Full Press Release Details
Reports First Quarter Fiscal Year 2018 Results
- February 14, 2018 - Oncobiologics, Inc. (NASDAQ: ONS) today reported financial results and business highlights
for its first fiscal quarter ended December 31, 2017. Oncobiologics had a net loss attributable to common stockholders of $17.7
million for the three months ended December 31, 2017 and total cash of $ 13.8 million at December 31, 2017. On an adjusted basis,
Oncobiologics had a net loss attributable to common stockholders for the three months ended December 31, 2017 of $5.0 million.
Chairman and Chief Executive Officer Dr. Pankaj Mohan commented, "With the closing of the GMS Tenshi strategic investment
in October 2017, in 2018 we plan to execute on a newly developed strategy to organically generate funding for our biosimilar development
programs, in addition to our ongoing efforts to secure additional development partners. The first step in this strategy is to leverage
the capacity and capabilities of our BioSymphony Platform to accelerate and maximize commercial revenues from our core expertise
in drug development and manufacturing. As we roll out this new contract development and manufacturing (CDMO) business, we initially
plan to assist our clients with the development and manufacturing of their drug product candidates for clinical trials."
Oncobiologics also completed the process of out-licensing rights to ONS-3010 and ONS-1045 biosimilar development programs for emerging
markets to GMS Tenshi. In each of these smaller, ex-U.S. markets, we identified potential synergies between our partner's
strategy to enter the biologics marketplace and access to our biosimilar development platform. For many of these emerging market
opportunities, our partners may be able to take advantage of differing regulatory requirements that could allow more rapid regulatory
approval of these product candidates and commercial sales."
Dr. Mohan continued,
"Going forward, we will continue to focus on the development of our biosimilar pipeline and look for partners for our most
advanced programs, ONS-3010 and ONS-1045, to move those candidates into Phase 3 clinical trials to support FDA and EMA approvals.
Additionally, we are excited to confirm two programs we are preparing for clinical development ONS-4010, a biosimilar of Prolia/Xgeva,
and ONS-3040, a biosimilar for Stelara. We have also begun work on ONS-5010, an innovative drug product candidate that will not
use the biosimilar regulatory pathway. Our intent is to seek and receive feedback from U.S. regulatory authorities and proceed
into Phase 1 clinical trials for ONS-5010 in 2018."
this updated strategy with the support of our new partner and investor, GMS Tenshi, we believe that the company is well positioned
to begin generating revenue from our new CDMO business in 2019, which we expect to cover the basic operating costs of running our
business and allow us to use funds generated from partnerships and other transactions for investment directly in our development
pipeline," concluded Dr. Mohan.
First Quarter Highlights
2018 - Anticipated Milestones
Long-term Milestones
Financial Highlights
For the three months ended December 31,
2017, Oncobiologics reported a net loss attributable to common stockholders of $17.7 million, or $0.71 per share, compared to $19.1
million, or $0.82 per share for the same period in the preceding year. For the three months ended December 31, 2017, net loss attributable
to common stockholders includes $1.9 million of non-cash stock-based compensation expense, $0.7 million of depreciation and amortization,
a $1.3 million loss from the extinguishment of debt, $0.1 million from a decrease in the fair value of warrant liability, $3.2
million benefit from the sale of state of New Jersey net operating losses, a $15.4 million beneficial conversion charge related
to the Company's Series A convertible preferred stock and a $3.2 million reduction in expenses from the favorable settlement
of the termination of a clinical contract. Adjusting for these items, the Company reported an adjusted net loss attributable to
common stockholders of $5.0 million, or $0.20 per share, on a non-GAAP basis as appears in the attached non-GAAP reconciliation.
Adjusted net loss attributable to common stockholders for the three months ended December 31, 2016 was $15.2 million, or $0.65
per share, on a non-GAAP adjusted basis comparable to the same period in the current fiscal year.
The primary factor for the decrease in
adjusted net loss attributable to common stockholders for the three months ended December 31, 2017 as compared to the same period
in the prior year was a significant reduction in research and development expenses, which was related to the Company's decision
to postpone the initiation of planned Phase 3 clinical trials for ONS-3010 and ONS-1045 until additional development partners have
Cash was $13.8 million as of December
31, 2017, compared to $3.2 million as of September 30, 2017.
Non-GAAP Financial Measure - Adjusted Net Loss Attributable
to Common Stockholders
Oncobiologics prepares its consolidated
financial statements in conformity with accounting principles generally accepted in the United States of America (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 Oncobiologics financial performance, Oncobiologics
sometimes uses non-GAAP financial measures (NGFM) as defined by the Securities and Exchange Commission. In this press release,
Oncobiologics uses the NGFM, "adjusted net loss attributable to common stockholders." Management uses this NGFM because
it adjusts for unusual transactions, transactions not related to the Company's core business or events that are not expected
to 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 GMS Tenshi, stock-based compensation expense, depreciation
and amortization expense, and fair value measurements for the Company's equity and debt securities. Management used this
NGFM to evaluate Oncobiologics' financial performance against internal budgets and targets. Management believes that this
NGFM is useful for evaluating Oncobiologics core operating results and facilitating comparison across reporting periods. Oncobiologics
believes this NGFM should be considered in addition to, and not in lieu of, GAAP financial measures. Oncobiologics NGFM may be
different from the same NGFM used by other companies.
For additional details on Oncobiologics'
financial performance during the quarter, please see the Company's filings with the Securities and Exchange Commission at:
About Oncobiologics,
Inc. and its BioSymphony Platform
is a clinical-stage biopharmaceutical company focused on identifying, developing, manufacturing and commercializing complex biosimilar
therapeutics. Its current focus is on technically challenging and commercially attractive monoclonal antibodies (mAbs) in the disease
areas of immunology and oncology. Oncobiologics is advancing its pipeline of biosimilar products, two of which are currently in
clinical development. Led by a team of biopharmaceutical experts, Oncobiologics operates from an in-house state-of-the-art fully
integrated research and development, and manufacturing facility in Cranbury, New Jersey. Oncobiologics employs its BioSymphony
Platform to address the challenges of biosimilar development and commercialization by developing high quality mAb biosimilars in
an efficient and cost-effective manner on an accelerated timeline. For more information, please visit www.oncobiologics.com.
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 "may,"
"might," "will," "should," "expect," "plan," "anticipate,"
"project," "believe," "estimate," "predict," "potential," "intend"
or "continue," the negative of terms like these or other comparable terminology, and other words or terms of similar
meaning. These include statements about the Company's new strategy and anticipated milestones, in particular the ability
to execute on its new CDMO strategy and generate revenues therefrom, the ability to receive regulatory approval and generate revenues
in emerging markets, the ability to find partners to conduct Phase 3 trials for its lead biosimilar assets, receive FDA approval
for ONS-5010 under a different pathway and commercially launch such product candidate, and the ability to conduct successful Phase
1 trials for ONS-4010 and ONS 3040, among others. Although Oncobiologics believes that it has a reasonable basis for forward-looking
statements contained herein, they are based on current expectations about future events affecting the Company 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. Therefore, they 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. Oncobiologics 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.
Condensed Consolidated Statements of