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 Present at the Retina World Congress 2024 • GlobeNewswire Inc. • 05/02/2024 01:05:00 PM
- Outlook Therapeutics® to Present at the Ophthalmology Innovation Summit (OIS) Retina Innovation Showcase • GlobeNewswire Inc. • 04/29/2024 01:00:00 PM
- Outlook Therapeutics® Announces Closing of Private Placement of $5.0 Million • GlobeNewswire Inc. • 04/15/2024 08:15:00 PM
- Outlook Therapeutics® Receives European Union Positive CHMP Opinion for ONS-5010 as a Treatment for Wet AMD • GlobeNewswire Inc. • 03/22/2024 11:35:35 AM
- Outlook Therapeutics® Announces Closing of Private Placement of up to $159 Million • GlobeNewswire Inc. • 03/18/2024 09:10:05 PM
- Outlook Therapeutics® Announces Effective Date for 1-for-20 Reverse Stock Split • GlobeNewswire Inc. • 03/12/2024 12:05:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/11/2024 08:43:10 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 09:30:50 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 09:18:39 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 09:11:11 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 03/08/2024 09:08:43 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/07/2024 09:16:07 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/14/2024 10:10:29 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/14/2024 09:40:14 PM
- Outlook Therapeutics® Reports Financial Results for First Quarter Fiscal Year 2024 and Provides Corporate Update • GlobeNewswire Inc. • 02/14/2024 01:05:00 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 02/08/2024 12:00:58 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 02/08/2024 11:59:42 AM
- Form SC 13D/A - General statement of acquisition of beneficial ownership: [Amend] • Edgar (US Regulatory) • 01/31/2024 09:01:44 PM
- Outlook Therapeutics® Doses First Subject in NORSE EIGHT • GlobeNewswire Inc. • 01/31/2024 01:05:00 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 01/29/2024 10:00:29 PM
- Form 10-K/A - Annual report [Section 13 and 15(d), not S-K Item 405]: [Amend] • Edgar (US Regulatory) • 01/24/2024 10:00:36 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/24/2024 11:02:07 AM
- Outlook Therapeutics® Receives FDA Agreement Under Special Protocol Assessment (SPA) for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces Private Placement of Up to $172 Million to Advance ONS-5010 • GlobeNewswire Inc. • 01/23/2024 01:00:00 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 12/22/2023 10:00:37 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/22/2023 09:15:27 PM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM
Cannabix Technologies to Deliver Breath Logix Alcohol Screening Device to Australia • BLO • Apr 30, 2024 8:53 AM
Hydromer, Inc. Reports Preliminary Unaudited Financial Results for First Quarter 2024 • HYDI • Apr 29, 2024 9:10 AM