Good day, and welcome to the RedHill Biopharma Third Quarter 2019 Financial Results and Operational Highlights Conference Call. At this time, I would like to introduce to the conference call, RedHill's CEO, Mr. Dror Ben-Asher; Mr. Micha Ben-Chorin, RedHill's CFO; Mr. Gilead Raday, RedHill's Chief Operating Officer; Mr. Guy Goldberg, RedHill's Chief Business Officer; and Mr. Rick Scruggs, RedHill's Chief Operating Officer, U.S. Operations. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] 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 RedHill, including statements with respect to RedHill's expectations regarding the initiation, timing, progress, and results of its research, manufacturing, preclinical studies, clinical trials, marketing applications, or approvals, if any other therapeutic candidate, development, efforts, and the timing of the commercial launch of Aemcolo and Talicia and its therapeutic candidates, as well as business promotion and other efforts related to RedHill's commercialization activities. 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, performance, timing, results, or commercialization activities may differ materially from what RedHill projects today. Additional information concerning factors that could cause actual events, performance, timing, results, or commercialization activities to materially differ from those contained in forward-looking statements can be found in the company's Annual Report on Form 20-F filed with are SEC on February 26, 2019, and in its other filings with the Securities and Exchange Commission. Thank you. I am transferring the mic to Dror.

Thank you, Milan [ph]. Good day everyone, and thank you for joining us. The last several weeks have included transformer period end for RedHill, including the FDA approval of Talicia for H. pylori infection in adults, and our strategic collaboration with Cosmo Pharmaceuticals. RedHill acquired the U.S. rights to Cosmo FDA approved Aemcolo for travelers' diarrhea in adults, and Cosmo invested $36 million in RedHill. Intensive and diligent preparations are ongoing for the commercial launches of Aemcolo and Talicia in Q4 '19, this quarter, and Q1, 2020, respectively, without lifting and expanding sales force. We plan to discuss our commercial strategy and plans for Talicia and Aemcolo in more detail during an investor and analyst event being held in New York this coming Friday, November 22, which will also be webcast live. Let me now turn the call to Micha, our CFO, who will discuss our financial results for the quarter, which we announced earlier today.

Thank you, Dror. Good morning, and good afternoon, everybody. I will provide a short overview of our financial results for the third quarter of 2019. We continue to remain cost disciplined with a cash burn of approximately $9 million during the third quarter. We remain debt-free, and obtained a strategic $36 million investment from Cosmo Pharmaceuticals, which considerably improved our already debt-free balance sheet, ahead of the planned Talicia and Aemcolo launches. We generated net revenues of $1.4 million in the third quarter of 2019, compared with $1.6 million in the second quarter of 2019. We recorded gross profit of $800,000 in the second quarter of -- in the in the third quarter of 2019, compared to $1.1 million in the second quarter of 2019. We recorded research and development expenses of $2.8 million in the third quarter of 2019, compared to $7 million in the second quarter of 2019. The decrease is attributable primarily to the completion of the Phase 3 study with Talicia and the one-time PDUFA fee of $2.6 million for the Talicia new drug application NDA in the second quarter of 2019. Selling and marketing, and business development expenses were $4.9 million in the third quarter of 2019, compared to $4.1 million in the second quarter of 2019. The decrease is attributable primarily to the company's launch preparations for Talicia. General and administrative expenses were $2.9 million in the quarter, compared to $2.4 million in the second quarter of 2019. The increase is attributable primarily to the increase in professional service related to the launch preparations of Talicia. Operating loss was $9.8 million in the third quarter of 2019, compared to $12.4 million in the second quarter of 2019. The decrease is attributable primarily to lower R&D expenses. Net cash used in operating activities were $8.9…

Thank you, Micha. As I mentioned earlier, a major milestone recently was the FDA approval of Talicia for the treatment of H. pylori infection in adults. Talicia is the only rifabutin-based therapy approved for the treatment of H. pylori infection, and is designed to address the high-resistance of H. pylori bacteria to clarithromycin-based standard of care therapies, and the imperative need for new treatment. H. pylori bacterial infection affects more than 50% of the world's population, and approximately 100 million Americans, which is classified as a Group 1 Carcinogen, and is the strongest risk factor for the development of gastric cancer, and a major risk factor for peptic ulcer disease, gastritis, and other diseases. Talicia is intended to target an estimated $2 million patients treated annually in the U.S. It is eligible for U.S. market exclusivity for a total of eight years in addition to the U.S. patent, which extend patent protection until at least 2034. With our established sales force and commercial capabilities already in place, we're excited to move ahead with the planned U.S. commercial launch of Talicia during the first quarter of 2020. We will continue to keep you apprised of the progress of the launch. This brings me to the other significant events. Last month, we announced a strategic collaboration with Cosmo Pharmaceuticals, including an exclusive license for the U.S. rights to Aemcolo, and simultaneous [ph] private investment by Cosmo of $36 million in RedHill equity. Aemcolo is a minimally-absorbed antibiotic that is delivered to the colon. It is approved by FDA for the treatment of travelers' diarrhea caused by non-invasive strains of E. coli in adults. Travelers' diarrhea presents a significant market opportunity for RedHill with 32 million Americans traveling to developing countries each year, of whom, high percentage develop traveler diarrhea. We plan to…

[Operator Instructions] Your first question comes from the line of Christopher Marai. Please go ahead, your line is open.

Hello. This is Jackson Harvey, on for Christopher Marai. I just have a question on RHB-204 and NTM, could you provide a little more color around the ongoing FDA discussions? Has this been moving a little bit more slowly than anticipated? Thank you.

Thank you for your question. We planned initially two FDA meetings following the results of the study. The study was very successful. We conducted one of the two meetings already, and we intend to have additional meeting. Currently we are focused on the solution to map diagnostics with regard to sorting out the patient population. That's as far as Crohn's is a concern, we plan another meeting and we'll take it from there. Regarding RHB-204, we have been checking all the right boxes, studies -- supportive studies to date have been successful, and we do plan to initiate the pivotal study activities in half one. To be more specific, we did experience some delays, although no major delays. We fully intend to conduct the study. It's not supposed to be a long one, and we feel very confident about our prospects.

Great, thank you.

Your next question comes from the line of Steve Brozak from WBB. Please ask your question, your line is now open.

Good morning, and thank you for taking the questions. I'll just ask one, and one follow-up. Given the fact that you've got these two products that you're launching, can you tell us how your sales force is going to approach it, both for the dedicated gastroenterology community and also what are your thought on general practitioners that are obviously going to be seeing a lot of these same and similar types of patients? And one follow-up after that, thank you.

Thank you, Steve. A lot of data analytics and planning have been happening in the last few months. I will defer this to Rick Scruggs, who is heading the U.S. operations, who is on the call today.

So, hey, that's a good question. We have done extensive research and targeted the right writers before the prescriptions for Talicia will be written. And the current base we have mapped for 140 territories which we are currently selling. We will promote both Talicia and Aemcolo into those offices. We are calling on a large number of primary care physicians, and over 11,000 gastros. So, we are going to promote both of these products into both of these environments, and we prepared to do that.

Okay, thank you. And the follow-up has to deal with Talicia. You mentioned something in terms of -- Talicia is a unique product as far as we've assessed. If someone were to go out there and try and look at the components and work with them, how difficult is that, and why -- what are the benefits, obviously, because any clinician that sees the data is going to say this is a no-brainer as far as we've assessed. What are your thoughts on that, and any feedback? Thank you.

We have done, Steve, extensive primary research with physicians of various specialties, obviously GI, primary care internees, nurse practitioners, other midlevel physician assistants, literally hundreds and hundreds of relevant healthcare providers have been interviewed, participated in panels, surveyed, you name it. And the results are very encouraging for us pretty much in all respects. With that said, I will defer to Rick if he would like to add some color.

So, yes, a little color. I mean it would be very difficult and almost impossible to ask a compounding pharmacy to make these products for an affordable cost for patients. So the convenience of having the product in one pill, the fact that we're going to promote to physicians, the fact that we are going to have it covered by the payers, so it'll be the normal process of getting a prescription filled. So there's no advantage really for someone to try to make this product and write three or four different prescriptions, you have three or four different co-pays. In actuality, some of these products are very expensive at pharmacies. So if you're trying to think about cash-paying patients that want to kind of create their own thing at some compounding pharmacy I think it's a very difficult thing. Plus the physicians and all of our research this has never come up, and in my experience of doing these launches and these products, I don't believe this is going to be an issue at all with us as far as someone trying to make a copy of the product by using the components and putting it together, I just don't think that's a realistic threat for the product.

Thank you, Rick. I will also add that if you look at the various layers surrounding the product, a compounding attempt is not the same product, entirely different PK profile, entirely different doses, very high out-of-pocket for patient, as Rick mentioned. The promotion is not possible both because of the QIDP status which gives us eight years of market activity [ph] in the U.S, but also because of the patents, 2034. So overall, an entirely different product that cannot be promoted, we just don't see it happening.

So, if I were to infer from everything you've said, with the interlocking advantages that you've got, this becomes the go-to product for anyone with H. pylori or any clinician treating anyone for H. pylori, you comfortable with that?

We know the label is H. pylori infection. We also know it's the only rifabutin-based therapy. We also know that in our study the data was very clear. The resistance to rifabutin and anything between just under 20% to over 40% resistance, we know this is growing to antibiotics commonly used in standard of care. Effectively, it positions us very well for the launch of Talicia, and we are planning for Talicia to be a well-established, well-received product for H. pylori. To remind the audience, there hasn't been a launch of anything materially new into this space for many years.

Got it. Thank you again for taking the questions and good luck with the launch of course.

Thank you. Your next question comes from the line of Scott Henry from ROTH Capital. Please ask your question. Your line is now open.

Thank you. Good morning and congratulations on the progress over the recent months. Just a couple questions, first for Aemcolo, how should we think about the Q4 launch? Obviously we've got the Thanksgiving holiday, and then we've got the other holidays, should we be thinking -- I mean is the launch more prepping the reps or should we expect any material revenues in Q4?

The launch will take place in Q4, both in the field, and obviously talking to the channels and so on, this is planned to be happening in Q4. For more color, I'm referring to Rick.

So, yes, so as you know, this is an approved drug, we have the opportunity now to launch it into the world. Cosmo didn't launch it except through a web based idea, which we're still going to follow with that as well. So to answer your question, we're launching the product into the channel, into the channel, I define that is our network of pharmacies, wholesalers, et cetera, we will sell product into the channel, actually next week, and then we will actually have our current sales force. We have currently 35 sales reps that are training and we will let those guys lose the first week of December, and they'll start promoting. So we'll see prescriptions in the month of December, but as you said, this is a short month, three weeks. So what we're doing really is prepping the market, prepping the physicians, getting the distribution out there. The product already had some pretty good coverage that Aries and Cosmo were able to ascertain, will have copay assistance programs that help will make sure the drugs gets filled at pharmacy, but revenue I think we're still deciding about what number we should sell into the channel based on the short period we have for promotion of that prescription. So I don't know what that number is yet. We were going to determine that in the coming days.

Okay, now, when we think about that category, obviously, similar mechanism of action with Xifaxan, how will you position this product relative to Xifaxan in the Travelers' Diarrhea segment?

Thank you, Scott. When you look at the detail of the studies and mechanism and the attributes overall of Aemcolo, there are several because of various compliance restrictions and because of competition reasons about pricing and other issues, we'd rather not elaborate the 4K with you.

Certainly, fair enough. And Dror, obviously you're going to be focusing on these two key launches, which are significantly more material, but the other products just for modeling purposes, do you think they'll benefit from the other -- from the new launches, or should we expect them to fade or how should we think of all those co-promotes in the wake of having more reps, but having more things to do?

Thank you, Scott. This is an excellent and timely question. We are currently in discussions with our three partners for the three products that we're currently selling and have been selling for a while. We expect conclusion one way or the other soon enough to be able to update the market, which products are going to be kept and under which economic structure and which products are not going to be kept because we would rather have 140 reps. Again, we are going from roughly 40 now to nearly 100 before the end of the year and 140 for the launch of Talicia, we want their capacity to be utilized for products to optimize, maximize revenue and gross profit.

Okay, thank you for the color, Dror and thank you for taking the questions.

Thank you. [Operator Instructions] Your next question comes from the line of Matt Kaplan from Ladenburg. Please ask your question. Your line is now open.

Thank you, and good morning, guys. This question more for Rick, you mentioned I guess in your prepared remarks about some efficiencies that you could have in your commercial operation. I guess can you help us understand in terms of when you roll-out the 140 reps, guess next year, what are the efficiencies and synergies that you hope to be able to exploit I guess when you're marketing Aemcolo and Talicia both?

Rick, you can handle this one.

Okay. I had a little difficulty; you broke up a little bit with the question. How we're going to market and what efficiencies we have but selling these products together? Was that the question?

Yes, you also said that you're able to create a situation that's a little bit different from, we typically see from commercial operations in terms of watching products in the space that could be more efficient just overall as well?

So I'm not sure, I still understand the question, but I'll take a shot at it. So we are currently building, we established a sales force, a smaller group that established the RedHill brand in physician offices. So, I look back in my experience and say like that tells the story. Then we started that company, we started out with 20 reps and we had one approved product and we started talking to the physicians, we had to explain who RedHill is and what was our first drug call is out. So, and that took a lot of time with physicians, we've been out there for almost four years, around three years now, establishing the RedHill brand. So we won't have to explain who RedHill is to the majority, a large majority of our physicians, who will be able to go right to selling our key products. So there's efficiency there, where we don't have to sell the company, but having said that, we are going to be able to add additional people to our group, we've already hired, approaching 30 more reps already to add to our group. We have a sales training class coming up here the first part of December, and as those people roll-out of those training classes, we put them into the field to go to work selling Aemcolo in our current basket of products and also doing disease day discussions with physicians around Talicia until we actually launched the product in first quarter. So we are going to be calling on over 23,000 physicians, we are going to be calling over close to 12,000 gastros, 10,000 primary care physicians, and about 2,000 mid-levels. So we have a great reach. When we look at the analysis of call points, there is a good synergy between the call points of Talicia writers and physicians that write for travelers' diarrhea, physicians that write Xifaxan. So there is good call synergy. So we have efficiencies in that respect. So, I think the efficiencies are the products line-up, we've been out there already, and we've had a lot of time to prep to go out there and understand the market and execute efficiently.

Great, that's helpful. Thank you. And Dror, I guess what are your thoughts now on pricing both Aemcolo and Talicia?

Thank you. We're actually there, but at this specific point in time, we would rather not elaborate and maybe we'll be in a position to provide more specific details on Friday this week during our event.

Okay, great. Well, thanks for taking the questions and look forward to Friday's presentation.

Thank you. Your next question comes from the line of Ed Woo from Ascendiant Capital. Please ask your question. Your line is now open.

Yes, thank you for taking my question and congratulations. My question is more on you said that you could possibly be breakeven in your commercial operations by 2021. Does that include your clinical development or is that only into sales and marketing of these drugs?

Thank you, Ed and thanks for noticing our important comment. That comment was about the commercial operations itself. R&D costs are tightly controlled, if you saw they went down significantly even in Q3 this year, and we made a statement qualified specifically about breakeven, potentially of commercial operations as early as 2021.

Great, well that answers my question. Thank you and good luck, I look forward to the call on Friday. Thank you.

Thank you. Your next question comes from the line of Jonas Peciulis from Edison Research. Please ask your question. Your line is now open.

Hi, yes, thank you and congratulations with the FDA approval, it's quite a milestone. Could you please sort of give us your thoughts, what is rationale behind the specific number of sales reps 140, I guess with this question, I would like to understand whether this 140 reps would be sufficient, really it's an optimal number for sales force or for example, you might need to increase that further. So, just any kind of feel whatever you can sort of give us what behind that 140?

Sure, yes. Thank you, Jonas. Excellent question, a lot of homework preparation, data analytics, a lot of discussions over month and month, when you decide territorial mapping, the number of reps, territory for each and so on and so on, with numerous factors being considered. It's a general comment and then I will defer to Rick, our goal was to take our existing almost 40 reps that have been with us for the last three years and expand for the launch of Talicia and Aemcolo as well in a way that is not too small because you only get to launch a product first time once to get it right but also not too big because if you go too big, you take risks, and we are a company that does not like unnecessary risks. You can see it in our model, in our preparations over three years for this moment, and various other components of our business model, 140 we felt is the optimal number, given the numerous factors that we took into account. That said I will refer to Rick if he would like to add anything.

Joe, I think you captured the question nicely. I mean, I can just add the mapping goes into the number of physicians would like to capture where these prescriptions actually reside in the market segments and the ability to reach those in a frequent manner, and get the message out to physicians and make the products available to the patients. So there is a lot of work that goes into that. And right now, we believe the number of 140 is the optimal number for our current launch of primary care physicians and gastroenterologists and also we think is the right number for Aemcolo, but these things could change as we get into this because we do believe these products can be very successful once were launched in the physicians offices.

Okay, thank you. Thank you for that. That's useful. One question on Bekinda and specifically the update on Bekinda that sort of you had in the press release. You mentioned that you talked - you had a meeting with the FDA to discuss pediatric study plans. So, what's your latest thinking about further R&D plans for Bekinda, so you're going to do both pediatric and adults for patients in one go as opposed to stepwise manner?

Thank you. Bekinda is a product we're very excited about, an R&D program that went through a sizable onto the patient's Phase 3 study in the U.S. and has done really well, and we would love to bring it to patients as quickly as possible. Obviously that requires an additional adequately-controlled Phase 3 pivotal study per FDA guidelines. We have been in discussions with agency about this program. What took a little bit of time was to reach an understanding about the pediatric plan, which is a regulatory requirement, which we obviously take very seriously. We have done that. The planned study will aim at an intended indication of adults. We are developing also for pediatrics. The study is a very short one. The duration of treatment is very short. Patients are recruited quickly. It's one of those rare indications where you can record quickly just like we have done in the previous Phase 3 study. And we're looking forward to bring this to patients. The one caveat being that we have not announced yet the planned timing of the study, we expect to do so in the next quarter or so to announce that the planned timing in more detail.

Okay, thank you. That's clear. Thank you.

[Operator instructions] Your next question comes from the line of Sean Lee from H.C. Wainwright. Please ask your question. Your line is now open.

Good morning. Thanks for taking my questions. Just two quick ones, first for Talicia, do you expand to -- what kind of coverage does 140 reps give you in the U.S. in terms of geographies, and do we expect to expand that further next year if the launch goes well?

Sean, great question, we will elaborate in much more detail on Friday, but since you got up going, we're so excited about this. We will say something now, which is H. pylori population in the U.S. is highly concentrated, while we're talking about 100 million Americans, the actually territories where vast majority of these patients are and not too many. What this allows us to do is to cover most of the relevant prescribers with 140 reps. This is the bottom line. We provide much more detail on Friday, unless Rick you underline, would you like to add anything?

No, I think that's good. I mean on Friday we will actually show the map, so you can see where everybody is located, where everybody is located. So, we will cover continental United States. Of course there will be some white areas like Wyoming, Montana, where there is really not a lot of physicians, and not a lot H. pylori cases for us to seek, I mean the cases are concentrated in certain states, but we will cover most of the country, and we will cover the -- what we call the white space with our telesales group as well. So we'll have a complete map to share with you on Friday.

Great, looking forward to that presentation, and my second question is on the marketing strategy for the two drugs, are you focusing primarily on the door-to-door visits to the physicians, or do you plan on having some organized physician education sessions, or would there be any direct to consumer marketing?

Rick, would you like to take this one?

Yes. So, we will do all of those things. We have a dedicated sales force of 140 sales people. We have five [indiscernible] liaisons working with key opinion leaders. We have currently a medical liaison science team of six people, it will be out there. We will be talking about disease day. We are presenting at ACG, American College of Gastroenterology, will be at DDW next year. We will be at numerous conferences this year with primary care etcetera. We will be working with patient advocacy groups. We will be doing Public Relations and Public Affairs, and we will be looking at direct to consumer at some point maybe not right now, but at some point, and as you know, there was already some limited direct to consumer with Aemcolo through the Web site and we will continue that. So, we will address the sales and marketing of the product in all venues as we go forward.

Thanks for the additional color. That's all I have.

[Operator Instructions] Your next question comes from the line of Hank Beinstein from Gagnon Securities. Please ask your question, your line is now open.

Thank you and congratulations on the announcement. Most of the questions that I had have been answered, but I did want to ask one question that's occurred to me. You indicated briefly that you were considering acquiring other products to put in your salesman's bag, could you give us a little color on exactly what you were thinking and how many additional products might be in your focus?

Thank you, Hank. It's highly relevant and timely question, because if you look back five years ago, we were entirely focused on R&D. Three years ago, we started building very carefully and gradually our commercial operation, starting with promoting several co-promotion, or licensed product from other companies to establish our presence. And while at it, the commercial operation became a major asset for us in the sense that we have the capabilities, we have the supportive functions, we have the reps in the field, very familiar with a health care providers, and vice versa, [indiscernible] already thousands of GI primary care call points, and soon enough, as Rick mentioned, almost 24,000 call points with 140 reps. This is in the GI space, or in any specialty of similar size and scale is a major capability that needs to be capitalized on. What it means is that we need to capitalize on our economies of scale and promote the most promising, largest most profitable product that we can into those call points. We already have three smaller products, which we discussed earlier, and we are launching Aemcolo, which is potentially a large product this quarter in the coming weeks. And Talicia, we are planning to launch in Q1, again, a potentially large or very large product. We do have the capacity to add very carefully and selectively highly promising potentially large FDA approved product into our universe of healthcare provider, which we call on sometimes weekly, sometimes monthly, depending on each name. This is where we are. We are in discussions for potential acquisition of several FDA approved products, commercial stage, or nearly FDA approved, both, and you could certainly expect us to do our very best in the coming quarter to add very exciting products into the bag of our sales [ph] force, as well as marketing, and medical affairs, and all the others that are dealing with it. It's the plan. It's been the plan all along. There is very few players in the GI space, and our goal and objective is to become a leading player, if not the leading player in the GI space highly focused, narrowly focused in the coming year. I hope I answered your question.

Very helpful, thank you so much, looking forward to Friday.

Thank you. There are no further questions at this time. So, I will hand over to the speaker for the final remark.

Thank you, and thank you everybody for being with us today. We are available should anybody have the follow-up question on the phone, by email as always. Otherwise, have a great day. Thank you.

This does conclude our conference for today. Thank you for participating. You may all disconnect.