ELUT - NASDAQ

Thank you for standing by and welcome to Aziyo Biologics Q1 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. [Operator Instructions]. As [Indiscernible] call is being recorded. I would now like turn the conference over to your host Leigh Salvo, Investor Relations. Ma'am you may begin.

Thank you, and thank you all for participating in today's call. Joining me are Ronald Lloyd, Chief Executive Officer, and Matthew Ferguson, Chief Financial Officer. Earlier today, Aziyo released financial results for the quarter ended March 31, 2022. A copy of the press release is available on the company's website. Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that do not relate to matters of historical fact or relate to expectations or predictions of future events, results, or performance are forward-looking statements. All forward-looking statements, including, without limitation, those relating to our operating trends and future financial performance, the impact of COVID-19 on our business and prospects for recovery, expense management, expectations for hiring, growth in our organization, market opportunity, guidance for revenue, gross margin, and operating expenses, commercial expansion, and product pipeline development, expected future product launches and milestones, and expected results and performance of our partnerships and commercial products, including patient outcomes, are based upon our current estimates and various assumptions. 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. Accordingly, you should not place undue reliance on these statements. For listening description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our public filings with the SEC, including Aziyo's annual report on Form 10-K for the year ended December 31, 2021. As such, factors may be updated from time-to-time in Aziyo's other filings with the SEC, including Aziyo's quarterly report on Form 10-K for the quarterly period ended March 31, 2022, to be filed with the sec, accessible on the SEC website at www.sec.gov. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, May 9, 2022. Aziyo Biologics disclaims any intention or obligation except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. Also during this presentation, we refer to gross margins excluding intangible asset amortization, which is a non - GAAP financial measure. A reconciliation of this non - GAAP financial measure to the most directly comparable GAAP financial measure is available in the company's earnings release for the first fiscal quarter ended March 31, 2022, which is accessible on the sec website and posted on the Investor page of Aziyo's website at www.aziyo.com. And with that, I'll turn the call over to Ronald.

Thanks, Leigh. Good afternoon. And thank you all for joining us. I a'm pleased to announce that Aziyo's off to a great start in 2022. So far this year, we're meeting our key product development milestones, delivering solid commercial results, and making significant progress in improving our operational efficiency. As expected, we submitted our 5 10-K application for CanGaroo RM, our next-generation biomaterial envelope, which was subsequently accepted for review by the FDA. As a result, we continue to plan for commercial launch in the second half of this year. We're obviously very excited about this milestone, and confident that with FDA clearance, CanGaroo RM can drive significant future growth for Aziyo as the only biomaterial envelope with antibiotics approved for implantable medical devices in the United States, and estimated $600 million annual market. In Q1 sales of our flagship CanGaroo products saw robust year-over-year growth in excess of 25%. Our direct sales force with support from our partners, Boston Scientific and BIOTRONIK, was successful in driving further product adoption. In our soft tissue reconstruction product, SimpliDerm, we also saw meaningful contribution to our top-line results with year-over-year growth also exceeding 25%. With continued advancement of clinical data and expanded access with hospital systems, I am confident that SimpliDerm has the potential for further market expansion and sustainable future growth. Overall, our business did see some negative impacts from the Omicron variant [Indiscernible] the quarter, as we noted on our last call, we were able to navigate those challenges and deliver strong revenue results in the first quarter, with overall growth in our continuing operations of 14% versus the first quarter of last year. We also saw a substantial improvement in our gross margin, which increased by five percentage points compared to the last two quarters of 2021. I'm looking forward to continue progressing in all of these areas. Turning to some of the highlights and updates for each of our product portfolios. First, in our products for implantable medical devices, as I noted earlier, our 5-10 application for CanGaroo RM is now under review by the FDA and we remain committed to tracking to a timeline that will enable launch in the second half of 2022. Come 2023, we anticipate this enhanced product to be the primary growth driver of our business. Looking at even longer-term, we believe this product has a potential to exceed $100 million in annual sales, with further upside driven by opportunities to expand this platform to international markets outside of Europe as well as develop applications for other implantable electronic devices. In Q1 of 2022, we once again saw significant strength from CanGaroo sales largely due to new account growth in greater penetration into existing contract at hospitals. As a reminder, our CanGaroo and cardiovascular products are sold primarily through a direct sales force that leverages our partnerships with Boston Scientific and Biotronik to enhance our presence throughout the United States. We continue to work closely with our partners and are pleased with the progress that we've made this far in 2022. Our partners are particularly excited about the FDA filings related to CanGaroo RM and the prospects of having net product in the market later this year. Continued investments, our commercial organization have already demonstrated a positive return and we believe will be a significant lever as we prepare for the launch of CanGaroo RM. As our reps have gained more tenure, we've been encouraged by their increasing productivity and pleased to see growing traction in driving usage of CanGaroo. We continue to leverage our breakthrough designation for CanGaroo at Premier, and the majority of our new accounts fall under this hospital network. Sales traction has also beginning to take hold internationally. CanGaroo sales in Europe remain a small percentage of our total, but we've begun to see uptake through our distribution partners there, and believe international opportunities can be a meaningful contributor to our long-term growth. More information about the benefits of our CanGaroo platform is also reaching investors in mid-April, talent hosted a key opinion leader call with two leading us electrophysiologists. On this call with doctors discussed the remodeling benefits of CanGaroo and how they envision its future use with implantable electronic devices. We're pleased to hear that both doctors support the benefits of creating a natural systemically vascularized pocket for implantable electronic devices. They also shared an enthusiasm for the potential FDA approval of our next-generation CanGaroo envelope preloaded with antibiotics. Investors interested in learning more about this event can visit our website or email us at [email protected]. In late April, we attended the Heart Rhythm society meeting and met with EPs throughout the conference. It was great to see that interest in CanGaroo as a biological solution for specific patient types, especially the novel patients, is continuing to grow. We also conducted market research for CanGaroo RM and found that EPs were impressed by the product design and its performance in our pre -clinical studies. As an update on our clinical trials for CanGaroo, enrollment in both the heal and the novel studies are progressing well. We continue to enroll patients and anticipate inner readouts from both studies later this year. As a reminder, the heal study compares patients with the CanGaroo envelope against patients with either a synthetic envelope or no envelope at time as CIED change out. The CanGaroo registry study follows de Novo CanGaroo, and no envelope patients for up to five years. Turning through our other core products, sales of our soft tissue reconstruction product, SimpliDerm, continue to expand in the first quarter. As we highlighted in our last call, we recently published clinical data confirming that SimpliDerm is clinically comparable to the market-leading AbCellera dermis product is proving to be a key factor expanding market access with hospitals. We believe SimpliDerm is now better positioned than ever to capitalize on the estimated $500 million total market. Moreover, our national distributor network has been a strong asset for us. We're pleased with our ongoing ability to generate revenue and anticipate growing momentum throughout the rest of this year. Turning to our products for orthopedic and spinal repair, which includes ViBone, OsteGro V, and our ViBone VBM, we saw results in line with recent quarters, and we're pleased with the continued traction in this category with our existing partners. One of our goals for 2022 is identifying onboard new distribution partners. As this process evolves, we believe that we're on track to see benefit of additional partnerships and relationships in the second half of the year, which will coincide nicely with our targeted launch of CanGaroo RM. We also have the ability to create additional products in the orthopedic and spinal repair space by leveraging our viable bone matrix platform. We anticipate launching at least one more product this year to complement and further expand our existing portfolio. Lastly, our contract manufacturing business saw significant growth over a year-ago quarter, as well as the fourth quarter of 2021. We were pleased with our partner’s contribution and leveraging our tissue processing and development capabilities of our Richmond, California facility. They're seeing strong growth in revenue and margin improved in this category of our business. In summary, the Aziyo team is off to an excellent start in 2022, and we continue to deliver on our major catalysts for growth. These include, first and foremost in our CanGaroo business, our 5 10-K submission, which has been accepted for review by the FDA for CanGaroo RM. Pending FDA clearance, we expect to commercially roll this product out by the end of the year. We're also expecting data readouts from our clinical trials to support the product lines, remodeling benefits, and commercial differentiation. For SimpliDerm, we'll leverage recently published clinical data to expand our customer base and support continued robust growth. In our orthopedic and spine business, new product launches and new partnerships are expected to drive steady growth from current levels and continued contribution to our bottom line. And finally, as discussed in previous calls, we're implementing multiple efficiency initiatives across our entire business that have already begun to yield in margin improvement with further gains expected throughout the year. With that, I'll turn the call over to Matthew to provide a review of our first-quarter results and outlook for the rest of 2022.

Thanks, Ronald. Net sales for the three months ended March 31, 2022 were $11.5 million. A 10% decrease from $12.9 million in the same period of the prior year. However, excluding the sales of FiberCel, we saw 14% growth over the first quarter of 2021. Gross margin for the first quarter of 2022 was 37% as compared to 49% in the corresponding prior-year period, and 31% in the fourth quarter of 2021. We also look at gross margin excluding the impact of non-cash amortization of intangible assets. And on that basis, Q1 would have been 45% versus 56% in the year-ago quarter, and 39% in the fourth quarter of 2021. The decline in gross margin compared to the prior year quarter primarily relates to product mix and lower yields in the company's viable bone product line. However, the sequential improvement in gross margin is an indicator of the more recent efficiency improvements in our Richmond production facility. Total operating expenses for the first quarter of 2022 were $11.2 million, a 12% increase from $10 million in the first quarter of 2021. The increase was primarily due to higher expenses related to the development of CanGaroo RM. Loss from operations was $6.9 million for the first quarter of 2022 as compared to a $3.7 million loss for the year-ago quarter. Net loss for the period was $8.1 million as compared to a net loss of $5.1 million in Q1 2021. Loss per share in the first quarter of 2022 was $0.60 compared to a loss per share of $0.50 in the year-ago quarter. We ended Q1 with a cash balance of $22.2 million, and total liquidity, including availability under our revolving line of credit, of $23.1 million. Turning now to our outlook for the full-year 2022, we continue to project net sales in the range of $47 million to $50 million. Excluding approximately $4.9 million of FiberCel sales in 2021, which has been discontinued, this range represents expected growth of 11% to 18%. The biggest variable in this range has to do with the timing of clearance and launch of CanGaroo RM. The low end of the range assumes no contribution from CanGaroo RM by the end of the year. And the high-end assumes clearance and commercial availability by the fourth quarter. We remain excited about the additional milestones we expect to achieve in 2022, as well as our ability to drive long-term growth and shareholder value. And with that, we'd like to open up the call for your questions.

Thank you. Again, ladies and gentlemen, should I got the question, please [Operator Instructions] our first question comes from David Rescott of Truist Securities, your line is open.

Hey, guys. Can you hear me?

We can, yeah.

Hey. Great. Thanks for taking the questions. First, CanGaroo, you mentioned 25% growth here in the quarter, within maybe some new accounts as well as the existing accounts. But I guess, could you provide any color on what maybe is impacting that? And perhaps, if at all, the submission here of the 510k has driven any incremental growth thus far.

Yeah, sure. Thanks for the question, David. To the answer the latter part, no, I don't believe the submission of the CanGaroo RM is impacting the current growth that we're seeing for CanGaroo. The growth rate that we're seeing really is attributed to the benefits that physicians are now seeing with CanGaroo. And the remodeling benefits that the product provides. And so I think the biological aspect of our product, and these benefits are starting to really resonate with our customers. And as such, I think we're seeing that as being a key driver. I think the second factor here is, as you know, we've got the breakthrough designation from Premier, and we've continued to leverage that breakthrough designation to add more accounts. And as we think about our growth in Q1, actually, the majority of our volume increase came through new accounts. So we're excited to see this uptick in new accounts and then the volume that is being generated from these new accounts because, obviously, that's very exciting news as it relates to future growth. Then finally, we are also driving deeper penetration in terms of our CanGaroo sales in our existing accounts, and we're doing that in conjunction with the partnerships that we have with Boston Scientific and Biotronik. So I think that's the main reasons for the growth that we're seeing in CanGaroo. And I think it sets us up very nicely for additional growth this year. Of course, obviously we're very excited then to have the potential to launch CanGaroo RM in the second half of the year, which then give us the opportunity also to talk about the benefits of having it pre -loaded with antibiotics.

[Indiscernible] Biotronik partnerships head of this launch? And as a second kind of part of that question, how do we think about this incremental OpEx spend as, as we progress through the rest of the year? Thanks.

Sure. Yeah. We're obviously very excited about CanGaroo RM. And as we think about it, we really have two benefits with this product. We've got the continuation of the biological aspect that comes with CanGaroo, and then the ability to have it then loaded with antibiotics to reduce the risk of infection. So we see it as an opportunity to drive growth for this product in both the Novo patients and then patients with change outs which have a higher rate of infection. So we're currently in the launch planning phases for this product. We have a very comprehensive launch strategy that we've developed. We look forward to working with the FDA to get this product through clearance. And then, as I mentioned before, hopefully rolling this product out in the second half of this year. As it relates to our partners, we've had a chance to spend time with them. We just completed the heart of society meeting earlier this month and had a chance to be with our partners at that meeting. Obviously, they're very excited about the submission of CanGaroo RM. They're looking forward to participating and assisting us with the launch of the product. And they see the opportunity of this product also as a way to be able to partner with the CanGaroo product in their devices and see as an opportunity to also be able to communicate with their customers the benefit of using CanGaroo with their specific devices. As it relates to the OpEx portion of your questions, Matthew, why don't you address that?

Sure. So in terms of OpEx, I think Q1 did a pretty good indicator of where we expect to be for on a quarterly basis for most of the year. We might see a bit of an uptake in Q2 as we're continuing to have, somewhere elevated R&D spending related to the completion of CanGaroo RM. I would think about R&D dropping off a bit in the latter half of the year, and that may be offset somewhat by increases in SG&A as we prepare for thE launch of CanGaroo RM in anticipation of FDA clearance. But all-in-all, I think pretty similar level of OpEx to what we've seen in the first quarter here.

Okay, that's helpful. Thanks for taking the questions.

Thank you. [Operator Instructions] Our next question comes from Josh Jennings with Cowen Inc. Your line is open.

Hi, this is Brian here for Joshua. Thanks for taking my questions.

Hi Brian?

Hi. On the first-quarter results, can you help characterize the strength in contract manufacturing? Is this existing customers or did you add customers? And how are you projecting growth specifically for contract manufacturing within your annual guidance?

Sure. So thanks Brian for the question. If you recall, back to 2021, we spent a fair amount of time in 2021 lining up new partners for our contract manufacturing business. And so we're seeing really the result of the partnerships that we've really added last year come to fruition as it relates to the growth that we saw in the second half of last year, and obviously, a very strong Q1 for this year. As we're pleased with that performance, again, we've been able to really leverage our product manufacturing, but also really our R&D aspects of our Richmond, California facility to our partners to make sure that we're designing and manufacturing the appropriate products for them. And again, the new partners we've brought on board have been a significant contributor to our growth that we've seen for the business in Q1. And we would anticipate that we would have roughly the similar level of sales from contract manufacturing in the subsequent quarters for 2022.

Okay. That's very helpful. Thank you for that. On the RM filing you disclosed as the filing was accepted, which I would interpret that you're on a fairly standard review timeline. Have you reached a point where the agency has agreed upon the sufficiency of the filing, or is that coming at the 60-day mark? How should we think about the submission timeline from here?

Yes, sure. So we submitted the application. The FDA reviewed the application of what we've turned in, and then accepted it for substantial review. So now it's under active review within the FDA. And at this point, we've not heard back from the FDA as it relates to any substantial questions or comments on this application. So we'll wait to hear from the FDA and then, of course, we'll hopefully be able to work closely with them to address any questions that they may have. So from a timeline standpoint, at this point, since we haven't heard anything back yet, it's probably not appropriate to be able to give you a more specifics on timing. And again, I think from our perspective, we're still planning for launch in the second half of this year.

Thank you. And if I could just ask one more on the HEAL study interim analysis, can you remind us of the study size you're targeting for the interim analysis and what the potential outcomes are? I guess my main question is, is there a possibility that you've stopped that earl? And just the use of the data, should we think about that data potentially being used for a label claim or should we think of it as a primarily being used for, I guess, commercial, non-regulatory purposes? Thanks again for taking my question.

Yes. So the heel study, again, is comparing patients that are coming back in for change out that have previously received CanGaroo or a synthetic envelope or no envelope at all. And then we'll look at, basically, the soft peeling tissue characteristics around those implants and look at complications that arise due to that procedure. Our goal is to enroll 100 patients, roughly 1/3 in each group. As it relates to the interim analysis, we're going to basically look at where we stand basically in the second half. We started the second half of this year. See where we are from patient perspective, and hopefully we'll have a large enough sample size that we can then run into [Indiscernible] analysis and look at the results. And to address your latter part of that question, really, from our perspective, this is not really designed to change a label. It's really just to get us the clinical evidence that physicians are telling us every day that they see when they see CanGaroo patients coming back for change outs. We're trying to collect and quantify that same information than to share to other physicians. So they also can understand the benefits of CanGaroo. So it's really more from a market education, customer education perspective.

Great. Thank you again.

Thank you. [Operators Instructions]. One moment, please. Thank you. I'm showing no further questions at this time. I'll like to turn the call back over to Ronald Lloyd, CEO for any closing remarks.

Yes, thank you. And so just to close here, as I think about Aziyo team, I want to first of all thank them a compliment them. Again, we've showed that we have the ability to execute, and I'm proud of the results of Q1 as well as the filing for CanGaroo RM because again, the reiteration shows our ability to drive execution with company perspective. We are also very excited, obviously confident about the future. We have a number of near-term growth catalysts and we look forward to updating you on those catalysts, as we proceed here throughout 2022 and look forward to giving you updates at our next earnings call. So again, thank you very much for your time today.