Earnings Labs

AxoGen, Inc. (AXGN)

Q4 2016 Earnings Call· Wed, Feb 22, 2017

$41.48

-1.30%

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Transcript

Operator

Operator

Greetings and welcome to the AxoGen’s Fourth Quarter and 2016 Full Year Financial Results Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference will be recorded. I would now like to turn the conference over to your host, Mr. Brian Korb. Thank you, Mr. Korb. You may begin.

Brian Korb

Analyst

Thank you, operator, and good afternoon, everyone. Thank you for joining us today for the AxoGen conference call to discuss the financial results for the fourth quarter and full year ended December 31, 2016. 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 available on the company’s website at www.axogeninc.com, under Investors. Before we get started, I would like to remind you that during the course of 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 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, regulatory environment, sales and marketing strategies, capital resources and operating performance. And with that, I would like to turn the call over to Karen Zaderej, President and Chief Executive Officer of AxoGen. Karen?

Karen Zaderej

Analyst · JMP Securities. Please proceed with your question

Thanks, Brian and good afternoon, everyone. Welcome to our fourth quarter and full year 2016 conference call. Joining me today is AxoGen’s Chief Financial Officer, Pete Mariani. I would like to begin today’s call with a review of our fourth quarter and full year highlights, a brief company overview and an update on our key strategic initiatives. Pete will then provide a review of our fourth quarter and full year results and 2017 financial guidance after which time we will open up the call to Q&A. We are pleased to report on a very busy and successful fourth quarter, which included several important strategic advancements across the company. These included the launch of our newest product, Avive Soft Tissue Membrane, the growth of our sales team and the launch of two new market development activities and breast reconstruction neurotization and the repair of lower limb iatrogenic nerve injuries, as well as increased efforts in surgeon education with four national education courses. And we closed the quarter with a record $11.4 million of revenue, which is an increase of 46% over last year. We believe that these efforts, combined with our recent equity raise and debt refinancing, demonstrate our ability to successfully execute our strategy and have positioned us to continue to drive awareness and growth in the emerging peripheral nerve repair market in 2017. We are building awareness of peripheral nerve repair and expanding usage of our products with innovator and early adopter surgeons and we are excited to be moving toward developing the middle adopter toward the majority segment of the nerve repair market. In fact, we continue to increase our surgeon training and conducted four national education courses in the quarter. Two of these events were fellows courses where we are training the next generation of neurosurgeons. This…

Pete Mariani

Analyst · Tao Levy of Wedbush Securities. Please proceed with your question

Thanks, Karen. Fourth quarter revenue was $11.4 million, a 46% increase over the prior year. The growth in revenue was primarily the result of the increases in unit volume as well as the net impact of price increases and changes in product mix. As in prior quarters, the majority of our revenue growth is driven by growth in active accounts. Additionally, we continue to see growth in our pipeline of new accounts as surgeons become familiar with our products and begin to expand their treatment algorithms. Gross profit for the fourth quarter was $9.6 million, an increase of 50% compared to the prior year’s fourth quarter. Gross margin for the fourth quarter was 84% compared to 81.9% in the prior year. The year-over-year increase was driven by growth in unit volume, operational efficiencies and the net impact of price increases and changes in product mix. Total operating expenses in the fourth quarter were $12.3 million, up 36% over prior year. This increase was due to additional surgeon education programs, increased investment in market development and awareness activities, cost associated with the launch of Avive Soft Tissue Membrane, and expansion of our sales team and leadership structure. These investments are driving growth in the company’s operating expenses, but importantly at a lower rate than sales growth, demonstrating the continued operating leverage of our business model. Sales and marketing expenses in the fourth quarter were $8.3 million up 43% over prior year. As a percentage of revenue, sales and marketing expenses improved to 73% compared to 75% in the prior year fourth quarter. And as Karen mentioned, we ended the quarter with 51 direct sales reps, up from 41 at the end of 2015. However, 7 of the 10 net sales rep additions during the fourth quarter – occurred in the fourth…

Karen Zaderej

Analyst · JMP Securities. Please proceed with your question

Thanks Steve. Before we close, I would like to highlight a few investor events in the coming months that we will be participating in. The BTIG Annual Medical Technology, Diagnostics and Healthcare IT Conference in Snowbird, Utah, March 1 and 2, the 29th Annual ROTH Conference in Dana Point, California on March 13, the Canaccord Genuity Musculoskeletal Conference in San Diego, California on March 14 and the Oppenheimer 27th Annual Healthcare Conference in New York City on March 21. Information about these events will be available on the AxoGen website. In closing, our efforts to execute against our strategic initiatives focused on building market awareness, educating surgeons and developing advocates, growing the body of clinical evidence, executing on our sales plan and expanding new products and applications in nerve repair. And these have resulted in record revenues and have positioned AxoGen to continue to lead and grow the emerging peripheral nerve repair market. We are building awareness and expanding usage of our products with innovator and early adopter surgeons and are excited to be moving towards developing the middle adopter segment of the nerve repair market. We are introducing our products portfolio to fellows allowing us to train the next generation of nerve repair surgeons. And we will continue to expand our portfolio of products and develop new nerve repair applications where we believe we can bring meaningful solutions to current clinical challenges. Before taking questions, I want to welcome our new investors and thank all of the members of the accident team for their commitment to helping patients with nerve injuries. At this point I would like to open up the line for questions. Operator?

Operator

Operator

At this time we will be conducting a question-and-answer session. [Operator Instructions] Our first question comes from the line of Dave Turkaly of JMP Securities. Please proceed with your question.

Dave Turkaly

Analyst · JMP Securities. Please proceed with your question

Thanks and just a firm one just a point of clarification, the guidance for ‘17, the 40% growth I was just curious, are you including any contribution from the new products. And as a quick follow-up on that if we are looking at sort of $16 million in incremental sales, I was wondering if you might provide any color on sort of the breakout between AxoGuard and Avance, the mix there and do we expect potentially AxoGuard continues to maybe become more of your mix to grow a little faster in 2017?

Karen Zaderej

Analyst · JMP Securities. Please proceed with your question

So first on the new products on – if you remember on AcroVal, we have said that AcroVal will always have modest revenue, it has no disposable component, it’s a capital project, it’s important part for our overall treatment algorithm and that it provides surgeons a way to measure their outcomes, but the revenue is not material, it is included in the guidance, but it’s not material. Avive, we believe is a great and important part of our overall portfolio, but we think surgeons will adopt in the same way they have adopted nerve repair products in the past which means that they will try a few products and then they will wait and see outcomes. And so we did not included in our thinking about the 40% growth, but we also believe it will be small this year. This year we are building a base that it really start to move into its rightful place next year. So well, it’s not included and it’s also not material in terms of the amount of revenue that it will provide in that first year. So we think it will continue obviously to grow. In terms of your question about mix, historically we have seen that our revenue for Avance has been a little more than a half of our revenue in total. We haven’t given any kind of breakdown in terms of forward booking projections, but that’s actually been consistent over the last several years. So historically you can see what our mix has been. [Technical Difficulty] And so Avive is really an ideal material to use in that type of application where the surgeon is wanting to separate tissue layers and again modulate inflammation.

Dave Turkaly

Analyst · JMP Securities. Please proceed with your question

Thanks a lot.

Operator

Operator

Our next question comes from the line of Tao Levy of Wedbush Securities. Please proceed with your question.

Tao Levy

Analyst · Tao Levy of Wedbush Securities. Please proceed with your question

Great. Thanks. Good afternoon.

Karen Zaderej

Analyst · Tao Levy of Wedbush Securities. Please proceed with your question

Thank you.

Pete Mariani

Analyst · Tao Levy of Wedbush Securities. Please proceed with your question

Hello.

Tao Levy

Analyst · Tao Levy of Wedbush Securities. Please proceed with your question

I think you haven’t provided this type of guidance in the past, but given that you are breaking out your active accounts, should we assume that that number roughly increases by 40% next year as well kind of in line with your revenue growth?

Karen Zaderej

Analyst · Tao Levy of Wedbush Securities. Please proceed with your question

So we believe that our revenue growth will continue be a combination of driving penetration in existing active accounts as well as adding new active accounts. Actually I think our primary driver will be driving penetration that’s the bigger piece. New active accounts come in a much smaller revenue dollar than obviously the opportunity exists to drive penetration. And so as we go forward in the next year, well, I think we would grow, certainly we will be adding new active accounts, it may not be at the same rate and I would not think that be detrimental to our revenue growth.

Tao Levy

Analyst · Tao Levy of Wedbush Securities. Please proceed with your question

Got it. And just maybe for clarification and so when you look at your 452 number of active accounts and you mentioned is around 5,100 centers out there, so it’s a little less than 10%, that doesn’t obviously mean that you are 10% penetrated in your opportunity, right, I mean that’s you are significantly lower than that within each of your active accounts, is that the right way?

Karen Zaderej

Analyst · Tao Levy of Wedbush Securities. Please proceed with your question

Actually, it’s true and in fact in our active accounts the level of penetration is usually very light. Our threshold for calling something an active account is just that they have got a very basic reorder patterns that are doing at least six orders in the last 12 months. And at that level, it’s a tinny single-digits penetrated in most cases. So we have got a lot of room for upside growth and that’s actually why I think that our biggest opportunity is driving penetration in the active accounts, because we are such an entry level penetration in the accounts that we are in.

Tao Levy

Analyst · Tao Levy of Wedbush Securities. Please proceed with your question

Got it, okay. And just lastly maybe for Pete, should we expect higher G&A expenses this coming year related to the either having to fix the internals accounting controls or is that not a meaningful expense this year?

Pete Mariani

Analyst · Tao Levy of Wedbush Securities. Please proceed with your question

Fixing the internal controls won’t drive additional significant G&A expense now. I think we have made some additions in the G&A line. We will continue to see some growth as necessary as we continue to grow, but not due to the controls this year.

Tao Levy

Analyst · Tao Levy of Wedbush Securities. Please proceed with your question

Okay, great. Thank you very much.

Karen Zaderej

Analyst · Tao Levy of Wedbush Securities. Please proceed with your question

Thank you.

Operator

Operator

Our next question comes from the line Bruce Jackson of Lake Street Capital Markets. Please proceed with your question.

Bruce Jackson

Analyst · Lake Street Capital Markets. Please proceed with your question

Hi, nice quarter. If I could challenge the remediation for the material deficiency, the way these things usually work [indiscernible] a year later when your auditors come in and then you get the final green light there everything is okay, so can you just tell us the process for fixing everything, you have made provisions to the procedures and then you are going to see how they are work and then should we just assume that the final audit takes place about a year from now, is that the way to think about it?

Pete Mariani

Analyst · Lake Street Capital Markets. Please proceed with your question

Yes, that’s exactly right, Bruce. I mean, the Sarbanes Oxley test is an annual test with our auditors. We have certainly made modifications already. We will continue to – and we have modified controls and we have modified procedures and we will continue to maintain that and we will test those ourselves, manage them well on a regular quarterly basis. So we are going to have confidence in that a lot sooner than what will show up in a formal Sarbanes Oxley 404 certification.

Bruce Jackson

Analyst · Lake Street Capital Markets. Please proceed with your question

Okay. And then just a quick question on the sales hiring plans for 2017, do you still plan to make a few adds to the sales force and do you have a target?

Karen Zaderej

Analyst · Lake Street Capital Markets. Please proceed with your question

Yes. Absolutely, we still see room for expansion in adding territories as well as splitting territories as they start to get above theoretical a peak level which we have set as – at about $2 million or above number. So we still see room to add. This year, we think we will add five to ten additional direct sales associates. The majority of those will probably be in the later half of the year, but we will add reps.

Bruce Jackson

Analyst · Lake Street Capital Markets. Please proceed with your question

Okay, great, that’s it for me. Thank you.

Operator

Operator

There are no further questions at this time. I would now like to turn the call back over to the President and CEO, Ms. Karen Zaderej for closing remarks.

Karen Zaderej

Analyst · JMP Securities. Please proceed with your question

Thank you, Tim. And I want to thank everyone for joining us on today’s call. I look forward to seeing many of you in person at one of the upcoming investor events and we look forward to speaking with you during our Q1 conference call in May. Thank you.

Operator

Operator

This concludes today’s conference. Thank you for your participation. You may disconnect your lines at this time. Have a wonderful evening.