INVO BioScience, Inc.

Good day and welcome to the InvoBioscience Report's fourth quarter and fiscal year 2020 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 touchtone phone. To withdraw your question, 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 Letham Partners. Please go ahead.

Thank you very much, Grant, and thank you all for joining us today to discuss InvoBioscience's year-end 2020 financial results. Joining us on today's call is InvoBioscience's Chief Executive Officer, Steve Shum, as well as the company's Chief Operating Officer and Vice President of Business Development, Mike Campbell. At the conclusion of today's prepared remarks, we will open the call for a question and answer session. Before we begin 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 with the SEC. The company is under no obligation and expressly disclaims any such obligation to update or alter the company's forward-looking statements, whether as a result of new information, future events, or otherwise. With that said, let me turn the event over to Steve Shum, Chief Executive Officer, Vinvo Bioscience. Steve, please proceed.

Thank you, Robert. We appreciate everyone joining today. As Robert mentioned, Mike Campbell, our Chief Operating Officer and Head of Business Development is on the call with us. Mike is a critical team member and heads up our commercialization efforts. Before we cover a few financial highlights for last year, I think it's important to review some key developments that occurred last year, which are important building blocks for the future. When we did our planning at the end of 2019 and heading into 2020, we certainly didn't anticipate or plan for a global pandemic, and while COVID impacted our existing and potential commercial partner efforts in general, primarily from a timing standpoint, we feel we made important progress in a number of key areas. First, our team. We realized early on in 2019 that we needed to strategically add members to our team in order to properly capitalize on the significant market opportunity for InvoCell. I give Mike tremendous credit with this effort. His long career in the fertility industry enabled us to locate some great industry people that are now part of the INVO team. Throughout 2020 and even into the early part of this year, we believe we've substantially completed this process. We certainly recognize this has added cost to our infrastructure, but we view it as a necessary investment to capture what we see as the big opportunity in front of us. During 2020, additional real-world evidence also became available, which continued to reflect the quality outcomes being achieved with usage of InvoCell in the field. Earlier this year, our U.S. partner, Fering, also published a peer-reviewed report further reflecting real-world usage data, and we would expect to see additional data published this year with SART likely to be out in the very near future. We cannot stress enough how valuable having this expanded retrospective real market usage data is for our commercial efforts. Validated data provides confidence, and we have a much expanded portfolio over the past year to point to now in this area, and it really should continue to grow. We believe this will be very important to expanding and accelerated market adoption as we move forward. In 2020, we also had an opportunity to highlight a particular clinical practice and their success with implementing InvoCell as their primary treatment option. I won't take time to cover all the details of their story, but the key takeaways are they had very good patient outcomes, provided a very attractive price point to the patients, which allowed them to see strong demand from all around the country, and they were able to handle more than a four to five-fold increase in terms of patient volume, thanks to the efficiencies of InvoCell, without any increase in their resources. It really is a success story around the business metrics for InvoCell. Having the benefit of their story, along with the additional real-world outcome data, provides a powerful combination in our commercial efforts. And the best conclusion to this story is that the key people involved in that practice decided to venture out and start their own practice, and we were fortunate enough to team up with them and help create that new practice, which was the basis of our most recent announcement to form a joint venture in Birmingham, Alabama to establish the first U.S. INBO clinic. With respect to the INBO-only clinic efforts, as many of you know, this has been an active part of our strategy dating back to early 2019. when we finalized the fairing agreement which provided the ability for us to create this concept here in the U.S. market. We've long viewed this effort as an important additional channel strategy that would complement the current distribution efforts to sell InvoCell to the existing fertility practices. I would even say that as we've learned over the past two years, we have even more conviction and confidence that this strategic effort is critical to our bigger success in the industry. The idea with an INVO clinic is to create a new practice that primarily offers INVO as the advanced treatment option. Our goal is to create a structure such as a joint venture in collaboration with a physician whereby we provide funding and technology or training support to establish the clinic and the practitioner runs the operations with us sharing in the overall profits. We believe these operations will drive broader awareness around InvoCell, and actually help improve adoption within the existing clinics. So again, we see this as a very important channel strategy and the one that allows us to benefit in a more significant economical way with the expansion of our technology. In the beginning of 2020, we actually entered into our first Invo Clinic venture with a partner for the India market. Shortly after that agreement, COVID really broke out and our partner over there had to delay the opening of that first clinic in the market. As the severe lockdowns in India loosen up, our partner will look to move that forward. Toward the end of 2020, we entered into a similar joint venture agreement for Mexico. Just last month, we completed the product registration process and our partner is now moving quickly. And then most recently, as I mentioned, our first U.S. partnership. The key point here is that after much planning, partner negotiations, initial hurdles to overcome, we are finally now moving the INVO clinics forward expeditiously with our partners. I cannot stress how excited the whole Invo team is to be finally at this point and how valuable we believe this will be for the company's future. And we have active discussions well in process with additional potential partners. Our key objective for the balance of this year is to bring these initial Invo clinics into an operational mode. I'll let Mike cover some additional details around that. During 2020, our team also worked through enhanced materials and processes to train our distributors and clinics online rather than in person in order to deal with travel restrictions. As we previously noted, product registrations for some of the countries where we established a distributor relationship have taken longer and a number of them are still pending due to COVID. However, others have completed and we are beginning to see initial international orders, which we believe will continue to build this year. In 2020, we also announced the formation of our scientific advisory board and the initial members, whom are all industry experts. We believe this will add important, valuable feedback and guidance from key opinion leaders as we move forward. And lastly, another key development for 2020 was the completion of our larger funding and simultaneous uplisting to the NASDAQ exchange completed in November. This was critical to supporting our strategic plan. As part of that effort, we also improved our listing status and visibility, as well as built out a fully independent board. Let me take a minute to turn this over to Mike for some additional details before I review financials, update our five-day labeling effort, and then open up for questions. Mike?