NASDAQ: OTLK outlooktherapeutics.com
Redefining the Standard of Carefor Ophthalmic Therapies
Corporate Presentation
June 2024
Thispresentation 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 "expect," "explore," "initiate," "intend," "may," "plan," and "potential," 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 U.S. Food and Drug Administration (FDA)-approved, and/or Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom approved ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the United States and United Kingdom, expectations concerning our ability to remediate or otherwise resolve deficiencies identified in our Complete Response Letter (CRL) issued by the FDA, including with respect to an additional clinical trial and chemistry, manufacturing and controls (CMC) issues, expectations concerning NORSE EIGHT enrollment, the timing for completion of NORSE EIGHT and resubmission of the Biologics License Application (BLA) for ONS-5010, the sufficiency of our capital resources, expectations concerning decisions of regulatory bodies, including the FDA and the MHRA, and the timing thereof, plans for potential commercial launch of ONS-5010 in the United States, European Union and United Kingdom, expectations concerning the relationship with Cencora and the benefits and potential expansion thereof, expectations concerning the size of the market for ONS-5010 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, including our ability to resolve issues identified in the CRL issued by the FDA, 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, 2023, and other filings with the Securities and Exchange Commission, which include the uncertainty of future impacts related to macroeconomic factors, including as a result of the ongoing overseas conflict, high interest rates, inflation and potential future bank failures on the global business environment. 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. 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.
Outlook Therapeutics prepares its consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (U.S. GAAP) and pursuant to accounting requirements of the Securities and Exchange Commission. In an effort to provide investors with additional information regarding the results and to provide a meaningful period-over-period comparison of Outlook Therapeutics' financial performance, Outlook Therapeutics sometimes uses non-U.S. GAAP financial measures (NGFM) as defined by the Securities and Exchange Commission. In this presentation, Outlook Therapeutics uses "adjusted net loss attributable to common stockholders," which is defined as net loss attributable to common stockholders excluding warrant related expenses (i.e., the excess of the fair value of the warrants upon issuance over the proceeds of the private placement that closed on March 18, 2024) and changes in fair value of warrants and convertible promissory notes, as well as "adjusted net loss attributable to common stockholders per share of common stock - basic and diluted," which is defined as net loss attributable to common stockholders per share of common stock - basic and diluted excluding warrant related expenses and changes in fair value of warrants and convertible promissory notes. Management uses these NGFMs because they adjust for certain non-cash items that impact financial results but not cash flows and that management believes are not related to its core business. Management uses these NGFMs to evaluate Outlook Therapeutics financial performance against internal budgets and targets. Management believes that these NGFMs are useful for evaluating Outlook Therapeutics' core operating results and facilitating comparison across reporting periods. Outlook Therapeutics believes these NGFMs should be considered in addition to, and not in lieu of, GAAP financial measures. Outlook Therapeutics' NGFMs may be different from the same NGFMs used by other companies. A reconciliation of these NGFMs to the most directly comparable U.S. GAAP financial measures have been providedin anappendix at the end of this presentation.
Now Approved In TheEU
LYTENAVA (bevacizumab gamma)for the Treatment of Wet AMD
ReceivedEuropean Commission Marketing Authorization in May2024
First and Only Approved Ophthalmic Formulation of Bevacizumab
in the European Union
Currently Estimated to be in Excess of $15.9 Billion Worldwide1
Market
Number of
Treated Patients
Physician Interest
in an Approved
Bevacizumab
Total Market Opportunity
United States
1.75 Million2
85%4 | $8.5 Billion1 |
EU + UK | 1.52 Million3 |
82%4
$3.6 Billion1
- Citeline (2023), Global Data (2023) and Market Scope (2022)
- Triangulation of Global Data, Market Scope Data, CDC Vision and Eye Health Surveillance System (VEHSS)
- Guidehouse Triangulation of Global Data, Market Scope 2022 Retinal Pharmaceuticals Market Report
- Navigant Quantitative Survey (n=152), 2019, Respondents who have interest or high interest in ONS-501
Redefining the standard of care for
retina disorders, including wet AMD
First European Union authorized form of bevacizumab for ophthalmology
Opportunity to expand into
DME andBRVO
Targeting$15.9billionglobal ophthalmicanti-VEGFmarket4
*Dates and timelines are listed incalendar year
1. ONS-5010 / LYTENAVA (bevacizumab-vikg) is an investigational ophthalmic formulation of bevacizumab in the United Sates; LYTENAVA (bevacizumab gamma) gained European Union marketing authorization
2. Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group, Daniel F. Martin, Ophthalmology, July 2012 Volume 119, Issue 7, Pages 1388-1398
ONS-5010 / LYTENAVA
(bevacizumab-vikg; bevacizumab gamma)1
Bevacizumab has been validated2 in wet AMD and is used off-label as a first-line treatment3
Europe
LYTENAVA (bevacizumab gamma) received European Commission Marketing Authorization for Treatment of Wet AMD in May 2024
First commercial launch expected Q1 2025
Submitted MAA in UK Using the New International Recognition Procedure (IRP)
United States
Ongoing NORSE EIGHT study with results expected Q4 2024
US FDA Biologics License Applications (BLA) resubmission expected before year end 2024
3. ASRS 2022 Membership Survey Presented at ASRS NY 2022. Q: Considering all
indications, what is your most commonly used first-lineanti-VEGF agent? | 5 |
4. Citeline (2023), Global Data (2023) and Market Scope (2022) | |
Bevacizumab (Brand Name Avastin®) Approved as an OncologyDrugin2004
Most Commonly Used Off-Label,First-Line
Anti-VEGF in Ophthalmology for Treatment of Wet AMD
Outlook Therapeutics Achieved First Authorization of Ophthalmic Formulation of Bevacizumab
in European Union in Treatment of Wet AMD and Working to Gain Potential Approval in theUKand United States
Current Situation
55.4% of new diagnosed wet AMD patients start with off-label, unapproved bevacizumab1
66.3% of US retina physicians state off-label, unapproved bevacizumab is their most commonly used first-lineanti-VEGF2
However, switching to an FDA approved anti-VEGF may occur up to over 40% of the time by year 3 of treatment1
This may be occurringdue to the limitations of off-label(non-ophthalmic) repackaged bevacizumab, specifically:
- Lack of potency,
- Significant safety issues
- Quality and supply issues
Outlook Therapeutics Opportunity
Ophthalmic formulation of bevacizumab isa 351 (a) BLA submission in the US and a full mixed MAA based on Article8.3 of Directive 2001/83/EC in the EU and the international recognition procedure in the UK
8 Years of data exclusivity and 10 years market exclusivity received with authorization in the EU
12 years regulatory exclusivity expected upon approval in the
United States
Potential to eliminate safety risks associated with repackaged bevacizumab used off-label, impurities, particulates, andlack of drug potency
- Medicare Claims Analysis 2023: Guidehouse Analysis
- ASRS 2022 Membership Survey Presented at ASRS NY 2022. Q: Considering all indications, what is your most commonly used first-lineanti-VEGF agent?
RepackagedBevacizumab Used Off-Label is Not Held to Ophthalmic Quality Standards
Variability in Potency1
81% of samples had lower protein
concentrations than required.
Demonstrated inconsistencies of compounded Avastinfromsyringe tosyringe
Safety and Sterility
Adverse Events2
Frequent recalls and compliance
issues by compounders cause service interruptions and endanger patient safety and consistency of treatment
SyringeAdverse Events3
Includemechanical failures,visibleparticulates, and quality challenges
caused by long-term storagein immediate use syringes
- JAMA Ophthalmol. 2015 Jan;133(1):32-9. doi: 10.1001/jamaophthalmol.2014.3591
- Goldberg, Roger A et al. "An outbreak of streptococcus endophthalmitis after intravitreal injection of bevacizumab." American Journal of Ophthalmology vol. 153,2 (2012): 204-208.e1. doi:10.1016/j.ajo.2011.11.035
- ASRS Member Alert, April 2019
Off-Label Compounded | FDA Approved Ophthalmic | |
Repackaged IV Solution | ||
Ophthalmic Solution Requirement | Solution for Intravitreal | |
Matches to Ophthalmic | ||
Injection | ||
Approval Requirements | ||
Sterile USP <71>1 | Unknown | Yes |
Particulates per USP <789> for ophthalmic solutions1 | Unknown | Yes |
GMP2,3 | Unknown | Yes |
Bacterial endotoxins USP <85>1 | No | Yes |
FDA approved ophthalmic package consistent with USP <771>1 | No | Yes |
FDA reviewed stability data supporting shelf life2,3 | No | Yes |
pH FDA approved and consistent with USP <771>1,2,3 | No | Yes |
Potency FDA approved specifications for shelf life2,3 | No | Yes |
Osmolarity specification for ophthalmic solution2,3 | No | Yes |
*Note: European Union has similar standards as US FDA; 1. USP general Chapter <771> OPHTHALMIC PRODUCTS-QUALITY TESTS USP40-NF35, second supplement, June 1, 2017; 2: Aldrich, Dale S., Bach, Cynthia M., Brown, William, Chambers, Wiley, Fleitman, Jeffrey, Hunt, Desmond, Marques, Margareth R. C., Mille, Yana, Mitra, Ashim K., Platzer, Stacey M., Tice, Tom, Tin, George W.; Ophthalmic Preparations USP STIMULI TO THE REVISION PROCESS Vol. 39(5) [Sept.-Oct. 2013]; 3: Missel PJ, Lang JC, Rodeheaver DP, Jani R, Chowhan MA, Chastain J, Dagnon T. Design and evaluation of ophthalmic pharmaceutical products. In: Florence, AT, Siepmann J. Modern Pharmaceutics-Applications and Advances. New York: Informa; 2009:101-189.
Price according to what payers and retina specialists have indicated is reasonable
United States | |||||
$75+ | $500 | $1,000 | $1,300 | $2,000 | $2,500+ |
Unapproved | Ranibizumab | Branded Premium Priced | |||
Repackaged | Biosimilars | ||||
Avastin (off-label) |
EU+UK Pricing spectrum of anti-VEGFs average per dose (range)1 | ||
€30-50* | €589 (€283-940) | €722 (€377-999) |
Biosimilars | ||
Compounded | ||
Bevacizumab | ||
Compounded Avastin | Biosimilars | Branded Products |
(off-label) | (ranibizumab or aflibercept) | |
AVERAGE EU+UKPRICING OF ANTI-VEGFS1
BRANDED
€446 (€377-€565) | €663 (€613-€700)€767 (€742-€843) | €845 (€759-€990)€889 (€642-€999) | |
€400 | €600 | €800 | €1000 |
BIOSIMILAR
€283 | €602 (€577-€609) | €626 (€567-€742) | €847 (€800-€940) |
1. Local pricing sources, ex-factory prices (UK: list prices exchange rate 1EUR : 0.85GBP, February 2024 | |||
*Price range is based on clinician feedback for EU4+UK. The use of off-label | Branded products: Eylea, Beovu, Lucentis, Vabysmo) | ||
bevacizumab varies widely across the EU4+UK | Biosimilars included Lucentis biosimilars Byooviz (Germany, UK) Ranivisio (France, Germany , Spain, UK) | ||
and Ximluci (Germany, Spain, UK) |
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Outlook Therapeutics Inc. published this content on 05 June 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 05 June 2024 21:31:05 UTC.