Amgen Inc. (AMGN) Q4 2021 Earnings Report, Transcript and Summary

Dr. Thomas Schall - Chairman, President and Chief Executive Officer Susan Kanaya - Executive Vice President, Chief Financial and Administrative Officer Tausif Butt - Executive Vice President, Chief Operating Officer Bill Slattery, Jr. - Vice President of Investor Relations & Corporate Communications

Good afternoon, and welcome to the ChemoCentryx's Fourth Quarter and Full Year 2021 Financial Results Conference Call. At this time all participants are in a listen-only mode. [Operator Instructions]. As a reminder, this conference call will be recorded. And I would now like to turn the call over to Bill Slattery, Jr., Vice President of Investor Relations & Corporate Communications at ChemoCentryx. Mr. Slattery, please go ahead.

Thank you, operator. Good afternoon and welcome to the ChemoCentryx Fourth Quarter and Full Year 2021 Financial Results Conference Call. For those of you I have not yet met, I recently joined ChemoCentryx as Head of Investor Relations & Corporate Communications. My contact information can be found at the bottom of the press release we issued earlier this afternoon, providing an overview of our financial results for the quarter and year ended December 31, 2021. The press release, along with a slide deck that you may find helpful while you listen to this call are available on the Investor Relations section of our website at www.chemocentryx.com. Joining us on the call today from ChemoCentryx are Dr. Thomas Schall, President and Chief Executive Officer and Chairman of the Board; Susan Kanaya, Executive Vice President, Chief Financial and Administrative Officer; and Tausif Butt, Executive Vice President and Chief Operating Officer. Tom and Susan will make introductory remarks before we open the call to your questions. During today's call we'll be making certain forward-looking statements. As explained on slide two, these forward-looking statements are based on current information, assumptions and expectations that are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These risks are described in the company's filings made with the Securities and Exchange Commission, including our Annual Report on Form 10-K filed on March 1, 2022. You are cautioned not to place any undue reliance on these forward-looking statements, and ChemoCentryx disclaims any obligation to update such statements. In addition, this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, March 1, 2022. ChemoCentryx undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this live conference call. I will now like to turn the call over to Tom.

Thank you, Bill. Good afternoon to everyone listening. Thank you for joining us. Please move to slide three in our presentation. Today I will cover three important topics that highlight our recent success and outline the significant milestones we expect throughout 2022. First, we'll take a look at our progress in the early weeks following the U.S. launch of TAVNEOS in ANCA-associated vasculitis. Second, I’ll update you on our plan to broaden TAVNEOS into our pipeline and our drug, including next steps that we expect to take at Lupus nephritis, severe hidradenitis suppurativa and C3 glomerulopathy. And third, we’ll discuss recent progress we’ve made and next steps for our unique, orally active, small molecule PD-L1, PD-1 checkpoint inhibitor CCX559 for which we expect initial Phase I data this year. Moving to slide four, you can see that 2021 was an historic year in our corporate journey. After over 20 years since the founding of ChemoCentryx we've navigated the uncertain and uncharted territory at the frontiers of science, and achieved our longstanding goal of bringing our first medicine to patients, suffering from a devastating and debilitating disease. Following FDA approval, we launched TAVNEOS as an adjunctive treatment for use in patients with severe active ANCA-associated vasculitis on October 18, leaving us 51 business days in the quarter r post launch. As we launched, we took a final step in our vertical integration. We now constitute and integrate U.S. biopharmaceutical company that discovers, develops and now markets innovative medicines of our own devising. It was a long and arduous journey to get here with some 17 years working on the TAVNEOS program alone. But the human rewards in bringing something truly different, to under serviced people, such as those enduring ANCA-associated vasculitis have made it all worthwhile. January of this year brought another significant advance with the EU approval of TAVNEOS. This means that TAVNEOS is now approved in the U.S., in Europe and Japan for ANCA-associated vasculitis indications. Further European approval triggered a milestone payment of $45 million from our partner Vifor Pharma. We are pleased to share that Vifor launched TAVNEOS in Germany on February 15 of this year, with additional territories expected in the first half of 2022. As a reminder, Vifor will pay ChemoCentryx royalties in the teens to the mid-20’s on ex-US sales of one aggregate net sales line. Back to the United States as shown on slide five, we set out to develop our commercial infrastructure in the months leading up to approval, including the hiring and meticulous training of professionals in medical science liaison physicians, as a sales representative, and in other key roles. As we approached the launch, our initial marketing focus was multi-faceted by design. First and foremost, we sought to educate physicians on the TAVNEOS approved label and supporting clinical data, raising awareness through a hybrid approach of in-person and virtual meetings that provided flexibility in these times of COVID. Through our commercial team, we are initially focusing on the top prescribing physicians. We calculated that a combined field force of about 75 would sufficiently cover the approximately 3,400 clinicians, comprising key external experts, top prescribers and community specialists who collectively are responsible for roughly 80% of all ANCA-associated vasculitis prescriptions in the United States. Further, we recognize the importance of working closely with patients, listening to advocacy groups and other active voices in the vasculitis community that it welcomed the arrival of a modern, orally administered and mechanistically targeted medication, which was designed from the start with their disease at mind. Too often orphan diseased patients seem to feel that they languished in a seldom visited treatment backwater, receiving occasionally repurposed drugs that may provide benefits to their condition, but were not designed specifically for that purpose. TAVNEOS was and is different. Now through branded campaigns we plan to educate appropriate patients on the TAVNEOS safety and efficacy profile, while also employing unbranded campaigns to provide disease awareness. These efforts are designed to support patients in having appropriate conversations with their healthcare professionals. Through these mechanisms we have activated a continuous positive feedback loop that will help inform our actions as we move forward, soliciting and obtaining prescriber and patient experiences in order to support continuous improvement of our commercial and outreach efforts. Let us now move to slide six. As we reflect on our first few weeks post U.S. launch. I am pleased to report encouraging progress. While the headline number is the top line revenue for Q4, which came in at approximately $1 million, including limited channel supply for our agreements with specialty distributors and specialty pharmacy selling TAVNEOS, we have stated before that we believe the best way to track our progress for the first few quarters is by focusing on three key performance indicators. Specifically during the fourth quarter, these metrics include the following: We received 127 patients start forms or patient referrals from 102 unique prescribers. At the end of Q4, there were 90 patients on drugs and the conversion rate of patient start forms, to patient on drugs was 71%. The result in these key metrics, mark promising progress for a rare disease such as ANCA-associated vasculitis, especially when considering that the launch took place mid-quarter preceding a major holiday season and that was of course impacted by the arrival of an Omicron wave of COVID even before the Delta surge had finally end. As we move through the current order, which will eventually be the first full quarter of commercial activity. The leading indicators are favorable for our expected upward growth curves. Moving to slide seven, we have superimposed the progress across key metrics from the beginning of the first quarter, i.e., through January. Accordingly, between the launch and January 31, we received 179 patients start forms from 140 unique prescribers and there were 141 patients on drug, representing the 79% conversion rate for patients start forms of PSFs. Since we are still at quite an early stage, I will also share with you today more largely qualitative color and context and we expect to give you a future quarters, when the qualitative - I'm sorry when the quantitative data will paint a more complete picture than it does today. On side eight for example, let us look at some of the prescribing patterns that we are seeing. Through January 31, as it relates to what types of physicians are prescribing TAVNEOS we estimate 66% of the prescriptions are coming from Rheumatologists, 28% from Nephrologists and 6% from other treating physicians, such as pulmonologists. As it relates to where these referrals are coming from, while we are pleased with the traction across centers of excellence, we are particularly enthusiastic about the in-roads we made within the community setting as well. This success is in-part a testament to our commercial teams reach, supplemented by the unaided awareness of TAVNEOS that has continued to blossom, since the advocate trial pivotal results were initially released in the New England Journal of Medicine last year. We are also pleased to share that approximately 33% of positions are repeat prescribers, through January 31. We believe this suggest physicians are having positive first experiences, which we hope to continue to build upon. Additionally, the time it takes to convert patients start forms, to patients on reimbursed medication is now tracking in line with our expectations, taking approximately four weeks to obtain a payer coverage decision, which we anticipate will continue to decrease over time. What's more, initial feedback from healthcare providers suggest that they are experiencing success now in obtaining reimbursements based on prior authorization, and if necessary appeals for appropriate patients who meet the criteria outlined in our FDA approved label. As these patients await coverage decisions, we have provided mechanisms for immediate access to treatment for eligible patients through or support program. While we continue to support access per plan via such patient support programs, we are now seeing an ever greater share of paid models as the launch progresses. Having launched into the unique environment, I’m very pleased with our progress to-date. Apart from the obvious constraints on the availability of in-person as opposed to virtual visits, whether by our reps to physicians or by patients to physicians the Omicron wave led to staff shortages amongst healthcare workers, which in turn means that physicians continue to face capacity challenges seeing their patients in person. We acknowledge that this is not a phenomenon unique to ChemoCentryx and in any case we plan for an orderly progression in the quarters following the launch, rather than a bold list of early patients which could have distorted the true growth picture. In short, we believe that TAVNEOS has the potential to become a blockbuster drugs at peak in our first indication alone. In the meantime, I look forward to updating you again in a couple of months when we release our full Q1 results. Let us now turn to slide nine, where we will look beyond our current commercial efforts. We have an exciting year ahead from a clinical development perspective as we aim to expand our patient reach by developing TAVNEOS as a pipeline and a drugs and also by advancing our novel-orally administered PD-L1, PD-1 checkpoint inhibitor known as CCX559. In 2021 as you know, we prioritized and focused on ANCA-associated vasculitis approval. In Q4 we were busy building up a New World class clinical development organization led by Dr. Rita Jain who joined ChemoCentryx full time in October as our Chief Medical Officer, in addition to her role as Director on our Board, a position she has held since March of 2019. Dr. Jain has enjoyed a distinguished medical academic and corporate career, and is an outstanding leader to take our development efforts to the next level. She will also oversee the post marketing studies on TAVNEOS in ANCA-associated vasculitis which is likely to yield useful supplementary data of interest to physicians and payers. Moving to slide 10, the biological rationale for TAVNEOS across several underserved inflammatory and autoimmune disorders is compelling, given us unique ability to selectively inhibit the C5a receptor, preserving other functions and components of the immune system. I will remind us, TAVNEOS was designed to be an anti-inflammatory agent based on its mechanism of action and not broadly immuno-suppressant. Throughout 2022, our focus includes three indicating, lupus nephritis, severe hidradenitis suppurativa and C3 glomerulopathy. First, we plan to meet with the FDA to discuss our plans for lupus nephritis, a disease in which uncontrolled complement activation has been implicated in kidney destruction. Once steps have been agreed upon, we anticipate initiating a clinical development program for TAVNEOS in patients with lupus nephritis in 2022. This should be followed in close order by another meeting with the FDA to discuss our plans for a pivotal Phase III trials of TAVNEOS in patients with severe hidradenitis suppurativa or HS, which we hope to initiate in the second half of this year. As you will recall, in our Phase II AURORA trial in HS, TAVNEOS showed a statistically significant improvement over placebo in a pre-specified subgroup of early stage 3 HS patients. To investigate and understand that clinical result, our research at ChemoCentryx has now provided evidence for clear differences at the molecular, the cellular and the histological level between more moderate HS disease for example early Stage 2, versus severe or early Stage 3 HS, a key differentiating feature appears to be a greater involvement of the C5a, C5a receptor access in early Stage 3 disease, versus milder forms of HS. Our data will be discussed at the upcoming dermatology conferences this year. As for C3G, later in 2022 we plan to meet the FDA to discuss our accolade trial results of TAVNEOS in the very rare kidney disease or C3 glomerulopathy data from which we have here previously. The accolade trial with the largest, blinded randomized controlled study conducted to-date in this indication, and we are keen to review the effects demonstrated in this study with the FDA, such as the evidence for slowing of fibrotic progression indicated by the endpoint of the C3G histologic index of disease chronicity and other effects seen with TAVNEOS administration. We don't propose to invest in additional large scale clinical work in C3G in the absence of some defined path forward by which TAVNEOS might be used as this indication, due to the long and costly nature of such trials involving for example, serial kidney biopsies, at baseline at other time points, along with the challenges of patient recruitment in this very rare disease. We are hopeful that the data will inform a positive discussion with the FDA and this potentially life threatening disease for which there are no approved therapies. Last, let me say a few words about CCX559. Our potent orally administered PD-L1/PD-1 inhibitor which entered first in human studies into Q3 of 2021. As seen on slide 11, after dosing multiple cancer patients, we can confirm that the drug is poorly absorbed well at levels that are approximately proportional to dose, and appearing generally well tolerated to-date. Additionally, a number of indicators confirm that immune cell activation is occurring. Given the physical limitations of large molecules, that is anti-checkpoint antibody therapy example, which may not penetrate the tumor microenvironment well, a small molecule medication has the potential to establish itself in several niches in what many believe could be a fairly short time frame, providing a beachhead from which we could substantially expand clinical development on CCX559 in this very valuable area. We plan to present initial data from the dose escalation phase of this CCX559 Phase I study in upcoming oncology meetings starting with the AACR in April and we expect to enter a phase Ib/II clinical trial in the second half of this year. With that, I'd like to turn the call over to Susan Kanaya to outline our healthy financial situation heading into 2022, which is sufficient to progress our TAVNEOS launch efforts as expected for the [inaudible] activities. Susan?

Thank you, Tom. Our fourth quarter and full year 2021 financial results were included in our press release today and are summarized on slide 12. Total revenue for the fourth quarter and year ended December 31, 2021 were $2.3 million and $32.2 million, compared to $4.4 million and $64.9 million in the same period in 2020. TAVNEOS U.S. net product sales were approximately $1 million for the fourth quarter and full year 2021. Product supply revenue contributed $1.3 million and $1.8 million for the fourth quarter and full year 2021 respectively. Collaboration and license revenue was $29.1 million for the full year of 2021 compared to $64.4 million in 2020. Cost of sales for the fourth quarter and full year 2021 was $302,000. Cost incurred from manufacturing campaigns initiated prior to the October 2021 FDA approval of TAVNEOS were recorded as research and development expense. Research and development expenses were $18.8 million for the fourth quarter of 2021, compared to $21.2 million for the same period last year. Full year 2021 research and development expenses were $83.0 million, compared to $77.9 million in 2020. These increases were primarily attributable to the manufacture of commercial drug supply in anticipation of the launch of TAVNEOS in ANCA vasculitis and higher research and discovery expenses, including those associated with the development of CCX559. Selling, general and administrative or SG&A expenses were $23.3 million for the fourth quarter of 2021, compared to $12.7 million for the same period in 2020. Full year 2021 SG&A expenses were $78.9 million compared to $42.2 million in 2020. These increases were principally due to higher employee-related expenses associated with commercialization planning efforts and the launch of TAVNEOS in 2021. Net loss for the fourth quarter and full year 2021 were $40.5 million and $131.8 million, compared to net losses of $29.9 million and $55.4 million for the respective periods in 2020. Total shares outstanding as of December 31, 2021 were approximately 70.4 million shares. We closed 2021 with approximately $352.3 million in cash, cash equivalents and investments. This year-end balance excludes the $45 million milestone for the EU approval of TAVNEOS received from Vifor in the first quarter of 2022. Lastly, for 2022 we expect to utilized cash and investments in the range of $120 million to $140 million. Tom?

Thank you, Susan. Moving to slide 13, before opening up to your questions, let me briefly summarize where we are. After a watershed year in which ChemoCentryx arrived upon the world stage as an integrated bio pharmaceutical company, we have positive feedback from the TAVNEOS launch and the leading indicators of further growth are favorable. We are focusing on our pipeline in a drug approach for TAVNEOS, aided by a world class clinical development function and have advances of lupus nephritis, severe hidradenitis suppurativa (HS) and C3 glomerulopathy in our sites for 2022. CCX559 is progressing through Phase I with initial clinical data to be presented this year and we are in a strong financial position to execute right across the scope of our enterprise. As we join the ranks of commercially integrated U.S. biopharmaceutical companies. I am happy to report that the landmark here of 2021 has positioned ChemoCentryx well. Our enterprise has traveled far to bring the benefits of medical innovation to clinicians and especially the patients that we serve. We’re also aiming to provide returns for our shareholders. And as momentous as 2021 was for the company, we have only just begun. I will now turn the call over to the operator for your questions. Operator.

Thank you, sir. [Operator Instructions] Our first question comes from Steven Seedhouse of Raymond James. Your line is open.

Hi there! This is Ryan Deschner on for Steve Seedhouse. I just want to ask, if you guys can give us anymore quantitative detail on patient start forms or on the demand in general seen in the month of February relative to January ’22. And then also, when do you expect to reach a majority proportion of paid scripts. Thank you.

Yeah, so thanks very much for that question. So we're not providing progress beyond the additional month of Q1 just yet, but again to remind you through January the patient start forms reached 179; patients on drugs reached 141, representing almost an 80%, 79% conversion rate, and we had 140 unique prescribers. So I think we're quite happy with that conversion rate. That’s accelerating over where we were in Q4, which indicates to us that physicians are having success getting patients on therapy. We're also happy to see 33% repeat prescribers, which suggests to us that physicians are having a positive first experience. And further, we're – we see the time to coverage decisions are down now to approximately four weeks on average, and that's down from our initial expectation of four to six weeks. So all those indicators are going in the right direction and I think we're pleased with that. We have an increasing number, an ever increasing number of paid prescriptions as we go forward, and again, we imagine that early on we were making an investment in the patient support programs appropriately to get eligible and appropriate patients on the drug as quickly as possible, with as few barriers, and we think that investment will pay off, and in future quarters I will tell you just how big that ever increasing percentage of paid prescriptions will be.

That’s helpful, thank you very much. And actually if I can squeeze one more quick one in. How many scripts does each patient receive on average; sort of a one for three months’ supply off the bat or how does that work? Thank you.

So essentially we have one month’s prescription and then we renew those.

Okay, thank you very much.

Welcome.

Thank you. Our next question comes from Dae Gon Ha of Stifel. Your line is open.

Good afternoon! Thanks for taking my questions. I’ll stick to one question, but a multipart one if I could if I may. So with regards to the separate, I guess your market research, 66% being Rhum’s and 28% being nephrologists. I guess how are you thinking about marketing wise strategically targeting nephrologists to gain a broader following in that cohort. And also as you think broadly about sort of the feedback you were getting from both, rheumatologists and nephrologists, is there any kind of reluctance or more, I guess stronger affinity by one group of doc's versus the other? Thanks.

Thank you, Dae Gon. Yeah, you know it's true we see more rheumatologists, maybe slightly more than we might have modeled. Having said that, these are very complicated patients and frequently they see more than one specialist, where – and again, not infrequently their primary doctors are rheumatologists. So even if they have kidney manifestations and are seeing a nephrologist, they will go back very frequently to the rheumatologist and as who writes – that’s who is writing the script. So I think that that explains in part some of that predominance of the rheumatology part of the equation. Having said that, we're very keen on helping nephrologists as well understand the benefits of the drug. As you know published data suggests that it has a quite marked effect on eGFR improvements, and I think that as the experience in the nephrology community expands and we've already heard some interesting first experiences in nephrology cases and when you start hearing about those either peer-to-peer or at major upcoming meetings in Europe and the United States, I fundamentally think you'll get a lot more attention from nephrology. I’d also say this, look, it's quite early days and this – the now, the preponderance of rheumatology script writer's versus nephrology may in fact be somewhat exaggerated at this early point. So we'll just have to see how that goes going forward.

Tom, I'm really sorry. If I can squeeze in one more question, the January trend that you provided today does seem like there is some sense of acceleration in terms of PSS and POD’s. So can you maybe speak to what you're seeing there and the dynamics and to what extent has omicron been still a headwind if you will as you commented two months ago at a competitor conference. Thanks.

You're absolutely right. Look, I think the acceleration looks good. I mean in January alone what did we add, about 50 more patients start forms, so you have 152 and about 50 additional patients on drug just in January alone. Those are really good trends, right. So those things are things that I'm very happy with. Look, let's talk about COVID. COVID is and will be a major factor for all of us and for some time to come. No matter what happens with the current wave of omicron, even if it disappeared tomorrow, nothing is going to change quickly and how COVID has impacted how we can interact in clinical settings, not just we as sponsors, but patients and physician as well. So we can't be naive about that, that's for sure. Having said that, you know I think that despite launching TAVNEOS in Q4 into like a sub quarter and major holidays and the omicron emergence, I think we were really pleased even with the Q4 trends at the breadth of the TAVNEOS prescribers, which includes not just the so called external experts, but the community physicians as well, and yes, both in rheumatology and nephrology. So look, it has impacted, COVID has and omicron has impacted certainly MSL access and Rep access to sites, especially at the large academic centers or centers of excellence. About 40% of our calls have been in-person and even in January so far with even a bit less than 40%. But that's okay; we planned for virtual visits to continue; we had planned when we were launching to have a hybrid approach. Our team has the tools needed to connect either in-person or online, so we hope that we'll be able to be providers when, how and where they need to be met. So I think overall we got the situation well in hand.

Great! Thanks for taking my questions and congrats on all the progress.

Thank you, Dae Gon.

Thank you. Up next we have Michelle Gilson of Canaccord Genuity. Your line is open.

Hi! Thank you for taking my questions. I guess Tom, just wanted to clarify, the numbers of patients on drugs, that's not necessarily patients on paid drug, right?

No, that’s correct.

Okay, and then…

That would be all patients on drug at this point.

Alright, sounds good. And then, could you kind of walk us through you know the timeline of patients of the submission of start forms, to beginning of treatment, and then you know – did you give – I don't think I heard you give us any numbers on like kind of the average time that you're seeing reimbursement. And you know could you also maybe Tosh, one for you. Could you outline for us your strategy around positioning and you know what your core messaging is to physicians around TAVENOS and selecting appropriate patients.

Excellent timed question Michelle. Let's try to take it all in sequence there. So we have – you're quite correct. Patients on drugs includes all patients on drugs, including those that benefited from our patients spot programs and patient assistance programs. Now you will recall maybe from previous discussions that we had very carefully considered our plan to make sure we were trying to remove as many barriers as possible or early and immediate access to drugs for eligible and appropriate patients, those who are eligible and early, right. So that's why, early on we knew that the patient support programs, including patient assistance where there is the ability to get on temporary supplies of unpaid medication was so important, and one of the reasons that we continue to indicate that our metrics in the early quarters are most importantly patient start form, patient on drugs and conversion rate. And then that, the revenue line will lag a little while, but overall we believe that lag will be much higher because of these early investments through patient support programs. So the number of paid folks as we go along grows and that's a trend we're seeing through Q4 and into the, as I mentioned – into the early parts of Q1 where we've analyzed the data quite closely. Now the time therefore to get people on drugs, again by design, is as we can provide that support and provide services to clinics and patients, can be very short, because again patients assistance can happen before the time that a decision is made on getting the coverage inactive, so that's important. We have noticed again, that the time to getting coverage is now dropping as an average, it's about four weeks, but you know it’s a wide range. It can be like basically the same day up to several weeks, but about four weeks. So that's a figure that I mentioned, and that's very reasonable because patient access and patient support programs are really designed around that sort of four week window at this early phase of the launch. So I think all of those are clicking in nicely with the program we designed and the metrics are coming out as if the performance in the real world is mirroring fairly well our model performance. And Tosh, I will turn it over to you for the other part or parts of that question of Michelle about message points for HCPs, etc.

Thank you, Tom. So Michelle, I’ll have a crack at your question. So now in terms of positioning and patient time, first of all just to review for everybody. Our positioning and promotion is in line with our FDA approved label. So we are essentially talking to physicians about newly diagnosed patients and relapsing patients, as long as they are both severe and active and TAVNEOS could be an appropriate option to add to their existing standard of care and at the same time reminding them that TAVNEOS does not eliminate glucocorticoids. In terms of the key messages, we try to keep it really straightforward and hopefully compelling to these physicians. We remind them essentially what we did in the advocate study, which is number one, we’ve replaced the standard glucocorticoids that they utilize for these patients, and when we did that at six months we remind them that TAVNEOS was equivalent or not inferior to the standard of care, and at a 12 months this improved to superiority of the standard of care, and in addition of that there are a few other secondary benefits. There was a reduction in relapsed rates, an improvement in kidney function as measured by eGFR, an improvement in quality of life, a reduction in glucocorticoid related adverse events, and all this achieved with an 86% mean reduction in glucocorticoids alone. That essentially is the nutshell of the story in 30 seconds. Now clearly we then engage into Q&A with those physicians, but that essentially is a message that we're focusing on.

Okay. And have you been able to engage a good number of physicians in that 400 top prescriber groups that you guys have outlined Tosh.

Yes in terms of outreach, we have – though January we reached just under 60% of those top 350,000 customers and we continue to get more reach into the months of February. And the top 400, yes we’ve interacted – yes, we have interacted with the majority of those as you know, prelaunch with the MSL, and post launch with the MSL and our reps.

Okay. Thank you so much for taking my question.

Thank you, Michelle.

Thank you. And next we have a question from the line of Joseph Schwartz of SVB Leerink. Your line is open.

Hi all! This is Will on for Joe. Thank you for taking our questions today and congrats on your recent progress. So one for us, from what we’ve seen in our own K-world [ph] checks and as we saw in the metrics reported today, there are clearly some physicians who are very early adopters of TAVNEOS, which is great to see. So we're wondering what defines an early adopter relative to the later adopters and what do you think the later adopters want to see in order to prescribe TAVNEOS. Any thoughts here would be appreciated. Thank you.

Yeah I, have some impressions. I guess I would say, let's just call them impressions we don't yet have enough data to have sort of granular evidence. But our early adopters, many of them were experienced with the drug in clinical trials. So they were very aware of the way TAVNEOS is used and has been used in those trials. They are very intimately aware of the advocate Phase III pivotal trial result and they are up-to-date on the findings that were published in the New England Journal of Medicine. So I would say many, though not all fit that profile. So I would – some, there is another group that is a little bit worried about in the era of COVID just how immune-compromised ANCA-associated vasculitis patient maybe as a consequence of their standard therapies, including B-cell depletion. So there are some that are wondering if TAVNEOS could have a role in helping these individuals particularly in a time of COVID and so there is a lot of outreach there. And then there's the third group, which again is a little – is a pleasant surprise at this point, early as we are in the launch. But these are the community physicians who have a great degree of unaided awareness about TAVNEOS and what the effects of TAVNEOS may well be for their patients with severe ANCA-associated vasculitis. So we see a healthy proportion from that group, and I think that that's quite encouraging. Fundamentally I see a lot of interest in the Nephrology community, notwithstanding the – what looks like a somewhat skewing to rheumatologist being the prescribers in the majority of the script so far. But Nephrologists have been very interested and very vocal with some of their early experiences. So I don't know how public those are yet, but I hope that they'll be coming out in discussions at meetings for the Nephrology community in Europe and in other meetings to come and I hope you'll be hearing about some of those, certainly those case studies from some of the leading Nephrologists that have used TAVNEOS in their patients. And I think that sumps up most of my impressions.

Great! Thank you. And if I could sneak in one quick follow-up. Are there any common questions that the sales force are getting or any kind of pattern here that you could talk about? Thank you.

Well I think – sure, I mean this is a new drug. Clearly people are very curious about how to use it. The label is fairly broad and leaves a lot to the physician's judgment discretion. So physicians are asking questions such as, how do I use this with my current medication on this patient? How do I use it, do I need to start glucocorticoids or reduced glucocorticoids in context of prescribing TAVNEOS and essentially how do I get people started on TAVNEOS. So it’s those kind of things that are questions about access as well and I think we've been able to address appropriately all those questions.

Great! Thanks again.

Thank you. And up next we have Yanan Zhu of Wells Fargo Securities. Your line is open.

Hi! Thanks for taking my questions and congrats on the progress. So first of all I wanted to understand a little bit better the conversion rate for the fourth quarter. That 71% number obviously indicates a 29% of patients did not convert. Could you touch upon what might be the reason for patient not go on to therapy and then for the January number, interestingly I think as you alluded to, you have a 50 new patients starts form and then 50 more patients on drug, suggesting perhaps 100% of the patients have converted. Could you say whether that's the correct interpretation and what's your expectation for the conversion rate going forward?

Well, all very good questions Yanan and thank you. You know some of it may just be from Q4, a timing issue. So there could have been folks that got patient starts sort of late in the quarter, and then spilled over into the New Year. So I think what we're seeing is all these kind of rolling, basically rolling averages. So the lag time from conversion earlier, sometimes just talk is the question of again access, well early access was being worked out and refined, also while early discussions around coverage were being worked out, etc. So we expect and we have seen a reduction in the time from the original four to six weeks down to four weeks as people go into the system, and I think that's reflected in an increasing conversion. I would hesitate to put a number on where we would like to be, but I can say that a conversion rate of around 80% is fairly good and you know most people that get on the drug are eligible for the drug, they fit squarely in the labeled indication, occasionally you'll get someone who either is eligible for the drug or cannot get into the system and even the patient access program is not suitable for them, and those are the reasons that you might have lack of certain conversions.

Okay, got it. Thank you. And if I may ask about any initial feedback on efficacy that you hear from the prescribers and how much of that 33% repeat prescribers do you think is driven by physicians seeing signs of efficacy. Thank you.

Well, you know it’s too early. One, I would hesitate to speculate. Secondly, I think it’s too early to say about the repeat prescribers. Look, I think its good news obviously that we are seeing increasing numbers of repeat prescribers, and again that trend seems to be accelerating in the appropriate direction, so we are encouraged by that. I am very much hoping that we'll start hearing some early reports on efficacy at the upcoming nephrology meetings, and I would hope that maybe you'll hear some things that you are. I don't know that as a fact, but I do know that a lot of the major players will be at the European, both European League of Rheumatology Meeting and the European Renal Association meetings in a couple of months. And I would be very interested to hear what some of those folks have to say, because I know they seem to have some patients on therapy. So maybe we'll hear as early as that, maybe there'll be some letters about case studies coming up in the not too distant future. It's really more up to what the investigators decide to do and how they are going to disseminate their information. So I hope that we'll hear a lot more about that in the very near future.

Great! I'm looking forward to those information. Thank you, Tom. Congrats again.

Thank you, Yanan.

Thank you. Our next question comes from Ed White of H.C. Wainwright. Your line is open.

Thanks for taking my question. So you had mentioned this core programs Tom. I'm just curious as to the amount of free drugs given in the fourth quarter; perhaps the dollar value if you have it or the number of patients and then what your outlook is for the year. Thanks.

Sure thing Ed. So we are not giving a lot of detail around the patient support and patient assistance programs. I think it's a little bit, it’s a little bit early to talk about that. Sufficed to say, we have said we have said we made a considerate investment in patient support, patient assistance program, and I think that is paying off for us. I think we're seeing rapid access to drugs matters. I will give you a little bit more granularity on this. So as we go through January, again, we're seeing an increasing amount of now patients on paid medication. Over one-third of the patients are now on paid medication and that number and proportion seems to be increasing, ever increasing. That is pretty much right in line where we thought it would be at this quite early stage of the launch, and we are happy with the trend line. Now, we will continue to support appropriate patient access, again with limited and temporary patient access to unpaid product, but again we think that's the appropriate investment as that ought to translate to an ever greater share a paid bottles as the launch progresses, and particularly as folks then get their prescriptions refilled and repeated and they work through the system. So I think we're right on track with where we want to be and I think the trend lines are well within our models at this point.

Okay, great. Thanks Tom.

Thank you. Our next question comes from Edward Tenthoff of Piper Sandler. Your line is open.

Great! Thank you very much for taking my question. My congratulations too! Really impressed with where you are. In the long term I think it speaks to the profile of the drug. I wanted to get a sense a little bit for the patient experience. It maybe early, but I'm trying to get a sense for how quickly patients are feeling better, how quickly they can actually start to see some of these kidney function improvements, and there wereimprovements in the other organ systems. How quickly they can start actually – a physician will actually start to reduce the steroid dose. A lot of really good question, but I wanted to get a sense for sort of what the patient might experience on TAVNEOS. Thanks guys.

Thank you very much. Yes, we know from our clinical work what we have been able to show in the controlled studies. Too early, and we don't have enough real world evidence, although we do have some anecdotes. But we know in our clinical work that we – for example if you just look at for patients with kidney dysfunction. If you look at the amount of protein in the urine, as measured in a variety of ways, but just say urinary albumin to creatinine ratio, we have shown in many – well, there are three controlled studies that we ran, and certainly the two were then called. Avacopan was used in the absence of that the daily scheduled oral prednisone taper. You know we see a really marked reduction in proteinuria within a week, certainly by two weeks; significantly different from those persons that are only on standard of care therapy, which includes high dose prednisone taper. So that can happen within a couple weeks, and if you're a kidney patient with a nephrologist, you're probably being watched very carefully if your Glomerular Infiltration rate is degrading, because that really is the fear and you'll be first watched for proteinuria, may be doing that at home with a simple dip stick test. So the patient is likely to see results in fairly short order if real world matches what the controlled trials helps. We also know in controlled trials that as a population you start to see an increase in estimated glomerular inflammation rate, which is based on the levels of Serum Creatinine, that's a question that starts with serum creatinine. So as serum creatinine goes down, then estimated glomerular filtration rate is going up. And what we see is, that can start happening quite rapidly as well, at least with population studies from the controlled trials. You know within about four weeks people start to see some inflections in there EGFR. I mean again, if your kidney patient that’s super important. Now we've also heard about the reports and I think there's a couple of case studies where even a reverse trend of declining eGFR can happened quite considerably, more swiftly than that. So we’ll be – I think there are some abstracts out there that have been published or accepted. It will be interesting to see more of those reports. So for the patients speaking to their nephrologists, those are all very encouraging signs and they can happen quite rapidly. We know in terms of patient reported quality of life, again in the Phase II studies. You know even by four weeks we started to see improvements in patients sense of wellbeing, increased vitality. Certainly those were very firmly established by week 12 in the Phase II studies, week 26 in the Phase III study and continuing improvement out at week 52. So in short, I think the data does support the idea that patients on TAVNEOS ought to actually feel better in fairly short order and whereas when they are on the totaled standard therapy, reporting, self-reporting any improvement in how they feel about their disease, is really rare and I don't know if there are many studies, controlled studies where it's actually been report. So I think that's going to be an interesting feature of the program. We’ll see what the real world tells us in pretty short order.

Great! Thanks for that color Tom.

Thank you.

Thank you. And next we have Anupam Rama of JPMorgan. Your line is open.

Hey guys! Thanks so much for taking the question. Just a quick one for me with some parts, which is you talked a lot about some of the dynamic for patient start forms, patients on drugs, you talked about some of the reimbursement trends. I guess specific to 1Q, how are you thinking about some of the seasonal dynamics around the order the quarter give, any growth in that, and it sounds like you have scripts being written for one month. Thanks so much.

Yeah so, Tosh do you have feelings about the trends in Q1 in seasonal dynamics?

I think its scripts related to one month. Typically they are approved for depending on the [inaudible] for a period of six months to one year. So we don't have any concerns about the scripting issued for one month. In terms of trends into Q1, look as Tom alluded to or not really – Tom just shared with you, we launched to-date, as of end of Jan 31, you can see the continued acceleration that we see in January and we look forward to sharing more details of that acceleration in February and March at the end of Q1 earning. When we look at January launch to-date we are encouraged.

Thanks so much.

Thank you.

Thank you. And I see no further questions in the queue. I will turn the call back over to Thomas Schall for closing remarks.

Well, thank you very much and thanks everyone for joining our call today. Thanks also for the very stimulating and insightful questions and you may now disconnect. Bye now.

That concludes today's conference call. Thank you for participating. You may now disconnect and have a pleasant day!