CorMedix (CRMD) Q2 2024 earnings summary

Executive summary

• DefenCath launched commercially in April 2024 for inpatient and July 2024 for outpatient hemodialysis, following FDA approval in November 2023, with strong early sales traction in both channels.

• Unaudited sales reached $5.2 million as of August 13, 2024, driven by outpatient orders, while Q2 2024 net sales were $0.8 million, reflecting initial shipments and trade stocking.

• Outpatient sales are primarily to small and mid-sized dialysis operators, with high pull-through rates and minimal trade stocking; several hundred clinics have ordered.

• The company secured key reimbursement milestones, including TDAPA and pass-through status, and signed multi-year supply contracts with dialysis providers and GPOs.

• Management is focused on expanding DefenCath's indications, qualifying additional manufacturing sources, and operationalizing new commercial supply agreements.

Financial highlights

• Net revenue for Q2 2024 was $0.8 million, with cost of sales at $0.5 million and gross profit of $0.3 million.

• Net loss for Q2 2024 was $14.2 million ($0.25/share), up from $11.3 million ($0.25/share) in Q2 2023; six-month net loss was $28.6 million ($0.50/share).

• Operating expenses rose 32% year-over-year to $15.6 million, driven by increased SG&A for the commercial launch.

• SG&A expenses increased 113% to $14.9 million; sales and marketing rose 127% to $7.4 million; G&A rose 103% to $7.6 million.

• Cash and cash equivalents totaled $45.6 million as of June 30, 2024.

Outlook and guidance

• Expect inpatient sales to ramp in Q4 2024 as more hospitals complete formulary reviews and adopt DefenCath.

• Quarterly operating expenses projected to remain in the $15–18 million range for 2024.

• Anticipate reaching break-even EBITDA on a run-rate basis by end of 2024, contingent on continued sales growth and new account onboarding.

• Clinical trial costs for TPN and pediatric studies are budgeted and expected to be funded without large dilutive financing.

• Management expects existing cash and investments to fund operations for at least twelve months from the report date.