Good afternoon, everybody, and welcome to Sientra's Q1 2023 financial results conference call. My name is Eric. At this time, all participants will be in a listen-only mode. After the Sientra executives provide their business updates, there will be a question-and-answer session. To ask a question, you may press star, then one on your telephone keypad. To withdraw your question, you may press star, then two. As a reminder, today's conference call is being recorded. Should you need assistance, please signal a conference specialist by pressing the star, followed by zero on your telephone keypad. I'd now like to turn the conference over to your host, Oliver Bennett, Sientra's Chief Legal, Compliance and Corporate Development Officer. Mr. Bennett, you may begin. Thank you. Good afternoon. We are pleased you could join us on today's call to discuss Sientra's Q1 2023 financial results. On our call today, we have Ron Menezes, Sientra's President and Chief Executive Officer, and Andy Schmidt, Sientra's Chief Financial Officer. As we reported earlier today, Sientra has continued its unbroken record of 11 consecutive quarters of record year-over-year growth. Importantly, we have achieved this revenue growth while also reducing our expenses and increasing our leverage through continued operational efficiencies and synergistic product additions. We have now had three consecutive quarters of record low free cash flow usage, translating into a $23.6 million year-over-year improvement over that same time period. We have seen similar improvements in our non-GAAP EBITDA performance, which has improved by nearly 30% year-over-year or $7.8 million in the past three quarters. As Ron and Andy will describe during the call, our continued market share and revenue growth, combined with our disciplined cost management, gives us confidence that we will reach cash flow break even run rate by the end of this year. Before I turn the call over to Ron and Andy, I must remind everyone that in our remarks today, 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. I'll ask our President and Chief Executive Officer, Ron, to comment on our exemplary Q1 results. Thank you, Oliver. Hello, everyone. Our continued success results from our ability to adapt to the ever-changing market and our focus on pursuing healthy, sustainable growth. We'll continue to prioritize operating efficiencies and creating leverage, providing a clear path to profitability. Our all-inclusive plastic surgery platform has enabled us to streamline resources towards Sientra's high-growth, high-margin business. We added close to 270 new accounts in the Q1 of 2023 alone, indicating our long-term solid growth prospects. Two and a half years ago, the Sientra management team made a top priority to capitalize on the value of reconstruction and devise a plan to achieve this goal. Sientra already had an impressive portfolio of products, including AlloX2, Dermaspan, and a fifth-generation implant with a decade's worth of unparalleled clinical data, but we lacked soft tissue support and fat transfer products. After adding Viality and SimpliDerm, Sientra now has the most compelling reconstruction platform in the industry. Achieving this was not an easy task. It required significant time and resources to develop this portfolio, penetrate the hospital environment, build relationships with surgeons, and establish a strong brand presence. This has not only allowed us to accelerate our gains in the hospital channel, but also created a moat for Sientra, making it difficult for new competitors to enter the market and compete. Our focus on reconstruction shows that we are not driving growth at any cost, that we are promoting profitable growth, creating clear line of sight to cash flow, break-even run rate by the end of 2023. Reconstruction cases represent a higher revenue opportunity per procedure, given the price points and use of multiple products. The commercial launch of our fat transfer product, Viality, combined with the addition of the SimpliDerm ADM to our portfolio, has more than doubled Sientra's total addressable market in the U.S. Those products are highly synergistic, allowing us to utilize our existing sales and distribution infrastructure without significant incremental investments. Our platform will continue to attract additional products and strategic partnerships with other companies going forward. By adding these complementary products, we expect to accelerate our market share gains and overall growth while increasing operating leverage and advancing our pathway to profitability. In April, at The Aesthetic Society Annual Meeting in Miami, we released the interim six-year data of our post-approval study. Our clinical data continues to show impressive results with over 5,000 patients and more than 10,000 implants across more than 130 sites. Demonstrate our implant's efficacy in diverse patient populations and surgical sites, rather than handpicked procedures for the best outcomes. During the meeting, we also hosted a Viality symposium, where over 50 plastic surgeons learned from three of our clinical sites about the benefits of Viality and how it is impacting their patients' outcomes. Viality, our innovative fat transfer solution, addresses every facet of our customer needs. The system offers natural, predictable, and safe outcomes. We're pleased to have received such a positive reception from customers. Fat transfer is an exciting area of growth for Sientra, enabling patients to increase their cup size using their own fat with or without implants. Moreover, our solution also provides additional body contouring benefits. Preliminary results presented at The Aesthetic Society's meeting of one of the ongoing studies of Viality have observed a remarkable 88% retention rate in the face. This represents an exciting opportunity for Sientra, with the potential to open an additional total addressable market of nearly $2 billion as Viality demonstrates its utility in the face, buttocks, and other areas of the body. Our customers have had a unique opportunity to experience the Viality system firsthand through our initial offering, and we have received overwhelmingly positive feedback. We're thrilled with the results from our initial early experience launch. We're confident Viality will continue to be a driving force behind our growth in the coming years, thanks to exceptional performance and the satisfaction it has delivered to our customers. As we look ahead and remind of the year, we're excited to share our plans for the pace of Sientra's product launches in aesthetics market. This quarter, we'll continue to roll out the Viality to most reconstruction and augmentation plastic surgeons, where we have already seen a very positive response. Later this quarter, we expect to launch SimpliDerm in the hospital market. Our focus on reconstruction and aesthetics has been a driving force behind our success this quarter. As we expand our portfolio of products and strategic partnerships, we remain committed to delivering the highest quality solutions to our customers. We're proud of what we have accomplished so far, and we're excited about the opportunities that lie ahead. We believe that Sientra Plastic Surgery Platform has the momentum to drive positive change in the market. I'll now turn the call over to Andy to discuss the financials. Thank you, Ron. Our Q1 2023 financial results showcase our continued trend of strong revenue performance, disciplined expense management, and exemplary free cash flow results. All three elements create our path to cash flow positive performance. Our key Q1 2023 financial highlights include: Record Q1 revenue of $22.6 million, as compared with $21.4 million for the prior- year- period, an increase of approximately 5.4%. non-GAAP operating expense of $18.9 million, as compared to $25.1 million for the prior- year- period, a 25% reduction. non-GAAP EBITDA of a $5.9 million loss, as compared to $11.8 million loss for the prior- year- period, a 50% improvement. Free cash flow of a $6.9 million cash burn, as compared to an $18.1 million cash burn for the prior- year- period, a 62% improvement. Considering our trends in 2023 view. 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 a small contribution from Viality as the product launched late in the quarter. Both products will be significant contributors in the H2 of 2023. Our non-GAAP EBITDA for Q1 2023 is the best we have seen post divestiture of the miraDry business and reiterates our focus on being a profitable pure play in the plastic surgery space. This was accomplished despite this being historically our lightest seasonal revenue quarter. Our free cash flow performance is also a spotlight. Our Q1 of a fiscal year carries seasonally high cash usage due to bonus payouts and materials payables due to seasonally high Q4 revenue and product shipment performance. This is the third consecutive quarter of improved cash flow performance. During the past three quarters, we saw free cash flow burn decrease from $37.7 million to $14.1 million this year at 63% improvement year-over-year. Completing the P&L view, complementing our revenues of $22.6 million, our pro forma gross margin for Q1 2023 was 60%, which compares to 62.2% for the same period last year. The year-over-year variance is due primarily to expensing prototype expenses related to the Viality launch. GAAP gross margin of 53.9% were negatively affected by a non-cash depreciation and amortization charge of $1.3 million. This is primarily due to the new inclusion of amortization of Viality manufacturing know-how and developed technology in cost of sales. In prior periods, this non-cash expense was charged to G&A expense. The accounting change is due to the launch and subsequent shipping of the product. Total GAAP operating expense for Q1 '23 was $22.7 million, which compares to $28.9 million in Q1 '22, a $6.2 million or 21% decrease. Total GAAP loss from continuing operations for Q1 '23 was $12.9 million, as compared to an $18 million loss for the previous year's period. Switching to key balance sheet items. Cash ending on March 31, 2023 was $19.4 million. Given our 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. Entering 2023, we continue to focus on working capital efficiencies. We see consistent strong performance in our inventory management, with ending inventories at March 31, 2023 of $40.6 million, down from year-end December 31, 2022 of $42.7 million. This performance includes building viability inventories. Accounts receivable also is performing well. At March 31, 2023, our AR balance was $35.5 million, down from $36.9 million at year-end 2022. In all, we've seen a fantastic start to 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 for a few concluding remarks. Thank you, Andy. At Sientra, we're not just satisfied with success. With 11 consecutive quarters of record-breaking revenue, we're proving our commitment to delivering excellence time and time again. We're not stopping there. Our mission is to be at the forefront of innovation and to provide the best possible products and services to our valued customers. Looking ahead, we have big plans for 2023 and beyond. We'll keep growing and expanding our reach in both the reconstruction and augmentation markets. We're not just looking to grow for growth sake. We're taking a strategic approach to ensure long-term profitability. By investing in the areas with the most potential for future growth, we are transforming Sientra into a company that offers a diverse portfolio of innovative products and services. With the addition of SimpliDerm, we're even better positioned to achieve our goal of doubling our revenue in the next three years. With that, I'll turn the call over to the operator for Q&A. Operator? Thank you. We will now begin the question-and-answer session. To ask a question, you may press star, then one on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been answered and you wish to withdraw your question, please press star then two. We will pause for one moment to assemble our roster. Our first question today will come from Alex Nowak with Craig-Hallum Capital Group. Please proceed with your question. All right, great. Good afternoon, everyone. We had a couple of calls this afternoon. You might have already covered this, but the label for SimpliDerm, can you just expand on how to ultimately sell a tissue mesh into the expanded business? Just given that it's… These meshes aren't on label for breast reconstruction. Would you ever pursue a label for breast reconstruction? You know, maybe talk through how you're ultimately going to implement SimpliDerm into the portfolio. Hey, thanks, Alex. We have Denise Dajles, our Chief Technical Officer with us. Denise? Yeah, thank you. Hi, Alex. soft tissue reinforcement is used in all reconstruction procedures, including breast reconstruction, for autologous type of procedures and reconstructions as well. For example, when you're replacing the dermis in a prepectoral reconstruction, it's highly used and it's an on-label use. There are other off-label uses that physicians might decide to undertake. We would not promote them as we are promoting the ADM for its own label applications of soft tissue reinforcements. Understood. maybe just kind of speak to how demand is trending, you know, specifically on the augmentation side, but also reconstructive. You know, in Q1, I guess I'm more interested in actually April or May. You know, there's been some interesting market commentary around the aesthetics demand and how that's been trending. Just what can you provide us around the macro side? The macro environment is also impacting the cosmetic side, Alex. Something you've probably seen similar to other areas as well across toxins and across fillers, et cetera. You see that impact. We seeing similar the first couple months of the year where the market is kind of mirroring what happened last year as well. For us, the big dominant player was obviously what happened in reconstruction. We saw dramatic growth in the Q1 for reconstruction. We don't have the data on the market for both areas. We're seeing very robust data. The bottom line on the augmentation is we'll continue to take share. You saw that we brought on board almost 150 new accounts. That's even a faster pace than we're bringing in recon accounts. We'll continue to create share. We don't have the share data yet, but as we position for the future, we'll be very confident that with our current pace of new accounts, that we'll be well-positioned when this market comes back. That's the beautiful thing about having a diversified type of products that we have now and leaning more on the reconstruction while we're seeing this market doing well, you know, we keep adding new products in reconstruction. Just last question, maybe just give us your view on the competition environment out there right now. You said you're gonna keep taking share, but, you know, when you speak to clinicians out there, specifically after recent data coming out for your data coming out from Establishment Labs, like what are you hearing out there? Is there buzz kind of on that data set or just your latest view on the competitive landscape? Yeah, we're very excited about our data. You know, we just, I'll let Denise talk about our data in a little more detail because it's a comprehensive data. It's not a pick data, just primary aug, includes, all three kinds of patients. From the competitors that we have now, Allergan and Mentor are great competitors. They are trying to protect their business, and we'll continue to gain share as we just discussed. Denise. Yeah. At The Aesthetic Society meeting, we released the six-year data set from our post-approval study, which has been submitted for publication and hopefully will be in print soon, where we have over 5,000 patients at over 100 sites. We have primary augmentation patients, revision augmentation, primary reconstruction, and revision reconstruction. We see outstanding data points when you add all the different cohorts with all the different types of complications. We have capsular contracture rates very low. You're talking about 3% for all cohorts and only 18 ruptured implants in over 10,000 implants implanted. We feel very confident that our customers continue to appreciate and value this outstanding clinical data that includes, you know, throughout traditionally the worst cohorts, which are the reconstruction cohorts. Even including those, our data and our numbers keep being at the top. All right. right. Excellent. I appreciate the update. Thank you. Thank you. Our next question comes from John Block with Stifel. Please proceed with your question. Hi, guys. This is Joseph Federico on for John. I wanted to start with fat grafting. I know you had previously mentioned that you expected that to be roughly 5%-10% of revenue exiting 2023. Are we still thinking that that's the right range? That is correct. We expect 5%-10%, depends on how quickly we get into reconstruction. We're very, very excited because we're getting now, starting June first, close to 400 hospitals that will have Viality available. Keep in mind, that's available now. That'll obviously be up to our representatives getting those hospitals and finding the users, et cetera. June first, we'll start a really high, kind of pace in the hospital environment. Okay. That's helpful. Then is there any update on the bundling, the bundle packages for Viality? I know that you had said that you were working with GPOs and trying to set up contracts. Is there any progress or timeline on that front? It is happening as we are talking right now. We are now going to GPOs and the hospitals and IDNs, and part of that discussion includes Viality, and we're starting to include SimpliDerm as well. The, really the critical part is Viality, and obviously AlloX2, Dermaspan, and our implants as well. Viality is part of it, not just in the hospital, but also with the cosmetic surgeons as well. Okay, great. Just if I could sneak in one last one here. On AlloX2 Pro, where does that currently sit? Could we see an approval in the near future? Is there anything specific holding that up at this point? Hi, this is Denise. Conversations are still ongoing with the FDA. We are still in the process of back and forth with questions and answers, but we're still very positive that we will have news from them very soon. Okay, great. Thank you. Thank you. Our next question comes from Anthony Vendetti with Maxim Group. Please proceed with your question. Thanks. Yeah, I just wanted to follow up on Viality. You said you began the commercial launch this quarter. Did you say at the end of the quarter? Yeah, Anthony, we just did it with early seeding, early experience programs, where you give some Viality, some users and in a kind of an entry-level to try it out as with some critical high users. The feedback, as I stated in my opening remarks, is overwhelmingly positive, and they are already buying more, those individuals that started those last two weeks of March. We're really starting now the full launch, and the majority of the revenue coming now is from the augmentation. Keep in mind, we expect that to flip by the end of the year, where probably 70%, 60%-70% will be coming from reconstruction, since 70%-80% of patients that go through reconstruction they use bio grafting. Sure, sure. The... Even though you began the commercial launch, you were seeding it, so there wasn't... For this quarter, your revenue number, of $22.6 was almost entirely ex Viality, right? Yes. It was immaterial, the amount of Viality. Yeah. That's what I thought. That's what I thought. Okay. Then do you see a cross-selling opportunity per se? You know, there's probably not going to be many physicians or patients using Viality that are not also using Sientra products or, do you think it's, do you think it's possible that they'll use Viality even if they're using other products? How does the sales force think about that, or how do you think about that strategically? Well, I'm going to use our own analog, Anthony. If you look at market share that we shared the beginning of the year with the Q4. For the longest time, our AlloX2 tissue expander had a much higher share of their implants because of the clinical benefits AlloX2 has over existing tissue expanders. For the first time, the Q4 of 2022, the share got closer and closer. For example, there used to be a separation of about three to four share points. In the Q4, we finished at 21.2 for our tissue expander in the marketplace, and the implants are 19.6. Now they're within a share point apart. We expect the same thing with Viality. We are opening new doors right now for Viality of current customers that are not our customer. As we enter the door with Viality and there was a huge positive buzz and excitement in Miami. Our booth was busy as everyone came over to ask questions about the Viality. Several speakers that had nothing to do with us, that were talking about different products, brought up Viality, the importance of fat grafting, importance of using a product has a high fat retention rates. We do expect to utilize Viality just like we use tissue expanders to open the door, get into the office or the hospital and start the process and start bringing it with the implants and then obviously tissue expanders as well. Okay. No, that sounds good. Just on the macro environment, you know, we've been hearing from some aesthetic practices, but, you know, maybe you're not seeing the same impact. I'm just curious, are you seeing any slowdown or your practices seeing any slowdown in the augmentation side of the business? Do you think that continues to be inflation/recession resistant? No, I think you have to divide it into several areas. If you look at primary augmentation, there's definitely a nice slowdown. It happened last year and probably happened as well. The first couple of months of this year. Revisions where patients are coming back for a different size or a smaller size of implants continue to be solid. The beautiful thing about having Viality now, it opens new doors for us. Some of the data that we saw in the first 6 months was patients that are using Viality for different uses that are beyond just using around a smaller breast implant. We're getting, becoming a diversified company within the cosmetic side, and we also start seeing the patients that surgeons are using for face. Obviously reconstruction is very solid. A lot of the data and a lot of the results we've seen in the Q1 was really the great performance in reconstruction. Having that diversification even within one specialty is a huge benefit for us. As I stated before, it has really created a moat. Now we're having our team walking in with multiple products, bundling those products with the hospitals, with the IDNs and also with GPOs, and be able to get one-stop shopping. That one-stop shopping is our company, which makes it really hard for a new competitor to come in with just one or two products. Okay. Yeah, that's very helpful. Thanks very much. I'll hop back in the queue. That concludes today's question and answer session, and the conference is now concluded. Thank you, everybody, for attending today's presentation. You may now disconnect your lines.
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