Ardelyx Inc (ARDX) 2015 Q4 法說會逐字稿

Hello, ladies and gentlemen. Thank you for standing by and welcome to the Ardelyx Fourth Quarter and Year End 2015 Earnings Conference Call. At this time, all participants are on a listen-only mode. Later, we will conduct a question and answer session and instructions will follow at that time. As a reminder today's call is being recorded.

It is now my pleasure to turn floor over to Bill Slattery, Account Manager at Burns McClellan, who will make introductory comments.

Thank you. Good morning and welcome to Ardelyx's Fourth Quarter and Yearend 2015 Earnings Conference Call.

Earlier this morning Ardelyx issued a press release providing the details of the Company's financial results for the fourth quarter and yearend of 2015, as well as a corporate and clinical update. The press release is available in the investor relations section of the corporate website at ir.ardelyx.com.

Today's call will be led by Mike Raab, Ardelyx's President and Chief Executive Officer. He will be joining by Mark Kaufmann, Chief Financial Officer, Dr. Paul Korner, Executive Vice President and Chief Medical Officer, and Dr. David Rosenbaum, Senior Vice President of Drug Development.

As a reminder, during today's call, Ardelyx will be making certain forward-looking statements. To the extent that statement discussed on this call are not description of the historical facts regarding Ardelyx, they are forward looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including with the with potential for tenapanor in treating patients with constipation for dominant irritable bowel syndrome.

The potential for tenapanor in treating hyperphosphatemia in patients with end-stage renal disease. Ardelyx's future development plans for tenapanor and the timing and cost thereof. The potential for RDX022 in treating hyperkalemia, Ardelyx's future development plans for RDX022 and the timing and cost thereof. The potential timing for filing an IND for RDX009 and the potential of Ardelyx's other product candidates in drug discovery and design platform.

Such forward-looking statements involve substantial risks and uncertainties that could cause the development of tenapanor, RDX022, or Ardelyx's future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in research and the clinical development process and the uncertainties in the manufacture of clinical trial material, including process development, scale up of manufacturing processes.

Ardelyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx's business in general, please refer to Ardelyx's Annual Report on Form 10-K to be filed with the Securities and Exchange Commission on March 4, 2016, and its future current and periodic reports filed with the Securities and Exchange Commission.

At this time, it is my pleasure to turn the call over to our Ardelyx's President and Chief Executive Officer, Mike Raab.

Thank you, Bill. Good morning, everyone, and thank you all for joining us.

On today's call, I'll review our key clinical and corporate accomplishments in 2015 and highlight our upcoming milestones and plans for 2016 and beyond.

As noted, joining me today is Mark Kaufmann, our Chief Financial Officer, who will review financial highlights to our fourth quarter and full year ended December 31st, 2015 as well our Executive Vice President and Chief Medical Officer Paul Korner, Dave Rosenbaum, our Senior Vice President for Drug Development and Jeremy Coldwell, our Chief Scientific Officer, who will be able to address questions that you may have concerning our growth and development programs.

In 2015, we've tried envisioning for the advance stage for the goal of the Company, initiating in the fourth quarter two phase III clinical trials evaluating our lead candidate, tenapanor in patients with constipation predominant irritable syndrome, or IBSC, as well as phase II B clinical trial evaluating tenapanor to manage hyperphosphatemia and to manage end-stage renal disease, or ESRD patients.

We also achieved a few milestones for RDX022, which we are evaluating to treat hyperkalemia. Subject to certain payment obligations with AstraZeneca, which we had previously disclosed, we now have full ownership of tenapanor, nor having reacquired rights from AstraZeneca as announced last June. We further strengthened our senior leadership team with the appointment of Doctor Paul Korner as Executive Vice President and Chief Medical Officer, and with the addition of two out of four members, Dr. Annalisa Jenkins and Bill Bertrand.

In the past 12 months, we have raised $154.7 million in net proceeds and two financings, including a $74.3 million emerging price placement and $80.4 million from our recently completed underwritten follow on public offering in January of this year.

In terms of our clinical progress, in October we initiated the first of two phase III clinical trials evaluating tepanor for the treatment of patients with IBSC and in December we began a second phase III clinical trial that had in our original plan which was to initiate a trial in the first quarter of this year. The design of these trials closely matched our previous phase IIB clinical trial, as well as the other two successful phase III IBSC clinical trials that were conducted in the industry.

As a reminder, the first beta III trial incudes a 12-week primary endpoint with a four week randomized with all phase followed by an open label extension. The primary endpoint of this study is the overall responder rate in six out of 12 weeks for patients treated with a 50 mL dose of tenapanor administered twice daily versus placebo. The second phase III study has an identical design in the 12 first weeks of the trial, including the same primary endpoint.

Additionally, the second study will evaluate tenapanor versus placebo at 13 and 26 weeks. All patients in both phase III trials will be eligible for an open label extension, which we anticipate and will allow us to meet the FDA's requirement prior to NDA's submission that has a sufficient safety database to support the prime use of tepanor. We are excited to have both phase III trials evaluating tepanor in IBSC underway. We currently anticipate data from both studies will be available in 2017.

In addition to tepanor for IBSC, in the fourth quarter we initiated our second phase IIB study evaluating tepanor for the treatment of hyperphosphatemia in patients in dialysis with ESRD. In the previous phase IIB trials, we found a statistically significant dose related increase in serum phosphorus. The goal of the ongoing phase IIB study is optimized efficacy with the best tolerability profile for these patients. The primary endpoint for the trial is the change in serum phosphorus levels from baseline following a washout period of up to three weeks to the end of an eight week treatment period. Following the eight week treatment period, there will be a four week randomized withdrawal period.

A few secondary endpoints we are measuring is the difference between the tepanor and placebo arms and the changes to the phosphorus levels after the four-week randomized withdrawal period. Results from this study are expected to be available in the second half of 2016.

Overall, tepananor has now been administered in over a thousand individuals across 14 clinical trials for multiple indications, and has demonstrated being minimally systemic and generally well tolerated. We are thrilled with tepananor's progress both in IBSC and ESRD patients with hyperphosphatemia.

We also made substansive progress in 2015 in our RDX022 clinical program. In June, we announced the development plans for RDX022, as we try to carry oral, non-absorbed detaching binding polymer based on polystyrene sulfonate, a well known and well characterized polymer used to treat hyperkalemia. We have engineered RDX022 to be an efficient potassium binder with improved physical and chemical properties that we expect will greatly enhance its palatability and could result in improved patient adherence and compliance.

Last year, we came back with a single standard randomized cross over study that valued the merits of all formulations of RDX022 in healthy subjects in which RDX022 consistently outperformed sodium polystyrene sulfonate in all aspects of case assessment including mouth feel, texture and flavor. We believe increased palatability can result in better patient compliance especially for the potentially significant chronic hyperkalemia market.

In addition, we recently announced positive results in an open label study evaluating the pharmacodynamics or PD study of RDX022 in healthy adult volunteers. The study demonstrated that RDX022 effectively binds potassium in the gastrointestinal tract and was generally well tolerated at all doses administered all with 27.5 grams per day. Based on the results of the PD study and the ongoing manufacturing efforts, we expect to begin a phase III clinical program with RDX022 in the second half of this year. The proposed phase III clinical study will enroll patients with chronic kidney disease with or without heart failure who have been diagnosed with hyperkalemia and who are being treated with drugs that inhibit the renin-angiotensin aldosterone system or RAAS.

Based on a discussion with the FDA early last year, we currently envision a potential two part phase III trial design. Part A will be single blind with all subjects receiving RDX022 for four weeks. Part B will be a double blind placebo control with a randomized withdrawal period of eight weeks. Key endpoints will be evaluating a change in serum potassium from baseline and a change in serum potassium versus placebo.

Given the available literature on safety and effectiveness with polystyrene sulfonate, we are pursuing the 505B2 regulatory pathway for RDX022, but we may not have been required to conduct such an expensive phase III clinical program for this regulatory pathway, we have chosen this path in order to have a robust competitive package insert along with a sales force to speak the benefits of RDX022 with similar clinical endpoints as those used for other commercial potassium binders.

And so, we have made remarkable progress by these programs having advanced tenapanor in two phase III trials as well as making significant progress with RDS022 including a recently conducted PD studies, which we believe bodes well for our upcoming pivotal phase III study. Further, we have enhanced our pipeline with multiple preclinical assets including RDX009, our TGR5 agonist to streamline slow dosed secretion of GLT1 and GLT2 in the gut.

Our client is to submit an [IND] in the second half of 2016. We expect to talk more about this program at our annual R&D day, which we are planning for later this year. We expect to provide more information on this event in the near future. I will now turn the call over to Mark Kaufmann, Ardelyx CFO, who will review our fourth quarter and full year 2015 financial results.

Thanks, Mike. As usual practice for the Company, rather than review all the information disclosed in the press release, I would like to focus on a few specific financial highlights.

First, I want to point at that despite a rough couple of months in the market and specifically in biotech, we were able complete one of the few follow on offerings in the industry during this period, raising $80.4 million net in January after ending the year with about $107 million in cash. Our current cash position is essential to us and to support our late stage clinical programs, which as Mike mentioned will generate important value driving milestones over the next 12 to 18 months.

I'll touch on the financial results starting 2015, it was the termination of the AstraZeneca agreement in June 2015, and after the return of tenapanor and the NHE3 program to us, and the commencement of our own late staged clinical programs for IBSC and hyperphosphatemia. We also began significant progress process development manufacturing activities for RDX022, as well as greater efforts thanks to our being a public company were felt in 2013 versus 2014. I'll walk you through some of these items now.

Our net loss for the year ended December 31st, 2015 was $29.6 million or $1.29 for basic and diluted share compared to a net loss of $3.2 million or $0.31 per basic and diluted share for the year ended December 31st, 2014. Net loss for the fourth quarter of 2015 was $17 million or $0.65 per basic and diluted share compared to a net loss of $4 million or $0.21 per basic and diluted share for the fourth quarter of 2014.

The revenues comprised of licensing revenue and collaborative development revenue with a source of funds coming largely from the AstraZeneca agreement, licensing revenue increased to $21.6 million for the year ended December 31st, 2013 or $18.4 million for the year ended December 31st 2014. The increase primarily reflects the impact of the regulation of the remaining deferred revenue balance related to the AstraZeneca license agreement of $43.1 million as a result of the termination of the license agreement with AstraZeneca in June 2015. This recognition of the program was offset primarily by optimum savings with AstraZeneca of $25 million in connection with the termination of the AstraZeneca agreement.

Collaborative development revenue comprised of savings through Ardelyx from AstraZeneca of reimbursed development expenses decreased $2.4 million for the year ended December 31st, 2015 from $13.2 million for the year ended December 31st, 2014, also primarily attributable to the termination of the AstraZeneca agreement in June 2015.

Research and development expenses for the year ended December 31st 2015 increased to $39.9 million from $25.9 million for the year ended December 31st 2014. But the change is primarily due to development related items first a $7.3 million expense incurred for tenapanor clinical trials and several trials from AstraZeneca and second, an increase in $6.7 million in expenses incurred for clinical development activities associated with tenapanor and RDX022 and manufacturing process development for RDX022.

Finally, general and administrative expenses of $13.5 million for the year ended December 31st 2015 compared to $7.3 million through the year ended December 31st 2014 and as I mentioned, the increase was primarily due to an increase of special service fees, personal cost and public company cost.

We're looking forward to updating you as we move forward.

Thank you, Mark. With that, we would now like to take any questions you may have and as a reminder, we're also joined today by Doctor Paul Korner, our Chief Medical Officer; Dr. David Rosenbaum, our Senior Vice President for Drug Development and Jeremy Caldwell our Chief Scientific Officer, if you have any questions related to our clinical programs.

Operator, we are now ready to take questions.

(Operator Instructions) Our first question comes from the line of Yigal Nochomovitz from Citi. Your line is now open.

I guess, I just want to ask a big picture question on IBSC, in terms of the market dynamics - assuming obviously, you guys get to the market. Just in terms of how you think about the existing players, lubiprostone has had a very strong launch and looking at the IMS data, it appears that it didn't really take share from Amitiza, but just grew the overall market.

I'm just trying to get your - take your pulse on sort of your overall strategy for how you think about launching tenapanor in terms of that dynamic in a way that you're basically just going to look for new patients that aren't on prescription therapy or is there also an argument to be made to target the switch population. Thank you.

Thanks Yigal, I guess there's a couple of things. As we know, this is a big market and the fact that Amitiza continues to perform as it does even with the growth that you are seeing on 30% growth in new prescriptions from [Lindata], it's really a sizable market that will continue to grow.

I think the important thing to note with both those drug - it's mostly - the drug mostly don't work given the overall responder rate and those therapies. So, I guess from my vantage point, I look it at us with tenapanor presuming that we repeat what we saw in our phase IIB of an overall respond rate of 50% not surprisingly for placebo that we should be able to get those patients who have not responded - get those patients who have a lot of diarrhea from the medicines that we have markedly less diarrhea than today and get - frankly, to take all coverage to make sure those patients are optimally [drugged].

And can you speak a little bit also, but just around the level of investment that you expect to make in the launch. Obviously, having investment in the DTC campaign, are you - is that something you're basically going to do with a partner as I understand it and could you just clarify any updates there on that front?

Yeah, I mean, as we've spoken before that our objective at this point is to wait until we have that first stage III result which would be in 2017 and with those data in hand, establish a partnership with a big pharma company who would then undertake [the drug and making some] advertising effort that we can see work, given the investors response.

My objective at this point would be to retain rights, to co-promote and for example, GI and OBGYN, because this is primarily the disease that 80% of the patients are women and then when you go view this primary care. So, we believe that in retaining, co-promoting the [influence with KOL] and put in place a relatively modified sales force to cover those two cold points.

Okay, thanks, and maybe just a few quick words on the plans for CIC development. Is there any more refined timelines there?

So I think as we mentioned before, if you look at the nine and 12 weeks variable responder analysis that we've shown. It's in our corporate deck on our website. The variable responder analysis that the chapter show the overall response in nine and 12 weeks. And then if you have a response in three of the last four weeks of therapy. That is the endpoint that would quantify and demonstrated for their CIC endpoint.

And if you look at it there are three criteria, there's a remarkable overlap between what you see with IBSC and CIC. It's also important to know that when they actually did their CIC clinical study prior to their IBSC studies, but waited until IBSC was completed before going to the FDA for approval. And so they advised that we have gotten from our KOLs is the real competition for CIC is the over the counter laxatives.

So we will pursue CIC, but they will be after the few trials are complete.

Okay. And then just one technical question on the plans for the phase III trial for RDX022 and hyperkalemia. It wasn't clear if you're pursuing a once a day dose there relative to the - what you did in phase two which I believe was b.i.d. or t.i.d.

David, you want to address that?

Yeah, sure. So, Yigel, the way that clinical trial design, it's - we will escalate at a dose in the first part to get people under control. The second part will allow people to be on maintenance dose, which may include either a once a day or twice a day dose.

Our next question comes from the line of David Nierengarten from Wedbush Securities. The line is now open.

Okay. Thanks for taking the question and mine would be on how your plans are or the thinking about the phase III as being informed by the launch of [Zeltasa] in terms of thinking about the endpoints or other aspects that you're looking at for competitive advantages to find that spot in the market for 022. Thanks.

David, you want to address that?

Yeah, sure. I think the clinical trial design that we have which is very similar to the developed phase III allows us to do two things. One, to show that we're able to get people who have film capacity of up to 6.5 down to the normal range and then two, over the eight-week phase to show that we're able to control people with a lower maintenance dose and I think if we're able to do that, then we'll be able to compete with the other treatments in the market.

And David, the other thing I know is, I think this is going to be really a competitional round of compliance and [PRNs]for these patients first and foremost, which is why we spent the time and money looking for formulations and it's got insights from food science and making this palatable and not - the knowledge and skill part would be terribly important. This is not a drug that needs to be refrigerated, multiple pass, the pack that's still in the counter, you have nine uses, may of course take - it may not be a big of a deal, but if you're treating your heart failure patient, it's pretty straightforward to have the clinician, do you have any ideas to provide this again to your treatment of your heart failure patients and of course the answer is no.

So the fact that we don't (inaudible) the counter on the work we have put in to the palatability of the drug on the fact that it's not refrigerated, we don't use all - all of those things are ways that we have differentiated the drug as compared to the competition.

Our question comes from the line of Mike King from JMP Securities. Your line is now open.

Good morning guys. Thanks for taking the question. I just wanted to follow up on David's question about 022 and I understand your product characteristics and the strategy there. But I'm just wondering at some point, do you feel it might be necessary - not so much - for approval but more for market uptake to either go up ahead Kalexate or one of the other combinations, [Aclonium] or [Peteremer] in order to improve your market uptake?

Yeah, I mean that's going to be all evaluated as we go forward. And see what else we would need to launch and do head to head with (inaudible) sizable market, I think. From our vantage point, the fact that AstraZeneca acquired ZS pharma is a good thing. AstraZeneca built the PPI marketplace. They clearly did a phenomenal job making drug stores bigger than it was even it's an 15/25 into the market and major multibillion drugs, so this is clearly a market that needs to be built and us following 18 to 24 months behind. We've certainly [relish that] and AstraZeneca are going - I think it only works to our benefit.

Okay. Thanks on that. And then just quickly it seems and maybe just because I don't pay attention carefully, but it just seems like you're talking more about manufacturing on your call today than you have in the past and I'm just wondering if we might be able to get a sense of what that is all about in terms of how much you're committing of your capital to manufacturing and to what degree, meaning is this manufacturing just for clinical supply or would you envision Ardelyx being in the business of creating its own manufacturing for commercial supply as well?

No, I certainly don't envisage us ever having our own factory. We'll be using a CMO to be making all of our drugs and the relationships that we're establishing with well-known, well-respected CMOs it's not only for clinical supply, it's also looking for validation of the manufacturing process and ultimately offer commercial supply.

Okay. Can you give a sense Mike of just how much that you expect in terms of capital commitment to be?

Yeah. This is Mark. We have not given any guidance on that specifically. I mean we have said that going forward, [DMC] would be a large part of the cost. And the cost that are noted in our co-confrontation in the last live is I'd say that - those costs which we have not changed at this point include DMC in order to get to an NDA.

Yeah, and I think we have to think about here, Mike, is this is for tenapanor, small molecule, so it's going to be pretty traditional small amount for the cost of goods and for polystyrene sulfonate, that is made by the metric ton. Obviously, this is a GMP grade versus what has been used for it in the past, so it's not going to be as expensive as some of the other polymers that are out there.

So pretty straightforward to derive those expenses.

Okay. Great. Thanks for the color. I also wanted to ask you in terms of - I didn't see guidance in the release on the cash runway. How much do you or how long do you expect the current cash to last?

So we haven't changed our guidance which again is on the last stage of our corporate deck, which effectively if you add all up, it means over the next couple of years with the phase III and CMC to get to an NDA for all three programs plus the run rate of the Company is $200 million plus. We have $187 after the follow on offering so pro forma in the bank and so if you do the division and we haven't been more specific than this guidance, but you divide by the couple of years that that gets us to NDA and you get to $25 million to $30 million dollar per quarter kind of burn, which is approximately where it is and so that effectively means we have seven plus quarters of cash if you do that division and which means that we can confidently get past the hyperphophatemia results at the end of this year and if we are required - if we get past at least, but probably one of the three IBSC clinical trial as well, so that sort of what we've been guiding people.

Our next question comes from the line of Jason Gerbbery from Leerink Partners. The line is now open.

This is [Esther] filling in for Jason. I had a couple of questions on IBSC and one on RDX022. So first on IBSC, I wondered if you could talk about how you IBSC phase III studies differentiate the market of the drug than other currently in the clinic and how might the secondary endpoints tie into the label with respect to durability for example and maybe your thoughts on the b.i.d. dosing versus the q.d. dosing in IBSC. Is there material sensitivity to frequency of dosing in the marketplace right now and then I'll follow up with my RDX022 question afterwards?

Dave, let me answer the dosing question first and then why don't you address the trial design questions.

So this is clearly a very motivated patient population and I think that we've done [insurance] that whether it's q.d. or b.i.d. isn't going to make much of a difference in terms of the adherence or compliance particularly since we have such a lower rate of diarrhea. That said, we have in our plan a study to q.d. dose at 100 mgs q.d. to allow for one day impact times to other capacity, which is to go down. That has been our plan.

Yes, so as far as the phase III clinical trial design goes, I think the first and most important point here is that our phase three clinical trials are the same as our phase IIB clinical trials, same inclusion and [reg araea] and the same endpoints. I also think it is important to note in our phase III that we have the endpoints of different 12 week overall responder six to 12 week complete with [antibowel] responder, as well as the abdominal pain responder and we have included the nine of twelve week overall CFDM and abdominal pain responder.

I think it is important to note that our clinical trial is designed almost the same as [Linzesa], it will allow people to be open to compare both the efficacy and the safety of our drug straight to market leader [Linzesa]

Thanks. So the question that I have on RDX022, I wonder if you could comment on your initial thoughts with respect to the Veltassa data on patient data disclosed thus for and what you think this could mean for RDX022?

Well, I think it's involving market. It's encouraging to see the data that we are able to get as many prescriptions they did. So yeah, that's your first data that's come out that we've all seen that is encouraging. I think the fact that we can see - we are looking forward to seeing as those data in the market emerge and then when ZS9 is produced at end of May, we're looking towards the end of the year to including our two players out there to have impact on the market.

(Operator Instructions) Our next question will come from the line of Tim Chiang from BTIG. Your line is now open.

Are you guys counting on just on how enrollments going tepananor IBSC trials right now?

Yes, we are disclosing where we are with enrollment at this stage.

And I guess just to follow up, I mean I know you guys have given a 2017 target for completion of both trials. Is there's anything you could be in terms of a little bit more specific - is this going to be a mid-2017 type of completion you think for at least one of the phase III trials?

Yeah. We haven't been more granular in saying it takes 12 months is what our expectation is for enrollment. So we started the first phase III in October. We expect that in the next 12 months and we've got a QC data then that would be released thereafter.

And I just want to follow up on RDX022, I mean what has to get done between now and the time you that you start the phase III in second half of the year?

Primarily manufacturing that would have be completed.

And I think, somebody asked about the cash burden, but there's really been no change in terms of the guidance you guys have provided in your slides that I think it's what the - I guess there is a range though right. I mean, there's like a $35 million range between the low end and the high end of your -

That's correct. For IBSC, we've said $55 million $80 million to get to an NDA, for hyperphosphatemia, it's $40 million to $50 million and hyperkalemia, it's $40 million to $50 million.

Our next questions comes from the line of Matt Kaplan from Ladenburg.

Sorry, but I dropped on my call a little bit later, but I apologize that this question was already asked. But I guess question for David in terms of the phase IIB trial design for tepananor in the hyperphosphatemia states, what do you hope to show in that study and can you specifically talk about the side effect profile?

Yeah sure. So I think, Matt, we've designed the clinical trial to show two things. Unlike the first clinical trial, which was four weeks long, this one we have an eight-week treatment period and we're - in this clinical trial, we've been looking at three different dose groups, a 3 mg twice a day, fixed dose and 10 mg twice fixed dose, as well as a down titration scheme where everyone's starts at 30 mg b.i.d. and they're allowed to based on GI tolerability titrate to either 20/15 and three. And the - I think we are provoking to show a nice phosphate-lowering effect so of greater than1.5 mg potentially effect as well with the down titration scheme I think we're looking to decrease the discontinuation rate due to the loose stools and diarrhea.

So I think those are the two major things we're looking to get out of here and to point the side effect profile. What is interesting is if you look at our driving capacity to the phosphate binders out there, what we see in a portion of the patients is with loose stool, but we really don't see anything else other than that. Whereas with the phosphate binders out there is nausea, vomiting as well as other GI side effects, so I think we'd like to confirm that also based on our talks with our experts and key opinion leaders, loose stools is actually - the good thing in this sodium in this fluid overload patient population, as well one that aren't limited fluid intake is a highly complicated patient population.

And then just a quick follow up on that that. Can you give us a sense in terms of the progress?

Yeah. We're on track to have the results in the second half of this year.

(Operator Instructions) We'll give it a couple of more minute to see if we have any more questions. All right and at this time, I'm not showing any further questions and I would like to turn the call back over to Mike Raab for any closing remarks.

Thank you, Operator. As mentioned in the press release issued this morning and reiterated on today's call, we've made a remarkable progress in 2015 and we remain to just advancing our product candidates towards registration and approval and this would becoming a fully integrated commercial biotech company focused on gastro-intestinal and cardio-renal diseases.

On behalf of the entire Ardelyx team, we appreciate your support and we look forward to updating you on the status of our clinical program throughout the year.

Thanks again for joining us. Operator you may now conclude this call.

Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program and you may all disconnect. Everyone have a great day.