Aurinia Pharmaceuticals Inc.
Q3 2018 Earnings Call Transcript

Published: 9 Nov 2018

[Operator:]

Greetings and welcome to Aurinia Pharmaceuticals Incorporated Q3 2018 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A 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 our host Celia Economides, Vice President of Corporate and Public Affairs. Thank you, you may begin.

[Celia Economides:]

Thank you, operator. Good afternoon, everyone, and welcome to Aurinia’s Q3 2018 earnings call and general business update. With me on the call today from Aurinia are Rich Glickman, Chief Executive Officer; and Dennis Bourgeault, Chief Financial Officer. Joining us for the Q&A will be Dr. Neil Solomons, our Chief Medical Officer. This afternoon we issued a press release detailing our Q3 2018 financial results and corporate update. The press release and financial statement package is available on our website at auriniapharma.com and a 6-K was filed with the SEC as well. 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 following the call. The content of today’s call is Aurinia’s property. It cannot be reproduced or transcribed without our prior written consent. During the course of this call, we may make forward-looking statements based on our current expectations. These forward-looking statements are subject to a number of significant risks and uncertainties and our actual results may make 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 6-K with the U.S. Securities and Exchange Commission. All of our statements are made as of today November 8, 2018 based on information currently available to us. Except as required by law, we assume no obligation to update any such statements. With that, let me turn the call over to Richard. Richard?

[Rich Glickman:]

Well, thank you, Celia. And thank you to everyone for joining us today as we review our third quarter financial results and provide a general business update. Once again, this has been an extraordinary quarter for our company and tremendous progress has been made on a number of fronts. Our largest milestone was the completion of the enrollment ahead of schedule of the AURORA Phase III clinical trial for the treatment of lupus nephritis. The target enrollment of 324 patients were surpassed due to high patients demand with 358 lupus nephritis patients randomized in sites across 27 countries. We would like to thank our trial patients, physician, our trial staff, and our staff and advocacy groups for their extraordinary efforts which led to this result. We are related by the significant interest in this trial that has garnered so much interest around the globe. 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 will 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 after which patients can choose to enroll in 104-week blinded extension study. We expect top line data from this trial towards the end of 2019. As of today, approximately 80% of the total patients enrolled in the study had been in the trial for more than three months. We believe the enhanced safety monitoring for this trial has been effective. The clinical team continues to review all safety data in a blinded manner, while the Data and Safety Monitoring Board review safety in an unblinded fashion. We remained pleased with the trials’ progress. During Q3, we also saw more patients roll over to the AURORA 2 blinded extension study from AURA. The purpose of AURORA is to assess the long-term benefit and risk of voclosporin patients with lupus nephritis. However, this study is not requirement for potential regulatory approval of voclosporin. Long-term safety and efficacy data for our novel CNI should prove to be a great value to the medical and patient community as we are committed to providing the relevant data that support treatment decisions. To that end, I'm also pleased to announce that the AURORA Phase II trial data has been accepted for publication in a high impact nephrology journal which will be published this month. This is a true testament to the importance of this study, it's both scientific and medical community, and I'm very proud of the clinical team for this accomplishment. 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 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 trial. Under voclosporin, fast track destination, we intend to utilize a 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 clinical module in the second quarter of 2020, and therefore we do not expect any delay in our originally planned regulatory timelines. Lastly, you will recall that we are now conducting our drug-drug interaction study in lupus patients rather than healthy volunteers in order to generate more meaningful data. I am pleased to say that we are currently initiating sites and enrolling patients in the DDI study. In this study, patients will be monitored for a period of two weeks. We believe the results of this study will add to our knowledge of voclosporin in a multi targeted therapeutic approach that should have no impact on our submission timeline or potential approval of voclosporin. That brings us to an update on new indications we are pursuing for voclosporin; the first being Focal Segmental Glomerulosclerosis or FSGS. According to NephCure, approximately 6,400 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 kidneys, filtering units, the glomeruli, causing serious scarring which leads to permanent kidney damage and even failure. Similarly to lupus nephritis, an early clinical response can be measured by the reduction of proteinuria. In addition to maintaining podocyte structural and functional integrity is thought to be critical for long-term kidney health. While guidelines exist for treatment of this disease, there are no currently approved therapies for FSGS in the United States or the European Union. After productive consultation with regulators in the first quarter, we successfully initiated this study in June. This is an open-label, proof-of-concept study of 20 treatment naive patients with FSGS. As very essentially enrolling newly diagnosed patients and this is a rare disease, we expect a 12-month enrollment period, but we intend to have planned interim data results throughout the course of this trial. As a company, we've been focused on lupus nephritis since our inception. Expanding our scope to include other proteinuric renal diseases is synergistic with our current strategy and long-term vision of the company. What's exciting about this trial is that we are assessing the potential of voclosporin as a first-line therapy for these patients in the complete absence of steroids. Massive steroid doses are often given to these patients that have many well-established side effects and an approved treatment can be a tremendous value to both patients and of course to our shareholders. In July, we initiated yet another exciting program with the new and patented topical formulation of voclosporin, the Voclosporin Ophthalmic Solution or VOS for the treatment of Dry Eye. This is a novel formulation of voclosporin, which is a unique patented aqueous, preservative-free, nanomicellar solution containing 0.2% of voclosporin. And as you know from previous disclosures, voclosporin has been shown to be 3x or 4x more potent than cyclosporine A. VOS has its own separate formulation patents with exclusivity through 2031. Dry Eye is a chronic syndrome – is a chronic disease in which a lack of moisture and lubrication on the eye’s surface results 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 treatment of Dry Eye, two of which are CNIs. There's an opportunity for a potential improvement in the efficacy and enhanced tolerability including onset of action and alleviating the need potentially 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 billion dollar market. A Phase I trial has previously been completed in 35 healthy volunteers and in patients with Dry Eye Syndrome. Our Phase II head-to-head tolerability study of VOS versus RESTASIS is well underway and we close screening today – have to be completed in the next couple of days. We expect the trial to complete before year end and we plan to report top line data before the end of January. This is a four-week study in approximately 90 patients. The goal of this program is to develop a best-in-class treatment option and I believe there’s tremendous potential value in this asset. So that's it for our clinical programs. Now Aurinia is in a substantial growth phase. And it has transitioned from an early stage clinical company with one indication to a late stage clinical company with multiple indications and preparing for commercialization. To that end, I feel that is an appropriate juncture for me to return to my retirement and begin the transition to a new CEO, who will build on our clinical success and lead the company to its next chapter. Nearly two years ago, which was a critical time in our Company's growth, I came out of my retirement to join arena as a CEO. My decision was fueled by my absolute conviction and the potential of voclosporin to transform the LN treatment landscape. I'm incredibly proud of Aurinia's progress over the last 21 months. And I know this is an awful time to bring on a new CEO. I had several goals when I returned from my retirement nearly two years ago and I feel these have all been successfully completed, the most important being the diligent execution of our Phase III clinical trial in voclosporin and LN, advancing new indications for – voclosporin and providing a financial runway for the company. I intend to step away from my role as CEO sometime next year when an appropriate successor is identified. I'm in no rush to do that. We will look very diligently to find that replacement. While this is a very challenging decision for me as I work with an extraordinary team of people and particularly enjoy my interactions with the physicians, patients, and our investors who have supported the development of voclosporin, I believe this is the right step forward for the company. My commitment to the company and these patients remain steadfast. And I plan to remain a resource for the Board and for the management team as we enter this next chapter. With that, I will turn the call over to Dennis Bourgeault, our CFO, to review the Q3three financials with you. Dennis?

[Dennis Bourgeault:]

Thank you, Richard. At September 30, 2018, we had cash, cash equivalents and short term investments of $138.9 million, compared to $150.2 million at June 30, 2018 and $173.5 million at December 31, 2017. Net cash used in operating activities was $11.3 million for the third quarter ended September 30, 2018 compared to $8.5 million for the third quarter ended September 30, 2017. We reported a consolidated net loss of $18.3 million or $0.21 per common share for the three months ended September 30, 2018, as compared to a consolidated net loss of $13.1 million or $0.16 per common share for the three months ended September 30, 2017. The increase in the loss for the three months ended September 30, 2018 compared to the same period in 2017 was primarily due to the non-cash change in the estimated fair value of derivative warrant liabilities of $5.2 million. The three months ended September 30, 2018 reflected a $4.8 million increase in the estimated fair value of derivative warrant liabilities, compared to a reduction of $355,000 for the three months ended September 30, 2017. The change in the revaluation of the derivative warrant liabilities is primarily driven by the change in our share price at each period end. An increase in our share price results in an increase in the estimated fair value of derivative warrant liabilities and vice versa. The derivative warrant liabilities will ultimately be eliminated on the exercise or forfeiture of the warrants and will not result in any cash outlay by the Company. The net loss before the non-cash change in estimated fair value of derivative warrant liabilities was $13.5 million for the three months ended September 30, 2018, compared to $13.5 million for the same period of 2017. For the nine months ended September 30, 2018, the consolidated net loss was $49.5 million or $0.59 per common share, compared to a consolidated net loss of $67.5 million or $0.91 per common share for the comparable period in 2017. For the nine months ended September 30, 2018 we recorded an increase of $9.4 million in the estimated fair value of derivative warrant liabilities, compared to $32.9 million for the comparable period in 2017. The net loss before the non-cash change in estimated fair value of derivative warrant liabilities was $40.1 million for the nine months ended September 30, 2018, compared to $34.5 million for the same period in 2017. The increased loss was primarily due to higher research and development expenses. Research and development expenses increased to $11.2 million for the three months ended September 30, 2018, compared to $10.8 million for the three months ended September 30, 2017. We incurred research and development expenses of $30.5 million for the nine months ended September 30, 2018, as compared to $25.2 million for the same period in 2017. The increased research and development expenses reflected costs associated with the commencements of AURORA 2 and the FSGS and dry eye studies. Corporate, administration and business development expenses increased to $2.9 million for the three months ended September 30, 2018, compared to $2.7 million for the same period in 2017. We incurred corporate, administration and business development expenses of $10.2 million for the nine months ended September 30, 2018, compared to $9.0 million for the comparable period in 2017. The increase was due primarily to higher non-cash stock compensation expense in 2018 compared to the same periods in 2017. With that I will turn the call back over to Richard for some closing remarks. Richard?

[Rich Glickman:]

Thank you, Dennis. Once again I want to thank the team for the tremendous progress that is made over the last quarter. We are diligently executing our clinical programs and we are looking forward to a very productive 2019 with data from our VOS dry program in January, followed by ongoing data readouts on the FSGS and top line data for our Phase III trial in LN, before the end of 2019. The last couple of years have been extremely pivotal to the company and we are now a late stage biotech company that's diversifying its portfolio and building out its core competencies. We're a nimble, dedicated team that continues to successfully execute against our pre-stated milestones. As a company, we have a drug candidate that is successful in Phase III, has the potential to be the first approved therapy for the treatment of LN. We believe the efficacy and safety data supporting this drug could be substantial. We have a clear regulatory path forward to approval. There is solid intellectual property base. And we believe the market opportunity for this drug is significant. It is with great confidence we continue to advance voclosporin to its final development phase for LN. With that, I'd like to turn the call back to the operator and open the line for the Q&A. Operator?

[Operator:]

Thank you. At this time we will conduct our question-and-answer session. [Operator Instructions] Our first question comes from Ed Arce with H.C. Wainwright and Company. Please state your question.

[Ed Arce:]

Great. Thanks for taking my questions, Richard. So I have a few. First is on FSGS. I know you've mentioned before, your expectation for a 12-month enrollment period and some interim readouts throughout next year. But I was just wondering if you could give us a little more detail around how enrollment is going. I know it's a bit challenging as an ultra orphan disease, but how that's going? And how do you think about when to readout these interim results? How should we think about those?

[Rich Glickman:]

Well, I'll let Neil jump in on this, but I will state first that enrollment is definitely slow and of course challenging in FSGS in general. We have, as you know, a long history of doing very difficult trials and very difficult to access patients. And so sometimes you got to sort of like rethink some of your strategies and build out upon that. So for example, we have significant presence in the U.S. and a number of sites open there. We’re also adding sites elsewhere potentially in the world because like when we did the open-label study, the AURION study, we found that it’s just much easier to access certain patients. We always find the U.S. be the slowest recruiting sites. So I think without giving you a defined timeline, I can't say that it's a slow process as one would expect, but the reaction have ways to actually increase the speed at which we've used historically. And Neil, anything to add on that?

[Neil Solomons:]

No, I mean, I think, no, that’s fair to say. What we do have there is we have some interim readouts written into the protocol after a few patients have reached the system at a time. I can’t go into the details in this statistical analysis part, but we have pre-specified some interim readouts. And also just to echo what Rich is saying, a 100 challenging disease, but on the other hand, a huge amount of enthusiasm in the community for this disease. This is a trusted drug which is known to be effective. And also we're targeting the steward free regimen, which has been met within incredible enthusiasm by the nephrology community.

[Ed Arce:]

All right. Okay, thanks. And then just turning to your VOS program. That certainly is the next near-term data catalyst for you, potentially in a little over a couple months now. I know that this was always thought of as a program where you could look at the options after this readout. Remind us how you're thinking about that once say we have a positive readout at the end of January, where to take it from there?

[Rich Glickman:]

I'm beginning to love this program. It's – the more I've learnt, the more I've learnt to differentiation that I believe that exists with voclosporin. And the more – and I understand about the issues that people face in treating this disease right now, I think there's a really, really exciting opportunity around this drug. And so when we get our data, we'll review it. And at that point in time I think we'll make a decision. We're preparing a multitude of plans presented to the board and say, here are our options based on the kind of data we generate and where we think an investment does makes sense. Does it make most sense to actually out licenses or sell it outright? Or is it really a second product for us with tremendous potential that we should develop further? And when you do the financial analysis on that and the cost of actual development of these areas is not that expensive. So I think there's a lot of value that potentially has been created here. But I think it really does come down to how differentiated we show we are and the quality of the data we generate, then the options open up. So the option is still on the table, but I got to tell you we're starting to like this program a lot.

[Ed Arce:]

Right. Great. Last question for me, Richard. This is for you. I know, as you said, this was a difficult decision for you to decide to move on and it does appear that there is a good time now as you're getting into a full enrollment now with AURORA and 10% over your target. So congratulations on that. My question is, and I know that you're coming in, you had really, in my view, reinvigorated the team back 21 months ago and so I know this was difficult and challenging for you, but the question is, I guess looking for the most appropriate successor, strategies around that, I would imagine you would want someone with some rare disease experience most likely with some commercial background and track record. Perhaps just talk around what kind of criteria that you and the board might be looking at.

[Rich Glickman:]

I think you probably could have written the ad for us. You're right, it was a very difficult decision. And I want to make a couple of things really clear; number one is I'm not running out the door. I'm staying around here until we have the right successor. We need to take our time. We need to be really, really cautious on until we bring him to the company because there's tremendous value here. And I'm certainly not going to let this value slip away. So if it takes long time, if it takes a year, if it takes – it'll take what it takes. And the reason I chose to do this now is it’s the right time to begin the process. My background has been primarily to my career development stage organization, some late stage, but really not commercialization. And I really believe this company requires that experience of launching the drug, positioning of the drug, some of the strategic expertise that our leader with the right background will bring to the table. So certainly the issue on commercialization, the ability to have succeeded. When you have a company in our situation which has plenty of money in the bank and has an exciting technology that’s delivered extraordinary clinical data, we should be able to find some really quality candidates and we're going to take our time and do that. So I hope I answered your question, but I also want to make it clear that this time it'll take to do this, time will take to do this. I'm not in any rush. I did make that decision for personal reasons primarily because I came back out of retirement because the company needed me then. I have a family. I've got six kids as you guys most often know from our discussions in the past and I wanted to find a balance. And this process of beginning now will give me that balance back sometime next year if we're successful. And it was really that balancing act between the personal aspects, but also the enjoyment I get of working with our team and my expectation that we're going to do really well. And I'm going to remain with the organization. I'm going to remain a CEO and I'm going to remain – or as a Chairman to find a successor. And at that point in time we're going to evaluate what should come next, what's in the best interests of the company, but I am very committed to being here until we have the right person that has the skills to take it to the next level.

[Ed Arce:]

Great, thanks. Fully understood, Richard. Thanks again for that.

[Rich Glickman:]

You're very welcome.

[Operator:]

[Operator Instructions] Our next question comes from Joseph Schwartz with Leerink Partners. Please state your question.

[Joseph Schwartz:]

Great. Thanks very much and congrats on all the progress. Richard, you've done a great job along with the rest of your team and you've got some big shoes to fill when the time comes. So I was hoping that you could help set some expectations for what you would hope to see in your Dry Eye program. It's a fairly large trial with 90 patients. And I know there's a few endpoints beyond safety and tolerability, so just signs and symptoms that could offer a glimpse into the efficacy profile. So could you help us envision what would be a successful outcome on that front?

[Rich Glickman:]

Well, I’ll have Neil answer the clinical part of the question. And what I just want to focus on up front is that if you take a look at VOS as a product and you take a look at – you’re delivering a drug that is 3x or 4x more potent than cyclosporine and you're actually delivering 4x as much as that drug potentially to the eye. And if the drug is tolerated well, you'll tend to keep it on your eye longer. So what really would be success for us, of course, is not only tolerability and superior tolerability, but also really strong early signs of potential efficacy. Now it’s not powered to the extent of really being able to necessarily pull out all of the benefits. But I do think we might see some trending, if it's – but it's really early, but that would be sort of when you ask would an outcome will be exciting for us. It's, yes, tolerability and some of the very interesting endpoints trending early on, but it is our expectation to the very nature of the drug we're giving that issues the differences. So Neil, did you want to qualify that a little bit more?

[Neil Solomons:]

Yes. I mean, so, Joe, as you know, the primary objective of this study as stated is actually dropped discomfort compared to RESTASIS. Yes, we do believe because we exclude patients who have used RESTASIS within 30 days prior to the study, or in fact who of you have used RESTASIS progressed in a month. We're going to get fairly kind of naive RESTASIS naive patients into this. And so as long as drop discomfort scores are at least as good as those of RESTASIS, I spec they're going to be better, but not still studies powered for. And we certainly saw in our Phase I study that there was no apparent drop discomfort, but the success for us is a drop discomfort least is as good as with RESTASIS. And as Rich has said some trending of efficacy early reductions in improvements, excuse me, in the Schirmer's test, eye joiner scores in the first couple of weeks I think would also be encouraging, as well. And this is just a 28-day study as you know. In order to look at approval, we need to look at signs and symptoms right out to Stage 4 that would come in the Phase II and Phase III studies that follow that. But I would just echo what Rich is saying, a drop discomfort at least as good as RESTASIS, some signal on improvements in Schirmer's test over the first four weeks of the study.

[Joseph Schwartz:]

Okay, that's helpful. Thanks. And I know RESTASIS can take a long time to exert its effect. What are the thoughts around a VOS and whether or not it would have an advantage upfront?

[Neil Solomons:]

What I can tell you – I have often talked, we had this partnership, as I’ve mentioned with Merck Animal Health. There's been a fair number of [indiscernible] that have been conducted. They own the data, so we've never presented their data. But what we've learned in our experience is that this drug does appear to work fairly quickly in what we believe will be a predictive model. And even our early Phase I study that was done in the limited number of patients we did see actually very early signs of activity on this drug. So that is one of the issues, I think, if you have a drug that works generally over three to six months that we see with RESTASIS, if we get shortened time period and if we could actually use it once a day, then you really do have a competitive advantage. You have a differentiation point that will actually matter for patients, because I can tell you that one thing we've learned is patients don't like taking the eyedrops, and they're not very compliant. So if you can make it simpler and if you can make it not hurt; that really will differentiate you because CNIs are clearly effective in this disease.

[Joseph Schwartz:]

Right, okay. So very helpful thanks. And then can I just ask I'm intrigued by your statement that a significant percentage of patients who exited AURORA have been entering into the open label extension study at their election. Can you put a finer point on that? And why would patient enter into – in the extension study if it were available to them?

[Rich Glickman:]

So Neil do you want to talk about that one first?

[Neil Solomons:]

Yes, we have certain criteria Joe about who can actually enter the study. Obviously we don't know if the study is blind, remains blind and continues to remain blind. So we have no idea who is going and who isn’t. But in general, those who have had a clinical response and that tends to be either a partial complete remission or those who, and sorry – and those who are on therapy so we have not dropped them. Those had to discontinue therapy for any reason, are eligible to go on and go into the study. And not at least as you know in difficulties should lupus, there are patients who don't respond and who have to withdraw for many reasons. And I think the point there that Rich is making is that at least to date most of the patients are electing to go through into the continuation study.

[Rich Glickman:]

It’s still early – I think it’s a little early to sort of look at the percentages numbers like we talked about over 80%. But quite honestly, I think, it's early to sort of use those numbers. I'd wait I think after another quarter or two we'll start getting a better sense of it. And my expectation of course is that those numbers in my opinion are more likely to drop in terms of overall percentages. And there's a lot of reasons people stay if they're having some response, even if the response is not great, they still have access to good medical care. And it's so difficult to predict from that success rate and entering into that on what it really means from a clinical response point of view and it's very difficult to draw conclusions from that. So I just caution everyone on that.

[Joseph Schwartz:]

Okay, makes sense. Thanks again for taking the questions.

[Rich Glickman:]

No, it's always a pleasure.

[Operator:]

Thank you. Our next question comes from Savneet Uppal from RBC Capital Markets. Please state your question.

[Savneet Uppal:]

Hey, there are just two quick questions from me. Just first Rich, I think, you mentioned something, will you be remaining on the Board or did I just make sure that, that you mentioned that you be a resource for the Board. I just want to clarify that.

[Rich Glickman:]

Go ahead with your second one and then I’ll answer.

[Savneet Uppal:]

Yes, sure. Second question is just on that, just trying to understand the timing of this Phase III data. So you guys are talking about the end of 2019, but if you could provide a little bit more color on how long it would take to from the point of the last patient finishes treatment to analyzing the data and all that stuff. I'm just any color on that would be helpful.

[Rich Glickman:]

So on your first question, as the Chairman of the company I was sort of involved in founding the company. And had been Chairman as you know, for since its inception. I'm quite content and remain committed to the company. But I also realize in any process they are building out of Board, building out – bringing in a new CEO. It depends on the, on that whole dynamic. And what the Board feels is that time is right. So I have to trust my Board that my Board will – in combination with myself, and the new CEO make the right decisions on what the composition should look like going forward. If you are asking me would I be prepared to stay on and committed to the organization, yes I remain very committed to the organization. It's just that some of these things are – they're not totally in my control. But that will remain as Chairman until such time as well quite likely to the AGM and at this point in time, it's really early to say. But no one has requested me not to be if you're asking that type of question. No one has requested at all that I not continue on in that role. So I will see if the guidance for my Board once we've reconstituted the Board with additional members.

[Savneet Uppal:]

Yes. That's helpful.

[Rich Glickman:]

And to your second question, in terms of timing, I'll let Neil speak to this as well, but I will say that one of the things we have a good track record of is being able to clean our data and to move fairly quickly between the time of the last patient entering into study and the availability of top line data. So Neil, did you want to provide a crisper answer?

[Neil Solomons:]

Yes so again I think we just said that the top line day is going to be available towards the end of the year. We have a little bit more internal granularity. But there's also some uncertainty around that because it turns where the patient, the last patient comes from, that goes into the study. In addition, it depends where that last patient then rolls over into AURORA 2 where they have a four-week follow-up. So that there are some uncertainties around exactly when we're going to get that data. As we just said were are very, very quick at clean data. We have a laboratory based endpoint. So there's no issue about reporting the endpoint thought. So it's done mostly programmatically. But I believe, and again, Richard, you can correct me if I'm wrong, but I believe that our guidance is just towards the end of next year, I was going to tell you. Yes.

[Savneet Uppal:]

Great, thank you Neil.

[Operator:]

There appears to be no further questions at this time. I'll turn the floor back to management for closing remarks. Thank you.

[Rich Glickman:]

Well thank you and thank you for being on the call today and of course for your questions. I really am excited about what we are approaching this next year. There's a lot of activity. For a change we've been waiting for this for a while. So I'm excited about potential news flow we're going to have and getting back in front of investors with news because of course we had a dry spell with a Phase III that's not uncommon and really remained very, very committed to moving this organization forward. And want to reemphasize that I won't be moving out of my role until I find someone who truly deserves to have that role. Thank you all very much for listening in today.

[Operator:]

Thank you. This concludes today's conference. All participants you may disconnect. Have a great day.