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spk03: Good day, and thank you for standing by. Welcome to the Connexa Pharmaceuticals third quarter 2023 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during that session, you will need to press star 11 on your phone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded, and I would now like to hand the conference over to your speaker today, Ms. Rachel Frank. Please go ahead.
spk12: Thank you, Operator. Good morning, everyone, and thank you for joining Connective Call to discuss our third quarter 2023 financial results in recent portfolio execution. Press release highlighting these results can be found on our website under the Investor 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 commercial execution. John Paolini, our chief medical officer, will provide a KPL 404 program review. Then Mark Ragosa, our chief financial officer, will review our third quarter 2023 financial results. And finally, Sondra will return for closing remarks and to kick off the Q&A session. 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 filing. 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.
spk08: Thanks Rachel and good morning everyone. I'm happy to review our third quarter 2023 financial results today. We've continued to advance all aspects of our business, including strong revenue growth with Arclist and clinical trial execution with KPL 404. On the commercial side, Q3 represented another quarter of growth for Arclist, with a net product revenue of $64.8 million. We continue to execute commercially, and we have seen strong prescriber adoption and patient enrollments in the third quarter. We also remain encouraged by the high patient satisfaction, payer approval rates, and the duration of therapy. And we're currently tracking towards the high end of our previously issued guidance of $220 to $230 million for 2023. We're also executing across our clinical development portfolio. And we have now completed enrollment of the third cohort of the phase two trial of KPL-404, which is our CD40 antagonist program. and is focused in rheumatoid arthritis. And we now expect data from cohorts one to three in the first quarter of 2024. This trial is designed to evaluate the efficacy, dose response, PK, and safety of chronic sub-Q dosing over a duration of 12 weeks. Dr. Jan Paolini will cover more details on this program in a moment. Additionally, we continue to pursue collaborative study agreements with Mabrilumab to evaluate its potential in rare cardiovascular diseases. This is a molecule that has the potential to impact a number of diseases. So with that, I'll turn it over to Ross to review our commercial execution of Arculus. Ross.
spk07: Thank you, Saj. I'm delighted to share further details on our third quarter commercial performance and the underlying drivers of our continued strong revenue growth. In Q3, the net revenue of Arculus grew to $64.8 million. This represents approximately 94% year-on-year growth and just over $10 million growth quarter-on-quarter. As has been the case since launch, the vast majority of growth this quarter came from increased demand due to a higher number of patients on therapy as a result of increased new patient enrollments and strong compliance and persistence. Additionally, the Q3 revenue benefited from a slight increase in inventory within the contracted range of our recently restructured specialty pharmacy network. The underlying driver of the continued increase in ARCALIS demand is our focus on a dual strategy of broadening the prescriber base, as well as deepening the experience within existing prescribers. This strategy has resulted in more than 1,450 individual prescribers since launch, and off that higher base, 24% have now prescribed for two or more recurrent pericarditis patients. Our payer approval rate continues to be greater than 90% of all completed cases. Patient compliance remains above 85%, and the duration of therapy currently sits in a total of around 20 months on average, may continue to evolve as more patients get towards the longer durations of therapy. Moving to slide eight, we're making good progress in continuing to build the market and change the treatment paradigm to establish Arclist as the standard of care in recurrent pericarditis. Through our experience launched to date, we've outlined several core priorities to drive our future growth. We need to drive a proactive mindset for the identification and treatment of recurrent pericarditis patients. In a Harris Poll survey, 96% of patients reported that they were incorrectly diagnosed with other conditions prior to their recurrent pericarditis diagnosis. In fact, they had an average of 2.7 diagnoses before the recurrent pericarditis diagnosis. This highlights the substantial room for improvement that's possible by advancing education on the disease. Additionally, once a diagnosis is reached, we need to evolve physicians' mindsets to be more proactive in treating earlier and preventing future flares, as well as increasing patient education on their disease and treatment options so they can advocate for themselves. Secondly, we're focused on closing the knowledge gap by increasing the awareness of our patients. We know that when Arclist is prescribed, both physicians and patients have a very positive experience. However, to continue growing the prescribing base, we need to increase knowledge within the broad cardiology and rheumatology audience. Based on a recent survey of 200 physicians, around 95% of the respondents were generally aware of Arclist. However, only half were very knowledgeable. which we interpret as having the critical information you would need in order to make a prescribing decision such as who it's for, how it works, and what the clinical data look like. So again, we have a lot of opportunity ahead. The good news is that the percentage of physicians who consider themselves very knowledgeable has been growing. And more importantly, of the physicians who were seen by a Connexer representative in the last three months, three quarters consider themselves very knowledgeable. which speaks to the impact of our sales force. Additionally, we're starting to evolve the treatment paradigm for recurrent pericarditis. While there are currently no consensus guidelines in the US, recent publications coming from thought leaders are introducing treatment algorithms that recommend interleukin-1 alpha and beta antagonism ahead of corticosteroids after a patient fails NSAIDs and colchicine. When you look at the current prescribing Around one-third of healthcare professionals report their prescribing Arcalis ahead of corticosteroids, which suggests great progress so far since launch, but still a substantial opportunity for future growth. Also encouraging is that physicians overwhelmingly report that they intend to increase their future prescribing of Arcalis, while 58% say that they intend to decrease their utilization of corticosteroids. which is exactly aligned to our positioning of ARCALIS. Based on the progress we've made to date, we believe there is significantly more opportunity to penetrate the recurrent pericarditis market. And we're excited to help even more patients who are suffering from this debilitating disease. Overall, we're delighted with our progress over the last quarter, growing both our net revenue and the profitability from our collaboration. Based on our current trajectory and accounting for the headwinds of Q4 industry dynamics and an expected level setting of inventory, we are currently tracking to the high end of the previously stated guidance range of $220 to $230 million. With that, I'll hand over to John to discuss KPL 404. John. Thanks, Ross.
spk09: The aim of the phase two trial of KPL-404 rheumatoid arthritis shown here is to evaluate the efficacy, dose response, pharmacokinetics, and safety of chronic subcutaneous dosing over a duration of 12 weeks. As Sanj mentioned, we've completed enrollment in cohorts one, two, and three of the study. Subsequently, we initiated an additional, or fourth, cohort of the study. whereas cohort three enrolled approximately 75 patients randomized in a one-to-one-to-one ratio to the five milligram per kilo subcutaneous dose level administered weekly versus biweekly versus placebo. This new fourth cohort will enroll approximately 40 patients randomized in a three-to-two ratio to a fixed subcutaneous KPL-404 dose administered monthly versus placebo. Specifically, participants in the active arm will receive a 600 milligram loading dose on day one, followed by 400 milligrams subcutaneously every four weeks for 12 weeks. We decided to initiate cohort four in order to provide a more comprehensive picture of the KPL-404 PK-PD dose relationship. This additional cohort of patients is predicted to reach a trough exposure level, which is complementary to the trough exposure levels already being tested in the other arms of the proof of concept portion of the trial. The primary endpoint remains the same as cohort three, which is change from baseline and DAS28 CRP at week 12. While this study is designed to test the efficacy of different subcutaneous dosing regimens versus placebo, we are also going to be looking at the raw horsepower of the mechanism relative to the competitive landscape. We expect data from cohorts one, two, and three in the first quarter of 2024, and data from cohort four in the second quarter of 2024. I will now turn it over to Mark to cover our financials. Mark?
spk10: Thanks, John. Our detailed third quarter 2023 financial results can be found in the press release we issued earlier today. There are a few items I'd like to call your attention to this morning. First, total revenue in the third quarter was $67 million, including ARCLIS net product revenue of $64.8 million, representing 94% year-over-year growth, and $2.2 million of collaboration revenue from the Genentech license agreement for VixarillaMAP. Second, strong ARCLIS net product revenue in the third quarter drove ARCLIS collaborating operating profit to $34.6 million, representing more than 275% year-over-year growth and leading to collaboration expenses of $17.3 million. Third, higher cost of goods sold and collaboration expenses, both of which were driven by our revenue growth, as well as advancement of the KPL-404 Phase II trial in rheumatoid arthritis, and investment related to ARCLIS commercialization contributed to year-over-year operating expense growth for the period. Lastly, in the third quarter, we received the $15 million development milestone from Genentech that was disclosed and recognized as revenue in the second quarter of this year. This led to net cash flow of $16 million for the third quarter and an ending cash balance of $201 million. We continue to expect these reserves as well as strong ARCLIS commercial execution to fund our current operating plan into at least 2027. And with that, I'll turn the call back to Sanj for closing remarks.
spk08: Thanks, Mark. As you've heard today and as demonstrated by our consistent execution, we are a well-capitalized and highly growth-orientated company. We're focused on maximizing the commercial opportunity with Arclist, as well as providing data from cohorts one, two, and three of the phase two clinical trial of KPL-404 in rheumatoid arthritis in the first quarter of 2024. In addition to the potential in our array, we believe KPL-404 could be a best in class therapy across a number of autoimmune indications. Given the company's cash reserves of $201 million, strong Arclist commercial execution, and our financial discipline, we have a cash runway into at least 2027. Ultimately, we continue to be focused on helping patients in need, creating massive value, and making a generational impact. And we believe we are strategically positioned to do exactly that. I do want to thank you all for your time today, and I'll now hand it back to the operator for questions.
spk03: Thank you. Thank you. As a reminder, to ask a question, please press star 1-1 on your phone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Stand by as we compile the Q&A roster. One moment for our first question. Our first question will come from Anupam Rama of J.P. Morgan. Your line is open.
spk06: Hey, guys. Thanks for taking the question, and congrats on all the progress. I'm wondering maybe what are you seeing on the pull-through from the Salesforce expansion for ArcList, and how are you kind of quantifying the return on investment there? Thanks so much. Thanks, Adam.
spk07: Good to hear your voice. Ross, do you want to start, and I can always jump in? Yeah, I mean, thanks for the question. I think I just started saying, you know, you can see from the last couple of quarters worth of revenue performance where we've had a pretty robust growth. I think a large part of that is down to the Salesforce expansion that we did towards the end of last year. And we said, you know, by the time that teamwork. in place and trained and we changed the territories around and had handovers. We saw a jump up in activity in the late stages of last year and the early parts of this year, and then an increase in patient enrollments associated with that higher activity. And then really from the Q2 sales, where we saw a growth of more than $11 million in its most recent earnings, a growth of over $10 million. we're starting to see some of the fruition of that hard work out there in the field. And I think it just speaks to the potential that's out there, but also the spread of the current pericarditis patients, the importance of getting out broadly to the cardiologists and rheumatologists.
spk06: Thanks so much.
spk02: Thank you.
spk03: One moment, please, for our next question.
spk04: And our next question?
spk03: One moment. Our next question will come from the line of Paul Choi of Goldman Sachs. Your line is open.
spk05: Hi. Thank you. Good morning, and thanks for taking our questions. My first question is for John with regards to the addition of the Cohort 4 to the KPL 404 study. The loading dose and the two other doses are higher than you're generally testing with the other weekly or every other weekly cohorts. So can you maybe just characterize for us, is there a view that you need to increase exposure here, or given the monthly dosing schedule, is it more of a test to see if you can improve on convenience relative to the other cohorts? My second question is for Ross, just with regard to his comments on misdiagnosis and the lack of treatment guidelines. Can you maybe just update us on what the status is of potentially getting either a consensus ACC or AHA guideline inclusion and just kind of what the timing and gating factors are for that? Thank you.
spk09: Sure. Good morning, Paul, and thanks so much for your question. So with regard to cohort four, yes, the approach was to provide a more comprehensive picture of the PK-PD relationship. But to be clear, the weekly and biweekly KPL-404 dose levels actually provide plasma concentrations that are higher. So actually, the 400 milligram Q4 week dose sits in between the 2 milligram per kilo sub-Q dose and the 5 milligram per kilo sub-Q dose. thinking, remembering that 5 milligrams per kilo is roughly 350 to 400 milligrams absolute, depending on the weight of the patient. And so this actually provides us an opportunity to test not only that intermediate trough plasma concentration, but also, to your point, to test the different dosing interval of giving it every month, which is, as you mentioned, more convenient. And so that's basically the approach, and the 600 milligram loading dose allows us to get to that trough plasma concentration quickly. And then, yes, the 400 milligrams every four weeks allows for the attainment of that trough plasma concentration, which is in between the other three. Okay, and then Ross, did you want to start with the and then I'll pick up from there?
spk07: Yeah, thank you. Thanks, Paul. So, maybe I'll start with your misdiagnosis question and have back on to John for the treatment guidelines. So, I think for the misdiagnosis, obviously, we shared some information and how commonplace that can be among this patient population. And I think that. really speaks to the need for education and awareness that I think we're taking good strides in, but have so much more to do. We're seeing substantial increases around the awareness of recurrent pericarditis, and I guess previously there were no targeted therapies approved for recurrent pericarditis, so now we're in a different place. I think we're starting to see the ramp up of education and awareness, and hopefully we'll see improvements to the time that it takes for patients to get a correct diagnosis. So we're focused across both our field team from a sales perspective, our medical affairs efforts out in the field, boosting education to physicians, direct to consumer awareness around doing things directly to patients so they can help to advocate for themselves. as well as just in the digital forum around webinars and speaker programs and various other ways that we can get messages out there very effectively across the populations as well. So we're seeing some good improvements to that, but certainly have a lot more work to do. John?
spk09: And then with regard to guidelines, maybe to point out that the last time guidelines were made was in 2015, and that was in the European Theater, so the European Society of Cardiology put those guidelines out, and of course, that predates really almost any of the work in the IL-1 space. And so, in that treatment paradigm, patients progress after NSAIDs and colchicine through corticosteroids, and then it's only in patients that are resistant to corticosteroids that IL-1 antagonism is used. So, therefore, the real evolution in the field came with the data from Rapsody demonstrating not only the resolution of the acute pericarditis flare, but also the prevention of subsequent flares while on therapy in two populations of patients, not only those who had been on corticosteroids, which is according to the old paradigm, but also about half of the patients in the study had failed NSAIDs and colchicine and had not yet progressed to corticosteroids. And so the similarity of the data in those two populations actually then provides an opportunity to advance the treatment paradigm into this space of using IL-1 antagonism in advance of corticosteroids. And so that is in fact what has been picked up in the literature by American thought leaders you know, in showing kind of that sequence of how to best manage the disease. And so, we see that as a very encouraging sign for patients, you know, to achieve, you know, resolution of their acute flares and prevention, you know, of subsequent flares on therapy. Okay.
spk04: Thank you. Thank you.
spk03: And one moment, please, for our next question. Our next question will come from David Neeringarten of Wedbush Securities. Your line is open.
spk00: Hey, thanks for taking the question. I had two. Just on the patient stops and restarts again, with another quarter worth of data, do you have any idea on the patients who discontinue therapy and don't return if there are you know, less severe or earlier stage in their disease. I'm just curious to get kind of a handle on the distribution of time on therapy. I know it seems like you have a tail there with a stable percentage on longer-term therapy, but I'm curious on the nature of those patients. And then the second question was on 404, if if we could expect discussion of any additional indications beyond RA when you release the data in Q1. Thanks.
spk07: Okay. Thanks, David. This is Ross. Happy to answer the part around the restarts, patient stops, and I guess just generally about what we're seeing around patient duration on therapy as well as a reminder that we We really educate physicians that the duration of therapy should be linked to the natural history of the disease, which is three years as a median from the natural history, and still one-third of the patients suffer from the disease five years out from their initial index episode as well. So, of course, the length of treatment should depend upon how long they've suffered from recurrent pericarditis at the time of diagnosis and treatment. And what we're seeing in the real-world setting is that the initial average time for treatment is around 14 months. The median is 12. The restart rate is around 45% of all those patients who have ceased therapy the first time around and come back onto therapy, most of which within an eight-week time period. And we're seeing a total average duration of around 20 months in total across all the patient populations. So you're part of the question around the nature of the patients. I think it's fair to say that there's no real commonality in terms of patient demographics that we can pick out at this moment in time around those that are more likely to stop or stay on for longer and so on. It really just comes down to how long they've suffered from the disease at the time of diagnosis and what their expected natural history is, how long they're going to need treatment for with Arcalis. Um, knowing that, of course, there's always a safety net there that if they do stop and they stop too early, and they're still underlying auto information presence or patients suffer again, they can go back on to treatments. But obviously, we want to avoid that happening through through robust proper treatments duration of our list in the first place.
spk08: David, this is Sam. Thanks for your question with regards to the cohorts. from the KPO-404 study in RA. We're definitely looking forward to those data from courts one, two, and three in the first quarter, as you mentioned. Now, as I mentioned earlier, we're definitely excited about the potential of KPO-404 in both RA, but also do believe there is a potential to show, hopefully, some differentiated effects and some strong efficacy, hopefully, across a number of autoimmune indications. At this point, we've not disclosed what those would be, but certainly watch your space. We're looking forward to some hopefully exciting developments in the future, data dependent.
spk04: Thank you. And one moment for our next question. Our next question will come from Jeff Meacham of Bank of America.
spk03: Your line is open.
spk01: Hey, thanks for giving me the question. This is John Joy for Jeff. I guess I have two quick questions. One is, you know, how are you guys thinking about sort of total prescriber TAM and payer like TAM? Do you think there's still headroom to grow or are you starting to kind of see that flatten out a bit? And second, just as you continue to grow, how are you thinking about capital structure?
spk07: Maybe I'll just take the first part, John. Thanks for the question. And then I'll hand over to Mark or Sanj for the second bit. And really around the prescriber growth and I just bear in mind that we still see that there's a huge opportunity ahead. We announced at the turn of the year that we had reached around 5% penetration when we looked at how many patients were on therapy at the end of 2022. And while we haven't updated that figure as of yet, that speaks to the opportunity that's still there and the fact that patients are reasonably widely dispersed around the U.S., and we're seeing the good growth in both the number of individual prescribers as well as the repeat prescribers, I think all speak to the opportunity that's still out there. I feel that we're still relatively embryonic in our launch with a pretty exciting opportunity ahead to reach many, many more recurrent pericarditis patients who are suffering.
spk10: Yeah, and I guess, you know, to your question regarding are thinking on capital. I mean, we think we're very well capitalized. As I mentioned, $201 million in reserves at the end of the third quarter. You know, at the end of the day, you know, our runway, which we got it to having cash until at least 2027, you know, the ultimate timeline depends upon the success of our current and future investments and sort of, you know, any future investments that are spawned from the original investment. So we feel very confident in our runway and, you know, in our cash reserve base of 201 at the end of the quarter.
spk04: Great, thanks.
spk03: Thank you. One moment for our next question. Our next question will come from Lilsa Baker of Evercore ISI. Your line is open.
spk11: Hi, thanks for taking my question. Can you maybe quantitate a little bit more the amount of inventory changes that you're seeing and how that's contributing to kind of, I guess, what seems like a flat quarter of a quarter into the fourth quarter. But I know this is offset by some inventory changes. So if you could quantify that, it'd be helpful. Thank you.
spk07: Yeah, that's right. In some regards, Lisa, this is Ross. So maybe I'll go through that a little bit. I mean, we continue to see robust performance across all the key drivers of the commercialization. And as I said, we believe we've still got a huge potential ahead. But when we look at the growth that we had in Q4 and thinking forward to the end of the year, to be very clear, we expect continued growth in Q4, despite a couple of expected headwinds and those being firstly related to some pressure on our gross to net in Q4. And that's driven from a couple of things. Firstly, from end of year accounting for insurance resets and increases to copay assistance. So they're really kind of industry-wide items in specialty medicine, but as well as changes that we've had to our specialty pharmacy network, which may drive a slightly higher gross to net in Q4. And secondly, we're expecting inventory to level out in Q4 following some of the favorability we had in that regard under the prior quarter of Q3. So we expect some additional pressure to the magnitude of the Q4 revenue growth, but certainly still expecting revenue growth in Q4. And as we said, we are tracking to the high end of the guidance we provided.
spk11: Great. Can you just quantitate the inventory change a little bit more? Amount are we talking about and then also what we're grossing as a third quarter? Thanks.
spk07: Yeah, so we haven't really quantified the imagery amount, but what we have said is that the, the, the majority, the vast majority of the growth comes down to having a higher number of patients on therapy has really been the key driver of all of our quarters worth of growth since the time of launch. So that's the vast majority and then to a smaller level, there's a little bit of inventory dynamic there, as we've mentioned. Gross to net year-to-date is 9.9%, and that's versus 9% in 2022. So there's always some quarterly fluctuations, but that's where we are at 9.9% so far this year. Thank you.
spk02: Thank you.
spk03: I am seeing no further questions in the queue. I would now like to turn the conference back to Sanj Patel for closing remarks.
spk08: Thank you very much for the questions and joining the call today. We clearly have an exciting time ahead of us and very much looking forward to providing additional updates in the future. So until then, thanks very much.
spk03: This concludes today's conference call. Thank you all for participating. You may now disconnect and have a pleasant day.
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