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60 Degrees Pharmaceuticals (SCTP) investor relations material
60 Degrees Pharmaceuticals Investor Update summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Commercial performance and strategy
ARAKODA, an FDA-approved malaria prevention drug, saw 140% net product revenue growth in fiscal 2024, with annualized gross sales between $1M and $2M and a gross margin stabilized at around 50%.
Sales were initially impacted by the pandemic and a supply chain disruption, but have since rebounded, with a formal commercial pilot for malaria now underway.
The commercial pilot includes increasing awareness via electronic media, virtual sales reps targeting physicians, and a copay program to reduce out-of-pocket costs for insured patients.
Market research identified low awareness and G6PD testing requirements as barriers to uptake, with generic alternatives offering lower costs.
Long-term market potential is estimated at over $200M, with malaria prevention representing about 25% and chronic babesiosis the majority.
Clinical development and regulatory milestones
Most ARAKODA sales to date have been off-label for chronic babesiosis, a tick-borne disease, with increasing demand from patients with chronic symptoms.
Three clinical trials are underway or about to start, targeting hospitalized, immunosuppressed, and chronic babesiosis patients, using the FDA-approved malaria dosing regimen.
A recent expanded access case showed a cure in an immunosuppressed patient who failed prior therapies, supporting the breakthrough therapy designation request.
The company expects feedback from the FDA on the breakthrough therapy request in December, with additional clinical outputs from all three studies anticipated in the second half of 2026.
The earliest possible NDA submission for babesiosis is targeted for the end of 2026, pending positive trial results.
Market opportunity and financial outlook
The total market potential for ARAKODA is estimated at over $200M, with $30M–$40M for malaria and the remainder for chronic babesiosis.
Capturing the babesiosis market depends on proving chronic infection can be reliably diagnosed and treated, with commercial strategy scaling existing infrastructure.
Cash runway extends through March 2026, with updates to be provided in Q3 financials; cash flow positivity will be reassessed after pilot program results.
Reimbursement strategies may differ for babesiosis, as there are no FDA-approved competitors, potentially easing market access.
Ongoing evaluation of commercial outreach will inform future scaling and resource allocation.
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