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spk02: Good afternoon and welcome to the first quarter 2021 earnings conference call for Performance, Inc. My name is Valerie and I will be your conference operator today. All I have in place on me to prevent background noise. After management's remarks, there will be a question and answer session. Before we begin, I would like to remind you that this call will include forward-looking statements within the meaning of federal security law, which are made pursuant to the safe harbor vision of the Private Security Litigation Reform Act of 1995. Any statements made during the call that are not statements of historical facts should be considered forward-looking statements. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements, including those discussed in the risk factors section of conformance public filing with the U.S. Securities and Exchange Commission. You should not place the undue reliance of the forward-looking statements conformance has claimed any obligation except as required by law to update or revise any financial projections or forward-looking statements, whether because of new information, further events, or otherwise. This conference call will include time-sensitive information and is accurate as of the live broadcast today, May 5, 2021. I will now turn the call over to Mark Auguste, President and Chief Executive Officer of Conformance.
spk05: Thank you and welcome to our first quarter 2021 earnings conference call. With me on the call today is our CFO, Bob Howe. We appreciate you joining us. In short, the year is off to a good start. Conformance's revenue was right where we expected it to be as we continued to manage through COVID-related headwinds. My thanks to the entire team, which continues to work relentlessly on our growth strategies. The healthcare industry continues to be impacted by COVID, resulting in hospitals operating at or near capacity, and thus impacting inpatient elective procedures. In addition, we believe COVID has affected the demand for knee arthroplasty, but as vaccination rates continue to improve, we believe we will see patients feeling less anxiety and making office visits and undergoing elective procedures. Like others, we believe we should start to realize the transition back to normal demand levels in the second half of 2021. Of course, this assumes that we don't experience anything unforeseen or unexpected. Our current goal is to have fourth quarter product revenue match or exceed the product revenue we realized in the fourth quarter of 2019. It has only been a short time since our fourth quarter call. However, I would like to take a moment to update you on our current growth strategy. Number one, grow our core knee business. Conformis is best known for its knee implants, and this accounts for over 90% of our revenue. Since most of our patients have been dealing with knee pain and discomfort for an extended period of time, their surgeries are most likely treated as elective. This means that our business has been impacted by the abnormally high levels of deferred elective procedures over the past 12 months. As knee replacement patients return, we believe we will see a corresponding improvement in business. More importantly, as we launch our new products and focus on the ASC, we expect to achieve procedure growth. We believe our needs deliver the best outcomes for those patients needing full or partial knee replacements, and we believe our efficient delivery model will increasingly be preferred as the market seeks efficiency savings. Number two, grow our HIP business. During the first quarter, we hit 700,000 revenue, which was 49% growth over the first quarter of 2020. This performance was in line with our pandemic adjusted internal expectations, But we don't like the fact that the pandemic has put us off our original business plan. We're working hard to get back in line with our internal more aggressive expectations to grow our hip franchise. The good news is that with the December 2020 commercial launch of the Kedara Match Hip System, we are driving incremental customer interest, and this should work in our favor, especially as we are able to train surgeons at rates more comparable to the pre-pandemic model. We remain excited about the traction we're getting with our HIP offering and are committed to investing in our product and commercial activities to maintain growth. Number three, continue to drive R&D efforts, launching new and differentiated products. We have several products in the pipeline, including three that we believe will be particularly impactful to our financial performance once they launch. The first is our anticipated new knee system, which we have named Identity Imprint. This system is expected to complement our personalized knee offering extremely well and will help us further penetrate the ASC and outpatient segment for total knee arthroplasty. Our 5K application is with the FDA for review with no significant update to report. While FDA clearance is pending, we are preparing our marketing and sales teams to ensure that we are ready to attract and train surgeons on the use of our new product later this year. The second is our cementless need. As I've outlined before, timing for the cementless product was delayed last summer due to resource constraints. Those constraints are now gone due to recent and expected infusions of capital, and we are working hard to get this product back to its original timeline. For now, we plan on launching this product by Q1 of 2022, which is consistent with the view we shared on our last earnings call. The third is our plan to introduce additional HIP stems that will complement our HIP portfolio in 2022. Having successfully completed the Striker Development Program, we have restructured our development team to add more resources and bring dedicated leisure to our HIP programs. And lastly, number four, continue to monetize our intellectual property. Because we successfully achieved the final milestone under the Stryker Development Agreement, we will receive an $11 million payment from Stryker and can now focus on manufacturing and supplying patient-specific instrumentation to Stryker. We have recently granted a non-exclusive license to a subset of our patents so that Paragon 28 can use our patient-specific instrumentation IP with their off-the-shelf implants in their Apex 3D total ankle replacement system. Conformance will receive $1.5 million from Paragon 28. Protecting our intellectual property is a strategic imperative for us, and we have a strong team of employees to do this. Through mutual agreements and litigation when necessary, Conformance has successfully and strategically licensed its technology to a number of respective companies. These licenses have generated over 50 million to date, and we continue to zealously protect conformance's position as a leader in patient-specific instrumentation and implant technology. In summary, we are pleased with the progress we are making on our growth strategy. Before I turn the call over to Bob, I'd like to touch on our capital infusion of nearly 80 million of net proceeds in mid-February. This cash provides us with the necessary runway to drive our growth strategy and it gives us reasonable cushion as we operate in the face of COVID headwinds. The first area where we have started to significantly invest this cash is our sales and marketing organization. Specifically, we've added a new dedicated sales leader to lead commercial activities targeting the ASC space. In addition, we are adding two to three new marketing resources to support the launch of our new imprint knee system and adding more medical education events to the calendar in order to more aggressively train surgeons. We believe that through these efforts, we will increase the number of surgeons who use conformance hip and knee products. The second area of investment is R&D. Our goals for incremental investment in R&D are as follows. Ensure proper resourcing to meet scheduled timelines, bring forward hip improvements in software and implants, restart our new third-generation partial knee program, and appropriately explore complementary technologies. Let me now turn the call over to Bob for a more detailed financial review. Bob?
spk03: Thank you, Mark, and good afternoon, everyone. Although Mark has already hit the highlights, I will start with our recent public offering since it was the most significant financial event of the first quarter. As a reminder, the offering was for just under 81 million shares at a price of $1.05 per share and closed on February 17th. The net proceeds were $79.6 million. We believe this capital infusion positions us well to execute on our growth strategy and provides the runway needed to reach cash flow breakeven. On the Stryker development front, we recently announced the achievement of the last remaining milestone, which was contingent on receiving FDA clearance. As a result of meeting this milestone, we now expect an $11 million payment from Stryker, which should be received in the second quarter. As a reminder, To date, we have not yet recognized royalty and licensing revenue in connection with the Stryker agreement. With the successful completion of the third milestone, we will recognize $25 million of royalty and licensing revenue in the second quarter of 2021. This final milestone is a testament to Conformist's significant development expertise, and we are excited about the next phase in our relationship with Stryker, which plays to another area of our expertise. manufacturing high-quality, patient-specific instrumentation. We now look forward to executing on our long-term supply and distribution agreement with Stryker. Lastly, as a reminder, during the quarter, we work with our partner, Innovatis, to amend our term loan agreement on March 1st. As part of that amendment, the revenue covenants will waive for the remainder of 2021 and lowered for 2022. I will now move to the financial highlights that Mark did not cover. We reported first quarter revenue of $13.8 million, representing a decrease of 16% year-over-year on a reported basis and 17% on a constant currency basis. First quarter product revenue was $13.7 million, representing a decrease of 16% year-over-year on a reported basis and 17% on a constant currency basis. Sales of our new products were $13.1 million, representing a decrease of 18% year-over-year on a reported basis and 19% on a constant currency basis. Sales of our conformance HIP system were approximately 700,000, an increase of 49% year-over-year on both a reported and constant currency basis. U.S. product revenue was 11.6 million, representing a decrease of 16% year-over-year. U.S. sales of our knee products were 10.9 million, an 18% decline year-over-year. The rest of world product revenue was $2.1 million, a decrease of 14% year-over-year on a reported basis and 22% on a constant currency basis. Our first quarter gross margin was 45% of revenue compared to 44% of revenue for the same quarter the prior year, an increase of 80 basis points. This was driven primarily by lower canceled case inventory expense, partially offset by manufacturing variances resulting from lower production volumes. Total operating expenses for the first quarter were flat year-over-year, but there were a few variances within the different functions that I'd like to call out. Sales and marketing expenses were down $1.5 million, primarily due to lower marketing event, program, and advertising expenses, as well as lower sales commissions and travel expenses. R&D expenses were up by $600,000, primarily due to increased personnel costs as we continue to invest in our product pipelines. G&A expenses were up by $900,000, driven by higher legal fees related to the protection of our intellectual property. As Mark outlined, we are planning for some incremental investments in our sales, marketing, and R&D organizations to drive our growth strategy. Additionally, we expect an increase over the next three quarters in our litigation-related activity of $3 to $4 million to further protect our intellectual property. As a result of these expected increases, We anticipate sales and marketing expense to be between $26 and $27 million for fiscal year 2021, R&D to be between $16 and $70 million, and G&A to be between $28 and $29 million. Moving to our bottom line performance, net loss was $11.5 million, or $0.09 per share, compared to net loss of $9.4 million, or $0.14 per share, for the same period last year. Net loss in the first quarter included foreign currency exchange loss of $1.8 million compared to foreign currency exchange loss of $0.7 million in the same period last year. We significantly strengthened our balance sheet during the first quarter. We had cash and cash equivalents of $104.6 million as of March 31, 2021, compared to $28.7 million as of December 31, 2020. Lastly, I would like to provide some thoughts on our outlook. Our practice of providing full year guidance remains suspended due to the heightened level of unpredictability and volatility caused by COVID. However, we are giving next quarter guidance and some thoughts on the second half of the year. Based on our performance from April and our forecast for May and June, we expect our total product revenue to be between 14 to 14.5 million, which is a modest sequential improvement from the first quarter. As we exit a Q1 and through the month of April, We have seen sequential improvement in our weekly CT scans, which is encouraging. However, given the lag time between scan date and the actual surgery date, we expect Q2 revenue to continue to be negatively impacted by the overall market decline in elective procedures, as well as the decline in office visits seen in Q4 and Q1. We are cautiously optimistic about the positive trend we've seen in our scans, as well as the progress that has been made in vaccination adoption worldwide. We continue to believe that office visits and elective procedures will continue to improve through Q2 and into the second half of this year, assuming, of course, that there's no unanticipated complications with vaccinations or new COVID variants. With the anticipated improvement in the overall elective procedure market, we do expect to sequentially grow our existing base business in both the third and fourth quarters. In light of where we are today, and as Mark stated earlier, our goal is to have fourth quarter product revenue match or exceed revenue realized in the fourth quarter of 2019. With that, I'll turn the call back over to Mark.
spk05: Thank you, Bob. For the first time since the COVID pandemic began, I feel like we are starting to regain momentum. We have seen office visits, while still below 2019 levels, generally improve. We have been able to successfully work remotely, progress our product programs and continue to engage with our key surgeons. And we now have the capital to move forward with confidence. We achieved the goals of our striker development project and the new imprint need targeting. The ASC market remains on track for launch in the second half of this year. Most importantly, the global vaccine rollout seems to be progressing. We're excited about what's in store for the rest of 2021 and for 2022. One additional point before I close. I could not be more proud of the entire conformance organization and more appreciative of our Stryker partners who delivered and continue to deliver on a very aggressive timeline. Recall this, we announced the transaction with Stryker in October 2019, and now here we are in May 2021 with FDA clearance as of April. This is a tremendous testament to the hard work and the effort of both organizations, as well as to Conformis' clear competency and expertise in the area of patient-specific instrumentation. In closing, I would like to thank Conformance employees, our physician customers, and their non-physician partners we do business with to help make people's lives better. There's no better feeling than knowing we help people live without pain. With that, Bob and I are happy to take your questions.
spk01: Thank you. To ask a question, you will need to press star then 1 on your telephone. To withdraw your question, please press the pound key. Again, that is star then 1 if you would like to ask a question. Our first question comes from the line of Josh Jennings with Cowan & Company. Your line is now open.
spk04: Hi, this is Eric on for Josh. Thanks for taking the question. Hi, guys. How are you doing? Just thinking now that we're almost halfway through 2Q, is there anything you can share on volume trends that you've observed through April and early May? And then to that point, what sort of backlog do you think has accrued at this point? Would you be able to quantify that?
spk05: Yeah, Eric, so we definitely, as we said, we've definitely seen an increase in scans for April. We're pretty pleased on the trajectory. And that's continued through, you know, the first few days of May here. It's still early May. So I think that goes to, you know, patient demand for knee arthroplasty coming back. I think that goes to the vaccines progressing, especially in the arthroplasty patient population, the age population. And again, as Bob alluded in his section, we need those office visits to come back. We need people to come in and be willing to be assessed for surgery and then go to CT scan. So that's sort of that early thing that we're seeing. As far as, you know, talking about quantifying a backlog, I don't know, you know, we're going to comment on quantifying it, but I think we can say that all along we've seen backlog gets scheduled, you know, a patient's return, because, you know, as you recall, we will have built some cases, and then, you know, surgeries were delayed, and they came back, and we're continuing to see those trickle in, and we have seen a slight uptick in that category of business, but the real positive momentum is just an uptick in, you know, basically scan volumes, and that's what we need to drive our business, and so that's making us positive around Q2.
spk04: Understood. That's fair. And then you've previously set LRP targets with a few milestones for 2024 around revenue and margin. I'm just wondering, do you still expect to meet those or should we be anticipating a refresh of the LRP at some point? And just as one more question to that. What were your expectations for the striker partnership a few years down the road? Was that included in that initial LRP range? And I think you've previously said that the supply portion of the agreement could be 10 to 20 percent of the company's total revenue. Is that still an appropriate way that we should be thinking about it? Thank you for the questions.
spk03: Yeah, that's right. Eric, 10 to 20 is what we had signal, and then, you know, that hasn't changed. And to your comment on the ranges, you know, we're still sticking with those ranges. You know, we still believe that's achievable, and that's our goal to meet it. So it's still on track.
spk05: I mean, I think it's fair to say, look, when we published those, we had insight into the first part of the COVID, not a crystal ball in the second, but we gave some ranges, you know, on purpose. So... We certainly, as part of our responsibility, stewards of the ship, so to speak, will always look at our LRP. And if we move off that stuff, we have an obligation to signal that. But we still believe that we're credibly in that range. So, you know, but I guess my point is, obviously, we had to take some hits in the fact that the slow start here in 2021, because that wasn't contemplated. when we put that together, but we're still in those ranges and we still see opportunity to, you know, drive business with these new product programs. And I think importantly, the other thing is, and that's why, you know, we will do a refresh and, you know, signal where that comes, but we're committed to those ranges. But we just talked about in my comments adding, for instance, partial meet, you know, with the funding and commitment and support from our shareholders. we have to be appropriately, you know, invest that money. And one of the exciting things it allows us to do now is continue to progress new product programs. So we'll signal more of that later. But we're, you know, as I said on this call, we've signaled we're going to be doing a partial need program, which will happen within the 2024 timeline as well. Okay?
spk04: Thank you. Thank you for the question.
spk01: Thank you. Our next question comes from the line of Robbie Marcus with JP Morgan. Your line is now open.
spk07: Hi, thank you. You've got a for Robbie here. So, you know, I saw your comments on 4Q reaching and coming in line with what you saw in 4Q19. So I'm trying to get a sense of what that implies for 3Q, does that mean that it's going to come in lower than 19? And so what needs to happen here in 2Q in terms of scans to make sure you're getting kind of close to that number in 3Q? And I understand you're not quantifying it, but how much do these new scans and office visits need to improve over the next month and a half or so to kind of ensure that 3Q is in line with this trajectory?
spk05: Yeah, I think maybe Bob can add some color, but I think I think we're thinking if things continue to progress the way they are, and we hope they will and expect they will at this point, because we don't have anything to the contrary, that we might actually be able to do Q3 levels of 19 in Q3 here of 2021. It just is an expectation to see how that's going. To answer your question, that's sort of the trajectory that we could see coming out of Q2 that sets us up for actually a nice Q3, and I think Again, in our comments, we said we expect to see sequential improvement in both Q3 and Q4.
spk03: I mean, we still need to see improvement. We've seen improvement through April, as you mentioned, and early May. But, you know, we're on our way to get to those levels in Q3. Still some work to do, but we're heading in the right direction.
spk07: Okay, great. And with the upcoming ASC new launch, What's being assumed right now in this guidance or what are your expectations for the contribution here in the back half of the year, both to the top line as well as the P&L? How does this affect your margins here?
spk05: We're not breaking out that specifically. Part of the challenge is we don't know exactly when approval will happen. We have limited release and we're going to launch it, but it's tough to predict the uptake. I think we've appropriately baked it in and we have opportunity for upside. Early days, it's not going to have huge margin improvement because it's sort of the beginning of the production cycle. But as we said, longer term, it's going to have significant margin improvement. And Longer term will be sort of like after we get four or five quarters under our belt and driving volume increases as well as production efficiencies. So, you know, we don't see it being a huge gross margin mover beyond what we've talked about in the past. And I think you sort of indicated that in our previous comments, right, Bob?
spk03: Yeah, that's right. It's more of a 22 impact than a 21. All right.
spk07: Thanks for your time, guys.
spk05: Thank you. Thank you.
spk01: Thank you. As a reminder to ask a question, you will need to press star then 1 on your telephone. Our next question comes from the line of Stephen Lippman with Oppenheimer. Your line is now open.
spk06: Hi, guys. This is Amir on for Steve.
spk03: Hey, Amir.
spk06: Hi. So I just wanted to quickly ask another question on standard needs. I guess, are there any metrics you can provide on how many ASCs you guys are hoping to target initially? And as a follow-up, will you be looking to create like a separate sales force for the ASCs?
spk05: Yeah, Amir, appreciate it. Welcome. So let me answer in reverse order. We're not looking to create a separate sales force. However, as I indicated in the comments, we have hired a person specifically dedicated to ASC sales and marketing to support our existing Salesforce and agents in the rollout of the product, training of the project, more importantly, you know, lead, identification, execution. And we actually see that as a model where we'll probably add one or two more people around there as we get closer to launch time. And so it's a little bit of a different twist. It's not a separate Salesforce. We'll still use our local agents and the good relationships we have with them. but we're going to support them with the economic sell as well as some other things around how we go to market and focusing on the ASC. As far as metrics, that's a great question. I think if you could just defer that to later. Let's get the product launch, and then we've had some conversations ourselves about what metrics we may share about product adoption, and you'll hear more from us after we get closer to launch about what kind of Insight we'll give you around that, and I'll leave it at that. Okay?
spk06: Great. Great. Thank you. Thanks for that, Mark. And then just last question on my side. Last quarter you mentioned, you know, difficulties in launching, like, new products like the HIP during COVID. Any updates or progress on the training side? Thanks. Thanks.
spk05: Yeah, a little bit there, and I was, and I think, look, I think as you can see, even as the rest of industry reported, I think in my comments and even in subsequent talks, I talked the fact that we had to understand that we're primarily a knee arthroplasty company, and the knee arthroplasty U.S. market would be down in Q1, and I think as we're seeing the reports come from fellow competitors the market was down it's improving but it was down and we're seeing monthly improvement and I want to reiterate that you know March was better than January February April's much better than March and we're hoping that May is going to be better than April so we're seeing good movement here but so that's good so then and then as far as training it was hard to train in the first quarter because there was still a resistance to travel but the good news is is Most surgeons are vaccinated now because they got vaccinated early on as healthcare providers. They seem more willing to train and to travel to train. And so, for example, we just had a big course out west and we had sort of the most participation we've had in six quarters. So we're very excited. And we were able to, it was really interesting, we were able to do, I'm thinking out loud, about two-thirds to three-quarters of the people that got trained were live, hands-on, cadaver work, didactic sessions, both hip and knee. And then we were also then able to do about another 25 to 30% were available through virtual training. So we actually had a session that, you know, was going on at the same time so that the virtual people could drop in on the didactic session. And then we had a cadaver session set up with the right camera and IP equipment so we could actually do a remote cadaver surgery by one of our proctors. And that worked out well. I mean, that's gone well. So I think that could be a model going forward for people that can travel. But the good news is we were able to actually get a really nice amount of participation. And so that's one of the reasons why I feel comfortable, as I indicated in my comments, to add more MedEd events here in the second half. of the year, late Q2, but more importantly, early second half, to help drive training towards our new product launches, and specifically the ASCME. But as well as the HIP, we had good HIP performance. We want to do better, but we're continuing to see interest in our HIP. So, yeah, it's a great question. MedEd's going to be a critical component of that through the remainder of the year. Okay? Thank you.
spk01: Thank you. There are no further questions. Ladies and gentlemen, this concludes today's conference call. We thank you for your participation. You may now disconnect.
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