Applied Therapeutics (APLT) Q2 2024 earnings summary

Executive summary

• NDA for govorestat in Classic Galactosemia accepted by FDA with Priority Review; PDUFA date set for November 28, 2024, and EMA review ongoing with improved cognition data.

• NDA submission for govorestat in SORD Deficiency planned for early Q1 2025, with FDA support for Accelerated Approval and confirmatory study as post-marketing requirement.

• Added to Russell 3000® Index in June 2024, enhancing institutional investor visibility.

• Pipeline includes AT-001 for diabetic cardiomyopathy and AT-003 for diabetic retinopathy in preclinical stages.

• No product revenue to date; operations funded by equity, licensing, and milestone payments.

Financial highlights

• Q2 2024 net income of $2.9M ($0.02 per basic share), compared to net loss of $29.6M in Q2 2023, driven by a $22.7M gain from warrant liability revaluation.

• Six months ended June 30, 2024: net loss of $81.0M, up from $39.7M loss in prior year, mainly due to a $40.7M warrant liability expense.

• Cash and cash equivalents at June 30, 2024: $122.2M, up from $49.9M at year-end 2023, due to equity financings and warrant exercises.

• R&D expenses decreased to $10.0M in Q2 2024 from $11.9M in Q2 2023; G&A expenses rose to $10.6M from $5.3M, reflecting commercialization prep.

• Revenue for Q2 2024 was $0.1M (R&D services), down from $10.7M in H1 2023 (license revenue from Advanz Pharma).

Outlook and guidance

• Cash runway expected into 2026, contingent on milestone payments from Advanz Pharma and potential PRV sale upon Galactosemia approval.

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

• NDA for SORD Deficiency planned for early 2025, pending Classic Galactosemia approval.

• Anticipates increased expenses as clinical and commercial activities expand, especially with potential product launches.