Item 2.02 Results of Operations and Financial
Condition.
On
May 7, 2020, the Company
issued a press release announcing that the Company will present its
operational results for the fiscal third quarter ended March 31,
2020 on Thursday, May 14, 2020, at 4:30 p.m. ET. A copy of the
press release is attached as Exhibit 99.1 and incorporated herein
by reference.
In
accordance with General Instruction B.2 of Form 8-K, the
information in the press release attached as Exhibit 99.1 hereto
shall not be deemed to be “filed” for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), nor shall such information be deemed
incorporated by reference in any filing under the Securities Act of
1933, as amended, or the Exchange Act, except as shall be expressly
set forth by specific reference in such filing.
Forward-Looking Statement
This
press release includes forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, or the
Exchange Act. All statements other than statements of historical
facts contained in this presentation, are forward-looking
statements. Forward-looking statements are generally written in the
future tense and/or are preceded by words such as ''may,''
''will,'' ''should,'' ''forecast,'' ''could,'' ''expect,''
''suggest,'' ''believe,'' ''estimate,'' ''continue,''
''anticipate,'' ''intend,'' ''plan,'' or similar words, or the
negatives of such terms or other variations on such terms or
comparable terminology. These statements are just predictions and
are subject to risks and uncertainties that could cause the actual
events or results to differ materially. These risks and
uncertainties include, among others: our ability to successfully
commercialize the Healight platform technology, our ability to
obtain FDA authorization for use or approval for the Healight
platform technology, the safety and/or effectiveness of the
Healight platform technology in treating patients with COVID-19 or
other illnesses, our ability to adequately protect the intellectual
property associated with the Healight platform technology,
regulatory delays, the reliability of the Healight platform
technology in killing viruses and bacteria, market acceptance of UV
based medical devices, risks associated with the our COVID-19 rapid
tests including our ability to enforce the exclusivity provisions
of the distribution agreements, the reliability of serological
testing in detecting COVID-19, shipping delays and their impact on
our ability to introduce the COVID-19 rapid tests, the ability of
the COVID-19 rapid tests to accurately and reliably test for
COVID-19, the manufacturers of the COVID-19 rapid tests’
ability to manufacture such testing kits on a high volume scale,
manufacturing problems or delays related to the COVID-19 Rapid
Test, our ability to satisfy any labelling conditions or other FDA
or other regulatory conditions to sell the COVID-19 rapid test
kits, the demand or lack thereof for the COVID-19 rapid test kits,
our ability to obtain additional COVID-19 rapid tests to meet
demand, our ability to secure additional tests if the manufactures
of the COVID-19 rapid tests are unable to meet demand, the effects
of the business combination of Aytu and the Commercial Portfolio
and the recently completed merger ("Merger") with Innovus
Pharmaceuticals, including the combined company's future financial
condition, results of operations, strategy and plans, the ability
of the combined company to realize anticipated synergies in the
timeframe expected or at all, changes in capital markets and the
ability of the combined company to finance operations in the manner
expected, the diversion of management time on Merger-related issues
and integration of the Commercial Portfolio, the ultimate timing,
outcome and results of integrating the operations the Commercial
Portfolio and Innovus with Aytu's existing operations, risks
relating to gaining market acceptance of our products, obtaining or
maintaining reimbursement by third-party payors for our
prescription products, the potential future commercialization of
our product candidates, the anticipated start dates, durations and
completion dates, as well as the potential future results, of our
ongoing and future clinical trials, the anticipated designs of our
future clinical trials, anticipated future regulatory submissions
and events, our anticipated future cash position and future events
under our current and potential future collaboration. We also refer
you to the risks described in ''Risk Factors'' in Part I, Item 1A
of the Company's Annual Report on Form 10-K and in the other
reports and documents we file with the Securities and Exchange
Commission from time to time.