NASDAQ$OTLK

Outlook Therapeutics Inc · Q1 2020 earnings

Q1 2020 earnings · · Investor relations

Briefing

Reported business highlights and financial results.

Outlook Therapeutics reported a net loss attributable to common stockholders of $18.5 million, or $0.62 per basic and diluted share, for the fiscal first quarter ended December 31, 2019. The company is advancing towards a new BLA submission to the FDA for ONS-5010 in 2021, with a potential commercial launch in 2022.

  • Phase 3 development program for ONS-5010 continues to make progress.
  • Patient recruitment for the NORSE 2 study is expected to be completed by the end of May 2020.
  • Topline data for the NORSE 1 study is expected to be announced in August 2020.
  • Agreements with BioLexis and MTTR were entered into to streamline the Company’s capital structure and regain 100% ownership of any future net profits for ONS-5010.

Headline financials

Total Revenue

$1.07M

Previous: $1.07M+0.0%
EPS (adj)

-$12.40

Previous: -$14.40+13.9%
Capital Expenditures

-$236K

Previous: -$236K+0.0%
Free Cash Flow

-$16.8M

Previous: -$9.98M-68.8%
Net Income

-$16.6M

Previous: -$9.74M-70.4%
Operating Income

-$8.18M

Previous: -$10.3M+20.2%
Gross Profit

$1.07M

Previous: $1.07M+0.0%
Cash & Equivalents

$1.33M

Previous: $228K+485.6%
Total Assets

$10.4M

Previous: $18.7M-44.3%

Revenue & EPS history

Outlook Therapeutics · Revenue · Quarterly

$1.07M

Q1 2020+0%vs Q1 2019
Beat estimate in 3 of 9 quarters(33%)
ActualEstimate

Forward guidance

Outlook Therapeutics is focused on advancing ONS-5010 towards a BLA submission to the FDA in 2021 and a potential commercial launch in 2022.

Tailwinds

  • Ongoing patient recruitment for the NORSE 2 study, expected to be completed by the end of May 2020.
  • Planned announcement of topline data for the NORSE 1 study in August 2020.
  • Agreements from the FDA on three Special Protocol Assessments (SPAs) for three additional registration clinical trials for its ongoing Phase 3 program for ONS-5010.
  • Intention to complete development of ONS-5010 for submission to the FDA as a new Biologics License Application (BLA) for the treatment of wet AMD, DME and BRVO.
  • Intention to seek the requisite stockholder approvals under agreements with BioLexis and MTTR

Headwinds

  • Risks associated with developing pharmaceutical product candidates.
  • Risks of conducting clinical trials.
  • Risks in obtaining necessary regulatory approvals.
  • The company had cash of $1.3 million at December 31, 2019, compared to $8.0 million at September 30, 2019.
  • Net loss attributable to common stockholders of $18.5 million for the quarter ended December 31, 2019, compared to a net loss of $9.9 million for the same period last year.

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 2020

Historical avgQ1 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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