Corporate Presentation
January 2023
NASDAQ: OTLK | outlooktherapeutics.com |
Enhancing the standard of care for retinal disorders by working to achieve the first FDA approval for bevacizumab in ophthalmology
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Disclaimer
This presentation contains forward-looking statements about Outlook Therapeutics, Inc. ("Outlook Therapeutics" or the "Company") based on management's current expectations, which are subject to known and unknown uncertainties and risks. Words such as "anticipate," "believe," "estimate," "expect," "initiate," "intend," "may," "plan," "seek," "target," "will," and variations of these words or similar expressions are intended to identify forward-looking statements. These forward-looking statements include, among others, statements about ONS-5010's potential as the first FDA-approved ophthalmic formulation of bevacizumab-vikg, our expectations for ONS-5010 market exclusivity, the timing of potential approval and commercial launch of ONS-5010,ONS-5010's ability to replace and address issues with off-label use of Avastin, other drug candidates in development, commercial drivers for ONS-5010 and its potential, the success of ongoing ONS-5010 trials for wet AMD, planned trials for ONS-5010 for DME and BRVO, expectations concerning the size of the market for, and potential issuers of ons-5010 the sufficiency of our capital resources and other statements that are not historical fact. Our actual results could differ materially from those discussed due to a number of factors, including, but not limited to, the risks inherent in developing pharmaceutical product candidates, conducting successful clinical trials, and obtaining regulatory approvals, as well as our ability to raise additional equity and debt financing on favorable terms, among other risk factors. These risks are described in more detail under the caption "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended September 30, 2022, and other filings with the Securities and Exchange Commission. Moreover, Outlook Therapeutics operates in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Moreover, any such risks may be heightened as a result of the ongoing COVID-19 pandemic. In light of these risks, uncertainties and assumptions, the forward-looking statements discussed in this presentation may not occur and actual results could differ materially and adversely from those anticipated or implied.
Except as required by law, neither Outlook Therapeutics nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. We are providing this information as of the date of this presentation and do not undertake any obligation to update any forward-looking statements contained in this presentation as a result of new information, future events or otherwise. This presentation contains trademarks, registered marks and trade names of Outlook Therapeutics and of other companies. All such trademarks, registered marks and trade names are the property of their respective holders.
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Leadership Team: Global Ophthalmic Development and Commercial Launch Excellence
C. RUSSELL TRENARY III | LAWRENCE KENYON | JEFF EVANSON | TERRY DAGNON |
President, CEO and Director | Chief Financial Officer and Director | Chief Commercial Officer | Chief Operations Officer |
JOEL PRIEVE | JENNIFER KISSNER | ALICIA TOZIER | CHRISTOPHER YONAN |
SVP, Commercial Operations | SVP, Clinical Development | SVP, Market Access and Marketing | SVP, Technical Operations |
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Investment Highlights
FDA Market Approval of ONS-5010(bevacizumab-vikg)1, an Investigational Therapy
for the Treatment of Wet AMD, Targeted for August 29, 2023 PDUFA Date
Targeting $13.1 Billion Global Ophthalmic Anti-VEGF Market2
Differentiated
Drug Product
- Designed to meet robust standards required for FDA ophthalmic approval
- Potential to eliminate risks associated with off-label repackaged bevacizumab, including potential impurities and particulates from compounders re-packaging processes
- Delivery ultimately expected through a convenient pre-filled syringe
Potential for 1st FDA Approved Ophthalmic Bevacizumab
- U.S. FDA BLA accepted with target PDUFA action date of August 29, 2023
- Potential launch in Q4 2023 in U.S.
- Received validation of Marketing Authorization Application by European Medical Agency
- Provides an economically elegant anti-VEGF solution for patients, payers and doctors
Attractive Market
Opportunity
- Strategic commercialization agreement with AmerisourceBergen
- Over 50% of the U.S. market estimated to be available for conversion to ONS-5010, representing up to billions in potential yearly sales
- 12-yearsUS regulatory exclusivity expected upon approval
- Label expansion opportunity into DME and BRVO
- ONS-5010 /LYTENAVA™ (bevacizumab-vikg) is an investigational ophthalmic formulation of bevacizumab
- Guidehouse Triangulation of Global Data, Market Scope and Investor Forecasts (2020)
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AMD = Age-Related Macular Degeneration; DME = Diabetic Macular Edema ; BRVO = Branch Retinal Vein Occlusion
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Outlook Therapeutics Inc. published this content on 09 January 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 January 2023 13:38:03 UTC.