Good afternoon, welcome to the Sientra Second Quarter 2023 Financial Results Conference Call. My name is Keith. At this time, all participants are in listen-only mode. After the Sientra executives provide their business update, there will be a question-and-answer session. As a reminder, today's conference call is being recorded. I now would like to turn the conference over to the host, Oliver Bennett, Sientra's Chief Legal, Compliance, and Corporate Development Officer. Mr. Bennett, you may begin. Welcome, and thank you for joining us on today's call to discuss Sientra's second quarter 2023 financial results. On our call today, we have Ron Menezes, Sientra's President and Chief Executive Officer, Dr. Denise Dajles, Sientra's Chief Technical Officer, Andy Schmidt, Sientra's Chief Financial Officer. We are pleased to have reported earlier today another quarter of record results for revenue, EBITDA, and free cash flow performance. We achieved our twelfth successive quarter of year-over-year revenue growth, with revenues of $23.1 million, representing 7.5% growth over the prior period. Significantly, we achieved these results while also attaining a 63% year-over-year improvement in non-GAAP EBITDA, and a 95% improvement in free cash usage of under $700,000 this quarter. As Ron Menezes and Andy Schmidt will describe, these results give us confidence of meeting our goal of positive free cash flow performance by fourth quarter of this year. Before I turn the call over to Ron Menezes, I must remind everyone that we will include forward-looking statements in our prepared remarks and in response to any questions you may ask. These forward-looking statements are based on management's current assumptions and expectations of future events and trends. Our actual results may differ materially from those expressed in or implied by the forward-looking statements. The company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. For more detailed discussion of the company's risks and uncertainties, I would refer you to our SEC filings, including our Form 10-K and Form 10-Q, to be filed later this month, available on the company's website. With that, I'll ask our President and Chief Executive Officer, Ron, to comment on our second quarter results. Thank you, Oliver. Sientra has reached a critical inflection point that supports our strategic direction of becoming a profitable and diversified surgical aesthetics company. As we reported earlier today, we recorded the lowest ever free cash flow usage in the history of the company. With this near breakeven performance, combined with our continued market growth and disciplined financial management, we're confident we'll achieve positive free cash flow in the fourth quarter of 2023. Entering the second half of 2023 with a fully built-out leadership team and a new product suite of high-value products, Sientra is in the best fundamental position in our company's history. Importantly, for investors, we're committed to rewarding their patience. Here, at the midpoint of the year, I'm confident that Sientra is a tipping point with market-leading top-line revenue at a scale where it can be leveraged to generate highly attractive, sustainable operating profit growth. It was just last year when Sientra was reporting an average of $10 million free cash flow usage each quarter. As we explained at that time, some of this was tied to necessary investments in Sientra's infrastructure and operations to support our path to profitability. Today's results are the product of those investments, combined with the disciplined financial management that we have instilled as we have consistently reduced the free cash flow usage over the past several quarters. In the most recent quarter, we reduced it again, coming in under $700,000, representing a 95% year-over-year improvement. A strong financial performance has not come at the expense of growth, and we have reported another record quarterly revenue result, representing a 12 consecutive quarter of year-over-year growth. What is exciting about these results is that the growth was fueled by our core business, implants and expanders, and does not yet reflect the acceleration of growth we expect to see in the coming quarters from the new products we're introducing to the market. We're single-minded in our drive for long-term, profitable growth. Our success is driven by three areas that differentiate Sientra in the market. Our comprehensive product platform to serve the needs of board-certified plastic surgeons, our transformative products, backed by robust clinical data, and a clear strategy for growth and disciplined financial management, steering us to profitability. Let me elaborate. Sientra is a surgical aesthetics company with a platform of high-value products focused on board-certified plastic surgeons. We're positioning ourselves as a preferred partner for plastic surgeons, with a platform of products and services to meet their needs in both augmentation and reconstruction. We know that plastic surgeons value partners who can meet their needs. Sientra has demonstrated its agility and capacity to evolve alongside them. This has shown Sientra's evolution of the past several years from a single-product company to one that has expanded rapidly into reconstruction with industry-leading expanders, fat grafting, and other technologies to assist plastic surgeons in this complex area of care. Our focus in reconstruction shows that we are not driving growth at any cost, but we are driving profitable growth, creating a clear line of sight to positive free cash flow performance by next quarter. I'm extremely proud of our accomplishment this quarter in obtaining FDA clearance of our AlloX2 Pro tissue expander, the first and only FDA-cleared tissue expander that is MRI compatible. We expect that this product will be a game changer in the standard of care for reconstruction patients, as Denise will explain a little bit later in the call. This clearance, which is the first new tissue expander cleared by the FDA in many years, demonstrates Sientra's commitment to innovation and bringing transformative products to the market. While other companies may talk about getting products to the FDA, Sientra is one of the select companies with proven track record of doing so, having had three new products cleared or approved by the FDA in the past 15 months. We have also introduced two new products to the market, Viality and SimpliDerm, and have additional new products launches planned for 2024. This level of innovation set us apart from the competition and will fuel our growth and profitability going forward. One example of that growth would be our fat grafting product, Viality. We began the early commercial launch of this product in the past quarter. While we continue to work through the contracting process of getting this product into hospitals, we're encouraged by what we're seeing in the early stages of the launch. Most hospitals that had placed their first orders for Viality at the beginning of the quarter have already reordered products. We expect to see an acceleration of orders in the coming quarters as more hospitals begin ordering and reordering. In addition to this innovation, we have also expanded to three new international markets in the last 12 months. We're seeing solid growth in these new markets as we take share away from the existing companies in those countries. Physician interest in our products continue to grow internationally, as demonstrated by the recent scientific presentation on Sientra implants held at the ICOPLAST conference in Dubai. The event earned two Guinness World Records, one for the most attended plastic surgery lesson ever, and another for the most nationalities present at a plastic surgery conference. Looking forward to the balance of 2023, it is important to remember that augmentation and reconstruction are two different segments in plastic surgery with very unique market dynamics. The augmentation segment is cyclical and more sensitive to changes in consumer buying behavior. As a result, we're seeing softness in the augmentation segment this year. As is typical of a cyclical market, we expect to see an upswing in augmentation in the future as our market research continues to indicate that interest in breast augmentation remains strong. The reconstruction market, on the other hand, is less sensitive to market fluctuations. Reconstruction cases also represent a higher revenue opportunity per procedure, given the price points and use of multiple products. As a reminder, with the recent launch of Viality and SimpliDerm, Sientra has more than doubled its total addressable market from more than $600 million to close to $3 billion. Our focus in both reconstruction and augmentation has been the foundation of our growth. We continue to add new accounts, just this quarter, added close to 240 new accounts. During the past three years, we have doubled our market share in our core business of implants and expanders. Moving forward, we aim to enhance our penetration with existing accounts as they are more productive and drive most of our growth. As we look forward to the balance of the year, we're revising our full year revenue guidance to $98 to 102 million from the previous announced of $104 to 109 million. The new guidance is an increase of 8% to 13% over 2022 full year revenue. This revision reflects our expectation that we'll see continued softness in the augmentation segment. While we expect the softness to be offset by our continued double-digit reconstruction growth, we're also seeing the cadence of adoption of our Viality and SimpliDerm products follow the normal hospital contracting process. Achieving steady adoption in a hospital can take up to six months from getting the product or contract before we start to see meaningful revenue contributions. Given the number of accounts that are adding both products to their contracts, we believe that this will set us up for strong acceleration as we head into 2024 and beyond. As we continue to leverage our infrastructure and generate operating efficiencies, we're revising our non-GAAP operating expense guidance to $75 to 78 million, a decrease of 16.5 at the midpoint versus 2022. On a GAAP basis, our guidance is $84 to 87 million, a decrease of 23% versus last year at the midpoint. This reflects our confidence that Sientra can be cash flow positive by the end of this year. I'll now turn the call over to Denise Dajles, our Chief Technology Officer, to share more about our product and clinical data. Thank you, Ron. Ron has already spoken to you about how our platform is designed to serve the needs of augmentation and reconstruction patients and plastic surgeons. We continue to expand our portfolio, transformative innovation continues to be top of mind. We continue to add products and solutions to support total body transformation, and we are excited about the groundbreaking products and clinical research we have. One example of that innovation is our AlloX2 Pro tissue expander, the first and only FDA-cleared MRI-compatible tissue expander. This is a significant advancement in the standard of care for reconstruction patients because it helps remove the limitation for women undergoing tissue expander-based reconstruction who cannot presently have MRIs. An MRI may be needed for these patients to test for recurrence of the cancer that led to the reconstruction in the first place, or to screen for other underlying conditions and injuries, because the magnetic infusion ports of tissue expanders were considered unsafe for MRI. Before AlloX2 Pro, women were left with a choice of foregoing MRI screening or having an additional surgery to remove the tissue expander. Once on the market next year, Sientra's AlloX2 Pro will provide a new option that not only does not interfere with MRIs but also has negligible interference with radiotherapy and allows for faster healing, which we believe will be groundbreaking for women and plastic surgeons. We are committed to transparency and accountability in our product development, which is evident in the clinical research data we share. We have significant depth in our research, and we believe that we provide more relevant and transparent data in our presentations and publications than anyone in the market. I will remind you that our breast implants were evaluated over a 10-year clinical trial with unparalleled safety and clinical results. Our implants have been clinically shown to have one of the lowest rates of capsular contracture and the lowest rupture and reoperation rate in the industry. Our ongoing post-approval study, nearing its 10th year, continues to provide data that reinforces our safety profile with real-world evidence. As we shared at the Aesthetic Society Annual Meeting in Miami in April of this year, our post-approval study six-year data continues to show impressive results. The study, which has over 5,000 patients and over 10,000 implants across more than 130 sites, demonstrates our implant efficacy in a wide range of patients and surgical sites, rather than handpick patients and procedures for the best outcome. This is part of our commitment to accountability, and it is also why Sientra provides an industry-leading warranty that far surpasses similar products in the market. Importantly, we are not selective in the data that we present, but provide the data for all complications across all cohorts. We believe that this openness and transparency in the presentation of clinical data is critical and provides more meaningful information for physicians and patients than highly curated and selective, self-reported post-market surveillance data, or incomplete presentation of clinical data that excludes cohorts and omits presentation of relevant complications. Our new products are also supported by deep and transparent research. We continue our ongoing 13-site, long-term volume retention clinical study with Viality. As we have previously stated, preliminary results from this study show that Viality yielded over 80% volume retention at both the three-month and six-month time points, post-breast augmentation and reconstruction. This preliminary data makes Viality the first and only system to have clinically demonstrated such high retention results. We expect to provide more data from this study in the early fourth quarter. Again, it is our goal to seamlessly bridge the gap between innovation and safety. We know these procedures are life changing for patients, and they trust our products to help them with self-confidence and self-respect as they transform and rebuild their bodies, completing their journey and helping them feel feminine and good about themselves. That is a responsibility we take very seriously as we bring products to market that we believe will transform the aesthetics industry. Now I will turn the call over to Andy Schmidt, our Chief Financial Officer, to discuss the financials. Thanks, Denise. As Ron mentioned earlier, our second quarter 2023 financial results showcased our continued trend of strong revenue performance, disciplined expense management, and exemplary EBITDA and free cash flow results. All of these elements support our path to cash flow positive performance, which we expect to achieve by fourth quarter this year. Our key second quarter 2023 financial highlights include record second quarter revenue of $23.1 million, as compared with $21.5 million for the prior year period, an increase of 7.5%. Non-GAAP operating expense of $17.5 million, as compared to $22.3 million for the prior year period, a 22% reduction. non-GAAP EBITDA of a $3.4 million loss, as compared to a $9.2 million loss for the prior year period, a 63% improvement. Free cash flow usage was $693,000, as compared to free cash flow usage of $13.2 million for the prior year period, a $12.5 million or 95% improvement. Our core product revenues continue to build with market share gains across both augmentation and reconstruction, with a key focus on new hospital wins. Our current period revenue does not reflect the launch and expected revenue contributions from SimpliDerm, and only includes a small contribution from Viality as we began our early launch programs in second quarter. Our free cash flow performance is a spotlight as our operating expense discipline, combined with efficient working capital management, combined for a near free cash flow break-even performance this quarter. This is the fourth consecutive quarter of improved cash flow performance. During the past four quarters, we saw free cash flow usage decrease from $50.5 to 14.8 million from a year-over-year perspective. A 71% improvement. This trend is the result of the hard work we have been communicating to the Street over the past year, and we expect this trend to continue over the next several quarters. Completing the P&L view, our pro forma gross margin of second quarter 2023 was 61%, which compares to 61% for the same period last year. The current year's performance includes Viality launch costs, which will decrease over the second half of the year. GAAP gross margin of 55% was negatively affected by a non-cash depreciation and amortization charge of $1.5 million. This charge is primarily due to the inclusion of amortization of Viality manufacturing know-how and developed technology and cost of sales. Prior to product launch, this non-cash expense was charged to G&A expense. This cost is fixed in nature, hence will not impact GAAP margins as significantly in future periods as Viality sales continue to increase. Total GAAP operating expense for second quarter 2023 was $19.7 million, compared to $28.7 million in second quarter 2022, a $9 million or 31% decrease. Total GAAP loss from continuing operations for second quarter 2023 was $9.5 million, as compared to an $18.2 million loss for the prior year period, a 48% year-over-year improvement. Switching to key balance sheet items. Cash at 30 June 2023, was $18.6 million, a decrease of only $0.8 million from the previous quarter. Given our improving free cash flow performance and growing revenues, we feel that we have sufficient cash to drive the business to free cash flow positive performance exiting fiscal year 2023. We continue to focus on working capital efficiencies. We see consistent, strong performance in our inventory management, with ending inventories at 30 June 2023 of $39.4 million, down from year-end 31 December 2022 of $42.7 million. This performance includes building Viality inventories. Accounts receivable also is performing well. At 30 June 2023, our AR balance was $31.8 million, down from $36.9 million at year-end 2022. In all, we've seen a strong first half of 2023 in all facets of our financial model and look forward to continuing our trend of improving financial performance. At this time, I'll turn the call back to Ron. Thank you, Andy. Our progress would not have been possible without a clear strategy for long-term, sustainable, profitable growth. As I said in my earlier remarks, we have reached an inflection point in our business model. We have remained singularly focused on providing the safest and most innovative solutions for the best aesthetic outcomes. At Sientra, we seek to empower patients during every step in their journey, innovate for their needs, and reduce the potential for risk and guide them in making informed decisions about their health. We have invested in the areas with the most potential for future growth and profitability, and it has helped us transform Sientra into a company that offers a diverse portfolio of transformative products and services. With that, I'll turn the call over to the operator for Q&A. Operator? Yes, thank you. At this time, we will begin the question-and-answer session. To ask a question, you may press star, then one on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star, then two. At this time, we will pause momentarily to assemble the roster. The first question comes from Anthony Vendetti with the Maxim Group. Hi, good evening. Thank you for taking the question. This is actually Jeremy on for Anthony. I just first want to start with the macro environment. You said that softness, you've seen softness in the augmentation market. Do you think that's due to higher interest rates or maybe just customers have a fear of a pending recession, so they're just hesitant to, you know, invest now in some type of- in that type of surgery? You know, this is Ron. I, I don't know if I would speculate what the reasons were, but one of the great things about where we at now as a company is that augmentation, obviously, is important. It was 47% of our business in the, that quarter, this past quarter. But soon, sometime in, in late next year, in 2025, will be a smaller part, because at the end of the day, as we become a diversified company and we've started entering new TAMs, close to $3 billion TAM from $650 million, that will change. Now, what we've seen in the augmentation market, even though there is a softness there, there's still a much higher interest by prospective patients. We did a market research in March of this year. The same market research we did last, in 2022, had about 13% of patients thinking about getting breast aug within seven to 18 months, and now it's 53%. There is a high interest of still getting breast augmentation, much higher than last year, but I think between the second quarter and, and all the different travels, whatever everyone's thinking, it's hard to measure. There's a softness during augmentation, but there's still a very high interest for that, getting that surgery done in the next seven to 18 months. Oh, yeah, understood. It seems, seems like it's a cyclical, more cyclical, and then it, it should rebound, you know, healthy rebound when the market rebounds, the macro environment. Just actually switching to the Viality, the assembly. I know you said there's a, you're in the middle of a, there's a six-month-long hospital contract process. What% of the, of the, of the hospitals and what does that represent of the accounts that you currently have, are you, are you in the middle of this process? We're just introducing, we actually just introduced Viality beginning of the quarter, and SimpliDerm in the process of reaching out to some accounts, trying to do contracting. We're very encouraged what's happening in the beginning. As I stated earlier, we actually have seen the hospitals that came on board for in the first, in March, April, they already reorder at the same rate as they ordered tissue expanders and implants. Now we're going through that process of getting more accounts. It's happening weekly. For SimpliDerm, we're introducing the product to hospitals and products to GPOs, so we're seeing some good, very good feedback on that discussion as well. We're very excited about some of the networks that are experiencing and trying Viality, and we've seen as well, an example is a well-known hospital that has a very high interest in SimpliDerm. We're in the introduction part for very early stages for our SimpliDerm, and the same thing for Viality, but very excited about what's happening with Viality of the hospitals that came on board. Okay, great. Yeah, it sounds really great. I think it's gonna really be a nice contributor to revenue. Just the last question from us. You, sorry, excuse me. Yeah. The, what... Oh, sorry. Yeah, I don't know if you could see... Oh, sorry, I just lost the question here. Yeah, I'll, I'll hop back in queue. If I, if I pull up the question again, I'll jump back in. Okay. Sorry. Thank you. Thank-thank you. The next question comes from Jonathan Block with Stifel. Hey, it's Jordan Bernstein on for John. I guess my first question is on new account growth. You reported 240 in the quarter. Where would you expect further new account growth to come from? Is that Viality and some of the newer products opening new doors for the business? Then if you could just break that down, the 240 between aug and reconstruction for us. Thanks. Yeah. The, about 75% to almost 80% of our revenue comes from existing accounts. Those accounts really drive our, our business. Obviously, the new accounts is future revenue coming in. And right now, over the 240, 125 are augmentation and 115 came from reconstruction. Still much higher for au-augmentation, which we find to be exciting for the future, as we were discussing before. The market is, is cyclical. The great thing is we continue to gain share. I don't have the data for second quarter, but data that we already share in first quarter continue to grow share in both augmentation and reconstruction. Great. Thank you. I guess my follow-up would just be on the demand environment in general. I am hearing from some of your aesthetic peers, you know, a bit more hesitancy on the purchasing side. That said, now that we are into August, would you say there's some seasonal summer demand that you're experiencing in the augmentation side? How would you anticipate the second half of the year progressing cadence-wise, third quarter versus fourth quarter, with the fourth quarter being the strongest of the year, if I have that correct? Thanks. Remember, keep in mind that as we becoming a surgical aesthetic company focusing on the hospital environment as well, there is no cyclical impact there. We continue to grow extremely well on the reconstruction side, and as we roll new products in a hospital environment, we'll be entering new markets that we're not even discussing right now. We're really excited about the future of the company, the timing of the launch of our two products, I just said, that we're introducing, and it was acceleration of new accounts and hospitals adopting both Viality and SimpliDerm. Then the beginning of next year, we have AlloX2 Pro that will be introduced to the market, which is a complete game changer. We already have requests by hospitals. They want the product, we try to tell them we're setting up manufacturing everything in the next five months. That's going to be our big focus as well. On the augmentation side, you'll see more of a cyclical. Usually in the summer is a little softer in augmentation, and then it picks up again in late fall and definitely in fourth quarter from augmentation. The critical thing is, the interest by the patients is still very, very high and has not changed independent of what's happening in a macroeconomic area. Great. And then last, last question for me, just on Viality, the fat grafting system. It seems like the contracting processes are ongoing with the hospitals, would you still think that the, that the revenue stream would account for 5% to 10% of revenues exiting 2023? How would you characterize that moving forward? That's the last thing. Yeah, I, I think, yeah, we still think it would be in that range, exit fourth quarter this year. Yeah. Great. Thanks for the color. Thank you. The next question comes from Alex Nowak with the Craig-Hallum Group. Hey, great. Good afternoo\n, everyone. you know, Ron or Andy, do you expect to remain cash flow positive after fourth quarter, so in first quarter 2024? Do you think throughout 2024, the cash flow might, positivity might jump around a little bit as you're rolling out the new products? Sure. This is Andy. Yes, we're modeling it. It's gonna be variable depending on the launches. However, it's not unusual for us to see a seasonal first quarter, where cash flow usage is higher than the other quarters. That has a lot to do with paying, you know, paying our key vendors, have to do with manufacturing coming off of a very, very strong fourth quarter. Again, our seasonally best quarter has to do with just basic corporate structure of paying commissions, paying year bonuses, and so on. That's the one piece of it. Again, we're, we're, we're not concerned at all about our cash balance going into the first quarter and into second quarter, but that's the only quarter where we see seasonality on cash. The other quarters are pretty predictable. That's helpful. When you think about how the bundling strategy is working so far this early in the Viality launch, is it, you know, basically a, a hospital or a physician is, is placing and using Viality fat grafting one-to-one with a Sientra implant? Or maybe is it being used maybe one to two? Like, like, how, how to think about how often the Viality is being used with another Sientra product? Yeah, it's too early on that. We do have a strategy that we're not going to get into details for obvious reasons. We do have a strategy, we have a plan, and we have discussions with hospitals about adding all products. There is obviously an advantage for the hospital. As I stated before, most hospitals prefer to deal with one vendor, and now we have the ability to walk into the hospital and offer almost everything that a surgeon needs in their reconstruction, from obviously implants, tissue expanders, an ADM, and also a fat grafting. We are seeing some wins already in some of those hospitals based on this multiple product strategy. Let me kind of add to the modeling side of that. As Ron said, we've got the complete suite now, the ADM, the expander, the implant, and the fat grafting. When you look at that, and, and if you look at how procedures are done, a single procedure utilizing a full suite, can be as high as $19,000 of revenue for Sientra for one patient. That compares to an augmentation patient that basically might be $500 to 600. Again, getting back at that suite, that hospital suite, the gross margin dollars are 20 times greater for one patient than basically one augmentation patient. It's a tremendous multiplier on this model. Certainly makes sense. Then, obviously, the FDA came in and gave you the approval on AlloX2 Pro. There's obviously the talk about them stepping, you know, putting that as a, as a PMA, potentially product line. I guess, why did what's the background? Why did FDA step away from going the PMA route? Hi, Alex Nowak, this is Denise Dajles. Actually, we're very excited with the recent clearance for AlloX2 Pro because it's, it's a nod of confidence to the strength in our products, the, the, the strong data that we have around it, and that we've gotten really, really good in our regulatory strategies to work with them and have quick turnaround. Right now, we're getting ready and focused on launching. We, we know that overall, there's recent data that shows that FDA is taking over 160 days for 510(k) of clearances and over 2.5 years for PMA approval. We are very excited that now we have the opportunity with this clearance to move on, launch the product, and, and introduce it, because there's a, a huge need in the market and a lot of excitement around it. The other interesting thing is, if they ever decide to go PMA route, which at the moment there are no active conversations, all products that are already available on the market will have an expedited path for PMA approval. That's what they have publicly said before. Got it. Okay, very helpful. Then just lastly, just the satisfying competition in the market, those who are already in the market, those who want to come to the market for implants, just what's the latest take on the market out there? Actually, I'll let Ollie address as well. In the current market environment in US, you have a two competitors that still own the majority of the market. We're very, very excited about the future as well. In both aug and recon, we have growth opportunities in reconstruction, and I announced in the first quarter that we are about 23% share in recon, so we've got a long ways to go to be a leading company there. Then we're in the mid-teens on the other side, in augmentation. They are great competitors. They are still very much focusing on their key products. Then from a new entry, right now, I don't expect anyone anytime soon, but I'll let Ollie make any comments on that. Yeah, just to follow Ron's comments, obviously, the existing competitors, you know, that we're seeing aggressive responses in the market. It's credit to our products and our sales force, so we're continuing to gain market share. As for the FDA, you know, it, you know, we're obviously not privy to those conversations, but as Denise, you know, alluded to, there's recent data from BTIG that showed it's, you know, it's on average two, 2.5 years, actually, almost, almost closer to three years for the FDA to approve a PMA. That suggests that, you know, any new entrants, you know, has a significant path to getting approval in the marketplace. All right. Appreciate the update. Thank you. Thank you. As I ask, I know further questions this time. We have no closing remarks. That concludes our session. Thank you for participating in today's meeting. Thank you.
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