Once again thank you for standing by and welcome to the Vericel’s First Quarter 2021 Conference Call. At this time, all participants are in listen-only mode. I would also like to remind you that this call is being recorded for replay. I would now like to turn over the conference over to Eric Burns, Vericel's Head of Financial Planning and Analysis and Investors Relations. Sir, the floor is yours.
Thank you, operator, and good morning, everyone. Welcome to Vericel Corporation's first quarter 2021 conference call to discuss our financial results and business highlights.
Before we begin, let me remind you that on today's call we will be making forward-looking statements covered under the Private Securities Litigation Reform Act of 1995. These statements may involve risks and uncertainties that could cause actual results to differ materially from expectations and are described more fully in our filings with the SEC, which are available on our website.
In addition, all forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. Please note that a copy of our first quarter financial results press release is available on the Investor Relations section of our website.
We also have a short presentation with highlights from today's call that can be viewed directly on the webcast or accessed on our website. I am joined on this call by Vericel's President and Chief Executive Officer, Nick Colangelo; and our Chief Financial Officer, Joe Mara. I will now turn the call over to Nick.
Thanks, Eric, and good morning, everyone. We entered 2021 with a great deal of momentum based on strong revenue, profitability and cash flow that we generated last year and the strength of the underlying growth drivers across our business. That momentum continued through the first quarter, as we had a very strong start to the year from both a financial and commercial perspective. This morning, we reported total revenue growth of 30% in the first quarter, achieving record first quarter revenue, gross margin, adjusted EBITDA and operating cash flow. We reported positive adjusted EBITDA for the first time in what is historically our seasonally lowest revenue quarter of the year and generated operating cash flow of more than $10 million for the second straight quarter, ending the quarter with $110 million in cash and investments and no debt. We believe that these results demonstrate the strength of the company's financial profile, as we continue to generate strong revenue growth and increased profitability and cash flow, which was recognized by the addition of Vericel to the S&P Small-Cap 600 index in March. Based on these results and our underlying business fundamentals, we're raising our revenue guidance and now expect total revenue for the year to be in the range of $165 million to $168 million, or approximately 33% to 35% growth, with MACI revenue growth in the mid-30% range and Epicel revenue growth in the high 20% range. Joe will provide further details regarding our updated financial guidance in a few moments. From a commercial perspective, both MACI and Epicel had strong performances in the quarter. MACI implant and biopsy growth exceeded 20% for the quarter, with the growth in biopsies continuing to outpace the growth in implants, which is important as biopsy growth remains a leading indicator for the MACI business. The growth in biopsies was driven by an increase in the number of surgeons taking biopsies in the quarter versus the first quarter of last year, as we continue to focus on broadening our MACI surgeon base.
While in most years, we see a seasonal step down in the number of surgeons taking biopsies in the first quarter compared to the prior fourth quarter. This year the number of surgeons taking biopsies in the first quarter was comparable to the fourth quarter of 2020 and we had the second highest number of surgeons taking biopsies in any quarter since we launched MACI.
Given the lingering COVID-19 headwinds in the first half of the quarter, we're very pleased with this performance and believe that we're on track to deliver over 20% growth in surgeons taking biopsies for the full year.
We also saw significantly higher approval rates for UnitedHealthcare patella cases following the expansion of its MACI medical policy, which became effective on February 1. We believe that the expanded coverage will not only improve access for UnitedHealthcare patients, but also reinforce with surgeons the broad access and favorable reimbursement profile for MACI and contribute to its continued growth in the years ahead. Overall, we believe that the underlying MACI business fundamentals remain very strong, positioning us to continue to drive sustainable penetration into the MACI's addressable market.
Turning to our burn care franchise. After a great close to 2020 for Epicel, with fourth quarter revenue of nearly $10 million, we continued to deliver very strong results to start the year.
First quarter revenue for Epicel increased over 50%, compared to the first quarter of 2020, as we achieved a new monthly volume record for Epicel grafts in February and the second highest quarterly revenue in history. The average quarterly revenue for Epicel over the past three quarters is now more than $8 million and the underlying Epicel business fundamentals remain very strong. Epicel biopsies over the past two quarters were the highest in history and the average number of grafts per patient, also continue to outperform historical levels.
Although, Epicel can be challenging to forecast, due to the variability in the number of severe burn patients, we believe that these recent trends indicate a sustainably higher level of utilization of this important product. And we therefore have increased our growth expectations for Epicel in 2021. To support the recent growth and increased demand for Epicel and to prepare for the planned launch of NexoBrid, we're continuing our staged expansion of the burn care commercial team.
Our increased commercial efforts on Epicel, together with the structural changes to our sales force to include both, sales and clinical support roles, have driven the increased demand for Epicel. We believe that additional resources for the burn care team will drive continued increases in the Epicel utilization and support our preparation for the planned launch of NexoBrid.
In terms of NexoBrid we continue to make significant progress with our -- with respect to our commercial and medical affairs pre-launch activities.
In addition to an ongoing disease state awareness campaign, our commercial team continues to advance multiple brand development and market access initiatives.
Our clinical and medical affairs teams also are continuing to engage with burn centers in training and educational initiatives through the next expanded Access study, which is enrolling new adult and pediatric patients at leading burn centers across the country. From a regulatory standpoint, the NexoBrid PDUFA goal date remains June 29.
However, as is apparent from recent FDA actions across the industry, travel restrictions related to the COVID-19 pandemic are impacting the FDA's ability to complete manufacturing facility inspections. And the FDA has informed MediWound that, due to these restrictions the agency may not be able to conduct the required inspections of NexoBrid manufacturing facilities in Taiwan and Israel, prior to the PDUFA-date. The FDA has also requested additional CMC information from MediWound and has informed MediWound that, it is unlikely that the additional CMC information provided will be reviewed during the current review cycle. Accordingly, we expect the timing of potential approval and commercial launch of NexoBrid to be impacted.
As we previously communicated, while we're not expecting any significant NexoBrid commercial revenue in 2021, we are expecting to recognize the remaining BARDA procurement revenue of approximately $3.8 million in 2021.
Given its robust clinical data package, we believe that NexoBrid remains well positioned to become a standard of care for removing eschar in patients with severe burns. And we look forward on approval to bringing NexoBrid to the U.S. market. I'll now turn the call over to Joe, to provide more details on our first quarter financial performance and our updated 2021 financial guidance.
Thanks Nick. Starting with the income statement, total net revenue for the first quarter increased 30% to $34.6 million, compared to $26.7 million in the first quarter of 2020, and included $23.8 million of MACI revenue and $9.8 million of Epicel revenue, compared to $20.3 million and $6.4 million of MACI and Epicel revenue respectively, in the first quarter of 2020. Total revenue for the quarter, also included approximately $0.9 million of revenue related to the procurement of NexoBrid, by BARDA for emergency response preparedness. MACI revenue grew 17%, compared to the first quarter of 2020. Note, that MACI revenue in the first quarter of both 2020 and 2021 included favorable revenue adjustments, related to prior period estimates. And if you exclude the net impact of those adjustments, revenue growth would have been over 20% which is in line with our implant growth. Epicel first quarter revenue grew 54%, compared to Q1 2020 and our total burn care revenue of $10.8 million, increased versus a strong fourth quarter of 2020. Gross profit for the quarter was $23 million or 66% of net revenue, compared to $16.8 million or 63% of net revenue for the first quarter of 2020, representing an approximate 350 basis point improvement in our gross margin versus the prior year. Total operating expenses for the quarter were $26.3 million, compared to $21.8 million for the same period in 2020. The increase in operating expenses was primarily driven by higher non-cash stock compensation expenses related to our higher share price as well as incremental employee expenses related to the MACI sales force expansion in 2020. Note that Q1 2021 results did not include a full quarter of stock compensation expense based on the increase in our share price. And we will see sequential growth in operating expenses into Q2 to account for a full quarter impact of this expense, which is already factored into our full year operating expense guidance. Net loss for the quarter was $3.3 million or $0.07 per share compared to a net loss of $4.7 million or $0.10 per share for the first quarter of 2020. Non-GAAP adjusted EBITDA for the quarter was $4.6 million or 13% of net revenue, compared with a loss of $0.7 million in the first quarter of 2020.
Importantly, this is our third consecutive quarter with positive adjusted EBITDA and our first time reporting positive adjusted EBITDA for the first quarter, which is seasonally our lowest revenue quarter of the year.
Finally we generated $10.1 million of operating cash flow in the first quarter. And as of the end of Q1, the company had approximately $110 million in cash and investments, compared to $100 million as of December 31, 2020 and no debt. Transitioning to our updated guidance for 2021. Based on the strength of both MACI and Epicel in Q1, both in terms of revenue and underlying growth drivers, we are increasing our full year revenue guidance and now expect total revenue of $165 million to $168 million or approximately 33% to 35% growth. This compares with our previous full year guidance of $161 million to $164 million or 30% to 32% growth.
In terms of our franchises, we expect MACI to be at the upper end of our previous guidance with growth in the mid-30% range. The increase to our full year revenue guidance range for MACI is driven by higher expectations for the second half of the year based on our biopsy performance over the past few months, which typically would begin to convert to implants in the third quarter.
Moving to our burn care franchise. After a strong start to the year both in terms of revenue and underlying commercial trends, we now expect revenue growth to be in the high 20% range for the year versus our previous guidance of mid-teens growth.
Our overall burn care franchise including NexoBrid BARDA revenue is now expected to be approximately 30% for the year.
Moving down to P&L, we continue to expect gross margin to be 70% to 71% for the full year and operating expenses to be approximately $115 million for the full year with a sequential increase of about $5 million in spend expected in the second quarter and then approximately $30 million of operating expenses in each of the remaining quarters. And finally based on our increased revenue expectations, we are increasing our non-GAAP adjusted EBITDA margin for the full year to be approximately 21.5% to 23.5% compared to the prior guidance of 21% to 23%. This concludes our prepared remarks. I'd now like to now ask the operator to open the call to your questions.
[Operator Instructions] Your first question is from the line of Ryan Zimmerman of BTIG.
Your line is now open.
Thanks for taking the question.
So maybe to start on the NexoBrid delay here. And I know MediWound is giving their call right now too.
So they have some additional commentary. But can you talk about kind of how long you expect this delay to occur? Or what guidance you have in terms of the review cycle? Just any color there I think in terms of helping investors think about when NexoBrid will be approved and then commercial activities pick up on and proceed?
Yes. Thanks, Ryan.
So at this point Ryan what we're trying to do is say with less than two months left to the PDUFA date and without an inspection being scheduled it's likely that there is going to be an impact.
Now, we certainly aren't in a position to speak for the FDA or predict what they're going to do or how the likely delay will play out. But what we're trying to do is bring the information that we have to investors' attention. There's a number of different scenarios that can happen.
You can see it across the industry right, where if there's a delay it can either fall into the category of a major amendment, when additional information is requested. It could be a deferral or it can be a complete response letter. And I think you see all of those happening in the recent history with the FDA around these kinds of issues.
Okay. We'll hear more about that as we proceed. Maybe turning to guidance for a moment to follow-up.
So Epicel, is certainly doing better I think than your expectations.
Your guidance of about 2.5% or so I think from the midpoint you guys beat by 7%.
So maybe just help us understand the underlying dynamics in terms of the composition of the guidance for the year? Or, maybe just said differently, how to think about MACI growth in the mid-30s here.
Just with respect to the biopsy dynamics, so you clearly have more surgeons sending you biopsies. But you exited last year, I think with a bit of a backlog and really strong biopsy growth.
And so how are you -- maybe some more additional color I think around biopsy dynamics in terms of, whether you're seeing maybe less biopsies per surgeon but a broader surgeon base? Any color there I think would be helpful.
Yes. I'll start Ryan, and then Joe can pick up the guidance. We mentioned on our fourth quarter call that, we saw strong biopsy growth in the fourth quarter. Obviously, it wasn't the same growth we would have had without the COVID-19 impact. And then, of course, 20% biopsy growth plus in the first quarter, so we're seeing a strengthening in that biopsy growth. And we also mentioned that the biopsies per surgeon after taking a dip, during the first half of the year related to COVID had sort of bounced back to 2019 levels, and we'd expect that to grow throughout 2021.
And so the dynamic remains the same, where we expect 20-plus percent growth in the biopsying surgeons.
You're right to note, as we pointed out in the call that, that was a big driver for the strong biopsy performance. But when we then guide to sort of mid-30% revenue growth, it's because we expect additional -- or an increase in the average number of biopsies per surgeon.
So that dynamic is pretty consistent with what we've been saying over the past couple of quarters.
Just to add as well.
So again, I think the way to think about that is as Nick talked about on the call and just referenced, again, is we are seeing underlying strength in both our surgeons and those biopsies over the last few months.
So as we think about that increase on the MACI guidance basically from about low to mid-30% growth to now mid-30s. It really is the strength in those biopsies. And as we think about the cadence of that our expectation is relative to our initial guidance that's going to be more in the back half of the year.
Our next question is from the line of Kaila Krum from Truist Securities.
Your line is now open.
Great. Hi, guys. Thanks for taking our questions.
So just a follow-up to Ryan's earlier question on NexoBrid. Can you just clarify the steps that have to be completed at this point before gaining approval in the US? And I mean, it sounds like the FDA hasn't officially scheduled the inspection for the MediWound facility, but have they given any sort of ballpark date for that yet? And then I think you guys were still trying to determine the right price for the product a couple of months back. Have you made any additional progress on that at this point?
So we -- the words that we used was that they may be unable to conduct an inspection prior to the PDUFA date and that's all we know at this time.
So there's no sort of indication of when that would get scheduled. And I think that's kind of standard practice.
In terms of the pricing study for NexoBrid that is wrapping up.
We expect to kind of get the final results here in pretty short order. And then we would sort of share that at the appropriate time.
Okay. That makes sense. And then just on Epicel. I mean you've now had two consecutive quarters of almost $10 million performance.
So first was there anything specific that drove the record month in February? And then can you help us understand why sort of $9 million wouldn't be a baseline for quarterly performance going forward? Thank you.
So there's -- you can't really say that there's anything particularly unique about February. We -- as we mentioned on the call we did have over the past two quarters a record number of biopsies for that time period.
And so, obviously when the top of the funnel is filled with more patients, you tend to get higher volumes but nothing particularly unique about February.
I think it really just goes back to what we've talked about before where we are having -- seeing a higher number of grafts per patient and per order which is important as our sales reps who are doing a great job sort of engaged earlier in the process on treatment plans with surgeons.
I think that's a clear dynamic that we've seen and that we expect that to continue going forward.
In terms of the baseline Joe I'll let you take that one.
So thanks for the question.
I think as we think about Epicel.
Of course this is a difficult product to predict in terms of -- just given the variability and the type of product it is. But if you look back over the last three quarters, as you talked about there's two really strong quarters in Q4 and Q1. And if you look really over the last three quarters, our run rate is about $8 million.
So as we think about guidance our initial guidance was in the teens, which was higher than single digits.
Now we're up to the high 20s.
So from a run rate perspective, you're looking at something closer to $8.5 million as we think about the remaining quarters in the year. And certainly as Nick said the team is doing a great job and we'll continue to push on the product. But I think it is an increase relative to where we were and still above our run rate over the last three quarters.
Great. Thanks guys.
Your next question is from the line of Danielle Antalffy of SVB Leerink.
Your line is now open.
Hi, thanks so much for taking the question. Congrats on a really strong start to the year. Nick or maybe Joe whoever wants to take this one? I'm just curious about what you're seeing from a productivity perspective with the sales force that you added. Granted you added them right before COVID, but it sounds like you were able to at least onboard them.
And so, their productivity ramp likely delayed, given that they started sort of correct me, if I'm wrong but kind of in the April timeframe of last year. But what have you seen now as you're seeing restrictions start to ease? Is that part of what's driving the stronger biopsy growth you're seeing the productivity start to ramp there? Any color would be great.
Yes. Thanks Danielle. And as we mentioned last year we've always followed the same practice in terms of our sales force expansions which have been pretty productive, I think compared to industry norms.
As we scaled our sales force we essentially were seeing increased rep productivity as measured by revenue per rep. And we expected that to take a bit of a step back when we added such a relatively larger number of reps. But the delay in getting into the field last year was about a month, but we talked about the fact that it really gave the teams a lot of time the new reps to build strong business plans and then get out there and hit the ground running.
I think in the third quarter last year we mentioned that in terms of growth of new biopsying surgeons, the new territories were leading the way. And that often happens right because we brought in really experienced reps.
I think average -- on average they were sort of large-cap med tech sports medicine reps with about 10 years of experience.
So they bring relationships. And I think we saw a little bit of that. And then as you look into the first quarter of the year you have to remember that at this point we're kind of taking existing territories and basically realigning them.
So it's not like the reps are walking into a Greenfield situation. There's a book of business there. And I think we can say that from a biopsy perspective and even an implant perspective that the metrics for those 27 expansion territories are pretty much aligned with our legacy the original territory growth rates.
And so we're feeling good.
We expect that they'll be -- have the same productivity profile as the prior cohorts of reps that we've added.
Understood. Thank you for that. And then just a question on the biopsy conversion rate.
So biopsies are outpacing implants, it sounds like which is great to see and certainly a positive leading indicator. But the other big needle mover here is on the conversion side of things. Are you guys seeing any progress on that front? And how should we be thinking about that contributing to the growth profile as we look ahead to 2021, but then also obviously more importantly over the next few years? Thanks so much.
Yes. Thanks, Danielle. And we've talked pretty consistently about the three growth drivers for the MACI-b business being the number of biopsying surgeons and the growth of those surgeons taking biopsies, the average number of biopsies per surgeon and then the conversion rate. And certainly, as we talked about earlier for this year and probably over the next couple of years, the primary growth drivers are going to be adding the new biopsying surgeons and then getting more biopsies per surgeon. And the first driver being the breadth of penetration into our target customer base, and then the second being the depth of penetration into their practices. And we expect the conversion rate to remain stable as that dynamic is unfolding. And that has a lot to do with the fact when we're adding a large number of new surgeons. They tend to convert at a lower rate as they first engage with the brand and then over time work up towards the average.
And so once we saturate our target surgeon base of 5,000 surgeons over the next few years then the number of biopsies per surgeon and the conversion rate will take the predominant role in terms of driving growth in the out years.
So for this year we expect the conversion rate to be stable and then increase over time.
Okay. Thanks so much.
Your next question is from the line of Chris Cooley from Stephens.
Your line is now open.
Good morning and congratulations on a great start on the year. And appreciate it taking the questions.
Just two quickly for me if I may. Nick, could you maybe just talk a little bit about the operating model now? And what we wanted to get at is with the leverage that you're seeing in the burn franchise, how do we think going forward just about the margin profile of the business? Are you essentially at scale now, although, with the existing group and so we just think about incremental reps coming on top of that? Or is the existing group there still scaling? You still see increased productivity opportunities there.
Just trying to get at the margin contribution from Epicel or the burn franchise more broadly longer-term? And then I have a quick follow-up. Thanks.
So I'll just start with sort of the first part of that question and then turn it over to Joe to talk about sort of the operating margin impacts. But I do think that as we restructured the Epicel sales force as we talked about into both sales rep and clinical support roles that we're seeing increased efficiencies there and this dynamic that's driving growth because we really haven't added a meaningful number of sales reps over the past two quarters for sure. And it's really just the fact that they're continuing to scale and increase productivity.
Now we did mention earlier on the call as you know as we are planning for the NexoBrid launch that we're planning to go from seven reps and four clinical support specialists to 11 reps and seven clinical support specialists. And we are embarking on that expansion currently.
So we're going to add another couple of clinical support people and one on the sales management side.
And so we're continuing our staged expansion and that's because we think there's a lot of room to grow still just in the Epicel business alone.
I think that's clear. And then of course to plan for the NexoBrid launch and get up to full-scale for that event.
So that's kind of the kind of approach that we're taking and I'll let Joe talk about sort of the operating margin impacts as those -- our margins generally continue to improve with our increased performance.
So thanks for the question. I mean just to add to what Nick talked about. I mean, I think broadly speaking we're certainly looking to continue the leverage we have in both franchises. But as we think about the burn franchise where it is right now, we still think this kind of fits into our gross margin profile of around 70% plus gross margins. We think about the operating income line potentially being around 20%. And I think as we're thinking about this increase on the Epicel or on the burn care side. I mean these are really modest investments from an operating expense perspective.
So I don't think it will have a material impact as we think about the burn care both this year and beyond. We'll continue to look to actually add leverage and increase margins. And I would point you back to kind of the bigger picture for the company, which is if you look at EBITDA for example last year, which is a great proxy for operating cash flow we're at around $18 million in 2020. And if you look at our guidance this year, you're at 2x that number of around $36 million, $38 million.
So this is certainly something we pay attention to from a margin perspective. But we think from an investment perspective, this will certainly help on the burn care side, but not impact our margins and that's something we're going to continue to look to grow over time.
Appreciate that color. And then I apologize if you covered this earlier in the call. But just curious I think in your prepared remarks, you stated that you were seeing increased acceptances from UnitedHealth. I'm just curious when you look at the increase in biopsies taken on the MACI side of the equation, are those surgeons that are skewed more towards a UnitedHealth type market? I'm just trying to parse that a little bit more finely there? Are you seeing basically a benefit from the growth in surgeons as a result of the change in the coverage from UNH? Thank you so much.
So yes, as we mentioned on the call and obviously, previously on our first quarter earnings call we believe that this is a very important win for us right, not only because we'll be able to treat these UnitedHealthcare patella patients more frequently, but just sort of the overall sort of halo effect of reinforcing really strong reimbursement for MACI.
So yes we saw an almost immediate uptick. Remember the policy update just became effective on February 1st.
So sort of middle of the first quarter. Immediate uptick in terms of approval rates for those cases that are at or maybe even slightly above non-patella cases and right in line or maybe slightly above the overall national average.
So really accelerated sort of increase in the approval rates. I'd say it's a little early to sort of take the fine cut of saying of the new surgeons that you've added are they principally United sort of focused or dominant physicians? I don't think we know that information yet. United is the largest commercial insurance plan in the country. But even then it only represents about 15% of covered lives right? So I'd be a little surprised if there's someone who jumped on board just because they happen to have a skewed United practice. I just think it's sort of the overall effect of a great product that people have and good success with their patients.
Your next question is from the line of Jeffrey Cohen from Ladenburg Thalmann.
Your line is now open.
Hi, Nick and Joe. How are you?
We’re doing well. Thanks, Jeff.
So Joe, if I could start with you on the OpEx guide that you gave at 115.
You had some additional commentary. Was there some additional composition of the OpEx that we should be thinking about throughout the cadence of the year?
So what we talked about on OpEx was -- we did about 26 -- I think our OpEx was $26 million in Q1. And what we said our previous guidance for the full year was $115 million and that full year guidance of $115 million has not changed.
So that's still our latest outlook on operating expenses. What we talked about in terms of the quarters was we expect a sequential increase in Q2 of about $5 million and then approximately $30 million in the remaining two quarters. And really what you're seeing there that we talked about is just the timing and the way that the higher share price which is impacting our non-cash stock compensation expense, which is part of operating expenses how that's flowing through the P&L.
So said differently there was a portion of that in Q1 and that will step-up in Q2 and then also in the remaining couple of quarters.
Okay. That’s super helpful. And could you talk about surgeon training throughout the first quarter? Maybe how that's looking so far in the second quarter? I didn't hear any previous commentary, but is there anything to call out there?
Yes. Jeff, we focus on the number of biopsying surgeons, right? The training element for MACI because it's such a simple procedure can be done online.
So that is not a gating item for us. It's really about how many -- what the growth in the biopsying surgeons is. And as we mentioned, the strength in the biopsies that we saw in the first quarter was really driven by the biopsy and surgeon growth.
So I think that tells you that the brand continues to be adopted broadly by an increasing surgeon base.
Okay, got it. And then lastly for me.
You've probably done some work on this front, but do you have a feeling about the additional extra TAM with regard to patella and some of the cartilage defects that are out there?
Yes. We talked about that around the United, obviously, medical policy expansion. And the way to think about it is of the 60,000 patients that make up our addressable market, about 20% of cartilage injuries or defects involved the patella. And then United covers about 15% of patient’s, commercial patients in the U.S.
So you can do the math and say that gets you to about I think 1,800 patients times our price point gets you to -- of the $2 billion TAM you could say $70-ish million of it relates to United patella cases.
Now we were already getting that business. The issue was not all of the business. Obviously the approval rates were much lower than the overall approval rates. But the issue is surgeons really don't want to spend a lot of time trying to go through the whole process on a one-off basis to get these cases covered.
So really it just helps. There's a portion of the addressable market that's attributable to these patients. There's a number of patients each year that were denied because it was patella and it wasn't on the medical policy.
So you pick up that piece and then there's incremental business out there for the years ahead.
Okay. And then lastly for me.
You had mentioned $3.8 million remaining on the BARDA contract for 2021.
I think we had estimated around $3 billion where we would see the Q1 rate continue through the balance of three quarters. And what does that look like for any commentary on this year and then also 2022 with regard to BARDA unto itself?
So we're -- for the year and obviously we recognized $900,000 of this revenue already. But the remainder of the contract was $3.8 million in total.
So there's a little bit less than $3 million to be recognized over the remaining three quarters.
So that remains the same. No commentary beyond that.
So for the -- at least for this year you can keep that in the model.
Okay. That’s it for me. Thanks for taking the questions.
All right. Thank you.
Your next question is from the line of Kevin DeGeeter of Oppenheimer.
Your line is now open.
Hey, great. Thanks for taking my question guys. With regard to NexoBrid, I appreciate the comments with regard to the site inspection probably not a big surprise there. But did I hear correctly that you stated the FDA has requested additional CMC information from MediWound? And if that's correct can you provide some context around that statement?
Yes. We did mention that right? So there's the inspection issue. And then any time you go through an FDA review there's requests for information and so on.
And so, yes, we did say that the FDA has communicated to MediWound that it's unlikely they'll be able to review that additional information during the current review cycle.
Got it. And then with regard to commercial preparation just given this uncertainty and with regards to timing. What portions of the prelaunch investment and scale up, do you feel comfortable continue more or less according to plan? And what elements do you at least need a little more clarity on our reduction in uncertainty before moving forward with investments? Just trying to put some of the -- particularly some of the OpEx guidance in context.
Yes. Well, I'll just start with our philosophical approach and Joe can, kind of, chime in on what that might -- the impact that might have on OpEx.
So, number one, as I mentioned from kind of the medical affairs and clinical side, we continue to enroll patients in the expanded Access study. That will continue during this period. From a commercial prep standpoint really the activities fall into three buckets, right? We developed a disease state awareness campaign that is still being implemented at the various conferences and so on. And then there's brand development and market access activities. And those continue to move forward. There's some things you can kind of slow down if you want. But it's still important. We're looking at completing our pricing study putting P&T kits together and all of those training materials all of that stuff is ongoing because we don't want to be caught flat-footed upon approval.
And so that's moving forward. And same thing -- so the market access activities once they began we're going to see them through to completion. And then brand development again that's moving forward. There's some small pieces.
You can potentially just gate the timing a little bit but we expect that these are just timing issues.
And so we're going to move forward with the majority of the initiatives that were already underway.
Just to add to that as we talked about in the call, we're going forward with the expansion of the burn care team of course, which will support the Epicel growth as well as the potential launch of NexoBrid. And then really as Nick said a number of launch preparations are still ongoing.
So certainly there could be some pieces of that to move around on the sales and marketing side, but I wouldn't expect that to materially impact our operating expenses for the year.
Great. Then lastly for me. Can you just provide an update with regard to the expanded access study the next study? Either number of surgeons you've been able to bring in and gain access to NexoBrid or patient procedures or whatever metric you think is most relevant here.
So we talked previously about, sort of, the program itself right which initially was treating up to 150 patients at up to 30 sites in the US. The pediatric NexoBrid study was ongoing at that time. And now the enrollment is closed in that study and pediatric patients can be treated in the next study.
So the protocol was actually amended to increase the number of sites up to 35 and then up to 200 patients.
And so there's -- we're probably somewhere in the low to mid-20s in terms of the number of sites that are currently engaged in that study. There have been COVID impacts right where sites weren't starting new studies and so on. But we hope to continue to increase that over the balance of this time ahead of approval.
And so we continue to enroll patients.
We have plenty of room to continue to enroll more patients, which is really important right? We want, sort of, the steady execution of the study up to approval so that we have the maximum number of centers and surgeons experienced with the product.
That’s very good. Congratulations on a really terrific quarter and in all progress.
[Operator Instructions] Your next question is from the line of Ryan Zimmerman of BTIG.
Your line is open.
One follow-up from me. The NexoBrid approval and the PDUFA date, excuse me I believe there's a milestone payment of $7.5 million.
So Joe, the $115 million OpEx guidance, I assume doesn't contemplate that milestone payment? And then second to that is, what provisions do you have in the agreement with MediWound to potentially modify that payment if at all given the open-ended question on timing? Thank you.
Yes. I'll take the first part.
So again, the $115 million of OpEx is unchanged. And actually that milestone was not part of that $115 million.
So there's some different accounting where certainly would impact our cash flow, but not the P&L this year. And then maybe you can repeat the second part of the question Ryan?
Yes. Well just any provisions in the contract that dictate that milestone payment and the amount that you may pay to MediWound, based on whether it's a timing delay or something at a certain point does the $7.5 million have the potential to become $6.5 million or $5.5 million based on whatever provisions you may have struck with the company?
Yes, Ryan. There are no provisions like that. And I don't think that's really typical to kind of scale those payments with timing.
So as Joe mentioned, number one that was never included in OpEx just because it has different accounting treatment.
So that -- no change there. And when the product is approved, we'll make the $7.5 million payment.
Okay. Thanks for taking the call.
Great. Thanks, Ryan.
Seeing no additional questions, I will now turn over the call back to Nick Colangelo for closing remarks.
Okay. Thank you operator and thanks to everyone for your questions and your continued interest in Vericel. I also wanted to thank all of our employees for their continued hard work and dedication to the patients we serve. The company executed extremely well in the first quarter and we remain focused on continuing to execute on our long-term growth strategy, providing our therapies to even more patients in need and in the process creating significant value for all of our stakeholders including patients and shareholders.
So thanks again and have a great day.
And with that, this concludes today's conference call. Thank you for attending.
You may now disconnect.