Earnings Call Transcript - AXGN Q1 2021

Operator, Operator

Good afternoon, ladies and gentlemen, and thank you for standing by. Welcome to the AxoGen Incorporated First Quarter 2021 Financial Results Conference Call. Please note this conference is being recorded. I will now turn the conference over to your host, Peter Mariani, Executive Vice President and Chief Financial Officer for AxoGen. Thank you. You may begin.

Peter Mariani, CFO

Thank you and good afternoon, everyone. Joining me on today's call is Karen Zaderej, AxoGen's Chairman and Chief Executive Officer and President. Karen will begin today's call with an overview of our first quarter performance, an update on our operational highlights, and a review of our reinitiated financial guidance. I will then provide an analysis of our financial performance, followed by closing remarks from Karen and a question-and-answer session. Today's call is being broadcast live via webcast, which is available on the Investors section of AxoGen's website. Within an hour following the end of the live call, a replay will be available in the Investors section of the Company's website at www.axogeninc.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. We encourage you to review the company's past and future filings with the SEC, including without limitation the company's forms 10-K and 10-Q, which identify these specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements. These factors may include without limitation, statements related to the expected impact of COVID-19 on our business, statements regarding our growth, our 2021 financial guidance, statements regarding product acquisition and/or development, product potential, the regulatory environment, sales and marketing strategies, capital resources, or operating performance. And with that, I'd like to turn the call over to Karen.

Karen Zaderej, CEO

Thank you, Pete, and good afternoon everyone. Our total revenue for the first quarter was $31 million, representing growth of 28% compared to the prior year. I'm pleased with our Q1 results, which continue to demonstrate our team's ability to execute our strategy despite ongoing COVID-19 challenges. The incidence of trauma and surgical procedures continue to be negatively impacted by new COVID resurgences that began in late 2020 and continued into the first quarter. Additionally, the severe winter storms across the country in mid-February further impacted the incidence of procedures. However, procedure volumes quickly recovered through March, resulting in increasing demand for our products. Our revenue volume and growth in the quarter continued to be driven by the repair of traumatic nerve injuries and by the use of Avance Nerve Graft across our nerve repair applications with more than 50,000 Avance implants since launch and 136 peer-reviewed clinical publications featuring Avance. Surgeon adoption of our flagship product continues to lead our growth as surgeons adopt the AxoGen algorithm using our portfolio of nerve repair products. In the first quarter, our commercial team remains focused on our strategy of driving deeper penetration of existing accounts, and surgeons and hospitals continue to place a high priority on nerve repair procedures with AxoGen products. Throughout the pandemic and despite access restrictions and limited surgical schedules, we've been able to effectively support our customers and remain close to surgeons as they continue their path of adoption. We believe that these efforts have positioned the business for improving growth as the incidence of trauma returns to normal levels, which we expect to occur over the course of the year with the continued rollout of vaccines and a gradual return to more normal activity levels across the country. We're pleased with the continued growth of our application for the surgical treatment of pain. Despite the reluctance of some patients suffering from chronic nerve pain to undergo a surgical procedure during the pandemic, an increasing number of our current surgeon customers are using AxoGen products with greater frequency to treat symptomatic neuromas as compared to a year ago. Our breast neurotization business slowed late last year and at the end of the first quarter of 2021 due to the increasing number of COVID-19 cases, which led many programs to suspend or limit breast reconstruction procedures. As the quarter progressed, several programs restarted these procedures, and our breast business improved. Although we anticipate that cancer diagnosis and reconstruction procedures may remain lower than normal in the near term as a result of pandemic-related delays and patients seeking care, we remain confident in the long-term growth potential of our breast neurotization business. Throughout the pandemic, our oral maxillofacial nerve repair business has lagged the recovery seen in our other applications as mandibular reception procedures have remained below normal levels. OMF repair is a highly invasive procedure involving the head and neck area, potentially increasing concerns associated with COVID-19. We're encouraged that our OMF business showed signs of improvement in the first quarter, and we expect continued recovery throughout the year. Turning now to commercial execution and our sales team. We ended the quarter with 106 direct sales representatives in the U.S. compared to 111 at year-end and 109 a year ago. The decline in sales reps is due largely to the timing of ordinary attrition and internal promotions, and subsequent to the end of the quarter, we increased by two reps for a current total of 108. We anticipate by the year-end there will be 115 to 120 sales representatives as we plan to strategically expand our sales team in the second half of the year. Meanwhile, our sales rep productivity continues to improve and will be the primary driver of our revenue growth in 2021. Our direct sales channel continues to be supplemented by independent sales agencies that generally cover more remote geographies. Our independent agencies represented 11% of our total revenue in the first quarter compared to 12% in the prior quarter. We are having deeper penetration within our existing surgeon customers, and accounts continue to be at the core of our strategy to increase revenue through improved sales productivity. In the first quarter, we had 919 active accounts out of the estimated 5,100 healthcare facilities that may treat nerve injuries in the U.S. This represents an 11% increase compared to 825 in the first quarter of 2020. As a reminder, an active account is one that has purchased at least six times in the past 12 months. Active accounts have typically gone through their committee approval process and have at least one surgeon who has converted a portion of his or her nerve repair algorithm to AxoGen products. During the past few years, active accounts have consistently represented approximately 85% of our total revenue, with the top 10% of our active accounts representing approximately 35% of our revenue each quarter. As our business continues to grow, we're adding a new account metric that we believe demonstrates the strength of adoption and the potential revenue growth in accounts that have developed a more consistent use of AxoGen products in the nerve repair algorithm. We refer to these as core accounts, defined as accounts that have purchased at least $100,000 in the last 12 months. Our core accounts typically have at least one surgeon who has adopted the AxoGen nerve repair algorithm for the majority of his or her nerve injury patients, and have other surgeons who are in earlier stages of AxoGen product adoption. In the first quarter, we had 274 core accounts, an increase of 13% from 243 one year ago. These core accounts represented approximately 60% of our revenue in the quarter. We see significant opportunity to drive increased revenue as more accounts reach this level of adoption and surgeons within these accounts increase their adoption across our nerve repair applications, including extremity trauma, breast, OMF, and pain. Turning now to our continued focus on building market awareness. As mentioned in our previous earnings call, early in the quarter, we participated in the virtual combined meeting of the American Association for Hand Surgery, American Society for Peripheral Nerve, and American Society of Reconstructive Microsurgery. AxoGen's nerve repair portfolio was featured in several clinical and scientific presentations during these meetings, including data from the AxoGen-sponsored RANGER Registry. In the first quarter, we continued to utilize our digital marketing capabilities to supplement the efforts of our sales team to provide important and timely nerve repair news and content to targeted surgeons. We were pleased with the continued high level of surgeon engagement with our email campaigns during the quarter, and additionally, our surgeon customers continued to participate in our Nerve Matters online surgeon community, discussing their use of peripheral nerve injury solutions. In the first quarter alone, over 2,300 surgeons engaged with the Nerve Matters platform. During the last year, these platforms have been particularly helpful for surgeons given access limitations for sales and clinical support. We continue to drive awareness of Nerve Matters with patient audiences through our direct-to-patient marketing campaigns. Our awareness efforts are spearheaded by targeted digital and media strategies focused on driving awareness of the recent station surgical technique and nerve repair as a potential solution for chronic nerve pain. On www.resensation.com, we saw a 400% increase in organic traffic in Q1 versus one year ago. Surgeon education and advocacy development remains a high priority for our team as we continue to operate in a virtual environment. We continue to provide virtual surgeon education events led by surgeon experts in nerve repair, targeting multiple constituencies including fellows, early career surgeons, and all nerve repair surgeons. Building on the very positive response to our 2020 invitation-only mastermind nerve program for early career upper extremity surgeons, we kicked off our second mastermind series in April, providing education for emerging leaders in nerve repair. We also remain committed to providing education and training for each class of fellows despite the COVID-19 restrictions. As in prior years, we are training more than three-quarters of the hand and microsurgery fellows in the class of 2021 through a combination of local in-person hands-on labs as well as virtual programs. We believe programs like these play an important role in providing future young attendings with the skills and knowledge to confidently incorporate nerve surgery early on in their practice. The majority of the new hand surgery attendings from the 2020 class have performed cases with our nerve repair portfolio since completing their fellowship training. We are encouraged by the early and positive adoption trends seen with this future generation of hand surgeons. Going forward, our surgeon education plans include a safe return to in-person programs in the back half of 2021 as we anticipate COVID-19 restrictions being lifted, with more of our surgeon customers being willing and able to travel to these events. We continue to expand the body of our clinical evidence in support of our product portfolio and increasing surgeon adoption. Our RANGER and MATCH registries continue to enroll with over 2,400 nerve repairs now enrolled in RANGER. In 2020, analysis of the MATCH registry data, which is the comparative population of conduit and autograft subjects for RANGER, demonstrated that Avance Nerve Graft outcomes were statistically better than conduit and were similar to those for autograft. Data from these two clinical programs continues to play an important role in informing surgeons’ clinical decision-making. Our RECON study remains on schedule, after completing enrollment of 220 subjects in July of 2020. As a reminder, RECON is our Phase 3 pivotal study supporting our biologics license application or BLA, which will transition our Avance Nerve Graft from a Section 361 tissue product to a Section 351 biological product. Our protocol includes a 12-month follow-up visit for all subjects, and given the impact of COVID-19, our plans allow for an additional three months for subjects to complete their final visits. We anticipate the final follow-up visit to occur in October of 2021, with the preliminary study data readout in the second quarter of 2022 and the filing of our BLA in 2023. Earlier in the quarter, we announced positive results on the 15-subject pilot phase of the RECON study evaluating the use of AxoGuard Nerve Cap in the management of painful neuroma. Findings from the pilot phase demonstrated that subjects experienced a clinically significant reduction in pre-operative pain and experienced clinically meaningful improvements in secondary endpoints including fatigue, physical function, sleep disturbance, pain interference, pain intensity, and pain behavior as measured by the validated PROMIS questionnaires. Pain medication utilization data also shows positive indicators for reduction of pain medication burden including opioids following the procedure. There were no AxoGuard Nerve Cap safety issues reported, and no observed recurrence of symptomatic neuroma. Enrollment in the comparative phase of RECON is well underway and assuming limited impact from COVID-19, we expect enrollment to be completed in Q1 2022 and study data readout in Q2 of 2023. Additionally, we are pleased to report that our breast and pain clinical registries Sensation NOW and Rethink Pain have re-initiated enrollment efforts after a temporary COVID-19 related hold in 2020. These programs both play an important role in our development of these clinical applications and will provide procedure-specific data on the role of AxoGen's portfolio in the care of these nerve injuries. As we advance the science of nerve repair, we remain committed to investing the time and resources necessary to provide meaningful and impactful clinical evidence on the utility of our nerve repair portfolio. Nerves regenerate slowly, which often necessitates long follow-up times to assess treatment effects and to gather the meaningful clinical data that surgeons, payers, and regulators have come to expect when making clinical care decisions. Our RECON and RANGER studies highlight the significant amount of time, effort, and expertise required to conduct clinical research in peripheral nerve. The RECON study began enrolling approximately six years ago, and the RANGER registry began enrollment more than 10 years ago. In RANGER, many of the nerve injuries have follow-up assessment periods of up to 36 months to fully appreciate the impact of the repair. We are fortunate to have an established body of clinical evidence supporting Avance Nerve Graft, and we remain committed to obtaining the clinical evidence to demonstrate the safety, performance, and utility of our nerve repair solutions. Before I turn the call over to Pete, I'd like to spend a moment discussing our outlook for 2021, including our re-initiation of financial guidance. We're encouraged by the trajectory of our business as we exited the first quarter. We expect the incidence of trauma will increase as communities relax pandemic-related restrictions, which we believe will lead to increasing procedure volumes as we move through the year. As a result, we are re-initiating financial guidance and expect the full year 2021 revenue will be in the range of $133 million to $136 million, and we expect full-year gross margin will remain above 80%. We are confident that our commercial execution, combined with our substantial investments in clinical data over the past decade, will continue to support surgeon adoption, bolstering our confidence in our long-term growth potential as we continue our mission to revolutionize the science of nerve repair. Now I will turn the call over to Pete for a review of financial highlights.

Peter Mariani, CFO

Thank you, Karen. First quarter revenue increased 28% to $31 million. Our revenue increase for the quarter was the result of a 22% increase in unit volume and a 6% net benefit from changes in pricing and product mix. The growth in volume was primarily attributable to growth in our active and core accounts and also reflects the initial impact of the COVID-19 pandemic, which began to negatively impact procedure volumes and revenue in March of 2020. Gross profit for the first quarter increased 33% to $25.9 million compared to $19.4 million in Q1 of 2020. Gross margin was 83.3% for the quarter compared to 80.1% for the prior year first quarter. Prior year gross margin was negatively impacted by lower revenue and additional inventory reserves resulting from the impact of COVID-19. In the current year, we have continued to ramp our tissue processing capacity across the quarter and increased inventory by nearly $1 million compared to the end of the year. Total operating expense in the first quarter increased 15% to $32.1 million compared to $28 million in the prior year. Total operating expenses in the first quarter included $2.6 million in non-cash stock compensation compared to $600,000 in the prior year. Prior year stock compensation included a credit of $1.7 million, primarily reflecting lower estimates on performance stock awards. Additionally, the increase over the prior year includes incremental investment in our R&D programs, increased compensation, costs associated with our new Tampa office and lab, and litigation charges, partially offset by decreases in travel, in-person conferences, and surgeon education programs due to the COVID-19 related restrictions in the current year. Sales and marketing expense in the first quarter increased 1% to $18 million compared to $17.8 million in the prior year. As a percent of total revenue, sales and marketing expense decreased to 58% for the three months ended March 31 compared to 74% in the prior year. Research and development spending in the first quarter increased 25% to $5.7 million compared to $4.6 million in the prior year. Research and development costs include product development, including the non-clinical expenses in support of our BLA for Avance Nerve Graft and expenses for clinical research. Product development expenses represented approximately 66% of total R&D in the first quarter compared to 50% in the prior year, while clinical expenses represented the remaining 34% in Q1 compared to 50% in the prior year. The increase in product development expenses reflects increased spending in specific programs, including the BLA for Avance Nerve Graft and the next generation Avance product. Additionally, pandemic-related restrictions lowered spending on certain clinical study programs beginning in March of 2020. In the first quarter of '21, we reinitiated activities on our Sensation NOW and Rethink Pain registries, and we expect that these and other clinical activities will continue to increase across the coming quarters. As a percentage of total revenue, research and development expenses were 18% in the first quarter compared to 19% in the prior year. General and administrative expense in the first quarter increased 52% to $8.4 million or 27% of revenue compared to $5.5 million or 23% of revenue in the prior year. The prior-year quarter included $1.8 million of lower non-cash stock compensation, primarily related to lower estimates for performance stock units. Additionally, current year general and administrative expenses include litigation charges of approximately $800,000. Adjusting for both these items, G&A expense in the first quarter would have increased approximately 4% to $7.6 million and represented approximately 25% of revenue. Adjusted net loss and net loss per share in Q1 of '21 was $3.1 million and $0.08 per share compared to adjusted net loss and loss per share in the prior year of $7.6 million and $0.19 per share. Adjusted EBITDA loss in the quarter was $1.9 million compared to an adjusted EBITDA loss of $7.6 million in the prior year. The reconciliation of these non-GAAP financial measures to GAAP can be found in today's earnings release and on our website. The balance of cash, cash equivalents, and investments on March 31 was $97.2 million compared to a balance of $110.8 million on December 31 of 2020. The $13.6 million change in cash in the quarter included $2.9 million of capital expenditures related to our new facilities in Dayton and Tampa and approximately $9.2 million related to items which typically occur in the first quarter of each year, including payment of the 2020 all-employee performance bonus, annual sales awards and related costs, and our annual sales meeting. As we noted on our last quarterly call, we resumed construction of our Dayton biologics processing center in January of '21. We anticipate completion of construction later this year, followed by a one-year validation process, and expect to convert production to the new center in late '22. We continue to anticipate total capital expenditures of approximately $26 million for this facility in 2021. Additionally, we expect to continue to ramp investment into projects that were placed on hold for the majority of 2020, including certain clinical trials, product development programs, and marketing and administrative initiatives, all of which are key to driving our long-term growth goals. As a result, we anticipate that operating expenses will increase sequentially and that we will continue to see moderate operating cash burn throughout 2021. Before I turn the call back over to Karen, I wanted to review the regulatory status of our Avive soft tissue membrane. The FDA has previously issued guidance on the regulatory considerations for human cells, tissues and cellular and tissue-based products with enforcement discretion through May 31 of 2021 for relevant products. We are currently in discussions with the FDA to confirm the regulatory classification of Avive soft tissue membrane as a tissue product. These discussions apply only to Avive, which represents approximately 5% of our revenue and have no impact on any other AxoGen products, including Avance Nerve Graft, which was granted enforcement discretion by the FDA in 2010, received RMAT designation in 2018, and for which we plan to submit a Biologics License Application in 2023. Additionally, we wanted to note that our existing shelf registration will be expiring on May 7, and we will be filing an updated shelf registration with the SEC, along with the filing of our first quarter 10-Q. This is purely a matter of corporate housekeeping, and we have no further plans to raise equity under this new shelf. We are encouraged by the trends we see in the business and the broader healthcare arena, and we remain confident in our ability to drive sustained, meaningful revenue growth as the environment continues to normalize across the second half of the year. We also remain extremely bullish about the long-term growth prospects of our business given the significant underpenetrated growth opportunity and our team's improved commercial execution and our continued investment in an expanding clinical portfolio. And with that, I'd like to hand the call back over to Karen.

Karen Zaderej, CEO

Thanks, Pete. I'm proud of the achievements of the entire AxoGen team as we continue to meet the challenges we faced during this quarter. We remain committed to delivering our innovative nerve repair solutions to patients, surgeons, and hospitals, and I believe we're well positioned for success throughout the rest of 2021 and beyond. At this point, I'd like to open up the line for questions.

Operator, Operator

Thank you. At this time we will be conducting a question-and-answer session. Our first question is from Richard Newitter with SVB Leerink.

Jaime Morgan, Analyst

I guess the third off just on the guidance and thank you for reinstating that and kind of giving us a target to look at. How are you guys thinking about the timing of a return to more normalized levels across the different market segments? And then just relative to the guidance, how should we be thinking about the different factors across these segments and what's contemplated in that range?

Karen Zaderej, CEO

If you examine our largest segment, extremity trauma, you'll notice a seasonal influence and an increase from Q1 to Q2 due to heightened summer activities leading to more traumatic injuries. We anticipate that as vaccination rates rise and people feel more confident, this trend will continue. While we don’t expect it to reach the same level as in previous years, we foresee a positive increase throughout the year driven by overall activity. Other segments will behave differently; for instance, breast reconstruction relies on surgical schedules opening up at various centers, many of which still have limited availability for certain procedures. We do see these centers starting to reopen, but it will be a gradual process over the summer. Additionally, we are aware that last year’s decrease in diagnoses, such as postponed mammograms, created a gap in patient flow that we expect to normalize by year-end, though we are still experiencing some interruptions. The surgical treatment for pain is progressing well; we are encouraged by our existing surgeon customers who are starting to increase patient intake for neuroma treatments. This segment is small since it was just launched early last year, but we are seeing promising growth and expect this to further develop throughout the year. Overall, our most challenging area is expected to remain subdued until March, but we anticipate improvements as we move forward.

Jaime Morgan, Analyst

And then I appreciate that you guys are now introducing this new metric of core account. Can you just talk a little bit about the growth trend that you saw in core accounts over 2020 and what strategies you're focused on in '21 to not only increase the number of core accounts but also drive up the revenue mix versus the 60% that you saw in the quarter?

Karen Zaderej, CEO

We introduced core accounts to enhance our understanding of active accounts. Previously, active accounts were mainly an entry point for sales, but the low threshold didn't accurately reflect our growth and repeat usage. Core accounts set a higher standard. Our ongoing strategy is to penetrate existing accounts more deeply, starting with current surgeons and then expanding to others at those same locations. We see significant potential in growing these core accounts, especially the larger ones, which currently exceed $1 million. We aim to increase both the revenue per core account and the number of core accounts. This approach is closely linked to our efforts in improving representative productivity, as both aspects are interconnected.

Operator, Operator

Our next question is from Brandon Folkes with Cantor Fitzgerald.

Brandon Folkes, Analyst

Congratulations on maybe good quarter and maybe just on gross margin. It's been very good for the last three quarters, granted the guidance I saw that. But how do we think about sort of gross margin? Maybe one for the remainder of the year, just any sort of lumpiness or should we expect this to improve? And then maybe just longer term. And then I just going back to this core accounts and following on core accounts, we have been following on from the prior question. Any way you can conceptualize in terms of how many of your active accounts you believe you can get into this core account category and then maybe just the focus? Is it going to be growing core accounts versus growing revenue within core count? Obviously, you mentioned some of your larger accounts at $18 million. So just anything to set the expectation from quarter to quarter, should we be focusing a lot on percentage of revenue here versus the actual number of accounts?

Peter Mariani, CFO

Why don't I take the gross margin question first. I mean in first, just as a reminder, everyone, it's been a while since we've given guidance, and we have historically given guidance that says that our gross margins will continue to be above 80%. Even though we've been running sort of normalized in the 83% to 84% range, that's just our way of looking at it. We think having gross margins above 80% is outstanding, and we believe that will continue to run above 80%, and then specifically to this quarter, I think in the 83% to 84% range has been normal for us and I think as we have gotten our processing center back up to full speed that we're getting back to that utilization level that allows us to run the gross margins at this level. And so I wouldn't suggest that it could be within the range a bit. I wouldn't expect significant increases from this, and I certainly wouldn't expect significant decreases from that normalized range now that we're at this level of production. And then the core counts.

Karen Zaderej, CEO

So in terms of our strategic intent, what we're looking at with both core and active accounts, think of these as the priority order that our sales team is working. Their first priority is to work with our existing users to increase their penetration across their algorithm. That is their first and highest priority, and by definition, that predominantly means they're going to be focused on existing accounts and increasing the dollars per account. However, we do know that surgeons may practice at multiple centers, and in that same work that we're increasing that surgeon's usage may cause us to add more active accounts because that surgeon may also practice down the road at another hospital where we hadn't historically been in place. The second priority is to add in new surgeons or expand surgeons at those same centers. And then the third priority is starting up from scratch in centers that we don't have current users. So all of those are dimensions of growth, but there is a very clear priority in the sales direction of first and foremost grow our existing users.

Operator, Operator

Our next question is from David Turkaly with JMP Securities.

David Turkaly, Analyst

Pete, maybe one for you. You mentioned rep productivity and great to see guidance out there again, and I'm just curious, given the length of time you guys have been added in, some of the trends you've probably seen, do you feel like your visibility is greater today than it was say in prior years? It seems like the performance has been remarkably consistent and better side. Still going to color you'd like to provide around sort of how that visibility is today, maybe it's better than it was in the past? Any thoughts on that front?

Peter Mariani, CFO

Yes, I appreciate the question. I believe we do have better visibility or improving visibility regarding the productivity ramp of our sales representatives. Last year, we were not significantly expanding our representatives. They were focused on their specific territories for extended periods, which allowed us to build connections with surgeons as they progressed in their adoption journey. This approach has proven beneficial in many ways, helping us consider the appropriate pace for expanding our representatives. When we do decide to split territories and add more reps, we will do so thoughtfully to ensure we maintain the connection between the representatives and the surgeons while continuing to grow our top-line revenue and increasing overall productivity.

David Turkaly, Analyst

I mean like looking at the level, it's certainly above where the Street's at so that's great. Maybe as a follow-up to 6% mix and price. Just love to get any color there, price evenly spread out maybe across Avance and AxoGuard, and I was wondering about the mix guard.

Peter Mariani, CFO

The 4% of that 6% is price, and we've been successful this year, last year, over the last several years of taking moderate price increases across the product line, and we continue to do that. This year's price increase was effective April 1, but we've got, this is the annualized impact of last year's increase coming through, but the additional 2% of mix is actually a reflection of increasing mix of Avance and the overall revenue results. We traditionally said that Avance has been slightly more than 50% of revenue, which is true, but this quarter we have moved that up a few more percentage points in that came through in the mix calculation.

David Turkaly, Analyst

And then thank you for that. One last one, I think you mentioned an AxoGen advanced product. You may not be able to talk about it, but I'd certainly love to know when we might hear more about that or any details you could share.

Karen Zaderej, CEO

Yes, we don't have any details at this point, Dave, that we can share other than we're excited to continue to look to the future and see opportunities to continue to improve our flagship product.

Operator, Operator

Our next question is from Anthony Petrone with Jefferies.

Anthony Petrone, Analyst

I apologize for jumping around with the calls. My first question is about breast neurotization, specifically regarding the turnaround potential of the backlog as we move into the vaccine cycle. The second question is about our new key account focus. When we consider using events for most of their procedures, how scalable is it to add more surgeons at an existing site where we already have one surgeon?

Karen Zaderej, CEO

Regarding breast neurotization, we do not observe a significant backlog overall, despite some fluctuations that may create temporary spikes in demand. Most of our centers have managed to recover, although about a third are still experiencing delays. The remaining centers are back to a stable pace, and we believe that the reserves from the centers facing shutdowns will help balance any backlog. As for surgeon adaptation at these centers, there has been no notable change in the nerve repair adoption process. This process is still gradual, largely because surgeons need to see clinical outcomes from the nerve repairs they perform themselves. They prefer to review our data first and then apply it with their patients. Typically, a surgeon will carry out a few cases and then wait to observe the results before proceeding further, particularly with digital nerve injuries that take around six months for results to manifest. They usually begin with three to six cases, assess the outcomes after six months, and if successful, they will continue to adopt additional nerve repairs. This established pattern remains unchanged. While we believe we have a solid grasp of this trend and a strategy to facilitate surgeon adoption, the pace of this process is not rapid.

Operator, Operator

Ladies and gentlemen, we have reached the end of the question and answer session. And I would like to turn the call back over to Karen Zaderej for closing remarks.

Karen Zaderej, CEO

Thank you, David. I want to thank everyone for joining us on today's call. We look forward to speaking with many of you virtually at the Canaccord Genuity Musculoskeletal Conference on May 20, the Jefferies Virtual Healthcare Conference on June 2, and the JMP Securities Life Sciences Conference on June 16. Thank you.

Operator, Operator

This concludes today's conference. Thank you for your participation. You may disconnect your lines at this time.