Summary:
$500M - $1B peak revenue forecast USA & EU.
Assumed ASP of 300 $/dose. After conversations with management, I think ASPs may be higher.
Assuming gross margins of 75%.
Assuming 12 yrs. exclusivity wAMD. May be opportunity to extend.
Getting prefilled syringe approval will increase penetration. Expect this to follow 1.5 years after wAMD FDA approval.
Your peak revenue multiple look reasonable. I’m at 5x revenue, but I’m probably low. Bad habit of mine.
Milestones:
- 2Q 2021: safety study data released
- August 2021: pivotal wAMD data
- YE 2021: wAMD filing USA
- late 2021/early 2022: initiate NORSE 4
- late 2021/early 2022: initiate NORSE 5
- late 2021/early 2022: initiate NORSE 6
- 1H 2022 wAMD: filing Europe
- Late 2022: BRVO filing
- 2023: DME filing
Risk are new innovative products, but there's not been a much progress recently:
- Roche eyes an uncertain market for faricimab | Evaluate
- Roche amps up its bispecific attack on Eylea with more PhIII data — but just how threatening is it? – Endpoints News (endpts.com)
- Safety scare knocks Novartis' Beovu | Evaluate
- US regulator still doesn’t buy abicipar | Evaluate
- Why Regenxbio’s eye gene therapy would have to be the cheapest yet | Evaluate
- Conbercept: New Generation of Product for Treatment of nAMD Completes 36-week Primary Endpoint Visits of Phase III Trial (yahoo.com)
- FDA issued a complete response letter for the Darpin anti-VEGF molecule
Recent OTLK News
- Outlook Therapeutics® to Participate in the Virtual Investor Closing Bell Series • GlobeNewswire Inc. • 09/16/2024 12:05:00 PM
- Outlook Therapeutics® Participates in the 2nd Annual Chardan Virtual Ophthalmology Conference Series • GlobeNewswire Inc. • 09/13/2024 01:05:00 PM
- Outlook Therapeutics® Announces Completion of Enrollment in NORSE EIGHT Clinical Trial • GlobeNewswire Inc. • 09/04/2024 12:35:00 PM
- Outlook Therapeutics® to Present at the H.C. Wainwright 26th Annual Global Investment Conference • GlobeNewswire Inc. • 09/03/2024 12:45:00 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 08/14/2024 08:55:20 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2024 08:15:28 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/14/2024 11:48:51 AM
- Outlook Therapeutics® Reports Financial Results for Third Quarter Fiscal Year 2024 and Provides Corporate Update • GlobeNewswire Inc. • 08/14/2024 11:05:00 AM
- Outlook Therapeutics® to Present at the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference • GlobeNewswire Inc. • 08/12/2024 01:05:00 PM
- Outlook Therapeutics® to Report Financial Results for Third Quarter Fiscal Year 2024 on August 14, 2024 and Host Quarterly Conference Call and Webcast • GlobeNewswire Inc. • 08/07/2024 12:35:00 PM
- Outlook Therapeutics® to Present at the BTIG Virtual Biotechnology Conference 2024 • GlobeNewswire Inc. • 07/30/2024 01:10:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/08/2024 12:41:41 PM
- Outlook Therapeutics® Announces UK MHRA Marketing Authorization of LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD • GlobeNewswire Inc. • 07/08/2024 12:35:00 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 06/14/2024 08:10:50 PM
- Outlook Therapeutics® to Present at the Virtual Investor Pitch Conference • GlobeNewswire Inc. • 06/11/2024 01:05:00 PM
- Outlook Therapeutics® Receives European Commission Marketing Authorization for LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD • GlobeNewswire Inc. • 05/28/2024 12:05:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/15/2024 09:19:05 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/15/2024 09:15:37 PM
- Outlook Therapeutics® Reports Financial Results for Second Quarter Fiscal Year 2024 and Provides Corporate Update • GlobeNewswire Inc. • 05/15/2024 09:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/13/2024 08:05:33 PM
- Outlook Therapeutics® Announces UK Submission of Marketing Authorization Application (MAA) for ONS-5010 as a Treatment for Wet AMD • GlobeNewswire Inc. • 05/13/2024 12:50:00 PM
- Outlook Therapeutics® to Report Financial Results for Second Quarter Fiscal Year 2024 on May 16, 2024 and Host Inaugural Quarterly Conference Call and Webcast • GlobeNewswire Inc. • 05/09/2024 12:45:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 05/07/2024 04:15:34 AM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 05/06/2024 08:09:46 PM
- Outlook Therapeutics® to Present at the Retina World Congress 2024 • GlobeNewswire Inc. • 05/02/2024 01:05:00 PM
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