NASDAQ$OTLK
Outlook Therapeutics Inc · Q1 2024 earnings
Q1 2024 earnings · · Investor relations
Briefing
Reported a net loss attributable to common stockholders and provided a corporate update, highlighting progress with the FDA on the NORSE EIGHT trial and CMC comments in the CRL.
Outlook Therapeutics reported its financial results for the first quarter of fiscal year 2024. The company highlighted the FDA's agreement on the NORSE EIGHT trial protocol and progress in addressing CMC comments in the CRL. They also entered into purchase agreements for a financing of up to $172 million, subject to shareholder approval.
- Received FDA agreement on NORSE EIGHT trial protocol under a SPA.
- First subject enrolled in NORSE EIGHT in January 2024.
- Identified approaches to resolve CMC comments in the CRL.
- Entered into purchase agreements for financing of up to $172 million, pending shareholder approval.
Headline financials
Revenue & EPS history
Outlook Therapeutics · Revenue · Quarterly
$0
Forward guidance
Outlook Therapeutics anticipates several milestones, including the NORSE EIGHT topline results, resubmission of the ONS-5010 BLA by the end of calendar year 2024, and a decision from the EMA on the ONS-5010 MAA expected in the first half of 2024.
Tailwinds
- Potential approval of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) as the first approved ophthalmic formulation of bevacizumab in the U.S. or EU.
- Expected NORSE EIGHT topline results by the end of calendar year 2024.
- Potential resubmission of the ONS-5010 BLA by the end of calendar year 2024.
- Estimated decision date from the EMA on the ONS-5010 MAA expected in the first half of 2024.
- Potential strategic partnering opportunities in the EU and other regions.
Headwinds
- Risks associated with developing pharmaceutical product candidates.
- Risks of conducting clinical trials.
- Risks in obtaining necessary regulatory approvals.
- Uncertainty of market conditions and future impacts related to macroeconomic factors.
- Potential delays in regulatory decisions.
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 Q1 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
| Quarter | Report date | Reaction (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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