NASDAQ$OTLK
Outlook Therapeutics Inc · Q4 2021 earnings
Q4 2021 earnings · · Investor relations
Briefing
Reported financial results for fiscal year 2021 and provided a corporate update.
Outlook Therapeutics reported a net loss attributable to common stockholders of $53.2 million for the fiscal year ended September 30, 2021. The company had cash and cash equivalents of $14.5 million at the end of the fiscal year and completed a $57.5 million gross proceeds equity offering subsequent to the fiscal year end.
- Successfully completed the registration clinical trials for ONS-5010.
- Reported statistically significant and clinically relevant data from clinical trials.
- Plans to submit a new BLA under the Public Health Service Act (PHSA) 351(a) regulatory pathway in the first quarter of calendar 2022.
- Began commercial launch planning for ONS-5010, including manufacturing, distribution, sales force planning, and engagement with physicians and payors.
Headline financials
Revenue & EPS history
Outlook Therapeutics · Revenue · Quarterly
$127K
Forward guidance
Outlook Therapeutics anticipates potential FDA approval in 2022 for ONS-5010 and expects to initiate registration clinical trials for ONS-5010 for DME and BRVO in 2023 if FDA approval is received for the wet AMD indication.
Tailwinds
- Potential FDA approval of ONS-5010 in the first quarter of calendar 2023, resulting in 12 years of marketing exclusivity.
- Plans to file a supplementary application for approval to provide the product in a pre-filled, silicone-free syringe.
- Collaborative discussions with payors and the retina community commenced.
- Developing registration documents for approvals in Europe.
- Exploring potential strategic commercialization partners.
Headwinds
- Risks associated with developing pharmaceutical product candidates.
- Risks of conducting clinical trials.
- Risks in obtaining necessary regulatory approvals.
- Uncertainty of future impacts related to the ongoing COVID-19 pandemic.
- Potential delays in clinical trials
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 2021
+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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