11/15/2021

speaker
Operator
Conference Operator

And welcome to the INVO Bioscience Report's third quarter of fiscal year 2021 financial results 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. Please note, this event is being recorded. And I'd like to turn the conference over to Robert Bloom with Litham Partners.

speaker
Robert Bloom
Litham Partners

Please go ahead. All right. Thank you very much, Jason. Good afternoon, everyone. And thank you all for joining us during today's InvoBioScience third quarter 2021 financial results conference call. Joining us on today's call is InvoBioScience's chief executive officer, Steve Shum, the company's chief operating officer and VP of business development, Mike Campbell, and the company's chief financial officer, Andrea Gorin. 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 INVO Bioscience may be 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 the company's forward-looking statements, whether a 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.

speaker
Steve Shum
Chief Executive Officer

Thank you, Robert, and welcome, everyone. Similar to our last quarter, both Mike and Andrea are participating on the call as well. Before we recap the third quarter and provide a general update, let me take a few minutes to address the most recent development regarding the change to our U.S. distribution approach and the termination of the Farian Agreement. It was something we announced last week and we recognize that it has created some questions. I would start by emphasizing what we conveyed in our press release. With the team we have assembled, many of whom have many years of experience in the device commercialization business within the fertility space, we feel very confident about our ability to take over and service the entire U.S. market. We are well positioned to do so, and we are excited by the opportunity to regain control of the U.S. moving forward. A tremendous amount of work has occurred over the past three years that provides a solid foundation and positions us really well to begin handling the entire US market again, and which will enable further progress moving forward. A few key points to keep in mind on this. We built a great team and a strong board of directors. We've seen much more real market usage data around InvoCell become available, along with peer reviewed papers and abstract posters. all of which reflects excellent patient outcomes, adding to the clinical validation around the technology, which builds confidence for practitioners and patients alike. Many practitioners have been trained on the technology now, including a growing list outside the US. Of course, we've just opened our first InvoCenters, a very substantial milestone for the company, and something we believe will be very impactful to the overall commercial progress moving forward. We've added marketing resources. Just recently completed our new branding, logo, website, and messaging. And we'll shortly be kicking off programs to help create greater awareness within patients and referring physicians. Again, as we regain control of the U.S. market, we can also really synchronize this marketing effort across all the key channels. We did not expect the decision by Faring, but we respect it. and thank them for their contributions towards advancing InvoCell. We knew, and I think many of our long-term shareholders also understood, that building InvoCell within the existing IVF clinics, which is where Faring was primarily focused, was and has been a slower process. Of course, this is why we are pursuing the additional channel strategies we've laid out and which are now underway. However, we also see the IVF clinics as important and we will fully support this part or channel of the market. Also, we do not need to add resources at this time to support the existing IVF clinic market. We do have a few transition details to work out with Faring, but an important point to remember is once we complete that process, we will begin selling product directly to the IVF clinics. We would anticipate that will also have the benefit of smoothing out the revenue from that part of the market rather than the occasional large orders and then periods of no activity, which will be beneficial for our planning purposes. So again, with all the foundational work and additive components that have occurred over these past three years, quite frankly, we could not be more excited to regain control over the US market at this stage. During the third quarter, we made progress towards our core objectives, especially with the Birmingham InvoCenter treating their first patients in the month of September. It was not a large number of patients, and we are running a promotional pricing program during these first couple of months. However, it's very important to note that relative how we modeled the clinics and the expectations, Birmingham ran ahead of our plan for the first month. So we are pleased, and we as we consider to be right on pace, actually a little ahead, toward the goals we have for first year operations and the expected ramp up. Equally, if not more exciting to our partners in Birmingham, as well as the whole INVO team, we now have a number of patients pregnant and on their way to having a child thanks to INVO Cell and our new INVO Center. As we've noted in separate releases, the Atlanta and Mexico centers are also now up and running and seeing patients, and we are moving the planned Bay Area center as our next planned opening. As we look ahead, the recent change in the U.S. does not impact our view of the market, the opportunity, and the methods in which we will continue to pursue commercializing InvoCell and open access to greater patient care. We have a clear objective and it hasn't changed. We intend to actively pursue establishing additional INVO centers. Of course, we can now also expand our approach and thinking around this effort in terms of the potential number of centers over time, but also how we might best approach such an expansion and better involve the OBGYN community. And again, we will look to fully support the existing IVF practices to drive improving utilization within that channel. Our international activities continue to progress as well. Mike will give a few highlights on this front. On the data front, as most of you know, the annual American Society of Reproductive Medicine, ASRM, conference was held last month. We were pleased to have four separate independent abstract posters presented this year on InvoCell at the event, which reflected further real-world data around InvoCell. As we've stressed many times, We cannot say enough how valuable and critical it is to have this growing body of validation data. It really helps with building confidence around the technology and will play a critical role in seeing increasing acceleration in the . This is another advantage with the InvoCenters. We expect to work with our JV partners to help further build data around our own centers that we can report on and further publish around InvoCell. To recap my remarks, we feel Invo is incredibly well positioned for success. Our team, our key opinion leaders, our partners, and our technology are all coming together nicely, although not expected we are excited to be regaining full control of the US market at the same time as this progress has occurred and we look forward to capitalizing on it. Our goals are clear and we remain focused at driving InvoCell toward addressing the very large unmet medical need and treat patients that need care. As the sheer numbers imply, There is a massive multi-billion dollar opportunity to add capacity, increase access, and treat those that go untreated today. This remains the essence of our strategy and approach. We also remain confident that the market progress and momentum occurring with both the info centers and distribution activities will become evident in the quarters ahead in terms of revenue growth and improving operating results. As we enter this fourth quarter specifically, we now have three INBO centers operating with a fourth on the horizon. Let me turn this over to Mike now for some additional details around the commercialization efforts. Mike?

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