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