Maurice Shani - Business Development Manager Dror Ben-Asher - CEO Ori Shilo - Deputy CEO, Finance and Operations.

Shibani Malhorta - Nomura Scott Henry - ROTH Capital Swayampakula Ramakanth - HC Wainwright Vernon Bernardino - FBR & Co. Ed Woo - Ascendiant Capital.

Thank you. This conference call may contain projections or other forward-looking statements regarding future events or the future performance of the Company. These statements are only predictions and RedHill cannot guarantee that they will in fact occur. RedHill does not assume any obligation to update that information.

Actual events, results or achievements may differ materially from what RedHill projects today.

Additional information concerning factors that could cause actual events, results or achievements to materially differ from those contained in the forward-looking statements can be found in the Company's Annual Reports on Form 20-F and in its other filings with the Securities and Exchange Commission. Please go ahead..

Thank you, Shani, and to those of you who are on our call live, thank you for joining us. We will focus today on selected 2015 operational highlights and the status of our lead programs including the three ongoing Phase III flagship programs for gastrointestinal or GI diseases.

RHB-105 for the treatment of Helicobacter pylori, a bacterial infection in short H. pylori, RHB-104 for Crohn's disease and BEKINDA for gastroenteritis and gastritis. We will briefly mention some of our other development programs including the Phase II programs with YELIVA, our innovative first-in-class oncology and information SK2 inhibitor.

In the coming days following our tradition, we expect to release a more comprehensive semi-annual R&D overview of RedHill development pipeline. But first I would like to refer to Ori for discussion of our fourth-quarter and full-year 2015 financial results announced earlier today..

Thank you Dror, good morning and good afternoon everybody. We’ll provide a short overview of our financial results for the fourth quarter of 2015 and for the entire year. In 2015, we did not record meaningful revenue compared to $7 million of revenue in 2014 from the licensing production of bowel preparation drug RHB-106 to Salix now Valeant.

R&D expenses during the fourth quarter of 2015 were $5 million compared to $3.7 million in the fourth quarter of 2014. R&D expenses for the entire year was $17.8 million compared to $12.7 million in 2014.

The significant increase in R&D expenses were mainly due to the progress in our R&D activity and mainly from the advancement of the two ongoing Phase II trial with RHB-104 for Crohn’s disease and BEKINDA for gastroenteritis and gastritis.

G&A expenses during the fourth quarter of 2015 were $1.7 million compared to $1.1 million in the fourth quarter of 2014. The increase related mainly to one-time expense from business development activity in the fourth quarter of 2015. G&A expenses for the entire world were $4.1 million compared to $4 million in 2014.

Operating loss for the fourth quarter of 2015 was $6.8 million compared to operating loss of $4.8 million in the fourth quarter of 2014. Operating loss for the entire 2015 was $22 million compared to $10.6 million in 2014.

The increase in both periods was mainly due to higher R&D expenses and to the $7 million revenues received from the Salix transaction in 2014. Our operational burn during the fourth quarter of 2015 was $6 million compared to $5.9 million in the fourth quarter of 2014.

The operational burn for the entire 2015 was $17.8 million compared to $12.2 million in 2014. The overall increase was mainly due to higher operating loss in 2015, increasing advanced payments to suppliers, and decrease in accounts payable. Our cash balance at the end of 2015 was approximately $58 million.

Our strong cash position allowed us to continue executing our development plans including the ongoing Phase III studies with BEKINDA for gastroenteritis and RHB-104 for Crohn’s disease, the planned confirmatory Phase III with RHB-105 for H.

pylori eradication, the Phase II study with BEKINDA for IBS-D and several other earlier stage programs mainly in oncology. I will now turn the discussion back to Dror and I will be happy to take questions later on. Thank you..

Thank your Ori. RedHill is focused on development of late clinical study proprietary orally-administered, small molecule drugs for gastrointestinal or GI diseases, inflammatory diseases and cancer.

We are pursuing multiple short-term goal strategy and headed into 2016 with a balanced pipeline including three ongoing Phase III potential blockbuster GI programs and several Phase II stage development programs.

Selected 2016 potential milestones including interim analysis of the RHB-104 Phase III study for Crohn's disease, top-line results from the Phase III study with BEKINDA for gastroenteritis and gastritis, and the initiation of the confirmatory Phase III study with RHB-105 for H.

pylori infection as well as interim top-line results expected in the coming weeks from the Phase IIa proof-of-concept study with RHB-104 for multiple sclerosis or MS Among the 2015 key operational highlights, we are particularly excited about the strong positive topline results from the first Phase III with RHB-105 for H.

pylori infection and the Phase I study with YELIVA for advanced solid tumors. In June 2015, we received positive topline results from the first Phase III study with RHB-105, this was called the ERADICATE Hp Phase III study. The study demonstrated 89.4% efficacy in eradicating the bacteria.

RHB-105 successfully met its primary endpoint of superiority over historical standard-of-care efficacy levels of 70% with very high statistical significance at .001. No serious adverse events related to the therapeutic candidate were noted in the study.

In September 2015, we announced a subsequent open-label treatment of patients in the placebo arm with standard-of-care therapy for persistent H. pylori infection demonstrated only 63% eradication rate with standard-of-care.

These results further support the potential superior efficacy of RHB-105 with nearly 90% eradication in our first Phase III study and validates the use of the historical standard-of-care efficacy threshold of 70% implemented in our study.

A meeting with the FDA is scheduled for early April this year to discuss the planned confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection. RHB-105 is clearly a potential blockbuster.

FDA has granted RHB-105 a Qualified Infectious Disease Product (QIDP) designation under the GAIN Act along for additional five years of market exclusivity in addition to existing exclusivity for a total of eight years market exclusivity.

We also received fast-track development status and priority review status which shorten review times for marketing applications. In addition, FDA has submitted RedHill to pursue with RHB-105 a significantly broader indication than that of existing H. pylori therapies targeting the first-line treatment of H. pylori infection regardless of ulcer status.

Approximately 100 million Americans and over a half of the world's population is estimated to be infected with H. pylori. The worldwide and US market potential for H. pylori eradication therapy was estimated in 2015 to be $4.8 billion and $1.4 billion respectively. Moving onto RHB-104 for the treatment of Crohn's disease.

2016 is going to be an important year for this Phase III flagship drive candidate with interim analysis expected in the second half of the year. The ongoing Phase III program with RHB-104 is potentially a partnering changeup as far the treatment of Crohn's disease is concerned.

We target the potential cause of the disease, the intracellular, Mycobacterium avium paratuberculosis or in short MAP. The Phase III study of course US MAP and it’s the first Phase III study with RHB-104 for Crohn’s disease.

It’s ongoing currently in the US and additional countries as I said with interim analysis expected in the second half of this year after half of the 270 patients that are enrolled in the study will have completed 26 weeks of treatment. RHB-104 is also being explored for the treatment of multiple sclerosis or MS.

In November 2015, we announced that we completed the last dosing and scheduled follow-up visit ahead of interim topline analysis in the Phase III – Phase IIa proof-of-concept study evaluating RHB-104 in patients treated for relapsing remitting multiple sclerosis, RRMS.

This open-label Phase IIa study called CEASE-MS study was designed to affect the efficacy and safety of RHB-104 as an add-on therapy to interferon beta and topline results from this exploratory study is expected that in the coming weeks. Moving on to our third Phase III program with BEKINDA.

Topline results from the ongoing Phase III study called the GUARD study are expected in the second half of 2016.

In October 2015, we announced following a meeting with FDA that ongoing Phase 3 study for gastroenteritis and gastritis may be sufficient as a single study to support the filing of the marketing application for BEKINDA 24 mg for gastroenteritis and gastritis. Subject to achieving sufficiently striking positive results.

In February 2016, we announced the submission to the FDA of the investigational new drug IND protocol for the Phase II clinical study with BEKINDA 12 milligram for irritable bowel syndrome or IBS-D. Plan to be initiated in the coming weeks subject to final preparations.

This randomized double-blind 2-arm parallel group Phase II clinical study is designed to evaluate the safety and efficacy of BEKINDA 12 milligram in patients suffering from IBS-D. The study will be conducted in up to 12 clinical sites in the United States and is expected to enroll 120 patients. Another product we will briefly discuss today is YELIVA.

In March 2015, RedHill and Apogee Biotechnology in short Apogee a privately held US company entered into an exclusive worldwide license agreement for the Phase II therapeutic candidate, YELIVA.

The YELIVA is a proprietary novel first-in- class orally administered SK2 inhibitor with anti-inflammatory and anticancer activities targeting multiple oncology and inflammatory GI diseases, clearly a potential blockbuster.

In October 2015, we announced positive topline results from the Phase I study with YELIVA in patients with advanced solid tumors. The study successfully met its primary and secondary endpoints providing key formation about the drug safety, toxicity, pharmacokinetics and pharmacodynamics supporting the ongoing planned Phase II study with YELIVA.

In June 2015, we announced the initiation of a Phase II clinical study in the US to evaluate YELIVA in patients with refractory/relapsed diffuse large B-cell lymphoma, DLBCL. The study is funded primarily by a $2 million grant awarded by National Cancer Institute, NCI to Apogee.

A Phase II study with YELIVA for the treatment of refractory or relapsed multiple myeloma is planned to be initiated during the second quarter this year. The study will be conducted at Duke University and it's supported by $2 million grant from the National Cancer Institute awarded to Apogee in conjunction with Duke University.

A third Phase II study is planned to evaluate YELIVA as a radioprotectant to prevent mucositis in cancer patients undergoing therapeutic radiotherapy. The last product we'll discuss today is RIZAPORT for migraine.

In November 2015, RedHill and its partner, IntelGenx Corp, announced that the Federal Institute for Drugs and Medical Devices of Germany, BfArM, granted marketing authorization for RIZAPORT, formerly called RHB-103. RIZAPORT is an oral thin film formulation of rizatriptan for the treatment of acute migraine.

The national approval of RIZAPORT in Germany was granted under the European Decentralized Procedure, DCP, in which Germany served as the reference member state. This marketing approval is the first national marketing approval of RIZAPORT.

In February 2016, the USPTO, Patent and Trademark Office issued a Notice of Allowance for a new patent covering RIZAPORT, which is expected, once granted, to be valid until 2034. RedHill and IntelGenx continue to work together to secure commercialization partners for RIZAPORT as well as secure FDA marketing approval in the U.S.

We continue to pursue extensive corporate development activities in relation to both vertical integration for acquisition of commercial assets in the United States within RedHill specially focused on GI and inflammation and we also continue to pursue partnership for commercialization of some of our products through out-licensing.

In relation to out-licensing, we are taking particular care to ensure that our future pharma partners and transaction terms are the right ones, providing the best possible home for our products, maximizing generation of shareholders value from RedHill late clinical stage assets.

To sum up, in conclusion, we headed into the fourth quarter of 2015 with plenty of catalysts in the horizon and balance pipeline. Heading into 2016, we have three Phase III stage programs targeting important GI diseases; all of these phase III assets being potential blockbusters.

Planned 2016 milestones include generation of new data from our Phase III studies with RHB-104 for Crohn's disease and BEKINDA for gastroenteritis and gastritis as well as the initiation of a confirmatory Phase III study with RHB-105 for H. pylori infection.

This positioning reflects both our strong and continued commitment to addressing strong unmet medical needs as well as our [indiscernible] risk mitigation strategy.

Following our July 2015 public financing, we are backed by strong US healthcare institution and investors and maintain a strong balance sheet with $58 million in cash and no debt in the end of 2015.

This allowed us to continue to aggressively execute our plans including further positioning RedHill as an emerging integrated specialty pharma focused primarily on GI and inflammation markets in the United States. Again, in the coming days, we expect to release the semi-annual R&D overview of our development pipeline. So please stay tuned.

I will now turn back to Benoit and we will be happy to take any questions you may have..

Thank you, sir. [Operator Instructions] We're now going to take our first question from Shibani Malhorta from Nomura. Please go ahead. Your line is open..

Hi. Thank you for taking my questions. I've just got two.

The first one, as you go into discussions with the FDA for the trial design of 105, can you just talk about what your expectations are going into this discussion in terms of whether or not you think the agency is going to want a factorial design and how many arms and what the study could look like, what is your ideal sort of outcome from this meeting, if you could just talk us through that.

And then second, Dror, you talked a lot about your commercialization plans and you've mentioned again today publicly about the possibility of acquiring disability, vertical integration, is this -- how much of a focus is this for the company and have things changed, given the asset pricing that we're seeing in this market, are things looking more attractive, are there many opportunities for you at this stage? So those are my two questions.

Thank you..

Thank you, Shibani. With regard to RHB-105 and the plans, confirmatory Phase III study, our plan going into FDA is to seek a head-to-head study against standard of care. Given the results we had in the recent Phase III study as well as the previous Phase II study that was conducted, we feel very comfortable with that kind of approach.

Regarding factual design, we will supply FDA with everything that's needed. If FDA will want us to have a factual design arm, sales arm, that's of course fine, we have to do what the agency requires, we are not too concerned either way, because the study is not going to be particularly long, nor is it an expensive study in pharma terms.

Did I answer that question, Shibani?.

I guess you did, but what are you looking at right now for the, what you think is standard of care, has it changed over the time.

I know we speak to about it every few months but as you go in, what are you hoping the agency is going to look at the standard of care?.

There is no new therapy approved for the last decade or so. So we're still looking at PPI plus either clarithromycin or metronidazole plus an additional antibiotic could be amoxicillin, so we’re talking about [indiscernible] in general, a triple therapy, we do not think there is a big question about that and we assume that's what's going to happen..

Okay.

So you see low risk of a high dose amoxicillin study?.

I don't see it as a particularly meaningful risk, because we think we know what PPI plus amoxicillin success rate in eradication of H. pylori is in the United States. So we don't see it as a significant risk. If we have to do it, we are of course open to it and we will do it..

Okay.

And then my question on commercialization capabilities?.

Yeah. It's very much focused, increasingly so and you rightly mentioned the timing, the timing is very good. It fits within RedHill's traditional history. We were founded at the very height of the economic crisis, when there was a perfect storm around us, the current weakness in the biotech sector plays very well again into what we know and like to do.

And we're very much looking forward to complete the acquisition of commercial assets in the United States within our therapeutic focus of GI and inflammation. We think that's where the greatest value is for our shareholders..

Great. Thank you so much. Really appreciate it..

We're now going to take our next question from Scott Henry, ROTH Capital. Please go ahead. Your line is open..

Thank you and good morning.

I guess for starters, going into 2016, just wanted to get a sense of spending levels as we model out the year, I would assume G&A trending upward, but the bigger question, R&D, there is a lot going on, I mean is 25 million a good number, that's where I was thinking, I was just hoping to get some color on that?.

Yes. Hi, Scott. G&A actually went up only in the last quarter and it was one-time expense, but if you take the yearly rate, you will see that 2015 was exactly like 2014. In terms of overall cost, we anticipate more or less about $6 million per quarter..

Okay. So $6 million a quarter overall for 2016..

Yeah. Maybe going up a little bit once we start the second Phase III with 105, but please for the first two quarters, that would be the -- right now, it’s more or less the same like in the last quarter..

Okay, great. Thank you. That's helpful.

And then when I look at the pipeline, just a couple of questions, in terms of products, the first one RIZAPORT, would you expect to have any revenues in 2016, either from the Europe or the US or is that more of a 2017 revenue generator?.

Scott, it’s Dror here. Hi. The short answer is we do not know, because it depends on commercialization. We are aiming to provide potential partners with clarity on the timing of the likely FDA approval. And that should hopefully expedite the partnership deals that we've been trying to do for quite a while.

So the short answer is, we just don't know whether we'll strike that partnership this year and the coming month or early next year..

Okay, fair enough.

And then RHB-106 with Valeant, I think in the past, the guidance has been a 2018 launch, I mean is that still viable as the calendar keeps ticking away, are there any signs of that product being in the clinic yet?.

We cannot speak for Valeant because they're a public traded company and it's not our product anymore. However, we are working with Valeant, we are assisting them as much as needed. Initially, I believe when Salix acquired the product, they spoke about 2017 launch, 2017 is not realistic now.

Whether or not 2018 is realistic is for Valeant to announce to the market..

Okay. Fair enough.

And then the final question, in terms of out-licensing some of your assets, partnering some of your assets, what is the timeline for that, I guess put another way, would you be surprised if you didn't do some sort of out-licensing deal in the next six months, I mean just trying to get a sense of expected timing for that?.

We have already declined, Scott, seven proposals for various RedHill programs -- products. And what guides us the most is that we have three Phase III assets in GI, all of them we believe are potential blockbusters. We do not believe that it is in our shareholders’ best interest to give those away easily.

And we are making sure that we are maximizing the value, the terms, the quality of the partner and when we feel sufficiently comfortable about all that, we will do a deal.

And then to remind you also that we are perfectly happy to co-promote our products, those products which we believe are potential blockbusters in the US two, three years from now by ourselves along with somebody. We keep that option. We are working towards that option to build our own capabilities.

We have time, we have the resources and we are very serious about maximizing the shareholder values and not doing anything rushed, just to apiece the short term interest of the market..

Okay, great. Well, thank you for taking the questions..

Thank you, Scott..

We are now going to take our next question from Swayampakula from the company HC Wainwright. Please go ahead, your line is open..

Good afternoon, Dror. How have you been? Few questions. The first one being on RHB-105, we know that you are going into the meeting with FDA in April.

Is one of the discussion points in that meeting going to be indication and a specific indication that you are looking for and also all would this meeting kind of work similar to having an SDA, [ph] instead of having an SDA you just want to INR [ph] everything that you can in this meeting in terms of the study.

And lastly within RHB-105, once this meeting is done, how long will it take for the management to get everything together and get the study going?.

Thank you. With regard to the indication, we have announced publicly repeatedly that we are aiming for H. pylori infection as such as our indication regardless of out of data. So why is that? It’s because following a couple of years’ discussion with FDA, the FDA has told us so in writing.

Now that this means that we are absolutely sure this will be our indication and it’s larger and broader than existing treatments. One can never be sure with regulatory agencies and we will not be sure until the drug gets approved and labeling discussions are over. But that’s the current situation. We are looking for H.

pylori infection as our own label indication based on what we know so far which by the way reflects existing medical practice in the United States. With regards to the talk to approval, we are certainly hoping to get out of the meeting with a clear path to approval.

We think we have shown strong results in our first Phase 3 study consistent with the previous Phase 2 study. And we are designing the next Phase 3 study as a confirmatory study. So we certainly hope for the study to be a study that supports approval registrational study.

With regard to your third question, how long will it take us to initiate the confirmatory Phase 3 study following the April meeting, we have been working towards to that study for a long time where we have been manufacturing for years and doing many other things.

And we expect to be able to launch the study not long after the FDA meeting probably around midyear. I hope I answered your question, RK..

Okay, thank you very much.

On the 104 program, regarding the MAP EU study when is that study planning to get started and would the design of the MAP EU pretty much look like what is on the US study? And in terms of the diagnostics that you are working on, would that be ready for commercialization as you are getting the MAP studies done?.

Thank you. This is a very important year RHB-104 for chronic disease, because we are going to generate data, Phase 3 data from this paradigm-changing drug for chronic disease. MAP EU is second Phase 3 study that we have been planning and preparing for a very long time.

To refresh your memory, we also have – we already have clearance to commence the study in some European countries, several European countries. However, we have not pressed the button yet and the main reason is related to what you said, the design.

We want to be sure that the design that we are going to follow in Europe is as supportive as possible for future registration. So it’s a little bit chicken and the egg situation in that. The more we learn from the ongoing Phase 3 study, MAP US, the more we will implement in the MAP EU, the second Phase 3 study primarily in Europe.

We did not provide timing. Again, we have the clearance already to commence in Europe. We have the clinical trial material that we need for this study to commence it. We have the CRO, we have pretty much everything we need. It’s out decision which we will announce in due course.

It has to do primarily with ongoing process of learning from the ongoing Phase 3 study in the United States. With regard to diagnostics, yes, we have been in it for a long time with Quest Diagnostics, if you know. We are making meaningful progress in coming up eventually with companion diagnostics for MAP.

There is none that exists that is FDA approved, not even validated, but our intention is to achieve that and we have made a significant progress in doing just that with Quest Diagnostics and continue to do so..

Okay. And then within the MS indication, the CEASE-MS Study, we are expecting top line interim analysis there as soon as – as you said.

And also you have always been saying that MS is something that is for other folks to continue development and not for RedHill, so would this interim analysis data be sufficient to start a dialog with potential partners are or you need to wait for the study to complete to start the discussions?.

Thank you. It’s a bit premature to discuss the partnership strategy for the MS indication. We first need to know the results, announce the results and then consider it based on the strength of the results and also taking into account that our lead indication is Crohn's where we have much more data.

It’s not and think of it as we eventually do some split indication and so on, but it is somewhat premature. I will just add that we have been doing early stage development of RHB-104 for additional autoimmune diseases, including RA and others. .

Okay. The last question from me is on the RP101 which is the new molecule that you introduced recently.

What’s the strategy there, because this is not an indication that RedHill normally works on especially it’s not GI inflammation, it’s pancreatic cancer, so what’s the expectation should be for the development of this molecule in the hands of RedHill..

Thank you. I am glad you asked about that. In 2014, we acquired two orally administered small molecule MCs in the United States for oncology, both of them are acquired from German companies. One of them is RP101 which you just mentioned and the second is MESUPRON. Both of them underwent numerous clinical studies in hundreds of patients.

So we are talking Phase 2 stage assets here.

However, we felt that based on developing science and based on the clinical data that we have studied thoroughly for both programs, we should go back to preclinical studies, better define the molecular targets, better define the patient population we should be going after and better define the combination we need to go with in the case of RP101, which is administered together with chemotherapy.

Specifically about RP101, we have been conducting for a while now a large scale program, preclinical program. We announced publicly that we expect to commence to complete it during the first half of this year.

Once it’s completed, assuming it’s successful, our plan is to go back into the clinic, probably into a Phase 2 in high unmet oncology disease needs where we think we can bring value. Again, this would depend on the strength of the results and on regulatory discussions in the US and in Europe regarding these assets.

One last note about it is that we feel it is very much with RedHill’s focus because those are indeed MCs, but they are orally administered small molecules with a lot of clinical data that we were able to acquire under very favorable terms and this kind of indications in oncology tend to receive a lot of government and other support as we saw happening with [indiscernible]..

Thank you, Dror. Thank you very much for taking all my questions..

Thank you, RK..

We are now going to take our next question from Vernon Bernardino from the company FBR & Co. Please go ahead. Your line is open..

Hi, Dror, and how are you? Congratulations on the progress in 2015 and thanks for taking my question. Just wanted to follow up on some questions already asked earlier.

Regarding the confirmatory Phase 3 study with 105, do you expect – you already mentioned some things about the design - you expect the design to be very similar or exactly the same or slightly different from the Phase 3 that was completed?.

It’s going to be very different, because previous Phase3 study that we successfully completed midyear 2015 was again historical standard of care. The meta-analysis that we have looked at has shown roughly 70% eradication with standard of care.

So that’s what we assumed as the control arm in our study, because our study was against placebo and we used historical standard of care as the control.

Remind you again that in our study placebo patients that went on to standard of care first line therapy only achieved 63% eradication whereas RHB-105 in our study achieved approximately 90% eradication, and that’s hardly surprising.

The confirmatory Phase III study we are in, that is different and we are looking to do a head-to-head study against standard of care, treatment therapy, so the control arm should the treatment therapy, standard of care, with or without a sales arm, which is structurally design arm that Shibani asked about earlier, either way we are comfortable. .

Okay.

So then do you anticipate the results with 105 need to be the same such as 90% or close to 90% or just better statistically versus the current standard of care?.

We have not fairly disclosed the statistical plan or the exact endpoint and so on, but it’s going to be freakish time in a sense that we need statistical significant of superiority over standard of care. In the previous Phase III study that was achieved big time. We hope to do so again, we repeat it in the confirmatory study against standard of care. .

Okay, thank you.

And moving on to one of our – you mentioned or RK mentioned that you had guided to perhaps just partnering 104 in MS, would you just be able to do that, or would you have to actually partner out 104 as the whole indication portfolio?.

It’s pretty much well known because the main goal of the MS program and additional early stage autoimmune exploratory programs was to increase the value, potentially increase the value of RHB-104 in the eyes of potential big pharma partner because RHB-104 may or may not be effective in non- Crohn's indication.

But by far the most important indication and the most advanced is Crohn's. Crohn's will be the main factor in deciding of our partnership. Hopefully, as a low-cost, we are able to increase the value of the full package for pharma partners by doing those exploratory autoimmune disease studies. .

Okay. Thank you.

And moving onto 102 BEKINDA, regarding the oncology support strategy, can you talk a little bit more about that how data from ongoing studies are maybe used?.

Oncology support is the fast and important for BEKINDA and the reason is the oncology support is an existing indication for ondansetron or the active ingredient. By far more important are the new indications for gastroenteritis and IBS-D.

We feel that they are far larger and BEKINDA can be unique in those indications as the very first of its class indicated on label for this indication. Oncology support, we are in Phase III because not doing [ph] oncology support is something that just wouldn’t make sense. It’s the existing indication.

We were in line to some extent, still are relying on PK program as opposed to efficacy study. In the US, we said long ago that FDA was not open to that, at least so far. In Europe, we are still hopeful and are still trying and in discussions with European Regulatory Agencies, several of them, and hope to have a clear answer.

Either way it’s not the most important and not even the second most important indication for BEKINDA as we see it as far as the value for the shareholders who are concerned. We hope to be able to get approval at least in Europe with PK program without having to do efficacy study in oncology support.

If we have to do efficacy study in oncology support, we will actually support on whole, see what is happening with gastroenteritis and IBS-D where we are doing efficacy studies and we consider them. .

Okay. Terrific, I find that interesting in the US because ondansetron from time to time in short supply. Moving onto 103 RIZAPORT, already has been discussed as far as commercialization partners.

Just wondering if you could talk about the status of securing commercialization partners specifically?.

Sure. I mentioned earlier that we are already declined proposals for some of our products. RIZAPORT is a non-core product, a legacy product in a way because its CNS or pain indication for migraines. Whereas RedHill for a very long time now is focused as we are on GI inflammation and to some extent oncology.

Nevertheless it’s a very important program and the reason is that is our most advanced program. We have validated our ability to get the product approved first in Europe, but we are certainly aiming to get an approval in the US as well, and it can generate revenues for us.

The most [Technical Difficulty] as far as FDA approval, the more likely that we would be able to secure the right type of deal for commercialization with local or territorial [ph]. We are putting a lot of efforts into making sure that RIZAPORT will get approved in the US as soon as possible.

Without going too much into details, it has to do with a lot of operational decisions that we have taken, but this is largely behind us. We hope to get approved in the United States and once this path is cleared, [indiscernible] strike a right deal over RIZAPORT..

Terrific. Thanks for taking my questions and congratulations again on the progress. Looking forward to more in 2016. .

Thank you, Vernon. .

[Operator Instructions] We now move to take on next question from Ed Woo, Ascendiant Capital. Please go ahead. .

Yes, thank you for taking my question.

With the recent disruption in, obviously the market valuation for a lot of these biotech companies, do you see yourself possibly adding to your product pipeline?.

Thank you, Ed. It’s a great question. Development pipeline, expanding the development is a low priority, although we keep seeing opportunities, this is a low priority. We have handful assays, our R&D team is extremely busy and executing on the numerous programs that we are pursuing. So it wouldn’t be the right thing to do.

However, as far as acquiring commercial assets is in GI inflammation space. In the United States, this is a high priority, and why is that? It’s because we think that it is our shareholders’ interest for RedHill to have the capabilities.

Once our GI Phase III programs reach maturity and get approved to launch or co-launch at least some of them by going into loan or co-promotion.

We think this makes a big difference between remaining a purely outlicensing development company and becoming a truly furious specialty pharma company in the United States and there are very clear examples of zones that strike it very big for our shareholders by doing the latter.

By focusing on specialty market and launching or co-launching their own products. And there are many examples to the contrary where our companies will have gone for fewer outlicensing model may have done very well, but they sort of encounter exactly in their ability to grow their company.

And once they decide to grow their company, it may take several more years before they can actually do it.

We have decided to pursue a specialty pharma model as for now [ph], and when we are advancing with our Phase III programs in GI to look and acquire commercial assets in the US, which we can deploy commercially, learn by doing and establish our commercial operation team in the United States, which we have been busy doing..

Great.

In terms of that strategy, when would you think you would actually establish that or make acquisition to acquire these assets, would it be after you get FDA approval or would you see it before that you will ready right on for approval to launch these products?.

It’s a high priority for 2016 to get going as quickly as possible as commercial assets in the United States. We are committed to doing it very carefully, gradually without jeopardizing what we have built and immense value we see in our development programs. We are not going to jeopardize everything we have built.

We are going to continue to do everything carefully gradually, pay the right price for our assets we are acquiring. And in that respect, the timing and the weakness in the biotech sector is actually excellent for us. .

Great. Well, thank you and good luck..

Thank you, Ed. .

We are now going to take our next question from Scott Henry (ROTH Capital). Please go ahead, sir. .

Thank you for taking the follow-up. Just a quick question, I don’t know if you gave clarity on it. But the GUARD study, should we be thinking about that in late 2016 or just wondering the timeline I had expected it to be in the fourth quarter, but I think you indicated second half.

Any color or thought what could move that timeline?.

We mentioned the second half, the study is ongoing, it’s a Phase III study, 320 patients all of them in United States. We recently doubled the number of sites, total number of sites for the study to expedite recruitment.

And in the coming months, we will provide more clarity on the exact quarter or maybe even the exact month that we expect to complete the study and come up with the topline results. .

Okay. Thank you for that additional color. .

So, as there are no further question in the queue, I will now turn the call back over to your sir. .

Thank you very much [indiscernible] and thank you to all listeners. We greatly appreciate the interest in RedHill. We do not take it for granted. We remain available to answer any of your questions, shoot us an email or call us, you will find us very responsive. And have a great day..