Applied Therapeutics (APLT) Q3 2024 earnings summary

Executive summary

• NDA and MAA filings for govorestat in Classic Galactosemia are under FDA Priority Review and EMA review, with decisions expected by late 2024 and early 2025; NDA for SORD Deficiency is anticipated in early 2025, pending regulatory alignment.

• The company reported a Q3 2024 net loss of $68.6 million and $149.6 million for the nine months ended September 30, 2024, reflecting increased R&D and commercialization expenses.

• Cash and cash equivalents were $98.9 million as of September 30, 2024, bolstered by a $92.3 million private placement and proceeds from warrant exercises and ATM sales.

• Management expects current cash and anticipated milestone payments to fund operations into 2026, contingent on regulatory and commercial milestones.

• The company is transitioning from clinical-stage to commercial organization, with pre-launch initiatives underway for govorestat.

Financial highlights

• Q3 2024 revenue was $0.1 million, up from $0 in Q3 2023, due to Advanz Pharma R&D services; nine-month revenue was $0.5 million, down from $10.7 million in 2023.

• Operating expenses for Q3 2024 rose to $29.9 million, driven by higher R&D and G&A costs related to late-stage clinical programs and commercialization prep.

• Net loss per share was $(0.48) for Q3 2024 and $(1.09) for the nine months, unchanged from the prior year period.

• Interest income increased to $1.4 million in Q3 2024 due to higher cash balances and rates.

• Non-cash expense from change in fair value of warrant liabilities was $40.2 million in Q3 2024 and $80.8 million for the nine months.

Outlook and guidance

• PDUFA target action date for govorestat in Classic Galactosemia is November 28, 2024; EMA decision expected in Q1 2025.

• NDA for govorestat in SORD Deficiency expected in early 2025, pending confirmatory study design alignment with FDA.

• If approved, govorestat would be the first medication for Galactosemia and the company's first commercial product.

• Management expects cash and milestone payments to fund operations into 2026, assuming timely regulatory approvals and product launches.