Organogenesis Holdings Inc (ORGO) Q2 2021 Earnings Call Transcript

Organogenesis Holdings Inc (ORGO -23.32%)
Q2 2021 Earnings Call
Aug 09, 2021, 5:00 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good afternoon, ladies and gentlemen, and welcome to the second-quarter 2021 earnings conference call for Organogenesis Holdings, Inc. [Operator instructions] Please note that this conference call is being recorded and that the recording will be available on the company's website for replay shortly. Before we begin, I would like to remind everyone that our remarks today may contain forward-looking statements that are based on the current expectations of management and involve inherent risks and uncertainties that could cause actual results to differ materially from those indicated, including the risks and uncertainties described in the company's filings with the Securities and Exchange Commission, including Item 1A, Risk Factors, on the company's most recent annual and quarterly reports. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made.

Although it may voluntarily do so from time to time, the company undertakes no commitment to update or revise the forward-looking statements, whether as a result of the new information, future events or otherwise, except as required by applicable securities laws. This call will also include references to certain financial measures that are not calculated in accordance with the generally accepted accounting principles, or GAAP. We generally refer to these as non-GAAP financial measures. Reconciliations of those non-GAAP financial measures to the most comparable measures calculated and presented in accordance with GAAP are available in the earnings press release on the Investor Relations portion of our website.

I would now like to turn the call over to Mr. Gary S. Gillheeney, Sr., Organogenesis Holdings president and chief executive officer. Please go ahead, sir.

Gary Gillheeney -- President and Chief Executive Officer

Thank you, operator, and welcome, everyone, to Organogenesis Holdings' second-quarter 2021 earnings conference call. And I'm joined on the call today by Dave Francisco, our chief financial officer. So let me start with a brief agenda of what we'll cover during our prepared remarks. I'll start with an overview of our revenue performance in the second quarter, including a discussion of the key drivers of the strong growth and improving profitability our team delivered in Q2.

After my opening remarks, Dave will provide you with a more in-depth review of our second-quarter financial results and the revised guidance for 2021 that we published in this afternoon's press release. And then we'll open it up for questions. Let me begin with a review of our second-quarter revenue performance, and I am pleased to report that we delivered another quarter of strong financial performance while continuing to make excellent progress against our strategic priorities. During the second quarter, we reported revenue growth of 79% year over year to $123.2 million.

Our growth in the period was driven by 87% growth in our sale of our Advanced Wound Care products with strong contributions from our amniotic portfolio and the PuraPly brand. In Surgical & Sports Medicine, we grew revenue by 27% year over year, despite the expected headwinds from our ReNu and NuCel product lines following the expiration of the FDA's enforcement grace period for those products, which ended on May 31 of this year. And for the avoidance of doubt, our strong second-quarter growth is not just a reflection of an easy comparison from the prior year, where we also grew revenue 6%. Rather, our second-quarter total revenue results represents growth of 90% over the second quarter of 2019, driven primarily by 102% growth in the sale of our Advanced Wound Care products.

And importantly, both of these rates reflect the sequential acceleration in the growth trends over 2019, which we view as strong evidence that our business continues to perform well. Our better-than-expected performance in Q2 reflected our continuing execution against the pillars of growth and our strategy, which include leveraging our comprehensive portfolio of products, diversifying our revenue sources across multiple sites of care and physician specialties and leveraging our broad and growing commercial reach. Let me provide more color on how each of these long-term drivers of growth contributed to the strong revenue performance in the second quarter. First, regarding the strength of our portfolio, sales of our amniotic products were once again the largest contributor to our year-over-year growth in the second quarter.

And as mentioned previously, we're pleased with the strong demand for these products given the amniotic portfolio's high degree of efficacy that clinicians and their patients truly value in the market. Additionally, sales of our PuraPly products increased 32% in the period, representing the third consecutive quarter of double-digit growth after coming off pass-through status in the fourth quarter of last year. This strong growth further validates the clinical utility of our brand and our strategic positioning of the product family with new SKUs, as well as additional clinical data, sites of care and physician specialties. We are proud of the unique customer value proposition our portfolio offers through the combination of our PuraPly brand, which is the only skin substitute with a broad-spectrum antimicrobial agent; our amniotic portfolio with the only fresh amniotic membrane on the market; and our PMA-approved products for both VLUs and DFUs.

Secondly, we continue to diversify our revenue by expanding into new physician specialties and multiple sites of care to better position the company for sustainable growth long term. Regarding physician specialties, we have widened our scope and therefore, expanded our therapeutic wound targeting where we believe our advanced modalities are well-positioned to win. Additionally, we have been continuing our efforts to further penetrate the office channel with offerings and further leveraging our channel expansion through our acquisition of CPN Biosciences, which we have recently rebranded as Organogenesis Physicians Solutions, or OPS. As a result, we continue to expand the number of customer accounts in the office channel, and we are experiencing increased utilization of our products from our existing customers.

Lastly, on enhancing our commercial reach, we continue to make significant investment to grow our sales force, and we believe our team of 325 direct representatives represents a key competitive advantage for Organogenesis in the market. With respect to the overall operating environment in the second quarter, as expected, we continued to see improving trends across our served markets during the second quarter. With the backdrop of these improving trends, coupled with our operational improvements in the quarter with adding 35 new sales representatives in Q2, increasing available product of our amniotic portfolio and continuing to grow active accounts, the business is well-positioned to continue to execute and to grow going forward. However, we are closely monitoring the potential impact to demand from the recent COVID surge in key areas of the country.

Nonetheless, as mentioned, our commercial strategy has resulted in broader diversification of our revenue, which has resulted in less exposure to the acute care and outpatient settings, which continue to face the most COVID-related headwinds. In summary, we are very pleased with our revenue performance in the second quarter, where we reported 79% revenue growth. Our highly differentiated competitive advantage has allowed us to continue to gain share in the market and deliver another strong quarter. We're also pleased with the significant improvement in profitability in Q2 as evidenced by the impressive growth in adjusted EBITDA, which increased nearly $25 million year over year and more than $9 million quarter over quarter.

Our second-quarter adjusted EBITDA margin improved more than 20 percentage points year over year to 20.4% of net revenue. These financial results continue to reflect the underlying profitability potential of our business in the years to come. Additionally, as you may have seen in a separate press release this afternoon, we closed on the refinancing of our bank facilities, which significantly lowers our cost of capital, provides greater liquidity and therefore, financial flexibility, as well as further validates the momentum behind the -- our strengthening financial profile. Before turning the call over to Dave, just to recap some of the key takeaways for the quarter, we delivered another quarter of outstanding financial performance with strong revenue growth and significantly improving our profitability.

We've made great progress toward our long-term strategic initiatives by increasing the sites of care, launching new products, entering new sales channels with our portfolio and our team capitalized on improving operating environments have contributed to gaining market share and expanding the market of our products. And with that, let me turn the call over to Dave for a review of our financial results for the second quarter, our balance sheet and financial condition as of quarter end and a review of the 2021 financial guidance we updated in this afternoon's press release. David?

David Francisco -- Chief Financial Officer

Thanks, Gary. I'll begin with a review of our second-quarter financial results. Unless otherwise specified, all growth rates referenced during my prepared remarks are on a year-over-year basis. As Gary mentioned, we delivered another excellent quarter.

Net revenue for the second quarter of 2021 was $123.2 million, up 79%. Our Advanced Wound Care revenue for the second quarter of 2021 was $111.4 million, up 87% with strong contribution to growth from all product groupings. Revenue from Surgical & Sports Medicine products for the second quarter of 2021 was $11.8 million, up 27% with strong year-over-year contribution to growth from the amniotic portfolio, which more than offset the impact related to the expiration of the FDA's enforcement grace period for ReNu and NuCel products on May 31. Revenue from PuraPly products for the second quarter of 2021 was $37.6 million, up 32%.

As Gary indicated earlier, we are pleased with the continued strong performance from the PuraPly brand as sales have increased 29% year over year over the first six months of 2021. Regarding our commercial footprint, we ended our quarter with 325 direct sales reps and believe we are well-positioned to achieve our goal of ending the year with over 340 direct sales representatives, compared to 290 as of March 31, 2021. Gross profit for the second quarter of 2021 was $93.3 million or approximately 76% of revenue, compared to 71% last year, an increase of approximately 480 basis points year over year and up approximately 60 basis points quarter over quarter. The increase in gross profit resulted primarily from increased sales volume, as well as a shift in product mix to our higher gross margin products.

Operating expenses for the second quarter of 2021 were $69.7 million, compared to $51.2 million last year, an increase of $18.5 million or 36%. The increase in operating expenses in the second quarter of 2021 was driven by a $15.8 million increase in selling, general and administrative expenses and a $2.7 million increase in research and development costs compared to the prior-year period. The year-over-year increase in selling, general and administrative expense was primarily due to a $10.2 million increase related to additional headcount, primarily in our direct sales force and increased sales commissions due to increased sales, a $4.2 million increase in marketing and travel expenses as compared to the low prior-year comparable amid COVID-related travel restrictions in the second quarter of 2020, as well as $3.3 million increase in volume related and other expenses. Second-quarter 2021 selling, general and administrative expenses included two items that did not impact prior-year period results.

A $0.9 million of restructuring costs associated with the closing of the La Jolla office and a $2.8 million noncash benefit related to the change in the fair value of the earnout liability in connection with the CPN acquisition. The year over year increase in R&D expense was primarily driven by an increase in the clinical study and related costs necessary to seek regulatory approvals for certain of our products. Operating income for the second quarter of 2021 was $23.6 million, compared to an operating loss of $2.3 million last year, an increase of $25.8 million. Second-quarter GAAP operating margin was 19.1% of net revenue.

Excluding the restructuring charge and the change in the fair value of the earn-out, operating margin was 17.6% in the second quarter of 2021, representing a year-over-year improvement in operating margin of approximately 20 percentage points. Total other expenses for the second quarter of 2021 were $2.4 million, compared to $2.9 million last year, a decrease of $0.5 million or 16%, driven primarily by lower interest expense related to lower average borrowings compared to the prior-year period. Net income for the second quarter of 2021 was $20.7 million or $0.15 a share, compared to a net loss of $5.2 million or $0.05 per share last year, an increase of $25.9 million or $0.20 per share. Adjusted EBITDA of $25.1 million for the second quarter of 2021, compared to adjusted EBITDA of $0.3 million last year, an increase of $24.9 million.

As Gary mentioned, adjusted EBITDA margin for the quarter was approximately 20% of net revenue. We have provided a full reconciliation of our adjusted EBITDA results in our earnings release issued this afternoon. Turning to the balance sheet. As of June 30, 2021, the company had $90.3 million in cash and restricted cash and $83.5 million in debt obligations, of which $13.7 million were capital lease obligations.

This compared to $84.8 million in cash and restricted cash and $84.8 million of debt obligations, of which $15.1 million were capital lease obligations as of December 31, 2021. As detailed in our press release and 8-K, on August 9, 2021, we secured a new credit agreement with SVB, the lead agent, and we are pleased to expand our banking partnerships with Bank of America, PNC and Citizens Bank. The agreement provides for a credit facility in the aggregate amount of $200 million, consisting of a $75 million term loan and a $125 million revolving credit facility. The new facility reduces our borrowing costs and enhances our financial flexibility, which, along with our improving profitability profile and related cash flow generation, has well-positioned us to continue to execute our strategic growth initiatives in the years to come.

Turning to a review of our 2021 revenue guidance, which we updated in our press release this afternoon. For the 12 months ending December 31, 2021, the company now expects net revenue between $456 million and $472 million, representing an increase of approximately 35% to 40% year over year, as compared to net revenue of $338.3 million for the 12 months ended December 31, 2020. This compares to our prior guidance range of $438 million to $454 million. The 2021 net revenue guidance assumes net revenue from Advanced Wound Care products of between $423 million and $436 million, representing an increase of approximately 44% to 48% year over year.

This compares to our prior guidance, which called for growth of 39% to 43% year over year. Net revenue from Surgical & Sports Medicine products of between $33 million and $36 million, representing a decrease of approximately 18% to 24% year over year. This compares to our prior guidance range, which called for sales to decrease 27% to 34% year over year. Net revenue from the sale of PuraPly products of between $179 million and $187 million, representing an increase of approximately 22% to 27% year over year.

This growth range is unchanged from our prior guidance. In addition to the formal revenue guidance, we'd also like to provide a few considerations for investors to bear in mind when evaluating our growth expectations for fiscal-year 2021. This additional color is intended to help the investment community better understand the assumptions supporting our revenue expectations for 2021. First, the largest contributor to our total net revenue -- total company net revenue growth in fiscal-year 2021 will be sales of our amniotic products, which at the midpoint of our full-year total revenue range now assumes amniotic growth of approximately 68% year over year in 2021.

This compares to our prior guidance range, which assumed growth at the midpoint of approximately 48% year over year. Second, we expect sales of our remaining non-PuraPly, non-amniotic products, which collectively form the group called PMA and Other, to increase at the midpoint of the range of approximately 10% year over year in 2021. This compares to our prior guidance range, which assumed growth at the midpoint of 20% year over year. Third, we expect to see steady improvement in the COVID-related headwinds as we move through the second half of 2021.

However, our guidance for the remainder of the year continues to reflect lower year-over-year growth in the second half of 2021 as compared to the prior year. As a reminder, this is driven primarily by two factors. First, given the strong performance of our Advanced Wound Care business in the second half of 2020, we expect our -- to see our year-over-year growth trends in the second half of 2021 to moderate as we lap the 56% growth from the second half of 2020. Second, as discussed in our first-quarter earnings call, we continue to expect an improving operating environment in the second half of 2021, benefit growth trends in our Surgical & Sports Medicine business, removing ReNu and NuCel from the market beginning June 1, 2021, represents a headwind to growth over the last seven months of 2021 of approximately $18 million, and therefore, a significant impact to the growth profile of the second half of 2021.

As we look beyond 2021, we are continuing down the BLA pathway for renew for the treatment of knee osteoarthritis. And based on favorable feasibility studies, believe this product has potential beyond knee OA for additional osteoarthritis and tissue regeneration applications. As such, given the broad-based growth opportunities for ReNu, we are targeting our investments on ReNu and have discontinued our IND efforts for NuCel. With respect to our -- for our expectations for financial performance in 2021, we continue to expect to report positive GAAP net income and positive adjusted EBITDA for the fiscal full-year 2021 period.

In addition to our formal financial guidance for 2021, we're providing some consideration for modeling purposes. For the full-year 2021 period, we now expect gross margins of approximately 75%, total GAAP operating expenses to increase approximately 27% year over year. This compares to our prior expectation for an increase of approximately 25% year over year, which reflects the incremental selling expenses related to second-quarter 2021 revenue performance, as well as incremental costs related to a tight labor supply, partially offset by the benefit of the reduction in the CPN earn-out liability. Note, our 2021 GAAP operating expenses include approximately $5 million of restructuring expenses related to our La Jolla, California facility, of which, approximately $1.9 million occurred in the first half on 2021.

Noncash G&A of approximately $9 million, noncash stock comp of approximately $3 million, weighted average diluted shares of approximately $134 million, we expect full-year 2021 capex of approximately $30 million, which -- of which approximately two-thirds is related to growth and gross margin improvement initiatives. Finally, we expect total interest and other expenses of approximately $9 million as the lower borrowing costs associated with the refinance facilities will be partially offset by exit costs expensed in the third quarter of 2021. With that, operator, I'll turn it back over to you.

Questions & Answers:

Operator

Thank you, sir. [Operator instructions] And our first question will come from Ryan Zimmerman with BTIG.

Ryan Zimmerman -- BTIG -- Analyst

Good afternoon. Thanks for taking the questions. Congrats on the quarter. Maybe, Gary, to start on the guidance, specifically within AWC, I'd love to get your perspective on your current capacity -- your manufacturing capacity within amniotics.

It continues to be a positive surprise for the business. I know you were constrained a little bit there. And then my second question is around the non-PuraPly, the PMA and Other products. And just would love to understand kind of the dynamics that were driving that performance and then the softer guidance on that category of products.

Thank you.

Gary Gillheeney -- President and Chief Executive Officer

Sure. Thank you, Ryan. Yeah, we did have a nice increase in capacity in Q2 for our Affinity and amnion products. So that was something that we were counting on, and we actually focused a lot of our attention, commercially, on driving and expanding our Affinity sales and expanding the launch of that product as a result of that capacity.

So that was a nice bump for the quarter for us for sure. On the PMA product side, I mean we're still seeing growth in our non-PMA products. I mean all our products are growing very nicely. We're also seeing, obviously, some revenue from our CPM Biosciences as well.

So a combination of the acquisition and our legacy products doing well. The expansion of our TRSs, or our sales representatives, have also been very, very powerful and helpful in the quarter, and we expect them to continue to provide results going forward as we've seen their productivity increase fairly dramatically in the quarter as well by selling the entire portfolio. Hopefully, that answers your question.

Ryan Zimmerman -- BTIG -- Analyst

That's helpful. And then just a -- sneak one in and a follow-up for Dave. You mentioned the tight labor supply. I just -- where are you seeing that specifically? Because your sales force is growing nicely.

So just help us understand kind of where you are maybe a little more constrained on labor.

David Francisco -- Chief Financial Officer

Yeah, sure. It's not really a constraint. It's just the costs are going up. So we're seeing a kind of change in the dynamic of new reps coming in and it's beyond the commercial resources as well.

So we're just feeling it a bit there. I just wanted to provide a little bit of color from that standpoint.

Ryan Zimmerman -- BTIG -- Analyst

OK. Thank you for taking the questions. 

Operator

Thank you. The next question comes from Matt Miksic with Credit Suisse.

Matt Miksic -- Credit Suisse -- Analyst

Hi. Thanks so much for taking my questions. So just one on environmental. I know you put up a really strong quarter here.

So it doesn't seem like it's something you're seeing widely right now. But when you talk about being sort of mindful of some of the risks related to COVID or Delta, what -- where are you seeing, if you are seeing anything now, where might we start to see that? Or what -- help us understand how that might flow through and impact your business here in the back half? And then I had one follow-up.

Gary Gillheeney -- President and Chief Executive Officer

Sure. So we are seeing impacts, particularly in the Missouri, Alabama, Oklahoma area. We started to see that in the last several weeks. We're also seeing impacts in the Texas area, particularly Houston and in Florida.

Florida was primarily in the northern area that was affecting us, but we're now seeing it coming up the West Coast in the Naples and Fort Myers area, which is an important area for us. So we're certainly monitoring it. Those areas are important to us, particularly Texas and Florida in the Advanced Wound Care side and kind of the Midwest, as you know, we're pretty strong in the South and the Midwest. So we do expect to have an impact.

Fortunately, for us, we've continued to expand our office presence where we did not see much of an impact, and we continued to open additional channels in the surgical side. And some of those areas like trauma, some really complex wounds, limb salvage are not as susceptible to elective surgery kind of issues that you find in a COVID environment. But we're definitely seeing the impact in the hospitals. We haven't seen a revenue impact yet, but we are cautious about it.

But those are the areas that we see things starting to get a little concerning.

Matt Miksic -- Credit Suisse -- Analyst

Great. And then if I could just -- I'm afraid I have two follow-ups, if I could. One, just on the cadence of -- you mentioned amniotic tissue products being an important part of the back half of the year. And I'm just wondering if you could dovetail or reconcile your comments on that and the physician office channel.

In other words, based on some of the things you mentioned, based on the channel -- the accounts that you're adding there and the integration of CPN, anything you can give us in terms of the magnitude or contribution to growth of that in the back half, maybe versus the rest of your business? And then I realize it's not an operating question, but I do have to ask about the shareholder agreement that you've disclosed in the 8-K just because of all the issues related to some of the disbursements and the pressure on the stock. I'd love to get your sense about how you arrived at that. What do you think it means in terms of your plans for further capital transactions? Again, it's a very complicated question because it's not -- it's got nothing to do with your operating results, but obviously, for folks on the call, I think, understand that it's an important topic to maybe highlight and air out.

Gary Gillheeney -- President and Chief Executive Officer

Sure. I'd be happy to address it. So your first question regarding the amniotic contribution in the second half. We don't expect to see a large contribution in Q3 for amnion.

It will really be Q4. And the reason for that, Matt, is we did get a bump in Q2, as I mentioned, in capacity, but that capacity is going to remain at the same level in Q3. We won't see another bump in capacity until Q4. And then we expect a fairly significant increase in capacity.

So we would expect more of a contribution in Q4 than in Q3. But collectively, will still be a strong contributor to growth. We did commit to two and a half times the capacity in '21 versus '20, and we definitely expect to see that. And you've seen the results in Q2 with the increase in capacity in those additional accounts.

It really did drive revenue as we expect it will in Q4. Related to the shareholder agreement, I think, as we stated in the 8-K, our large legacy shareholders that hold over 40% of Organogenesis stock, which is Alan Ades, Albert Erani, Dennis Erani, Glenn Nussdorf and related trusting companies that they controlled have agreed with the company, effective August 9, that they will not sell any shares of the company's capital stock that they hold until at least March 1, 2022, unless any such sale is completed in an orderly fashion as part of an underwritten secondary public offering. The company recognized, and I wasn't really happy with the sales, I'm sure most people weren't. So the board has agreed that they recognize that periodic unexpected selling by them in the market may cause some volatility or disruption.

So their entry into the lockup reflects their commitment to conduct any of these sales at least through March of 2022 in an orderly fashion. So I think the recognition that it could create some disruption in the market is certainly unintended and needs to be addressed, and we addressed it.

Matt Miksic -- Credit Suisse -- Analyst

That's great. Thank you.

Operator

Thank you. Our next question comes from Richard Newitter with SVB Leerink.

Erin Fahey -- SVB Leerink Partners -- Analyst

Hi. This is Erin on for Rich. Thanks for taking our questions, and congrats on the quarter. I just have a quick one on PuraPly trends.

It looks like revenue took a step -- slight step down in 2Q versus 1Q. But your guidance, which remains unchanged from the prior update, implies an acceleration in the back half versus 2019 levels. I was just wondering if you could maybe talk about some of the trends that you're seeing with this product. And then I'll have another follow-up as well.

Gary Gillheeney -- President and Chief Executive Officer

Sure. So we are happy with the growth -- 32% growth in PuraPly. As I mentioned earlier in addressing Matt's question, the -- our Affinity capacity increased dramatically in the second quarter as planned, and our commercial focus shifted dramatically to expanding the launch of our Affinity products in the geographies in which we sell it today. So that was a committed effort, and that had an impact on PuraPly sales.

Now that we've kind of got through that launch period or expanded launch period, we expect the product to continue to grow nicely in the back half of the year. So that was something that we planned, which is why we've reconfirmed our guidance for PuraPly. We haven't changed it at all. It was what we did expect.

So second -- Dave, you can jump in, second half, we expect PuraPly to grow quite nicely.

David Francisco -- Chief Financial Officer

Yeah, I think you're right, Gary. I mean 32% up in the quarter and 29% first six months of the year and holding the guidance, we feel good about the trajectory there.

Gary Gillheeney -- President and Chief Executive Officer

Thank you.

Erin Fahey -- SVB Leerink Partners -- Analyst

OK. Great. Thanks. And then I was just wondering if maybe you could provide an update on some of the pipeline products like Novachor and TransCyte.

And then also just if you wouldn't mind walking us through kind of the BLA time lines for ReNu and what to expect in terms of time lines for the trial and submission.

Gary Gillheeney -- President and Chief Executive Officer

Sure. So we're still expecting to launch TransCyte in 2022. It would be more of a soft launch and a full launch at the end of 2023. Our Novachor product we're expecting to have on the market by the end of this year, but really won't be a contributor until 2022.

But that launch is moving forward quite nicely. On the ReNu front, we are still expecting that we will complete the enrollment of the study by Q1 of 2022. We're expecting that our interim analysis will be available around the end of the first quarter, beginning of the second quarter. We expect to complete the study in mid-2023 and submit for approval and hopefully get approval in mid- to end of 2024.

Again, assuming one phase 3 trial is all that's required.

Erin Fahey -- SVB Leerink Partners -- Analyst

OK. Great. Thanks for taking our question. 

Gary Gillheeney -- President and Chief Executive Officer

You're welcome.

Operator

Thank you. [Operator instructions] Our next question comes from Steve Lichtman with Oppenheimer & Company.

Steve Lichtman -- Oppenheimer & Co. Inc. -- Analyst

Hi, guys. Congratulations on the quarter. Gary, I know early days, but now that we're past the FDA enforcement grace period, I'm wondering what you're seeing on the ground relative to the impact of your competitors. Have you seen a big enough impact to smaller competitors given more exposure to the impacted products is that net-net, you've been able to take share overall? I mean, obviously, you're growing ahead of the market, but do you see that as one factor?

Gary Gillheeney -- President and Chief Executive Officer

Yeah. It's -- I think it's a little too early to tell at this point. Obviously, we're not selling the product. There are competitors out there that have similar products that may be still on the market.

I'm not sure. So we're trying to figure that all out right now. We don't have enough data at this point to see what the real impact has been.

Steve Lichtman -- Oppenheimer & Co. Inc. -- Analyst

OK. Fair enough. And then just secondly, thanks for the update on ReNu and NuCel. Can you talk a little bit more about what you're seeing out of ReNu that is giving you the confidence of the broader applicability of the product and that's why you decided to not pursue the trial on NuCel?

Gary Gillheeney -- President and Chief Executive Officer

Yeah. I think what's important in our decision for NuCel is we assume that NuCel would be on the market, remain on the market and would help fund that study. It's a good product, a strong product. But without being able to sell the product and fund that study, we thought a better return would be looking at additional indications of ReNu.

And we do have several that we're studying now that we're pretty excited about. We haven't made any final decisions, but we think the market potential for ReNu indications is significantly higher than what NuCel may be. So it's worth the additional investment without the obviously associated revenue compared to NuCel.

Steve Lichtman -- Oppenheimer & Co. Inc. -- Analyst

Got it. Great. Thanks, guys.

Gary Gillheeney -- President and Chief Executive Officer

Sure.

Operator

Thank you. Our next question comes from Ryan Zimmerman with BTIG.

Ryan Zimmerman -- BTIG -- Analyst

I had a couple of follow-ups. Sorry, you couldn't get rid of me sooner. But just a couple of questions. Dave, these EBITDA margins, you're north of 20%.

And so I know you're in a very important growth phase and certainly the top line is the focus. But I'd love to get your thoughts just on the EBITDA margins over time. And your ability to generate cash here is increasing. And just how you think about the use of cash? I think it would be helpful for investors to get your perspective on that.

Thanks for taking the follow-up.

David Francisco -- Chief Financial Officer

Yeah, sure. I mean obviously, at the back half of last year, we had a big step-up in revenue and then COVID-related kind of savings. And so we did flow a lot to the bottom line. We saw the same thing in Q1 and then had great performance in Q2.

So I think it does illustrate the level of profitability that the business has and the operating leverage potential. But I think, as we mentioned, we still need to build out the infrastructure. It's not just the commercial teams, it's beyond that to really function as a high-growth company. So you're right.

We're focused very much on the top line and ensuring that we continue to invest in that. But that level of profitability is going to generate a lot of cash flow in the future. So we've been talking a lot about that internally about how to deploy that capital. I think there was a question earlier as to whether or not we needed any more equity capital, and I think at this stage, the answer is no.

But we'll continue to look for opportunities to add to the portfolio through potential growth acquisitions. Anything to add to that, Gary?

Gary Gillheeney -- President and Chief Executive Officer

No. Well said.

Ryan Zimmerman -- BTIG -- Analyst

OK. Appreciate it very much. Thank you.

David Francisco -- Chief Financial Officer

Thank you, Ryan.

Operator

[Operator signoff]

Gary Gillheeney -- President and Chief Executive Officer

Thank you very much.

Duration: 40 minutes

Call participants:

Gary Gillheeney -- President and Chief Executive Officer

David Francisco -- Chief Financial Officer

Ryan Zimmerman -- BTIG -- Analyst

Matt Miksic -- Credit Suisse -- Analyst

Erin Fahey -- SVB Leerink Partners -- Analyst

Steve Lichtman -- Oppenheimer & Co. Inc. -- Analyst

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