and Co-founder of Provention Bio, will be providing an update regarding our exciting announcement today and sharing some insights about the FDA approval of teplizumab, which we will refer to by its brand name, TZIELD. He will then turn the call over to Jason Hoitt, our Chief Commercial Officer, who will provide an overview of commercial launch plans for TZIELD and an update on our co-promotion with Sanofi. Lastly, Thierry Chauche, our Chief Financial Officer, Eleanor L. Ramos, our Chief Medical Officer and Francisco Leon, our Chief Scientific Officer, will be available for questions and answers. Before we begin, let me remind you that the various remarks we will make today constitute forward-looking statements. These include statements about our future plans and expectations in connection with the FDA approval and commercialization of TZIELD, including under the agreements we entered into with Sanofi, the safety and efficacy of TZIELD, our ability to make TZIELD broadly available to patients, the timing of onboarding new team members to market TZIELD and for our field market access team to work with payers on getting medical policies developed, our financial position and additional resources, as well as our business prospects and plans. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our most recent quarterly report on Form 10-Q and in other filings that we may make with the SEC in the future. Any forward-looking statements represent our views as of today only. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change, except as required by law. Therefore, you should not rely on these forward-looking statements as representing our views as of any subsequent date to today. There are more complete information about forward-looking statements, risks and uncertainties in the reports Provention Bio filed with the SEC. These documents are available on Provention Bio's website at proventionbio.com under the Investors section. We encourage you to review these documents carefully. I will now turn the call over to Ashleigh. Thank you, Heidy. Today, we are thrilled to share with you that the FDA has approved our CD3-directed antibody, teplizumab or TZIELD, as the first and only treatment to delay the onset of Stage 3 type 1 diabetes in adult and pediatric patients aged eight years and older with Stage 2 T1D. This is an historic day for the T1D community and for individuals who have or will develop Stage 2 disease. Sometimes referred to as juvenile diabetes, T1D disproportionately presents in young people, threatening and forever changing their lives and disrupting the lives of their families. Presently, there is nothing anyone can do to prevent T1D and there is no known cure. Distinct from type 2 diabetes, T1D is not a chronic metabolic disease. It is a serious autoimmune disease with dire metabolic consequences. We believe Stages 1 and 2 T1D are triggered weeks, months or sometimes years before diagnostic symptoms appear, a person's own immune system silently attacking the precious insulin-producing beta cells in their pancreas. By the time symptoms do appear, it is already too late, the person having insufficient beta cells remaining to effectively control blood sugar. Unlike kidney, liver and heart disease and an increasing number of cancers, screening for T1D in its early stages is not a standard of care in the United States. If chronic kidney disease went unscreened like T1D, people would find out they are sick the same day they need dialysis three times a week, every week just to stay alive. We can no longer allow this to happen with T1D and with the approval of TZIELD, the T1D community can now begin to catalyze the requisite paradigm shift in earnest. In approximately half of the 64,000 T1D cases diagnosed each year in the United States, patients present for the first time in diabetic ketoacidosis, a life-threatening metabolic crisis, often requiring emergency transport to a hospital, ICU admission to stabilize and monitor and all being well, referral out to an endocrinologist for a lifetime of insulin therapy with all its challenges and complications. While only 10%-20% of patients with type 2 diabetes use insulin to control their blood glucose levels, in order to survive, all people with Stage 3 T1D eventually require insulin replacement therapy, either via injection or insulin pump. Without insulin, people with Stage 3 T1D will die from high blood sugar levels. Over time, even short episodes of hyperglycemia can precipitate microvascular complications, including heart disease, kidney failure, lower limb amputations, blindness and nerve damage. Not just too little insulin but also too much insulin can be life-threatening, leading to dangerously low levels of blood sugar or hypoglycemia. People with Stage 3 T1D who are insulin-dependent must carefully and continuously balance insulin intake with eating, exercise and other activities. They also must measure blood sugar levels through finger pricks or by wearing a continuous glucose monitor. Bottom line, this serious disease, once it has progressed to Stage 3, can be both physically and mentally challenging, especially for a child or teenager and it never goes away. Targeting the CD3 receptor on T cells is thought to address an underlying cause of T1D autoimmunity, the autoreactive T cells that attack and destroy precious insulin-producing pancreatic beta cells. TZIELD was investigated in Stage 2 T1D patients in the pivotal TN-10 study conducted over several years by TrialNet and published in the New England Journal of Medicine in 2019. This study showed a median delay of 25 months in Stage 3 T1D onset as compared to placebo. The most common adverse reactions occurring during treatment and 20 days following administration being lymphopenia, rash, leukopenia and headache. The resulting median delay of more than two years in the onset of Stage 3 disease is a priceless therapeutic outcome for patients with Stage 2 T1D. Stage 2 patients can be identified by way of two straightforward tests conducted by clinicians. Firstly, readily available and relatively inexpensive screening to detect or confirm the presence of two or more T1D autoantibodies. Secondly, an oral glucose tolerance test to check for the early signs of poor blood sugar control or dysglycemia. As anticipated, the FDA's approval decision is accompanied by certain post-marketing requirements and commitments. In particular, we will be committing to setting up a registry to monitor TZIELD's long-term safety, as well as conducting a pediatric PK/PD and safety study in Stage 2 patients below eight years of age. In the United States, there are 1.8 million insulin-dependent Stage 3 type 1 diabetics. $16 billion in T1D-associated healthcare expenditures and lost income annually. Children diagnosed before the age of 10 have a reduction in life expectancy of 16 years. This is why the FDA's approval of TZIELD represents a truly historic, paradigm-shifting breakthrough in the management of adult and pediatric patients aged eight years and older with Stage 2 T1D, who now have a treatment to delay the onset of Stage 3 disease. We intend to help make TZIELD broadly available to these patients when prescribed our product. This is also why we are so excited to be joining forces with and working alongside Sanofi as we launch TZIELD in the United States, leveraging the outstanding reach and relationships of our partner's endocrinology and primary care-focused in-market infrastructure and customer-facing field teams, thereby significantly enhancing our ability to bring T1D autoantibody screening education and awareness, as well as TZIELD, to a greater number of Stage 2 T1D individuals. Before handing the call over to Jason to provide more details on our commercial launch, I would like to take a moment to acknowledge and thank, in addition to our Provention leadership team, colleagues, consultants and advisors, all the researchers, scientists, developers and investigators, especially Jeff Bluestone, Kevan Herold, MacroGenics, TrialNet and NIDDK. All the clinical trial participants and their families, the FDA and its reviewers and JDRF and other patient advocacy groups and champions who have, for more than two decades, tirelessly and selflessly contributed to the development and approval of this first and only therapy to address the underlying autoimmunity of T1D, thereby fundamentally changing the course of the disease rather than just treating its symptoms. Jason, over to you. Thanks, Ashleigh. We're both excited and proud to bring TZIELD to patients eight and older with Stage 2 T1D and are thrilled with the FDA's approval. We've been preparing for the FDA's approval of TZIELD in Stage 2 T1D for nearly three years now and we're well prepared to launch. Let me walk you through some of the details. We remain committed to the four strategic imperatives driving launch efforts that we discussed during our Commercial Investor Day back in May. One, advancing awareness and screening for autoantibodies in at-risk individuals and ultimately routine screening during pediatric well visits for the general population. Two, HCP belief in teplizumab and desire to prescribe it for their patients. Three, minimizing access and reimbursement barriers. Finally, ensuring that all customers have a positive and seamless experience with TZIELD. As we've described in previous calls, we have eight therapeutic specialists on board as a part of our pilot sales team initiated more than a year ago, alongside eight regional sales directors. These team members are standing by, completing their final day of training on the TZIELD prescribing information, nearly ready to be deployed into the field beginning on Monday to educate physicians at major centers of excellence and responding to unsolicited requests for education from healthcare providers. In addition, prior to FDA approval, we extended conditional offers to our remaining sales personnel to join our mission, which have been accepted by all 52 remaining therapeutic specialists. The team is completely staffed with high caliber salespeople from across our industry, with a cumulative total of 400 years of experience in endocrinology, 359 product launches and 97 product launches in rare disease among the team. We will begin to onboard our new team members during the month of December, alongside our new colleagues from Sanofi, with both teams deploying into the market to promote TZIELD in January. Following the FDA's approval, we've activated our COMPASS Navigator team to begin receiving and processing enrollment forms and they are now live. As you know, COMPASS is our in-house patient support program, with a staff of dedicated navigators available to answer questions and remove barriers for patients to access TZIELD by helping them navigate coverage and reimbursement. This includes administration of our co-pay assistance program for eligible commercially insured patients to address financial barriers to treatment, including costs for both TZIELD and its administration. Copies of our enrollment form, along with other helpful documents such as our COMPASS offering, billing and coding guide, sample letter of medical necessity and others, can be found under the COMPASS section of our TZIELD.com website that we plan to have fully operational next week. In parallel, our field market access teams are now ready to begin working with payers on getting medical policies developed in support of coverage for TZIELD, which we expect will happen in the next six-nine months and we still anticipate having drug in the channel by the end of the year. Today's news has been 100 years in the making. The type 1 diabetes community has been waiting since the introduction of insulin for a therapeutic advancement in the field. We are so incredibly excited to be able to announce that TZIELD has been approved by the FDA as the first disease-modifying treatment for Stage 2 T1D. TZIELD addresses the underlying cause of this autoimmune disease, delaying onset of the lifelong burden of clinical stage type 1 diabetes. While the onset of clinical or Stage 3 type 1 diabetes can occur at any age, we know most patients are diagnosed between the ages of 10 and 14. If you're diagnosed before the age of ten, your life expectancy is 16 years shorter than if you were diagnosed later in life. This is a disease that disproportionately affects individuals who should have their whole lives ahead of them without worrying about their own mortality with every meal, every activity and every night's sleep. When the disease arrives, it's very often a total surprise, appearing catastrophically for half of patients with a diabetic ketoacidosis event and days in the hospital, potential death. A single DKA event has a lifelong negative effect on the health of that T1D patient. Patients who are pre-symptomatic or Stage 2 can easily be identified through two simple blood tests. One checking for the presence of two autoantibodies and one that measures for dysglycemia. Today, children who are Stage 2 have a 75% risk of their disease progressing to Stage 3 within five years. Until now, individuals had no choice but to allow for this disease to progress and rob them of their freedom and independence. With today's approval, Stage 2 individuals have a chance at having more time. TZIELD is the first and only therapy indicated to delay the onset of Stage 3 type 1 diabetes for adults and pediatric patients eight and over with Stage 2 T1D. This would not have been possible without the clinical trial participants, caregivers, investigators and so many more we will be forever, ever grateful to. With this approval, we hope Stage 2 patients are more readily identified so the course of their disease can be changed. The Stage 2 T1D population is still a relatively small one and without broad population-based screening happening today. It will likely be the family members of T1D individuals who get screened and identified first and have the chance to get treated with TZIELD. We estimate that there are about 30,000 Stage 2 individuals with a family member with T1D in the U.S. today. We at Provention Bio are committed to changing the course of autoimmunity and we'll continue to work on bettering the lives of patients in the T1D community, the celiac community and in other autoimmune diseases. Today is a big step, a step the T1D community has been waiting for. We are Provention and we're not gonna stop here. We will continue to explore and develop TZIELD's potential in younger patients, newly diagnosed patients and investigate whether TZIELD could be either redosed or combined with other treatments for even greater benefit. That said, this indication is a major step forward, one that has the potential to save people years. How can one really value more time for a person, a child and their loved ones without the psychological and physical impact that comes with Stage 3 T1D diagnoses? For patients, it may mean more nights without worry, more time to be able to just be a kid, decreasing the risk of an emergency room visit related to DKA and more time dedicated to having fun with friends and family, potentially for years. We consulted with numerous stakeholders and did extensive research to try to put a value on what TZIELD means for patients and their families. Across the board, TZIELD was perceived to meet a great unmet need and deliver an impressive benefit on top of that. Considering the feedback from payers, KOLs, advocacy groups and others, as well as wanting to ensure patient access was optimized as much as possible, we landed on a wholesale acquisition cost per vial of $13,850, which translates to $193,900 per 14-vial continuous regimen. As is standard for body surface area-based drugs and weight-based drugs, some patients may require additional drug beyond the 14 vials. We believe that for the majority of patients, including those identified through familial screening and through general population screening in pediatrics, 14 vials will be sufficient. Our commitment to patients goes beyond the treatment itself because if the patient cannot access or afford TZIELD, we haven't done enough. We want every person who may benefit from TZIELD to have access to this important therapy. We've launched COMPASS, our patient support program with a staff of dedicated navigators to answer questions and help navigate reimbursement. For patients without insurance or those rendered uninsured that cannot pay for TZIELD, our patient assistance program may be able to help. Patients or providers who want more information can call COMPASS directly at 844-778-2846 or visit TZIELDHCP.com/patient-support. We've also made significant progress in our partnership with Sanofi since our co-promotion announcement in October. The core commercial and medical affairs leadership teams from Sanofi and Provention have been meeting regularly. As I've mentioned previously, our go-to-market strategy has always first focused on pediatric endocrinologists alongside high-decile adult endos and other specialties with a vested interest in T1D care. Our co-promotion with Sanofi allows us to immediately leverage Sanofi's 22 years in T1D and relationships with over 40,000 healthcare providers, including adult endocrinologists and primary care physicians, significantly expanding our reach during the launch. We look forward to working closely with physicians, patients, advocacy organizations and others to bring TZIELD to market. I'd now like to turn the call back over to Ashleigh. Ash? Thank you, Jason. Before we open the call for questions, let me touch on a few financial details. As of 30 September 2022, our cash equivalents and marketable securities position was $186.5 million. In October, under our co-promotion agreement with Sanofi, we received the $20 million non-refundable payment for the right of first negotiation exercisable through June 2023 to research, develop, manufacture and commercialize teplizumab globally in T1D. In addition, TZIELD's FDA approval triggers an obligation for Sanofi to make a $35 million investment in Provention common stock at 40% premium over the five-day volume weighted average price prior to a closing date at our discretion but no later than 16 February 2023. In addition, Provention now has the ability to draw down the next $40 million tranche under our Hercules term loan facility. When all of this optionality is taken into consideration, we believe Provention Bio is financially well positioned as we head into the launch and commercialization of TZIELD. I would now like to open up the call for questions. We'll now begin the question and answer session. To ask a question, you may press star then one on your touch-tone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we'll pause momentarily to assemble our roster. Our first question comes from Chris Howerton from Jefferies. Please go ahead. Excellent. Thank you so much for taking the questions. Ashleigh and team, congratulations on the approval. I'm sure it must feel great. I guess a couple questions for me. The first one that I would have, could you please just clarify what payments might be made to MacroGenics on the approval and, you know, how that considers into your cash needs moving forward for those, not only the milestone payments that I just described or mentioned, as well as kind of the commercial launch for Jason and his team? That's question one. Question two would be, you know, I guess, Jason, I would love to hear a little bit more in terms of any progress you've made on implementing autoantibody testing, you know, as your commercial efforts moving forward. How does that work within the pediatric endocrinologist office? Is that something that, I guess, your team can offer to them, something like that? I guess tactically, how does that work to increase the autoantibody testing? The third question, if you'll entertain it, just curious if you had any comments on the label, particularly around things like overlap between type 2 diabetes diagnosis and anything in the warnings and precautions. Thank you. Did you say type 2 diagnosis there, Chris? You know, I'm so sorry. What I meant was that in the dosage section of the label, it says just the clinical history needs to rule out type 2 diabetes and I was curious what the overlap was there in this pediatric population. Thanks. Okay. Thank you for the questions. Perhaps I'll ask Lenny to be ready to answer the question regarding type 2 overlap but as you'll appreciate, T1D autoantibody testing has been available for many years as a differential diagnosis for type 1, type 2 diabetes and therefore, the screening with those autoantibodies, in my estimation, removes the concern over type 2 diagnosis. I will let Lenny speak to that in a moment. Jason will answer your questions about autoantibody screening. Regarding MacroGenics, we have no updates today on payments. The payments are set out very clearly in our disclosures and attached agreements. We'll be providing an update on payments and on our cash position from the recently published earnings on our next earnings call. Let's go to Lenny next, please. Yes. Hi. Lenny Ramos here. As you might see in the label, the inclusion criteria or the eligibility criteria clearly states that these are individuals with an autoimmune background, meaning that they have developed two autoantibodies, T1D-related autoantibodies. Of course, the second part of that is the dysglycemia. Therefore, the label does state that the individuals who are eligible for this treatment should not be those who have a T2D type 2 diabetes diagnosis. Therefore it's an exclusion of these individuals by using the criteria for type 1. I believe the second question that you had and I might be able to address that, is the warnings and precautions. The information in our label is consistent with the clinical experience that we have through our 1,000-patient database, which includes the TN-10 participants and is consistent with discussions that we've had with the FDA, including what they have expressed during the outcome presentation in May of last year. This is all consistent with what we have seen and reported. Thanks, Lenny. Jason, screening? Yeah, thanks for the question, Chris. You know, obviously screening is critical to this launch. As we've mentioned on calls previously, you know, irrespective of the audience that we talk to in qualitative or quantitative research, whether it be healthcare providers or patients and caregivers, the primary barrier to acceptance of screening was the lack of an intervention. Today that all changes, right? You know, we know that these tests are readily available through commercial labs like Quest and Labcorp. We know that they're also reimbursed. If you look at Labcorp's own T1D website, you'll see that they show statistics about their autoantibody panel and that 98% of patients who get the autoantibody panel have an out-of-pocket cost of $25 or less. That 65% of those patients have an out-of-pocket of $0. We know that the test is both available and, you know, will be in more demand now that there's an intervention that can address the problem that is ultimately being screened for in Stage 2 type 1 diabetes. You know, lastly, if patients have reluctance in going to the physician or to a phlebotomist, this can be done from the convenience of their own home through a program that JDRF launched in late 2020 called T1Detect. That we were proud to be the founding sponsors of, that brings dry blood spot technology into the patient's home to complete an autoantibody panel. I think, you know, we will see an increase in screening based on everything we've heard in this market now that there's an approved intervention. Okay. Thanks. All right. That's very good. And Ashley, if you'll let me just clarify. So I guess the real question is, you know, i-is there any concern that you might do an o r maybe I'll just say it. There's concerns from investors that you might have to do an equity raise to satisfy both the milestone payments and the commercial launch. So I guess, could you please just address that concern? I think I set out tremendous optionality and we will explore the options as we go forward from this point. We start with funds coming in from the Sanofi investment, which is now triggered. We can call down funds from our Hercules loan facility. We have 100 and, think it was, $86 million in cash at the last earnings report. We will, you know, move forward as those options unfold and opportunities present. Thierry, maybe you just want to speak to the cash runway that we presented in the quarter three earnings in terms of how much cash we have to, you know, how long it will last under the commercial launch scenario. Thierry? Yeah. Thanks, Ashleigh and thanks Chris for the question. Yes, indeed, we have mentioned in our Q3 earnings, right, that with the investment available from Sanofi, the $35 million in equity at a 40% premium, as well as with the second tranche of $40 million on our debt with Hercules, we will be able to fund the launch and have cash runway through 2023. As Ashleigh was saying, we're looking at all the options. We believe that with this cash runway through 2023, it gives us time and flexibility around also securing additional capital. We expect to have options around the type of capital we may be able to access, including also non-dilutive sources of capital. I'll remind you also that we have just over $100 million of available capacity on our ATM program. That's not included in that. We're not assuming that we will be using this to meet our cash runway target through 2023 but this is obviously another tool that we have available. We're evaluating all the options and we'll make decisions based on what is in the best interest of our company and our shareholders. Awesome. Well, I really appreciate you taking all the questions from me and I do wanna end with the congratulations that this is awesome. Thanks. The next question comes from Justin Kim from Oppenheimer & Co. Please go ahead. Hi, good morning. Let me add my congratulations on yesterday's approval as well. You know, just maybe on the topic of regulatory interactions, you know, with the formal approval in hand, just wondering if you could discuss any details on how you think about expanding the label to Stage 2 patients below eight years of age and broadening potentially the setting of TZIELD treatment outside of the hospital. Thank you very much for the question. I'm gonna hand over to Lenny because yes, that is now a very exciting focus for this company. While Jason and Sanofi move forward with the launch, you know, the other half of our organization that has brought TZIELD to this point will be moving on to the post-marketing commitments and requirements, to the top-line results of the PROTECT study, which reads out in the middle of next year, which is an indication, a label potential indication expansion if those results are favorable and we submit a follow-on regulatory filing. They move on to the prospect of investigating redosing, investigating other stages of the disease and the prospect of combining teplizumab with other immunomodulatory agents but also with cell therapy and the prospect of collaborating with a company that is focused on beta cell transplantation in order to, you know, address the substantial unmet need of patients that have established type 1 diabetes and too little of their beta cells remaining to manage their daily blood sugar. Lenny, do you wanna specifically talk about the expansion or the commitment that we have to the pediatric population below the age of eight with this specific indication in Stage 2? Yes, happy to Ash. We do and as you might imagine, the patients below the age of eight is a very, very important population to address. Now as they're kind of finishing our activities in completing the BLA submission and getting the approval, we will be working with the agency to understand the design of that study and how we're going to execute on that to be able to have this product available for those younger kids. I do want to mention, because you asked about moving out of hospital, the administration of the teplizumab has always been in an outpatient setting. These individuals are never hospitalized. They do not need to be hospitalized. We envision that this will continue while we are now in the commercial space. Okay, great. Maybe just a commercial question for Jason. You know, in terms of the sort of list price, you know, curious, you know, how to think about COGS and sort of, you know, that 14-day cycle and how we should sort of be doing the modeling around that potentially. Jason can certainly address the pricing but cost of goods was not factored into the pricing calculations in the sense that the pricing was set based on the value that TZIELD brings to patients. You know, it was ranked exceedingly high across the full spectrum of payers, healthcare providers and patients from a perceived benefit point of view. That is what drove the pricing decision. Cost of goods certainly is a competitively sensitive parameter that companies don't usually provide publicly. You know, in this instance, it's not really a factor. Certainly, you know, pricing is supporting the substantial acquisition cost and the development costs to date as well as those going forward. You know, we certainly believe that it's a very commercially viable equation, you know, for the company. Jason, do you wanna add anything to that? No, the only thing I would add Justin is just a reminder. Going back to mid-May when we had our Commercial Investor Day, we talked about the distribution model that we had put in place for teplizumab and that distribution model is now operational. We have one specialty distributor in Cardinal Health. We've got two specialty pharmacies in Orsini and Amber. They are both ready to go. Both of the two specialty pharmacies have pediatric and adult home infusion capabilities in all 50 states. To Lenny's point, to date, all of the infusions have been done in an outpatient setting in the hospital. We anticipate that that's where they're gonna start, whether it be in a hospital or in an outpatient infusion center. As clinicians get experience treating patients and see how teplizumab is infused in their own patients, they'll have the option out of the gate of going to home infusion whether it be to the hybrid model where they start in an infusion center and then transition home. At the same time, you know, all 14 days of home infusion will be available. We just don't think that will be utilized until the clinician audience has experience in using teplizumab. The next question comes from Thomas Smith from SVB Securities. Please go ahead. Hey, guys. Good morning. Thanks for taking our questions and let me add my congrats on the approval. M aybe just on pricing just to follow up on the previous question. So wondering if you could elaborate a little bit on some of the factors that went into determining the wholesale acquisition cost pricing. I s there any early color you could provide in terms of what we could expect on gross to net adjustments? And then I know you guys had control over the commercialization and certainly the pricing aspects. Can you just talk to how much feedback or input Sanofi had with respect to the pricing? Thanks, Tom. Good morning. This, as our previous disclosures presented was very much Provention's decision. We've been working on pricing now for many, many months and presented a lot of the market research at that investor event back in April, May. The elements obviously, you know, Jason described those in the opening statements. The elements were the value that's perceived. This is not another symptomatic monoclonal antibody that's treating symptoms better than the previous one. This is a game-changing breakthrough innovation that brings a therapy to Stage 2 type 1 diabetes patients that previously had no option other than to wait for the progression of the disease. Combining all of that value that teplizumab is anticipated to deliver to optimize the price with respect to making this broadly available to as many patients who are eligible as possible. Jason, do you want to answer the other question, the other elements of the question? Yeah, absolutely. Thanks for the question, Tom. You know, just again, I'll remind you of a slide that we showed during our Commercial Investor Day back in May that highlighted the perceived clinical value of teplizumab from our pricing research across multiple stakeholder audiences, right? It's important to note that our pricing research included both payers, KOLs, advocacy organizations, as well as pediatric and adult endocrinologists in a quantitative piece of that study. The payers themselves, on a scale of one to five being a major clinical value of teplizumab in the Stage 2 indication, one being none, payers came in at a 4.2, right? Payers both understand the unmet need associated with Stage 2 type 1 diabetes and how teplizumab meets that unmet need. Our pricing decision was primarily driven by two factors, a price point that reflects the innovation and value that we're bringing to the Stage 2 type 1 diabetes market and frankly, a price that will optimize access for patients that we're all here to serve. When we tested this price point with payers, we found that the majority of payers told us they would anticipate covering teplizumab at this level with a prior authorization to label, with some indicating a prior authorization to the trial age group and potentially in some cases, to the inclusion/exclusion criteria, which are consistent with our labeling to begin with. We feel really confident that this price point reflects both the value and innovation that we're bringing to this market that's had nothing. It will optimize the access for patients just based on the feedback that we've heard from payers on how they would anticipate covering this drug. Okay, great. Got it. Yeah, I appreciate all the color on the thought process there. I guess just in trying to get a sense on early demand, maybe can you just remind us of the number of clinical centers that are involved in the teplizumab clinical program and have experience administering the drug? I know it's been, you know, less than 24 hours here but we've seen, you know, quite a bit of enthusiasm from the type 1 diabetes community around the drug. Can you just speak to some of the early anecdotal inbound feedback and maybe some of the early signs of demand? Yeah. Thanks, Tom. You know, what we have had in the field now for well over a year is a pilot sales team that has been scoping out the market space and collecting information and preparing, you know, our plan to launch. I think, Jason, you feel very comfortable that we have a good handle on the centers of excellence that might be first out of the gate. Jason? Yeah, absolutely, Tom. You know, I think the team's been out there for over a year and have done, you know, with a relatively small infrastructure, have really done yeoman's work in getting out to the major centers of excellence around the country and have a really good handle on which centers have the capacity infrastructure right now that are essentially ready to go right out of the gate. That's where they're gonna be focused over the next six weeks while we're in training with the rest of our team and our new colleagues from Sanofi. You know, it's gonna be a local activation, as I've mentioned before, right? We know that these centers of excellence, like we had on our Investor Day back in May, we had a KOL from the Barbara Davis Center who told us how she had over 50 Stage 2 patients that they were following and over 100 Stage 1 patients. It's gonna take this team getting into those accounts and activating those accounts to make the calls as, you know, Doctor Kimber Simmons had indicated that they had intended to do at the Barbara Davis Center once there was an approved treatment. They're gonna be out there. We've already got our first appointments lined up as soon as Monday. Our COMPASS Navigator line is now active and I can tell you we've already received our first phone calls. We are incredibly enthusiastic with the response that we're hearing from advocacy groups, what we're seeing on social media, press releases that are put out by the likes of JDRF Beyond Type 1, major groups in the space, as well as the physician society. The ADA put out a really nice statement on the approval of teplizumab as well. We couldn't be more thrilled with the stakeholder audience's response to the approval of teplizumab yesterday. The next question comes from Prakhar Agrawal from Cantor. Please go ahead. Hi. Good morning and thanks for taking my questions. Congrats on the approval. Very exciting news for everyone, Ashleigh and team. First question, following up on pricing, definitely looks a little higher than our expectations. Just curious as to, did the newly diagnosed indication factor in your pricing assessment? Because as I understand, the newly diagnosed indication is two courses, 24 vials, so it could be almost double the pricing. Just wanted to better understand if that indication was part of your pricing assessment. I had a couple of follow-ups. Yeah. Thank you for the question. We price therapies based on the approved therapy we have in front of us and the indication that we have. The newly diagnosed indication is a blinded study. It is yet to be unblinded and evaluated and assessed as to whether it will become an indication and everybody understands the risks associated with, you know that phase III development. We have not factored in the Stage 3 new onset indication in the pricing that we have set for the Stage 2 T1D patient population. Got it. Thanks, Ashleigh. Following up on commercial, will the initial few years uptake be mostly from the familial segment or do you expect some uptake in the non-familial segment as well, which is obviously a much larger addressable market? Like what do you think will take for a much stronger uptake in the non-familial segment? Is it mostly broad-based screening or are there other factors that we should think about? Thank you. Yeah. Again, great question. This is obviously the challenge when you have a nascent market is we're building a patient population that doesn't exist yet. The familial screening is much more straightforward. With the availability of a therapeutic that can now intersect the progression of the disease for eligible patients that are found to be in Stage 2, I believe that that screening, you know, will accelerate. Now also Jason, his team and our Sanofi colleagues, you know, have to work to change guidelines for general population screening and find other ways in which we can access the general population Stage 2 patients that do not have a T1D connection. Jason, do you want to talk about some of the initiatives there? Yeah, absolutely. Thanks for the question, Prakhar. You know, when we think about this, we've been saying for quite some time now, you know, our intent is that this launch will really happen in two phases, right? The early days of launch will be primarily focused on those relatives, that 30,000 patient addressable market that we've talked about extensively and you referenced. That's largely driven by the fact that it's a group that's easily reached because of the relative with type 1 diabetes that clearly understands the impact and the highs and lows associated with insulin dependence, given that they have a family member with this disease. Lastly, it's a group that by screening these individuals, you're enriching the pool of patients that you're ultimately screening for. Now, beyond that, obviously to get to the other 85% of this addressable market, we really do need to implement routine screening during pediatric well visits. There's recent literature that really supports that, you know, at different ages during a child's maturation, during routine pediatric well visits, if you screen for autoantibodies, you can pick up the vast majority of early-stage type 1 diabetes. Our intent is to continue to partner with groups like JDRF, the ADA, public policy experts, KOLs in the space to make sure that this becomes a reality in the United States. That'll take a little bit of time and that'll be kind of the wave 2 of the launch, so to speak. If you look at some of the comments that came out yesterday after we announced the approval from advocacy groups, there's a message in there talking about how enthusiastic they are about implementing population-based screening. The enthusiasm among the core stakeholders is there and now there's an approved treatment in the market that ultimately addresses the problem that we're screening for. We're gonna be working diligently to work with those stakeholders across the T1D ecosystem to make that a reality in the United States. We're not starting from zero right, Jason? There are some general population screening programs already up and running in the United States, the ASK program, around Barbara Davis, I think Sanford. We're not where Nordic countries are, like Finland, where autoantibody testing is part of a routine, you know, checkup during wellness visits for children under the state, you know, government system. We're also not starting from zero. Is that right? Yeah, that's 100% right, Ash. There are many localized population-based screening efforts that show a lot of consistency in the data in screening those early-stage patients and finding and being able to reduce the presentation in diabetic ketoacidosis, which in and of itself makes screening cost-effective. The next question comes from David Hoang from SMBC. Please go ahead. Hey. Good morning, everybody. Let me also extend my congrats on this great approval and thanks for taking the question. I just had a few here. With the pricing, can you remind me if there is any rebating expectations built into that? Should we be considering some level of rebates with just factoring into the gross-to-net? Jason, do you wanna speak to rebating? Yeah. David, it's a great question. We don't anticipate commercial contracting. Obviously, we have the standard 23.1 for government reimbursed patients but that would be the extent of the contracting that we anticipate. Our next question comes from Geulah Livshits from Chardan. Please go ahead. Hi. Good morning. This is Chloe on for Geulah. Thanks for taking the question and congrats on the approval. We're wondering here what additional avenues you're prioritizing at this point to broaden the label to autoimmune indications Beyond Type 1 diabetes. If you could comment on whether there's anything in the post-marketing requirements relating to CMC and manufacturing. Thanks. Thank you. There are some CMC manufacturing post-marketing commitments and requirements there, as we have previously disclosed and reported and well within, you know, our means to be able to deliver on those. They pertain to things like improvement of assays and so on and so forth for establishing stability and release criteria. I'm sorry, Chloe. I forgot your first question. Chloe, are you still there? Yes. Oh, sorry, I was muted. No, the first question was just how you're thinking about prioritizing broadening the label Beyond Type 1 diabetes to other autoimmune indications. You touched briefly on that in the comments but I was wondering if you would elaborate a little bit more. Yes. No, we're looking forward in the new year to set out our development plans for teplizumab in investigating other indications outside of T1D, for example, celiac disease. As you know, the company has a really good background and history in celiac therapeutic development and that's certainly one of the opportunities that we feel is a high priority. Gonna ask Francisco if he would like to speak any more regarding the ranking of opportunities that he sees for teplizumab's development outside of T1D. About half of all of the key autoimmune diseases are driven primarily by T cells. Celiac certainly is a part of our immunity. As Ashleigh mentioned, it would be a great place to start to expand our indications. We already have also proof of concept in psoriatic arthritis, so there's a lot of potential outside of T1D. The next question comes from Gregory Renza from RBC Capital. Please go ahead. Hey, good morning, Ashleigh and the Provention team. Let me add my congratulations and thank you for taking my questions. Ashleigh, just a question on commercial and implementation maybe best suited for Jason. Certainly a really nice label. When it comes to the 14-day treatment course, just noting that the label does allow some amenability on dose interruption and resuming those over missed days. My question is essentially just around your potential operational messaging or guidance with respect to centers. Will you be supportive of that flexible dosing missing days or will you be more preferring of the consecutive 14-day treatment course, certainly the weekend interruptions that we have spoken about? If there's any early read-through on efficacy with respect to missed dosing, it would be helpful to hear too. Thank you. Yeah. Thanks very much, Greg. Actually, I'm gonna turn that question over to Lenny because, you know, our guidance in the market space will be in strict adherence to the label. I know that Lenny in interactions with the FDA has been evaluating the prospect of a missed dose. I think, Lenny, you're best to answer the question. Thanks, Ash. Hi, Greg. Yeah. First and foremost, we definitely would like the patient to be able to complete, excuse me, all 14 doses. We recognize some may have circumstances that would dictate missing doses. The label has language to indicate that patients, if, when they're able to continue, they should just continue and finish the 14-day treatment course. This is a decision that the patient and the healthcare provider will need to make with respect to when to resume that dosing. The ideal situation is that they complete the 14 days of treatment. The next question comes from Ram Selvaraju from H.C. Wainwright. Please go ahead. Thanks very much for taking my questions and I'll add my congrats to the cavalcade here. Very nicely done. Just two questions regarding pricing. One is with respect to the possible application of value-based pricing paradigms in the context of the rollout of TZIELD and what implications, if any, you think this may have or if it's really too early to tell. Secondly, if you can comment, you know, if there are any implications of the U.S.-based pricing on perspectives for how the drug might be priced in ex-U.S. markets, most notably in Europe. Thank you. Thanks, Ram. So, you know, obviously, we we're focused on the US and the US launch and the value-based pricing here we will perhaps with our partner, our co-promotion partner Sanofi that has a right of first negotiation, as you know for the rights to commercialize and manufacture and develop teplizumab outside of the U.S.. Be exploring with them, the commercial strategy there. W e look to them if they are successful in negotiating those rights to guide and advise us. We could not have or wish for a better partner in that regard as that story unfolds, hopefully next year. Now we have the U.S. regulatory approval. Jason, do you wanna talk about the first question, value-based pricing and the impact that it might have on the rollout of TZIELD? Yeah. Thanks for the question, Ram. You know, I don't anticipate that we will be doing any commercial contracting at this point. You know, I think, you know, given the strategy that we had in pricing this drug, we priced it for the two reasons that I had mentioned earlier, right? Both wanting to optimize patient access to the drug and also reflecting the innovation and value that we're bringing to the market and we feel that this price point does exactly that. Don't anticipate contracting outside of, you know, mandatory 23.1 that we would have with Medicaid. This concludes our question and answer session. I would like to turn the conference back over to Ashleigh Palmer for any closing remarks. Well, thank you very much and thank you all for joining our call today. In closing, please allow me a moment to thank all of my Provention colleagues, past, present and future, as we continue our mission to disrupt the way in which patients with serious autoimmune diseases are currently underserved by our industry and medical systems, as we directly change their world and in so doing, indirectly change our own. My deep gratitude and appreciation goes to my co-founders, our executive team, all our people leaders, team members and their families and loved ones, our board members, all our strategic partners, especially our colleagues at Sanofi, all the patients, investigators, support staff and caregivers who have participated in our clinical trials and of course, our shareholders. Thank you all for your hard work, your long hours and your substantive contributions. We look forward to keeping you updated regarding our continued progress. Please enjoy the rest of your day. Conference has now concluded. Thank you for attending today's presentation. You may now disconnect.