Full Press Release Details
Outlook Therapeutics Reports Financial
Results for Fiscal Year 2022 and Provides Corporate Update
ISELIN, N.J., December 29, 2022 - Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working
to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced its
financial results for its fiscal year ended September 30, 2022, and provided recent corporate highlights.
Recent Corporate Highlights
"Our fiscal year 2022 laid a solid foundation for what we believe will be a transformational 2023. We are driving our commercialization
planning towards expected launch with the accepted FDA filing of our BLA for ONS-5010 and PDUFA date set for August 29, 2023 and
review of our MAA in the EU underway with a decision date expected in early 2024. We believe that ONS-5010 has the potential to be a game-changer
for patients and physicians in the retina community, and we now have the necessary capital to support these efforts. We remain steadfast
in our mission to enhance the standard of care in the retinal anti-VEGF space," commented C. Russell Trenary III, President and
Chief Executive Officer of Outlook Therapeutics. "On behalf of the entire team, I would like to thank all stakeholders for
their continued support and look forward to what we believe will be an exciting future for Outlook Therapeutics."
Upcoming Anticipated Milestones
ONS-5010 / LYTENAVA (bevacizumab-vikg)
Pre-Launch Commercial Planning Underway
According to GlobalData, the use of unapproved repackaged IV bevacizumab from compounding pharmacies is estimated to account for approximately
50% of all wet AMD injections in the United States each year. Globally, the nine major markets account for an estimated $13.1 billion
market for anti-VEGF drugs to treat retina diseases.
In anticipation of potential FDA marketing approval in 2023, Outlook Therapeutics has begun commercial launch planning, including best-in-class
partnerships with FUJIFILM Diosynth Biotechnologies for drug substance, and with drug product manufacturer Aji Bio-pharma Services for
the finished drug product.
Outlook Therapeutics is actively building out
its sales and commercial team, and in September 2022, Outlook Therapeutics entered into a strategic commercialization agreement
with AmerisourceBergen in preparation for the anticipated commercial launch in the United States of ONS-5010. As Outlook Therapeutics
moves toward a potential launch in the United States, AmerisourceBergen's commercialization support will expand to include
additional services. Through the agreement with AmerisourceBergen, Outlook Therapeutics expects to significantly increase market access
and efficient distribution of ONS-5010, if approved by the FDA. Moreover, working with AmerisourceBergen will help to provide Outlook
Therapeutics with an accelerated pathway to deliver a high-quality customer experience to retina specialists. To bring ONS-5010 to market
in a way that benefits all stakeholders - patients, clinicians, and payors - Outlook Therapeutics has also been in collaborative
discussions with payors and the retina community.
Outlook Therapeutics is also developing registration
documents on a parallel path for approvals in Europe and submitted them in December 2022. The formal review process of the MAA by
the EMA's CHMP is now set to begin with an estimated decision date expected in early 2024 and is also exploring a relationship
with AmerisourceBergen to support the launch of ONS-5010 in international markets. AmerisourceBergen expanded its global distribution
capabilities in 2021 with the acquisition of Alliance Healthcare, a leading wholesaler of healthcare products in Europe. Additionally,
Outlook Therapeutics continues to explore potential strategic commercialization partners, such as the current partnership with Syntone
Biopharma JV in China.
In addition to the clinical development program evaluating ONS-5010 for wet AMD, Outlook Therapeutics has received agreements from the
FDA on three Special Protocol Assessments (SPAs) for three additional registration clinical trials. These SPAs cover the protocols for
a planned registration clinical trial evaluating ONS-5010 to treat branch retinal vein occlusion (BRVO), NORSE FOUR, and two planned registration
clinical trials evaluating the drug candidate for the treatment of diabetic macular edema (DME), NORSE FIVE and NORSE SIX.
ONS-5010 / LYTENAVA (bevacizumab-vikg)
As previously announced, if ONS-5010 receives FDA approval, Outlook Therapeutics plans to submit a supplementary application (sBLA) for
approval to provide the product in a pre-filled, silicone oil liquid-free syringe that meets the FDA's strict specifications for
ophthalmic use. To support the anticipated submission of this sBLA, Outlook Therapeutics is conducting its NORSE SEVEN clinical trial
to compare the safety of ONS-5010 in vials versus pre-filled syringes. NORSE SEVEN is expected to enroll approximately 120 subjects with
visual impairment due to retinal disorders. Patients will be treated for three months; the enrollment of patients in the arm of the study
receiving ONS-5010 in vials has already been completed.
Financial Highlights for the 2022 Fiscal Year
Ended September 30, 2022
For the fiscal year ended September 30, 2022,
Outlook Therapeutics reported a net loss attributable to common stockholders of $66.1 million, or $0.31 per basic and diluted share, compared
to a net loss attributable to common stockholders of $53.2 million, or $0.35 per basic and diluted share, for fiscal 2021.
At September 30, 2022, Outlook Therapeutics
had cash and cash equivalents of $17.4 million.
Subsequent to September 30, 2022, the Company
closed a registered direct equity offering priced at-the-market under Nasdaq rules, resulting in aggregate gross proceeds of approximately
$25.0 million. Additionally, the Company closed on an unsecured convertible promissory note (the "Note") with a face amount
of $31.8 million and net proceeds of approximately $30.0 million after original issue discount and after deducting the Lender's
transaction costs covered by the Company in connection with the issuance. The combined proceeds from the Note and the registered direct
offering are expected to provide funding through the anticipated FDA approval of ONS-5010 in the third calendar quarter of 2023.
About ONS-5010 / LYTENAVA (bevacizumab-vikg)
ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development as an intravitreal injection for the treatment
of wet AMD and other retinal diseases. Because no currently approved ophthalmic formulations of bevacizumab are available, clinicians
wishing to treat retinal patients with bevacizumab have had to use unapproved repackaged IV bevacizumab provided by compounding pharmacies,
products that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010 can replace the need
to use unapproved repackaged oncologic IV bevacizumab from compounding pharmacies for the treatment of wet AMD.
Bevacizumab-vikg is a recombinant humanized monoclonal
antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes
VEGF's biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on
the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab-vikg to VEGF prevents the interaction of
VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood
vessel formation in the retina.
About Outlook Therapeutics, Inc.
Outlook Therapeutics is a biopharmaceutical company
working to develop and launch ONS-5010/ LYTENAVA (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab
for use in retinal indications, including wet AMD, DME and BRVO. The FDA accepted Outlook Therapeutics' BLA submission for ONS-5010
to treat wet AMD with a PDUFA goal date of August 29, 2023. The submission is supported by Outlook Therapeutics' wet AMD clinical
program, which consists of three clinical trials: NORSE ONE, NORSE TWO, and NORSE THREE. If ONS-5010 ophthalmic bevacizumab is approved,
Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in
treating retinal diseases in the United States, United Kingdom, Europe, Japan, and other markets. As part of the Company's multi-year
commercial planning process, and in anticipation of potential FDA approval in August 2023, Outlook Therapeutics and AmerisourceBergen
have entered into a strategic commercialization agreement to expand the Company's reach for connecting to retina specialists and
their patients. AmerisourceBergen will provide third-party logistics (3PL) services and distribution, as well as pharmacovigilance services
in the United States. For more information, please visit www.outlooktherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts are "forward-looking
statements," including those relating to future events. In some cases, you can identify forward-looking statements by terminology
such as "anticipate," "believe," "continue," "could," "estimate," "expect,"
"may," "might," "intend," "potential," "predict," "should," or
"will," the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These
include, among others, statements about ONS-5010's potential as the first FDA-approved ophthalmic formulation of bevacizumab-vikg,
including benefits therefrom to patients, payors and physicians, including expectations of market exclusivity, potential approval and
commercial launch of ONS-5010 and the timing thereof, expectations about the sufficiency of our capital, upcoming anticipated milestones,
expectations concerning decisions of regulatory bodies, including the FDA and the EMA, and the timing thereof, our estimated market, expectations
concerning our relationship with AmerisourceBergen and the benefits thereof, plans for and the timing of potential future clinical trials,
including the expected completion of NORSE SEVEN and the expected commencement of NORSE FOUR, NORSE FIVE and NORSE SIX, potential strategic
partners, plans for regulatory submissions, approvals and commercialization of ONS-5010 in other markets and other statements that are
not historical fact. Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained