Q4 2019 Earnings Call

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Thursday Thursday, ladies and gentlemen, thank you for standing by and welcome to the fourth quarter earnings results conference call with this time. All participants are in a listen-only mode after the speaker's presentation. There will be a question-and-answer session to us to question during the session. You will need to press * then one on your telephone keypad. Please be advised today's conference is being. If you require further assistance, please press star then zero or not like to hand the conference over to your speaker today Mark quick senior director of Business Development and investor relations. Please dead.

Good afternoon, everyone. Welcome to the fourth quarter 2019 earnings call join me on the call today our president and chief executive officer. John supposedly and Chief Financial Officer Doug rice.

During this call will be making forward-looking statements involve risks and uncertainties all statements other than those of historical fact are forward-looking statements including earnings guidance. We provide any statements of our thoughts and beliefs and strategies expectations goals or objectives investors are cautioned not to place undue Reliance on such forward-looking statements. If there's no Assurance of the matters contained in such statements will occur June 4th on our beliefs and expectations as of today, February 24th, 2020. We do not undertake any obligation to revise or update such statements.

In our form 10-K for the year ended, December 31st 2019 as well as additional SEC filings we make in the future. If you need copies of these documents, please contact my office at work fix in Lewisville, Texas.

In addition on today's call will refer to non-gaap financial measures. We believe that in order to properly understand our short-term and long-term Financial Trends investors may wish to review page as a supplement to financial measures determined in accordance with gaap.

Please refer to today's press release announcing our 2019 results for reconciliations of these non-gaap Financial measures to our US gaap Financial results at this point. I'll turn them over to John. Thanks, Mark and good afternoon everyone. I appreciate you joining us on today's call. My first Orthopedics Ernie's call since transitioning to president and CEO. The agenda today is to walk through the key aspects of our strategic plan after which will provide commentary around our fourth-quarter top-line results before handing the call over to Doug to discuss the remaining Financial results month plus our outlook for 2020.

Press spend significant time with our Global teams as well as many surgeon customers distributor partners and Industry administrators as a result of these conversations. I'm even more enthusiastic about the opportunity in front of us then before I join the company first and foremost we have well defined market and or technology leadership positions and bone growth stimulation cellular-based allograft extremity deformity correction, and of course artificial cervical disc,

They're a significant opportunity for us to enhance and build strong offerings. In addition. We have the most comprehensive offering of cervical products and with the recent recently announced purchase of both internal and external options collectively. These are impressive impressive positions for the company of our size.

Or the fix and express my gratitude for the patience. You've delivered during our quiet. Leading up to this call during this time. We've been working to assess wage companies current status and prepare a strategic plan with key strategic initiatives to create accelerated growth and take orthofix to the next level while this transformation won't happen overnight and we'll take some investment. I'm certain the company can execute on these objectives and I'm pleased to say we can fully fund these initiatives that I'm about to talk about.

Apart from our strengths The Talented team or the fix has done a great job creating a solid business Foundation from which we can grow with our strong infrastructure wage legal Finance accounting ordered cash and compliance programs or to fix as well positioned to execute commercially.

I've been impressed by the spirit and enthusiasm that have personally seen in the team at orthofix across all geographies and all business units and it all levels. I would like to thank everyone at Nike for their support as we collectively developed the Strategic plan to take the company successfully into the future.

Now let's move on to areas where I see substantial opportunity to prove our commercial performance and financial results as we discussed on the third quarter earnings call the distraction from the CEO transition combined life Leadership departures in the Spy business over the last year negatively impacted our performance.

Some of these channels just carried over into the fourth quarter as I will discuss in a bit. However, I'd like to I think it's important to remind everyone that the leadership departures occurred, but we are also implementing a 2018 strategic initiative to realign the Legacy businesses of bone growth therapies biologics spinal implants and motion preservation into a single Global spine business unit and life experience a great deal of organizational uncertainty and a lack of clear path for so let me tell you about the Strategic plan. I'm going out line for key strategic areas of investment in Focus which are structure and Leadership.

Which is focused on structure and leadership in terms of structure. We will complete the previously-announced business unit realignment efforts to focus our thoughts in an extremely businesses while we seek to improve coordination between these businesses to maximize Revenue across our entire organization. The only some of the vacancies in addition to our talented leadership team has been a huge Focus for me since I have arrived and I'm pleased to share with you some of our early progress.

Let me start with M performance teams throughout his career. In fact at Medtronic spine and biologics who's part of the team that built the largest and most successful sales channel is fine. I believe the combination of his spine market knowledge leadership skills Channel creation expertise and key relationships will give us a huge advantage in the marketplace.

Progress in bolstering Kevin spine team with the addition of chill Ross as senior vice president of motion preservation Joe has spent his entire career in spine and I consider him one of the foremost experts and commercializing spine problems and procedures importantly. It still has significant experience in artificial discs. He's part of the first commercial launch of a lumbar disc in the United States ten. Most recently. He was a fine job where he took the artificial cervical disc to the fastest-growing product and most sought-after disc in the market.

She was excited to join the team and we think he can generate success on our next Generation artificial disc.

Another significant addition to the spine team is Paul coasters who recently joined as senior vice president and managing director of international spine. Paul comes to us having held similar roles at nuvasive and Medtronic spine and biologics. We have a significant opportunity in our International markets in polls relationships and experience will maximize their potential.

We are closed.

Feeling are you a VP of spinal sales position?

We have identified a number of excellent candidates and others have reached out to me directly based on the opportunity to fix. I'm please report these candidates are experienced by leaders looking for a new opportunity.

We are building these Executives have tremendous spine experience and have done this before we are already making a big impact and I know this is just the beginning.

At the corporate level has been hired as a newly-created global head of quality Regulatory and clinical Affairs to support existing and accelerate new product introduction. He is an experienced Medtech executive who has previously worked at Zimmer Biomet, right and Smith & Smith & Nephew in similar capacities.

To build our Global operations role. He was the managing our extremities operations group where he built a high performance group in our Verona Italy business starting in 2007 and truly embodies the Flawless execution culture we seek to have globally

Taking a new additions and combining them with the talent will position us for success and look forward to this team coalescing as we execute commercially within our new streamlined structure of that will say was into our second strategic initiative, which is operational execution to me. This means ensuring that we get our high-quality products and tissue to our customers when and how they wanted. The win is pretty obvious and primarily entails optimizing our supply chain. Well, this will have Financial benefits down the road. My immediate focus is on creating an aggressive agile competitive culture focused on Flawless execution and winning.

Choice with many customers who include Physicians Patients Hospital Administration and payers to understand their views and assist us in defining our future Direction. This is something I'm very passionate about and we'll focus on going forward. We are creating the view that everyone at or the fix owns the total customer experience. Now, let's move to our third strategic initiative, which is product differentiation.

those of you in the call know how

Our markets are and how difficult it is to develop disruptive Technologies.

Needs that require Solutions. We're going to be laser focused on both developing and acquiring high-value products and procedures solutions that solve these unmet needs.

We will discuss this is where you will see the bulk of our investments in the short-term.

It is easy to talk about new product Innovations. But executing on these initiatives requires a focused plan. We've not fully invested in research and development over the past few years and rebuilding the spine page and take some time as we focus on accelerating our new product Innovation cycle. It will be done with intense engagement Talent additions changing the processes used the development groups and alignment with spine and extremity thought leaders around the world.

Best in our clinical and Regulatory execution with the launch of our new m6c to level study to expand our future Market opportunity additional studies in our spinal and extremity businesses wage also planned on an inorganic front will continue to be disciplined acquires of assets that have strong strategic fits and we can purchase at a reasonable price in a significant value both our acquisition of spinal kinetics as well as the recently announced acquisition of fit phone that will discuss in a moment are good examples of the types of deals that we need to execute on in both cases. We acquired products that fit well strengthen our portfolio and we're Orthopedics can add significant value. We also believe that both of these Acquisitions will drive significant Revenue in the future.

No, I'd like to spend a moment sharing my excitement about the recently-announced agreement to acquire.

Pitbull and platform. This is a highly strategic asset for us as lengthening nail technology has been a gap in our extremities pediatric deformity correction. Pope portfolio is clearly an area where we want to maintain our Market leadership with this technology will be the only company offering both internal and external limb lengthening options along with the pack for angular deformity correction.

We are very excited about where we can take it home, which is currently used our TLX products into our fifth phone product offering in order to make these complex extremity procedures simpler for the surgeons in their patients. In addition to the Bone linking. Now, there is a scoliosis application technology called it's fine while the clinical and Regulatory efforts are very early for the use and deformity care. This song long with future applications have us excited about the platform technology for years to come. We just made the market opportunity for this technology at roughly three hundred million a day going higher digits and only about one-third penetrated by one competitor. Well, we only expect the sales contribution from flip phone to the approximately 1 million in 2020. We believe this technology

generate significant revenue for us in the future

Almost four million has double touch on in the bit later. We expect to still to be approximately 2 million dollars to loot of two twenty20 adjusted ebitda. We expect to close the transaction in late March 2020 lastly in definitely not least. Our fourth strategic initiative is our commercial Channel with the leadership teams. We have created in both spine and extremity business office in our commercial channels over the next 24 months. Our plan is to focus on adding or developing long-term strategic Partnerships. These Partners will suck your vision for differentiation and growth and sell multiple Orthopedics product lines. This will enable us to realize inherent synergies across our product lines and realize sustained growth.

At this point we're agnostic to model whether it be sales agents stocking distributors or direct reps. Our focus is on Commercial Talent the fundamental threat to our sales partner that we are highly aligned to collectively grow our businesses together over the long term that requires a great deal of trust commitment and delivering on expectations from both sides.

She's on her for strategic initiatives. We know we have significant work ahead of us. Here are some tangible goals and metrics will be looking at for 20 28 structure and Leadership. We must fill the vacancy of the VP of life for our spine business and transition to our new structure and operational execution. We tend to tend to implement supply chain improvements to reduce the lead time and set availability for an organization with respect the product Innovation and differentiation on the organic side or goal is to implement a new product development process. Our objective is to reduce our contract commercialization time will increase it while increasing the volume of new product introductions.

Which excludes a tax benefits?

For our initiative to increase the increase the number of factors to carry more than one of our product Lines by 5%

Than others to reach our expected performance levels, and I look forward to updating you on our progress.

Now let's shift and discuss the fourth quarter sales performance over the results results Illustrated a continuation of the trends from the third quarter which caused that to come in at the low end of life on a constant currency basis. We grew 9%

and business structure transition, which is offset by driven by the success of M60 us launch.

You know the revenue decreased 7% over prior-year. Let me provide you a little color on each of our key product families starting with bone growth therapy. This is down year-over-year 3.5% which is at the low end of our expectations. This is due mostly to normal churn in the commercial channel in the loss of two key Distributors, which are now being billed we have taken steps to rectify this disruption and early 2020 sales reflects stabilization. However, I do expect the recovery in this business to be very gradual throughout T. I would also like to address an item with respect to our bone growth therapy business as some of you may have questions about this in the coming weeks today FDA published in the Federal Register notice announcing an advisory committee panel meeting on April 23rd to consider whether bone growth stimulator devices should be reclassified from class to class to medical school.

You may recall that a 2006 FDA convened a panel and ultimately determine for safety and efficacy reasons to maintain the class-3 status of these products. We continue to be very confident in our position that these devices should remain class 3 in order to ensure efficacy of the therapy. We together with other manufacturers of bone growth stimulator will participate in the hearing and submit testimony or the fix has the market-leading bone growth stimulation platform wengie. Enjoy. The only cervical indication granted by the FDA month and we are the only company investing in to expand indications for use

I'm not sure of and of the dissimilarities among bgs devices a single set of special controls could not reasonably assure the safety and effectiveness of each distinct type of Bee Gees device simply stated. These are not 510k devices even with special controls.

Now, let's move back to spinal the spinal implant performace in spinal implants sales were up 2.3% in constant currency over prior year with m-16s driving the growth for the quarter.

Let me give you a little more than a year, which is driven by the slow ramp-up of new Distributors and continued void in sales leadership has mentioned earlier with our new tenured spine team. We have significant attention on this business off and now they good understanding of the current Dynamics. We are currently crafting a plan for success and feel positive about the future of this business.

Moving on reservation due to the success of the US launch finished above a guidance at 4.1 million for the year. We are very excited about the early adoption and what the new team can do to continue to propel the trajectory We are continuing our focus on Education and Training to ensure long-term success of this novel technology.

We demonstrated a solid quarter with 4.2% year-over-year growth a deceleration from previous quarters was due to tougher cops after the anniversary of Distributors that were added on a 2018. We do expect some headwinds for this business as we progress into twenty-twenty given the continuation of our realignment efforts. However, with the strong MTF biologics partnership and The Trinity lead tissue, I believe we have a solid platform to build on additionally we continue to rule out fiber fuse dbm with handing. Characteristics like trim package, which should continue to contribute to these sales over the coming years are biologic portfolio is built around Trinity Elite in this competitive offering meets the needs of our customers.

Thursday it's 0.3% off having the product available will relieve some of the competitive pressure. We've been experienced in certain geographies.

With that I will now hand over the call to Doug for further commentary around the quarter's financial performance and twenty twenty guidance.

I'd like to begin by saying it's been a great few months already and on behalf of the rest of the team. We want you to know how excited we are that you are here with that. Good afternoon everyone. I will bring some additional details internet sales and earnings results along with our outlook for 2020 and then discuss some of our other Financial measures starting with Revenue total net sales for the quarter or a hundred and twenty one point five million dollars that point 3% on a reported basis and 9% on a constant currency basis, when compared to the fourth quarter of 2018 based on the current outlook for our business aspect for your 2020 Revenue to be in the range of $467 to $477 representing 1 and 1/2 to 3.7% year-over-year growth on a reported basis off on the constant currency basis growth is expected to be between 2.3% and 4 and a half percent given an estimated foreign currency headwind of approximately 3 and 1/2 million dollars.

this group is led by

Line segment which we expect to grow at 3 to 5 % in 2020 going through each of our spine product categories bone growth therapies is expected to be flat to 1000 Grove due to the gradual recovery expected throughout the year that John mentioned we expect spinal implants Global Revenue to grow at approximately ten to fourteen percent within this category. We expect our motion president in US sales and twenty twenty to be between 15 and 17 m in biologics given the head winds and realignment initiatives that John mentioned we expect flat too low single-digit Revenue growth for the full year finally in extremities with the majority of the three and a half million dollar foreign currency headwinds negative negatively impacting this business. We expect reported 2020 Revenue to be approximately flat to down 2% This includes approximately a million dollars of contribution from fit bill as John mentioned.

Considering the Cadence impact from these moving parts. We are providing first quarter 2020 net sales guidance of 106 $209 which includes approximately $2 impact from currency wage stabilization and Recovery through the year and bone growth therapies and spinal implants on a reported basis. This represents a decline of 2.9% to Flat from the prior month on the constant currency basis. This reflects the decline of 1% to growth of 1.7% from the prior-year gross. Margin in the fourth quarter 2019 was 78.4 per month compared to 78.8% in the prior year. In line with our expectations for the full year twenty-twenty. We expect margins to be in the seventy eight seventy-nine percent range approximately flat to 2019.

sales and marketing

Fences or 48% of net sales in the fourth quarter 2019 up from forty four and a half percent in the fourth quarter of 2018. This increase primarily reflects. Both product mix as wage is increased training and education programs to support the m6c US commercial launch.

For the full year twenty-twenty we expect adjusted sales and marketing expenses as a percentage of sales to be roughly flat 2019.

Up from 16.2% and the prior-year. This increase was due primarily to higher spending on succession and took us an expensive as well as legal settlement expenses in the fourth quarter of 2019.

Down from 7.3% in the prior year. Do you primarily to decrease clinical studies for the full year twenty-twenty we expect them to learn the expenses as a percentage of sales to be between 9 and 9. 5% as we significantly ramp up our efforts to drive organic Innovation and differentiation including the initiation of or two level study the m6c post-approval study continued enrollment in our bgt rotator cuff study investments in next-generation tissues and building a robust product pipeline in spinal extremities, as a reminder due to the significance and the bearing timing of the underlying compliance initiatives associated with the recent EU medical device regulations. We will continue to adjust for these implementation costs. We expect to incur 525 and 1/2 million dollars of these implementation costs in 2020.

Decreased to twenty two and half million dollars or eighteen and half percent of Revenue down from twenty four point four million dollars or 20.2% of Revenue in the fourth quarter of 2019. This decrease reflects our own Investments towards accelerating top-line group primarily related to the m6c commercial launch that are reflected in sales and marketing for the full year twenty-twenty. We anticipate adjusted ebitda dead in the 65 the $68 range which reflects increased R&D spending as well as approximately two million dollars of dilution from fifth phone as John mention now turning to tax office had income tax benefit for the quarter of 7 and 1/2 million dollars or -176 percent of income before income taxes as compared to income tax expense of two point seven million or 24% of income before income taxes in the same period of 2018 the tax provision for this quarter was significantly impacted by the timing of earnings during the year, including the impact of the spinal kinetics contingent consideration wage.

Pencil is recorded in Q3.

For tax purposes and did not recur in 2 4-4 a non-gaap results. We will continue to use 27% as our adjusted effective long-term tax rate in 2028.

For the fourth quarter 2019. We reported gaap EPS of sixty cents per diluted share as compared to forty six cents per share for the fourth quarter 2018 after adjusting for certain items and when normalizing for tax using a non-gaap long-term effect of tax rate adjusted EPS for the fourth quarter 2019 was $0.51 compared to $0.56 in the fourth quarter of 2018, The majority of the decrease was due to the investments in the US launched for the full year twenty-twenty, assuming weighted average diluted shares outstanding of 19.7 million. We expect just a DPS to be in the range of a dollar to a dollar ten which includes approximately eight cents of expected dilution from Pitbull consistent with our historically lower volume in the first quarter. We expect our dog twenty-twenty adjusted EPS to approximate approximate 9 to 12 cents.

Highlights, do you sales outstanding or dsos? We're sixty sixty six days at the end of the fourth quarter 2019 up from 59 days at the end of the fourth quarter 2018. We expect increased to be temporary and to improve in the coming quarters our inventory turns at the end of the fourth quarter 2019. We're at one point two times compared with one point three times in the fourth quarter 2018 faith in cash equivalents restricted cash at the end of the year 2019 total 70.4 million dollars compared to seventy two point two million dollars at the end of the previous year.

Cash flow from operations for the quarter was 11.9 Million down from twenty one point 1 million dollars in the fourth quarter 2018 due primarily to increases in inventory and other working capital Investments to support our top-line growth initiatives, including the commercial launch of insects in the u.s. Capital expenditures were up in the quarter to five point six million dollars from 4.5 million dollars and the prior year due primarily to investments in manufacturing capacity expansion for the m6c artificial cervical disc for the full year twenty-twenty. We expect capex to be aprox $1,000 a year over year increase of about $5 that is mostly due to the deployment of additional additional instruments sets.

Which we calculate by taking cash flow from operations and subtracting capex with 6.3 million dollars during the quarter compared to sixteen point six million dollars in the prior-year this production during the issue was primarily due to changes in working capital with a rampant inventory to support our growth. I'll now turn the call back over to John. Thanks Doug on a closing note. I would like to thank all of our team members customers and investors for their patience during this leadership transition period changes hard. It would have been easy to come here and not make the necessary hard decisions off, but it did not come here to do that took him to do the same.

Or to fix already has a strong profile for its size and skill. The easy path would be to continue slowly expanding margins and growing and low single-digits. However, I don't believe that this is the path that maximizes shareholder value rather. I see an alternative path where we invest to accelerate organic growth rate that will provide us with skill and then ultimately off down the road. I look forward to discussing the Strategic plan and sharing our successes with you over the coming quarters name is Doug highlighted to implement our strategic initiatives that I'm carefully monitoring all spending going on throughout the organization through my previous roles working in in advising private equity-owned or companies. I have developed an Acumen for prudently managing expense to drive future value further month.

We have certain areas to help offset some of these.

A passion for delivering these solutions to our customers with flawless execution passion for all the hard work behind the scenes that facilitates these efforts and off at least passion for growing markets and growing or ethics.

Finally, I just want to reiterate my excitement to be here and thanks to the current and new team members the future and Orthopedics is very bright with that operation to open up the line for questions.

At this time, if you would like us to question over the phone line, please press star then one on your telephone keypad. You will pause for a moment while the TNA roster. Your first question comes from Raj of Geoffrey's your line is open. This is Anthony and and and congratulations on on the first call here and look forward to working with you John month. Maybe just a few on on bone growth and then I'll have one on on M6 just to follow up but you know, we we look at bone growth. Obviously last quarter facing a number of wins. It was you know, partially sales leadership related also Salesforce turn over and then as an extent of that just lost market share. So, you know, we look at the 1% constant currency, you know, we're off that historical sort of, you know, mid single-digit growth range, you know, when you look at those three categories leadership Salesforce turnover,

And just share. Can you kind of just

And you know to what extent the business is facing pressures from each three, and then you're sort of outlook for when we should see a a turn in some of those drivers and then I'll have a follow-up. Thanks.

Thanks Anthony regarding those three items the the leadership is being addressed. Now as we basically bring on the new spine team and that was a gap that have been open for a number of quarters. And so from that that basically focusing on the sales and then competitive conversions and also Market expansion for those products was basically being more in a dual mode and that was part of the issue regarding the question point on constant currency. We sell bgt only in the US right now. And so I think that'll do with that matter.

I guess the the the fall. Would be again. Can you quantify you know, how much hair is actually been been lost in in in bone growth one and then you know, you mentioned the panel coming up with, you know, the the potential classification shift to class to status from class 3. Can you can you just sort of maybe frame, you know the risk around that a try, then it's mostly around the competitive front as a risk, but on the other hand it we're in the camp that the moat around this business for Orthopedics is you know, sort of expensive and durable how much of a risk is the panel but on the other end, you know, how durable is the competitive positioning for orthofix within bone growth stem?

well on the

We see a number of portion of this is just normal charms as far as moving customers around and basically and Distributors around so that's part of the issue that we were not addressing and so we'll look together after the just off and then basically make more strategic Acquisitions as as available regarding the risk. As I said in my prepared remarks. We I buy the team believes. This is a club device and we gone through this with the FDA since 2006 and because of the safety and efficacy requirements and the diversity of those products that are in this bgt catalog category. We see it as a as a hard position decision to move off the class-3 device.

Okay, and then the last four for us here would be just on On Em. Obviously better than expected. Can you maybe describe a little bit in more detail? You know how much of that in the quarter specifically offer was from new surgeon ads as opposed to just deeper utilization within early adopter accounts. Thanks again.

Yeah.

At this stage. We are adding surgeons at a rapid pace. And so we look at not only surgeons in to the surgeons added service to do their first case and surgeons to do multiple cases after that and we see increase in all those categories. So it's a combination of all of the above great. Thanks.

Our next question comes from line of of cancer is open.

Hi guys. Thanks for taking the questions. John obviously laid out a number of strategic initiatives in your plan change and you know from a from a high-level wanted to get a sense for how much of what you're planning to do is getting or ethics kind of back to normal or you know, establish quo basically status quo versus some of the your future growth initiatives that maybe new you brought in with, you know, your your experience and I guess just kind of the time, you know, I'm getting back to a normalized business.

on the competitive rest

Thanks Craig. The the way that approach that is that bringing the talent on is a key component of getting back to a state where this is an operational spine business. When you ever you have Gap, especially the gaps that were there it basically takes away from the growth or even the future view of that business. So we're bringing a talent back and then also to basically just capitalize on our existing portfolio. They just threw execution just through sales and Commercial execution is really key. And then as we move on into the out here out periods is looking at new technologies or new additions to the portfolio organic and inorganic and is that as you mentioned my background, you know, the previous four years of joining. I probably enjoy more than fix I spent in a space where I would venture and private-equity looking at how do we disrupt these markets? And we think there's really good Avenues not only product and procedure base that can help disrupt these markets and and basically take and transition them to birth.

Health Care is being provided his procedures in the future. So we look to look to explore all those.

Obviously, you know, the Q one is a little bit softer than the overall guidance Revenue guidance for 20 20 20 20. So I want to go to sense for your your confidence that you can see that acceleration throughout the year. And I know you touched on it in in script, but maybe just a little bit more detail on what what specific products or segments are going to be driving that that that full year 2020 guidance.

So our initial initial activities are make sure that we stabilize leadership and just start executing on our core and basically that'll be the process will happen in in long term and then in mid and later in the in the period in the year, we'll look forward to executing and driving top-line with em 6. And then also we have some new additions that are coming into my life with a expandable interbody and then also moving into bgt and its performance with some of the stem on track initiatives that we have in place as well.

Got it. That's helpful if I can ask on guidance in 20.

Great, that's helpful. Last one for me. Just on the on the the p.m. A study for sorry the two level study. I wanted to see is that is that a PMA studying any any help on timing or maybe spend on on that study?

So it's a it's an idea men that that we just submitted to the FDA few days ago and we did we went to an amendment because for economic reasons, we found a package where we think we can economize portions of a two-level study. And so we're looking at doing that as well as we put together a fairly aggressive plan to have patient enrollment. So it'll be at the the typical case. Hopefully we'll basically did take some of it off the front end of it, but it'll be at a at a relatively rapid pace for a full IDE study.

Great. Thanks for taking my questions.

Thanks, Greg.

To our next question comes from Ryan Zimmerman of four line is open. All right, great. Thank you for taking the questions John welcome home or so want to touch on a few items here that have already been asked about it and asked a few others just the fob to Anthony's earlier question is the phone no indication in terms of timing around the decision. I know when this last came up it kind of puttered along for some time and you know kind of dissipated but you have any sense for timing on when we could hear every classification for months and well, we know we know certainly the April date that they gave us today, but after that it's goes through a process and determine what happens in the April date and if it off and back to the to the agency, it will take months the the historical on the four that have gone before in that area has taken between 6 and 20 months to actually log.

Go through the agency and make a ruling.