NASDAQ$OTLK

Outlook Therapeutics Inc · Q4 2020 earnings

Q4 2020 earnings · · Investor relations

Briefing

Announced corporate highlights and financial results for the fiscal year ended September 30, 2020.

Outlook Therapeutics reported a net loss attributable to common stockholders of $48.9 million, or $0.67 per basic and diluted share, compared to a net loss attributable to common stockholders of $36.0 million for the prior fiscal year.

  • Completed patient enrollment in its pivotal Phase 3 (NORSE TWO) clinical trial in July 2020.
  • Completed enrollment of 195 subjects with a range of retinal diseases for its open-label safety study (NORSE THREE) in November 2020.
  • Received agreements from the FDA on three Special Protocol Assessments (SPAs) for three additional registration clinical trials.
  • Commercial launch planning for ONS-5010, including distribution, physician and patient outreach, key opinion leader support and payor community engagement, remains ongoing.

Headline financials

EPS (adj)

-$0.60

Previous: $1.00-160.0%
Net Income

-$48.9M

No prior period
Operating Income

-$10M

No prior period
Cash & Equivalents

$12.5M

No prior period
Total Assets

$19.7M

No prior period
Stock-Based Comp

$785K

No prior period

Revenue & EPS history

Outlook Therapeutics · Revenue · Quarterly

$127K

Q2 2026
Beat estimate in 2 of 6 quarters(33%)
ActualEstimate

Forward guidance

Outlook Therapeutics is focused on completing the Phase 3 study and data readout in Q3 2021, followed by BLA submission. They are also engaged with regulatory authorities in Europe and planning registration clinical trials for DME and BRVO later in 2021.

Tailwinds

  • Successful completion and data readout for the pivotal Phase 3 study in the third calendar quarter of 2021.
  • Planned BLA submission.
  • Engaged with regulatory authorities in Europe for anticipated submissions in those markets.
  • Planning to initiate registration clinical trials for ONS-5010 for DME and BRVO later in 2021.

Headwinds

  • Uncertainty of future impacts related to the ongoing COVID-19 pandemic.
  • Risks associated with developing pharmaceutical product candidates.
  • Risks of conducting clinical trials.
  • Risks in obtaining necessary regulatory approvals.
  • Risks of negotiating and finalizing binding definitive agreements with third parties.

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 2020

Historical avgQ4 2020

+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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