Full Press Release Details
Outlook Therapeutics Provides Business Update
and Reports Financial Results for Fiscal
CRANBURY, N.J., December 18, 2018 - Outlook
Therapeutics, Inc. (NASDAQ:OTLK) (the "Company") today reported financial results and business highlights for its fiscal
year ended September 30, 2018.
"In recent months, we have made tremendous progress implementing
a complete shift in strategy for our development pipeline and we recapitalized the business. This new strategy, which includes
significantly restructured operations and reduced costs, improves our ability to pursue a high value opportunity with ONS-5010
in the multi-billion dollar anti-VEGF ophthalmic market," said Lawrence A. Kenyon, President, Chief Executive Officer and
Chief Financial Officer. "The development of ONS-5010 is being overseen by a new executive team, with significant experience
in the ophthalmic markets and the program is gaining momentum as we have now reached the mid-point for enrollment in our first
clinical trial. With this exciting new program, experienced team and the financial commitment from our key investors, we expect
to make great progress in 2019 towards providing more options to patients and creating value for our stockholders."
Recent Operational Highlights
The Company's wet AMD clinical program was reviewed at a successful
end of Phase 2 meeting held with the U.S. Food and Drug Administration (FDA) conducted in 2018. The Company initiated its first
clinical trial for ONS-5010, a proprietary ophthalmic bevacizumab product candidate, in patients with wet age related macular degeneration
(wet AMD). The study is being conducted outside of the U.S. and is designed to serve as the first of two adequate and well controlled
studies for wet AMD. The U.S. portion of the second study is expected to begin in early 2019 upon the submission of an investigational
new drug (IND) application. If the clinical program is successful, it will support the Company's plans to submit for regulatory
approval in multiple markets in 2020.
The Company appointed two new executives to its leadership team,
including Jeff Evanson as Chief Commercial Officer and Terry Dagnon as Chief Operating Officer. Mr. Evanson joins the Company with
more than 25 years of commercial expertise, most notably with Novartis (Alcon) between 2010 and 2014 where he was most recently
the Vice President and Global Commercial Head of the Pharmaceutical Franchise where he was responsible for all aspects of strategy,
portfolio (both internal and external opportunities), global brands, launches and campaigns.
As the Company's new Chief Operating Officer, Mr. Dagnon brings
more than 20 years of regulatory experience with domestic and global investigational and marketing approvals in the pharmaceutical
and medical device industries, including serving as the North America Head of Regulatory Affairs at Alcon, a Novartis company.
He is also experienced in quality and compliance and working with R&D, marketing, sales, legal, and manufacturing, quality
and supply chain organizations.
On December 3, 2018, the Company announced that it changed its name
from Oncobiologics, Inc. to Outlook Therapeutics, Inc. The Company continues to be listed on the Nasdaq Capital Market and its
common stock and Series A warrants began trading under the new ticker symbols "OTLK" and "OTLKW," respectively,
beginning on Tuesday, December 4, 2018.
Financial Highlights for the Fiscal Year Ended September 30,
For the fiscal year ended September 30, 2018, the Company reported
a net loss attributable to common stockholders of $48.0 million, or $1.22 per diluted share, compared to $40.0 million, or $1.80
per diluted share, for fiscal 2017.
For the fiscal year ended September 30, 2018, the Company reported
an adjusted net loss attributable to common stockholders of $29.9 million, or $0.76 per diluted share, as compared to an adjusted
net loss of $26.7 million, or $1.24 per diluted share, in fiscal 2017. Adjusted net loss attributable to common stockholders in
fiscal 2018 includes $2.0 million of non-cash stock-based compensation, $3.1 million of depreciation and amortization, $1.3 million
of noncash interest expense, $1.3 million of loss on extinguishment of debt, $16.0 million for recognition of the beneficial conversion
feature for convertible preferred stock, and a $1.9 million stock dividend for the Company's Series A and A-1 convertible
preferred stock, which was partially offset by $1.0 million of income from a decrease in the fair value of warrant liability, $3.2
million of tax benefit recognized from the sale of state of New Jersey net operating losses and $3.2 million of benefit from the
settlement of a clinical development contract. For the fiscal year ended September 30, 2017, adjusted net loss attributable to
common stockholders included $8.6 million of non-cash stock-based compensation expense, $2.7 million of depreciation and amortization,
$1.2 million for recognition of the beneficial conversion feature for convertible preferred stock, and $4.0 million of noncash
interest expense, which was partially offset by $3.2 million of income from a decrease in the fair value of warrant liability.
At September 30, 2018, the Company had cash of $1.7 million, compared
to $3.2 million at September 30, 2017.
On November 5, 2018, Outlook Therapeutics announced that it has
received an equity financing commitment for $20.0 million from BioLexis and restructured and extended the maturity of its senior
secured notes that were previously scheduled to mature on December 22, 2018. To date, the Company has completed the sale of the
first two tranches of common stock to BioLexis in this private placement for aggregate cash proceeds of $12.0 million. The remaining
$8.0 will be funded in two equal tranches on each of January 3, 2019 and February 1, 2019, subject to meeting certain funding milestones
as set forth in the purchase agreement. In combination with these improvements to its balance sheet, the Company has committed
to reduce expenses, sell or license the rights to some or all of its clinical stage biosimilar assets and to explore strategic
options for its manufacturing plant.
Nasdaq Listing Update
The Company received formal notice on December 17, 2018 that the
Nasdaq Hearings Panel has granted the Company's request for an extension through April 22, 2019 to evidence compliance with
all applicable requirements for continued listing on Nasdaq, including the applicable $1.0 minimum bid price requirement for at
least ten consecutive trading days.
ONS-5010 is a proprietary ophthalmic formulation of bevacizumab
to be administered as an intravitreal injection for the treatment of wet AMD and other retina diseases. Bevacizumab is a full length
humanized anti-VEGF (Vascular Endothelial Growth Factor) antibody that inhibits VEGF and associated angiogenic activity. The Company's
proprietary ophthalmic bevacizumab product candidate is an anti-VEGF recombinant humanized monoclonal antibody (or mAb) formulated
as a single use vial for IVT injection. By inhibiting the VEGF receptor from binding, bevacizumab prevents the growth and maintenance
of tumor blood vessels. Previously, this product candidate met the primary and secondary endpoints in a 3-arm single-dose pharmacokinetic
(PK) Phase 1 clinical trial. All of the PK endpoints met the bioequivalency criteria of the geometric mean ratios within 90% confidence
interval of 80-125% when compared to both U.S.- and EU-sourced Avastin reference products.
About Outlook Therapeutics, Inc.
Outlook Therapeutics is a clinical-stage biopharmaceutical company
focused on developing its lead clinical program, ONS-5010, a proprietary ophthalmic bevacizumab product candidate for the treatment
of wet age related macular degeneration (wet AMD). ONS-5010 is currently in its first clinical trial, which is being conducted
outside of the U.S. and is designed to serve as the first of two adequate and well controlled studies for wet AMD. For more information,
please visit www.outlooktherapeutics.com.
Non-GAAP Financial Measure - Adjusted Net Loss Attributable
to Common Stockholders
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 press release,
Outlook Therapeutics uses the NGFM, "adjusted net loss attributable to common stockholders." Management uses this NGFM
because it adjusts for certain transactions management believes are not related to the Company's core business or events
that may not recur, such as losses from extinguishment of debt, sales of state net operating losses, as well as the settlement
of a clinical development contract in connection with the decision to postpone Phase 3 clinical trials of two biosimilar programs,
as well as significant non-cash items that impact financial results but not cash flows, such as the recognition of the beneficial
conversion feature due to the issuance of Series A Convertible Preferred Stock to BioLexis and related stock dividends, stock-based
compensation expense, depreciation and amortization expense, interest expense, and fair value measurements for the Company's
equity and debt securities. Management used this NGFM to evaluate Outlook Therapeutics financial performance against internal budgets
and targets. Management believes that this NGFM is useful for evaluating Outlook Therapeutics core operating results and facilitating
comparison across reporting periods. Outlook Therapeutics believes this NGFM should be considered in addition to, and not in lieu
of, GAAP financial measures. Outlook Therapeutics NGFM may be different from the same NGFM used by other companies.
Forward-Looking Statements
This press release contains forward-looking statements. All statements