Kiniksa Pharmaceuticals International, plc (KNSA) Earnings Call Transcript & Summary

Good day, and thank you for standing by, and welcome to the Kiniksa Pharmaceuticals Fourth Quarter and Full Year 2022 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would 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 Kiniksa's call to discuss our fourth quarter and full year 2022 financial results and recent portfolio execution. A press release highlighting these results can be found on our website under the Investors & Media section. As for the agenda, our Chief Executive Officer, Sanj K. Patel, will start with an introduction. Ross Moat, our Chief Commercial Officer, will provide an update on our ARCALYST commercial execution. Then Mark Ragosa, 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 Eben Tessari, 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 ARCALYST. 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 million 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 II study in rheumatoid arthritis, which is designed to evaluate the efficacy dose response, PK and safety of chronic subcu 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 cohort of the PK lead-in, 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 mavrilimumab 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 ARCALYST. 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 continued to deliver solid sequential quarter-on-quarter growth of ARCALYST 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 ARCALYST. 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 prescriber base who have written for 2 or more patients. Slide 8 outlines some of the key metrics and drivers of the ARCALYST growth. Since launch, we have been laser-focused on the 14,000 target population of recurrent pericarditis patients who have had 2 or more flares. At the end of 2022, we have achieved $122.5 million in net revenue by activating approximately 5% of this target population on ARCALYST treatments. This penetration demonstrates that ARCALYST is being well received. We have meaningful and growing revenue, and we continue to have a significant opportunity ahead of us. The payer approval rate in Q4 remains 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 and 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 are 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 that average total duration of therapy is now at approximately 18 months. This may continue to evolve, but what we are seeing in the commercial setting is that initially patients have stayed on treatment for around 12 months and then a high proportion, approximately 45% restarting treatment fairly quickly after trial and stop. This reflects what we know about the persistence of the disease, where 60% of multiple recurrence patients suffer for 2 years and from our clinical data showing that continuous treatment with ARCALYST throughout the disease results in long-term prevention of flares. We acknowledge that treating this debilitating and complex disease with ARCALYST 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 ARCALYST, 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 are 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 pericarditis 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 ARCALYST 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 to 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 RESONANCE, 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 pericarditis 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 that do just that. Our data are exceedingly compelling. We have an ever-growing prescriber base. Physicians and patients are reporting positive experiences with ARCALYST, and we have an excellent field team who are executing our strategy brilliantly. Looking to 2023, we expect to grow our ARCALYST net revenue to between $190 million 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 hand over to Mark to cover our financial results.

Thanks, Ross. Good morning, everyone. Over the next few minutes, I'll walk through our fourth quarter and full year 2022 financial performance and review our 2023 financial guidance. You can find our detailed financial information in today's press release, and I'd like to call your attention to a few items. First, fourth quarter total revenue was $61.9 million and consisted of ARCALYST net product revenue of $39.9 million as well as collaboration revenue of $21.9 million from our license agreement with Genentech. Full year 2022 total revenue was $220.2 million and consisted of ARCALYST net product revenue of $122.5 million as well as collaboration revenue of $97.7 million from our license agreements with Huadong Medicine and Genentech. Second, ARCALYST collaboration profit grew to $15 million in the fourth quarter and collaboration expense was $7.5 million. Full year 2022 ARCALYST collaboration profit was $36.2 million and collaboration expense inclusive of a $6 million payment related to our license agreement with Huadong was $24.1 million. Third, over the course of the year, net income benefited from collaboration revenue as well as the release of valuation allowance on noncash deferred tax assets. For the fourth quarter and full year 2022, net income was $4.5 million and $183.4 million, respectively. Lastly, turning to our financial guidance. As Ross just mentioned, we expect total 2023 ARCALYST net revenue of between $190 million and $205 million, and we ended 2022 with cash reserves of $190.6 million. We expect these reserves as well as continued ARCALYST commercial execution to fund our current operating plan into at least 2025. And with that, I'll turn the call back to Sanj for closing remarks.

Thanks, Mark. We believe there is a lot to be excited about as we move into the rest of the year. As a corporation, we're revenue producing and continue to have a profitable ARCALYST collaboration. And as both Ross and Mark mentioned, we expect a full year 2023 net product revenue of $190 million to $205 million, which represents greater than 50% growth year-over-year at the midpoint of that range. As I mentioned previously, in addition to our successful collaboration and commercialization of ARCALYST and recurrent pericarditis, we also have a pipeline of mid-stage clinical programs aimed at making a big impact on patient lives. As a reminder, we're enrolling patients in the Phase II study in rheumatoid arthritis, and we expect data in the first half of next year. Importantly, we are well capitalized. We have growing ARCALYST revenues, non-diluted capital from strategic out-licensing transactions and continued financial discipline, which all support providing us cash runway into at least 2025. Ultimately, our mission is to continue to help patients in need, create massive value and make a generational impact. And with that, I want to thank all of you for your time today, and I'll hand it back to the operator for questions.

[Operator Instructions] And our first question comes from Anupam Rama from JPMorgan.

Just a quick question on the guidance. What's that delta between the bottom end and the top end of the guidance range of $190 million to $205 million? Is it just straight market penetration, any seasonal factors we should be considering? Is it compliance, the reinitiation post dosing? What metrics you would be considering there? And then a quick second question. What type of pull-through are you seeing from the expanded sales force?

Yes. Anupam, this is Ross. So maybe I can take that question. So thanks very much for the 2 parts. I'll take the guidance one first. So we've provided guidance, which is a $50 million delta, which is the same as what we provided last year as well, knowing that there are some uncertainties, of course, of the things that you mentioned, the prescriber continued growth, growth in the fee prescribers, compliance and adherence rates as well. Also the total duration of therapy, which we announced today that is -- we're expecting 18 months' worth of duration, which is higher than what we have announced in previous calls. So I think there's multiple facets there that are important going into the guidance, which I've provided the range. And we look forward to executing against that. But the feedback we get from the field is incredibly positive. The thing that we realized is that patients are dispersed around the U.S. So we're delighted to have a 5% penetration into the 14,000 target population so far, but we've got a lot more work to do to get the message out there, create awareness, create familiarity and comfortable -- physicians to be comfortable in prescribing ARCALYST when they see appropriate patients. So we've got to keep driving that penetration throughout the year. On the sales force, we haven't really provided many more metrics around that yet. This is really our full year '22 and Q4 earnings call. And we've built the field team, we expanded field team throughout Q4 with an aim to have everyone in place by the end of that year. So it's a bit too early to kind of judge what that impact is yet. Although we're really happy with the people that we've been able to recruit at a very high number of applications into clinics to come and join our exceptional current team and are pleased with who came in. Obviously, then we completed some onboarding and training, which we were very rigorous doing as well. So that takes up some time. And then for the field to kind of be out there in the field making the difference. And we've seen an uptick in activity rates associated with that in Q4, and we'll wait to see what the throughput of that is in the results in terms of enrollments and new patients coming onto therapy as we move throughout the year.

And our next question comes from Paul Choi from Goldman Sachs.

I also want to ask a question on the guidance, particularly with regard to any sort of patient behaviors and if you had seen anything exiting the fourth quarter that might have indicated some patient economic sensitivity in the RP market. And just maybe if you could articulate how much conservatism because of this is built into your guidance? And then I have a couple of follow-up questions.

Yes. Paul, so we haven't really seen anything of note in Q4 around the kind of economic sensitivity of patients, of course, which is not our first time now in the commercial setting, gets into the end of the year and, of course, starting off Q1 as well, and we know that there's some seasonal implications in all specialty medicine around that, around changes of insurance plans, resetting of co-pays and all those types of dynamics. So we have an experienced robust patient services team on the Kiniksa OneConnect, which we set up prior to launch and have been amazing at supporting patients all throughout their journey on ARCALYST. So they have very high contract rates with the patients to understand their situations and changes to insurances and so on moving forward. So we work very closely with the patients to make sure that kind of economic circumstances like that are dealt with in appropriate way as we can and to try to support patients going on to -- going back to commercial therapy if they're provided bridge therapy and so on throughout insurance plan changes as well. So we have all those programs in place for eligible patients and look forward to continuing to support those patients to make sure that they can remain on commercial therapy.

Okay. And then I wanted to maybe just ask with the growing patient base, what your potential relative exposure in the early part of the year to the Medicare donut hole might be? And then 1 pipeline question is, maybe can you provide us just an enrollment update on 404 where you are and when you potentially expect to complete enrollment here in the dose escalation?

Thanks, Paul. So maybe I'll take the first part of the question and pass on to a colleague to talk about the next part. But in terms of the donut hole and patients that face that in the start of the year is, as I say, we've -- we've been there before and supported patients in a way that we can through that, through catastrophic coverage, which happens reasonably quickly with our type of job as well. So we just remain very close to the patients, and we have wealth of services to support them through each eventuality. So we're quite confident in having all the programs in place that we can to support patients throughout the year.

Paul, it's Eben. I'll take the other part of the question on the enrollment. Yes, what we've obviously said is that we'll have results in the first half of next year, and we're certainly on track to meet that objective and no updates.

And our next question comes from David Nierengarten from Wedbush.

I have a question on the patients who discontinue. And do they -- after treatment, of course, initial treatment, are they -- do you know or are they tending to be patients who are earlier line or less severe? I'm just trying to get a handle for the duration of therapy in patients who might be a little bit earlier line than the initial group of patients that you have treated over the past 1.5 years.

Yes. David, this is Ross. Thanks. It's a great question. And really, we need to wait for data to build on that to try to understand some of the deeper dynamics on the types of patients that maybe stopping and restarting and if there's anything, any particular trends there to be aware of. But at the moment, it's relatively early days with fairly small in size that we can't really draw very clear conclusions to at the moment. So really, our focus is on educating around the duration of the disease with physicians to make sure that they know that 60% of patients do have disease for 2 years. The median is 3 years in that particular data set that we use. And some patients have it for many years beyond that as well. It's a very long tail. So we know the importance of treating throughout the disease and to try to help physicians to understand that and play that into their thinking. What we have seen is that the approximate end of the initial treatment duration is around 12 months on average, which is probably driven by the fact that the majority of prescribers are prescribing for 12 months' worth of refills and also the payers also approving for 12 months before in general, before [indiscernible] requiring a simple reauthorization for the patients to continue longer. So of course, that does create a bit of a junction in that 12 month-ish time period where physicians and patients will consider whether to stay on therapy or trying to stop or not. And I've certainly seen some patients do try to stop. But out of all those patients that do stop regardless whether it's at the 12-month time period or much shorter or even longer than that, we see a restart in total of 45%, which I think really alludes and speaks to what we know about the duration of the disease and how persistent this disease can be. So I think people are maybe learning along the way as well and wanting to make sure that patients do get treated for the adequate amount of time so they don't have to suffer future flares.

And our next question comes from Geoff Meacham from Bank of America.

Thanks for the question. I just have a couple. So ARCALYST, another question on persistence rates. Where do you think it could ultimately go, I guess, is the question. And then when you look at new starts if you guys shorten the time to onboarding, the -- I guess the question would be like, whether you guys have shortened the diagnostic path to try to get patients on drug at accelerated rate? And then the second one for Sanj. The question is how important is profitability as a strategic objective. It is very differentiated among SMID cap peers. I wasn't sure that where this ranks as a priority for you guys in the near term.

Thanks, Geoff. Maybe I'll have Ross answer the first part, and I'll come back to the second one.

Yes. Thanks, Sanj. So maybe if I take your question around persistence rates and duration first. Yes, this is the first time we've announced that we expect the total average duration to be around 18 months. And we know that, that may well have a long tail with it due to what we know about the disease. But yes, that's a longer time period than we have previously anticipated and mentioned. And is there the ability for that to be even longer? I mean the answer is quite possibly yes, but we just need to wait for the data to build on that. We know what the initial treatment duration looks like. We know what the restart percentage looks like so far. But knowing that when you get that far out, the number of patients that we are tracking are reasonably limited. We've only been on the market for 21 months or so now. So we've tracked that with a very keen eye and look forward to sharing more information on that as time goes on. But for now, we've said that the approximate average duration will be 18 months' worth of therapy from what we've seen through to the end of 2022. The second part of your question around the diagnostic path or time through to diagnosis and then initiation on ARCALYST, again, it's difficult to tell, knowing that the patients are very widely spread throughout the U.S., and we're making very keen efforts on educating physicians, promoting ARCALYST, creating the awareness. And we are seeing that success in the prescriber rates, the number of patients on therapy and how the revenue is building. But remembering what we're doing here is ultimately building a market where we are the first and only approved therapy and we're going in and educating physicians and actually changing the treatment paradigm, which I think takes some time to do if you look at other analogs in a similar type of market space as well. And this is a rare flaring disease. So it takes some time. But we've always said we see this as a good, steady sequential launch with 5% into the penetration of the target population so far. And that's why we are exceedingly excited by the opportunity that we have ahead.

And Geoff, to the latter part of your question in terms of profitability and how important that is to us. Well, obviously, it is important to us. And that's not going to miss. But I think in addition to that and perhaps even more so, growth and increasing opportunities to increase the value are even more important. I think we've shown that we can be very disciplined as far as financial discipline is concerned, and we've shown that quarter-on-quarter. So while obviously profitability is important, we are very much focused on increasing the value. That's why we've made some of the changes we've made in our portfolio, [indiscernible] licensing that for a significant amount of non-dilutive capital. And we'll continue to be disciplined and strategic moving forward.

And our next question comes from Liisa Bayko from Evercore ISI.

Just curious on how you're thinking about gross to net for 2023. You had guided to around 10% for 2022. I know it came in more at 9%. What are you thinking for this year?

That sounds like a fantastic question for Mark Ragosa, Chief Financial Officer.

Thanks, Liisa. So as Ross mentioned, gross to net was 9% for the year-to-date. And I don't think -- while there's always some quarterly fluctuations, we do not expect big swings at this point in gross to net going forward, but certainly have not provided formal guidance.

Okay. So wait, so 9% was for year-to-date? Or was for...

Yes 2022. Yes, exactly. So year-to-date 2022.

Okay. And then just back to the patients who restarted, I want to clarify to make sure I understand what percentage of patients, I guess, discontinued therapy. Are you saying 45% of those who discontinued restarted or 45 -- like what is the 45%? I'm trying to understand what -- does that represent the patients who discontinued or those are the restart of the patients who discontinued? And if so what was the discontinuation?

Yes. So maybe I can clarify that, Liisa. The 45% is 45% of all of those patients who discontinued ARCALYST treatments for recurrent pericarditis throughout 2022. So regardless of when they stop, so even if they stop therapy after 1 month worth or the 12 months or been on therapy for longer, out of all of those who started aggregated when we look at those, those have stopped aggregated, when we look at those that restart therapy, that number is 45%. So a stop means that they've gone more than 28 days beyond when their prescription ran out or their latest refill ran out. So they're kind of 2 months on from having their last script. So classifying that as having stopped therapy. And then yes, 45% restart.

Okay. And what -- so what is the discontinuation rate then that you see?

Yes. So we haven't provided an actual number of the discontinuation rate aside from saying that the average approximate discontinuation time was 12 months across all of the patients that started. In our investors slide deck as well, we do have a graph, which shows that kind of discontinuation distribution in broad terms without specifics on it. So that gives you a little bit of a flavor there. But yes, the average is 12 months.

Okay. And then can you discuss this valuation release a little bit more? I know you quantitated, I just missed it.

Yes, sure. So I'm happy to take that. So it happened in the third quarter of this year. So if you kind of go back and go back a little bit in the second quarter, we had a full valuation allowance against our deferred tax assets as we were in a 3-year cumulative tax loss position in both the U.S. and the U.K. And then with the proceeds from the vixa license agreement plus sort of actual and forecasted ARCALYST sales, we reached a 3-year cumulative tax gain position in the U.K. And as such, we were required to release the valuation allowance on our U.K. deferred nontax -- noncash deferred tax assets. And that was the main driver of the reported $172 million net income tax benefit in 2022.

Okay. And you've had 85% compliance so far, is that pretty stable, do you think? Or do you that's going to shift around from here?

The 85% compliance rates on ARCALYST. Yes, we just said in totality across 2022, it was greater than 85% as a compliance rate. And we've got a lot of efforts into our touch points with patients to make sure that they kind of helped all the way along the journey and that they also understand the high importance of compliance and adherence to therapy, driven from our data showing the continuous treatment duration results and continuous response. So we have adherence scores and various other touch points with patients that are on therapy as appropriate. So that was greater than 85% across the totality of 2022.

And I am showing no further questions. I would now like to turn the call back over to Sanj Patel, Chief Executive Officer, for closing remarks.

Thanks, operator. Thanks, everybody, for the questions and joining the call today. We've clearly got a very exciting year ahead of us, and we look forward to providing additional updates in the future. So thanks, everyone.

This concludes today's conference call. Thank you for participating. You may now disconnect.