Q1 2022 Aurinia Pharmaceuticals Inc Earnings Call
Yeah.
Greetings and welcome to the Radiopharmaceutical, that's first one.
22 financial and operational results conference call.
At this time all participants are in a listen only mode and a question and answer session will follow the formal presentation. As a reminder, this conference is being recorded I would now like to turn the conference over to your host Dana Lynch already as senior director of corporate Communications and corporate affairs. Thank you Dana you may begin.
Yeah.
Thank you Jim and thank you all for joining today's call and webcast to discuss <unk> first quarter 2022 financial results.
Joining me this morning are Peter Greenleaf, President and CEO , Joe Miller Chief.
Chief Financial Officer.
Both of whom will be leading the call. Other members of the executive team, specifically, Max Colao, Chief Commercial officer and Dr. Neil Solomons, Chief Medical Officer will also be available at the conclusion of our prepared remarks for the Q&A portion of the call.
This morning, we issued a press release announcing our financial results and recent operational highlights and filed our quarterly report on Form 10-Q for more information. Please refer to our filings with the U S Securities and Exchange Commission, which are also available on our web site at Www Iranian pharma dotcom.
During this call we will make forward looking statements based on our current expectations. These forward looking statements are subject to a number of significant risks and uncertainties and our actual results may differ materially for a discussion of factors that could affect our future financial results and business. Please refer to the disclosures in our press release and our.
Quarterly report on Form 10-Q, along with our 10-K and all of our recent filings with the U S Securities and Exchange Commission and Canadian Securities authorities.
Please note that all statements made today during made during today's call are current as of today May 10 2022.
Otherwise noted and are based upon information currently available to us at this time.
Except as required by law, we assume no obligation to update any such statements now. Please let me turn the call over Germany, as President and CEO , Peter Greenleaf Peter.
Well, thanks, Dana and thanks to everyone for joining us on the call today.
For today's agenda I'll start with a review of the commercial business, including our performance in the first quarter and the positive trends, we're seeing for loop kindness as we move through the second quarter.
After that I'll provide a brief update on our efforts to gain regulatory approval for Luc kindness in Europe , and the additional clinical work ongoing to reinforce Luke <unk> benefits for patients.
And then finally I'll provide a quick update on our R&D pipeline and cash position before handing over the call to Joe Miller, who will provide a more detailed update on the Q1 results are expenses and overall financial position as a company.
So let's get started on our first quarter business performance in spite of some challenges early on we're off to a great start in 2022 in the first quarter, we generated $21 $6 million in net sales.
As discussed on our year end call in late February we experienced a slowdown in patient start forms starting in December given the impact of COVID-19 on prescribers and patients.
Many patients face delays and we're filling prescriptions and many were unable to attend position appointments on a normalized schedule.
As is typical in our industry at the start of a new calendar year changes and employer covered insurance carriers and policies and Pico and patient co pay resets of the new coverage year, often slowdown converting patient start forms to patients on treatment and affect the timing it takes for.
For existing patients to get a new year.
Exiting the quarter, though we began to see considerable improvements and encouraging trends within our commercial results.
First prescribing has increased significantly and in fact, we experienced monthly record high for patient start forms in March as well as notable notable improvements in prescription refill rates.
In the quarter ending March 31, 2022, we added 461, new patient start forms as compared to 257 recorded in the first quarter of 2021.
With a clear upturn since the start of the year. We now stand at 647 total prescriptions start forms as of Friday may six since the start of the year.
Conversion rates and patient access to drug also remain robust and are at the highest level since launch.
Patient start form conversion rates are now at 80% for after 90 days.
On the access front, we have confirmed patient access to loop kind of through payers and plans representing about 90% of total U S lives.
And while still early we're encouraged by persistence trends through six months of therapy, approximately 70% of patients are remaining on treatment.
Additionally efforts to increase health care provider adoption of Luke guidance and regular practice remains consistent and positive.
Each month, we're adding new prescribers and growing the number of repeat prescribers.
Prescribing rates remained balanced between both Rheumatologists and Nephrologists.
Beyond prescribing, we've seen important increase in awareness of loop guidance and its benefits among health care providers base.
Based on recent surveys.
Unaided brand awareness is over 70% and if you add brand and awareness to the equation over 90%.
And most significant intent to use in the next three months is now over 70%, which represents the highest level since launch of the drug.
Given these progressive trends there were approximately 1071 patients on <unk> therapy at March 31, 2022.
Compared with 884 patients on therapy at the end of 2021.
Net realizable revenue per patient remains above our initial guidance of 65000 per patient per year, but as we've discussed previously we expect to approach. This figure as more patients go on and stay on therapy over time.
Finally, we're happy to report that with conditions continuing to normalize there are more in person opportunities to interact directly with healthcare providers and with patients are commercial.
<unk> activities are ramping up accordingly, just last month Iranian attended the first in person medical meeting with our first commercial boost since we launched <unk> with representatives from our costs, our advocacy marketing medical affairs and sales teams attending the National Kidney Foundation spring clinical meetings in Boston.
Additionally, we launched an extensive set of new healthcare provider marketing programs to further share and educate on Aurora two data and have begun to develop and rollout a number of patient focused awareness and engagement initiatives, including the initiation of a <unk> patient Ambassador program.
<unk>.
With the continued return to normal health care practices in the United States and our plans for expanded commercial execution, we remain confident and reaffirm our guidance for net loop kind of sales of $115 million to a $135 million for the full year of 2022.
As a reminder, our guidance does not include any milestone payments royalty or manufacturing revenue.
<unk> anticipated ex U S sales related to our licensing agreement with <unk> to market market Barco score and in the European Union and Japan.
If <unk> is approved for use in the European Medicines agency, depending on the favorability of the approved label, we have the potential to receive up to $30 million in the second half of 2022 and potentially low double digit royalties on sales as well as supply cost recovery through a cost plus.
We have with us silica.
We continue to work close closely with otsuka to support the European approval process.
We have received a day 157 question document posed by the EMA and given the ongoing interactions. We believe we remain on track with for EMA approval in the second half of 2022.
With regard to our R&D work next week, we will present for the first time more complete results from <unk> Aurora two continuation study at the 59th European Renal Association Congress. This will be followed up by a presentation at the 2022 <unk>.
European Congress of Rheumatology European Alliance of associations for Rheumatology in June .
Data from this study, which we reported in December looked at 216 patients continuing from the 12 months of Aurora study for an additional 24 months of treatment.
This data reinforces the favorable risk benefit profile of <unk> over a three year period with safety and efficacy comparable to that seen in the original Aurora one trial.
We still plan to submit a manuscripts for peer reviewed publication in the second half of 'twenty two.
As well as abstract submissions for presentations at additional major scientific conferences throughout both 2022 and 2023.
Under the research fronts recruitment of patients and initial new sites into the vocal pediatric study and the light L. N registry is continuing.
As a reminder, we committed to the vocal study as part of our FDA approval, while we initiated the registry to gain further knowledge about patients taking loop kinase as well as help their clinicians and payers to improve patient care and ensure access to therapy.
And finally, we continue to advance IND, enabling work for both the Aurora 200, and EUR 300, and we remain on track to submit <unk> for both compounds in 2023.
These are important next steps in the build out of our pipeline to build long term sustainable value and growth for iridium.
As I said previously we are well positioned relative to many of our Biopharma company peers with a healthy balance sheet and no significant debt our obligations with approximately $420 million through the quarter on hand, and continued look kind of revenue contribution we.
Can fund our business operations for at least the next few years and remain flexible while weathering the current weakness in the biotech market and the overall economy in the U S.
I will now turn the call over to Joe Miller for a more detailed review of our financial results. I will then return at the end of the call for a recap and to answer any questions. You may have Joe. Thanks.
Thank you Peter and good morning, everyone as of March 31, 2022, we had cash cash equivalents and restricted cash and investments of $418 8 million compared to $466 1 million at December 31, 2021. The decrease is primarily related to the continued investment in commercialization activities payments.
Made for our ongoing post approval obligations and advancement of our pipeline payments associated with inventory purchases to ensure adequate supply to meet forecasted demand and a payment for the achievement of a onetime milestone partially offset by an increase in cash receipts from the sale of <unk> guidance.
We believe that we have sufficient financial resources to fund our current operations, which include funding commercial activities, including FDA related post approval commitments manufacturing and packaging of commercial drug supply funding, our supporting commercial infrastructure conducting planned research and development R&D programs investing in <unk>.
Blind and operating activities for at least the next few years.
Total revenue was $21 6 million and 914000 for the quarters ended March 31, 2021, and March 31, 2022, and March 31, 2021, respectively. Our revenues primarily consisted of product revenue net of adjustments for Lipkind us following FDA approval in late January 2021.
Quarter over quarter revenue growth is attributed to further progress in the launch of loop kindness.
Total cost of sales and operating expenses at March 31, 2022 were $59 5 million in comparison to $51 5 million as of March 31, 21 to quarterly fluctuations can be broken down as follows.
Cost of sales were 256040 8000 for the quarter ended March 31, 22, and March 31, 2021, respectively. The increase was primarily due to the growth of loop kind of sales in comparison to the prior year period.
Gross margins for the quarter ended March 31, 2022, and 2021 was approximately 99% and 95% respectively. The fluctuation in gross margin is driven primarily by fixed specialty pharmacy costs in the first quarter of 2021 as a percentage of overall cost of sales. These costs were a higher percentage of overall cost of sales.
<unk> due to lower sales volumes in the first quarter of the launch.
Selling general and administrative as straight as SG&A expenses were $45 2 million and $39 8 million for the quarters ended March 31, 2022, and March 31, 2021, which is consistent with the prior quarter and represents a fully burdened quarter as the company has not have approval until late January of 2021.
The increase was primarily due to an increase in employee related expenses professional fees related to various corporate matters pharmacovigilance cost and consulting related expenses tied to the increased investment in our back office infrastructure to support the commercial commercialization of kindness.
Noncash SG&A share based compensation expense for the quarter ended March 31, 2022, and March 31, 2021 was <unk> 6 million and $6 6 million respectively.
R&D expenses were $12 6 million and $9 8 million for the quarters ended March 31, 2022, and 2021, respectively. The primary driver for the increase quarter over quarter was due to an increase in expenses related to EUR 200, and EUR 300 development, partially offset by a decrease in expenses related to the Aurora two.
<unk> study, which was completed during the fourth quarter of 2021, but had wind down activities on going into the fourth into the quarter ended March 31 2022.
Noncash R&D share based compensation expense for the quarter ended March 31, 2022 at March 31, 2021 was $1 million compared to $1 1 million respectively.
For the quarter ended March 31, 2022 Arena recorded a net loss of $37 6 million or 27 net loss per common share as compared to a net loss of $50 4 million or <unk> 40, <unk> net loss per common share for the quarter ended March 31, 2021 with that I'd like to hand, the call back over to Peter for closing remarks.
Peter.
Hey, Thanks, Joe and as you heard throughout the call. We are excited by the trends we've seen in the recent months the increases in prescribing a number of patients on therapy signals more health care provider experience and comfort in treating with their lupus nephritis patients with loop kindness, which we are optimistic will result in healthcare providers providing.
Continuing to address and therefore, improving early urgent diagnosis and treatment of the condition.
Beyond the U S. Commercial results, we are quickly moving towards possible approval in Europe , triggering the potential for additional milestones as well as moving closer to IND submission and our two novel assets AUR 200, AUR 300.
We continue to operate with a healthy balance sheet, which will enable us to execute on our long term strategy.
That's all we have for today and look forward to updating you on these items as the year progresses and look forward to taking your questions with that let me turn it to the operator for Q&A.
Thank you, ladies and gentlemen, joining over the phone today, if you would like to ask a question at this time simply press star and one on your telephone keypad.
If you are joining us today on a speaker phone we ask that you. Please return to your handset prior to pressing star one to be certain that Youre signal does reach our equipment. Once again, ladies and gentlemen that is star one if you would like to ask a question.
And we'll pause for just a moment to assemble our queue. Our first question today is going to come from Joseph Schwartz at SBB Securities. Please go ahead.
Hi, all this is will on for Joe and thank you for taking our questions today Congrats on the recent progress.
So one for US can you just remind us on the ongoing litigation with Sun Pharmaceuticals, and has the company filed its response to the IPR and when should we expect an update here and kind of how does this process unfolds. Thank you.
Okay, Thanks and that was.
Joe Schwartz team over at SBB, Leerink, sorry, a little choppy coming in so let me repeat the question for everybody on the call.
It related to any updates on the Sun pharmaceutical litigation.
IPR process and have we actually submitted our response to the IPR submitted by Sun to the U S patent and trade office.
So to start with the Sun Pharma litigation there is really no news there.
Most recent update we'll have for you is probably sometime in 2023 is that up that litigation is ongoing we're calling that that is the litigation, where we are suing sun for patent infringement on our ophthalmic solution that we believe their products sequent infringes upon our patents for <unk>.
<unk> solutions, so no new news, there, Joe and wouldn't look for any until 2023.
On the IPR process, so officially the patent office recognized the application.
Date for response, so our response back to them.
In late June late June and then <unk>.
<unk> has at least three months to review the initial filing alongside of our response, so I would look for.
Something in the back half of the year call it.
Late <unk> early <unk>, but nothing new we have not submitted a response as of yet because we're still formulating it and we have until the latter part of June to get that submission in.
Great. Thank you.
Thank you Mr. Swartz. Our next question is going to come from the line of Olivia Brayer at Cantor Fitzgerald.
Hi, Good morning, guys and thanks for the questions. Joe can you give us a sense for.
Some of the different factors that drove the Dragon <unk>, how big of an impacted omicron have or for some of the seasonality impacts around around things like insurance changes.
Maybe we should think more of that as a potential headwind going forward.
And then I recognize it's still early days in the launch, but how are you guys seeing uptake play out between Rheumatologists and Nephrologists.
Nephrologist so far.
You may be seeing more willingness initially from from one group versus the other and is there anything that you can do to help drive similar adoption between the two going forward and then I've got one on one follow up on capital allocation.
Alright, let me, let me start in Mexico hours here with me too. So you can get into deeper detail, but as we said on the call right. Now are split in terms of prescribing between Nephrologist Rheumatologist office, almost right down the middle So and I think that therein lies the importance between both specialties. So we value.
Them equally.
Albeit the caveat that there is the caveat that lupus patient as a rheumatologist patient first.
And obviously as we increase diagnosis and we want to put emphasis on earlier diagnosis. There is a higher intensity that needs to go against rheumatology in terms of.
Ongoing seasonality sort of consideration so I'll give my take and then I'll turn it over to.
Max.
I think on a go forward basis, barring COVID-19 like being out of the equation.
Much like any other specialty pharma company as we enter into January and you can look at others, who have a large bulk of rare and specialty products.
That patients employers.
Change insurance plans patients after reset Copays and I think as you face January February of every year, you're going to see some impact in that time period as things start to reset as you move into Q2 and beyond I think our our overall analysts base out there has done a good job of sort of distributing where the year.
Our locks and while we don't give quarterly guidance, we give annual guidance and I think the ramp in PSS and patient starts should be accordingly.
Whether the impact will be exactly the same to January every year is TBD because as you have mentioned we're early on in the launch Max what would you add.
Thanks. Thanks for the question, yes, what I would add to that is as Peter highlighted just the beginning of January January beginning of February what we saw is there was just the care impact above and beyond just your general reset of insurance and that had an impact on refill rates and also on patients.
Being able to continue therapy, and so but we felt that completely normalize as things open up in March and in fact, as we highlighted March was a record month in terms of patient start forms and we saw refill rates go right back to where they were in Q4, and then what I would add on the physician product is that we've seen just completely.
Balanced intent to treat between Rheumatologists and Nephrologists and that is actually when we look at the three months intensive treat it's over 70%.
And Thats, what reflected in prescribing, where we see balanced prescribing across both specialties.
Maybe you had another question.
And Mr. <unk>. This is the operator, if I could can I invite you to re signal with star and one where you've lost me from Mchugh presently.
Thank you Ms. <unk>. Your line is open once again.
Hey can you guys hear me now.
Yes ma'am.
Okay, great. Thanks, guys and then on the M&A front you guys, obviously have a nice cash position. So is there much willingness to do a deal near term and can you give us a sense of.
Where you would have more of a strategic interest whether it's doing a partnership first versus adding a wholly owned asset that is maybe more mid stage development with some level of de risking.
Well I think as we've said historically.
Firmly believe in diversification and.
Continuous innovation is part of our mission as a company and part of our strategy.
So business development is key to that as evidenced through both the EUR 200, 300 deals that we did in 2021, so it's important but I'll emphasize that.
There is no magic to how these things come together and we are not going to push a higher sense of urgency just to get deals done we want to try to get the right deal is done.
But the current market. The fact that valuations are where they are.
And raising money is as difficult as it is right now I think represents significant opportunity for everything from partnership programs I E licensing.
Of assets licensing of indications of assets and M&A are all becoming more attractive even for our size, which obviously we are we are not we are not one of the larger cash position companies out there we have a healthy balance sheet, but we're not pfizer.
And in order of priority, yes, we'd prefer to license something over acquiring a company.
It's likely only acquire a company if in fact, we couldnt.
Leverage the asset out of the company individually or the company itself had capabilities that we thought were.
Critical to the success of the program and towards the intrinsic value of the company. So.
But is a priority, but making sure everybody is clear our priority number one is look guidance U S launch and globalization of Luke on us and nothing steering our head away from that we will keep you posted on progress on the business.
Business development front.
Got it thanks very much.
Thank you. Thank you Mr. <unk>. Our next question today will come from the line of Maury Raycroft of Jefferies. Dr. Rick Your line is open.
Hi, good morning, Congrats on the progress and thanks for taking my questions.
Let's see so just wondering if you can elaborate on patient discontinuation that you mentioned in your <unk> update are these transient compliance issues or related to how the doctor is managing the patient or are there any other insights or explanations you can provide at this point.
Yes, im going to ask Max to join me on that conversation I think more my answer would be it's across the board and we're providing six months of data because we have a healthy number of patients who have crossed six months therapy.
Obviously since we launched at the end of January the number of patient seen 12 months of therapy is lighter.
So as we go forward, we'll start to give longer term views on that but Matt do you want to give any color as to why patients.
The 30% or so might be.
The product that yes sure sure. Thanks for the question Maury and I'll make one more point before commenting that which is that 30% discontinuation at six months, we've seen that now consistent for a for a couple of quarters here. So.
In terms of reasons for discontinuation, but I would say that.
It's really the typical reasons that you would expect patients discontinuing as it start those tolerability issues for some patients that show up early in the treatment and those that's the primary reasons that patients will discontinue I'll make one just one more for you which was we talked about that there is there was above and beyond that just the discontinuation.
And there is just a temporary impact in the beginning of the quarter on refill rates and that was that was outside of the kind of discontinuation and then as I noted that just rebounded and and really what we see now is consistent this consideration with what we saw in the fourth quarter.
Got it okay, and so presumably outside of the safety or Tolerability.
These patients could actually come back onto therapy is that the right way to think about it or.
Yes.
We've seen even just tracking analog products like MMS and others that patients.
It's not it's not in the guidelines, but patients do cycle on and off a product and I think one way to explain that would be a patient.
Stops taking therapy finally sees their doctor Doctor says you Yuri is still high start taking your therapy again so.
They can come back its not like we see this as once they've seen the product. They are considered a non responder or something and don't come back and we're not getting reasons coming back to are saying the patients' proteinuria wasn't under control a lot of these are patient driven decisions and.
We will have to continue to and you heard that we have an increase in our focus on the patient educating the patient and all of that pertains to education on disease itself importance to stay on your medication and keep on your medication over time.
Got it that's really helpful perspective, and then just wondering if you can talk more about what youre seeing with pricing metrics and what are your latest assumptions are.
Well as we said.
We are giving aid average net in the first year of launch it at or around this 65000 net per year per patient.
As we indicated in the quarter, it's been above that and we haven't given specifics because the last thing that we really want you to do is plug in a number that's had variability and then carry that forward and then it changes. The one thing. We do know is that we believe it will continue to migrate towards that average net that's why we are.
Sticking pretty consistent to that.
Adherence once a patient goes on drug Marty has been at or around 80%. So if they are on the prescription they're staying high and that's a good thing in terms of looking at your average monthly number of doses et cetera.
So.
As we've said average net has been hired 65, but we think it's a safe bet to land on 65 at this stage until we just have more data because mix of patients depending on insurance carrier public versus private pay.
How much Egfr dosing is utilized and adherence are all going to vary over time.
Got it okay. It makes sense, thanks for taking my questions.
Thanks Martin.
Coming up next are the question to follow is Stacey <unk> at Cowen <unk> Company. Your line is open. Please go ahead.
Hi, good morning, congrats on the quarter, thanks for taking our questions.
So first.
Specific one on the patient.
Sure.
From our.
Your comments from last quarter.
Sure.
Patient starts.
That we added in March this applies to confirm that.
What are you seeing in terms of the cadence.
Kind of quarter over quarter.
What are you seeing them.
So far.
How should we be thinking about the.
In March.
On a run rate.
Are you are you seeing.
From that number.
Question.
The second question is.
We could talk about prescribers.
Think about how to use with planning.
Okay.
Okay. Okay.
Okay.
Wow.
What.
What kind of.
All right.
So is that kind of have adopted.
Okay.
Great.
Yes. It does thank you.
So let me, let me start with PSS and Joe Miller, just make sure.
It's with the math, what what we said was we didn't give the exact number for March but just told you that in March.
Our ice yet and I don't know Joe do calc, what she said $2 68.
That's a little bit high we gave kind of an average number coming into year end earnings. It wasn't the full full February through the end of the month. When we did that number. So you are a little bit high on March but overall as you kind of look at monthly run rates March was our highest month to date.
And what I would say about quarter, we report and we've consistently done this.
We'll give you the year end noteworthy year end of quarter number, but then will always give you did depending on when we do the earnings call. We'll give you. The most up to date Psf number and Thats. What we gave you as of Friday of last week.
That was what was the number we reported year to date 646 47, what I can tell you about that number Stacy is it is.
On track with their growing ahead of where we were in Q4, which is what I think you want to see you want to see consistent quarter on quarter growth and as we noted we saw a slight dip.
From Q4 to Q1, and then we're seeing gross debts representative growth over Q4, so far into Q2, and that's right on track with where we want to be in terms of your question on prescriber habits and repeat prescribers, let me share just a couple of things here.
And just for being expedient here kind of cover off on this for Max.
One yes.
Prescribers are more apt to use the product once they've used it so we do see strong.
Secondary prescribing and do so from after initial prescription repeat prescribing is quite high and consistent.
Second obviously, we decile our docks and in our top decile docs are penetration increase in continues to grow and to put that into perspective, the top tier docs have in some cases 10 to 12 times the number of patients. So we're talking a small number of patients per Doc, but then the average lower decile.
And our penetration there has continued to grow as we get over the next couple of quarters.
We'll continue to share more as to what our both our depth and breadth of prescribers look like but we've been quite happy based upon our deployment with our sales force as to what our penetration spend and the highest decile.
The breadth of our prescribing and then more importantly, the debts physicians are reusing the drug after stock more apt to once they do.
That's very helpful.
Our next question today will come from Ed Arce H C. Wainwright. Please go ahead.
Yeah.
Hi, everyone. Thanks for taking my questions can you hear me okay.
Sure.
Great.
Few questions for me first.
Wanted to ask you mentioned in the release the psf conversion rates.
At about 80% after 90 days my question is.
If you could describe for us the.
For that conversion the average period from the PSS to treatment.
On average what does that look like.
And then.
Wondering now that you.
Over a year now.
Experience with patients any.
Any lessons learned.
So far as.
<unk>.
You work on.
Keeping patients on therapy, the consistency the persistence compliance.
Obviously towards not just refill rates.
Good thing same consistent any lessons learned there and perspective you could share.
And then lastly.
Regarding the $30 million.
$230 million in potential milestones from Otsuka.
Potentially later this year from the EU approvals.
Is there any details you could provide on to the split.
What would be required.
In terms of labeling and so forth.
And then I have a follow up.
Okay I'll go backwards on NES, because as you go through those less usually the last ones first one on my mind, so on the $30 million from Otsuka, Here's what we've said historically.
The closer we come to a match in the U S label of a closer will be assured to a $30 million payment the range of up to $30 million is all comes down to how the label comes together and duration of utilization so meaning if the product were by the EMA.
Said to be a therapy that can only be used for three to six months the payment would be lower.
All the color I can give you on up to 30, but the closer it comes to match the U S. The closer you can be assured that.
$30 million is the number we would see and.
So far in our conversations both at $120 157 days and conversations to the Raptor co Raptor, we don't see any showstoppers here. So we feel good about it.
Tom.
But the psf conversion rate and then let me go to lessons learned because I want don't want Max as input there I had plenty but.
Specifically about patients and I think we should give you our color their TSM.
Psf Ginsberg and rate on average.
We are above at 30 days more than 50% of patients are converting on to drill. So we give you a 90% number which was 80% or 90 day number and but at 30 days more than 50 almost up to over 60.
Andre so they get on them pretty quick were improving as I've said historically, we're looking at 30, we're looking at even pre 30, but the important one to 30 60, and 90 days and we want to have as many converted within that 90 day period as possible and I think we're getting to a point of almost like a 100% prefer.
And where any and we want to get them on faster and now to be up over 60% at 30 days as is.
We're on track with where we wanted it lastly on lessons learned with patients.
I'll just emphasize that it's critical and that because this disease presents with no physical signs and symptoms.
There is no natural patient quality of life indicator that forces a patient to stay on drug if your joints hurt you're more apt to stay on a biologic therapy for rheumatoid arthritis.
Is it helping your joints loop.
Lucas and price is a quiet disease until it's not.
And we need to health care providers, we need the patient to be educated on the overall impact of the disease and we need the patients themselves to be overly educated to stay on therapy, because their kidneys and potentially.
Because of what the data shows if the disease progresses or lives maybe at risk so patient education patient support programs.
Our continuing to be Paramount and as we mentioned in the call script, we're increasing our investment there.
Yes, I mean, what I would add and I think Peter hit the nail on the head what I would add is that we have improved our processing speed every quarter.
We are having more than 80% adherence rate is significant for this patient population and really the key as Peter highlighted certification, we put significant resources in R&D Alliance, our case management team that connects with patients on a regular basis.
We put significant resources in support of physician offices and academic centers to ensure that.
Patient start forms are converted fast and those investments are bearing fruit in speeding up conversion and also helping patients stay on treatment.
That's great. Thank you that's helpful.
Just one more follow up for me.
You mentioned the vocal pediatric study.
Underway.
And enrolling.
Patients just wondering if you could.
Delineate for us.
Any other post approval commitments.
So just be aware of what's coming up.
Down the line. Thanks, so much.
Yeah as previously mentioned here just a reminder for everyone on the call are post marketing commitments were one the Aurora two extension data, which has been shared with the agency and the EMA and as part of our application and the EMA.
The vocal Peds study, which is a pediatric study obviously.
<unk> is ongoing and then lastly, there was a lactation study and I think a drug on drug interaction studies. One has been completed the lactation study is ongoing the peds study is ongoing and we'll report out on those.
Over time as I said.
Drug on drug to drug interaction study has I believe been submitted at this stage completed and submitted there arent too has been submitted and then the vocal Peds study will take some time. Obviously this is primarily a disease a disease that affects on middle age females.
So.
Getting down into a.
A younger audience will take time, but we have all the belief that we can do that so those are our commitment said and we continue to through the enlighten <unk> study invest in further research bolt on.
Higher level like a global registry and secondarily with individual investigator initiated studies and things of that nature to support understanding the therapy in the real world environment.
Great. Thanks, so much Peter.
Thanks, Ed.
Next we'll hear from the line of <unk> <unk> at RBC.
Good morning. This is sahil alright. Good morning. This cycle for doesn't mean, thank you for taking my questions.
My first question is can you please elaborate on the quarter on quarter decline in revenues.
When I look at the total number of patients on therapy. They have increased from 84 at the end of the year too.
1071 by end of Q.
Q1, 'twenty two so is it a function of leases or is it a function.
You have more fulsome Egfr doctors driving revenue slip one quick one can you please comment on that.
And then I have a follow up.
Yes, I'm not sure I understand the question.
You are asking about the net price per patient or you're asking the patient says.
Cumulated patients have grown what are you pointing at debt that I just need to understand Gabby clarify over a warm I sure I get it.
So in the press release. It was mentioned that there were 84 patients at the end of Q4 at the <unk> 21 at 1071.
At the end of March 'twenty two so they are net editions took patient spot theatre venues have declined. So I just wanted to understand is it a function of lower defense during Q1 or is it like there are more patients on.
The dose reduction program.
Or is there anything else.
Okay.
Yeah, So as we said.
Because I got it now you're just doing the straight line math Youre, saying. The question is if you had 884 and you grew a net 200 patients why was the quarter will be down and what youre not taking to account. There is one is a patient growth number you also have to look at refill rates right and as we mentioned with pace.
<unk> insurer plan changes with the Covid impact in patients.
Not picking up prescriptions due to that as we mentioned in the call that your refill rates were lower so even though we increased the number the net revenue per patient in the quarter went down and I think.
And then we will see that hopefully in the next quarter, but we up partially why we.
<unk> tried to keep consistent on this net revenue number because in a quarter like this obviously, we saw a dip primarily due to retail so the simple answer for you. There is it's based on refill rate per patient.
And the patients on dose reduction data consistent with the prior quarter.
Yes, we haven't seen any any dramatic changes there.
Yes, I would not look to Q1 as anything significant happened with dose adjusting on patients.
We've seen pretty consistent at or around what we saw in our clinical trials so far in practice in the market.
Okay.
One more question.
You haven't mentioned that the discontinuation rate, which happens within three months. The patient is on the drug that is that was around 25% to 30%.
And today you have commented on for six months compliance Street, which is around 70%. So when we're looking at net patients should we deduct.
All of them be mutually or cause it combined.
No what we've done is where we originally when we did not give data for six months or 12 months was we gave you the best grouping of data, we add which was what happens at 90 days.
On a go forward basis, you should look at our persistency numbers that we gave Mike at six months, 70% of patients that get on drug remain on drug as being one number inclusive of those who have actually discontinued drug in the first 90 days. So it's not a double hit.
Yes.
Great. Thank you so much.
Got it from my questions that is all from my end.
Thank you.
And moving forward. Our next question comes from David Martin at Bloom Burton.
Yes. Good morning, David most mornings are most of my questions been asked but I'll go back to a couple of previous quarters.
The doctors that are using our prescribing clinics are they also prescribing generally been list.
Or do they tend to pick one or the other and if they're prescribing false drugs any insight yet as to which patients they decided to give them.
Some of which they decided to give up in Washington.
Okay.
Yeah. Thanks, Thanks for the question and.
The answer to that question Thats pretty consistent with what we've said in the past which is.
Really the.
When we talk with Rheumatologists.
They think about been list and look for.
For different types of patients.
And really there is almost a different positioning as they think about what the patient's manifestations are their level of proteinuria.
There Lucas health state and how they position how they think about whether to use will kind of absorb unless stuff. While we've also what we've seen in nephrology is a is a stronger preference for kind us.
Then than bandwidth and that comes from just adjust there.
General experience also with prior generation C&I.
For me on this one and we have with its tough in the data.
Really breakthrough rheumatologists have the abilities to use than list for the treatment of lupus. So sometimes they keep a lupus patient on as they get lupus nephritis, sometimes they initiate lupus benlysta when the patient has lupus nephritis and it seems to us that even the rheumatologist is.
Selecting the patients when they get lupus nephritis for a new patient to when they use benlysta or when they use our drug.
And the good thing is in nephrology, we are getting preferential right now so.
We will keep you posted on how those numbers move moving forward.
Okay.
Patients with newly diagnosed lupus nephritis or.
Are the doctors waiting until they fail and then that's been steroids before they put them on.
Or is that first line combination.
Well I think our greatest tracking towards success in what we've said is our goal is to change the treatment paradigm is to track over time, the amount of patients who start receiving <unk> in combination with MMF and steroids as first line therapy, but as you can appreciate David these patients are coming in the.
40 of these patients.
At our in the diagnosed untreated population are going to be an MMF and steroids first.
So we.
We are seeing growth in newly diagnosed patients, but it's a smaller percentage of the yen and we're going to track. It over time. The majority of our patients have seen of course are currently on MMF and steroids and our drug is added to the equation, which is as predicted.
Okay and last question.
Doctors, keeping the patients on China's only if they achieve a complete remission or is just a lowering of proteinuria partial remission good enough to keep them on.
Yes, I don't know that we see.
Longitudinally track.
Proteinuria rates on.
Monthly euro.
Can only give you what we hear anecdotally and I'll pitch it to Max to give you that what we're hearing from the docs and what we're hearing from the docs is that they're looking for a partner.
Decrease overall in there.
They reached a certain level they were happy with a 50% decrease in proteinuria and clearly their goal is to get it to a complete response, but it won't stop treatment.
The goal is to get coronary down.
And recall again and.
Most cases, David they are adding our drug to the mix, so youre getting an incremental benefit over the current standard of care for the majority of patients.
Okay, Great and I do have one other question when you say, adding it to the mix of these patients with lupus that are already on that list.
Are you seeing loop kindness being layered on top.
We haven't we haven't we have not seen that yet although our thought leader based talks about whether a strategy in combination with C&I and b cell inhibition could be an approach, but that's one that's talked about hypothetically as a treatment strategy, we do not see that.
Practice right now at least in our data.
Okay got it thank you that's it.
Thanks, David.
And now we'll hear from Justin Kim at Oppenheimer.
Hi, good morning, and thanks for taking the question.
Maybe just a follow up on <unk> question.
It seems to suggest a pretty stable quarterly script number between fourth quarter through even our estimate of the <unk> run rate.
Just trying to understand what the team back.
Maybe those numbers to shift or change as you.
Look.
<unk> reached the high end of guidance.
Whether it's macro factors or sort of micro with like.
Physician practices and depth of prescription can you walk us through how you think about those script numbers changing or maybe not changing over the balance of the year.
Well I think if you look at the total number per script of prescription start forms that were produced in Q4 and you look at Q1, it was down slightly and when I say slightly Joe what are we talking dependent it's tens of patients. It's not it's not like 200 patients.
So as we move into Q2, we are back at least in our run rate and again, we don't give quarterly projections on on PSS, but directionally, we're back in a growth trajectory over Q4.
So that's where we want to be.
Given but you can probably do your own estimated math on if you believe 70% of patients on or at six months and make an assumption on where they are at 12 months you carry a prescription start form right into the quarter and figure backwater and attrition rate could look like in the quarter what are.
Both in PSS that you also can estimate what the retentive rate can be and maybe there are improvements there. All I can tell you is the way we think about it is the retentive rates. We're working on we want to continue to improve on but if we held steady what would the prescription start for rate has to be in order to achieve.
Growth numbers from Q4 numbers, where we were into Q2 because from a pure revenue standpoint, the numbers from Q2 have to be bigger obviously than where we were in Q4 not based off of where we are in Q1. So they have to grow above Q4 and then.
Seeing that growth continue throughout the year and multiple assumptions are around continued opening prescription start form activity refills throughout our entire model and our execution its not one factor.
Okay, Okay got it.
And does the team have any updated observations or thinking around how this kinase is being administered.
Beyond maybe the 12 month time point.
Just having onboard at several hundred patients in the commercial setting.
At this point.
Yeah, I mean, that's to me the magical question is what's it going to be at 12 months and then what's it going to be at 18% and 24 months.
We benchmark this by the way against biologics and other indications other rare diseases et cetera, but.
In all honesty, just like before we'd rather report 12 month numbers. When we have a significant end of patients that are on the drug and through this through six months, especially had several hundred patients who had seen the drug at that point the number of small at 12 months.
But I think it's fair to say that our assumption would be that if youre at 70% at six months, you're probably going to be less than that at 12 months. That's just the natural way.
<unk> business over time will progress and probably less at 18 and less at 24, it's just a matter of what it is so.
Just so we can't comment on it outside to say, we'll report it when we have a sizable enough and with each quarter. It grows and so that we can give you something that we think is going to be consistent and projected <unk> and that generally speaking we believe it will continue to decline, it's just decline at what rate.
Okay, and maybe just a final question if I can squeeze one in.
Taking a look at the abstract at <unk>.
What's just kind of curious if there was any observations on the duration of therapy.
Time to renal response observed commercially just sort of curious with some of the data around share class five taking longer time to reach sponsors is that sort of mix.
Mix of patients being observed maybe as you look at sort of the population that at later and later time point that maybe they are.
Falling into one class or another.
But I think he's stepped right into the reason we're doing the vocal study so that we can track prospectively.
Some of those numbers like in real world, what the time to renal response actually looks like so I can't give you what the time to renal response or the in light <unk> registry, sorry, I think I said vocal.
But.
I can't give you what real world evidence shows in terms of time to renal response, but.
Dr. Solomon's on the phone he can probably give a little bit more on the abstract specifically youre talking about Neil you want to give any commentary if you heard the question.
Yes.
Both of them quite sure exactly what it was you are guessing you were saying.
Did you have any.
For additional information around.
How quickly customized response compared to patients.
The question.
So just just around whether the time to respond.
Is or.
Maybe just class in general and severity of disease.
Is.
Observed a different among the various populations at various time points, so our patient that longer term duration therapy potentially more severe disease.
The commercial setting and whether there are any trends observed is too.
Yes.
Yes.
What we've said about the real world.
Registry is going to give us some well for information.
Around that.
That's the reason we're doing it.
So many things at play and of course, when you look at it.
Data is being presented.
15% of patients who maintain for example to the Aurora trial or trials.
So we're kind of looking at relatively small.
Populations of patients.
I think we just don't have.
At this point.
Yeah.
Moreover, as we do more and more cars and light registered so I mean, that's.
So we are at this point.
Understood. Thanks.
Alright, so I want to thank everyone for joining us for the call today I think with that last question that concludes our Q1 earnings. Thank you for the time and have a good day.
Ladies and gentlemen, this does conclude today's already of Pharmaceuticals first quarter 2022 financial and operational results Conference call. You May now disconnect your lines and we hope that you enjoy the rest of your day.
Okay.
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