RedHill Biopharma's (RDHL) CEO Dror Ben-Asher on Q4 2016 Results - Earnings Call Transcript

| About: Redhill Biopharma (RDHL)

RedHill Biopharma Ltd. (NASDAQ:RDHL)

Q4 2016 Earnings Conference Call

February 23, 2017 09:00 AM ET

Executives

Dror Ben-Asher – Chief Executive Officer

Micha Ben Chorin – Chief Financial Officer

Guy Goldberg – Chief Business Officer

Gilead Raday – Chief Operating Officer

Analysts

Scott Henry – Roth Capital Partners

Swayampakula Ramakanth – H.C.Wainwright & Co.

Jonas Peciulis – Edison Investment Research

Vernon Bernardino – FBR & Co.

Guy Goldberg

This conference call may contain projections or other forward-looking statements regarding future events or the future performance of RedHill including statements with respect to RedHill’s expectations regarding the initiation, timing, progress and results of its research manufacturing research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts as well as business promotion and other efforts related to U.S. commercialization activity. 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.

Dror Ben-Asher

Thank you, Guy. And to those of you who are on our call live, thank you for joining us. We will briefly discuss our upcoming milestones in the coming months and leave some time to answer your question. But first, I would like to refer to Micha our CFO, for a discussion of our Fourth Quarter 2016 and Full Year Financial Results announced earlier today.

Micha Ben Chorin

Thank you, Dror. Good morning or good afternoon everybody. I will provide the short overview for our financial results for the fourth quarter of 2016 and for the year ended December 31, 2016. Fourth quarter of 2016 results; revenues for the fourth quarter of 2016 were $100,000 compared to immaterial revenues for the fourth quarter of 2015. Research and development expenses for the fourth quarter of 2016 were $7.5 million, higher 50% compared to the fourth quarter of 2015. The increase was mainly due to the ongoing Phase III and Phase II studies with BEKINDA for gastroenteritis and IBS-D, the ongoing Phase III study with RHB-104 for Crohn’s disease and ongoing studies with YELIVA for multiple indications.

General, administrative and business development expenses for the fourth quarter of 2016 were $1.6 million, lower 7% compared to the fourth quarter of 2015. The decrease was mainly due to a decrease in professional services. Operating loss for the fourth quarter of 2016 was $9 million, higher 33% compared to the fourth quarter of 2015. The increase was mainly due to the increase in research and development expenses. Net cash used in operating activities for the fourth quarter of 2016 was $10.1 million, higher 69% compared to the fourth quarter of 2015. The increase reflects the increase in operating loss. Net cash provided by financing activities for the fourth quarter of 2016 was $35.9 million compared to immaterial amount for the fourth quarter of 2015. The increase was mainly due to December 2016 public offering.

The results for the full year 2016 are as follows; revenues for 2016 were $100,000 compared to immaterial revenues in 2015. Research and development expenses for 2016 were $25.2 million, higher 42% compared to 2015. The increase was mainly due to the ongoing Phase III MAP US study with RHB-104 for Crohn’s disease, the ongoing Phase III and Phase II studies with BEKINDA for gastroenteritis and IBS-D, and ongoing studies with YELIVA for multiple indications. General, administrative and business development expenses for 2016 were $5.4 million, higher 31% compared to 2015. The increase was mainly due to an increase in professional services, compensation and other operating expenses.

Operating loss for 2016 was $30.5 million, higher 39% compared to 2015. The increase was mainly due to an increase in research and development expenses. Net cash used in operating activities for 2016 was $28.2 million, higher 59% compared to 2015. The increase reflects the increase in operational loss. Net cash provided by financing activities for 2016 was $36 million, lower 34% compared to 2015. The decrease is a result of lower cash rate. Cash balance, as of December 31, 2016 was $66.3 million, an increase of $8.2 million compared to $58.1 million as of December 31, 2015 and an increase of $25.8 million compared to $40.5 million as of September 30, 2016.

I will now turn the discussion back to Dror and we’ll be happy to take questions later on. Thank you.

Dror Ben-Asher

Thank you, Micha. As of the end of Q4, 2016 until now, we maintained a balanced pipeline including a three ongoing Phase III GI focused programs and several additional Phase II stage development programs. Generally speaking, without repeating previous publications, announcements and details, the last year has been a very busy year and the RedHill team has made significant clinical development progress with our Phase III programs, all of them in GI, including RHB-104 for Crohn’s disease, RHB-105 for H. pylori infection and BEKINDA for gastroenteritis as well as our Phase II stage drug candidate YELIVA. We recently announced that we have completed both recruitment and treatment in our Phase III study for gastroenteritis 320 patients all of them in the United States and we expect top-line Phase III results in the second quarter this year.

Our strategy is to become revenue generating gastrointestinal GI focused specialty pharmaceutical company with commercial presence in the United States. To that end, last month, we entered an exclusive co-promotion agreement with a subsidiary of Concordia International, granting RedHill certain U.S. promotional rights for Donnatal. Donnatal is a prescription oral drug used with other drugs in the treatment of IBS, irritable bowel syndrome and acute enterocolitis. We expect to initiate promotion of Donnatal in the coming months to be driven by a U.S. commercial management team headquartered in Raleigh, North Carolina and approximately 30 sales reps to be deployed in selective territories nationwide.

Select upcoming development pipeline on the coming months include the initiation of confirmatory Phase III study with RHB-105 for the treatment of h. pylori infection which we expect to commence in the second quarter, in the coming quarter, we are connecting all the dots there making sure that the preparation is thorough and that all goes well, assuming the study is successful, we have the best shot at getting the drug approved without additional study. Also a second independent DSMB meeting for the Phase III study with RHB-104 for Crohn’s disease - MAP US study, the DSMB look includes interim efficacy analysis and evaluation of an option for an early stop for success for overwhelming efficacy. We expect the DSMB meeting to take place in the coming quarter. Top-line results from BEKINDA Phase III study for gastroenteritis I mentioned this earlier, study is called the GUARD study.

We expect top-line results in the coming quarter as well, second quarter 2017 again, we completed both enrollment and treatment of all patients in the study. Top-line results from BEKINDA Phase II study for IBS-D is expected around mid-2017. We recently announced that we have randomized 100 out of the 120 patients, so we are getting there as far recruitment. We continue our extensive operating development activities in relation to both acquisition of commercial asset in the U.S. Within RedHill, specialty focus on gastrointestinal disease and partnerships for commercialization for some of our products through our licensing particularly outside of U.S., but also in the U.S. outside the GI space.

2017 is a year of important potential milestones and catalyst. With a strong balance sheet, several ongoing Phase III programs and several Phase II programs, growing U.S. commercial operations. We continue to position RedHill as an emerging specialty pharma focused primarily on specialty GI markets in the U.S. With advanced GI focused clinical development pipeline as well as integrated GI focused U.S. commercial operations.

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

Question-and-Answer Session

Operator

Thank you. [Operator Instructions]. We will take our first question from Scott Henry from Roth Capital. Please go ahead.

Scott Henry

Thank you and good morning. I guess just starting on the financial. Any comments on what we should expect for spending levels in 2017, at least directionally relative to 2016?

Dror Ben-Asher

Good morning, Scott. Roughly $10 million a quarter.

Scott Henry

Okay. And where were shares outstanding at the end of the year? I didn’t see that in the press release I know you have the offering and I guess that will come in Q4 as well as Q1.

Micha Ben Chorin

$170 million.

Scott Henry

Okay. Let’s see, other questions I had with regards to the GUARD study, given that trial has been fully completed, should we expect that data sort of in April, perhaps the early part of Q2? Any color on that?

Dror Ben-Asher

On April 27, we are planning Analyst Day to discuss both the IBS-D and gastroenteritis programs with BEKINDA. We do not expect the results to be available to us or to the market before that. So it will be between then and the end of the quarter some time.

Scott Henry

Okay. So you would expect to have the data after that event not at that event, is that correct?

Dror Ben-Asher

Correct.

Scott Henry

Okay. And then with regards to RHB-105, I thought I had recalled that that trial was going to start in April. Is that still accurate or perhaps 2Q a better way to describe that?

Dror Ben-Asher

The latter. We are in the very final preparations for the study, connecting all the dots, making sure everything is in place, everything is in agreement with the agency. We are little bit taking our time to do the best and most thorough job we can envision to get it right, but there’s no meaningful delay or anything. We are looking to commence in Q2.

Scott Henry

Okay. Fair enough. That should do it for me. Thank you for taking the questions.

Operator

Thank you. We will now take a question from Swayampakula Ramakanth from H.C. Wainwright. Please go ahead.

Swayampakula Ramakanth

Thank you. Good morning or good afternoon, Dror and just a couple of questions here. Probably one of the bigger projects for 2017 for you guys is to get this commercializing of Donnatal growing in the U.S. So can you highlight to us some of the work management is doing to make sure that you start-off smoothly when you start commercializing Donnatal?

Guy Goldberg

Thank you for the question. We’re operating in three areas here I guess is one way to think of it. The first one is our coordination with Concordia itself. Concordia of course still owns the product and is doing a lot of the support for our sales activities such as manufacturing. So one element of this is coordinating closely with them in such activities as mapping territories and devising strategy. The second element is creating a back-office infrastructure -- RedHill back-office infrastructure that would support our activities and to that end, we are establishing a physical presence in Raleigh in North Carolina and we will have probably a handful of back-office employees covering core functions such as IT, HR, finance, things like that to support the sales force. And the third and most important element is our sales force activities itself, we have a national sales director and we’re in the process of recruiting regional managers and also sales rep to get to possibly we’re not sure yet the exact compute around the range is about 30 sales reps who will be detailing this project for us. So that’s the rough level of activities that we’re conducting. We’ve been -- we started immediately after the contract was signed, so essentially in the beginning of the year. We’re making good progress and that’s where we are.

Swayampakula Ramakanth

Fantastic. Two question more on Donnatal, so, assuming you start commercializing this sometime probably in the second half type of thing. When do you think we can start seeing some meaningful revenues from this relationship? And also, do you have any sort of commitment to Concordia to maintain your co-promotion agreement like in terms of sales minimums or something like that?

Dror Ben-Asher

In terms of meaningful revenues I guess it’s pretty broad what meaningful means. But I would say, sometime on the basis of the first quarter, we should start seeing something coming out of this operation. And then, others will talk, we’re not providing any guidance at this point. Over time, we should see an improvement. With regard to Concordia and our commitment and their commitment, we have committed to deploy up to 30 sales reps for as long as the agreement is valid. The agreement is for three years, so that’s a commitment of both company and of course there is opt-out provisions which we did not elaborate upon. I hope I answered your question okay?

Swayampakula Ramakanth

Yeah, pretty good. So, in terms of adding into the bag in addition to Donnatal I’m sure you’re planning to put something in as you wait for breaking the other molecules to come through. What sort of products would you be looking for to add and is there a plan in place such that you start adding them within this year or next year, how should we think about that?

Dror Ben-Asher

We’re in discussions for several product, none of it is close enough to a point where we feel comfortable to announce to the market. None has been sent up yet, but the short answer really is as soon as possible. We would certainly hope to add at least one additional commercial asset to the reps basket this year, at least one we would hope.

Swayampakula Ramakanth

So the last sort of question is on BEKINDA for me, in terms of the gastroenteritis Phase III study, I understand if you can show significance in the study, then probably you can apply for approval. So when you’re ready to announce the top-line data in the second quarter, what sort of information would we see in that reporting? Would it just say primary end-point was met with significance of xx or is there more that we can get during that first announcement?

Dror Ben-Asher

We will announce the results – significance, at the time of announcement, we will not know whether we can file for NDA. So if we fail, then it’s the answer I guess. If we meet the endpoint and it’s not very striking, we just succeed, we assume that we will need another study because that’s always the default, but we will not really know until we approach the agency. Now if the results are highly statistical significant or let’s say in general striking as strong results, we will of course be optimistic about being able to file an NDA and get the drug approved without having to do the confirmatory Phase III study. But all of this will not be known at the time of the announcement, we will let the market know what the significance is and what the important results were.

Swayampakula Ramakanth

Okay. And the last question on which is again on BEKINDA, we are expecting to see data from the Phase II study in the first half. So, if we see positive data, would RedHill initiate a larger registration directed study on your own money or would you be looking to seek a partner to do the larger study?

Dror Ben-Asher

The IBS-D date is expected around mid-year. It’s a different formulation, the gastroenteritis, BEKINDA for gastroenteritis is 24 milligram, IBS-D is 12 milligram. But the product is potentially seen as a package. We will be looking to out-license BEKINDA outside GI and obviously outside the U.S. We hope to be able to keep BEKINDA both for gastroenteritis and IBS-D to go it along NGI in the U.S. in that narrow niche. Whether or not we will opt to do a Phase III study by ourselves in IBS-D assuming the results are positive, it remains to be seen but the – is to become a GI integrated specialty company in the U.S. which means we would love to keep this program all the way to the market and promote also BEKINDA and IBS-D in the U.S. by ourselves. There’s no guarantee, a lot can happen between now and then.

Swayampakula Ramakanth

Thank you, Dror. Thank you, Guy. Talk to you guys soon.

Dror Ben-Asher

Thank you.

Operator

Thank you. We now have a question from Jonas Peciulis from Edison Investment Research. Please go ahead.

Jonas Peciulis

Thank you for taking my question. There are couple from my side. So you have posted final results from Phase IIa with 104 multiple sclerosis recently. Are you able to elaborate a bit more detail where this could go forward? Is it up for licensing or is there potential to take it forward – I mean just your thought.

Dror Ben-Asher

Thank you, Jonas. It’s still under review with the issue being the primary indication that we are pursuing with the same product as the 104 for Crohn’s disease. In the second quarter, we have DSMB we have an independent committee second look at the data. And this time the data that they look at, as you know on the safety but also efficacy. In terms of partnering or doing it along, a lot will depend on the Crohn’s data because at the end of the day it’s the same drug and it’s a package. Both MS and Crohn’s are large indication. It’s very difficult to stiff indication when you are trying to do a lucrative business development or partnership. Therefore, the likely scenario is to answer your question that we continue full steam ahead with Crohn’s, generate the data and only then, you are likely to see a partnership for MS. At this particular point in time, we do not have an intention to conduct by ourselves a large Phase IIb study for MS, with RHB-104, our resources are better used going into the Phase III study for Crohn’s study. I hope I answered your question.

Jonas Peciulis

Thank you. Yes, that’s very useful actually. And the follow up question on Donnatal, I’m trying to understand what kind of value could be tying to your U.S. commercial operation now that you’re ramping at the start of the business. So probably you’re not in the position at the moment to provide a level of investment - to make that [indiscernible] but do you expect it to be a case where you could separate it - as a separate business segment in upcoming results?

Dror Ben-Asher

It will be a gradual process. In that, we remain primarily focused on advanced clinical stage GI programs on development. The commercial operation is evolving. Its initiative that is taking off, but we don’t want the market to put too much emphasis on it until it becomes clear what are the numbers? And the numbers do not only depend on Donnatal, they depend on whether and how many additional commercial GI aspects we are able to add to the basket of our reps. This will become clearer later this year. The larger scale of the commercial operation, the more products we have, the more emphasis we will put on this vis-à-vis the financial market. It’s all work in process, while going, I wish I could shed more light for you but I think this is the right approach.

Jonas Peciulis

Right I think it makes sense. Thank you.

Dror Ben-Asher

Thank you.

Operator

Thank you. [Operator Instructions]. We will take our next question now from Vernon Bernardino with FBR Company.

Vernon Bernardino

Hi, good morning. Good afternoon, gentlemen, and congrats on the 2016 milestone. Most of my questions have been answered, but just a few more on Donnatal. Could you comment on the level of effort Concordia placed on the promotion of Donnatal in the U.S. and what kind of role is Concordia expected to have once you have initiated the year on promotional efforts?

Guy Goldberg

Thank you. So previously they used contract sales force, and they terminated their relationship with them. So when we will be in the field, we will be the only sales force out there. They will continue to be working closely with us, so for example, manufacturing is something they are responsible for and pharmacovigilance and other aspect of the efforts. Our focus will be mostly on sales force and promotion, essentially assisting them for other aspects of things such as managed care that we might do together, but they will be definitely involved in working with us and we’re excited to have them as our partner.

Vernon Bernardino

Thank you. And just as a follow up, can you let us know, how long they have been promoting Donnatal in the U.S.?

Dror Ben-Asher

Vernon, it’s Dror. They have acquired the rights to the product in 2014. We do not feel comfortable to comment on the – they have been excellent partner so far, extremely cooperative, professional and friendly. We’re very happy with the partnership and the relationship but it’s for Concordia to comment and provide a bit about what they have done and how they --

Vernon Bernardino

Okay, just thought I’d ask, looking forward to picking the day. Thank you for taking my questions.

Dror Ben-Asher

Thank you, Vernon.

Operator

Thank you. [Operator Instructions]. Gentlemen, we have no further questions at this time. I’d like to turn the conference back over to you for any additional or closing remarks.

Dror Ben-Asher

Thank you, Emma and thank you all participants for your interest and for following RedHill. We remain available at the management company, you would find us responsive as always and we look forward to an exciting year. Thank you.

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