Aurinia Pharmaceuticals - Earnings Call - Q4 2018

Transcript

Speaker 0

Greetings, and welcome to the Aurinia Fourth Quarter and Full Year twenty eighteen Financial Results and Operational Highlights Conference Call. At this time, all participants are in a listen only mode. A brief 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 Doctor.

Glenn Schulman. Thank you. Please begin.

Speaker 1

Thanks, Roya, and good afternoon, everyone. Welcome to Aurinia's Q4 year end twenty eighteen earnings call and general business update. Joining me on the call today from Aurinia are Doctor. Richard Glickman, Chief Executive Officer Dennis Bourgeult, Chief Financial Officer Doctor. Neil Solomon, Chief Medical Officer Mr.

Michael Martin, Chief Operating Officer. This afternoon, we issued a press release detailing fourth quarter year end twenty eighteen financial results and our corporate update for the year. The press release and associated financial statement package is available on our website at www.auriniapharma.com and on Forms 40 F and six ks filed earlier on EDGAR and SEDAR. I'd like to remind you that today's call is being webcast live on Aurinia's Investor Relations website, and a replay will also be available approximately two hours after today's call completes. The content of today's call is Aurinia's property.

It cannot be reproduced or transcribed without prior written consent. During the course of this call, we also 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 a discussion of factors that could affect our future financial results and business, please refer to the disclosure in today's press release, our most recent filings with Canadian securities authorities and reports that we file on Form 40 F with the U. S.

Securities and Exchange Commission. All of our statements are made as of today, March 1939, based on information currently available to us. Except as required by law, we assume no obligation to update any such statements. Now with all that, let me turn the call over to Doctor. Richard Glickman.

Rich?

Speaker 2

Thank you, Glenn, and thank you all for joining us today as we review our fourth quarter and year end twenty eighteen financial results and provide a general business update. This past year has truly been extraordinary for the team here at Aurinia with significant progress made on a number of fronts. As a quick level set, I think it's important to bring everyone up to speed on the progress made and what we are looking forward to during the year to come. Aurinia has three programs ongoing in parallel that highlight the potential of a pipeline and a drug for our lead candidate voclosporin. First and foremost, we are evaluating voclosporin in a Phase III trial for lupus nephritis.

In addition, oral voclosporin is being tested in FSGS or focal segmental glomerulosclerosis and lastly, VOS, our ophthalmic solution is being tested in the treatment of dry eye syndrome. Reflecting on this past year, our most significant milestone was in September when we announced the early completion of enrollment in the AURORA Phase III clinical trial for the treatment of lupus nephritis. The target enrollment of three twenty four patients was surpassed due to the high patient demand with three fifty eight lupus nephritis patients randomized at sites across 27 countries. We would like to thank all our trial patients, the physicians, our CROs, the advocacy groups, and especially the team at Aurinia for their extraordinary efforts, which led to this result. We are related by the significant interest in this trial and it reinforces the need for new treatment options for patients living with lupus nephritis.

I continue to be impressed by the level of dedication exhibited by our team to execute this trial with great diligence and expediency, but without compromising quality. As you recall, the AURORA clinical trial is a global double blinded placebo controlled study to evaluate whether voclosporin when added to background therapy of mycophenolate mofetil or CellCept can increase the speed and overall renal response rates in the presence of low dose steroids. The primary endpoint for the study is complete renal response at fifty two weeks and we look forward to sharing these trial results towards the end of the year, which if positive will form the basis of a regulatory filing. As you know, LN is a debilitating disease and our team is extremely motivated and working diligently to potentially provide the first FDA approved therapy for patients who are desperate need of new treatment options. We believe the totality of the data from both the AURORA and the AURORA clinical studies will serve as the basis for a new drug application submission with the FDA following a successful completion of the AURORA clinical study.

Under voclosporin's Fast Track designation, we are also utilizing the rolling NDA process, which will allow us to begin the submission process following a positive pre NDA meeting with the FDA, which we anticipate to occur during the 2020. To that end, we are actively preparing the non clinical and CMC modules required for the NDA submission. Our current plan is to complete the NDA submission including the clinical module in the 2020 in line with our previously disclosed regulatory timelines. With respect to intellectual property, we recently announced that we received notification from after extensive interaction with the USPTO that our patent which covers how we treat patients and how they are managed during the initial titration period had been allowed and should be granted shortly. This method of use patent is intricately tied into the label we seek to obtain for voclosporin, which relates to dose adjustment used in both the AURA and the AURORA studies.

The patent provides potential coverage until December 2037 for not only the treatment of lupus nephritis, but also other proteinuria kidney diseases that could be treated with voclosporin, representing an additional potential for ten years of additional patent protection. So we're really excited about this development. That brings us to an update on FSGS program with voclosporin. According to NephCure, approximately five thousand four hundred new patients are diagnosed with FSGS each year, accounting for the largest segment of almost thirty percent of patients with nephrotic syndrome. FSGS is a rare disease that attacks the kidney filtering units, the glomeruli, causing serious scarring which leads to permanent kidney damage and even failure.

Similar to lupus nephritis, an early clinical response can be measured by the reduction of proteinuria which appears to correlate with improved long term outcome. Vocusporin also appears to play a key role in maintaining podocyte structural and functional integrity, which is thought to be critical for long term kidney health. While guidelines exist for the treatment of this disease, there are no currently approved therapies for FSGS in The United States or in European Union. Our ongoing open label proof of concept study seeks to evaluate up to 20 treatment naive patients with FSGS. The goal of this study is to assess the potential of voclosporin as first line treatment option for these patients before other interventions such as steroids or immunosuppressions are utilized.

As we're essentially enrolling newly diagnosed treatment naive patients with this rare disease, enrollment remains slow. We are opening up additional sites to enhance enrollment. We look forward to providing additional update later in this year. Finally, I am very excited to present the data generated in our Phase 2a study with VOS in the treatment of dry eye syndrome. As you recall, in July 2018, we initiated the dry eye program with a new patented topical formulation of voclosporin called VOS.

This novel formulation of voclosporin is a unique patented aqueous, preservative free, and anti cellular solution containing 0.2% of voclosporin. And you know from previous disclosures, voclosporin has been shown to be several times more potent than cyclosporin, the active ingredient used in restasis. Dry eye syndrome is a chronic disease in which a lack of moisture and lubrication in the eye surface results in irritation and inflammation of the eyes. Dry eye is a multifactorial heterogeneous disease, estimated to affect greater than twenty million people in The United States alone. While the FDA approved products do exist for the treatment of dry eye, two of which are CNIs, there are plenty of opportunities for potential improvements in efficacy, tolerability, including onset of action and alleviating the need for repetitive dosing.

We believe that calcine inhibitors will remain the mainstay in the treatment of dry eye and that VOS has the potential to be the best in class calcine inhibitor within this billion dollar market. We initiated an exploratory Phase II head to head study of voclosporin ophthalmic solution versus RESTASIS for the treatment of moderate to severe dry eye in July 2018. The four week study enrolled 100 patients and in January 2019 we announced the results of the study. The study evaluated and compared the efficacy, safety and tolerability of VOS and RESTASIS. The primary endpoint we used evaluated drop discomfort at one minute post drop installation looking to see whether there's a difference between the two treatment arms.

What we learned did surprise us and apparently the market. Both VOS and Restasis showed low levels of one minute drop discovered. Restasis demonstrated less than anticipated drop discomfort. However, the secondary outcome measures on efficacy, namely in the Schirmer tear test and the fluorescein corneal staining, VOS achieved statistically superior results of restasis. We were surprised that after only four weeks of treatment that VOS showed statistical superiority to restasis on FDA accepted objective signs of dry eye syndrome with forty two point nine percent of VOS patients versus eighteen point four percent of restasis subjects achieving greater than a 10 millimeter improvement in the Schirmer tear test at week four with a p value of less than 0.005.

VOS also demonstrated statistical superiority to restasis and fluorescein corneal staining with a p value of less than 0.0003. The primary endpoint of drop discomfort at one minute on the first day of therapy showed no statistical difference between the treatment groups as both groups as I mentioned exhibited low drop discomfort scores. Again, as a first exploratory Phase two study which evaluated VOS against Restasis, the results observed just after twenty eight days of treatment is very striking and beyond our expectations. Currently, we're developing a roadmap assessing different protocols and regulatory strategies with the goal to rapidly advance VOS into its next phase of clinical development. We look forward to providing updates as we invest in the dose in the dry eye indication.

I also want to mention that today on our call is Doctor. Neil Solomon, our Chief Medical Officer and Mike Martin, our Chief Operating Officer, who will answer questions related to both intellectual property and the VOS 2A Phase 2A program today. So Aurinia is in a substantial growth phase and has transitioned from an early stage clinical company with one indication to a late stage clinical company with multiple indications and we are diligently preparing for commercialization. The past two years we've seen have been a critical time in our company's growth driven by the potential of voclosporin to transform the LN treatment landscape and now by our belief in its ability to enhance the management of dry eye syndrome. In 2018, our team focused on a number of essential goals and objectives and I believe we have successfully completed all of them.

The most important being the diligent execution of our Phase III clinical trial of voclosporin. We also expanded our intellectual property footprint for voclosporin. We advanced an additional renal indication for voclosporin in FSGS and we developed an additional standalone product for the treatment of dry eye. And we did so while maintaining a robust balance sheet to provide appropriate financial runway for the company. With that, I will turn the call over to Dennis Bergereau, our CFO, to review the Q4 and year end twenty eighteen financial results with you.

Dennis?

Speaker 3

Thanks, Richard. On the consolidated have been prepared in accordance with IFRS as issued by the International Accounting Standards Board. The consolidated financial statements are presented in U. S. Dollars, which is the company's functional and presentation currency.

As of December 3138, we had cash, cash equivalents and short term investments of $125,900,000 compared to $173,500,000 at the 2017. Net cash used in operating activities was $51,600,000 for the year ended December 3138 compared to $41,200,000 for the year ended December 3137. On November 3038, we entered into an open market sale agreement with Jefferies LLC pursuant to which we could from time to time sell through ATM offerings common shares that would have an aggregate offering amount of up to $30,000,000 Subsequent to year end, we further strengthened our balance sheet as the ATM was fully utilized during the 2019. We received gross proceeds of $30,000,000 and issued 4,600,000.0 common shares. We incurred share issue costs of $1,200,000 comprised of a 3% commission and professional and filing fees related to the ATM offering.

We believe based on our current plans that we have sufficient natural resources to fund our existing LN program, including the AURORA trial and the AURORA two extension trial, complete the NDA submission to the FDA, conduct the ongoing Phase two study for FSGS, commence additional dry eye studies and fund operations into mid-twenty twenty. For the 2018, we reported a consolidated net loss of $14,600,000 or $0.17 per common share as compared to a consolidated net loss of $3,300,000 or $04 per common share for the fourth quarter ended December 3137. The loss for the fourth quarter ended December 3138 reflected an increase of $593,000 in the estimated fair value of derivative warrant liabilities compared to a reduction of $9,000,000 in the estimated fair value of derivative warrant liabilities for the fourth quarter ended December 3137. The net loss before this non cash change in estimated fair value of derivative warrant liabilities was $13,900,000 for the fourth quarter ended December 3138, compared to $12,300,000 for the same period in 2017. Research and development or R and D expenses increased to $10,800,000 in the 2018 compared to $8,700,000 in the 2017.

The increase in these expenses primarily reflected costs incurred for the AURORA two extension trial, the drug drug interaction study and the FSGS and dry eye Phase two studies, which were newly enrolled studies in 2018. Corporate administration and business development expenses increased to $3,500,000 for the 2018 compared to $3,100,000 for the 2017, primarily reflecting higher professional fees incurred in the 2018. For the year ended December 3138, we recorded a consolidated net loss of $64,100,000 or $0.76 per common share, which included a non cash increase of $10,000,000 related to the estimated fair value annual adjustment of derivative warrant liabilities at December 3138. After adjusting for this non cash impact, the net loss before this change in estimated fair value derivative warrant liabilities was $54,100,000 This compared to a consolidated net loss of $70,800,000 or $0.92 per common share in 2017, which included a non cash increase of $23,900,000 in the estimated fair value of derivative warrant liabilities for the year ended December 3137. After adjusting for this non cash impact for 2017, the net loss before this change in estimated fair value of derivative warrant liabilities was 46,900,000.0 The change in the revaluation of derivative warrant liabilities is primarily driven by the change in our share price.

Our share price of $6.82 was higher at December 3138 compared to our share price of $4.53 at December 3137. The increases in our share price resulted in large increases in the estimated fair value of derivative warrant liabilities for each of 2018 and 2017. Derivative warrant liabilities will ultimately be eliminated on the exercise of the warrants and will not result in any cash outlay by Aurinia. We incurred R and D expenses of $41,400,000 for the year ended December 3138 as compared to $33,900,000 for the year ended December 3137. The increase in R and D expenses in 2018 for the year, again, primarily reflected costs related to the enrolled trials of the AURORA two extension trial, the DDI study and the FSGS and dry eye Phase two studies.

We incurred corporate administration business development expenses of $13,700,000 for the year ended December 3138 as compared to $12,100,000 for fiscal twenty seventeen. The increase in these expenses reflected higher corporate activity levels overall and higher personnel compensation costs. Compensation costs for corporate administration development personnel reflected an increase in non cash stock compensation expense of $1,000,000 for twenty eighteen compared to 2017. With that, I'll turn the call back over to Richard for some closing remarks. Richard?

Speaker 2

Thank you, Dennis. So once again, I want to thank the team for the tremendous progress we've achieved over the past year. The work completed provides the foundation for the data and program advances anticipated through 2019. We continue to diligently and efficiently execute our clinical programs and are looking forward to a very exciting 2019 with top line data from our AURORA study before the end of the year along with updates on dry eye and FSGS. As a company, we have a drug candidate that if successful in Phase III has the potential to be the first approved therapy for the treatment of lupus nephritis.

We believe the efficacy and safety data supporting this drug to be substantial. We have a clear regulatory path forward to approval and we believe the market opportunity for this drug to be very significant. It's with great confidence that we continue to advance voclosporin and its development programs. Thank you all for taking the time this afternoon. And with that, I'd like to turn the call over to the operator and open the line for Q and A.

Operator?

Speaker 0

Thank you. We will now be conducting a question and answer session. Our first question comes from the line of Ed Arth with H. C. Wainwright.

Please proceed.

Speaker 4

Hi. Good afternoon, Richard, Michael, Neil. Thanks for taking my questions.

Speaker 2

Hi, Ed.

Speaker 4

I have a few. Hi. First on FSGS, it's been about nine months now since you initiated enrollment. Just wondering, I know you said that there are a few extra sites that you're planning or have recently added to improve enrollment. But just wondering when you see that coming in at least qualitatively?

And could you consider, I know it's a very small study, but could you consider decreasing the number of patients to complete that. Then

Speaker 1

So there Yes.

Speaker 4

Sorry. And then just turning quickly to the VOS program. Obviously, some pretty strong data. What are the considerations and next steps and including is there something that's gating in regards to discussions with partners?

Speaker 2

Okay, very good. First question on the FSGS in terms of enrollment. We're dealing with treatment naive patients as I mentioned and what we found in the study is that while the KOLs anticipated they'd be able to access patients fairly quickly given patients generally don't want steroids. The issue has been is that the physicians, patients present themselves and immediately are put on steroids and by the time they get into our clinical program to the KOLs, they're no longer eligible to actually be in the study. And we recognize that the KOLs are just aren't able to deliver the patients at the rate that we anticipated.

Now there are countries in which we've worked in before, are very close and have very good health care systems that actually apparently have a much greater population that we could access prior to therapy. So the first of those major countries that are coming online that really matter should be online, my expectation is in May. And after that, think we get a pretty good idea of what our patient flow will look like and we will provide an update at that time. Alternatively, we could do which doesn't really alter our study a tremendous amount would be to probably looking at amend the protocol, a patient to receive a bolus like they do in some of our other studies as you would in clinical practice and then wean them off that and then continue them on your therapy. So we're looking at all options to actually move forward.

The patients are out there. I think that at this point in time FSGS has become even more important to us given the social property change that has occurred in the company. The opportunity around FSGS has actually grown in considerable importance to us. So we're going to put more resources behind this program now as a consequence of that. So that's basically the answer to your first question.

In terms of VOS and the considerations that drug, number one, we're not an ocular company. We really have developed a lot of renal expertise, but we work with really, really excellent CROs in the ophthalmology space and the ones that all the other major companies tend to work with. And so we're getting access to excellent clinical execution. So what we believe is and what our board has supported is in this further investment in the dry eye program and a further investment in VOS. On a relative basis this is a relatively low risk asset for the company.

And even for our standards, which we think are relatively this is even lower risk asset for us. We understand the space. We understand the regulatory environment we're operating in. We know what the regulators are looking for in terms of a classic approval pathway. And so we believe we should invest further take this drug to the next level.

And then we could look at post LN data and while we've got data coming in after that and possibly decide what's best to do with this asset. But I think an awful lot of value could be created for our shareholders by further investing in that asset rather than licensing it out right now. I think there certainly would be interest, but I really I'm going to be articulate I really do not want to actually out license this asset until after we take it to the next level unless the terms of such a deal were so substantial they really offset our costs. Once again take it through the next level then when we divest it how we divest it could make a meaningful impact on the cash requirements for the company that moves towards commercialization in its renal space.

Speaker 4

That's very helpful. Thanks, Richard. And then a couple more if I may. Actually the segue is good. The next question is around the patent.

I know you're you and the whole team are quite excited about the potential to the value of the whole program. And I think rightly so. Wondering if you could talk a bit about the importance of that patent being viewed as critical in particular as a safety issue by the agency and the implications of that on the protection of it. And also the breadth of the coverage given that it's for nephrotic diseases. So LN and FSGS obviously, but what others potentially could be covered in there.

And then one final just housekeeping question. What is your current share count now after the recent changes? Thanks.

Speaker 2

Okay. You gave me so many questions. I'm not sure I could track of all of them. Let's speak to the patent for a moment. All right.

Several years ago when we started writing a number of patents, this is just one of several that were written by the company, but one of the ones we were most excited about because basically it's based on the fact that we included in our protocols a dose reduction strategy, that was based originally around the safety parameter. And what was surprising was that we actually ended up discovering that in fact as we treat patients certain way and as we dose reduce we actually saw enhanced efficacy. It was unanticipated. And as a consequence we when we saw that we had an interesting opportunity to go in front of the patent office and really present what is basically kind of a personalized approach to treating these patients based on understanding how the glomerular filtration rate is responding to the drug. Very easy to test for.

It doesn't require very complex therapeutic drug monitoring. And what it essentially does and I guess to your question what you're really asking which is the key question is what is the probability that the actual claims in the patent that form the dose reduction protocol land up as part of the actual label for the drug? And the probability is extremely, extremely high because it really is a critical safety protocol. It's how we treat patients. And so it's very likely there's always a risk, but it's a very unlikely risk that it wouldn't be included.

So we believe that the patent itself, which covers the dose reduction strategy will be included as part of the safety component that you would have in any label where dose reductions are regularly conducted. In terms of what it covers for us, it gives us till December 2037 and that means anyone wishing to practice or treat proteinuria kidney diseases using our protocol would actually have to either license from us in order to be able to practice their art even if they file a generic. Now as long as we only get approvals for drugs that require voclosporin indications require the dose reduction strategy then we're in good shape because it'll provide I think very, very strong protection for us on that. Now that means that we have a number of opportunities within that space FSGS being obvious, but there are other ones. And I don't know Neil if you want to jump in from a clinical perspective with other potential protein or kidney diseases we could potentially cover with voclosporin as well.

Neil, are you on mute?

Speaker 5

Sorry. We've looked at a number of them. I was on mute, such as idiopathic membranous pediatric nephrotic syndrome. And to be honest with you, we kind of discounted them for exactly the reasons that we may now consider them, because of the improved patent, the length of time it would take to recruit in these diseases now makes them potentially more appealing and we're going to certainly going to go back and have a look at these other proteinuria kidney diseases. There are lots and lots of them.

A lot of our connections in the lupus nephritis and FSGS space have been very keen on us looking at this drug in these diseases. So we're certainly going to go back and have discussions on these now.

Speaker 2

Thanks, Neil. And Dennis, do you happen to have had you that share count number?

Speaker 3

Yes. At the March 15, which is the date of our audit report, we have 91,600,000.0 shares outstanding.

Speaker 4

I'm sorry, say that again. I'm sorry, didn't get that.

Speaker 3

Yes, sorry, 1,600,000.0 common shares outstanding.

Speaker 4

Great. Thanks for all the help. It's very helpful and congrats on the patent.

Speaker 2

Thank you.

Speaker 0

Thank you. Our next question comes from the line of Joseph Schwartz with SVB Leerink. Please proceed.

Speaker 1

Thanks very much and congratulations as well on all the progress. I was wondering since you all have been involved in advancing the lupus nephritis field since developing CellCept. How have you seen the market evolve to the current time now that you're so close to the finish line for voclosporin? And how is your program taking that into account in order to and then how is your strategy to penetrate the market meaningfully incorporating these types of learnings?

Speaker 2

Okay. Well, I got to say that's our first commercial question we've had during conference call. So thank you for doing that, Joseph. We have been actually for quite some time, the team has been involved in it. It's kind of interesting to watch when you look back at what evolved with CellCept.

But people don't understand with CellCept, it's how quickly it was taken up. That market was so desperate. Back at those days, was using drugs like cyclophosphamide to treat cyclophosphamide that they were using to treat patients mostly. And of course that was extremely toxic. So having another agent available was just phenomenal.

I remember watching and you go back historically and take a look at the growth of CellCept and Roche's documentation through their transplant experience and then opening it up into autoimmune and primarily LN. So what we saw is an extremely rapid uptake. And I would say that given the response we had to the Phase two data when it was announced, what we saw immediately the Lupus Foundation of America had over 100,000 hits the first week alone of that data. So number one, I think the market is absolutely primed for a drug. But it's not just about needing the drug, it's about the value proposition that one builds around the actual drug.

And so we spent a lot of time and a lot of money, and this is where our pre commercial activities have been, is understanding the reimbursement landscape and understanding the value proposition for a patient, what it means, what it costs to treat a patient, what it means to treat them with this drug and what it means in terms of their life. And there's some things that are intangibles and there are others that are actually quite tangible in terms of financial impact of a drug like this. So I think that there's an easy story to tell. I think accessing that patient population, particularly in The U. S, requires a relatively small sales force.

If this company actually lands up fulfilling and actually being a commercial entity and actually selling directly as opposed to being acquired in the process, it won't take a huge sales force. And we are actually building out that capability in the event that we don't get acquired. You've got to build your business, as I've often said in the past. And so I think one, it's a market that's absolutely ready. It's a market that there is very little competition in our space right now.

We will have to look at competition again a little bit differently now when we look out to 2038 because things will look a little bit different in the long run. But certainly, we don't see any immediate competition. This is a drug that could be used hand in hand with other therapies. So if you're using an sort of body based therapy or biological therapy, this all sort of fits in together. You can use these type of multi target therapy approaches across the board.

And that's why I feel very comfortable with new drugs being synergistic with this drug. So I think in terms of not having anything else out there to be to reimburse against, having only approved drug is actually going to make a big difference in terms of reimbursement as well. And we have a pretty good idea of precedent out there of what these drugs are relatively worth in the space. So I think all of those factors go into sort of really position this as being a drug that can actually be launched and it could be launched aggressively and it actually would have a very aggressive uptake curve. Is that helpful?

Speaker 1

That's extremely helpful. Thank you, Richard. And if you were to have to, which hopefully you will in the not too distant future have to quantify the pharmacoeconomic benefit of remission and then put it into context with your drug and how if it achieves your target product profile, how would you go about formulating the equation of what the value of or what the pharmacoeconomic equation would look like for voclosporin. I don't want to ask you to give us where you're going to price it, but just help us parameterize the price the pharmacoeconomic equation. What would the value of a remission be?

And I'm sure you've done a lot of work on that front.

Speaker 2

We have. But actually, next time I'm to have this call, I'm going to bring a commercial expert on the call with us too, not just clinical, because your questions are actually very good. I don't have a precise equation to give you, and I'm happy you didn't ask for one. I think when one looks at the space and takes a look at what your value proposition is, this drug we tend to see works within sort of eight weeks of being delivered to a patient. If you take a look at the only other approved drug in the lupus space at all, Benlysta, and you take a look at even their clinical program in lupus nephritis where they're looking at they're looking at one hundred and four week sort of endpoint in their study.

You look at where that drug is priced and it's readily available out there right now, I think you could build against that. You have a drug that will work much quicker. Could be synergistic. And I think it forms a really good basis to where you'd likely price this drug. I think in terms of there's other parameters that come into play here in the long run.

I've often mentioned from a commercial perspective is what would be most exciting to me actually and having been involved with CellCept would be the idea that this new drug voclosporin could be used in such a way that essentially if you look at the patient population, it's eighty five percent female, It's childbearing age women. And one of the things that you find that happens is people feel better right away when they're on these medications or it doesn't take very long. When they recover, they often want to have families. And as a consequence, I think that there's promise for the use of this drug where you take away something like CellCept which is know, teratogenic and contraindicated and when you take away Benlysta which is currently contraindicated in pregnancy as well. We know that CNIs have been used in pregnancy for a long time.

We know there's been a number of births on this drug as well. And I think that with a proper registry I think we could actually change the value equation too in a very, very significant way because this may be I think a really excellent important go to drug for these patients for a variety of these reasons. So the next call we're on I'll give you a really, really crisp equation sort of. But I think that sort of gives you a sense of how we see the value of this molecule and the role we see it's going to play in the community and socially as well for patients.

Speaker 1

Very helpful. Thanks again.

Speaker 0

Thank

Speaker 2

you.

Speaker 0

Thank you. We have reached the end of our question and answer session. Allow me to hand the floor back over for closing remarks.

Speaker 2

So you see if I give really, really long answers to those questions, get fewer questions. I get it now. And now thank you all for being on the call today and thank you too for your questions. I'm really excited about what's on the horizon this year at Aurinia. I am excited about the potential news flow we're going to have especially towards the end of the year.

And I'm particularly excited about getting a chance to see the top line Phase III results from our program of lupus nephritis. I also am pretty excited about the new intellectual property because I think it really provides the company with a really different value proposition. We have opportunities to look at additional indications, plus we get so much more runway in terms of lupus nephritis program. I think that this is a was a very pivotal year for us, and I think 2019 is actually poised to be a real standout year for us as well. Anyhow, thank you very much for being on the call today, and have a great evening.

Bye now.

Speaker 0

Thank you. This concludes today's teleconference. You may disconnect your lines at this time and thank you for your participation.