Elutia Inc (ELUT) 2023 Q4 法說會逐字稿

Greetings. Welcome to Elutia fourth quarter and full year 2023 financial results call. (Operator instructions) Please note this conference is being recorded. I will now turn the conference over to Matt Steinberg with Finn Partners. Thank you. You may begin.

問候。歡迎參加 Elutia 第四季和 2023 年全年財務業績電話會議。（操作員說明）請注意，本次會議正在錄製中。我現在將會議交給 Finn Partners 的 Matt Steinberg。謝謝。你可以開始了。

Thank you, operator, and thank you all for participating in today's call. Earlier today, Elutia released financial results for the quarter and full year ended December 31, 2023. A copy of the press release is available on the company's website.

謝謝接線員，也謝謝大家參加今天的電話會議。今天早些時候，Elutia 發布了截至 2023 年 12 月 31 日的季度和全年財務業績。該新聞稿的副本可在該公司網站上取得。

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 the federal securities laws, which are pursuant to the Safe Harbor provision of the Private Securities Litigation Reform Act of 1995.

在我們開始之前，我想提醒您，管理層將在本次電話會議期間發表聲明，其中包括聯邦證券法含義內的前瞻性聲明，這些聲明符合美國《私人證券訴訟改革法案》的安全港條款。 1995年。

Any statements contained in this call that do not relate to matters of historical facts or relate to expectations or predictions of future events results or performance are forward-looking statements. All forward-looking statements include without limitation, those relating to our operating trends and future financial performance are based upon our current estimates and various assumptions.

本次電話會議中包含的任何與歷史事實無關或與對未來事件結果或績效的預期或預測無關的陳述均為前瞻性陳述。所有前瞻性陳述包括但不限於與我們的營運趨勢和未來財務表現相關的陳述，這些陳述均基於我們目前的估計和各種假設。

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 a list and 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 our recent annual report on Form 10-K for year ended December 31, 2023, to be filed with the SEC accessible on the SEC's website at www.sec.gov. Such factors may be updated from time to time in Elutia's other filings with the SEC.

這些陳述涉及重大風險和不確定性，可能導致實際結果或事件與這些前瞻性陳述預期或暗示的結果或事件有重大差異。因此，您不應過度依賴這些陳述。有關與我們業務相關的風險和不確定性的清單和描述，請參閱我們向 SEC 公開提交的文件中的風險因素部分，包括我們最近的截至 2023 年 12 月 31 日的 10-K 表格年度報告，向SEC 提交的文件可透過SEC 網站www.sec.gov 存取。這些因素可能會在 Elutia 向 SEC 提交的其他文件中不時更新。

The conference call contains time-sensitive information and is accurate only as of the live broadcast today, March 7, 2024. Elutia 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.

該電話會議包含時間敏感訊息，僅截至今天（2024 年 3 月 7 日）直播時準確。Elutia 不承擔任何意圖或義務，除非法律要求更新或修改任何財務預測或前瞻性陳述，無論是因為新資訊、未來事件或其他原因。

Also during this presentation, we refer to gross margin, excluding intangible asset amortization, which is a non-GAAP financial measure. A reconciliation of this non-GAAP financial measure to most directly comparable GAAP financial measure is available in the company's financial results release for the fourth quarter ended December 31, 2023, which is accessible on the SEC's website and posted on the Investor page of the official website at www.elutia.com. With that, I will turn the call over to Elutia's CEO, Randal Mills

此外，在本簡報中，我們指的是毛利率，不包括無形資產攤銷，這是一項非公認會計準則財務指標。該非GAAP 財務指標與最直接可比較的GAAP 財務指標的對帳可在該公司截至2023 年12 月31 日的第四季度財務業績發布中找到，該財務業績可在SEC 網站上訪問，並發佈在官方投資者頁面上。接下來，我會將電話轉交給 Elutia 的執行長 Randal Mills

Thank you, Matt. I am super excited to be with you today and to share the story of Elutia. Our mission humanizing medicine so that patients can thrive without compromise. When I talked about that were compromised today and what that means, particularly with our flagship product that we're in the process of getting ready to launch CanGarooRM. But what we're really trying to do is we're trying to take away those instances in patient care where patients and physicians are forced to choose between two options when in fact, we could actually give them both.

謝謝你，馬特。我很高興今天能與大家分享 Elutia 的故事。我們的使命是使醫學人性化，使患者能夠在不妥協的情況下茁壯成長。當我今天談到受到損害以及這意味著什麼時，特別是我們正在準備推出 CanGarooRM 的旗艦產品。但我們真正想做的是，我們試圖消除患者護理中患者和醫生被迫在兩種選擇之間做出選擇的情況，而事實上，我們實際上可以同時提供這兩種選擇。

So Elutia is a commercial stage company. We have two proprietary product platforms CanGaroo, which is for our pacemaker and internal defibrillator space and SimpliDerm which we use in breast reconstruction but more importantly, and I think what a lot of you are on the call today, we are pioneering the drug eluting biometrics to solve some of the most complex problems that exist.

所以Elutia是一家商業舞台公司。我們有兩個專有產品平台CanGaroo（用於我們的起搏器和內部除顫器空間）和SimpliDerm（我們在乳房重建中使用），但更重要的是，我認為今天接到電話的許多人，我們正在開創藥物洗脫生物辨識技術解決一些存在的最複雜的問題。

I'm going to be giving an update in this, and I'm super excited to do it where we're going to be talking about our regulatory progress that we've made. We're really excited about that. We're really excited about moving on and watching this product. So that, let's jump right into it.

我將對此進行更新，我非常高興能夠在其中討論我們在監管方面取得的進展。我們對此感到非常興奮。我們對繼續觀看這個產品感到非常興奮。那麼，讓我們直接開始吧。

For the year, we had an exceptional year in a transformational year at Elutia, and I couldn't be more proud of this team. Our commercial teams kept their eye on the ball, delivering 3.4% growth in CanGaroo and a stunning 38% growth in SimpliDerm. All the while, we were making these rather significant strategic shifts within the company, but everybody kept a focus and kept their eye on the ball and really did a beautiful, beautiful job commercially and operationally.

今年，我們在 Elutia 的轉型年中度過了非凡的一年，我為這個團隊感到無比自豪。我們的商業團隊密切關注，CanGaroo 實現了 3.4% 的成長，SimpliDerm 實現了驚人的 38% 的成長。一直以來，我們都在公司內部進行這些相當重大的策略轉變，但每個人都保持專注，密切關注，在商業和營運方面確實做得非常出色。

From a development standpoint, as many people on this call, though, we submitted our 5-K, 10K premarket notification in December, the FDA accepted that application and that review is progressing really pretty much exactly the way we expected. We have not had any requests for any new data. We've had some requests for clarification, but we are looking squarely at a clearance decision expected in the first half of 2024 . We believe actually, this is really going to be a May June timeframe. But for us, we're our standpoint where we are everything is we believe we're right on track.

從開發的角度來看，正如本次電話會議中的許多人一樣，我們在12 月提交了5-K、10K 上市前通知，FDA 接受了該申請，並且審查的進展確實與我們預期的完全一致。我們沒有收到任何新資料的請求。我們收到了一些澄清請求，但我們正在認真考慮預計 2024 年上半年做出的許可決定。我們相信實際上，這確實是一個五月六月的時間框架。但對我們來說，我們的立場就是我們的一切，我們相信我們走在正軌上。

In preparation for that launch, we have established a strategic advisory committee to help us prepare and get the most value out of CanGarooRM launch. CanGarooRM is a very transformational event. We think business this is a transformational product for the company and we need to make sure that we're able to position in a way such that we could realize not just the most value for the product with the most value for the company.

為了準備該發布，我們成立了一個策略諮詢委員會來幫助我們準備 CanGarooRM 的發布並從中獲得最大價值。CanGarooRM 是一個非常具有變革性的活動。我們認為這對公司來說是一個變革性的產品，我們需要確保我們能夠以一種不僅能夠實現產品的最大價值，而且能夠為公司帶來最大價值的方式進行定位。

So with that end, we've established this strategic advisory committee that really has to do with the best been there done that mines from the space. We're talking about leading executives from the pacemaker and implantable defibrillator space, people that have led significant marketing and commercial launches of sophisticated biologic products, obviously, business development is in there as well as reimbursement and hospital penetration. So really first-class group of advisors to help us make sure we get this launch right.

為此，我們成立了這個策略諮詢委員會，該委員會確實與太空採礦領域的最佳成果有關。我們談論的是起搏器和植入式除顫器領域的領先高管，他們領導了複雜生物產品的重大行銷和商業發布，顯然，業務發展以及報銷和醫院滲透都在那裡。真正一流的顧問團隊幫助我們確保這次發布順利進行。

And then lastly, one of the things that I'm very proud that we do at Elutia is execution. And we continue to actually we announced last year that we divested our Orthobiologics business, but the group handling that kept our eye on the ball and actually closed that divestiture bringing in gross cash proceeds of $14.6 million. So, thank you to the team all around for an exceptional year.

最後，我為我們在 Elutia 所做的事情之一感到非常自豪，那就是執行力。實際上，我們去年宣布剝離 Orthbiologics 業務，但集團管理人員一直密切關注並最終完成了剝離，帶來了 1460 萬美元的總現金收益。因此，感謝整個團隊度過了非凡的一年。

Quick overview on what we do. So Elutia is developing the drug leading biologic really to reduce and remove the complications that exist at the device host interface. And so, when a surgeon implants a device into a patient that's going to be there for a long period of time, there were a number of complications that arise quite predictably, things like device migration, erosion of the device through particularly in thin skin patients, obviously, infection and pathologic fibrosis, which can lead to things like capsular contracture and when you look at the two markets that we're in pacemakers, we're seeing complication rates, you're 7% to 11% breast reconstruction and a stunning 20%. So we think this is an area where we can go and add really significant value and improve outcomes for our patients.

快速概述我們所做的事情。因此，Elutia 正在開發領先的生物製劑藥物，真正減少並消除設備主機介面上存在的併發症。因此，當外科醫生將設備植入將要長期存在的患者體內時，可以預見的是，會出現許多併發症，例如設備遷移、設備侵蝕，特別是對於皮膚薄的患者顯然，感染和病理性纖維化會導致包膜攣縮等情況，當你觀察我們在起搏器領域的兩個市場時，我們會看到併發症發生率，7% 到11% 的乳房重建和驚人的20%。因此，我們認為這是一個我們可以為患者增加真正重要價值並改善治療結果的領域。

So how do we do that? When we do that with the drug-eluting biologics, again, which is able to solve these problems without compromise, we don't think a patient in a position should have to decide, hey, should I go with the device that offers a pharmaceutical payload and drug efficacy or should I go with the natural biologic that will remodel into the patient's own natural tissue and have a lower fibrotic response.

那我們該怎麼做呢？當我們使用藥物洗脫生物製劑來做到這一點時，它能夠毫不妥協地解決這些問題，我們認為處於這種位置的患者不必決定，嘿，我應該選擇提供藥物的設備嗎？藥物功效，或者我應該選擇天然生物製劑，它將重塑為患者自身的自然組織並具有較低的纖維化反應。

We look at that we say both should be the answer. And so that's why we've developed the drug with a biologic that provides all of the benefits of an active pharmaceutical payload. But on a regenerative scaffold that enables it to regenerate and patient's own healthy tissue.

我們認為兩者都應該是答案。因此，我們開發了具有生物製劑的藥物，可提供活性藥物有效負載的所有優點。但在再生支架上，使其能夠再生患者自身的健康組織。

So let's get into CanGaroo and CanGarooRM. So a little bit of a landscape overview here from a commercial standpoint. Each year there are about 500,000 CIED's, this is a term that we use for pacemakers and internal defibrillators that are placed into patients in the United States alone. When you look at that market space, Medtronic has 40% approximately of that space.

那麼讓我們來看看 CanGaroo 和 CanGarooRM。這裡從商業角度對景觀進行一些概述。每年大約有 50 萬個 CIED，這是我們用來描述僅在美國植入患者體內的心律調節器和體內除顫器的術語。如果你看看這個市場空間，美敦力（Medtronic）大約佔據該市場 40% 的份額。

Boston Scientific and Abbott have another 50% of them Biotronic at this and fourth at about 10%. But this is a really some really interesting market dynamics that this sets up because only one of these players actually has an antibiotic eluting pouch and that's obviously Medtronic, but all of them have really, really significant pacemaker business.

波士頓科學公司 (Boston Scientific) 和雅培公司 (Abbott) 擁有另外 50% 的 Biotronic 公司，排名第四，約 10%。但這確實是一個非常有趣的市場動態，因為這些參與者中只有一個實際上擁有抗生素洗脫袋，這顯然是美敦力，但他們都擁有非常非常重要的起搏器業務。

And so we start about Medtronic a little bit and their product TYRX. So TYRX was actually developed by the TYRX company back in the early 2010. It is a synthetic polymer envelope that as it dissolves in the body, it releases antibiotic and this product requires the development and eventually got it's clearance from FDA in 2014 and shortly after clearance from Medtronic was able to acquire this product for about $200 million.

我們先來了解一下美敦力（Medtronic）及其產品 TYRX。所以TYRX其實是TYRX公司早在2010年初就開發出來的。它是一種合成聚合物包膜，當它在體內溶解時，會釋放抗生素，該產品需要開發，最終於2014 年獲得FDA 批准，在獲得批准後不久，美敦力(Medtronic) 就以約2 億美元的價格收購了該產品。

Again, this is in 2014 numbers and they have since just knocked it out of the park. So they've grown this product to about $250 million to $300 million by our estimates, and they've really done a great job. They've really done a huge change here.

再說一次，這是 2014 年的數字，從那時起他們就已經取得了巨大的成功。因此，根據我們的估計，他們已經將該產品的銷售額成長到了約 2.5 億至 3 億美元，而且他們確實做得非常出色。他們確實在這裡做了巨大的改變。

So first, they were able to have a foresight pay $200 million in 2014 when there was no market for this technology. They had to create the market. The second thing that they did was they actually proved out that this market could exist and that the value proposition to physicians and particularly electrophysiologists about local antibiotic delivery really worked. These physicians like the idea of having a local antibiotic present with their surgery so that they don't have to worry about a post-operative infection.

首先，他們能夠在 2014 年這項技術沒有市場的時候支付 2 億美元。他們必須創造市場。他們做的第二件事是，他們實際上證明了這個市場是可能存在的，並且對醫生，特別是電生理學家來說，關於局部抗生素輸送的價值主張確實有效。這些醫生喜歡在手術中使用局部抗生素，這樣他們就不必擔心術後感染。

But Medtronic did a great job here. But TYRX isn't a perfect product and that's why we developed CanGarooRM. TYRX does a really great job alluding antibiotics, rifampin, and minocycline, but it doesn't have any of the benefits of biologic. As you said, it's a polymer that dissolves in the body.

但美敦力（Medtronic）在這裡做得很好。但 TYRX 並不是一個完美的產品，這就是我們開發 CanGarooRM 的原因。TYRX 在提及抗生素、利福平和米諾環素方面做得非常出色，但它沒有生物製劑的任何好處。正如你所說，它是一種溶解在體內的聚合物。

We like the idea of using biologic scaffolds for a couple of reasons. One is a biologic scaffold around the pacemaker fits and forms really like a glove. It gives the physician great fit and feel. There's less inflammation. Therefore, there's less pathological remodeling, change out easier and that's better for the patient in the long run. And it all remodels into the patient's own tissue.

我們喜歡使用生物支架的想法有幾個原因。一種是起搏器周圍的生物支架，其形狀和形狀非常像手套。它給醫生帶來了良好的貼合感和感覺。發炎少了。因此，病理重塑較少，更換更容易，長遠來看對患者更好。這一切都會重塑為患者自身的組織。

So again, this was an example where we looked and said, there is an opportunity where a patient and the physician are having to make a compromise and we can remove that compromise. We can help patients thrive without compromise, and we've done a pretty good job of that with CanGarooRM. We went out and talked to electrophysiologists about this concept.

再次強調，這是一個我們觀察並說的例子，病人和醫生有機會必須做出妥協，而我們可以消除這種妥協。我們可以毫不妥協地幫助患者茁壯成長，並且我們透過 CanGarooRM 在這方面做得非常好。我們出去與電生理學家討論了這個概念。

It was studied 88% of electrophysiologist and these are TYRX users, 88% of electrophysiologist that use TYRX would start using CanGaroo once the product became available, 88% and we think that gives us a really, really great opportunity to move into the $600 million market and actually have some really great penetration.

根據研究，88% 的電生理學家都是TYRX 用戶，88% 使用TYRX 的電生理學家一旦產品上市就會開始使用CanGaroo，88%，我們認為這給了我們一個非常非常好的機會，進入6 億美元的市場市場，並且實際上有一些非常大的滲透力​​。

So back to our market, our favorable market dynamics slide is sort of the payoff of this. So, when you look now, you overlay the drug-eluting envelope on top of this, you have Medtronic sitting there with TYRX and they do about $250 million to $300 million in TYRX. And then you have Boston, Abbott and Biotronic and they don't have a balance between them. Now here's what we found was really, Mark, we started doing our own internal market research. 50% to 75% and it's probably more like 70% to 75% of TYRX is actually used on non-Medtronic pacemakers.

回到我們的市場，我們有利的市場動態下滑是這一點的回報。所以，當你現在看時，你將藥物洗脫膜覆蓋在上面，美敦力（Medtronic）和 TYRX 坐在那裡，他們在 TYRX 上做了大約 2.5 億到 3 億美元的投資。然後還有波士頓、雅培和 Biotronic，他們之間沒有平衡。現在我們發現，馬克，我們真的開始做我們自己的內部市場研究。 50% 到 75%，可能更像是 70% 到 75% 的 TYRX 實際上用於非美敦力起搏器。

So, a lot of TYRX is going on to a Boston Scientific or an Abbott pacemaker. And we think when you sort of when you look at this all together, this does two things. One is, it creates a great opportunity for us to go out and launch this product. We are viewed kind of like Switzerland here. It doesn't matter whether you're Boston or Abbott or Biotronic, if you're going to ask them whose drug eluting envelope would you rather have in your case, Elutia's or Medtronic, they're going to say Elutia every single time. Why it's simple? We don't make a pacemaker and Medtronic does.

因此，大量 TYRX 將用於波士頓科學公司 (Boston Scientific) 或雅培 (Abbott) 起搏器。我們認為，當你綜合考慮這一切時，你會發現這有兩件事。一是，它為我們走出去推出這個產品創造了一個很好的機會。我們在這裡被視為有點像瑞士。無論您是 Boston、Abbott 還是 Biotronic，如果您要問他們您希望使用哪種藥物洗脫信封，Elutia 還是 Medtronic，他們每次都會說 Elutia。為什麼說很簡單？我們不製造起搏器，而美敦力製造。

And so, that's a real great opportunity for us to go out and take this really lower hanging fruit of $70 million, $75 million TYRX sale. But really 60% of the market that's essentially uncontested right now in this space. But if you also look at it from the company's point of view, you're talking about a plug-and-play product here, it could do $100 million, $150 million we're estimating gross margins in the 70%, no additional selling costs, right, because these players are already in every one of these cases anyway.

因此，這對我們來說是一個真正的絕佳機會，可以走出去，獲得這個真正唾手可得的 7000 萬美元、7500 萬美元的 TYRX 銷售成果。但實際上，目前該領域 60% 的市場基本上是沒有競爭的。但如果你也從公司的角度來看，你在這裡談論的是即插即用產品，它可以賺 1 億美元、1.5 億美元，我們估計毛利率在 70% 左右，沒有額外的銷售成本，對吧，因為無論如何，這些玩家已經處於上述每一種情況。

And so, you do the sort of the math on that, you're dropping something like $90 million a year to earnings, look at their CIED's somewhere between $25 million to $60 million and you're talking about a product that could add $2.5 billion to $5 billion in value to these companies.

所以，你對此進行數學計算，你每年會減少大約 9000 萬美元的收入，看看他們的 CIED 大約在 2500 萬美元到 6000 萬美元之間，你正在談論一種可以增加 25 億美元的產品這些公司的價值高達50 億美元。

So, we are really, really can't tell. We are really, really excited about CanGarooRM coming to market, but we also understand its value and we'll have the discipline and the patience to methodically roll this thing out and take it to market, launch it, so that we get the greatest value for both the product and the company.

所以，我們真的真的不能說。我們對 CanGarooRM 進入市場感到非常非常興奮，但我們也了解它的價值，我們將有紀律和耐心有條不紊地推出這個產品並將其推向市場，推出它，以便我們獲得最大的價值對於產品和公司來說。

Okay. Now, let's move on to our clearance and our clearance strategy and activities. So, we filed as you guys know, we filed this 5-K, 10-K December 18, 2023. We did that after meeting with the FDA, the pre-submission meeting. The interactions since that we've been having with the FDA have actually been very positive and they're going exactly as we thought.

好的。現在，讓我們繼續討論我們的清理以及我們的清理策略和活動。所以，正如你們所知，我們在 2023 年 12 月 18 日提交了 5-K、10-K。我們在與 FDA 的提交前會議會面後做到了這一點。自那以來，我們與 FDA 的互動實際上非常積極，而且進展完全符合我們的預期。

As we stated on this call a number of times, we expected we were going to be asked questions and we haven't asked questions. Fortunately, they've all been really of the clarification variety. And importantly, the FDA has asked actually for no new data in this. So, we believe we are in a really, really good shape here. And as I said, lining up what we think will be a favorable clearance decision in the second quarter May, June time frame If you're scoring on at home.

正如我們在這次電話會議中多次指出的那樣，我們預計我們會被問到問題，但我們沒有提出問題。幸運的是，它們都是真正的澄清品種。重要的是，FDA 實際上並沒有要求提供這方面的新數據。所以，我們相信我們現在的狀態非常非常好。正如我所說，如果您在主場得分，那麼在五月、六月第二季的時間範圍內，我們會做出我們認為有利的清理決定。

And we are, therefore, we are internally preparing accordingly for the launch of this product in the second half of the year. That's why we have Strategic Advisory Committee. We're also doing work with reimbursement, getting ready to get on value-added committees, pulling up manufacturing and all of those other things. And then just as a reminder, we're not done with the pacemaker space.

因此，我們內部正在做相應的準備，爭取下半年推出這個產品。這就是我們設立策略諮詢委員會的原因。我們也正在進行報銷工作，準備加入增值委員會，拉動製造業和所有其他事情。提醒一下，我們的起搏器空間還沒結束。

We actually expect you get approval in indications like NeuroStim, Parkinson's, and sleep apnea and the like. And so, there is a bigger future here for CanGarooRM than just the pacemaker market, but we're going to make sure we don't triple the goal and we're going to do our best to do that.

實際上，我們希望您能獲得 NeuroStim、帕金森氏症和睡眠呼吸中止症等適應症的批准。因此，CanGarooRM 的未來不僅僅是起搏器市場，但我們將確保我們不會將目標增加兩倍，並且我們將盡最大努力做到這一點。

Okay. Turning now just quickly to SimpliDerm. I will not bore you guys going over press construction, one on one again. Just to point out, this is a really huge market with a really big unmet medical need. There's about 151,000 mastectomies in the United States each year that are of the variety that require breast reconstruction. That's where we come in with our SimpliDerm products.

好的。現在快速轉向 SimpliDerm。我不會讓你們再一對一地討論新聞構造。只是指出，這是一個非常巨大的市場，有著巨大的未滿足的醫療需求。美國每年約有 151,000 例乳房切除手術需要乳房重建。這就是我們的 SimpliDerm 產品的用武之地。

And so , we look at how this is going here. SimpliDerm, we say it's simply a great product. It has better handling characteristics, it is pre hydrated. What that means is it actually comes to the surgeons. They open it up and it is ready to go. It's already voiced. It doesn't require soaking or anything like that.

因此，我們來看看這是如何進行的。SimpliDerm，我們說它是一款很棒的產品。它具有更好的處理特性，經過預水合。這意味著它實際上涉及外科醫生。他們打開它，就可以使用了。已經發聲了它不需要浸泡或類似的東西。

It's also sterile. This is a product that's been terminally sterilized, and we've been able to demonstrate that it invokes a lower inflammatory and therefore, fibrotic response. So the surgeons that use this product loves this product and they keep using. And so that's why we have seen growth of this product quarter after quarter after quarter.

它也是無菌的。這是一種經過最終滅菌的產品，我們已經能夠證明它會引起較低的發炎反應，從而降低纖維化反應。因此，使用該產品的外科醫生喜歡該產品並且他們會繼續使用。這就是為什麼我們看到該產品逐季成長的原因。

And this year being no exception, 38% growth. So we distribute this product two different ways. One is through our own proprietary network of distributors. The other is with Sientra which owns 23% of the breast reconstruction plate and between these two, they are crushing it . So we see really, really good things ahead for simpler and going forward.

今年也不例外，成長了38%。因此，我們以兩種不同的方式分銷該產品。一種是透過我們自己的專有經銷商網路。另一個是Sientra，它擁有乳房重建板塊23%的股份，在這兩者之間，他們正在碾壓它。因此，我們看到未來會發生非常非常好的事情，讓事情變得更簡單和向前發展。

Our end goal here is to obviously combine our RM technology with this base scaffold of Simpler and create SimpliDermRM to be able to go after and help those women who experience post-operative infections following glass reconstruction.

我們的最終目標顯然是將我們的 RM 技術與 Simpler 的基礎支架相結合，並創建 SimpliDermRM，以便能夠追蹤並幫助那些在玻璃重建後經歷術後感染的女性。

With that, I will inhale take a breath and turn the call over to our Chief Financial Officer, Matt Ferguson .

說到這裡，我將深吸一口氣，然後將電話轉給我們的財務長 Matt Ferguson。

All right. Thanks, Randy. Exciting stuff and we really are excited about all of the progress being made, CanGarooRM and SimpliDerm and all of the value-driving catalyst that we see in the near future and continuing for the medium to long-term here at Elutia.

好的。謝謝，蘭迪。令人興奮的事情，我們對 CanGarooRM 和 SimpliDerm 所取得的所有進展以及我們在不久的將來看到的以及在 Elutia 中長期持續的所有價值驅動催化劑感到非常興奮。

As a financial update, I'm just going to touch on a few of the highlights. We provided a lot of information in our earnings release and we're aiming to file our 10-K tomorrow. So, there will be tons more there as well. But just getting on a couple of the highlights here, our net sales were $24.7 million for 2023, modestly growing from $23.8 million in 2022, but that performance actually masked what really is going on underneath, which was the really significant growth of our proprietary products, CanGaroo and SimpliDerm.

作為財務更新，我只想談談一些亮點。我們在收益發布中提供了很多信息，我們的目標是明天提交 10-K。所以，那裡也會有更多。但這裡僅介紹幾個亮點，我們2023 年的淨銷售額為2470 萬美元，較2022 年的2380 萬美元略有增長，但這一業績實際上掩蓋了真正發生的情況，即我們專有產品的真正顯著增長、CanGaroo 和 SimpliDerm。

If you just look at those two growth was about 19% year-over-year and what was going on in cardiovascular, which as you probably recall, we've partnered with LeMaitre Vascular as the exclusive distributor in the United States for that. So, for most of 2023, we were selling at a transfer price for that product, roughly half of end-user pricing. So, while we're selling similar amounts of the product, we are not generating as much revenue. So that affects the optics of our top line.

如果您只看這兩項的年成長率約為 19%，以及心血管領域的情況，您可能還記得，我們​​已與 LeMaitre Vascular 合作，作為其在美國的獨家經銷商。因此，在 2023 年的大部分時間裡，我們都以轉移價銷售該產品，大約是最終用戶定價的一半。因此，雖然我們銷售的產品數量相似，但我們並沒有產生那麼多的收入。這會影響我們頂線的光學效果。

It also affects our gross margin, but at the operating level that's actually a positive thing for us and it also has allowed us to really focus on the two main growth drivers for the company, which has been a very positive thing overall.

它也會影響我們的毛利率，但在營運層面上，這對我們來說實際上是一件積極的事情，它也使我們能夠真正專注於公司的兩個主要成長動力，這總體上是一件非常正面的事情。

As an adjusted gross margin, as I mentioned may look like it's down a little bit year over year at 58% versus 63% on an adjusted basis and again, we provide a reconciliation in the earnings release and on our presentation online. Really pleased with the operational performance for the company, and we actually see room to continue to see those numbers grow as we go into 2024.

正如我所提到的，調整後的毛利率看起來可能比去年同期略有下降，為 58%，而調整後毛利率為 63%，我們再次在收益發布和線上演示中提供了調節表。我們對公司的營運表現感到非常滿意，而且我們實際上認為，隨著 2024 年的到來，這些數字還有繼續成長的空間。

So the only other point that I'll touch on here are a couple of other points I'll touch on here. Adjusted EBITDA, which really allows us to cut through a number of the noncash and nonrecurring and discontinuing operations within the company. We had adjusted EBITDA of $14.6 million for 2023 compared to $22.9 million for the year.

因此，我在這裡要談的唯一一點是我要在這裡談的其他幾點。調整後的 EBITDA，這確實使我們能夠削減公司內的許多非現金、非經常性和非持續性業務。我們將 2023 年的 EBITDA 調整為 1,460 萬美元，而當年為 2,290 萬美元。

So that reflects not just the revenue growth, but also really, really good expense control that we had over the course of the year and we would see as we continue to scale, we would see those numbers also continuing to prove improve going forward.

因此，這不僅反映了收入的成長，也反映了我們在這一年中所進行的非常非常好的費用控制，隨著我們繼續擴大規模，我們將看到這些數字在未來也將繼續得到改善。

And then last but not least, from a cash perspective, we ended the year with $19.3 million in cash. That reflects the proceeds from the divestiture of our ortho biologics business that Randy mentioned previously. So we feel like we're in good shape there. But on top of that, and you probably also recall we did a financing in Q3 that had cash exercise warrants attached to it.

最後但並非最不重要的一點是，從現金角度來看，我們年底擁有 1,930 萬美元現金。這反映了蘭迪之前提到的剝離我們的正生物製品業務的收益。所以我們感覺我們在那裡狀態良好。但最重要的是，您可能還記得我們在第三季進行了一項附帶現金行使權證的融資。

Those warrants now are far significantly in the money to the tune of about 150%, and they expire 30 trading days after the clearance of CanGarooRM . So that's not only a seminal event for us from a strategic perspective, but it also will be the trigger for bringing in about $16 million of additional cash is our expectation.

這些認股權證現在的價值遠高於 150%，並且在 CanGarooRM 清算後 30 個交易日到期。。因此，從戰略角度來看，這不僅對我們來說是一個開創性的事件，而且我們預計，這也將觸發我們帶來約 1600 萬美元的額外現金。

So that's the overall picture from a financial perspective, we feel like '23 was a really strong year for us, and we expect to see that continuing to improve going forward. And before we turn it over to your questions, I would just say that done from a strategic point of view, we feel like we're really well positioned for growth. We have multiple value-driving catalysts in the near future. First and foremost, the clearance of CanGarooRM which will lead to the launch of the product. And we're really excited about all the plans that are coming into place there and then the continued development of our drug, including biologic platform with additional products in the pipeline.

這就是從財務角度來看的整體情況，我們覺得 23 年對我們來說是非常強勁的一年，我們預計未來會繼續改善。在我們回答您的問題之前，我只想說，從策略角度來看，我們覺得我們確實處於成長的有利位置。在不久的將來，我們有多種價值驅動催化劑。首先也是最重要的，CanGarooRM 的批准將導致該產品的推出。我們對正在實施的所有計劃以及我們藥物的持續開發感到非常興奮，包括生物平台和正在研發中的其他產品。

So with that, I will turn it over to you and your questions. Thank you.

因此，我將把它交給你和你的問題。謝謝。

Thank you. We will now be conducting a question-and-answer session . (Operator instructions)

謝謝。我們現在將進行問答環節。 （操作員說明）

Frank Takkinen, Lake Street Capital Markets.

Frank Takkinen，湖街資本市場。

Great. Thanks, for the questions and congrats on all the progress and appreciate all of the background on CanGarooRM market. I was hoping to start by following up on some of the FDA interactions. Was curious if you're comfortable divulging any more about some of the requests they made? I heard loud and clear that they were not new data requests, which I think is most important to understand, but anything else you can divulge and then maybe bridge us to the expectation of a May June time frame and how you got to that estimation?

偉大的。感謝您提出的問題，祝賀您取得的所有進展，並感謝 CanGarooRM 市場的所有背景知識。我希望先跟進 FDA 的一些互動。想知道您是否願意透露更多關於他們提出的一些要求？我清楚地聽到，它們不是新的數據請求，我認為理解這一點是最重要的，但是您可以透露其他任何內容，然後也許可以將我們與五月六月時間框架的預期聯繫起來，以及您是如何得出這項估計的？

Yes right . So basically, no, we're not going to go too much into the details of the question. That is not for a lack of transparency. It's actually centered around some of the intellectual property that you have is the technology that's you can imagine super important to us.

是的，沒錯。所以基本上，不，我們不會過多討論這個問題的細節。這並不是因為缺乏透明度。它實際上以您擁有的一些智慧財產權為中心，您可以想像這些技術對我們來說非常重要。

What I can tell you about the questions are if they were of the clarifying variety, right? So they were also completely contained within the scope of what we have responded to FDA from the NSC letter. So they only had four issues . We provided them the data for that. So none of the questions were outside of that. So they're not that's good. They're not doing anything else there.

我可以告訴你的是，這些問題是否屬於澄清問題，對嗎？因此，它們也完全包含在我們從 NSC 信函中回覆 FDA 的範圍內。所以他們只有四個問題。我們向他們提供了這方面的數據。所以沒有一個問題是除此之外的。所以他們並不是那麼好。他們在那裡沒有做任何其他事情。

And then the questions as I said were all sort of this clarifying writing. We submitted to them a pretty substantial package. You know, when we answer these questions, they have validations and all kinds of other Scientific Reports, we submitted to them a pretty substantial package.

然後我說的問題都是這種澄清性的寫作。我們向他們提交了一個相當大的包裹。你知道，當我們回答這些問題時，他們有驗證和各種其他科學報告，我們向他們提交了相當多的材料。

So within that, as you expect -- as we expected and as we said actually on our last call, we fully expected them to have some of these types of questions. We knew what they were, we would have answered them ahead of time. But they've asked us these kinds of questions about tell us more about this method or submit us this underlying report for this for that, like that kind of stuff.

因此，正如您所期望的那樣，正如我們所期望的那樣，正如我們在上次電話會議中實際上所說的那樣，我們完全期望他們會提出其中一些類型的問題。我們知道它們是什麼，我們會提前回答它們。但他們問了我們這些問題，告訴我們更多關於這種方法的信息，或者向我們提交這個基礎報告，諸如此類的事情。

As I said, really importantly, they didn't say this isn't sufficient. You're going to need to provide a support here. We had no requests for any additional data there.

正如我所說，非常重要的是，他們並沒有說這還不夠。您需要在這裡提供支援。我們沒有要求任何額外數據。

With regards to the time line with, that's me being really conservative. The May June timeframe, and I don't mean just conservative in telling The Street, our expectations. But the most important thing for our company right now is to get this clearance over the goal line.

關於時間線，我真的很保守。五月六月的時間框架，我的意思不僅僅是保守地告訴華爾街我們的期望。但對我們公司來說，目前最重要的事情是獲得越過球門線的許可。

And so we have a very positive interactive relationship right now going with the FDA. Our R&D teams are in back and forth with them on a collaborative basis. The idea is to make sure the FDA has exactly what they want before we before we tell them to go and it's a race for the last 30 days.

因此，我們現在與 FDA 建立了非常積極的互動關係。我們的研發團隊與他們進行反覆協作。我們的想法是，在我們告訴他們離開之前，確保 FDA 確實得到了他們想要的東西，這是過去 30 天的競賽。

So, we're not going to do anything to save off a week or two weeks here or there that would in any way jeopardize that. So I'm being really conservative. I'm being really -- we being really careful, very methodical, but it's the most important thing for us right now. So, in my view, that's the only responsible way to aim.

因此，我們不會採取任何措施來節省一周或兩週的時間，而這會以任何方式危及這一點。所以我真的很保守。我真的——我們非常小心，非常有條理，但這對我們來說是現在最重要的事情。所以，在我看來，這是唯一負責任的目標方式。

Got it. That's helpful. That makes sense to me. And then maybe extending on some of the comments you made around the committee you put in place for under trying to understand how you're going to launch the product and whatnot. How quickly could you have supply up and running and should we assume it's more of a limited launch in the second half? And then a full launch in '25? Or how do you think about that assuming it's cleared in the May June time frame?

知道了。這很有幫助。這對我來說很有意義。然後也許會擴展您圍繞您設立的委員會所做的一些評論，試圖了解您將如何推出該產品等。你們能多快完成供應並運行？然後在 25 年全面推出？或者假設它在五月六月的時間範圍內清除，您如何看待這一點？

Yes. So right now, our and we are right now, we are I can't emphasize this enough, right now we are exactly on track of where we thought we would be . And so right now we are looking for a soft launch or a limited launch, particularly in the third quarter. Most of that has to do with getting into hospital VAC'S, getting through hospital VAC'S on formulary, pulling up supply, although we have a pretty good manufacturing team that's ready to go with this.

是的。所以現在，我們，我們現在，我們現在，我怎麼強調都不為過，現在我們完全走在我們認為我們會達到的軌道上。因此，現在我們正在尋求軟啟動或有限啟動，特別是在第三季。其中大部分與進入醫院 VAC'S、透過醫院 VAC'S 處方、增加供應有關，儘管我們有一支非常優秀的製造團隊已準備好應對這一挑戰。

But really doing the underlying things that we need to do to get to was it most of it has to do with reimbursement getting on formulary, and we'll also be expanding the sales team as well during that time, they'll be training and the like associated with that. So that's largely third quarter. Our expectation at this point right now is going into the fourth quarter. We would be taking the training wheels off and be ready to go.

但真正要做我們需要做的基本事情是，大部分與處方藥報銷有關，在此期間我們還將擴大銷售團隊，他們將進行培訓和與此相關的類似內容。這主要是第三季的情況。我們目前的預期是進入第四季。我們將卸下輔助輪並準備出發。

Got it. That makes sense. And then maybe just transitioning for my last one talking about SimpliDerm , great to see that continue to grow at an impressive clip. How should we be thinking about a growth expectation in that line item for 2024?

知道了。這就說得通了。然後也許只是過渡到我最後一篇談論 SimpliDerm ，很高興看到它繼續以令人印象深刻的速度增長。我們該如何考慮 2024 年該訂單項目的成長預期？

I could speak to that a little bit, Frank. I think we are continuing to see SimpliDerm show really strong performance even as we're going through in the current quarter. As you are aware, we have our distributor in that space. Sientra is doing some restructuring right now.

弗蘭克，我可以談談這一點。我認為即使我們在本季經歷過，我們仍將繼續看到 SimpliDerm 表現出真正強勁的表現。如您所知，我們在該領域有我們的經銷商。Sientra 目前正在進行一些重組。

We actually have seen them continue to perform well even through that process and we are optimistic that they'll come out of that even stronger than they were when they're there, they went into it. So we really expect that we can continue to see the same type of growth that we saw in 2023, continue in 2024 as we move forward.

事實上，我們已經看到他們在整個過程中仍然表現良好，我們樂觀地認為，他們會比他們在那裡、他們投入時更強大。因此，我們確實希望我們能夠繼續看到 2023 年看到的相同類型的成長，並在 2024 年繼續前進。

Yes, I mean, I was sort of color commentary that a little bit Frank. We obviously when that news came out, we thought about it and so it will be interesting to see how this goes. We haven't seen an effect. They've done a nice job with their team. Still the bulk, the vast majority of our product is sold through our own line, but both of them have been performing really, really, really well. So, we are excited and stoked about how CanGarooRM or SimpliDerm, I got a lot of is performing right now too.

是的，我的意思是，我是一種帶有一點弗蘭克色彩的評論。顯然，當這個消息傳出時，我們考慮了這個問題，所以看看事情的進展會很有趣。我們還沒有看到效果。他們和他們的團隊做得很好。我們的大部分產品仍然是透過我們自己的生產線銷售的，但它們的表現都非常非常非常好。因此，我們對 CanGarooRM 或 SimpliDerm（我現在也有很多了解）的表現感到興奮和興奮。

Got it. Perfect. I always appreciate the color commentary. Thanks for taking the questions.

知道了。完美的。我一直很欣賞色彩評論。感謝您提出問題。

Ross Osborn, Cantor Fitzgerald.

羅斯·奧斯本，康托·菲茨杰拉德。

Guys congrats on the progress and thanks for taking the question. It's shaping up to be a very transformative year for the company. I think we have some guidance. Apologize for the background noise traveling today. But starting off, the CanGaroo number for the quarter came in a little bit below where we were expecting and realize the story is really all about where I am this year. But anything to call out from a market stand point there?

夥計們祝賀你們取得的進展，並感謝你們提出問題。對該公司來說，今年將是非常改變的一年。我認為我們有一些指導。對今天的背景噪音表示歉意。但一開始，本季的 CanGaroo 數據略低於我們的預期，並意識到這個故事實際上是關於我今年的情況。但從市場角度來看，有什麼值得指出的嗎？

No, I mean, we have shifted our focus now from CanGaroo to CanGarooRM. We still have our sales reps and our accounts in place, but CanGarooRM isn't a successful product, if it's doing anything like what CanGaroo does. This is a product that literally needs to be an order of magnitude or more bigger than that.

不，我的意思是，我們現在已將重點從 CanGaroo 轉移到 CanGarooRM。我們的銷售代表和客戶仍然存在，但如果 CanGarooRM 的做法與 CanGaroo 的做法類似，它就不是一個成功的產品。這個產品實際上需要比這個大一個數量級或更大。

So, while our reps are crushing it from an internal marketing standpoint, from an internal leadership standpoint, we have really focused our energy now on the product they're about to sell. And we haven't seen any softness in the underlying market for Reaport.

因此，雖然我們的代表從內部行銷的角度來看，從內部領導的角度來看，我們現在確實將精力集中在他們即將銷售的產品上。我們還沒有看到 Reaport 的基礎市場有任何疲軟的情況。

In fact, I was blown away that we did a restructuring at the beginning of last year. And we essentially cut the commercial team in half. And at that time, we thought, if we hold 60% of our sales together there that would be really impressive. Well that team, not only did they hold it together, that's the most revenue we've ever had in CanGaroo. And it's just a tighter, leaner, but far more focused group of really incredible professionals and I cannot wait to give them the product that frankly they deserve to have and let them just go terribly.

事實上，我對我們去年初進行的重組感到震驚。我們基本上將商業團隊削減了一半。當時我們想，如果我們將 60% 的銷售額集中在那裡，那將是非常令人印象深刻的。那支球隊不僅團結一致，而且這是我們在 CanGaroo 獲得的最高收入。這是一個更緊密、更精簡、但更專注的團隊，由真正令人難以置信的專業人士組成，我迫不及待地想給他們坦白他們應得的產品，並讓他們盡情發揮。

Okay sounds great. I'm glad to hear it. And then maybe one more, but on SimpliDerm. That continues to exceed expectations. At what point does it make sense to devote more resources to that asset to reach its full opportunity? So, the 2025 story once you get RM out?

好吧，聽起來很棒。我很高興聽到這個消息。也許還有一個，但是在 SimpliDerm 上。這繼續超出預期。在什麼情況下，投入更多資源以充分利用其機會才有意義？那麼，一旦你把 RM 拿出來，2025 年的故事會變成什麼樣子呢？

We think it's a great product too. We're not holding anything back from it. It is performing really impressively and it is continuing to perform really impressively. We are in active work from an R&D standpoint on developing simpler RM, and we continue to have our own proprietary sales channel and the Sientra sales channel. It's is kind of we actually feel really good about that product and how it's working and if we used to say that is a really small numbers, the numbers are getting a little bigger and the growth rates stay high. So we're pretty excited about that, but we're not holding back from it, Ross.

我們認為這也是一個很棒的產品。我們不會隱瞞任何事。它的表現確實令人印象深刻，並且將繼續表現得令人印象深刻。我們從研發的角度積極致力於開發更簡單的 RM，並且我們繼續擁有自己的專有銷售管道和 Sientra 銷售管道。我們實際上對該產品及其運作方式感覺非常好，如果我們過去常說這是一個非常小的數字，那麼這個數字正在變得更大，並且成長率保持在較高水平。所以我們對此感到非常興奮，但我們不會阻止它，羅斯。

Okay. Sounds great. Thanks for taking my question. Congrats on the progress.

好的。聽起來很棒。感謝您提出我的問題。祝賀取得的進展。

We have reached the end of our conference call. You may disconnect your lines at this time and thank you for your participation.

我們的電話會議已經結束。此時您可以斷開線路，感謝您的參與。