Aurinia Pharmaceuticals Inc (AUPH) 2018 Q4 法說會逐字稿

Greetings, and welcome to the Aurinia Fourth Quarter and Full Year 2018 Financial Results and Operational Highlights Conference Call. (Operator Instructions) As a reminder, this conference is being recorded.

I would now like to turn the conference over to Dr. Glenn Schulman. Thank you. Please begin.

Thanks, Royanne. Good afternoon, everyone. Welcome to Aurinia's Q4, Year-End 2018 Earnings Call and General Business Update. Joining me on the call today from Aurinia are Dr. Richard Glickman, Chief Executive Officer; Dennis Bourgeault, Chief Financial Officer; Dr. Neil Solomons, Chief Medical Officer; Mr. Michael Martin, Chief Operating Officer.

This afternoon, we issued a press release detailing fourth quarter, year-end 2018 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 informs 40-F and 6-K 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 2 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 the 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 19, 2019, based on information currently available to us. Except as required by law, we assume no obligation to update any such statements.

Now with all of that, let me turn the call over to Dr. Richard Glickman. Rich?

Well, thank you, Glenn, and thank you all for joining us today as we review our fourth quarter and year-end 2018 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 3 programs ongoing in parallel that highlight the potential of a pipeline in 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 324 patients was surpassed due to the high patient demand with 358 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 elated 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 end point for this study is complete renal response at 52 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 in desperate need of new treatment options. We believe the totality of the data from both the AURORA and the AURA clinical studies will serve as the basis for 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 in the first quarter of 2020. To that end, we are actively preparing the nonclinical and CMC modules required for the NDA submission. Our current plan is to complete the NDA submission, including the clinical module, in the second quarter of 2020, in line with our previously disclosed regulatory time lines.

With respect to intellectual property, we recently announced that we received notification from the U.S. Patent Office after extensive interaction with 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 this 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 of 2037 for not only the treatment of lupus nephritis but also other proteinuric kidney diseases that could be treated with voclosporin, representing an additional potential for 10 years of additional patent production. So we're really excited about this development.

That brings us to an update on FSGS program with voclosporin. According to NephCure, approximately 5,400 new patients are diagnosed with FSGS each year, accounting for the largest segment of almost 30% 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. Voclosporin 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 immunosuppressors, 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 IIa study with VOS and the treatment of dry eye syndrome. As you recall, in July of 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 nanomicellar solution containing 0.2% of voclosporin. And from previous disclosures, voclosporin has been shown to be several times more potent than cyclosporine, the active ingredient used in Restasis. Dry eye syndrome is a chronic disease in which the lack of moisture and lubrication in the eye's surface results in irritation and inflammation of the eyes. Dry eye is a multifactorial, heterogeneous disease estimated to affect greater than 20 million people in the United States alone. While the FDA-approved products do exist for the treatment of dry eye, 2 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 calcineurin inhibitors will remain the mainstay in the treatment of dry eye and that VOS has the potential to be the best-in-class calcineurin 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 of 2018. The 4-week study enrolled 100 patients, and in January of 2019, we announced the results of this study. The study evaluated and compared the efficacy, safety and tolerability of VOS and Restasis. The primary end point we used evaluated drop discomfort at 1 minute, post drop instillation, looking to see whether there's a difference between the 2 treatment arms. What we learned did surprise us and apparently the market. Both VOS and Restasis showed low levels of 1-minute drop discomfort. 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 over Restasis. We were surprised that after only 4 weeks of treatment that VOS showed statistical superiority to Restasis on FDA-accepted objective signs of dry eye syndrome, with 42.9% of VOS patients versus 18.4% of Restasis subjects achieving greater than 10-millimeter improvement in the Schirmer Tear Test at week 4 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 end point of drop discomfort at 1 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 II study, which evaluated VOS against Restasis, the results observed just after 28 days of treatment is very striking and beyond our expectations. Currently, we're developing a road map assessing different protocols and regulatory strategies with a goal to rapidly advance VOS into its next phase of clinical development. We look forward to providing update as we invest in the dry eye indication.

I also want to mention that today on our call is Dr. Neil Solomons, our Chief Medical Officer; and Mike Martin, our Chief Operating Officer, who will answer questions related to both intellectual property and the VOS IIa -- Phase IIa program today.

So Aurinia is in a substantial growth phase and has positioned 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 2 years, we've seen -- had been a critical time in our company's growth, driven by the potential of voclosporin to transform the LN treatment landscape and now by, I believe, 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 of voclosporin and FSGS, and we developed an additional stand-alone 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 Bourgeault, our CFO, to review the Q4 and year-end 2018 financial results with you. Dennis?

Thanks, Richard. On the [financial] front, the consolidated [financial statements] 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 31, 2018, we had cash, cash equivalents and short-term investments of $125.9 million compared to $173.5 million at the end of 2017. Net cash used in operating activities was $51.6 million for the year ended December 31, 2018, compared to $41.2 million for the year ended December 31, 2017.

On November 30, 2018, 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 million. Subsequent to year-end, we further strengthened our balance sheet as ATM was fully utilized during the first quarter of 2019. We received gross proceeds of $30 million and issued 4.6 million common shares. We incurred share issue costs of $1.2 million, 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 2 extension trial, complete the NDA submission to the FDA, conduct the ongoing Phase II study for FSGS, commence additional dry eye studies, and fund operations into mid-2020.

For the fourth quarter of 2018, we reported a consolidated net loss of $14.6 million or $0.17 per common share as compared to a consolidated net loss of $3.3 million or $0.04 per common share for the fourth quarter ended December 31, 2017. The loss for the fourth quarter ended December 31, 2018, reflected an increase of $593,000 in the estimated fair value of derivative warrant liabilities compared to a reduction of $9 million in the estimated fair value of derivative warrant liabilities for the fourth quarter ended December 31, 2017. The net loss before this noncash change in estimated fair value of derivative warrant liabilities was $13.9 million for the fourth quarter ended December 31, 2018, compared to $12.3 million for the same period in 2017.

Research and development, or R&D, expenses increased to $10.8 million in the fourth quarter 2018, compared to $8.7 million in the fourth quarter of 2017. The increase in these expenses primarily reflected costs incurred for the AURORA 2 extension trial, the drug-drug interaction study and the FSGS and dry eye Phase II studies, which were newly enrolled studies in 2018. Corporate, administration and business development expenses increased to $3.5 million for the fourth quarter of 2018, compared to $3.1 million for the fourth quarter of 2017, primarily reflecting higher professional fees incurred in the fourth quarter of 2018.

For the year ended December 31, 2018, we recorded a consolidated net loss of $64.1 million or $0.76 per common share, which included a noncash increase of $10 million related to the estimated fair value annual adjustment of derivative warrant liabilities at December 31, 2018. After adjusting for this noncash impact, the net loss before this change in estimated fair value of derivative warrant liabilities was $54.1 million. This compared to a consolidated net loss of $70.8 million or $0.92 per common share in 2017, which included a noncash increase of $23.9 million in the estimated fair value of derivative warrant liabilities for the year ended December 31, 2017. After adjusting for this noncash impact for 2017, the net loss before this change in estimated fair value of derivative warrant liabilities was $46.9 million. 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 31, 2018, compared to our share price of $4.53 at December 31, 2017. The increases in our share price resulted in large increases in the estimated fair value of derivative warrant liabilities for each of 2018 and '17. 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&D expenses of $41.4 million for the year ended December 31, 2018, as compared to $33.9 million for the year ended December 31, 2017. The increase in R&D expenses in 2018 for the year again primarily reflected costs related to the newly enrolled trials of the AURORA 2 extension trial, the DDI study and the FSGS and dry eye Phase II studies. We incurred corporate, administration and business development expenses of $13.7 million for the year ended December 31, 2018, as compared to $12.1 million for fiscal 2017. The increase in these expenses reflected higher corporate activity levels overall and higher personnel compensation costs. Compensation costs, corporate, administration, development, personnel reflected an increase in noncash stock compensation expense of $1 million for 2018 compared to 2017.

With that, I'll turn the call back over to Richard for some closing remarks. Richard?

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 a foundation for the data and program advances anticipated through 2019. We continue to diligently and efficiently execute our clinical programs, and I'm 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 in 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&A. Operator?

(Operator Instructions) Our first question comes from the line of Ed Arce with H.C. Wainwright.

I have a few. First, on FSGS, it's been about 9 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? And then...

So there's -- yes?

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

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 would 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 and 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, which are very close and have very good health care systems, that actually -- apparently have 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 in my expectation is in May. And after that, I think we can get a pretty good idea of what our patient flow would look like, and we will provide an update at that time. Alternatively, what we could do, which doesn't really alter our study a tremendous amount, would be to probably looking at amend the protocol, allow patients receivable -- it's like they do in some of our other studies, as you would in a clinical practice, and then wean them off of 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 intellectual property change that we've -- that just occurred in the company, the opportunity around FSGS is actually growing in considerable importance to us. 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 around 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 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 low risk, 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 can look at post-LN data and, well, we've got data coming in after that in VOS. We could decide what's best with in terms of this asset, but I think an awful lot of value can 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 it turns into such a deal where it's so substantial they really offset our cost. Once again, take it through the next level and then we'll divest it if -- and how we divest it could make a meaningful impact on the cash requirements of the company that moves towards commercialization in its renal space.

That's very helpful, Richard. And then a couple more, if I may. Actually, the segue is good. The next question is around the patent. I know you and the whole team are quite excited about the potential to the value of the whole program, and I think rightly so. I'm 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 a housekeeping question. What is your current share count now after the recent changes?

Okay. You gave me so many questions. I'm not sure I could track them all. All right. Let's stick to the patent for a moment. All right. Several years ago, when we started running a number of patents, this is 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's surprising was that we actually ended up discovering that in fact, as we treat patients in a certain way and as we dose reduce, we actually saw enhanced efficacy. It was not anticipated. 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 and doesn't require a very complex therapeutic drug monitoring. And what it essentially does is -- and I guess to your question which you're really asking, which is the key question, is that 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 of 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, I guess, 2038 or 2037, December 2037. And that means anyone wishing to practice their art, treat proteinuric 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 -- our voclosporin indications require the dose reduction strategy, then we're in good shape because it will provide, I think, very, very strong protection for us on that. Now that means 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 the other potential proteinuria kidney diseases we could potentially cover with voclosporin as well. Neil, are you on mute?

Sorry, we've looked at a number of them -- and I was on mute, such as idiopathic membranous nephropathy, [PGFC] nephrotic syndrome. And to be honest with you, we kind of discount 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 this disease now makes them potentially more appealing. And we're going to -- certainly going to go back and have a look at these other proteinuric 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 and these diseases. So we're certainly going to go back and just have discussions on these now.

And Dennis, do you happen to have that share count number?

Yes, at March 15, which is the date of our audit report, we have about 91.6 million shares outstanding.

I'm sorry. Say that again. I'm sorry. We didn't get that.

Yes, sorry, 91.6 million common shares outstanding.

Our next question comes from the line of Joseph Schwartz with SVB Leerink.

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?

Okay. Well, I've got to say that's our first commercial question we've had during the conference call. So thank you for doing that, Joe, okay. We have been -- actually, for quite some time, the team has been involved in this. It's kind of interesting to watch when you look back at what evolved with CellCept. What people don't understand with CellCept is how quickly it was taken up. That market was so desperate. Back at those days, they're using drugs like cyclophosphamide to treat -- yes, 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, historically, and take a look at the growth of CellCept and Roche's documentation through their transplant experience and then opening 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 II data when it was announced, what we saw immediately, the Lupus Foundation of America, 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 you want built 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. It's understanding the reimbursement landscape and understanding the value proposition for a patient, what it means for the cost to treat a patient, what it means to treat them with this drug and what it means in terms of their life. And there are some things that you -- are intangibles and 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 businesses, 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 a sort of antibody-based therapy or biological therapy, this all sort of fits in together. You can use this type of multi-targeted therapy, [pure] 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 again and having the only approved drug is actually going to make a big difference in terms of reimbursement as well. And we have a pretty good idea precedent out there, what these drugs are relatively worth in the space. So I think all of those factors go into sort of really positioning this as being a drug that could actually be launched and could be launched aggressively and that actually would have a very aggressive uptake curve. Is that helpful?

That's extremely helpful, 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 a remission and then put it into context with your drug and how -- if it achieves your target product profile, how would you go about formally in the equation of what the value of -- or what the pharmacoeconomic equation would look like for voclosporin? I don't want to ask -- I want to ask you to give us where you're going to price it, but just help us parameterize the price -- the pharmacoeconomic equation. Where -- what would the value of a remission be? And I'm sure you've done a lot of work on that front.

We have but actually, the next time we're going to have this call, we're going to bring our 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 that you didn't ask for one. I think 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 8 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 104-week sort of end point in their study. If 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 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 are other parameters that to come into play here in the long run. I have often mentioned from a commercial perspective, it's -- 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 85% female. It's childbearing-age women. And one of the things that you find that happens is people feel better right away when on these medications or it doesn't take very long and 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 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 or could just maybe that, I think, it acts an 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.

(Operator Instructions) We have reached the end of our question-and-answer session. Allow me to hand the floor back over for closing remarks.

See, if I give really, really long answers to those questions, I get a few questions. I get it now. And I 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. So I think that this is -- 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.

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