RedHill Biopharma Ltd (NASDAQ:RDHL) has reported its financial results and operational highlights for the first quarter ended March 31, 2021, with the company highlighting a strong end to the first quarter.
The company had a cash balance as of March 31, 2021, of approximately $92.1 million.
In the results statement, Dror Ben-Asher, RedHill's chief executive officer, commented: "The progress of our two novel, oral COVID-19 programs has put RedHill at the forefront of oral COVID-19 therapeutics development. Opaganib, one of the most advanced and promising novel, dual-mode of action, oral drug candidates in development for COVID-19, now has almost 100% enrollment in its global 464-patient Phase 2/3 study in severe COVID-19."
He added: "Commercially, a strong end to the first quarter has set up 2021 for growth, reversing a slow start to the year across the industry. Movantik's new prescriptions in the first quarter outperformed the same quarter last year, while Talicia's growth in prescription volume, repeat prescribing and new prescribers will be key growth drivers going forward. With the US now emerging from the shadows of COVID-19, patients returning to clinics and travel resuming, positively affecting Aemcolo's prospects, we are excited for the promise 2021 holds."
Enrollment in opaganib’s global Phase 2/3 study in hospitalized patients with severe COVID-19 (NCT04467840) is almost 100% complete. RHB-107’s Phase 2/3 study is ongoing in non-hospitalized patients with symptomatic COVID-19 (NCT04723527) who do not require supplemental oxygen. Together, this covers potential treatment for the vast majority of affected patients.
Movantik ended the quarter strongly with a 4% increase in new prescriptions compared to the first quarter of 2020, with market leadership position holding strong at 75% US market share. Talicia, which was launched in March 2020, continued to achieve new launch year milestones with 11% growth in prescription volume and a 39% increase in the number of repeat prescribers compared to the previous quarter. The quarter ended strongly, resulting in the highest levels of monthly and weekly prescription volume and number of prescribers for Talicia since launch.
The company said its net revenues were approximately $20.6 million for the first quarter of 2021, a decrease of $0.9 million compared to the fourth quarter of 2020, which was mainly attributable to typical cyclical trends in Movantik sales.
Its gross profit in the period was approximately $10.3 million, a decrease of $0.5 million compared to the fourth quarter of 2020, mainly reflecting the decrease in net revenue, while it maintained a consistent gross margin of approximately 50%..
Micha Ben Chorin, chief financial officer at RedHill noted: "A strong March helped rebalance quarterly revenues, as we maintained cash burn rate at previous quarter levels. With a healthy balance sheet, we are well-positioned to drive our late-stage R&D programs forward, as we work diligently to build on the upward trends across our core business."
RedHill is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes three gastrointestinal drugs; Movantik for opioid-induced constipation in adults, Talicia for the treatment of Helicobacter pylori (H. pylori) infection in adults, and Aemcolo for the treatment of travelers' diarrhea in adults.
The company's key clinical late-stage development programs include:
- (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease;
- (ii) opaganib (Yeliva, ABC294640), a first-in-class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing;
- (iii) RHB-107 (upamostat), a serine protease inhibitor in a US Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases;
- (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease;
- (v) RHB-102 (Bekinda), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D;
- (vi) RHB-106, an encapsulated bowel preparation.
Contact the author at jon.hopkins@proactiveinvestors.com