Q3 2017 Aurinia Pharmaceuticals Inc Earnings Call
Nov 14, 2017 AM EST
AUP.TO - Aurinia Pharmaceuticals Inc
Q3 2017 Aurinia Pharmaceuticals Inc Earnings Call
Nov 14, 2017 / 09:30PM GMT
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Corporate Participants
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* Celia Economides
Aurinia Pharmaceuticals Inc. - VP of Corporate & Public Affairs
* Dennis Bourgeault
Aurinia Pharmaceuticals Inc. - CFO and Secretary
* Michael R. Martin
Aurinia Pharmaceuticals Inc. - Co-Founder and COO
* Richard M. Glickman
Aurinia Pharmaceuticals Inc. - Founder, Chairman & CEO
* Robert B. Huizinga
Aurinia Pharmaceuticals Inc. - EVP of Corporate Development
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Conference Call Participants
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* Antonio Eduardo Arce
H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst
* Dae Gon Ha
* Justin Alexander Kim
Cantor Fitzgerald & Co., Research Division - Analyst
* Vernon Tolentino Bernardino
Seaport Global Securities LLC, Research Division - MD of Equity Research & Equity Research Analyst
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Presentation
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Operator [1]
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Greetings, and welcome to the Aurinia Pharmaceuticals Inc. Third Quarter 2017 Financial Results. (Operator Instructions)
As a reminder, this conference is being recorded.
I would now like to turn the conference over to your host today, Celia Economides, VP of Corporate and Public Affairs. Thank you. You may begin.
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Celia Economides, Aurinia Pharmaceuticals Inc. - VP of Corporate & Public Affairs [2]
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Thank you, operator. Good afternoon, everyone, and welcome to Aurinia's Q3 2017 earnings call and recent corporate updates. With me on the call today from Aurinia are Richard Glickman, Chief Executive Officer; and Dennis Bourgeault, Chief Financial Officer. Joining us for the Q&A will be Michael Martin, Chief Operating Officer; and Robert Huizinga, EVP of Corporate Development.
This afternoon, we issued a press release detailing our Q3 2017 financial results and corporate updates. The press release 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. It is also being recorded. A replay will be available on our website following today's 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 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 filed on Form 6-K with the U.S. Securities and Exchange Commission.
All of our statements are made as of today, November 14, 2017, 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 our CEO, Richard.
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Richard M. Glickman, Aurinia Pharmaceuticals Inc. - Founder, Chairman & CEO [3]
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Well, thank you, Celia, and thank you to everyone for joining us today as we review our Q3 results and recent corporate events.
First off, I would like to commend the entire team for the tremendous progress that we've made over the course of this year and especially over the recent quarter. Our priority over the last 6 months has been to execute the AURORA Phase III trial in lupus nephritis without compromise. The trial is in full swing. We continue enrolling patients, and we remain on track to complete enrollment by the end of 2018. This is a 52-week study, and we expect to see results at the end of 2019.
As of today, we have 138 sites that are currently activated and able to enroll patients throughout the world. As you can imagine, enrollment in studies of active lupus nephritis can be challenging, but we are confident in our ability to do so with our previously stated guidance of 18 months. As a reminder, our 265-patient Phase II AURA study took us 16 months to enroll, which was one of the fastest-enrolling global studies ever conducted in active lupus nephritis. This team has an unparalleled track record in shaping the current treatment landscape for lupus nephritis where there are no FDA- or EMA-approved therapies, and we continue to believe that we can execute a successful Phase III program for voclosporin. Our previous work continues to be recognized by the medical community. We recently presented a poster at the American Society of Nephrology meeting in New Orleans demonstrating that certain biomarkers can be predictive of complete and partial remission rates in patients with lupus nephritis.
Additionally, at the recent American College of Rheumatology meeting, Dr. David Wofsy, who leads the rheumatology center at the University of San Francisco's School of Medicine and past President of the American College of Rheumatology and recipient of the American College of Rheumatology's Presidential Gold Medal award, presented a subgroup analysis of the Phase II data, which demonstrated consistency of the results across age, gender, race and ethnicity.
We have a wealth of data that has been generated on voclosporin, and the AURORA trial is the final piece of that puzzle. To that end, under voclosporin's fast-track designation, we intend to utilize a rolling New Drug Application, NDA, process with a nonclinical module being submitted in the second half of 2018. We have plans to submit the CMC module in the first half of 2019 and the clinical module in the first half of 2020, following the completion of the Phase III AURORA trial, with a potential approval in late 2020. Furthermore, in order to add to our clinical dossier and to collect long-term data for voclosporin in lupus nephritis, we will also be initiating a 2-year extension study for patients in the Phase III trial. This extension of the study will not impact our time lines for NDA submission and potential approval. However, it should provide valuable data on the long-term use of voclosporin.
We've made a lot of progress in multiple areas over the quarter. We have successfully hit all of our major milestones, and we have -- that we promised to our key stakeholders, with the most important being the execution of our Phase III clinical program in lupus nephritis. Having secured the necessary financial resources, we are now poised to grow our business and extract maximum value out of our lead asset, voclosporin.
On October 20, we held an R&D day in New York City to review plans to execute our vision of the company, which I will review with you today. We announced plans to expand our voclosporin renal franchise to include focal segmental glomerulosclerosis, FSGS, and minimal change disease. Furthermore, we announced plans to evaluate our proprietary nanomicellar voclosporin ophthalmic solution for the treatment of keratoconjunctivitis sicca, or dry eye syndrome, DES for short. The advancement of these new indications in addition to lupus nephritis represents an expansion of our strategy, pipeline and commercial opportunities.
A Phase II proof-of-concept clinical trial for voclosporin in FSGS and minimal change disease will be initiated in the first half of 2018. FSGS and minimal change disease affect nearly 150,000 patients globally, accounting for almost half of all patients with nephrotic syndrome. Nephrotic syndrome is a collection of symptoms that indicate kidney damage, including large amounts of protein in the urine, low levels of albumin and higher-than-normal fat and cholesterol levels in the blood and edema. Similar to lupus nephritis, early clinical response in reduction of proteinuria is thought to be critical to the long-term kidney health. We are focused specifically on FSGS, a lesion characterized by persistent scarring identified by biopsy and proteinuria; and on minimal change disease, a disease in which large amounts of protein are lost in the urine, as they are both characterized by high morbidity. While guidelines exist for their treatments, there are currently no approved therapies for FSGS or minimal change disease in the United States and the European Union. This Phase II proof-of-concept study will evaluate approximately 20 FSGS and minimal change disease patients. It is an open-label study, and there will be planned interim data readouts during the second half of 2018. And upon conducting our regulatory interactions, our intent will be to initiate a Phase III trial for this -- these diseases in the first half of 2019. As a company that has been focused on lupus nephritis since its inception, expanding our scope to include these diseases that cause nephrotic syndrome is synergistic with our current strategy and long-term vision of the company. We seek both to provide a treatment option for patients where high unmet medical need remains while creating significant additional value for our shareholders.
As I mentioned, we also announced that we will be advancing VOS for the treatment of dry eye syndrome. Dry eye syndrome is a chronic disease in which a lack of moisture and lubrication on the eye results in irritation and inflammation of the eye. It is a multifactorial, heterogeneous disease estimated to affect greater than 20 million people in the United States. VOS is an aqueous, preservative-free, nanomicellar solution that contains 0.2% voclosporin, intended for use in the treatment of dry eye syndrome. Studies have been completed in rabbit and dog models, and a single Phase I study has also been completed in healthy volunteers and patients with dry eye syndrome. VOS has its own separate IP for voclosporin with protection until 2031.
In April of this year, we had announced an agreement granting Merck Animal Health worldwide rights to develop and commercialize VOS for the treatment of dry eye in dogs, where previously conducted proof-of-concept research with VOS in dogs suffering from dry eye, which affects approximately 1 out of every 22 dogs, and they made a decision to move forward with VOS as a development project. As a reminder, Merck Animal Health was the developer of the largest-selling treatment for canine dry eye, Optimmune, which is the equivalent of RESTASIS in humans.
We will be initiating a Phase IIa tolerability study of VOS versus RESTASIS, which is the current standard of care for the treatment of dry eye, by the second quarter of 2018. We expect data to be available in the second half of 2018. Calcineurin inhibitors are the mainstay in the treatment of dry eye, and the goal of this program is to develop a best-in-class option demonstrating improved efficacy and tolerability for patients with dry eye. We then intend to monetize this asset either through partnering or divestment.
We are excited by the opportunity that voclosporin offers in these new indications and, of course, in lupus nephritis. And we continue to believe that leveraging our expertise to expand voclosporin's application while making minimal investments will create significant value for our shareholders.
With that, I would like to turn it over -- our call to our Chief Financial Officer, Dennis Bourgeault, who will review our Q3 financials with you. Dennis?
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Dennis Bourgeault, Aurinia Pharmaceuticals Inc. - CFO and Secretary [4]
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Thank you, Richard. On the financial front, the condensed consolidated financial statements of Aurinia have been prepared in accordance with IFRS as issued by the International Accounting Standards Board. The consolidated financial statements are presented in U.S. dollars, which is the company's functional and presentation currency. All amounts mentioned are in U.S. dollars, therefore.
Cash, cash equivalents and short-term investments were $182.4 million as at September 30, 2017, compared to $189.8 million as of June 30, 2017, and $39.6 million at December 31, 2016. We believe, based on our current plans, that we have sufficient financial resources to fund our existing lupus nephritis program, including the AURORA trial, conduct work on the new indications and fund our operations into 2020.
For the 3 months ended September 30, 2017, we reported a consolidated net loss of $13.1 million or $0.16 per common share as compared to a consolidated net loss of $7.4 million or $0.21 per common share for the 3 months ended September 30, 2016. The increase in the loss is primarily due to an increase of R&D expenses of $7.5 million.
We incurred R&D expenses of $10.8 million for the 3 months ended September 30, 2017, as compared to $3.3 million for the same period in 2016. The increase in R&D expenses for the 3 months ended September 30, 2017, reflected AURORA clinical expenses, such as contract research organization service fees and costs for activities, including site activations, regulatory submissions, patient treatment as well as drug costs for manufacture of voclosporin drug product; and drug encapsulation, packaging and distribution for the trial.
We incurred corporate, administration and business development costs of $2.6 million for the 3 months ended September 30, 2017, as compared to $1.7 million for the same period in 2016. These costs included a noncash stock compensation expense of $795,000 for the 3 months ended September 30, 2017, compared to $469,000 for the 3 months ended September 30, 2016.
With that, I will turn the call back over to Richard for some closing remarks.
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Richard M. Glickman, Aurinia Pharmaceuticals Inc. - Founder, Chairman & CEO [5]
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So thank you, Dennis. And once again, I'd like to thank the team for the tremendous progress that we've made over the last quarter. I know we're a small, nimble and dedicated team that continues to successfully execute and complete all of our major milestones.
I'd like to end the formal part of this call by sharing a few thoughts as to where we are today and how I see Aurinia's business as we look to the future. Now I believe that Aurinia really represents extraordinary opportunities for patients and for investors. As a company, we have a drug candidate that, if successful in Phase III, has the potential to be the first approved therapy in the treatment of lupus nephritis. We have generated significant Phase II data supporting the potential of this drug, and we believe we have a clear regulatory path forward to approval. There's a solid intellectual property base, and we believe we have the -- the market opportunity for this drug is very significant. It's with great confidence, actually, that we continue to advance voclosporin into its final stage of development. Furthermore, with our recent announcement on indication expansion, we are focusing on ways to extract maximum value of voclosporin, which can benefit both patients and our shareholders. And with the addition of these new indications, we see the potential peak sales of this drug increasing from about $1.4 billion to in excess of $2 billion globally.
And with that, I'd like to turn the call over to the operator and open the line for Q&A. Operator?
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Questions and Answers
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Operator [1]
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(Operator Instructions) Our first question comes from Joseph Schwartz with Leerink Partners.
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Dae Gon Ha, [2]
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This is Dae Gon dialing in for Joe. I just had a couple on the expansion program, specifically in the FSGS and the MCD indication. So the open-label trial that you'll be embarking on next year, I was just wondering if you could comment on your rationale behind just pursuing that single dose of 23.7 mg b.i.d., and then I've got a few follow-up.
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Richard M. Glickman, Aurinia Pharmaceuticals Inc. - Founder, Chairman & CEO [3]
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Yes. I think that I'll give a quick answer to that, and I'll turn it over to Rob eventually. The -- I think the dosage and interest in that dosage just reflects the experience we have now working with this drug. We've got 2,400 patients that have been exposed to this medication. We have a really good understanding of its PK/PD. We have a really good understanding of how it performed in proteinuric kidney disease at this point in time, and so it just made sense to move forward with that dosage. And we're actually very -- we're really quite comfortable with what we see in the clinic with that dosage range. Rob, do you have anything to add?
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Robert B. Huizinga, Aurinia Pharmaceuticals Inc. - EVP of Corporate Development [4]
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No, Rich, I think you covered it perfectly. That's the effective dose we found in lupus nephritis, and given what we know with calcineurin inhibitors, it seems to be the right dose to move forward with.
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Dae Gon Ha, [5]
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So in that case, looking at the end point, looking at sort of the clinical meaningfulness of the complete remission, partial remission, just trying to get a sense of the clinical meaningfulness behind the definition of these remission end points. And as you know, your competitor in FSGS has conducted a trial looking at modified partial remissions. So how should we think about those differences, if any?
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Richard M. Glickman, Aurinia Pharmaceuticals Inc. - Founder, Chairman & CEO [6]
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So Rob, do you want to address that question?
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Robert B. Huizinga, Aurinia Pharmaceuticals Inc. - EVP of Corporate Development [7]
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Yes, I can do those. Thanks for the questions. So unlike lupus nephritis where complete remission is really key, even a partial remission in diseases like FSGS and minimal change are important, both clinically in terms of patient management and in terms of long-term patient outcome. I think one of the keys to us finding the end point is finding one that has less variability. We're using the same approach in FSGS and minimal change as we are in LN, and so we don't think that we would have to use a modified response rate as has been done by some of the other companies.
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Dae Gon Ha, [8]
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And is there any reason to believe that since you're including corticosteroid-free patients into your open-label trial, if you were to have patients on a concurrent immunosuppressant therapy, that there would be any drug-drug interaction? And are you including any patients that are on immunosuppressant therapy at baseline?
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Robert B. Huizinga, Aurinia Pharmaceuticals Inc. - EVP of Corporate Development [9]
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The plan for the study is voclosporin monotherapy, so just voclosporin on its own. So any patients that are on other immunosuppressants coming into the screening period would have to stop those other immunosuppressants and be cleared of those before they could be entered into the study.
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Richard M. Glickman, Aurinia Pharmaceuticals Inc. - Founder, Chairman & CEO [10]
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I also want to comment. You're dealing with these diseases that are really podocytopathies. And I think when you really look at the mechanism of action of voclosporin, I think one of the things that excites me most is that dual nature. At first, people were actually concerned over the dual nature of voclosporin, one being an immunosuppressant and reducing IL-2 and T-cell activation but the other being its direct impact on the podocyte. And I think that combination gives us the potential for a really quick response in this disease but also, over time, a real impact on the disease from an immunological perspective. So it's -- I think it's actually an ideal-type therapy for FSGS and minimal change disease.
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Dae Gon Ha, [11]
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And then last one from me. In terms of the long-term goal of FSGS, how should we think about in terms of kidney function? Is it stabilization that should be looked at or more improvement of the kidney function?
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Richard M. Glickman, Aurinia Pharmaceuticals Inc. - Founder, Chairman & CEO [12]
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That's a really fair question and then -- and Rob, I'll let you jump in on that, but in listening to Dr. Tumlin at the past -- when he gave his presentation, he really does believe that you can see some regeneration at the -- with the podocyte level and the improvement in performance of kidney function as a consequence of podocytes being protected. But do you want to add to that, Rob?
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Robert B. Huizinga, Aurinia Pharmaceuticals Inc. - EVP of Corporate Development [13]
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Certainly. I think, very similar to lupus nephritis, in the short term in these studies, we're looking for stabilization of renal function. But Rich raised a really important point that these are all podocytopathies, and we know from more recent data that's come out this year that if you're able to interact on the podocyte directly soon, you may actually be able to see repair of that podocyte. So that's an encouraging long-term view for us.
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Operator [14]
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Our next question comes from Ed Arce with H.C. Wainwright.
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Antonio Eduardo Arce, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [15]
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And thanks again for detailed discussion at your recent Investor Day. A couple questions from me. First is on the 2-year extension study, I realize this is a safety study outside of your NDA requirements for voclosporin in LN. But just wondering, aside from safety, how do you think about that in terms of labeling, marketing the drug? And then I have a couple of follow-ups.
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Richard M. Glickman, Aurinia Pharmaceuticals Inc. - Founder, Chairman & CEO [16]
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Yes. No, that's a -- thank you for your question. That's a very -- also a very important question. These aren't cheap studies, and so making a decision to run it for 2 years wasn't done trivially, but I do think it's important. When you actually look at these treatments, for instance with CellCept, these tend to be used more long term. Because there's so few treatment options, physicians, once they have a patient that's actually stable with the disease, they really don't want to mess with medications a whole lot. That said, having this 2-year study, I think, will have very important implications for longer-term safety. One has to be cautious, of course, in how one then goes back to regulators with that long-term data and present that data to see how it might affect your labeling. But certainly, our intent here is to try to show long-term safety with the drug that we believe has usefulness over a longer term than through the initial sort of induction into stable disease phase of treatment.
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Antonio Eduardo Arce, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [17]
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Okay, great. And then a question about your program for VOS. Just wondering if you can provide any meaningful updates yet on partnering discussions and remind us of how you think about the criteria there to execute on a partnership for that asset.
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Richard M. Glickman, Aurinia Pharmaceuticals Inc. - Founder, Chairman & CEO [18]
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As a general rule, I've been taught to not comment on partnering and where we are in any sort of processes, and so I'm going to respect that rule here because I'll get kicked under the table if I don't. But I do think that when it comes down to what is it we're trying to show, we own an asset that's got great IP. We know that we can deliver a lot more drug to these patients with this combination than they currently receive using a drug like RESTASIS. We believe that if we could show it's more tolerable, that we're putting ourselves in a position where it can really differentiate what is the largest-selling drug in this space. And it is believed by ophthalmologists that, in fact, that calcineurin inhibitors are going to play a role long-term in dry eye. That being said, with good IP and good data, particularly if we can show this drug performance well from a tolerability perspective, I don't think we're going to have a shortage of suitors because it's -- it fits a lot of potential companies' profiles.
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Antonio Eduardo Arce, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [19]
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Okay. That's great. And then one last one, Rich, perhaps since you had mentioned at the close of your remarks the projection of $2 billion or perhaps more globally on peak sales for the drug across the indications, I was wondering if you might hazard to give us a bit more of a breakdown on how you see that across the indications.
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Richard M. Glickman, Aurinia Pharmaceuticals Inc. - Founder, Chairman & CEO [20]
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Well, we originally presented, and fairly conservatively, I believe, what we thought were LN projections that exceeded $1.4 billion. And so it's easy to do the math and get to the point where you could see that we're projecting that when you look at the additional indications related to nephrotic syndrome, minimal change, FSGS, and those primarily, although I have to remind you that we don't believe the drug is going to be limited. But those will be the on-label strategies that we have as a company, and that if we deem there's additional opportunity, we'll add additional on-label strategies. But we're just looking at those on-label strategies for the company right now where we're looking for regulatory approvals, that's how it would roughly break down.
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Operator [21]
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Our next question comes from Vernon Bernardino with Seaport Global.
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Vernon Tolentino Bernardino, Seaport Global Securities LLC, Research Division - MD of Equity Research & Equity Research Analyst [22]
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My question actually was on complete remission as an end point, but I was wondering if you could perhaps discuss a little further, perhaps, if, just looking at proteinuria as an option as far as the endpoint, since these are patients with the direct effect on proteinuria is clinically meaningful, or do you need to show remission?
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Richard M. Glickman, Aurinia Pharmaceuticals Inc. - Founder, Chairman & CEO [23]
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So now you're really -- are you -- your question is specific, Vernon, to FSGS and minimal change disease?
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Vernon Tolentino Bernardino, Seaport Global Securities LLC, Research Division - MD of Equity Research & Equity Research Analyst [24]
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Yes, I'm sorry.
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Richard M. Glickman, Aurinia Pharmaceuticals Inc. - Founder, Chairman & CEO [25]
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Okay, just wanted to be clear on that. Rob, did you want to give that a go?
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Robert B. Huizinga, Aurinia Pharmaceuticals Inc. - EVP of Corporate Development [26]
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Yes. So we look at 2 definitions there. The first is a complete remission, which brings the UPCR, so the urine protein/creatinine ratio, from wherever the patient comes in at to a level of 0.5 or less. And we're also looking at a partial remission, which is a 50% reduction in that patient's UPCR, again dependent on where they come in at. So we're looking at both of those. We'll also, in the secondary end point -- this is a small Phase II trial in the secondary end points. We'll look at other things as well, too, which will help inform us to potential design and attributes for the Phase III program.
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Vernon Tolentino Bernardino, Seaport Global Securities LLC, Research Division - MD of Equity Research & Equity Research Analyst [27]
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Okay. So the ratio is going to be the most important as far as determinants of remission. Just wanted to confirm that.
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Robert B. Huizinga, Aurinia Pharmaceuticals Inc. - EVP of Corporate Development [28]
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Correct.
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Operator [29]
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Our next question comes from Justin Kim with Cantor Fitzgerald.
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Justin Alexander Kim, Cantor Fitzgerald & Co., Research Division - Analyst [30]
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So most of my questions were asked but perhaps just a follow-up on the VOS program. Do you believe that speed of response would alone be sufficient to differentiate the VOS profile? And with respect to the standard of care and sort of, can you refresh us on mechanistically why we might expect that from the drug?
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Richard M. Glickman, Aurinia Pharmaceuticals Inc. - Founder, Chairman & CEO [31]
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Okay, I apologize. I missed the first part of your question when you were referring to what we -- the reference point.
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Justin Alexander Kim, Cantor Fitzgerald & Co., Research Division - Analyst [32]
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So just trying to understand if speed of response, whether VOS demonstrating a clinical response faster might be enough to differentiate the profile.
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Richard M. Glickman, Aurinia Pharmaceuticals Inc. - Founder, Chairman & CEO [33]
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Oh, speed. Okay. I think it's also another very good question. I think that when you actually talk to physicians working within this space and you look at the current therapy, one of the issues around the current therapy or the standard of care today is actually it's fairly slow in responsiveness, the so-called wow effect where the patient takes the drug and actually really shows a very significant response quickly. I think with the addition of the newest drug entering into that field, I think we do see a more rapid response. So I think in order to really truly be successful here, you need to have also -- you need to show tolerability, which is critical, the efficacy. And I think you have to do it faster than the current standard of care actually does, if you really are going to stand out in the long run and actually be a treatment of choice. Now Mike, you're on the line. You might want to answer that question better than I did.
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Michael R. Martin, Aurinia Pharmaceuticals Inc. - Co-Founder and COO [34]
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No, sure. I think that onset of action would be a key differentiator if you're just looking at the CNIs in that class. And RESTASIS causes significant burning and irritation on application, and arguably, a lot of those patients on that therapy really don't stay on long enough to get an effect. So clearly, tolerability, probably number one. Onset of action, I think that'd be a major benefit to the market. And there is reason to believe, in follow-up to your question that mechanistically in the formulation, that we're delivering so much more drug to the target tissues. We're really, really encouraged about that.
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Operator [35]
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Thank you. At this time, there are no questions in queue. I'd like to turn the call back over to management for closing comments.
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Richard M. Glickman, Aurinia Pharmaceuticals Inc. - Founder, Chairman & CEO [36]
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Okay. Well, I'd like to close off and actually thank you all for taking time out of your afternoon to join us, and I look forward to sharing developments as we progress. I think next year is going to be a very big year for our company. We've got a lot of developments occurring. And once again, thank you for your time. Good afternoon.
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Operator [37]
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This does conclude today's teleconference. Thank you for your participation. You may disconnect your lines at this time.
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