Emmaus Life Sciences Inc (OTCQX:EMMA) CEO Yutaka Niihara said the company has made substantial progress in expanding access to Endari for sickle cell disease patients over 2021.
Recently, the Torrance, California-based firm presented data from a post-hoc analysis of the Phase 3 clinical study of Endari, the company's prescription L-glutamine oral powder, in patients with sickle cell disease, that confirmed Endari meaningfully reduces both pain crises and hospitalizations.
During the year to the end of December 31, 2021, the biopharmaceutical company also said it generated $20.6 million in revenue compared to $23.2 million in 2020.
READ: Emmaus Life Sciences says its Endari sickle cell treatment to be added to Florida Medicaid’s preferred drug list
Emmaus told shareholders that sales volumes of Endari were steady, but revenues were hit by higher and more frequent discounts afforded distributors on bulk pre-orders in 2021 compared to 2020.
"Although our financial results for 2021 were below our expectations, we anticipate that the full roll-out of our new telehealth solution in the coming weeks will improve patient access and efficiency in the delivery of Endari to sickle cell patients throughout the United States,” Niihara said in a statement accompanying the numbers.
“Internationally, we are pleased to have recently received marketing approval of Endari in the UAE and our first major order from our exclusive distributor there. We are actively pursuing additional marketing approvals of Endari to treat the approximately 225,000 sickle cell disease patients throughout the Middle East North Africa (MENA) region and we expect this expanded distribution, along with our telehealth solution, to help generate increased sales of Endari during 2022," he added.
For the 2021 financial year, Emmaus reported a net loss of $15.9 million or $0.32 per share compared to net income of $1.4 million or $0.03 per share in the same year-ago period, which it attributed to higher research expenses and a $3.5 million increase in foreign exchange losses, among other expenses.
But the Emmaus CEO told investors that the 2022 year is shaping up to be “an exciting one” as the company expands its clinical pipeline.
“We have seen promising results from our ongoing preclinical studies of the IRAK4 inhibitor licensed from Kainos (LSE:KNOS) Medicine Inc in October 2021, which may prove to be a novel, potential treatment option for hard-to-treat lymphomas such as Waldenstrom's Macroglobulinemia with MYD88 mutation,” Niihara added.
“We also eagerly anticipate results from an additional proof-of-concept study of Endari as a treatment for diverticulosis, expected in mid-2022. If positive, we should be able to move directly into a registration trial," he concluded.
The company ended the year with US$2.3 million in cash.
Contact Angela at angela@proactiveinvestors.com
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