Anika Therapeutics Inc (ANIK) 2023 Q4 法說會逐字稿

And yes, yes, good evening, ladies and gentlemen, and welcome to Anika's Fourth Quarter and Year End 2023 earnings conference call. At this time, all lines are in a listen only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call, the required immediate assistance, please press star zero for the operator. I will now turn the call over to Mark Namaroff, Vice President, Investor Relations, ESG and corporate communications. Please proceed.

是的，是的，女士們、先生們，晚上好，歡迎參加 Anika 的 2023 年第四季和年終收益電話會議。此時，所有線路都處於只聽模式。演講結束後，我們將進行問答環節。如果在此通話期間的任何時間需要立即協助，請按接線員的星號零。我現在將把電話轉給投資者關係、ESG 和企業傳播副總裁 Mark Namaroff。請繼續。

Thank you, and good afternoon, everyone. Thank you for joining us for Anika's Fourth Quarter and Year End 2023 Conference Call and Webcast. Our earnings press release was issued after the close of the market today and is available on our Investor Relations website located located at www.Anika.com as our supplementary PowerPoint slides that will be used for discussion today. With me on the call today are Dr. Cheryl Blanchard, President and Chief Executive Officer, and Mike Levitz, Executive Vice President, Chief Financial Officer and Treasurer. Please take a moment and open.

謝謝大家，大家下午好。感謝您參加 Anika 2023 年第四季和年底的電話會議和網路廣播。我們的收益新聞稿是在今天收盤後發布的，可在我們的投資者關係網站 www.Anika.com 上獲取，作為我們今天討論的補充 PowerPoint 幻燈片。今天與我一起參加電話會議的有總裁兼首席執行官謝麗爾·布蘭查德 (Cheryl Blanchard) 博士以及執行副總裁、首席財務官兼財務主管邁克·萊維茨 (Mike Levitz)。請花點時間打開。

The slide presentation refer to slide number two. Before we begin, please understand that certain statements made during the call today constitute forward-looking statements as defined in the Securities Exchange Act of 1934. These statements are based on our current beliefs and expectations and are subject to certain risks and uncertainties. The company's actual risks and results could differ materially materially from any anticipated future results, performance or achievements. We make no obligation to update these statements. Should future financial data or events occur that differ from our forward-looking statements presented today Please also see our most recent SEC filings for more information about risk factors that could affect our performance.

幻燈片簡報請參閱第二張投影片。在我們開始之前，請先理解，今天電話會議中所做的某些陳述構成 1934 年《證券交易法》中定義的前瞻性陳述。這些陳述是基於我們當前的信念和期望，並受到某些風險和不確定性的影響。公司的實際風險和結果可能與任何預期的未來結果、績效或成就有重大差異。我們沒有義務更新這些聲明。如果未來發生的財務數據或事件與我們今天提出的前瞻性陳述不同，請另參閱我們最近向 SEC 提交的文件，以了解有關可能影響我們業績的風險因素的更多資​​訊。

In addition, during the call, we may refer to several adjusted or non-GAAP financial measures, which includes adjusted gross margin, adjusted EBITDA, adjusted net income and adjusted earnings per share, which are used in addition to results presented in accordance with GAAP financial measures, we believe that non-GAAP measures provide an additional way of viewing aspects of our operation and performance. When considered with GAAP financial measures and the reconciliation of GAAP measures, they provide an even more complete understanding of our business. A reconciliation of these adjusted GAAP non-GAAP financial results to the most comparable GAAP measurements are available at the end of the presentation slide deck and our fourth quarter and year end 2023 press release.

此外，在電話會議期間，我們可能會參考一些調整後或非GAAP 財務指標，其中包括調整後毛利率、調整後EBITDA、調整後淨利潤和調整後每股收益，這些指標是除了根據GAAP 提交的結果之外使用的財務指標，我們相信非公認會計原則指標提供了另一種方式來查看我們的營運和績效的各個方面。當考慮 GAAP 財務指標和 GAAP 指標的調整時，它們可以讓我們更全面地了解我們的業務。這些調整後的 GAAP 非 GAAP 財務業績與最具可比性的 GAAP 衡量指標的對帳可在簡報幻燈片的末尾以及我們的 2023 年第四季度和年底新聞稿中找到。

And now I'd like to turn the call over to our President and CEO, Dr. Cheryl Blanchard.

現在我想將電話轉給我們的總裁兼執行長謝麗爾·布蘭查德博士。

So thanks, Mark. Good afternoon, everyone, and thanks for joining us. Please refer to Slide 3. We are pleased to report strong fourth quarter results, which nicely rounded out the year for Anika over the course of the year, we achieved key milestones. We learned a lot about the business and we are taking decisive action to further focus our strategy to optimize performance and drive even stronger results, we began 2024 with renewed energy and a clear more accelerated path to profitability.

謝謝，馬克。大家下午好，感謝您加入我們。請參閱幻燈片 3。我們很高興地報告強勁的第四季度業績，這為 Anika 的這一年畫上了圓滿的句號，在這一年中，我們實現了關鍵的里程碑。我們學到了很多關於業務的知識，我們正在採取果斷行動，進一步集中我們的策略，以優化績效並推動更強勁的業績，我們以新的活力和明確的、更快的盈利之路開始了2024 年。

Let me start with our key achievements. First, revenue growth and adjusted EBITDA exceeded expectations in the fourth quarter and full year. We had a record year in OA pain management with revenues up 12% for the quarter and 11% for the year on strong growth of Monovisc globally and the sustained double-digit growth of single-hulls outside the US. While we benefited from some favorable order timing of transfer shipments to J&J MiTAC, the underlying business is strong and we continue to grow our number one market position in the U.S. and anticipate that position strengthening single continues to do very well as the next-generation non-opioid OA pain product of choice in over 35 countries, and we continue to explore more near term opportunities for commercial partnerships in the U.S. and select Asian markets. We are continuing to interact with FDA and are doing all we can to obtain clarity on what they will require for nonclinical data so that we can move ahead with those remaining tests with certainty.

讓我從我們的主要成就開始。首先，第四季度和全年的收入成長和調整後的 EBITDA 超出預期。我們在OA 疼痛管理領域創下了創紀錄的一年，由於Monovisc 在全球範圍內的強勁增長以及美國以外單船體的持續兩位數增長，本季度收入增長了12%，全年收入增長了11% 。雖然我們受益於向強生神達 (J&J MiTAC) 轉移發貨的一些有利訂單時機，但基礎業務強勁，我們將繼續提高我們在美國第一大市場的地位，並預計，隨著下一代非-阿片類OA 疼痛產品在超過35 個國家成為首選，我們將繼續在美國和選定的亞洲市場探索更多短期商業合作機會。我們正在繼續與 FDA 互動，並盡一切努力明確他們對非臨床數據的要求，以便我們能夠確定地繼續進行剩餘的測試。

We remain excited to bring this tremendously effective product to the U.S. market and provide a meaningful non-opioid pain medicine to help alleviate the osteoarthritis knee pain.

我們仍然很高興能夠將這種極其有效的產品引入美國市場，並提供一種有意義的非鴉片類止痛藥，以幫助緩解骨關節炎膝蓋疼痛。

Of the 32.5 million U.S. citizens who continue to suffer on a daily basis. In fact, we expect singles expansion into the U.S. to double our OA pain market opportunity from 1 billion to $2 billion single is and will continue to be positioned to win OA pain management is our core business and will continue to be a key driver of growth and profitability for Anika with single signal in the U.S. providing a significant future value-building opportunity in joint preservation. Our HA regenerative solutions, sports medicine and Arthrosurface businesses also progressed nicely throughout the year in regenerative solutions news. We've already completed well over 100 surgeries with our integrity implant system since its limited market release at the end of last November. This is a significant ramp, especially during a limited release, and it speaks to the exciting preclinical data strength of the regenerative implant itself and the full system approach we took in the design. Physician feedback has been incredibly positive. And most importantly, their first patients are doing very well with many having reached their eight week follow-up. We are intentionally constraining the early rollout to ensure we incorporate surgeon feedback from the limited release and refine the arthroscopic delivery and deployment instruments. The full-market release of integrity is on track for mid 2024 and based on the current usage and limited release is expected to drive accelerated growth in our regenerative business in the back half of the year. Integrity, along with Tyler fast, will serve as key technology platforms for near term regenerative product expansion. I'm excited to share more details on that refresh regenerative focused R&D roadmap on future calls, pilot test, our eight K, single-stage off-the-shelf cartilage repair product continues to sell very well outside the US with a market leadership position in a number of key countries and active geographic expansion underway. As a reminder, pilot tests was granted Breakthrough Device Designation by the FDA and the U.S. clinical trial. Last patient out milestone remains on track for early next year. We also remain on track to begin filing the modular PMA this year with a target product launch by 2026. Pilot test remains a key value driver for Anika and will be a meaningful and differentiated entrant into the $1 billion plus U.S. cartilage repair market.

3,250 萬美國公民每天仍在遭受苦難。事實上，我們預計單打擴展到美國將使我們的OA 疼痛市場機會翻一番，從10 億美元增加到20 億美元，並將繼續定位於贏得OA 疼痛管理是我們的核心業務，並將繼續成為成長的關鍵驅動力和美國單一訊號 Anika 的獲利能力，為聯合保護提供了重要的未來價值建構機會。我們的 HA 再生解決方案、運動醫學和關節表面業務在再生解決方案新聞方面全年也取得了良好進展。自去年 11 月底有限市場發布以來，我們已經使用我們的完整性植體系統完成了 100 多例手術。這是一個顯著的成長，特別是在有限的發布期間，它說明了再生植入物本身令人興奮的臨床前數據強度以及我們在設計中採用的完整系統方法。醫生的回饋非常正面。最重要的是，他們的第一批患者狀況良好，許多患者已經完成了八週的追蹤。我們有意限制早期推出，以確保我們吸收外科醫生從有限發布中獲得的回饋，並改善關節鏡輸送和部署器械。完整性的全面市場釋放預計將於 2024 年中期進行，根據目前的使用情況，有限釋放預計將在下半年推動我們再生業務的加速成長。Integrity 與 Tyler Fast 將成為近期再生產品擴張的關鍵技術平台。我很高興能在未來的通話、試點測試中分享有關更新再生重點研發路線圖的更多細節，我們的 8 K 單階段現成軟骨修復產品繼續在美國以外的地區暢銷，並處於市場領導地位在一些主要國家和地區正在進行積極的擴張。提醒一下，試驗測試已獲得 FDA 和美國臨床試驗的突破性設備稱號。最後一個患者出院里程碑仍有望在明年初實現。我們也將繼續按計劃於今年開始提交模組化 PMA，目標是在 2026 年推出產品。試點測試仍然是 Anika 的關鍵價值驅動因素，並將成為進入價值超過 10 億美元的美國軟骨修復市場的一個有意義且差異化的市場。

As I mentioned at the outset, we also learned a lot last year, largely as it relates to our joint preservation and restoration business where we delivered 7% growth for the quarter and 9% growth for the year as the ramp from our new products was offset by slower sales of our more mature products. We've been intentional in developing high-value products to fill key gaps in our portfolio while advancing our core HA and HA-based regenerative businesses to ultimately capture a larger market opportunity in the fast-growing early intervention orthopedic space. Those investments have yielded great products, Intacta set, extra West Regal motion and integrity. We are now turning our focus to reaping the rewards of those investments and driving revenue with these new products this year and beyond.

正如我在一開始提到的，去年我們也學到了很多東西，主要是因為它與我們的聯合保護和修復業務有關，隨著我們新產品的推出，我們在該季度實現了7% 的增長，在今年實現了9% 的成長。我們更成熟產品的銷售放緩所抵消。我們一直致力於開發高價值產品，以填補我們產品組合中的關鍵空白，同時推進我們的核心HA 和基於HA 的再生業務，最終在快速增長的早期幹預骨科領域抓住更大的市場機會。這些投資產生了出色的產品、完整的套裝、額外的西富豪運動和誠信。我們現在將重點轉向今年及以後獲得這些投資的回報並透過這些新產品增加收入。

In sports medicine and Arthrosurface, we made important progress with our new product launches, including extra twist and Reba motion. Actually, peak is now beginning to gain significant traction in the market, particularly with surgeons in the ASC. who are looking for competitive alternatives. The bio composite version of Xtra has entered the market in Q1 this year in a limited release, and we are receiving great initial feedback on its clinical performance. With both versions now available, we can address the entire $600 million plus U.S. rotator cuff market. We expect the new vial composite suture anchor to be a key driver for the extras product line in 2024. Our new mega motion Reverse Shoulder System, which competes in the faster-growing $1 billion US reverse shoulder market was fully launched at the end of Q. three last year, and we are continuously engaging with our distributors to drive adoption as well as actively training surgeons on the safe and effective use of the system. Clinical feedback remains very positive, and our top distributors continue to do very well despite despite a slower than expected pace of adoption. Given the more complex sales cycle, we secured key contracts in the fourth quarter that we expect to further open up market access and the recent momentum positions us well to drive growth in 2024, especially now that CMS is reimbursing shoulders in the ASC., where we are well-positioned with our two instrument trade design. The key takeaway here is that the underlying adoption for X twist is strong and growing and Revo motion is increasing. And as we work to improve our channel and commercial execution. We expect that the pace of adoption will continue to accelerate. In fact, we recently returned from this year's American Academy of Orthopedic Surgeons meeting where we met with a number of surgeons who showed real excitement around our new products. I'm very proud of our accomplishments in 2023 with the important product launches of extra with RevA motion and integrity and the completion of the USIFS. clinical trial enrollment. With these major developments developments behind us, clarity on the current pace of growth in JPR. and the meaningful progress we made on key investments such as meeting the MDR regulatory requirements in Europe. We are now in a position to refine and focus where we place our future investments. That renewed focus will be on driving Anika's new products that provide for the greatest growth opportunities and on selective development of our highly differentiated HA. and BJ. HA-based regenerative technologies, which set the foundation for our future. I will note here that beginning in mid 2023, we undertook a strategic review of the business with the support of Piper Sandler. As part of this review, we evaluated a wide range of options for the company to increase shareholder value, including a potential sale. We remain open to all value-enhancing opportunities and regularly review what makes the most sense for our business. We have a lot of conviction in our new refocused strategy, leveraging our core strengths and highest-value opportunities as we accelerate our pivot to profitability. And we are making this pivot from a position of strength with a healthy balance sheet, positive cash flow generation and a solid cash position with no debt. In addition, we are taking action to lower spending and more immediately accelerate EBITDA in 2024, while we simultaneously grow our top line in terms of cost actions, we recently made the very difficult but necessary decision to reduce our global headcount by about 9% and are actively reducing spending for 2024 Together these actions are expected to drive annualized cost savings of approximately 10 million, excluding the impact of onetime costs. Going forward, we will have a refined focus with our new products that are driving our growth and have the highest value building potential. These actions are already well underway, and we expect that adjusted EBITDA will be between 25 to $30 million this year, an increase of over 75% at the midpoint as we accelerate our pivot to profitability.

在運動醫學和關節表面領域，我們透過新產品的推出取得了重要進展，包括 Extra Turn 和 Reba Motion。事實上，Peak 現在開始在市場上獲得巨大的吸引力，特別是對於 ASC 的外科醫生來說。他們正在尋找有競爭力的替代品。Xtra 的生物複合版本已於今年第一季限量上市，我們收到了大量有關其臨床表現的初步回饋。兩個版本現已上市，我們可以滿足整個 6 億美元以上的美國肩袖市場的需求。我們預計新型小瓶複合縫合錨釘將成為 2024 年附加產品線的關鍵驅動力。我們新的大型運動反肩系統於去年第三季末全面推出，該系統在快速成長的 10 億美元美國反肩市場中展開競爭，我們正在不斷與經銷商合作，推動採用並積極培訓外科醫生如何安全有效地使用該系統。臨床回饋仍然非常積極，儘管採用速度慢於預期，但我們的頂級經銷商仍然表現出色。鑑於銷售週期更加複雜，我們在第四季度獲得了關鍵合同，我們預計這些合約將進一步開放市場准入，並且最近的勢頭使我們能夠很好地推動2024 年的增長，特別是現在CMS 正在償還ASC的責任。我們的兩種工具交易設計處於有利位置。這裡的關鍵要點是，X Twist 的潛在採用率非常強勁且不斷成長，而 Revo Motion 也不斷增加。我們致力於改善我們的通路和商業執行力。我們預計採用的步伐將繼續加快。事實上，我們最近剛從今年的美國骨科醫師學會會議回來，我們會見了一些外科醫生，他們對我們的新產品表現出了真正的興奮。我對我們在 2023 年所取得的成就感到非常自豪，其中包括 RevA 行動和完整性的 extra 重要產品的發布以及 USIFS 的完成。臨床試驗註冊。有了這些重大進展，JPR 目前的成長速度就變得清晰起來。以及我們在滿足歐洲 MDR 監管要求等關鍵投資方面取得的有意義的進展。我們現在能夠完善並專注於未來投資的方向。新的重點將是推動 Anika 的新產品提供最大的成長機會，並選擇性地開發我們高度差異化的 HA。和北京。基於 HA 的再生技術為我們的未來奠定了基礎。我要在此指出，從 2023 年中期開始，我們在 Piper Sandler 的支持下對業務進行了策略審查。作為本次審查的一部分，我們評估了公司增加股東價值的多種選擇，包括潛在的出售。我們對所有增值機會持開放態度，並定期審查對我們業務最有意義的機會。我們對重新定位的新策略充滿信心，利用我們的核心優勢和最高價值的機會，加速獲利。我們正在以健康的資產負債表、積極的現金流產生和穩定的現金狀況且無債務的優勢地位來實現這一轉變。此外，我們正在採取行動降低支出，並在2024 年更迅速地加速EBITDA，同時我們在成本行動方面增加我們的收入，我們最近做出了非常困難但必要的決定，將我們的全球員工人數減少約9%，正在積極減少 2024 年的支出，這些行動預計將每年節省約 1000 萬美元的成本，不包括一次性成本的影響。展望未來，我們將更加專注於推動我們成長並具有最高價值創造潛力的新產品。這些行動已經在順利進行中，隨著我們加速轉向盈利，我們預計今年調整後的 EBITDA 將在 25 至 3000 萬美元之間，中間增幅超過 75%。

Now I'd like to turn the call over to Mike to review the details of the fourth quarter and full year results and our outlook for 2024.

現在我想將電話轉給 Mike，回顧第四季度和全年業績的詳細資訊以及我們對 2024 年的展望。

Thank you, Cheryl. Please turn to Slide 4 in the online slide presentation. I'm pleased to report. Total revenue for the fourth quarter grew to 43 million, exceeding our expectations, driven by better than expected growth in US and international awaiting management, our largest product family as well as continued growth in joint preservation and restoration revenue in OA Pain Management increased 12% in the fourth quarter to 25.1 million as our international business finished another strong year, driven by double-digit growth in both single and Monovisc. Our US revenues from J&J Mitek grew 7% with a quarterly growth, reflecting some favorable order timing year over year. Our joint preservation and restoration revenue increased 7% in the fourth quarter to 15.3 million, driven by continued growing international sales as well as by our recent product launches in the United States with Axe twist and relay motion, which were partially offset by lower sales of our more mature products.

謝謝你，謝麗爾。請參閱線上幻燈片簡報中的幻燈片 4。我很高興報告。第四季總收入成長至4300 萬美元，超出了我們的預期，這得益於美國和國際等待管理、我們最大的產品系列的增長好於預期以及OA 疼痛管理領域聯合保存和修復收入的持續增長，成長了12%在單一和 Monovisc 兩位數成長的推動下，我們的國際業務又完成了強勁的一年，第四季度達到 2510 萬。我們來自 J&J Mitek 的美國營收季度成長 7%，反映出年比有利的訂單時機。我們的聯合保護和修復收入在第四季度增長了7%，達到1,530 萬美元，這得益於國際銷售的持續增長以及我們最近在美國推出的Axe 扭轉和繼電器運動產品，但部分被以下產品的銷售額下降所抵銷：我們的產品比較成熟。

Lastly, our non orthopedic revenue decreased 8% to $2.6 million year over year order timing and high risk veterinary sales.

最後，我們的非骨科收入年減 8% 至 260 萬美元，訂單時間和高風險獸醫銷售收入較去年同期下降 8%。

Moving to gross margin, our gross margin in the fourth quarter was 61% and included the noncash impact of 1.6 million of acquisition-related amortization expense from the acquisitions made in 2020. Our adjusted gross margin was 65% in the quarter, down slightly from the 66% last year due primarily to revenue mix.

說到毛利率，我們第四季的毛利率為 61%，其中包括 2020 年收購產生的 160 萬收購相關攤銷費用的非現金影響。本季調整後的毛利率為 65%，略低於去年的 66%，主要是因為收入組合的原因。

Moving to operating expenses. In the fourth quarter, Anika recorded a noncash impairment charge of 62.2 million on the intangible assets from the early 2020 acquisitions of Parcus Medical and Arthrosurface. As we previously mentioned, revenue growth of sports medicine and Arthrosurface in 2023 was lower than expected as the ramp following the recent new product launches was not sufficient to offset lower sales of our more mature products. As a result, we lowered our long-term outlook for the sports medicine and Arthrosurface product families resulting in the impairment charge in the fourth quarter. Also, based on this lower outlook, we've reduced our planned spending for 2024 as I will describe to you shortly.

轉向營運費用。第四季度，Anika 對 2020 年初收購 Parcus Medical 和 Arthrosurface 的無形資產記錄了 6,220 萬美元的非現金減損費用。正如我們之前提到的，2023 年運動醫學和 Arthrosurface 的收入成長低於預期，因為最近新產品推出後的成長不足以抵消我們更成熟產品的銷售下降。因此，我們降低了對運動醫學和關節表面產品系列的長期前景，導致第四季度出現減損支出。此外，基於這種較低的前景，我們減少了 2024 年的計劃支出，我很快就會向您介紹。

Apart from the impairment charge, our operating expenses totaled 27.9 million in the fourth quarter, down from 30.8 million in the same period of 2022 due to continued operating efficiency, managing expenses, a lower level of MDR activity based on our progress to date and ramping up major development projects as we move to limited market release of integrity in November due primarily to the non-cash impairment charge. Our net loss for the quarter was 63 million or $4.30 per share compared to a net loss of 4.9 million or $0.34 per share in the fourth quarter of last year. Excluding the accounting to intangibles from the 2020 acquisitions, we generated adjusted net income of $800,000 in the fourth quarter or $0.05 per diluted share, up from an adjusted net loss of 3 million or $0.21 per share in the same quarter last year. Anika generated adjusted EBITDA in the quarter of $5.8 million, up from $1.4 million in the fourth quarter of last year. And our adjusted EBITDA margin in the quarter grew to 13%, up from 4% in the same period last year to nine point improvement was primarily due to the combined benefit of both revenue growth and reduced spending.

除減損費用外，我們第四季的營運費用總計2,790 萬美元，低於2022 年同期的3,080 萬美元，原因是持續的營運效率、管理費用、基於我們迄今為止的進展和成長的MDR 活動水平較低主要由於非現金減損費用，我們將在 11 月向市場發布有限的誠信，從而增加主要開發項目。我們本季的淨虧損為 6,300 萬美元，即每股 4.30 美元，而去年第四季的淨虧損為 490 萬美元，即每股 0.34 美元。不包括2020 年收購中的無形資產會計，我們第四季調整後淨利為80 萬美元，即稀釋後每股收益0.05 美元，高於去年同期調整後淨虧損300 萬美元，即每股0.21 美元。Anika 本季調整後 EBITDA 為 580 萬美元，高於去年第四季的 140 萬美元。本季調整後的 EBITDA 利潤率從去年同期的 4% 增長至 13%，提高了 9 個百分點，這主要是由於收入增長和支出減少的綜合效益。

Lastly, with regards to our cash flow and capital structure, we generated operating cash of 3.6 million during the fourth quarter, up from $500,000 in the same quarter last year, reflecting business growth, operating efficiency and reduced spending. Our capital expenditures in the quarter totaled $1.8 million, reflecting continued investments in manufacturing capabilities, supporting growth in our OA pain management product lines, as well as instruments associated with our new product launches. Our capital expenditures were approximately $2 million less than planned due to timing where these expenditures are now expected to occur in 2024. We ended the fourth quarter was 72.9 million in cash and no outstanding debt on positive free cash flow in the quarter of 1.8 million, 13.4 million decrease in cash year over year as a result of $5 million used to repurchase our common stock in 2023, as well as over 8 million in nonrecurring costs associated with the settlement of the Parcus Medical arbitration, shareholder activism and other nonrecurring corporate costs. Anika maintains a healthy balance sheet and is well positioned to drive shareholder value as we employ a balanced capital allocation strategy where we both continue to self-fund our growth initiatives and continue to opportunistically repurchase stock under our $20 million authorized stock repurchase program, of which 15 million remains outstanding. Please turn to Slide 5. I would now like to walk you through our full year results for 2023 as compared to both the prior year and to our most recent guidance, and then I'll provide our expectations for 2024.

最後，關於我們的現金流量和資本結構，第四季度我們產生了 360 萬美元的營運現金，高於去年同期的 50 萬美元，反映了業務成長、營運效率和支出減少。本季我們的資本支出總計 180 萬美元，反映出對製造能力的持續投資，支持我們 OA 疼痛管理產品線以及與新產品發布相關的儀器的成長。由於這些支出預計在 2024 年發生，我們的資本支出比計畫少了約 200 萬美元。截至第四季末，我們的現金為7,290 萬美元，無未償債務，本季自由現金流為180 萬美元，現金年減1,340 萬美元，原因是2023 年用於回購普通股的500 萬美元，如下：以及與解決 Parcus Medical 仲裁、股東激進主義和其他非經常性公司成本相關的超過 800 萬美元的非經常性成本。Anika 保持健康的資產負債表，並有能力推動股東價值，因為我們採用平衡的資本配置策略，我們繼續為我們的成長計劃提供資金，並繼續根據我們的2000 萬美元授權股票回購計劃機會性地回購股票，其中仍有 1500 萬未償還。請翻到投影片 5。現在，我想向您介紹我們 2023 年全年業績與前一年和最新指引的比較，然後我將提供我們對 2024 年的預期。

For the full year, Anika generated revenue of 166.7 million, an increase of 7% above our most recent guidance of 164 to 166 million by product family. Our OA Pain Management revenues finished up 11% at 101.9 million, beating our recent guidance expectations. This growth reflects 12% growth internationally, led by over 20% growth in single and 10% growth in the U.S. from J&J medtech on 6% growth in royalties from end-user sales and 14% growth in transfer sales to J&J due to growing demand and some favorable order timing. Our joint preservation and restoration revenue grew 9% to 54.9 million for the year, in line with our most recent guidance. The increase was driven by growing momentum from our new products as well as continued international growth, offset in part by lower revenues from our more mature products.

Anika 全年營收為 1.667 億美元，比我們最新的產品系列指引值 1.64 至 1.66 億美元成長了 7%。我們的 OA 疼痛管理收入最終成長 11%，達到 1.019 億美元，超出了我們最近的指導預期。這一增長反映了國際上12% 的增長，其中強生醫療科技的單次增長超過20%，美國增長了10%，最終用戶銷售的特許權使用費增長了6%，由於需求不斷增長，強生的轉讓銷售成長了14%以及一些有利的訂單時機。我們的聯合保護和修復收入今年增長了 9%，達到 5,490 萬美元，與我們最新的指導一致。這一成長是由我們的新產品的成長動力以及持續的國際成長所推動的，但部分被我們更成熟產品的收入下降所抵消。

Our non orthopedic revenues totaled 9.9 million for the year down 29% from the prior year, primarily due to high risk veterinary order timing and last-time buys of other non orthopedic products in 2022, finishing slightly favorable to our guidance for the full year, our GAAP gross margin was 62%, up from 60% in prior year, and our adjusted gross margin was 66% in line with last year and our 2023 guidance. Adjusted EBITDA margin for the year reached 9%, beating our guidance of 6% to 8% on reduced spending following accomplishment of key objectives such as the launch of a number of major products and addressing MDR requests.

我們今年的非骨科收入總計 990 萬美元，比前一年下降 29%，主要是由於高風險獸醫訂單時間和 2022 年其他非骨科產品的最後一次購買，最終略好於我們的全年指導，我們的GAAP 毛利率為62%，高於上年的60%，調整後的毛利率為66%，與去年和2023 年指引一致。今年調整後的 EBITDA 利潤率達到 9%，超出了我們在實現推出一些主要產品和滿足 MDR 要求等關鍵目標後減少支出的 6% 至 8% 的指導。

Now I'd like to turn to review our financial outlook for 2024. As Sheryl mentioned, we have prioritized accelerated growth and profitability in 2024 with a focus on the products where we have the greatest growth opportunities. As such, we expect revenues for 2024 to grow to between 168 and 173 million. That's up 1% to 4% compared to 2023. This growth rate is down from 2023, primarily due to some order timing from J&J InnoWave being managed by product family. We expect OA pain management to grow to 102 to 104 million. That's up 0% to 2%. The underlying business remains strong, but our guidance reflects a different difficult comparable in 2023 due to order timing. We continue to expect above market mid-single digit growth in end-user sales, led by growth of Monovisc and continued double-digit growth of single outside the United States. We expect joint preservation revenues to grow to 58 to $60.5 million, up 6% to 10% as faster growth in our newest products, integrity ex twist and repo motion is offset by slower growth in our more mature products. We expect our non orthopedic revenues to be eight to $8.5 million, a decrease of 14% to 19%. We expect adjusted gross margin for 2024 to improve slightly to a range of 66% to 66.5%. Please note that our GAAP gross margin will improve more significantly and be more in line with our adjusted gross margin on much lower amortization of intangible assets from the 2020 acquisitions following the Q4 impairment charge.

現在我想回顧一下我們 2024 年的財務前景。正如 Sheryl 所提到的，我們優先考慮 2024 年的加速成長和獲利能力，並專注於我們擁有最大成長機會的產品。因此，我們預計 2024 年營收將成長至 1.68 至 1.73 億美元之間。與 2023 年相比，成長 1% 至 4%。這一增長率低於 2023 年，主要是由於 J&J InnoWave 的一些訂單時間由產品系列管理。我們預計 OA 疼痛管理人數將成長至 102 至 1.04 億。上漲了 0% 到 2%。基礎業務仍然強勁，但由於訂單時間安排，我們的指導反映了 2023 年的不同困難。我們繼續預計，在 Monovisc 成長和美國以外地區持續兩位數成長的帶動下，最終用戶銷售額將高於市場中個位數成長。我們預計聯合保全收入將增長至 58 至 6,050 萬美元，增長 6% 至 10%，因為我們最新產品、誠信除息和回購動議的較快增長被我們更成熟產品的較慢增長所抵消。我們預計非骨科收入為 8 至 850 萬美元，下降 14% 至 19%。我們預計 2024 年調整後毛利率將小幅改善至 66% 至 66.5% 的範圍。請注意，我們的 GAAP 毛利率將得到更顯著的改善，並且與我們在第四季度減損支出後 2020 年收購的無形資產攤銷大幅降低的調整後毛利率更加一致。

From a spending perspective, based on our cost reduction initiatives, we now expect our operating expenses to decrease in 2024 following the successful 2023 U.S. launches of Exelis RevA motion and integrity as well as our progress addressing European MDR requirements. We are reducing our spending across both R&D and G&A SG&A in 2024. This spending reduction includes the difficult decision to reduce approximately 9% of our global workforce here at the end of the first quarter, we expect to record a severance charge of approximately 1 million in the first quarter related to the headcount reduction, excluding the severance charge, these actions taken together are expected to provide approximately $10 million in savings on an annualized basis since the actions are taking place now at the end of the first quarter, the full annual savings will not be realized until 2025 and 2024. A portion of the savings will be used to fund the filing of the first PMA module for Hyalofast in the United States in support of its planned launch in the U.S. by 2026, as well as additional clinical follow-up for our HA-based regenerative products such as integrity. With these actions and anticipated revenue growth, we expect our adjusted EBITDA in 2024 to be between 25 and 30 million, representing an increase of over 75% at the midpoint. This translates to an adjusted EBITDA margin improvement of over six points, growing to at least six, at least 15% for the year. It also positions Anika to pivot to positive adjusted net income as we currently reported and generate positive free cash flow even with higher capital spending focused on our OA Pain Management manufacturing operations in part due to the timing from 2023.

從支出角度來看，基於我們的成本削減舉措，繼2023 年在美國成功推出Exelis RevA 動議和完整性以及我們在滿足歐洲MDR 要求方面取得的進展之後，我們現在預計我們的營運支出將在2024 年減少。我們將在 2024 年減少研發和一般行政管理 (SG&A) 支出。這筆支出削減包括在第一季末裁減約 9% 的全球勞動力的艱難決定，我們預計第一季將記錄與裁員相關的約 100 萬歐元的遣散費（不包括遣散費）由於這些行動是在第一季末開始實施的，因此這些行動合計預計將每年節省約1000 萬美元，全部年度節省要到2025 年和2024 年才能實現。節省的部分資金將用於資助 Hyalofast 在美國的第一個 PMA 模組備案，以支持其計劃於 2026 年在美國推出，以及我們基於 HA 的再生產品的額外臨床隨訪例如誠信。透過這些行動和預期的收入成長，我們預計 2024 年調整後的 EBITDA 將在 2500 至 3000 萬美元之間，中點增幅超過 75%。這意味著調整後的 EBITDA 利潤率提高了 6 個百分點以上，今年成長到至少 6 個百分點，即至少 15%。它還使 Anika 能夠轉向我們目前報告的正調整淨利潤，並產生正的自由現金流，即使由於 2023 年的時間安排，我們的 OA 疼痛管理製造業務的資本支出有所增加。

On an administrative note, please note that beginning in the first quarter of 2024 adjusted net income and adjusted EPS will also exclude stock-based compensation expense to better align with our calculation of adjusted EBITDA.

在行政說明中，請注意，從 2024 年第一季開始，調整後淨利潤和調整後每股收益也將不包括基於股票的補償費用，以更好地與我們調整後 EBITDA 的計算保持一致。

Looking beyond 2024, we have accelerated our profitability growth and are now targeting reaching our multiyear 20% adjusted EBITDA target in 2025 a year earlier than previously expected, while due to the slower growth in Arthrosurface and sports medicine. We no longer expect to reach our previously stated multiyear revenue target by 2025. Our accelerated profitability target as a result of our strong and growing core HA-based OA pain management and regenerative franchises, including our exciting new integrity implants as well as the lower spending levels and significantly higher EBITDA. We now expect in 2024, and we're just getting started as we still have before us the benefits from our near term regenerative pipeline and the planned U.S. launches of Hyalofast in single once we gain FDA approval in summary, in 2023, we grew the top and bottom line ahead of expectations. We launched high-quality products, and we took action to adjust spending that positions Anika for a bright future. In 2024, we will continue driving top line growth, but even more significant growth in the bottom line while advancing high opportunity, new products that form the basis of Anika's future growth acceleration. We remain laser focused on our mission and on driving shareholder value, and we greatly appreciate your support as we do this.

展望 2024 年後，我們加快了盈利能力增長，目前的目標是在 2025 年實現多年期 20% 調整後 EBITDA 目標，比之前的預期提前一年，同時由於關節表面和運動醫學領域的增長放緩。我們不再期望 2025 年達到先前設定的多年收入目標。由於我們強大且不斷增長的基於HA 的核心OA 疼痛管理和再生特許經營權，包括我們令人興奮的新型完整性植入物以及較低的支出水平和顯著較高的EBITDA，我們加快了盈利目標。我們現在預計到 2024 年，我們才剛剛開始，因為我們仍然可以從我們的近期再生管道中獲益，並且一旦我們獲得 FDA 批准，計劃在美國推出 Hyalofast 。 總之，在 2023 年，我們增長了頂線和底線超出預期。我們推出了高品質的產品，並採取了調整支出的行動，為 Anika 帶來了光明的未來。2024 年，我們將繼續推動營收成長，但在推動利潤成長的同時，也將推出高機會新產品，為 Anika 未來加速成長奠定基礎。我們始終專注於我們的使命和推動股東價值，我們非常感謝您在我們這樣做時的支持。

I'll now turn the call back over to Sheryl.

我現在將把電話轉回謝麗爾。

Thanks, Mike. Please refer to Slide 6. Before we open up the call for Q&A, I want to reiterate a few key points. 2023 was a very strong year for our business. We had a record year in OA pain management and exciting progress with our regenerative portfolio, which are both core to our future. Our products across the business continue to receive incredibly positive feedback, and we are encouraged about the opportunity ahead for our broader portfolio.

謝謝，麥克。請參閱幻燈片 6。在我們開始問答之前，我想重申幾個要點。 2023 年對我們的業務來說是非常強勁的一年。我們在骨關節炎疼痛管理方面取得了創紀錄的一年，並且在再生產品組合方面取得了令人興奮的進展，這兩者都是我們未來的核心。我們整個業務的產品繼續收到令人難以置信的正面回饋，我們對更廣泛的產品組合未來的機會感到鼓舞。

We also gained important clarity about the pace of growth in our joint preservation business and completed significant investments. Taking all of these elements together, we've determined to focus our strategy to optimize performance and drive even stronger results. We're confident that we are well on a path to deliver accelerated profitability this year and beyond. To our employees past and present, I want to say thank you for your contributions and work at Anika and to our distributors and sales partners. We are absolutely continuing to invest in new products, training and those areas that have the most growth potential in 2024 and beyond. We appreciate your continued support and partnership in delivering our great products to surgeons and the patients they treat together.

我們也對聯合保存業務的成長速度有了重要的了解，並完成了重大投資。將所有這些要素結合在一起，我們決定將策略重點放在優化績效並取得更強勁的成果。我們相信，今年及以後我們將順利實現獲利加速成長。對於我們過去和現在的員工，我想感謝你們在 Anika 的貢獻和工作，以及我們的經銷商和銷售合作夥伴。我們絕對會繼續投資新產品、培訓以及 2024 年及以後最具成長潛力的領域。我們感謝您持續的支持和合作，為外科醫生和他們一起治療的患者提供我們優質的產品。

We are restoring active living for people around the world and with we'll open up the line for questions.

我們正在為世界各地的人們恢復積極的生活，我們將開通提問熱線。

Thank you. Ladies and gentlemen, we will now conduct a question and answer session. If you have a question, please press star followed by the number one on your touchtone phone. You will hear a three-toned prompt acknowledging your request.

謝謝。女士們、先生們，我們現在將進行問答環節。如果您有疑問，請按按鍵式電話上的星號，然後再按數字 1。您將聽到三聲提示音，確認您的要求。

Your first question comes from the line of Jim Sidoti from Sidoti & Company.

您的第一個問題來自 Sidoti & Company 的 Jim Sidoti。

Your line is now open.

您的線路現已開通。

Yes.

是的。

So this is Alex Hammond on for Jim. My first question is what areas of the Company will be impacted by the workforce reduction?

這是亞歷克斯·哈蒙德 (Alex Hammond) 替吉姆 (Jim) 發言。我的第一個問題是公司的哪些領域會受到裁員的影響？

Hey, Alex, this is Cheryl. And thanks for joining us. Yes, the main areas that are being impacted our R&D and SG&A, primarily in marketing and from a spending standpoint, the $10 million annualized savings, it's split pretty evenly between R&D and SG&A.

嘿，亞歷克斯，這是謝麗爾。感謝您加入我們。是的，影響我們研發和 SG&A 的主要領域，主要是行銷方面，從支出的角度來看，每年節省 1000 萬美元，在研發和 SG&A 之間平均分配。

Got it.

知道了。

Thank you for the context and I know we've discussed some of the changes to distributors and from the joint preservation business. Are you happy with the results so far and do you but any additional changes for 2024?

謝謝您提供的背景信息，我知道我們已經討論了經銷商和聯合保存業務的一些變化。您對迄今為止的結果感到滿意嗎？2024 年您還有其他改變嗎？

Yes, great question.

是的，很好的問題。

In terms of commercial execution, what I will tell you is that our top distributors continue to do very well. We obviously continue to move forward with ongoing optimization. We're really starting to feel from them and from the clinicians of a real pull for integrity and and a significant acceleration from X to especially now that we've got bio composite launched Revo RevA motion is really starting to gain as we gain additional market access and continue on with great product feedback. So I think that we're really doubling down on our strength relative to what we see working with those strong distributors and continuing to optimize going forward.

在商業執行方面，我要告訴你的是，我們的頂級經銷商繼續做得很好。顯然，我們將繼續進行持續優化。我們真的開始從他們和臨床醫生身上感受到真正的誠信拉動，以及從X 到顯著的加速，特別是現在我們已經推出了生物複合材料Revo RevA 運動隨著我們獲得額外的市場而真正開始獲得收益訪問並繼續獲得良好的產品回饋。因此，我認為，相對於我們與那些強大的經銷商的合作，我們確實加倍了我們的實力，並繼續優化前進。

Great.

偉大的。

Thank you for the context. And last question from me, what do you expect next meeting with the FDA regarding synbio?

謝謝你的背景。我的最後一個問題是，您對下次與 FDA 就 Synbio 的會議有何期望？

Yes, we we have ongoing dialogue with FDA. We had our Type C meeting last year, as you know, on the ongoing dialogue is productive and we're doing all we can to obtain that clarity on what they're going to require for the nonclinical data. So we can move ahead with those remaining tests with certainly certainty. So I think the message there is rest assured that we're doing all we can and the dialogue is ongoing.

是的，我們正在與 FDA 進行對話。如您所知，我們去年舉行了 C 類會議，正在進行的對話富有成效，我們正在盡一切努力明確他們對非臨床數據的要求。因此，我們可以毫無疑問地繼續進行剩餘的測試。因此，我認為大家可以放心，我們正在竭盡全力，對話正在進行中。

Appreciate all the color, and thanks again.

欣賞所有的顏色，並再次感謝。

You're welcome. Thank you.

不客氣。謝謝。

Your next question comes from the line of George tellers from Stephens Inc.

您的下一個問題來自史蒂芬斯公司的喬治出納員。

Your line is now open.

您的線路現已開通。

Hey, good afternoon and thanks for taking the question. Maybe to start, I'm just curious if you could give some initial color on what I read the motion contributed in the quarter? And then also how many surgeons have been trained thus far? And how should we think about sort of the progression of surgeons trained there?

嘿，下午好，感謝您提出問題。也許首先，我只是好奇您能否對我讀到的該議案在本季度做出的貢獻提供一些初步的了解？到目前為止，有多少外科醫生接受了訓練？我們應該如何看待在那裡接受培訓的外科醫生的進步？

2024, George, thanks for the question?

2024，喬治，謝謝你的提問？

In terms of training on, we haven't broken out training specifically by product because we tend to train across products within a training session. So what we have talked about is we trained about 600 surgeons last year in face-to-face training activities. So we'll continue on with focused training around our new products as we've talked about and RevA motion will be a part of that.

在培訓方面，我們沒有專門按產品進行培訓，因為我們傾向於在一次培訓課程中進行跨產品的培訓。所以我們談到的是去年我們透過面對面的訓練活動培訓了大約600位外科醫生。因此，正如我們所討論的那樣，我們將繼續圍繞我們的新產品進行集中培訓，RevA 運動將成為其中的一部分。

Okay. That's helpful.

好的。這很有幫助。

And then maybe shifting gears a little bit to the guidance. Just curious if you could break out the contribution from some of the new devices that you've recently launched, like read the motion, the hay rotator cuff patch system as well as some of the items that you talked about today, OS. and that are going to be launched this year with AIM. and the Pro pass, how should we think about growth from those versus your legacy devices?

然後也許會稍微轉向指導。只是好奇您是否可以列出您最近推出的一些新設備的貢獻，例如閱讀動議、乾草肩袖補丁系統以及您今天談到的一些項目，操作系統。今年將與 AIM 一起推出。和 Pro 通行證，我們應該如何考慮這些設備與傳統設備的成長？

Hi, George.

嗨，喬治。

It's Mike. In terms of the growth expectations for those new products, we are pleased with the growing momentum that we are seeing in exquisite, where it's been out for now a few quarters and now we have the bio composite that that's now a limited market release. So that excess is going to be a big contributor here for the growth in 2020 for Regal motion. We have just a few months because that launched in full market release at the end at the end of the third quarter. That will also be contributing this coming year. So when you think about the the growth that we've described in joint preservation of the new products, integrity at Swift and we have a motion are the primary drivers of that growth on that. The growth in the more mature products is really not a there isn't a lot of growth in the more mature products and that is offsetting the exciting growth that we are seeing in these new products. So we're very pleased with the acceleration that we're seeing. We're learning a lot as we bring these to the market in terms of our ability to commercialize those with our distribution force and are taking a lot of actions to continue to run to see that acceleration in 2024.

是麥克。就這些新產品的成長預期而言，我們對在精緻產品中看到的成長勢頭感到高興，它已經上市幾個季度了，現在我們擁有生物複合材料，目前在市場上有限發布。因此，這種過剩將成為 Regal Motion 2020 年成長的一大貢獻者。我們只有幾個月的時間，因為該產品將在第三季末全面發布市場。這也將為來年做出貢獻。因此，當你想到我們所描述的新產品聯合保存的增長時，Swift 的誠信和我們的一項動議是這一增長的主要驅動力。更成熟產品的成長實際上並不是更成熟產品沒有太多成長，而是抵消了我們在這些新產品中看到的令人興奮的成長。因此，我們對所看到的加速感到非常滿意。當我們將這些產品推向市場時，我們在利用我們的分銷力量將這些產品商業化的能力方面學到了很多東西，並且正在採取大量行動繼續努力，以期在 2024 年看到這種加速。

And I would add on integrity. We mentioned that we're in a limited market release, and we're really intentionally holding back on on further availability of that product. And at the same time are really fueling a pull of that product really because of everything we've talked about around it that we were very focused on delivering our regenerative patch that had greater regenerative capacity that had very high strength even when wet and manipulate, it will come in a center version in the scope and that we took a real full system approach and we're healing that pole we're excited to be able to get to that full market release and are on track to do that in the second half of the year where we see the opportunity to accelerate in that regenerative business with integrity.

我還要補充誠信。我們提到我們正處於有限的市場發布階段，並且我們確實有意推遲該產品的進一步上市。同時，確實推動了該產品的發展，因為我們圍繞它所討論的一切，我們非常專注於提供我們的再生貼片，該貼片具有更大的再生能力，即使在潮濕和操縱時也具有非常高的強度，它將出現在範圍內的中心版本中，我們採取了真正的完整系統方法，我們正在治愈這個極點，我們很高興能夠獲得完整的市場發布，並且有望在第二個版本中做到這一點今年下半年，我們看到了誠信加速再生業務的機會。

Okay. Got it.

好的。知道了。

That that's really helpful. And then one last one, maybe if I can squeeze it in here on the impairment charge that you discussed related to a lower longer-term outlook, I believe you said for Arthrosurface and then the sports medicine business. Can you just give us some additional color on sort of what changed maybe some as specific products and devices that you're less constructive on as you think about the longer-term opportunity they present?

這真的很有幫助。最後一個，也許我可以把你討論的與較低的長期前景相關的減值費用擠在這裡，我相信你說的是關節表面，然後是運動醫學業務。您能否給我們一些額外的信息，說明一些具體的產品和設備發生了哪些變化，當您考慮它們所帶來的長期機會時，您對這些產品和設備的建設性較差？

Sure, George, this is Mike.

當然，喬治，這是麥克。

Yes, we recorded the impairment charge and I based on the reassessment of the trajectory there coming out of the fourth quarter. As you know, the fourth quarter is always the biggest quarter in orthopedics. We had a number of new products. And so the key question that we wanted to see in 2023 is what the acceleration of new products compared to power than the more mature products doing. And what we found is that more mature products were more challenged than we had wanted them to be and hope that they would be and so on that that drove a revisiting of the valuation of the asset. The assets were originally valued back when the acquisitions happened at the beginning of 2020, just before COVID. And so once we went through that reevaluation process. That's what led to the impairment charge. And so we are seeing a nice growth of these new products even early days, but not enough to offset the slower growth than expected in the more mature products. And so that's part of what Charles talked about in terms of driving focus. And that's why we've taken spending down to focus on those areas where we have the greatest opportunity and done. And that's that's why we're able to drive significant growth in the bottom line here as we go into 2024.

是的，我們記錄了減損費用，我是根據對第四季度的軌蹟的重新評估來記錄的。如您所知，第四季度始終是骨科領域最大的季度。我們有很多新產品。因此，我們希望在 2023 年看到的關鍵問題是，與更成熟的產品相比，新產品的加速速度如何。我們發現，更成熟的產品所面臨的挑戰比我們希望的和希望的還要多，這促使我們重新審視資產的估值。這些資產最初是在 2020 年初（即新冠疫情之前）進行收購時進行估值的。一旦我們經歷了重新評估過程。這就是導致減損費用的原因。因此，即使在早期，我們也看到這些新產品的良好成長，但不足以抵消更成熟產品的成長速度低於預期。這就是查爾斯談到的駕駛焦點的一部分。這就是為什麼我們減少了支出，並將重點放在那些我們擁有最大機會並已完成的領域。這就是為什麼我們能夠在進入 2024 年時推動利潤大幅成長。

Okay, got it. Great.

好，知道了。偉大的。

Thank you all again for the time.

再次感謝大家抽出時間。

Thanks, George.

謝謝，喬治。

Your next question comes from the line of Mike Petusky from very Barrington Research.

您的下一個問題來自 Barrington Research 的 Mike Petusky。

Your line is now open.

您的線路現已開通。

So Mike, I feel like you've answered this question about 85% of the way in.

麥克，我覺得你已經回答了這個問題大約 85% 的問題。

Yes, that if you set aside the three new products that you guys, foreign JPR. will the rest of the business lower end of your guidance? Does the rest of your business grow at all in in 24? Or do you assume sort of flat or worse performance in the leg, pardon?

是的，如果你拋開你們這三個新產品，國外的JPR。其餘業務會降低您的指導嗎？您的其他業務在 24 年內有成長嗎？還是您認為腿部表現平平或更差，請原諒？

Hi, Mike. Yes, our guidance for 2024 is really driven by the new products.

嗨，麥克。是的，我們對 2024 年的指導確實是由新產品驅動的。

There is some contribution from the more mature products.

較成熟的產品有一些貢獻。

But the key growth drivers for us and that's reflected in our guidance is, is it are the new products what's reflected in our range for 2024 is we have taken action to reduce spend and that that can have an impact on sales. And so we're just watching that because, as Cheryl said, we're prioritizing the bottom line over a faster growth in the top line and is specifically there in joint preservation and around the more mature products and so on.

但我們的關鍵成長動力（反映在我們的指導中）是，新產品反映在我們 2024 年的產品系列中，我們已採取行動減少支出，這可能會對銷售產生影響。所以我們只是在關注這一點，因為正如謝麗爾所說，我們優先考慮的是利潤而不是收入的更快增長，特別是在聯合保護和更成熟的產品等方面。

Yes, that's something we're going to watch and continue to balance.

是的，這是我們將觀察並繼續平衡的事情。

Mike, I want to make sure that I understood where you decide. You said contribution. Are you saying there it contribution to growth more than flat from the like or?

麥克，我想確保我理解你的決定。你說貢獻。您是說它對成長的貢獻超過了類似的水平還是？

Yes, Mike, I there is a contribution. One of the things that I'm balancing here is that when we talked about the contribution of the new products, the new products are principally launched in the United States.

是的，麥克，我有一個貢獻。我在這裡要平衡的一件事是，當我們談到新產品的貢獻時，新產品主要在美國推出。

So there's an international component that I'm weighing just in how I answer the question, but the primary growth driver in the United States are the new crop.

因此，我在如何回答這個問題時考慮了國際因素，但美國的主要成長動力是新作物。

There is some some variability that you can get in the international business where we don't we aren't able to launch the products as quickly because of MDR requirements and Sheryl, I think I want to forgive me because I know you've just want to make sure I understand so integrity sort of say, hey, we're getting interest. We continue to be really enthusiastic, but we're still sort of holding back at.

在國際業務中，您可能會遇到一些變化，但由於 MDR 要求，我們無法盡快推出產品，Sheryl，我想我想原諒我，因為我知道您剛剛我想確保我理解所以誠實地說，嘿，我們正在引起興趣。我們仍然非常熱情，但我們仍然有所保留。

Could you one more time sort of walk me through exactly why is there an issue in terms of the way you're delivering this product. Can you just talk about what what the holding, but essentially the catalyst for the hold?

您能否再一次詳細地向我解釋一下您交付該產品的方式存在問題的原因。您能否簡單談談持有的是什麼，但本質上是持有的催化劑？

Absolutely.

絕對地。

I mean, we've very purposely in each of our product launches in the in the years that I've been here, I've done limited market releases in order to get feedback from a limited group of surgeons. Some of them are the designing surgeons that we work with primarily around the instrumentation and delivery systems, surgical technique, elements like that with integrity, we took a very specific approach around designing a surgical technique that had ease of use arthroscopic instrumentation and fixation, the regenerative patch itself. His is doing great. And again, you know, from us from a patient perspective, we're hearing great things clinically also from the patch perspective around its manipulate ability under Arthur spoke in wet conditions, its strength, its regenerative capacity in terms of the patient outcomes. We always know when launching a new system that there are going to be tweaks that you want to make to the instrumentation. And before we do do a build that will allow us to go out to the full market we want to make sure that those tweaks are complete. And so that is what we're doing right now. We're absolutely on track for doing it. There were minor tweaks that that we got feedback on they're being implemented and then we'll do a much larger build inventory build around that so that we have the inventory with the finalized instrumentation ready to go about midway through the year. And my commentary about intentionally limiting is because we are feeling such a pull from the market with the limited group of surgeons that have been doing this the word is out the surgeons that have seen this product in training and at meetings like the Academy are chomping at the bit to get it in their hands and so we just want to make sure that those tweaks are done on the instrumentation and then the full inventory build that we do around that full-market release incorporates those. So it is all on track. It is all as planned, and it is sort of the normal way that we like to do a good robust product launch here.

我的意思是，在我任職的這些年裡，我們非常有目的地推出每一款產品，我進行了有限的市場發布，以便從有限的外科醫生群體中獲得反饋。其中一些是設計外科醫生，我們主要圍繞器械和輸送系統、手術技術、諸如此類的完整性要素進行合作，我們採取了一種非常具體的方法來設計一種易於使用的關節鏡器械和固定的手術技術，再生補丁本身。他的表現很棒。再說一次，你知道，從我們病人的角度來看，我們從貼片的角度也聽到了臨床上的偉大事情，圍繞著亞瑟在潮濕條件下講話時的操縱能力、它的強度、它在患者結果方面的再生能力。我們總是知道，在啟動新系統時，您需要對儀器進行調整。在我們進行建造以使我們能夠進入整個市場之前，我們希望確保這些調整已經完成。這就是我們現在正在做的事情。我們絕對走在實現這目標的正軌上。我們收到了有關它們正在實施的反饋，進行了一些細微的調整，然後我們將圍繞這些進行更大的構建庫存，以便我們擁有最終儀器的庫存，準備在今年中期使用。我對故意限制的評論是因為我們感受到市場的拉力，一直在做這件事的外科醫生數量有限，在培訓和像學院這樣的會議上看到過這個產品的外科醫生都在咬緊牙關。所以我們只是想確保這些調整是在儀器上完成的，然後我們圍繞整個市場發布所做的完整庫存構建包含了這些。所以一切都步入正軌。一切都按計劃進行，這是我們喜歡在這裡進行良好穩健的產品發布的正常方式。

Curious And I you would communicate it all that you had hopes that integrity at least word of care. And I was just curious, I mean, have you gotten any?

好奇，我會傳達你所希望的一切，至少是正直的關懷。我只是很好奇，我的意思是，你收到了嗎？

Yes, we wouldn't.

是的，我們不會。

Anyway, sorry, bolster your confidence or it well that, hey, there really.

不管怎樣，抱歉，增強你的信心，否則很好，嘿，真的。

I think there's a genuine feedback from the surgeons that have used the system that this is of a highly differentiated product in all the aspects I mentioned and I won't repeat, although I love repeating it because we spent so much time, I think developing a really great system and frankly, a really great set of technologies around the integrity implant itself that we intend on leveraging for additional near term regenerative pipeline activities. So yes, I think the answer is absolutely yes. And I think that's evidenced by the fact that we've done well over 100 surgeries since late November, which is a ramp that is really nice even in a win, especially actually in a limited market release last one and I'll jump off.

我認為使用該系統的外科醫生給出了真實的反饋，即在我提到的所有方面，這是一個高度差異化的產品，我不會重複，儘管我喜歡重複它，因為我們花了很多時間，我認為開發這是一個非常出色的系統，坦白說，這是圍繞完整性植入物本身的一套非常出色的技術，我們打算利用這些技術來進行其他近期的再生管道活動。所以是的，我認為答案是絕對肯定的。我認為，自11 月下旬以來，我們已經完成了100 多例手術，這一事實證明了這一點，即使在勝利的情況下，這也是一個非常好的斜坡，尤其是在最後一次有限的市場發布中，我會跳下去。

Can you just talk about because it doesn't it doesn't come up come up very often. These conference calls as you think about the longer-term opportunities for Heiler fast in the US. Can you just talk about why this also could be sort of a needle mover for the company longer term place in the market and why why it could matter?

你能簡單談談嗎，因為它不會經常出現。這些電話會議讓您思考 Heiler fast 在美國的長期機會。您能否談談為什麼這也可能對公司在市場中的長期地位產生推動作用以及為什麼它可能很重要？

Yes. Yes.

是的。是的。

Absolutely.

絕對地。

First and foremost, this is a product that's been for sale for over 15 years outside the United States. And in fact, we'll have 15-year data published on high-low fast likely this year. There's a there's a paper that is going through the review process right now. That's fairly unusual when you get to a product launch in the United States. We've got over 40 clinical publications on the product. We know how well it works. We have a lot of clinical data already. We also know what the United States market looks like. And the market leader in the US today is a product that is a two stage procedure requires two separate surgeries. It's very costly it's a product that requires the patient to go through two sets of rehab and sign up for a second surgery process is going to be a single stage. So off-the-shelf one surgery available when a surgeon is in process of doing its scope and sees a cartilage defect to be able to pull it off the shelf and use it in the surgery that they're in. There's also we think, a significant unmet need that's not being met today because the current market leader and really the technology requires a second surgery. And in the expense of it is another factor. And so there's a well established market in the United States today, but we think there's a market expansion opportunity for a product that's available off the shelf that just doesn't exist today with the current product and the current market leader. So yes, we're very bullish on pilot tests for all of those reasons.

首先，該產品已在美國境外銷售超過 15 年。事實上，今年我們可能會發布 15 年的數據，數據可能會從高到低快速變化。有一篇論文正在審查中。當你在美國發布產品時，這是相當不尋常的。我們已經發表了 40 多篇關於該產品的臨床出版物。我們知道它的效果如何。我們已經有很多臨床數據。我們也知道美國市場是什麼樣的。今天美國的市場領導者是一種兩階段手術的產品，需要兩次單獨的手術。這是一種非常昂貴的產品，需要患者經過兩套復健治療並報名參加第二次手術，過程將是一個階段。因此，當外科醫生在進行範圍檢查並發現軟骨缺損時，可以將現成的手術從架子上拉下來並在他們正在進行的手術中使用。我們還認為，一個重大的未滿足需求今天尚未得到滿足，因為當前的市場領導者和真正的技術需要進行第二次手術。其代價是另一個因素。因此，今天在美國有一個成熟的市場，但我們認為，對於現成的產品來說，存在市場擴張的機會，而目前的產品和當前的市場領導者並不存在這種機會。所以，是的，出於所有這些原因，我們非常看好試點測試。

Great.

偉大的。

Thank you.

謝謝。

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

女士們、先生們，今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。