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INVO BioScience, Inc.
4/17/2023
Hello and welcome to the InfoBioscience fourth quarter and fiscal year 2022 financial results conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw from the question queue, please press star then two. Please note, this event is being recorded. I would now like to turn the conference over to Robert Bloom with Liz and Partners. Please go ahead.
Thank you so much. Good afternoon, everyone. And as the operator said, thank you for joining us for today's InvoBioscience fourth quarter and fiscal year 2022 financial results conference call. Joining us on today's call is InvoBioscience's CEO, Steve Shum, the company's chief operating officer and VP of business development, Mike Campbell, and Andrea Gorin, the company's chief financial officer. At the conclusion of today's prepared remarks, we'll 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 InvoBioscience may be forward-looking statements within the meaning of Section 27A of the Securities Act 1933 as amended, Section 21E of the Securities Exchange Act 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 anticipates, If, believe, plan, estimate, expect, intend, may, could, should, will, and other similar expressions are forward-looking statements. All forward-looking statements involve risks and 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 X 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, I'd like to turn the event over to Steve Shum, Chief Executive Officer of InvoBioscience. Steve, please proceed.
Thank you, Robert, and welcome, everyone. Let me first say we appreciate everyone's patience while we took a few extra days to finalize our annual 10-K. It was a busy end of March period for our accounting group and auditors, primarily due to the significant acquisition transaction announced and the subsequent capital raise. As many of you know, we had previously discussed our intent to make this acquisition and more broadly incorporate this added approach to our overall strategy, all of which took us longer than originally anticipated. But we are very excited to have reached this event, this recent, very important milestone. From our vantage point, 2022 was another important year overall for INVO. Our initial three INVO centers made steady progress throughout their first year of operations. We set the stage and continued our planning to build additional new InvoCenters with Tampa set to open soon. And we further evolved our commercial efforts to build InvoBioscience by way of adding an acquisition strategy where we can synergistically introduce InvoCell into existing IVF clinics that we take ownership of. Finally, we also made significant progress with our five-day label enhancement efforts Although admittedly, that process has also taken longer than we originally expected. Collectively, our efforts remain focused on our core mission, expanding patient access, utilizing our InvoCell technology for advanced fertility care to help address the very large underserved marketplace. As many of you know, we have discussed these market dynamics and how we are working to address them extensively in our communications. Commercially speaking, and from the standpoint of building the company, the most important development was the very recent announcement of our plans to acquire an existing, established, and profitable IVF clinic located in Wisconsin, the Wisconsin Fertility Institute, led by Dr. Elizabeth Pritz. The clinic has been in operation for approximately 15 years and is well known and has an excellent reputation not only in the local community, but nationally recognized as one of the top fertility centers in America. We announced the signing of the binding purchase agreements for this acquisition a few weeks ago on March 20th. As part of that announcement, we issued an AK which provided two years of audited financials along with the nine month review for the clinic. And then we further reflected those financials on a pro forma basis as if it had been part of Invo's operations during that historical period. I would encourage you to take a look. You will see that the clinic is very well managed and produces excellent results with about 5.5 million in trailing revenue and generating around 1.9 million in net income, which will most certainly be very positive material to our operations on a go-forward basis. The importance and material nature of Wisconsin's operations required that full financial audit to be performed, and it was a key element that lengthened the timeline to executing the binding agreements. Last year, when we had announced our plans to make this acquisition, we had noted that the pending nature of the transaction also restricted our ability to conduct a normal public financing, which forced us to conduct a series of small private transactions during the past four to five months, as we worked through the necessary steps to sign the binding documents and complete the audit process. And of course, raising private funds was particularly challenging given the changing market backdrop. Of course, once we did announce the details of the transaction, we then completed a public offering, maximizing the current availability under our shelf registration currently on file. This acquisition is strategically significant for a number of reasons. First and foremost, it provides meaningful revenue and positive net income to our overall operations, thus adding scale to our operations and accelerating our pathway to overall profitability. It demonstrates our ability to use our public company status as a platform to take a more comprehensive and creative approach to building the company via an acquisition component, which we view as additive to our other important development efforts. And we believe that we can structure these types of transactions in a win-win manner. We also believe it helps further our goal of advancing our core technology, the InvoCell and the IVC treatment method. We will look to integrate our solution into acquired practices and help to drive new additive revenue and profits in addition to the existing conventional IVF business these established clinics are already providing. Thus, it provides another pathway to further our efforts to bring added care to the marketplace and help patients in need. As you can hear, we believe the acquisition approach is very complementary with our ongoing efforts to building new InvoCenter practices and represents a third key aspect to our commercial strategy, further expanding on our previous multi-channel strategy. which now includes supporting, servicing, and expanding InvoCell across existing IVF practices, building new dedicated InvoCenters, and now selectively acquiring existing IVF practices. We will plan to take a measured and methodical approach to seeking out additional acquisition opportunities, and we'll focus on smaller to mid-sized established fertility practices in the marketplace. We already have several discussions occurring, and we believe there's an attractive universe of potential practices in our defined size and criteria. We will focus on pricing deals attractively and structuring them in a win-win manner. And of course, we want to work with operators that share our mission and approach. Shifting back to our InvoCenters, as mentioned, our three operating centers in Birmingham, Atlanta, and Monterey all made progress throughout the year. On a combined basis, these centers generated approximately 1.4 million in revenue, and we believe they are continuing to trend upwards and will produce strong growth for 2023. Please remember that only the revenue derived from our Atlanta center is consolidated into our results. whereas Birmingham and Monterey are accounted for under the equity method. As for new InvoCenters, Tampa is now making good progress towards an opening, targeted around mid-summertime. As we previously noted, we had experienced some delays with the planned project, but we didn't view that as a negative given our focus on our first acquisition. We are excited about Tampa. We engaged a great physician with a strong reputation in the market, and the market itself is large and attractive. So we are excited to be on a clear pathway to bringing that center operational on the near horizon. We are also excited by the potential partnering opportunities for the previously mentioned Kansas City InvoCenter location. We look forward to providing further updates on this location as they become available. As we had previously noted, these partnering arrangements could help drive more rapid patient growth once it is up and running. On the distribution side, as most of you know, we regained full U.S. commercial rights in February of 2022, so we now handle selling direct to the U.S. IVF clinics. We believe we are making steady progress in our efforts to convince other IVF clinics to adopt our technology. Of course, when comparing 2022 to 2021, there is a bit of apples and oranges comparison. The prior year, fiscal 2021, purchases of product by the prior distribution partner was required under the agreement and was realistically being bought in as inventory rather than reflective of sell-through in the market. Thus, when we look at what we believe is real sell-through in 2022, we believe growth is beginning to occur. Shifting to our clinical activities, as we had previously mentioned, we submitted an updated 510 in the third quarter of last year with all the additional data collected over the previous year. We received a response toward the end of the year with some additional questions from FDA. We have recently completed tabulating the additional data related to those questions and expect to submit our final response over the next two to three weeks. We continue to believe the data, including the additional tabulations, look very good and we are very pleased with the outcomes and excited to share those with the market as soon as possible. Let me turn this over to Andrea to quickly cover the financial highlights. Andrea?
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