Q4 2021 Aurinia Pharmaceuticals Inc Earnings Call
Okay.
Greetings and welcome to the Arena Pharmaceuticals fourth quarter and full year 2021 results conference call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad. As a reminder, this conference is being recorded I would now like to turn the conference over to your host Dana Lynch Irenaeus director of corporate Communications and corporate affairs. Thank you you may begin.
Thank you Melissa and thank you all.
Joining today's call to discuss 2021 in the fourth quarter and year end financial results.
Joining me this morning are Peter Greenleaf, President and CEO .
Kevin Miller, Chief Financial Officer, who will be leading the call other members of the executive team specifically Mark.
Commercial officer and Dr. Neil Solomons, Chief Medical officer will be available at the peak.
<unk> of our presentation 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 annual report on Form 10-K .
For more information please refer to our filings with the U S Securities Exchange Commission, which are also available on our website at Www Iranian pharma have dotcom.
During this call we may 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 discussion of factors that could affect our future financial results and business.
Please refer to the disclosure in our press release and our annual report on Form 10-K , along with all of our recent filings with the U S Securities and Exchange Commission and Canadian Securities authorities.
Please note that all statements made during today's call are current as of today February 28, 2022, unless 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 let.
Let me now turn the call over to <unk>, President and CEO Peter Peter.
Peter.
Thanks, David and thanks to everyone for joining us today.
<unk> 2021 was a transformational year for hernia across every part of the company, we achieved major strategic and operational milestones.
With these achievements, we evolved from being a small drug development company with limited capabilities to become a fully integrated revenue producing biopharmaceutical company.
To start the year, we received U S. FDA approval for <unk> in lupus nephritis, a serious and life threatening rare disease by demonstrating superior clinical results over the current standard of care.
We jumped immediately into launching our first commercial product and with that we shifted from strictly cash utilization to cash generation and the ability to now treat and serve patients and health care professionals and the community.
In June we hit another major milestone with the filing of a market author marketing authorization application for approval of <unk> with the European Medicines Agency. This was a key step in globalizing, our business alongside our partner Otsuka and in furthering our ability to serve patients beyond.
The U S.
To establish our leadership in lupus nephritis, we recognize the clinical evidence and the ongoing data generation is paramount to driving loop kindness adoption as well as establishing its duration of therapy.
In June of last year, the lancet published dilute kindness pivotal Registrational study and in December . We also unveiled the positive results of the Aurora two continuation study.
Luke This is now the first and only FDA approved medicine for lupus nephritis with three years of pivotal trial results, including long term safety data.
The Aurora two results will be submitted to the FDA in connection with our post marketing commitments in the first half of this year and they'll also be added to our package of information being submitted to the EMA.
Supplementing our already filed MAA, we filed this additional data and we believe it will be important to prescribers and assessing the long term benefits of using loop kinase in the treatment of lupus nephritis.
Finally, we took the first big step in 2021 towards diversifying our pipeline and driving new innovation with the acquisition of two preclinical compounds with the addition of these assets as well as building out our capabilities in research translational medicine and process development.
We have moved forward from a single asset company to a now diversified integrated Biopharma organization.
And a year of major milestones I'm, most proud of the team's accomplishments in realizing our vision to serve patients impacted by this rare autoimmune disease.
Confident that this work will end progress puts us in a position of strength to drive future growth.
With that all of this context, I'm now going to move to provide further detail on first our fourth quarter and full year commercial results.
Followed by our outlook for 2022 with loop kindness revenue guidance.
I'll then provide an update on our globalization efforts for Boquist foreign and I'll also touch on the status of our pipeline and give a brief preview of our anticipated business milestones.
Finally, I'll roll that all up and review our current financial position.
So let's begin with our business performance relative to the U S launch of loop guidance in the fourth quarter, we generated $23 $4 million in net sales representing an increase of 60% from the prior quarter, bringing total recognized revenue for 2021 to <unk> 45 points.
$6 million, which is right on target with where we guided for 2021.
We are very pleased with these strong results, especially considering we built our commercial team launched our product and achieved all of these results, while managing the impact and unpredictability of the ongoing and unprecedented COVID-19 global pandemic.
Our commercial launch metrics and impact continue to improve across multiple dimensions.
In Q4, we added 477, new patients start forms ending the total year with 1500 72 patient start forms.
The months of October and November showed notable psf growth over the prior quarter. While December we did see a slowdown in Psf says the omicron variant of Covid started to impact our prescriber and patient universe.
In addition, we continue to see progress in moving Psf's to patients on therapy.
60 day Psf conversion rates are now in excess of 70%.
We are also on track with ongoing improvements in both 30 and 60 day conversion rates each month.
On the patient access front.
We are making great headway Iranian has confirmed patient access to <unk> through payers and plans that represent roughly 90% of U S. Total lives.
This notable improvement reflects the efforts of our access team and working with payers to develop more loop kind of specific coverage coverage policies and the efforts of our personalized patient support team to ensure that patients can begin treatment as quickly as possible.
Of course, and unfortunately as more patients begin treatment with Luke on this we can expect to see some more patients discontinuation.
It's still too early to see statistically significant trends in overall drop off rates, thus far discontinuation or aligned with what we track in our clinical trials, which is about 25% to 30%.
When we look at patient adherence with loop kindness here too and it's too early to site emerging trends remember the emerging blue <unk> patients on drugs started treatment in mid Q3, and Q4 of 2021.
Obviously in most cases these patients have only been on treatment between three to six months. So we will need more time to understand understand overall adherence rates.
As we gather more information on patient adherence and persistence, we will continue to work with our advocacy partners into our personalized patient support resource a rainy alliance and direct to consumer activities to provide education tools and support to ensure patients adhere to their treatment and <unk>.
To improve the continuity of their overall lupus nephritis care.
When we look at 2022, we have thus far experienced the same circumstances that most other specialty pharma companies worked through at the beginning of the calendar year.
Changes in employer covered insurance carriers and policies and patient co pay resets can slow things down when getting patients off to a start or refilling their medications at the start of a year.
And of course, the Covid pandemic and in particular Omicron Varian has significantly impacted our patient base and continues to impact access and continuity to overall treatment and care.
This is reflected in our overall psf's numbers to date 1700 773 since launch through last week.
These results point to our strong first year, coupled with the slowdown during the early start of the second year.
We have confidence that our commercial capabilities that delivered on quarter over quarter over quarter over quarter growth in 2021, and we will continue to execute.
And drive growth.
Building on the strong momentum we saw in Q4 in spite of the challenges. We're seeing in Q1, we are setting guidance for revenue from sales of loop kindness to be in the range of $115 million to $130 million for the FERC for the fiscal year of 2022.
This range represents an increase of more than 150% to 200% in revenue, which we see as aggressive growth year over year in light of the challenging environment. We're currently facing.
We are confident we can achieve these results by driving new prescriptions, and ensuring efficient and seamless conversion of patient starts to patients on treatment.
Our guidance does not include milestone payments royalty or manufacturing revenue or anticipated ex U S sales related to our licensing agreement agreement with Otsuka to market <unk> foreign and the European Union and Japan.
As a reminder, rainy it will receive up to $30 million upon EMA approval contingent upon the favorability of the of the approved label as well as double digit royalties low double digit royalties on sales and supply cost recovery through cost plus to a cost plus arrangement.
As reported previously we filed our marketing authorization application in Europe in June of 2021, and we're working closely with otsuka to support the approval process.
This includes submission of answers to the standard 120 day questions posed by the European Medicines agency as well as sharing our most recent Aurora two data with them.
We are pleased that the process has been moving along as expected and we continue to expect EMA approval in the second half of 2022.
Let's now shift gears to research and development work were doing here at Iranian ads.
As I've mentioned in December we reported on the final positive are results of the Aurora two continuation study.
Data from this study, which looked at 216 patients continuing from Aurora, One study for an additional 24 months of treatment reinforces the favorable risk benefit profile of loop kindness over a three year period.
With safety comparable to that seen in the original Aurora, one as well as sustained efficacy we plan to submit a manuscript manuscript for peer reviewed publication in the first half of this year as well as abstract submissions for presentations at major scientific com.
Princes throughout 'twenty, two and 'twenty three.
All of this activity should provide further support for health care professionals patients and payers to safely continue loop kindness treatment beyond one year of therapy.
Other loop kind of clinical work will be ongoing this year as well with the continued recruitment of patients into the vocal pediatric study and the setup of trial sites for the enlighten and light <unk> registry.
To remind you we aim to initiate up to 75 sites in the U S for rates for this registrar registry study and plan to leverage real world data collected to gain further knowledge about patients and loop kindness.
The insights we gained from this study will then be shared with clinicians and payers to improve patient care and ensure access to therapy.
Our research team continues to drive IMD, enabling work on our pipeline assets Aurora or EUR 200, and EUR 300, and we plan to submit <unk> for both compounds in 2023.
As you can imagine these are important next steps in the build out of our pipeline for the future.
I'm happy to report that all of this work achieved we continue to operate with a healthy balance sheet, including approximately $466 million of cash equivalents and investments on hand, and no outstanding debt.
With the strength of our balance sheet and the cash flows for incoming from loop kindness, we can fund our business for the next few years.
I will now turn the call over to Joe Miller for more detail on these activities in our financials and I'll return at the end of the call to recap and also to answer any questions you might have Joe.
Thank you Peter and good morning, everyone as Peter previously stated as of December 31, 2021 Arena had cash and cash equivalents and investments of $466 1 million compared to $422 7 million at December 31, 2020 incur.
The increase was primarily due to the receipt of net proceeds from the company's ATM offering cash receipts from the sale of his guidance and cash proceeds from the exercise of stock options and warrants offset by the commercial infrastructure spend to support the launch of with kindness. It also.
<unk> payments for inventory and upfront payment made as part of our collaboration agreement with Wanda to build a dedicated manufacturing capability or our mono plant and an upfront license payment related to our recently acquired developmental programs AUR 200, and EUR 300 <unk>.
As a reminder, in the prior year the company was still on the FDA pre approval phase.
And was the only in the beginning phase of building out its commercial and back office infrastructure.
Regarding the ATM mentioned early we raised net proceeds of $196 7 million in the fourth quarter and an average price of $19 91.
The company has terminated this ATM effective as of today there'll be no more sales under the ATM.
We believe that we have sufficient financial resources to fund our current plans, which include funding commercial activities, including FDA related post approval commitments manufacturing and packaging of commercial drug supply funding us are supporting commercial infrastructure conducting plan research and development programs investing in our pipeline.
Executing on our business development strategy and funding our operating activities for at least the next few years.
Total net revenue was $23 4 million and $50 million for the quarters ended December 31, 2021, and December 31, 2020, respectively. Total net revenue was $45 6 million and $50 1 million for the year ended December 31, 2021, and 2020, respectively. The net revenue for the quarter ended.
And year ended December 31, 2021, primarily consisted of commercial sale of love kindness. Following FDA approval in January of 2021.
Total revenue for the quarter and year ended December 31, 2020 was primarily due to an upfront payment from us sugar of $50 million, resulting from entering into a collaboration agreement with that.
Cost of sales were 500000 and zero for the quarters ended December 31, 2021, and December 31, 2020, respectively cost of sales were $1 1 million and zero for the years ended December 31, 2021, and December 31, 2020, respectively and two in 2020. The company did not have any drugs approved for commercial sale in the.
From payment for Mazzuca did not have cost of sales associated with it.
Gross margins for the three and 12 months ended December 31, 2021 was approximately 98%.
Selling general and administrative SG&A expenses were $44 2 million and $38 8 million for the quarters ended December 31, 2021, and December 31, 2020, respectively. For the years ended December 31, 2021, and 2020 SG&A expenses were $771 4 million and 90.
$6 million, respectively. The increase for both periods was due to an increase in employee related costs associated with the expansion of the commercial and administrative functions to support the launch and commercialization commercialization of with kindness, which ramped up during the third quarter of 2020.
Also contributing was an increase in travel trade shows and sponsorships connected with the sales at kit activity occurring throughout 2021.
Noncash SG&A share based compensation expenses was $7 2 million and $4 5 million for the quarters ended December 31, 2021, and December 31, 2020, respectively. For the years ended December 31, 2021, and 2020 SG&A noncash share based compensation expense was $26 4 million and 13.
$6 million respectively.
For the quarters ended December 31, 2021, and December 31, 2020 research and development expenses were 11, 1% and $13 2 million. The primary driver for the decrease was due to the decrease in employee related costs due to the allocation of certain costs post FDA approval to SG&A and the termination of certain programs in late <unk>.
20.
For the years ended December 31, 2021, and December 31, 2020, R&D expenses were $51 1 million and $53 million respectively. The primary drivers for the increase was due to an upfront license and accrued milestone expenses related to our recently acquired developmental programs EUR 200, and EUR 300, and higher clinical <unk>.
Research organization expenses related to its new clinical programs offset by a decrease in <unk> four in development costs. Following the approval of the guidance.
Noncash R&D share based compensation expense was $1 2 million and $600 for the quarters ended December 31, 2020 at December 31, 2020, I'm sorry for the quarters ended December 31, 2021, and December 31, 2020, respectively for.
For the years ended December 31, 2021, and 2020 R&D related noncash share based compensation expense was $4 4 million and $3 $7 million respectively.
For the quarters ended December 31, 2021 Arena reported a net loss of $33 3 million or <unk> 25, net loss per common share as compared to a net loss of $8 1 million or <unk> <unk> net loss per common share for the quarter ended December 31 2020 for.
For the years ended December 31, 2021 Arena reported a net loss of $181 million or $1 40, <unk> net loss per common share as compared to a net loss of $102 7 million or <unk> 87, net loss per common share for the previous period.
With that I'd like to hand, the call back over to Peter for some closing remarks, Peter Thanks, Joe as you've heard throughout the call. We have made a profound impact in 2021, delivering a safe and effective treatment of paid to a patient population with high on underserved needs and growing our company to ensure continued commitment to our mission of serving.
Patients for the years to come.
Want to thank everyone again for joining us today I'll now open up the microphone to your questions.
Thank you if you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question. Kim You May press star two if you'd like to remove your question from the queue for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys in the interest of time, we ask that you read.
Each keep to one question and one follow up thank you.
Our first question comes from the line of Alicia Young with Cantor Fitzgerald. Please proceed with your question.
Hey, guys. Thanks for taking my question, maybe just wanted maybe a one and a half just could you talk a little bit more maybe about the potential cadence of the COVID-19 impact that you're seeing that do you expect that to kind of be sustained over the year is that what you're factoring in and then also can you just characterize how these impacts are different than what you may have.
Seen in the first 12 months of launch last year versus you know, what's been going on but I'll, let Brian . Thank you.
Thanks Alicia.
And I appreciate the question so the way because we're not giving quarter on quarter guidance, but we tried to be pretty clear in the call that.
Most like any specialty pharma company out there in the space, we're seeing the typical.
Start of the year impact of things like patients, having insurance plan changes co pay co pay resets et cetera, and then on top of that of course, we had the omicron varian impacts which impact the last couple of weeks of December and into January which we do see starting to improve.
So theres two ways I guess I would think about this with respect to giving annual guidance, but not quarterly guidance. We hope the omicron varying impacts will start to lessen and then on a year on year basis. I think every January early February time period in our business. This will be a continuing impact just like.
It is for <unk>.
Any company, that's marketing and selling drugs in our space today. So if I were thinking about it from a gating standpoint, we anticipate.
The first quarter being impacted and then getting back to a healthy growth pattern into Q2 through Q4 of the year.
Okay, and just to clarify that I've gotten this question already.
I feel confident about the trends there underlying the launch besides the things you've highlighted like Covid, you know payer dynamics in the first quarter, but you feel like the trends in growth are still there for this product.
That's correct.
Awesome. Thank you guys.
Thanks Alicia.
Thank you. Our next question comes from the line of Maury Raycroft with Jefferies. Please proceed with your question.
Hi, good morning, and thanks for taking my questions. I was just wondering if you can provide more specifics around reasons for discontinuation and adherence challenges.
Q excuse me and how these compared to what you saw in clinical studies and if you can talk more about your assumptions for 2022, and how you you talked a little bit about managing some of these issues throughout the year can you talk more about how you are planning on doing that.
Sure.
On discontinuation and adherence I would tell you that the reasons are across the board.
What I would underscore is theyre not.
Payer related it's not like we're getting.
PSS that come in and then the payers not paying for the drug that's not been one of the ones, we've seen but to try to range in on.
Our host from a host of different reasons as to why patients might be discontinued discontinuing.
Our product, it's kind of across the board right now.
<unk> from.
Tolerability to patients just not picking up prescriptions, which we are trying to flush out more remember.
No remember, we're dealing with primarily a patient population that's an African American Hispanic and Asian female population in the U S and we can look to other.
Disease States is analogues to understand that adherence and.
Longer term compliance are challenged with that population in general So we're looking.
Looking at this one closely and when we have more data, especially on the adherence side the long term.
Persistency will provide some guidance and steer there, but as we said since the majority of patients have gone on in the third and fourth quarter of this year to really report out on what three and six months persistency looks like I don't think of being really a good characterization of of where we are aware where.
Actually going so it's across the board Maury and.
It pretty much maps to what we saw in our clinical trials.
Got it Okay and maybe just a quick question in your 10-K you note.
That son filed an IPR against your <unk> hundred six pattern and I'm. Just wondering if you can comment on your latest thoughts on IP positioning and also this particular issue.
Sure Let me, let me actually take a minute to address just want I want to thank you for the question. We did received notice of an eye and enter par case to review or IPR petition being filed on February 24th with respect to our patent that is claims directed at loop kinds of loose guidance dosing protocol for lupus nephritis used in our.
Clinical trials and you'll all recall.
That patent has a term extending out to December 2037 at this stage, it's really too preliminary to give a full assessment of this IPR as it positions. Our petition that was filed from Sun Pharmaceuticals, who you all may recall, if you've been reading our case, we are showing for patent infringement and a separate matter.
Which I'll talk about in a second was really just received so we're looking at it but we're confident in our processed prosecute all our patents. This patent in particular had significant review as we've mentioned previously at the U S patent and trade office before being approved as being an actual valid.
Patent by that office, we're putting together our reply and as I've said before we will vigorously defend this patent and other challenges we get again from any party that bring.
Bring any challenge to our patents.
With respect to the separate litigation, we have with some that I just mentioned and as has been disclosed in our 10-K in December 2020, we actually commenced on an action in the U S District Court in New Jersey against Sun and certain of their affiliates and in summary, the action as a claim for patent infringement.
Under U S patent laws of rising relating to Sun sequel product, which is a C&I immuno suppression ophthalmic solution prior to the expiration of our patents relating to <unk> ophthalmic solution. So basically in our action, we requested relief and forms of Infor.
From a an order confirming that sun is infringe those patents and injunction preventing sun for manufacturing using or selling sequel, and monetary relief, including cost. Obviously Sun has responded by denying infringement and <unk> asserting that the patents here are valid.
In Sun actually of exchange initial pleadings and patent disclosures and we're in the process of book what lawyers.
Qualifies claim construction and that's all ongoing trial action on this one is probably somewhere on or around March of 2023. So that gives the full backgrounder on on the previously mentioned Sun litigation and the IPR.
Side of the equation.
Got it okay. That's helpful. Thanks for taking my questions.
Thanks Martin.
Thank you. Our next question comes from the line of Joseph Schwartz with SBB Securities. Please proceed with your question.
Alright, Thanks, very much I was wondering if you could help us understand the main assumptions underlying your 2022 revenue guidance for the kinase in terms of things like patient start forms conversion rates in times in discontinuation.
Either on an absolute basis or relative to what you've been seeing.
And then I think.
Peter a couple of weeks ago at our healthcare conference you had.
Uh huh.
I'm sure some plans to issue aggressive guidance are there particular aspects of this revenue guidance that are aggressive or more aggressive in some you know.
And others.
Yeah, well, let me, let me start there and I underscored in our in our call today I think a 150 to 200 plus percent growth year on year as aggressive in light of that.
The challenges everyone is facing and the start of the year with the omicron Barry its impact on offices or individuals companies and our reps the patients themselves et cetera.
Most companies are I think guiding to two challenges and that net area and I think that kind of growth doubling.
More than doubling up our business year on year as aggressive.
And that was the context for my comments going into the conference and it's my context for the comments given today.
In terms of how to think about how the forecast gates for the year, obviously, we don't give quarter on quarter.
Guidance, but what is what underlies us achieving these numbers is getting too after the first quarter getting back to significant growth in PSM for prescription start forms and maintaining an adherence level at or around what we're seeing currently so again as we are.
Estimated somewhere around that 25% to 30% that we've seen coming out of our clinical trials.
In addition.
Zinc.
We have to see good persistency over time, but as I said earlier it's.
With respect to how long patients have already been on drug. It's it's sort of hard to qualify what we've seen and what we need to hold too, but all of those are factors Joe.
Okay. Thanks for that color, maybe just a quick housekeeping question, if I could on the EU approval hopefully later this year.
I think the range of milestones that you stand to gain is $15 million to $30 million I was wondering and that depends on the label as I understand it can you share with us any.
More color on what kind of factors would determine whether you come out the high or the low end of that milestone range.
Yes, I'll try to over simplify it if we come with a label that is very similar to what we see in the U S. You can.
We feel confident that we'll get a full $30 million.
There are other areas such as length of therapy et cetera that if those were more constrained in Europe , we might get the lower end of that range, we feel really confident because of the Aurora two continuation study in a way that the 120 day comments came back that we should be on the upper.
And of that but obviously you never know until we actually get the approval, which is targeted for the back half of this year.
Makes sense, thanks, very much for the help.
Thanks, Joe.
Thank you. Our next question comes from the line of Stacy <unk> with Cowen and company. Please proceed with your question.
Good morning, Thanks for taking our questions.
So we have one around the net pricing per patient for the Chinese and how should we be thinking about Q4, and as we adjust the pricing to stay consistent with the Q4 metrics you've provided around enrollment forms and conversion.
It would imply that the pricing is much better than our initial 65000 placeholder pricing annually.
Our rough math with getting closer to 100, K, so any guidance would be appreciated.
Also related to this question.
Given the potentially stronger pricing as we think about Q1 and given all your commentary do you expect to see the conversion of the client.
Significantly down from Q4, thank you.
So let me start with the first on net pricing we maintained the previous guidance of 65, net or higher and the reason that we are not giving sort of quarterly adjustments to this is almost aligns directly with my previous commentary on.
Patient persistency until we really know what the average dose is going to look like on a monthly basis, but more importantly, how the average length of therapy is going to look per patient, it's hard to estimate and not give the street overconfidence in a number that could vary right what we can.
Can tell you is that we're confident that right now our 65 net estimate or above is where we're tracking and it seems like that should stay consistent throughout we've not commented on sort of breaking down net versus total number of patients on therapy et cetera, because those numbers can swing around.
Round.
Lastly, your question on patient start forms and how we should be thinking of that first quarter versus rest of the quarters of the year as I said to previous questions. I think it's safe to say, while we're not giving quarterly guidance that we see a softness in the first quarter and patient start forms and we would estimate that we're going to need to see it.
Pickup in patient start forms as we move into Q2 and Q3 Q4, obviously for the rest of the year and we feel confident that those trends are starting to move in the right direction.
Thank you.
Thank you. Our next question comes from the line of Ed Arce with H C. Wainwright. Please proceed with your question.
Alright, Thanks for taking my questions and congrats on a strong into the year.
Couple of questions for me.
Yeah.
Could you discuss.
Your what you believe to be the key headwind headwinds to further sales growth in 2022, perhaps.
Even beyond your strong guidance.
Obviously, given as you said.
Covid.
And on the Con variant.
Issue as well as the 90% payer coverage at this point.
Some of the key headwinds going through the year as well as you know, perhaps key drivers that may factor in as a key swing for the upside.
And then I have a follow up.
Yeah, I think it's two fold one is obviously this this COVID-19 environment and endless and I'm sure investors have heard plenty of other companies characterize this but from our perspective it impacts the entire ecosphere right like our direct representatives it Sir.
<unk> to get access to institutions into offices.
Inclusive of that is the way patients are excuse me physicians and physicians office staff are are operating today, and then lastly, and I think most importantly, which will bleed into my second comment is the fact that patients and how they relate to the health care system, how aggressively they are at.
Keeping their visits on the books to picking up their medications et cetera have all been impacted and we previously quoted growth or lack of growth in 2020 to 2021 and diet new diagnosis.
For lupus nephritis at least from our ICD nine code poll data showed almost a 30% drop in new patient died.
Diagnosis, so that just as one example, so.
<unk> is the only thing we can point to to say why these numbers have declined and obviously there have been other companies, whose cant come out and even said that cancer therapies cancer diagnosis adherence to chemotherapy regimens have seen direct input as well so I won't belabor that one anymore, because I think that by and large is.
As the largest swing factor and then as I said I think we're seeing some really good signs of life that we're that we're moving out of that the second part for me is if we can continue to which we fully expect we will identify new patients and patient start forms is how long will work keeping patients on therapy and of those.
Patients, who actually do get the drug approved how many are actually picking up the prescription and adhering to the profile and as we've said right now at least adherence and discontinuation.
Page to cancellations and discontinuation were about 25% to 30% of our overall patient start forms it'll.
It'll be interesting and a big swing factor in our forecast this year or a meaningful one to know how long those patients are actually staying on therapy over time, because it just compounds the effect of getting new patients on drug if patients are staying on drug.
One that we look forward to talking more about as we get more data.
Okay Alright.
For that.
And then.
Related to what you just said the second question is around discontinuation.
As you've said a couple of times already 25% to 30%.
Is where you're tracking now similar to your phase.
Phase III.
Question is.
Given it.
It seems like there's some mobility or at least effort to improve that over time, where do you think discontinuation could settle into.
Further down the line as a sort of a steady state and then related to that I'm wondering if there's any.
Expectations or if you could help us understand.
The potential impact of.
Many patients that may have dropped off and that may come back later on.
Is that something that you think about them factories as well thanks so much.
Yep.
Two things here on discontinuation barring having any new data I at least from a company mindset, we're carrying that number forward and while we always hope to.
Prove upon it with all of the things that I mentioned in terms of our tactical activity.
Probably the safest estimate is to look to our trials and what we've seen early on.
But note that we've got good effort against trying to improve upon it.
At least that just gives you sort of our current view, we see improvement there will be the first to report it to you.
The second part of your question was centered around.
Can you repeat one more sorry.
Yeah.
Yes, no problem.
<unk> said that may drop off for whatever reason.
And you see them come back.
Yeah, Yeah got it got it.
Meaningful proportion.
Given some of these things that's nothing to do with the drug at all like just not picking it up and maybe they went to the doctor again in and decided to to really start the program.
What we do know from just tracking sort of the surrogate drugs that these patients had been on historically in polling data all the way back to say 2017 up until today is.
If you look at the actual prescription activity patients do Miss doses here or there they do seem to cycle on and off of drug and I think as many know that does not align with either the U R ACR or <unk> guidelines at once.
Protein areas in control.
These guidelines are fairly silent on length of therapy, they say keep patients in control and I think.
The reason for that is what we've talked about earlier that patients can miss it prescription and ended up coming back on to growth at least that's what we've seen through the data now how to qualify that against our own data. Our hope is that we're going to see more adherence over time and then as I said I think we need to see more than that.
Three months of therapy or six months of therapy before we re.
Really give any steer on what we think the average adherence will look like but I think the net of your question is is once a patient on drug are they forever lost to the system and at least the data would say no that physicians seem to actively put patients back on drug if they've missed picking up a prescription or have fallen out for some.
Reason.
Great. Thanks, Peter that's helpful. I appreciate it.
Thanks, Ed.
Thank you. Our final question. This morning comes from the line of David Martin with Bloom Burton. Please proceed with your question.
Yes, most of my questions have been answered, but I have kind of a follow on to the last question.
So the discontinuation is 25% to 30% you said, it's not the payers and it sounds like most physicians are encouraging patients to stay on but.
So go back on if they've dropped off but are any physicians using this kind of as an induction therapy, but not a maintenance therapy.
At least what we've seen so far is the answer to that would be no, but I think it will if we wouldn't really find that out David in.
It's sort of tracking through a rainy alliance why patients might not be picking up their prescription.
I think it'll bear out more than what we see in terms of the persistency trends over time I can tell you sort of qualitatively that when we talk to physicians no. One is telling us that they're looking to use this as an induction and then bridging them to some other therapy. That's that's not with the intent of the prescribers are.
What we believe they are doing and when I say there is a host of different reasons that patients either discontinue or cancel.
A prescription it is a host there is no <unk>.
Actual one trend of consistency there it's everything from you know.
The office didn't follow through or the patient didn't follow through the patient didn't pick up the prescription decided not to stay on therapy couldn't tolerate the therapy. It is a host of different reasons, including general sort of a loss to follow up patients change addresses a change phone numbers, so I'm, making.
Sure that we're able to continue to track them down and work very closely as well as we can through our efforts commercially.
In a compliant way is is going to remain to be something that's top of our list of activities, we need to try to drive.
Okay. Thanks, and my second question is.
Do you have any idea of how your lupus nephritis starts in discontinuation as compared to bed Lister in lupus nephritis and any idea of what's driving the decision of physicians to treat with one or the other drug.
By the first part of your answer and I always hesitate to speak about other drugs, but I will tell you just from what we track again through coding and prescribing data is they see the same sort of challenges.
Since being as they started at a little bit of a higher base I think if you go back and look at Benlysta utilization and you tag it to IC ICD nine codes, they've been getting pretty active treatment of lupus nephritis patients long before they had approval for the drug and I think again. This is a question for.
For Dan but.
My review of that is that says much patients who've been on the drug for S. L. Lee that stay on it through a patient suffering a lupus nephritis spout and whether the patient the physician decides to discontinue the drug or not is TBD there.
New patient growth and their adherence at least from what we can see in discontinuation rate results are in line with what we're seeing right now so I do think its population not drug based from what I can see how physicians are making a decision on benlysta versus our drug.
Is a little bit across the board, but what we do know is that physicians have a unique patient mine or our drug that's different Denver, Benlysta and we do know that our messaging around the results. We produced in Aurora, one end and the Aurora two continuation study.
Nate with physicians I mean, they directly align with what the treatment goals are for therapy here and right now at least from what we can see our data best aligns to the guidelines that are out there in terms of treatment outcomes. So we think we've got a good position there David.
Okay. Thanks.
Thank you.
This concludes our question and answer session and thus concludes our call today. We thank you for your interest and participation you may now disconnect your lines.
Okay.