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Outlook Therapeutics Inc · Q4 2024 earnings

Q4 2024 earnings · · Investor relations

Briefing

Outlook Therapeutics reported financial results for fiscal year 2024 and provided a corporate update.

Outlook Therapeutics reported a net loss of $75.4 million for the fiscal year ended September 30, 2024, compared to a net loss of $59.0 million for the prior fiscal year. The company had cash and cash equivalents of $14.9 million as of September 30, 2024. They are preparing for commercial launch in the UK and Germany, expected in the first half of calendar 2025, and plan to resubmit the BLA in the first quarter of calendar 2025.

  • Received Marketing Authorization for LYTENAVA™ in the EU and the UK for wet AMD treatment.
  • National Institute for Health and Care Excellence (NICE) recommended LYTENAVA™ as an option for treating wet AMD.
  • Plans for a potential 2025 launch in the UK and Germany are ongoing.
  • Plans to resubmit the BLA for ONS-5010 in the first quarter of calendar 2025.

Headline financials

Total Revenue

$0.00

Previous: $0.00
EPS (adj)

-$0.94

Previous: -$1.00+6.0%
Capital Expenditures

$0.00

No prior period
Net Income

-$75.4M

Previous: -$59M-27.8%
Operating Income

-$22.9M

Previous: -$12.5M-83.6%
Gross Profit

-$28.8K

Previous: $0.00
R&D Expense

$12.5M

Previous: $4.94M+153.3%
Stock-Based Comp

$1.41M

Previous: $1.39M+1.2%

Revenue & EPS history

Outlook Therapeutics · Revenue · Quarterly

$0

Q4 2024
Beat estimate in 0 of 6 quarters(0%)
ActualEstimate

Forward guidance

Outlook Therapeutics is preparing for the commercial launch of LYTENAVA™ in the UK and Germany in the first half of calendar 2025 and plans to resubmit the BLA for ONS-5010 in the first quarter of calendar 2025.

Tailwinds

  • Potential launch of LYTENAVA™ in the UK and Germany in the first half of calendar 2025.
  • Plans to resubmit the BLA for ONS-5010 in the first quarter of calendar 2025.
  • LYTENAVA™ has an initial 10 years of market exclusivity in the EU and UK.
  • Strategic collaboration with Cencora to support the commercial launch of LYTENAVA™ globally.
  • Direct commercialization planned in the EU and the UK, with assessment of licensing and partnering options.

Headwinds

  • ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 in the NORSE EIGHT trial.
  • Resubmission of the BLA is contingent on positive month 3 efficacy and safety results from NORSE EIGHT.
  • Commercial launch is subject to regulatory approvals and market access.
  • Uncertainty of market conditions and future impacts related to macroeconomic factors.
  • Potential delays or setbacks in clinical trials and regulatory approvals.

Historical earnings impact

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

Avg. return before/after earnings

Based on 19 quarterly earnings reports · overlaid with Q4 2024

Historical avgQ4 2024

+5.1%

Avg return

Earnings day

+6.9%

Avg return

5 days after

-0.7%

Avg return

30 days after

61%

25 / 41 earnings

Positive

+48.5%

Q2 2019

Best reaction

-14.6%

Q3 2021

Worst reaction

Earnings price reactions
QuarterReport dateReaction (Day 0)+5 days+30 days
Q2 2026+1.3%-0.9%
Q1 2026-13.9%-15.7%-31.4%
Q4 2025-2.9%-11.6%-73.6%
Q3 2025+14.1%+23.5%-51.2%
Q2 2025+1.2%+9.9%-0.6%
Q1 2025+1.6%-7.9%-14.7%
Q4 2024+9.4%+11.2%+17.1%
Q3 2024-0.9%-7.6%-16.5%
Q2 2024-0.9%+7.4%+3.6%
Q1 2024+21.2%+13.0%+3.0%
Q4 2023+4.2%+8.2%-18.5%
Q3 2023-3.1%-16.9%-85.3%
Q2 2023+3.5%+16.5%+46.1%
Q1 2023-3.3%-7.5%-15.8%
Q4 2022+6.9%+4.0%+15.8%
Q3 2022-3.4%+5.9%-4.2%
Q2 2022+7.4%+2.7%-37.1%
Q1 2022+3.7%+8.1%+36.3%
Q4 2021-4.2%-1.4%-14.6%
Q3 2021-14.6%-16.2%-1.6%
Q2 2021+16.0%+21.2%+34.1%
Q1 2021-0.4%-4.0%-9.5%
Q4 2020+1.3%-4.6%-13.1%
Q3 2020+5.2%+14.2%-54.5%
Q2 2020+1.9%-1.9%+40.4%
Q1 2020+0.0%-1.1%-35.1%
Q4 2019-1.7%-53.0%-11.1%
Q3 2019-4.2%-8.9%-17.8%
Q2 2019+48.5%+191.3%+125.2%
Q1 2019+28.2%+28.2%-5.8%
Q4 2018+24.5%+42.9%+34.7%
Q3 2018+1.2%-8.8%+0.0%
Q2 2018+2.7%+1.1%-13.3%
Q1 2018+4.3%+3.5%-19.0%
Q4 2017+0.0%-7.9%-4.8%
Q3 2017+0.5%+3.0%+77.8%
Q2 2017-8.7%-34.1%-24.5%
Q1 2017+10.6%+2.1%-1.2%
Q4 2016+28.6%+40.3%+59.8%
Q2 2016+28.6%+40.3%+59.8%
Q3 2016-3.9%-5.3%-8.1%
Q1 2016
Q4 2015
Q3 2015
Q2 2015
Q1 2014

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