60 Degrees Pharmaceuticals (SCTP) investor relations material

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.