Dror Ben Asher - CEO Ori Shilo - Deputy CEO, Finance and Operations Guy Goldberg - Chief Business Officer.

Scott Henry - Roth Capital Vernon Bernardino - MLV Ramakanth Swayampakula - H.C. Wainwright.

Good day and welcome to the Redhill Biopharma 2014 Fourth Quarter and Year End Financial Results and Business Highlights Conference Call. At this time, I would like to introduce to the conference, Redhill’s CEO, Mr. Dror Ben Asher and Mr. Ori Shilo, Deputy CEO, Finance and Operations. Before we begin, we will read from Redhill’s Safe Harbor statement.

Please go ahead..

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 report on Form 20-F and in its other filings with the Securities and Exchange Commission..

Thank you, Serge and Guy and to those of you who are on our call live. Thank you for joining us. Today, we will review the status of our lead program as well as several important events that took place in the last quarter 2014. I will also refer to upcoming corporate events and milestones with emphasis on important short term events.

But, first I’d like to refer to Ori for discussion of our fourth quarter and full year 2014 financials announced earlier today..

Thank you, Dror. Good morning and good afternoon everybody. I will provide a short overview for our financial results for the year of 2014 and we will be happy to take questions later on.

In 2014, for the first time we booked meaningful revenues of $7 million mainly from the licensing transaction of our bowel preparation drug RHB-106 to Salix Pharmaceuticals back in February 2014. In terms of operational activities during the fourth quarter, R&D expenses were $3.7 million, compared to $2.6 million in the fourth quarter of 2013.

For the entire year, we had meaningful increase in R&D expenses to around $13 million compared to about $ 8 million in 2013. The increase is mainly due to the three ongoing Phase III trials with RHB-105 for H. pylori RHB-104 for Crohn disease and BIKANDA for gastroenteritis and gastritis.

G&A expenses during the fourth quarter were approximately $1.1 million compared to $900,000, in the fourth quarter of 2013. For the entire year G&A expense were about $4 million compared to $2.7 million in 2013. The increase was mainly due to the increase personnel and share-based compensation and professional fees.

We anticipated seeing more or less the same limelight of G&A expenses during 2015. Operational loss for the fourth quarter was $4.8 million compared to $3.5 million in the fourth quarter of 2013 mainly due to higher R&D expenses. For the entire year operational loss was $10.6 million compared to $10.8 million during 2013.

The operational loss in 2014 drives mainly from higher R&D expenses offset by the $7 million revenues from the Salix transaction. In terms of cash position, our burn rate in the fourth quarter of 2014 was around $6 million, mostly related to increase in R&D activities and advanced payments to service providers.

Our cash position at the end of 2014 remains strong about $23 million in cash without debt. In February 2015, we have successfully completed our shares public offering in the U.S. raising a total of $14.4 million with the participation by prominent investors.

At closing, we now have over $34 million in cash with no debt which should allow us to continue executing our R&D and business development plans, including the three ongoing Phase III trials. At this point, I would turn the discussion back to Dror. Thank you.\.

Thank you, Ori. To refresh your memory right here, we are primarily focused on development of late-clinical stage proprietary orally administered treatment for gastrointestinal and inflammatory conditions including cancer.

In accordance with our multiple short-term goal, risk mitigation strategy and our primary therapeutic focus in inflammatory and gastrointestinal diseases, we are currently conducting in parallel three Phase III studies in the United States as well as other countries. The first is RHB-105 for H.

pylori infection eradication with top-line Phase III data expected in the second quarter of this year position us around the corner. RHB-102 and other Phase III study is indicated for the treatment of gastroenteritis and gastritis.

We recently announced the drug is currently being called BEKINDA, but we keep using both names BEKINDA and RHB-102 in order not to confuse anybody. Top-line Phase III data from that study is expected in the first of this year and we also have Phase III study running with RHB-104 for the treatment of Crohn’s disease, also largely in the United States.

So, we currently have three Phase III studies running in the U.S. with three different products in three different gastrointestinal disease indications. In accordance with our multiple short-term goal strategy. The first near-term major milestone, we are expecting is generation of top-line Phase III data with RHB-105 for the treatment of H.

pylori infection. This deserve some additional discussion, the Phase III study is called eradicate H. pylori. And H. pylori infection is a major cause of chronic gastritis, peptic ulcer disease and gastric cancer.

It has recently been named a qualifying pathogen by the FDA under the GAIN Act, which is intended to encourage development of the new antibiotic drugs for the treatment of serious or life-threatening infections. In fact approximately, two-thirds of the world population is infected with H.

pylori and over $3 million patients are treated annually in the United States to eradicate the H. pylori. With potential market estimated by Redhill in the U.S. it’s about - up to $1.5 billion. So, we are talking about a large scale infection that affects large portions of the population both in the United States and the rest of the world.

In November 2014, we announced that FDA has granted RHB-105 the QIDP status under the GAIN Act. Well this means basically is that RHB-105 is eligible for additional five years of market exclusivity in addition to existing exclusivity, which we have only three years. So total of eight years market exclusivity.

Fast-track developments status and our priority review the new drug application once filed. We had also announced earlier in 2014 that FDA has permitted Redhill pursue with RHB-105, a significantly broader indication than that of existing H. pylori therapies. Accordingly we are targeting this first line treatment of H.

pylori infection regardless of ulcer status, meaning that we do not need to know whether the patient has ulcer or not for the patient to fall under the label. Again we expect to generate top-line data from our H. pylori Phase III study with RHB-105 in the second quarter of 2015 and obviously this is a major event for the company.

Moving on to another important near-term milestone, this one with BEKINDA or RHB-102. To refresh your memory BEKINDA is our once-daily oral ondansetron, it’s an antiemetic drug and we have the only once-daily extended-release oral formulation.

In December 2014, we announced first patient in the Phase III study of BEKINDA for gastroenteritis and gastritis. The Phase III study is called the GUARD study and it is ongoing in the United States.

It’s randomized, double-blind, placebo-controlled, parallel group Phase III study, which will enroll 320 gastroenteritis and gastritis patients in the U.S. both adults and children over the age of 12.

Acute gastroenteritis is an inflammation of the gastrointestinal tract causing nausea and vomiting with a potential worldwide market estimated to $650 million. It’s approved for marketing by FDA; BEKINDA is expected to be the first ever 5-HT3 antagonist drug indicated for acute gastroenteritis.

Again we expect top-line data from this study in 2015 meaning that it’s another near-term milestone.

I would like to add that we have filed a marketing application with BEKINDA in Europe for oncology support indications, chemotherapy and regular therapy induced nausea and vomiting and we expect the regulatory feedback from the U.K MHRA, the U.K equivalent of the FDA in the second half of 2015.

With regard to our third Phase III gastrointestinal drug, RHB-104 for the treatment of Crohn’s disease obviously, one of our flagship product. The Phase III MAP U.S. study continues with approximately 70 clinical sites already up in running and enrolling in the United States, Canada and Israel.

Our team continues to work closely with the CRO, the sites and many other service providers involved in the study, as well as with the Crohn’s and Colitis foundation of America, CCFA on campaign promoting the study among the Crohn’s patients population.

The total number of planned clinical sites have been increased to up to 120 and we also added Australia, New Zealand and Europe for additional sites. The number of patients in the MAP U.S. study has been increased from 240 to 270 to account for potential drop outs.

And we also allow patients own anti-TNF therapies such as Remicade, Humira to be included in the study if they qualify. The idea here is to increase the potential pool of patients, potentially eligible to enter the study that expediting recruitment. We’re looking to provide further details about the Phase III MAP U.S.

Crohn study next quarter as we continue to learn more about the over recruitment pace and likely interim analysis and study completion time.

It is also important to note that RHB-104 is being developed for multiple sclerosis with the recruitment of patients in the ongoing Phase II proof-of-concept study close to completion and top-line interim Phase II results expected in the second half of 2015, which is another important near-term milestone for the company.

With regard to RHB-106, the encapsulated bowel cleanse that we have out-licensed to Salix Pharmaceuticals roughly a year ago. And here is another important short-term milestone, because Salix will commence clinical study in the second quarter or third quarter of this year.

To refresh your memory, we have out-licensed the drug to Salix in addition to several associated rights and received upfront payment of $7 million around a year ago, Salix are ready to pay an additional $5 million in subsequent potential milestone payment linked to development progress.

As well as tiered royalties on net sales ranging from low single digits up to low double digits. Salix publicly estimates the it’s encapsulated bowel prep prescription share outlook at 20% of the markets and annual revenues of $280 million in peak year.

We also continue our extensive builds, development activities in relation to partnerships for commercialization of some of our product and we continue to explore potential acquisition that fit our focus on development and commercialization of orally administered proprietary late clinical stage gastrointestinal and inflammation related conditions, including gastrointestinal concept.

To sum up, we headed into the year 2015 with a balanced pipeline including three ongoing Phase III program and two products for which three marketing applications have been filed. As well as a number of early stage development program reflecting our continued commitment to addressing unmet medical needs.

We have a strong partnership in place with an industry leader Salix Pharmaceutical for another GI gastrointestinal product RHB-106. We are backed by strong healthcare investors and maintain a strong balance sheet allowing us to execute on our plans. I will now turn back to Serge and we’ll be happy to take any questions you may have..

Thank you. [Operator Instructions] We will now take our first question from Scott Henry of Roth Capital. Please go ahead, your line is open..

Thank you. And good morning, couple of questions.

First, I thought I heard you mention the RHB-104 trial wouldn’t allow patients on kinase inhibitors into the trial, is that a new amendment to the trial? And, do you have any concerns how that could - make the data more challenge to interpret?.

Thank you, Scott. It’s a very good question indeed in January we announced a new amendment and that amendment includes anti-TNF patients some of them not all of them, those who qualify. And we are talking about anti-TNF failures to be clear and only Remicade and Humira.

The idea here was to increase very significantly the patients pooled of those potentially eligible for the study thus expediting recruitment.

Did I answer your question?.

Yes. I appreciate that color that’s very helpful.

And then, any thoughts on, spending levels for 2015, G&A should be pretty straightforward, but how should we think about R&D?.

So we haven’t provided any guidelines about expenses, but basically as we said G&A will stay more or less the same. In terms of R&D, we anticipated some increase, but not the very meaningful one. And we feel very comfortable with our cash position that will take us deep into 2016..

Okay, perfect.

And final question, any thoughts on the partnership front, what should we be thinking about as far as, I know you are working on RHB-101, but how should we think about the partnership front over the next kind of 6 to 12 months?.

Right, this is one of most important tasks; right now the most important item here is the divestment of non-core assets. All other non-core assets, the non-core assets are those that are not within our therapeutic focus of GI and inflammation. And those are specifically RHB-103 RIZAPORT for migraine and RHB-101 which is a cardio drug.

RHB-101 is a legacy drug, we have recently announced last month, we announced that we are in discussions for both of these product for out-licensing, which we hope to complete in the first half of 2015.

So this is the highest priority, obviously discussion on other product, but Redhill is in the fortunate position that we are able to complete our Phase III studies with our existing results, resources and as time goes by obviously the value of the assets keeps going up.

So we are in no rush to out-license everything else and so there is obviously in track..

Okay.

And I guess the final question, 106, obviously a lots going on with Salix, any preliminary thoughts on if they will have any impact at all on that program?.

Redhill has been working with Salix closely before and after the transaction. They have been great partners and continue to be great partners. We are not aware of anything that should be reported at this point.

So there is really nothing to add to what is publicly available information, which is the acquisition, the planned acquisition of Salix by Valiant..

Okay, great. Thank you very much for taking the questions..

Thank you. We will now take our next question from Vernon Bernardino of MLV. Please go ahead, your line is open..

Hi, gentlemen and thanks for taking my question. Congrats on very productive and fantastic 2014.

Just I had a few questions on 104, regarding the interim analysis, what kind of data should we expect from the interim analysis?.

Good morning, Vernon. Both safety which is obvious and fertility analysis under the charter of the data and safety monitoring board will be - will be on up..

Okay.

Have you disclosed or do you planned to disclose the statistical plan, powering into one of 104?.

We have not publicly announced the statistical plan yet, no..

Okay.

Moving on to the - what are the plans still for commencement of Phase III in Europe?.

We enter operations for Phase III in Europe, we have a lot happening on that front, but nothing that we should report immediately. You can expect later in the year to see developments on that front..

Okay, terrific. Just wanted to get an update there.

And then, I’m sorry if I missed that I missed this number, you had mentioned that you had increased the target number of patients to enroll, what was the number again?.

We have increased the number 240 to 270..

270, okay. And let’s see that’s really I had from my question, congrats on being well positioned to complete these three Phase IIIs, looking forward to the rest of 2015..

Thank you, Vernon..

Thank you. [Operator Instructions] We will now take our next question from Ramakanth Swayampakula of H.C. Wainwright. Please go ahead, your line is open..

Good morning, Dror, and thank you very much for taking my call. This is regarding RHB-104 and your announcement in January. So within that announcement you also talked a diagnostic that you’re trying to put together along with the help of Quest Diagnostics.

Could you please give us a little bit more color on this, on the diagnostic in the term - terms of like PAL, what kind of a test is that, is it like a PCR or - what kind of a diagnostic is this from that?.

Thank you, RK. It’s an interesting question, the companion diagnostic development with Quest has seen an interesting development recently following meeting with FDA that we have conducted with Quest together and reported upfront immediate thereafter. It is a PCR test and we are going to use this throughout the ongoing Phase III study.

We also announced that we will be doing a 40 patient diagnostic tests in the coming months together with Quest. So, we should be able to generate additional detection data later in the year..

Thank you. Do you think, you could use this diagnostic to help speed up some of the recruitment issues that you have been having in the North American study. And again then you would start planning for your European study. Can you take this diagnostic out of the U.S.

and use it there or do you need to do a pilot study within the European population to use it in those geographies?.

To answer your second question first, we aren’t decided about the use in Europe, in the European Phase III study. But the likelihood is that, we will of course try to test for MAP as well.

With that said, referring to your first question, MAP mycobacterium avium paratuberculosis, the bacteria that believe is the cause of Crohn’s disease is not our primary endpoint in the study. The Phase III study currently ongoing in the United States, the MAP U.S. study for Crohn’s as a primary endpoint that is not related to MAP status.

That is because, we allow all comers into the study for reason that has been discussed in the past. The most important of which is that, we believe MAP prevalence among the Crohn’s population is very, very high, maybe 80%, 90%, some say more.

So the primary effort is not related to that, and therefore it’s not affecting the recruitment, because we are not testing for MAP as a prior exquisite, pre-condition for allowing a patient into the study. A patient does not need to be MAP positive to enter our study. I hope I answered your question..

Yes, yes. That’s very clear. Thank you.

One last question on 104, I am sure you are, you rather talk about something else, but recently again in that, you started including the anti-TNF background, but my, and what I’m trying to figure out is, how much of this additional anti-TNF background is going to skew the results that you have, because so far you did not include them.

And how it is going to impact the results or there is no impact because of the inclusion?.

There has been a lot of discussion about that; it’s actually a very good point. And what I can say is that, we would not have made that amendment, it’s a material amendment to the study. If we thought that, this is going to skew the results in a way that will significant affect the study..

Okay. Thank you. Thanks for taking my questions again..

Thank you, RK..

Thank you. We have a follow-up question from Vernon Bernardino of MLV. Please go ahead, your line is open..

Thank you. And thank you for taking my follow-up question.

Regarding the diagnostic format in the 104 study, would you be taking, if you use the test, the diagnostic will you be using at the time of enrollment or perhaps during or at the end of the patient treatment?.

Thank you, Vernon. We are using various detection methods throughout the study and to multiple time points, including the beginning and throughout the study and the end. And we are not only using our PCR test. We are using other methods as well..

Okay. Thank you for taking my follow-up..

Thank you. [Operator Instructions] As there are no further questions in the queue, that will conclude today’s Q&A session. I would now like to turn the call back to our speakers for any additional or closing remarks..

Thank you, Serge. We would like to thank our listeners. As the management, we are committed to transparent and timely communication and we are available to discuss with you following the call via email or on the phone at your convenience, any concerns or question you may have. Again, thank you for your interest in Redhill..

Thank you. That will conclude today’s conference call. Thank you for your participation. Ladies and gentlemen, you may now disconnect..