ENGLEWOOD, Colo., Nov. 9, 2017 /PRNewswire/ -- Aytu
BioScience, Inc. (NASDAQ: AYTU), a specialty life sciences company
focused on global commercialization of novel products in the field
of urology, today provided an overview of its business, including
the Company's operational and financial results for its fiscal
first quarter of 2018. The Company will host a live
conference call and webcast today at 4:30
p.m. ET. Conference call details are provided at the
end of this press release.
"During the first fiscal quarter of 2018, we achieved our
commercial objectives and experienced substantial prescription
demand growth for Natesto®. The Company also increased our base of
business outside the U.S. for the MiOXSYS® System, and received
positive reception from clinicians during the early
commercialization of our newly added commercial-stage product
Fiera®," commented Josh Disbrow,
Chief Executive Officer of Aytu BioScience.
Q1 2018 Operational Highlights
- Recognized $1.1 million in total
net revenues for the first quarter of fiscal 2018, representing a
54% increase over Q1 fiscal 2017
- Listed the Company's common shares on the NASDAQ Capital
Market, on which trading of shares under the ticker symbol "AYTU"
began October 20, 2017
- Increased Natesto prescription demand to 2,036 total
prescriptions, representing a 411% increase over Q1 fiscal
2017
- Increased shipped Natesto factory sales units to over 7,000,
representing an increase of more than 85% over the previous
quarter
- Increased the number of Natesto prescribers across the U.S. to
991, which represented a 21% increase over the previous
quarter
- Increased the number of MiOXSYS System placements globally to
96 since Q1 fiscal 2017, and placed 29 instruments in six countries
through the Company's distribution partners
- Initiated commercial integration of the women's sexual wellness
product line, Fiera, and the launch of the Company's first
international distribution agreement in Japan
Q1 2018 Financial Results
Net revenue for the Company, for the first quarter of 2018,
totaled $1,076,000 from sales of
Natesto, MiOXSYS, Fiera, and ProstaScint, compared to net revenue
of $698,000 for the same period last
year, an increase of 54%. Natesto and MiOXSYS comprised the
majority of sales in the first quarter of 2018. Product sales
in the same quarter of 2017 were mostly comprised of ProstaScint
and Primsol, a product that was divested in late fiscal
2017.
Gross sales for the company totaled $2,243,000, representing an increase of 142% over
the same period last year.
Sales, general, and administrative expenses for the first
quarter of 2018 were $4,618,000, down
20% from the same quarter last year, and the Company's net loss for
the quarter was reduced by 26% to $4,245,000.
Cash and cash equivalents totaled $7.1M as of September 30,
2017.
With the increasing net revenues due to the sales growth of
Natesto, expansion of MiOXSYS outside the US and the integration of
Fiera, the Company believes it has adequate cash to achieve
profitability and effectively operate into the middle of fiscal
2019.
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:
1 (855) 656-0926 (U.S.)
1 (412) 542-4198 (international)
The webcast will be accessible live during the conference call
and archived on Aytu BioScience's website, within the Investors
section under Corporate Presentations & Media, at aytubio.com,
for 90 days.
A replay of the call will be available for seven days. Access
the replay by calling 1 (877) 344-7529 (U.S.) or 1 (412) 317-0088
(international) and using the replay access code 10114103.
About Aytu BioScience, Inc.
Aytu BioScience is a commercial-stage specialty life sciences
company focused on global commercialization of novel products in
the field of urology, with a focus on products addressing vitality,
sexual wellness, and reproductive health. The Company currently
markets two prescription products in the U.S.: Natesto®, the first
and only FDA-approved nasal formulation of testosterone for men
with hypogonadism (low testosterone, or "Low T") and ProstaScint®
(capromab pendetide), the only FDA-approved imaging agent specific
to prostate specific membrane antigen (PSMA) for prostate cancer
detection and staging. Additionally, Aytu is developing MiOXSYS®, a
novel, rapid semen analysis system with the potential to become a
standard of care for the diagnosis and management of male
infertility caused by oxidative stress. MiOXSYS® is commercialized
outside the U.S. where it is a CE Marked, Health Canada cleared,
Australian TGA approved product, and Aytu is planning U.S.-based
clinical trials in pursuit of 510k medical device clearance by the
FDA. Aytu's strategy is to continue building its portfolio of
revenue-generating products, leveraging its focused commercial team
and expertise to build leading brands within growing markets. For
more information visit aytubio.com. Aytu also now owns wholly-owned
subsidiary Aytu Women's Health (formerly Nuelle, Inc.), a personal
health and wellness company focused on women's sexual wellbeing and
intimacy. Aytu Women's Health markets Fiera, a personal care device
for women that is scientifically proven to enhance physical arousal
and sexual desire. Fiera is a consumer device and is not intended
to treat, mitigate, or cure any disease or medical condition. For
more information about the Fiera personal care device visit
fiera.com.
Forward-Looking Statements
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: the risks related to Natesto sales not increasing, MiOXSYS
not expanding outside the US, and setbacks related to the
integration of Fiera that would affect having adequate cash to
achieve profitability and effectively operate into the middle of
fiscal 2019, risks relating to gaining market acceptance of our
products, obtaining reimbursement by third-party payors, 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 Aytu
BioScience, Inc.'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.
Contact for Investors:
Amato and Partners, LLC
Investor Relations Counsel
admin@amatoandpartners.com
Aytu BioScience,
Inc.
|
Consolidated
Balance Sheets
|
Unaudited
|
|
|
September
30,
|
|
June
30,
|
|
2017
|
|
2017
|
|
|
|
|
Assets
|
|
|
Current
assets
|
|
|
|
Cash and cash
equivalents
|
$
7,021,527
|
|
$
802,328
|
Restricted
cash
|
75,371
|
|
75,214
|
Accounts
receivable, net
|
1,211,845
|
|
528,039
|
Inventory,
net
|
1,171,260
|
|
1,312,221
|
Prepaid
expenses and other
|
262,057
|
|
310,760
|
Total current
assets
|
9,742,060
|
|
3,028,562
|
|
|
|
|
|
|
|
|
Fixed assets,
net
|
566,913
|
|
647,254
|
Developed
technology, net
|
1,294,306
|
|
1,337,333
|
Customer
contracts, net
|
76,667
|
|
77,667
|
Trade names,
net
|
158,238
|
|
164,037
|
Natesto asset,
net
|
8,901,391
|
|
9,231,072
|
Goodwill
|
238,426
|
|
238,426
|
Patents,
net
|
264,944
|
|
271,278
|
Deposits
|
2,888
|
|
2,888
|
Total long-term
assets
|
11,503,773
|
|
11,969,955
|
|
|
|
|
Total
assets
|
$
21,245,833
|
|
$
14,998,517
|
|
|
|
|
Liabilities
and Stockholders' Equity
|
|
|
Current
liabilities
|
|
|
|
Accounts
payable and other
|
$
1,660,764
|
|
$
2,220,400
|
Accrued
liabilities
|
903,386
|
|
782,536
|
Accrued
compensation
|
680,545
|
|
339,704
|
Deferred
rent
|
6,455
|
|
6,673
|
Current
contingent consideration
|
257,036
|
|
261,155
|
Total current
liabilities
|
3,508,186
|
|
3,610,468
|
|
|
|
|
Long-term
contingent consideration
|
7,566,443
|
|
7,386,782
|
Deferred
rent
|
-
|
|
1,451
|
Warrant
derivative liability
|
3,818,263
|
|
-
|
Total
liabilities
|
14,892,892
|
|
10,998,701
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
Preferred Stock, par
value $.0001; 50,000,000 shares authorized; shares
issued and outstanding 2,250
(unaudited) and 0, respectively as of September 30, 2017 and June 30, 2017
|
1
|
|
-
|
Common Stock, par value
$.0001; 100,000,000 shares authorized; shares
issued and outstanding
4,224,840 (unaudited) and 824,831, respectively as
of September 30, 2017 and
June 30, 2017
|
422
|
|
82
|
Additional paid-in
capital
|
79,667,289
|
|
73,069,463
|
Accumulated
deficit
|
(73,314,771)
|
|
(69,069,729)
|
Total stockholders'
equity
|
6,352,941
|
|
3,999,816
|
|
|
|
|
Total
liabilities and stockholders' equity
|
$
21,245,833
|
|
$
14,998,517
|
Aytu BioScience,
Inc.
|
Consolidated
Statements of Operations
|
Unaudited
|
|
|
|
Three Months
Ended September 30,
|
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
|
|
Product
revenue
|
|
$
1,076,368
|
|
$
697,980
|
Total
revenue
|
|
1,076,368
|
|
697,980
|
|
|
|
|
|
Operating
expenses
|
|
|
|
|
Cost of
sales
|
|
287,201
|
|
191,924
|
Research and
development
|
|
140,954
|
|
232,022
|
Research and
development - related party
|
|
-
|
|
47,998
|
Sales, general
and administrative
|
|
4,618,403
|
|
5,704,750
|
Sales, general
and administrative - related party
|
|
-
|
|
50,772
|
Amortization
and impairment of intangible assets
|
|
385,841
|
|
437,014
|
Total operating
expenses
|
|
5,432,399
|
|
6,664,480
|
|
|
|
|
|
Loss from
operations
|
|
(4,356,031)
|
|
(5,966,500)
|
|
|
|
|
|
Other income
(expense)
|
|
|
|
|
Interest
(expense)
|
|
(188,745)
|
|
(415,381)
|
Derivative
income (expense)
|
|
299,734
|
|
(70,609)
|
Unrealized gain
on investment
|
|
-
|
|
728,100
|
Total other
(expense) income
|
|
110,989
|
|
242,110
|
|
|
|
|
|
Net
loss
|
|
$
(4,245,042)
|
|
$
(5,724,390)
|
Weighted
average number of Aytu common
shares outstanding
|
|
2,415,402
|
|
244,937
|
|
|
|
|
|
Basic and
diluted Aytu net loss per
common share
|
|
$
(1.76)
|
|
$
(23.37)
|
Aytu BioScience,
Inc.
|
Consolidated
Statements of Cash Flows
|
Unaudited
|
|
|
Three Months
Ended September 30,
|
|
2017
|
|
2016
|
|
|
|
|
Cash flows from
operating activities
|
|
|
|
Net loss
|
$
(4,245,042)
|
|
$
(5,724,390)
|
Adjustments to
reconcile net loss to cash provided by (used in) operating
activities
|
|
|
|
Stock-based
compensation expense
|
195,105
|
|
1,043,712
|
Issuance of
restricted stock
|
72,306
|
|
75,466
|
Depreciation,
amortization and accretion
|
653,313
|
|
822,161
|
Derivative (income)
expense
|
(299,734)
|
|
70,609
|
Amortization of
prepaid research and development - related party
|
-
|
|
30,496
|
Unrealized (gain) on
investment
|
-
|
|
(728,100)
|
Compensation through
issuance of stock
|
-
|
|
509,996
|
Issuance of warrants
to initial investors
|
-
|
|
589,377
|
Adjustments to
reconcile net loss to net cash used in operating
activities:
|
|
|
|
(Increase) in
accounts receivable
|
(683,806)
|
|
(347,013)
|
Decrease (increase)
in inventory
|
140,961
|
|
(60,650)
|
Decrease (increase)
in prepaid expenses and other
|
48,703
|
|
(337,525)
|
(Decrease) in
accounts payable and other
|
(559,636)
|
|
(109,365)
|
Increase (decrease)
in accrued liabilities
|
120,850
|
|
(498,516)
|
Increase (decrease)
in accrued compensation
|
340,841
|
|
(668,792)
|
(Decrease) increase
in deferred rent
|
(1,669)
|
|
75
|
Net cash used in
operating activities
|
(4,217,808)
|
|
(5,332,459)
|
|
|
|
|
Cash flows used in
investing activities
|
|
|
|
Purchases of property
and equipment
|
-
|
|
(4,721)
|
Installment payment
for Primsol asset
|
-
|
|
(500,000)
|
Net cash used in
investing activities
|
-
|
|
(504,721)
|
|
|
|
|
Cash flows from
financing activities
|
|
|
|
Issuance of
preferred, common stock and warrants
|
11,839,995
|
|
-
|
Issuance costs
related to preferred, common stock and warrants
|
(1,402,831)
|
|
-
|
Issuance of common
stock to Lincoln Park Capital
|
-
|
|
631,481
|
Costs related to sale
of common stock
|
-
|
|
(24,247)
|
Net cash provided by
financing activities
|
10,437,164
|
|
607,234
|
|
|
|
|
Net change in cash
and cash equivalents
|
6,219,356
|
|
(5,229,946)
|
Cash and cash
equivalents at beginning of period
|
877,542
|
|
8,054,190
|
Cash and cash
equivalents at end of period
|
$
7,096,898
|
|
$
2,824,244
|
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SOURCE Aytu BioScience, Inc.