Q4 2021 ChemoCentryx Inc Earnings Call
Good afternoon, and welcome to the chemotherapy <unk> fourth quarter and full year 2021 financial results Conference call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session. As a reminder, this conference call will be recorded.
And I would now like to turn the conference call over to Bill Slattery Junior Vice President of Investor Relations and corporate Communications Chemo Centrex.
Flattery. Please go ahead.
Okay.
Thank you operator.
Good afternoon, and welcome to the chemo centric fourth quarter and full year 2021 financial results Conference call.
For those of you I have not yet met I recently joined chemo centric kind of Investor Relations and 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.
This press release, along with a slide deck that you may find helpful. I listened to this call are available on the Investor Relations section of our website at Www Dot chemo centric dot com.
Joining us on the call today from <unk> are Dr. Thomas Schall, President and Chief Executive Officer, and Chairman of the Board Susan.
Susan.
Executive Vice President Chief financial and administrative officer, and Josh about Executive Vice President and Chief Operations Officer.
Common Susan will make introductory remarks before we open up the call to your questions.
During today's call, we will 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 statement.
<unk>.
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 one 2022.
You are cautioned not to place undue reliance on these forward looking statements and Cumulus <unk> 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 one 2022.
Central 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 would 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 outlined the significant milestones we expect throughout 2022.
First we will take a look at our progress in the early weeks following the U S launch of <unk>.
Associated Vasculitis second I will update you on our plan to broaden <unk> to our pipeline in a drug including next steps that we expect to take in lupus nephritis.
<unk> hidradenitis, Suppurativa and CBRE preliminary allopathy.
Third we will discuss recent progress we've made and next steps for our unique orally active small molecule PD Lone PD, one checkpoint inhibitor <unk> 505, nine for which we expect initial phase one 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 chemo centers, we've navigated the uncertainty and uncharted territories at the frontiers of science and achieved our long standing goal of bringing our first medicine to patients suffering from a devastating and debilitating disease.
Yeah.
Following FDA approval, we launched tab news.
Adjunctive treatment for use in patients with severe active <unk> associated vasculitis on October 18th.
Leaving us 51 business days in the quarter post launch.
As we launch we took the final step in our vertical integration.
We now constitute an integrated U S. Biopharmaceutical company that discovers develops now markets innovative medicines of our own device.
It was a long and arduous journey to get here.
Some 17 years working on the <unk> program alone.
But the human rewards in bringing something truly different.
Underserved people such as those enduring <unk> associated vasculitis.
Made it all worthwhile.
January of this year brought another significant advance with the EU approval of <unk>. This means the top notes is now approved in the U S.
Europe , and Japan for <unk> associated vasculitis indications.
Further the European approval triggered a milestone payment of $45 million from our partner <unk> pharma.
We are pleased to share that fly for launched top news in Germany on February 15th of this year with additional territories expected in the first half of 2022.
As a reminder, <unk> will pay <unk> royalties in the teens to the mid <unk>.
On ex U S sales off 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 and medical science liaison positions, our sales representatives and in other key roles.
As we approach the launch our initial marketing focus was multifaceted by design.
First and foremost we sought to educate physicians on the <unk>.
Crude label and supporting clinical data raising awareness through our 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 our combined field force of about 75.
Sufficiently cover the approximately 3400 clinicians comprising key external experts.
Prescribers and community specialists, who collectively are responsible for roughly 80% of all <unk> associated vasculitis prescriptions in the United States.
Further we recognize the importance of working closely with patients.
Listening to adversity advocacy groups and other active voices in the vasculitis community that have welcome the arrival of a modern orally administered and Mechanistically targeted medications, which was designed from the start.
Their disease in mind.
Too often.
Often diseased patients seem to feel that they languished and are seldom visited treatment backwater, receiving occasionally repurpose drugs that may provide benefits to their condition, but were not designed specifically for that purpose.
<unk> was and is different.
Now through branded campaigns, we plan to educate appropriate patients on the tab in the safety and efficacy profile.
Also employing unbranded campaign to provide disease awareness. These efforts are designed to support patients and having appropriate conversations with their healthcare professionals Ruby.
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 pharmacies selling tap yes.
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 for patient referrals from 102 unique prescribers.
At the end of Q4, there were 90 patients on drug and the conversion rate in patient start forms that patient on drug was 71%.
The results in these key metrics.
Mark promising progress for a rare disease, such as <unk> 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 rival of an <unk> wave of Covid, even before the Delta Serge had finally.
As we move through the current quarter, which will eventually be the first full quarter of commercial activity. The leading indicators are favorable for our expected upward growth curve moving.
Moving to slide seven we have superimpose the progress across key metrics from the beginning of the first quarter I E through January .
Accordingly between launch and January 31.
We received 179 patients start forms from 140 unique prescribers and there were 141 patients on drug representing 79% conversion rate from patient start forms or PSS PSS.
Since we are still at quite an early stage.
I will also share with you today more largely qualitative color in context, then we expect to give you in future quarters.
When the qualitative I'm sorry, when the quantitative data will paint a more complete picture than it does today.
On slide eight for example, let's look at some of the prescribing patterns that we're seeing.
Through January 31.
As it relates to what types of physicians are prescribing tap deals we estimate 66% of the prescriptions are coming from Rheumatologists.
The 8% 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 inroads we've 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 <unk> 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 physicians are repeat prescribers through January 31.
We believe this suggests physicians are having positive first experiences, which we hope to continue to build upon.
Additionally, the time it takes to convert patient start forms to patients on reimbursed medication is now tracking in line with our expectations, taking approximately four work for weeks to obtain a payer coverage decision, which we anticipate anticipate it will continue to decrease.
Time.
What's more initial feedback from health care providers suggests that they are experiencing success now in obtaining reimbursement based on prior authorizations 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 eligible patients through our support programs.
While we continue to support access per player via such patient support programs. We are now seeing an ever greater share uptake models as the launch progresses.
Having launched into a unique environment.
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 position whereby patients to physicians.
<unk> waved 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 <unk> and in any case, we plan for an orderly progression in the quarters. Following the launch rather than a bolus of early patients, which could have distorted the true growth picture.
In short.
We believe that <unk> has the potential to become a blockbuster drug 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 <unk> as a pipeline in a drug and also.
Advancing our novel orally administered PD Lone PD, one checkpoint inhibitor known as <unk> five.
Nine.
In 2021 as you know.
We prioritized and focused on anchor associated vasculitis approval.
In Q4, we were busy building up a new World class clinical development organization led by Dr. Rita Jain who joined Chemo Centrex full time in October as our Chief Medical Officer. In addition to her role as a 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 untapped nios in <unk> associated vasculitis, which is likely to yield useful supplementary data of interest to physicians and payors.
Moving to slide 10, the biological rationale for tab news.
Across several underserved inflammatory and autoimmune disorders.
Alan.
Given its unique ability to selectively inhibit the <unk> receptor.
Reserving other functions and components of the immune system.
I will remind us <unk> was designed to be an anti inflammatory agent based on its mechanism of action and not broadly immuno suppressive.
Throughout 2022, our focus includes three indications Lucas.
Lupus nephritis severe hidradenitis, Suppurativa and C III preliminary allopathy.
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 dysfunction.
One steps have been agreed upon we anticipate initiating clinical development program for <unk> in patients with lupus nephritis.
2022.
This should be followed didn't close order another meeting with the FDA to discuss our plans for a pivotal phase III trial of <unk> in patients with severe hidradenitis, suppurativa or Hs H S, which we hope to initiate in the second half of this year.
As you will recall in our phase II Aurora trial in Hs <unk> showed a statistically significant improvement over placebo in a pre specified subgroup of Hurley stage three Hs patients.
To investigate and understand that clinical resolved our research at human centric has now provided evidence for clear differences at the molecular the cellular and the histological levels between more moderate Hs disease. For example, early stage two versus severe or early stage.
<unk> three Hs.
Key differentiating feature appear.
Appears to be a greater involvement of the <unk> receptor axis and early stage III disease versus milder forms of agents.
Our data will be discussed at upcoming Dermatology conference this year.
As for <unk> later in 2022, we plan to meet the FDA to discuss our accolade trial results of <unk> and the very rare kidney disease or <unk>.
Data from which we have shared previously the accolade trial was 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 a slowing of fibrotic progression indicated by the end point of the season.
<unk> Histologic index of disease Chronicity.
And other effects seen with <unk> administration.
We don't propose to invest an additional large scale, but it will work in CPG and the absence of some defined path forward by which <unk> might be used in this indication due to the long and costly nature of such trials involving for example serial kidney biopsies at Bay.
Line and 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 CTX five five times.
Our potent orally administered PDL, one PD, one inhibitor, which entered first in human studies in 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 for example, which may not.
Penetrating the tumor microenvironment as well.
A small molecule medication.
The potential to establish itself in several niches and what many believe could be a fairly short timeframe.
Riding a beachhead from which we could substantially expand clinical development of <unk>.
<unk> by five nine and this very valuable area.
We plan to present initial data from the dose escalation phase of this <unk> $505 nine phase one study at upcoming oncology meetings, starting with the ACR in April and we expect to enter a phase one b two clinical trial in the second half of this year.
With that I'd like to turn the call over to Susan can I add to outline our healthy financial situation heading into 2022, which is sufficient to progress our <unk> launch efforts and expected clinical development activities Susan.
Thank you Tom.
<unk> fourth quarter and full year 2021 financial results were included in our press release today and are summarized on slide 12.
Total revenue.
Quarter and year ended December 31, 2021, or $2 3 million and $32 2 million compared to $4 4 million $64 9 million in this.
Same period in 2020.
<unk> U S. Net product sales were approximately $1 million by the fourth quarter and full year 2021.
Got it supply revenue continued at one three revenue $1 3 million and $1 8 million.
Linked quarter and full year 2021.
Collaboration and license revenue was $29 1 million for the full year 2021.
Compared to $64 4 million in 2020.
Cost of sales for the fourth quarter and full year 2021 was 302000.
Constant current from manufacturing campaigns initiated prior to the October 2021, FDA approval attempt meals are recorded as research.
<unk> 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 million compared to $77 9 million in 2020.
These increases were primarily attributable to the manufacturer of commercial agenda supplying in anticipation of the launch and Nielsen, Inc, Vasculitis, and higher research and discovery expenses, including those associated with the development of Ccs.
Selling general and administrative or SG&A expenses were $23 3 million for the fourth quarter of 2021 compared to $12 7 million the same period in 2020.
Full year 2021 is any incentive.
$8 9 million compared to $42 2 million in 2020.
Increases were principally due to higher employee related expenses associated with commercialization planning efforts and the launch of <unk> in 2021.
<unk> 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 instrument in respective periods in 2020.
Total shares outstanding as of December 31, 2021 were approximately 74 million shares.
We closed 2021 with approximately $362 3 million in cash cash equivalents and investments.
It's year end balance excludes the $45 million milestone for the EU approval of <unk>, we see frontline for <unk> first quarter 2020.
Lastly for 2022, we expect to utilize cash and investments in the range of 120 to 114, one yet.
Yes.
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 chemo centrex arrived upon the world stage as an integrated biopharmaceutical company.
We have positive feedback from the <unk> launch and the leading indicators of further growth are favorable.
We are focusing on our pipeline in a drug approach for target was aided by a world class clinical development function and have advances in lupus nephritis severe hidradenitis, suppurativa and <unk> lots of IP in our sites for 2022.
<unk> nine is progressing through phase one 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 joined the ranks.
Of commercially integrated U S biopharmaceutical companies.
Happy to report that the landmark year of 2021 has positioned <unk> well.
Our enterprise.
Traveled far to bring the benefits of medical innovation to clinicians and especially to 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.
As a reminder to ask a question you will need to press star one on your telephone to withdraw your question. Please press the pound key standby as we compile the Q&A roster.
Our first question comes from Steve <unk> Raymond James.
Your line is open.
Hi, This is Ryan Deschner on first DC houses as well.
To ask if you can.
Can you give us any more quantitative detail on patient start forms or on demand in general.
And 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.
Yes.
So thank you very much for that question so.
<unk>.
We're not providing progress beyond the additional month of Q1, just yet but.
But again to remind you through January the patients start forms reached $1 79 patients on drug reached $1 41, 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 Q.
For 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 were.
We see that's kind of the time to coverage decisions are down now to approximately four weeks on average and Thats down from our initial expectation of four to six weeks. So all of those indicators are going in the right direction and I think we're pleased with that.
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.
Yet.
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 so basically if I could squeeze one more quick one.
Scripps with each patient with Steve on average.
Sort of.
143 months supply off the bat or how does that work.
So <unk>.
Essentially we have one months prescription and then we redo those.
Okay. Thank you very much.
Welcome.
Thank you.
Our next question comes from Stifel. Your line is open.
Good afternoon, and thanks for taking my questions.
I'll stick to one question about a multipart one if I can if I may so with regards to the separate I guess your market research, 66% being around 28% being Nephrologist I guess, how are you thinking about marketing why strategically targeting nephrologist to gain a broader following in that cohort and.
Also as you think broadly about sort of the feedback youre getting from both Rheumatologists and Nephrologists is there any kind of reluctance or more I guess stronger affinity by one group of docs versus the other thanks.
Thank you Dan.
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.
Sure.
And again not infrequently their primary doctor as a rheumatologist, so even if they have kidney manifestations nursing neurologist.
They will go back very frequently to the Rheumatologists who writes.
He was writing the script, so I think that that explains in part some of that.
Eminence in the rheumatology rheumatology.
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 suggest that has a quite marked effect on egfr improvements and I think.
As the experience in the nephrology community expands we've already heard some interesting first experiences in nephrology cases, and when you start hearing about those either peer to peer or major upcoming meetings in Europe , and the United States I fundamentally think youll get a lot more attention from the.
<unk> I would also say this look it's quite early days and this.
Preponderance of Rheumatology script writers 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 I'm really sorry, if I can squeeze in one more question on the January trend that you provided today does seem like there is some sense of acceleration in terms of <unk>. So.
So can you maybe speak to what Youre seeing there and the dynamics and to what extent has the omicron being been.
Still a headwind if you will as you commented in two months ago at a competitor conference. Thanks, Eric Youre, absolutely right look I think the acceleration looks good I mean.
In January alone what did we add about 50 more patients start Barnes.
Jimmy Choo and about 50 additional patients on drug just in January alone. That's a 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.
<unk> with the current wave of OMA chronic.
Disappears tomorrow, nothing is going to change quickly and how COVID-19 has impacted how we can interact in clinical settings, not just sponsors but patient to physician as well. So we can't be nave about that that's for sure.
Having said that.
Think that despite launching <unk> in Q4 until like a stub quarter in major holidays, and the omicron emergence.
We were really pleased even with the Q4 trends at the breadth of the <unk> prescribers.
<unk> includes not just the <unk>.
Called external experts, but the community physicians as well.
Yes, both in the rheumatology and nephrology.
So look it is impacted Covid has an omicron has impacted certainly MSL access and rep access to sites, especially at the large academic centers are centers of excellence.
About 40% of our calls have been in person at even in January so far was even a bit less than 40%, but that's okay. We plan for virtual visits to continue we 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 beat.
Providers, when how and where they may need to be met so.
I think I think overall, we've got the situation well in hand.
Great. Thanks for taking my questions and congrats on all the progress.
Thank you Dave.
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 just wanted to clarify.
The numbers of patients on drugs, that's not necessarily patients on drug right.
That's correct.
Okay, and then that would be all patients on drug at this point.
Alright, it sounds good and then could you kind of walk us through the timeline of patients of the submission of start forms to be getting a treatment.
And then.
No.
Did you give I don't think I heard you give us any numbers on like kind of the average.
Time that youre seeing reimbursement.
And.
Could you also maybe cash one for you could you outline for US your strategy around positioning and what your core messaging is to physicians around.
<unk> and selecting appropriate patients.
Excellent compound question, Michelle let's try to take this.
Secrets there.
So.
We have youre quite correct patients on drug includes all patients on drugs, including dose.
Benefited from our patient support 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 for early and immediate access to drug for eligible and appropriate patients those that were eligible under earlier 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 patients start forms patient on drugs and conversion rate and then that the <unk>.
Revenue line will lag a little while but overall, we believe that line will be much higher because of these early investments through patient support programs. So.
The number of paid folks as we go along.
Gross.
And that's 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 correct closely.
Now the time, therefore to get people on drug again by design.
As much as we.
Can provide that support and.
<unk> provides 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 enacted so that's important.
Have noticed again that the time to getting coverage is now dropping as an average its about four weeks, but there is a wide range it could be like.
Basically the same day after several weeks, but about four weeks. So that that's the figure that I mentioned and thats 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 just the performance in the real world is mirroring fairly well our model performance.
I will turn it over to you for the other part or parts of that question of Michelle about message points floor.
Hcp's et cetera, Thank you, Tom and Michelle other practical question. So in terms of positioning in patients.
First of all just to reassure everybody.
Our positioning and promotion is in line with our FDA approved label.
Essentially talking to physicians about newly diagnosed patients and relapsing patients as long as they are both superior and active.
And <unk> could.
Could be an appropriate option to add to their existing standard of care and at the same time reminding them.
Not eliminate glucocorticoid in terms of the key messages, we try to keep it really straightforward and hopefully compelling for these physicians, we remind them essentially what we did in the advocate study, which is number one.
Place defended glucocorticoid Titan they utilized for these patients.
When we did that at six months, we remind the <unk> equivalent or non inferior to the standard of care at a 12 months this improved to superiority versus standard of care and in addition to that.
Alright SKU.
Secondary benefits.
And relapse rates and.
The improvement in kidney function as measured by Egfr and improvement in quality of life reduction glucocorticoid related adverse events and all this achieved with an 86% mean reduction in glucocorticoid load that essentially is the notion that the story in 30 seconds.
Now clearly, we then engage into Q&A with the physician, but that essentially is the message that we're focusing on.
Okay.
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 through January we reached just under six zero of 60%.
<unk> three <unk> customers and we continue to get more reach into the month of February .
Thank you once again, we've interacted with we have interacted with the majority of those as you know prelaunch, MSL and postpone without MSL and direct.
Okay. Thank you so much for taking my questions.
Thank you Michelle.
Thank you.
And next we have a question from the line of Joseph Schwartz of SVP Leerink. Your line is open.
Hi, all this is will on for Joe and thank you for taking our questions today and congrats on the recent progress so one for us from what we've seen in our own parallel checks and as we saw in the metrics reported today. There are clearly some physicians who are very early adopters of tapioca, which is great to see so we're wondering what defines it.
Early adopter relative to the later adopters and what do you think the later adopters wanted to see in order to prescribe tasiast any thoughts here would be appreciated. Thank you.
I have some impressions I.
I guess I would say is let's just call them impressions, we don't yet have enough data to have sort of granular evidence, but look our early adopters. Many of them were experienced with the drug in clinical trials. So they they were very aware of the.
The way <unk>.
Used has been used in those trials are theyre very intimately aware of that the advocate phase III pivotal trial results and they are very up to date on the findings that were published in the New England Journal Medicine. So I would say, many though not all fit that profile.
So.
Some there is another group that is a little bit worried about in the era of Covid, just how immuno compromised.
<unk> associated vasculitis patient may be as a consequence of their of their standard therapies.
Including B cell depletion. So there are some that are wondering if if <unk> can have a role in helping these individuals, particularly in a time of COVID-19 .
And so theres a lot of outreach there and then there's this third.
<unk> group, which again is a little is a pleasant surprise at this point early as we are in the launch but he said the community physicians, who have a great degree of unaided awareness about <unk> and.
And what the effects of top news may will be for their patients with severe activate the vasculitis. So we see a very healthy proportion from that group.
And I think that thats quite encouraging.
Fundamentally I see a lot of interest in the nephrology community notwithstanding that what.
Well it looks like a somewhat skewing to rheumatologists being the prescriber prescribers and the majority of the.
The script, so far but nephrologists have been very interested and very vocal with some of their early experiences side I don't know how public those are yet, but I hope that they'll be coming out in discussions at meetings.
Or 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 nephrologist abused.
Some of their patients.
That sums 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 patterns here that you could talk about thank you.
Well I think sure I mean, there is.
This is a new drug.
Clearly people are very curious about how to use it. The label is is fairly broad and leaves a lot to the physicians judgment and 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 glucocorticoid are reduced glucocorticoid in context prescribed.
Prescribing tab.
And essentially how do I get people started on caveat. So it's those kind of things are questions about access as well.
And I think we've been able to address appropriately all those questions.
Yeah.
Great. Thanks again.
Thank you.
And up next we have yanan Zhu.
Wells Fargo Securities. Your line is open.
Hi, Thanks for taking my questions and congrats.
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 a patient.
To therapy, and then for the January number Interestingly I think.
Alluded to you'll have 15, new patient start forms and 50 more patient on club, suggesting perhaps 100%.
Patients have converted could you.
Yeah.
Whether that's the correct interpretation and what's your expectation for the conversion rate.
Going forward.
Well all very good questions John Thank you.
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 healthy as kind of rolling basically rolling averages. So.
The lag time from conversion earlier, sometimes just talk is the question of.
<unk> access while early access was being worked out and refined also while early.
Discussions around coverage were being worked out et cetera. So we expect and we have seen a reduction in the time.
From the the original.
Four to six weeks down to four weeks as people go into the system and I think thats reflected in the increasing convergence.
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 occasion.
Occasionally you'll get someone who either isn't 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 lacked.
Certain convergence.
Got it thank you and if I may ask about any initial feedbacks on efficacy that you hear from the prescribers and how much of that.
33% repeat prescribers do you think is driven by traditional seeing signs of efficacy. Thank you.
Well it's.
It's too early and I would hesitate to speculate and secondly, I think it's too early to say about the repeat prescribers.
It's 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 its act, but I do know that a lot of the major players will be at the European.
Both the European League of Rheumatology meeting and the European.
Renal associating association meetings and a couple of months and I would be very interested to hear what some of those folks have to say because I know they they seem to have some patients on therapy. So maybe well here. It's early is 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 decided to do and how theyre going to disseminate their information so.
I hope that we'll hear a lot more about that in the very near future.
Great looking forward to two those information thank you Tom.
Thank you Anna.
Thank you.
Our next question comes from Ed White of H C. Wainwright.
Your line is open.
Okay.
Thanks for taking my question.
So you had mentioned this core programs time.
I'm, just curious as to the amount of free drug.
Given 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, so we're not giving a lot of detail around the.
The patient support and patient assistance programs.
I think it's a little bit it's a little bit early to talk about that suffice. It to say we have said we made a considered investment in patient support patient assistance program.
And I think that is paying off for us.
I think we're seeing.
Rapid access to drug 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 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 lines now we will continue to support appropriate patient access.
<unk> with limited or temporary.
Patient access to unpaid product.
But again, we think thats the appropriate investments as that ought to translate to an ever greater share of 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 <unk> of.
Piper Sandler your line is open.
Great. Thank you very much for taking my question my congratulations really impressed with where you are.
Walter I think it speaks to the profile of the truck.
To get a sense a little bit for the patient.
Maybe it's early.
But I'm trying to get a sense for how quickly patients.
Our feeling better how quickly they can actually start to see some of these chemical folks were underwater.
<unk> and other.
Or how quickly they can start to actually a perpetual will actually start to reduce the steroid dose.
A lot of really good question, but I wanted to give us folks were sort of what the patient experience.
Thanks Scott.
Thank you very much.
We know from our clinical work, what we have been able to show in the controlled studies.
Too early we don't have enough real world evidence, although we do have some anecdotes.
But we know in our clinical work and 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 the three controlled studies that we ran.
And certainly the two were then call tobacco Pan was used in the absence of.
The daily schedule oral prednisone taper.
We see a really marked reduction in proteinuria.
Within a week certainly by two weeks.
Inefficiently 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 of weeks and if you're a kidney.
Patients with a nephrologist youre, probably being watched very carefully if your <unk>.
<unk> filtration rate is degrading.
Does that really is the peer and youll be first watch for generic maybe doing that at home with simple dipstick 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 pop.
Malaysian you start to see a increase in estimated glomerular filtration rate, which is based on the levels of serum creatinine. That's an equation 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 and the controlled trials within about four weeks people start to see some inflections in their egfr and again, if you're a kidney patient that's super important now we've also heard of other.
And I think Theres, a couple of case studies, where even a reverse trend of declining egfr can happen 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 patient speaking to their nephrologist 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, even by four weeks, we started to see improvements in patient sense of wellbeing increased vitality certainly those were very firmly established by week 12, and the phase III studies week 26, and the phase III study and continuing improvement out to week.
Too so.
In short I think the data does support the idea that patients on <unk> at to actually feel better in fairly short order.
And whereas when theyre on the.
Total standard therapy.
Porting self reporting any improvements in how they feel about their disease is really rare and I don't know I don't know if there are many studies controlled studies, where it's actually been reported so I think that's going to be an interesting feature of the program. We will 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 <unk> Rama of Jpmorgan. Your line is open.
Hey, guys. Thanks, so much for taking the question just a quick one from me with the sub parts.
Which is you talked a lot about some of the dynamics or patient start forms patients on drugs, you've talked about some of the reimbursement trends.
Specific to <unk>, how are you thinking about some of the seasonal dynamics around the quarter given.
Any gross or net and then it sounds like you have scripts being written for one month.
Thanks, so much.
Yeah. So Todd do you have any feelings about the trends in Q1 and seasonal dynamics and just to clarify.
So yes.
But typically the approved full depending on the payer front period of six months to one year.
So we don't have any concerns about script being issued for one month.
In terms of trends into Q1 look good Tom's alluded to.
As shared with you the launch to date.
<unk> Gen 31, you can see the continued acceleration that we've seen January and we look forward to sharing more details of that acceleration in February and March but at end of Q1 earnings.
We look at January launched 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 for everyone for joining our call. Today. Thanks also for the very stimulating and insightful questions and you may now disconnect.
Bye now.
Goodbye includes todays.
This concludes today's conference call. Thank you for participating you may now disconnect and have a pleasant day.
Okay.
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