Earnings Labs

AxoGen, Inc. (AXGN)

Q3 2017 Earnings Call· Wed, Nov 1, 2017

$41.48

-1.30%

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Transcript

Operator

Operator

Greetings and welcome to the AxoGen Incorporated Third Quarter 2017 Financial 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. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Patrick Till. Please begin Mr. Till.

Patrick Till

Management

Thank you, operator and good afternoon, everyone. Thank you for joining us today for the AxoGen Inc. conference call to discuss the financial results for the third quarter ended June 30, 2017. 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'd like to remind you that during the course of this conference call, the Company will be making 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 limitations, the Company’s Forms 10-Q and 10-K 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 limitations, statements regarding product acquisition and/or development, product potential, 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, President and Chief Executive Officer of AxoGen. Karen?

Karen Zaderej

President

Thanks, Patrick and good afternoon, everyone. Welcome to our third quarter 2017 conference call. Joining me today is AxoGen’s Chief Financial Officer, Pete Mariani. I'd like to begin today’s call with a review of our third quarter highlights, a brief Company overview and an update on our key strategic initiatives. Pete will then provide a review of our third quarter financial results and review financial guidance after which time we will open up the call to Q&A. We are pleased to report another successful quarter. Third quarter revenue grew 43% to a record $16 million. Our year-to-date growth is 46% with revenue of $43.5 million. It is gratifying to see surgeons expanding use of our product portfolio in oral and maxillofacial procedures. In addition we see increased adoption by hand surgeons and response to data in mixed and motor nerve repair as well as long-gap nerve repair. As a reminder, last quarter we announced a change in our addressable market opportunity due to expanded use of the AxoGen product portfolio in oral and maxillofacial procedures including nerve repair during mandible reconstruction due to benign tumor resection. We believe this additional application of our product portfolio moved current addressable market opportunity to $2 billion in our current markets of trauma, upper extremity, and oral and maxillofacial surgery. As in prior quarters, our revenue growth is continuing from both active and new accounts as we continue to build and strengthen our commercial team. This increased focus on commercialization will allow us to drive penetration of our existing markets, expand into new applications, introduce new products and build global markets. These efforts along with the continued development of our certain education events, market awareness activities and further development of clinical data are helping surgeons develop confidence in the adoption of the AxoGen platform…

Peter Mariani

Management

Thanks, Karen. Third quarter revenue grew 43% to $16 million. The growth in revenue 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, 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 develop their treatment algorithms. Gross profit for the third quarter was $13.5 million an increase of 42% compared to the prior year's third quarter. Gross margin for the third quarter was 84.4% compared to 84.9% in the prior year. Total operating expenses in the third quarter were $15 million up 41% over the prior year. The increase includes continued investment in our sales force, market development and awareness activities, clinical, R&D and general corporate expenses associated with our growth including non-cash stock comp expenses. 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 third quarter were $9.5 million up 34% over the prior year. As a percent of revenues sales and marketing expenses in the quarter improved to 59% compared to 63% in the prior year. As Karen mentioned, we currently have 53 direct sales reps up from 44 this time last year. We completed four national education programs in the quarter and 12 year-to-date and anticipate conducting three additional events this year for a total of 15. Research and development spending in the third quarter was $1.8 million compared to $1.1 million in the prior year's third quarter. R&D costs include product development and expenditures for clinical efforts…

Karen Zaderej

President

Thanks, Pete. Before we close, I'd like to highlight a few events in the coming months that we will be participating in. Our second annual AxoGen Analyst and Investor Day in New York City will be on November 20. The 29th Annual Piper Jaffrey Healthcare Conference in New York City on November 28th, Guggenheim’s 5th Annual Healthcare Conference in Boston on December 13th, the Trout Group Annual one-on-one Management Access Event in San Francisco January 9th through the 11th and the 2018 combined meeting of the American Association for Hand Surgery, American Society for Peripheral Nerves, and the American Society of Reconstructive Microsurgery in Phoenix on January 10th through the 16th. I mentioned our second annual Analyst and Investor Day in New York City on November 20th. I invite you to join me, Pete, and other company executives, as well as our surgeon thought leaders for a discussion of AxoGen’s comprehensive platform for nerve repair. I look forward to seeing many of you there. Information about all of these events will be available on the AxoGen website. In closing, our efforts to executing and start 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. We continue to produce record revenues and have positioned AxoGen to lead and grow our platform for peripheral nerve repair. We are building awareness, developing additional clinical data and expanding use of our products with innovator and early adopter surgeons and are excited to be moving toward developing the middle adopter segment of the nerve repair market. We are also pleased to see expanded use in oral and maxillofacial procedures and increased adoption and mix in motor nerve repair as well as long gap nerve repair. We're introducing our platform for nerve repair to fellows allowing us to train the next generation of never repair surgeons. We are creating a world class commercial team that will continue to scale and enable us to drive growth in current and expanded applications where we believe we can bring meaningful solutions to current clinical challenges. And we will continue to expand our platform and develop new nerve repair applications challenging the norms of historical repair options and evolving the practice of nerve repair. Before taking questions, I want to welcome our new investors and thank all the members of the AxoGen team for their commitment to helping patients with nerve injuries. At this point, I'd like to open up the line for questions. Operator?

Operator

Operator

Thank you. [Operator Instructions] Our first question comes from Richard Newitter with Leerink Partners. Please proceed.

Unidentified Analyst

Analyst · Leerink Partners. Please proceed

Hi Karen and Pete. This is Jaime on for Rich. Congrats on a nice quarter. I wanted to follow up on 2018 guidance that you introduced of course you're guiding to again above 40% revenue growth and greater than 80% gross margin. So a question that I have is, is this kind of reflective of a trend that you expect in 4Q and kind of what gives you confidence in this above 40% revenue growth heading into 2018?

Peter Mariani

Management

Well, thanks Jaime. Yes, we’re pleased to be able to give that guidance for 2018. I think we've seen nice momentum in the business. We continue to see good momentum in our core trauma business. We're seeing nice expansion into the oral maxillofacial space and when we look at our expansion opportunities that we'll talk more about on the 20th we think all of that together gives us confidence of where we could continue to maintain this minimum growth profile of at least 40%.

Unidentified Analyst

Analyst · Leerink Partners. Please proceed

Okay, great and then just to follow up on that, so you mentioned of course the new market opportunities and just on that front, do you guys actually factor this into the 2018 guidance that you're giving or should we be viewing this more as upside and after another way when do you think we will start seeing some sort of revenue contribution from these opportunities assuming you're launching on at least one in the middle of November?

Karen Zaderej

President

So when we give the guidance on the business we're really thinking about the total business, but you need to think about nerve repair as we said in the past that surgeons are going to remain we believe relatively cautious adopters. The new segment that we move into will have revenue in 2018, but surgeons will still continue to want to build data and understand in their hands with the outcomes are. And so we'll see the sort of ramp up that we've seen in each of the segments in the past where there's an initial start and then weak period as surgeons begin to adopt the new technology.

Unidentified Analyst

Analyst · Leerink Partners. Please proceed

Great thanks.

Operator

Operator

Thank you. Our next question comes from Dave Turkaly with JMP Securities. Please proceed.

David Turkaly

Analyst · JMP Securities. Please proceed

Thank you. Obviously 40% another impressive year on tap it appears so. I was wondering if you might be willing to even share sort of what you think you might need to do from a rep standpoint or active accounts, do we consider that they grow sort of in line with your revenues as well here or any sort of details on some of the components that might get you to that 40% number?

Karen Zaderej

President

We're not quite ready to share the rep count. We will continue to expand. I mean the bottom line is we see expansion both in increasing penetration and active accounts and in adding new accounts and we'll do that through a strong execution plan which will include adding some capacity in our sales team. We're not quite ready to roll out those numbers actually I suspect on November 20th we'll have a little more information to share.

David Turkaly

Analyst · JMP Securities. Please proceed

Great. And then if you could look at some of these new up market opportunities, breast and the lower limb joint replacement neuromas, do you think as you move forward will you expand the sales force into specialist areas where you add distributors maybe that focus on potentially a different area or can you kind of attack all these indications with your core direct group?

Karen Zaderej

President

Well, actually we already have some clinical specialists within our sales team who help in selected applications especially if surgeons are starting up and I would continue to see that in the future where we would have some clinical specialists. Remember from an account standpoint these accounts and the applications are overlapping. So we will always have a rep who is the expert in that area and the primary contact for the account, but we will have clinical specialists who will help support selected applications.

David Turkaly

Analyst · JMP Securities. Please proceed

Last one if I may, just quickly because it's a topic of interest amongst many companies, did you have, are you willing to break out any sort of impact from hurricanes or storm related disruptions in the quarter? Thank you very much.

Peter Mariani

Management

Yes, Dave I think it was immaterial. I think as we look at it, it did have some impact as in both Texas and Florida, but not more than a few hundred thousand dollars.

David Turkaly

Analyst · JMP Securities. Please proceed

Thank you.

Operator

Operator

Thank you. Our next question comes from Tao Levy with Wedbush Securities. Please proceed.

Unidentified Analyst

Analyst · Wedbush Securities. Please proceed

Hi Karen, hi Pete. This is Na [ph] I’m on for Tao. So one of the questions that I have is regarding your - like the guidance for 2017it is same the revenue is continuing to be above 40%. And I'm just looking at the fourth quarter here. Sequentially - do you see continuing on this momentum, even if you keep the same revenue going, you're going to be above 45% growth year-over-year for 2017. Is that like a fair assumption or do you see like a sequential slight decrease as maybe you are ramping up the reps, spending more energy there.

Peter Mariani

Management

Yes, no we don't see any negative momentum in the business at all. Now the way we are looking at this now is we're really not trying to guide and I think all of you have seen. We're not trying to guide to a specific outcome. We're really guiding to a minimum growth profile here and so we see nothing in the fourth quarter that would cause us to think that there are some concerns in the fourth quarter. Our business has historically had some seasonality where the second and third quarter you have these very nice sequential step ups from Q1 to Q2 and then the Q3 and then Q4 and Q1 can be flattish or up a little bit sequentially. No reason to think that historical patterns wouldn't be the same here, but again our answer is that we're not trying to guide to a specific outcome and we're more interested in continuing this momentum and looking at the opportunity in 2018 to continue to run at least 40% at the top line.

Unidentified Analyst

Analyst · Wedbush Securities. Please proceed

Great and another question on productivity per rep, do you see like a slight sequential increase this quarter?

Peter Mariani

Management

Yes, no we continue to see, I mean when you look at our active account growth of 36%, but our revenue growth in the quarter was 43% so obviously our same-store sales and sales rep productivity is increasing on a year-over-year basis and we see that, we track it, both year-over-year and sequentially and the group is doing a nice job of continuing to build their effectiveness in the market.

Unidentified Analyst

Analyst · Wedbush Securities. Please proceed

Great. That will be all from me. Congratulations on a good quarter.

Peter Mariani

Management

Thank you.

Karen Zaderej

President

Thank you.

Operator

Operator

Thank you. Our next question comes from Bruce Jackson with Lake Street Capital Markets. Please proceed.

Bruce Jackson

Analyst · Lake Street Capital Markets. Please proceed

Hi everyone, nice quarter.

Peter Mariani

Management

Hi Bruce.

Bruce Jackson

Analyst · Lake Street Capital Markets. Please proceed

So I just wanted to hum in on the account number which looked really good this quarter and wanted to know if we could get some more color on whether or not you've got an increase in the number of stocking accounts and whether you're starting to see some adoption by surgeons outside of your core target market?

Karen Zaderej

President

So, stocking accounts are an important thing for us to do as we move forward, because it helps to make sure that we don't miss cases. Today for the most part we are still ordered four cases and so a lot of our revenue is not based on stocking. Our revenue is based on procedures. But we're in trauma and trauma is not a scheduled case and so because of that we know we miss cases. So getting inventory stocks in the hospitals is strategically important to us. We are seeing some increase in the stocking. It's not a significant part of our revenue. It’s in fact as a percentage of our revenue, it still remained relatively flat. It appears that hospitals do want to go through a period of usage to establish a re-order pattern, so that they're comfortable having the inventory and so it does take some time to establish that and then working with the account to do what we call par level order which is an established amount that they keep on stock and they replenish as they use it.

Bruce Jackson

Analyst · Lake Street Capital Markets. Please proceed

Okay. And then the other thing we've discussed in the past are the so-called middle adopters who are trailing behind the early adopters. Do you have any updates through anecdotal stories about the progress you're making with those surgeons?

Karen Zaderej

President

I would still say that it is something that we're working towards. We're not at that point yet. But anecdotally you do see significant interest from surgeons that we haven't met before and you see that at the conferences like the Hand Society Meeting and the Oral Maxillofacial meeting that we had earlier this year in this quarter. We sponsored a panel meeting at the Hand Society. It was I believe the largest that we had and what was interesting to me is as I looked around the room, there were a lot of people I didn't know in the room. So we're bringing in new surgeons, surgeons who have not before been interested in the AxoGen portfolio and algorithm of nerve repair and are now gaining interest. And the other interesting thing that I noted in that panel is that the questions and the tone of the questions have totally changed. If I go back a year or two ago, the questions were about the science and how did the product work and really trying to understand the mechanism of action. The questions today are around how do I get inventory stocked in my hospital? How did you get it approved to your – committee? What’s the right inventory to have for this type of case mix? How do you manage your patient flow and being able to order? Again, this is a trauma, so if the trauma happens today, if they don't have inventory stocked in the hospital, they have to delay the patient repair until tomorrow, so that we can get them inventory tomorrow. And so, those questions around logistics and how to use the product, not should they use the products. I think that's a very interesting change and a good signal that surgeons are starting to think about how would I use this in my practice?

Bruce Jackson

Analyst · Lake Street Capital Markets. Please proceed

All right that’s super. Thanks for taking my questions.

Karen Zaderej

President

Thank you, Bruce.

Peter Mariani

Management

Thanks Bruce.

Operator

Operator

There are no further questions. I would like to like the floor over to Karen for closing comments.

Karen Zaderej

President

Thank you, operator and I want to thank everyone for joining us on today's call. I look forward to seeing many of you in person at our Analyst and Investor Day or at another one of the upcoming Investor events. Thank you very much.

Operator

Operator

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