RedHill Biopharma – EKF interview

Thank you for hosting me.

Sure, happy to do that. So, RedHill is a NASDAQ-listed company. Our focus is on gastrointestinal and infectious disease, which is a very hot topic and very important topic these days. What makes us unique is that we're a very fast-growing specialty pharma company with both advanced R&D and commercial operations. On the R&D side, most of the news and attention that's come our way is for opaganib, that's our treatment for COVID-19. Opaganib is one of the most advanced novel investigational drugs worldwide today for COVID-19. It's an oral drug, it has a very unique dual mechanism of action and very strong preclinical data. We are right now in parallel a U.S. Phase II study and a global Phase II/III study with very near-term data readouts. In addition, we have a full pipeline with other late-stage products. On the commercial side of things, we have operations based in Raleigh, North Carolina with 100 sales reps. We're seeing very strong growth and we expect this continued revenue growth to bring us to cash flow break-even on a quarterly basis possibly sometime next year. The two key drivers of that are Movantik, which is a brand leader in opioid-induced constipation, a very important indication. We acquired this product in the beginning of April from AstraZeneca. And Talicia, it's another great product. This is one we developed ourselves for H. pylori infection. We got it approved and launched it just recently. It's targeting a very large medical need, first new drug approved in over a decade, and we expect it to be best-in-class and potentially first-line and the new gold standard really for H. pylori infection.

Yeah, thank you for the question. As I mentioned, opaganib is one of the most advanced novel investigational drugs out there today for COVID-19. It has a unique mechanism of action that's supported by extensive pre-clinical and clinical data, which has allowed us to advance the drug rapidly into advanced clinical studies. As I mentioned, a U.S. Phase II and a global Phase II/III study, both of them are well into recruitment with data right around the corner. And after that, we could potentially submit for emergency use authorization, so we're talking about very near-term timelines. As I mentioned, it's a novel molecule with a unique mechanism of action in that it's both anti-viral and anti-inflammatory, and I think that makes it really stand out among the competition. And of course, being an oral pill is also very important. Two key sets of data really get us excited about the potential. The first is pre-clinical data that we have in an actual COVID-19 cell line, a model that models the disease. We showed complete inhibition of viral replication in that model. And importantly, remdesivir was used as a control and we had great success even compared to remdesivir. Second, we also made the drug available on a compassionate use basis with hospitalized COVID-19 patients. This was back in March, April, and the results were also very, very exciting. Of five valuable patients with moderate to severe COVID-19 who were in the hospital requiring oxygen, all of them were weaned off oxygen and were able to be released from the hospital after treatment. So this is another piece of very important supportive data. So we're very excited about where we are. We're getting very close to data announcements, and if we're successful, it really could revolutionize treatment protocols for this disease. As a reminder, there's no really good drug out there right now despite all the money that's been invested both by pharma companies and by the government. None of the treatments out there so far have really shown to solve the problem that we're facing on a global level.

Yeah, thanks for the question. So we're very excited about where we are on the commercial side. We've developed and expanded our commercial team significantly. And at the end of the day, especially with pharmaceutical commercial sales, the foundation of success is your people. Our headquarters are in Raleigh, North Carolina, our U.S. headquarters, and we brought in a very experienced team. Many of them came from Salix. Salix, for those of your listeners who may not be familiar, was one of the most successful GI companies in the world before it was bought out by Valeant. And many of the people who made it successful were unfortunately for them let go, fortunately for us, because we were able to bring them in and have them help lead our commercial operation. So you have a team that's worked very closely together already. You have a team that's been very successful in the gastrointestinal space and they're basically leading the drive for our commercial operations. As I mentioned, it's 100 sales reps right now, supported by core functions including managed markets team, medical affairs team, trade team, all the core teams you would want to see in a full commercial operation. The two key products, you mentioned correctly, is first Movantik that we acquired from AstraZeneca. They spent a huge amount of money, significant investment to make this a brand leader in opioid-induced constipation. It's a great synergy for our commercial efforts for Talicia, which is our other major product, in addition to Aemcolo. And we get to benefit from that significant investment made by AstraZeneca who made it the brand leader. In our first quarter of the product being in-house, it did $20 million approximately in revenue, and that's with the restrictions on the industry that the whole industry has faced because of the pandemic. Since taking it over, we've seen script growth. We have a larger sales footprint than what AstraZeneca was putting behind the product, more focus. We have, for example, a digital marketing strategy that we're working on. So we're very excited about the potential for this product. Talicia is our second major product. We're seeing script growth there as well, a lot of market enthusiasm. We see continued wins in managed care and we're looking forward to taking this product and making it the gold standard for H. pylori. We also have a third product, Aemcolo, which is an important product for us. It's for travelers' diarrhea, to travel as a stop. So that is one that will become an important product for us when travel returns.

Yeah, so I think I would break it into two buckets. The first is on the commercial side. So every quarter we're going to have an earnings call and we'll be reporting all our financials and giving an update on our commercial progress. So I definitely encourage people who are interested in our story to follow those earnings calls and listen in. What we hope to see is continued revenue growth and expanded commercial activities that we hope will bring us to operational break-even on a quarterly basis sometime next year. That will be a very, very important milestone for the company. For Talicia, we want to become the new gold standard for H. pylori infection. The data is great, it's an area of huge unmet medical need and we think this product is well positioned to do that. For Movantik, we want it to continue to grow in the opioid-induced constipation space. This is a disease area with still huge unmet medical need and we think Movantik is a great solution for a lot of patients. On the R&D side, as I mentioned, opaganib, we have data readouts in COVID-19 for our two clinical studies. Nothing else out there that people have developed really works very well despite all the research and investment. So this really could be a game changer that will get everyone talking. So we're very excited about that. We also have other products in our R&D which are advancing. NTM, for example, HP204 in NTM, it just got clearance from FDA to begin a Phase III. And we have other programs that we don't have the time unfortunately to elaborate on, but we have a very active R&D program to supplement our commercial operation. So there's a lot to look forward to and a lot for investors to follow, and we look forward to a very successful year coming up.

Thank you very much.