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AxoGen Inc  (NASDAQ:AXGN)
Q4 2018 Earnings Conference Call
Feb. 26, 2019, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Greetings, and welcome to the Axogen Fourth Quarter 2018 Results Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. (Operator Instructions) As a reminder, this conference is being recorded.

I would now like to turn the conference over to Kaila Krum. Thank you. Please begin.

Kaila Krum -- Vice President, Investor Relations and Corporate Development

Thank you, Roya, and good afternoon, everyone. Welcome to Axogen's fourth quarter 2018 and full year financial results conference call. We appreciate you joining us. I'm Kaila Krum, Vice President of Investor Relations and Corporate Development. With me on the call today are Karen Zaderej, Chairman, Chief Executive Officer and President; and Pete Mariani, Chief Financial Officer. The format for today's call will be as follows: first, Karen will discuss 2018 fourth quarter and full year highlights and review our guidance for fiscal year 2019. She will then turn to our key operational and strategic objective. Next, Pete will provide details on the financial results outlined in today's press release. We will then open the call for your questions.

Today's call is being broadcast live via webcast, which is available on the Axogen website. Within an hour, following the end of the live call, a replay will be made available on the Company's website at www.axogeninc.com under Investors.

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 Form 10-K and 10-Q, which identify the 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 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 Zaderej. Karen?

Karen Zaderej -- Chairman, President and Chief Executive Officer

Thanks, Kaila, and good afternoon, everyone. 2018 was an exciting, but challenging year for Axogen. We added to our capabilities across the organization, including the strengthening of our commercial, clinical, surgeon education and product development team. Although we experienced certain headwinds during the year, we are pleased with the foundation we've built, and we entered 2019 stronger than ever.

We are the leading company solely dedicated to restoring quality of life for patients suffering from peripheral nerve damage. Our purpose-driven team of professionals works with skilled clinicians to further our mission and deliver life-changing evidence-based solutions to better serve this patient population. Axogen was built on adaptation along with sound values and business principles. We are confident that the underlying fundamentals of our business are strong, and we believe that the execution of our strategic initiatives will drive our long-term sustainable growth.

I'll now talk through highlights from the fourth quarter and full year. Our total revenue for the fourth quarter of 2018 was $23.4 million, an increase of 38% from the fourth quarter of 2017. For the full year 2018, total revenue was $83.9 million, up 39% from the prior year. Our growth continues to be fueled by growing surgeon acceptance of the increasing body of clinical evidence across our portfolio of products. This clinical data is helping to drive penetration of our active accounts and allowing us to gain access to and develop new accounts.

In October, our Avance Nerve Graft received the Regenerative Medicine Advanced Therapy designation, otherwise known as RMAT, from the FDA acknowledging that Avance, our biologically active nerve allograft is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition. And preliminary clinical evidence indicates that Avance has the potential to address the unmet medical needs of the disease or condition.

In November, we updated our total addressable market to be $2.7 billion. The increase is primarily based on revised assumptions for net procedure revenue values and increased prevalence of Connector Assisted Repair in trauma cases.

We also announced that we would begin market development and clinical initiatives to further study the surgical treatment of chronic neuropathic pain, an application that we believe could add more than a billion dollars to our total addressable market. I am proud of the progress our team made in 2018, and all we've accomplished to provide surgeons with improved nerve repair techniques to offer patients better quality of life outcomes. We have a big opportunity in front of us and are confident that we're building a strong foundation for long-term sustainable growth.

We entered 2019 with a renewed and sharpened focus on consistent commercial execution. We made a number of changes to enhance our broader commercialization capabilities, including the addition of clinical sales specialists focused on the development of our OMF and breast reconstruction applications, the expansion of our sales leadership structure and the enhancement of our sales training programs. These changes allowed us to add 25 new sales representatives during 2018, of which nine were added in the fourth quarter. We ended the year with a total of 85 direct sales representatives.

We announced the appointment of Chris Crisman as our VP of US Sales and Eric Sandberg as our new Chief Commercial Officer. Both executives joined us in January and bring extensive experience launching new therapies that changed the standard of care and leading and scaling commercial organizations to deliver results. The transition is ongoing, these new leaders are integrating quickly, and we're encouraged by the energy and commitment to execution across our commercial teams.

While we're pleased with our sales performance today and the sales leadership transition, we are still early in the year and believe it is important to consider a range of productivity scenarios. We are updating our approach to guidance and going forward, we'll be providing our revenue outlook in the form of a dollar range. We expect 2019 revenue will be between $109 million and $114 million. The revised range we provided will be largely driven by revenue growth from the sales representatives onboard at the end of 2018 and includes only a modest contribution from the representatives we hire in 2019. We expect to hire more than 30 direct sales representatives in 2019 and end the year with more than 115 sales representatives. These additional hires will be added throughout the year with their primary contribution to revenue growth occurring in 2020 and beyond.

Our revenue guidance assumes growth across all current applications and that the direct sales revenue growth outpaces growth from the independent channel. We assume a mid-single digit net price increase in both the high and low end of our guidance range and no contribution from our surgical treatment of pain initiatives.

Before reviewing our progress on strategic initiatives, I want to briefly comment on the RECON study. Our Phase 3 pivotal study to support our BLA for Avance Nerve Graft. Previously, we announced that we completed enrollment of 170 subjects and that we initiated a planned and blinded interim analysis conducted by an independent statistician as part of our study protocol. As a reminder, the interim analysis looks only at the pooled standard deviation of the first 80 subjects enrolled in the study and does not include an interim look at outcomes. This analysis was put in place to allow us to increase the study size, if necessary, to maintain the power of the study. While we have a limited update today, we have reconvened conversations with the FDA and are now working with them to review the interim analysis findings and obtain agreement on the next phase of the study. We will wait to provide further comment until we finalize the next steps.

Now turning to our strategic initiatives, which we refer to as our five pillars of growth: building market awareness, educating surgeons and developing advocates, growing the body of clinical evidence, executing on our sales plans and introducing new products and expanded applications in nerve repair. I'll now comment on our progress in each of these areas.

First, we continue to build market awareness of Axogen and our products by engaging with patients and surgeons. Our focused vision to address the unmet needs of patients with nerve damage led us to launch an update to our corporate brand, including a new logo and company tag line. The new brand represents Axogen's ongoing commitment to be a driving force in revolutionizing the science of nerve repair. At Axogen, we envision a world where everyone can kiss, smile, hug walk, eat, touch, run and feel, all the things healthy peripheral nerves allow us to do. This new identity reflects our strong momentum and pipeline of solutions to help surgeons address peripheral nerve damage and provide patients with improved quality of life.

We continue to grow clinical awareness of our product and repair algorithm within the surgeon community. Our platform for nerve repair was well represented at the recent combined 2019 meetings of the American Association for Hand Surgery, American Society for Peripheral Nerve and the American Society for Reconstructive Microsurgery. Axogen hosted an educational symposium that explored the rapid evolution of options to treat complex nerve injury. In addition to our symposium, there were several clinical and scientific presentations throughout the meetings that highlighted Axogen's full product portfolio, including data from the AxoGen-sponsored RANGER registry.

Our second pillar of growth is focused on surgeon education and the development of surgeon advocates. We conducted six national education events in the fourth quarter and a total of 18 in the full year 2018. The surgeon-led programs focus on advances and best practices in nerve repair. They allow surgeons to gain additional confidence in nerve repair techniques, and they drive adoption and increased utilization of our products. On average, we see Axogen product utilization from surgeon attendees more than double six months after they attend the program. In 2019, we plan to conduct a total of 25 national education programs, including six fellows programs with the goal to provide advanced nerve repair training to approximately three quarters of our hand and microsurgery fellows.

Our third pillar is to grow the body of clinical evidence. Our library of peer-reviewed clinical publications now numbers 77. In 2018, we saw an increase in investigator-initiated publications, including review articles recommending use of our portfolio as well as innovative surgical techniques and applications leveraging our products. The variety and volume of presentations and publications reinforces both the importance of peripheral nerve repair and the growing body of evidence for Axogen's nerve repair portfolio.

In addition to publications, I'd like to comment on our clinical programs pipeline. Our RANGER registry has now enrolled more than 1,600 Avance Nerve Graft repairs and continues to provide significant new evidence in the management of nerve injuries. Data from the registry continues to support meaningful recovery in a variety of gap length and in sensory and motor function and consistently demonstrates that Avance outcomes exceed those associated with synthetic conduits and are similar to nerve autographed without the associated donor site morbidity. Surgeons are using this data to better understand nerve repair outcomes and to expand their treatment algorithms. Additionally, we continue to enroll patients and build the clinical evidence in the Sensation Neurotization Outcomes for Women or Sensation-NOW clinical registry. We believe the data from this registry will demonstrate that the ReSensation technique provides meaningful recovery of sensation and quality of life for women who choose autologous reconstruction following a mastectomy.

In 2018, we launched our REPOSE clinical study. REPOSE is a prospective randomized controlled study evaluating the use of AxoGuard Nerve Cap in the management of painful neuroma as compared to a standard neurectomy procedure. REPOSE is a two-phase study consisting of a 15-subject pilot and an 86-subject pivotal phase. This study is currently enrolling and includes a one-year follow-up.

Our fourth pillar is sales execution. As I mentioned earlier, we made several changes to enhance our commercialization capabilities and continue to grow our field sales team. We also continue to convert high potential geographies to direct sales representatives, increase our number of active accounts and expand the treatment algorithms of surgeons. We ended the year with 17 independent sales agencies. These agencies continue to be important in supporting the execution of our commercial strategy, and we expect to add agencies in select geographies. This strategy will reduce territory size and create efficiencies for our direct sales team, allowing them to drive deeper penetration in their current active accounts. Our number of active accounts increased 20% to 712 in the fourth quarter, up from 591 in Q4 of 2017. Axogen defines an active account as an account that has typically gone through the committee approval process, has at least one surgeon who is converted a portion of his or her treatment algorithms to peripheral nerve repair to the Axogen portfolio and has ordered Axogen product at least six times in the last 12 months.

The top 10 percent of our active accounts represented approximately 35 percent of revenue in the fourth quarter, which we believe demonstrates the continued potential for expansion of our revenue base. We believe that most of our active accounts are still at an early stage of penetration and provide additional opportunities for growth. Our objective is to continue expanding the treatment algorithm to surgeons to include all four of our surgical implants across their full continuum of nerve repair. This is important because accounts ordering three of our four nerve repair products generate more than six times the revenue of an account ordering just one of those products.

Our fifth pillar of growth is the introduction of new products and expanded applications in nerve repair. There are many unmet needs in the surgical repair of peripheral nerves. We're making investments in opportunities to innovate both our current portfolio as well as introduce new solutions for patients with peripheral nerve damage. In November, we announced several foundational initiatives planned for 2019 to help support a broader launch into the surgical treatment of pain, an application we believe could add more than a billion dollars to our total addressable market. The Company plans to initially focus on patients experiencing pain following traumatic injuries, including amputations and orthopedic surgeries.

Before I turn the call over to Pete, I want to reiterate that I am proud of the many accomplishments of the Axogen team in 2018. We continue to execute against our strategic initiatives to deliver long-term sustainable growth.

Now I'll turn the call over to Pete for a review of financial highlights. Pete?

Peter J. Mariani -- Chief Financial Officer

Thanks, Karen. Fourth quarter revenue grew 38% to $23.4 million. Revenue growth was primarily the result of increases in unit volume as well as the net impact of price increases and changes in product mix. As in prior quarters, our revenue growth was driven primarily by increased revenue and active accounts and the addition of new active accounts. We had a net increase of 33 active accounts in Q4 and now have 712, an increase of 20% over the prior year. We also continue to see growth in our pipeline of new accounts as surgeons become more familiar with our products and begin to incorporate them into their treatment algorithms.

Gross profit for the fourth quarter was $19.8 million, a 38% increase compared to Q4 2017. Gross margin was 84.5% for Q4 compared to 84.6% in the prior year's fourth quarter. Total operating expenses in the fourth quarter was $25.6 million, up 59% over the prior year. The increase included additional investments in our expanding commercial capabilities as well as increased investments in clinical, R&D and general corporate expenses associated with our growth. Operating expenses include non-cash stock compensation expenses of $1.6 million in Q4 of '18 compared to $1.1 million in the prior year. Sales and marketing expense in the fourth quarter was $15.5 million, up 53% over the prior year. As a percent of revenue, sales and marketing expense in the quarter was 66% compared to 60% in the prior year.

Research and development spending in the fourth quarter was $3.8 million compared to $2 million in the prior year fourth quarter. R&D costs include product development expenditures for our biologic license application for Avance Nerve Graft, support of the RANGER registry and other clinical studies as well as expenses associated with the development of the new Axogen processing center. As a percent of revenue, R&D expense for Q4 was 16.2% compared to 11.6% in the prior year. We continue to build out our R&D capabilities and are increasing investments in important clinical study work and product development. We expect that investments in these activities, along with expenses associated with our new processing facility, will maintain 2019 R&D spend as a percentage of revenue at higher than historical levels.

General and administrative expense in the fourth quarter was $6.4 million, up 57% over the prior year. The increase includes higher compensation expenses, including higher noncash stock compensation related to supporting our organizational growth. As a percent of revenue, G&A expense in Q4 was 27.2% compared to 24% in the prior year. Net loss in the fourth quarter was $5.2 million or $0.13 cents per share compared to $2.5 million or $0.07 per share in the prior year. Excluding the impact of noncash stock compensation, adjusted net loss and net loss per share in Q4 of 2018 was $3.6 million and $0.09 per share compared to $1.4 million and $0.04 per share in the prior year. Adjusted EBITDA loss in the quarter, which excludes the impact of stock comp, was $4 million compared to an adjusted EBITDA loss of $531,000 in the prior year's fourth quarter. On our balance sheet, we ended the year with $122.6 million in cash, cash equivalents and investments compared to $126.4 million at the end of Q3.

And turning to guidance, as Karen discussed earlier, we are updating our outlook, and we'll be providing guidance in the form of a dollar range going forward. We've been pleased with the performance to date, though recognize we are still early in the year and believe it is important to consider a range of productivity scenarios that we are now incorporating in our 2019 guidance. We expect 2019 revenue will be between $109 million and $114 million. We expect gross margins will continue to exceed 80%. And additionally, we expect to have at least a 115 direct sales representatives by the end of the year.

In addition to the investments in our commercial capability Karen discussed earlier, we are building the facility infrastructure to support our long-term growth. In early August, we completed the acquisition of a facility in Dayton, Ohio, where we will transition our existing processing to support our long-term capacity needs. We expect the building to be complete in 2020 and begin production in 2021 following validation of the facility. We continue to advance our plans to expand our corporate office footprint. In late 2018, we extended the lease on our current Alachua campus to at least -- till at least 2020 -- mid-2021 and expanded our R&D lab space. We have also made progress toward opening a second headquarters office in Tampa. Construction of the new office facility began early this year, and we anticipate opening the new office in early 2020. Last week, we opened a temporary office facility in Tampa, and we'll use this temporary facility to support our headquarters growth until the permanent office is complete.

2018 was another year of strong growth, and we made significant investments building long-term capabilities across our organization. These investments resulted in spending growth that outpaced our revenue growth in 2018. Although we expect spending growth will exceed revenue growth in early 2019, we expect this growth to moderate across the year and see a return of leverage in the business model in the second half. And also our Annual Report on Form 10-K was filed today and is available on the SEC website.

And with that, I'd like to hand the call back over to Karen.

Karen Zaderej -- Chairman, President and Chief Executive Officer

Thanks, Pete. We have an exciting vision to revolutionize the science of nerve repair. We remain the leading company solely dedicated to improving quality of life for patients suffering from peripheral nerve damage. We believe that we have developed a solid foundation based on science and clinical outcomes that will allow us to address these important unmet clinical challenges. We are confident that the underlying fundamentals driving our business are strong, and we believe that the continued execution of our strategic initiatives will continue to allow Axogen to deliver long-term sustainable growth.

Before taking questions, I do want to welcome our new investors and thank the Axogen team for their commitment to our mission and to our values. And at this point, I'd like to open up the line for questions. Roya?

Questions and Answers:

Operator

Thank you. (Operator Instructions) Our first question comes from line of Richard Newitter with Leerink Partners. Please proceed.

Richard Newitter -- Leerink Partners -- Analyst

Hi. Thanks for taking the questions. I have one on guidance and then one on your clinical RECON study. Just on the guidance, can you give us any color on the quarterly pacing? I know you've had some sales leadership changes that happened at the end of the year -- sorry, at the very beginning of the year -- of '19 in January. And I was just wondering kind of what's baked in as you said from the range of rep (ph) productivity outcomes with respect to kind of how that plays out in the first half of the year versus second half of the year, and how should we think of kind of the growth trajectory within that backdrop?

Peter J. Mariani -- Chief Financial Officer

Well -- hey, Rich, how are you. I think the way we think about the range for the guidance is you're right. We had nine reps start in Q4, and we think about the key drivers of our revenue in '19 being driven by that group of 85 that were here with us by the end of '18. And so as that group that we hired early in the year comes up to speed here at the end of the fourth quarter and the first quarter and that group in Q4 comes up to speed through the middle of the year, I think that does lead us toward thinking about that productivity increasing across the year and certainly more so in the back half of the year.

Richard Newitter -- Leerink Partners -- Analyst

So I guess, Pete, just -- is it fair to assume maybe something below the average growth rate implied at the midpoint of the guide in the first half of the year, particularly in the first quarter and then maybe something in the second half, maybe a little higher. Is that a fair way to think about it? Again, I'm just trying to calibrate just given kind of (multiple speakers).

Peter J. Mariani -- Chief Financial Officer

Yes. No, I get it. I think that's probably a fair assumption or a fair way of looking at it. I think it just depends on how people build their models and how you think about the impact of those Q4 of '18 new hires impacting the overall average from the start of the year versus what it looks like in the back half of the year. So taking the approach as you just suggested might be a good way of looking at it.

Richard Newitter -- Leerink Partners -- Analyst

Okay. Great. Thanks. And I wanted to just ask on the RECON study. What exactly is kind of the new update here because I know you provided an update that you completed enrollment of the 170 patients with your press release preannouncement in January and that interim kind of statistical look for the deviations was anticipated at that point in time. And now I think you're saying kind of as expected, you're starting to go through that interim look. Is that kind of the new information we learned today? And I guess I'm -- ultimately just what are we supposed to kind of make of this with respect to the study?. Is this going to require greater 170 than patients required to be enrolled in the study? When's the FDA potentially going to make this determination? Was this agreed upon in the original protocol? It would be helpful, I think, to get some color on that.

Karen Zaderej -- Chairman, President and Chief Executive Officer

Sure. So the only update on progress is the last time we talked about this, the government was shut down and there was no progress with the FDA. The FDA is back at work again and they've been going through their list of things that they had to do and they have reached us and we're starting a conversation now to talk about this interim look. In terms of the impact, so first, yes, this was a planned analysis when we first designed the study and worked with the FDA. Just recognizing that in 2011, we were drafting this protocol, the data on particularly standard deviation was pretty limited, both for Avance because we didn't have as much clinical data, but also because conduits are (inaudible) devices. There's not that data repository that you would have where there's more robust clinical studies. And so we had to estimate the standard deviation of conduits on the basis of literature. And so recognizing at that time that that process has error in it and this pooled standard deviation is one of the key values we can use and kept for a given power in calculating what your sample size of a study is.

So at that time, we created a table that's in the statistical analysis plan, that says when we have this first 80 subjects -- the first 80 enrolled subjects when we have the pooled standard deviation, it will allow us if there's a shift from the original assumption to expand the enrollment to maintain the power. So this is again part of the original protocol. There's a set structure into what we would change given a change in the pooled standard deviation. And then, just I'll add what this is and is not. It is only a look at the pooled standard deviation, no outcomes. We don't see them and neither does the blinded statistician. So again, the only thing they get to see is that the standard deviation -- I guess the standard (inaudible). The statistician sees that we don't see any of the outcomes. We only see the standard deviation and neither the statistician or Axogen sees anything about the individual groups. So we don't have any insight into conduit outcomes or insight into what the advance outcomes are, just what this pooled standard deviation is.

Richard Newitter -- Leerink Partners -- Analyst

OK. But if the FDA comes back and determines that you need to expand the number of patients in the study, is there anything to read into that or is that just purely a statistical phenomenon and if you really can't read positive or negative one way or the other from that?

Karen Zaderej -- Chairman, President and Chief Executive Officer

Yes. You can't read anything positive or negative out of the outcome of the study. The only thing that you can see is FDA's commitment to maintain the power of the study.

Richard Newitter -- Leerink Partners -- Analyst

Okay. Thanks. And if I could actually just squeeze one more in. The timing on the management changes in early January, can you just describe a little bit about kind of what went behind the decision-making there, how long was it in the works and again, the rationale? Thank you.

Karen Zaderej -- Chairman, President and Chief Executive Officer

Well, I look at the talent that we brought in with Chris and Eric and just recognize that I think we've brought into a couple of very strong executives who have experience in scaling, growing and growth organizations and leading a commercial team that is used to doing this sort of market development and change management that Axogen is all about. And so really excited to have these two folks joining us on the team.

In terms of the timing, honestly, we were looking getting through 2018 and transitioning into 2019. So it's not a coincidence that the timing was January, it was just trying to handle it so that we could complete out a good sales year with our sales team and launch into a new sales year with a strong initiation of the year in our sales meeting with our new sales leadership.

Operator

Thank you. Our next question comes from the line of Raj Denhoy with Jefferies. Please proceed.

Raj Denhoy -- Jefferies -- Analyst

Hi, good afternoon.

Peter J. Mariani -- Chief Financial Officer

Hello, Raj.

Raj Denhoy -- Jefferies -- Analyst

Wonder if could start with the guidance as well. I guess the new range this year, I know you want to give us numbers -- numerical numbers and not percent ranges, but it does imply 30% to 35%, which is a bit lower from what you offered. I think it was November of last year at analyst meeting. And so I guess I'm curious about that additional sort of 5 % cut in the guidance and whether that's just conservatism on your part or whether it's perhaps a lingering effect of what you described on the fourth quarter softness with the sales team maybe not being as productive once they caught wind of the sales change really is trying to get what's behind that conservatism now that's in those numbers.

Peter J. Mariani -- Chief Financial Officer

Well, I think -- Raj, as we said, I think as we dig into our own numbers a little better and look at what these productivity ranges could look like for the folks who came in, in 2018 and what it means to drive growth across '19, I think being on the low end of productivity range at this point given where we're at, at this point a quarter, honestly, we actually feel like we're off to a pretty good start here in the first quarter, but we have a lot of growth ahead of us. And I just think it's appropriate for us to stay in this range for now. Let's deliver the first quarter and the second quarter and see where we are. But that being said, the group has done, I think, a really solid job of implementing the changes that we put in place last year. And I think we're rolling into this year in a good place with the commercial team. We want to give our new sales leaders a chance to get fully settled and rolling in. Like we said in the release, we're doing really well. We're excited about the -- just the mood and the tone of the organization right now. We're excited about the opportunities to continue to drive growth in the year. But as we start at this point in the year, we think this is an appropriate range for us to be in.

Raj Denhoy -- Jefferies -- Analyst

And maybe just to put a finer point on that. So the dynamic you described in the fourth quarter where, again, there was a little bit of lower productivity as the sales team maybe anticipated some change. Have we now moved beyond that? Can you unequivocally say that the -- that there's no impact at this point from the sales change -- sales leadership change?

Peter J. Mariani -- Chief Financial Officer

Yes. I think we can. I mean, I think we can say that the growth that we saw -- we saw nice growth in our direct force sales force through Q3. We actually saw it continuing in October and November. The issue that we talked about before really had to do uniquely with the leveling off or the slowing of the growth in December versus what we would have liked to have seen, and we've transitioned well into January and into the first quarter. So I think the team has done really well as we get started here in the year.

Karen Zaderej -- Chairman, President and Chief Executive Officer

No. I think any time we change sales leadership, it's a change. And so sales teams not always respond favorably to change. I think we're progressing well on our plan. I don't want to say it's zero impact. I think there's always some impact when you change sales leadership, but I think Chris and Eric have both done a marvelous job of diving in and being accepted by the team and really stepping up into what is a very fast-pace changing organization. So I think we're off to a great start.

Raj Denhoy -- Jefferies -- Analyst

Okay. That's fair. Maybe just one last one, just on the chronic neuropathic pain opportunity. I think you said we shouldn't expect too much contribution this year, but any updates on timing on when we might get more detail on the programs there when you might have, where it might become more real for you?

Karen Zaderej -- Chairman, President and Chief Executive Officer

I think it's going to take us a few quarters to get some more information to understand a little more on the clinical side, but more importantly, thinking about patient referral and awareness and how you can identify the right patients for this and get them referred to the right surgeon, and that's something that we've got some work to do on. So I think it's going to take us a few quarters to get confidence in that.

Raj Denhoy -- Jefferies -- Analyst

Great. Thank you.

Operator

Thank you. Our next question comes from the line of Brian Weinstein with William Blair. Please proceed.

Brian Weinstein -- William Blair -- Analyst

Hey, guys, thanks for taking the questions. Just to kind of drive a little bit more on the last round of questions there. Can you talk just about specific steps that have been taken by the commercial and sales leadership teams since stepping in and kind of what is the difference in strategy that you think that they're going to employ with the sales force versus kind of what we saw before? Can you -- are there any concrete things that you can kind of point to there?

Karen Zaderej -- Chairman, President and Chief Executive Officer

Well, I don't think -- first of all, I think it is continuing and enhancing some of the things that we put in place already. So -- and continuing to enhance our development programs for -- and coaching programs for sales team so that we can continue to look at productivity and see if we can improve that productivity from where we are today, both in established reps and in new reps. I think that's a key focus area for both Eric and Chris. So there's certainly going to be something that we'll spend time on, and you'll see some of it in the script that we had when we talked about thinking about territorial alignment and the role of independent agencies.

One of the things that we're, I think, doing a very good job of is really looking at rep productivity and how much time is spent as windshield time versus selling time. And can we improve productivity by just carving off some of these longer distance, more isolated cities that may be better served by an independent agency rather than have a sales associate drive five hours to go and visit the surgeons there? That's the sort of, I think, experienced approach that the sales leadership is bringing in, and it's been very well received by the sales team.

Brian Weinstein -- William Blair -- Analyst

Okay. Great. And then a follow-up. Have you guys looked at or considered any other market resources which may be broader in scope to what you've used in the past to get even more comfortable to validate again that this is a $1.9 billion market on the trauma side, which you guys have been very clear about kind of where you've come up with those numbers, but is there any other validation work that you guys have done or are considering doing just to validate that?

Karen Zaderej -- Chairman, President and Chief Executive Officer

Yes. We've actually done a number of projects to look at primary market research with surgeons. It's very hard to quantify this area of, in particular, the traumatic injury to peripheral nerve. Those who aren't familiar with what the issue is that this is -- nerves are really a step of a procedure rather than most of the time a procedure in and of themselves. And so you can't go to procedure codes. We started originally thinking CPT codes, which is something that measures the surgeon's work, but in surgeon's work, many payers limit the number of codes that they'll pay in a given procedure. That's typically going to be less than five or five or less. And so often in a trauma, there's a lot of things that are going on in trauma and nerve may or may not be represented on the list that they end up reporting. They do the work, but it's just not coded because they don't get paid for that additional work or they don't get it recorded for that additional work. And so we've used more empirical methods and we supplemented that with direct research with surgeons. We'll continue to do that. I'm not sure -- I think, for us, it's a picture that we try and triangulate that says here is multiple ways that we've looked at it and we come up with pretty much the same number each time that we do it. And we've given you one of the ways that we've looked at it. But yes, we continue to think about other ways to evaluate that. And so far, when we've done that, we've been confident we're still on the right size.

Brian Weinstein -- William Blair -- Analyst

Okay. Thank you.

Operator

Thank you. Our next question comes from line of Ryan Zimmerman with BTIG. Please proceed.

Sam -- BTIG -- Analyst

This is Sam on for Ryan. Can you guys hear me?

Karen Zaderej -- Chairman, President and Chief Executive Officer

Yes.

Peter J. Mariani -- Chief Financial Officer

Yes, Sam. How are you?

Sam -- BTIG -- Analyst

Great. So just a few logistical questions to start. So on the RECON study, and I'm sorry if I missed this, but do you have an estimated time frame when you might hear back from the FDA about whether they want to see a larger cohort to measure that standard deviation? And then for the rep count, of that 115 number, is that including the OMF and breast specialists in their?

Karen Zaderej -- Chairman, President and Chief Executive Officer

So on the first one, I don't have a timeline. It's always hard to schedule the FDA, but I don't think it'll be long. It's just -- they're actively discussing it now and I don't want to put a deadline on that. On the rep count, yes, the 115 number is all (inaudible), which includes breast specialists.

Sam -- BTIG -- Analyst

Okay. Great. And then just thinking about productivity into '19, are you envisioning more growth from that existing 85 rep number from increasing procedure volume or the increase in procedure value from the use of increased products in procedure? And then as a side question on the specialty products in OMF and breast, can you give any more clarity into how much of the guided growth you think will be coming from those segments. Thanks.

Karen Zaderej -- Chairman, President and Chief Executive Officer

So we -- our biggest driver of growth is a number of procedures, that's the primary driver. We do look to make sure that we're maximizing -- maybe right-sizing would be a better way to say, right-sizing what the revenue per procedure is. There are actually places that we work with the sales teams to see if we can help choose a smaller size or a more economical product for a particular type of surgical repair. But we also want to make sure that the patient is getting the best quality of care. And we believe, for example, Connector Assisted Repair does add value for the patient. And so we would look to have Connector Assisted Repair continue to increase in some of those procedures.

In terms of the breakout, we don't actually break out each of the areas or segments. Trauma is, by far, biggest segment, but we don't break them out beyond that from a growth standpoint, while the others are coming off of a much smaller base. As a percentage, they are growing faster than trauma, but not in -- but the majority of the dollar growth is still coming from trauma.

Sam -- BTIG -- Analyst

Okay. And then one quick follow-up with you. Any frame about what percentage of your current Avance procedures are also including the Connectors?

Karen Zaderej -- Chairman, President and Chief Executive Officer

No. We've not put a guidance out there. It is increasing, but it is not at this point the majority of the procedures. I put that comfortably there. We see actually greater adoption in breast reconstruction and in the OMF segment of Connector Assisted Repair and see it expanding in trauma.

Sam -- BTIG -- Analyst

Great. Thank you.

Operator

Thank you. We have reached the end of our Q&A portion. Allow me to hand the floor back over for closing remarks.

Karen Zaderej -- Chairman, President and Chief Executive Officer

Oh, thank you, Roya. Well, I want to thank everyone for joining us on today's call, and we look forward to talking with many of you at the Leerink and BTIG conferences later this week. Thank you.

Operator

Thank you. This concludes today's teleconference. You may disconnect your lines at this time, and thank you for your participation.

Duration: 48 minutes

Call participants:

Kaila Krum -- Vice President, Investor Relations and Corporate Development

Karen Zaderej -- Chairman, President and Chief Executive Officer

Peter J. Mariani -- Chief Financial Officer

Richard Newitter -- Leerink Partners -- Analyst

Raj Denhoy -- Jefferies -- Analyst

Brian Weinstein -- William Blair -- Analyst

Sam -- BTIG -- Analyst

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