Aurinia Pharmaceuticals Inc (AUPH) Q4 2018 Earnings Conference Call Transcript

Aurinia Pharmaceuticals Inc (AUPH 3.74%)
Q4 2018 Earnings Conference Call
March 19, 2019, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

See all our earnings call transcripts.

Prepared Remarks:

Operator

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. If anyone should require operator assistance during the conference, please press *0 on your telephone keypad. As a reminder, this conference is being recorded.

I would now like to turn the conference over to Dr. Glenn Schulman.

Glenn Schulman -- Corporate Communications

Thanks and 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, and 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 Forms 40-F and 6-K filed earlier on EDGAR and CEDR. I'd like to remind you that today's call is being webcast live on Aurinia's investor relations website and a replay will also be available approximately two hours after today's call completes.

The content of today's call is Aurinia's property. It cannot be reproduced or transcribed without prior written consent. During the course of this call, we also may make forward-looking statements based on our current expectations. These forward-looking statements are subject to a number of significant risks and uncertainties and our actual results may differ materially.

For a discuss of factors that can affect our future financial results and business, please refer to the disclosure on today's press release, our most recent filings of Canadian securities authorities and results that we file on Form 40-F for the US Securities and Exchange Commission. All of our statements are made as of today, March 19th, 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?

Rich Glickman -- Chief Executive Officer

Thank you, Glenn. 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 were looking for during the year to come.

Aurinia has three programs ongoing in parallel that highlight the potential of a pipeline and a drug for our late 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. 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 AUROROA Phase 3 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. 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 compromise in quality.

As you recall, the AUROROA clinical trial is a global double-blinded placebo-controlled study to evaluate whether voclosporin when added to background therapy of mycophenolate mofetil or CellCept can increase the speed and overall renal response rates in the presence of low dose steroids. The primary endpoint for the study is complete renal response in 52 weeks and we look forward to sharing these trial results toward 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 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 submissions with the FDA following the successful completion of the AURORA clinical study.

Under voclosporin's fast track designation, we are also utilizing the rolling NDA process, which will allow us to begin the submission process following a positive pre-NDA meeting with the FDA, which we anticipate to occur during the first quarter of 2020. To that end, we are actively preparing the non-clinical and CMC modules required for the end of 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 previous disclosed regulatory timelines.

With respect to intellectual property, we recently announced that we received notification from the US patent office after extensive interaction with US PTO that our patent which covers how we treat patients and how they are managed during the initial titration period had been allowed and should be granted shortly.

This method of use 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 prototeinuric kidney diseases that could be treated with voclosporin, representing an additional potential for ten years of additional patent protection. So, we're really excited about this development.

That brings us to an update on FSGS program with voclosporin. According to NephCure, approximately 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 the 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 naïve patients with FSGS. The goal of the study is to assess the potential of voclosporin as first line treatment option for these patients before other interventions, such as steroids or immunosuppressants are utilized.

As we're 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 recall in July of 2018, we initiated the dry eye program with a new patented topical formulation of voclosporin called VOS. This nominal formulation of voclosporin is a unique patented aqueous preservative-free nanomicellar solution containing 0.2% of voclosporin.

And you know from previous disclosures, voclosporin has been shown to be several times more potential than cyclosporin, the active ingredient used in Restasis. Dry eye syndrome is a chronic disease in which a lack of moisture in the vocation of the eye surface results in irritation and inflammation of the eyes. Dry eye is a multi-factorial heterogenous diseases that estimates to affect greater than 20 million people in the United States alone.

While the FDA-approved products to exist for the treatment of dry eye, two of which are CNIs, there are plenty of opportunities for potential improvements in efficacy, tolerability, including onset of action, and alleviating the need for repetitive dosing. We believe the calcine inhibitors will remain the mainstay in the treatment of dry eye and then VOS has the potential to be the best in class calcine inhibitor within this billion-dollar 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 of 2019, we announced the results of the study. The study evaluated and compared to the efficacy, safety, and tolerability of VOS and Restasis. The primary endpoint we used evaluated drop discomfort at one-minute post-drop installation, looking to see whether there's a difference between the two treatment arms.

What we learned did surprise us and apparently the market. Both VOS and Restasis showed low levels of one-minute drop 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 of Restasis.

We were surprised that after only four weeks of treatment that VOS showed statistical superiority to Restasis on FDA-accepted objective signs of dry eye syndrome with 42.9% of VOS patients versus 18.4% of Restasis subjects achieving greater than a 10-millimeter improvement in the Schirmer tear test at week four with a P-value of less than 0.005. VOS often 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 are developing a roadmap assessing different protocols and regulatory strategies with a goal to rapidly advance VOS into its next stage 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 Phase 2A program today.

So, Aurinia is in the 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 now by our belief in its ability to enhance the management of dry eye syndrome.

In 2018, our team focused on a number of essential goals and objectives and I believe we had successfully completed all of them. The most important thing, 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 and FSGS and we developed an additional stand-alone product for the treatment of dry eye. 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?

Dennis Bourgeault -- Chief Financial Officer

Thanks, Richard. The consolidated [inaudible] have been prepared in accordance with IFRS as issued by the International Accounting Standards Board. The consolidated financial statements are presented in US dollars, which is the company's functional and presentation currency. As of December 31st, 2018, we had cash, cash equivalence, 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 31st, 2018 compared to $41.2 million for the year ended December 31st, 2017. On November 30th, 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 operating 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 encouraged share reach across of $1.2 million comprised of a 3% commission and professional filing fees related to the ATM offering.

We believe based on our current plans that we have sufficient master 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 31st, 2017. The loss for the fourth quarter ended December 31st, 2018 reflected an increase of $593,000 in the estimate 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 31st, 2017.

The net loss before this non-cash change in estimated fair value of derivative warrant liabilities was $13.9 million for the fourth quarter ended December 31st, 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 of 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 nearly 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 31st, 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 31st, 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 and the estimated fair value of derivative warrant liabilities for the year ended December 31st, 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 derivative warrant liabilities is primarily driven by the change in our share price. Our share price of $6.82 was higher at December 31st, 2018 compared to our share price of $4.53 at the December 31st, 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 would ultimately be eliminated on the exercise of the warrant and will not result in any cash outweighed by Aurinia.

We incurred R&D expenses of $41.4 million for the year ended December 31st, 2018 as compared to $33.9 million for the year ended December 31st, 2017. The increase in R&D expenses in 2018 for the year, again, primarily reflect the costs related to the enrolled trials of the AURORA 2 extension trial, the DDI study, and the FSGS and dry eye Phase 2 studies.

We incurred corporate administration/business development expenses of $13.7 million for the year ended December 31st, 2018 are 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?

Rich Glickman -- Chief Executive Officer

Thank you, Dennis. 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 topline 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 in Phase 3, has the potential to be the first approved therapy for the treatment of lupus nephritis. We believe the efficacy and safety data supporting this drug to be substantial. We have a clear regulatory path forward to approval, and we believe the market opportunity for this drug to be very significant. It's with great confidence that we continue to advance voclosporin and its development programs.

Thank you all for taking the time this afternoon. With that, I'd like to turn the call over the operator and open the line for Q&A. Operator?

Questions and Answers:

Operator

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press *1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. Press *2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the * key. One moment please while we poll for questions.

Thank you. Our first question comes from the line of Ed Arce with H.C. Wainwright. Please proceed.

Ed Arce -- H.C. Wainwright and Company -- Managing Director

Hi, good afternoon, Richard, Michael, Neil. Thanks for taking my questions. I have a few. First, on FSGS, it's been about nine months now since you initiated enrollment. Just wondering, I know you said that there are a few extra sites that you're planning or have recently added to improve enrollment, but just wondering when you see that coming in, at least qualitatively and could you consider -- I know it's a very small study, but could you consider decreasing the number of patients to complete that?

Then turning quickly to the VOS program, obviously, some pretty strong data. What are the considerations and next steps, including is there something that's gating in regard to discussions with partners?

Rich Glickman -- Chief Executive Officer

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

Now, there are countries which we've worked in before which are very close and have very good healthcare systems that actually apparently have a much greater population that we could access prior to therapy. The first of those major countries that are coming online that really matter or should be online, my expectation is in May. After that, I think we get a pretty good idea of what our patient flow will look like. We will provide an update at that time.

Alternatively, what we could do which doesn't alter our study our tremendous amount would be to amend the protocol, allow a patient to receive a bullous as they do in some of our other studies as you would in clinical practice and then wean them off that and then continue them on your therapy. 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 for us, given the intellectual property change that has occurred in the company. The opportunity around FSGS has actually grown in considerable importance to us. So, we're going to put more resources behind this program now as a consequence of that. So, that's basically the answer to your first question.

In terms of VOS and the considerations 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, the ones that all the other major companies tend to work with. So, we're getting access to excellent clinical execution.

So, what we believe is and what our board has supported is further investment in the dry eye program and further investment in VOS. On a relatively 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 an 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 the classic approval pathway.

So, we believe we should invest further, take this drug to the next level and then we could look at post-LN data and while we've got data coming in after that and VOS, you can decide what's best to do with 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 -- if I'm going to be articulate, I really do not want to actually out-license this asset until after we take it to the next level unless the terms of such a deal were so substantial they really offset our cost. Once again, take it through the next level, then when we divest it and how we divest it, it could make a meaningful impact on the cash requirements of the company that moves toward commercialization in its renal space.

Ed Arce -- H.C. Wainwright and Company -- Managing Director

That's very helpful. Thanks, Richard. 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. 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.

Also, the breadth of the coverage given that it's for nephrotic diseases -- so, LN and FSGS, obviously, but what others could be covered in there? Then one final just housekeeping question -- what is your current share count now after the recent changes? Thanks.

Rich Glickman -- Chief Executive Officer

Okay. You gave me so many questions. I'm not sure I kept track of all of them. Let's speak to the patent for a moment. All right. Several years ago when we started writing a number of patents. This is just one of several that were written by the company but one of the ones we were most excited about because basically, it's based on the fact that we included in our protocols a dose reduction structure that was based originally around the safety parameter.

What was surprising was that we actually ended up discovering that, in fact, as we treat patients a certain way and as we dose reduce, we actually saw enhanced efficacy. It was not anticipated. As a consequence, when we saw that, we had an interesting opportunity to go in front of the patent office and present what is basically kind of a personalized approach to treating these patients based on understanding how their glomerular filtration rate is responding to the drug, very easy to test for. It doesn't require very complex therapeutic drug monitoring.

What it essentially does is -- I guess to your question you're really asking, which what is the probability that the actual claims in the patent that form the dose reduction protocol end up as part of the actual label for the drug? The probability is extremely extremely high because it really is a critical safety protocol. It's how we treat patients.

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 the patent itself, which covers a 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 until 2038 or December of 2037. That means anyone wishing to practice 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 are required or voclosporin and indications require the dose reduction strategy, then we're in good shape.

It will provide, I think, very strong protection for us on that. That means 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 with other potential proteinuric kidney diseases we could potentially cover with voclosporin as well. Neil, are you on mute?

Neil Solomons -- Chief Medical Officer

Sorry. I was on mute. We've looked at a number of them such as idiopathic membranous, pediatric nephrotic syndrome, we kind of discount them for exactly the reasons that we may now consider them because of the length of time it would take to recruit into these diseases now makes them potentially more appealing. We're simply 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 this, looking at this drug and these diseases. So, we're certainly going to go back and have discussions on these now.

Rich Glickman -- Chief Executive Officer

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

Dennis Bourgeault -- Chief Financial Officer

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

Ed Arce -- H.C. Wainwright and Company -- Managing Director

Say that again. I didn't get that.

Dennis Bourgeault -- Chief Financial Officer

Sorry, 91.6 million common shares outstanding.

Ed Arce -- H.C. Wainwright and Company -- Managing Director

Thanks for all the help and congrats on the patent.

Operator

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

Joseph Schwarz -- Leerink Partners -- Managing Director

Thanks very much. I was wondering, since you all have been involved in advancing the lupus nephritis field since developing CellCept, how have you seen the market evolved 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? How was your strategy to penetrate the market meaningfully incorporating these types of learnings?

Rich Glickman -- Chief Executive Officer

Okay. That's our first commercial question we've had during the conference call. So, thank you for doing that. We have been actually for quite some time, our team has been involved -- it's kind of interesting to be watch when you look back at what evolved with CellCept. What people don't understand with CellCept was how quickly it was taken up. That market was desperate. Back in those days, it was using drugs like cyclophosphamide to treat patients mostly. Of course, that was extremely toxic. So, having another agent available was just phenomenal.

I remember watching -- go back historically and take a look at the growth of CellCept and Roche's documentation through their transplant experience and then opening it up into autoimmune and primarily LN. So, what we saw was an extremely rapid uptake. I would say that given the response we had to the Phase 2 data when it was announced, what we saw immediately, the Lupus Foundation of America had over 100,000 hits the first week alone of that data.

 So, number one, I think the market is absolutely primed for a drug. But it's not just about needing the drug. It's about the value proposition built around the actual drug. We spent a lot of time and a lot of money -- this is where our pre-commercial activities have been -- is understanding the reimbursement landscape and understanding the value proposition for a patient, what it means, what it costs to treat a patient, what it means to treat them with this drug and what it means in terms of their life.

There are some things that are intangibles and there are others that are actually quite tangible in terms of financial impact of a drug like this. So, I think that there's an easy story to tell. I think accessing that patient population, particularly in the US, requires a relatively small salesforce. If this company ends up fulfilling and being a commercial entity and selling directly as opposed to being acquired I Netherlands earnings per share, it won't take a huge salesforce. We are actually building out that capability in the event that we don't get acquired. You've got to build your business, as I've often said in the past.

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 the 238 because things will look a little bit different in the long-run, but certainly, we don't see any immediate competition.

This is a drug that could be used hand in hand with other therapies. So, if you're using an antibody-based therapy or biological therapy, this all fits in together. You can use these types of multi-targeted therapies across the board. 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 the only approved drug is actually going to make a big difference in terms of reimbursement as well. We have a pretty good idea of precedent out there of what these drugs are relatively worth in the space. I think all of those factors go into really positioning this as being a drug that can actually be launched and it could be launched aggressively and actually can have a very aggressive uptake curve. Is that helpful?

Joseph Schwarz -- Leerink Partners -- Managing Director

That's extremely helpful. Thank you, Richard. If you were to 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 formulating the equation of what the value of pharmacoeconomic equation would look like for voclosporin? What would the value of the remission be. I'm sure you've done a lot of work on that front.

Rich Glickman -- Chief Executive Officer

We have. Actually, next time I'm going to have this call, I'm going to bring a commercial expert on the call with us too, not just clinical. Your questions are actually very good. I don't have a precise equation to give you. I think one looks at the space and takes a look at what their value proposition is.

This drug we tend to see works within 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 take a look at even their clinical program in lupus nephritis, they're looking at 104-week endpoint, you look at where that drug is priced, I think you can work against that. It could be synergistic. I think it forms a very good basis to where you'd likely price this drug. I think there are other parameters that come into play in the long run.

From a commercial perspective, and having been involved with CellCept, what would be most exciting would be the idea this new drug, voclosporin is that essentially, if you look at the patient population, it's 85% female. It's child-bearing age women. One of the things that you find that happens is people feel better right away on these medications. It doesn't take very long. They often want to have families.

As a consequence, I think there is promise for the use of this drug when you take away something like CellCept, which is contraindicated. When you take away Benlysta, which is contraindicated in pregnancy as well -- we know that CNI has been used in pregnancy for a long time and there have been a number of births on this drug as well. I think we can change the value equation in a very significant way.

This may be, I think, a really important go to drug for these patients in a variety of reasons. The next call we're on, I'll give you a really crisp equation. I think that gives you a sense of this molecule and the role we see it's going to play in the community and socially for patients.

Joseph Schwarz -- Leerink Partners -- Managing Director

Very helpful. Thanks again.

Operator

Thank you. Again, if you'd like to ask a question, please press *1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. Press *2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the * keys. One moment while we poll for additional questions.

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

Rich Glickman -- Chief Executive Officer

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

I'm particularly excited about getting a chance to see the topline Phase 3 results from our program in 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 programs. This was a very pivotal year for us and 2019 is poised to be a standout year for us as well. Thank you all for being on the call today. Have a great evening.

Operator

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

Duration: 42 minutes

Call participants:

Glenn Schulman -- Corporate Communications

Rich Glickman -- Chief Executive Officer

Dennis Bourgeault -- Chief Financial Officer

Neil Solomons -- Chief Medical Officer

Ed Arce -- H.C. Wainwright and Company -- Managing Director

Joseph Schwarz -- Leerink Partners -- Managing Director

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