Aytu Biopharma, Inc 8-K, filed Nov 12, 2020
Aytu Biopharma, Inc (AYTU)
8-K
2020-11-12
For: 2020-11-12
View Original
Added on
April 10, 2026
About this 8-K
Aytu Biopharma, Inc filed this 8-K on November 12, 2020.
Items reported
- Item 2.02: Financial results
- Item 9.01: Financial statements and exhibits
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. FORM 8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of
1934
Date
of Report (Date of earliest event reported):
November
12, 2020
AYTU
BIOSCIENCE, INC.
(Exact
name of registrant as specified in its charter)
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Delaware
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001-38247
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47-0883144
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(State or other
jurisdiction of incorporation)
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(Commission File
Number)
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(IRS Employer
Identification No.)
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373
Inverness Parkway, Suite 206
Englewood,
CO 80112
(Address
of principal executive offices, including Zip Code)
Registrant’s
telephone number, including area code: (720) 437-6580
N/A
(Former
name or former address, if changed since last report)
Check the
appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
☐
Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
Securities
registered pursuant to Section
12(b) of the Act:
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Title
of each class
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Trading
Symbol(s)
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Name
of each exchange
on
which registered
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Common
Stock, par value $0.0001 per share
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AYTU
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The
NASDAQ Stock Market LLC
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Indicate by check
mark whether the registrant is an emerging growth company as
defined in Rule 405 of the Securities Act of 1933 (§230.405 of
this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934
(§240.12b-2 of this chapter).
Emerging growth
company ☐
If an emerging
growth company, indicate by check mark if the registrant has
elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. ☐
Item
2.02 Results of Operations and Financial Condition.
On
November 12, 2020, the Company issued a press release announcing
the Company’s financial results for the three months ended
September 30, 2020. 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.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
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Exhibit
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Description
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Press release
dated November 12, 2020
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SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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AYTU BIOSCIENCE,
INC.
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Date: November 12,
2020
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By:
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/s/ Joshua R.
Disbrow
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Joshua R.
Disbrow
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Chief Executive
Officer
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Exhibit 99.1
Aytu BioScience Announces Fiscal Q1 2021 Net Revenue of $13.5
Million, an Increase of 839% Year-Over-Year
Q1 Consumer Health revenue reaches an all-time high of $7.8
million
Live Conference Call and Webcast
at 4:30 PM EST
ENGLEWOOD, CO / ACCESSWIRE / November 12, 2020
/ Aytu BioScience, Inc.
(NASDAQ: AYTU), a specialty pharmaceutical company (the "Company")
focused on commercializing novel products that address significant
patient needs today reported financial results for its fiscal first
quarter 2021, for the three month period ending September 30,
2020.
First Quarter Fiscal 2021 Financial Highlights
●
Q1
Net Revenue increased 839% year-over-year to $13.5
million
●
Q1 Consumer Health Net Revenue was an all-time
high of $7.8 million, compared to $6.9 million in Q4
20201
●
Q1
Rx Net Revenue was $5.8 million, compared to $1.4 million in Q1
last year
●
Q1
Net loss of $4.3 million and Q1 adjusted EBITDA loss of $1.3
million
●
Cash,
cash equivalents and restricted cash of $38.2 million on September
30, 2020
Commenting on the first quarter of fiscal 2021,
Josh Disbrow, Chief Executive Officer of Aytu BioScience, stated
"Net revenue increased substantially in Q1 2021, to $13.5 million,
compared to $1.4 million for Q1 2020. It is critical to highlight
that this was just the second full quarter of revenue contribution
from the combined Aytu and Innovus businesses, along with the
Cerecor assets. Turning to the bottom line, adjusted EBITDA loss
was reduced to just $1.3 million for Q1 2021, compared to a $3.6
million adjusted EBITDA loss for Q1 2020. On the balance sheet,
with approximately $38.2 million in cash and less than $1 million
of debt, and at current spending levels, we believe we have
adequate resources to achieve profitability."
Mr. Disbrow continued,
"Taking a closer look at the top line, on the Consumer Health side,
we generated $7.8 million in net revenue, an all-time high and an
increase compared to Q4 2020. Contributing to those results was a
strengthened e-commerce business and the launch of
OmepraCare®, an over-the-counter proton pump inhibitor for
acid reflux, and Q4 2020 launch of Regoxidine®, an
over-the-counter foam formulation of minoxidil for hair loss. On
the Rx side, net revenue was $5.8 million, also an increase
compared to Q1 2020. Contributing to Rx revenue was a relatively
balanced contribution across the prescription portfolio inclusive
of COVID-19 test kits. Additionally, our commercial partner Acerus
Pharmaceuticals launched their dedicated specialty sales team to
promote Natesto® to urologists and endocrinologists across the
United States, ZolpiMist® was approved by the Therapeutic
Goods Administration (TGA) in Australia, and pilot scale
Healight™ investigational devices, were manufactured and
delivered to enable the initiation of the first COVID-19 clinical
study. Importantly, with respect to the Healight™ clinical
study, patient enrollment and treatment with the Healight
investigational devices is now underway."
Mr. Disbrow
concluded, "At $13.5 million of net revenue with record Consumer
Health quarterly revenue, a narrowed adjusted EBITDA loss of just
$1.3 million, and $38.2 million of cash, cash equivalents and
restricted cash on the balance sheet, we have strong momentum to
maximize shareholder value moving ahead in our fiscal 2021 and
beyond."
Conference Call Information
The company will host a live conference call at 4:30 p.m. ET today.
The conference call can be accessed by dialing either:
888-506-0062 (toll-free) Participant Entry Code -
318202
973-528-0011 (international) Participant Entry Code -
318202
The webcast will be accessible live and archived at the following
link https://www.webcaster4.com/Webcast/Page/2142/38489 and on Aytu
BioScience's website, within the Investors section under Events
& Presentations, at aytubio.com, for 90 days.
A replay of the call will be available for fourteen days. Access
the replay by calling 1-877-481-4010 (toll-free) or 919-882-2331
(international) and using the replay access code
38489.
About Aytu BioScience, Inc.
Aytu BioScience is a commercial-stage specialty pharmaceutical
company focused on commercializing novel products that address
significant patient needs. The company currently markets a
portfolio of prescription products addressing large primary care
and pediatric markets. The primary care portfolio includes (i)
Natesto®, the only FDA-approved nasal formulation of
testosterone for men with hypogonadism (low testosterone, or "Low
T"), (ii) ZolpiMist®, the only FDA-approved oral spray
prescription sleep aid, and (iii) Tuzistra® XR, the only
FDA-approved 12-hour codeine-based antitussive syrup. The recently
acquired Pediatric Portfolio includes (i) Cefaclor, a
second-generation cephalosporin antibiotic suspension; (ii)
Karbinal® ER, an extended-release carbinoxamine
(antihistamine) suspension indicated to treat numerous allergic
conditions; and (iii) Poly-Vi-Flor® and Tri-Vi-Flor®, two
complementary prescription fluoride-based supplement product lines
containing combinations of fluoride and vitamins in various for
infants and children with fluoride deficiency. Aytu also
distributes a COVID-19 IgG/IgM rapid test. This antibody test is a
solid phase immunochromatographic assay used in the rapid,
qualitative and differential detection of IgG and IgM antibodies to
the 2019 Novel Coronavirus in human whole blood, serum or plasma.
Aytu has also licensed the Healight™ Platform Technology.
Healight is a pre-clinical investigational device being studied as
a potential treatment for COVID-19 in severely ill, intubated
patients and potentially other respiratory illnesses.
Aytu also operates a consumer health subsidiary, Innovus
Pharmaceuticals, Inc. ("Innovus"), a specialty pharmaceutical
company licensing, developing, and commercializing safe and
effective consumer healthcare products designed to improve health
and vitality. Innovus commercializes over twenty consumer health
products competing in large healthcare categories including
diabetes, men's health, sexual wellness and respiratory health. The
Innovus product portfolio is commercialized through
direct-to-consumer marketing channels utilizing the company's
proprietary Beyond Human® marketing and sales
platform.
Aytu's strategy is to continue building its portfolio of
revenue-generating Rx and consumer health products, leveraging its
focused commercial team and expertise to build leading brands
within large therapeutic markets. For more information visit
aytubio.com and visit innovuspharma.com to learn about the
company's consumer healthcare products.
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: market and other conditions,
our ability to successfully commercialize Healight Platform
Technology, our ability to obtain FDA approval for the Healight
Platform Technology, the 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, the regulatory and commercial risks associated with
introducing the COVID-19 rapid tests, any delays in shipment that
may impact our ability to distribute the COVID-19 rapid tests, any
reputational harm we may incur if there are delays in receiving the
shipment of the COVID-19 rapid tests, 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 tests, 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 manufacturers of the COVID-19 rapid tests are unable to meet
demand, the effects of the business combination of Aytu and the
Pediatric 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 Pediatric
Portfolio, the ultimate timing, outcome and results of integrating
the operations the Pediatric 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.
Contact for Media and Investors:
James Carbonara
Hayden IR
(646) 755-7412
james@haydenir.com
Non-GAAP Financial Information
This press release contains a financial measure that does not
comply with U.S. generally accepted accounting principles (GAAP),
Non-GAAP adjusted EBITDA. Non-GAAP adjusted EBITDA excludes (i)
amortization, (ii) depreciation, (iii) stock-based compensation,
(iv) other expenses comprising net interest expense, (v) non-cash
gains and/or losses recognized in the quarter or year due to
changes in the fair value of certain of Aytu’s financial
liabilities, such as contingent consideration, derivative warrant
liability, or certain exchanges of debt, (vi) bad debt expense,
(vii) impairment of certain long-lived assets; (viii) one-time
transaction costs and (ix) costs associated with non-routine
development activities. Management believes these measures are
useful to supplement its GAAP financial statements with this
non-GAAP information because management uses such information
internally for its operating, budgeting and financial planning
purposes. In addition, Aytu believes these non-GAAP financial
measures are useful to investors because they allow for greater
transparency into the indicators used by management as a basis for
its financial and operational decision making. Non-GAAP information
is not prepared under a comprehensive set of accounting rules and
therefore, should only be read in conjunction with financial
information reported under U.S. GAAP when understanding
Aytu’s operating performance. A reconciliation between GAAP
and non-GAAP financial information is provided in the financial
statement tables below.
AYTU BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(Unaudited)
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Three
Months Ended
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September
30,
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2020
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2019
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Revenues
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Product
revenue, net
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$13,520,246
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$1,439,826
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Operating
expenses
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Cost
of sales
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3,819,156
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375,720
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Research and
development
|
182,865
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78,020
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Selling,
general and administrative
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11,490,370
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5,146,443
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Amortization
of intangible assets
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1,584,581
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575,117
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Total
operating expenses
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17,076,972
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6,175,300
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Loss from
operations
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(3,556,726)
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(4,735,474)
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Other
(expense) income
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Other
(expense), net
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(751,541)
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(195,386)
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Gain from
change in fair value of contingent consideration
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2,336
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-
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Gain from
warrant derivative liability
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-
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1,830
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Total other
(expense) income
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(749,205)
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(193,556)
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Net
loss
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$(4,305,931)
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$(4,929,030)
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Weighted
average number of common shares outstanding
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121,585,939
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15,325,921
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Basic and
diluted net loss per common share
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$(0.04)
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$(0.32)
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AYTU BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(Unaudited unless indicated otherwise)
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September
30,
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June
30,
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2020
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2020
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(audited)
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Assets
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Current
assets
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Cash and cash
equivalents
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$37,911,065
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$48,081,715
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Restricted
cash
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251,778
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251,592
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Accounts
receivable, net
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6,111,911
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5,175,924
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Inventory,
net
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11,479,557
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9,999,441
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Prepaid
expenses and other
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3,681,401
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5,715,089
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Other current
assets
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6,017,888
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5,742,011
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Total current
assets
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65,453,600
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74,965,772
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Fixed assets,
net
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106,153
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258,516
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Right-of-use
asset
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334,289
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634,093
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Licensed
assets, net
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16,018,064
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16,586,847
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Patents and
tradenames, net
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10,639,080
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11,081,048
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Product
technology rights, net
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20,619,166
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21,186,666
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Deposits
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9,900
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32,981
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Goodwill
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28,090,407
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28,090,407
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Total
long-term assets
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75,817,059
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77,870,558
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Total
assets
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$141,270,659
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$152,836,330
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AYTU BIOSCIENCE, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets, cont’d
(Unaudited unless indicated otherwise)
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September
30,
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June
30,
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2020
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2020
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(audited)
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Liabilities
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Current
liabilities
|
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Accounts payable
and other
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$5,773,768
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$11,824,560
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Accrued
liabilities
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8,692,693
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7,849,855
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Accrued
compensation
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1,967,035
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3,117,177
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Debt
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930,416
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982,076
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Contract
liability
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232,576
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339,336
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Current lease
liability
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97,458
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300,426
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Current portion of
fixed payment arrangements
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2,138,514
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2,340,166
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Current portion of
CVR liabilities
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954,800
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839,734
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Current portion of
contingent consideration
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718,647
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713,251
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Total current
liabilities
|
21,505,907
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28,306,581
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Long-term
contingent consideration, net of current portion
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13,058,876
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12,874,351
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Long-term lease
liability, net of current portion
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237,497
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725,374
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Long-term fixed
payment arrangements, net of current portion
|
10,679,903
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11,171,491
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Long-term CVR
liabilities, net of current portion
|
4,714,359
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4,731,866
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Other long-term
liabilities
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11,371
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11,371
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Total
liabilities
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50,207,913
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57,821,034
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Commitments
and contingencies
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Stockholders'
equity
|
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Preferred Stock,
par value $.0001; 50,000,000 shares authorized; shares issued and
outstanding 0 and 0, respectively as of September 30, 2020 and June
30, 2020, respectively.
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-
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-
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Common Stock, par
value $.0001; 200,000,000 shares authorized; shares issued and
outstanding 125,837,357 and 125,837,357, respectively as of
September 30, 2020 and June 30, 2020.
|
12,584
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12,584
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Additional paid-in
capital
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215,366,272
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215,012,891
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Accumulated
deficit
|
(124,316,110)
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(120,010,179)
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Total stockholders'
equity
|
91,062,746
|
95,015,296
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Total
liabilities and stockholders' equity
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$141,270,659
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$152,836,330
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AYTU BIOSCIENCE, INC. AND SUBSIDIARIES
Consolidated Statements of Cash Flows
(unaudited)
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Three
Months Ended
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|
|
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September
30,
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|
|
|
2020
|
2019
|
|
|
|
|
|
Operating
Activities
|
|
|
|
Net
loss
|
$(4,305,931)
|
$(4,929,030)
|
|
Adjustments to
reconcile net loss to cash used in operating
activities:
|
|
|
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Depreciation,
amortization and accretion
|
2,092,618
|
869,312
|
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Stock-based
compensation expense
|
454,918
|
165,171
|
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Loss / (gain) from
change in fair value of contingent consideration
|
(99,895)
|
-
|
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Loss on sale of
equipment
|
112,110
|
-
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Gain on termination
of lease
|
(343,185)
|
-
|
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Changes in
allowance for bad debt
|
408
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-
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Loss / (gain) from
change in fair value of CVR
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97,559
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-
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Derivative
income
|
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(1,830)
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Changes in
operating assets and liabilities:
|
|
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(Increase) decrease
in accounts receivable
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(928,895)
|
35,359
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(Increase) decrease
in inventory
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(1,480,116)
|
59,340
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Decrease in prepaid
expenses and other
|
2,027,358
|
384,582
|
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(Increase) in other
current assets
|
(237,720)
|
-
|
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(Decrease) increase
in accounts payable and other
|
(4,519,601)
|
276,917
|
|
Increase in accrued
liabilities
|
412,328
|
3,441
|
|
(Decrease) increase
in accrued compensation
|
(1,150,142)
|
152,911
|
|
(Decrease) in
contract liability
|
(106,760)
|
-
|
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(Decrease) in
deferred rent
|
-
|
(3,990)
|
|
Net cash used in
operating activities
|
(7,974,946)
|
(2,987,817)
|
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Investing
Activities
|
|
|
|
Deposit
|
2,200
|
-
|
|
Contingent
consideration payment
|
(19,140)
|
(42,103)
|
|
Note
Receivable
|
|
(1,000,000)
|
|
Net cash used in
investing activities
|
(16,940)
|
(1,042,103)
|
|
Financing
Activities
|
|
|
|
Issuance cost
related to registered offering
|
(1,632,727)
|
-
|
|
Payments made to
borrowings
|
(136,364)
|
-
|
|
Payments made to
fixed payment arrangements
|
(409,487)
|
-
|
|
Net cash provided
by financing activities
|
(2,178,578)
|
-
|
|
Net change in cash,
restricted cash and cash equivalents
|
(10,170,464)
|
(4,029,920)
|
|
Cash, restricted
cash and cash equivalents at beginning of period
|
48,333,307
|
11,294,227
|
|
Cash, restricted
cash and cash equivalents at end of period
|
$38,162,843
|
$7,264,307
|
AYTU BIOSCIENCE, INC. AND SUBSIDIARIES
Consolidated Statements of Cash Flows, cont’d
(unaudited)
|
|
Three
Months Ended
|
|
|
|
September
30,
|
|
|
Supplemental
disclosures of cash and non-cash investing and financing
transactions
|
2020
|
2019
|
|
Warrants issued to
underwriters
|
$356,139
|
$-
|
|
Cash paid for
interest
|
247,869
|
3,390
|
|
Fair value of
right-to-use asset and related lease liability
|
-
|
412,691
|
|
Contingent
consideration included in accounts payable
|
-
|
3,430
|
|
Fixed payment
arrangements included in accrued liabilities
|
430,510
|
-
|
|
Acquisition costs
included in accounts payable
|
-
|
59,014
|
|
Exchange of
convertible preferred stock into common stock
|
$-
|
$44
|
AYTU BIOSCIENCE, INC. AND SUBSIDIARIES
Reconciliation of GAAP to Non-GAAP Financial
Information
(Unaudited)
|
|
Three Months
Ended
|
||
|
|
September
30,
2020
|
June
30,
2020
|
September
30,
2019
|
|
Adjusted
EBITDA
|
|
|
|
|
Net
Loss
|
$(4,305,931)
|
$(3,145,097)
|
$(4,929,030)
|
|
Amortization
expenese
|
1,584,581
|
1,590,913
|
575,117
|
|
Depreciation
expense
|
33,921
|
33,529
|
15,834
|
|
Other
expense, net
|
751,541
|
1,425,281
|
195,386
|
|
Stock-based
compensation
|
454,918
|
536,567
|
165,171
|
|
(Gain)/Loss
on change in fair value of contingent consideration
|
(2,336)
|
(5,230,446)
|
-
|
|
Gain/loss on
extinguishment of debt
|
-
|
315,728
|
-
|
|
(Gain)/Loss
on change in fair value of derivative warrant
liability
|
-
|
-
|
(1,830)
|
|
Bad debt
expense
|
189
|
408,365
|
-
|
|
Impairment of
intangible assets
|
-
|
195,278
|
50,000
|
|
Development
costs
|
199,266
|
1,309,080
|
-
|
|
Transaction
costs
|
12,632
|
814,033
|
310,437
|
|
Furniture
& Equipment Write-off
|
119,610
|
-
|
-
|
|
Lease
Termination
|
(194,761)
|
-
|
-
|
|
Adjusted
EBITDA
|
$(1,346,370)
|
$(1,746,769)
|
$(3,618,915)
|