Full Press Release Details
Bioscience Reports First Quarter 2022 Financial Results
to Host Conference Call Today at 4:30pm ET
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
Operational Highlights
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."
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."
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.
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.
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.
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.
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.
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.
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.
of March 31, 2022, the Company had approximately $3.8 million in cash.
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.
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.
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.
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.
| 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 |
| 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 | ) |
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 |
INVO Bioscience: Steve Shum, CEO, 978-878-9505, sshum@invobio.com, Investor Contact: Lytham Partners, LLC, Robert Blum, 602-889-9700,