Cara Therapeutics, Inc.

Good afternoon. My name is Andrew, and I will be your conference facilitator. I would like to welcome everyone to the CARA Therapeutics fourth quarter 2021 financial results and update conference call. All lines have been placed on mute to avoid any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star and the number one on your telephone keypad. If you would like to withdraw your question, press the pound key. Please be advised that this call is being recorded. I would now like to introduce Iris Francesconi, Interim Head of Investor Relations from Care Therapeutics. Ms. Francesconi, you may begin your call.

Thank you, Andrew, and good afternoon. Just after market closed today, we issued a press release detailing our corporate progress and financial results for the fourth quarter and full year 2021. Press release can be found on our website at www.caratherapeutics.com. You may also listen to a live webcast and replay of today's call on the investor section of the website. Participating in today's call are Chris Posner, CARA's President and Chief Executive Officer, Tom Riley, CARA's Chief Financial Officer, and Joanna Goncalves, CARA's Chief Medical Officer. Before we begin, let me remind you that statements made on today's call regarding matters that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the company's ability to successfully commercialize Cursiva injection, including the timing of the product launch, planned future regulatory submissions, and potential future regulatory approvals. the company's ability to obtain and maintain coverage and adequate reimbursement for Koshu injection, the performance of our commercial partners, including B4 Pharma, expected timing of the initiation, enrollment, and data readouts from the company's plans and ongoing clinical trials, the potential results of ongoing clinical trials, timing of future regulatory and development milestones for the company's product candidates, the potential for the company's product candidates to be alternatives in the therapeutic areas investigated, the company's expected cash reach, and the potential impact of COVID-19 on the company's commercial launch, clinical development, and regulatory timelines and plans. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in carotherapeutics filings with the Securities Exchange Commission, including the risk factor section of the company's most recent annual report, on Form 10-K and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in today's call speak only as of the date on which they were made. Kara Therapeutics undertakes no obligation to update such statements to recent events that occur or circumstances that exist after the date on which they were made. With this, I will turn the call over to Chris.

Thanks, Iris, and good afternoon, everyone. With me today are Tom Riley, our Chief Financial Officer, and Dr. Joe Consalves, our Chief Medical Officer. Today I will give you a quick review of our tremendous progress delivering against our milestones, commitments, and plan. Then I will provide some updates on our preparations for the launch of our first product, Corsuv Injection. Tom will follow with a financial update, and then after that we will be available to take your questions. I am very excited to join you today to lead my first quarterly earnings conference call as CEO of Kara Therapeutics. In my first 120 days in this role, I have listened and learned to make sure we are doing the necessary things to build trust in our ability to deliver on our goals and continue growing. I am confident that we have the ingredients to build a long-term growth platform here at Kara, and it starts now. We have the right strategy in place, and our work ahead is very focused on executing against our strategy. We are building the category-defining leader in paritis. This guiding mission drives our strategy and our actions. Chronic paritis is often a severe, intractable problem for patients in a wide range of diseases, and it is underserved by currently used treatments. In light of this lack of treatment options, chronic pruritus remains underreported, even though it can have a significant negative impact on the quality of life of millions of patients. We are committed to enhancing the awareness of this disease and improving the treatment protocols for patient care so that our novel science benefits the most patients possible. Over the past year, we made excellent progress executing on three strategic priorities. Our first priority is to optimize the commercial potential of Corsuv injection. In 2021, we had a defining moment at CARA. In August, Corsuv injection became the first and only FDA-approved treatment for moderate to severe pruritus in adult chronic kidney disease patients undergoing hemodialysis. With pivotal data in more than 1,300 patients, our team swiftly submitted the NDA to the FDA for priority review. Now, as you will recall, we granted V4 Pharma an exclusive license to commercialize Corsuva injection in the U.S. V4 Pharma has been working diligently to prepare the market for this important new product. This is a readily addressable market of $200,000 U.S. hemodialysis patients with moderate to severe pruritus associated with chronic kidney disease. In addition, CMS granted Korsuv injection to DAPA reimbursement status in December. Now, I will provide more detail on the current launch preparations in a moment. Outside the U.S., we also see significant opportunities for Korsuv injection. We expect the European Medicines Agency to make a decision on our MAA in the second quarter of this year based on the CHMP positive opinion last week. As a reminder, an EMA approval entitles us to a $15 million cash milestone payment from our ex-U.S. partner, V4 Forcentius Medical Care Renal Pharma. In Japan, our partner, Mariushi Pharmaceuticals, recently announced positive Phase III study results. Our second strategic priority is to advance our oral Corsuva platform into Phase III pruritus programs for advanced chronic kidney disease not requiring dialysis and in atopic dermatitis. Following end-of-Phase II meetings with the FDA, we have a clear path forward with these two pivotal programs. We expect to initiate phase three trials in both indications this month. There will be more details on these trials at our upcoming virtual R&D day on March 11th, which I hope you all can join. Our third strategic priority is to expand the clinical utility of oral Corsuva in other therapeutic areas, including Notalgia Parasitica and chronic liver disease. Because of its novel mechanism of action, we see oral Corsuva with the potential to be a pipeline and a product, treating chronic pruritus across a broad spectrum of diseases. In 2022, we expect data readouts from Phase II proof-of-concept studies in notalgia parasitica and in primary biliary cholangitis. In both trials, we expect to see separation from placebo at the respective endpoints. These trials will provide us with critically important information to inform our path forward in these indications. Now, I'd like to provide more insight into the preparation and execution of the impending launch of course of injection, and we are excited and we are prepared for the upcoming early April launch. First and foremost, we have the right partner in V4 Pharma who will be leading commercialization efforts. Together, we have a terrific partnership. We have a joint steering committee that makes all key decisions concerning the launch and commercialization efforts. Our commercial partnership with V4 gives us a reach and frequency as well as efficiency and speed. V4 is a leading nephrology company with a large sales force and long-standing relationships with key prescribers and dialysis organizations. particularly one of the top two, Fresenius, with whom they have a joint venture. The focus has been on a fast start to the launch of course of injection. To achieve that, the cross-functional commercialization team has completed an array of pre-launch activities. These activities will allow us to hit the ground running from the first day and hopefully steepen the launch trajectory. Three pillars support our pre-launch work. First, The V4 sales force is trained and engaged to prepare the market for launch. V4 is deploying a sales force of approximately 100 representatives. This field force has been conducting disease state education since the fourth quarter of last year for pruritus patients on hemodialysis. Throughout the first quarter of this year, the sales team has been engaging with the entire range of healthcare professionals, including physicians, advanced practice providers, and nurses. in an effort to identify prospective patients who could begin therapy quickly once Corsuva injection is available. In addition, sales representatives have been trained on the package insert, and they are currently using the PI in their ongoing discussions with healthcare providers. All promotional campaign materials are also completed and ready to go. Representatives will be trained on these materials at live meetings in March. the commercial team has made significant progress on pricing, reimbursement, and access. On pricing, we have set a list price, or WAC, for Korsuv injection of $150 per vial, or roughly $21,000 per patient per year. On reimbursement, Tdapa and the J code for Korsuv injection are effective April 1. On access, V4's account team is actively engaged in formulary discussions with dialysis centers, and we're really confident that course of injection will be on all formularies. The consolidated nature of this market helps with this important process and the launch overall. Recall, the top six large dialysis organizations represent about 90% of the total market. We fully expect the product to be available at the dialysis centers. The third pillar is preparing the supplier product to drive a robust launch. We have manufactured sufficient launch quantities of course of injection, and the product is already at the distribution center awaiting shipment to wholesalers and dialysis centers. One final note on the launch. As an anchor product, we see course of injection and its launch as a solid step in the validation of our mission and our strategy. Paritis is a significantly underserved symptom across many diseases, and patients want and need new treatment options. Positive anecdotal feedback from healthcare providers in recent months is an early but important indicator that we are on the right track. In conclusion, we are on the road to creating significant value. In 2021, we did what many companies have not managed to do, identify and bring a novel drug through clinical development to approval as a first-in-class therapy. We have also made significant progress in building our oral Coursiva platform. Looking ahead, we see 2022 as a transformational year for CARA. Our focus on execution gives us confidence that we will deliver on our strategic priorities and our objectives. The first priority is to optimize the commercial potential of course of injection. Through our partner, V4, we plan to launch the first and only approved product for pruritus patients on hemodialysis. We are ready to roll for the launch with the field force, pricing and reimbursement, and product availability all in place. Second, we are advancing our world course of a platform with two pivotal phase three programs for pruritus and in advanced kidney disease and in atopic dermatitis. We are in the process of initiating both programs this month, and we are excited to detail these programs in more depth at our upcoming R&D day. Third, we are expanding the clinical utility of oral Corsuva in other therapeutic areas, including notalgia parasitica and chronic liver disease. with Phase II readouts to further characterize the potential of our product pipeline. I look forward to interacting with all of you over the coming months as we build CARA into the leader in chronic pruritus. Now, I'd like to hand it over to Tom, our CFO, who will go over our fourth quarter and end of year results in detail. Over to you, Tom.