Thank you for standing by, and welcome to the Reata Pharmaceuticals SKYCLARYS FDA-Approved Conference Call. An audio recording of today's webcast will be available shortly after the call in the investor section of Reata's website at reatapharma.com. Before the company proceeds with its remarks, please note the forward-looking statements disclosure in the company's press release. There are many factors that could cause results to differ from expectations, including those noted in the company's SEC filings. Today's statements are not guarantees of future outcomes. Please also note that any comments made on today's call apply only as of today, February 28th, 2023, and may no longer be accurate at the time of any webcast replay or transcript rereading. Following the prepared remarks, we will open the call up for questions. We ask that you please limit yourself to one question and one follow-up so that we can accommodate as many questions as possible. We are joined today by Warren Huff, Reata's Chief Executive Officer, Manmeet Soni, President, Colin Meyer, Chief Innovation Officer, Dawn Bir, Chief Commercial Officer, and Seemi Khan, Chief Medical Officer. At this time, I'd like to turn the call over to Warren Huff. Good afternoon, everyone. This is a very exciting day, we thank you for joining us. I'll begin on slide four. Since Reata's founding in 2002, our mission has been to change patients' lives for the better by developing therapeutics with novel mechanisms of action and the potential to have high clinical impact on life-threatening diseases that have few or no approved therapies. Earlier today, we announced that the FDA has approved SKYCLARYS as the first and only FDA-approved drug indicated for the treatment of Friedreich's ataxia, or FA, in adults and adolescents aged 16 years and older. For these FA patients, treatment with SKYCLARYS demonstrated significantly less impairment over time and represents a major step forward for those living with this devastating and progressive neuromuscular disease that, until today, had no approved treatments. With this approval, we're pleased to announce that the FDA also granted a rare pediatric disease priority review voucher. The approval of SKYCLARYS is a historic milestone for FA patients and their families, as well as the FA support community. It is also an important milestone for Reata because it is the culmination of more than 15 years of scientific research and clinical development on our Nrf2 platform, conducted by our team and our collaborators to bring this important first therapy to FA patients. It's gratifying to have received this approval on Rare Disease Day that underscores the progress that has been made by many patient groups, researchers, investigators, regulators, and others in the development of therapeutics for rare diseases. In that regard, I'd like to thank the Friedreich's Ataxia Research Alliance, FARA, for their critical help with our development program. FARA and its researchers identified Nrf2 as an important therapeutic target in FA. They did groundbreaking work on FA clinical endpoints and collected critical natural history data on the disease. They helped us design and conduct our FA clinical trials, aided us in data interpretation, and provided important patient and investigator perspectives to us and to the FDA. I'd also like to thank the FDA. The FDA played an important role in the development of SKYCLARYS by working with FARA to develop clinical endpoints for FA clinical studies, providing us with important guidance regarding the design of our pivotal study, as well as the design and data analysis of our long-term extension study, and performing a thoughtful review of our NDA. Finally, I'd like to thank the patients and their families for participating in our clinical trials and the FACOMS natural history study. We know that participation in these clinical programs places a heavy burden on FA patients and their families, often with no expectation of direct benefit to the participant. Next slide. Looking ahead, over the past several months, we've been actively preparing for the commercial launch of SKYCLARYS. We are very pleased with the SKYCLARYS label, which provides that SKYCLARYS is indicated for patients with Friedreich's ataxia that are 16 years old and older. We believe that the prescribing information provides physicians the safety and efficacy information they need to prescribe SKYCLARYS. There are no contraindications or limitations based on pes cavus status, cardiovascular status, ambulation status, high or low mFARS score, or older age. There are no box warnings. Colin Meyer, our Chief Innovation Officer, will provide more detail concerning the prescriber information in a moment. We understand that in some patients, symptoms of FA manifest early in life, and SKYCLARYS is not currently indicated for patients younger than 16 years of age. Addressing this is our top priority, and we are planning to engage with the FDA about possible label expansion for pediatric patients younger than 16 years of age. As Seemi Khan, our Chief Medical Officer, will discuss, we received full approval for SKYCLARYS and FA, and we finalized our post-marketing commitments and are preparing to meet those commitments on a timely basis. Our medical affairs team is in place and prepared for the launch of SKYCLARYS. As Dawn Bir, our Chief Commercial Officer, will discuss, our commercial team is hired, and they're prepared for the launch of SKYCLARYS. This includes our sales leadership team, the field sales team, the payer team, and the field reimbursement managers. Importantly, we are committed to ensuring that patients have access to our therapies. Patient access is fundamental to our SKYCLARYS launch strategy, as Dawn will discuss in a moment. Regarding our plans outside the United States, I'm pleased to announce that we submitted our marketing authorization application for Omav for the treatment of patients with FA to the European Medicines Agency in the fourth quarter of 2022. We look forward to working with the European agency during their review of our application. Reata's commitment to patients is to bring life-changing medicine to those who need them the most. We plan to continue to focus our Nrf2 activator platform on devastating neurological diseases with limited or no therapeutic options, and to pursue programs that have the potential to produce meaningful clinical impact for these patients. Manmeet Soni, our President, Chief Operating and Chief Financial Officer, will provide an overview of our operations, strong balance sheet, and non-dilutive financing options. I'll now turn the call over to Colin Meyer to review the now approved SKYCLARYS label. Thanks, Warren. I'll be on slide seven. FA is a relentlessly progressive and debilitating neuromuscular disorder, which affects approximately 5,000 diagnosed patients in the U.S. FA is a hereditary disease caused by the silencing of frataxin, which leads to impaired mitochondrial function and energy production. Patients with FA typically become dependent on walkers and then wheelchairs in their mid-20s, and unfortunately pass away from the disease in their mid-30s. However, as of today, SKYCLARYS is the first approved drug for these patients. Slide eight provides an overview of the prescribing information. SKYCLARYS is the first and only drug indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 and older. The label is very informative, will help guide healthcare providers to treat patients with FA, and we are very pleased with it. The recommended dosage of SKYCLARYS is 150 mg taken orally once daily. The label contains recommended dose adjustments for patients with hepatic impairment and those taking CYP3A4 inhibitors and inducers. There are only three warnings and precautions: elevation of aminotransferases, elevation of B-type natriuretic peptide or BNP, and lipid abnormalities. They each provide healthcare providers with clear monitoring instructions which are not burdensome. I will discuss the details on the next slide. The most common adverse reactions with SKYCLARYS treatment, with an incidence of at least 20% and greater than placebo, are elevated liver enzymes, headache, nausea, abdominal pain, fatigue, diarrhea, and musculoskeletal pain. Contraindications can be included on the label if the FDA determines that certain patients should not have access to a drug because the risk from use clearly outweighs any possible therapeutic benefit. Our label has no contraindications, meaning healthcare providers are not prevented from prescribing SKYCLARYS to their patients due to their underlying disease characteristics or comorbidities. For instance, patients with or without pes cavus or high-arched feet will be able to access SKYCLARYS. Patients who are ambulatory or wheelchair-bound will be able to access SKYCLARYS. Patients who have pre-existing cardiovascular disease, including cardiomyopathy, which is common in FA patients, will also be able to access the drug. There are no restrictions for older patients, such as those older than 40 years, or mFARS scores, including high and low scores. Our label does not include a boxed warning, which is the FDA's most stringent and highest safety-related warning for drugs. It is used to alert healthcare providers and patients to serious or life-threatening side effects. The SKYCLARYS label does not include a risk evaluation and mitigation strategy or REMS. A REMS is a drug safety program that the FDA can require for medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. Slide nine highlights the warnings and precautions on the label, which, as I mentioned, include elevation of aminotransferases, elevation of BMP, and lipid abnormalities. ALT, AST, and total bilirubin should be monitored prior to initiation of SKYCLARYS every month for the first three months of treatment and periodically thereafter. If transaminases increase to levels greater than 5 x the upper limit of normal or greater than 3 x the upper limit of normal with evidence of liver dysfunction, SKYCLARYS should be discontinued and liver function tests repeated as soon as possible. If transaminase levels stabilize or resolve, SKYCLARYS may be reinitiated with an appropriate increased frequency of monitoring of liver function. BNP should also be evaluated prior to initiation of SKYCLARYS, and patients should be monitored for signs and symptoms of fluid overload. Management of fluid overload and heart failure may require discontinuation of SKYCLARYS. If signs and symptoms of fluid overload develop, evaluate BNP and cardiac function and manage appropriately. Finally, lipid parameters should be assessed prior to initiation of SKYCLARYS and monitored periodically during treatment. Any lipid abnormalities should be managed according to clinical guidelines. Regarding safety on slide 10, SKYCLARYS has been evaluated in 165 patients with FA, including 137 patients who are exposed to SKYCLARYS for at least 48 weeks and 125 patients who are exposed for at least 96 weeks, including during the open label extension. Generally, SKYCLARYS was well tolerated in the MOXIe Part 2 study. AEs were generally mild to moderate in intensity. Four or 8% of SKYCLARYS patients and two or 4% of placebo patients discontinued the study due to adverse events. The table on the right of this slide shows the adverse reactions that occurred in at least 10% of patients treated with SKYCLARYS and more frequently than in placebo-treated patients. Next slide. On the next few slides, I will review the clinical efficacy and safety data from the pivotal study MOXIe Part 2, which was the primary evidence supporting the approval of SKYCLARYS. I will also discuss the extension data which also supported approval. MOXIe Part 2 was a double-blind, placebo-controlled, randomized international study and was one of the largest global interventional studies ever conducted in FA. The study enrolled 103 FA patients aged 16 years- 40 years across a wide range of disease severity. Patients were randomized evenly to either 150 mg of SKYCLARYS or placebo for a duration of 48 weeks. The pre-specified primary analysis population or full analysis set included the 82 patients who did not have severe pes cavus. As I mentioned earlier, pes cavus is the medical term for a high-arched foot, and most FA patients have some form of pes cavus. The primary analysis patients included patients with pes cavus, yet we excluded patients who had severe manifestations leading to complete loss of lateral support of the feet. We prospectively defined and analyzed the primary analysis population of 82 patients as well as the all randomized population of 103 patients. The status of FA patients over time is measured in clinical studies by the Modified Friedreich's Ataxia Rating Scale or mFARS, a physician-assessed neurological exam. This was the primary endpoint for the trial at week 48. The mFARS consists of four domains to evaluate bulbar function or speech and swallowing, upper limb coordination, lower limb coordination, and upright stability. A lower score on the mFARS score signifies lesser physical impairment. Based on the FACOMS natural history study, a 2-point difference in mFARS represents 1 year- 2 years of progression. Moving to slide 12. SKYCLARYS is the first drug to demonstrate a clinical benefit in patients with FA. MOXIe Part 2 met its primary endpoint. Treatment with SKYCLARYS resulted in statistically significant lower or improved mFARS scores compared to placebo at week 48. Patients treated with SKYCLARYS experienced on average an improvement compared to baseline, whereas patients who received placebo worsened. Overall, the placebo-corrected difference between the two groups was -2.41 points with a p-value of 0.0138. Additionally, the all randomized population, which included patients with severe pes cavus, demonstrated a statistically significant placebo-corrected improvement in mFARS favoring patients who received SKYCLARYS. Treatment with SKYCLARYS resulted in less physical impairment over time. Next slide. To provide additional clinical evidence in support of SKYCLARYS's approval, we performed a post-hoc propensity-matched analysis of the MOXIe extension data compared to the largest, most robust FA natural history study, FA-COMS. FA-COMS is a global multi-center longitudinal prospective observational study that has enrolled more than 1,250 patients. Clinical outcome measures, including mFARS, are assessed annually, and patients are followed for up to 25 years. Patients from FACOMS were matched to MOXIe extension patients using propensity scores based on five covariates, including sex, baseline age of FA onset, baseline mFARS score, and baseline gait score. Selection of these covariates was made in collaboration with the principal investigator and statistician for FACOMS based on clinical relevance, the relevance as prognostic indicators for disease progression, and availability in both studies. In this post-hoc propensity-matched analysis, lower or improved mFARS scores were observed in patients treated with SKYCLARYS after three years relative to a matched set of untreated patients from a natural history study. These exploratory analyses should be interpreted cautiously given the limitations of data collected outside of a controlled study which may be subject to confounding. In summary, the data from MOXIe Part 2 and the extension study showed that treatment with SKYCLARYS resulted in less physical impairment over time for patients in this relentlessly progressive disease, which now has its first available FDA-approved therapy. With that, I will now turn the call over to Seemi. Thanks, Colin. I'll continue on slide 15. The FDA granted full approval to SKYCLARYS, a post-marketing confirmatory study is not required. We have agreed to several post-marketing requirements. The first is to conduct a clinical drug-drug interaction study to determine the effect of concomitant administration of moderate CYP3A4 inducers on the pharmacokinetics of SKYCLARYS in healthy volunteers. Secondly, we will conduct a QT study to assess the risk of QT prolongation with SKYCLARYS. Third, we will conduct a study to assess the concentration of SKYCLARYS in breast milk. Fourth, we will conduct a global descriptive study to collect prospective and retrospective data in women exposed to SKYCLARYS during pregnancy and lactation to assess risk of maternal and fetal or neonate complications. Finally, we have agreed to conduct additional non-clinical studies. Next slide. Beyond our post-marketing requirements, we will be sponsoring a voluntary post-marketing prospective observational multinational registry study of patients treated commercially with SKYCLARYS. The primary objective of the study is to evaluate the long-term safety of SKYCLARYS in FA patients in the real-world setting. Next slide. Turning to our pharmacovigilance and medical affair activities, we have established the infrastructure necessary to support our pharmacovigilance and safety obligation for SKYCLARYS in the United States. We have a medical information call center that has been established and is now active. We have optimized our medical affair growth structure and strengthened our medical science liaison team to support SKYCLARYS launch. We have expanded and refined our medical affairs strategic and tactical plans and our data generation, dissemination, and publication programs. I will now turn the call over to Dawn. Thanks, Seemi. Good afternoon, everyone. I'll begin on slide 19. Friedreich's ataxia is an ultra-rare, debilitating neuromuscular disease impacting a very small patient population. Like many other diseases without therapeutic options and limited drug development, FA is a disease that many outside of neurology have never heard of. FA strikes the young and vulnerable at a time when kids are just kids, enjoying sports, friends, school, and perhaps thinking about college. This serious and devastating disease slowly robs patients of full independence, their ability to walk, speak, perform normal daily activities, and all too soon, their lives. Until today, only palliative and symptomatic treatment was available. Next slide. FA represents a significant commercial opportunity. In the U.S., there are approximately 5,000 diagnosed FA patients today that can be linked to healthcare providers, of which an estimated 4,500 or 90% represent our total on-label addressable market. This number excludes the approximately 10% of diagnosed patients under the age of 16. Additionally, we see that about 2,500 unique patients with FA were seen by a neurologist or other HCP in the last two years. Much of the FA patient community is engaged, connected, well-informed, and motivated. Now, with the first approved drug indicated for patients with Friedreich's ataxia, we expect that many patients will return to their physicians for treatment. Next slide. We are pleased to introduce SKYCLARYS, the first and only approved drug for FA in adults and adolescents 16 years of age and older. Our commercial launch strategy engages our three key launch stakeholders: HCPs currently treating Friedreich's ataxia, on-label patients diagnosed with FA, and the payer community. With our attention on physicians currently treating patients with FA, our objective is to communicate the value of SKYCLARYS, the significance of our clinical data, and how this data translates to a clinically meaningful impact on the disease. FA patients and caregivers have created a well-connected community. Because SKYCLARYS is the first and only drug approved for Friedreich's ataxia, we will work to inform and educate patients and their families on the approval and encourage them to see their healthcare provider. Lastly, and core to our promise to patients, we will facilitate coverage, access, and affordability through payer education and our robust programs designed to minimize or eliminate patient out-of-pocket cost burden. Turning to slide 22. Because there has been no FDA-approved drug for Friedreich's ataxia until now, most patients today seek routine care by their local neurologist or primary care physician. We expect that with the approval of SKYCLARYS, many patients will return to their FA specialists and treatment centers over time. Important commercial launch targets include CCRN centers or collaborative clinical research network sites, ataxia centers, and HCPs with FA patients linked to their practice. Through the evaluation of ICD-10 claims data, we've identified approximately 2,500 target healthcare providers treating patients with Friedreich's ataxia today. About 1,200 FA patients are linked to approximately 200 highest target physicians. Several hundred of these patients can be tied to 14 ataxia centers and nine CCRN sites recognized as centers of excellence by FARA. We are prepared to reach these providers at their local practice or clinic. This targeted approach will allow us to reach the majority of the United States FA market efficiently. Additionally, our marketing outreach efforts through digital, social, email, and print have been deployed to reach up to an additional 9,300 practicing neurologists, driving the awareness of SKYCLARYS' approval as newly diagnosed patients are identified and others return to their neurologists for treatment. Next slide. In September 2022, we conducted market research with HCPs currently treating FA. When presented with the SKYCLARYS product profile and pivotal data, neurologists shared their willingness to prescribe following approval, with approximately 85% indicating that they anticipate prescribing within six months and about 95% indicating within the first year. Furthermore, PCPs treating FA are also likely to prescribe, with over 75% stating they would do so within the first year. Many HCPs expressed their dissatisfaction with the lack of treatment options available and indicated their likelihood to prescribe quickly. Turning to slide 24. An experienced commercial team is hired, trained, and prepared to launch SKYCLARYS. This team includes seasoned brand marketers, a team of veteran biotech sales professionals, training, market access, product distribution, and commercial operations. Go-to-market plans are in place and ready to execute. With SKYCLARYS approval, we now begin to inform the FA network of patients, caregivers, and healthcare providers. Omnichannel outreach efforts are wide-reaching, we start immediately with the launch of our brand websites, online search, social media, and digital campaigns that go live today. Our sales organization consists of a team of region business directors and neurology account managers responsible for educating HCPs. Each member of the sales team has years in the industry and experience across neurology or rare diseases. All have worked with specialty therapeutics. Most have launched first products with emerging commercial companies. The sales team is completing their final training this week and will be in the field on Monday morning, March 6th, educating physicians on the efficacy and safety of SKYCLARYS. Lastly, our field access team consists of national account directors focused on SKYCLARYS coverage by top national and regional payers and a patient access liaison team hired to support practice-level access needs. Together, this team's primary responsibility is to facilitate patient access to the drug by working to minimize and navigate payer criteria. Coverage by most national and regional payers is expected to take approximately 4 weeks-8 weeks via medical exception while formulary re-review progresses over the next 3 months-6 months. We anticipate that most plans will place SKYCLARYS on their specialty tier along with most rare specialty therapeutics. SKYCLARYS will be shipped directly to the patient's home through a single specialty pharmacy. The Reata REACH program is at the center of these services. I'll introduce this program on the next slide. We believe that every eligible person with Friedreich's ataxia should have access to the only approved drug available, and we offer programs to help make this happen. Reata REACH, or the Reata Education, Access, and Care Helpline, is an integrated exclusive specialty pharmacy and patient services program. It will serve as the single point of contact for HCPs prescribing SKYCLARYS, FA patients receiving drugs, and their caregivers. REACH is designed to create a simple and positive experience through new patient start process, insurance navigation, therapy adherence, access, and commercial co-pay support. Through claims data analysis, we believe that today approximately 60% of currently diagnosed FA patients have commercial insurance. The remainder have coverage through Medicare Part D or Medicaid, with a very small portion uninsured. This mix could change slightly, and more uninsured patients may be identified with a new therapeutic coming to the market. We've designed our access programs with this knowledge, offering specific programs where possible to bring down the patient's potential out-of-pocket cost. Regardless of coverage, no Friedreich's ataxia patient will face more than a nominal co-pay for SKYCLARYS treatment. Next slide. The ultra-rare disease ecosystem stimulates innovation and development for serious diseases impacting very small patient populations. Because of this environment, there's been much success in recent years bringing new drugs forward. We considered several factors and constraints in setting the SKYCLARYS price. First, the price re-reflects the small size of the patient population. The current estimated total addressable market in the United States is approximately 4,500 diagnosed patients. Second, there's an urgent need for treatment. Friedreich's ataxia is a progressive debilitating and life-threatening disease that robs patients of their ability to function, impacting their independence and shortening their expected lifespan. Third, SKYCLARYS is the only FA drug approved by the FDA, which has demonstrated significantly less impairment over time in a well-controlled clinical trial. Before today, there were no FDA-approved drugs for Friedreich's ataxia. Fourth, SKYCLARYS has a novel mechanism of action that required 15 years of research and development with our Nrf2 platform to bring SKYCLARYS to market. We evaluated recent ultra-rare disease launches between 2016 and 2022 and established a peer group of products approved for diseases with very small patient populations like Friedreich's ataxia. SKYCLARYS is priced below the midpoint of these peer analog disease therapies. An annual WAC price of $370,000 will support sustainability, our commitment to advancing groundbreaking science, and developing new novel therapies. Next slide. Our SKYCLARYS launch efforts begin today. Patient access services are now active and operational. New patient start forms are available for download on the Reata REACH website at reatareach.com. Care navigators are available to answer questions Monday through Friday at the Reata REACH call center. FA patients or their caregivers seeking SKYCLARYS treatment should see their healthcare provider. Since payer coverage may take several weeks, HCPs can submit new patient start forms immediately to initiate the benefit verification process and coverage through medical exception. SKYCLARYS will ship to the patients as soon as it is in the channel. With that, I will now turn the call over to Manmeet. He will provide our operational and financial updates. Thank you, Dawn, and I'll continue on slide 29. First of all, let me start by adding that we are thrilled to be at this stage of our company's journey. Becoming a commercial company has always been our plan. We have been working hard to prepare for this day. I speak for our entire Reata team when I say how excited we are to reach this important milestone of getting SKYCLARYS approved to help patients who had no current approved therapy. SKYCLARYS' approval represents a culmination of the perseverance and commitment over the last 15 years of our research and development team for our Nrf2 activator platform. Moving on to the update on operations, we are working diligently to ensure we get the drug to the market as soon as possible. Currently, we are in the final stages of SKYCLARYS manufacturing, which includes encapsulation, packaging, and labeling. We expect to complete these manufacturing activities by the end of April 2023. Recently, a process-related drug substance impurity above the reporting threshold was observed. This impurity had been observed previously below the reporting threshold. Based on the chemical characteristics of the impurity and testing results, there are no expected safety concerns. An update to the drug substance specification with this new information will be submitted to the FDA as soon as the required data and documentation are available. The change will become effective 30 days after submission, absent further action required by the FDA, which we do not expect. We believe SKYCLARYS commercial drug product will be available to the specialty pharmacy in May 2023 or early June 2023. We continue to work diligently on the last steps of production and to shorten the timelines, and currently don't expect any further delays. Regarding our operations in Europe, following a submission of our M&A in the fourth quarter of last year, we have accelerated build-out of our European infrastructure to support the potential commercial launch of Omav in the European region by early 2024 if approved. Additionally, we are working to set up early access programs in certain European countries to provide early access to Omav for patients in need where possible. Moving to our intellectual property, composition of matters of patents claiming SKYCLARYS have been granted in the United States, Europe, Japan, China, and more than 20 other territories. We believe that the composition of matter patent protection for SKYCLARYS could be extended to 2037 in the United States and 2038 in Europe. Next slide. I will now provide color on our cash position and funding options. As of December 31st, 2022, we maintained a solid balance sheet with approximately $387.5 million in cash equivalents, and marketable debt securities. We currently have no outstanding funded debt on our balance sheet. I wanted to remind everyone of a few items. We have multiple options to raise additional funding to strengthen further our cash balance and future investments into the pipeline and fuel the growth of SKYCLARYS beyond the United States. The granted rare pediatric disease priority review voucher will provide us the future optionality to monetize the voucher. If you recall, we previously had a debt facility of $155 million with Silicon Valley Bank and Oxford in mid-2020 prior to entering into a royalty agreement with Blackstone. We prepaid that debt post-financing from Blackstone. Under our royalty agreement with Blackstone, we have the right to obtain secured debt with a first lien on our assets to replace our previous debt of $155 million. Our agreement with Blackstone only requires us to pay royalty from the revenues generated from bardoxolone. We do not owe any royalty on the SKYCLARYS revenue to Blackstone. Based on our current plan, our cash balance will enable us to fund operations through the end of 2024. With the option to monetize the priority review voucher and raise non-dilutive debt financing, we believe we can further extend our cash runway and get to the point of self-sustainability and break even with our financial discipline. We'll continue to invest appropriately in our product pipeline and expansion of Omav into Europe and Brazil, which could have significant revenue potential. Please note that on today's call, we will not provide any guidance on market assumptions or sales potential. We'll continue to evaluate the possibility of providing guidance over the next few quarters once we gain comfort with the ramp of the launch, market dynamics, and key metrics. We plan to do an R&D Day later this year to provide more details on our programs, including our Nrf2 activators. With that, I will turn the call back over to Warren. Thanks, Manmeet. Continuing on slide 32, the approval of SKYCLARYS is a transformative moment for Reata as a company as we work to bring SKYCLARYS to patients as a commercial enterprise. We would like to again thank FARA, FA scientists and researchers, the FDA, and most of all, FA patients and their families for their help with our FA development program. We are well prepared for the commercial launch of SKYCLARYS in the United States. Importantly, we are committed to ensuring that eligible FA patients have access to SKYCLARYS and to the continued development to address the group of FA patients that are younger than 16 years of age. We've submitted our marketing authorization application for Omav for the treatment of patients with FA to the European Medicines Agency, and we will be working throughout this year to support the European agency during their review of our application. Reata's promise to patients is to bring life-changing medicine to those who need them the most. We plan to continue to focus our Nrf2 activator platform on devastating neurologic diseases with limited or no therapeutic options, and to pursue programs that have the potential to produce meaningful clinical impact for these patients. That concludes our prepared remarks. We'd like to thank everyone who dialed in. I'll now turn the call over to the operator for questions. Ladies and gentlemen, at this time, we will begin the question-and-answer session. If you would like to ask a question, you may press star followed by one on your telephone keypad. If for any reason you would like to remove your question, you may press star followed by two. As a reminder, if you are using a speakerphone, please remember to pick up your handset before asking your question. We'll pause here for just a moment to compile the Q&A roster. Our first question comes from the line of Madhu Kumar with Goldman Sachs. Madhu, your line is now open. Hey, everyone. Thanks for taking our question. First, congratulations. I'm sure you must be really proud of what you guys have achieved here today. I guess we have really a handful of questions. The first one is, can you give us more detail about how you're thinking about a potential pediatrics trial and kind of what are the key differences between that study and a study like MOXIe? Seemi, would you like to address that? Yes, we have been thinking about it, and then, it will be, well, age younger than 16 because we already have the adolescent population in the MOXIe trial. Currently, we are just working with the EMA, and we have the pediatric investigational plan, and then we are considering age six to 16, and also we'll allow the patients to enter younger than six years old. Given where we are right now in terms of approval, we'll be considering the open label study, and we will monitor them, and we will be evaluating the propensity match within EpiCom database as well. Yeah. I'd just like to add too that that plan's been developed to address the requirements for our application in Europe. We also view this as a top priority. We know how important it is to the parents of FA patients that are diagnosed earlier than 16 to have access to therapy. There are multiple ways that we may be able to accomplish this goal in the United States, and we're planning to engage with the FDA about a possible label expansion with multiple different approaches. I guess maybe a little more granular. As you think about the mFARS scale, is there any aspect of that that might be more complicated for younger children as compared to adolescents and adults? Like, is there anything you should be thinking about, like certain aspects of that, of that protocol that would need to be amended for a younger population? This is Colin. There's a few different approaches, as Warren mentioned. You know, one of which we'll be discussing is an extrapolation approach where you justify that your currently available data could apply to patients who are younger. That, you know, would potentially not require an additional study. You know, that is of interest to us. We'll be discussing that with the regulators. Number two, because of all that FARA has done to characterize the course of the disease, there's, you know, well-established rates of progression and variability, in patients, you know, throughout the age range. That data to support this first approval of SKYCLARYS, and we'll be able to leverage that same data to generate what we hope would be an efficient trial if required to be able to get the age lowered in those younger patients. Okay. Maybe one more about the commercial launch. I guess, as you think about, you mentioned the kind of 2,500 targeted HCPs. To what extent do you feel that like the handful of kind of key opinion leaders in the FA kind of physician community? Like, how much of the FA population is currently covered by those like, key physicians? How much do you feel that like, they get you a large fraction of the kind of currently diagnosed population? Yeah. Thank you for the question. We feel very confident through the claims data analysis that we know where patients are being treated today. Of course, with a new product approved, we're gonna see more patients move from their local neurologist or primary care treater back into CCRN centers or ataxia centers. We also feel very confident in our target 2,500 HCPs that we are really reaching the majority of the United States opportunity. I further shared that there's about 1,200 actively treated patients within the top 200 accounts, which also accounts for those CCRN centers, ataxia centers. As you can tell, there are many patients that are being treated by a small number of physicians, and we anticipate that as the product hits the market and more patients are emerging for, you know, ready and active treatment, that we're gonna see even more move into those centers. All right. Good. Thanks. Once again, congratulations. I was very proud of what you guys have accomplished here. Thank you. Thank you. As a reminder, please limit your questions to one question and one follow-up to accommodate as many questions as possible. Our next question comes from the line of Yatin Suneja with Guggenheim Partners. Yatin, your line is now open. Hey, guys. Let me add my congratulations to you and the FARA community as well. Great achievement here. Two questions from me. Could you just elaborate a little bit on the impurity that you found? What information you need to submit and by when you need to submit so that the drug is in the channel by May or June? The other part of the same question is that in the meantime, you are figuring this out and getting the drug into the channel, the prescribing can happen. Just clarify if physicians can prescribe so that by the time the drug is launched, you do have a bolus of patients that are ready. Of these 4,500 addressable patients that you have, do they exclude patients below 16? Thank you. I'll take the last question first since it's the easiest. Yes, the 4,500 excludes the patients that would be on label. Manmeet, would you like to address the impurity issue? Sure. Yatin, you know, as you know, we very recently, you know, observed this process related drug substance impurity, which was just above the reporting threshold. We have, we had noted this, you know, impurity earlier, and now we have done, you know, testing and based on the chemical characteristics of this impurity, there are no expected safety concerns. We have to do a update to the drug substance specification with this new information, which we plan to submit to the FDA pretty soon. This change will become effective within 30 days of the submission. As you know, we are in the final stages of SKYCLARYS manufacturing, including encapsulation, packaging, and labeling. You know, all those activities we expect, you know, to wrap up and have the drug delivered to patients, by either May or early June. We are working very diligently to get, you know, all that paperwork, you know, completed and submitted to the FDA. Very good. Thank you so much. I'll get back in the queue. And, uh- Thank you. I will pass on the question on the bolus you asked to. Access. Access. Access? Yes. I think the third question was related to patient access and starting the prescription. Yes, our REACH services are active today. This is our single specialty pharmacy and integrated patient access services. That's active now. New patient start forms can be downloaded and completed and submitted immediately. Thank you. The next question comes from the line of Yigal Nochomovitz with Citigroup. Yigal, your line is now open. All right, great. Thanks so much. First of all, a huge and hearty congrats to the whole team on the approval. Obviously, we were believers all the way. Also not having an AdComm indeed proved to be a huge positive. Big congrats. Well, it seems like an incredibly clean label as you outlined this morning, Colin. I'm just wondering, is this essentially the draft label that you had submitted to the FDA? Or did FDA make any modifications that are worth mentioning when you had your discussions on the label? Thanks, Yigal. Yeah, you called that the AdComm cancellation accurately. No, the answer is no. We actually submitted a more restrictive label. I have to say, just personally, from my own standpoint, I was incredibly impressed with the work that the FDA did on our label. They did a better job than we did of laying out how the drug should be used. They actually broadened the label. They provided more guidance to the physicians about how the drug should be used. They actually provided a dosing scheme for patients with hepatic impairment that we did not propose. They knew the drug very well, and they gave very good instructions about how the drug should be used. This is Colin. I'll further add that, obviously in a clinical trial setting, we have, you know, very strict criteria for enrollment of patients, for monitoring of patients. The label represents a broader set of patients, with more flexibility given to healthcare providers to manage their patients. Okay, great. And maybe these two are for Manmeet. Manmeet, I think you mentioned that the plan is to monetize the PRV. I'm just wondering if is that sort of set in stone or is there some potential that you might keep it for Reata and use it for a future application? With respect to the manufacturing agreements, could you just reference how many suppliers do you have currently and what's your plan to expand that footprint as you get deeper into the commercial stage? Sure. Thanks, Yigal, for your questions. First one, as I mentioned, we have the option to monetize. It's a very, you know, recent news to us. You know, we are very, very pleased with this grant of the PRV voucher. We have not decided yet, but again, it gives us an optionality to monetize it, kind of a very good source of non-dilutive financing. You know, that's number one. On manufacturing agreements, I think currently we have all our manufacturers lined up for SKYCLARYS production. Obviously, with this approval, we'll be investing much more and, you know, expanding our network to have, you know, more production lineup. I think we have enough capacity right now to produce and supply to the patients under the targeted or, you know, under the approvals, right. All the patients right now. We have enough capacity right now with our current supply chain. This one you may not be able to answer because it's early, but you mentioned the WAC of $370. Any early comments on what the net price, the gross to net might look like so far? Obviously, we have not given any guidance on the net price, and the net price depends on multiple factors, including the payer mix, which, Dawn provided some color. You know that mandatory, you know, payer discounts for Medicare and Medicaid are pretty much known. Obviously it depends on the mix and what it comes. I think it will take a couple of quarters where before we could guide you the exact amounts. We'll be reporting our actual revenues and, you know, those will with the time, and we will provide you a little bit more guidance. Today, it's pretty early to guide on any amount. That's what I would say. Okay. Thank you. Sure. The next question is from the line of Annabel Samimy with Stifel. Annabel? Hi. Thanks for taking my question. Again, congratulations from us. It's been long coming for these patients. I guess a lot of my questions been have been answered, but just I was curious about Are there any patients that remain in open label studies that are able to now become pretty immediate paying patients as you roll this out? Secondly, you know, what are your thoughts around how we should see a ramp? I know that obviously you're not gonna have the drug available until May or June, but it is going through a single pharmacy. There doesn't seem to be any kind of stocking, or will there be some kind of stocking initially and then it starts to disseminate, or is it a more of an on-demand type of, distribution by these patients? Are two things. Okay. Annabel. Sure, Annabel. Thank you. Thanks for your question. This is Manmeet. I will answer, and I'll pass on if needed. On first, on your second question, right, it will be stocked right at our specialty pharmacies, and we'll try to get them, you know, as soon as, you know, possible. That's why we said, we're diligently working on that. There would be stocking on your second question. On your first question regarding patients who were on the extension trial, you know, we are still evaluating, and we will be continuing to evaluate that. Currently our plan is to continue those patients on MOXIe extension study to get some more longer term data. Obviously, we'll evaluate further. As of now, our plan is to continue them. Great. And when you were doing the analysis of the neurologists, and looking at percentages of patients they would be treated, was this primarily neurologists who were in the centers, or is this broadly across the neurologist, the 2,600 neurology base, that we're talking about? Because obviously this is very, very high penetration for this population. Just curious how you framed that. Thanks. Thank you, Annabel. I appreciate the question. Again, because there hasn't been a therapeutic or drug developed for FA patients are treated in centers by their local neurologists and even by their local primary care physicians. Again, with the approval of a specialty therapeutic, we expect that local neurologists will prescribe, neurologists within clinics and centers will prescribe, and even some primary care physicians are comfortable prescribing as well, as I shared in that market research. We expect more patients to move back into neurology. When I think about the, you know, the HCP target list, the majority of them are neurologists, but they're spread across the whole country. They're in private practice, and they're also in clinics. Great. Thank you very much. Congratulations again. The next question comes from the line of Maury Raycroft with Jefferies. Maury? Hi. Thanks for taking my questions, and I'll add my congrats on the milestone. I was wondering if you can talk a little bit more about what metrics you're gonna be providing on a quarterly basis. You mentioned patients on the radar and concentrated at centers, but can you comment on the ongoing FA-COMS study and whether you anticipate a bolus of patients who come on drug soon after launch, potentially from that study? Thank you, Maury. I'll take your second question first. We do know that the FA community is extremely motivated, and so, you know, a bolus of patients would really be that motivated community that's, you know, actively seeking treatment. We definitely expect that to happen. Can you, Second question or the first question that you asked, could you clarify that? Sure. Yeah. The first question was. Oh metrics that you could be able to provide on a quarterly basis. Since we're starting our REACH program immediately and new patient start forms are available for media-immediate download, we expect that this will be a good measure of our early launch success, and we'll be reporting this out quarterly. Got it. Okay. Congrats again. And that's- Thanks for taking my questions. Thank you. Maury to add, this is Manmeet. I think it will be. Obviously, the best metric would be our revenue. As John mentioned in the beginning, you know, if the as the drug is coming around May or June, for the next quarter, it might be the early indicator would be the start forms, which would be a, you know, which would support us a lot. Our next question comes from the line of Charles Duncan with Cantor Fitzgerald. Charles? Hi, Warren and team. Let me add my congratulations. Obviously, really amazing persistence that you have demonstrated and absolutely appreciate that for the FA community. I had a couple of quick questions. One was, I guess around the idea of persistence. Do you have any thoughts on persistence expectations and/or any evidence that if patients start drug early, they can do even better in terms of progression of the disease? Can you provide any additional color on when we might see visibility on the, on the less than 16-year-old label expansion efforts? Thanks, Charles. I appreciate the comments. We, you know, have disclosed our data on our propensity-matched analysis, you know, that made it, you know, into the label at a high, high level. Recall that in that analysis, there were 136 patients who received Omav for on average approximately three years, some approximately four, and they demonstrated, you know, a slowing of progression versus the matched patients in the FACOMS natural history study. Those are the data that we have available today. Obviously it's longer than the one-year placebo-controlled trial. We look across the patients who demonstrated a improvement versus placebo. There was at least a numerical benefit across all subgroups. As discussed, you know, we'll be potentially following those patients. The data thus far suggest persistence. For 16, as mentioned, we need to talk with the regulators. There's multiple approaches. We've had discussions with the European regulators. There are, in the U.S., multiple approaches to lowering the age. As Warren said repeatedly, that is our utmost priority to make sure that younger patients have access to SKYCLARYS. Options include extrapolating based upon available data, which would potentially not require another study. Alternatively, FDA may require another study, but there are options including propensity matching as we did, you know, in our confirmatory evidence, you know, as well as placebo-controlled study. We need to discuss those with the regulators to determine how. John, are there any other questions? To proceed. Do you have any further color that you can provide on the EU commercial plans? Would that be something that you pursue yourselves? What are you thinking about Asia? Yeah, I'd just say currently, you know, we've retained the worldwide commercial rights to Omav, and we're building the team to, you know, commercialize the drug on a worldwide basis. Thanks, Warren. Congrats. Thank you. Thank you. The next question is from the line of Carter Gould with Barclays. Carter? Great. Good evening. Let me echo the previous prior congratulations to the team. Maybe following on that prior question around, I guess, persistence and just thinking about how the liver monitoring language, and to the extent the, I guess the elevated enzymes we saw in the first part of MOXIe may, you know, may be a good proxy as we think about patients coming off, starting, stopping, and the commercial implications of that. Second question, I guess now with this in hand, as you kind of take a step back and think bigger picture about corporate strategy, does this change in any way how you guys think about how aggressive to be with bardoxolone or things that you could do maybe to accelerate enrollment in FALCON or, you know, the broader portfolio? Thank you. Thanks. This is Colin. In regards to persistence and the effect of the label and monitoring, once again, we were very pleased with what FDA recommended for our label. Our clinical trial was more conservative. Fortunately, we had the evidence from MOXIe Part 1, MOXIe Part 2, and the extension study that allowed FDA to craft the language that's currently in the label. When we look at transaminase elevations or liver enzymes, we in MOXIe Part 2, I'll note that approximately 13.7% of patients had elevations above 5x the upper limit normal. The only patient, you know, who did not continue treatment and complete the study was a patient who hit 8x, and that patient was required to stop, you know, per our protocol. The label provides flexibility for patients. As I mentioned, even those patients who hit 5x, all but one were able to continue receiving drug after appropriate monitoring. For the one patient who hit 8x, if that occurs in the post-marketing setting, once again, FDA provides guidance that there should be potentially dose modification, temporarily discontinuing drug or permanently discontinuing drug. That gives the healthcare providers flexibility in accommodating those changes. As far as how this affects, you know, our strategy with bardoxolone and FALCON, you know, we are still committed to our CKD program. Our FALCON trial on ADPKD, you know, is actively enrolling. In an important data readout, as we've discussed on prior earnings calls, is our Japanese partners, AYAME trial and diabetic kidney disease. That will read out further guidance in the first half of this year. That should, you know, allow us to determine what our options are, you know, with bardoxolone moving forward. Thank you. Thank you. I'm showing no further questions in the queue. Again, thanks for your participation on today's conference call. As a reminder, an audio recording of the call will be available shortly after the call on Reata's website at reatapharma.com in the Investors section. Thank you very much for your participation. You may now disconnect.