RedHill Biopharma Announces Increase in Net Revenue, Prescriptions and Gross Profit for Q3 2021, Accelerates COVID-19 Pill Programs in Light of Potential Against Omicron



Dror Ben-Asher, CEO of RedHill, commented: “Our business in the United States continues to drive growth, posting a second consecutive quarterly net income record of $ 21.6 million despite a still challenging pandemic environment. “

RedHill Biopharma Ltd (NASDAQ: RDHL) released its financial results and operating highlights for the third quarter ended September 30, 2021, showing a second consecutive quarter of record net revenues, an increase in gross margin and growth in prescriptions of Talicia and Movantik.

The company also announced that it is accelerating its two advanced coronavirus (COVID-19) clinical programs, both of which act independently of spike protein mutations via unique host-targeted mechanisms of action, and which have potential compared to Omicron and other SARS-CoV-2 variants.

Redhill posted net revenues of $ 21.6 million for the third quarter of 2021, compared to $ 21.5 million for the second quarter of 2021. The increase is due to increased sales of Talicia and Movantik, partially offset by an increase in net deductions, mainly trade rebates and Medicare rebates.

The company reported 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, CEO of RedHill, said, “Our business in the United States continues to drive growth, posting a second consecutive quarterly net income record of $ 21.6 million despite the environment. continually difficult pandemic. Talicia generated another record quarter with 15% growth in new prescriptions, while Movantik continues to record a 1.1% increase in new prescriptions. Both products also continue to make progress in obtaining commercial and government formularies coverage. “

Ben-Asher continued, “Given the recent emergence of the highly mutated Omicron variant as well as the likely emergence of other variants over time, the importance of drug candidates that act independently of the protein of viral peak increases. This makes both opaganib and RHB- 107 host-targeted mechanism of action and expected maintenance of effect against newer variants, increasingly relevant in the battle against COVID-19 . “

“The first first-line results required further investigation and our rigorous post-hoc analysis provided much greater clarity on the potential of the new orally administered opaganib in the under-served group of moderately severe hospitalized patients. This is a group of patients for whom no new therapeutic pill has shown benefit until opaganib, which has shown a 62% reduction in mortality, better return to room air and earlier discharge from hospital for patients treated with opaganib The results of this analysis, in a group of more than half of the total study population, were consistent with what we saw in our study of phase 2 and our compassionate use experience. “

The CEO of RedHill added: “Although this is a post-hoc analysis, the consistency between several parameters and territories gives us a high degree of confidence in the results showing the effect of opaganib on this. patient population. This analysis also shed light on key issues in classifying COVID-19 disease severity, suggesting that FiO2 may be an improved method for classifying disease severity and predicting treatment outcome. We have now provided regulators in various countries with all the data necessary to facilitate discussions on next steps and continue to provide the data to regulators in other countries. “

“At the same time, we continue to advance our Phase 2/3 study in the United States and South Africa with our other new once-daily COVID-19 oral antiviral drug candidate, RHB-107, which has now completed enrollment for Part A of the study, with first-order results expected in the first quarter of 2022. Our phase 3 study of RHB-204 in non-tuberculous mycobacterial lung disease (NCD) continues to enroll patients in the United States. -United and progressing with phase 3 RHB104 for Crohn’s disease is expected to gain momentum thanks to recent and much anticipated potential advances in research into the detection of Mycobacterium avium subspecies paratuberculosis (MAP) “.

Ben-Asher concluded: “With a sharp reduction in quarterly operating and net losses and continued growth in business activity, leading to potential business operational break-even by year-end, coupled with progress advanced, exciting and timely R&D pipeline, I believe RedHill is well positioned for short, medium and long term success. “

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