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spk07: Welcome to the AxiGEN third quarter 2022 conference call. At this time, all participants are in listen-only mode. The brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference today, please press star zero from your telephone keypad. As a reminder, this conference is being recorded. I'd now like to turn the conference over to your host, Ed Joyce, AxiGEN's Director of Investor Relations. Please begin, Mr. Joyce.
spk05: Thank you, Rob. And good morning, everyone. Joining me on today's call is Karen Zatteray, AxiGen's Chairman, Chief Executive Officer and President, and Pete Mariani, Executive Vice President and Chief Financial Officer. Karen will discuss the quarter and our outlook for the year, and Pete will provide an analysis of our financial performance, followed by a question and answer session. Today's call is being broadcast live via webcast, which is available on the investor section of the AxiGen website. Following the end of the live call, a replay will be available in the investor section of the company's website at www.axigeninc.com. Before we get started, I'd like to remind you that during this conference call, the company will make projections and forward-looking statements regarding future events. Forward-looking statements are based on current beliefs and assumptions and are not guarantees of future performance and are subject to risks and uncertainties, including, without limitation, the risks and uncertainties reflected in the company's annual and periodic reports. Actual results or events could differ materially from those described in any forward-looking statement as a result of various factors, including, without limitation, the impact of COVID-19 on our business, global supply chain issues, record inflation, hospital staffing issues, product development, product potential, expected clinical enrollment timing and outcomes, regulatory process and approvals, APC renovation timing and expense, financial performance, sales growth, product adoption, market awareness of our products, data validation, our visibility at and sponsorship of conferences and educational events, global business disruptions caused by Russia's invasion of Ukraine and related sanctions, and other factors including legislative, regulatory, political, and economic developments not within our control. The forward-looking statements are representative only as of the date they are made or And except as required by applicable law, we assume no responsibility to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances, or otherwise. And with that, I'd like to turn the call over to Karen. Karen?
spk01: Thank you, Ed. And thanks to everyone joining us this morning. We're pleased to report revenue of $37 million, representing 18% growth over last year's third quarter, driven by strong commercial execution with increases in each of our products and across our applications. As expected, we continue to see sequential improvement in surgical procedure volumes during the quarter as hospitals address staffing and other challenges resulting in improved consistency in emergency department staffing and an increased surgical capacity. We're pleased with the sequential improvement Although we note that hospitals continue to report some residual impact from these challenges, and accordingly, we remain measured in our outlook regarding the pace of continued improvements over the near term. Our strategy remains anchored with continued focus and execution in our core and active accounts. As a reminder, active accounts are those that have ordered at least six times in the last 12 months and may still be in the early stages of adoption. Core accounts represent more penetrated accounts, defined as those that have had greater than $100,000 in revenue in the trailing 12 months. The number of our core accounts increased to 331 in the quarter, representing growth of 11% sequentially and 17% over a prior year adjusted level of 283, excluding the impact of Avive purchases in 2021. This growth represents the impact of our strategy to drive deeper penetration into accounts as they continue to open surgical capacity across nerve repair applications. Core accounts continue to represent about 60% of our revenue and typically contain at least one surgeon who has adopted the oxygen nerve repair algorithm for a significant portion of his or her nerve injury patients. Leveraging this surgeon's success with our products We focus on gaining more cases with that first early adopter surgeon and gaining use by additional surgeons including middle adopters in that account. We continue to see that our best opportunity for growth resides with our core accounts by driving more deeply penetrating the treatment of traumatic injuries and continuing to expand into other nerve repair applications including breast, OMF, and the surgical treatment of pain. The number of our active accounts increased to 952 in the quarter, representing growth of 1% sequentially, and 2% over an adjusted prior year of 930. Active accounts continue to represent about 85% of our total revenue, with the top 10% contributing about 35% of our revenue. We ended the quarter with 111 direct sales representatives, down five from the end of second quarter, and up from 109 a year ago. Our commercial execution in the quarter was strong, and we're continuously evaluating the productivity of our sales representatives and making adjustments as necessary. We believe our revenue growth can be primarily driven by sales rep productivity gains, and we will continue to add additional sales reps as their territories approach targeted levels. Our direct sales force continues to be supplemented by independent sales agencies that represent approximately 10% of our total revenue. In September, we participated at the American Society for Surgery of the Hand meeting in Boston. This annual conference is a valuable event for driving innovation and an important forum for Axigen's expanding portfolio of clinical data. We were pleased to see the continued discussion of the importance of our recently reported recon study results at the conference. As a quick reminder, our RECON study is the culmination of years of work with the FDA and serves primarily as the pivotal study for our biologics license application, or BLA, towards transitioning advanced from a 361 tissue product to a 351 biological product. We expect to submit this BLA in the second half of 2023. At the ASSH conference, the RECON study data was the focus of a surgeon panel symposium titled State-of-the-Art Nerve Reconstruction Data, the How and Why of Implementing This New Data into Your Clinical Practice. We believe RECON is a landmark addition to our growing body of clinical evidence used to drive surgeon engagement and adoption. As a reminder, the study achieved its primary endpoint, The study also observed that as nerve gap lengths increased, Avance demonstrated statistical superiority over conduits in the return of sensibility as measured by static two-point discrimination in gaps greater than 12 millimeters. Also for gap lengths greater than 10 millimeters, Avance had statistically superior time to recovery, with patients achieving normal two-point discrimination up to three months earlier than in the conduit group. The study also demonstrated lower incidences of persistent and unresolved pain for advanced subjects. The ASSH symposium also included a presentation by the surgeon authors titled, A Systematic Review and Meta-Analysis of Nerve Gap Repair. This comprehensive clinical review and analysis compared the meaningful recovery rates between allografts, autografts, and conduits. For this meta-analysis, several hundred peer-reviewed studies were screened for nerve injury type and similar outcome measurements, with over 1,500 nerve repairs included in this analysis. This is the largest peripheral nerve repair meta-analysis to date, and the study concluded that meaningful recovery rates for allograft and autograft repairs were comparable across all gap lengths and up to 70 millimeters. and that there were no statistical differences between allograft and autograft outcomes in both sensory and motor repairs. Additionally, allograft and autograft repairs delivered significantly better rates of meaningful recovery in short gaps as compared to conduit repairs. Lastly, an additional part of this meta-analysis was an examination of the acute procedure-related costs comparing autograft procedures to allograft procedures. and the study found the costs were comparable. Overall, we were excited with the high level of interest and engagement at the ASSH conference this year. The strong surgeon participation highlights the importance of clinical data to peripheral nerve surgeons. We continue to build market awareness of nerve repair with both healthcare providers and through our direct-to-patient initiatives, particularly for breast and pain applications. We utilize our marketing initiatives to drive patient engagement to our Resensation and Rethink Pain websites. These sites are aimed at increasing patient awareness and education for the potential of nerve repair procedures to improve outcomes for those undergoing mastectomy and reconstruction and those suffering from chronic neuropathic pain. October was Breast Cancer Awareness Month, and this annual campaign raises awareness about the impact of breast cancer. Our breast team has been highly involved in the monthly awareness events. For us, quality of life for patients undergoing mastectomy and reconstruction is a year-round focus, and we're pleased to see that throughout the quarter, there were eight presentations at clinical conferences on restoring sensation and incorporating neurotization into these patients' reconstructions. We believe the increased awareness and enthusiasm from the thought leaders in the space will continue to elevate both the importance of incorporating nerve reconstruction into these surgeries and the role the re-sensation technique plays in providing the opportunity for a return of sensation following mastectomy. Our surgeon education programs remain a top priority for Axigen and continue to generate interest in the surgical community. We have achieved our annual goal of training more than 75% of the most recent class of hand and microsurgery fellows, And as I mentioned, we had great interactions and engagement during all of our educational events at the ASSH conference. Moving on to updates in our growing body of clinical evidence. We remain committed to developing the clinical evidence to demonstrate the safety, performance, and utility of our nerve repair solutions to support the continued adoption of the oxygen algorithm across our full portfolio of nerve repair products. We added 11 new peer-reviewed publications this quarter, now with a total of 207 across extremity, trauma, breast, OMF, and pain. As I mentioned, our RECON study was discussed during ASSH. We believe that the addition of the RECON study's Level 1 evidence will provide compelling incremental data to support further expansion into the middle adopters in our core accounts. We believe that our growing portfolio of high-quality clinical evidence is the most comprehensive in the area of nerve repair and a key data-driven part of gaining surgeon adoption. Our ranger and match registries continue to enroll, now with over 2,700 advanced nerve graft repairs enrolled in ranger. Data from these two clinical registries continue to play an important role in informing surgeons in their clinical decision-making. Repose is our study of Axigard nerve cast compared to standard treatment for reducing symptomatic neuroma. Earlier this year, we announced strong top-line data results from the pilot phase of this study, and we've achieved full enrollment with 86 subjects in our comparative phase of this study. We expect top-line data readout from the comparative phase in Q4 of 2023. We remain on track towards We remain on track working towards all the requirements necessary for a BLA submission for advanced nerve graft in the second half of 2023. Our new tissue processing facility in Dayton, Ohio, also remains on track, and we anticipate beginning transitioning production in the first quarter of 2023. Turning now to our outlook. Today we narrowed the range of our full-year guidance and expect 2022 revenue to be in the range of $137.5 to $140 million, compared to our prior guidance range of $135 to $142 million. Full-year gross margin is expected to be above 80%. Now I'll turn the call over to Pete for a review of financial highlights. Pete?
spk03: Thank you, Karen. Revenue this quarter was $37 million, an 18% increase over the third quarter of 2021. Growth was driven with increases in unit volume of 12%, as well as 3% increases in both price and changes in product mix. As a reminder, there was no Avive revenue in either the third quarter of 2022 or 2021. Gross profit for the quarter was 30.8 million as compared to 26 million in the third quarter of 2021. Gross margin was 83.3% for the third quarter compared to 83.2% in last year's third quarter. Total operating expense in the third quarter increased 9% to $35.6 million compared to $32.7 million in the prior year. The increase in total operating expenses is primarily the result of compensation costs of $2.6 million and occupancy-related expenses of $500,000. Sales and marketing expense in the third quarter increased 8% to $19.8 million compared to $18.4 million in the prior year. The increase was primarily due to compensation costs offset by a decrease in marketing program expense. As a percent of total revenue, sales and marketing expense was 54% compared to 59% in the third quarter of 2021. Research and development expenses increased 10% to $7.1 million compared to $6.4 million in the prior year. Product development expenses represented approximately 50% of total R&D in both the current and prior year and included spending in a number of specific programs, including the BLA for advanced nerve graft and a next-generation advanced product. Clinical expenses represented approximately 50% of total R&D in both the current and prior year and included spending in support of our various clinical programs as a percent of total revenues. Research and development expense was 19% in Q3 compared to 21% in the prior year. General and administrative expenses increased 12% to $8.8 million in the third quarter as compared to $7.9 million in the prior year. The increase was primarily due to higher net compensation expenses, partially offset by decreases in professional service fees. GNA as a percent of revenue was 24% in the quarter compared to 25% the prior year. Net loss for the quarter was $4.3 million or 10 cents per share compared to net loss of 7.1 million or 17 cents per share in the third quarter of 2021. Adjusted Adjusted net loss was $368,000 or approximately one cent per share in the third quarter compared to a loss of 3.6 million or eight cents per share in the prior year. Adjusted EBITDA in the quarter was $368,000 compared to an adjusted EBITDA loss of 2.5 million in the prior year. The reconciliation of these non-GAAP financial measures to GAAP can be found in today's earnings release and in our website. The balance of all cash, cash equivalents and investments on September 30th, 2022 was $59.4 million compared to a balance of 64.3 million at the end of Q2. The net change includes capital expenditures of 3.9 million related to the construction of our new processing facility in Dayton, Ohio and $1 million of net operating cash burn in the quarter. The construction and validation of the new APC facility is on schedule, and we expect to begin transitioning nerve tissue processing to this new facility in the first quarter of next year. And as a reminder, we expect to have dual facility and other startup expenses during the transition and expect our gross margins to be temporarily below 80% during the transition. and we'll provide additional guidance for 2023 gross margins at our Q4 and full-year call in March of next year. We expect our operating cash to continue trending towards cash flow break-even, driven by revenue leverage on our fixed-cost infrastructure, along with our continued focus on thoughtful operating expense management. We believe this trend, combined with the return to more normalized capital expenditures, will allow us to maintain our strong balance sheet position, providing ample support as we continue our path to profitability. Lastly, today we narrowed our full-year revenue guidance and now expect 2022 revenue to be in the range of $137.5 to $140 million dollars. compared to our prior revenue range of 135 to 142 million. We're pleased with our strong commercial execution, particularly as staffing issues continue to stabilize in the second half of the year, and the new guidance implies a midpoint Q4 revenue growth of approximately 17%, excluding the impact of a VIVE revenue in 2021. Additionally, our full year 2022 gross margin is expected to be above 80%. We're pleased with the strength of our execution and performance in the quarter, including strong top line growth and solid gross margins, while also providing a line of sight towards cash flow break even over time and longer term profitability. We have achieved several important clinical and operating milestones and look forward to transitioning our new APC processing facility and filing our BLA in 2023. We believe we've built a solid foundation to support our next phase of company growth anchored in clinical science and improved outcomes for patients. And we continue to be confident in our ability to deliver sustainable long-term growth. And at this point, we'd like to open up the line for questions. Rob?
spk07: Thank you. We'll now be conducting the question and answer session. If you'd like to ask a question today, please press star 1 on your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants that are using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Thank you. Our first question is coming from the line of Mike Sarcone with Jefferies. Please proceed with your questions.
spk10: Hey, good morning, and thanks for taking the questions.
spk03: Hey, good morning.
spk10: So the first question, just on the revised 2022 guide, it seems to apply for 4Q, if I'm doing my math correctly, about a mid-teen year-over-year growth rate for 4Q, and that's kind of down off the 18%. You know, you posted in 3Q, and I know Karen mentioned, you know, you're – Being somewhat conservative, but you have seen some improvements in the hospital setting with kind of staffing shortages and constraints around there. I was wondering if you could just talk about what you've got baked in into the 4Q guide, and, you know, are there any other factors outside of, you know, being measured in your outlook that would explain, you know, the deceleration and growth at the midpoints?
spk03: Yeah, no, happy to answer. Like you said, we're very pleased with our performance in the third quarter and expectations going forward. And you're right, the midpoint would imply about a 17% Q4 number. We typically see Q4 being sequentially flat to down. And so we're thinking through that piece. But we also recognize that the top end of the range would allow us to see continued improvement in staffing and in our continued performance through the fourth quarter. But we just also want to continue, like Karen said, be measured in the pace of continued improvements of staffing issues in the hospitals.
spk10: Understood. That's really helpful. And just one more question. I think Karen also mentioned that the best opportunity for growth resides within the core accounts and increasing utilization. I was wondering, with that in mind, can you speak to what the environment looks like for new account additions, and are staffing constraints impacting your ability to get into new accounts? We'd just love to hear your thoughts there.
spk01: Sure. So we continue to see some growth in our active accounts, and then active accounts become core accounts. So this quarter we had growth in both the number of core accounts, but also the size, or the average size of our core accounts. So we think the lowest hanging fruit is to continue to move deeper in those core accounts, but it's not exclusively that we're only going to do that. We'll continue to grow active accounts to be core accounts, and develop some new accounts. It's just it's an emphasis of where we're spending our time. I don't see staffing as an impediment to getting into new active accounts. We haven't seen that be a particular barrier since very early on in the pandemic. So that's not driving this. It's really a decision about strategy and how we approach commercial execution.
spk10: Okay, great. Thank you.
spk07: Our next question comes from the line of Chris Pasquale with Nefron. Please proceed with your questions.
spk02: Thanks, and you're asking a nice quarter. I want to ask a couple questions about the sales force. Karen, you made some operating changes back in the summer, more of the direct reporting coming to you. Can you talk about the impetus for that and what you're hoping to achieve?
spk01: Yeah, so we ended up splitting so that – We have a marketing team and a sales team, and just splitting those functions so that they both report the chief marketing role reports to me as well as the sales team reports to me. And this is really just recognizing that those are really different functions, and we want to make sure that we have a focus on both commercial execution as well as from the marketing standpoint, real emphasis on building awareness of this great body of clinical evidence that we have that we think ultimately will be a real driver for middle adopters. And that's a stage that we're at. We're starting to move into middle adopters, and we want to make sure that we have the right emphasis on that. And I think it's paying off. As I look at our commercial execution, as well as what the marketing team is working on, I think we have some good, we're on a good track.
spk02: Oh, I'm sorry. I was just saying, it looks like you're now going to end the year with fewer reps than you originally planned, but better productivity. How are you thinking about the pace of rep ads from here and heading into 23?
spk01: Yeah, we will bring in a few more reps yet here in the fourth quarter. And then next year, while we haven't given a guidance number yet, I think you can think about the pace as being similar to this year. that as territories reach a certain threshold level, we will still add capacity in, but it'll be really focused on growth through productivity.
spk07: Great, thank you. Our next question is from the line of Ryan Zimmerman with BTIG. Please receive your questions.
spk06: Good morning, Karen, Pete, Ed. Thanks for taking our questions. I know you're not going to guide to 23 at this point, but, you know, we look at the street looking for about mid-teens growth, and maybe you guys can just kind of help tee up in terms of some of the puts and takes you're thinking about as we move into 2023, just qualitatively. And, you know, you've had so many kind of macro dynamics that have impacted your ability to grow. You know, does it feel like we're starting to come out the other end of that and this maybe will allow you to be a little more unconstrained in terms of your ability to grow in that mid-teens rate.
spk01: Yeah, I think we're really pleased with where things are right now and the execution that we've seen and that we're executing to the plan that we laid out and that it's yielding the results we expect. So if you use where we are today to think about the future, I think we are fairly optimistic about the future, but we want to remain measured in our guidance just because there are still macro effects out there that we can't control. And so you kind of hear that in the guidance that we provided is, well, we're optimistic about the growth that we see and excited to return to you know, sort of high team's growth, we don't want to get out over our skis and getting too aggressive in guidance. And you'll see that as we, you know, round out our guidance for 2023.
spk06: Okay. Appreciate that. And if I could just squeeze two more housekeeping questions in. Number one, repos, I think, shifted back maybe a quarter from third quarter 23 to fourth quarter 23. Can you just elaborate on that and then You know, Pete, as we think about the gross margin impact, again, I know you're going to give more commentary on the next call, but, you know, how long does a transition of this magnitude take, just as we kind of contemplate margins for next year? Thanks for taking the questions, guys.
spk01: Sure. On repose, you're right. The last few subjects ended up taking a little longer to get into this study than we had originally forecasted, so it's pushed it. We're at the end of third quarter. We're now in the beginning of fourth quarter and fourth quarter that we'll have the results. But now fully enrolled and looking forward to getting that top line readout from the comparative phase, especially with the encouraging pilot data that we had.
spk03: Yeah, and on the margin side, first of all, two things. Our team on the production side is doing a fantastic job on yields and managing the production in our current facility. The other team is working great on getting the facility up and running, and we're excited to be able to start transitioning that. That facility is going to give us significant capacity well into the future. On the transition, I think about a negative impact in the first couple of quarters next year, and then think of it as sort of ramping to some improvement across Q3 and Q4. What that means specifically for numbers we'll give more guidance later, but like I said in my remarks, we would expect pressure below 80% in the first couple of quarters as we have dual facilities charges and other startups, but then moving back towards normalized margins over time.
spk06: Thank you, guys. Nice quarter.
spk07: Thanks. Our next question is from the line of Kyle Rose with Canaccord Genuity. Please proceed with your questions.
spk09: Great. Thank you very much for squeezing me in. So a lot's been asked, so I'll just ask one. I appreciate the previous commentary on the sales force, but maybe just help us understand, you know, you're down five reps quarter over quarter, obviously up still a little bit year over year, but Just help us understand those transitions out and just your confidence that we won't see any disruption when we think about moving forward. Thank you.
spk01: Yeah, I think one of the really great things as we've moved into kind of a new stage in our accounts is that as we have a core account, we find that they remain pretty sticky as we have transitions. And so we don't see... as much turbulence when you performance manage a territory and make transitions of reps. It doesn't mean we want to do too much of that. We want to make sure that we continue to train people up as much as we can, but we're not anticipating a lot of disruption in the short term from these transitions.
spk07: Thank you. Our next question is from the line of Russ Osborne with Cantor Fitzgerald. Please receive your question.
spk08: Hi. Congrats on the quarter. So just one for me. It sounds like the operating environment did improve sequentially, but I would be curious to hear how the more elective procedures, such as breast recon, perform during the quarter in your outlook for the rest of the year, maybe 2023 if possible.
spk01: Yes, we've talked about before breast reconstruction and oral maxillofacial procedures do tend to be our earliest warning signs that hospitals are having challenges for staffing because they're both very resource intensive, long in the OR, inpatient stay. We saw those rebound in Q3 back to being up and running. Now, the one thing that I would say is that hospitals are still constrained on overtime. So while there is a backlog of procedures, we're not making headway on the backlog. They're really trying to meter those in, but it's just, again, they're resource intensive and they're just not getting enough capacity to do much on the backlog. So they're scheduling pretty far out. But we're up to steady operating in those procedures, which is a good sign.
spk09: Got it. Thank you.
spk07: Thank you. The next question is from the line of Dave Turkelian with JMP. Please just use your questions.
spk04: Hey, good morning. Maybe one for Karen and one for Pete. Karen, you mentioned again that next-gen advanced product, and I was just wondering how we should think about that, whether it's going to be processed differently or functioned differently, or I guess any sort of details that you could share would be Much appreciated. And I'll just ask the one for Pete here as well. Pete, just remind us what's been spent on the Ohio facility and what's left in terms of the CapEx as we look ahead. Thank you.
spk01: Well, mine will be short because I don't have a whole lot I can tell you. We haven't really provided any details on the second generation of ants. And we have mentioned that we also have a third generation of ants that's in our pipeline. We think it's important to continue to be the innovator and leader in nerve repair, and that's what those products represent. As a biologic, the cycle time can be a little bit longer, so we just recognize we need to make sure we continuously have improvements in our pipeline. But as far as what the features are, we're not quite ready to talk about those just yet.
spk03: Yeah, and on the building, we've got about, we'll have about 8 million left to go between now and the end of the first quarter. I think we've spent right around 57, so we'll be all in about 65 million by the time we're done.
spk00: Thank you.
spk07: Thank you. Our next question is from the line of Ryan Zimmerman with BTIG. Please receive your question.
spk06: Apologies, I have a follow-up and just can't get enough here. But the operating expense profile was a little bit better than I think we expected this quarter. And you're running kind of flattish relative to second quarter. And so, Pete, I just would appreciate your commentary as we think about kind of OPEX in the next year. And given the slower pace of ads on headcount in the sales force, I mean, does Do you guys feel like you might be able to see a little more leverage in 23?
spk03: No, absolutely. I think what you saw in the third quarter was some evidence of our ability to drive leverage off this model. We've been talking about the opportunity to drive increased rep productivity and drive leverage off of our fixed cost base, which has been fairly flattish over the last few quarters. we think there's more leverage that we can gain certainly through the next quarter. And as we think about 2023, without specifically giving guidance, we would expect to see continued leverage as we see rep productivity continue to improve. We will have some additional spend and additional costs, especially early in the year as we continue to get ready to file the BLA. You'll see some moderate increase in spend in the first part of next year. But again, similar to the messages we've been saying for a while, we really do not feel we need to spend significantly more sequentially in order to drive the revenue growth that we've been targeting.
spk06: Thanks, Pete.
spk07: Thank you. At this time, we've reached the end of our question and answer session, and I'll turn the call over to Karen Zadarich for closing remarks.
spk01: Thank you. I'd like to thank the Axigen team, who remain committed to our mission of improving nerve function and quality of life for patients with peripheral nerve injuries. We're happy with the progress we've made towards our goals this year, and we remain focused on ensuring our long-term success. I want to thank everyone for joining us this morning. And we look forward to meeting with you at several upcoming investor conferences, including Jefferies in London, Canaccord Genuity and Piper Sandler in New York, and the Cantor Fitzgerald Conference in Miami. Thank you, and have a great day.
spk07: This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation, and have a wonderful day.
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