Revenues increased by 384% year over
year
Debt ratio decreased to 7% from 75% at
year-end 2021
SAN
DIEGO, Nov. 7, 2022 /PRNewswire/ -- Ainos, Inc.
(NASDAQ: AIMD, AIMDW) ("Ainos", or the "Company"), a diversified
medtech company focused on the development of novel point-of-care
testing, low-dose interferon therapeutics, and synthetic RNA-driven
preventative medicine, today announced its unaudited financial
results for the third quarter ended September 30, 2022.
Third Quarter 2022 Financial Highlights
- Revenues were US$1,757,774 in the
third quarter of 2022, up 384.2% year over year.
- Gross profit was US$581,742, up
124% year over year, representing a gross margin of 33.1% in the
third quarter of 2022.
Chun-Hsien Tsai, Chairman of the Board, President, and Chief
Executive Officer of Ainos, commented, "We once again delivered
robust year-over-year revenue growth and continued to develop and
advance the monetization of our innovative product pipeline.
Looking ahead, we are recalibrating our R&D efforts to focus on
the development and commercialization of our key VOC POCT and
VELDONA® technologies. During the quarter, VELDONA®, our very
low-dose oral interferon alpha formulation, showed its antiviral
efficacy in a hamster study, and is on track to initiate Phase 2
clinical trials in Taiwan. We are
also pursuing out-licensing for five Phase 2 VELONDA® candidates,
with the goal of accelerating them to Phase 3 trials and
commercialization. Our non-invasive and telehealth-friendly VOC
POCT product pipeline delivers solutions to large and expanding
markets such as STI testing and women's health. Our Ainos Flora
product, which allows users to easily and discreetly test for
vaginal infections and certain STIs in just minutes, is currently
going through clinical studies in Taiwan. In regards to our current product
line, we will broaden distribution and expand sales channels for
our COVID antigen test kits in Taiwan, while ramping up sales to our existing
customer base. Going forward, we will further strengthen our
monetization capabilities and deliver long-term sustainable value
for our shareholders."
Hui-Lan Wu, Chief Financial
Officer of Ainos, commented, "Year-over-year top-line growth of
384.2% was driven by strong sales of our COVID19 Antigen Self-Test
Kits during the third quarter. During the quarter, in addition to
delivering strong topline growth, we reduced our debt and
strengthened our balance sheet following the conversion of our
convertible notes and proceeds from our public offering. As a
result of these efforts, our debt ratio now stands at just 6.8%,
down from 75% at year-end 2021. We will continue to ramp up our
COVID antigen test business in Taiwan as we further develop and commercialize
our product pipeline as scheduled."
Third Quarter 2022 Financial Results
Revenues
Revenues increased by 384.2% to US$1,757,774 in the third quarter of 2022 from
US$363,052 in the same period of
2021, driven by increased sales of the Company's COVID-19 Antigen
Self-Test Kits in Taiwan. An
increase in the number of COVID-19 cases in Taiwan and increased acceptance of our highly
accurate self-test kit contributed to the strong performance.
Cost of Revenues
Cost of revenues was US$1,176,032
in the third quarter of 2022, compared with US$103,638 in the same period of 2021. Such
increase was consistent with the corresponding increase in sales
volume, as the Company shipped more of its COVID-19 Antigen
Self-Test Kits.
Gross Profit
In the third quarter of 2022, gross profit was US$581,742, representing a 33.1% gross margin,
compared to US$259,414, or a 71.5%
gross margin a year ago. The decline in gross margin was driven by
a shift in the Company's revenue mix. To align with Taiwan's infection control policy, we
generated more revenue from the COVID-19 Antigen Self-Test Kit in
the third quarter. In comparison, the majority of our revenue
during the comparable period had been generated from sales of our
COVID-19 Rapid Test Kit for use by healthcare professionals. The
self-test kit accounted for all our business in the third quarter,
compared to 7% in the previous quarter.
Total Operating Expenses
Total operating expenses increased to US$8,404,013 in the third quarter of 2022 from
US$1,442,756 in the same period of
2021. The increase was mainly attributable to depreciation and
amortization expenses and share-based compensation. Operating
expenses excluding depreciation and amortization expenses and
share-based compensation remained relatively flat, reaching
US$1,118,205 in the third quarter of
2022 as compared to US$759,589 a year
ago.
- R&D expenses increased to US$1,834,786 in the third quarter of 2022 from
US$646,798 a year ago. When excluding
depreciation and amortization expenses, R&D expenses increased
to US$628,367 from US$401,526 over the same period.
- SG&A expenses increased to US$6,569,227 from US$795,958 over the same period. When excluding
depreciation and amortization expenses and share-based
compensation, SG&A expenses increased to US$489,838 from US$358,063 over the same period.
Net Loss
Net loss attributable to common stock shareholders was
US$7,821,756 in the third quarter of
2022, compared with US$1,160,110 in
the same period of 2021.
Balance Sheet
As of September 30, 2022, the
Company had cash and cash equivalents of US$2,417,147 compared with US$1,751,499 as of December 31, 2021.
Recent Developments
On August 15, 2022, the Company
announced that it had signed a Master Service Agreement with Swiss
Pharmaceutical Co., Ltd. (Taiwan)
("Swiss Pharma"). According to the agreement, Swiss Pharma will
test, manufacture, and package the Company's VELDONA® "GMP Clinical
Batch" and "GMP Commercial Batch" product candidates for the
Company's planned clinical trials under both Pharmaceutical
Inspection Co-operation Scheme Good Manufacturing Practice and U.S.
Food & Drug Administration Current Good Manufacturing Practice
regulations.
On August 24, 2022, the Company
announced that it had submitted an Investigational New Drug
application to the U.S. Food and Drug Administration for conducting
a Phase 2 trial of its low-dose oral interferon alpha formulation,
VELDONA®, for treatment of mild symptoms related to COVID-19.
On September 30, 2022, the Company
announced the results from its antiviral efficacy study in hamsters
against the Omicron variant of SARS-CoV-2. The Company's results
showed that its low-dose oral interferon alpha formulation,
VELDONA®, had a therapeutic effect on lungs infected with the
SARS-CoV-2 virus by regulating the immune response, thereby
expediting recovery of infected animals. The Company has submitted
the application documents for U.S. FDA Phase 2 clinical trials for
evaluating the efficacy of VELDONA® in patients with mild
COVID-19.
On October 31, 2022, the Company
announced that it is pursuing out-licensing opportunities for five
new drug candidates for its low-dose oral interferon-alpha
formulation, VELDONA®. Ainos has completed Phase 2 trials for the
five new drug candidates and will work with potential partners to
accelerate the candidates to Phase 3 trials and eventual
commercialization of VELDONA®.
About Ainos, Inc.
Headquartered in San Diego,
California, Ainos, Inc. (f/k/a Amarillo Biosciences, Inc.)
is a diversified medtech company engaged in developing innovative
medical technologies for point-of-care testing and safe and novel
medical treatment for a broad range of disease indications. In
addition to its proprietary therapeutics using low-dose
non-injectable interferon, Ainos is committed to developing a
comprehensive healthcare business portfolio encompassing medical
devices and consumer healthcare products. While prioritizing the
commercialization of medical devices as part of its diversification
strategy, Ainos has also expanded its product portfolio to include
Volatile Organic Compounds (VOC) and COVID-19 POCTs. Leveraging its
patents related to VOC technologies and three issued patents for
COVID-19 POCT products, the Company seeks to expedite the
commercialization of its medical device pipeline, beginning with
Ainos-branded COVID-19 POCT product candidates.
Forward-Looking Statements
This press release contains 'forward-looking statements' within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by words such as "anticipate,"
"believe," "estimate," "expect," "intend," "plan," "predict,"
"project," 'target," "future," "seek," "likely," "strategy," "may,"
"should," "will," and similar references to future periods.
Forward-looking statements are based only on our current beliefs,
expectations, and assumptions. Forward-looking statements are
subject to inherent uncertainties, risks, and changes in
circumstances that are difficult to predict and many of which are
outside of our control. Our actual results may differ materially
from those indicated in the forward-looking statements.
Important factors that could cause our actual results to differ
materially from those indicated in the forward-looking statements
include, among others, the following: the cost of production and
sales potential of the planned drug treatments announced in this
press release; the impact of final approvals from the U.S. Food and
Drug Administration (the "FDA") or other regulatory bodies for the
planned drug treatments including the availability of emergency use
authorization; the Company's limited cash and history of losses;
the Company's ability to achieve profitability; intense competition
and rapidly advancing technology in the Company's industry that may
outpace its technology; customer demand for the products and
services the Company develops; the impact of competitive or
alternative products, technologies and pricing; the Company's
ability to manufacture any products it develops; general economic
conditions and events and the impact they may have on the Company
and its potential customers, including but not limited to the
impact of Covid-19; the Company's ability to obtain adequate
financing in the future; the impact of promulgation and
implementation of regulations by the World Health Organization, the
FDA and by other governmental authorities with functions similar to
those of the FDA on the Company's operations and technologies;
lawsuits and other claims by third parties or investigations by
various regulatory agencies governing the Company's operations; the
Company's ability to secure regulatory approvals for its products;
and our success in managing the risks involved in the foregoing
items. Readers should also review the risks and uncertainties
listed in our Annual Report on Form 10-K for the year ended
December 31, 2021 and other reports
we file with the U.S. Securities and Exchange Commission.
Any forward-looking statement made by us in this press release
speaks only as of the date on which such statement is made. We
undertake no obligation to publicly update any forward-looking
statement, whether written or oral, that may be made from time to
time, whether as a result of new information, future developments
or otherwise.
Investor Relations Contact
ICR, LLC
Robin Yang
Tel: +1 646-224-6971
Email: Ainos.IR@icrinc.com
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Ainos,
Inc.
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Condensed
Consolidated Statements of Operations
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(Unaudited)
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Three months ended
September 30,
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Nine months ended
September 30,
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2022
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2021
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2022
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2021
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Revenues
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$ 1,757,774
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$
363,052
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$ 2,481,602
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$
568,164
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Cost of
revenues
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(1,176,032)
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(103,638)
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(1,536,074)
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(174,395)
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Gross
Profit
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581,742
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259,414
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945,528
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393,769
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Operating
expenses:
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Research and
development expenses
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1,834,786
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646,798
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5,047,096
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646,798
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Selling, General and
administrative expenses
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6,569,227
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795,958
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7,748,060
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2,178,969
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Total operating
expenses
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8,404,013
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1,442,756
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12,795,156
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2,825,767
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Operating
loss
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(7,822,271)
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(1,183,342)
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(11,849,628)
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(2,431,998)
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Non-operating income
and expenses,net
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Interest expenses,
net
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(9,821)
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23,517
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(45,304)
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(9,361)
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Other Losses
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10,336
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(285)
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19,250
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(2,532)
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Total non-operating
income and expenses,net
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515
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23,232
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(26,054)
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(11,893)
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Net
loss
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(7,821,756)
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(1,160,110)
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(11,875,682)
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(2,443,891)
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Net loss per common
shares-basic and diluted
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$
(0.51)
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$
(0.12)
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$
(1.03)
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$
(0.48)
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Weighted average common
shares outstanding– basic
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15,301,396
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9,494,468
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11,538,013
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5,061,160
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and diluted
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Ainos, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
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September 30,
2022
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December 31,
2021
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Assets
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Current
assets:
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Cash and cash
equivalents
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$
2,417,147
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$
1,751,499
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Accounts
receivable
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400,198
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-
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Inventory
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698,295
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-
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Other current
assets
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152,406
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466,198
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Total current
assets
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3,668,046
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2,217,697
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Intangible assets,
net
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33,946,391
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37,329,191
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Property and equipment,
net
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1,350,960
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1,187,702
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Other
Assets
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116,425
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87,571
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Total assets
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$
39,081,822
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$
40,822,161
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Liabilities and
Stockholders' Equity
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Current
liabilities:
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Convertible notes
payable
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$
376,526
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$
3,376,526
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Notes
payable
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884,000
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213,405
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Contract
liabilities
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33,055
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59,575
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Accrued expenses and
others current liabilities
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1,349,666
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945,293
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Payable -related
party
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-
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26,000,000
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Total current
liabilities
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2,643,247
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30,594,799
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Long term
liabilities:
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Operating lease
liabilities-non-current
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12,505
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30,255
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Total
liabilities
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2,655,752
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30,625,054
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Stockholders'
equity
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Preferred stock, $0.01
par value; 10,000,000 shares
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authorized; none
issued
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Common stock, $0.01 par
value;
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300,000,000
shares authorized as of Sep 30, 2022 and
December 31, 2021;
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19,478,270 shares and
9,625,133 shares issued and
outstanding as of Sep 30, 2022 and December 31, 2021
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194,783
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96,251
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Additional paid-in
capital
|
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58,491,505
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20,203,972
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Accumulated
deficit
|
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(21,984,598)
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(10,108,916)
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Translation
adjustment
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(275,620)
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5,800
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Total stockholders'
equity
|
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36,426,070
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10,197,108
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Total liabilities and
stockholders' equity
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$
39,081,822
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$
40,822,161
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View original
content:https://www.prnewswire.com/news-releases/ainos-reports-unaudited-third-quarter-2022-financial-results-301670143.html
SOURCE Ainos, Inc.