Hello, ladies and gentlemen. Thank you for standing by and welcome to Ardelyx First Quarter 2016 Earnings Conference Call. At this time, all participants are in 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 the call over to MR. Bill Slattery Jr., Account Manager at Burns McClellan Incorporated who will make introductory comments.

Thank you. Good afternoon and welcome to Ardelyx’s first quarter 2016 earnings conference call. This afternoon, Ardelyx issued a press release providing the details of the Company’s financial results for the first quarter 2016 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 joined by Mark Kaufmann, Chief Financial Officer; Dr. Paul Korner, Executive Vice President and Chief Medical Officer; Dr. David Rosenbaum, Senior Vice President of Drug Development; and Dr. Jeremy Caldwell, Executive Vice President and Chief Scientific Officer. As a reminder, during today’s call, Ardelyx will be making certain forward-looking statements. To the extent that statements discussed on this call are not descriptions of 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 the potential for tenapanor in treating patients irritable bowel syndrome with constipation or IBS-C, the potential for tenapanor in treating hyperphosphatemia in patients with end-stage renal disease or ESRD, Ardelyx’s future development plans for tenapanor and the timing and cost thereof, the expected timing for the receipt of results from T3MPO-1 and T3MPO-2, the two ongoing Phase 3 clinical trials evaluating tenapanor for the treatment of IBS-C, the expected timing for the receipt of results for the Phase 2b hyperphosphatemia clinical trial, the potential for RDX227675 in treating hyperkalemia in kidney and heart disease patients, Ardelyx’s future development plans for RDX227675, the expected for the initiation of the Phase 3 clinical trials for RDX227675, the expected timing for the filing of an IND for RDX98940, and the potential of Ardelyx’s drug discovery and design platform. Such forward-looking statements involve substantial risks and uncertainties that could cause the development of tenapanor, RDX227675 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 the research and the clinical development process and the uncertainties in the manufacture of clinical trial material, including process development, scale up and tech transfer 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 quarterly report on Form 10-Q, filed with the Securities and Exchange Commission on May 9, 2016 and its future current and periodic reports to be filed with the Securities and Exchange Commission. At this time, it is my pleasure to turn the call over to Ardelyx’s President and Chief Executive Officer, Mike Raab.

Thank you, Bill. Good afternoon everyone and thank you for joining us. On today’s call, I will review our recent clinical and corporate accomplishments and walk through Ardelyx’s ongoing and planned clinical activities for the remainder of 2016 and 2017. Mark Kaufmann, our Chief Financial Officer will then provide an overview of the financial highlights for the first quarter of 2016. Dr. Paul Korner, Executive Vice President and Chief Medical Officer; Dr. David Rosenbaum, Senior Vice President of Drug Development; and Dr. Jeremy Caldwell, Executive Vice President and Chief Scientific Officer are also joining me today and will be available to address any questions you may have. We continue to make excellent progress across our late stage programs and execute on our strategic objectives. We also continue to advance our preclinical programs being developed at our proprietary drug discovery and design platform. We anticipate a number of major catalysts throughout the remainder of the year and into 2017. So, this is a very exciting time for Ardelyx. With respect to our cardio-renal franchise, we’re developing tenapanor for the treatment of hyperphosphatemia in patients with end-stage renal disease or ESRD. Hyperphosphatemia is a particularly vexing [ph] independent risk factor for cardiovascular morbidity and mortality in dialysis patients and it remains a significantly underserved market. Even with dietary restrictions and legacy therapies like phosphate binders as reported by DOPPS, we still have approximately 60% of dialysis patients in the U.S. with elevated levels of serum phosphorus. As many of you know, one of the greatest challenges for dialysis patients is the number of pills they need to ingest every day while on a fluid restricted diet. On average, they ingest 15 to 20 pills per day, often including multiple large pills with each meal to manage their phosphorus. This has understandably led…

Thanks, Mike. As usual practice for the Company, rather than review all of the information disclosed in the press release, I would like to focus on a few specific financial highlights. As we’ve mentioned in the past, our burn rate is expected to be in the roughly $25 million to $30 million range over the next several quarters, including both R&D and G&A, resulting from our clinical programs and manufacturing activities. And this guidance has not changed. This quarter, net loss was $23.5 million or $0.70 per basic and diluted share compared to a net loss of $3.5 million or $0.19 per basic and diluted share for the first quarter of 2015. The $23.5 million include primarily $19.3 million in R&D expense and $4.3 million in G&A expense. R&D expense for the first quarter of 2016 of $19.3 million, increased from $6.2 million for the first quarter of 2015, primarily because of clinical development activities as well as clinical manufacturing and process development activities associated with tenapanor and RDX227675. General and administrative expense for the first quarter of 2016 of $4.3 million, increased from $3.2 million for the first quarter of 2015, primarily because of an increase in professional services fees, personnel and public company costs. On the revenue side, in the first quarter of 2015, total revenues were comprised of licensing revenue and collaborative development revenue, both primarily related to the AstraZeneca agreement, which as you know, was terminated in June 2015, resulting in no licensing or collaborative development revenue in first quarter 2016. Our cash and cash equivalents as of March 31, 2016 were $171.7 million compared with $107 million as of December 31, 2015 and the increase was related primarily to the underwritten public offering of our common stock completed in January of this year that yielded approximately $80.8 million in net proceeds, offset by $16.1 million in cash required for operating and other activities.

Thank you, Mark. With that, we would like to now take any questions you may have. And as a reminder, Dr. Paul Korner, Executive Vice President and Chief Medical Officer; Dr. David Rosenbaum, Senior Vice President Drug, Development; and Dr. Jeremy Caldwell, Executive Vice President and Chief Scientific Officer have joined us on today’s call if you have any questions related to our programs. Operator, we’re now ready to take questions.

[Operator Instructions] And our first question is coming from Yigal Yokohama [ph] of Citibank. Your line is open.

Thanks for taking the questions; I guess I had sort of three. Number one, maybe you could discuss a little bit more the features of tenapanor? Do you believe or going to create a drug with first line potential after filling laxatives and that can’t be addressed LINZESS and AMITIZA? And then number two, you could comment a little bit more on your long terms strategy with 022 with regard to potential differentiation or competitive positioning versus Veltassa and ZS-9 as well as thoughts on price potentially? And then last, just a question on whether you’d ever do a study combing tenapanor with a phosphate binder to synergize phosphate lowering as a future development strategy? Thank you.

Sure, absolutely. Thanks for the questions, Yigal. And if we’re forgetting them, please come back on the latest where we’ve forgotten them. First, let me make a couple of comments on differentiation versus laxatives and LINZESS and AMITIZA, their ultimate plecanatide to the market is I think it’s important to note that projects in particular, although constipation might be relieved, pain is not benefited by taking laxatives, the pain continues. It’s important to notice if you look at the overall responder rate for the GCC agonist and it’s even less so for AMITIZA, those drugs mostly don’t work in patients, right? And certainly for GCC agonists, it tends to be that the greatest side effect of that is diarrhea versus what we saw with ours at a 11% rate. Now plecanatide certainly appears to have a similar lower diarrhea rate but there I guess by simply looking at the amount of peptide is taken 3 milligrams versus micrograms, it appears to be a less potent form of what LINZESS is. So, I think the data are going to drive us. I think the trials that I think David and Paul are running, ultimately those data will drive how we differentiate. But we certainly because we’re titratable because we’re an inhibitor versus an agonist that we have other benefits as compared to those molecules. David, Paul, any additional comments?

I think the other factor that you’ve touched on Mike was the fact that this is a completely different mechanism of action whereas the plecanatide and LINZESS are in the GCC agonist that leading two-thirds of the population that are going to take those not getting a good response and then obviously requiring an alternative.

I think your second question, Yigal, was about differentiation of 022 versus other potassium binders, was that right?

Yes, exactly. And just anything you wanted to highlight on what you know so far about the profile and thoughts on price?

Yes. So, pricing, it’s too early to talk about that. I think at least historically the way I’ve dealt with pricing is it’s ultimately the clinical benefit that drives those kinds of strategic decisions and the dynamics of the marketplace. This undoubtedly is an emerging marketplace, and we’re thrilled with AZ’s acquisitions, yes because that’s clearly a group company that is done and we know them well, knows how to build markets as they did with PPIs and Crestor. So, this is a market that needs to be built in. And I think as we’ve spoken before, Yigal, that this is going to be a modest slope in terms revenue growth, I think for all of us. I think we’re fortunate to be 18 to 24 months behind both Veltassa and ZS-9. We are learning from the stumbles that they have made and will make in an emerging market, which tends to be the case when you’re the first ones out, the followers learn. What I can say is from our vantage point taking advantage of background, the people involved in developing the 22 program have been intimately involved with successfully commercializing development polymer. [Ph] So, we understand, both the strengths and weakness extremely well of binders. And mass and pill burden is the biggest issue, and the ability to adhere and tolerate and be compliant to take what you’ve been prescribed when you’re supposed to take it. So, all those things together have gotten us to where we are with 22. And as we’ve also said, we believe what we’ve done, although it allows us to be within the 505(b)(2) pathway that there is a chance with -- what we’re filed with the PTO that there is intellectual property that could issue is that we have improved significantly the…

Yes, just curious, if you would consider a future study after your Phase 2b and hyperphosphatemia if you would think of a strategy to add a phosphate binder to tenapanor to prove the hypothesis that the synergistic effect is really -- would be really beneficial clinically.

I’ll make comments first commercially and then David or Paul can chime if you have any comments. Historically, combo use of binders, although it’s a logical, has been the name of the game. If you look at the majority of patient [indiscernible] use a calcium whether it’s coming over the counter or [indiscernible] So, large percentage of patients which doesn’t make any sense, because they’re just on an exchange for matography resins, you really want to think of it in a simple fashion. Don’t really have an additive or synergistic effect. They’re just replacing an ion-exchange resin for another. I think theoretically, there’s clearly the potential for some additivity activity work that we certainly are interested in doing but that’s also something that naturally is going to occur in the marketplace. So strategically that’s something we continue to debate. So that’s certainly something that we’re interested in and something that our KOLs have asked the exact same questions. David, anything to add?

Yes, I think, what you just said, the end is key. I think people will use our drug in combination with binder. And I think, based on the results that we see, we are thinking about it, but we have to evaluate a little more but it is something that we thought about whole a lot though, Yigal.

And our next question comes from Jason Gerberry of Leerink Partners. Your line is open.

Just quickly, noticed that 022 Phase 3 pivotal you find to fourth quarter of this year, just wondered if may be there was also any updates on the timelines to file the regulatory approval and also wondered if you could comment at all on any updates that you have been gathering from how Veltassa is performing in the market? Thanks.

Sure. So, with regards to your observation about the refinement of the timing, that is something that we have done in the past and we’ll continue to do as we get more comfortable with the timing of different programs, we will narrow our guidance, as we get closer to when we expect data or filings to occur. With regard to Veltassa, I think if you look at their earnings call and what John said, I believe it was Wednesday of last week, they are making progress. And this is a market that needs to be built. By any measure at any study that you look at, we are under dosing RAAS inhibitors and mineralocorticoid receptor antagonists in those patients where we know that we can help them by lowering their potassium. Right now protocols are basically -- don’t include binders or potassium lowering agents. What they tell you to do is first to try a low potassium diet and then they tell you to lower your RAAS inhibitors mineralocorticoid receptor antagonist, which is countering intuitive as well. So, I think what we’re seeing is, them working extremely hard to begin building those -- that knowledge based in the context of both payers, market access and the physicians, between cardiologists and nephrology different uptake that you’re going to see there and they are doing a yeoman’s job in doing so. I think we’ll see, AZ probably come out with a similar approach and try to educate the marketplace of the importance of managing hyperkalemia aggressively and effectively with programs like we have and what they have. So, it’s a big market and I think our advantages as we’ve spoken before across the 3 and across the 4, if you include [indiscernible] is mouth feel, I think we’re better and will be better than all. If you look at what is going to take to have people ingest this every single day to make it work as it should, I think our ability to mask flavors, improve flavors and taste is going to be a differentiator. And if you look at ZS-9, we use calcium; they use sodium as a counter ion; and Veltassa uses some sorbitol and what they’ve chosen in it that’s something we have clearly chosen to stay far away from, given they can package inserts. So, I think we can differentiate ourselves in the market. This is a well-characterized polymer; it’s been around for 60 plus years. And if we get the intellectual property that we believe we will that certainly changes the dynamics quite a bit in the marketplace.

And just quickly, is the expectation to file sometime in 2017?

So, we’ve not disclosed any filing date.

And our next question comes from David Nierengarten of Wedbush. Your line is open David.

Was there any more clarity on the timing for the Phase 3 for tenapanor and IBS-C? That’s my first question. And the second one was, have you guys narrowed down the indications for the IND for 09? Thanks.

So, let me just quickly address the -- I think it’s similar to the other question, David, is that as we get more clarity on enrollment, rates all that kind of stuff, we’ll be providing some more definition around the Phase 3. So, we’re not in a position yet to do so at this stage, hope to assume. I think Paul, if you want to address your thinking, as we look at the myriad of potential applications for TGR5, I think the Phase 1 is going to talk a lot in terms of the PD response. But, Paul, if you want to lay in a little bit in terms of your thinking as we explore this?

Well, I think as you mentioned, Mike, that the potentials you already illustrated in terms of IBD, NASH current filing and then endocrine diabetes side. And I think we’ve not disclosed anything further beyond that point, but obviously we’re looking mechanistically towards indications that could be well-served by this type of agonist and this target.

Maybe are you leading towards a more PCP directed indication or family of indications or leaning more towards rare diseases do you think or somewhere between?

If you look at, if you think about what we’re trying to do in the intro is we’re building a company that has both cardio-renal and GI franchise. But I really think as we look at the data that come out of the Phase 1 in terms of GLP-1 and GLP-2 for that program, it’s going to help drive both our interest and others interest frankly in what the potential is for the program. So we will learn a lot from this Phase 1 trial that will help drive the path that we take for the program.

And our next question comes from Mara Goldstein of Cantor. Your line is open.

I wanted to ask on 675, the lead molecules reflected at RDX022 program. Could you maybe just run through what you think as differentiated features that maybe selected as you read for this program?

Sure. And just to reiterate, I think that’s one of things that we went through with Yigal is I think -- so first of all, this molecule is the backbone, polystyrene sulfonate has been around since for over 60 years and it’s made by the metric ton for water filtration…

No, I apologize, Mike, within in your molecules that you pick; not versus Veltassa or the ZS-9, what is…

Yes, exactly. That’s what I’m getting to. But, the big part of it was 505(b)(2) pathway that allowed us with, second was understanding within the context of 505(b)(2) kind of immensely changes that we could take advantage of to make that molecule 7675 more palatable, smaller, have better flow rates and better overall properties for the patients is what drove us to select that molecule 7675 stay forward. Then on top of that our ability to formulate it, both the flavorings and other things that allow us to make us more palatable and easier for the patients say how much they take, when they should take it to make the difference on the RAAS inhibitors.

Okay. And how long do you anticipate the trial will take to complete on a 505(b)(2) pathway?

I don’t think we disclose specific timeframes in terms of how long it’s going to take. These are pretty straightforward. We’re following some previously gotten pads, if you look at our design from Veltassa, I think we’ll continue to evaluate other types of trials, both longer and shorter depending upon what the market shows. I mean I think it’s one of the benefits of us being 18 months or so behind the others with learning what market access is at and what additional data need to be generated and what’s happening with the market that precedes us.

[Operator Instructions] And our next question comes from Matt Kaplan of Ladenburg Thalmann. Your line is open.

I guess following up on one of the questions in terms of tenapanor and IBS-C Phase 3 studies, can you remind us what your plans are with respect to number of sites that you’ll be enrolling the study in?

Yes. So, what we’ve said is there is approximately -- and you can go onto clinicaltrials.gov website. There is around 100 sites per clinical trial.

And I agues at this point how many sites do you have opened?

Yes, I mean we haven’t said but it’s that that with level to almost fully open all the sites.

And do you anticipate opening additional sites or you’re going to hold it at that level right now?

At this time, I really -- I mean we haven’t really said anything more on that, but clinical trial that…

Matt, the only think I would say to that is David gets it, by the time I call him on this. We will look at everything and ensure that we have all the right sites opened, closed sites that are unproductive, open other sites in due course. So David travels nonstop making sure that these are working as they should. So, in the nature of these sorts of clinical trials, so that many sites, they’re those get closed and new ones that open, as a result to make sure we stay on track.

And any comments in terms of how enrollment is going so far?

It’s on track and it’s early yet in the game, and we will narrow those -- that guidance as we get more comfortable with rates of enrollment.

And then in terms of during 2016, do you expect to have any presence at the upcoming DDW meeting or the AFN meeting in November with respect to data for tenapanor or other products?

Yes. I mean so the answer is yes to both. There will be abstracts and presents both from us and AZ at both meetings.

And then just going back to RDX022 and your lead there, can you remind us again what the Phase 3 trial there will look like?

David.

Yes, sure. So that’s a two-part clinical trial, the first part is a dose escalation for four weeks in which you -- a lot of people of course get dosed to get them into controlled potassium. Those people that respond then go on an eight-week placebo-controlled randomized with against placebo.

And I guess going back to the question in terms of data at upcoming meetings, will you have the, do you expect to have the Phase 2 data at the SN meeting in terms of tenapanor and hyperphosphatemia?

Yes, we have not disclosed any timing of that yet.

I’m showing no further questions at this time. I’d now like to turn the call back over to Mr. Mike Raab, Ardelyx’s President and Chief Executive Officer for closing remarks.

Thank you. And as mentioned in the press release issued this afternoon and we reiterated on today’s call, we remain committed to advancing our clinical and preclinical product candidates towards registration and approval and to becoming commercial biotech company focused on gastrointestinal and cardio-renal diseases. The remainder of 2016 and 2017 will be characterized by number of key milestones for Ardelyx. And I am confident in our team’s ability to achieve our objectives. We look forward to maintaining an open dialogue with you all over the coming months and providing updates on our clinical and preclinical programs. Thanks again for joining us. Operator, you may now disconnect this call.

Ladies and gentlemen, this concludes today’s conference. Thank you for your participation. Have a wonderful day.