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IVF

INVO FertilityD
Nasdaq / Health Care Equipment & Services
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2026-06-22
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Investor releaseQuarter not tagged2026-06-22

INVO Fertility Reports First Quarter 2026 Results Reflecting Strong Revenue Growth, Expanded Fertility Clinic Platform, and Improved Capital Structure

GlobeNewswire
23% revenue growth, elimination of all Series C-2 Preferred Stock and warrant liabilities, and a strengthened balance sheet Growth reflects both organic clinic initiatives and acquisition contribution from Family Beginnings, reinforcing INVO's two primary growth avenues SARASOTA, Fla., June 22, 2026 (GLOBE NEWSWIRE) -- INVO Fertility, Inc. (Nasdaq: IVF) ("INVO Fertility" or the "Company"), a healthcare fertility company focused on the establishment, acquisition, and operation of fertility clinics and related businesses and technologies, today announced financial results for the first quarter ended March 31, 2026. Q1 2026 Financial Highlights (all metrics compared to Q1 2025 unless otherwise noted) Revenue was $2,015,225, an increase of 23% compared to $1,637,185. Consolidated clinic revenue increased 22% to $1,982,233, compared to $1,621,553. Net loss from continuing operations was $(5.5) million compared to $(1.5) million. The 2026 period included a $3.8 million non-cash loss on changes in fair value related to liability-classified warrants that were reclassified to equity during the quarter. Net loss was $(5.5) million compared to $(17.4) million. The prior-year period included a $15.9 million loss from discontinued operations related to NAYA Therapeutics. Adjusted EBITDA (see table included) was $(1.26) million compared to $(0.6) million, reflecting recent investments made in advance to support additional clinic expansion and overall future growth. Capital Structure and Balance Sheet Highlights Key balance sheet improvements: As of March 31, 2026, all Series C-2 Preferred Stock had been converted or retired, and warrant liabilities were eliminated. The Company ended the quarter with $0 of Series C-2 Preferred Stock and $0 of warrant liabilities, compared to $2.4 million and $1.9 million, respectively, at December 31, 2025. Substantially strengthened equity base: Stockholders' equity increased 108% to $15.0 million, or $9.16 per share, at March 31, 2026, compared to $7.2 million at December 31, 2025. Improved liquidity: Cash increased to $4.9 million at March 31, 2026, compared to $2.1 million at December 31, 2025 and $0.8 million at March 31, 2025. Reduced liabilities: Total liabilities decreased 26% to $9.6 million at March 31, 2026, compared to $13.0 million at December 31, 2025, while current liabilities decreased 39% to $6.4 million. Financing support…Read full document

23% revenue growth, elimination of all Series C-2 Preferred Stock and warrant liabilities, and a strengthened balance sheet Growth reflects both organic clinic initiatives and acquisition contribution from Family Beginnings, reinforcing INVO's two primary growth avenues SARASOTA, Fla., June 22, 2026 (GLOBE NEWSWIRE) -- INVO Fertility, Inc. (Nasdaq: IVF) ("INVO Fertility" or the "Company"), a healthcare fertility company focused on the establishment, acquisition, and operation of fertility clinics and related businesses and technologies, today announced financial results for the first quarter ended March 31, 2026. Q1 2026 Financial Highlights (all metrics compared to Q1 2025 unless otherwise noted) Revenue was $2,015,225, an increase of 23% compared to $1,637,185. Consolidated clinic revenue increased 22% to $1,982,233, compared to $1,621,553. Net loss from continuing operations was $(5.5) million compared to $(1.5) million. The 2026 period included a $3.8 million non-cash loss on changes in fair value related to liability-classified warrants that were reclassified to equity during the quarter. Net loss was $(5.5) million compared to $(17.4) million. The prior-year period included a $15.9 million loss from discontinued operations related to NAYA Therapeutics. Adjusted EBITDA (see table included) was $(1.26) million compared to $(0.6) million, reflecting recent investments made in advance to support additional clinic expansion and overall future growth. Capital Structure and Balance Sheet Highlights Key balance sheet improvements: As of March 31, 2026, all Series C-2 Preferred Stock had been converted or retired, and warrant liabilities were eliminated. The Company ended the quarter with $0 of Series C-2 Preferred Stock and $0 of warrant liabilities, compared to $2.4 million and $1.9 million, respectively, at December 31, 2025. Substantially strengthened equity base: Stockholders' equity increased 108% to $15.0 million, or $9.16 per share, at March 31, 2026, compared to $7.2 million at December 31, 2025. Improved liquidity: Cash increased to $4.9 million at March 31, 2026, compared to $2.1 million at December 31, 2025 and $0.8 million at March 31, 2025. Reduced liabilities: Total liabilities decreased 26% to $9.6 million at March 31, 2026, compared to $13.0 million at December 31, 2025, while current liabilities decreased 39% to $6.4 million. Financing support for growth strategy: During Q1 2026, the Company received net proceeds of approximately $7.1 million from warrant exercises, a portion of which was used to satisfy approximately $2.0 million of deferred acquisition consideration related to the Wisconsin Fertility Institute acquisition and reduce debt. Share count clarity: As of June 22, 2026, the Company had 1,786,035 shares of common stock outstanding. Assuming the full exercise of all outstanding cash-exercisable warrants and options, and the conversion of all convertible debt, the Company’s fully diluted common shares outstanding would be approximately 4.85 million shares. Recent Highlights Revenue Growth Across the Clinic Platform: Q1 2026 revenue growth was driven by both organic clinic growth initiatives and the partial-quarter contribution from the acquisition of Family Beginnings P.C., underscoring INVO Fertility's two core growth pillars: expanding revenue within existing clinics and acquiring established fertility practices. Indiana Expansion: The Company completed the acquisition of Family Beginnings in February 2026, adding a fourth operational fertility clinic in the United States and expanding INVO Fertility's Midwest presence. Family Beginnings offers a comprehensive range of fertility services, including IVF and IVC, and was an early adopter of the Company's INVOcell solution. Operational Investments to Support Growth: During Q1 2026, the Company added personnel across operations, human resources, and finance intended to support further expansion of its fertility operations in 2026 through both organic growth and acquisitions. These investments had an impact on Q1 2026 Adjusted EBITDA, but are expected to support and drive future growth, operational improvements and greater scalability, which management believes can contribute to Adjusted EBITDA improvements throughout the year. Focused Fertility Strategy: Following the 2025 divestiture of a majority interest in NAYA Therapeutics, the first quarter of 2026 reflects a cleaner reporting period without losses from discontinued operations, providing investors with a clearer view of the Company's fertility-focused operating platform. Expanded Operating Platform: With four fertility clinics in the United States and ongoing INVOcell commercialization through third-party clinics, INVO Fertility remains focused on building scale in fertility services while continuing to pursue innovative technologies that can benefit patients and enhance clinic operations. Strategic Outlook The first quarter of 2026 represented an important inflection point for INVO Fertility. The Company believes investors can now see the impact of a more focused operating strategy, a simplified capital structure, and a balance sheet that has been strengthened compared to year-end 2025. INVO Fertility's strategy is centered on two complementary growth pillars: driving organic growth across existing clinics through improved execution, payer access, added services, and patient-centered innovation, and pursuing disciplined acquisitions of established fertility clinics that can add scale, expand the Company's geographic footprint, and enhance long-term earnings power. The Company believes fertility care remains supported by favorable long-term demand trends, including a large underserved patient population, growing awareness of fertility treatment options, expanding employer-benefit coverage, and continued demand for more accessible assisted reproductive technology care. With a growing clinic network, strengthened balance sheet, and focused fertility strategy, INVO Fertility believes it is better positioned to execute against its long-term growth plan. Management Commentary "The first quarter reflected an important period for INVO Fertility," said Steve Shum, Chief Executive Officer of INVO Fertility. "We believe investors can now see a much cleaner operating company: the Series C-2 Preferred Stock has been eliminated, warrant liabilities have been removed, cash has increased, and stockholders' equity has more than doubled from year-end. Just as importantly, we delivered revenue growth through both of our core growth pillars - organic growth within our existing clinics and acquisition growth through Family Beginnings. We believe this combination creates a more stable foundation and a springboard for the next phase of our strategy." "Looking ahead, our priorities are straightforward: integrate and grow the current clinic base, continue implementing organic growth initiatives, and pursue disciplined acquisitions of established fertility clinics that can add scale and enhance long-term earnings power. We continue to believe INVO Fertility is becoming a stronger platform company in an attractive and underserved fertility market," Shum concluded. First Quarter Financial Discussion Revenue for the first quarter of 2026 was approximately $2.0 million, compared to approximately $1.6 million for the first quarter of 2025. The increase was primarily attributable to increased revenue from growth initiatives at the Georgia clinic, as well as the addition of Family Beginnings following the February 2026 acquisition. Cost of services was approximately $1.3 million for the first quarter of 2026, compared to approximately $1.0 million for the first quarter of 2025, generally correlating with the increase in clinic revenue. Selling, general and administrative expenses were approximately $2.2 million, compared to approximately $1.6 million for the first quarter of 2025, reflecting higher professional fees, personnel costs and general administrative operating expenses as the Company invests in the infrastructure required to build and support its clinic platform. The Company reported a net loss from continuing operations of approximately $5.5 million for the first quarter of 2026, compared to approximately $1.5 million for the first quarter of 2025. The 2026 net loss included approximately $3.8 million of non-cash expense related to the remeasurement of liability-classified warrants immediately prior to their reclassification to equity during the quarter. The Company reported no loss from discontinued operations during the first quarter of 2026, compared to a $15.9 million loss from discontinued operations in the first quarter of 2025 related to NAYA Therapeutics. Net cash used in operating activities improved to approximately $1.9 million in the first quarter of 2026, compared to approximately $3.5 million in the prior-year period. The Company ended the first quarter of 2026 with approximately $4.9 million in cash. Use of Non-GAAP Measure Included in this press release is a reconciliation of Adjusted EBITDA. 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 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. About INVO Fertility We are a healthcare services fertility company dedicated to expanding access to assisted reproductive technology ("ART") care to patients in need. Our principal commercial strategy is focused on building, acquiring, and operating fertility clinics, including "INVO Centers" dedicated primarily to offering the intravaginal culture ("IVC") procedure enabled by our INVOcell® medical device ("INVOcell") and U.S.-based, profitable in vitro fertilization ("IVF") clinics. We have four operational fertility clinics in the United States. We also continue to engage in the sale and distribution of INVOcell to third-party owned and operated fertility clinics. INVOcell is a proprietary and revolutionary medical device, and the first to allow fertilization and early embryo development to take place in vivo within the woman's body. The IVC procedure provides patients with a more connected, intimate, and 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 IVF and is a significantly more effective treatment than intrauterine insemination. For more information, please visit invofertility.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, including statements regarding organic growth initiatives, acquisition opportunities, integration of acquired clinics, balance sheet improvements, liquidity, the growth of our clinic platform and our ability to achieve cash flow break even or profitability, 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. For more information, please contact: INVO Fertility, Inc.Steve Shum, [email protected] Investor ContactLytham Partners, LLCRobert [email protected]

Investor releaseQuarter not tagged2026-06-02

INVO Fertility Announces Fiscal Year 2025 Financial Results

GlobeNewswire
SARASOTA, Fla., June 02, 2026 (GLOBE NEWSWIRE) -- INVO Fertility, Inc. (Nasdaq: IVF) (“INVO Fertility” or the “Company”), a healthcare fertility company focused on the establishment, acquisition, and operation of fertility clinics and related businesses and technologies, today announced fiscal year 2025 financial results. FY2025 Financial Highlights (all metrics compared to FY2024 unless otherwise noted) Revenue was $6,841,250, an increase of 5% compared to $6,532,000. Consolidated clinic revenue increased 4% to $6,721,057, compared to $6,450,431. Revenue from all clinics was $8,021,929, including both consolidated and equity method clinics, an increase of 4% compared to $7,731,177. Net loss from continuing operations was $(5.3) million compared to $(7.7) million. Adjusted EBITDA (see table included) was $(3.2) million compared to $(2.2) million. Recent Highlights Financing and Balance Sheet Strengthening: The Company announced financing transactions in December 2025 ($4 million) and January 2026 ($7.5 million) representing approximately $11.5 million of aggregate gross proceeds before expenses, providing additional flexibility to execute the Company's growth strategy and pay down certain liabilities. Further, as of March 31, 2026, all Series C-2 Preferred Stock had been converted or retired, warrant liabilities have been eliminated, and cash balances are higher, resulting in a further strengthening of the balance sheet and streamlined capitalization structure.   After the first quarter 2026 financing and conversion of remaining Series C-2 Preferred Stock, the total common shares outstanding as of June 2, 2026 is approximately 1.8 million shares. Indiana Expansion: The Company successfully closed the acquisition of Indiana-based Family Beginnings in February 2026, adding a fourth operational fertility clinic in the United States and expanding the Company's Midwest presence. Family Beginnings generated approximately $1.2 million in revenue and approximately $0.2 million in net income for the trailing twelve-month period ended September 30, 2025. Employer-benefit Access Expansion: Wisconsin Fertility Institute joined the Progyny network, broadening access to employer-sponsored patients and strengthening the Company's payor mix. Innovation and Intellectual Property: The Company continued investing in technology and platform differentiation through issuance of a…Read full document

SARASOTA, Fla., June 02, 2026 (GLOBE NEWSWIRE) -- INVO Fertility, Inc. (Nasdaq: IVF) (“INVO Fertility” or the “Company”), a healthcare fertility company focused on the establishment, acquisition, and operation of fertility clinics and related businesses and technologies, today announced fiscal year 2025 financial results. FY2025 Financial Highlights (all metrics compared to FY2024 unless otherwise noted) Revenue was $6,841,250, an increase of 5% compared to $6,532,000. Consolidated clinic revenue increased 4% to $6,721,057, compared to $6,450,431. Revenue from all clinics was $8,021,929, including both consolidated and equity method clinics, an increase of 4% compared to $7,731,177. Net loss from continuing operations was $(5.3) million compared to $(7.7) million. Adjusted EBITDA (see table included) was $(3.2) million compared to $(2.2) million. Recent Highlights Financing and Balance Sheet Strengthening: The Company announced financing transactions in December 2025 ($4 million) and January 2026 ($7.5 million) representing approximately $11.5 million of aggregate gross proceeds before expenses, providing additional flexibility to execute the Company's growth strategy and pay down certain liabilities. Further, as of March 31, 2026, all Series C-2 Preferred Stock had been converted or retired, warrant liabilities have been eliminated, and cash balances are higher, resulting in a further strengthening of the balance sheet and streamlined capitalization structure.   After the first quarter 2026 financing and conversion of remaining Series C-2 Preferred Stock, the total common shares outstanding as of June 2, 2026 is approximately 1.8 million shares. Indiana Expansion: The Company successfully closed the acquisition of Indiana-based Family Beginnings in February 2026, adding a fourth operational fertility clinic in the United States and expanding the Company's Midwest presence. Family Beginnings generated approximately $1.2 million in revenue and approximately $0.2 million in net income for the trailing twelve-month period ended September 30, 2025. Employer-benefit Access Expansion: Wisconsin Fertility Institute joined the Progyny network, broadening access to employer-sponsored patients and strengthening the Company's payor mix. Innovation and Intellectual Property: The Company continued investing in technology and platform differentiation through issuance of a new patent for its modified INVOcell device, extending protection through 2040. Advanced Laboratory Innovation: The Company announced the availability of time-lapse incubation technology at the Wisconsin Fertility Institute, adding an advanced embryo monitoring solution intended to support informed clinical decision-making and enhance patient engagement, reinforcing the Company’s commitment to quality, innovation, and patient-centered fertility care. Strengthened Operations Team: INVO is strengthening its operations through the addition of key support personnel with deep clinical operations experience to drive organizational growth, optimize day-to-day clinic performance, and support consistent, patient-centered care across INVO Fertility clinics. New Organic Growth Initiatives: Starting in March 2026, the Company implemented a series of organic growth initiatives at its Atlanta clinic which are having meaningful impact. Strategic Outlook Over the past year, INVO Fertility has taken meaningful steps to simplify and strengthen its capital structure. Management believes the Company's balance sheet is the strongest it has been in more than three years, providing additional optionality to pursue acquisitions from a position of strength, invest in organic growth initiatives, and navigate the market with greater confidence. The Company believes fertility care remains supported by favorable long-term demand trends, expanding employer-benefit coverage, increased public awareness around access to care, and a more supportive environment for IVF. INVO's strategic priorities are centered on driving organic growth across its existing clinics, integrating and expanding Family Beginnings, pursuing disciplined acquisitions that can enhance long-term earnings power, and continuing to expand the commercial and intellectual property value of the INVOcell platform. Management Commentary "This past year marked an important transition for INVO Fertility marked by meaningful progress across operations, acquisitions, and capital structure, positioning the Company for growth through both organic initiatives and strategic clinic acquisitions moving forward," commented Steve Shum, CEO of INVO Fertility. "We believe the business has now moved beyond stabilization and into a higher-growth phase. The financing actions completed around year-end and early 2026 improved our flexibility and clarity of capital structure, while the closing of the Family Beginnings acquisition expanded our clinic network to four operational fertility clinics. At the same time, we continue to see attractive opportunities to drive organic growth across our clinics through payer access expansion, added services, operational improvements, and patient-centered innovation. Importantly, our growing track record as an owner-operator of fertility clinics has enhanced our credibility in the marketplace. As sellers increasingly look for partners who understand both the clinical and operational aspects of fertility care, we believe INVO Fertility stands out as a trusted and capable acquirer.” "As we look to the future, we are optimistic about what lies ahead. With a stronger operational foundation, a growing clinic network, a robust acquisition pipeline, and the improved balance sheet, INVO Fertility is well positioned for the next chapter of its growth," Shum concluded. Use of Non-GAAP Measure Included in this press release is a reconciliation of Adjusted EBITDA. 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. About INVO Fertility We are a healthcare services fertility company dedicated to expanding access to assisted reproductive technology (“ART”) care to patients in need. Our principal commercial strategy is focused on building, acquiring, and operating fertility clinics, including “INVO Centers” dedicated primarily to offering the intravaginal culture (“IVC”) procedure enabled by our INVOcell® medical device (“INVOcell”) and US-based, profitable in vitro fertilization (“IVF”) clinics. We have four operational fertility clinics in the United States. We also continue to engage in the sale and distribution of INVOcell to third-party owned and operated fertility clinics. INVOcell is a proprietary and revolutionary medical device, and the first to allow fertilization and early embryo development to take place in vivo within the woman's body. The IVC procedure provides patients with a more connected, intimate, and 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 IVF and is a significantly more effective treatment than intrauterine insemination. For more information, please visit invofertility.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. For more information, please contact: INVO Fertility, Inc. Steve Shum, CEO [email protected] Investor Contact Lytham Partners, LLC Robert Blum 602-889-9700 [email protected]

Investor releaseQuarter not tagged2026-06-02

INVO Fertility Receives Nasdaq Notification Regarding Late Filing of Quarterly Report on Form 10-Q

GlobeNewswire
SARASOTA, Fla., June 02, 2026 (GLOBE NEWSWIRE) -- INVO Fertility, Inc. (Nasdaq: IVF) (“INVO” or the “Company”), a healthcare services fertility company, today announced that on May 27, 2026, it received a delinquency notice (the "Notice") from the Listing Qualifications Staff of The Nasdaq Stock Market LLC ("Nasdaq") stating that the Company is not in compliance with Nasdaq Listing Rule 5250(c)(1), which requires listed companies to timely file all required periodic financial reports with the Securities and Exchange Commission (the "SEC"). The Notice relates to the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (the "10-K"), and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 (the "10-Q"). The Notice has no immediate effect on the listing of the Company's common stock on Nasdaq, and the Company's common stock will continue to trade on Nasdaq under the symbol “IVF” at this time. The Company filed the 10-K with the SEC on June 2, 2026, and is working diligently to complete and file the 10-Q as soon as possible. The previous delay in filing the 10-K was due to additional time required to review certain complex accounting matters, including its tax provision, variable interest entities, and derivative accounting. The Company expects the pending first quarter 10-Q to reflect further progress on its core business objectives, which included the completion of a $7.5 million financing in January 2026 and the acquisition of Family Beginnings, an Indiana-based fertility clinic, which together strengthened the Company's operations, balance sheet and overall growth strategy. Pursuant to Nasdaq Listing Rule 5810(c)(2)(F), the Company has 60 calendar days from Nasdaq's April 23, 2026 notice regarding the 10-K delinquency to submit a compliance plan, which is no later than June 22, 2026. If Nasdaq accepts the plan, the Company may be granted up to 180 calendar days from the 10-K’s due date, or until October 13, 2026, to regain compliance. If Nasdaq does not accept the plan, the Company may appeal to a Nasdaq Hearings Panel. This press release is being issued pursuant to Nasdaq Listing Rule 5810(b), which requires prompt public disclosure of receipt of a deficiency notice. About INVO Fertility We are a healthcare services fertility company dedicated to expanding access to assisted reproductive technology (“ART”) care t…Read full document

SARASOTA, Fla., June 02, 2026 (GLOBE NEWSWIRE) -- INVO Fertility, Inc. (Nasdaq: IVF) (“INVO” or the “Company”), a healthcare services fertility company, today announced that on May 27, 2026, it received a delinquency notice (the "Notice") from the Listing Qualifications Staff of The Nasdaq Stock Market LLC ("Nasdaq") stating that the Company is not in compliance with Nasdaq Listing Rule 5250(c)(1), which requires listed companies to timely file all required periodic financial reports with the Securities and Exchange Commission (the "SEC"). The Notice relates to the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (the "10-K"), and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 (the "10-Q"). The Notice has no immediate effect on the listing of the Company's common stock on Nasdaq, and the Company's common stock will continue to trade on Nasdaq under the symbol “IVF” at this time. The Company filed the 10-K with the SEC on June 2, 2026, and is working diligently to complete and file the 10-Q as soon as possible. The previous delay in filing the 10-K was due to additional time required to review certain complex accounting matters, including its tax provision, variable interest entities, and derivative accounting. The Company expects the pending first quarter 10-Q to reflect further progress on its core business objectives, which included the completion of a $7.5 million financing in January 2026 and the acquisition of Family Beginnings, an Indiana-based fertility clinic, which together strengthened the Company's operations, balance sheet and overall growth strategy. Pursuant to Nasdaq Listing Rule 5810(c)(2)(F), the Company has 60 calendar days from Nasdaq's April 23, 2026 notice regarding the 10-K delinquency to submit a compliance plan, which is no later than June 22, 2026. If Nasdaq accepts the plan, the Company may be granted up to 180 calendar days from the 10-K’s due date, or until October 13, 2026, to regain compliance. If Nasdaq does not accept the plan, the Company may appeal to a Nasdaq Hearings Panel. This press release is being issued pursuant to Nasdaq Listing Rule 5810(b), which requires prompt public disclosure of receipt of a deficiency notice. About INVO Fertility We are a healthcare services fertility company dedicated to expanding access to assisted reproductive technology (“ART”) care to patients in need. Our principal commercial strategy is focused on building, acquiring, and operating fertility clinics, including “INVO Centers” dedicated primarily to offering the intravaginal culture (“IVC”) procedure enabled by our INVOcell® medical device (“INVOcell”) and US-based, profitable in vitro fertilization (“IVF”) clinics. We have four operational fertility clinics in the United States. We also continue to engage in the sale and distribution of INVOcell to third-party owned and operated fertility clinics. INVOcell is a proprietary and revolutionary medical device, and the first to allow fertilization and early embryo development to take place in vivo within the woman's body. The IVC procedure provides patients with a more connected, intimate, and 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 IVF and is a significantly more effective treatment than intrauterine insemination. For more information, please visit invofertility.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. For more information, please contact: INVO Fertility, Inc. Steve Shum, CEO [email protected] Investor Contact Lytham Partners, LLC Robert Blum 602-889-9700 [email protected]

Investor releaseQuarter not tagged2025-11-17

INVO Fertility Announces Third Quarter 2025 Financial Results

GlobeNewswire
SARASOTA, Fla., Nov. 17, 2025 (GLOBE NEWSWIRE) -- INVO Fertility, Inc. (Nasdaq: IVF) (“INVO Fertility” or the “Company”), a healthcare fertility company focused on the establishment, acquisition and operation of fertility clinics and related businesses and technologies, today announced third quarter 2025 financial results. Q3 2025 Financial Highlights (all metrics compared to Q3 2024 unless otherwise noted) Revenue was $1,757,094, an increase of 23% compared to $1,433,151. Consolidated clinic revenue from the Company's INVO Center in Atlanta, Georgia, and fertility clinic in Madison, Wisconsin, increased 21% to $1,722,223, compared to $1,418,011. Revenue from all clinics, including both consolidated and equity method clinics, was $1,995,007, an increase of 18% compared to $1,686,093. Net loss was $(2.6) million compared to $(1.6) million. Adjusted EBITDA (see table included) was $(947,568) compared to $(945,949) in the prior year. Operational and Strategic Highlights Organic Clinic Growth: The Company achieved strong 23% organic growth during the quarter driven by added increased patient flow at its Wisconsin and Georgia clinics. Initiatives to improve patient awareness, expand geographic reach through telehealth capabilities and increase the comprehensive suite of fertility services all contributed to the growth. Acquisition Strategy: The Company’s ongoing acquisition efforts have developed a pipeline of fertility clinics that it believes are interested in becoming part of INVO. The Company believes it offers target clinics a compelling opportunity to help build and become part of a public-company platform within the fertility industry. INVOcell Device Expansion: The Company has expanded clinical and embryology training support and improved pricing for its innovative INVOcell® technology, resulting in 130% year-over-year growth in INVOcell device revenue. This underscores the Company’s dual mission as an innovator of cutting-edge fertility solutions and a provider of compassionate, patient-centered clinical care. Policy Updates: In October 2025, the U.S. Departments of Labor, Health and Human Services, and the Treasury announced that employers can now offer standalone benefit packages to employees interested in coverage for treatment of infertility, including IVF, representing a large opportunity to expand access to IVF coverage and make fertility more affo…Read full document

SARASOTA, Fla., Nov. 17, 2025 (GLOBE NEWSWIRE) -- INVO Fertility, Inc. (Nasdaq: IVF) (“INVO Fertility” or the “Company”), a healthcare fertility company focused on the establishment, acquisition and operation of fertility clinics and related businesses and technologies, today announced third quarter 2025 financial results. Q3 2025 Financial Highlights (all metrics compared to Q3 2024 unless otherwise noted) Revenue was $1,757,094, an increase of 23% compared to $1,433,151. Consolidated clinic revenue from the Company's INVO Center in Atlanta, Georgia, and fertility clinic in Madison, Wisconsin, increased 21% to $1,722,223, compared to $1,418,011. Revenue from all clinics, including both consolidated and equity method clinics, was $1,995,007, an increase of 18% compared to $1,686,093. Net loss was $(2.6) million compared to $(1.6) million. Adjusted EBITDA (see table included) was $(947,568) compared to $(945,949) in the prior year. Operational and Strategic Highlights Organic Clinic Growth: The Company achieved strong 23% organic growth during the quarter driven by added increased patient flow at its Wisconsin and Georgia clinics. Initiatives to improve patient awareness, expand geographic reach through telehealth capabilities and increase the comprehensive suite of fertility services all contributed to the growth. Acquisition Strategy: The Company’s ongoing acquisition efforts have developed a pipeline of fertility clinics that it believes are interested in becoming part of INVO. The Company believes it offers target clinics a compelling opportunity to help build and become part of a public-company platform within the fertility industry. INVOcell Device Expansion: The Company has expanded clinical and embryology training support and improved pricing for its innovative INVOcell® technology, resulting in 130% year-over-year growth in INVOcell device revenue. This underscores the Company’s dual mission as an innovator of cutting-edge fertility solutions and a provider of compassionate, patient-centered clinical care. Policy Updates: In October 2025, the U.S. Departments of Labor, Health and Human Services, and the Treasury announced that employers can now offer standalone benefit packages to employees interested in coverage for treatment of infertility, including IVF, representing a large opportunity to expand access to IVF coverage and make fertility more affordable and accessible for patients. Operational Efficiencies: The Company continues to focus its efforts to improve operating efficiencies at its clinics to drive enhanced profitability. The clinic efficiencies include a recent strategic partnership with Heidi Health to integrate its innovative AI-powered scribe platform. Management Commentary “This quarter showcased meaningful progress across the two core pillars of our growth strategy: strengthening organic performance within our existing operations and advancing accretive acquisition opportunities,” commented Steve Shum, CEO of INVO Fertility. “We saw a robust 18% organic growth across our clinics driven by higher patient volume and increased awareness of our fertility services. This resulted from our enhanced marketing efforts, expanded telehealth reach, and continued investment in a comprehensive suite of fertility offerings, helping more individuals and families access the care they need. At the same time, policy momentum continues to build, with recent federal updates enabling employers to offer standalone infertility benefits—an important step forward in further expanding access to IVF and related treatments nationwide and driving continued strong growth for our industry.” “We are also executing effectively on our strategic initiatives to scale the business. Our pipeline of target clinics continues to grow, and we expect to complete at least one acquisition in the coming months, as more providers recognize the value of joining our mission to build an exciting, patient-centric platform. And lastly, our INVOcell device expansion initiatives delivered respectable performance, with expanded training support and improved pricing driving 130% year-over-year device revenue growth.” “Across the organization, we also remain committed to operational efficiency to drive the business toward profitability as we grow,” Shum concluded. Use of Non-GAAP Measure Included in this press release is a reconciliation of Adjusted EBITDA. Additional financial tables are included in the Company’s Form 10-Q, which can be found on the Company’s website at invofertility.com/sec-filings or at sec.gov. 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. About INVO Fertility We are a healthcare services fertility company dedicated to expanding access to assisted reproductive technology (“ART”) care to patients in need. Our principal commercial strategy is focused on building, acquiring, and operating fertility clinics, including “INVO Centers” dedicated primarily to offering the intravaginal culture (“IVC”) procedure enabled by our INVOcell® medical device (“INVOcell”) and US-based, profitable in vitro fertilization (“IVF”) clinics. We have two operational INVO Centers in the United States and one IVF clinic. We also continue to engage in the sale and distribution of INVOcell to third-party owned and operated fertility clinics. INVOcell is a proprietary and revolutionary medical device, and the first to allow fertilization and early embryo development to take place in vivo within the woman's body. The IVC procedure provides patients with a more connected, intimate, and 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 IVF and is a significantly more effective treatment than intrauterine insemination. For more information, please visit invofertility.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. For more information, please contact: INVO Fertility, Inc. Steve Shum, CEO 978-878-9505 [email protected] Investor Contact Lytham Partners, LLC Robert Blum 602-889-9700 [email protected]

Investor releaseQuarter not tagged2025-08-16

INVO Fertility Reports Second Quarter 2025 Earnings

Simply Wall St.

Explore INVO Fertility's Fair Values from the Community and select yours Net loss: US$3.21m (flat on 2Q 2024). US$8.07 loss per share. Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. All figures shown in the chart above are for the trailing 12 month (TTM) period Looking ahead, revenue is forecast to grow 9.7% p.a. on average during the next 3 years, compared to a 8.2% growth forecast for the Medical Equipment industry in the US. Performance of the American Medical Equipment industry. The company's shares are down 13% from a week ago. Before you take the next step you should know about the 6 warning signs for INVO Fertility (3 are potentially serious!) that we have uncovered. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

Investor releaseQuarter not tagged2025-08-15

INVO Fertility Announces Second Quarter 2025 Financial Results

GlobeNewswire
SARASOTA, Fla., Aug. 14, 2025 (GLOBE NEWSWIRE) -- INVO Fertility, Inc. (Nasdaq: IVF) (“INVO Fertility” or the “Company”), a healthcare services fertility company focused on expanding access to advanced treatment through the establishment, acquisition and operation of fertility clinics and related businesses and technologies, today announced second quarter 2025 financial results. Q2 2025 Financial Highlights (all metrics compared to Q2 2024 unless otherwise noted) Revenue was $1,863,654, an increase of 1% compared to $1,836,597, a new quarterly record for the Company. Consolidated clinic revenue from the Company's INVO Center in Atlanta, Georgia, and fertility clinic in Madison, Wisconsin, increased 1% to $1,832,094, compared to $1,807,921. Revenue from all clinics, including both consolidated and equity method clinics, was $2,188,893, an increase of 2% compared to $2,141,229. Net loss from continuing operations was $(3.2) million compared to $(2.2) million. Adjusted EBITDA (see table included) was $(587,230) compared to $(509,623) in the prior year. Operational and other Highlights Wisconsin Fertility Institute recognized on Newsweek’s List of America’s Best Fertility Clinics for 2025. The ranking lists the top facilities defined as a fertility clinic and advanced reproductive technologies (ART) provider by the Centers for Disease Control and Prevention (CDC). Launched telehealth capabilities at the Wisconsin clinic to expand its geographic reach and to provide patients with expert fertility care in a convenient manner. Added Platelet-Rich Plasma (PRP) therapy to its comprehensive suite of fertility services at the Wisconsin clinic. This cutting-edge treatment offers additional options for individuals and couples facing fertility challenges, further expanding the clinic’s commitment to innovative, patient-centered care. Received a notice of allowance on a new patent for a modified version of the Company’s proprietary INVOcell device. The new patent extends intellectual property protection on the Company’s INVOcell device through 2040 based on a modified design which reflects feedback from leading embryologists to simplify use of the device. Expanded clinical and embryology training support and improved pricing for its innovative INVOcell® technology. This underscores the Company’s dual mission as an innovator of cutting-edge fertility solutions and a provide…Read full document

SARASOTA, Fla., Aug. 14, 2025 (GLOBE NEWSWIRE) -- INVO Fertility, Inc. (Nasdaq: IVF) (“INVO Fertility” or the “Company”), a healthcare services fertility company focused on expanding access to advanced treatment through the establishment, acquisition and operation of fertility clinics and related businesses and technologies, today announced second quarter 2025 financial results. Q2 2025 Financial Highlights (all metrics compared to Q2 2024 unless otherwise noted) Revenue was $1,863,654, an increase of 1% compared to $1,836,597, a new quarterly record for the Company. Consolidated clinic revenue from the Company's INVO Center in Atlanta, Georgia, and fertility clinic in Madison, Wisconsin, increased 1% to $1,832,094, compared to $1,807,921. Revenue from all clinics, including both consolidated and equity method clinics, was $2,188,893, an increase of 2% compared to $2,141,229. Net loss from continuing operations was $(3.2) million compared to $(2.2) million. Adjusted EBITDA (see table included) was $(587,230) compared to $(509,623) in the prior year. Operational and other Highlights Wisconsin Fertility Institute recognized on Newsweek’s List of America’s Best Fertility Clinics for 2025. The ranking lists the top facilities defined as a fertility clinic and advanced reproductive technologies (ART) provider by the Centers for Disease Control and Prevention (CDC). Launched telehealth capabilities at the Wisconsin clinic to expand its geographic reach and to provide patients with expert fertility care in a convenient manner. Added Platelet-Rich Plasma (PRP) therapy to its comprehensive suite of fertility services at the Wisconsin clinic. This cutting-edge treatment offers additional options for individuals and couples facing fertility challenges, further expanding the clinic’s commitment to innovative, patient-centered care. Received a notice of allowance on a new patent for a modified version of the Company’s proprietary INVOcell device. The new patent extends intellectual property protection on the Company’s INVOcell device through 2040 based on a modified design which reflects feedback from leading embryologists to simplify use of the device. Expanded clinical and embryology training support and improved pricing for its innovative INVOcell® technology. This underscores the Company’s dual mission as an innovator of cutting-edge fertility solutions and a provider of compassionate, patient-centered clinical care. Completed divestiture of NAYA Therapeutics, Inc. (“NAYA”). Return to Focus on Fertility Operations On June 2, 2025, the Company completed the divestiture of a majority stake in NAYA. The Company has retained a minority position in NAYA that offers the potential to benefit from NAYA’s ongoing clinical development of its bifunctional antibodies. The revised corporate structure enables both businesses to focus on their respective opportunities and operations, with the existing Company management team and board leading the public company (INVO Fertility, Inc.). NAYA has returned to being a privately held biotechnology company led by a separate management team and board. Management Commentary “Following the decision in April 2025 to refocus exclusively on our fertility operations, we have made progress in driving growth and innovation in our existing operations and in taking key steps required for continued operating improvement moving forward,” commented Steve Shum, CEO of INVO Fertility. “Working collectively with our clinic operators, we have expanded our service offering to include new telehealth options and PRP therapy, demonstrating our commitment to quality patient-centered care. We ramped up our training support for our INVOcell® technology with clinicians and embryologists, in pursuit of our dual mission as an innovator of cutting-edge fertility solutions and healthcare services provider.” “We remain committed to our goal of maintaining a highly efficient and scalable operating structure while layering in complementary and accretive revenue-generating businesses and technologies as we move forward.” Use of Non-GAAP Measure Included in this press release is a reconciliation of Adjusted EBITDA, which does not include the loss from NAYA or the corresponding merger-related costs. Additional financial tables are included in the Company’s Form 10-Q, which can be found on the Company’s website at invofertility.com/sec-filings or at sec.gov. 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. About INVO Fertility We are a healthcare services fertility company dedicated to expanding access to assisted reproductive technology (“ART”) care to patients in need. Our principal commercial strategy is focused on building, acquiring, and operating fertility clinics, including “INVO Centers” dedicated primarily to offering the intravaginal culture (“IVC”) procedure enabled by our INVOcell® medical device (“INVOcell”) and US-based, profitable in vitro fertilization (“IVF”) clinics. We have two operational INVO Centers in the United States and one IVF clinic. We also continue to engage in the sale and distribution of INVOcell to third-party owned and operated fertility clinics. INVOcell is a proprietary and revolutionary medical device, and the first to allow fertilization and early embryo development to take place in vivo within the woman's body. The IVC procedure provides patients with a more connected, intimate, and 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 IVF and is a significantly more effective treatment than intrauterine insemination. For more information, please visit invofertility.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. For more information, please contact: INVO Fertility, Inc. Steve Shum, CEO 978-878-9505 [email protected] Investor Contact Lytham Partners, LLC Robert Blum 602-889-9700 [email protected]

Investor releaseQuarter not tagged2025-05-21

INVO Fertility Announces First Quarter 2025 Financial Results

GlobeNewswire
Company now exclusively focused on the growing fertility market following the April 2025 announcement to divest a majority stake in Naya Therapeutics SARASOTA, Fla., May 20, 2025 (GLOBE NEWSWIRE) -- INVO Fertility, Inc. (Nasdaq: IVF) (“INVO Fertility” or the “Company”), a healthcare services fertility company focused on expanding access to advanced treatment through the establishment, acquisition and operation of fertility clinics and related businesses and technologies, today announced first quarter 2025 financial results. Q1 2025 Financial Highlights (all metrics compared to Q1 2024 unless otherwise noted) Revenue was $1,637,185, an increase of 4% compared to $1,576,286. Consolidated clinic revenue from the Company's INVO Center in Atlanta, Georgia, and fertility clinic in Madison, Wisconsin, increased 5% to $1,621,553, compared to $1,537,199. Revenue from all clinics, including both consolidated and equity method clinics, was $1,943,763, an increase of 4% compared to $1,869,513. Net loss was $(17.4) million compared to $(1.6) million. Included in net loss was a non-cash impairment charge of $14.6 million on the assets related to the acquisition of NAYA Therapeutics, Inc. (“NAYA TX”), a $1.3 million operating loss related to NAYA TX, and costs associated with the NAYA TX transaction of $0.2 million. Adjusted EBITDA (see table included) was $(606,551) compared to $(427,467) in the prior year. Adjusted EBITDA does not include the impairment and operating losses from NAYA TX, or corresponding transaction related costs, since, as recently announced, the Company is in the process of divesting a majority stake in NAYA TX. Management Commentary “After announcing the divestiture of a majority stake in NAYA TX, we’ve sharpened our focus on our core mission as a fertility company, poised to seize opportunities in a dynamic market bolstered by supportive policy shifts of the current administration supporting developments that underscore the importance of fertility care,” commented Steve Shum, CEO of INVO Fertility. “This strategic move aligns with the ongoing decline in U.S. fertility rates and growing demand for accessible fertility solutions, reinforcing our commitment to broadening care for patients in need.” “With our strategic focus on fertility now clear, we have implemented a series of initiatives at our existing clinics that we believe will help accelerate or…Read full document

Company now exclusively focused on the growing fertility market following the April 2025 announcement to divest a majority stake in Naya Therapeutics SARASOTA, Fla., May 20, 2025 (GLOBE NEWSWIRE) -- INVO Fertility, Inc. (Nasdaq: IVF) (“INVO Fertility” or the “Company”), a healthcare services fertility company focused on expanding access to advanced treatment through the establishment, acquisition and operation of fertility clinics and related businesses and technologies, today announced first quarter 2025 financial results. Q1 2025 Financial Highlights (all metrics compared to Q1 2024 unless otherwise noted) Revenue was $1,637,185, an increase of 4% compared to $1,576,286. Consolidated clinic revenue from the Company's INVO Center in Atlanta, Georgia, and fertility clinic in Madison, Wisconsin, increased 5% to $1,621,553, compared to $1,537,199. Revenue from all clinics, including both consolidated and equity method clinics, was $1,943,763, an increase of 4% compared to $1,869,513. Net loss was $(17.4) million compared to $(1.6) million. Included in net loss was a non-cash impairment charge of $14.6 million on the assets related to the acquisition of NAYA Therapeutics, Inc. (“NAYA TX”), a $1.3 million operating loss related to NAYA TX, and costs associated with the NAYA TX transaction of $0.2 million. Adjusted EBITDA (see table included) was $(606,551) compared to $(427,467) in the prior year. Adjusted EBITDA does not include the impairment and operating losses from NAYA TX, or corresponding transaction related costs, since, as recently announced, the Company is in the process of divesting a majority stake in NAYA TX. Management Commentary “After announcing the divestiture of a majority stake in NAYA TX, we’ve sharpened our focus on our core mission as a fertility company, poised to seize opportunities in a dynamic market bolstered by supportive policy shifts of the current administration supporting developments that underscore the importance of fertility care,” commented Steve Shum, CEO of INVO Fertility. “This strategic move aligns with the ongoing decline in U.S. fertility rates and growing demand for accessible fertility solutions, reinforcing our commitment to broadening care for patients in need.” “With our strategic focus on fertility now clear, we have implemented a series of initiatives at our existing clinics that we believe will help accelerate organic clinic growth in the future. Furthermore, building on our three established fertility centers, we’re actively exploring expansion, with a near-term focus on acquisitions. These initiatives, coupled with a highly efficient and scalable operating structure, should allow us to drive toward our key objective of reaching cash flow break-even and profitability,” Shum concluded. Return to Focus on Fertility Operations On April 14, 2025, the Company announced its decision to divest a majority stake in NAYA TX. The retained minority position is expected to provide value upside for the Company, assuming the successful clinical development of NAYA TX’s bifunctional antibodies. The revised corporate structure is intended to enable both businesses to focus on their respective opportunities and operations, with the existing management team and board of directors set to lead the public company (INVO Fertility, Inc.) moving forward. NAYA TX will return to being a privately held biotechnology company led by its management team and board. The final separation is subject to completing definitive transaction documents and key closing conditions, including receipt of necessary approvals. Use of Non-GAAP Measure Included in this press release is a reconciliation of Adjusted EBITDA, which does not include the loss from NAYA TX or the corresponding merger-related costs. Additional financial tables are included in the Company’s 10-Q, which can be found on the Company’s website at https://www.invofertility.com/sec-filings/ or at https://www.sec.gov/. 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. About INVO Fertility We are a healthcare services fertility company dedicated to expanding assisted reproductive technology (”ART”) care to patients in need. Our principal commercial strategy is focused on building, acquiring and operating fertility clinics, including “INVO Centers” dedicated primarily to offering the intravaginal culture (“IVC”) procedure enabled by our INVOcell® medical device (“INVOcell”) and US-based, profitable in vitro fertilization (“IVF”) clinics. We have two operational INVO Centers in the United States and one IVF clinic. We also continue to engage in the sale and distribution of our INVOcell technology solution into third-party owned and operated fertility clinics. The INVOcell is a proprietary and revolutionary medical device, and the first to allow fertilization and early embryo development to take place in vivo within the woman's body. The IVC procedure provides patients with a more natural, intimate, and 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 IVF and is a significantly more effective treatment than intrauterine insemination (“IUI”). For more information, please visit www.invofertility.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. For more information, please contact: INVO Fertility, Inc. Steve Shum, CEO 978-878-9505 [email protected] Investor Contact Lytham Partners, LLC Robert Blum 602-889-9700 [email protected]

Investor releaseQuarter not tagged2025-04-30

INVO Fertility Announces 2024 Financial Results with 116% Annual Revenue Growth and Further Improvements in Adjusted EBITDA

GlobeNewswire
SARASOTA, Fla., April 30, 2025 (GLOBE NEWSWIRE) -- INVO Fertility, Inc. (Nasdaq: IVF) (“INVO Fertility” or the “Company”), a healthcare services fertility company focused on expanding access to advanced treatment through the establishment, acquisition and operation of fertility clinics, today announced fourth quarter and full year 2024 financial results. Q4 2024 Financial Highlights (all metrics compared to Q4 2023 unless otherwise noted) Revenue was $1,685,966, an increase of 22% compared to $1,381,754. Consolidated clinic revenue from the Company's INVO Center in Atlanta, Georgia, and fertility clinic in Madison, Wisconsin increased 24% to $1,687,300, compared to $1,362,938. Revenue from all clinics, including both consolidated and equity method clinics, was $2,034,332, an increase of 24% compared to $1,634,912. Net loss increased to $(3.6) million compared to $(2.0) million as a result of the addition of NAYA Therapeutics during the period and the corresponding merger costs. Adjusted EBITDA (see table included) was $(450,908) compared to $(1.0) million in the prior year. Adjusted EBITDA does not include the loss from NAYA Therapeutics, Inc. (“NAYA TX”) or corresponding merger related costs, which, as recently announced, the Company is in the process of divesting a majority stake in. 2024 Financial Highlights (all metrics compared to 2023 unless otherwise noted) Revenue was $6,532,000, an increase of 116% compared to $3,020,575. Consolidated clinic revenue increased 125% to $6,450,431, compared to $2,862,574. Revenue from all clinics was $7,731,177, including both consolidated and equity method clinics, an increase of 78% compared to $4,346,933. Net loss increased to $(9.1) million compared to $(8.0) million as a result of the addition of NAYA Therapeutics and corresponding merger costs. Adjusted EBITDA (see table included) was $(2.2) compared to $(4.9) million. Management Commentary “We achieved record revenue during 2024 of $6.5 million, an increase of 116% compared to 2023, thanks to the hard work of our fertility teams at our clinics across the U.S.,” commented Steve Shum, CEO of INVO Fertility. “Importantly, we have dramatically streamlined and improved our fertility-based operating structure to move the Company towards positive cash flow. In fact, Adjusted EBITDA for the fourth quarter of 2024 was the best quarterly period in the Company’s recent his…Read full document

SARASOTA, Fla., April 30, 2025 (GLOBE NEWSWIRE) -- INVO Fertility, Inc. (Nasdaq: IVF) (“INVO Fertility” or the “Company”), a healthcare services fertility company focused on expanding access to advanced treatment through the establishment, acquisition and operation of fertility clinics, today announced fourth quarter and full year 2024 financial results. Q4 2024 Financial Highlights (all metrics compared to Q4 2023 unless otherwise noted) Revenue was $1,685,966, an increase of 22% compared to $1,381,754. Consolidated clinic revenue from the Company's INVO Center in Atlanta, Georgia, and fertility clinic in Madison, Wisconsin increased 24% to $1,687,300, compared to $1,362,938. Revenue from all clinics, including both consolidated and equity method clinics, was $2,034,332, an increase of 24% compared to $1,634,912. Net loss increased to $(3.6) million compared to $(2.0) million as a result of the addition of NAYA Therapeutics during the period and the corresponding merger costs. Adjusted EBITDA (see table included) was $(450,908) compared to $(1.0) million in the prior year. Adjusted EBITDA does not include the loss from NAYA Therapeutics, Inc. (“NAYA TX”) or corresponding merger related costs, which, as recently announced, the Company is in the process of divesting a majority stake in. 2024 Financial Highlights (all metrics compared to 2023 unless otherwise noted) Revenue was $6,532,000, an increase of 116% compared to $3,020,575. Consolidated clinic revenue increased 125% to $6,450,431, compared to $2,862,574. Revenue from all clinics was $7,731,177, including both consolidated and equity method clinics, an increase of 78% compared to $4,346,933. Net loss increased to $(9.1) million compared to $(8.0) million as a result of the addition of NAYA Therapeutics and corresponding merger costs. Adjusted EBITDA (see table included) was $(2.2) compared to $(4.9) million. Management Commentary “We achieved record revenue during 2024 of $6.5 million, an increase of 116% compared to 2023, thanks to the hard work of our fertility teams at our clinics across the U.S.,” commented Steve Shum, CEO of INVO Fertility. “Importantly, we have dramatically streamlined and improved our fertility-based operating structure to move the Company towards positive cash flow. In fact, Adjusted EBITDA for the fourth quarter of 2024 was the best quarterly period in the Company’s recent history showing an improvement of approximately $570,000 from the comparable period of a year ago.” “Following our announcement to divest a majority stake in NAYA TX, we have refocused our efforts towards being a fertility company to continue capitalizing on the favorable market trends and recent policy developments that underscore the importance of fertility care. Leveraging the success of our existing three operating fertility centers in Wisconsin, Georgia and Alabama, we are actively pursuing expansion into additional markets. Our planned expansion comes at a pivotal moment given the further declines in the U.S. fertility rate and rising public demand for solutions which are aligned with our objective to expand access to care for patients in need.” Return to Focus on Fertility Operations On April 14, 2025, the Company announced its decision to divest a majority stake in NAYA TX. The retained minority position is expected to provide value upside for the Company, assuming the successful clinical development of NAYA TX’s bifunctional antibodies. The revised corporate structure is intended to enable both businesses to focus on their respective opportunities and operations, with the existing management team and board of directors set to lead the INVO Fertility, Inc. public company moving forward. NAYA TX will return to being a privately held biotechnology company led by its management team and board. The final separation is subject to completing definitive transaction documents and key closing conditions, including receipt of necessary approvals. The global fertility services market is projected to grow driven by rising infertility rates, delayed parenthood, and increasing acceptance of assisted reproductive technologies (ART). In the U.S., the Centers for Disease Control and Prevention reported a 50% increase in ART-conceived births from 2012 to 2021, with ART now accounting for 2.3% of all births. Use of Non-GAAP Measure Included in this press release is a reconciliation of Adjusted EBITDA, which does not include the loss from NAYA TX or corresponding merger related costs. Additional financial tables are included in the Company’s 10-K, which can be found on the Company’s website at https://www.invofertility.com/sec-filings/ or at https://www.sec.gov/. 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. About INVO Fertility We are a healthcare services fertility company dedicated to expanding assisted reproductive technology (”ART”) care to patients in need. Our principal commercial strategy is focused on building, acquiring and operating fertility clinics, including “INVO Centers” dedicated primarily to offering the intravaginal culture (“IVC”) procedure enabled by our INVOcell® medical device (“INVOcell”) and US-based, profitable in vitro fertilization (“IVF”) clinics. We have two operational INVO Centers in the United States and one IVF clinic. We also continue to engage in the sale and distribution of our INVOcell technology solution into third-party owned and operated fertility clinics. The INVOcell is a proprietary and revolutionary medical device, and the first to allow fertilization and early embryo development to take place in vivo within the woman's body. The IVC procedure provides patients with a more natural, intimate, and 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 IVF and is a significantly more effective treatment than intrauterine insemination (“IUI”). For more information, please visit www.invofertility.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. For more information, please contact: INVO Fertility, Inc. Steve Shum, CEO 978-878-9505 [email protected] Investor Contact Lytham Partners, LLC Robert Blum 602-889-9700 [email protected]

TranscriptFY2023 Q22023-08-14

FY2023 Q2 earnings call transcript

Earnings source - 20 paragraphs
Operator

Good afternoon. And welcome, to the INVO Bioscience Second Quarter Fiscal Year 2023 Financial Results Conference Call. All participants will be in listen-only mode. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Robert Blum of Lytham Partners. Please go ahead.

Robert Blum

Great. Thanks so much, Kate. Good afternoon, everyone and thank you all for joining us for INVO Bioscience’s second quarter 2023 financial results conference call. Joining us on the call today are INVO Bioscience’s CEO, Steve Shum; the company’s Chief Operating and VP of Business Development, Mike Campbell; and Andrea Goren, the company’s Chief Financial Officer. At the conclusion of today’s prepared remarks, we will open the call for a question-and-answer session. Before we begin with the event, we submit for the record the following statement. Certain matters discussed on this conference call by the management of INVO Bioscience maybe forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 as amended, Section 21E of the Securities Exchange Act of 1934 as amended. And such forward-looking statements are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements regarding the company’s 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 the company’s 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 the company’s filings at www.sec.gov. The company is under no obligation to and expressly disclaims any such obligation to update or alter our forward-looking statements, whether as the result of new information, future events or otherwise. With that said, let me turn the event over to Steve Shum, Chief Executive Officer of INVO Bioscience. Steve, please proceed.

Steve Shum

Thank you, Robert. And welcome everyone. We are excited to be on the call today just a few days after completing and announcing what we believe is one of the most important developments in the company’s history, and one that we also believe targets the company for operating cash flow breakeven in 2024. The final closing of the acquisition of the Wisconsin fertility Institute announced on Friday not only adds important operating scale to the business, but also further accelerates our transition from purely a medical device company to a healthcare services provider focused on the fertility market. And to remind everyone why this transition is important, it provides us the ability to capture a greater portion of the revenue and profit opportunity associated with treatment in general and with the treatment solution that INVOcell provides. To put that in context and INVOcell device sold on its own creates revenue of approximately $400 per unit. A complete IVC procedure can generate about $4500 to $7,000 per cycle of revenue, with operating profits at scale well in excess of the device profit. This ability to capture greater revenue and profitability scandal, while also expanding the use of INVOcell and the IVC procedure is why we are – we remain excited by the progress being made and as the key driver behind the transition. As background, this transition started in the latter part of 2021 with the opening of our first INVO Center in Birmingham, Alabama. We quickly then added centers in Atlanta, Georgia, and Monterrey, Mexico, which combined with Birmingham recorded revenues of 712,000 during the second quarter, and an increase of 145% compared to the year ago period, which equates to an annualized rate of approximately 3 million. Importantly, these centers are operating close to a breakeven point currently. A significant accomplishment just more than a year since operations with incremental growth expected at these clinics in the future and high contribution margins in here are not in this model. We expected, we expect strong profitability in the years to come. The INVO Center growth potential and profitability model is why we look forward to expanding those efforts. Which brings us back to the acquisition of Wisconsin fertility, which is not only highly profitable, but we believe there are added growth opportunities available as we look to integrate the INVO Cell solution within those existing operations. As we have reported Wisconsin fertility Institute had revenue of more than $5 million at their single location last year with net income of approximately $1.7 million. These are important metrics for a couple of reasons. First, it immediately doubles the existing run rate of our clinic operations. Second, the profitability of the clinic substantially improves our overall operating performance. And finally, it highlights the revenue net income potential that we believe is available with each of our existing INVO Centers. Over $5 million and $1.5 million in net profit per center is a goal we are looking to achieve and all of our centers, when they reach scale. So as we look to the future, our center expansion strategy will be to fold company built centers with our next one center open in Tampa soon and acquisitions where we can synergistically introduce INVOcell into existing IVF clinics that we take ownership of. The why was Wisconsin fertility Institute such a logical choice for our first acquisition beyond the attractive financial profile. First, the clinic has an excellent reputation not only in the local community, but nationally is one of the top Fertility Centers in America, having helped to welcome over 5000 babies since offer opening its doors in 2007 and with approximately 550 conventional IVF procedures completed in 2022. It is led by an internationally renowned and well respected fertility expert Dr. Elizabeth Fritz, who shares in our vision and opportunity to democratize fertility. We look forward to having the Wisconsin clinic and staff now part of our operations. With a fantastic team in place a long established track record in the local market, a shared vision and of course, the highly profitable nature of the operations. There is excitement all around on the completion of this transformative acquisition. Taking a step back to our existing operations, as I mentioned at the onset, our existing clinics continue to make solid progress. Revenue from all clinics during the quarter improved nicely compared to last year. It is our belief that the – this ongoing progress validates the complete build INVO Center model and concept. Further, we have also gained significant experience and insight from these initial centers, which we believe we can apply to future centers to more quickly ramp-down. On the topic of expansion, we are moving closer to opening the new INVO Center in Tampa, which we expect to be ready in the next 60 to 90 days. We are excited about Tampa, which we believe in a large interactive market, we have assembled an excellent team to operate the practice, with that team well into training and planning phases in preparation for the opening. We will keep you updated on the plan opening in the coming months. We are carefully evaluating timing on future INVO Centers, especially given our balanced efforts now between company built and acquired practices. We believe there are a number of existing opportunities for both going forward. In addition to our clinics, we continue to support service and expand in INVOcell craft existing IVF clinics, to that end product revenue increased 82% during the second quarter. The key component that we believe will further drive adoption is the FDA is 5x clearance we received to expand the labeling on the INVOcell device and it's incubate – indication for use to provide for a 5-day incubation period. This occurred in June of 2023. The results demonstrate and validate the improved patient outcomes with longer incubation time, which we believe will help build further credibility in the market around the solution. I cannot say enough what a significant accomplished this was and the importance and value this will bring in our efforts to increase adoption. Importantly, with that effort now successfully completed, we have now been able to eliminate the prior costs associated with this effort on a go forward basis. On that note in connection with our transition to a healthcare services company, we have implemented further corporate expense reductions, which when combined with the profitable acquisition, the ongoing improvements in our existing INVO Centers and the 510(k) cost reductions significantly improves our operating picture and will lead us to a shorter timeframe to reach an overall adjusted EBITDA profit which again we are targeting in 2024. With that, let me turn this over to Andrea to quickly cover added financial details. Andrea?

Andrea Goren

Thank you, Steve. Revenue for the quarter totaled approximately $316,000 compared to approximately $146,000 in the prior year period, approximately 81% of Q2 revenue or $254,000 consisted of consolidated service revenue from our Atlanta INVO Center in comparison to $112,000 in the prior year period. The remaining 19% represents product revenue from in INVOcell sales to IVF clinics. As a reminder, our operating INVO Centers in Birmingham and Monterrey are accounted for using the equity method. Revenue from all three clinics totaled $712,000 in the quarter compared to $291,000 in the prior year period. The increase in revenue reflects the cumulative impact of marketing efforts to build awareness for the clinics, their respective services, and INVOcell and IVC in general. We expect 2023 clinic revenue to continue to build throughout the year, primarily from the inclusion of the Wisconsin clinic results and to a lesser degree from the launch of our Tampa INVO Center. Both clinics are wholly owned and will be – excuse me, and will be consulted into our financial statements. Reflect our transition from medical device company to fertility service provider. From this quarter onwards, cost of revenue is presented in the operating expense section of our income statement. Our operating expenses decreased to approximately $2.4 million from approximately $2.8 million in the prior year period, largely as a result of lower personnel marketing, non-cash stock based compensation, and research and development costs. Operating Expenses attributable to Atlanta IVNO Center were approximately $275,000 compared to approximately $186,000 in the prior year period. On a combined basis, our three inverse centers had approximately $799,000 in operating expenses, compared to approximately $680,000 of the prior year period. Our adjusted EBITDA loss which is net of non-cash charges, mainly related to equity based compensation improved to approximately $1.6 million compared to an adjusted EBITDA loss of approximately $2.2 million last year. These amounts included a gain of approximately $4,000 and the loss of approximately $118,000 respectively, attributable to our INVO Center joint ventures accounted for with the equity method. With the inclusion of Wisconsin, along with a recent expense reductions Steve mentioned, we expect to achieve further improvements in our EBITDA performance moving forward. On June 30, 2023, we had approximately $112,000 in cash and $1.3 million in debt. We have since repaid approximately $140,000 of convertible debt in the quarter we raised approximately $4.5 million in gross proceeds in a public offering of common stock and warrants. In advance of the offering we implemented a 1 for 20 reverse split, which allowed us to regain some clients under NASDAQ's minimum bid price requirements. As of today, we have approximately 2.4 million shares of common stock, and approximately $3.5 million warrants outstanding. Back to you, Steve.

Steve Shum

Thank you, Andre. Before we open for your questions, let me summarize. As highlighted, we believe the recent events in progress has substantially improved the company's operations on a go forward basis. We finalized and closed a major acquisition adding meaningful revenue and operating profits. Our existing centers are becoming self-sustaining and we expect further growth. We concluded our FDA clinical efforts with a very successful outcome that further validates this success of INVOcell, and we can now eliminate those costs moving forward. We are close to the opening of the new INVO Center in Tampa, which will provide an added growth and we will seek out additional acquisitions to further help accelerate building added scale in our operations. We believe we have now transitioned beyond just a medical device technology company and selling the INVOcell device. We have now become an integrated clinic company focused on offering treatment solutions to patients within the large and growing fertility market. We expect our enhanced commercial approach will also naturally increase the utilization and grow in INVOcell and the IVC treatment process within the market. We believe our efforts along with our technology put us in a unique position. And we have set the foundation from which we believe we can drive shareholder value. With that, we will open up for questions. Operator?

Operator

Thank you [Operator Instructions] The first question is from Michael [indiscernible] of Maxim. Please go ahead.

Unidentified Analyst

Hey, guys. Congratulations on the progress this quarter and thanks for taking my questions today.

Steve Shum

Thank you, Michael.

Unidentified Analyst

So I'd like to see if you could expand a little bit more on the importance of gaining that 510(k) clearance for the 5-day incubation period. Obviously, this is a really important development. But can you talk a bit about how this changes your competitive messaging when you are talking to prospective patients, and they are evaluating in both cell versus traditional IVF?

Steve Shum

Yes. Sure, great. Well, as a reminder, everyone, our original clearance for the device was for a three-day incubation period, which is similar to IVF has lower outcomes, patient outcomes success rates. And so as we have been in the marketplace, we have to message marketing wise and so forth to both physicians as well as patients, what our label approval was for and the results of that. So, what we often found in the market was that it was really, the comparison that was often occurring was comparing conventional IVF treatment, which was often being done at five-day, compared to our three-day wait to the label approval. Even though many of our early adopters of the technology were using our device off-label and incubating for five days, which is why we had a volume of data that we could use to – real world data that we could use to support a 510(k) submission for label enhancement. So, the advantage of having gone through that multi-year process is that now we can better reflect our technology that we have long known, has a better outcome rate similar to IVF, then you can incubate for a longer period of time. And so in our minds, it really helps to equalize the playing field in the marketplace. So, I would say it’s in our mind, it’s very significant. It’s why we went through that multi-year effort to achieve that improve labeling for the device. And now we can speak more openly and actively to both patients, as well as physicians, and reflect validated data to them that demonstrates the higher quality outcomes for patients based on a five-day incubation period. So, again, it’s very significant for our marketing efforts. We think it’s very significant for potentially partnering with physicians, to team up with us whether we are doing – building new INVO centers, or potentially acquisitions, so it has significance in many aspects of the business for us.

Unidentified Analyst

Alright, yes. And so actually, I do want to follow-up a little bit on that last point you are making and just if you could talk about how the five-day incubation approval, how you expect that to benefit the clinics, or is this more about attracting new practitioners, new clinics, or do you see this is something that will actually benefit your existing clinics and their growth rates?

Steve Shum

I think it’s hugely beneficial to our existing clinics, again, they can now – even clinics themselves have to be careful about how they are marketing a technology in terms of its official labeled usage. So, now, our own centers and our physicians within those centers can do more proactive marketing to patients and we think that could be very instrumental in helping to attract further build awareness around the technology and bring a higher volume of patients into the clinic. Because obviously, for patients, a successful outcome is one of the most important drivers in their minds, of course, their ability to afford the treatment is important too, but they want to, as we always say, internally, and the most important thing is having a successful outcome and having a baby. So, being able to, again, do bigger picture marketing that can demonstrate those results more proactively, we think could be a very significant driver again in bringing more traffic and more patient volume into the clinics. I thought that Mike Campbell even add to that. I just probably got some thoughts on that too, go ahead Mike.

Mike Campbell

Yes. Just briefly, Michael, I mean we are at a significant disadvantage competitively because our competitors, who are the IVF clinics are telling their patients that the INVO cell technology is only 29% successful and their outcomes with conventional IVF 50% plus. And again, for the FDA, those were 29% was the day-three data that was approved for the label. And so there is a misconception in the market, that our technology is significantly inferior, when in fact, it isn’t. So, now we are finally able to put the real data out there in front of the community. And again, this is a patient driven market, it’s very important that patients understand that this technology delivers the same outcome for last mile.

Unidentified Analyst

Yes. No, it’s certainly a key point here. And then just I guess looking to your breakeven 2020 [ph], could you expand on what sort of assumptions go into that? Does this a factor any additional clinics? What level of growth are existing clinics are factored in there? And what kind of cost savings do you look at when you are making that evaluation?

Steve Shum

Sure, great question. So, what our key assumptions are is that we will get some incremental growth out of Wisconsin off of its current baseline as we integrate in both. So, we are not trying to be too aggressive there. Just looking to bring the technology in and add some patient volume into that practice as we go into next year. Obviously, bringing Tampa up and running here this year, we anticipate to be a factor and benefiting that goal for next year. And then of course, our existing centers staying on the same trajectory. That’s really the key components. We are not even factoring in additional acquisitions. We do think there are potential additional acquisitions, but which would only help us accelerate and get there faster in our minds, but it’s not part of how we see the plan to do it with just what I just laid out from a revenue standpoint and growth standpoint. And then on the cost reduction side, we have already implemented those. Again, that really was happening in the beginning of the current quarter that we are in as we concluded the 510(k) costs, and then we made some other corporate adjustments. So, we have taken some costs out of the business to be able to more focused. Now, of course, we are going to be adding in the Wisconsin operation. So, from an absolute standpoint, there will be more substance to the business. And they are sort of costs, but remember, they are profitable. So, when we look at what we have taken out costs from sort of the corporate side and those were pretty meaningful between the 510(k) costs and some of the other corporate costs we have reduced. Those are – we would probably – I would say at ballpark that about 30% of the corporate costs have been reduced. And we expect to maintain those levels as we go into next year.

Unidentified Analyst

Alright. Thank you very much.

Steve Shum

Thank you.

Operator

[Operator Instructions] This concludes our question-and-answer session. I would like to turn the conference back over to management for closing remarks.

Steve Shum

Great. Thank you everyone that joined the call today. We appreciate your time. As always, please do not hesitate to reach out if you have any follow-up questions. Thank you again.

Operator

The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.

As of 2026-06-27 • Updated weeklySource: Earnings sourceIngestion runbook