UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 (Address of principal executive offices) (Zip Code) (978) 878-9505 (Registrant's telephone number, including area code) Not applicable OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________________ to __________ ...

INVO Bioscience, Inc. (NASDAQ:INVO) Q2 2022 Earnings Conference Call August 15, 2022 4:30 PM ET Company Participants Robert Blum – Investor Relations Steve Shum – Chief Executive Officer Mike Campbell – Chief Operating Officer and Vice President of Business Development Andrea Goren – Chief Financial Officer Conference Call Participants John Heerdink – Vista Partners LLC Curtis Thom – Paulson Operator Good day, and welcome to the INVO Bioscience's Reports Second Quarter 2022 Financial Results Call. All parti ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________________ to ________________ Commission File Number: 001-39701 INVO Bioscience, Inc. (Exact Name of Registrant as Specified in its Charter) | Nevada | 20-4036208 ...

Financial Data and Key Metrics Changes - Revenue for Q1 2022 totaled $163,000, a decrease from $685,000 in the prior year period [33] - The net loss was $2.8 million compared to a net loss of $2.5 million in the prior year [33] - Adjusted EBITDA loss was $2 million, compared to an adjusted EBITDA loss of $1 million last year [33] Business Line Data and Key Metrics Changes - Revenue consisted of product sales from INVOcell to IVF clinics in the U.S. and international distribution partners, as well as consolidated revenue from the Atlanta INVO Center [34] - The Atlanta INVO Center generated $106,000 in revenue for the quarter, showing a healthy increase from the previous quarter [36] - Combined revenue from Birmingham and Monterrey joint ventures was $170,000 in Q1 2022 [38] Market Data and Key Metrics Changes - The company has seen increased order flow from U.S. IVF clinics since taking over direct sales efforts in February [13][28] - A new distribution agreement was signed for China, with expected annual minimums totaling over $14 million over the initial five-year period [30][31] - Approximately 498 IVF clinics exist in China, with local sources indicating around 1 million treatment cycles annually [58][59] Company Strategy and Development Direction - The company plans to expand its INVO Center footprint, with ongoing discussions for new centers in Tampa, Kansas City, and San Francisco [10][17] - Marketing programs initiated in Atlanta are being applied to Birmingham and Mexico, with the goal of accelerating revenue ramp for future clinics [25][41] - The company is exploring ways to lower costs and accelerate expansion through partnerships with existing IVF clinics [12][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth trends at existing INVO Centers and the impact of multi-channel marketing programs [9][41] - The company anticipates that increased patient flow will contribute to improved revenue activity in the coming months [82] - Management highlighted the importance of establishing strong partnerships and the evolving conversations with potential partners [42][80] Other Important Information - The company ended the quarter with approximately $3.8 million in cash and no outstanding debt [38] - The company is sourcing additional capital to support its expansion plans and corporate needs [39] Q&A Session Summary Question: Criteria for Evaluating Targets for Clinical Expansion - The company evaluates both quantitative and qualitative factors, including demographics and existing care levels in the market [46][47] Question: Progress on 5-Day Incubation Label Expansion - The company is finalizing submission for the 5-day clinical label and has collected sufficient data despite delays due to COVID [50][54] Question: Overview of IVF Clinics in China - There are approximately 498 IVF clinics in China, with local sources indicating around 1 million treatment cycles annually [58][59] Question: Distribution Strategy in China - The company plans to work with existing facilities in China and is excited about the partnership with Onesky for product registration [62][74] Question: Impact of Marketing Initiatives on Patient Flow - Marketing initiatives in Atlanta have led to increased patient inquiries, with direct results from advertising efforts [76][78]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 INVO Bioscience, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Commission Nevada 001-39701 20-4036208 (I.R.S. Employer Ide ...

Call Start: 16:30 January 1, 0000 5:34 PM ET INVO Bioscience, Inc. (NASDAQ:INVO) Q4 2021 Earnings Conference Call March 31, 2022, 4:30 PM ET Company Participants Steven Shum – Chief Executive Officer Andrea Goren – Chief Financial Officer Michael Campbell – Chief Operating Officer and Vice President, Business Development Robert Blum – Lytham Partners, LLC Conference Call Participants John Heerdink – Vista Partners, LLC Lawrence Fidel – Fidelity Investments Scott Proctor – Private Investor Operator Good day, ...

Part I [Business Overview](index=5&type=section&id=Item%201.%20Business) INVO Bioscience is a commercial-stage fertility company expanding ART with its INVOcell product, offering an affordable and natural IVF alternative - INVO Bioscience is a commercial-stage fertility company focused on expanding assisted reproductive technology (ART) with its **INVOcell** product[21](index=21&type=chunk)[186](index=186&type=chunk)[285](index=285&type=chunk) - INVOcell is a medical device allowing in vivo fertilization and early embryo development, offering a more natural, intimate, and **affordable experience** compared to traditional IVF[21](index=21&type=chunk)[186](index=186&type=chunk)[285](index=285&type=chunk) - The commercialization strategy includes opening dedicated **'INVO Centers'** (three operational in North America) and selling INVOcell to existing fertility clinics[21](index=21&type=chunk)[186](index=186&type=chunk)[285](index=285&type=chunk) - Recent developments include the termination of a stock purchase agreement with Paradigm Opportunities Fund, LP and a joint venture agreement with Medesole Healthcare and Trading Private Limited, India, both due to unfulfilled commitments[24](index=24&type=chunk)[25](index=25&type=chunk)[382](index=382&type=chunk)[383](index=383&type=chunk) - The company operates with a core internal team and outsources manufacturing, packaging/labeling, and sterilization to contract medical manufacturing companies[26](index=26&type=chunk)[188](index=188&type=chunk) - As of December 31, 2021, INVO Bioscience had **ten full-time and two part-time employees**[28](index=28&type=chunk) - The global ART market is a **multi-billion industry** growing due to increased infertility rates and patient awareness, yet remains vastly underserved due to capacity and cost barriers[29](index=29&type=chunk)[192](index=192&type=chunk) - In the U.S., **10-15% of childbearing-age couples** experience infertility, with approximately **6.7 million women** having impaired fertility, yet only about **326,000 IVF cycles** were performed in 2020, indicating a large underserved population[30](index=30&type=chunk)[193](index=193&type=chunk) - INVOcell offers **lower costs** than traditional IVF (IVC procedure: **$5,000-$11,000** vs. IVF: **$12,000-$17,000+**), improved efficiency for greater capacity (up to **30% increase** in fertility cycle volume), and greater patient involvement through in-body incubation[31](index=31&type=chunk)[32](index=32&type=chunk)[34](index=34&type=chunk)[35](index=35&type=chunk)[194](index=194&type=chunk)[195](index=195&type=chunk)[196](index=196&type=chunk)[199](index=199&type=chunk) - The company's sales and marketing efforts focus on identifying distributors, establishing INVO Centers, and selling directly to U.S. fertility clinics, having re-assumed direct control of U.S. market distribution after the Ferring International Center S.A. agreement termination on **January 31, 2022**[36](index=36&type=chunk)[38](index=38&type=chunk)[39](index=39&type=chunk)[200](index=200&type=chunk)[202](index=202&type=chunk)[203](index=203&type=chunk)[228](index=228&type=chunk) International Distribution Agreements (as of December 31, 2021) | Market | Distribution Partner | Date | Initial Term | INVOcell Registration Status in Country | | :--- | :--- | :--- | :--- | :--- | | Canada | Invaron Pharmaceuticals Inc. | July 2020 | 1-Year | Completed | | Mexico (a) | Positib Fertility, S.A. de C.V. | Sept 2020 | TBD** | Completed | | Malaysia | iDS Medical Systems | Nov 2020 | 3-year | Completed | | Jordan | Biovate | Sept 2019 | 1-year | Completed | | Pakistan | Galaxy Pharma | Dec 2020 | 1-year | In process | | Thailand | IVF Envimed Co., Ltd. | April 2021 | 1-year | Complete | | Sudan | Quality Medicines, Cosmetics & Medical Equipment Import | Sept 2020 | 1-year | In process | | Ethiopia | Quality Medicines, Cosmetics & Medical Equipment Import | Sept 2020 | 1-year | In process | | Uganda | Quality Medicines, Cosmetics & Medical Equipment Import | Sept 2020 | 1-year | Not required | | Nigeria | G-Systems Limited | Sept 2020 | 5-year | Completed | | Togolese Republic | INVOSOLUX TOGO | Nov 2019 | 1-year | In process | | Iran | Tasnim Behboud | Dec 2020 | 1-year | Complete | | Sri Lanka | Alsonic Limited | July 2021 | 1-year | In process | Current Joint Venture Arrangements (as of December 31, 2021) | Affiliate Name | Country | Percent (%) Ownership | | :--- | :--- | :--- | | HRCFG INVO, LLC | United States | 50% | | Bloom Invo, LLC | United States | 40% | | Positib Fertility, S.A. de C.V. | Mexico | 33% | | SNS MURNI INVO Bioscience Malaysia Sendirian Berhad | Malaysia | 50% | | Ginekalix INVO Bioscience LLC Skopje | Republic of North Macedonia | 50% | Current Partnership Arrangements (as of December 31, 2021) | Partner | Country | Partnership Split | | :--- | :--- | :--- | | Lyfe Medical | United States | 40% | - The fertility industry is highly competitive, with INVOcell competing against drug-only stimulation, IUI, and conventional IVF, and its principal ART medical device competitor is **AneVivo™ by Anecova**[59](index=59&type=chunk)[60](index=60&type=chunk) - INVOcell received de novo **Class II clearance from the FDA in November 2015** for 3-day incubation, and the company is pursuing a 510(k) effort to expand labeling to a **5-day incubation period**[62](index=62&type=chunk)[197](index=197&type=chunk) - The company relies on patent, copyright, and trademark laws to protect its intellectual property, with one INVOcell device patent expiring on **July 14, 2024**, and a new patent application filed in **November 2020** for redesigns[69](index=69&type=chunk)[70](index=70&type=chunk) [Risk Factors](index=13&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks from operating losses, capital needs, joint venture performance, competitive pressures, global instability, regulatory hurdles, and financial market volatility - The company has an accumulated net loss of **$38.9 million** as of December 31, 2021, and requires additional capital to finance growth and operations, posing a high-risk investment[78](index=78&type=chunk)[79](index=79&type=chunk) - Joint ventures, essential for INVO Centers, carry risks such as partners not performing obligations, disputes over payments, non-compliance with regulations, intellectual property issues, and potential termination[80](index=80&type=chunk)[81](index=81&type=chunk) - The fertility industry is highly competitive, with risks of new ART services rendering INVOcell obsolete and competition based on pregnancy rates, requiring adequate pregnancy rates and patient satisfaction to compete effectively[82](index=82&type=chunk) - Global operations are subject to risks including currency fluctuations, exchange controls, political/economic instability, governmental pricing directives, trade restrictions, and compliance with laws like the U.S. Foreign Corrupt Practices Act[84](index=84&type=chunk)[85](index=85&type=chunk) - The company's intellectual property, including patents, may be challenged, invalidated, or circumvented, and laws in some foreign countries offer limited protection, making defending IP rights costly[88](index=88&type=chunk)[89](index=89&type=chunk)[90](index=90&type=chunk) - As a medical device provider, the company faces substantial tort injury claims, especially in artificial reproduction, and insurance coverage may not be adequate, with risks including long-term effects of fertility medication and potential regulatory bans[91](index=91&type=chunk)[93](index=93&type=chunk) - Reliance on third-party manufacturers and package delivery services introduces risks of quality lapses, supply disruptions, and increased costs[94](index=94&type=chunk)[95](index=95&type=chunk) - The company is subject to significant domestic and international governmental regulations, including FDA clearance processes, continuing compliance (MDR, QSR), and potential enforcement actions for improper marketing or off-label use[104](index=104&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk)[108](index=108&type=chunk)[111](index=111&type=chunk)[112](index=112&type=chunk)[113](index=113&type=chunk)[114](index=114&type=chunk)[115](index=115&type=chunk)[116](index=116&type=chunk) - Compliance with the EU's Medical Device Regulation (MDR) is increasingly stringent, requiring significant resources and potentially causing delays in commercialization in foreign jurisdictions[118](index=118&type=chunk)[119](index=119&type=chunk) - The success of INVOcell and the IVC procedure depends on adequate coverage and reimbursement from third-party payers, which varies significantly and is subject to cost-containment efforts[123](index=123&type=chunk)[124](index=124&type=chunk)[125](index=12

Financial Data and Key Metrics Changes - Revenue for Q3 2021 totaled $219,000, down from $336,000 in the prior year period, indicating a decrease of approximately 35% [40] - The net loss for the quarter was $2.2 million compared to $1.8 million in the prior year, reflecting an increase in losses [40] - Adjusted EBITDA loss was $1.6 million, compared to a loss of $935,000 in the previous year, showing a significant increase in operational losses [41] Business Line Data and Key Metrics Changes - The Birmingham INVO Center generated $38,000 in revenue starting in September, with expenses totaling $515,000, resulting in a loss of $239,000 net of non-controlling interest [43] - The Atlanta INVO Center was operational for only a few weeks in the quarter, with a note receivable of $201,000 reflected on the balance sheet [44] - The Monterey, Mexico INVO Center was not operational during the quarter, with a total investment of $44,000 in the joint venture to date [44] Market Data and Key Metrics Changes - The company has identified over 20 ideal locations in the U.S. for potential INVO Centers based on demographics and the lack of advanced fertility services [31] - The Birmingham facility is expected to ramp up patient flow, with outreach programs targeting approximately 600 OB/GYNs within a 100-mile radius [92] - The company is engaged in a 40-patient trial in Malaysia to compare INVO to IVF, with expectations for completion in early Q2 next year [33] Company Strategy and Development Direction - The company is regaining control of the U.S. market and plans to actively pursue establishing additional INVO Centers while supporting existing IVF practices [19][24] - The strategy includes expanding involvement with the OB/GYN community to enhance patient care access and increase utilization of INVO technology [25][86] - The company aims to address the large unmet medical need in fertility treatments, viewing it as a multibillion-dollar opportunity [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to take over U.S. distribution and service the market effectively, citing a strong team and clinical validation of INVOcell technology [11][12] - The management anticipates that all three INVO Centers will reach cash flow breakeven and start generating equity distributions during 2022 [47] - There is optimism regarding the potential for revenue growth and improved operating results as the company enters the fourth quarter with three operational INVO Centers [24][46] Other Important Information - The company has approximately $3 million in deferred license revenue to be recognized, with no obligation to return any portion to Ferring [45] - The company ended the quarter with approximately $4.7 million in cash and closed a $4 million offering in early October [46] - The company is ramping up marketing activities, including direct-to-consumer campaigns to create awareness for the INVO procedure [38] Q&A Session Summary Question: Were there any hurdles that Ferring had while selling INVOcell? - Management noted that they are not privy to Ferring's internal decision-making but acknowledged that the adoption process in existing clinics was slower than expected [55] Question: How might assumptions for 2022 change regarding the number of INVO Centers? - Management indicated they are reevaluating plans and are eager to pursue additional opportunities beyond the previously anticipated seven centers [59] Question: What types of interactions have been had with the FDA regarding label enhancement? - Management expects a 60 to 90-day timeframe for FDA review after submitting additional data [63] Question: How is the uptake going in Atlanta compared to established areas? - Management reported that the Atlanta center is progressing as expected, with outreach efforts yielding positive feedback from referring physicians [71] Question: What is the expected revenue capacity for the INVO Centers? - Management stated that approximately 200 patients per year would lead to breakeven, with a target of 500 to 600 patients annually, translating to potential revenues in the $3 million to $4 million range [78]

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 INVO Bioscience, Inc. (Exact name of registrant as specified in its charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q Nevada 001-39701 20-4036208 (I.R.S. Employer Identification No.) 5582 Broadcast Court Sarasota, Florida, 34240 (Address ...

INVO Bioscience, Inc. (NASDAQ:INVO) Q2 2021 Earnings Conference Call August 16, 2021 4:30 PM ET Company Participants Robert Blum - Lytham Partners Steve Shum - CEO Mike Campbell - COO & VP of Business Development Andrea Goren - CFO Conference Call Participants Scott Henry - ROTH Capital Kyle Bauser - Colliers Securities John Heerdink - Vista Partners Rodney Baber - Paulson Ben Haynor - Alliance Global Partners Operator Good afternoon and welcome to the INVO Bioscience Second Quarter Fiscal Year 2021 Financi ...