RedHill Biopharma Ltd (NASDAQ:RDHL) has reported its financial results and operational highlights for the third quarter ended September 30, 2021, showing a second consecutive quarter of record net revenues, increased gross profit and growth in Talicia and Movantik prescriptions.
The company also announced it is accelerating its two advanced coronavirus (COVID-19) pill clinical programs, both of which act independently of spike protein mutations via unique host-targeted mechanisms of action, and that hold potential versus Omicron and other SARS-CoV-2 variants.
Redhill posted net revenues of $21.6 million for the third quarter of 2021, as compared with $21.5 million for the second quarter of 2021. The increase was attributable to an increase in sales of Talicia and Movantik, partially offset by an increase in gross-to-net deductions, mainly commercial rebates and Medicare discounts.
The company reported a gross profit of $12.4 million for the third quarter of 2021, compared to $10.9 million for the second quarter of 2021 - an increase of 14%. Its gross margin increased from 51% in the second quarter of 2021 to 57% in the third quarter of 2021. RedHill's cash balance as of September 30, 2021, was $51.5 million.
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In a statement, Dror Ben-Asher, RedHill's chief executive officer commented: "Our US commercial business continues to drive growth, delivering a second consecutive quarterly net revenue record of $21.6 million despite the continuously challenging pandemic environment. Talicia generated another record quarter with 15% growth in new prescriptions, while Movantik continues to perform adding a 1.1% increase to new prescriptions. Both products are also continuing to make strides in gaining both commercial and government formulary coverage.”
Ben-Asher continued: "Given the recent emergence of the heavily mutated Omicron variant as well as likely emergence of other variants over time, the importance of drug candidates that act independently of the viral spike protein is growing. This makes both opaganib and RHB-107's host-targeted mechanism of action, and expected maintenance of effect against new variants, increasingly more relevant in the battle against COVID-19.”
"The initial top-line results demanded further investigation and our rigorous post-hoc analysis provided much greater clarity into the potential of novel, orally-administered opaganib in the underserved hospitalized moderately severe patient group. This is a group of patients for which no novel therapeutic pill has shown a benefit until opaganib, which demonstrated a 62% reduction in mortality, improved return to room air and earlier hospital discharge for opaganib-treated patients. The results of this analysis, in a group of more than half the total study population, were consistent with what we had seen in our Phase 2 study and compassionate use experience."
RedHill's chief executive officer added: "Despite being a post-hoc analysis, the consistency across multiple endpoints and territories provides us with a high degree of confidence in the results showing opaganib's effect in this patient population. This analysis also shed light on key issues of the COVID-19 disease severity classification, suggesting that FiO2 might be an improved method for classifying disease severity and predictor of treatment outcome. We have now provided regulators in various countries with all the necessary data to facilitate discussions on the next steps and we continue to provide the data to regulators in additional countries."
"In parallel, we continue to progress our Phase 2/3 study in the US and South Africa with our other novel, once-daily, oral COVID-19 antiviral drug candidate, RHB-107, which has now completed enrollment for Part A of the study, with top-line results expected in the first quarter of 2022. Our Phase 3 study of RHB-204 in pulmonary nontuberculous mycobacteria (NTM) disease continues to enroll patients in the US and progress with Phase 3-stage RHB104 for Crohn's disease is expected to speed up thanks to recent, much-awaited, potential progress in Mycobacterium avium subspecies paratuberculosis (MAP) detection research."
Ben-Asher concluded: "With a steep reduction in quarterly operating and net loss and continued commercial business growth, leading to a potential commercial operational breakeven before the end of the year, coupled with advanced, exciting and timely R&D pipeline progress, I believe RedHill is well-positioned for short, medium and long-term success."
Contact the author at jon.hopkins@proactiveinvestors.com
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