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spk06: Good day, and thank you for standing by. Welcome to the CIENTRA second quarter 2021 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Oliver Bennett, General Counsel and Chief Compliance Officer, please go ahead. Oliver Bennett, General Counsel and Chief Compliance Officer, please go ahead. Oliver Bennett, General Counsel and Chief Compliance Officer, please go ahead. Oliver Bennett, General Counsel and Chief Compliance Officer, please go ahead. Oliver Bennett, General Counsel and Chief Compliance Officer, please go ahead. Oliver Bennett, General Counsel and Chief Compliance Officer, please go ahead. Oliver Bennett, General Counsel and Chief Compliance Officer, please go ahead. Oliver Bennett, General Counsel and Chief Compliance Officer, please go ahead. Oliver Bennett, General Counsel and Chief Compliance Officer, please go ahead.
spk03: Oliver Bennett, General Counsel and Chief Compliance Officer, please go ahead. Oliver Bennett, General Counsel and Chief Compliance Officer, please go ahead. Oliver Bennett, General Counsel and Chief Compliance Officer, please go ahead. Oliver Bennett, General Counsel and Chief Compliance Officer, please go ahead. Oliver Bennett, General Counsel and Chief Compliance Officer, please go ahead. Oliver Bennett, General Counsel and Chief Compliance Officer, please go ahead we will include statements that are considered forward-looking statements within the meaning of United States security laws. In addition, management may make additional forward-looking statements in response to your questions. Forward-looking statements are based on management's current assumptions and expectations of future events and trends, which may affect the company's business, strategy, operations, or financial performance. A detailed discussion of the risks and uncertainties that the company faces is contained in its previously filed annual and quarterly reports on Form 10-K and 10-Q and its quarterly report on Form 10-Q that the company filed this afternoon. Actual results may differ materially from those expressed in or implied by the forward-looking statement. The company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. I would also like to note that Cientra uses its investor relations website to publish important information about the company, including information that may be deemed material to investors. Financial and other information about Cientra is routinely posted and is accessible on the company's investor relations website at www.cientra.com. I'd now like to turn the call over to Ron Menezes, Cientra's President and Chief Executive Officer. Ron.
spk05: Thanks, Ali, and thank you all for joining us today for our second quarter 2021 earnings call. Let's begin by welcoming Andy Schmidt, our new Chief Financial Officer. Andy joined us last month and has already hit the ground running assessing our financial performance. Later, you'll have an opportunity to hear from him on how Cientra is in great financial position to support our rapid growth. On the call today, I'd like to share some of the highlights of our recent progress and why we're very excited about where Ciantra's headed. Once again, Ciantra has delivered outstanding results in the second quarter, which includes record revenue of $20.1 million from our brass product business, reflecting year-over-year growth of 116%. We're especially encouraged by the increased acceleration of sequential growth that resulted in almost 10% improvement over the first quarter of 2021, nearly 80% growth over pre-COVID levels in the second quarter of 2019. We estimate the overall breast augmentation market to have grown 1.5% in second quarter 2021 compared to second quarter 2019. and it is encouraging to see market recovery and demand for breast aesthetics start to surpass pre-COVID levels. More importantly, it is exciting to see revenue growth from our augmentation business significantly outpacing the market, increasing 142% in second quarter 21 versus second quarter 2020, and 121% versus second quarter 2019. These results clearly demonstrate that we are making notable progress towards our goal of being a top two implant and expender company in two years by taking sizable market share. Following the successful closing of the sale of our Miradry business, Ciantra is now only focused on the plastic surgery market, enabling us to channel all of our resources into one dynamic and rapidly growing sector of aesthetics. This focus is reflected in our results, with our commercial execution in the second quarter generating the highest breast product revenue in the company history. Additional commercial execution includes an increase in our sales rep productivity. Our sales rep territory revenue grew 25% in the first half of 2021, and we're seeing this trend continue to improve as we enter the second half of this year. As you know, our business today is focused on two primary plastic surgery markets, breast augmentation and breast reconstruction. Augmentation is our primary growth driver today, leveraging a very strong market. We'll continue to build on our strong momentum from the first quarter, with key high-growth strategies extended through Q2 that are demonstrating traction, substantially outperforming market growth, as I noted earlier. The number of accounts reached the highest level in Cientra's history, growing 13% over Q1 2021 to a new base of over 2,400 accounts. However, most of our growth continues to come from existing accounts, demonstrating our ability to drive sustainable growth through execution of our commercial strategies. During the second quarter, our mid- to high-tier accounts which drove nearly 50% of our volume in the quarter, grew almost 200% versus second quarter 19, and 170% versus second quarter 2020. As part of our strategy to get patients to ask for Cientra by name, we have been very successful through digital patient acquisition, which has referred over 10,000 patients to plastic surgeons practice year to date. In Q1, we referred over 3,000 patients to surgeons, and in the past quarter, we nearly doubled that number to over 6,000 referrals. In a recent survey with 150 potential breast aug patients, Ciantra's brand recognition has gone up from 16% to 22% versus last year's data, putting us in the number two position among all brands in the survey patients. Those patients heard about Ciantra from surgeons, friends or family and our company website. We'll also expect our physician loyalty program to increase repeat purchases and expand market share in current accounts. Now turning to our reconstruction business. Our industry-leading product advantages in this space continue to be recognized and appreciated by surgeons, hospitals, and patients. This past quarter, we added more than 140 new hospital accounts. and our recon revenue was 61% higher than Q2 2019 and 100% higher than second quarter 2020. In addition, as we announced last quarter, we are leveraging the butterfly ultrasound devices to gain new accounts. This partnership has proven to be an advantage over competition for our reconstruction clinical managers to get new contracts for local hospitals. Now, looking at the second half of this year, we're excited because we see a strong augmentation market. Our survey of 150 potential patients uncovered that breast augmentation is in the top three aesthetic procedures where they're choosing to spend money. As a matter of fact, 75% of them are thinking about getting breast aug within the next 12 months, reinforcing the rebound of the market. And during our most recent surging interactions, They have highlighted that despite some vacation plans, many of them are booked for surgeries well into the fourth quarter. And Cientra will continue to fill this momentum in the second half through a range of initiatives. They include continued improvement on our Surgeon Loyalty Program by adding additional benefits and incentives to grow volume tiers. We're going to be partnering with patient influencers to expand our reach with real-world stories that reinforce our position of safety, trust, and differentiation. We plan to increase our digital presence to generate more brand awareness and interest. And we'll be launching the Sientra Academy training to guide the patient's path to the surgeon's office and booking a procedure. We'll also be adding additional support in the reconstruction business to highlight our product's clinical advantage. We'll be increasing our peer-to-peer education as physicians are once again participating in live events. And we'll be starting digital and social outreach, targeting surgeons and hospital decision makers. Before I turn the call over to Andy to cover our financial results in more detail, I want to highlight the addition of three dynamic women to the CIENTRA leadership team. In June, Denise Diles joined us as Vice President of Research and Development. Denise has already begun making exciting contributions to our product pipeline and will look forward to sharing more of those plans later this year. In addition, we recently added Dr. Irina Ehrenberg and Nori Ebersole to our board of directors. We expect that their experience in medical aesthetics will prove invaluable as we continue to take share in the overall breast products market. Adding greater diversity to our organization continues to be a critical objective for Cientra. We're proud that half of our board of directors and half of our executive leaders are female, which is a competitive advantage for our company as we continue to focus on becoming the leaders for bringing transformative treatments to progress the art of plastic surgery. I'll now turn the call over to Andy for a more detailed review of our second quarter financial results. Andy.
spk04: Thanks, Ron. First, I'd like to note how pleased I am to be representing Cientra as their new CFO. From my perspective, fiscal 2021 has been a solid rebound year for the company's commercial operations. But more importantly, the work that has been accomplished during the first half of 21 sets the stage for a great second half of the year and a great fiscal 2022. Our current period financial results showcase not only an improving business model, but also critical structural changes at the company. Before I dive into the financial results, let me address a key structural accounting item that is represented in our current period operating results. Due to the sale of our Miradry business during Q2, we are reporting the Miradry business as discontinued operations. Going forward then, we will no longer be breaking out our breast products business, which comprises our breast implants, tissue expanders, and biocorneum products, and we'll be reporting the operating results for Sientra as a whole. This is a great transition, as our current period and comparative continuing operations results and presentation now represents the company as a pure play in the plastic surgery space. Similarly, we no longer have a need to segment our financial results, creating a very clear presentation of our go-forward business model. Shifting to our Q2 21 financial results. As Ron noted, Q2 is a record revenue quarter for Santra. Ciantra posted best product revenues of $20.1 million, which is up 116% as compared to Q220 and up 9.8% from Q121. As Ron has covered the critical revenue market drivers, I'll move forward to gross margins. Gross margin for Q221 was 56%. That compares to 56.5% for Q220 and 55.4% for Q121. As the company has previously communicated, we have a clear line of sight to upper 50s gross margins. The key driver to gross margins is product and channel mix. As Ron also discussed, our current quarter showcased great performance from our augmentation business. Given the timing of the overall industry recovery from COVID shutdowns, we are not yet at overall expected mix between augmentation and reconstruction procedures. Similarly, while difficult to forecast the timing of the recon market recovery, we feel that we have not lost sales due to the COVID shutdowns but are experiencing a deferred sales dynamic. The further comment on our confidence in our gross margin opportunity is that the company utilizes a standard costing methodology. As such, gains in productivity are not realized immediately. Rather, they are capitalized and amortized over future periods. Cientra is sitting on a significant positive cost variance that will be realized over the next three quarters. Additionally, we added to our positive variance this period, which is indicative of continued productivity gains in our Franklin manufacturing facility. Continued production improvements in our 2021 relocation of our distribution center from Santa Barbara to Franklin, Wisconsin, likewise creates future efficiency opportunities. Switching to operating expense. Total operating expense for Q221 was $20.4 million as compared to $14.5 million in Q2 of 20. The primary increase in expense was due to sales and marketing, which represented $5 million of the $5.9 million increase. This increase is as expected as the company has invested in our go-to-market assets to capitalize on the reopening of the economy and future market opportunity that lies ahead. Our 2020 sales and marketing expense was curtailed due to COVID shutdowns, and we have now resumed planned revenue growth initiatives. As compared to Q1 2021, operating expense decreased $1.5 million from $21.9 million as a result of reduced sales expenses, which have a variable cost component. Total gap loss from continuing operations for the current period was $18.5 million, or $0.32 per share. However, this includes a non-cash charge of $7.3 million related to the derivative accounting treatment associated with our convertible debt instrument. Adjusted EBITDA for Q221, which we believe is a more accurate reflection of the company's performance due to these non-cash items, was a $5.5 million loss, or $0.09 per share, as compared to a $6.7 million loss, or $0.13 per share, for Q220, an 18% improvement. Switching to key balance sheet items. We ended the June 30, 2021 period with a cash balance of $82.4 million. This compares to a balance of $55 million at December 31, 2020. The net increase of cash is due to our Q1-21 capital raise and other financing activities that netted $34.4 million in cash this year. Year-to-date cash used in operations was $15.1 million. an increase in accounts receivables due to increasing 2021 sales, and an increase in inventories to address future market demand. Finally, the sale of Miradry resulted in an inflow of $11.3 million during the period, which was partially offset by a $7 million milestone payment from our initial purchase of Miradry. Total debt in June 30, 2021. and total outstanding shares were $57.9 million. This debt consists of our convertible note and term loans, as well as the company's Paycheck Protection Plan loan of $6.6 million, for which the company applied for full forgiveness during the second quarter. I'm very pleased to report that at the time of this call, the company has received approval for full forgiveness of the $6.6 million loan. Our Q3 2021 results will recognize the full PPP loan forgiveness. Turning to guidance for 2021, we are raising our guidance to expect revenue in the range of $74 to $78 million, reflecting growth of 34% to 41% compared to sales of $55.4 million in 2020. This guidance does not include revenue from our discontinued operations. We continue to expect 2021 annual operating expenses to be in the range of $85 to $90 million. Finally, in terms of housekeeping, we will be filing our Q2 2021 Form 10-Q today. And now, Ron, our controller, Valerie Miller, and I would like to open up the call for Q&A. Operator?
spk06: Thank you. As a reminder, to ask a question, you'll need to press star 1 on your telephone. To withdraw your question, please press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from John Block with Stiefel. Your line is now open.
spk01: Great. Thanks, guys, and good afternoon. Maybe the first one, Ron, or Andy, embedded in the guidance, you talked about the momentum ongoing with an augmentation. Maybe we can just talk about what the expectations are for the recon market. Last quarter you talked about it accelerating in the third quarter or fourth quarter, expecting to accelerate in 3Q and 4Q. Anything to call out around the Delta variant in certain markets like Florida, or maybe your tempering thoughts around recon in the back part of the year? Thanks.
spk05: Thanks, Sean. It is going to be a very regional issue, very unlike probably the latter part of 2020 that impacted every state. In this case, yes, you said Florida. We're seeing a very strong California, a strong Northeast, and Texas as well. So Florida is the one we heard maybe one hospital closing down, not all hospitals. So that is our expectation. We, you know, as part of the guidance, you have a range of 74 to 78. If things are not back as we expect, maybe in the low end, if things accelerate, as this is a different environment with vaccinations out there, increased vaccinations coming up, so that we're keeping that range. We're very confident in that range, though, even with what may be happening here in the next couple months.
spk01: Okay, that's great. And then maybe I'll stick to two questions, but I'll make this one two parts. So the pipeline, Ron, anything to call out on your progress with the agency on the next-gen tissue expand or additional markets like, you know, Canada, et cetera? And then, Andy, maybe for you, you commented on gross margins, which beat us in the quarter. You also talked about a really good line of sight to the high 50s. I just wanted to be clear, is that high 50% range as early as the back half or 2021, or was that some commentary into the early part of 2022? Thanks for your time, guys.
spk05: John, in regards to the pipeline, we're progressing well with Allo X2 Pro. It's continuing to move forward. We still have expectation submission before the end of year, 2022 launch. In regards to Health Canada, we are in negotiations and discussions with Health Canada. We're hoping for a late 21 approval. And like I stated before, this will be a 2022 launch in Health Canada.
spk04: Sure. And just commenting on the gross margin dynamic, you know, the key, again, is going to be mix. And as we looked at this current period, we're heavily skewed for us in terms of augmentation versus recon. If that next day is identical, then we'll be ticking up, let's say, 1.25, and that's just basically from the accounting amortization of the gains that we've already received. Again, if that mix actually moves more towards our expectation between AUG and recon, at that point then the gross margins will move to the upper 50s in a faster manner. But, again, it should be incremental. Again, the other side of the equation is, for whatever reason, AUG is even a bigger piece of the mix, overall mix, in the next period or two, due to what Ron's been talking about in the recon market. Well, then maybe it's going to be 55, 56. So it's going to be quarter to quarter, but at some point we're going to get at that product mix that's expected and be definitely upper 50s.
spk01: Great. Thanks, guys.
spk06: Thank you. Our next question comes from Alex Nowak with Craig Hallam. Your line is now open.
spk02: Great. Good afternoon, everyone. Following up on the pipeline question, maybe expand on that on items that you would expect to detail later this year. Just where else could you go within the breast space? What other products would you add on top of that? And then going beyond breasts, what other solutions here could you bring to the plastic surgeons? Thanks.
spk05: Thanks, Alex. We're looking from an organic perspective, additional products. Obviously, we discussed in the past large sizes and missing SKUs that we need to be in the market. Those are the things we're looking at right now. We're also looking at areas that enhances our commercial team ability and presence in that plastic surges. And those are things I can't get into specifics, but they are related right now to breast augmentation and reconstruction. We are looking for opportunistic, you know, products within plastic surgery, but it's not our focus right now in the next 6-12 months. We're still very focused on our core business, and that's something we're going to be looking at in 2022, and that's some of the things that Denise will be discussing when we do an R&D day. But right now, big focus is still our core business and filling the gaps of products who may not have existing products right now, so.
spk02: Yep, understood. That makes sense. And then just another question for Andy on the cost side. You've had a couple weeks now to understand the cost structure. Where else do you see cost of good reduction initiatives, and potentially on the OPEC side as well, going out more so in 2022? Where else can you take cost out of the system? And then how are you thinking about the OPEC spend into 2022?
spk04: Sure. So let's talk hogs first. Again, we expect continued efficiencies out of our Franklin site. But just this period that we're in right now, we just finished relocating our distribution center from Santa Barbara to Wisconsin. Just that single move saves near a million dollars in shipping costs, where previously we had to ship finished goods from Wisconsin to Santa Barbara and then to points beyond. So that's great. That's just comes right straight to the bottom right away. The other part is now we're going to be centrally located in Wisconsin, and we have an opportunity to reduce outbound expense, which actually hits down the sales and marketing line, which gets down into operating expense. Kind of adding to that, the way I look at it is, you know, the company has gone through quite a bit of work in terms of getting levels set as being a pure play in the plastic surgery space, And that takes many forms. You know, one such form is the company used to work on three different ERP systems. So that created a great deal of inefficiency, and we just finished the final migration to one ERP system, which then should create some more opportunity. Likewise, we are now a pure play, so we're not focused on multiple businesses. So when we look at the back end, more again in operating expense, We should be looking for efficiencies and what that means in order to support this business.
spk02: That's great. Appreciate the update. Thank you.
spk06: Thank you. And our next question comes from Margaret Consor with William Blair. Your line is now open.
spk07: Hey, guys. Good afternoon. Thanks for taking the questions. I wanted to start a little bit with guidance so I can get a better sense of what's being implied. And correct me if I'm wrong, but it looks like maybe you're assuming a bit of a deceleration or a down sequential in kind of the second half of the year or at least maybe passing through the beat. So I was curious if you could break that down by AUG, recon, or some of the other things, whether it's Japan or otherwise, and whether you're assuming impact of Delta in those numbers at this point.
spk05: Hey, Margaret, I'll start and I'll punt over to Andy. But, yeah, remember as we're comparing now to a robust Q3, Q4 of 2020, and when you compare those numbers, obviously it's no longer comparing to the second quarter. But we are assuming seasonality for augmentation in the third quarter. I did state that talking to surgeons, they are busy. They are booked into fourth quarter. At the same time, they're all taking vacation or have been taking vacation the last two, three, four weeks, which didn't happen in the third quarter. So that's where you see that little slowdown. From a recall from our side, we expect to come back. We expect to build slowly. And I did share in the past, it's a slow build. We did add 140 new accounts. We're still seeing robust hospitals coming on board due to a tissue expander. But this whole thing takes four to six months. as we bring new accounts. If there are some parts of the country that have a little slowdown, such as Florida and Louisiana and Mississippi, then you're going to have that slowdown. So that's where we're thinking, but we're very comfortable in that range of 74 to 78.
spk04: Sure, and just kind of adding what Ron said, we're actually very bullish on the second half here. I think one of the key messages is even though our checks are showing, again, plastic surgeons are really focused on bringing this year back, considering last year everyone had a down year in the whole ecosystem. They're very motivated to, let's say, take shorter vacations or what have you, but we still expect them to take vacations. They're significantly backlogged in a positive way so that we expect to have continuing demand from the market. But Q2, excuse me, Q3 should show a little bit of seasonality, and all that really means is Second half of the year is going to be very solid, and we believe the two quarters together are going to hit the numbers that we need to hit. Q3 is going to compare well year over year. It's going to be positive. But Q3 is arguably, in a normal seasonality space, it's going to be a little less than Q2, and then we bounce back in a hard, robust Q4. So that's our expectation in terms of the market. Again, it can surprise us, and it just keeps driving without that seasonality, but we're Our message is the second half is going to be strong. Let's assume some seasonality in Q3 as expected. And in Q4, again, very strong, traditionally a quarter. So, again, overall, bullish. Again, whether it comes from the recon space coming back or the AUG space continuing to charge hard, we have many different levers that we think are going to be pulled.
spk07: Okay. That's very helpful. And I'll I'll slide into things like John did for the second follow-up versus the true follow-up on the first question. So if I'm understanding correctly, you would apply a little bit more than traditional seasonality in the third quarter. So, you know, could we see something that's kind of down double digits and then, like you said, rip-roaring back into Q4 as folks come back? And then the second question I had was, Really just longer term, right? So if you go into 22, there's two underlying dynamics. You've got the current COVID recovery, and then you've got the investments you guys are making strategically long term. Now, functionally from the numbers, it doesn't look like COVID really impacted you that much. We heard Ron's comments up front. But, Andy, you did talk about some delays maybe to some of those strategic investments. So I was curious what those investments were, how material can that be, and what does that mean for 22? Thanks, guys.
spk05: Yeah, I would say, Margaret, I'll start and then I'll move over to Andy. No, so there are no delay in strategic investment. We are part of their commitment to bring the needs on board is to think about the future. I think the story of this year for Cianti is all about execution in 2021 and how the marketing team took a fantastic group of strategies. The sales team took that and executed. And now we'll be transitioned with the needs coming aboard about what products, what missing areas we'll have, how do we enhance the products we'll have for 22 and 23. So there is no slowdown. And as I discussed in the past, Our commitment is to invest more this year and next year into three key areas. One, commercial. Two, R&D. Three, manufacturing. We plan to keep OPEX kind of flattish for next year, but those three areas will grow. So no plans to slow down there. Sure.
spk04: Just adding, just making sure I'm not being confusing here. You know, Q3 last year, as Ron said, Q3 and Q4 were recovery quarters. Q3 last year for breast products was 15.3 million. We expect to perform very favorably to that number. Again, will it be 20.1 or 20.2 again this year as we did this quarter? Possibly not, but it's going to be a very positive number. And the key is the second half is going to perform very strongly overall. So, again, we're expecting in the market to perform in a manner. We've got the right inventory. We've got the right sales force out there. We've got the great recurring orders, as Ron talked to in his prepared remarks. We've got everything in place from that perspective, and we put the investment in, and that's why you see sales and marketing, you know, kind of jumping up to 10.4 million this period versus 5.4 million last year. That's a real significant commitment in terms of our belief in the market and what we can do, and we think we're executing very well in what this market's offering us.
spk06: Thank you. Our next question comes from Richard Newiter with SVB. Lee Rink, your line is now open.
spk00: Hi, this is Jamie on for Rich. Thanks for taking my question. I guess I wanted to start. You highlighted that the mid to high tier accounts are driving 50% of the volume into Q. Could you just remind us how that's trended over the past one to two quarters and where you see that mix settling out over the coming quarters?
spk05: We kind of went through a new way of setting up the accounts. We set up a certain level of dollars, so we have tiers A, tiers B, C, and D, different dollar amounts, and we'll get into details of dollar amounts. What is amazing is that in the tier A, which is our highest volume accounts, those are really to drive probably about 30% of overall business. Just to keep in mind, in the first, actually second quarter of 2020, we had 19 accounts. We have now 50 of those accounts. And the next tier, combined with A, B, and tier that drive almost 50% overall volume, Back in second quarter last year, we have 32 accounts. We almost have 90 accounts. So what we're seeing is an acceleration of mid-tier accounts into the high-volume driving accounts, which goes back to expanding our market share. So we're expanding our share on existing accounts. What we're very proud of is that same-store sales, those accounts have been with us for more than six months. They have ordered those on board for the last six months. 65% of them order in this quarter. So we're seeing improvement of those accounts ordering a quarter later, two quarters later, and that's why you see the high volume coming from the mid- to high-tier accounts. So that's what we're seeing, and right now the growth is being driven by that. Now, we're adding a lot of new accounts, but those accounts are usually low volume to begin with. Eventually they may become high volume.
spk00: Got it. That's helpful. And then just could you provide any color on just how the tissue standard business performed in the quarter and you guys are talking about your expectations between augmentation and breast reconstruction business in the context of gross margin. Could you just give us a sense of where what the mix is now and really where you see that settling out over the longer term? Thank you.
spk05: Yeah, because now it's 62% of our business is the brass augmentation. That in the past was about 52% to 55%. obviously has impacted our recon business, and our LX2 tissue expander drives our penetration in hospitals. We've seen some lower sales than we wanted, but that's part of what we expect in the second quarter as hospitals are coming online. And that's why for the second half, we'll put some extra incentives for our sales team and our marketing team to drive are tissue expanders specifically, not just implants in the hospitals. Keep in mind, in the hospitals, it's both implants that have done very, very well in tissue expanders in those hospitals. So we've put some extra incentives. We've developed some new strategies that the marketing team has already rolled out.
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