Steve Shum
Analyst · ROTH Capital. Please go ahead
Thank you, Joe and welcome everyone listening on the call today. Mike Campbell, our Chief Operating Officer, who would normally participate on the call, had an important meeting come up last minute and won’t be joining this time. He will be sure to make sure to make the next call. As we noted in the release that went out today, it’s been an exciting start to the year and a very busy one for our team. We worked hard to put the necessary resources and people in place to take advantage of the market opportunity and feel we are starting to see early progress and benefits. Most important, we advanced our INVO Clinic strategy here in the U.S. with the signing of our first two agreements. I would note that we expect to be executing on a third agreement soon. Both Mike and Chris Meyer have been instrumental in moving these efforts forward both in the U.S. and Mexico. With the leadership of Inger Britt Carlson, our VP of Medical Affairs, along with support from the team, including our Scientific Advisory Board members, we have substantially enhanced our training materials and process. It’s important to note that proper training is critical to the success of our distributors and partners. And training is not a one event session it’s generally multiple sessions, with multiple Q&A follow-up activities. We have really experienced a notable increase in these training and support activities this year, which are occurring weekly now. Of course, this is exciting for us to see this activity level as it’s a reflection of our team’s efforts, the growing awareness around INVOcell and the expanding number of international distributors. The most important benefit is we also see this as a precursor or a leading indicator for the business and driving future revenue growth. I want to also praise our international business development team who have been on the frontlines and critical to pushing these activities along and supporting those efforts. Another very important milestone for international activities, we have recently seen INVOcell procedures recycled to being performed in Spain and Malaysia. These locations are reporting very good fertilization and embryo quality rates, consistent with what we have seen throughout with INVOcell and positive patient satisfaction levels as well. We look forward to much more of this activity in the near future. And again, this is a result of proper training and support. Another important building block we recently expanded on this year and something that is absolutely necessary to supporting our commercialization efforts is marketing. We added both a new board member with strategic marketing expertise as well as an internal team member with the addition of Meryle Lynn Chamberlain as our Director of Marketing. As we highlighted on our last call, additional published outcomes data with the recent Ferring peer-reviewed publication and the SART data, which further demonstrates quality outcomes with INVOcell also continues to be impactful for our commercialization activities. This expanded retrospective data helps further validates technology and provides confidence in the INVOcell solution. We intend to further advance these activities this year with additional planned publications. In fact, a few abstracts on INVOcell were submitted recently for the upcoming ASRM Conference later this year. I will take a few minutes to expand further on the commercial activities which Mike wanted to make sure we highlighted for everyone. The commercialization activities have made solid progress just since the end of March when we held our last investor call. In U.S. as announced earlier we executed on the partnership agreement with Life Medical for our second INVO clinic to be located in the San Francisco Bay Area. We have started planning meetings with our partner and they are eager to finalize location and begin the build out phase. Structure wise, it’s a little different than our other U.S. joint venture agreement, but we expect that we will have similar economics in terms of profit split. On the Birmingham Clinic, we are making progress towards opening. We received the construction permits to initiate the space build out which begins this week and is expected to be completed in 8 to 10 weeks. All of the clinic equipment is on order and there are no foreseeable delays in obtaining any of the required products. We do not have a specific opening date ready to share just yet, but we can say that we are feeling more confident that we can be ready to start seeing patients in the July-August timeframe. We will provide additional updates as they become available. I know we have highlighted our Birmingham Partners a number of times, but it’s worth noting again as this is a critical point. The clinicians we are working with have already demonstrated success from a business model and patient standpoint with implementing INVOcell in a clinical practice. This is a huge benefit and provides us with tremendous confidence regarding the potential success of this clinic. Ferring and our distribution partner here in the U.S. continues to focus on promoting and selling into the existing IVF clinics and they are continuing to expand patient awareness through their marketing activities. We believe our strategy around creating the INVO Clinics will really help add to that awareness, create market acceleration with INVOcell and compliment Ferring’s efforts. In Mexico, once we cleared the product registration process in February of this year, Dr. Arredondo and Dr. Ramirez started working at an accelerated pace to bring this joint venture operational as well. The site location in the City of Monterey is finalized and the INVO central will be located within a local hospital. They are targeting a July timeframe for the construction build out to be completed. Lab equipment has been ordered here as well, which has an approximate 6 to 8 weeks lead time. They do need to complete some local licensing, which is in process as such our partners are targeting a September-October timeframe to begin operational and begin treating patients. But again, we will provide more specific dates as we work through these remaining steps. Also, as a reminder, similar to Birmingham, Dr. Arredondo was an early adopter of INVO at his fertility clinic in San Antonio and Austin and is well versed in the technology and how to successfully implement within a clinical practice. We remain active in Canada and expect to report on some developments there soon. As another reminder, the product already has clearance and can be sold into the Canadian marketplace. In other parts of the world, earlier this year, we reported that we began initial sales to a few clinics in Spain. We have hosted a number of training sessions with clinics and more recently, they began performing initial procedures. While it’s just a start treating patients within INVOcell, it is a very important milestone for this market. In Malaysia, we have conducted a number of training sessions with our new distributor. One of the local hospitals in the country also started treating patients recently as part of an evaluation and preliminary outcomes are good and what we would expect to see. Similar to Spain, these initial patient procedures are important as they begin the process of building real world experience and confidence with the clinicians in these markets and something that can be built on within these regions. We do anticipate more of this in other markets soon. By the way, as a side note, our distributor in Malaysia has also recently inquired about expanding their territory outside of Malaysia. They are a great distribution partner and we will leave that request reflects their confidence as they have devoted time and resources to training and the initial activities within Malaysia. We recently entered into a distribution agreement for Thailand. The distributor is helping our team work through the local product registration process and we have also begun training and recruiting local key opinion leaders to initiate procedures. They are a strong local player and have set some aggressive goals for INVOcell within that market, which is very encouraging. We will look forward to additional updates as we complete initial steps in that market. As we noted previously, Pakistan remains a very interesting market opportunity, while the fertility industry there is small currently in terms of annual procedure volume, it’s a large potential patient market with significant potential for growth. And our partner, Galaxy Pharma is really the dominant player and market share leader. They too have been very active in training and been one of the more aggressive partners of bringing a large audience of clinicians in their network to our training sessions. They are eager to start and we hope to have product registrations completed around the July timeframe of this year. Our India partner remains challenged by the very difficult COVID situation over there. They are still working to try and bring the first center up and running this year, but we know it’s a challenge currently and we will provide further updates as they occur. Just a quick update on a few other earlier distribution agreements we executed in Africa, Turkey and Jordan. All these markets have been severely impacted by COVID. We have completed our training programs and these partners are prepared to begin promoting marketing and selling in the local markets. We are seeing some forward progress and believe these areas will begin contributing later this year. Overall, we feel the commercial team has come together and performing well. Our data and validation profile has vastly improved, which is critical for the commercial effort. We have really honed our training proficiency and now our marketing is quickly coming together to support these activities. We have an increasing pipeline and our distributor and partner activities continue to develop at a more accelerated pace. Turning back to the INVO Clinics just for a minute, I realize we keep stressing the INVO Clinic activities, but this is really an important point for everyone to understand. We believe this new business activity which serves as an additional method for bringing INVOcell to the marketplace will prove to be transformative to the business. We expect these clinics will highlight and drive greater awareness and adoption of the technology, which we believe will in turn help accelerate volumes within the existing IVF clinics that offer INVOcell as part of their overall practice. And the INVO Clinics will also allow us to participate in greater economics on a per-procedure basis. We are keeping our original stated goal to have the initial 3 to 5 clinics up and running in the second half of this year. Turning to a few financial highlights, revenues for the quarter totaled $684,000, which compared to $258,000 in the prior year period. We record a net loss of $2.5 million compared to a loss of $1.4 million in the prior year. However, excluding non-cash charges related to equity-based expenses and additional amortization of the convertible debt discount, we had an adjusted EBITDA loss of approximately $981,000 compared to an EBITDA loss of $625,000 last year. We had approximately $224,000 in this year’s first quarter related to cost associated with the INVO Clinic activities. So, much of the actual cash increase over last year was related to the added business efforts, which again we view as necessary before we start to see the added revenue impact of those efforts. We closed the quarter with approximately $8.4 million in cash. Subsequent to the quarter end, we also collected just over $500,000 in cash from receivables. During the quarter, we had $1.2 million of our convertible debt outstanding convert into common shares. So at period end, we have just a remaining $500,000 in convertible debt. As a reminder, that remaining debt is convertible at a fixed price of $3.20 per share. We also had over just over half of our outstanding warrants convert during the quarter, part on a cash basis and part cashless we have approximately 216,000 warrants to remain outstanding. Our current outstanding shares stand at approximately 10.4 million. On the clinical side, with respect to our 5-day label enhancement for the U.S. market, we do not have any updates reported just yet. That remains a very active effort and we have set a goal of completing the process this year and we will provide updates as we have them. Also, as a reminder, the 5-day labeling is just for the U.S. market. Our CE Mark is already based on 5-day. I will conclude our prepared remarks by simply restating what we often highlight in many of our press releases and updates. There is a very significant underserved patient base around the world suffering from infertility. And there are some real challenges with respect to providing enough care to treat all those in need, in terms of affordable, efficient and effective solutions and ones that can add capacity to the overall infrastructure. All of which are issues that we believe INVOcell can address. We are excited for the balance of 2021 and beyond and look forward to leveraging the progress we are making and the impact we believe that will have on our forward operating results. I will now open this up for questions.