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spk04: Hello, thank you for standing by and welcome to the CIENTRA fourth quarter and full year 2021 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star one on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Oliver Bennett. Please go ahead.
spk05: Thank you, operator. Good afternoon and welcome to the CIENTRA fourth quarter and full year 2021 earnings conference call. I would like to remind everyone that in our remarks today, we will include statements that are considered forward-looking statements within the meaning of United States securities 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. 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 estimates, projection, or forward-looking statement. A detailed discussion of the risks and uncertainties that the company faces is contained in its previously filed quarterly reports on Form 10-Q and its annual report on Form 10-K for the year ended December 31, 2021, to be filed with the SEC and available on the company's website and at sec.gov. 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. Today on our call, we have Ron Menezes, Cientra's President and Chief Executive Officer, and Andy Schmidt, Cientra's Chief Financial Officer. I will now turn the call over to Ron.
spk08: Ron. Thanks, Oliver, and hello, everyone. 2021 was a transformational year for Sientra. Sientra became the fastest growing breast implant company in the U.S. with market share gains that nearly doubled in both augmentation and reconstruction when compared to 2019. This performance has set the foundation for 2022 and beyond for accelerated expansion in the plastic surgery market and sustainable long-term growth. We had record plastic surgery Q4 revenue of 22.6 million, a 26% increase over Q4 2020, and brought our running total to six consecutive quarters of record revenue performance. Total plastic surgery revenue for fiscal year 21 was 80.7 million, as compared to 55 million for fiscal year 2020, an increase of 47%. The decision to focus our business on the plastic surgery market accelerated share gain in U.S. breast products markets, and separated Sientra from the competition. We started the year with the goal of advancing our position as the partner of choice for plastic surgeons by focusing on three key areas. One, taking action to shed non-strategic assets. Two, identifying, investing in, and executing commercial strategies targeted at accelerating Sientra's growth breast augmentation and reconstruction. And number three, a total commitment to bring innovation and superior technology to our surgeons, practices, and hospitals. As a result, in 2021, Sientra continued to rapidly gain market share, which has nearly doubled in both augmentation and reconstruction since 2019. Our existing accounts continue to perform extremely well, and drove more than 70% of our revenue in 2021. New accounts also served as a leading indicator of our long-term growth profile. We added more than 100 accounts in the fourth quarter, with 80% of them in the reconstruction area, reflecting our decision early in the year to focus on addressing this very important segment of the market. As a reminder, when we're bringing a new reconstruction account, it typically takes four to six months before we see significant sales volumes So we expect these new accounts to be accretive to Cientra's top-line growth in 2022 and beyond. We'll continue to drive patient demand through unique, direct-to-consumer marketing initiatives, including training events that result in high pull-through from participating surgeons. Now let's look a little bit more specific by market. Brass reconstruction was once again an important driver of our sales in the quarter. with 33% year-over-year growth and for the full year growing 70% versus 2020, resulting in the best year ever for a reconstruction business. While our market research estimates the reconstruction market actually declined 5% overall in 2021 versus 2020 due to hospital restrictions, our market share actually increased by almost 4% in the rest of the year with an estimated 14% market share. Early 2021, we made the decision to focus on reconstruction, leveraging the great clinical data of our products and the high GPO access, allowing us to bring in more hospital contracts. This is a critical market for us. It supports our profitability goal due to its higher margins in long-term hospital contracts. In support of this goal, we launched last week the six-stab version of our DermAspan Tissue Expander to address the surge in need for greater fixation options. This new version of DERMAspan provides all the benefits of a traditional DERMAspan tissue expander while also providing a 360-degree tab orientation for additional placement support options. DERMAspan 6 Tabs is another key product in our portfolio to support our initiatives to further increase share in the reconstruction market. We also recently submitted a 510K application for our next generation Allo X2 Pro tissue expander with an anticipated launch later this year. We believe this dual-port MRI-compatible tissue expander will be the first and only of its kind to be available in the U.S. and will be an important addition for patients and surgeons in the reconstruction market. We expect even stronger upside from this market in 2022. We have already started expansion of our sales force to continue to drive demand to an industry-leading reconstruction portfolio. Now, turning to the augmentation market. According to data from both the Aesthetic Society and American Society of Plastic Surgeons, brass augmentation remains one of the top procedures performed by plastic surgeons and one of the highest revenue generators for them. Market research indicates the brass augmentation market in 2021 grew to an all-time high, increasing more than 20% versus 2020 and plus 30% versus 2019. and Cientra continued to outperform this market, and we ended up the year with approximately 11% share. Domain remains strong in the fourth quarter, resulting in 22% year-over-year growth, and for the full year, increasing over 40%. We also doubled our consumer awareness over the past two years, growing at the highest rate in the category, and putting us in the number two position amongst all brands. The key drivers for the success in our augmentation business were the following. First, the shift towards consumerization, building on position and loyalty through sales and marketing support, and our product advantages, specifically our unmatched safety profile. We'll continue to market directly to the consumer. We have seen through our market research the impact of our programs. The consumer preference does influence surgeon implant choice. We had over 500,000 website visits and sent more than 20,000 referrals to our surgeon partners. The second thing we did, we started a physician loyalty program in 2021. They included revenue-driving benefits, and we're rolling it out to a broader group of customers in 2022 based on the initial success of the program. And finally, our safety messaging used in advertising collateral is making a very positive impact on our performance. The box warning put into place by the FDA last October now requires transparency in reporting complications among the manufacturers. and very clearly highlights Cientra's unrivaled safety profile. Safety remains a top driver in brand choice among patients. I'm proud that Cientra's unmatched safety profile, coupled with a 20-year Platinum 20 warranty program, are the cornerstone of our brand education among patients seeking breast surgery. To further advance our goal of making Cientra a diversified aesthetics company focused on plastic surgeons, on January 5th, announced a transformative acquisition of Orogen Aesthetics' novel fat grafting technology, developed by leading researchers and plastic surgeons at Mass General Hospital. This product has been clinically proven to provide superior fat retention and predictability in utilizing a patient's own fat to augment the breast and other areas of the body. The addition of fat grafting technology to our product portfolio is exciting for the present and future of Sientra, as we have an opportunity to expand our camp even further. This innovative product is a game changer for reconstruction where almost 80% of the surgeries use fat grafting. We also expect expanded use of fat grafting and augmentation due to its unique fat retention, predictability, and ease of use properties. Longer term, we plan to expand into additional aesthetics applications, including the significant opportunity for face, hands, and gluteal augmentation. Additionally, our new Senior Vice President of R&D Regulatory, Denise Dials, will be leading a 200-patient clinical study to further validate the benefits of the Orogen system in breast while we prepare for a commercial launch in the first quarter of 2023. On April 21, our team is planning to host our first R&D Day in San Diego, where we plan to highlight our product pipeline. And briefly, on the international expansion, we have entered into agreements with distribution partners in Canada, China, and the Middle East in preparation for approval in those markets. Our clinically superior portfolio continues to generate interest in a number of OUS markets, and we'll continue to strategically look for the right partners in the right markets for expansion. In closing, with strong momentum behind us, we have many exciting catalysts on the horizon. In 2022, we expect continue to expand our market share in a number of accounts in both the reconstruction and augmentation. We are focused on driving towards profitability in 2023 by further growing our top line and by optimizing expenses. We plan to fuel our future by transforming Sientra into a full aesthetics company, leveraging the full potential of our existing products and new fat grafting platform. Looking ahead, I'm confident that we're on track to double our revenue within the next three years. With that, I'll turn the call over to Andy.
spk07: Thanks, Ron. Considering our Q4 21 financial results, we recorded record plastic surgery Q4 revenue results, which brings our running total to six consecutive quarters of record revenue performance. Cientra posted revenues of $22.6 million as compared to 17.9 million in Q4 of 20, an increase of 26%. Total revenue for fiscal year 21 was 80.7 million as compared to 55 million for fiscal 20, an increase of 47%. Gross margin for Q4 of 21 was 54.4%, which is consistent with Q3 of 21. The key driver for gross margins is product and channel mix. Similar to the first three quarters of 2021, Q4 revenue was driven by augmentation, which has lower gross margins than the reconstruction space. Consistent throughout 2021, we experienced price stability across our entire product line and, as expected, product cost performance. Sientra continues to experience transition expenses in Q4 related to our distribution center move, reducing our gross margins by approximately two percentage points in Q4. Okay, now switching to operating expense. Total operating expense for Q4 21 was 26.1 million, which is flat with Q4 of 20. Total operating expense for fiscal 21 was 90.7 million, as compared to our operating expense guidance of 85 to 90 million. The slight increase above our guidance range is attributed to the incremental shipping expense associated with our $2 million plus Q4 21 consensus revenue B. Total gap loss from continuing operations for Q4 21 was 15.9 million as compared to a $20.7 million loss for the previous year period. Total year 2021 loss from continuing operations was $62.5 million as compared to a loss of $67.1 million in 2020. Adjusted EBITDA for Q4 21 was a $9.8 million loss as compared to a $9.6 million loss for Q4 of 20. Adjusted EBITDA loss for total year 21 was $31.2 million as compared to a loss of $32.8 million in 2020. Switching to key balance sheet items. We ended the December 31, 2021 period with a cash balance of $51.8 million. This compares to a balance of $55 million on December 31, 2020. Year-to-date cash used in operations was $44.5 million. However, $14.7 million of that amount was attributed to an increase in accounts receivable due to increasing 2021 sales and our transition in ERP systems in Q3, which caused the delay in delivery of customer statements. We expect to recapture much of that increase in accounts receivable in 2022. We also increased inventories by approximately 13.8 million in 2021 to address increasing sales and to support our growing reconstruction business that includes significant consignment inventory. Total debt on December 31, 2021 was approximately 76 million and total outstanding shares totaled approximately 62 million shares of the year. Turning to guidance for 2022, we expect plastic surgery revenue in the range of $93 to $97 million, reflecting growth of 15% to 20% compared to sales of $80.7 million in 2021. At this point, I'll turn the call back to Ron.
spk08: Thanks, Andy. We will now open the call for questions. Operator? Actually, before we get to Q&A, you know, we're supposed to not be checking text messages when you're on a call, but I'm very excited. I quickly glanced, and I'm very excited to report that Health Canada just approved our submission for implants in Canada. So very, very excited. This is literally hot off the press that Health Canada just approved our implants to be marketed in Canada. So we're very excited for that. We'll be glad to share more specifics. But with that, we'll now open up the call for Q&A.
spk04: Thank you. As a reminder, to ask a question, you'll need to press star 1 on your telephone. To withdraw your question, press the pound key. Our first question comes from John Block with Stifel. You may proceed with your question.
spk02: Hey, guys. This is Tom Stephan on for John. Thanks for the questions. If I can start off with guidance, maybe in the context of the 15% to 20% growth. Ron, how should we be thinking about both market growth and also kind of the share gains you're expecting between both recon and OG? Should we still expect kind of that accelerated share gains you've talked about?
spk08: Yeah, so we're looking at, as I shared in the past, is for augmentation, We expect the market now at an all-time high versus 2021. So it will be single-digit growth, a low single-digit, which is exactly what the market was doing before COVID. So we expect that. And for reconstruction, we expect acceleration in the reconstruction market quite a bit because as a share, the market was actually down 5% in 2021 versus 2020. For our share growth, we expect continued growth share. Recon, we're closer to 14%, which would be the mid-teens to upper teens here in the next 12 to 18 months. And augmentation will continue to accelerate the growth as well. You know, they'll have a specific number, but we have seen in the beginning of this year as well a continuous share growth, so no expectation of slowing down. Got it. That's helpful.
spk02: And then, Andy, a couple kind of below the revenue line, maybe just on gross margins in 2022, do you still feel good about that line of sight into the high 50% range and maybe quarterly cadence, if you can also help us there? Then moving a bit lower, just on OpEx, I think for the quarter it was $26 million. There was maybe some elevated shipping in there, but You know, at a basic level, can we kind of extrapolate that out for full year 2022? Or how should we be thinking about OPEX for the year? Thanks, guys.
spk07: Sure. So I'll start with the first part on gross margins. As I noted, it's really going to be subject to product mix. And as Ron's been consistently communicating, we're highly motivated and incentivized to really build a reconstruction business That product mix dynamic alone brings us into the high 50s, we feel. When we look at the first half of 22, we're going to continue optimizing our distribution center, which basically costs a little bit of money. We experienced that expense in Q3, Q4. Being conservative, we expect to see some of that expense in Q1, possibly Q2. So the back half of 22 is really where we get our win in our sales in terms of not just product mix, but in terms of having optimized our operations. So we still feel very strong about that. In terms of op expense, Q4. Very unique in terms of very, very strong revenue performance. Again, our outbound shipping to customers, we carry that expense in the sales and marketing line, OPEX. So that was elevated in Q4. Likewise, in a very positive way, we hit some great milestones and hit accelerators in terms of commission plans. And so that's a specialized expense for Q4 that I'm very happy to pay out. It was a very strong quarter. As we consider 2022, 2021, if you look at the 2020 year-over-year, we were flat in terms of OpEx. We expect in 2022 to be investing in sales and marketing. We've been consistently communicating that. And that's going to be a net increase in OpEx. We expect also to increase incrementally in R&D in terms of new product launch opportunities and so on. We said with Denise on board, we want to make sure she has the tools and the opportunity to actually deliver. Another part that's going to be in that ad will be the purchase of origin, where we've said it's going to be probably about $2 million worth of launch prep in 2022 to launch in 2023. That's going to be an ad. And a possible add, G&A, we expect to be flatter down, which is great. We were flat year over year, 21 to 20. We expected to be flatter down with the possible exception of investment in Q4 in Sarbanes-Oxley preparation. And that would be a high class problem, so to speak, and that we would be doing that in anticipation of cresting $100 million in revenue. in 2022. So those are the different items in play. We expect in our Q1 announcement, which will be in May, of course, to talk more in terms of very specific guidance range for OPEX. But I will say this, we will be building it up using non-GAAP operating expense. Our non-GAAP operating expense in 2021 was $78 million. So we will provide a range on top of that 78 million. It will be a larger number based on what I said in terms of where we expect to operate. Again, the reason why we're waiting until that timeline is we are having typical Q1 meetings in terms of how we look at the market, how we look in terms of different projects we're going to pursue, both in terms of the IT side, but also in terms, most importantly, in terms of R&D. So we're basically looking at that plan for 2022, and that's going to drive OpEx one way or another. So stay tuned in May for that OpEx specific guidance.
spk05: That was great. Thanks, Andy. Thanks, Ron.
spk04: Thank you. Our next question goes from Margaret Cazor with William Blair. You may proceed with your questions.
spk01: Hey, guys. This is Maggie Bowie on for Margaret today. How dare you do it? Just given the fact Good, thanks. Just given the fact that we're mostly through the first quarter, I wanted to see if you guys could give us an idea of what the trends you've been seeing so far and how you expect that to continue into the second quarter.
spk08: Hey, Maggie. I was in the field in Long Island, New York, in January. And it's actually what we saw in November, December. I met with a lot of reconstruction surgeons. They were very busy. in the beginning, meaning a lot of surgeries. However, a lot of the patients had to cancel last minute because they tested positive on the morning of the surgery. So what we saw in November and December for recon was happening all through January and February. But just like everything else, we're seeing a very strong latter part of the quarter. So we expected recon to come back. Augmentation, we didn't see anything that slowed down augmentation. However, keep in mind, Q1 and Q3 are usually the lower quarters from a seasonality, and Q2 and Q4 are the higher quarters from seasonality. We expect those the same.
spk01: Got it. Thank you. That's helpful. And I'm just kind of building on the previous question asked about you guys continuing to expand your market share. You know, you've seen both the augmentation and the recon share expand pretty quickly. So just with all of the momentum, particularly within the augmentation market, how do you ensure you can capitalize on that momentum and grow your market share at sustainable levels? Thank you.
spk08: Now, one of the things we focus a lot in the Q4 is since the majority of our growth is coming from existing customers, about 70% coming from existing customers, the decision was made to how do we accelerate share within existing customers. It's a lot easier to go from a 10-15 share to 40-50 than from a zero to 10. So we saw a lot of double down in going back to some of the current customers, find ways to expand, leveraging a lot of the great marketing initiatives and projects that we have that bring that ability for that surgeon to expand utilization and the uses of Cientra products. from the Sanford Academy and other programs that we've done, we started inviting those surgeons to attend those programs. So that's some of the things we saw. So that's our plan still for this year is continue to focus existing customers. We're not going to stop adding new customers. We'll continue to add new customers. But there's a much faster return investment on getting our current customers to accelerate in augmentation.
spk01: Got it. Thanks so much.
spk04: Thank you. Our next question comes from Alex Noah with Craig Allen Capital. You may proceed with your question.
spk09: Great. Good afternoon, everyone. This is Connor. I'm for Alex. Congrats on the great quarter. I guess first off, you know, when we when we think about that 15 to 20 percent growth in 2022, how much of that growth is going to come from new accounts, you know, as opposed to gaining share in existing accounts?
spk08: Yeah, I like I would say that I don't expect to change. Seventy percent will come from existing accounts. still from both augmentation and recon. Recon will continue to add new accounts, but I don't see that changing this year based on what we very successfully saw in 2021. Sure. Okay. That's helpful.
spk09: And then, you know, there were some changes at the FDA regarding labeling. You know, you spoke on that during the prepared remarks, but, you know, can you give any other updates on the regulatory environment, you know, and kind of where your larger sizes stand in the review process?
spk08: Yeah, those changes were very positive for Sanford because one of the things we're very proud of is our safety profile. If you look at capsule contractors, look at risk of ruptures or leaking of the plucking plant across our 10-year data compared to the competition, we have one of the lowest ones, not the lowest one. So we support the FDA changes, support their recommendation that the patient have full disclosure of any kind of risk. At the same time, our arrival safety is very clear when somebody looks at our implants versus the competition. So we're very comfortable with those changes. Large sizes, we are in conversations with the FDA right now, and we'll look forward to something, you know, to share in the future.
spk09: Great. Sounds good. Thank you.
spk04: Thank you. Our next question comes from Chris Coon with Stevens. He may proceed with your question.
spk03: Good afternoon, and thanks for taking the questions. Maybe just two for me at this point. It was a record year, and congratulations, by the way, on the Health Canada approval as well just now. So as we just think a little bit about the momentum going into 22, can you help us think a little bit more about the seasonality? I know you referenced the historical seasonality on the AUG side in the prior question, but just with the growth that we saw in 21 and the normalization that you're talking about in AUG, and we coupled that with an acceleration in recon, can you just help us think a little bit more about just kind of the gating, first half, second half, is that different? And as a result, do we see, sounds like still kind of a flattish adjusted EBITDA number for the full year, year over year, but does that too have more of a, second half loading, if I'm thinking about this correctly, and then I've got a quick follow-up.
spk07: So, let me start on this one. As you point out, what's going to be interesting to see how it plays out in 2022 is going to be the comeback in recon. If AUG follows the typical patterns, what we would expect to see is first half, second half, really about equal, maybe 49% first half, 51% second half. However, As Ron has mentioned before, Q1 and Q3 are our weakest quarters, and so if you consider all four quarters at 25%, no seasonality, we would view Q1 and Q3 as perhaps, at this time, 22% of the total, with basically the balance being picked up in Q2 and Q4. Okay, thank you.
spk03: And then maybe just similarly, just from a longer-term perspective, as we think through the year, obviously there's additional competitive interest expected coming in around calendar year-end or early into 23. Can you speak to just how you're able to contract, in particular on the reconstructive side, both from an expander as well as from an implant perspective, and just, I guess, how defensible do you think that is or what type of barriers do you have there that can help you sustain that well above market growth? And in conjunction with that, could you maybe elaborate a little bit more on the physician loyalty program, how that's being modified, if at all, here in 22? Thanks so much, and again, congrats on the record here.
spk08: Thanks, Chris. The great thing about the hospital is, as I stated, is a three-year contract. So it really, it blocks it. Now, one of the critical things the hospitals look for is clinical data. What is your clinical data? In this case, on our AllerX2 Pro Tissue Expander and ability to provide that clinical data to hospitals. We have that. We're continuing to add more and more publications coming out this year on a tissue expander and our implants as well. So you have that three-year contract. And we talk about a competitor entering. I would ask a competitor that may be entering, what is their project, their tissue expander? I would ask that question to them because I don't think we have any clarity on that if they're really coming in 23. I don't know. So that protects it from the programs that we have for surgeons. The loyalty program is more in the augmentation side. And those are the kind of programs we've found to be very effective. Our marketing team did an outstanding job. Pressure test them last year to see which ones work. We were expanding, adding more. Matter of fact, at one time, we only had 10% to 20% of our surges in those programs. Now we have close to 50%. And that's why you'll see more and more shared acceleration with existing customers. And again, that protects us from any current competitors and possibly new ones. But keep in mind, I did state we have an 11% share in augmentation. We have 89% of the market to go. So we're very excited to move forward and continue to still share away from the two giants we're competing with. That's my main focus here in the next 12 months and the next 24 months.
spk03: Thank you.
spk04: Thank you. And as a reminder, to ask a question, you'll need to press star 1 on your telephone. Our next question comes from Anthony Venditti with Maxim. You may proceed with your question.
spk06: Thanks. Yes. I know it's early since you said the news is basically hot off the press about Health Canada just approving your implants, but do you have a plan in place? What do you think that contribution could be in 2022? How do you, are you ramping up the sales force? Is there going to be a direct force there? Are you going to go to distributor or Just maybe a little bit of color around that.
spk08: Yeah, Anthony, we are well set to go. We have a fantastic team up there that's going to help us roll it out. We're waiting for approval. We thought it would be maybe a month ago, so they're ready to go. It's going to be what we call a distributor of light approach, where we send the products of consignment, and obviously as they sell, they'll reimburse us for the amount of money. So we're going to build slowly. There are two major competitors there, the same ones are competing here in the U.S., And we expect a really nice contribution, probably in 2023, but we'll start building a lot of part of the second quarter into the rest of the year. But, Andy, can you give a little more color on the total contribution from international?
spk07: Sure. So, you know, as all are aware, obviously we're in Japan. Now we're in Canada. Even later in Puerto Rico, again, we're starting small. This is early for us. Canada, earliest launch is key, too. And as Ron said, it will build as we go, starting with new accounts. But it's going to be under 5% of total revenue when you consider our guidance in 2022. But it's a nice contributor, and basically it's a foothold that builds for the future.
spk06: Okay, great. And then just a couple quick follow-ups. In terms of Salesforce expansion, you made, I think, a comment during your prepared remarks. Can you just remind us where – where that is in terms of direct feed on the street right now, and what's the goal by the end of 22?
spk08: Yeah, we had 11 total representatives at the beginning of this year. We obviously found with the current performance in some states, such as California, Florida, and other states, we needed more help. So we divided some territories in half. We went from 48, we called it PSCs, to 55. and then we added three more of our reconstruction managers. We had four that covered the whole country. We now have seven to cover the whole country and for obvious reasons because of the big focus on reconstruction. But keep in mind there are PSCs calling both reconstruction and both augmentation because 80 plus percent of the plastic surgeons out there to both Recon and Aug. So they call them both. So that's about 11 total additions, in addition to also an international director, because of its reasons, as we continue to expand and have goals to get into China in the next two-plus years, and other markets as well.
spk06: Okay, and then just the last. verification. Market share, you said, is that 14% up 4% from the last quarter?
spk08: From the last 2021 total, we are up almost 4% to almost 14% for reconstruction. Within augmentation, we're actually close to 11% at the end of last year.
spk06: Okay, perfect. Thank you all for talking to me. Appreciate it.
spk04: Thank you, and I'm not showing any further questions at this time. I would now like to turn the call back over to Ron Menendez for any further remarks.
spk08: Well, thanks, everyone. I look forward to our first quarter call, so I'm talking two months from now, but thank you for joining us, and I hope everyone has a safe and a wonderful 2022.
spk04: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
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