Cara Therapeutics, Inc.

Good afternoon. My name is Shannon, and I will be your conference facilitator. I would like to welcome everyone to the Carer Therapeutics third quarter 2022 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 11 on your telephone keypad. Please be advised that this call is being recorded. I'll now like to introduce Matt Murphy, CARA's Manager of Investor Relations. Mr. Murphy, you may begin your call.

Thank you, operator, and good afternoon. Just after market closed today, CARA issued a news release announcing the company's results for the third quarter of 2022. Copies of this news release and SEC filings can be found in the investor section of our website at www.caratherapeutics.com. Before we begin, I would like to remind you that during the course of this conference call, we will be making certain forward-looking statements about CARA and our programs based on management's current plans and expectations. These statements are being made under the Private Securities Litigation Reform Act of 1995, and they are subject to various risks and uncertainties. Actual results may differ materially due to various factors, and CARA is under no duty to update these statements publicly. Investors should read the risk factors set forth in CARES 10-K for the year ended December 31st, 2021, and the 10-Q for the quarter ended September 30th, 2022, and any subsequent reports filed with the SEC. With that said, I'd like to turn the call over to Chris Posner, CARES Chief Executive Officer. Chris?

Thanks, Matt, and good afternoon, everyone. The third quarter was about traction for CARES. where strong execution on our strategy has started to propel us on the road to accelerated growth for years to come. We believe our goal to become the world leader in pruritus has a unique long-term value proposition. Our clear focus is to provide potential solutions to this underserved condition affecting millions across many disease areas. As we gain strategic momentum, this focus is a differentiating factor. The third quarter showed that the pieces are in place for near-term and long-term success of our strategy. Demand for Corsuva injection is accelerating as we anticipated. We are quickly expanding internationally with the launch of Corsuva and Capruvia in countries around the world. And our rapidly advancing oral difelikephalin pipeline presents the opportunity to build sizable franchises in nephrology and dermatology. We are pleased with the launch progress for Kursuv injection in the third quarter. Net sales for Kursuv injection were $16.2 million. Kara's profit-sharing revenue was $7.4 million. And demand jumped 100-fold to over 180,000 vials shipped from wholesalers to clinics. Product demand is the key to Corsuva's injections momentum and how it builds towards a successful franchise. The significant quarter-to-quarter acceleration in demand is the result of continued strong execution from the CSL V4 and Fresenius field forces. It also reflects the underlying strong value proposition of Corsuva injection for the appropriate dialysis patients. As we outlined last quarter, large dialysis organizations are the key drivers of long-term sustainable demand. And in the third quarter, most of the demand acceleration did come from the LDOs, primarily from Fresenius. For some extra color, almost all Fresenius medical care clinics placed an order by the end of the quarter, and we are closely monitoring reorder rates to understand the number of patient starts in all clinics. DaVita's up product has been more gradual, which we expected based on similar prior launches in this space. Nevertheless, there is positive momentum. We have seen more than half of the DaVita clinics who have previously ordered Corsuba reorder. Moreover, we are seeing continued growth at midsize and independent dialysis organizations with high penetration and solid reorder rates. Positive anecdotal market feedback keeps rolling in across our stakeholder groups. Patients, caregivers, medical providers, and our launch partner, CSLv4, have relayed very encouraging comments on the clinical benefit from course of injection. Driving all of this is the continued strong market engagement. In the third quarter, CSLv4 launched a comprehensive CKD pruritus awareness program in conjunction with the National Kidney Foundation that includes a CKD associated pruritus webpage, infographics, fact sheets, patient testimonials, and a Facebook live event. This is on the heels of the CKD associated pruritus awareness programs with the American Kidney Fund and the American Association of Kidney Patients, which were launched in the second quarter. In early October, CSLV4 conducted a large symposium at the 2022 American Nephrology Nurses Association fall meeting. And recently, CSLV4 had a significant presence at the American Society of Nephrology annual meeting with multiple initiatives targeting patients and providers, including a new patient campaign. Overall, after the second full quarter into the US launch, we see significant progress and momentum driven by the acceleration of product demand. This is the essence of any successful product launch. We are still early in this launch and we continue to expect demand and wholesaler shipments to normalize over the coming quarters with some potential quarterly variability in the process. Keeping the big picture in view, the Korsuv injection launch is on its way. and we are very pleased with how it's progressing. Internationally, CARA has made significant strides in making Corsuva available globally. In the EU, the Capruvia launch has started with Germany leading the rollout across the continent. Germany has also updated its clinical guidelines to include Capruvia as a first-line option for the treatment of pruritus and chronic kidney disease. We are pleased with this positive development at the start of the launch. Capruvia's launch has also commenced in Austria. We expect the majority of the EU countries to launch in 2023. Now, our product was also approved in 3Q under the name Corsuva in Canada and Capruvia in Singapore and Switzerland, and we expect approval in the last access consortium country, Australia, in the coming months. In Japan, Our partner, Marawishi Pharmaceutical, recently announced filing for approval with the PMDA. We expect a decision on this application in the second half of 2023. Moving on to our pipeline. We are making great progress in our strategic priority of expanding the utility of oral difelocephalin. We are enrolling patients in our ongoing Phase III clinical trials in pruritus associated with advanced chronic kidney disease and atopic dermatitis. We continue to expect reporting top-line data for the CKD program in the second half of 2024, and we are still on target for the internal readout of Part A of the Phase III AD study in the second half of 2023. We recently presented exciting additional data for oral diphellocephalin in notalgia peristatica. The late breaker presentation at the EADV Congress in Milan highlighted difelocephalin's rapid onset of action, which occurred as early as day one, and its sustained effect throughout the active extension phase to week 12. We have a meeting scheduled with the FDA this quarter to discuss the steps to a pivotal clinical trial program in NP, and we look forward to providing an update on the program in the future when appropriate. Finally, onto our 16-week proof of concept trial in pruritus associated with PBC. Given the continued slow enrollment, we made a strategic decision to discontinue the study and unblind the data. The small number of patients limits the interpretability of the data. However, efficacy was trending in the right direction and there were no new safety signals. It is important to note that the data do not preclude us from pursuing this indication at a later date. With the potential of NP advancing toward a pivotal program, at this time we are focusing our resources on building our dermatology franchise and expanding our nephrology franchise. We have significant opportunities in both therapeutic areas, and we are pleased with the progress we have made to date. In conclusion, we believe that this quarter has shown that we are continuing to build momentum. We are gaining traction in our strategy to drive long-term growth for CARA and create value for our shareholders. This was evident three ways this quarter. Product demand is accelerating for course of injection. We are rapidly moving toward becoming a world leader in pruritus, and we are laser-focused on maximizing the potential of oral diphellocephalin in nephrology and dermatology. Now, I'd like to introduce Ryan Maynard, our new chief financial officer for his first quarterly earnings call with CARA. Ryan will provide details on our third quarter results, and we'll all be available for your questions after that. Over to you, Ryan. Thank you, Chris.