Aurinia Pharmaceuticals Inc. (AUPH) Q4 2018 Earnings Report, Transcript and Summary

Greetings and welcome to the Aurinia Fourth Quarter and Full Year 2018 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. [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, Rydia, and good afternoon, everyone. Welcome to Aurinia’s Q4year-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, our 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 on 40-F and 6-K was filed with the 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 the today's call complete. 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 US 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 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 year for the team here at Aurinia with significant progress made on a number of fronts. As the 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 our pipeline and a drug for our lead candidate voclosporin. First and foremost, we are evaluating voclosporin in a Phase 3 trial for lupus nephritis. In addition, oral voclosporin is being tested in FSGS or focal segmental glomerulosclerosis. And lastly, VOS, our ophthalmic solution being tested in the treatment of dry eye syndrome. Reflecting on this past year, our most significant milestone was in September where we announced the early completion of enrollment in the AURORA Phase 3 clinical trial for the treatment of lupus nephritis. The target enrolment 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 group 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’ll 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 speed and overall renal response rates in the presence of low dose steroids. The primary endpoint of the study is complete renal response at 52 weeks, and we look forward to sharing these trial results towards the end of the year which is positive forming the basis of the 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 AURA clinical studies will serve as a basis for a new drug application submission with the FDA following a successful completion of the AURORA clinical study. Under voclosporin’s Fast Track destination, 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 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 second quarter of 2020, in line with our previously disclosed regulatory timelines. With respect to intellectual property, we recently announced that we received notification from the US Patent Office after extensive interaction with the US PTO, that our patent which covers how we treat patients and how they are managed during the initial titration period have been allowed and should be granted shortly. This method of this patent is integrally tied into the label we seek to obtain for voclosporin, which relates to dose adjustment used in both the AURA and 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 on additional potential for 10 years of additional patent protection. So 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 structure 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 is to evaluate up to 20 treatment naïve patients with FSGS. The goal of this study is to assess potential voclosporin as first line treatment option for these patients before other interventions such steroid immunosuppressants are utilized. As we are essentially enrolling newly diagnosed treatment naïve 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’ll 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 disclosers, 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 a 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, two of which are CNIs and there are plenty of opportunity for potential improvements in efficacy, tolerability including onset of action and alleviating the need for repetitive dosing. We believe the calcineurin inhibitors will remain a mainstay for treatment of dry eye and VOS has the potential to be a best-in-class calcineurin inhibitor within this $1 billion market. We initiated an exploratory Phase 2 head-to-head study of voclosporin ophthalmic solution versus RESTASIS for the treatment of moderate to severe dry eye in July of 2018. The four-week study enrolled 100 patients. And in January 2019, we announced 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 drug discomfort. RESTASIS demonstrated less than anticipated drug discomfort. However, the secondary outcome measures on efficacy, namely in the Schirmer Tear Test and the Fluorescein Corneal Staining, VOS achieved statistically superior results to RESTASIS. We were surprised that after only four weeks of treatment that VOS showed statistical superiority to RESTASIS and FDA accepted objective science 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 four, with a P value of less than 0.005. VOS also demonstrated statistical superiority to RESTASIS in 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 2 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 roadmap 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 updates 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 2a -- our 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 have been a critical time in our company's growth, driven by the potential of voclosporin to transform the LN treatment landscape, and thereby 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 3 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 Bourgeault our CFO to view the Q4 and year-end 2018 financial results with you. Dennis?

Thanks Richard. The consolidated financial results have been preparing the according to the IFRS as issued by the International Accounting Standards Board. The consolidated financial statements represented in US 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 the 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 it’s in our current plans that we have sufficient financial 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 2 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, reflects 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 non-cash change in estimated fair value 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 2 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 non-cash increase of $10 million related to the estimated fair value annual adjustment of derivative warrant liabilities at December 31, 2018. After adjusting for this non-cash impact, the net loss before this change in estimated fair value 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 non-cash increase of $23.9 million in the estimated fair value of derivative warrant liabilities for the year end December 31, 2017. After adjusting for this non-cash impact for 2017, the net loss before this change in estimated fair value of derivative warrant liabilities was $46.9 million. The change in the revaluation of the 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 2 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 for corporate, administration, development, personnel, reflected an increase in non-cash 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 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 is successful and Phase 3 has a potential to be the first approved therapy for the treatment 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. So with great confidence as 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&A. Operator?

Thank you. [Operator Instructions]. And thank you. Our first question comes from line of Ed Arce with H. C. Wainwright. Please proceed.

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. So 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 just turning quickly to the VOS program, obviously some pretty strong data? What are the considerations, the next steps, and 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 naïve patients as I mentioned, and what we found in the study is that while KOLs anticipated be able to access patients fairly quickly given patients generally don’t want steroids. The issues been as the physicians present themselves and immediately put on steroids by the time they get into our clinical program deal with 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 worked in before which are very close and have very good healthcare systems that actually apparently have a much greater population that we can access to us prior to therapy. So first of those major countries that are coming online that really matter should be online, my expectation is in May. And after that I think we can have 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 in tremendous amount would be probably looking at amend the protocol, allow patients receivable or simply do other studies as you would in a clinical practice and then win most of that and then continue them on your therapy. So we're looking at all options to actually move forward. Patients are out there. I think that at this point in time FSGS has become even more important to us given the intellectual properties change that occurred in the company. The opportunity around FSGS has actually grown and considerably important 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 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 gaining access to excellent clinical execution. So what we believe is and what our Board has supported is in the further investment in the dry eye program and further investment at VOS. On a relative basis, this is a relatively low risk asset for the company even for our standards which we think are relatively even lower risk assets 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 and what we’ve got data coming in after that and decide what's best to process it, but I think also a lot of value can be created for shareholders by further investing in that asset rather than licensing it out right now. I think there certainly would be interest but I really not going to be articulate that -- really did not want to actually out license this asset and to 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 to the next level, when will we divest it and how we divest it, could make a meaningful impact on the cash requirements of the company that was move towards commercialization in this renal space.

That's very helpful. Thanks, Richard. And then a couple more if I may. Actually the segway is good. The next question is around the patent. I know you're doing the whole team are quite excited about the potential to the value of the whole program. And I think rightly so. I -- 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 in 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? Thanks.

Okay, you gave me so many questions I am not sure I could track them all. Let's speak to the patent for a moment. All right. Several years ago when we started writing a number of patents, this is one of several that were written by the company. They are one of the ones that we’re 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 surprising was that we actually ended up discovering that in fact as we see patients certainly and as we dose, we actually saw it has the efficacy, there was unanticipated. And as a consequence, when we saw that we had an interesting opportunity to go in front of the patent office with 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 is -- and I guess your question what you're really asking, which is, the key question is, what is the probability the actual claims in the patent that form the dose reduction protocol land at the start of the actual label for the drug and the probability is extremely, extremely high because it really is a critical safety protocol, how we treat patients and so it's very likely. There's always a risk but it was very unlikely risk that wouldn't be inclusive. We believe that the patent itself that 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 2038 or 2037 -- December 2017 and that means anyone wishing to practice or 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 voclosporin and 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, I don't know Neil if you want to jump in from a clinical perspective what other potential proteinuric kidney diseases we could potentially cover with voclosporin as well. Neil, are you on mute?

Sorry, we will attend number of them, and I was on mute, such as [indiscernible] nephrotic syndrome and relatively we kind of discounted them for exactly the reasons that, that we may now consider them because of the improved patent, the length of time it would take to curating these diseases, now makes them potentially more premium. We then are certainly going to go back and have a look at these other proteinuria kidney diseases. There are lots and lots and lot of our connections in lupus nephritis in FSGS space have been very keen on us looking at this drug in these diseases. So we're certainly going to go back and just have discussions on these now.

Thanks Neil. And Dennis do you happen to have handy your share count number?

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

I'm sorry. Say that again, I am sorry I didn’t get that.

91.6 million common shares outstanding.

Thank you. Our next question comes from one of Joseph Schwartz with SEB Leerink. Please proceed.

Thanks very much and congratulations as well and all the progress. I was wondering since you all have been involved in advancing the lupus nephritis fields since developing CellCept, how have you seen market evolve till 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 we got to say that's our first commercial question we’ve had during conference call. So thank you for doing that, Joe. Okay, we have been actually for quite some time the team has been involved in. It's kind of interesting to watch when you look back at what evolves with CellCept. But people don't understand with CellCept that’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, of course, that was extremely toxic, so having other agent available was just phenomenal. I remember watching -- I need to go back historically, and take a look at the growth of CellCept and Roche's documentation through their transplant experience and opening up into autoimmune and primarily LN. So we saw was extremely rapid uptake. And I would say that given the response we had to the Phase 2 data when it was announced that we saw immediately, the percentage 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 using the drug, it's about value proposition that you want to build 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 our patients. What it means -- what it costs to the 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 then others 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 US 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 to 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 have also said in the past. And so I think, one, it’s a market that’s absolutely ready. It's a market that there's very little competition in our space right now. We will have to look at competition again a little bit differently now, when we look at 2038, because things look a little bit different in the long run. But certainly we don't see any immediate competition. This is a drug to be used hand in hand with other therapies. So if you're using an antibody any sort of body based therapy or biological therapy, this all sort of fits in together. You can use these types of multi-targeted therapy risk 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 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 with these drugs are relatively worth in the space. So I think all of those factors go into sort of really position us as being a drug that’s actually launched and could be launched aggressively and that actually we have a very aggressive uptake curve. Is that helpful?

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 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 and I don't want to ask you to give us where you're going to price it? But just help us parameterize the price, maybe pharmacoeconomic equation. 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, next time we’re going to have this call, we are 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 happy 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 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 and you take a look at even their clinical program in lupus nephritis where they're looking at 104 weeks sort of endpoint in their study. If you look at where that drug is priced and it's readily available out there right now, I think you can build against that. If a drug that were worth much quicker, it could be synergistic and I think it forms a really good basis where you'd likely price this drug. I think in terms of the other parameters that come into play here in the long run, I have often mentioned from a commercial perspective this will 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, that essentially if you look at the patient population, it's 85% female, it's child bearing age women. And one of the things that you find that happens is people feel better right away when on these medications are, it doesn't take very long and they recover. They often want to have families and as a consequence I think that there is promise for this drug where you take away something like CellCept which is transgenic and contraindicated and when you take away the most of which is currently contraindicated in pregnancy as well. We know the CNI has been used in pregnancy for long time. We know there has been never birth on this drug as well. And I think that with the proper registry I think we could actually change the value creation too in a very, very significant way. I think it’s really excellent and important go to drug for these patients for a variety of these reasons. So the next call we're I will 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.

Thank you. [Operator Instructions]. Thank you. We've reached the end of our question-and-answer session. Allow me to hand the floor back over for closing remarks.

Excuse me if I gave really, really long answers to those questions. I get it now. And I thank you all for being on the call today and thank you too for your questions. I am really excited about what's in horizon this year at Aurinia. I'm 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 3 results from our program with lupus nephritis. I also am pretty excited about the new intellectual property, because I think it really provides the company with the really different value proposition. We have opportunity to look at additional indications, plus we get so much more runway into the lupus nephritis program. So I think that this is a very pivotal year for us. And I think 2019 is actually poised to be a real standout year for us as well. 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.