Company to Host Conference Call Today at
4:30pm ET
SARASOTA, Fla., May 16, 2022 /PRNewswire/ --
INVO Bioscience, Inc. (Nasdaq: INVO) ("INVO" or the
"Company"), a commercial-stage fertility company focused on
expanding access to advanced treatment worldwide with its INVOcell®
medical device and the intravaginal culture ("IVC") procedure
it enables, today announced financial results for the first quarter
ended March 31, 2022 and provided a
business update.
Recent Operational Highlights
- The three INVO Centers in Birmingham,
Alabama, Atlanta, Georgia,
and Monterrey, Mexico experienced
a 40% increase in patient inquiries and consultations compared to
the 4th quarter of 2021. This, in part, is the result of
our locally targeted marketing efforts and is a positive indicator
for potential treatment cycle growth in the coming periods.
- Announced plans to open additional INVO Centers in Tampa, Florida, and Kansas City, Missouri, in addition to the
previously announced planned clinic in the San Francisco Bay Area.
- Signed an exclusive distribution agreement with Onesky Holdings
Limited ("Onesky") for mainland China (excludes Hong
Kong, Macau and
Taiwan). The exclusivity is
subject to minimum annual purchase amounts over a 5-year term
starting upon product registration, the cost of which is to be
borne by Onesky.
- Processed initial product orders from direct sales to U.S. IVF
clinics and engaged with approximately 80 clinics, including both
new relationships and those already trained on the INVOcell and IVC
by Ferring.
- Received product orders from our Spain, Pakistan and Nigeria partnerships.
Management Commentary
"We are pleased with the progress at our INVO Centers in
Birmingham, Atlanta and Monterrey," commented Steve Shum, CEO of INVO. "In the first quarter,
we witnessed significantly increased patient flow at each center,
which we believe will contribute to growing treatment cycles in the
coming periods. Based on the typical timeframe it takes from
patient inquiry, to consultation, to initial diagnostic testing, to
addressing patient-specific timing issues, and to ultimately
completing a treatment cycle, the timeframe between initial patient
contact to cycle completion can range from 2 to 4 months or
longer. We were also pleased to see increased treatment
cycles in the first quarter, which largely represented patients
that began this process in the prior quarter. With respect to
our INVO Center expansion plans, our development team is making
solid progress on identifying additional suitable locations. As our
INVO Center activities expand and demonstrate positive results, we
expect to have greater leverage in securing favorable terms both
for landlord buildout contributions and for equipment and other
leasing options. We are targeting these opportunities to cover a
growing portion of our INVO Center start-up costs, and believe
that, in time, they could fund over 50% of these expenses. We were
also pleased with the order flow from our U.S. distribution
business along with several international market distributors, and
we expect this will continue to expand throughout the year."
"We remain enthusiastic about our multi-channel approach to
commercializing INVOcell," continued Shum. "Our INVO Center model
allows us to capture a significantly larger percentage of the
per-cycle IVC procedure revenue enabled by the INVOcell and
provides attractive economics for our shareholders, medical
practitioner partners and patients alike. Our international
distribution allows us to efficiently expand global adoption and
accelerates our efforts to address the fertility industry's biggest
challenges of cost and capacity. We look forward to continued
strength in both channels going forward."
Financial Results
Revenue for the three months ended March
31, 2022, was approximately $0.2
million compared to approximately $0.7 million for the three months ended
March 31, 2021. Of the $0.2 million in revenue for 2022, $0.1 was related to clinic revenue from the
consolidated Atlanta JV. The decrease of approximately $0.5 million, or approximately 76%, from the
first quarter of the prior year was related to a one-time bulk
order from Ferring in the previous year that was made to meet
calendar year 2020 minimum purchase commitments in the Ferring
Agreement.
Gross margins were approximately 60% and 91% for the three
months ended March 31, 2022, and
2021, respectively. The decrease in gross margin reflects the lack
of Ferring license revenue in the first quarter compared to last
year, as well as the inclusion of consolidated INVO Center cost of
goods sold expenses.
Selling, general and administrative expenses for the three
months ended March 31, 2022, were
approximately $2.6 million compared
to approximately $2.1 million for the
three months ended March 31, 2021.
The increase was primarily the result of approximately $0.2 million in increased expenses related to the
operations of the consolidated Atlanta JV, $0.2 million in increased personnel expenses, and
$0.1 million in marketing activities.
We also incurred approximately $0.7
million of non-cash, stock-based compensation expense in the
period, compared to $0.6 million for
the same period in the prior year.
We continue to make progress in our 5-day label expansion
efforts. R&D expenses were approximately $0.1 million and $0.07
million for the three months ended March 31, 2022, and March
31, 2021, respectively.
Loss from equity investments for the three months ended
March 31, 2022, was approximately
$0.07 million compared to
$0.0 for the three months ended
March 31, 2021. The increase in loss
is due to the investments in Alabama and Mexico JV's, which became
operational in the second half of 2021.
Interest expense and financing fees were approximately
$0.1 thousand for the three months
ended March 31, 2022, compared to
approximately $0.9 million for the
three months ended March 31,
2021.
Adjusted EBITDA (see Adjusted EBITDA Table) for the three months
ended March 31, 2022, was
$(2.0) million, which included
$0.2 million loss attributable to our
joint ventures, compared to adjusted EBITDA of $(1.0) million for the quarter ended March 31, 2021.
As of March 31, 2022, the Company
had approximately $3.8 million in
cash.
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 has scheduled a conference call for Monday, May 16, 2022, 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://app.webinar.net/6XQVP1XJjRA, 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 May
23, 2022, at (877) 344-7529 or (412) 317-0088, confirmation
#4725753. 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 commercial-stage fertility company dedicated to
expanding the assisted reproductive technology ("ART") marketplace
by making fertility care accessible and inclusive to people around
the world. Our primary mission is to implement new medical
technologies aimed at increasing the availability of affordable,
high-quality, patient-centered fertility care. Our flagship product
is INVOcell®, a revolutionary medical device that allows
fertilization and early embryo development to take place in vivo
within the woman's body. This treatment solution is the world's
first intravaginal culture technique for the incubation of oocytes
and sperm during fertilization and early embryo development. This
technique, designated as "IVC", provides patients a more natural,
intimate, and more affordable experience in comparison to other ART
treatments. We believe the IVC procedure can deliver comparable
results at a fraction of the cost of traditional in vitro
fertilization ("IVF") and is a significantly more effective
treatment than intrauterine insemination ("IUI"). Our
commercialization strategy is focused on the opening of dedicated
"INVO Centers" offering the INVOcell® and IVC procedure (with three
centers in North America now
operational), in addition to continuing to distribute and sell our
technology solution into existing fertility clinics. 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
|
|
|
|
|
|
|
|
March 31,
2022
|
|
|
December 31,
2021
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
Cash
|
$
|
3,839,862
|
|
$
|
5,684,871
|
Accounts
receivable
|
|
58,720
|
|
|
50,470
|
Inventory
|
|
294,631
|
|
|
287,773
|
Prepaid expenses and
other current assets
|
|
228,178
|
|
|
282,751
|
Total current
assets
|
|
4,421,391
|
|
|
6,305,865
|
Property and equipment,
net
|
|
491,995
|
|
|
501,436
|
Intangible assets,
net
|
|
132,551
|
|
|
132,093
|
Lease right of
use
|
|
1,980,153
|
|
|
2,037,052
|
Investment in joint
ventures
|
|
1,494,143
|
|
|
1,489,934
|
Total assets
|
$
|
8,520,233
|
|
$
|
10,466,380
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
$
|
462,211
|
|
$
|
443,422
|
Accrued
compensation
|
|
391,877
|
|
|
581,689
|
Deferred revenue,
current portion
|
|
5,793
|
|
|
5,900
|
Lease liability,
current portion
|
|
224,361
|
|
|
221,993
|
Total current
liabilities
|
|
1,084,242
|
|
|
1,253,004
|
Lease liability,
net of current portion
|
|
1,844,784
|
|
|
1,901,557
|
Deferred tax
liability
|
|
1,139
|
|
|
1,139
|
Total
liabilities
|
|
2,930,165
|
|
|
3,155,700
|
|
|
|
|
|
|
Stockholders' equity
|
|
|
|
|
|
Common Stock, $.0001
par value; 125,000,000 shares authorized; 12,096,798 and 11,929,147
issued and outstanding as of March 31, 2022 and December 31, 2021,
respectively
|
|
1,210
|
|
|
1,193
|
Additional paid-in
capital
|
|
47,254,192
|
|
|
46,200,509
|
Accumulated
deficit
|
|
(41,665,334)
|
|
|
(38,891,022)
|
Total equity
|
|
5,590,068
|
|
|
7,310,680
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
$
|
8,520,233
|
|
$
|
10,466,380
|
INVO BIOSCIENCE,
INC.
|
|
|
|
|
|
|
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
For the Three Months
Ended
March 31,
|
|
|
|
2022
|
|
|
2021
|
Revenue:
|
|
|
|
|
|
|
Product
revenue
|
|
$
|
56,750
|
|
$
|
505,952
|
Clinic
revenue
|
|
|
105,848
|
|
|
-
|
License
revenue
|
|
|
-
|
|
|
178,571
|
Total
revenue
|
|
|
162,598
|
|
|
684,523
|
Cost of goods
sold:
|
|
|
|
|
|
|
Production
costs
|
|
|
57,533
|
|
|
60,314
|
Depreciation
|
|
|
7,428
|
|
|
2,431
|
Total cost of goods
sold
|
|
|
64,961
|
|
|
62,745
|
Gross profit
|
|
|
97,637
|
|
|
621,778
|
Operating
expenses
|
|
|
|
|
|
|
Selling, general and
administrative
|
|
|
2,694,395
|
|
|
2,115,303
|
Research and
development
|
|
|
104,180
|
|
|
66,267
|
Total operating
expenses
|
|
|
2,798,575
|
|
|
2,181,570
|
Loss from
operations
|
|
|
(2,700,938)
|
|
|
(1,559,792)
|
Other income
(expense):
|
|
|
|
|
|
|
Loss from equity method
joint ventures
|
|
|
(71,117)
|
|
|
-
|
Interest
income
|
|
|
225
|
|
|
2,013
|
Interest
expense
|
|
|
(1,456)
|
|
|
(895,226)
|
Foreign currency
exchange loss
|
|
|
(1,026)
|
|
|
(464)
|
Total other
expense
|
|
|
(73,374)
|
|
|
(893,677)
|
Net
loss
|
|
$
|
(2,774,312)
|
|
$
|
(2,453,469)
|
|
|
|
|
|
|
|
Net loss per common
share:
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.23)
|
|
$
|
(0.25)
|
Diluted
|
|
$
|
(0.23)
|
|
$
|
(0.25)
|
Weighted average number
of common shares outstanding:
|
|
|
|
Basic
|
|
|
12,050,696
|
|
|
9,888,025
|
Diluted
|
|
|
12,050,696
|
|
|
9,888,025
|
ADJUSTED
EBITDA
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
|
|
March 31
|
|
|
|
|
2022
|
|
2021
|
|
|
|
|
|
|
|
Net
loss
|
|
$
(2,774,312)
|
|
$
(2,453,469)
|
|
|
Interest
expense
|
|
1,231
|
|
35,071
|
|
|
Foreign currency
exchange loss
|
|
1,026
|
|
464
|
|
|
Stock-based
compensation
|
|
310,212
|
|
192,064
|
|
|
Stock option
expense
|
|
428,488
|
|
376,523
|
|
|
Amortization of debt
discount
|
|
-
|
|
860,155
|
|
|
Depreciation and
amortization
|
|
15,547
|
|
8,654
|
Adjusted
EBITDA
|
|
$
(2,017,808)
|
|
$ (980,538)
|
|
|
|
|
|
|
|
|
|
Loss from equity method
JV
|
|
$
71,117
|
|
$
-
|
|
|
Loss from consolidated
JV (less depreciation)
|
178,697
|
|
-
|
Adjusted EBITDA for
INVO corporate
|
#
|
$
(1,767,994)
|
|
$ (980,538)
|
INVO Center
RESULTS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following tables
summarize the combined financial information of our consolidated
and equity method joint venture INVO Centers:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months
Ended March 31,
|
|
|
|
|
|
2022
|
|
2021
|
Statements of
operations:
|
|
|
|
|
|
Operating
revenue
|
|
|
$
275,683
|
|
$
-
|
Operating
expenses
|
|
|
(572,965)
|
|
-
|
Net income
|
|
|
|
$
(297,282)
|
|
$
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
2022
|
|
December 31,
2021
|
Balance
sheets:
|
|
|
|
|
|
|
Current
assets
|
|
|
|
$
696,237
|
|
$
660,877
|
Long-term
assets
|
|
|
|
2,170,824
|
|
2,374,471
|
Current
liabilities
|
|
|
|
(583,453)
|
|
(585,226)
|
Long-term
liabilities
|
|
|
(605,337)
|
|
(743,972)
|
Net assets
|
|
|
|
$
1,678,271
|
|
$
1,706,150
|
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SOURCE INVO Bioscience, Inc.