Greetings, and welcome to Apollo Endosurgery's Second Quarter 2020 Results Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. I'd like to remind you that this conference is being recorded. It is now my pleasure to introduce Matt Kreps, Managing Director at Darrow Associates Investor Relations. Mr. Kreps, you may begin.

Thank you, Taren, and thanks, everyone, for participating in today's call to discuss Apollo's second quarter 2020 financial and operating results. Joining me on the call today are Todd Newton, Chief Executive Officer; and Stefanie Cavanaugh, Chief Financial Officer. Before we begin, I would like to caution listeners that comments made by management during this conference call will include forward-looking statements within the meaning of federal securities laws, including Apollo's financial outlook and Apollo's plans and timing for product development and sales. In addition, there is uncertainty about the spread of the COVID-19 virus, and the ultimate impact it may have on our operations, the demand for our products, global supply chains and economic activity in general. These forward-looking statements involve material risks and uncertainties and actual results may differ materially. For a discussion of risk factors, I encourage you to review the company's annual report on Form 10-K for the year ending December 31, 2019, as well as our most recent Form 10-Q filed today with the Securities and Exchange Commission. The content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, August 4, 2020. Except as required by law, Apollo undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this call. During this call, we will interchangeably use the term ESS for OverStitch and the term IGB for Orbera and vice versa. And with that, I'd now like to turn the call over to Todd.

Thank you, Matt. Good afternoon, everyone, and thank you for joining today's call to discuss our second quarter 2020 results. I hope all of you joining us today and your families are remaining safe and healthy. On July 20, we preannounced our second quarter revenue and highlights. And in just a moment, Stefanie Cavanaugh, our CFO, will take you through the details of the second quarter. Before she does, I will open with four key points that best describe for investors the state of the company here at the midway point of 2020. One, the immediate liquidity preservation actions we took at the start of the COVID disruption were successful. These decisions were hard to make and hard to implement because of the impact on our team. But we knew that the actions were necessary to preserve the interest of our shareholders, and the Board of Directors fully supported management's plans. Two, we have made sacrifices to reduce spending, but we have continued to pursue shareholder value creation by investing in our most important development programs such as the X-Tack program. This took tremendous teamwork and adaptation due to stay-at-home directives and travel restrictions, but our team persevered. And as announced on July 7, the X-Tack 510k application was submitted to the FDA and is now in the regulatory review process. Three, our business is coming back. The COVID pandemic had an immediate and significant impact on all healthcare procedures, and of course, it impacted our sales in the second quarter. But since March and April's initial shutdown of elective procedures, we have been on a positive recovery path. In June, U.S. product sales were close to 90% of June sales in 2019. Our recovery trends outside the United States are also encouraging but tracking slower in June than the U.S. pace. Four, our liquidity has been shored up. While COVID-related market risk continues to cloud the immediate future with uncertainty, our recently completed equity financing and simultaneous credit amendment provides us the capital to accelerate our business recovery from this period of COVID market disruption and fund through the X-Tack launch. I will pause with that and turn the call over to Stefanie now to cover the second quarter financial results in greater detail. Stef?

Thank you, Todd, and good afternoon, everyone. As addressed in our press release from earlier today and the 10-Q filing, the dominant theme in the second quarter has been the COVID-19 disruption to healthcare resources and elective or deferrable procedure volumes worldwide, including procedures that use our products. As a result, our revenue decreased 60% in the second quarter of 2020 from the second quarter of 2019. By geography, U.S. endoscopy sales declined 40%, while OUS endoscopy sales declined close to 68%. The difference in geographic decline is that U.S. procedure volumes and healthcare activity appears to be recovering at a quicker rate, and the OUS decline includes our distributor channel, which was down by 76% compared to the second quarter of 2019. Both ESS and IGB worldwide sales were affected by COVID-19. As a result, total endoscopy product sales were $5.4 million, which is a 56% reduction. Foreign currency movements in the quarter did not materially affect revenue trends. The proportion of the ESS product sales to total endoscopy product sales was 67% in the second quarter of 2020, which is roughly equivalent to its share of sales back in the second quarter of 2019. Total revenues in the second quarter of last year also included $1.9 million in transition service revenues related to our former surgical product line that we sold in December of 2018, while transition services were only $200,000 in the second quarter of this year. We expect to be completely free of any remaining service obligations by the end of 2020. Gross margin for the second quarter was 43% compared with 50% for the second quarter of 2019. The liquidity preservation program we implemented in the early stages of the COVID-19 pandemic resulted in a series of postponements and cancellations of inventory purchases. Furthermore, we reduced our production plan to align our inventory with the expected decline in product demand. These efforts idled our production facilities for a large portion of the second quarter and resulted in a direct charge of $0.5 million to cost of sales in the period. Without this charge for unabsorbed overhead in the second quarter, our gross margin would have been comparable to the second quarter of last year and more consistent with our pre-COVID gross margin percentage expectations. Total operating expenses were $6.7 million, over 50% reduced compared to the second quarter of 2019 due to cost-saving initiatives the management team implemented in response to the COVID-19 pandemic. As we have discussed, we undertook several aggressive actions at the beginning of the pandemic to preserve cash. Our goal was to complete the second quarter with the same net cash use we expected before the COVID crisis, and we met this goal. We will continue to closely manage cash during the remainder of the COVID-19 disruption to maintain a balance between our cash commitments and business improvements. Descriptions of these cost saving initiatives were detailed in our past shareholder periodic reports on Form 10-K for 2019 and 10-Q for the first quarter of 2020 and the Form 8-K dated April 20. Our operating loss in the second quarter of 2020 decreased 40% to $4.3 million from $7.2 million in the second quarter of 2019. Similarly, our net loss for the second quarter of 2020 improved to $6.3 million compared to $8.8 million for the second quarter of 2019, an improvement of 29%. Cash at the end of the second quarter was $19.7 million, and we were in compliance with our credit agreement. Subsequent to the quarter-end, on July 21, we completed the transaction to sell common stock and prefunded warrants for total gross proceeds of $25 million. Concurrently, we modified our existing loan agreement to waive any minimum revenue covenant requirement for the remainder of 2020 and decreased our minimum liquidity requirement that was set to increase to $20 million this quarter down to $12.5 million. The combination of these two transactions increased our liquidity by $32.5 million and greatly reduces our COVID-19 near-term market risk. The length of the runway from these transactions somewhat depends on the pace at which our business continues to improve from COVID-19. But in any event, we expect, as of today, that our liquidity will be sufficient to get us past this year's 2020 disruption through the readout of the MERIT trial in 2021 and fund the X-Tack launch in 2021 as well. I will now turn it back to Todd.

Thank you, Stefanie. The first half of this year has been an unprecedented, unpredictable, and difficult period for everyone. But Apollo Endosurgery has tremendous opportunities in front of us, and these opportunities are the management team's focus. The equity raise that we just completed, which was entirely funded by existing shareholders, is a testament to the support and belief of our current shareholder base in these opportunities. And I'll highlight three of these opportunities today. First, core GI use has been an important part of our OverStitch growth story, particularly in the United States. We've spoken for a while now of the goal to bring the benefits of flexible endoscopic suturing to core GI needs in the lower GI tract, especially the colon. And this is what X-Tack is designed for. During our development labs, doctor feedback has been very positive. The feature that stands out is its through-the-scope delivery designed to work with any 2.8-millimeter or larger working channel, which includes any of the leading gastroscopes or colonoscopes on the market. Advanced endoscopists, like those who use OverStitch today, will find it distinctive with broad case applications. Every endoscopist should find it easier to pick up and use and economical. It is specifically designed to easily and effectively close larger or irregularly shaped defects, which would otherwise be very challenging for the endoscopist to address with the existing closure devices in the market. X-Tack should also be a very good fit with our sales organization. Our top 100 OverStitch accounts in the United States where we generated 80% of our U.S. OverStitch sales last year, and we think there will be strong core GI demand for X-Tack at more than 75% of these same top 100 accounts. The range of use for X-Tack runs from being a rescue tool for acute perforations on one end of the spectrum to the prophylactic closure following a mid to large-sized polyp removal for patients at higher risk of delayed bleeding because of either polyp size, location, or the need to use anti-thrombotic medications being at the other end of the spectrum, and many uses in between. X-Tack will materially expand our addressable market in core GI. With more than 20 million colonoscopies performed each year in the United States, X-Tack moves us into a large and important market where our existing customers have an unmet need that X-Tack will address. If typical 510k processing time is a guide, we believe that X-Tack could be cleared by the end of this year. Second, we have substantial bariatric growth potential still ahead. The bariatric procedure market is a roughly 200,000 procedure per year market in the United States alone, and the endoscopic sleeve gastroplasty, or ESG procedure, that is enabled by the full-thickness suturing capabilities of OverStitch, has a very attractive value proposition for patients, physicians, and the healthcare system at large due to its effectiveness, low adverse event rate, and ease to revise when revision is needed. While bariatrics have been an important part of our OverStitch past growth, as has core GI, we have yet to tap the potential of ESG. The ESG procedure continues to build momentum worldwide, and we estimate that there were probably around 5,000 ESG procedures performed worldwide last year. But data generation is required to break into a bigger share of the bariatric market or to grow the market. And the MERIT trial, which we've spoken about many times before, is intended to provide this data. As a reminder, MERIT is a randomized prospective multicenter trial being conducted at various sites in the United States to study the effectiveness and safety of the ESG procedure and is a key piece of our reimbursement strategy for the ESG procedure and label expansion for OverStitch. We remain very confident that the MERIT study will achieve its goals. The reason for our optimism is simple. ESG has already been studied and reported on multiple times by multiple centers with highly consistent results across the globe. In 2019, there were three meta-analyses published that pooled the results of over 1,700 patient experiences. Some of the MERIT site activities experienced some COVID-19-related delays. But as of last week, less than 10 crossover procedures remain to be performed. The PIs anticipate the primary MERIT data readout by the middle of 2021. With reimbursement, we believe the ESG procedure will be disruptive to today's bariatric marketplace. Third, expanding physician access to our products remains a priority for us. COVID-19 has disrupted travel and many of the planned in-person physician meetings we have historically leveraged to address medical education demand. However, there remains a strong physician interest to learn more about OverStitch, and we have found alternative ways to address this interest. In the second quarter, we held two international webinars on the benefits of endoluminal suturing. The first webinar focused on the benefits of endoluminal suturing as part of the core GI basket of procedures and was attended by 300 persons. The second discussed endoluminal bariatric suturing applications, and that was attended by almost 500 participants. At the end of July, we also hosted two didactic training sessions here in the United States. Again, one for bariatric and one on core GI, designed as precursors to hands-on training activity. We had more than 80 registrants for each of these classes. Subsequently, we conducted our first in-person lab training session since the beginning of COVID just this past Friday to test how we might reopen the hands-on aspects of our education programs. As normalcy returns, the level of engagement we have seen on our virtual platforms makes us feel confident that new user interest will be as high as we were experiencing pre-COVID. Expanding physician interest in our products goes beyond medical education. In 2019, we launched the SX OverStitch device as part of the strategy to avail our suturing technology to those physicians or account locations that did not have access to a dual-channel endoscope. Since that launch, about a third of all new OverStitch accounts globally are SX users. By the end of this year, we will be making minor modifications to further improve the user experience with SX. Additionally, during the second quarter of this year and despite COVID, our regulatory team succeeded in securing market approvals or clearances for one or more of our endoscopic products in seven countries. These new markets will be served by either new or existing third-party distributors. Regulatory efforts are ongoing inside of Apollo to further expand the availability of our products to new markets. Indeed, we have multiple growth drivers ahead for our business following COVID-19 recovery. I want to say a couple of words as well about our gross margin improvement programs. These remain important but had to be put on hold as part of our liquidity preservation program. Of course, we kept X-Tack moving forward. X-Tack is probably our most important gross margin improvement project as we expect X-Tack at its launch to be accretive to our overall gross margin. We will resume other gross margin improvement projects as our business recovery and organizational bandwidth dictates as reasonable. Finally, a soft outlook for the third quarter ahead. Our team has built a solid growing business. This business is coming back as quickly as elective procedures are allowed to come back. In the United States, in the second quarter, we had very good recovery in the Mid-Atlantic, Southeast, as well as the Southwest and Western states. Still, the Northeast area of the United States, where we have a sizable business, was severely hit by COVID-19 and slower to recover during the second quarter. Outside the United States, direct markets such as Germany, Spain, and Italy showed good signs of recovery throughout the second quarter, while the United Kingdom and France trailed behind. Some of our larger distributor markets, such as the Middle East, have yet to show signs of recovery. But overall, we like what we are seeing so far in the third quarter based on July from both OverStitch and Orbera. In July, our direct market endoscopy product sales both in the United States and outside the United States increased compared to July of 2019. If we combine June and July of 2020, our direct market endoscopy product sales increased compared to those same two months in 2019. The third quarter is traditionally a seasonally soft quarter, but all indications right now are that the third quarter sales will be sequentially up compared to the second quarter. However, much COVID risk remains and we are still planning for the third quarter to be below the third quarter of last year. By the end of the fourth quarter, perhaps we'll see a return to pre-COVID procedure levels. With that, we'll now open the lines up for questions. Taren, please proceed.

Thank you. The floor is now open for questions. We will take our first question from Matt Hewitt with Craig-Hallum Capital Group. Please go ahead.

Good afternoon and thanks for the update and for taking the questions.

Good afternoon, Matt.

Maybe on the first one regarding the rebound that you've seen from May to June, and now it sounds like through July, how much of that is just kind of getting back or getting through the backlog that was created in late March and April versus new pipeline opportunities for your GI customers? And maybe what does that pipeline look like today if you have any thoughts there?

Yes. It's a good question, Matt. It's one of the uncertainties, I think, I would say, right now, as we look at our business, knowing to what degree we have been dealing with backlog, especially in June and July, versus to what degree we are really back to more of a normal healthcare utilization pattern. Undoubtedly, we have concerns, as do others, that higher unemployment rates and loss of insurance potentially can impact beyond the current backlog that we see, and could impact recovery rates in the latter half of this year. So it's a good question, very difficult to answer. It's one of the reasons why we still anticipate that even though July has been a very satisfactory month, we still anticipate that the third quarter will likely be below the third quarter of last year. And it'll be a little bit longer before we see a return to pre-COVID procedure levels. We hope that we're being too conservative.

That's helpful. Thank you and then one of the key risk categories for coronavirus patients is obesity. There have been a number of tweets from some of your customers talking about seeing an incremental demand once the lockdown orders were lifted for ESG and for other bariatric procedures. I'm just curious, is that something that you think could become a little bit of a tailwind here? I realize it's a tough environment, but given that risk factor, does that create opportunities for you?

Matt, it's a good question again. I think our opportunities were always exceedingly large in the bariatric marketplace. As we mentioned in the prepared remarks, this is a market of 200,000 procedures per year in the United States, and we haven't even tapped it in any meaningful way. This is, of course, the whole investment thesis behind the MERIT study. Our goal is reimbursement. If the market grows as a result of the higher COVID risk factors associated with obese patients, that is something we aspire to help address. But we just see that the bariatric market pre-COVID was already very attractive for us and one worth pursuing, and I think once we are able to tap into it and compete on a reimbursed basis, we will see tremendous growth potential arise.

Okay. Great. And then one last one, I'll hop back into queue. The in-person training that you spoke about in your prepared remarks, was that in a customer facility? Or was that using your mobile lab? I would think that you'd be able to control that mobile lab environment maybe a little better than even one of your customers' facilities. Is that something that you're looking to exploit, I guess, at least over the near term when there's still coronavirus circulating?

What I mentioned that was conducted on Friday, that was actually done at a lab in Chicago at the ASGE. They have a fantastic facility. And I think this was actually their first training course that they hosted at that facility since the beginning of COVID as well as ours. We've enjoyed always a really good relationship with physician societies, such as the ASGE, and we've always had very good success with their facility, which is a top-notch facility. We have yet to turn back on, so to speak, the mobile lab, and we're going to be continuing to evaluate that here in the second half of the year.

We'll take our next question from Adam Maeder with Piper Sandler. Please go ahead, sir.

Hi guys, this is Drew on for Adam. Thank you for taking the questions and congrats on a nice quarter. I was wondering if you could speak a little bit to either quantitatively or qualitatively, some of the mindset of your customers, given that you guys have a sizable cash pay exposure. You mentioned a couple of things on the previous question that feel a little more cautious as far as insurance or the financial health of some of your customers. But just to be clear, is that something you're hearing at all so far? And then just any patient concerns as far as coming in due to COVID?

Yes. Let me take the first part of your question, and you may have to repeat the second part of your question, I'm not sure I heard it, Drew. But the prominent, let's call it, message from customers throughout the second quarter, lesser so now, but throughout the second quarter was that they just wanted to get back to work. It really had more to do with them than it had to do with anything related to us or our procedures. It was just a desire to get back to work, but there was a large need to address things such as patient intake procedures and how to keep the hospital or ambulatory surgical environment secure from this highly contagious situation. We’ve had for some time a communication from our customers that they were ready to go and get started. I think what is interesting right now is that while Q3 tends to be a seasonal period that is somewhat lower than Q2 because of that period of disruption, I think we're hearing more from accounts that they plan to continue working through the third quarter at rates that perhaps in the past would not have been typical. In the past, maybe they would have taken more vacation in August because that's seasonally what is done. But right now, what we are hearing in the marketplace suggests that procedures may continue to move forward, although probably because of these intake type of safeguards that have been put in place at a lot of places, capacity may be slightly reduced.

Okay. That makes sense.

What was the second part of your question, Drew? I missed it.

Yes. So the second part of the question was just more on the patient side. Are you hearing at all from your customers that some of their patients are concerned about coming in due to COVID? I mean, I think based on your answer to your previous question, I think the answer is no, but anything on the patient side would be helpful too.

I think I'll just go with your answer, Drew, no. That's a good answer.

That's what we're experiencing.

Okay. That's very helpful. And then congrats on the submission for X-Tack. It sounds like it could be pretty complementary to some of your products. Forgive me if I missed this, but assuming you get approval in a couple of months down the road, what can we expect as far as a full or a limited launch probably late this year or early next? And then from a sales model perspective, is there a bundling opportunity into some of those large accounts you spoke about?

So I'll start with our launch plans at this point. We believe if everything progresses at the normal rate of the 510k submission that we will have approval by the end of this year, late this year. At that point, we will begin a limited launch that we would expect to carry forward with a small group of people for a couple of months. When we have our national sales meeting in the middle-ish of the first quarter, we would then begin a full launch and roll out our lessons learned from that limited launch experience through to our full sales force. As far as a bundling opportunity, I'm not aware of any discussion along those lines.

No, I don't anticipate bundling at this time. We have two very innovative products, which makes bundling less necessary to improve access. However, we will evaluate pricing strategies as we approach the point of introducing the product to the market.

Okay. That makes complete sense. Just one more quick one from me here. Just on the expense side, obviously, you took some chunks out of the business due to COVID, particularly on the sales and marketing portion, how quickly should we think about some of that investment returning to the business as recovery happens here? And then, I guess with the recent capital raise, do you feel like you're in a good place to go on the offensive right away? Or do you kind of stay in cash preservation mode until there's a little bit more clarity with COVID? Thank you for taking the questions.

Thank you, Adam. I appreciate your question. The speed at which our expenses return will depend entirely on how quickly our revenue recovers. We will carefully consider when to reinstate our expenses for furloughed employees, salary reductions, and sales and marketing initiatives to align them with our revenue recovery. We are monitoring this closely on a daily and weekly basis to make informed decisions. From a liquidity standpoint, we are very pleased with the equity we recently raised, which provides us with a solid runway through this disruption and supports our X-Tack launch while helping us through the MERIT readout in 2021. As a result, our risk has been significantly reduced. Thank you, Adam.

My apologies. Ladies and gentlemen, that will conclude our question-and-answer session for today. I'll now turn the floor back over to Mr. Newton. Sir, the floor is yours.

Well, thank you, Taren. And thank you, everyone, for joining us today on the call. Should you have any questions or would like to arrange a call to have questions asked, please contact Matt Kreps at Darrow Associates. We also plan to participate in several investor conferences during the third quarter, all virtual for the moment. These include the LD Micro event in early September on September 1 through September 4 and the H.C. Wainwright Conference in September on the 14th through the 16th and potentially others. So we would welcome a chance to visit with one of you as part of those events. So please contact Matt again if you would like to request a meeting. Stay safe, everyone, and thank you again.

Ladies and gentlemen, this does conclude today's teleconference. We thank you for your participation. You may disconnect your lines at this time, and have a great day.