SARASOTA, Fla., Nov. 15, 2021 /PRNewswire/ -- INVO
Bioscience, Inc. (Nasdaq: INVO) ("INVO" or the "Company"), a
medical device company focused on creating alternative treatments
for patients diagnosed with infertility and developers of
INVOcell®, the world's only in vivo culture system, today announced
financial and operating results for the third quarter ended
September 30, 2021, and provided a
business update.
Recent Operational Highlights
- Set to regain full U.S. commercialization rights for INVOcell®
due to Ferring's termination for convenience of its Distribution
Agreement with INVO effective January 31,
2022 (and the corresponding termination of the related
Supply Agreement between Ferring and INVO), enabling the Company to
sell directly into existing IVF clinics, to expand the number of
INVO Centers free of any limitations, and to pursue a more
aggressive market expansion strategy to increase access to
care.
- Initial treatment cycles commenced at the Company's first
U.S.-based INVO Center in Birmingham,
Alabama following its opening in August 2021.
- Opened the second U.S.-based INVO Center in Atlanta, Georgia, in September 2021. The practice began seeing
patients and performed its initial treatment cycles last week.
- Opened the first international INVO Center, and third overall
in Monterrey, Mexico, on
November 1, 2021. The Monterrey INVO
Center has begun seeing patients, with the first cycles scheduled
to occur later this year.
- Completed its acquisition of a Canadian-based entity,
originally formed to offer INVOcell®, to advance its distribution
in Canada.
- Signed a partnership agreement with Lyfe Medical, LLC to
establish and operate an INVO Center in the San Francisco Bay area
to offer the INVOcell®.
- Four poster abstracts discussing INVOcell® were presented at
the 77th Scientific Congress & Expo of the American Society for
Reproductive Medicine ("ASRM") held in Baltimore, Maryland in October 2021.
- Completed a $4.0 million
registered direct offering of common stock priced at-the-market
under Nasdaq rules with participation from INVO Bioscience's
management team. The Company also entered into a stock purchase
agreement for the sale of approximately $2
million of its common stock at a fixed price, expected to
close on or before November 30,
2021.
- Revenue was $218,874 for the
quarter ended September 30, 2021,
compared to $336,071 for the quarter
ended September 30, 2020.
- Adjusted EBITDA for the third quarter of 2021 was $(1.6) million, which included $0.3 million loss attributable to our joint
ventures, compared to $(0.9) million
in the prior year's third quarter (see Adjusted EBITDA Table).
"We continue to execute against our core mission of improving
access to advanced fertility services for the many patients around
the world through the use of the INVOcell solution," commented
Steve Shum, CEO of INVO Bioscience.
"During the quarter, we achieved a significant milestone with the
opening of our very first INVO Center, based in Birmingham, where we have commenced initial
cycles. Further, we opened clinics in Atlanta, Georgia and Monterrey, Mexico to expand the INVO Center
business model and we are working to open the San Francisco Bay Area clinic as soon as
possible. We completed the acquisition of a Canadian-based entity
that will be used to distribute the INVOcell in Canada and to develop INVO Centers in the
region. With our INVO Center strategy now successfully underway, we
are optimistic on the prospects for further expansion using this
unique and innovative model. As part of a detailed review, we
have initially identified more than 20 cities here in the U.S. that
we believe have excellent characteristics in terms of demographics
and level of current fertility care that would be ideal locations
for an INVO Center."
"As an important development to our ability to expand the INVO
Center model, we will regain full U.S. commercialization rights to
INVOcell® from Ferring in early 2022, which removes certain
limitations we had on expanding this business model in the U.S.
Further, it allows us to resume direct sales to IVF clinics in our
home territory and further expand our channel development plan.
With our strong team of leaders highly experienced in
commercializing advanced reproductive technologies, we are
optimistic about our prospects as we pursue our multi-channel
market expansion strategy."
"In addition to the opening of our INVO Center in Monterrey, Mexico, we continue to advance our
international commercialization plans. Clinical validation of
INVOcell® continues to grow with four poster abstracts presented at
ASRM this year."
Shum concluded, "We are excited about the recent developments to
advance commercialization of the INVOcell® solution. We look
forward to leveraging the recent success of our INVO Centers,
particularly in the U.S. With a great team, board of directors, and
key advisors in place, we believe we have laid a strong foundation
to achieve our goal of democratizing advanced fertility treatment
with the INVOCell® solution, which should lead to strong revenue
growth going forward."
Financial Results
Revenue for the three months ended September 30, 2021, was $0.2 million, compared to $0.3 million for the same three-month period in
2020. Of the $0.2 million in revenue
for 2021, $37,513 was related to
clinic revenue from the consolidated Alabama JV, the INVO Center
was only open for part of the period and still in the early ramp up
phase. The decrease in overall sales was related to a decrease in
product sales to Ferring.
Gross margin reported for the three months ended September 30, 2021, was 91% compared to
approximately 92% for the three months ended September 30, 2020.
Selling, general and administrative expenses for the three
months ended September 30, 2021, were
$2.4 million compared to $1.5 million for the three months ended
September 30, 2020. The increase of
$0.9 million was primarily the result
of increased expenses related to the operations of the consolidated
Alabama JV and increased personnel and public company expenses.
We also incurred $0.5 million
of non-cash, stock-based compensation expense in the period,
compared to $0.3 million for the same
period in the prior year.
We began to fund additional research and development ("R&D")
efforts in 2021 as part of our 5-day label expansion efforts.
R&D expenses were $0.06 million
and $0.10 million for the three
months ended September 30, 2021, and
September 30, 2020, respectively.
Loss from equity investments for the three months ended
September 30, 2021, was $0.1 million compared to $0 for the three months ended September 30, 2020. The increase in loss is due
to the investment in the Georgia JV, which became operational late
in the third quarter and is still in the early ramp-up phase.
Interest expense and financing fees were $0.09 million for the three months ended
September 30, 2021, compared to
approximately $0.5 million for the
three months ended September 30,
2020.
Net loss attributable to INVO Bioscience for the three months
ended September 30, 2021, was
$(2.2) million compared to
$(1.8) million for the three months
ended September 30, 2020.
Adjusted EBITDA (see Adjusted EBITDA Table) for the three months
ended September 30, 2021, was
$(1.6) million, compared to adjusted
EBITDA of $(0.9) million for the
three months ended September 30,
2020.
As of September 30, 2021, the
Company had approximately $4.7
million in cash. Subsequent to the end of the quarter, the
Company completed a $4.0 million
registered direct common stock offering priced at-the-market under
Nasdaq rules.
Use of Non-GAAP Measure
Adjusted EBITDA is a non-GAAP measure. This measure is not
intended to be a substitute for those financial measures reported
in accordance with GAAP. Adjusted EBITDA has been included because
management believes that, when considered together with the GAAP
figures, it provides meaningful information related to our
operating performance and liquidity and can enhance an overall
understanding of financial results and trends. Adjusted EBITDA may
be calculated by us differently than other companies that disclose
measures with the same or similar terms. See our attached
financials for a reconciliation of this non-GAAP measure to the
nearest GAAP measure.
Conference Call Details
INVO Bioscience has scheduled a conference call for
Monday, November 15, 2021, at
4:30 pm ET (1:30 pm PT) to review these results and recent
events. Interested parties can access the conference call by
dialing (833) 756-0861 or (412) 317-5751 or can listen via a live
Internet webcast at
https://www.webcaster4.com/Webcast/Page/2162/43563, which is also
available in the Investor Relations section of the Company's
website at https://www.invobioscience.com/investors/. A
teleconference replay of the call will be available
through November 22, 2021, at (877) 344-7529 or (412)
317-0088, confirmation #10161468. A webcast replay will be
available in the Investor Relations section of the Company's
website at https://www.invobioscience.com/investors/ for 90
days.
About INVO Bioscience
We are a medical device company focused on creating simplified,
lower-cost treatments for patients diagnosed with infertility. Our
solution, the INVO® Procedure, is a revolutionary in vivo method of
vaginal incubation that offers patients a more natural and intimate
experience. Our lead product, the INVOcell®, is a patented medical
device used in infertility treatment and is considered an Assisted
Reproductive Technology (ART). The INVOcell® is the first
intravaginal culture (IVC) system in the world used for the
natural, in vivo incubation of eggs and sperm during fertilization
and early embryo development, as an alternative to traditional in
vitro fertilization (IVF) and intrauterine insemination (IUI). Our
mission is to increase access to care and expand fertility
treatment across the globe with a goal to lower the cost of care
and increase the availability of care. For more information, please
visit www.invobio.com.
Safe Harbor Statement
This 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, as amended.
The Company invokes the protections of the Private Securities
Litigation Reform Act of 1995. All statements regarding our
expected future financial position, results of operations, cash
flows, financing plans, business strategies, products and services,
competitive positions, growth opportunities, plans and objectives
of management for future operations, as well as statements that
include words such as "anticipate," "if," "believe," "plan,"
"estimate," "expect," "intend," "may," "could," "should," "will,"
and other similar expressions are forward-looking statements. All
forward-looking statements involve risks, uncertainties, and
contingencies, many of which are beyond our control, which may
cause actual results, performance, or achievements to differ
materially from anticipated results, performance, or achievements.
Factors that may cause actual results to differ materially from
those in the forward-looking statements include those set forth in
our filings at www.sec.gov. We are under no obligation to
(and expressly disclaim any such obligation to) update or alter our
forward-looking statements, whether as a result of new information,
future events or otherwise.
INVO BIOSCIENCE,
INC.
|
CONSOLIDATED
BALANCE SHEETS
|
(UNAUDITED)
|
|
|
|
|
|
|
|
|
September
30,
2021
|
|
|
December
31,
2020
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
Cash
|
$
|
4,713,119
|
|
$
|
10,097,760
|
Accounts
receivable
|
|
50,659
|
|
|
21,699
|
Inventory
|
|
290,390
|
|
|
265,372
|
Prepaid
expenses and other current assets
|
|
275,818
|
|
|
157,700
|
Total current assets
|
|
5,329,986
|
|
|
10,542,531
|
Property and
equipment, net
|
|
854,130
|
|
|
132,206
|
Capitalized patents,
net
|
|
21,703
|
|
|
5,427
|
Lease right of
use
|
|
1,391,228
|
|
|
79,319
|
Trademarks
|
|
110,445
|
|
|
89,536
|
Notes receivable from
joint ventures
|
|
200,579
|
|
|
-
|
Other
assets
|
|
-
|
|
|
240
|
Investment in joint
ventures
|
|
237,476
|
|
|
98,084
|
Total
assets
|
$
|
8,145,547
|
|
$
|
10,947,343
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
Accounts
payable and accrued liabilities, including related
parties
|
$
|
515,583
|
|
$
|
328,927
|
Accrued
compensation - related party
|
|
461,911
|
|
|
527,326
|
Deferred
revenue, current portion
|
|
714,286
|
|
|
714,286
|
Lease
liability, current portion
|
|
107,513
|
|
|
22,707
|
Notes
payable – Payroll Protection Program
|
|
-
|
|
|
157,620
|
Convertible notes, net
|
|
340,539
|
|
|
536,063
|
Income
taxes payable
|
|
-
|
|
|
1,062
|
Total current liabilities
|
|
2,139,832
|
|
|
2,287,991
|
Lease liability,
net of current portion
|
|
1,327,693
|
|
|
58,634
|
Deferred revenue, net
of current portion
|
|
2,321,429
|
|
|
2,857,143
|
Deferred tax
liability
|
|
469
|
|
|
469
|
Total
liabilities
|
|
5,789,423
|
|
|
5,204,237
|
|
|
|
|
|
|
Stockholders' equity
|
|
|
|
|
|
Common Stock, $.0001
par value; 125,000,000 shares authorized; 10,464,035 and
9,639,268 issued and outstanding as of September 30, 2021 and
December 31, 2020, respectively
|
|
1,046
|
|
|
964
|
Additional paid-in
capital
|
|
41,343,118
|
|
|
37,978,224
|
Accumulated
deficit
|
|
(38,749,497)
|
|
|
(32,236,082)
|
Noncontrolling
interest
|
|
(238,543)
|
|
|
-
|
Total stockholders'
equity
|
|
2,356,124
|
|
|
5,743,106
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
$
|
8,145,547
|
|
$
|
10,947,343
|
INVO BIOSCIENCE,
INC.
|
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
(UNAUDITED)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three
Months Ended
September 30,
|
|
For the Nine
Months Ended
September 30,
|
|
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
revenue
|
|
$
|
2,790
|
|
$
|
157,500
|
|
$
|
538,642
|
|
$
|
305,000
|
Clinic
revenue
|
|
|
37,513
|
|
|
|
|
|
37,513
|
|
|
-
|
License
revenue
|
|
|
178,571
|
|
|
178,571
|
|
|
535,714
|
|
|
535,714
|
Total
revenue
|
|
$
|
218,874
|
|
$
|
336,071
|
|
$
|
1,111,869
|
|
$
|
840,714
|
Cost of goods
sold:
|
|
|
|
|
|
|
|
|
|
|
|
|
Production costs
|
|
|
17,987
|
|
|
24,966
|
|
|
90,464
|
|
|
71,268
|
Depreciation
|
|
|
2,431
|
|
|
2,432
|
|
|
7,294
|
|
|
7,294
|
Total cost of goods
sold
|
|
|
20,418
|
|
|
27,398
|
|
|
97,758
|
|
|
78,562
|
Gross
profit
|
|
|
198,456
|
|
|
308,673
|
|
|
1,014,111
|
|
|
762,152
|
Operating
expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling,
general and administrative expenses
|
|
|
2,416,791
|
|
|
1,463,887
|
|
|
6,581,516
|
|
|
4,311,872
|
Research
and development expenses
|
|
|
55,391
|
|
|
112,552
|
|
|
152,674
|
|
|
177,492
|
Total operating
expenses
|
|
|
2,472,182
|
|
|
1,576,439
|
|
|
6,734,190
|
|
|
4,489,364
|
Loss from
operations
|
|
|
(2,273,726)
|
|
|
(1,267,766)
|
|
|
(5,720,079)
|
|
|
(3,727,212)
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from equity method joint venture
|
|
|
(113,492)
|
|
|
-
|
|
|
(113,492)
|
|
|
-
|
Other
income
|
|
|
-
|
|
|
-
|
|
|
159,126
|
|
|
-
|
Interest
income
|
|
|
(843)
|
|
|
-
|
|
|
3,595
|
|
|
-
|
Interest
expense
|
|
|
(92,544)
|
|
|
(504,061)
|
|
|
(1,078,895)
|
|
|
(811,888)
|
Foreign
currency exchange loss
|
|
|
(721)
|
|
|
-
|
|
|
(2,213)
|
|
|
-
|
Total other
expenses
|
|
|
(207,600)
|
|
|
(504,061)
|
|
|
(1,031,879)
|
|
|
(811,888)
|
Net loss
|
|
|
(2,481,326)
|
|
|
(1,771,827)
|
|
|
(6,751,958)
|
|
|
(4,539,100)
|
Net loss attributable
to noncontrolling interest
|
|
|
(238,543)
|
|
|
-
|
|
|
(238,543)
|
|
|
-
|
Net loss attributable
to INVO Bioscience, Inc.
|
|
$
|
(2,242,783)
|
|
$
|
(1,771,827)
|
|
$
|
(6,513,415)
|
|
$
|
(4,539,100)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common
share:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.24)
|
|
$
|
(0.36)
|
|
$
|
(0.66)
|
|
$
|
(0.92)
|
Diluted
|
|
$
|
(0.24)
|
|
$
|
(0.36)
|
|
$
|
(0.66)
|
|
$
|
(0.92)
|
Weighted average
number of common shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
10,463,981
|
|
|
4,946,125
|
|
|
10,267,495
|
|
|
4,932,405
|
Diluted
|
|
|
10,463,981
|
|
|
4,946,125
|
|
|
10,267,495
|
|
|
4,932,405
|
|
Adjusted
EBITDA
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Nine Months
Ended
|
|
|
|
September
30
|
|
September
30
|
|
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable
to Invo Bioscience, Inc.
|
$
|
(2,242,783)
|
|
$
|
(1,771,827)
|
|
$
|
(6,513,415)
|
|
$
|
(4,539,100)
|
|
|
Other
Income
|
$
|
-
|
|
$
|
-
|
|
(159,126)
|
|
-
|
|
|
Interest
expense
|
$
|
15,563
|
|
$
|
88,963
|
|
60,341
|
|
133,845
|
|
|
Foreign currency
exchange loss
|
$
|
721
|
|
$
|
-
|
|
2,213
|
|
-
|
|
|
Stock-based
compensation
|
$
|
130,123
|
|
$
|
74,203
|
|
557,331
|
|
480,975
|
|
|
Stock option
expense
|
$
|
391,194
|
|
$
|
255,797
|
|
1,151,800
|
|
852,187
|
|
|
Amortization of debt
discount
|
$
|
77,824
|
|
$
|
415,098
|
|
1,014,959
|
|
678,043
|
|
|
Depreciation and
amortization
|
$
|
17,721
|
|
$
|
2,980
|
|
23,680
|
|
8,938
|
Adjusted
EBITDA
|
$
|
(1,609,637)
|
|
$
|
(934,786)
|
|
$
|
(3,862,217)
|
|
$
|
(2,385,112)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from equity
method JV
|
$
|
113,492
|
|
|
|
$
|
113,492
|
|
$
|
-
|
|
|
Loss from
consolidated JV (less depreciation)
|
$
|
223,802
|
|
|
|
223,802
|
|
|
Adjusted EBITDA
for INVO corporate
|
$
|
(1,272,342)
|
|
$
|
(934,786)
|
#
|
$
|
(3,524,923)
|
|
$
|
(2,385,112)
|
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SOURCE INVO Bioscience, Inc.