This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk14: Good day and welcome to the Integra Life Sciences second quarter 2021 financial results call. Today's call is being recorded. At this time, I'd like to turn the call over to Mike Volliou, Director for Investor Relations. Please go ahead.
spk06: Thank you, Stephanie. Good morning and thank you for joining the Integra Life Sciences second quarter 2021 earnings conference call. Joining me on the call are Peter Arduini, President and Chief Executive Officer, Glenn Coleman, Chief Operating Officer, and Carrie Anderson, Chief Financial Officer. Earlier today, we issued a press release announcing our second quarter 2021 financial results. Along with the release, an earnings presentation, which we will reference during the call, is available at IntegralLife.com under Investors, Events and Presentations, and the file named Second Quarter 2021 Earnings Call Presentation. Before we begin, I'd like to remind you that statements made during this call may be considered forward-looking. Factors that could cause actual results differ materially are discussed in the company's Exchange Act reports filed with the SEC and in the release. Also, in our prepared remarks, we'll make reference to both reported and organic revenue growth. Organic revenue growth excludes the effects of foreign currency, acquisitions including ASEL, divestitures including the sale of our extremity orthopedics business, as well as discontinued products. The list otherwise stated, all disaggregated and franchise-level revenue growth rates are based on organic performance. Lastly, our comments today will include certain non-GAAP financial measures. Reconciliations of any non-GAAP financial measures can be found in today's press release, which is an exhibit to Integra's current report on Form 8K filed today with the SEC. With that, I'll now turn the call over to Pete.
spk17: Thank you, Mike, and good morning, everyone. I'm pleased to report strong results this morning, reflecting the continued momentum in the business, which enabled us to raise our full year guidance. If you'll turn to slide five in the deck, I'll begin with a review of our second quarter performance. Total revenues were $390 million, representing reported growth of 51% and organic growth of 49% compared to the prior year. Our growth rates were above the high end of the guidance we provided in April and represent organic growth of approximately 3.7% compared to 2019. The gradual recovery in our business, coupled with growth acceleration in products launched over the last 18 months, drove much of our strong performance in the second quarter. Sales were particularly robust across a vast majority of our franchises in both segments. Sales of capital equipment and products in some of our indirect markets are still early in their recovery and showing encouraging trends. Based on feedback from our commercial teams, we expect year-over-year improvement in the second half, especially with respect to capital. Profitability was also very strong in the second quarter, with EBITDA margins of nearly 26% and adjusted earnings per share of 79 cents. Higher revenue, favorable mix, and integration savings drove much of our performance, offset somewhat by normalization of our expenses. As a result of our first half performance and our expectations for our recovery to continue through the second half, we're raising our full-year 2021 revenue guidance by $15 million and our full-year adjusted earnings per share guidance to a new range of $2.98, to $3.05. At our May 20th Investor Day, we laid out a path to achieving our long-term targets. Following the Codman integration, the divestiture of the extremity orthopedics business, and most recently, the integration of Acell, Integra is at an inflection point with two highly focused business segments in neurosurgery and regenerative tissue technology. I'd encourage you to visit our website and watch our Investor Day webcast, Members of our leadership team presented detailed strategies, market opportunities, and catalysts to support our long-term targets. As we illustrated in our presentation, our operating model drives how we run the company on a day-to-day basis and ensures alignment of priorities and consistent execution. The company is in a strong position both strategically and operationally. Please turn to slide six. On June 24th, we announced a leadership transition. After an incredible 11 years, I'll be stepping down as president and CEO of Integra to run the healthcare business at GE. Our board has appointed a special committee, retained an executive search firm, and initiated a formal process to identify a successor, including both internal and external candidates. The process is moving swiftly, and we remain committed to a seamless transition by the end of the year. The company has an outstanding leadership team capable of executing our strategic plans, and we have a deep pipeline of new products to drive market growth and market expansion for years to come. Our strategy, which was developed by this management team and has the full support of the board, is backed by a strong operating model, and we have the financial strength and flexibility to successfully execute our plan. I'm confident that this strategy, coupled with this management team, will deliver a faster top line growth, and consistent profitability. And with that, I'd like to turn the call over to Glenn to discuss our accomplishments and performance in the second quarter in more detail.
spk04: Glenn? Thanks, Pete. Good morning, everyone. Please turn to slide eight. As Pete indicated, our second quarter operating performance was better than expected. And I'd like to highlight a few of the factors that contributed to our results and some of the progress we made during the quarter. including an update to the catalyst we discussed at our May investment. Our performance in the second quarter sequentially increased $30 million, or 8%, and was led by a recovery in our core portfolio of products in neurosurgery, instruments, burn trauma, and surgical reconstruction. This recovery was broad-based, with total organic growth of approximately 3.9% in the U.S., and 3.2% outside the U.S. compared to 2019. Growth outside the U.S. was strongest in Asia Pac, led by Japan and China, both of which grew double digits versus 2020 and 2019. Excluding our indirect business outside the U.S., our international organic growth was approximately 8% compared to 2019. Turning to ASL, all critical components of the integration were completed ahead of schedule, and our commercial teams are increasing penetration into existing and new accounts. Having said that, the integration of the sales force during the pandemic has been more challenging than expected as a result of continuing restrictions on access to hospitals and surgeons, leading to a slower start. We expect these disruptions to be short-term in nature, since in-person sales calls and cases are increasing monthly. Harry will provide additional details on our outlook in a few minutes, and we remain confident in our long-term growth expectations for the ASL portfolio. Turning to new product introductions, a controlled market release of Serolink, our next-generation intracranial pressure monitor, will begin in the third quarter. Suralink will provide enhanced accuracy, usability, and advanced data analytics resulting in better patient outcomes. We have seen a high level of interest from physicians, and with our large global installed base, are excited to get this rollout underway. The Aurora Surgeon Scope is another high priority product offering, and we plan to place a limited number of surgeon scopes in the third quarter as part of a clinical evaluation. As we discussed in detail at our investor day, the initial therapeutic area we are targeting with the Aurora platform is minimally invasive cranial tumor removal using our proprietary scope and instruments. In this evaluation, we'll be leveraging our KOL relationships at select sites to generate clinical evidence and gain insights we believe will help define protocols for minimally invasive neurosurgery. We expect this work to position us for a broader commercial launch in the second half of 2022. We also remain on track to leverage this technology platform customized for surgical intervention in intracerebral hemorrhage or ICH cases. The combination of our scope and extraction device has the potential to redefine the standard of care. Our U.S.-based MIRA registry, which is designed to collect clinical evidence in ICH cases, It's currently in progress, and we look forward to providing a more detailed update later this year. It is an exciting time, as we have a robust list of short and midterm catalysts to drive market expansion. I'll wrap up with a few comments on the PrimeMatrix DFU study and NeuroGen3Date. On July 15th, the Online Journal of Wound Care published the results of a prospective randomized controlled trial of our Prime Matrix ADM for treating hard-to-heal diabetic foot ulcers. This multicenter study enrolled over 225 patients and found that Prime Matrix demonstrated statistically and clinically significant results, healing more DFUs in 12 weeks versus standard of care. In the second half of 2021, we'll be sharing this important new clinical evidence with commercial payers in an effort to significantly expand outpatient reimbursement for PrimeMatrix. Finally, NeuroGen3D, our innovative solution for peripheral nerve repair, remains on track for a 2022 launch. NeuroGen3D's unique inner matrix has porous channels to accelerate nerve regeneration. This product will expand our portfolio of leading wraps and conduits and provides access to a larger portion of the fast-growing nerve repair market. We've accomplished a lot in the first six months of 2021, which gives us the confidence to raise our full-year guidance. Now I'll hand the call over to Carrie to provide a detailed review of our second quarter financial performance. Carrie?
spk15: Thanks, Glenn, and good morning, everyone. I'd like to start with a summary of our second quarter highlights on slide 10. Second quarter total revenues were $390 million, representing an increase of 51% on a reported basis, and 49% on an organic basis compared to the prior year. Compared to 2019, organic growth was 3.7% in the quarter and was broad-based, including positive organic growth in both segments, as well as in both our U.S. and international markets. Revenues were approximately $12 million above the high end of the guidance range. Adjusted gross margins in the second quarter was 68.1%, an improvement of 190 basis points compared to 2020, and an improvement of 70 basis points compared to 2019. These gains were driven by a better than expected recovery in our revenues and favorable U.S. product mix, including the addition of ASAL. Our Q2 adjusted gross margins came in slightly better than expectations, But as mentioned on our Q1 earnings call, our adjusted gross margins in the first half were impacted by higher manufacturing costs related to tight labor supply. We are also experiencing longer lead times for select source materials, resulting in some increases in freight. These labor and supply chain challenges will likely persist into the second half and will keep us near the lower end of our full year adjusted gross margin range, of 68.2% to 68.5% that was provided during our investor day meeting. Consistent with this outlook, though, second half adjusted gross margin should be modestly higher than the first half. We are closely watching material cost inflation and have supply contracts to largely reduce near-term exposure. Any significant inflation risk will factor into our continued thinking about opportunities to pass along these impacts through pricing. Q2 adjusted EBITDA margin of 25.9% improved 550 basis points from the prior year and benefited from the higher revenue and higher adjusted gross margins. EBITDA margin also benefited from the ASEL commercial cost synergies. These benefits were partially offset by higher operating expenses, which are gradually increasing following the reduced levels of spending in the same period last year in response to the global pandemic. We expect a further gradual increase in spending in the second half, investing for growth for new product plans, further geographic expansion, and clinical studies. Due to the slower ramp of expenses in the first half, we now expect a full-year adjusted EBITDA margin slightly above the high end of our May Investor Day range of 24.5% to 25%. Adjusted earnings per share for the second quarter was 79 cents compared to 33 cents a year ago. I'll provide an update on our full year adjusted EPS in a moment. And finally, second quarter operating cash flow was $91 million, our highest level in the company's history. If you turn to slide 11, I'll now review the second quarter performance of our CSS segment. Q2 revenues in CSS were $257 million, an increase of 51% on a reported basis and approximately 50% on an organic basis from the prior year. Both global neurosurgery and instrument sales increased double digits on an organic basis compared to 2020. Within neurosurgery, sales in each of our franchises increased double digits recovering from the COVID-related impact of 2020. Compared to 2019, CSS sales increased approximately 4.5% on an organic basis. Sales in advanced energy, CSF management, and dual access and repair all increased between low to high single digits organically compared to 2019, while neuromonitoring was slightly down. Second quarter sales in instruments increased nearly 4% compared to 2019 on an organic basis. International sales in CSS increased double digits across all regions compared to the prior year. Compared to 2019, international sales increased double digits in Asia-Pac, but declined low single digits in Europe as there was variability in our recovery, especially in our European indirect markets. Moving to our tissue technology segment on slide 12. Q2 sales and tissue technologies were $133 million, an increase of 50% on a reported basis and 47% on an organic basis from the prior year. Second quarter sales and wound reconstruction increased 52% on an organic basis compared to 2020, with all major product families increasing double digits. If we look at our performance compared to 2019, Sales in wound reconstruction increased mid-single digits and was led by Integra Skin and Surgimen in our burn, trauma, and surgical reconstruction markets. Sales in private label increased double digits compared to 2020, driven by a recovery in demand from our partners. And compared to 2019, sales declined low single digits due to order timing in 2019. If you turn to slide 13, I'll provide a brief update on our balance sheet, capital structure, and cash flow. Operating cash flow in the quarter was $91 million, and free cash flow was $85 million. Free cash flow conversion was 125% in the second quarter, reflecting a benefit from higher earnings and lower capital spend due to timing. We do expect capital expenditures to increase during the second half of the year, but likely will remain below $60 million for the full year. Our operating cash flow for the first six months of the year was strong at $160 million with free cash flow of $147 million and over 100% free cash flow conversion. In Q2, we repaid $100 million of debt while still ending the quarter with a cash balance of $397 million. Net debt at the end of the quarter was $1.17 billion and our consolidated total leverage ratio was 2.4 times an improvement of over half a turn from December 31st of 2020. Turning to slide 14, I'll provide an update to our consolidated revenue and adjusted earnings per share guidance in the third quarter and full year 2021. For the third quarter, we forecast revenues to be in the range of $382 to $389 million, representing reported growth of approximately 3% to 5%, and organic growth of 5% to 7% compared to 2020. And for the full year 2021, we are increasing our revenue guide by $15 million to a new range of $1.54 to $1.55 billion. This upward adjustment reflects a full flow-through of the full second quarter revenue beat at the midpoint of our original guidance range. The new range represents reported growth of 12% to 13%, and organic growth of 13% to 14% compared to 2020. Embedded in our full-year guidance is a new revenue range for ASEL of $70 to $74 million. We are actively working to improve access and existing and new customer accounts, as well as expand resources and territory coverage. We expect sequential quarterly sales improvement in the second half, and our year two accretion targets remain on track. Our strong performance in other parts of our CSS and TT business more than offset the slower start with ASEL, and as a result, we have raised our full-year revenue guidance by $15 million. The midpoint of our revised guidance range represents second-half organic growth of approximately 7% compared to 2020 and 5% compared to 2019. Turning to adjusted earnings guidance for 2021, we expect third quarter adjusted EPS to be in the range of 71 cents to 74 cents, which reflects a sequential improvement in adjusted gross margin. For the full year, we are increasing adjusted EPS to a new range of $2.98 to $3.05, representing growth at the midpoint of approximately 23% compared to 2020, and 10% compared to 2019. With that, I'd like to turn the call back over to Pete for some closing remarks.
spk17: Thanks, Carrie. If you turn to slide 15, I'd like to summarize a few of the takeaways. Our first half performance in COVID recovery were very strong, and when coupled with our outlook for the second half, gives us confidence to raise our full year outlook on both the top and bottom line. We'd all hoped that the pandemic would be completely behind us as we begin the second half of the year, but it's now clear that the lingering effects are going to be with us globally for the coming months. That said, we're seeing very healthy recovery trends across all our businesses and geographies, and we remain optimistic about a strong second half of the year and full recovery in 2022. Our teams are adopting to a hybrid environment, and while we're returning to a more returning to more in-person meetings, will continue to leverage all the digital tools that we've implemented over the last 16 months. In the second quarter, growth in many parts of our business exceeded pre-pandemic levels. Our new products will drive growth in 21 and beyond, and we believe many of these products in both neuro and regenerative tissue business represent breakthrough technologies that will deliver better patient outcomes through innovative therapeutic advances. We look forward to the launches of SaraLink, our neurocritical care monitor, and the AuroraScope, the first product from our minimally invasive surgical platform. Each of these products raises the bar in their respective markets and advances our leadership position within neurosurgery. For the second half of the year, we remain focused on execution. We've sharpened our strategy and put in place the operational capabilities and leadership team to drive faster growth and greater value for shareholders in 21 and into the future. So that concludes our prepared remarks. Thanks for listening. And operator, if you wouldn't mind, please open up the lines for questions.
spk14: Thank you. If you'd like to ask a question, please signal by pressing star 1 on your telephone keypad. If you're using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, you may press star 1 to ask a question. Our first question comes from Steve Lichtman with Oppenheimer & Company.
spk05: Hi, good morning, guys. I guess first question I wanted to touch on was Sterling with the launch pending here in 3Q. Can you give us a sense of what the outlook on the rollout is? You've talked in the past about a lot of potential targets out there of both old Codman systems and competitive systems. Now, how are you seeing Sterling potentially contributing to growth in the second half and then into 2022?
spk04: Steve, it's Glenn. Good morning. I'll start off and maybe just first highlight some of the differentiating features of Serling and why we're excited about it. First, it's more accurate than other products that are on the market. It has less microsensor drift. It's MR compatible. The sensor durability and flexibility is the best on the market, so it doesn't have kinking or bending because you can coil it, you can tunnel it, and surgeons really like that capability. And then it's got this advanced data presentation, which think of it as a waveform on the actual product versus point-in-time reading. So you can measure ICP burden over time. And measuring that pressure and having some historical data can really inform clinical decisions, which is an important part of this new product rollout. And keep in mind, why we're excited about it, in addition to those features, is we have the largest neuro sales force that's going to be rolling this out. So in terms of the launch itself, we're going to do a controlled market release here in the third quarter, both in the US and a handful of sites outside the US. So don't expect a lot of revenue in the third quarter associated with the controlled market release. We expect to then pivot, though, to a full market release in the fourth quarter. We do have some pent-up demand, so we should see a nice uptick in revenues in the fourth quarter once we move to a full market release. What I really like about this product, though, is, you know, we talk about hitting peak year sales three to five years out, and that's probably where we'll be in the U.S. market, you know, in 2025 or 2026. The nice thing is, though, we're going to then be launching in China around that same timeframe, which will drive additional growth for really the next 10 years when we look at Serling. So we see a real nice path here for a number of years relative to Serling, the growth it's going to bring to us, not just on the upfront capitalization, So hopefully that gives you some color in how we're seeing it. But there's probably something close to 9,000 units out there that we could replace. Almost half of those are in China. So that's why we're excited about the longer-term aspects of not just the next three to five years, but the next 10 years we have a real big opportunity here to upgrade the installed base and take market share from others that are in the market today.
spk17: I think it's fair to say as well, I mean, both our existing installed base and most of the competitors I think a lot of you know that this idea of cerebral pressure, brain swelling is one of the most critical metrics. And so having all the features Glenn talked about, it's a pretty big deal. So we're excited about what this can represent really over the next three to five years.
spk05: Got it. Great. Thanks. And then just secondly, you know, with the higher sales performance in the first half and the EBITDA coming in higher, that's translated, you know, Do you anticipate the use of cash in terms of M&A to pick up again here in the coming quarters? Are you comfortable now with the leverage ratio where we could see some more tuck in M&A on the technology side?
spk15: Yeah, I think, Steve, you're right on in terms of understanding that we've got a lot of flexibility on the balance sheet now with our target leverage window is usually 2.5 to 3.5, and we're at 2.4 times now. really good flexibility to give us to be opportunistic on M&A. I'll let Glenn talk about, you know, some of the areas that we're focused on on that side. But M&A has always prominently been part of our capital allocation strategy. We want to continue to be opportunistic in M&A and certainly can support that with the balance sheet. Glenn?
spk04: You know, it's great to see the performance of the cash flows of the business over the past six months to nine months. And the carrying team have done a real nice job and that does provide a lot of flexibility, and we take a balanced approach to it. So what I mean by that is what investments are needed to fuel growth in the actual core business, including the catalyst that I walked through in some of my prepared remarks, and then obviously M&A is a big part of that as well. As we talked about during the investor day, acquisitions and integrations are a core competency for us as a company. And so as we look at the M&A landscape right now, You know, we're focused on doing tuck-in acquisitions. I'd love to be able to get a couple done before the end of the year, but we'll have to see how that plays out. We're looking at adjacent opportunities in neurosurgery, along with our regenerative business, and then still looking at international partnerships. So not necessarily going out and acquiring technologies, but licensing deals where we can leverage our large commercial channels in places like Japan and China to name two. But listen, we're going to remain very disciplined on M&A. We've got great cash flows, as we talked about during our prepared remarks. We've got a number of things that are in the pipeline. But, you know, expectations around valuation are quite high right now, so we'll have to see how some of that plays out. But we're in a really good position from a balance sheet and flexibility point of view.
spk03: Great. Thank you, guys.
spk14: Thank you. Our next question comes from Dave Tricolet with JMP Securities.
spk16: Hey, good morning. Good morning. Just to start with, you mentioned A-cell, and I think you highlighted sort of restricted access in terms of the delta of the 13 or so million that we're looking for for the year now. And I'm just curious, should we think of that as like headcount turnover some as well? I know there's a lot going on in the biologic space, but when you say that, are you talking about duplicative folks, or how should we just Kind of think about that specifically. Is it they can't get in, or is it that there's going to be fewer reps?
spk04: Yeah, Dave, it's Glenn. Let me take a shot at this one. So I think, first off, ASL is a great asset, and it has a really nice synergistic fit into our overall business. In terms of the integration itself, all the integration activities are on or ahead of schedule. All the functional areas are really running well. So think of that as the two plants that we inherited, quality organization, distribution, all the back office functions, that's all going really well. But let me take you back to the beginning of the year. And one of the key assumptions that we had was we had to do a Salesforce integration in order to get this business to be profitable. As a standalone business, this was not a profitable business. And I would just tell you that that Salesforce integration has actually gone really well. The short-term challenge that we're facing is... you know, as our reps are handing off the relationships and selling these new products, it's been more difficult to get face-to-face in-person selling versus a virtual environment. I think as we start to see more and more access being lifted and getting access into the hospital theater, that's going to really help to get the momentum we need for the ASL business. But it's been a challenge because we have had restricted access, and the good news is month to month we are seeing improvements. Having said that, the sales will come. The sales growth will happen. And so we feel quite confident around the ASL business. Like I mentioned before, it's a great fit. And one of the nice things and positives around this is also the fact that it's enabling us to have new conversations with our existing portfolio in complex wound and surgical reconstruction. And you saw that performance in our base business in the current quarter. If you just look at our U.S. sales performance, we grew over 20% in 2020. our PRS, our plastic and reconstructive business, mid-single-digit growth and wound reconstruction in the U.S., and so getting some positive benefits in the base business as well. So, Carrie, I don't know if you want to add anything.
spk15: Yeah, I would just say the way I look at it is everything that Glenn mentioned, but from a guidance perspective, I look at we de-risked the second half. We had a slower start in A-cells, so the guidance reflects an improvement in the second quarter but a slower ramp for the rest of the year it doesn't change my outlook for for 2022 and hitting our accretion target so everything is on track there but we've de-risked the second half and because of the fact that the rest of the business the organic base of the business is really performing really quite nicely so when you think about guidance we took guidance up by 15 million dollars a cell came off a little bit but the underlying based organic business was up $28 to $29 million embedded in that guidance.
spk16: Great. Thank you for all the color. I guess as a follow-up, you know, neuro and instruments, your Codman side has been really strong and, you know, kind of always thought of those as sort of lagging. But as you sort of look at the performance, some of the things you called out, CSF, general access, I mean, do you think these markets are accelerating, or is it your portfolio, or I guess just any thoughts around some of the strength there? Thank you.
spk15: Yeah, in Q1, those were certainly the neuro side of the business was a little weak, and it was mainly due to some of the surges that we saw in the wintertime and went in with storms in February, so a little bit weaker on the procedure side of the business. And our expectation was the second quarter we would see some improvement in the neuro side of the business, the procedure-based pieces of the business, which we absolutely did. We saw that in burn and trauma and surgical reconstruction as well. And then instruments, particularly in the doctor office side of the instrument side, saw some nice lift as well. Whether that's deferrals or pent-up demand, it's really hard to know for sure. But I'm sure there was a piece of that that we benefited in the second quarter, but ultimately saw some nice recovery. And we think it bodes well for the second half of the year. Dave, there are parts of the business that are still not at 100%, like capital, like our indirect markets. And so as we move into the second half, I think, and move to more getting everything on all cylinders, I think it bodes well for a strong second half.
spk04: Yeah, Dave, I would just add, keep in mind, in 2019, we launched a number of new products coming out of the Codman portfolio that have a multi-year ramp to them, and then COVID hit. So we never saw the benefit of that first, second year ramp, which we're starting to see now. So in addition to these procedures coming back, we look at our CSF portfolio, a number of the Sirtis valve enhancements that we rolled out, the toolkit, our surgical headlamp, Duragen in Japan, all these products are really gaining momentum now that we're coming out of COVID. And so that's another driver of what you're seeing in terms of the stellar performance in our neurosurgery business.
spk03: Thank you.
spk14: Thank you. Our next question comes from Kayla Crum with Truva Securities.
spk13: Great. Hi, guys. Thanks for taking our questions. So I guess just at the midpoint of your third quarter guidance, I mean, you you know, you're assuming a step down from Q2. And to me, that makes sense because of traditional seasonality. But you're also effectively assuming that Q3 is only up about 2% relative to the third quarter of 2019. And I think, you know, your goal is to or has been, you know, to grow the business higher than that. So, you know, can you just walk me through sort of how you're thinking about your guidance specific to the third quarter and just some of the puts and takes there?
spk15: Yeah, Kayla, I'll take that one. And I think you're thinking about it exactly correct. If you look at her historical patterns of seasonality, typically Q2 to Q3 is about flattish because there's European holidays, U.S. holidays, summer vacations that happen, and that's kind of comprehended within our guidance there. In addition, again, I do think that we benefited from some deferrals and pent-up demand in the second quarter as it relates to some of the performances, I think. as I responded to Dave's question. And so if you normalize that, you kind of get to that flattish type of Q3 number. And I would say at the low end of our guidance, we are, you know, do comprehend some variability related to recovery as it relates to continuing Delta variant impacts potentially, the variability and the vaccination rates. And at the same time, we did take down a cell a little bit within those numbers, which implies a 6% organic growth compared to 2020 on the base business. So we think Q3 is set up nicely, and certainly the trends that we've seen thus far would support that. But overall, I think you're thinking about it correct, Kayla.
spk13: Okay, great. That makes sense. And then, you know, you guys are lifting guidance for the full year, but, you know, as you've mentioned, you're cutting the ASEL contributions. you know, the base business is doing a lot better than expected. But, I mean, what is it that is performing so much better than you guys had expected in the organic business? And then what gives you confidence that you can recover those lost revenues in ASEL, you know, over the next sort of 12, 18 months? Thanks for taking the question.
spk04: Yeah, so relative to your guidance numbers and why we were confident in our base business, we're really seeing it across the board in our disposables businesses. So, Outside of capital, we've seen real good strength in our door repair business. We've seen good strength in our CSF management business. Instruments has come back very nicely. And on the tissue side of the business, we're seeing some really strong growth both on the wound reconstruction side as well as our PRS side. So I would just say in general, all those areas are doing quite well. The two laggards are still the indirect markets piece that Carrie mentioned in capital, which both are actually showing positive trends but are still – not where we'd like them to be in terms of a normal spending environment. Pete, I don't know if you want to add anything to that.
spk17: Yeah, I would just say, Kayla, on the neuro bigger picture side, if you remember the charts Carrie showed me last year about where it fits on the scale of elective versus emergent, it's obviously one of the first in line emergents. If you look at our two businesses, the first sales reps that really could get back into the hospital and the OR by far was our neuro team because those procedures had some level of pent-up necessity Obviously, people only have a certain time to wait on many of these procedures. And then as things opened up, TBIs or traumatic brain injuries and those type of procedures have increased. And so we think, again, with the breadth of our product portfolio, that's going to continue. And then with this addition of these new products, that's going to continue to fuel it. So we're actually in quite a good spot. You know, Neuro in some cases had a six-month running start over kind of TT as far as access from at least our perspective of the world.
spk04: Yeah, and I would just say, too, why we're confident in raising our guidance is we are seeing better-than-expected performance in our direct markets outside the U.S., which have outperformed, and we're expecting that to continue. So certain markets in Asia, such as Japan and China, that we've talked about are performing really well. We expect that to continue. And certain... Direct markets in Europe are also outperforming, and so I would just highlight the international performance. It's been quite good, and we're expecting that to continue. Kaylee, you also had a question on ASEL. Can you just repeat that?
spk13: Yeah, sure. Just, you know, what gives you guys confidence that you can recover those lost revenues in ASEL, again, over sort of the next 12, 18 months going into next year?
spk04: Yeah, no, listen, again, we think this is a great asset. The team has done a real nice job in terms of the integration work. The issue that we're facing at the moment is short-term just because of the rep access being challenging and not being able to do face-to-face, in-person selling. And I think that will subside over the next few months, and we'll start to see better performance sequentially in the business. And then moving into next year, you'll start to see the growth that we expect. And so... We're very confident that this is a great asset and that we'll work through the short-term challenges that are really caused by COVID at the moment.
spk14: Thank you. Thank you. Thank you. Our next question comes from Matt Missick with Credit Suisse.
spk00: Great. Thanks. Thanks. Good morning. And I should say, oh, congrats, Pete, on the opportunity and good luck to the team in sorting out succession. But look forward to seeing that all. come into play. So a couple of follow-ups just on, you know, I'm sorry to ask after the ASEL changes and the rep access comments that you made, but since we haven't heard a lot of that type of, those types of challenges from other folks in the space, just to maybe clarify, is this you know, the difference between, you know, you point out emergent and critical ICU cases for cranial surgery and so on, being some of the first cases that came back. You know, we hear a lot about reps in ortho and spine and cardio, you know, being also given access, but is this the difference between sort of rep support for acute care surgeries is one thing, but you know, reps and access to selling new products or bringing new products to a new call point just has a different set of priorities around it, and that's what you're facing? I don't want to put words in your mouth. I'm just trying to understand the difference.
spk17: Yeah, Matt, it's a very good question. So, first of all, the emergent nature of neuro has definitely the need for a surgeon to ask for a rep to come in and be invited in more often in neurosurgery than the rest of our portfolio. So that's clearly some of it. But your other point is a really important one here, is if you're a rep that's been in an account and you inherit a new product, either an NPI that we created or one that we buy, there needs to be some time for discussing with the doctor. There needs to be some time to get it on the shelf, particularly if it wasn't a stocked item, it was a carried-in item, And so that takes a little bit more time. In the case of Acell, look, we transitioned this in the midst of COVID. We knew that in the January time period. And we handed off in certain territories the product from a legacy Acell rep to an Integra rep. And that Integra rep needs to get in and see those doctors that were using it. Well, the access to those doctors was reasonably limited for really most of first quarter and most into second. It's now opening up significantly, and that's really at the core of it. I think it's equalized out now, but as Kerry said, you know, our guidance reflects the increase in the second half, but we're also kind of positioning it in such a way that, you know, we want to make sure that we come back appropriately and I think longer term for this product, there's no reason why it won't be a wildly successful product in our portfolio. It complements everything we do. And, you know, we had a slow start, but we'll get it fixed and be back up where we expect to be here as we head into 22.
spk00: That's great. And one follow-up, if I could, on margins. So, Carrie, appreciate the color on sort of the mix and progress on the gross margin line. And great to see sort of the, you know, what sounds like slightly better expanding opportunity in EBITDA. Can you talk a little bit about, you know, the ASL, you know, reduction in expectations feels like maybe you were clear about this as sort of a headwind to gross margins. Is there anything else happening in the integration process that's coming in better or worse or different, you know, whether it's related to the pace or the slowness or the access or anything else that you can comment on in terms of, you know, EBITDA contributions specifically from ASEL? Thanks.
spk15: Yeah, Matt, I would say from a gross margin perspective, it actually was additive, meaning, you know, it comes in very healthy, high gross margins. in our portfolio. So it does support a favorable mix as it continues to grow. So as we move from the second quarter and we start to see a bigger ramp and obviously get back on track in 2022, it will continue to drive favorable mix. So from that perspective, it's contributing to some gross margins. And then on the just overall what I would call SG&A type of synergies, we're We've accelerated that. I mean, we're well on track on that. We've seen some benefit of that in the second quarter. So it is definitely tracking ahead of schedule in terms of realization of our synergies. Remember, that business, when we acquired it, it was break-even. And part of what we needed to do was to right-size that business. A big piece of that was on the sales channel part. And obviously, we've achieved those synergy. As Glenn mentioned, we're well on track, and I've seen the benefit in our second quarter numbers. So, yeah, I mean, certainly from a dollar perspective, you lose a little bit when you don't hit the revenue. But overall, the margin mix is favorable.
spk03: Great. Thank you.
spk15: Great.
spk14: Thank you. Thank you. Our next question comes from Anthony Padron with Jefferies.
spk07: Great, thanks, and I want to second Peter. Congratulations on the move, and also good luck to the team as the transition gets underway. Maybe one just on the broader strategy. It sounds like from the prepared remarks, Peter, as it relates to your transition, the board really has a mindset where the strategy that has been in place over the last several years, which has largely been a portfolio reshuffle sort of strategy, is going to remain intact. But as you look ahead, you know, does that accelerate? Does it slow down? Maybe anything from the board level as they're thinking about this transition? I'll have a couple of follow-ups.
spk17: Yeah, Anthony, I think, you know, I think I've kind of communicated pretty much everything I can relative from that standpoint. From a board standpoint, obviously, we have a very active, integrated board. They're heavily involved with our strategy. And again, a big part of what we've been trying to do over the last X years was to bring assets in or only keep assets where we know we can be a strong player. And the reason for that is because as hospitals continue to consolidate, competition consolidates, having areas where you can have a leadership position we think is the way that future growth, both top and bottom, is going to come. And I think we've been able to demonstrate that. So from that standpoint... I think the board is obviously very much aligned. On a future standpoint, you know, we have obviously adjacency areas to neurosurgery. You know, you could argue that from the neck up we have expertise at some level, and so there's lots of interesting scenarios there. And on TT now, as we mentioned at the investor day, moving broader than wound care is a big opportunity. We've talked about breast. We've talked about nerve surgery. We've talked about hernia. We've talked about other areas within plastics. All of those have accretive margins and growth rates. And so I think, you know, whoever comes into the role, I think they'll have plenty of opportunities with the base business to continue to grow it and a pretty nice palette to expand into other faster-growing areas. And I think that's kind of how I see it. And I think – I can't speak for the board, but I think – The board is very much aligned with what we've laid out at this point in time.
spk07: Thanks for that. And again, congratulations to you and the team. And good luck on the transition. Thank you. The follow-up would be on margins. Just going back to the LRP target, the 28% to 30% adjusted EBITDA margin for 2023. Just trying to get a handle on that, just given the ASEL revision here. Where does the ASEL margin... profile sit in that LRP target, perhaps in the near term as a headwind, but the offset certainly, Pete, you mentioned the new product categories, Aurora, Surgiment Breast, Serolink, of course, those all seem to be set as margin tailwinds. So just maybe the complexion and mix as you approach that 28% to 30% Where does ASEL now sit in that equation and where do new products contribute in that equation? Thanks again.
spk15: Yeah, Anthony, I'll take that one. And as we mentioned, ASEL, our expectation is we will be back on track in 2022. That's our expectation for our accretion being additive in year two. There's nothing that would suggest that we will not hit that target in terms of additive from an EPS perspective. And it favorably contributes to our margin profile, both in gross margin as well as the SG&A cost savings that we've been able to achieve. As I think about the long-term 28% EBITDA margins, 70% gross margins, all of those levers are still intact. And so just as a reminder, just refresh on what those levers are. Starting with gross margins, there's a number of things that continue to be tailwinds for us in gross margins. Let's start with the mixed piece of those pieces. First of all, you know, you think about revenue recovery. As we mentioned, not all of our portfolio is yet at 100%. Indirect capital still have positive growth opportunity for them. And as Glenn mentioned, Sarah Link, that should be a very nice 2022 lift for us as we think about next year in terms of revenue as well as margin opportunity for us. You have overall the TT side of the business, which has higher margins than CSS. And so as that business continues to recover, including ASEL, bringing strong favorable mix to that. And then as we, again, wind down out of those discontinued products that carry lower margins, all of that is helping. And one last lever on the gross margin side is around manufacturing. productivity efficiency. We've got two big initiatives there. One is exiting the TSA agreement with the Codman integration at the end of the year. That will provide some gross margin lift, as well as we're closing a facility in France by the end of 2022, which should help as well. And then we've got just, you know, overall just SG&A leverage as our revenue recovers, productivity improvement. So all of that allows us to stay on the path of a 28% type of EBITDA margin.
spk04: Yeah, and I would just highlight the fact that these new product introductions and these key catalysts that I walk through in some of the prepared remarks are all accretive to the company average. And so when you look at those growth drivers in the short to midterm, those are all going to be nice tailwinds for us relative to our margins.
spk03: Thank you again.
spk14: Thank you. Our next question comes from Ryan Zimmerman with BTIG.
spk09: Hey, good morning. Thanks for taking the questions. Congrats, Pete and the team. So just want to ask on the margin side a little bit, Carrie, you mentioned just some of the inflationary pressures that you're seeing and higher freight costs. And you talked a little bit about just adding potential for price. I'm wondering where you could specify kind of where you can pass that along specifically within a product category versus maybe other areas where you intend to absorb some of those inflationary pressures?
spk15: Yeah, so right now I'd say the biggest impact is around the tight labor market. You know, certainly a couple different things. We have open positions in our factories. We have open positions in our SG&A areas. Where it's happening in our factories, that creates some idle capacity for because of the fact that you don't have a full team as you're trying to ramp up production. However, it helps on the SG&A side because you don't have all your positions filled. And the second area on the labor side is we are seeing some select wage pressure at certain sites where we're trying to ramp up. As we think about Boston as an example, that's an important site as we're trying to ramp up there and seeing some wage pressure there. In terms of the supply side, it's really right now limited to just longer lead times as it relates to select source materials that create some amount of expedited freight costs that we're dealing with. But for the most point, I think we've been successful. We've got long-term contracts. We have opportunities to offset some of that internally with initiatives. So we haven't seen a lot of what I'd call material inflation yet It's something we're watching very, very carefully. We do have the opportunity to price. We have been successful there, and I'll have Glenn maybe talk a little bit. There is our approach to price, but I would say we have the opportunity both on the CSS side as well as the TT side to look at opportunities to pass through in terms of pricing. Glenn?
spk04: Yeah, no, the only thing I'd add is first on the cost side, yeah, we are seeing some obviously headwind as it relates to cost pressures. But I want to recognize our global operations and procurement teams. They've done a real nice job to identify a number of cost savings initiatives over the last 12 months to offset some of these cost pressures. And so I want to recognize the team that's been working hard to minimize the impact of what you're seeing. As it relates to pricing, again, there's opportunity for some limited price increases given the increase in the materials that we're seeing coming into our sites. And Carrie mentioned we're fortunate in that we've got some longer-term contracts where we can offset some of the short-term headwinds around this. But I would anticipate in certain cases we'll have some select price increases to also mitigate the effect on both sides of the portfolio.
spk09: Got it. Thank you, Glenn. And then, Glenn, for you, just Can you give us kind of a state of the state on Prime Matrix just following the study? I mean, you know, in terms of kind of covered lives and where you're at and where you need to get to and how to think about, you know, your reimbursement strategy with Prime Matrix given the study.
spk04: Yeah. So keep in mind, we had pretty good reimbursement prior to the study. So think of that as over 100 million covered lives. But we really didn't have a lot of covered lives with the commercial payers. What this does for us with this clinically and statistically differentiated data that is significant and the results showing significant improvement in DFU closure in 12 weeks versus standard of care enables us to now go to the commercial payers over the next 6 to 12 months and increase the amount of reimbursement. So you can think of it as doubling the amount of covered lives, what I just said, as a rough order of magnitude. And so that's obviously going to open up more sales opportunities and more revenue growth for Prime Matrix. It's been a product that's been very well received, both inpatient and outpatient, and so this should be a real nice opportunity for us as we move forward. But, again, think of it as doubling the amount of covered lives once we get through going to all these commercial payers and getting reimbursement.
spk09: And just to put a finer point on that as a last, Glenn, I mean doubling over what period in your mind?
spk04: So the base number of covered lives today is over $100 million, so going over $200 million. Over, call it 12 months. Thank you. I think it's fair to say in 12 months we'll have whatever we're going to have from a reimbursement perspective in place. Thank you.
spk03: Yep, thanks.
spk14: Thank you. Our next question comes from Robbie Marcus with J.P. Morgan.
spk01: Oh, great. Thanks for taking the question. Two from eight. Maybe first, Carrie, you know, we've touched on it a bit, but I wanted to just dig into it a little further, particularly as it relates to the guidance raise and what's implied for third and fourth quarter here. You know, the beat was a very nice beat, but now looking at third quarter guidance that captures the street at the high end and What's implied for fourth quarter is also capturing the street, but at the high end. So it's just trying to get a better sense of exactly what's going into it. How much is conservatism versus lowered thoughts on second half? How much of the impact is from lower A cell? And if FX or anything else played into the decision here.
spk15: Yeah, no, FX did not factor into any change in our thinking there, and so we're not assuming any significant FX tailwinds in the second half of the year. But I would look at it again. I'll go back to that math equation I said, you know, $15 million raise. Embedded within that $15 million raise is taking ASEL down about $13 to $14 million, which implies that the The base business, the organic base business, is up $28 to $29 million. So we've de-risked ASEL. We've had a slower start. I think Glenn and Pete have talked about that. I'm not sure that I would characterize it as conservative. I'd say it's balanced. I would say that we've de-risked the second half. We think that what we're seeing in the base business is really some really nice trends still have the opportunity to see some further growth in indirect and capital as we exit the year and move into 2022. So, you know, I would look at it more as just some timing. You know, I answered Kayla's question on the Q3 that the 382 to 389 does capture some normal seasonality in the third quarter as well as maybe some pent-up demand in the second quarter. But the base business is a 6% organic growth in the third quarter compared to 2020, and some nice growth in the fourth quarter as well compared to either 2019 or 2020. I think overall we're very pleased with the performance of the business thus far.
spk01: Sorry, maybe I should have been a little clearer. I meant more focused on the bottom line.
spk15: Oh, yeah. On the bottom line, I would say, you know, the thing, Robbie, to consider is that we'll probably see some additional normalization of OPEX in the fourth quarter, or sorry, in the third quarter. We have some, you know, as I think about the second half, we've got some investments we need to do around new product launches. Glenn talked about Serolink. We're obviously looking at opportunities on the breast side. And so we want to continue to invest in Aurora. So lots of new product opportunities there that we want to continue to invest in growth with clinical studies. So I would say the third quarter does comprehend some additional investments that we want to do in the third quarter. I think, you know, I expect that we've got plenty of room to make those investments, but it is a priority for us in terms of investments. From a gross margin perspective, Robbie, I would say second half will be modestly higher than first half. I think some of the manufacturing pressures around the tight labor supply and some pressure on the long lead times will continue to persist into the second half. But even with that said, I do think that we'll see some modestly improvements in gross margin into the second half compared to the first half.
spk17: Robbie, I would just add that Glenn mentioned this earlier, and we talked about it at the Investor Day. The five big kind of we view as breakthrough technology opportunities that we have are all on track. And what that means is, too, the ramp of their spend will begin here in the second half, which is great news because all of those have the opportunity for significant growth profile, everything from, you know, being in a position to file a PMA for breast, to the discussion on Aurora. And so, again, if you think about Aurora, this is really the first platform that can be a regularly used product to actually minimally and basically remove a brain tumor. And so the work with clinicians on, you know, all the big names that you've heard in neuro institutes doing work on that, how we customize our instruments, including CUSA and other things, that's going to generate some added tweaks and work, which we want, so that we can create this really differentiated custom set. And in a case of that, no other player out in the marketplace will have something like that. And so a lot of that work to optimize it starts here within Q3 for all of those.
spk01: Great. Thanks. And maybe just one last one. On R&D, you guided at the analyst day to get that up to 6% of sales in the next few years. It came in lower than expected, or at least we expected in the second quarter. How do we think about when we start to see that tick up? And really, what projects is that going to be focused on?
spk15: Yeah, Robbie, I think it's really consistent with Pete's comments that I would expect that you'll start to see that R&D investments move up in the second half of the year as we, again, continue to advance some of those new product opportunities. So that would be my expectation is that consistent with some of the spend increase that will be a piece of that will definitely be in the R&D side.
spk01: Great. Thanks a lot.
spk14: Thanks, Robbie. Thank you. Our next question comes from Matthew O'Brien with Piper Sandler.
spk08: Morning. Thanks for taking the question. And I'll just stick with one question. And I'm sorry to kind of beat a dead heart here on ACL, but you guys, you know, kind of swapped out extremities for ACL. And so there's a lot of attention on it. That's why I wanted to ask a bit more. That was a $101 million business back in 19, and I get the pandemic. And access to accounts now, but now we're down about 30% as far as what that did in 19. So I guess for investors, as they're really focused on this asset, you know, based on what I just said, can you give us any more just commentary about, you know, sales rep attrition, account attrition versus what you had expected? Is it much better on those two metrics? Are you, are you guys, Is it anything on the accretion side? You know, things seem to be moving faster there, so maybe you're cutting a little bit faster. That's affecting the top line a little bit. And then when do you think you can get back to about $100 million in sales in that business? Is that kind of 2023 or beyond? Thank you.
spk04: Yeah, Matt, thanks for the question. Just to set some of the groundwork on the $101 million reference point for ASL, a couple things to keep in mind. We had about one month less of sales this year, so when you look at that 30%, in. And then there's certain accounting for GPO fees that are different within Integra versus how they were treating it. So those are two factors. But relative to the business itself, listen, I think the attrition has been as expected. We've taken the necessary actions around synergizing the sales force. For us, it's really just around access. And I think once we start getting better access in these face-to-face in the second half of this year, we'll start to see the pickup in the business. So I'm very confident in that. When we get back to something that's close to $100 million, we'll have to talk about it as we get into 2022. I don't think we're ready to commit to anything other than expect to see a sequential improvement in the business, and we expect long-term this business to be growing in line with the overall tissue tech business, which is in the 7% to 9% range.
spk08: Okay, Glenn, but just to be clear, you're not seeing anything from an attrition perspective on the Salesforce side or account side competition getting a little bit more elevated here. I don't know if TEI is an analog you can use as well as far as how you did on the integration side there, but I think that went pretty well.
spk04: Yeah, no, just normal attrition. So nothing abnormal that we've seen in the first five months that we've owned the asset.
spk15: Yeah, and I would further say as you look at Q1 to Q2, I mean, they're not comparable periods because we didn't own ASAL for the full quarter. But as you look at a kind of on a daily kind of run rate, we didn't see any deterioration in the business. We just didn't see the growth that we expected. But, you know, I don't think there was any deterioration from the first quarter to the second quarter. It's just that We just have had more limited access, and it just didn't allow us to ramp as fast as we expected to.
spk08: Okay. Thank you so much.
spk03: Thanks, Matt.
spk14: Thank you. Our next question comes from Joanne Winch with Citi.
spk12: Thank you for taking my question. So many have been already answered. But very briefly, what kind of CEO do you think is the right person for the next phase, given how much progress you've made over your tenure? And then my secondary question was, and again, I'm going to apologize, but I feel like we're all circling the same question. If you lower ASL, raise total revenue, what is it that's giving you the confidence in that raise of the lower revenue? Is it new products? Is it momentum in the recovery phase? any sort of like that would be helpful. And thanks.
spk15: Yeah, Joanne, I'll take the second part of your question and I'll defer to Pete on the first part. But, you know, I think in terms of the underlying business, it's a very broad base. I think, you know, with the exception of the indirect markets and capital that isn't yet at full recovery, most of the other parts of the business has recovered very, very nicely and The procedure-based pieces of our business in neurosurgery, as Glenn mentioned, the disposable, the consumable pieces of the business, our IDRT skin products, surge amend products, all seeing some really nice rebounding growth. And even instruments, as I mentioned in my second quarter prepared remarks here, 4% organic growth compared to 2019 when that's a business that would probably grow low single digits. So very nice performance there. And so as we think about going into the second half, I go back to all of some of those comments that Glenn made about products that we launched in the middle of 2019. We had about seven products that we launched in the middle of 2019. And COVID interrupted that opportunity to really see that nice ramp on them. And that's what you're seeing is you're seeing a lot of those products really taking hold as the recovery comes back in. So it's the combination of of international growth, and it's a combination of some NPIs as well, and certainly some pensive demand and deferred procedures that kept some of that recovery handcuffed in the second half helping us in the first half as well. Glenn, anything else you want to add?
spk04: Yeah, the only other thing I'd highlight is, and why we feel more confident in the second half of the year, is capital has lagged, but the actual capital funnels themselves are really strong right relative to trialing and advancing our capital through the selling cycles. And so I believe once we start to see that open up, we're going to see a really nice windfall on the capital front in the second half of the year. And again, that's lagged the first half of the year, but when I just look at the activity, I look at the progress in terms of the funnel, it's the strongest I've seen in a very long time. So that's why we're all so confident.
spk17: So just on the point, you know, look, uh, I would say that the key here is the company is in very good shape. I think, you know, for you followed it, everything from our systems and the speed that we can access data to close to the product pipeline that we have. And so finding someone that can come in and obviously take what's here and be able to make it better, but have a vision for the future about how to find faster growth. I think we're at – and we use this term inflection point for a reason – the amount of things that need to be kind of fixed internally versus the opportunities to take things and focus on them grow, the scale has clearly tilted to more tools in the bucket to be able to focus on to have the company grow faster. And I think we talked about that in Investor Day, and I think finding the right leader that can come in and balance the two of those is ultimately what I would hope for. It's obviously the board's decision to do so and find that, and And I think there's a lot of interest and excitement about the company, and I think we'll come out here before the year's over with the right leader.
spk14: Thank you. Thank you. Thank you. Our next question comes from Shagan Singh with Wells Fargo.
spk11: Thank you for taking the questions, and I'll keep it brief given the time. So you indicated that the base business was up about $28, $29 million. How much benefit did you see from backlog in Q2, and what are your expectations for the second half? And then with respect to U.S. capital, can you give us the growth rate, and I'm sorry if I missed it, relative to the double-digit pace of decline that you had posted within advanced energy in Q1? Thank you.
spk15: Yeah, Shagan, I'll take that. In terms of the $28 to $29 million, the question was regarding... What was it?
spk06: The backlog.
spk15: Oh, the backlog. Yeah, the backlog. In terms of some of that pent-up demand, I think there was a piece of that. It's hard to be able to quantify how much of the $12 million beats the upside of our, the high end of our guidance range came from deferrals or pent-up demand, but certainly a portion of that did as we think about that the surgical reconstruction side of our business was down in the first quarter year over year, and it came back really nicely in the second quarter. Instruments saw really nice recovery in the second quarter. So certainly there was elements of that pent-up demand benefit in the second quarter. And as we think about the third quarter, we tended to try to normalize that in our third quarter revenue guidance there. But overall, it was just seeing some nice recovery in most parts of the business. And as Glenn mentioned, really where we think the opportunity in the second half will be seeing more normalization of capital, seeing a really full pipeline and expect capital to be a contributor, which goes to your next question, Shagan, which is capital in the U.S. was down in the first quarter. It's still down in the second quarter about single digits, high single digits, but sequentially it was up from Q1 to Q2 in the U.S., And so as we think about, again, going into the second half, seeing those full pipelines and capital gives us some nice comfort that capital will rebound nicely in the second half coupled with the clinical launch of Sarah Lang into Q3 and then following full market release in Q4.
spk11: Thank you so much.
spk14: Thank you. Our final question comes from Jason Bedford with Raymond James.
spk02: Good morning and congrats, Pete. Just a couple questions that require, I think, pretty quick answers. You mentioned restricted access. Is this restricted access dynamic negatively impacting sales in your base tissue technology business?
spk04: No, because again, they have the existing relationship, so it's much easier to do the sale with our existing portfolio. So we haven't seen that impact our base business. It's really around new products and and obviously the transition of the relationships from the ASL portfolio. So the answer is no.
spk02: Okay. And then what is the level of discontinued revenue implied in the organic growth guidance for the year? And then also what's the assumption for FX in 21? Thanks.
spk15: Yeah, for FX, let me start with that. You know, we saw probably $11 million to $12 million of benefit of FX in the first half. We're not assuming a tailwind or a headwind in FX in the second half of the year. So depending on where rates go, we're not really counting on FX to be a benefit in the second half. So about $11 to $12 million was the FX for the first half of the year. And then for discontinued products, discontinued product revenue has been a little bit higher, again, as people continue to do some last-time buys there. probably about a $10 to $11 million type of year-over-year change in the discontinued revenue, about $20 million of revenue in discontinued products in 2020 and about $10 to $11 million in 2019. So essentially that year-over-year delta is probably about $10 to $11 million. Okay.
spk10: Okay. Stephanie, is that our last question?
spk14: Thank you. This concludes our question and answer session. I'd like to now turn it back to Pete Arduni for closing remarks.
spk17: Thanks, Stephanie. And thanks, everyone, for your questions. Look, I'll just close by saying there's never been a more exciting time at Integra. We're clearly at an inflection point to accelerate scale and growth and really market leadership. We're now aligned to faster growth markets with the changes we've made and the discussions we've had on the pipeline. Hopefully you can see that not only do we have a lineup of products with faster growth, but higher margins, which will drop through. So thank you for your continued interest in Integra. Look forward to speaking with many of you here in the near future and providing an update on our progress at the next quarter. But in the meantime, please enjoy your summer. And that concludes our call. Thank you.
spk14: Thank you ladies and gentlemen. This concludes today's presentation. You may now disconnect.
Disclaimer