NASDAQ$OTLK
Outlook Therapeutics Inc · Q3 2023 earnings
Q3 2023 earnings · · Investor relations
Briefing
Reported financial results for the third quarter of fiscal year 2023 and reiterated key anticipated near-term milestones.
Outlook Therapeutics reported a net loss attributable to common stockholders of $20.7 million for the fiscal third quarter ended June 30, 2023. The company's cash and cash equivalents were $33.7 million as of June 30, 2023, expected to fund operations through the anticipated approval of the BLA for ONS-5010.
- Submitted a PHSA 351(a) BLA for ONS-5010 as an original biologic application.
- ONS-5010 consistently improved BCVA by ≥ 15 letters from baseline to 11 months (41.7% compared to 23.1% in LUCENTIS group, p = 0.0052) in the NORSE TWO Phase 3 clinical trial.
- Pre-launch preparations for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) are proceeding as planned, including commercial inventory production and a strategic distribution partnership with AmerisourceBergen.
- Submitted a Marketing Authorization Application (MAA) in Europe, which was validated for review in December 2022.
Headline financials
Revenue & EPS history
Outlook Therapeutics · Revenue · Quarterly
$127K
Forward guidance
Outlook Therapeutics anticipates potential FDA approval of the BLA for ONS-5010 in the third calendar quarter of 2023, and potentially through the fourth calendar quarter of 2023.
Tailwinds
- Potential FDA approval of ONS-5010 in the third calendar quarter of 2023.
- Ongoing commercial planning to support potential approval of ONS-5010.
- Strategic distribution partnership with AmerisourceBergen to increase market access.
- Collaborative discussions with payors and the retina community to bring ONS-5010 to market.
- Formal review process of the MAA by the EMA's Committee for Medicinal Products for Human Use (CHMP) is underway with an estimated decision date expected in the first half of 2024.
Headwinds
- Uncertainty of future impacts related to macroeconomic factors, including as a result of the ongoing conflict between Russia and Ukraine.
- High interest rates.
- Inflation.
- Potential future bank failures on the global business environment.
- Risks associated with developing pharmaceutical product candidates and obtaining necessary 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 Q3 2023
+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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