RedHill Biopharma Ltd. Q3 FY2020 Earnings Call

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. 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 continued 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, reversing the trend of prescription decline prior to its acquisition by 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's 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 nontuberculous mycobacterial 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 of building and leading a lasting specialty pharma company. Our highly motivated team remains focused on RedHill's exciting short-term, mid-term and long-term growth trajectory. In the short term, we continue to work towards the goal of 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 to see our detailed slides as we present select business highlights to be followed by a 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 million and gross profit of $10.6 million, or approximately 51%, up substantially from around 32% in the second quarter of this year. Research and Development expenses were $4.3 million compared to $3.2 million in the previous quarter. The increase was primarily attributable to progress in our COVID-19 study. Net cash used in operating activities was reduced to $9.2 million in Q3 compared to $15 million in the 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 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 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 those by big pharma, we are at the forefront here and could be among the very first companies with a truly effective treatment, and excitingly, we will know the answer very soon. This is our disclaimer, which echoes the disclaimer presented at the start of the call. For the new folks on the call who are not familiar with RedHill, we are a rapidly growing fully integrated U.S. specialty company, NASDAQ listed with a focus on gastrointestinal and infectious disease. We are commercializing three FDA-approved products; Movantik, which is indicated for opioid-induced constipation, the most common side effect of opioid therapy. Talicia, which is indicated for H. pylori infection, a serious and widespread bacterial infection, needing new, more effective treatments. And Aemcolo, which is indicated for travelers' diarrhea caused by E. coli, and which will become an increasingly important product as soon as international travel returns, which we believe will happen next year. We are undertaking several brand promotional activities to get Aemcolo ready for full promotion when travel resumes, and we are excited about its commercial prospects. We have a robust and very advanced R&D pipeline with several important late-stage products and a strong track record of clinical success. Importantly, opaganib, our novel, orally administered COVID-19 drug candidate is currently in both the U.S. Phase 2 and global Phase 2/3 study. They are both very close to data readouts. Opaganib is being increasingly noticed and stands out from the crowd, thanks to its unique dual mechanism of action, dramatic preclinical data and viral inhibition and rapid advance through clinical trials. The second quarter was a transformative quarter in our company's history as we generated record net revenues. Now in the third quarter, we continue that progress and again report 300% quarter-over-quarter script growth with Talicia and also steady quarter-over-quarter growth with Movantik. Overall Q3 net revenues were approximately $21 million with improved gross profit. We mentioned on the earnings call last quarter that we believe the renegotiated terms with Daiichi for Movantik will improve our gross margins, and in fact, they have done that. We completed the Movantik acquisition. After a period of decline in scripts before we took over, we've been able to turn the script around. We expect script growth to continue as we now have a larger sales effort targeting more doctors than AstraZeneca did when we took over the product. As you get more experienced with the product and indication, we continue to see strong script growth in Talicia. We expect to continue to build on that momentum as we expand our launch activities, even with the current challenging pandemic conditions. We are well positioned to reach operational breakeven next year. As Micha said, this is a consistent message we have given since last quarter. On the R&D side, our COVID-19 studies with opaganib are moving quickly. We are nearing completion of our U.S. Phase 2 study expected in the next month, depending on recruitment rates of the last few patients at the end of the study. We are moving at a great recruitment pace for our global Phase 2/3 study, we expect that in Q1 of 2021. Given these timelines, emergency use authorization applications could come as soon as Q1 2021. We have begun ramping up manufacturing in anticipation of this. Our RHB-204 Phase 3 study for nontuberculous mycobacterial disease was cleared by the FDA in July. The study will be for first line and could be the first one to market. RHB-204 is the stand-alone orally administered treatment we are currently initiating clinical trial activities and expect the first patient to be enrolled soon. This is our pipeline chart. The top part shows the commercial products, and the bottom part shows R&D. For R&D, since we will discuss COVID and NTM on this call, I will briefly mention several other important products that are not being discussed today. For investors new to the story can appreciate our diverse development activities. First, RHB-104 for Crohn's disease, we had a successful Phase 3 study, and now we are working on a diagnostic for MAP infection before we begin our next Phase 3 study. RHB-102, we had positive results for Phase 3 in gastroenteritis and positive results in Phase 2 in IBS-D; RHB-106, our bowel prep product, which we plan to move into a Phase 2 study. Finally, in oncology, we have ongoing Phase 2 studies with opaganib led by a U.S. oncology center. This slide puts us in perspective, where we came from and where we're going. We've grown from an R&D company to a fully integrated Specialty Pharma Company with a small-scale commercial operation to now being an important U.S. specialty company and one of the leaders in GI infectious diseases. We have built a world-class commercial team headquartered in Raleigh, North Carolina and a field sales team with our leadership led by Rick Scruggs, who's on the line, coming from Salix, one of the most successful GI companies ever. We have a very highly motivated sales team with 100 reps. Our reps are very good at what they do. We're excited to have them back in the field working wonders, with our continued rapid and consistent growth, both organically such as with Talicia, which we developed ourselves, and non-organically, such as with our acquisition of already approved products Movantik and Aemcolo. We hope in the coming years to be a leader in specialty pharma in the U.S. I will now turn it over to Gilead to walk through the progress we have made in R&D.

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 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 advantage of likely remaining effective despite viral mutations, which might render direct antiviral acting compounds ineffective. Both of 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, representing a multi-billion dollar global market opportunity. 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 combines 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. In addition, extensive preclinical data indicates broad properties of Opaganib and also anti-inflammatory activity, which is highly applicable to the damaging hyper immune responses associated with COVID-19. Importantly, by targeting a human host cell factor involved in viral replication, Opaganib has the key advantage of being far less vulnerable to the possible emergence of viral resistance through mutation. Opaganib clinical safety data has been obtained in over 200 patients indicating its good safety and tolerability. Furthermore, as published on medRxiv, compassionately using Opaganib in severe COVID-19 patients demonstrated a substantial benefit to those patients treated with Opaganib compared to matched case controls from the same hospital treated with standard of care. Encouraging signals were obtained in reducing the need for mechanical ventilation with zero such cases in the Opaganib treated patients compared to one-third of the matched case controls. In addition, marked improvements in time to recovery and in inflammatory markers were observed. With its unique dual mechanism of action, Opaganib has the potential to address the full spectrum of COVID-19 populations from mild outpatients to severe inpatients. On the basis of the highly promising profile of Opaganib, we have been rapidly advancing rigorous clinical studies of Opaganib and hospitalized COVID-19 patients, and are also wrapping up manufacturing to support commercial distribution in anticipation of potential emergency use application as early as Q1 2021. For a quick update on the progress of our ongoing Opaganib COVID-19 studies, the Phase 2 study is over 90% enrolled with three subjects remaining to get to the full 40 subjects. The object of this study is to establish safety and efficacy signals and it was not powered for statistical significance. We already know that the studies' independent unblinded Safety Monitoring Committees have twice recommended continuing the study without any changes, providing another positive indication regarding Opaganib's safety. We have been very careful about screening and randomizing appropriate patients into the study to ensure high data quality and reliability. We anticipate completing enrollment in the coming days with top line readout by the end of this year. The ongoing global Phase 2/3 study has been approved in the U.K., Italy, Russia, Israel, Mexico, and Brazil. It is enrolling swiftly and we are nearing 50% of the target 270 hospitalized patients with severe COVID-19. We are pleased with the pace of enrollment and are continuing to expand the study to additional territories. The Phase 2/3 study includes safety and efficacy analysis by an Independent Monitoring Committee. The outcomes will be reported as we receive the committee's recommendations in the coming weeks. The global Phase 2/3 study is designed to detect the benefit of Opaganib in reducing the proportion of patients progressing to either requiring mechanical ventilation or, unfortunately, dying. The study will also assess a comprehensive array of standard outcomes, including times to recovery, viral load, and inflammatory markers. A positive outcome of these studies could potentially support emergency use application as early as Q1 2021. We are cautiously optimistic about these prospects given Opaganib's highly promising product profile and the safety and efficacy signals obtained to date. The final update is our second Phase 2/3 COVID-19 program, targeting COVID-19 patients in the outpatient setting. It is a novel orally administered serine protease inhibitor with potent anti-SARS-CoV-2 activity, as demonstrated in a model of human bronchial tissue. Upamostat also has a demonstrated clinical safety profile from over 300 patients across multiple clinical studies. Given its promising profile, we have designed a Phase 2/3 study of Upamostat in COVID-19 applications, which is planned to be initiated in the U.S. in the coming weeks. On other pipeline fronts, we are initiating the Phase 3 study for treating first-line nontuberculous mycobacterial infection with RHB-204. Nontuberculous mycobacterial infection, or NTM in short, is a rare disease with chronic debilitating manifestations, and with no FDA approved first-line therapy. RHB-204 is a promising potential first-line standalone oral therapy intended to safely and effectively treat NTM. We have received FDA clearance to initiate the Phase 3 study in pulmonary NTM disease. The randomized placebo-controlled study is planned to enroll 125 subjects at up to 40 sites across the U.S., and we expect to start screening and enrolling patients in the coming weeks. RHB-204 has been granted both orphan drug and qualified infectious disease product designation, so it is eligible for fast track development, priority review of the NDA, and the full 12 years of market exclusivity. With the initiation of the Phase 3 study, RHB-204 is well-positioned to address the unmet medical need for an approved, safe and effective first-line therapy for the growing numbers of NTM patients, reflecting a U.S. market opportunity in excess of $500 million. I'll now turn it back to Guy to update on our commercial progress.

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, a serious and widespread bacterial infection in need of new, more effective treatments; 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, there have been no disruptions to our supply chain. Our field promotion, which was shut down from March through May, like everyone else's, has been returning steadily to the field since early June. We are now calling on doctor's 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 reemphasize that this slide is industry-wide data; it's not specific to RedHill. 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 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 continue to be significantly lower. This is especially true for gastroenterologists and primary care physicians, which are two major target physician groups for us. Industry-wide levels of new-to-brand scripts is an important metric, since launches depend on new brand writing by doctors. Notwithstanding those caveats, we are happy with the progress we are making and our prospects in the coming quarters, as you will now see. So I'll now discuss our Talicia launch performance. To recap, we launched Talicia in March and due to the restrictions related to the pandemic, only since June have we been gradually returning to the field, and with our return to the field we see a very nice correlating increase in monthly script volume, which you see here. As we mentioned, about 300% quarter-over-quarter growth. Launches are very promotion-sensitive, and September was our best month yet, both in terms of presence in the field and also script volume, and we expect continued momentum and significant growth in this product. Similar to the prescription trend, the ability to engage with healthcare professionals in Q3 was influenced by the rate of new COVID-19 cases. Our sales team, medical science team, and our Thought Leader Liaison have been actively educating healthcare professionals throughout the pandemic, whether virtually or in-person. We expect the mix to continue to trend towards in-person detailing depending, of course, on the course of the pandemic. We believe in the immense potential of Talicia. There are at least 2 million Americans treated for H. pylori every year, possibly as many as 3 million, and Talicia is on its way to become the new standard of care for first-line H. pylori treatment. This slide shows another reason why we are optimistic. It is not just the script volume that is increasing, but also the type of scripts we are getting. We're seeing growth both in the number of unique prescribers and also in the number of prescriptions per prescriber; both are important metrics for changing prescribing habits and resulting future growth. Considering the number of prescribers we have versus the numbers out there, we are only scratching the surface of what is possible here. This slide looks at the coverage status; we are very happy with the initial coverage we have. As you can see on the right, we put a lot of effort to make sure there was good coverage at launch, and we have been working very hard since then to increase that number. Right now, we have national coverage for 167 million lives. This includes importantly, Express Scripts and Prime as the biggest PDMS in terms of commercial lives. This is a high priority for us as a company, and we have a fully dedicated managed markets team spread around the country focused on getting more wins with payers all the time. We have a lot of initiatives underway to drive awareness with healthcare practitioners and patients. This slide shows a few of them. This launch is a highly coordinated activity across our entire commercial organization. We're working very hard to keep the momentum going. So switching gears to Movantik, our brand leader for opioid-induced constipation. Our key initial focus after we acquired this product from AstraZeneca has been reversing the decline in scripts in recent years, and critical to that goal was getting this product fully transitioned to RedHill from AstraZeneca. The transition activities are important because the product and all related aspects of it need to be in our hands for us to have control and drive growth the way we want. We are pleased that we were able to seamlessly take over Movantik, especially in light of how challenging transitions can be. We have now completely taken over the product and are ready to take it to the next level of success. This slide shows one of the critical things we're doing differently that has been successful, and not only stopping the brand decline seen with AstraZeneca, but also turning the product around into growth. What we have done is increased the physician base that we are targeting, and we continue to add targets all the time. So right now, we have about 40% more targets than AstraZeneca. That is important because with more quality targets come more opportunities to generate scripts. As we continue to grow our sales footprint, we plan to eventually reach more than 20,000 healthcare practitioners with Movantik. This slide shows quarterly new prescriptions and total prescriptions from Movantik. Despite the pandemic, we're seeing Movantik growth, which, as I mentioned, has turned around the trend that existed before we took over the product. We're very proud of our commercial team for this accomplishment. This slide provides script data on a more granular monthly basis and also shows Movantik's brand leadership position within the promoter class. The promoter class has stayed pretty consistent over time in terms of overall script volume, and this slide shows the excellent coverage we have from Movantik. AstraZeneca did a great job getting coverage both in terms of percent of lives covered and also percent of lives with preferred coverage. We have maintained that excellent coverage during the transition, and this is a very important accomplishment. We are in great shape to begin with, and we aim to build on that success even further. And finally, here are some of the extensive marketing initiatives we are undertaking to support the ongoing tireless efforts of our sales team in the field. As examples, we're doing broad patient outreach programs such as online engagement, and are also running professional education programs. We are very active in digital media. Turning to our third commercial product, we are excited about Aemcolo, which we acquired from our great partners at Cosmo. Aemcolo is indicated for travelers' diarrhea and, of course, because international travel has come to a halt, that has significantly affected this market. We know that international travel will return. We believe this will happen next year. And when it does, we will be prepared with Aemcolo, a product with enormous potential that could become the standard of care for this largely neglected and important indication. I will now turn it over to Micha for discussion of the financial highlights of this quarter.

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 questions that the audience has.

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 several larger-scale manufacturing 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 EUA application. As things progress, we expect to 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 U.S. 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 chains are being compiled and secured as we speak. Some of them are already secured.

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

The most important factor here is, of course, scripts, which we presented in detail. The ex-factory sales can be pretty random, especially when launching a product. Therefore, what we would urge people to do is to look at the scripts. The pricing is publicly available, and that's really the best available key indicator for growth. As we discussed, there was 300% growth in prescriptions 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 scripts, 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 program's 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 planned to enroll 125 patients, and we hope to complete the enrollment at up to 40 sites across the U.S. within a year. 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 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 progress.

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 the 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 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's intentions, we know the product. We are aware of several differentiating factors; I will name a few. RHB-204 is an orally administered drug; it will be administered three times a week. It is a standalone drug and is not administered on top of anything else. You can also feel that the absence of a device provides us a somewhat more price elasticity. The Insmed brand ARIKAYCE is indicated for refractory patients, and it's inhaled. It's not a standalone drug; it comes on top of two antibiotics separately and is priced at over $100,000 per year. We are looking forward to seeing the results of our study, which we believe will be generated relatively quickly. We believe that the eventual value proposition for this treatment option of a standalone orally administered first-line therapy, three times a week, may be attractive for patients if and when approved by the agency. I hope I answered your 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. The FDA has a dynamic process of reviewing and interacting with academia, key opinion leaders, 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 and generate great results. If successful, as we believe, the value proposition for patients and payers will be such that the 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 EUAs being issued for therapeutics, does that sort of change how you think about where opaganib 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 required 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 Remdesivir 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 needs to really find a therapeutic that will be a potential game changer in helping and benefiting the patients suffering with COVID-19. We believe opaganib and upamostat have the potential to uniquely address this unmet need, given the profile that has a dual activity for opaganib, which combines very potent antiviral activity and anti-inflammatory activity, which supports and prevents the hyper immune response. Together, we think 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, do you view that as appropriate for your needs at present? And, you know, would you consider any future expansion of the sales force, and what would trigger that?

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

Hey. Sure. Thanks for the question. So we currently feel that our 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 consider adding additional staff for integrated health systems or hospital sales, particularly as opaganib gets emergency 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're comfortable with our current sales force 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 on the line for Bert Hazlett. Congrats on the progress. I have two questions related to Talicia. Could you talk about any feedback that you're getting from your sales physicians on the willingness to embrace this new rifabutin-based approach for H. pylori treatment with Talicia, especially in the context of the antibiotic resistance in the space? And then second on the commercial size, could you give a bit of detail on the sales force 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 is underlying this whole space. We know how high and how far the resistance 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 has been phenomenal. Physicians love the product. It works in patients across the board, new patients or refractory patients; we are seeing physicians adopt the product immediately. As you remember, there is no one else out there selling against us in this space to speak out, and there have been no new therapies in years. 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 had to close down until about mid-June. Now, we are seeing more restrictions across the country. We have to abide by those restrictions. Our guys are doing great work out there. Physicians love the product. Regarding the size of the field team, as I stated previously, we're comfortable with the size we are right now. We are doing an analysis in the fourth quarter to determine if this is the right size. We do not envision needing to grow much larger 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. 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. We urge analysts, investors, and everybody to look at the script numbers, which we have detailed earlier in our presentation, and we are happy to send it over to you. The scripts really are the best indication, as ex-factory sales, as you know, can oftentimes be random. The scripts are strong and trending well with 300% growth quarter-over-quarter. The pricing is logically available, so 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 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 with our three approved products that we completely control: Movantik, Talicia, and Aemcolo. Secondly, ex-factory sales can again be somewhat random. Therefore, we urge you to look at the scripts. Both Talicia and Movantik are growing; Movantik is growing for the second consecutive quarter in terms of scripts, which is what matters. After years of decline from the moment we 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 our highly motivated sales force. With Talicia, the initial launch was into COVID in mid-March, but from the moment our 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 total revenues in the coming quarters.

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 PPP program in the second quarter and did not have it 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 travelers' diarrhea is indeed very significant. This is currently under development and managed by our partners. If and when the data is available sufficiently, we will work with them to decide on the next step. For now, we should comfortably focus on travelers' diarrhea because we are very confident that the pandemic will melt away over time, and 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 associated with loss of travel, particularly 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 groundwork for that Guy mentioned. So, we are doing everything we need to lay the ground for a rapid takeoff in scripts and demand for Aemcolo as soon as international travel resumes, whether for business or leisure.

Okay. Great. Thank you for taking my question.

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

Thank you, Valerie. 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.