Kiniksa Pharmaceuticals International, plc

Good day and thank you for standing by and welcome to the Kineska Pharmaceuticals fourth quarter and full year 2022 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you'll need to press star 1, 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1, 1 again. Please be advised that today's conference is being recorded. We'd now like to hand the conference over to your speaker today, Rachel Frank, Head of Investor Relations. Please go ahead.

Thank you, Operator. Good morning, everyone, and thank you for joining Connexa's call to discuss our fourth quarter and full year 2022 financial results in recent portfolio execution. A press release highlighting these results can be found on our website under the Investors in Media section. As for the agenda, our Chief Executive Officer, Sanj K. Patel, will start with an introduction. Ross Mote, our Chief Commercial Officer, will provide an update on our ARCALIS commercial execution. Then, Mark Vergoza, our Chief Financial Officer, will review our fourth quarter and full year 2022 financial results. And finally, Sanj will return for closing remarks and to kick off the Q&A session for which Evan Tesari, our Chief Operating Officer, and John Paolini, our Chief Medical Officer, will also be on the line. Before getting started, please note that we will be making forward-looking statements today that are subject to risks and uncertainties that may cause actual results to differ materially from these statements. A review of such statements and risk factors can be found on this slide, as well as under the caption, Risk Factors, contained in our SEC filings. These statements speak only as of the date of this presentation, and we undertake no obligation to update such statements except as required by law. With that, I will turn it over to Sanj.

Thanks, Rachel, and good morning, everyone. I'm looking forward to reviewing our fourth quarter and full year 2022 financial results today. In 2022, we continue to execute across our cardiovascular and autoimmune franchises, which positions us for continued success and growth in 2023. On the commercial side, as we announced in January, Q4 represented another quarter of continued growth for Arclist. The net product revenue of $39.9 million represents approximately 20% sequential growth versus the previous quarter Q3. Our full year 2022 net revenue of $122.5 million is right in the middle of the guidance we gave at the beginning of the year, which was $115 to $130 million. We are very pleased with our commercial execution to date, and as we move into the year ahead, we're highly focused on reaching more patients with recurrent pericarditis by expanding the breadth and depth of our prescriber base. Ross will provide more details on this in a few moments. We also remain focused on building the maximum value across our portfolio of clinical stage assets, including KPL-404, which is our CD40 antagonist program. We're currently conducting a phase two study in rheumatoid arthritis, which is designed to evaluate the efficacy, dose response, PK, and safety of chronic sub-Q dosing over a duration of 12 weeks. In terms of where we are right now with this program, we fully enrolled the first and second cohorts of the PK leading. And we're now focused on starting the third and final cohort, which is the efficacy portion. We expect the proof-of-concept data from this study in the first half of next year. We continue to pursue collaborative study agreements with Mabalinumab to evaluate its potential in rare cardiovascular diseases. This is a molecule that we continue to be excited about and has the potential to impact a number of diseases. And with that, I'll turn it over to Ross to review our commercial execution of Arcus. Ross? Thank you, Sanj. I'm pleased to share further details on our fourth quarter and full year 2022 commercial performance and our plans for continued growth in recurrent pericarditis. Throughout the year, we continue to deliver solid, sequential, quarter-on-quarter growth of ARC List revenue. The growth in Q4 resulted in a net revenue of $39.9 million, representing approximately 20% sequential growth versus the prior quarter. This means our full-year 2022 net revenue was $122.5 million. Our team has continued to activate an ever-growing prescriber base, and there are now more than 800 unique prescribers for recurrent pericarditis since launch, which is a growth of more than 100 additional new prescribers every single quarter. We continue to hear from both prescribers and patients that they're having a positive experience with Arculus. And this is resonating in the repeat prescriber rate, where considering we have a larger overall prescriber base, we have maintained around 22% of the total prescribing base who have written for two or more patients. Slide eight outlines some of the key metrics and drivers of the ARCLID growth. Since launch, we have been laser focused on the 14,000 target population of the current pericarditis patients who have had two or more flares. At the end of 2022, we had achieved $122.5 million in net revenue by activating approximately 5% of this target population on ARC-List treatments. This penetration demonstrates that ARC-List is being well received. We have meaningful and growing revenue, and we continue to have a significant opportunity ahead of us. The payer approval rates in Q4 remained greater than 90% of all completed cases, as it has been every quarter since launch. Another important driver of growth, which I will highlight in more detail on the next slide, is duration of therapy, which is currently at approximately 18 months in total. Additionally, compliance continues to be strong at greater than 85%, with refills generally completed on time, highlighting that once a patient starts on therapy, They see the benefits and stay adherent throughout the duration. Our gross to net also continues to be very healthy at 9% overall in 2022. All these metrics point in the direction of a successful, progressive commercial launch with significant room for substantial growth. And we're extremely excited by what we can achieve with this franchise. I'd like to take a moment to highlight the total duration of therapy metric I mentioned on the previous slide. As we follow more patients over longer periods of time, we believe the average total duration of therapy is now at approximately 18 months. This may continue to evolve, but what we're seeing in the commercial setting is that initially patients are staying on treatment for around 12 months, and then a high proportion, approximately 45%, of restarting treatment fairly quickly after trial and a stop. This reflects what we know about the persistence of the disease, where 60% of multiple recurrence patients suffer for two years, and from our clinical data showing that continuous treatment with Arculis throughout the disease results in the long-term prevention of flares. We acknowledge that treating this debilitating and complex disease with Arclist requires an evolution in mindset and practice for cardiologists. Whereas the focus in the past was aimed at minimizing treatment duration, in particular with steroids due to their toxicity burden and potentially worsening and prolonging the disease, but now with Arclist, the aim is to treat continuously throughout the duration of the disease. And we are rapidly advancing the education on this to cardiologists across the U.S. Our commercial launch strategy has been successful, and now we're continuing to execute and enhance this strategy to reach many more patients in 2023 and beyond. We're focused on a dual approach of continuing to broaden our base of prescribers as well as deepening the depth of repeat prescribers. At the end of last year, we expanded our sales force to around 50 sales representatives. which we believe will enable greater call frequency with our target doctors as well as broaden our reach overall. We understand the importance of having multiple calls on our target base and how to provide the education needed to ensure cardiologists become comfortable with addressing the root cause of recurrent peritonitis by prescribing a targeted biologic therapy. We are planning to make far stronger inroads into digital marketing having built a patient database of more than 3,000 pericarditis patients where we will advance the education so patients can self-advocate for ARCALIS if and when patients have their next recurrence. Currently, patients are widely spread throughout the country. We plan to lead the charge to support centers who wish to advance their services by focusing on pericardial diseases and creating networks of local referrals for centers who specialize in the management of these diseases. We also want to be at the leading edge of evidence generation. For example, with our longitudinal registry called Resilience, which is focused on the severity and burden of the disease, as well as understanding and educating further on the outcomes associated with appropriate disease management. And turning to slide 11, Our efforts on commercializing the first and only FDA-approved drug for recurrent peritonitis has resulted in a cracking launch, with hundreds of patients gaining access to therapy. The next stage for us is to dig much deeper into the opportunity. We believe we have built strong foundations to do just that. Our data are exceedingly compelling. We have an ever-growing prescriber base, physicians and patients are reporting positive experiences with Arculus, and we have an excellent field team who are executing our strategy brilliantly. Looking to 2023, we expect to grow our Arculus net revenue to between $190 and $205 million. This would represent a significant year-on-year growth of greater than 60% at the midpoint of that range. We're delighted with our current commercial performance and are very excited about the growth we have ahead. With that, I'll hand over to Mark to cover our financial results. Mark.