On this page of StockholderLetter.com we present the 2/15/2023 shareholder letter from Outlook Therapeutics, Inc. — ticker symbol OTLK. Reading current and past OTLK letters to shareholders can bring important insights into the investment thesis.

 •  2/15/2023 Letter Continued (Full PDF)
 •  2/8/2024 OTLK Stockholder Letter
 •  2/10/2025 OTLK Stockholder Letter
 •  More "Biotechnology" Category Stockholder Letters
 •  OTLK Benford's Law Stock Score = 99

OTLK 2/15/2023 Shareholder/Stockholder Letter Transcript:

January 2023
To our valued shareholders,
I am pleased to be writing you after a noteworthy 2022 that we believe was foundational for a
transformative 2023 for Outlook Therapeutics. Our team has continued to execute, and with the
accomplishments made to date, we anticipate a potential wet AMD FDA approval for our investigational
therapy, ONS-5010 / LYTENAVA    (bevacizumab-vikg), this year. As we progress towards this exciting event
in 2023, I want to take a moment to reflect on key milestones accomplished over the last year:
    Submitted, and announced that the FDA accepted, our Biologics License Application (BLA) for
ONS-5010 for the treatment of wet AMD and received a PDUFA goal date of August 29, 2023.
    Received validation of Marketing Authorization Application (MAA) by the European Medicines
Agency (EMA) for ONS-5010.
    Raised the necessary capital to support pre-launch activities through anticipated U.S. approval of
ONS-5010 in third calendar quarter 2023.
    Entered into a strategic commercialization agreement with AmerisourceBergen, a global healthcare
company and leader in specialty pharmaceutical distribution and services, who will provide third-party
logistics (3PL) services and distribution, as well as medical information and pharmacovigilance
services in the United States.
    Expanded our commercial team with key appointments in Commercial Operations, Marketing and
Market Access.
We executed on our goals for 2022, and Outlook Therapeutics is well underway in its pivot towards
becoming a commercial-stage company. With these foundational achievements, we are striving to bring
ONS-5010 to the commercial starting line with potential FDA marketing approval for our lead program this
year.
As a reminder, bevacizumab that was designed for intravenous administration is not FDA approved for
ophthalmic use but is currently used by physicians off-label to treat approximately 50% of the wet AMD
market. If ONS-5010 is approved, it is expected to result in 12 years of regulatory exclusivity in the United
States as the first and only ophthalmic formulation of bevacizumab approved by the FDA to treat wet AMD.
Our plan is to offer an anti-VEGF solution that enhances the standard of care as it addresses issues
associated with the currently available off-label product, that is re-handled and re-packaged after it leaves
the original manufacturer. Our goal is to provide physicians, patients and payers a safe, effective and FDAapproved version of bevacizumab that meets standards required for ophthalmic injections.
With potential commercialization of ONS-5010 on the horizon, we continue to execute on our precommercial launch initiatives. We are actively building out a robust medical information and commercial
team and continue to make key appointments that bring added medical affairs and commercial expertise.
Additionally, our strategic commercialization agreement with AmerisourceBergen provides us with what we
believe will be a significant increase in market access and efficient distribution of ONS-5010 in the United
States, if approved by the FDA. We believe that a partnership like the one we have established with
AmerisourceBergen positions us well for an accelerated pathway to deliver a high-quality customer experience
to retina specialists while enhancing value to patients and payers. In parallel, we have also developed
registration documents for approvals in Europe and submitted them in December 2022. The formal review
process of the MAA by the EMA   s CHMP is now able to begin, with an estimated decision date expected in
early 2024.
Looking ahead, we remain steadfast in our mission to enhance the standard of care in the retinal antiVEGF space and believe we are well-positioned for a successful launch of ONS-5010 for wet AMD, if

approved. We wholeheartedly believe that ONS-5010 has the potential to be a significant contribution to
the retina community and we are excited for what is to come for Outlook Therapeutics.
On behalf of our team, I thank you for your continued support. We look forward to an exciting year
ahead by potentially changing the treatment landscape for wet AMD.
Sincerely,
C. Russell Trenary III
President & CEO
Outlook Therapeutics



 2/15/2023 Letter Continued (Full PDF)