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
- Closed on approximately $50 million
net proceeds from two new financings to support pre-launch
activities through anticipated approval of ONS-5010 in third
calendar quarter 2023.
- Approximately $25 million
registered direct equity offering priced at-the-market under Nasdaq
rules.
- Approximately $30 million net
proceeds from issuance of an unsecured convertible promissory note
with an initial conversion price of $2.00.
- Received validation of Marketing
Authorization Application (MAA) by the European Medicines Agency
(EMA) for ONS-5010/ LYTENAVA™ (bevacizumab-vikg).
- Announced that the FDA accepted its
Biologics License Application (BLA) for ONS-5010 / LYTENAVA™
(bevacizumab-vikg) for the treatment of wet AMD and set a PDUFA
goal date of August 29, 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.
- Strengthened Board of Directors
with appointment of Julia Haller, MD, one of the country’s most
accomplished professionals in ophthalmic education, research and
clinical ophthalmic practice.
“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
- Continued progress with ongoing
pre-launch commercial preparations in anticipation of potential
approval for ONS-5010 in 2023;
- PDUFA goal date of August 29, 2023;
and
- Estimated decision date from the
EMA’s Committee for Medicinal Products for Human Use (CHMP) on the
Company’s submitted MAA in EU for ONS-5010 expected in early
2024.
ONS-5010 / LYTENAVA™
(bevacizumab-vikg) Pre-Launch Commercial Planning
UnderwayAccording 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) Development
Updates 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
herein, they are based on current expectations about future events
affecting Outlook Therapeutics and are subject to risks,
uncertainties and factors relating to its operations and business
environment, all of which are difficult to predict and many of
which are beyond its control. These risk factors include those
risks associated with developing pharmaceutical product candidates,
risks of conducting clinical trials and risks in obtaining
necessary regulatory approvals, as well as those risks detailed in
Outlook Therapeutics’ filings with the Securities and Exchange
Commission (the “SEC”), including the Annual Report on Form 10-K
for the fiscal year ended September 30, 2022 to be filed with the
SEC and future quarterly reports we file with the SEC, which
include the uncertainty of future impacts related to the ongoing
COVID-19 pandemic and the impacts of the pandemic and other
macroeconomic factors, including as a result of the ongoing
conflict between Russia and Ukraine, on the global
business environment. These risks may cause actual results to
differ materially from those expressed or implied by
forward-looking statements in this press release. All
forward-looking statements included in this press release are
expressly qualified in their entirety by the foregoing cautionary
statements. You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
Outlook Therapeutics does not undertake any obligation to update,
amend or clarify these forward-looking statements whether as a
result of new information, future events or otherwise, except as
may be required under applicable securities law.
CONTACTS:Media Inquiries:Anna
ArmyAccount SupervisorLaVoie Health ScienceT:
617-351-0246aarmy@lavoiehealthscience.com
Investor Inquiries:Jenene ThomasChief Executive
OfficerJTC Team, LLCT: 833.475.8247 OTLK@jtcir.com
Outlook Therapeutics, Inc. |
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Consolidated Statements of Operations |
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(Amounts in thousands, except per share data) |
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Year ended September 30, |
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2022 |
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2021 |
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Operating expenses: |
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Research and development |
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$ |
42,331 |
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$ |
38,958 |
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General and administrative |
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20,740 |
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12,769 |
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63,071 |
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51,727 |
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Loss from operations |
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(63,071 |
) |
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(51,727 |
) |
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Loss on equity method investment |
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49 |
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46 |
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Interest expense, net |
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1,487 |
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936 |
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Loss on extinguishment of debt |
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1,025 |
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- |
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Change in fair value of unsecured convertible promissory note |
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883 |
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- |
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Change in fair value of warrant liability |
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(466 |
) |
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452 |
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Loss before income taxes |
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(66,049 |
) |
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(53,161 |
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Income tax expense |
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3 |
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2 |
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Net loss attributable to common stockholders |
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$ |
(66,052 |
) |
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$ |
(53,163 |
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Per share information: |
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Net loss per share of common stock, basic and diluted |
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$ |
(0.31 |
) |
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$ |
(0.35 |
) |
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Weighted average shares outstanding, basic and diluted |
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212,079 |
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152,676 |
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Consolidated Balance Sheet Data |
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(Amounts in thousands) |
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September 30, |
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2022 |
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2021 |
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Cash and cash equivalents |
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$ |
17,397 |
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$ |
14,477 |
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Total assets |
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$ |
28,528 |
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$ |
22,811 |
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Current liabilities |
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$ |
19,730 |
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$ |
6,752 |
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Total stockholders' equity |
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$ |
8,737 |
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$ |
4,607 |
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Outlook Therapeutics (NASDAQ:OTLK)
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