Redhill Biopharma
Tässä vähän luettavaa RDHL:n tiedotustilaisuudesta 12.11.2020 faasi 2/3 dataa tulossa marras-joulukuussa myös Covid-19 - lääketesteistä
Dror Ben-Asher
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.
Guy Goldberg
Hello, this is Guy Goldberg, Chief Business Officer. Hello, everyone.
For the new folks to the call who are not familiar with RedHill, we are rapidly growing fully integrated, U.S. specialty company, NASDAQ listed with the focus on GI 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, very serious and widespread bacteria infection, a need of new more effective treatments. And Amecolo, 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 Amecolo ready for full promotion when travel resumes, and 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 readout. Opaganib is being increasingly noticed, and stands out of the crowd, thanks to its unique dual mechanism of action, dramatic preclinical data and viral inhibition and rapid advance through clinical trials.
Second quarter was a transformative quarter in our company’s history, as we generated record net revenues. Now in 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 have done that.
We completed the Movantik acquisition. And 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.
And also as you get more experienced with the product and indication, we continue to see strong script – strong script growth in Talicia. And we expect continue to build on that momentum, as we launch and expand, 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 moving quickly. We are nearing completion of our U.S. Phase 2 study. That is expected in the next month, depending on recruitment rates of the last few patients at the end of the study.
And 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. And we have begun ramping up manufacturing in anticipation of this.
Our RHB-204 Phase 3 study for NTM disease was cleared by FDA in July. The study will be for first line and could be the first one to market. RHB-204 the stand-alone orally administered treatment we are currently initiating clinical trial activities and expect first patient any 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.
So investors knew to the story can appreciate our diverse development activities. First, RHB-104 for Crohn’s, 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. And finally, in oncology, we have an ongoing Phase 2 – we have ongoing Phase 2 studies with opaganib a leading 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 specifically.
We have built a world-class commercial team headquarters 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. And 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.
Gilead Raday
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.