OrthoPediatrics Corp (KIDS) 2020 Q4 法說會逐字稿

Welcome to the Fourth Quarter and Full Year 2020 OrthoPediatrics Corp. Earnings Conference Call. My name is April, and I'll be your operator for today's call. (Operator Instructions) Please note that this conference is being recorded. I will now turn the call over to Christine Petraglia. Thank you. You may begin.

Thank you, operator, and thanks, everyone, for participating in today's call. Joining me from the company are Mark Throdahl, Chief Executive Officer; Fred Hite, Chief Operating Officer and Chief Financial Officer; and David Bailey, President.

Before we begin, I would like to caution listeners that comments made by management during this conference call will include forward-looking statements within the meaning of Federal Securities laws, including the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve material risks and uncertainties, and the company's actual results may differ materially. For a discussion of risk factors, including, among others, the risks related to COVID-19, the impact such pandemic may have on the demand for the company's products and the company's ability to respond to the related challenges, I encourage you to review the company's most recent annual report on Form 10-K, which will be filed with the Securities and Exchange Commission soon.

During the call today, management will also discuss certain non-GAAP financial measures, which are used as supplemental measures of performance. The company believes these measures provide useful information for investors in evaluating its operations period-over-period. For each non-GAAP financial measure referenced on the call, the company has included a reconciliation of the non-GAAP financial measures to the most directly comparable GAAP financial measures in its earnings release. Please note that the non-GAAP financial measures have limitations, and analytical tools should not be considered in isolation or as a substitute for OrthoPediatrics' financial results prepared in accordance with GAAP.

In addition, the content of this conference call contains time-sensitive information that is accurately only as of the date of this live broadcast, today, March 11, 2021. Except as required by law, the company undertakes no obligation to revise or update any statements to reflect events or circumstances that take place after the date of this call.

With that said, I'd like to turn the call over to Mark.

Good morning, everyone, and thank you for joining us today on our fourth quarter and full year 2020 earnings conference call. We stand at the 1-year anniversary of the COVID-19 pandemic, which is the greatest public health crisis in a century. 2020 reminded us how fortunate we are to partner with surgeons and health care providers who so deeply impact the lives of patients and their families, particularly during the past year.

2020 also brought out the best in our company and our associates who rose to meet unprecedented challenges, found new ways of working, demonstrated resilience and most importantly, continued the disciplined and consistent execution of our growth strategies. Their efforts position us well as we emerge from the pandemic stronger than when we entered it.

On March 16, 2020, we closed our office and began working remotely. My colleagues and I immediately resolved to stabilize our employee base by announcing that there would be no job cuts or salary reductions. We stabilized our sales organization by making available low interest loans to our 36 domestic sales agencies and reassured suppliers that we would not reduce orders for new consignment inventory. We continue to stand by pediatric surgical societies throughout the world that depend on our leading financial support, and we were the only industry sponsor that did not reduce or eliminate its financial contributions to these organizations in 2020. I am proud that OrthoPediatrics has managed through the pandemic in a manner befitting a company that has been recognized as one of the best places to work in Indiana recently for the fifth year.

As a result of the resilience of our people, we delivered full year sales of $71.1 million, down 2% from 2019, primarily due to fewer elective deformity surgeries and international stocking distributors who were affected by the economic collapse of their markets. However, fourth quarter and annual sales were also impacted by a $2.7 million revenue reduction booked in December 2020 due to the repurchase of inventory from a stocking distributor in Germany, Austria and Switzerland that we converted to a sales agency in December. This $2.7 million reduction decreased fourth quarter revenue growth by 14% and total year revenue growth by 4%. It's important to separate the impact of this accounting treatment from the fundamentals of the business, which continued to improve in the fourth quarter.

In fact, during the fourth quarter, our domestic business grew 26% to $17.9 million. Total domestic sales grew 14% to $63 million. While we saw a slowdown in December, which continued into the first 6 weeks of 2021, we are encouraged by an acceleration in domestic sales over the past several weeks, and we look forward to reporting continued growth in the first quarter of 2021.

International sales in 2020 were $8.1 million, representing a 54% decrease year-over-year, impacted by the reluctance of our 42 stocking distributors to purchase inventory due to the decline of elective surgeries in their markets. International sales were also negatively impacted by the aforementioned repurchase of $2.7 million of inventory from Germanic countries as they converted to the sales agency model in December. However, it is important to note that international sales agency revenues grew 51% in the fourth quarter, nearly double the impressive 26% growth in the third quarter of 2020. And this growth was before the conversion of Germany, Austria and Switzerland, which we anticipate will further stimulate agency growth in 2021 and beyond. We are encouraged by the momentum of international sales agency growth throughout the second half of the year and are pleased to have expanded the sales agency model in December 2020 to 14 agencies in 13 countries.

Even though we're not yet out of the woods on COVID, our domestic and international recoveries give us confidence in our guidance for 2021, which is full year sales growth in the range of 31% to 38%, reaching $93 million to $98 million.

This morning, Fred will provide a detailed review of these results and discuss our financials and procedure recovery rates by geography and business unit. I would now like to focus on 4 factors that give us confidence in the outlook for 2021 and our plan to execute a seamless management transition this year. I'll then turn the call over to Fred. After which, we will open the call up to your questions.

There are at least 4 reasons we are optimistic about the 2021 sales outlook. They include: continued domestic sales momentum; the turnaround in international stocking distributor purchases; international sales agency growth; and synergies from our 3 acquisitions.

Point number one, domestic revenue continues to demonstrate significant momentum. In the fourth quarter of 2020, U.S. sales were $17.9 million, a 26.1% increase compared to $14.2 million for the same period in 2019 and an acceleration from the 17% growth in the third quarter of 2020. This represented a turnaround from the second quarter of 2020 when domestic sales declined 12%.

While we faced domestic headwinds late in the fourth quarter of 2020 and during the first 6 weeks of 2021 when we saw a temporary decline in elective surgical volumes, domestic sales have improved dramatically since that time. We believe that recent progress on vaccines and vaccination rates, coupled with the greater capability of hospitals to treat COVID patients, should allow us to weather any future spikes in COVID cases over the next 6 months when a majority of American adults are being vaccinated.

Domestically, we were encouraged in the fourth quarter of 2020 by the performance of our Trauma products such as PNP|FEMUR, which exceeded 1,000 cases since its introduction in 2018. The -- our Sports Medicine/Other category delivered $1.0 million of revenue and benefited from the addition of Telos sales. Scoliosis revenue was $6.6 million, a 35.7% increase compared to $4.9 million in the fourth quarter of 2019. Throughout the year, we built solid momentum in our RESPONSE 5.5/6.0 System and FIREFLY Pedicle Screw Navigation Guides as we added 23 new RESPONSE users.

Point number two. While international revenue in the fourth quarter of 2020 was $1.1 million, a 77.7% decrease compared to $4.8 million for the same period last year, sales reflected the aforementioned $2.7 million reduction of revenue as well as the impact of weak sales to international stocking distributors. Many of these distributors are small private companies focused on specialty orthopedic products, and they've been reluctant to commit to additional inventory given the economic dislocations in their home markets. Beginning in January 2021, however, international stocking distributors have begun purchasing increased quantities of product. This may be due both to the depletion of their inventories as well as what we believe to be an enormous backlog of surgical procedures in many European countries and Brazil.

Point number three. International sales agency revenues accelerated from 26% in the third quarter of 2020 to 51% in the fourth quarter. That is why we're pleased by the successful conversion of the largest European market, Germany, Austria and Switzerland to the sales agency. Past conversions and other markets have produced an approximate doubling of revenues and gross margins because we bill hospitals at retail prices rather than selling the stocking distributors at wholesale prices. Over time, we have also increased the organic growth rate in converted markets by consigning instrument sales more aggressively.

The turnaround in stocking distributor demand, the significant backlog in several countries, coupled with continued growth by international sales agencies, give us confidence that our international business is rebounding. It is in this context that we can cite receiving U.K. regulatory clearance for PNP|FEMUR and initiating the clinical use of our ApiFix system in the U.K. where initial feedback from surgeons has been overwhelmingly positive.

Additionally, the first Orthex surgical cases for pediatric orthopedic deformities in Europe were performed at the Paley European Institute and Medicover Hospital in January and February 2021. We look forward to launching Orthex across additional locations in Europe, the Middle East and Africa during the first half of this year.

In addition to Europe, we received 14 regulatory approvals in Canada in 2020, including Orthex, PNP|FEMUR, PediFoot, RESPONSE 4.5/5.0 and 5.5/6.0 and BandLoc. We also expanded our product offering in Australia to include PNP|FEMUR, RESPONSE 4.5/5.0 and Orthex.

Point number four. Our recent acquisitions have delivered strong synergies in 2020, and we're confident they will do so to an even greater degree in 2021. Orthex, which we acquired in 2019, continued to deliver strong growth with 38 surgeon conversions in 2020, and we recently received CE Mark approval for Orthex in Europe. International sales agencies have performed their first cases, and inventory has been built for what we anticipate will be the largest international launch in our company's history. Orthex increases our reach from 65% to 85% of the Trauma and Deformity addressable market, and it has fulfilled the promise of positioning our company for total account conversions, both domestically and internationally.

In April 2020, we acquired ApiFix, which is 1 of 2 recently approved nonfusion technologies and represents a revolutionary approach to how scoliosis is treated. We then received FDA approval to expand the label to 35 to 60 degrees for progressive curves from 40 to 60 degrees previously, which allows ApiFix to compete head-to-head with spinal tethering, the only other nonfusion technology approved for use in skeletally immature patients.

ApiFix enables surgeons to provide permanent curve correction while retaining spine flexibility and is a less invasive surgical procedure compared to spinal fusion. At the end of January 2021, ApiFix had received full IRB approvals at 11 of the 20 IRB hospitals and has conducted 27 extremely successful surgeries. Surgeons continue to be impressed by its results. And we anticipate that in 2021, ApiFix will complete the 200 cases to fill the registry, whereupon, we will expand the launch in the United States.

ApiFix produces very high revenue contribution per dollar of set inventory and improves our return on capital.

Telos has also produced robust sales growth. Our rationale for this acquisition was to gain access to state-of-the-art expertise on the complex and sweeping changes in the worldwide regulatory environment. We had not expected that Telos' expertise would be in significant commercial demand and are delighted that Telos continues to win significant contracts at medical device companies, some of which are in the orthopedic space.

To summarize, domestic momentum, the international turnaround and acquisition synergies are all potentiated by other investments we continued to make in 2020 despite the pandemic. We deployed $5 million in consigned sets during the fourth quarter, bringing the total investment in 2020 to $18 million, the same level of investment we made in 2019. We also completed a 20,000-square-foot expansion of our distribution facility in our Warsaw headquarters, which represented the second expansion in the past 2 years. We believe that our investments in international markets, consigned sets and facilities will allow us to advance our commitment to being the end-to-end provider of pediatric orthopedic surgical products around the globe.

Turning to management succession. You will recall that in April 2020, the Board elected Dave Bailey, President; and Fred Hite, Chief Operating Officer and Chief Financial Officer. These appointments took effect on June 3, 2020, at our Annual Shareholder Meeting and represented an orderly succession process that began 3 years ago. And I informed the Board of my intention to step aside as CEO upon reaching my 70th birthday in 2021. At the upcoming annual meeting, it is expected that Dave Bailey will become CEO, and I will become Executive Chairman of the Board. I plan to remain involved in Investor Relations, strategy development and field travel as an executive officer of the company. Dave's expected appointment as President and CEO will meet both our Board's intention to execute a seamless leadership succession and my personal desire to make way for a new generation of management while continuing to contribute to the company's goal of helping children throughout the world.

Dave has been with OrthoPediatrics over 14 years. And during his time with OP, he has cultivated an extensive knowledge of our technologies, customers and sales organization. Fred has been our CFO for 6 years and has deep experience in operations and corporate development from his years at Symmetry Medical and General Electric. I've had the pleasure of working closely with Dave and Fred over many years. And I have seen firsthand their acumen, professionalism and character.

Our goal has been to conduct an orderly, one might say even an inevitable management succession. And I'm confident that Dave and Fred are a powerful team that will lead the company to the next stage of its development.

Before turning the call over to Fred to review the financials, I want to take a moment to thank our shareholders for standing by us in late 2020 and early 2021. We will continue operating with integrity and transparency, guided by our company's cause of transforming the lives of children with orthopedic conditions. As of last week, OrthoPediatrics products have been used in an estimated 200,000 surgeries throughout the world, and we're just getting started.

With that, I'd now like to turn the call over to Fred to review our financial results and provide an outlook for the first quarter. Fred?

Thank you, Mark. Total revenue in fourth quarter of 2020 -- Mark, can you mute your line, please? Total revenue for the fourth quarter of 2020 was $18.9 million, a 0.1% decrease compared to $19.0 million for the same period last year. U.S. revenue for the fourth quarter of 2020 was $17.9 million, a 26% increase compared to $14.2 million for the same period last year, representing 94.3% of total revenue.

International revenue for the fourth quarter of 2020 was $1.1 million, a 78% decrease compared to $4.8 million for the same period last year, representing 5.7% of total revenue. In December 2020, we recorded a $2.7 million revenue reduction due to the repurchase of inventory from a large stocking distributor in Germany, Austria and Switzerland as we converted the DACH region to a sales agency model. The $2.7 million reduction impacted fourth quarter total revenue growth by a negative 14%.

Total revenue in 2020 was $71.1 million, a 2% decrease compared to $72.6 million for 2019. U.S. revenue in 2020 was $63.0 million, a 14% increase compared to $55.1 million for 2019, representing 89% of total revenue. International revenue in 2020 was $8.1 million, a 54% decrease compared to $17.5 million for 2019, representing 11% of total revenue. The aforementioned $2.7 million reduction of revenue impacted total year 2020 revenue growth by a negative 4%.

We are strongly encouraged that we could build on the momentum we carried from the third quarter to deliver accelerated domestic growth in the fourth quarter of 2020. Outside of the U.S., as Mark has mentioned many times, with fewer stand-alone pediatric hospitals, ex-U.S. procedure trends are taking longer to normalize. And recovery in the international market continues to lag the recovery seen thus far in the U.S., which again resulted in little-to-no set sales during the fourth quarter of 2020 to our stocking distributors. That being said, international performance was strongest in EMEA and Asia Pacific, particularly with our sales agencies.

Our fourth quarter and full year revenue by product category was as follows: Trauma and Deformity revenue in the fourth quarter of 2020 was $11.3 million, a 17% decrease compared to $13.6 million in the same period last year and $47.7 million for the full year of 2020, a 3% decrease compared to $49.4 million in 2019, driven particularly by stronger Trauma growth and encouraging signs of recovery in elective deformity corrective surgeries, specifically our PNP|FEMUR and Cannulated Screw Systems. The aforementioned $2.7 million reduction of revenue impacted the Trauma and Deformity fourth quarter growth rate by a negative 20% and impacted the full year 2020 revenue growth by a negative 5%.

Scoliosis revenue in the fourth quarter of 2020 was $6.6 million, a 36% increase compared to $4.9 million in the same period last year and $20.7 million in 2020, a 3% decrease compared $21.5 million in 2019. The decrease was driven by lower sales of our RESPONSE 5.5/6.0 system and FIREFLY Pedicle Screw Navigation Guides, resulting from fewer elective procedures.

Lastly, Sports Medicine/Other revenue in the fourth quarter of 2020 was $1.0 million, representing a 135% increase when compared to $430,000 in the same period last year. Sports Medicine/Other revenue in 2020 was $2.7 million, a 57% increase compared to $1.7 million in the same period in 2019, due primarily to the acquisition of Telos.

Moving down the income statement. Gross profit for the fourth quarter of 2020 was $15.1 million, a 5% increase compared to $14.5 million for the same period last year. Gross profit margin for the fourth quarter of 2020 was 79.9% compared to 76.2% for the same period last year. Gross profit was negatively impacted by $1.1 million for both the fourth quarter and full year 2020 due to the aforementioned $2.7 million reduction of revenue.

Gross profit in 2020 was $55.0 million, an increase of 1% compared to $54.6 million in 2019. Gross margin for the full year 2020 was 77.4% compared to 75.3% for 2019. The increase in gross margin was due primarily to the increased domestic revenue and the addition of sales agents in our international markets driving favorable mix.

Sales and marketing expenses in the fourth quarter of 2020 increased 13% to $9.4 million compared to $8.4 million in the same period last year. And full year sales and marketing expenses increased 2% to $31.9 million when compared to $31.3 million in 2019. The increase was due primarily to increased sales commission expenses driven by both domestic sales growth as well as the converted sales agents in our international markets.

General and administrative expenses in the fourth quarter of 2020 were $10.0 million, an increase of 39% compared to $7.2 million in the fourth quarter of 2019. Full year 2020 G&A expenses were $38.3 million, an increase of 44% when compared to $26.7 million in the prior year. The increase in G&A expense was due primarily to: increased stock compensation expense driven by a third year of restricted stock grants in a 3-year cliff vesting cycle and onetime stock grants related to executive management transitions; the addition of personnel and resources to support the growth of our business; increased legal expenses related to our ongoing litigation and acquisitions; increased depreciation from additional consigned sets; increased amortization from our recent acquisitions; and the increased G&A expenses associated with the acquisition of ApiFix and Telos.

In the fourth quarter of 2020, we accrued $6.3 million related to multiple legal settlements as those amounts became estimatable and probable. The amounts in the future may differ from our accrued amounts.

Research and development expense was $2.1 million in the fourth quarter of 2020, an increase of 8% from $1.9 million in the fourth quarter of 2019. For the full year 2020, research and development expense decreased 8% to $5.3 million compared to $5.7 million in 2019. The decrease in full year research and development expense was driven by a reduction -- reduced investment in research and development projects as a result of the sales decline related to COVID-19 pandemic.

Total operating expenses for the fourth quarter of 2020 were $27.9 million, a 59% increase compared to $17.9 million for the same period last year. The primary increases during the fourth quarter were due to the accrued legal settlements of $6.3 million as well as other G&A expense previously mentioned.

Full year operating expenses were $81.8 million for 2020, a 28% increase compared to $63.7 million for 2019. The increase in operating expense for full year 2020 was primarily driven by a 44% increase in G&A previously mentioned, including the accrued legal settlements.

Operating losses for 2020 was negative $26.8 million compared to negative $9.1 million for 2019. Adjusted EBITDA for the fourth quarter of 2020 was negative $2.6 million compared to negative $919,000 for the fourth quarter of 2019. Adjusted EBITDA for the full year of 2020 was negative $5.9 million from a negative $1.1 million for the full year of 2019. The changes were primarily driven by the impact of COVID on our demand.

Interest expense in the fourth quarter was $0.6 million compared to $1.3 million in the same period last year and was $3.4 million for 2020 compared to $3.5 million for 2019. Fair value adjustment of contingent considerations was $1.7 million in the fourth quarter and $3.5 million for the full year 2020 as compared to 0 in 2019. These amounts represent the time value of money associated with our year 4 system sales payment on the ApiFix acquisition and will continue in varying amounts until the second quarter of 2024.

Net loss from the continuing operations for the fourth quarter of 2020 was $14.0 million compared to a net loss of $4.3 million in the same period last year. Net loss per share in the fourth quarter of 2020 was negative $0.73 per basic and diluted share compared to a negative $0.36 per basic and diluted share in the same period last year. And net loss from continuing operations in 2020 was $32.9 million compared to $12.7 million in 2019. Net loss per share in the full year of 2020 was negative $1.82 per basic and diluted share compared to a negative $0.94 per basic and diluted share in 2019.

Turning to our balance sheet. As of December 31, 2020, our cash, restricted cash and short-term investments were $85.3 million compared to $89.7 million as of September 30, 2020. Currently, we have no outstanding obligation on our $25 million revolving credit facility, which expires in January of 2024.

The change in net purchase of PP&E during the fourth quarter of 2020 was $4.1 million as compared to $1.3 million for the same period last year and was $10.5 million in 2020 compared to $11.8 million in 2019. This investment reflects the deployment of consigned sets, which includes product-specific instruments and cases and trays. Including the implants, $5.1 million of consigned sets were deployed during the fourth quarter of 2020 compared to $4.5 million during the fourth quarter of 2019. For the full year 2020, we deployed $18.2 million of consigned sets compared to $18.2 million in the full year 2019.

I would now like to turn to our outlook for 2021. As we head into the first quarter and full year of 2021, we remain diligent and pay close attention to the evolving landscape of surgical procedures. Domestically, elective surgeries were being deferred in Southern California and at several of the hospitals in the Northeast. However, unlike the widespread deferrals during the second quarter of 2020, children's hospitals are less affected by the surge in adult COVID cases. Hospitals appear to be treating adult patients more effectively in this environment. With that being said during the end of the fourth quarter 2020 as well as the start of the first quarter of 2021, we did continue to hear of selected cases that were canceled as pediatric patients tested positive for COVID prior to surgery. Recently, we have seen a significant increase in demand and expect that to continue for some time to come as reported COVID cases decline and a larger percentage of the population becomes vaccinated.

Internationally, there's a wide divergence on the COVID impact. Germany, Australia, New Zealand appear to have controlled the pandemic very well, and there is little to no impact on elective surgeries. However, their partial deferrals of elective surgeries in several countries in the EU and the U.K. remains significantly impacted. For the full year 2021, we expect to see very significant growth over the prior year, with sales reaching $93 million to $98 million and representing a 31% to 38% growth. We believe the following developments will significantly contribute to reaching our expected sales goals in 2021. ApiFix will have the 200-case registry completed by late 2021.

Orthex will benefit from 38 new domestic users, and conversions will continue to accelerate our launch of the Orthex and sterile-packaged products in Europe during the second quarter of 2021. Major pediatric center conversions to 80% or more; benefits from the countless hours of virtual training, which we have completed in 2020; $18 million of consigned sets deployed in 2019 and 2020 will impact domestic and international sales agency markets.

International stocking distributors are starting to place larger replenishment orders, and for the first time since March of 2020, they are starting to place set orders to meet the increased demand in their market. Germany, Austria and Switzerland conversions are already showing favorable impacts in the first quarter of 2021 and will continue for the full year of 2021 and beyond. As the pandemic environment continues to evolve, we believe our business model focused on strong execution, cost containment and a robust balance sheet position us optimally to execute and adapt to these new challenges.

Let me now turn the call back over to Mark for some final comments.

Thank you, Fred. While we have not yet emerged from the COVID pandemic, we have recently seen a significant uplift in sales to international stocking distributors. This turnaround, coupled with strong international sales agency growth, should correct the performance issue we had in 2020. With continued domestic growth and strong synergies from Orthex, ApiFix and Telos, we believe that the company will indeed emerge even stronger from the pandemic than when we entered it. As always, this is due to the dedication of our associates around the world who have risen so admirably to the challenges of the past year. OrthoPediatrics' designation as one of the best places to work in Indiana, recently named to that honor for the fifth year, reinforces our conviction that our performance in 2020 and our outlook for 2021 are due to our culture, which is this company's most valuable asset.

With that, let's turn the call over to your questions, please.

(Operator Instructions) Your first question comes from Kaila Krum with Truist Securities.

So first, can you guys just provide a little bit more detail on this $2.7 million revenue reduction, just what prompted the change from the preliminary number? What did we learn, I guess, from the time of the January pre-announcement and today that resulted in that change?

Yes, absolutely. Thank you for the question, Kaila. This -- the agreement that we had with the stocking distributor in Germany, Austria and Switzerland was signed on December 31, 2020. And the new agency agreement was then signed the 1st week of January in 2021. And we completed our normal sales reporting process in early January, and we issued the preannouncement on January 11 before the investor conferences at that time.

As we subs -- as we then really got into it and examined the transaction, we recognized its complexity. And working with our auditors, we determined that the correct accounting treatment in light of the new revenue recognition guidelines, ASC 606 required us to book this as a revenue reduction in December of 2020. This situation is a bit unique in that this is a very, very large, I guess, stocking distributor for us, unlike some of our other smaller independent family-owned businesses. And so the current agreement that we had, the termination agreement and the new agency agreement were different, I would say, than other agreements we have in place. That all culminated throughout the auditing process as we were closing our financials. And obviously, it shows up as it does in the results that you're seeing today.

Got it. No, that makes a ton of sense. And then you guys mentioned that this international stocking picking up in the first quarter. Is there a way to quantify that potential benefit?

I'm not sure we want to put exact number on it. But I would say that it gives us high confidence in our $93 million to $98 million for the year and as well as making a statement that we expect to report continued increase in growth for the overall business here in the first quarter of 2021.

Great. Understood. And then I guess just one on ApiFix. I mean it sounds like the early rollout is going really well and that you're expecting to complete the registry numbers this year. Can you just help us frame sort of the supply capacity because I think that myself and a lot of us on the line get pretty excited about ApiFix. And just how comfortable are you sort of that you have the right capacity this year and next?

Yes. Another great question, Kaila. And those are good problems to have. Listen, the demand for this, we have been anticipating for some time. And so we have been building inventory of this product in anticipation of this launch and of the anticipated significant increase in demand for the product as more and more of these 20 surgery hospitals come online.

So I am pleased to report that we will not have a lack of inventory for this product. Again, as Mark said, the investment required for these sets are very, very small. So it makes a ton of sense to have plenty of sets available as well as plenty of inventory on our shelves to make sure we can meet the ever-increasing demand across the world for this product.

Your next question is from Ryan Zimmerman with BTIG.

So 2020 was obviously a unique year, and your cadence of sales got a little turn on tad through the year, just given what we normally think of with kids and its typical seasonality kind of in the second and third quarter. Curious if Mark or Dave or Fred, if you want to give any color in terms of expectations around seasonal cadence for the year, how you're thinking about this? I appreciate, obviously, the impact in the first quarter. But could we get back to maybe a more normalized scoli season, for example, midyear? Just some thoughts there, I think, would be helpful.

Yes. That's a really good question. I think at this stage, we can't say for sure. But it does appear, particularly in the last several weeks that we're moving back to a more normal environment. And hopefully, that continues. We don't know exactly how this will affect, obviously, our busy summer season. But there's no question that there are patients that are still backlogged through the back part of the fourth quarter and early part of the first quarter. And while we may be seeing an increased volume of those patients come online now, I guess, Ryan, we would expect to see those -- that continue throughout the balance of the summer.

We believe there's still a reasonable backlog of pediatric patients from even last summer that didn't get done. Again, this is speculation at this point. Obviously, we've had a difficult time with the impact of COVID to really understand the seasonal impact on our business. But I do think it's fair to say that we will get back to a more normalized environment. Well, we hope to see us get back to a more normalized environment and have the cadence of our revenue and the volumes return back to normal throughout the summer season.

Okay. And maybe one, Fred, for you. Historically, you've given us your expectations for deployment of capital in '21. You talked about the capital you did deploy in '19 and '20. Can you talk a little bit about your expectations for deployed capital, particularly in sets for '21?

Yes. I guess rather than putting a number on it, I would just say that we're going to continue to deploy sets, for sure. We're going to continue to invest in the business, just like we did throughout of 2020 despite the lower volume. I think we're also going to start to see the benefit of the ApiFix lower capital required to drive those growth numbers. So we can deploy very little amount of capital and drive significant multimillion dollars of growth with ApiFix, which will reduce -- slightly reduce the necessary capital to continue to deploy more and more. So we're going to continue to deploy sets and meet the demand of our products. But it may be at a slightly lower pace as we kind of let the demand catch up with what we've done here in the last 2 years.

So, okay. Fair enough. And then if I could squeeze one more in. Just you ended with 171 reps, and, hey, help us understand kind of how you think about that sales agent group increasing in '21, particularly as we think about productivity per rep and the implied guidance and the necessary requirement step-ups, if you will, in productivity for '21?

Good question, Ryan. So as you know, this isn't a metric that we -- we track it, but it's primarily for the benefit of the market. We don't necessarily track productivity of reps because it has such a difference between the geography on a rep-by-rep basis and the volumes within a specific hospital. That said, I think what you could probably expect to see is a more normalized environment in terms of our sales agents in the United States adding reps to meet demand. As you know, 90%, 95% of our surgeries are covered, so there's a sales rep in the room. and as sales grow by 31% to 38%, it's just simply going to require more people to be able to cover those cases. And so I think that you probably will see sales rep growth, but it may not mirror that 31% to 38% range, but it certainly will be better than you saw in 2020.

Your next question is from Rick Wise with Stifel.

Let me start off, coming back to the -- some of your quarterly thinking and the cadence of quarters at a higher level. Just starting with the first quarter, I sort of say to myself we're -- it's March 11. You're seeing some clear trends. I appreciate that things could change. But can you help us think through how the first quarter could shape up? Are we likely to see it off the -- now reduced fourth quarter number because of the stocking accounting?

Should we assume it's sequentially better than the fourth quarter given the trends you've seen? Just help us think through the first quarter and how you all are thinking about the flow of quarters to get to your guidance as the year unfolds, stronger second half versus first, I assume? Just any color would be great.

Yes, Rick, I think we see continued increase in the growth rate. So we saw 7% in the third quarter. If you back out the $2.7 million, which had a negative 14% on the fourth quarter, the first quarter could be something like 21% growth. So continued increased revenue growth of the business as the recovery continues to impact us. And I think, obviously, the second quarter is going to be tremendously high growth because of last year. But we would see the revenue continue to then kind of increase and follow a similar pattern of ex-COVID historical. So many of the schools today are back in full swing. So there are some patients that are not getting surgery until the summer months because right now, they're in school. And so we would expect to see very strong June and July. And then if things continue as expected, the fourth quarter will probably be a lower revenue dollar than the third quarter.

So Fred, just to make sure I'm understanding. So first quarter dollars ahead of fourth quarter. Second, ahead of first. Third quarter, as always, as you say, the strongest and sort of returning to, hopefully, more normal seasonally slower fourth quarter. So that would be the one sequentially lower quarter as we sort of frame the year. Am I hearing you correctly?

Yes, that is absolutely correct. That was better said. Thank you.

All right. Good. And I was hoping also to get a little more color on gross margins. And you sort of alluded to it. Gross margins were much better than we looked for this quarter. Again, I assume that's the U.S. versus greater U.S. mix versus OUS. How will we think about gross margins this year? Because I say to myself, volumes are turning, yes, U.S. -- OUS rebounding, but now you've got direct in 3 of your largest markets, Germany, Austria, Switzerland. I mean help us think through the GM setup for '21 as well?

Sure. I think it's important to understand the negative 2.7% impact on the fourth quarter gross margin rate at 79.9%. The -- that the products we returned had been -- they're used sets that we had sold to that stocking distributor over the last 5, 7, 10 years, and they came back to us at a discount. And so it came back to the books at a 40% gross margin. So it's a negative. So it's a return of sale of 40%, which did inflate the fourth quarter gross margin rate because of that transaction.

And so if you were to back that out, I think it's going to be something more like a normalized 75%, 76%, which is kind of where we see the overall business on a full year basis going forward, 76-ish, and then having the positive impact of the agencies. But if we start selling sets to our stocking distributors at our cost, that's a negative impact. So it's kind of offsetting one another for 2021.

Great. I'm so glad I asked actually. Two other questions for me. Can you talk a little bit about your thinking about your strong balance sheet and how you might deploy it in 2021? Should I'd be thinking that given everything that's going on and integrating your acquisitions of 2020, et cetera, that you're probably not going to be as active on the M&A front or technology tuck-in front as you've been in the recent past? Or is that not the a right way to think about it?

I would say that we continue to look for good technologies that we can deploy and help this industry. And so if there's an opportunity out there, we would look to take advantage of it. The strong balance sheet helps us make those decisions. And if necessary, we could go get some debt, which we don't have any debt really to set on the balance sheet today to help finance something like that. We'll continue smaller tuck-ins, but we continue to look for anything that could help this industry regardless of size.

With that being said, I don't anticipate us making any announcements anytime soon. But we continue to look.

Got you. And just last, for some reason, I'm obsessed with the total account conversion aspect of the story. Can you -- is it possible to tell us how many accounts at this point or give us any color around what percentage of your U.S. business today is what you would define as total account conversion? And is there a pipeline? How do we think about your activities around that and the impact of that kind of mindset on your '21 outlook or business?

Yes. Rick, great question. So we have a pipeline. That pipeline consists of -- I -- in fact, I just looked at it before this call. We have a pipeline of well over 100 accounts that we are monitoring very specifically and looking for opportunities, obviously, to improve share, but also to contract with to move our business to that, let's say, 80% plus, particularly in the trauma and limb deformity area. We normally place about 10 of those accounts as very, very high order kind of possibilities. And hope to close a couple of those accounts every quarter and have a very specific number of accounts that we want to move into that 80% category every year.

And so we observed as an executive leadership group, about 10 of those accounts on a quarter-over-quarter basis and measure against that, and we like the pace of conversion of a few of these accounts kind of every quarter. And at this stage, Rick, we have a very long runway. As you know, we are present in every major children's hospital in the United States and most in kind of the developed world. And there's, I would say, at this stage, very few of those are at the 80% range of our trauma and limb deformity products.

That said, as you talk about inventory and the inventory we deployed last year, we deployed $18.2 million worth of inventory last year on a sales number that was expected to be a lot larger, obviously, but got affected by the pandemic. And we are starting to see the deployment of that inventory that we put out last year going right into hospitals. And a few of accounts, even over the last few months, we're seeing -- we're not deploying a few sets into an account, but we may be deploying 25 sets into a specific account. And whether those are contracted to be 80% contracts or not, we know when we get shelf space, when we have a rep that's there present every day, that those are the types of accounts that tend to grow to -- from 30% to 50% to ultimately 80% share. And we like the funnel that we have, and we like our position right now.

Your next question is from Mike Matson with Needham.

Fred, I guess, first, has the audit been completed? And when do you expect to file your 10-K?

Yes, absolutely. We have completed everything, have a clean opinion from Deloitte and the 10-K, we filed yet -- yesterday. So that should be out there.

Okay. Great. And then for the distributor that you acquired, the $2.7 million of revenue -- sorry, of the revenue adjustment into context, can you quantify their annual sales?

They're probably doing about $2 million a year of annualized sales today with definite opportunity to grow. But I would say that was probably 2020's revenue throughout COVID, but it's around $2 million.

Okay. All right. And then is -- has the experience with COVID and the fact that a lot of these -- the stocking distributors, OUS, were really kind of going through these destocking phase. Has that caused you to accelerate your conversion effort? Or is it just continuing at kind of the normal pace?

No, I think it just -- it's continuing at its normal pace. I mean clearly, we see the benefit. We saw the benefit when we started down this row many years ago of having, I would say, eliminating some of the lumpiness of the revenue and not having our partners rely or not have cash available to invest in the business. And so I think it absolutely encouraged us to continue moving forward. But I don't know that we're going to really change any direction because of it.

I would add that, this is a big one. This is one that we've had on the docket for a long time. It was extremely complex as Fred talked about earlier. And I don't see anything in the near term that's of that scale. But certainly, we expect this one to have a very substantial impact on revenue next -- this year and into the future. And then I think we will resume this pace of maybe 1, maybe 2 of these a year. But we definitely haven't accelerated these things -- these. And again, even the small ones are complex. So it's a matter of bandwidth as well.

Okay. Got it. And then finally, just on the legal settlement, the accrual there. Can you provide any additional detail around what that involves?

Yes. I think as most everybody knows, we've got several outstanding items with K2M. There's a Dr. Barry matter. There's the IMED in Florida, typical cases related to IP. And some things have, I guess, progressed here recently, such that those have become -- potential settlements have become estimatable and probable.

And so we, for the first time, put those on the books because we can now see the end is in sight on many of those. And so while those amounts are not final, they're estimates, we think were a lot closer than we were just 6 months ago to wrap in some of these things up and get them behind us.

Your next question is from David Turkaly with JMP Securities.

Sorry about that. Can you hear me?

Yes. Yes, we can hear you.

Okay. I didn't hear my name called, but thanks for getting me in. So just to understand this and I think this puts it to bed, hopefully. You recognized $2.7 million in sales, let's say, over the last, I don't know, maybe 5, 10 years, I think you even mentioned.

And this new ASC 606 you mentioned, I'm not familiar with that. But is that something new? Are you familiar with it? And I imagine that is the pronouncement that says, hey, take it all if you buy that stocking distributor, reverse or contrarevenue, the cumulative sales in 1 period. Is that fair? And have you seen that before?

Yes. It's -- I have seen it before. As you said, we've sold these sets, which is what we bought, are sets so that we can consign inventory into the hospitals and continue to serve the marketplace. We've sold those sets to them over many, many years.

They're used -- they're now used sets, but they're absolutely required to be able to service the marketplace. And yes, ASC 606 is related to revenue recognition and returns. And so it is -- I have seen it before, and it is absolutely correct where you would book a lower revenue number for this, in this case $2.7 million, as we brought that back on to our books.

Got it. And then looking at the guidance, return to solid growth in 2021. I was wondering if you might want to give us any color in terms of -- whether it's operating or net loss? Like do we think you guys experienced some incremental leverage as the revenue growth comes back? The loss shrinks or grows? Or just any color there in terms of what your kind of high-level thoughts are for '21 maybe on the bottom line.

Yes, absolutely. So obviously, adjusted EBITDA was negatively impacted by COVID, by this legal settlement, by other things. But aside from those, we have continued the statement that we want to grow the business aggressively on the top line and at the same time, from an operating point, improve the bottom line of the business.

We have definitely learned how to do some things differently related to travel and communicating effectively, obviously, with Zoom and other methods. And we'll be deploying those and continuing to deploy those in 2021 to save some money. So as that revenue returns very aggressively, 31% to 38%, we'll be controlling our spending and improving the bottom line of the business, for sure.

Great. I'm going to sneak one last one if I could. I think you said you had 14 OUS sales agencies and 42 stocking distributors. As you look at the 42, the conversion -- potentially for conversion, are there others in there that you think would, I don't know, meet the materiality level of this ASC 606? Or are most of them smaller?

I guess just any thoughts there because I don't recall seen it in the past, so I'd figure maybe you have an idea of the size of some of those entities and if there's certain ones you're considering converting?

Yes, absolutely. What I would say is that if there's somebody else out there of any anywhere close to this size, this was by far our largest, most sophisticated stocking distributor. But really, it wasn't just the size. It was the contracts, the legal contracts that were in place as well. And so we'll evaluate each one of them independently as we move forward and make the right decision. But they're all going to be in a much smaller nature for sure.

Your next question is from Matthew O'Brien with Piper Sandler.

And Mark, I know you're going to stay involved in the business. I just wanted to recognize your outstanding stewardship of the company since joining.

Well, thank you, Matt. I appreciate that very much.

Okay. Of course. I guess if we could just deconstruct the Scoli performance in Q4, it was obviously eye-catching how strong it was. And, Dave, you talked a little bit about the elongated scoli season this time around. But can you deconstruct what we saw in Q4 as far as maybe some of that backlog of cases, ApiFix kicking in?

Then more importantly -- or not, I guess not more importantly, but other underlying dynamics that are durable going forward in terms of new account capture going deeper in existing accounts, things like that because the scoli market is obviously enormous and that's a huge opportunity for you over the next couple of years.

Yes. Matt, good question. So yes, to deconstruct fourth quarter, I think we saw about what a number of the other spine companies saw was this almost a whiplash effect. And we're seeing a bit of that now here again in the first quarter where we have a backlog of surgeries throughout the early fall. Then we saw October, November, really, really strong scoliosis demand, saw elective demand across-the-board in those periods. We had a really solid December, but it was a slowing rate of demand for scoli, and then that kind of continued here into the first -- early part of the first quarter.

So I think what we've seen from a demand standpoint, it's pretty consistent with what I have been reading, at least from some of the other companies on the scoliosis side or on the spine side in elective. I think what we're really pleased about is these numbers that we have 23 new users that we captured in 2020. And again, there's only 200 and -- about 300 children's hospitals. So and only a certain number of pediatric orthopedic surgeons that regularly do scoliosis. So at 23 new users is a very substantial and concrete representation of share gain for us.

And we have kind of a goal of that order of magnitude again for this year and feel like we're off to a really, really good start. So I think that's what's durable. There's no question we're getting a larger percentage of the take of some of our accounts already. So some of the accounts that we had before these 23 new users. I think we are getting deeper penetration. But adding new users that are consistently calling for the RESPONSE scoli system, I think, is a very concrete thing we're resting on for growth next year. Obviously, we're extremely excited about ApiFix, and we continue to see accelerated interest in being part of the IRB sites. Although, as you know, we have our 20 and it will remain there until we fill this 200-patient registry.

What I will say, though, is that we can very clearly -- we're very clearly deriving revenue and new customers from our acquisition of ApiFix and people being connected to this nonfusion technology. Not every patient, as you well know, is a candidate for nonfusion surgery. And so a number of patients are being driven to these clinics that have access to the site. And ultimately, in some of those sites, there are places where we didn't have previous fusion business. And we're definitely seeing an increase in fusion business with our RESPONSE system at locations where -- that have access to the ApiFix technology. So like the synergies there. And as that continues to expand and become a bigger part of our business in 2021, 2022, we would expect to see that synergies only get better.

Got it. That's great to hear. And then following up on one of Rick's questions on just the kind of core domestic business. You've got those 10 accounts I think you said that you target. How sizable are those 10? I mean I'm assuming you're in some of the really big children's centers around the U.S. already.

Are there some areas where you just haven't historically been able to penetrate? Or are you able to get into some bigger places you hadn't been in the past? Are you going deeper? I guess the question, just to sum it all up, is can you keep growing the domestic business around 20% in the future or in more normalized times?

There is no question that we are on the early -- we are still in the early innings of kind of this growth curve. We are present in every major children's hospital here in the United States. But as we've said in the past, I mean, this is a surgeon-by-surgeon, product-by-product conversion. And with 35 implant systems and a lot of these accounts that have a lot of surgeons, Matt, we may have 1 or 2 surgeons out of 10, let's say, that use all of our products.

But that's obviously only accounts for 20-or-so percentage of the volume in that account. And so we were measuring those accounts of their -- as on an individual basis by their TAM. And I would say that most of those accounts that we are measuring are accounts that were -- are worth in excess -- certainly in excess of $1 million and some accounts in excess of a few million dollars, particularly for T&D. And again, we're just in the early phases of moving more and more accounts into that kind of 50% to 80% share range. But again, we like the pace with which this is happening. I feel like we can maintain that pace for a really long time in the future.

And there are no further questions at this time.

All right. Very good. Well, let me thank everyone for joining today's call. We certainly expect 2021 to prove to be a pivotal year, although a more normal year for the company. And we'd like to thank all of you for your continued interest and support of our mission to help children throughout the world. So have a good day.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.