NASDAQ$APLT

Applied Therapeutics Inc · Q3 2023 earnings

Q3 2023 earnings · · Investor relations

Briefing

Reported third quarter 2023 financial results and provided updates on regulatory submissions and clinical trial readouts.

Applied Therapeutics reported its third quarter 2023 financial results, highlighting progress in its late-stage pipeline and upcoming regulatory and clinical milestones. Key activities include the planned regulatory filings for govorestat for Classic Galactosemia and upcoming Phase 3 trial readouts for ARISE-HF and INSPIRE trials.

  • Regulatory submissions for govorestat (AT-007) for the treatment of Classic Galactosemia to US FDA and EMA are on track for 4Q 2023.
  • Phase 3 ARISE-HF Trial of AT-001 (caficrestat) in Diabetic Cardiomyopathy is on track for data readout in 4Q 2023.
  • Phase 3 INSPIRE Trial of AT-007 trial in Sorbitol Dehydrogenase (SORD) Deficiency is expected to readout in 1Q 2024.
  • The company is developing govorestat for CNS rare metabolic diseases and AT-001 for Diabetic Cardiomyopathy.

Headline financials

Total Revenue

$10.7M

No prior period
EPS (adj)

-$0.47

Previous: -$0.40-17.5%
Capital Expenditures

$0.00

No prior period
Free Cash Flow

-$14.7M

No prior period
Net Income

-$42.4M

Previous: -$18.8M-125.3%
Operating Income

-$15.5M

Previous: -$19.4M+19.9%
Gross Profit

-$118K

No prior period
Cash & Equivalents

$37.5M

Previous: $40.4M-7.3%
Total Assets

$45.2M

Previous: $56.7M-20.3%
R&D Expense

$10.8M

No prior period
Stock-Based Comp

$1.84M

Previous: $2.86M-35.7%

Revenue & EPS history

Applied Therapeutics · Revenue · Quarterly

$10.7M

Q3 2023
Beat estimate in 4 of 9 quarters(44%)
ActualEstimate

Forward guidance

Applied Therapeutics anticipates key regulatory and clinical inflection points later this quarter and in early 2024.

Tailwinds

  • Timing of data readouts for ARISE-HF trial
  • Timing of data readouts for INSPIRE trial
  • Plans to submit an NDA for approval
  • Plans to submit an MAA for approval

Headwinds

  • Plans to develop, market and commercialize product candidates
  • The initiation, timing, progress and results of current and future preclinical studies and clinical trials and research and development programs
  • Ability to take advantage of expedited regulatory pathways for any of product candidates
  • Estimates regarding expenses, future revenue, capital requirements and needs for additional financing
  • Ability to successfully acquire or license additional product candidates on reasonable terms and advance product candidates into, and successfully complete, clinical studies

Historical earnings impact

How earnings announcements have historically affected this stock's price.

Avg. return before/after earnings

Based on 12 quarterly earnings reports · overlaid with Q3 2023

Historical avgQ3 2023

-2.6%

Avg return

Earnings day

-9.9%

Avg return

5 days after

-14.9%

Avg return

30 days after

52%

14 / 27 earnings

Positive

+24.0%

Q1 2025

Best reaction

-71.6%

Q3 2025

Worst reaction

Earnings price reactions
QuarterReport dateReaction (Day 0)+5 days+30 days
Q4 2025
Q3 2025-71.6%-68.9%-77.9%
Q2 2025+5.6%+9.1%-5.6%
Q1 2025+24.0%-22.5%-26.9%
Q4 2024+0.1%+4.3%+1.5%
Q3 2024+4.6%+2.7%-86.8%
Q2 2024+5.7%-4.4%-6.4%
Q1 2024-6.8%-1.9%-1.3%
Q4 2023+7.3%+2.6%-6.2%
Q3 2023-12.1%-10.8%+34.6%
Q2 2023-3.2%-14.1%+1.3%
Q1 2023-3.6%-7.3%-10.9%
Q4 2022-5.6%-7.9%+6.3%
Q3 2022-0.2%
Q2 2022+3.0%
Q1 2022-1.7%
Q4 2021-9.1%
Q3 2021+1.6%
Q2 2021+3.6%
Q1 2021-2.2%
Q4 2020+3.3%
Q3 2020+5.9%
Q2 2020+13.8%
Q1 2020+3.3%
Q4 2019-27.7%
Q3 2019-7.5%
Q2 2019+7.0%
Q1 2019-6.7%
Q4 2018
Q3 2018
Q2 2018
Q1 2018

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