Monday, 12 August 2013

Baxano Surgical's CEO Discusses Q2 2013 Results - Earnings Call Transcript

Executives

Mark Klausner – IR

Ken Reali – President and CEO

Joe Slattery – EVP and CFO

Analysts

Matt Miksic – Piper Jaffray

Greg Chodaczek – First Analysis

Jason Wittes – Brean Capital

Baxano Surgical Inc. (BAXS) Q2 2013 Earnings Call August 8, 2013 4:30 PM ET

Operator

Good afternoon ladies and gentlemen, and welcome to the Baxano Surgical, Conference Call. As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Mr. Mark Klausner of Westwicke Partners.

Mark Klausner

Thanks, operator. Joining us on today’s call are Baxano Surgical’s President and Chief Executive Officer, Ken Reali; and its Executive Vice President and Chief Financial Officer, Joe Slattery.

Before we begin, I would like to caution listeners that certain information discussed by management during this conference call will include forward-looking statements covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual results could differ materially from those stated or implied by our forward-looking statements due to risks and uncertainties associated with the company’s business.

The company undertakes no obligation to update information provided on this call. For a discussion of risks and uncertainties associated with Baxano Surgical’s business, I encourage you to review the company’s filings with the SEC, including its Annual Report on Form 10-K for the year-ended December 31, 2012; the Form 10-Q for the quarter ended March 31, 2013; the Form 10-Q for the quarter ended June 30, 2013 which the company plans to file with the SEC on or about August 14, 2013; and the Form 8-K filed with our earnings release.

Baxano Surgical disclaims any obligation to provide any forward-looking statements or to update any forward-looking statements made during the course of this call.

In addition, please note that we will discuss certain Non-GAAP and pro forma financial measures on this call, which should be considered as supplement to and not as substitute for financial measures prepared in accordance with GAAP. A reconciliation of these Non-GAAP and pro forma measures to the comparable GAAP measures is included in the earnings release posted on our website at www.baxanosurgical.com in the Investor Relations section.

With that, it’s my pleasure to turn the call over to Baxano Surgical’s CEO, Ken Reali.

Ken Reali

Thank you, Mark. On today’s call, I will review the second quarter operating results for the new Baxano Surgical, and then Joe will discuss our financial results in greater detail. I will then provide some additional color on the progress we are making on our key operating priorities for 2013.

During the second quarter, Baxano Surgical reported $3.9 million in revenue. Since the merger of TranS1 and Baxano Incorporated closed on May 31, we did not own both businesses for the full quarter.

On a pro forma basis, revenue would have been $5.7 million for this quarter, in line with our guidance of $5.6 million to $6.3 million. Our surgeon customers completed 153 domestic AxiaLIF procedures, up from the 132 in the prior quarter. This represented our first quarter of meaningful, sequential domestic case growth since early 2009, when the Category III code was put in place.

Since the Category I code became effective on January 1st of this year, we have continued to work on broadening reimbursement coverage, and are beginning to see the results of these efforts as we have experienced increasing numbers of AxiaLIF comeback surgeons. 69 VEO cases were performed in the quarter, a strong sequential up-tick from the prior quarter, demonstrating our continuing market acceptance.

679 iO-Flex cases were performed in the quarter, down sequentially and slightly up year-over-year. iO-Flex case count was impacted by the unit version. We are beginning to see a rebound in procedure volumes and believe strongly in the future prospects for this product.

Our cash and investments increased $5 million this quarter to $19.7 million due to the $17.2 million financing completed in conjunction with the merger, offset by cash used in operations and merger-related expenditures. Since the Baxano acquisition closed on May 31, we have been working diligently on integration, and we have already taken many steps to realize the anticipated cost synergies.

We believe we already realized over $3 million in cost synergies during this past quarter. As an example of these efforts, headcount now stands at 139, down 17 employees since the announcement of the acquisition. We have selected our sales leadership and management and have designated sales people for each respective territory. We’ve also made significant progress in cross training our sales team. Back office operations integration is also continuing to progress smoothly.

At the end of the quarter, we executed the final agreement with the U.S. Department of Justice, related to the subpoena issue in October 2011. As previously announced, we agreed with the staff of the Department of Justice to settle this matter for $6 million, and include this amount in the fourth quarter of 2012. The $6 million settlement plus accrued interest of 2% will be paid in nine quarterly installments which began in July 2013.

As part of the settlement, Baxano Surgical has entered into a corporate integrity agreement with the HHS OIG, and with this agreement we are advocated to maintain or established compliance program and undertake a series of compliance-related obligations including training and monitoring procedures and demonstrated maintenance of compliance obligations in the next five years.

This has been a long process for us, and we are pleased to put this behind us and return our full focus to running the business.

I would now like to turn the call over to Joe to review the financial results from the second quarter. Joe?

Joe Slattery

Thank you, Ken. I want to begin today by briefly reviewing our reported financial results until the selected closing of the Baxano acquisition on May 31. I will then review pro forma results for the combined company, as if Baxano has been all periods discussed.

For the second quarter, we reported worldwide revenues of $2.9 million, an increase of 12.1% over the second quarter of last year. Revenues increased primarily due to the inclusion of one month of acquired revenues and an increase in VEO revenues offset by a 21% decline in AxiaLIF revenue, as we worked to continue to recover the business lost due to the change in the investment.

Gross margins were 67%, a decrease from 74% in the prior year period. The decrease in gross margin was due primarily to increased depreciation expense on reusable kits, increased royalty expenses and the new medical device tax that became effective on January 1, 2013.

Operating expenses were $11.1 million in the quarter, an increase of $2.2 million from the prior year period. The increase was due to the inclusion of one month of acquired expenses, as well as an inclusion of $1.7 million in one-time costs related to the merger and integration expense, as well as expenses related to the U.S. government settlement.

Net loss was $8.5 million in the quarter or $0.26 per share. Excluding the one-time costs referenced above, net loss would have been $6.9 million or $0.21 per share.

Turning to pro forma results. Revenues at $5.7 million for the second quarter were in line with our guidance of $5.6 million to $6.3 million and flat from the prior year period. Domestic revenues were $5.5 million, up slightly from last year’s revenue of $5.4 million. International revenues were fairly consistent at about $200,000.

Domestic AxiaLIF revenues were $1.8 million in the quarter, down 21% year-over-year, but up 7% sequentially. This quarter represented the first meaningful sequential increase in cases since the first quarter of 2009, when the Category II code was put into effect. 153 domestic AxiaLIF cases were performed in the quarter, as we began seeing results of the Category I code and our focus on comeback surgeons.

Year-to-date, we have seen 23 surgeons that hadn’t done an AxiaLIF case in over a year, performed 43 AxiaLIF cases. ASP per AxiaLIF case was approximately 11,600 hours. This is down sequentially due to a higher portion of cases being single level cases in the quarter. It seems to be expected as we see greater volumes from comeback surgeons who are more likely to perform single level cases in line with the Category I code.

Total domestic VEO revenue was $664,000 in the quarter, up 49% from the second quarter of last year, and up sequentially by 16%. 69 procedures were performed in the quarter, up 72% from last year and 30% sequentially due to continued interest in the differentiated system that allows direct visualization of the psoas muscle.

Pro forma, domestic iO-Flex revenues was $2.6 million in the quarter, a 15% increase from the prior year period, and a 9% decline sequentially. 679 procedures were performed in the quarter, down 8% than 741 in the prior quarter, due to some dislocation as we integrated the sales force.

Certain high volume iO-Flex users preferred the convenience by stocking inventory directly. This stocking revenue was approximately $150,000 in the quarter, consistent with the prior quarter.

Pro forma gross margin for the quarter was 65.7%, down 370 basis points from the second quarter of last year. The decrease in gross margin was due primarily to increased depreciation expense on reusable kits, increased royalty expenses, and the new medical device tax that became effective on January 1.

Pro forma operating expenses were $15.8 million in the quarter. This included $2.8 million in expenses related to the merger and the OIG settlement. Excluding this one-time expenses operating expenses declined $2.9 million, compared to the prior year quarter. This improvement reflects the initial cost synergies achieved from the merger.

Pro forma net loss in the quarter was $12.2 million and pro forma net loss per share was $0.27 versus a loss of $11.7 million, a $0.26 per share in the second quarter of 2012. Pro forma net loss excluding special items in the quarter was $8.4 million and net loss per share was $0.19, versus a loss of $11 million or $0.24 a share in the second quarter of 2012. Special items include a merger and integration expenses and charges related to the OIG settlement.

Moving onto the balance sheet. Our cash and investments increased $5 million this quarter to $19.7 million, due to the $17.2 million financing completed in conjunction with the merger, offset by cash used in operations and merger-related expenses. Accounts receivable days sales outstanding were 60 at quarter end compared to 64 in the prior quarter after adjusting for the receivable from the China stocking order which has extended premium terms. Inventory turns were 1.2 at quarter end.

Turning to guidance, we partly anticipate that revenues in the third quarter of 2013 will be in the range of $5.6 million to $6.2 million, reflecting the seasonality of the summer months. Based on the results in the first half of the year, and our current outlook for the balance of the year, we have reduced our annual guidance to a range of $23.5 million to $25.5 million, and expect to exit the year poised for meaningful growth.

Taking into account with that channel acquisition and the financing transactions, we believe that we have adequate cash in investments to sustain the business midway through the first quarter of 2014. We are currently in the process of evaluating debt financing alternatives that would expand our cash runway through the end of 2014.

I will now turn the call back over to Ken. Ken?

Ken Reali

Thanks, Joe. I would now like to provide you with an update on our key operating goals for 2013. These goals are: number one, fully integrating TranS1 and Baxano to the focus on achieving revenue and cost synergies; number two, leveraging our accomplishments in 2012 to generate revenue growth in our AxiaLIF and VEO products; number three, continuing our efforts to increase the number of private payors that cover AxiaLIF; number four, meeting our product development goals which include the iO-Tome launch in the fourth quarter, and development of the MIS pedicle screw system product; and number five, generate an additional clinical and economic data to differentiate our products from current standards of care.

As mentioned previously, we closed the acquisition and financing transactions on May 31, and officially changed our name to Baxano Surgical. We have made good progress on the sales force integration and our new sales leadership and management has been in place since May. We have also successfully combined two sales forces into one integrated sales team.

Any integration of two sales forces naturally results in some dislocation and as we have discussed above, it had some impact on our business in the quarter relative to the iO-Flex products. We are working diligently to protect the current phase of business with both companies, while also obtaining anticipated costs to synergies.

We have completed the initial cross training of our integrated sales force and expect that by the end of the third quarter, the entire sales force will be fully qualified to sell and cover cases for all of our marketed products. We have already integrated many of the back office operational processes and expect the remaining aspects of integration will be fully completed by the end of 2013.

As we seek to generate AxiaLIF revenue growth, we have been pleased with the initial results from our focused and comeback surgeons. We had 23 surgeons that had returned to AxiaLIF this year and expect that this number will continue to grow. In the quarter, almost 10% of our cases were done by comeback surgeons. As our sales force becomes totally trained at all class, we are now also increasing our focus on cross-selling AxiaLIF to iO-Flex users.

We believe increasing reimbursement coverage and the improved AxiaLIF implant and instruments will allow us to build the surgeon base and increase procedure volume. We also continued to expect positive revenue results from VEO, which will benefit from our large sales force in cross-selling abilities with iO-Flex. We are continuing our focus on surgeon training, holding larger scale trainings remotely and smaller group trainings that take advantage of our training center and allowing North Carolina and our state of the opened West Coast training center in San Jose, California. All of our surgeon training events now incorporate iO-Flex into the training curriculum.

On the reimbursement front, we estimate that we currently have over 100 million covered lives for our AxiaLIF procedure, which is consistent with last quarter. We believe that this number will continue to grow and are employing a two-pronged strategy to continue to expand the coverage. First, we are leveraging surgeon demand and lifting clinical data to have procedures pre-authorized on a case-by-case basis.

This strategy applies to payors that still regard pre-sacral interbody fusion with our AxiaLIF implant as an investigational or experimental procedure. We are starting to gain traction with this strategy and are getting some cases approved with private payors on an individual basis. While we feel this tactic will eventually lead to broader coverage of our Category I code by the private payors, it will take time.

Apart from the cases approved in the code, we also have scheduled cases that were cancelled due to lack of coverage. While we are encouraged by the interest surgeons have in performing the procedure, it points out the effort that still needs to go into broadly in our private payor coverage.

Secondly, we continue to have a further data published which have increased the body of evidence we are sharing with medical directors, and help over-term investigation for experimental policies.

Turning to our R&D efforts, we are continuing to prudently invest to broaden and deepen our product lines. Our primary near-term focus is launching iO-Tome, an instrument used with a TLIF procedure to perform minimally invasive facetectomy, which we expect to launch fully by the end of the year. We are also working on MIS [ph], a minimally invasive pedicle screw system to be used with our AxiaLIF and VEO products, which we anticipate launching in 2014.

We continue to be active on the clinical front. We had four papers submitted for peer review and four papers accepted for publication in the quarter. These include the first two VEO clinical papers along with the positive AxiaLIF 2-Level paper. Now with the Category I code is in place, the number of sites for the ramp randomized clinical trial comparing AxiaLIF with TLIF is growing. We currently have eight sites enrolling patients, and we expect two more to be added soon which will be boost our enrollment numbers.

We are also focusing on closing out the original iO-Flex study and working on the STRiDE study. The one year data from the original iO-Flex study shows that the use of iO-Flex can improve clinical outcomes and health economics versus decompression performed with traditional instruments.

The results from the one year follow-up paper will be submitted for publication this year. You will have two year data from this study that reduce the effectiveness of the iO-Flex instrument based on based derived clinical outcomes in the middle of next year. The STRiDE study seeks to demonstrate the clinical value of the iO-Flex instruments used in the decompression for a stable spondylolisthesis indication, where fusion may not be necessary. This study currently is on track to complete enrollment of 50 patients by the end of the year.

We believe the progress that we have made this year including the Baxano acquisition, the re-launch of AxiaLIF, and the continued VEO market penetration, will position us to deliver revenue growth in the coming quarters. We feel we have positioned the company well over the past couple of years and are pleased with where we sit today as the new Baxano Surgical.

We will focus solely on the minimally invasive segment of the spine market. We believe this is the most attractive opportunity in spine, as we have expected to far outpace the growth of the traditional spine segment. We believe that our current and planned MIS focus products represented strong platform for growth. The positive MIS market dynamics coupled with our strong surgeon training and the maturing of our sales team, will allow us to execute on our growth plans.

With that, I’d like to open the call to take your questions.

Question-and-Answer Session

Operator

Thank you. (Operator Instructions) And the first question is from Matt Miksic of Piper Jaffray. Please go ahead.

Ken Reali

Good afternoon, Matt.

Matt Miksic – Piper Jaffray

Thanks. Good afternoon. Do you hear me okay?

Ken Reali

We can hear you great, Matt.

Matt Miksic – Piper Jaffray

So thanks for taking my questions. One – and I have to apologize for this, there is a lot of people I think were hoping back and forth between – there is sort of an emergency call here going on, with other company in our space. But can you explain – and again I apologize for this, but the differentiator between pro forma second quarter and this $3.9 million. I am just looking to the press release trying to understand, and I am sure you covered in your prepared remarks. So pro forma second quarter revenues $5.7 million, reported $3.9 million?

Joe Slattery

Sure, Matt. It’s Joe. Yes, we – it does help a lot to get the schedules on the press release. We’ve had a couple of moving pieces in traditional non-GAAP measures or the one-time items, and then we’ve got pro forma. Basically pro forma is said for two companies together and put some adjustments on that, and then the one-time or the non-GAAP measures, so removing the OIG and the merger expenses. So the GAAP revenues were $3.9 million and that includes one month of the sales of the legacy Baxano products.

Matt Miksic – Piper Jaffray

Okay. So this is just, I think similar to last quarter you were saying had you owned the other assets for all three quarters then it would have been $5.7 million, that’s the point you’re making?

Joe Slattery

Correct.

Matt Miksic – Piper Jaffray

Okay. That’s the great point, but thanks for that. And again I apologize for being little deck [ph] here around that. I wanted to get a sense of the environment on the MIS side, which is – when I say MIS, I guess I mean, broader MIS including lateral. Can you talk a little bit about just maybe – just what sort of wins you have had, what sort of interests you’ve had. There is an awful lot of competition kind of converging around that space sort of small, some large. And I just looked to the year, if you think you have what you need in terms of the full system. Are there implants that you need, or are you with what you’ve now already having some successes and how?

Ken Reali

Yes, Matt that’s a great question. And I’ll start off by saying that, that what we anticipated by acquiring Baxano was a greater access to MIS focused spine surgeons, whether that be orthopedic spine or neuro. And we have not been disappointed in that whatsoever. What we found early on in our diligence before the acquisition was not a large overlap in the customer bases.

And early on we’ve been able to, for instance with iO-Flex surgeons, develop that report and gained that access and we are able to introduce them to AxiaLIF and VEO. And these are surgeons that we would not normally have an audience with. And at the same point, a lot of our loyal AxiaLIF and VEO surgeons that were not predominantly users of iO-Flex, we were also able to and have been able to introduce to the iO-Flex instrumentation for their decompressions.

So the early results on this have been positive, and certainly our sales force is still getting fully cross trained. So I don’t think we’ve probably maximized that opportunity. We continue to feel that the MIS market segment will encompass a larger and larger portion of the traditional market segment. Our estimates today are about 25% of the total spine market. If you count lateral, and you count things like AxiaLIF and percutaneous pedicle screws, so when we look at the market segment and the opportunity we expect over the next four to five years, MIS procedures to still approaching half of the traditional spine market.

So when we look at our portfolio today of AxiaLIF and VEO and iO-Flex and then by the end of the year, iO-Tome, and then by next year, advance our MIS pedicle screw system, we’re starting to develop a real focus albeit strictly lumbar with the minimally invasive procedures, all with the same type of mentality, Matt, of being minimal collateral damage to the spine. And our philosophy is if you do minimal collateral damage to spine, you’re going to ultimately improve outcomes, reduced complications and reduced costs in the healthcare system. And that’s certainly the philosophy of Baxano Surgical.

That’s the philosophy that our customers, our surgeon customers share as well. And we’ll actively continue to pursue more clinical data in that area, but also continue to look for products that we feel organically or through other means stick with that philosophy as well.

Matt Miksic – Piper Jaffray

That’s great. And thanks for that, Ken. The follow-up just on some of the dynamics that you’ve talked about with respect to surgeons who are heavy users of TLIF, surgeons who may be facing some pressure from payors, difficulty in getting sort of maybe less busier cases of instability or struggle or refuses [ph] or something like that approved, and the opportunity there to penetrate iO-Tome beyond perhaps what it would – where the company was reaching into before. Can you talk a little bit about that dynamic and maybe what you’re seeing so far?

Ken Reali

Yes, absolutely. And I think that works two ways based on your question. First of all, iO-Flex which is our decompression instrument can penetrate – the decompression procedures that are now…

Matt Miksic – Piper Jaffray

Yes, I am sorry to interrupt you, actually I meant iO-Flex but (inaudible) right.

Ken Reali

Yes, so think about that. Yes, so what we’re seeing with iO-Flex and certainly this is something that Baxano incorporates before the acquisition is really the good growth of decompression procedures as a surgical solutions with fusions where two or three years ago. And one of the goals of the STRiDE study which is stable spondylolisthesis is to show the effectiveness of iO-Flex, that instrumentation in that type of indication. So using the iO-Flex instruments in (inaudible) that should really get in and clean out the foramen.

What our surgeons like about that approach is they do not have to remove the facet joint when they use iO-Flex, but they can go in and clean out the foramen and not destabilize the spine. And many of them feel that that actually prevents a further surgical procedure down the road like a fusion, or like a TLIF in this case because they can keep the facet joint in place and hence maintain the stability of the spine.

But clearly just based on the medical necessity portion of that, and where payors are pushing back, that’s just continued opportunity for us to continue to grow the iO-Flex technology and instrumentation and decompression procedures. So that has been affirmed. We have – I was talking with a doctor – couple of doctors last week that just were affirming their view that iO-Flex based on its less invasive approach in clearing up the foramen reduces hospital stay in a typical Medicare occasion versus a standard decompression, because they don’t have to remove the facet joint, they can get full visualization of the neural elements and clean up the foramen then probably take them out, removing a big portion of the spine, those patients go home the next day while the typical other patient even on decompression, they are staying in the hospital two or three days.

So those are the type of results that we’re trying to capture that we think that clinical data will allow iO-Flex to continue to penetrate the market.

Matt Miksic – Piper Jaffray

Great. Thanks Ken, and thanks Joe.

Ken Reali

Thanks, Matt.

Operator

(Operator Instructions) The next question is from Greg Chodaczek. And excuse my pronunciation of First Analysis. Please go ahead.

Ken Reali

Greg Chodaczek. Welcome, Greg.

Greg Chodaczek – First Analysis

Ken, in terms of reimbursement, you have 100 million covered lives. I am assuming half are about Medicare. Can you talk about what type of patients had an AxiaLIF on – did you see any progress [ph] of Medicare patients come in over the last six months? And you talked about strategy going forward with data, but what’s going to get the big boys to finally decide that this is a real product and reimburse this thing?

Ken Reali

Right, that’s a great question, Greg. And certainly that sequential case growth that we saw for the first time, the 21 case up-tick here in the second quarter was driven larger by Medicare patients, and doctors that had a larger percentage of Medicare patients. So we had certainly seen that in pockets. Certainly our goal is to continue to grow those pockets. We have a focused strategy on surgeon that would do a higher proportion of Medicare patients and fusions, because that is a short-term opportunity to us until we get to the private payor, to big private players such as the United, Aetna and Cigna to fully cover the pre-sacral interbody fusion with AxiaLIF.

With that said, we have seen one-off cases approved by the private payors, and we continue to have I think a 50/50 shot at those cases. Some seem to get approved and some don’t. But our goal with that bottoms up approach is to show utilization and demand for the Category I code for this procedure, so when it comes time for that private payor to review the policy again, the fact that they see demand coupled with increased clinical data and publications, we’ll force them to make a coverage decision in our favor.

And that’s part of our strategy, but we continue to have surgeons come to our training center to get trained on AxiaLIF, and certainly their goal when they go back is to do Medicare patients which they know its covered and then work with us as well to try to get private payors to pay for cases.

So we really try to manage expectations there, because we do not want to alienate a surgeon that may get frustrated in not getting a case approved with the private payor. Many spine surgeons, Greg, are used to this because they went through cervical disk replacements, which was the last (inaudible) spine four or five years ago, and they remember what that’s like. Now surgical disks are more broadly recognized for coverage, but we can relate that back and certainly regain their support, because it’s real important that we not just target Medicare, but we also try to push the private payors for coverage on a case-by-case basis.

Greg Chodaczek – First Analysis

Okay. Thanks, Ken. And in terms of product synergy, have you seen any small up-tick in AxiaLIF based on seeing a surgeon who is an iO-Flex surgeon or vice-versa?

Ken Reali

That’s a great question. We have just started to see that. We actually have a surgeon in our training lab here in Raleigh, North Carolina last Saturday that was brought in to get used to an iO-Flex user and he was there to get trained on AxiaLIF. So as we’ve trained our sales force and integrated our sales force – it’s taken some time, probably a little longer to get the sales force integrated than we had initially hoped for, but some of that was delayed based on our closing time, but we’re just starting to see that.

What we’ve seen to a greater degree already especially in the past month or so is, you set the iO-Flex instruments in decompression by AxiaLIF and VEO surgeons. That’s a little bit of a shoulder hurdle to adoption and certainly it’s why we see iO-Flex rebounding strongly here going forward, and it just becomes the learning curve and the ability to adopt the iO-Flex instrumentation and the impression is a shoulder learning curve than learning a new fusion procedure.

Greg Chodaczek – First Analysis

And so that would be my next question is, do you see more synergies going that way, than a decompressing going to an AxiaLIF patient?

Ken Reali

I think in the short-term, yes, I think the longer-term it’s going to go both ways pretty strongly. Certainly there are many more iO-Flex customers than are our AxiaLIF or VEO, just because it’s a product that is used in a much broader group of MIS surgeons. So, one of the attractive portions of this acquisition for us was scale and access.

We have felt through some time that getting the access to surgeons, access and the operating room being able to develop a pore with them, and then being able to cross-sell is a critical ingredient. So as we’re going forward, we really view the iO-Flex to AxiaLIF or VEO cross-selling opportunity as a very strong one for the company’s growth going into next year.

Greg Chodaczek – First Analysis

And the last but not least to find out what’s the pipeline of product. Well you talked about pedicle screws – MIS pedicle screws. Can you give us a little more info on that, I mean why is that different – just teach us a little bit on that?

Ken Reali

Yes, absolutely, Greg. Well this is a project we started a year ago with a surgeon design team, and certainly have had wrapped up a strong portfolio intellectual property that we’ve licensed in this area for a percutaneous pedicle screw system. We’ve often felt that with AxiaLIF and VEO, we miss out on a revenue opportunity in every case we’re in where they bring in a competitive pedicle screw system we just cannot participate in that at this point in time.

So our objective there is to participate. And in that opportunity can offer a bundled opportunity with AxiaLIF, VEO, and in some cases, as the iO-Flex or iO-Tome as well. So it’s good expansion for us, it’s not I would say differentiated like our other technologies, but it will be a system that will compare very well with the best systems out there, the best percutaneous systems on the market. And that’s certainly been our benchmark. We will look forwards to launching that about middle of next year.

Greg Chodaczek – First Analysis

Okay. So the way I look at it, is it’s – I don’t know what to say, commodity product, but it’s more of a possibility of expanding revenue per case than a revolutionary product?

Ken Reali

That’s the way to look at it, Greg, absolutely.

Greg Chodaczek – First Analysis

Okay, great. I appreciate it guys.

Ken Reali

Thank you, Greg. Thanks for your questions.

Operator

Your next questioner is Jason Wittes of Brean Capital. Please go ahead.

Jason Wittes – Brean Capital

Hi, thanks for taking the question.

Ken Reali

Good afternoon, Jason.

Jason Wittes – Brean Capital

Good afternoon. Little time I lost I think in the beginning, so I apologize if some of these questions have been answered. But and looking you mentioned 23 surgeons have returned to AxiaLIF this year and it’s about 10% of your case load. Could you remind us again how many return surgeons you’re targeting this year, and I guess 23 is in line with your expectations going into this year?

Ken Reali

Yes, we have not given out an number on that, Jason, but it is in line with – I would say what our goals and expectations have been particularly with not having gotten all the private, the large part of payors in line yet. So, certainly as we roll the private payor coverage, we expect the comeback surgeons to also grow, but I would also keep in mind that we are shifting our focus to a little broader target area now, as I mentioned in the script we’re going after new surgeons with AxiaLIF, particularly those that were exposed to iO-Flex and add as a new target area that we’ll be focusing on in the third quarter going forward.

So, it’s now a broader field, it’s not just a comeback guys which are the lowest hanging fruit of course, but I’ll say it’s new MIS surgeons. A typical target for us is a younger surgeon that’s using iO-Flex that is certainly looking for a better solution at L5-S1 than in ALIF or a PLIF or a TLIF. And are certainly are minimally invasive pre-sacral approach is appealing to a lot of those surgeons as well.

Jason Wittes – Brean Capital

Okay. Thank you. That’s helpful. Also in terms of training. I guess I wanted to clear, I know that you’re kind of cross-training iO-Flex. For these training sessions that you’re hiring [ph], are they specific to one of your four platforms, or are they some of the mix of iO-Flex maybe TranS1 or even VEO mixed in or is it kind of very specific?

Ken Reali

Do you mean when we do a surgeon training?

Jason Wittes – Brean Capital

Yes.

Ken Reali

We try to train on all of our products. Certainly, there may be a surgeon that will come to our training center with a particular focus to learn AxiaLIF or iO-Flex or VEO, but certainly our goal is to expose them to all of our technologies. And typically, if they take a trip to Raleigh, North Carolina or to San Jose, California, they are going to open to doing that. And what we found frankly is, as they come in and they see other products, their focus sometimes shifts and it might go from, I want to get trained on iO-Flex, but I really like what you’ve done with AxiaLIF and the improvements you’ve made or VEO is not what expected, it gives me much better visualization than what I get today with a three-bladed retractor system. So we’ve certainly continued to see that. And to us, one of our most critical focus is that the business today that we think will really move the needle is peer-to-peer surgeon training.

So, our goal is to bring surgeon in and also have another surgeon that can come in and train on our other products. So getting a faculty to be adapting that training on iO-Flex actually than VEO is extremely important to us, because that training piece and that peer-to-peer training is a critical driver to our business, and it will be for some time.

Keep it in mind that in our world, most of these surgeons are not exposed to our technologies in our fellowship programs. like they are with pedicle screws or doing a TLIF case or ALIF case. So it falls to us and our surgeon faculty to properly train surgeons to get the best outcomes in our technologies.

So, that is a critical area of focus for the company. It’s one that we’ll continue to look at and how we can raise the bar and do it in a way that it’s going to drive better and better outcomes for the surgeons’ patients.

Jason Wittes – Brean Capital

Is there no real expansion in those programs this – if I look at the second half of this year, now that you’re sort of combining Baxano with TranS1 plus obviously?

Ken Reali

Definitely, we continue to expand our surgeon training. And with the integration of the two companies, we will be able to upgrade our professional education group significantly with a combined team, and we’re certainly leveraging that now. And I see our surgeon training just growing. Now those aren’t numbers that we’re disclosing, but certainly with our leverage, the San Jose training center in the West Coast which will open in early September and continue to have our Raleigh training center available to surgeons across the country as well as internationally. So we do expect surgeon training to climb as we go through the year.

Jason Wittes – Brean Capital

Okay. And then on AxiaLIF reimbursement, you’re basically currently in about 100 million lives and I think you’re testing to see how much further you can push that, but also should we expect some of the major insurers usually make decisions towards the end of year. Is that still kind of a milestone to look out for, obviously not one that we can nationally predict here but?

Ken Reali

Yes, I can’t make any promises or predictions, but you are right, Jason. The end of the year, early next year, is when they typically reevaluate. And as I articulated earlier, our goal is to show strong utilization and demand for our Category I code, and that’s why appealing to these payors on a case-by-case basis is important, and we’ve had some success there and we’ve had some that have not been successful.

The other piece to this is continued publications. And those publications are pre-sacral interbody fusion with AxiaLIF continues to grow. The head-to-head comparison of AxiaLIF to ALIF just got published electronically and that’s available on PubMed now. So those type of papers will make a difference as well, as they look to re-evaluate the technology at the end of the year or early next.

So our fingers are crossed, and certainly we’ll continue to drive our strategy. And this is benchmarked with how cervical disk replacements gain broader private payor coverage when they got to Category I code in spine. And it came down to utilization and clinical data. And certainly we feel our bar maybe a little lower because we’re not a PMA product, we’re certainly just another fusion by many means just a different access to the spine, and that positioning is important.

So we’ll continue to follow that pathway and continue to handle that home of the payors and the medical directors at the payors.

Jason Wittes – Brean Capital

Okay, great. Thank you very much.

Ken Reali

Thanks, Jason.

Operator

At this time, I would like to turn the conference back to Mr. Reali for any further remarks.

Ken Reali

Thank you, Jeanine. Well, let me close by thanking all of you for taking the time to join us on our call today. I am encouraged with the continued progress in our business, and enthusiastic about the opportunities in front of us at Baxano Surgical. We sincerely appreciate your interest and look forward to updating you on our progress next quarter. Have a good day.

Operator

Ladies and gentlemen, thank you for participating in today’s program. This does conclude the conference, and you may all disconnect. Everyone have a good day.

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