In This Article:
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FY 2024 net product revenues increased 140% to $607.6 thousand.
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FY 2024 gross profit increased $443.8 thousand from ($221 thousand) to $222.8 thousand.
WASHINGTON, March 28, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, reported today their financial results for the 2024 fiscal year, ended December 31, 2024.
Financial Highlights for the Fiscal Year Ended December 31, 2024:
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Net product revenues increased 140% from $253.6 thousand for fiscal year 2023 to $607.6 thousand for fiscal year 2024; the Company credits growth from domestic commercial sales of ARAKODA®.
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The Company achieved a gross profit of approximately $222.8 thousand in fiscal year 2024, compared to an approximate gross loss of $221 thousand in fiscal year 2023. Increased sales volume allowed the Company to overcome fixed cost of goods expense associated with the Drug Supply Chain Security Act that previously led to a gross loss.
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Operating expenses were approximately $10.0 million in fiscal year 2024, compared with approximately $4.9 million in fiscal year 2023. The increase in operating expenses was primarily due to a non-recurring non-cash Research and Development charge of $2.63 million, non-recurring non-cash delivery of research materials ($0.6 million) and Research and Development costs associated with the Company’s babesiosis clinical trial program ($1.36 million).
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Net loss attributable to common shareholders in calendar year 2024 was approximately $8.43 million, or $18.55 per share, compared with a net loss of approximately $3.925 million, or $59.18 per share in fiscal year 2023, representing a $4.505 million decline. This decline in profitability is mostly attributed to an increase in non-recurring non-cash Research and Development expenses of $3.23 million.
Recent Business Highlights
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Due to a recent surge in demand for Arakoda® in the U.S. market, the Company submitted a regulatory discretion request to FDA in December 2024 to allow importation of Kodatef® (Australian-branded equivalent of Arakoda) to ensure continuous U.S. commercial supply. This was granted in February 2025, and Kodatef was made available for distribution on March 10, 2025, through a specialty pharmacy serving all 50 states.
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The Company is completing validation of two additional lots of Arakoda, to be released into the supply chain by early Q2 2025.
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Preparations for the Company’s commercial pilot are complete. Outreach to physicians commenced on March 17, 2025.
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The Company commenced a randomized evaluation of tafenoquine versus placebo in hospitalized patients with babesiosis in 2024, randomizing N=6 of the minimum 24 patients required to trigger an interim endpoint (all completed the study). The Company recently increased its recruitment capacity for this study by establishing an additional clinical site at Brigham and Women’s Hospital. Interim analysis is expected in Q1 2026.
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We initiated an open label evaluation of Arakoda in immunosuppressed patients who have a diagnosis of relapsing/persistent babesiosis. The first patient was enrolled during Q1, 2025. Up to 15 patients in total will be enrolled.
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The epidemiological study sponsored by the Company, and conducted by North Carolina State University, is complete. The study evaluated the incidence of babesiosis by PCR and DNA sequencing in patients with persistent fatigue and neurological problems. Results of the study will be submitted to a peer-reviewed journal.
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The total prevalence of post-infectious syndromes (severe chronic fatigue, chronic fatigue syndrome, encephalomyelitis, long COVID, and post-treatment Lyme disease syndrome), and the potential contribution of Babesia infection to that burden of disease, is not known. The Company is conducting additional market research to determine the size of these market segments in the U.S., with a view to defining an upper limit on the potential prevalence of chronic babesiosis.
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The Company has secured IRB (ethics) approval for an open label evaluation of Arakoda in patients with severe fatigue and a presumptive diagnosis of babesiosis. The Company is now establishing the feasibility and cost of conducting such a study.