Good day and welcome to the RedHill Biopharma's Third Quarter 2020 Financial Results Conference Call. At this time, all participants are in listen-only mode. Today's presentation and slides can be viewed online via the webcast. After the speaker's presentation, there will be a question-and-answer session. [Operator Instructions] At this time, I would like to introduce to the conference call, RedHill's CEO, Mr. Dror Ben-Asher; Mr. Micha Chorin, RedHill's Chief Financial Officer, Mr. Rick Scruggs, RedHill's Chief Commercial Officer; Mr. Gilead Raday, RedHill's Chief Operating Officer; Mr. Guy Goldberg, RedHill's Chief Business Officer; and Mr. Adi Frish, Chief Corporate and Business Development Officer. 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 closing of the strategic agreements with Cosmo Pharmaceuticals, the business, promotion, and other efforts related to RedHill's commercialization activities and the initiation, timing, progress, and results of RedHill's research, manufacturing, preclinical studies, clinical trials, marketing applications, and approvals, if any, and the clinical trials of opaganib in the U.S., Israel, and elsewhere for the treatment of COVID-19. These statements are predictions and RedHill cannot guarantee that they will in fact occur. RedHill does not assume any obligation to update our 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 the forward-looking statements can be found in the company's Annual Report on Form 20-F filed with the SEC on March 4th, 2020 and its other filings with the Securities and Exchange Commission.

Thank you, Alexandra. Good day, everyone and thank you for joining us. We'll be presenting select business highlights today. So, please remember to press on the link to the slide deck that we'll be presenting later on. Thanks to the strength of the RedHill organization, and its relentless focus on execution, we experienced significant and rapid progress in the third quarter despite the challenging pandemic environment and the disruption it created. I would like to thank the RedHill team for their dedication, resilience, and that continued the impressive growth during the last quarter. Specifically, our extensive promotional efforts for Talicia delivered 300% quarter-over-quarter prescription growth as well as rapid expansion of the prescriber base supported by an existing national payer coverage for 167 million Americans, which continues to grow. Movantik prescriptions grew for a second consecutive quarter, just reversing the trend of prescription decline prior to its acquisition RedHill. The global Phase 2/3 and the U.S. Phase 2 studies with opaganib for COVID-19 are quickly approaching completion and we have generated important data demonstrating opaganib complete integration of SARS-CoV-2 application. In parallel with ongoing discussions with several U.S. government agencies for potential collaboration and funding, we have initiated manufacturing ramp up in preparation for potential emergency use applications for opaganib as early as the first quarter of 2021. In parallel, we are initiating the Phase 3 study of RHB-204 as an oral first-line therapy for pulmonary NTM infections, a disease with a significant unmet need and no FDA-approved first-line treatment. We view RHB-204 as a significant future growth driver for the company. Turning for the big picture, we view Talicia, Movantik and Aemcolo in the curricular travel area as important revenue growth drivers. We continue to invest in the fields of our future organic and inorganic growth, to realize our vision, building and leading and lasting specialty pharma company. Our highly motivated team remains focused on RedHill exciting short term, mid term and long term growth trajectory. In the short term, we continue to work towards the plant operational breakeven next year. Before turning to our CFO, Micha to discuss the third quarter results, I remind the audience to press on the link in order to see our detailed slide as we present selectiveness highlights to be followed by Q&A session during the remainder of the time. All yours, Micha.

Thank you, Dror. Good morning and good afternoon, everyone. I will provide a short overview of our financial results for the third quarter. This quarter has been very positive for RedHill. We have increased prescriptions from both of our core products, Movantik and Talicia and completely discontinued all legacy products. We have increased gross profit and reduced cash burn despite the challenges of the COVID 19 environment. With a cash balance of approximately $51 million, as of September 30, we are well positioned to continue our growth trend towards operational breakeven next year, while maintaining financial discipline. In Q3, we reported net revenues of approximately $21 billion and gross profit of $10.6 million, or approximately 51%, up substantially from around 32% in second quarter of this year. Research and Development expenses were $4.3 million dollars, compared to $3.2 million in the previous quarter. The increase was primarily attributable to progress in bargaining COVID-19 study. Net cash used in operating activities was reduced to $9.2 million in Q3 compared to $15 million in second quarter. The decrease was primarily attributable to positive changes in working capital, which compensated for the increase in net loss of $2.6 million. Overall, net cash burn in the quarter decreased to $2.2 million, which is lower than the cash burn of approximately $9 million in the previous quarter. This is due to both, lower net cash used in operating activities, as I just mentioned, and also higher proceeds from the company's ATM. I will now turn the discussion back to Dror, and we’ll be happy to take questions later on. Thank you.

Hello, this is Guy Goldberg, Chief Business Officer. Hello, everyone. We're excited to walk you through our second earnings call presentation. As mentioned last quarter, we put special effort and emphasis on these costs to give as much transparency as we can, especially about what we're seeing on the commercial side. With ever changing macro conditions, these presentations are a way for us to keep you informed about what is affecting our business and how our business is performing. Some of these metrics will be shown on a one-off basis in order to help investors better understand our markets and appreciate why we are so enthusiastic in these early critical stages of our commercial activities. The overall message echoed what Dror said this quarter is -- of this quarter is that we're making great progress in spite of the pandemic challenges and in the case of our COVID program, even because of it. 2020 continues to be a year of remarkable progress for RedHill, and we are very proud of our accomplishments. We will give you a detailed review of our commercial operations. Our entire commercial team has worked tirelessly with determination, resilience and creativity to adapt and thrive during this challenging time. Our launch of Talicia is going very well with about 300% quarter-over-quarter prescription growth. We will also give an update on our R&D activities. Importantly, we will have results very shortly with opaganib in our two clinical studies in hospitalized COVID patients, a very large and still underserved market. If you consider the recent high profile, late stage clinical failures in COVID drug development including by big pharma, we are at the forefront here and could be among the very first -- few very first companies with a truly effective treatment, and very excitedly, we will know…

Thank you, Guy. I'm pleased to provide some R&D progress highlights. On the COVID-19 front, we are as far as we know, the only company currently advancing to novel Phase 2, 3 stage therapeutic candidates. This positions RedHill at the forefront of the global efforts against COVID-19 with near term data readouts of our lead or Opaganib program, potentially supporting emergency use application as early as Q1 2021. The few therapeutics that have to date received emergency use authorization have assessed an incremental benefit. There clearly remains an urgent unmet need for a highly effective and safe COVID-19 therapy. Both our compounds Opaganib and upamostat are highly promising, orally administered, novel small molecules with potent antiviral activity. They each have a unique mechanism of action. Each of them targets a distinct human host cell factor, as such both have the importance of advantage of being likely to remain effective despite viral mutations, which might render direct antiviral acting compounds ineffective. Both our compounds have already demonstrated potent and specific anti SARS-CoV-2 activity and also have an established safety database in hundreds of patients. With two shots on goal, our compounds have the potential to cover the full spectrum of COVID-19 patient populations from the mild outpatients to the severe hospitalized patients, potentially addressing these urgent unmet medical needs, which represents a multi-billion dollar global market opportunity. Slide 9. Opaganib is our leading highly promising Phase 2, 3 therapeutic candidate for COVID-19 with near term data readouts. It is an orally administered pill with an advantageous dual mechanism of action. It combined potent antiviral activity with supportive anti-inflammatory action. As a potent antiviral Opaganib completely blocked SARS-CoV-2 viral replication in a model of human bronchial tissue, in fact, it compared favorably with remdesivir, which was the positive control in the study.…

Thank you, Gilead. So turning attention back to our commercialization efforts for our three FDA approved products. So as a reminder, we commercialize Movantik, which is indicated for opioid induced constipation, the most common side effect of opioid therapy, Talicia, which is indicated for H pylori eradication, and very serious and widespread bacterial infection in need of new, more effective treatments given problems of growing resistance to current standard of care. And Aemcolo, which is indicated for travelers diarrhea caused by E. coli. So I want to talk a little bit about the impact of the pandemic on our industry. The good news is, as we've said before, in the past there have been no disruptions to our supply chain. Our field promotion, which was shut down in March through May, like everyone else's has been returning steadily to the field since early June. We are now calling on doctors offices at rates approaching, where we would be without pandemic restrictions. Keep in mind that there is a strong regional effect here and we do see situations where in some parts of the country, restrictions get reimposed, and that can affect our commercial activities. The challenges we face are shown here on the slide and mostly affect Talicia. I want to re emphasize that this slide is industry-wide data. It's not specific to RedHill. So the top chart shows that the rates of lab testing compared to last year at the same time continue to be down. Lab tests are critical for Talicia because identification of H pylori positive patients is necessary to facilitate treatment. We also know the colonoscopies are down significantly year-over-year, which is an important H. pylori diagnostic tool for gastrointestinal doctors. The bottom chart shows that new-to-brand scripts across all types of doctors continues to be…

As previously discussed, we are well positioned for reaching a plant operational profitability next year with a cash balance of approximately $51 million as of September 30. Strong revenues and script growth substantially improved gross profit together with gross discipline supporting modest cash burn of approximately $11 million in Q3, which is approximately only $2 million net of ATM inflow.

Thank you, Micha. We will now take any question that the audience have.

Hi. Good morning guys. Thanks for taking the question. I want to focus in on opaganib for a second in terms of your COVID-19 program there. You mentioned that you could have data later this year for the phase 2 study in the U.S. and the phase 2/3 study in the first quarter. I guess can you give us a sense in terms of where you are with manufacturing preparation, given that you could potentially have the emergency use authorization request as early as first quarter of next year?

Thank you, Matt. Good morning. We have initiated the several manufacturing larger scale initiatives. Starting with agreements with Canadian and European suppliers, there will be several more such agreements in the coming days and weeks, and we expect to have a larger inventory going into the UI application. As things progress, we expect two -- the other two manufacture at several different places, including the U.S., Europe and Canada, all-in parallel towards a larger inventory. We do expect that given success in our studies, we are highly likely to receive the U.S. government and other government support as well as meaningful centralized government orders. So, funding for large scale manufacturing is likely to become less and less of a challenge, the more positive results we continue to show in our studies As Gilead mentioned, we are near data points that could be exciting, assuming we are successful. So, you could assume several parallel supply chain that are been compiled and secured, as we speak. Some of them already have been secured.

Okay. Thank you. That’s helpful. And just shifting to your commercial products, you saw some strong script growth for both I guess, Movantik and Talicia during the quarter. Can give us a sense in terms of how those are translating to revenue growth from quarter-over-quarter for each of the products.

The most important factor here is of course, scripts, which we have just presented in detail. The ex-factory sales, as you know, can be pretty random, especially when you launch a product. Therefore, what we would urge people to do is look at the script. The pricing is publicly available. And that's really the best available, effectively speaking, key indicator for growth. As we discussed, there was 300% growth in prescription for Talicia as well as growth for Movantik for the second consecutive quarter for the first time literally in years. So, this is very exciting for us. Again, we would look at the script, and the ex-factory sales will continue to be disclosed in totality in the coming quarters, reflecting the script growth.

Okay, fair enough. And then last question. In terms of your initiation of the RHB-204 programs, Phase 3 program for NTM. Can you give us a sense in terms of potential timeline for that program in terms of being able to read out Phase 3 data?

Sure. Thanks, Matt. We are initiating the Phase 3 study, which is plan to enroll 125 patients, and we hope to complete the enrollment up to 40 sites across the U.S. within a year. And the end points of highest importance start at month eight, where we will have the specific conversion analysis of the six months time point and where we will have the reported outcomes, clinical outcomes from a variety of pro questionnaires that have been developed. So that will be the main timeline to look out for.

Thanks a lot for added detail and congrats on the project.

Thank you.

Thank you. Next question comes from the line of David Hoang of SMBC. Please go ahead.

Hey guys. Thanks for taking my questions and congratulations on the progress this quarter. So my first one was in relation to MTD, NTM study, just wanted to know if you expected that to be an accelerated or full approval. And then, do you expect any post-marketing commitments with that product? And lastly, there is a competitor product, ARIKAYCE from Insmed which is looking to advance into the first line setting. So just curious to hear your guys' thoughts on how your positioning might compare to their product?

Thank you, David. Excellent question. So when it comes to post-marketing, we actually do not know. We will probably not know until the very last moment, when we submit the NDA. In relation to Insmed intentions, we know the product. We know that several differentiating factors, I will name a few as a factual statement. AAD204 is an orally administered drug. It is going to be administered three times a week. It is a standalone drug. It is not being administered on top of anything else. And you can also feel that the fact that there's no device involved gives us a somewhat more price elasticity that is a fact. The Insmed brand ARIKAYCE is kind of indicated for refractory patient, its inhaled. It's not a standalone drug. It's comes on top of two antibiotics separately and it's priced to well over $100,000 per year. We are looking forward to seeing the results of our study, which we believe will be generated relatively fast and believe that the eventual value proposition for this treatment option of a standalone orally administered first-line therapy, three times a week may well be attractive for patients if and when approved by the agency. I hope I answered the -- this question. I think you also asked about the acceleration?

Right? That's right. It, whether it would be an accelerated versus a full approval?

Right? The nature inherently of NTM infection and the way the regulatory agency looks at it, implies that there is a high degree of uncertainty, all the way to the market, to be honest, it's part of life. It's not unique to NTM infections. FDA has the dynamic process of reviewing and interacting with Academia and the KOL, and of course companies like ourselves and Insmed and things may not be clear until the very end. It's part of life. We are ready for that. We will conduct our study generate great results. And if successful as we believe there will be -- we are confident that the value proposition for patients and the payers will be such that agency will take those into account whatever regulatory uncertainty would remain at that point.

Great. Really appreciate the color on that one. And then maybe just on opaganib in COVID. So, you know, with the vaccine being likely close and several, you know, several EUAs being issued for therapeutics, does that sort of change how you think about where opaganib of best fits in, in the treatment paradigm, you know, whether that's more along the spectrum of -- outpatient versus the more severe hospitalized cases?

Thank you. So, the consensus is that vaccines and therapeutics are both going to be continued to be required in order to adequately control the COVID-19 pandemic in the foreseeable future. In terms of the Emergency Use Authorizations that have been granted to therapeutics, these as we mentioned, are at best incremental benefits that have been observed. The WHO has stated that [indiscernible] has little if any benefit from the studies that it conducted in various territories. Convalescent plasma has failed various studies. And the latest approval is also based on some minor improvements -- relatively minor improvements in secondary endpoints only. So there's a lot of unmet need to really find a therapeutic that will be a potential game changer in helping and benefiting the patients that sick with COVID-19. We believe opaganib and upamostat have a potential to uniquely address this unmet need given the profile that has a dual activity for opaganib, which combines the anti-viral -- very potent anti-viral activity and the anti-inflammatory activity which supports that and prevents the hyper immune response. So together, we think that this could provide a game changing outcome, of course, pending the outcome from the studies which we're conducting.

Okay. Got it. I will flip one more in. Just on the commercial front, in terms of the sizing of the sales force, you view that as appropriate for your needs at the present? And, you know, would you consider any, I guess, future expansion of the sales force and what would be the, you know, what would be the events that could trigger that?

Thank you, David. I'll refer this question to Rick Scruggs, our Chief Commercial Officer, out Raleigh, North Carolina. Rick, all yours.

Hey. Sure. Thanks for the question. So we currently feel that our current sales force size is sufficient to address our needs. We are currently looking at how we might optimize that group better. We're going through a process right now. We may are looking at considering additional people for integrated health systems or hospital sales, in particular as opaganib get emergency relief, authorization, merge to use authorization, we may need some help in hospitals and things like that. So, we're looking at all those things. So right now we'll come with our current salesforce size. Thank you.

Got it. Thanks for taking my questions.

Thank you. And your next question comes from the line of Bert Hazlett of BTIG. Please go ahead.

Hi, thanks for taking the call. This is Perry [ph] on the line for Bert Hazlett. Congrats on the progress. I've two questions related to Talicia, could you talk about any feedback that you're getting from your sales physicians on the willingness to kind of for this new approach, new rifabutin based approached for H. pylori treatment with Talicia, especially in the context like you said of antibiotic resistance in the space? And then second on the commercial size, could you give a bit of detail on the Salesforce size and any plans for growth if any going into the coming months and into 2021? Thanks.

Thank you, Perry. You raise the issue of resistance which is indeed critical and underlying this whole space. We know how high and how far the distance is growing and this is reflected in the ACG guidelines. Regarding your questions about feedback from the field, about the way prescribers look at it. And also the sales force size and our plans. I'm referring to Rick again.

Hey, thanks for the question. With regards to positions, acceptance of the product, it is been phenomenal. Physicians love the product. It works in patients across the board, new patients or factory patients, we are seeing physicians adopted product immediately. As you remember, there are no one else out there selling against us in this space to speak out. And also there's been no new therapies and new numerous years. So we're doing wonderful with the product. Our challenge with the product really is its access because of COVID. Our representatives are out there working diligently. Our marketing teams did a great job delivering the message to physicians, but still we have off to the close to start back up until middle of June. And then now, we're seeing more restrictions across the country. And so we have to abide by those restrictions. But our guys are doing great work out there. Physicians love the product. With regards to feel for sizing, as I stated previously, we're comfortable with the size we are right now. We are doing analysis right now in the fourth quarter to determine, you know, is this the right size? We don't envision that getting bigger? Do we need to do some other things for integrated health systems or hospitals or things, we're looking at that, but we're comfortable with the size we are in this size we are, can deliver the results that we're achieving. So, we're not looking to expand the Salesforce in the beginning of the year. Thank you.

Okay. Thanks. Thanks for the detail.

Thank you. And your next question comes from the line of Scott Henry of ROTH Capital. Please go ahead.

Thank you and good morning. And I apologize, if you've covered any of this already. I've been juggling multiple calls. But that said, first, Talicia, did you give any specific revenue for that product in the quarter?

Thank you, Scott, for being on the call. We have not. What we urge analysts, investors, everybody to do is to look at the script numbers, which we have detailed earlier in our presentation and happy to send it over to you. As scripts really is the best indication, because x factory sales are as you know oftentimes random. So the scripts are there. The numbers are available. That is in our presentation. The trend is very clear and very good with 300% growth quarter-over-quarter, and the price is logically available. So I'm sure, it can be figured out where we are heading given the information we provided.

Okay. And I guess just asking another way. Revenue was somewhat flat from second quarter to third quarter despite scripts going up for both. Were there any changes in inventory or anything that we should maybe factor in when we kind of back out the revenues?

Yes. So I mentioned earlier the legacy products, the legacy products are no longer with us. We voluntarily gave them back. They still had a meaningful impact in the previous quarter. So that answers part of your question. Everything you see now is our three approved products that we completely control Movantik, Talicia and Aemcolo. Secondly, X factory sales again can be somewhat random. Therefore, what we would urge is looking at the script, both Talicia and Movantik growing. Movantik is growing for the second consecutive quarter in terms of scripts, which is what matters. After years of decline from the moment that it took over, we have reversed the trend and that is very telling about what we could do with a product given our fresh thinking and highly, highly motivated sales force. With Talicia, the initial launch was into COVID in mid March, but from the moment of field salesforce went into the field in the end of May, beginning of June, you are seeing a very strong growth indicating how detail oriented the product is. You will see the products growing. And you will see a very healthy mixture of products in the total revenues in the coming quarter.

Okay. Great. Now shifting gears, expense items went up kind of notably sequentially from 2Q to 3Q and I know you have that PPP loan, which is sort of a contra reduction to expenses. So I guess the question is, when we look at Q3, should we think of those expense levels as being indicative going forward?

Thank you. This is Micha. Yes, we can look at Q3 expenses as indicative, as you rightly said, we had the positive impact of the triple P program, in the second quarter and did not have in this current quarter.

Okay. Thank you. And the final question, just on Aemcolo, obviously, that product has a lot of potential and other expanded indications beyond travelers' diarrhea. Can you talk about the thoughts about expanded indications there? And, I don't know what kind of -- how that is? It's obviously impacted by the Cosmo agreement. But can you just talk about potential for, leveraging that molecule?

Yes. Thank you, Scott. It's a, great question the potential outside the travelers' diarrhea is indeed very significant. This is currently under development and managed by our dear partners, that's a Cosmo. If and when the data is available sufficiently, we will be working with Cosmo to decide on the next step. For now, we would comfortably focus on travelers' diarrhea, because we are very confident, that the pandemic melts away over time, international travel will come back big time. Not only that, but it will come back with a far higher awareness of the risk of infection, and infections associated with loss of travel in particular, as we are all experiencing right now, given the COVID pandemic. So we have very high aspirations, for a quarter to come back big time and we're laying the ground for that Guy mentioned it. So we are doing everything that we need to do, to prepare the ground for a rapid takeoff. In scripts and demand for Aemcolo as soon as the international travel is back, the business or leisure or anything else.

Okay. Great. Thank you for taking my question.

Thank you. There are no further questions at this time.

Thank you, Valerie [ph]. Thank you all for joining the call. Please reach out to us if you have any additional questions. Keep safe. We wish you all a pleasant day.

Thank you, sir. Ladies and gentlemen, that does conclude your webcast for today. Thank you for participating. And you may now disconnect.