Anika Therapeutics Inc (ANIK) 2023 Q1 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to Anika's First Quarter 2023 Earnings Conference Call. (Operator Instructions) This call is being recorded on Tuesday, May 9, 2023.

女士們、先生們，下午好，歡迎參加 Anika 2023 年第一季度收益電話會議。 （操作員說明）此通話錄音時間為 2023 年 5 月 9 日星期二。

I will now turn the call over to Mr. Mark Namaroff, Vice President, Investor Relations, ESG and Corp Communications. Please go ahead.

我現在將把電話轉給投資者關係、ESG 和企業傳播部副總裁 Mark Namaroff 先生。請繼續。

Thank you. Good afternoon, everyone. Thank you for joining us for Anika's first quarter conference call and webcast. Our Q1 earnings press release was issued after the close of the market today and is available on our Investor Relations website located at anika.com as our supplementary PowerPoint slides that we used for the discussion today.

謝謝。大家下午好。感謝您參加 Anika 第一季度的電話會議和網絡廣播。我們的第一季度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 anika.com 上獲取，作為我們今天討論時使用的補充 PowerPoint 幻燈片。

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 the slide presentation and refer to Slide #2.

今天與我一起參加電話會議的是總裁兼首席執行官謝麗爾·布蘭查德 (Cheryl Blanchard) 博士；執行副總裁、首席財務官兼財務主管 Mike Levitz。請花點時間打開幻燈片演示並參考幻燈片 #2。

Before we begin, please understand that certain statements made today during the call 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 results could differ 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 the forward-looking statements presented today. Please also see our most recent SEC filings for more information about risk factors that could affect our performance.

在我們開始之前，請理解今天在電話會議期間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。這些陳述基於我們當前的信念和預期，並受到某些風險和不確定性的影響。公司的實際結果可能與任何預期的未來結果、業績或成就存在重大差異。如果未來的財務數據或事件與今天提出的前瞻性陳述不同，我們沒有義務更新這些陳述。另請參閱我們最近向 SEC 提交的文件，了解有關可能影響我們業績的風險因素的更多信息。

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. But when considered with GAAP financial measures, the reconciliation of GAAP measures, they provide an even more complete understanding of our business. The reconciliation of these adjusted non-GAAP financial measures to the most comparable GAAP measurements are available at the end of the presentation slide deck and our first quarter 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措施。我們相信，非公認會計原則衡量標準提供了另一種查看我們運營和績效方面的方式。但當考慮到 GAAP 財務指標、GAAP 指標的調節時，它們可以讓我們更全面地了解我們的業務。這些調整後的非 GAAP 財務指標與最具可比性的 GAAP 指標的對賬可在演示幻燈片和我們 2023 年第一季度新聞稿的末尾找到。

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

現在我想將電話轉給我們的總裁兼首席執行官謝麗爾·布蘭查德博士。謝麗爾？

Thanks, Mark. Good afternoon, everyone, and thanks for joining us. Please turn to Slide 3.

謝謝，馬克。大家下午好，感謝您加入我們。請翻到幻燈片 3。

We're pleased to report that Anika had a positive start to the year. While our reported revenue showed growth of 3%, the core parts of our business were up 9% in Q1 as we've seen the environment for some orthopedic elective procedures improving. Osteoarthritis Pain Management revenue was stronger than expected in the quarter and remains a market-leading business that continues to win globally.

我們很高興地報告，阿尼卡今年取得了積極的開局。雖然我們報告的收入增長了 3%，但我們的核心業務在第一季度增長了 9%，因為我們看到一些骨科擇期手術的環境有所改善。本季度骨關節炎疼痛管理收入強於預期，仍然是市場領先的業務，並繼續在全球範圍內獲勝。

We were excited to see double-digit growth in Joint Preservation and Restoration in the quarter, which included early traction from our recent product launches with X-Twist and RevoMotion and international growth, driven by geographic expansion and timing. Our OA Pain Business, including our sales and marketing partnership with J&J Mitek for Monovisc and Orthovisc in the U.S. continues to provide a healthy financial foundation to support the investments driving our growth strategy. In addition to our market-leading products in the U.S., we're also particularly pleased with our strong international performance as we grow market share of our OA pain products, especially Cingal as more and more clinicians and their osteoarthritis patients realize the benefits of this truly next-generation non-opioid OA pain product.

我們很高興看到本季度關節保護和修復業務實現兩位數增長，其中包括我們最近推出的 X-Twist 和 RevoMotion 產品帶來的早期牽引力，以及地理擴張和時機推動的國際增長。我們的 OA 疼痛業務，包括我們與 J&J Mitek 在美國的 Monovisc 和 Orthovisc 的銷售和營銷合作夥伴關係，繼續提供健康的財務基礎，以支持推動我們增長戰略的投資。除了我們在美國市場領先的產品外，我們還對我們強勁的國際業績感到特別滿意，因為我們的 OA 疼痛產品的市場份額不斷增加，尤其是 Cingal，因為越來越多的臨床醫生及其骨關節炎患者認識到該產品的好處真正的下一代非阿片類 OA 疼痛產品。

With respect to Cingal, we are actively engaging with the FDA regarding next steps for U.S. regulatory approval and exploring commercial partnerships to advance Cingal in the U.S. and select Asian markets. We're excited about our continued progress and momentum in our Joint Preservation and Restoration portfolio. We had great traffic and training opportunities at our booth at the American Academy of Orthopedic Surgeons meeting in March, with a lot of interest across our full Joint Preservation portfolio.

就 Cingal 而言，我們正在積極與 FDA 合作，討論美國監管部門批准的後續步驟，並探索商業合作夥伴關係，以推動 Cingal 在美國和部分亞洲市場的發展。我們對聯合保護和修復投資組合的持續進步和勢頭感到興奮。在三月份的美國骨科醫師學會會議上，我們的展位擁有良好的人流量和培訓機會，人們對我們完整的關節保護產品組合產生了濃厚的興趣。

We're building traction and adoption as we continue to hear great feedback from surgeons following the Q1 full market release of X-Twist, Anika's cornerstone suture anchor system as we increase awareness and educate surgeons about its flexibility and surgical versatility across procedures in the shoulder and the foot and ankle.

隨著 Anika 的基石縫合錨釘系統 X-Twist 第一季度全面上市後，我們不斷收到外科醫生的良好反饋，我們正在建立牽引力和採用率，同時我們提高了外科醫生的認識，並對其在肩部手術中的靈活性和手術多功能性進行了教育以及腳和腳踝。

We're receiving great early clinical feedback following the successful limited launch of our new RevoMotion reverse shoulder system, which significantly expands our shoulder arthroplasty portfolio. Patients are doing well in their early post-op visits, some now out to 4 months, and surgeons are extremely pleased with the post-op X-rays. We look forward to build momentum ahead of a full launch, which we're continuing to target towards the end of this year.

在成功有限推出新的 RevoMotion 反向肩關節系統後，我們收到了很好的早期臨床反饋，該系統顯著擴展了我們的肩關節置換術產品組合。患者在術後早期就診時表現良好，有些患者現在已經到了 4 個月，外科醫生對術後 X 光檢查非常滿意。我們期待在全面推出之前積聚動力，我們的目標是在今年年底全面推出。

Tactoset, Anika's regenerative solution for insufficiency fractures and hardware augmentation received an additional 510(k) clearance, further building the Tactoset franchise. Tactoset is now cleared for use with autologous bone marrow aspirate, a key component in regenerative healing.

Tactoset 是 Anika 針對骨折不全和硬件增強的再生解決方案，獲得了額外的 510(k) 許可，進一步建立了 Tactoset 專營權。 Tactoset 現已獲准與自體骨髓抽吸物一起使用，這是再生癒合的關鍵成分。

I'm also happy to welcome Gary Fischetti, who is appointed as a new independent director in April. Gary brings decades of relevant experience in the medical device industry, including more than 35 years at Johnson & Johnson with both domestic and international leadership responsibilities. And we look forward to leveraging his expertise as we advance our strategy and capture the significant opportunities ahead.

我也很高興歡迎加里·菲謝蒂 (Gary Fischetti)，他於四月份被任命為新的獨立董事。 Gary 在醫療器械行業擁有數十年的相關經驗，其中包括在強生公司工作超過 35 年，擔任國內和國際領導職務。我們期待利用他的專業知識來推進我們的戰略並抓住未來的重大機遇。

Now moving on to Slide 4. Over the past 3 years, we've been investing with purpose to fundamentally reposition Anika to be a global leader in joint preservation with a focus on early intervention orthopedics, leveraging our core expertise in hyaluronic acid and our design heritage of early intervention bone-sparing devices. Our efforts have successfully expanded Anika's market opportunity from $1 billion to more than $8 billion today and created a powerful growth engine for years to come as we remain focused on launching new products in the high opportunity spaces and faster-growing segments within orthopedics.

現在轉到幻燈片 4。在過去 3 年裡，我們一直在投資，目的是從根本上將 Anika 重新定位為關節保存領域的全球領導者，重點關注早期干預骨科，利用我們在透明質酸和設計方面的核心專業知識早期干預骨保留裝置的遺產。我們的努力成功地將 Anika 的市場機會從 10 億美元擴大到今天的超過 80 億美元，並為未來幾年創造了強大的增長引擎，因為我們仍然專注於在骨科領域的高機會領域和快速增長的領域推出新產品。

The first update is for Tactoset. As a reminder, Tactoset is an important franchise we're building and a product we continue to get great clinical feedback on. We're now in the process of launching the new indication for use with bone marrow aspirate as we continue to expand our portfolio for regenerative healing with an additional 510(k) planned.

第一個更新是針對 Tactoset 的。提醒一下，Tactoset 是我們正在打造的一個重要的特許經營產品，也是我們不斷獲得良好臨床反饋的產品。我們現在正在推出與骨髓抽吸物一起使用的新適應症，同時我們還計劃增加 510(k) 計劃，繼續擴大我們的再生癒合產品組合。

Moving on to X-Twist. Now that we're in full market release, we are also developing a biocomposite version as we continue to expand on our differentiated suture anchor platform. As we announced last quarter, we've developed a new hyaluronic acid-based arthroscopic regenerative rotator cuff patch system which will further strengthen Anika's growing and differentiated shoulder portfolio.

繼續 X-Twist。現在我們已全面上市，隨著我們繼續擴展我們的差異化縫合錨平台，我們還在開發生物複合材料版本。正如我們上季度宣布的那樣，我們開發了一種新的基於透明質酸的關節鏡再生肩袖補片系統，該系統將進一步加強 Anika 不斷增長的差異化肩部產品組合。

We've initially designed the patch for the shoulder to provide augmentation to the tendon to support healing for rotator cuff tears. Anika's patch is mechanically stronger and further improves regenerative capacity compared with the first-generation collagen patches on the market. We completed multiple 510(k) submissions at the end of 2022 ahead of a planned launch next year. We'll share additional details about the product once the entire system has been cleared, and we're gearing up for first surgeries.

我們最初設計了肩部補片，以增強肌腱，以支持肩袖撕裂的癒合。與市場上的第一代膠原蛋白貼片相比，Anika 的貼片機械強度更強，並進一步提高了再生能力。我們在 2022 年底完成了多項 510(k) 提交，計劃於明年推出。一旦整個系統清理完畢，我們將分享有關該產品的更多詳細信息，並且我們正在為第一次手術做準備。

In short, we believe our regenerative patch will be a game changer for patients and Anika as it helps complete an innovative and highly differentiated shoulder portfolio. We are also advancing our longer-term opportunities, which will further augment and reinforce Anika's growth once they're available in the U.S.

簡而言之，我們相信我們的再生貼片將改變患者和 Anika 的遊戲規則，因為它有助於完成創新且高度差異化的肩部產品組合。我們還在推進我們的長期機會，一旦這些機會在美國上市，這將進一步增強和加強 Anika 的增長。

In addition to our active engagement with the FDA regarding next steps for Cingal approval, which we believe could potentially double our $1 billion addressable market in OA Pain, we're working to enroll the final subject in the pivotal Phase III clinical trial for HYALOFAST, our highly differentiated single-stage off-the-shelf cartilage repair product.

除了我們積極與 FDA 就 Cingal 批准的後續步驟進行接觸之外（我們相信這可能會使我們在 OA 疼痛領域 10 億美元的潛在市場增加一倍），我們正在努力將最終受試者納入 HYALOFAST 的關鍵 III 期臨床試驗，我們高度差異化的單階段現成軟骨修復產品。

Last quarter, we announced that HYALOFAST was designated as a breakthrough device by the FDA, allowing for prioritized interaction and review to enable patients faster access to new therapies. We remain on track to file a PMA for HYALOFAST in 2025. And given its differentiation as a single-stage off-the-shelf solution, we believe that HYALOFAST has significant market-expanding potential.

上季度，我們宣布 HYALOFAST 被 FDA 指定為突破性設備，允許優先互動和審查，使患者能夠更快地獲得新療法。我們仍有望在 2025 年為 HYALOFAST 提交 PMA。鑑於其作為單級現成解決方案的差異化，我們相信 HYALOFAST 具有巨大的市場拓展潛力。

As you can see on Slide 5, we're focused on building a robust and differentiated shoulder portfolio by providing solutions for the full spectrum of rotator cuff pathologies that brings a unique value proposition to surgeons across the ASC and hospital settings. This positions Anika for continued growth as we capitalize on the approximately $2 billion market opportunity across the shoulder continuum of care. Prevalence and progression of rotator cuff disease needs multiple strategies and solutions, which Anika is addressing through our comprehensive portfolio of products across sports medicine, regenerative solutions and Arthrosurface joint solutions.

正如您在幻燈片 5 中所看到的，我們致力於通過為全方位的肩袖病變提供解決方案來構建強大且差異化的肩部產品組合，為 ASC 和醫院環境的外科醫生帶來獨特的價值主張。隨著我們利用肩部連續護理中約 20 億美元的市場機會，這使 Anika 能夠持續增長。肩袖疾病的流行和進展需要多種策略和解決方案，Anika 正在通過我們涵蓋運動醫學、再生解決方案和關節表面關節解決方案的全面產品組合來解決這個問題。

RevoMotion is a highly differentiated reverse shoulder system that now gives Anika access to the full shoulder replacement market with a focus on a bone-sparing design and a streamlined 2-instrument tray system. The launch of RevoMotion has dramatically enhanced the opportunity to drive our Arthrosurface Joint Solutions products specifically OVOMotion and Inlay Glenoid, our total shoulder system.

RevoMotion 是一款高度差異化的反向肩關節系統，現在使 Anika 能夠進入全肩關節置換市場，重點關注骨保留設計和流線型 2 器械托盤系統。 RevoMotion 的推出極大地增加了驅動我們的關節表面關節解決方案產品的機會，特別是 OVOMotion 和 Inlay Glenoid（我們的全肩部系統）。

In sports medicine, our X-Twist design facilitates soft tissue repairs that other systems are unable to accommodate. We're adding new surgeon accounts and surgery centers as the product gains acceptance and we drive deeper penetration into those accounts.

在運動醫學領域，我們的 X-Twist 設計有助於軟組織修復，這是其他系統無法實現的。隨著產品獲得認可，我們正在增加新的外科醫生賬戶和手術中心，並推動對這些賬戶的更深入滲透。

On the regenerative side, we offer the innovative solution of Tactoset to augment hardware, specifically with suture anchors when surgeons encounter poor quality bone. This provides a truly meaningful solution to achieve a strong repair. With the recent launch of X-Twist, we now have the opportunity to cross-sell Tactoset for augmentation, providing an additional growth driver as Anika products are used in more rotator cuff procedures.

在再生方面，我們提供 Tactoset 的創新解決方案來增強硬件，特別是當外科醫生遇到質量較差的骨骼時使用縫合錨釘。這為實現強力修復提供了真正有意義的解決方案。隨著最近推出 X-Twist，我們現在有機會交叉銷售用於增強的 Tactoset，隨著 Anika 產品在更多肩袖手術中的使用，提供了額外的增長動力。

Finally, as we look to its planned launch in 2024, our HA-based arthroscopic regenerative rotator cuff patch system provides a strong foundation in regeneration alongside Tactoset. Given the attractive market for regenerative patches, we believe this arthroscopic system has expansion opportunities beyond the shoulder and will also be a key driver for growth.

最後，當我們計劃於 2024 年推出時，我們基於 HA 的關節鏡再生肩袖補片系統與 Tactoset 一起為再生提供了堅實的基礎。鑑於再生補片市場的吸引力，我們相信這種關節鏡系統具有超越肩部的擴展機會，也將成為增長的關鍵驅動力。

With that overview, I will now turn it over to Mike for a review of our first quarter 2023 financial performance. Mike?

有了這個概述，我現在將其交給 Mike，讓他審查我們 2023 年第一季度的財務業績。麥克風？

Thank you, Cheryl. Please turn to Slide 6. I will now walk you through our financial results for the first quarter of 2023. .

謝謝你，謝麗爾。請轉到幻燈片 6。我現在將向您介紹我們 2023 年第一季度的財務業績。

I'd like to remind everyone that beginning in the first quarter, veterinary sales historically reported within OA Pain Management are now included in the non-orthopedic product family for all periods presented.

我想提醒大家，從第一季度開始，OA 疼痛管理中歷史上報告的獸醫銷售額現在已包含在所有時期的非骨科產品系列中。

Total revenue for the quarter was $37.9 million, an increase of 3% over the prior year as continued growth in OA Pain Management and accelerated double-digit growth in Joint Preservation and Restoration were partially offset by lower ancillary nonorthopedic revenues. The lower nonorthopedic revenues reduced total company growth in the quarter by approximately 6 percentage points.

本季度總收入為 3790 萬美元，比上年增長 3%，因為 OA 疼痛管理業務的持續增長以及關節保護和修復業務的兩位數加速增長被輔助非骨科收入的下降部分抵消。非骨科收入的下降使該季度公司總體增長下降了約 6 個百分點。

Revenue in our largest product family, OA Pain Management, increased 8% to $22.6 million due primarily to favorable ordering patterns from J&J Mitek and sales growth on increasing customer demand. As a reminder, revenues can vary significantly on a quarterly basis based on ordering patterns by our partner in the U.S. and distributors internationally. However, that quarterly volatility generally stabilizes on an annual basis.

我們最大的產品系列 OA 疼痛管理的收入增長了 8%，達到 2,260 萬美元，這主要歸功於 J&J Mitek 有利的訂購模式以及客戶需求增加帶來的銷售增長。請注意，根據我們在美國的合作夥伴和國際分銷商的訂購模式，每個季度的收入可能會有很大差異。然而，季度波動性通常會在年度基礎上趨於穩定。

Our Joint Preservation and Restoration revenue in the quarter increased 11% to $13.5 million on growth from our new products as well as geographic expansion and favorable order timing internationally. Our nonorthopedic revenue declined 49% to $1.8 million primarily reflecting unfavorable order timing by our veterinary distributor as well as our exit from legacy product lines that do not support our growth and profitability objectives.

由於新產品的增長以及地域擴張和國際上有利的訂單時機，本季度我們的聯合保護和修復收入增長了 11%，達到 1,350 萬美元。我們的非骨科收入下降了 49% 至 180 萬美元，主要反映了我們的獸醫分銷商的不利訂單時機以及我們退出了不支持我們的增長和盈利目標的傳統產品線。

Our gross margin in the first quarter was 60% and includes the impact of $1.6 million of noncash acquisition-related expense amortization from the 2020 acquisitions of Arthrosurface and Parcus Medical. Our adjusted gross margin, which excludes the acquisition-related amortization, was 64% in the quarter, in line with the same quarter last year.

我們第一季度的毛利率為 60%，其中包括 2020 年收購 Arthrosurface 和 Parcus Medical 帶來的 160 萬美元非現金收購相關費用攤銷的影響。本季度調整後毛利率（不包括收購相關攤銷）為 64%，與去年同期持平。

From a spending standpoint, our operating expenses totaled $35.4 million in the first quarter, up from $25.4 million in the same period of 2022. Our operating expenses in the quarter included $5.8 million of nonrecurring corporate costs, including a charge for $3.25 million related to our arbitration settlement in April to close any further claims from the 2020 acquisition of Parcus Medical; $800,000 of costs related to shareholder activism, which was also resolved in April as well as $1.7 million of other nonrecurring corporate costs. Apart from these nonrecurring costs, our operating expense growth in the quarter reflects increased cost to comply with expanded global regulatory requirements and investments in operational capabilities to support our sustainable growth, the majority of which are associated with our OA Pain Management and other legacy products as well as new product development and expanded marketing in support of key product launches.

從支出角度來看，我們第一季度的運營支出總計 3540 萬美元，高於 2022 年同期的 2540 萬美元。我們本季度的運營支出包括 580 萬美元的非經常性企業成本，其中包括與我們的業務相關的 325 萬美元費用。 4 月份達成仲裁和解，以了結 2020 年收購 Parcus Medical 的任何進一步索賠；與股東激進主義相關的 80 萬美元成本以及 170 萬美元的其他非經常性公司成本也在 4 月份得到解決。除了這些非經常性成本外，我們本季度的運營費用增長還反映了為遵守擴大的全球監管要求而增加的成本以及為支持我們的可持續增長而對運營能力進行的投資，其中大部分與我們的 OA 痛點管理和其他遺留產品相關，例如以及新產品開發和擴大營銷，以支持關鍵產品的發布。

Our net loss for the quarter was $10.4 million or $0.71 per share compared to net loss of $2.9 million or $0.20 per share in the first quarter of last year. Our adjusted net loss was $5.3 million or $0.36 per share compared to our adjusted net loss of $1.6 million or $0.11 per share in the prior year. Again, our lower bottom line reflects the impact of the significant nonrecurring expenses incurred in the quarter as well as the increased spending to support the continued sustainable growth of our legacy product lines as well as our growth acceleration initiatives.

我們本季度的淨虧損為 1040 萬美元，即每股 0.71 美元，而去年第一季度的淨虧損為 290 萬美元，即每股 0.20 美元。我們調整後的淨虧損為 530 萬美元，即每股 0.36 美元，而上一年調整後的淨虧損為 160 萬美元，即每股 0.11 美元。同樣，我們較低的利潤反映了本季度發生的重大非經常性費用以及為支持我們的傳統產品線的持續可持續增長以及我們的增長加速計劃而增加的支出的影響。

Our adjusted EBITDA in the quarter was a negative $1.2 million, down from adjusted EBITDA generated of $2.6 million in the first quarter of last year. The decrease in adjusted EBITDA was primarily due to $1.7 million of nonrecurring corporate costs, as well as the cost to comply with expanded global regulatory requirements and expansion of our operational capabilities to support our continued growth.

本季度調整後 EBITDA 為負 120 萬美元，低於去年第一季度調整後 EBITDA 的 260 萬美元。調整後 EBITDA 的下降主要是由於 170 萬美元的非經常性企業成本，以及遵守擴大的全球監管要求和擴大我們的運營能力以支持我們持續增長的成本。

Lastly, with regards to our cash flow and capital structure. Anika's balance sheet remains strong with $79.7 million in cash and no outstanding debt as of March 31. We had operating cash outflows of $3.6 million during the first quarter compared to outflows of $1.9 million in the prior year period. And our capital expenditures in the quarter totaled $1.4 million, up slightly from $1.3 million last year, reflecting investments in support of our new product launches and overall business growth.

最後，關於我們的現金流和資本結構。截至 3 月 31 日，Anika 的資產負債表依然強勁，現金為 7,970 萬美元，沒有未償債務。第一季度我們的經營現金流出為 360 萬美元，而上年同期流出為 190 萬美元。本季度我們的資本支出總計 140 萬美元，略高於去年的 130 萬美元，反映了支持我們新產品發布和整體業務增長的投資。

We also recently announced that in April, our Board of Directors authorized a new stock repurchase program of $20 million, with the first $10 million split between an accelerated stock repurchase program and an open market program and the second $10 million through an open market program subject to positive cash flows.

我們最近還宣布，四月份，我們的董事會批准了一項 2000 萬美元的新股票回購計劃，其中第一筆 1000 萬美元在加速股票回購計劃和公開市場計劃之間分配，第二筆 1000 萬美元通過公開市場計劃主題分配為正現金流。

Please turn to Slide 7. Now I'd like to review our full year financial outlook for fiscal year 2023. Based on our progress to date, we are reiterating our full year 2023 total company revenue outlook of $158 million to $163 million, representing growth of 1% to 4% compared to 2022 and reiterating our outlook by product family as continued growth in OA Pain Management and accelerated double-digit growth in Joint Preservation and Restoration are partially offset by lower ancillary nonorthopedic revenues. The lower nonorthopedic revenues reduced total company growth by approximately 3 to 4 percentage points.

請轉到幻燈片 7。現在我想回顧一下我們 2023 財年的全年財務前景。根據迄今為止的進展，我們重申 2023 年全年公司總收入前景為 1.58 億美元至 1.63 億美元，代表著增長與 2022 年相比，增長 1% 至 4%，並重申我們對產品系列的展望，因為 OA 疼痛管理的持續增長和關節保護和修復的加速兩位數增長被輔助非骨科收入的下降部分抵消。非骨科收入的下降使公司總體增長下降了約 3 至 4 個百分點。

In OA Pain Management, we expect revenue of $93.5 million to $96 million, up 2% to 4% over 2022 as our market-leading products continue to gain adoption globally, but also reflects favorable international timing last year from a comparative standpoint.

在 OA 疼痛管理方面，隨著我們市場領先的產品繼續在全球範圍內得到採用，我們預計 2022 年收入將達到 9350 萬美元至 9600 萬美元，比 2022 年增長 2% 至 4%，但從比較的角度來看，這也反映了去年有利的國際時機。

With the timing of multiple product launches this year in Joint Preservation and Restoration, we expect full year 2023 revenue growth to accelerate to $55.5 million to $58 million, up 10% to 15% over last year, with that growth weighted more towards the second half of the year. We expect nonorthopedic revenue to decrease approximately 35% to $9 million as we anniversary out of revenues in the prior year from last time buys of legacy products we exited and reflecting order timing in veterinary sales last year.

隨著今年聯合保護和修復領域推出多種產品，我們預計 2023 年全年收入增長將加速至 5550 萬美元至 5800 萬美元，比去年增長 10% 至 15%，其中下半年的增長更為重要今年的。我們預計非骨科收入將減少約 35% 至 900 萬美元，因為我們去年退出了上次購買遺留產品的收入周年紀念日，這反映了去年獸醫銷售的訂單時間。

With regard to gross margin, we continue to expect adjusted gross margin for the year to be roughly in line with last year's gross margin as we remain focused on driving margin expansion, but also anticipate the ongoing headwinds from the global trends in supply chain and staffing challenges will likely continue.

關於毛利率，我們繼續預計今年調整後的毛利率將與去年的毛利率大致一致，因為我們仍然專注於推動利潤率擴張，但也預計全球供應鍊和人員配置趨勢將持續帶來阻力挑戰可能會持續下去。

With regards to spending, while spending will be higher in the first half of the year due to a number of nonrecurring situations such as the Parcus Medical arbitration and shareholder activism, now that we have settled both of those in the second quarter, we expect operating expenses to normalize in the second half of 2023. We continue to expect operating expenses for fiscal 2023 to increase over 2022 as a percentage of revenue as we self-fund our growth strategy, including both the cost to comply with expanded regulations globally and investments in operational capabilities, the majority of which are associated with our OA Pain Management and legacy products as well as our product development and launch initiatives to drive accelerated growth.

在支出方面，雖然由於 Parcus Medical 仲裁和股東激進主義等一些非經常性情況，今年上半年的支出將會更高，但既然我們已經在第二季度解決了這兩個問題，我們預計運營支出將會增加。費用將在 2023 年下半年正常化。我們繼續預計 2023 財年的運營費用佔收入的比例將比 2022 年有所增加，因為我們為增長戰略自籌資金，包括遵守全球範圍擴大的法規的成本以及對運營能力，其中大部分與我們的 OA 疼痛管理和遺留產品以及我們的產品開發和推出計劃相關，以推動加速增長。

We continue to expect our adjusted EBITDA margin for the year to be in the low single digits and capital expenditures to increase in 2023 above historic depreciation to support the rollout of key new product introductions and equipment to support our legacy business. Our team remains focused on both Anika's mission to restore active living and on driving value creation for our stakeholders, and we look forward to updating you on our continued execution of this strategy.

我們仍然預計，今年調整後的 EBITDA 利潤率將保持在較低的個位數，資本支出將在 2023 年增加到歷史折舊之上，以支持關鍵新產品的推出和設備的推出，以支持我們的傳統業務。我們的團隊仍然專注於 Anika 恢復積極生活的使命和為我們的利益相關者推動價值創造，我們期待向您通報我們繼續執行這一戰略的最新情況。

I will now turn the call back over to Cheryl.

我現在將把電話轉回給謝麗爾。

Thanks, Mike. Please turn to Slide 8. Before we open the call up for Q&A, I want to reiterate our excitement for the coming year. As our first quarter results demonstrate, we're just starting to realize the significant potential of our comprehensive and expanding portfolio. Our targeted investments have helped us build a uniquely focused joint preservation portfolio across the continuum of care and regenerative solutions, sports medicine and Arthrosurface joint solutions. Anika is well positioned to continue to execute on our growth strategy with multiple near-term value drivers, including the full market release of X-Twist now underway and of RevoMotion later this year, and the launch of our HA-based arthroscopic regenerative rotator cuff patch system in 2024. And finally, we have a healthy balance sheet with a solid cash position and no debt, positioning Anika to drive significant shareholder value. .

謝謝，邁克。請參閱幻燈片 8。在我們開始問答徵集之前，我想重申我們對來年的興奮。正如我們第一季度的業績所表明的那樣，我們剛剛開始意識到我們全面且不斷擴大的投資組合的巨大潛力。我們的針對性投資幫助我們建立了一個獨特的關節保護產品組合，涵蓋護理和再生解決方案、運動醫學和關節表面關節解決方案的連續性。 Anika 處於有利位置，可以繼續執行我們的增長戰略，包括多個近期價值驅動因素，包括目前正在進行的 X-Twist 和今年晚些時候的 RevoMotion 的全面市場發布，以及基於 HA 的關節鏡再生肩袖的推出2024 年修補系統。最後，我們擁有健康的資產負債表，現金狀況穩定且沒有債務，使 Anika 能夠推動顯著的股東價值。 。

I would like to take a moment to thank all of our employees for their continued hard work and dedication to supporting our efforts. We're building momentum as we work to achieve our mission of restoring active living for people around the world.

我想花一點時間感謝我們所有員工的持續辛勤工作和對支持我們努力的奉獻。我們正在積蓄動力，努力實現為世界各地的人們恢復積極生活的使命。

And with that, we'll open up the line for questions.

至此，我們將開通提問熱線。

(Operator Instructions) Your first question comes from the line of George Sellers from Stephens, Inc.

（操作員說明）您的第一個問題來自 Stephens, Inc. 的 George Sellers。

This is Harrison on for George. I wanted to start by asking you about what you're seeing in terms of procedures moving to the ASC specifically in terms of the reverse shoulder. I know the RevoMotion was designed with the ASC in mind. So what kind of impact are you seeing from that dynamic now while still in the limited market release? I mean how do you see that market moving longer term?

這是哈里森替補喬治。我想首先詢問您在轉向 ASC 的程序方面所看到的情況，特別是在反向肩部方面。我知道 RevoMotion 的設計考慮了 ASC。那麼，在市場發布有限的情況下，您認為這種動態會產生什麼樣的影響呢？我的意思是，您如何看待該市場的長期發展？

Thanks for the question, Harrison. It's a great question. And we did design RevoMotion with the ASC in mind. We are in our limited release, we are seeing procedures done in the ASC and the hospital setting. And the majority of that market, those procedures are still done in the hospital setting just because of the current situation with reimbursement from CMS.

謝謝你的提問，哈里森。這是一個很好的問題。我們在設計 RevoMotion 時就考慮到了 ASC。我們處於有限發布狀態，我們正在看到 ASC 和醫院環境中完成的程序。由於目前 CMS 報銷的情況，大部分市場中的這些手術仍然在醫院進行。

But the patients that qualify and the payers that are inclined in that direction will support those procedures being done in the ASC. So for our limited release surgeons, whatever their respective share of patients that they do in the ASC, we are seeing it being used there with really great feedback. And the feedback in general on that system has been very positive.

但符合資格的患者和傾向於此方向的付款人將支持在 ASC 中進行的這些程序。因此，對於我們的有限釋放外科醫生來說，無論他們在 ASC 中處理的患者比例如何，我們都看到它在那裡得到了非常好的反饋。對該系統的總體反饋非常積極。

I mentioned in my prepared remarks that we're seeing really great X-rays coming back from the surgeons. The surgeons are reporting that their patients are doing very well. Many of them out to 4 months at this point in time. And that the system is working very well in both the hospital and the ASC setting. So we look forward to continue to serving both of those call points with the opportunity for our system to really have uptake in that ASC because of the way it was designed.

我在準備好的發言中提到，我們看到外科醫生返回的 X 射線效果非常好。外科醫生報告說他們的病人情況很好。其中許多人此時的時間已經長達 4 個月。該系統在醫院和 ASC 環境中運行良好。因此，我們期待繼續為這兩個呼叫點提供服務，讓我們的系統有機會真正在 ASC 中得到應用，因為它的設計方式。

Yes. That's great. Sounds good. I had another question on Tactoset, the additional 510(k) clearance. I was wondering how we should think about that market opportunity? I know you've tagged Tactoset as a $100 million-plus market. Is that additional clearance going to be incremental to that $100,000 -- or sorry, $100 million market? Or is that just kind of filling out the market?

是的。那太棒了。聽起來不錯。我還有關於 Tactoset 的另一個問題，即額外的 510(k) 許可。我想知道我們應該如何看待這個市場機會？我知道您已將 Tactoset 標記為價值 1 億美元以上的市場。額外的許可是否會增加到 10 萬美元——或者抱歉，1 億美元的市場？或者這只是填補市場？

Yes. We really felt like bringing that bone marrow aspirate indication to Tactoset was still targeting that $100 million market and was an important part as we continue to build out that franchise. So I would think of that market opportunity really bringing that additional 510(k) clearance to fill out that full market of $100 million.

是的。我們真的覺得將骨髓抽吸指示引入 Tactoset 仍然是針對 1 億美元的市場，並且是我們繼續建立該特許經營權的重要組成部分。因此，我認為這個市場機會確實會帶來額外的 510(k) 許可，以填補 1 億美元的整個市場。

And your next question comes from the line of Mike Petusky from Barrington Research.

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

Yes, a couple of questions. Mike, on the R&D expense, when you refer to the global requirements, I'm assuming, is that an MDR or is there something else there that's driving incremental costs? And can you just speak to sort of what's the new normal in terms of R&D expense going forward?

是的，有幾個問題。邁克，關於研發費用，當您提到全球要求時，我假設是 MDR 還是有其他因素導致成本增加？您能否談談未來研發費用的新常態是什麼？

Mike, yes, you're absolutely right. The increased regulatory requirements are largely associated with MDR in Europe, but they're not limited to that. So we had in the quarter, about $800,000 of external spend alone related to MDR. We think it's going to be probably $3 million to $4 million for the full year because there is a bolus of costs associated with getting all of those filings in and all the associated testing and work to support those filings.

邁克，是的，你說得完全正確。監管要求的增加很大程度上與歐洲的 MDR 有關，但不僅限於此。因此，本季度我們僅與 MDR 相關的外部支出就約為 800,000 美元。我們認為全年的費用可能為 300 萬至 400 萬美元，因為提交所有這些文件以及支持這些文件的所有相關測試和工作會產生大量成本。

So it is definitely an incremental spend, and it's something that we would expect will come down over time as we get through this because a lot of that spend, the majority of that spend is related to our legacy products where we sell those in Europe and globally. But it's not just limited to MDR. So when we think about the incremental cost, there's the external cost associated with MDR, and then there's the internal costs to support all of that extra work, the complexities associated with that.

因此，這絕對是一項增量支出，隨著時間的推移，我們預計這會下降，因為其中很大一部分支出，大部分支出與我們在歐洲和歐洲銷售的遺留產品有關。全球。但這不僅限於 MDR。因此，當我們考慮增量成本時，首先是與 MDR 相關的外部成本，然後是支持所有額外工作的內部成本以及與之相關的複雜性。

And what we're seeing is the same discussions that you're hearing on the MDR side, you're seeing expanded global requirements. We're seeing expansion globally in our business, both in visco and in sports med, so between joint preservation and OA pain management. As we enter in these different countries, there's just more work and more complexity. So we've got the external costs associated with the MDR and then we've got the work internally supporting those. And those are the things that are driving the R&D cost up.

我們看到的討論與您在 MDR 方面聽到的討論相同，您看到了擴大的全球要求。我們看到我們的業務在全球範圍內擴張，包括粘性和運動醫學領域，以及關節保護和骨關節炎疼痛管理領域。當我們進入這些不同的國家時，工作量會增加，複雜性也會增加。因此，我們得到了與 MDR 相關的外部成本，然後我們得到了內部支持這些成本的工作。這些都是導致研發成本上升的因素。

So I mean $8.5 million, $9 million a quarter. I mean is that where we sort of -- sort of peg this going forward? Or I mean, can you just speak to that?

所以我的意思是每季度 850 萬美元、900 萬美元。我的意思是，這就是我們未來的發展方向嗎？或者我的意思是，你能談談這個嗎？

Yes. As I said, there's about -- so as I said, there's about $800,000 this quarter related to MDR. And I think it's going to go up and down on a quarterly basis depending on the work. I do expect it's going to be $3 million to $4 million of cost which is probably maybe $2 million or so higher than last year if you want to look at it from a run rate basis.

是的。正如我所說，本季度大約有 80 萬美元與 MDR 相關。我認為它會根據工作情況按季度上下浮動。我確實預計成本將達到 300 萬至 400 萬美元，如果您想從運行率的角度來看，這可能比去年高出 200 萬美元左右。

And then there's the -- as I said, the incremental costs associated with all the internal teamwork to manage all these different efforts. So -- we haven't given guidance specifically for the line items within OpEx. But I did reiterate our guidance expectation from a total EBITDA standpoint. So nothing has changed as it relates to our expectations for the year.

然後，正如我所說，與管理所有這些不同工作的所有內部團隊合作相關的增量成本。因此，我們沒有專門針對運營支出中的項目提供指導。但我確實從總體 EBITDA 的角度重申了我們的指導預期。因此，與我們今年的預期相關的一切都沒有改變。

Okay. And then I guess on Cingal, Cheryl, the conversation with the FDA, and I don't know how active these are. But I mean, when would you expect some road map as far as, hey, this is what you need to do or don't need to do sort of to move this forward down the track. I mean when do you think you'll have a sort of a sight line towards what you need to do?

好的。然後我猜想 Cingal、Cheryl 以及與 FDA 的對話，我不知道這些活動有多活躍。但我的意思是，你什麼時候會期望一些路線圖，嘿，這是你需要做或不需要做的事情，以推動這一進程向前發展。我的意思是，你認為什麼時候你會對你需要做的事情有一定的了解？

Yes. Great question. And we are actively engaging with FDA right now. It is difficult to predict timing in some cases with active interactions with the FDA. But I would tell you that those engagements are actively occurring. And I would look forward to being able to give an update to you all as soon as possible.

是的。很好的問題。我們現在正在積極與 FDA 合作。在某些情況下，很難預測與 FDA 積極互動的時間。但我想告訴你，這些接觸正在積極發生。我期待能夠盡快向大家通報最新情況。

Can I just ask you -- and I understand speculation, but I mean, do you think by the timing of the next conference call, you'd likely have a path forward? Or do you think it could drag throughout -- longer into the year?

我可以問你嗎——我理解猜測，但我的意思是，你認為在下一次電話會議的時間安排上，你可能會找到前進的道路嗎？或者你認為它會拖到今年更長的時間嗎？

Yes. I don't know that it's healthy for any of us for me to speculate on timing. Like I said, we are actively engaging with them. And I -- as soon as I have an update, I will provide it.

是的。我不知道我推測時機對我們任何人來說是否健康。正如我所說，我們正在積極與他們接觸。一旦有更新，我就會提供。

Would that be the kind of update that would wait until the conference -- quarterly conference call? Or would that actually be a press release?

這種更新會等到季度電話會議之後進行嗎？或者這實際上是一份新聞稿？

Not necessarily. It could be a press release. It could be an update that I give at a future investor conference. It just kind of depends on the timing of it and the content of it. But it doesn't necessarily have to wait until the next conference call.

不必要。這可能是一份新聞稿。這可能是我在未來的投資者會議上提供的更新。這只是取決於它的時間和內容。但不一定要等到下一次電話會議。

All right. And then I was just wondering -- and this may also be tough to provide. But obviously, love to hear any further commentary around the X-Twist. I know it's very early innings, probably the top of the first inning. But I mean anything you can say around number of docs that have tried the product, reorder rates? I mean any -- anything you can share there even anecdotally as far as what getting traction means?

好的。然後我只是想知道——這可能也很難提供。但顯然，我很高興聽到有關 X-Twist 的任何進一步評論。我知道現在是很早的幾局，可能是第一局的上半局。但我的意思是你能說的關於嘗試過該產品的文檔數量、重新訂購率嗎？我的意思是任何你可以在那里分享的東西，甚至是軼事，就獲得關注意味著什麼？

Yes. I mean, I guess what I would say is we are -- we really are building traction and adoption. We've done a lot of training. We are starting to see additional kind of depth in accounts with additional surgeons and ASCs that are beginning to use it. .

是的。我的意思是，我想我想說的是，我們確實正在建立吸引力和採用率。我們做了很多訓練。我們開始在更多的外科醫生和 ASC 開始使用它的賬戶中看到更多的深度。 。

It's still early days. We're a quarter into the full release. So that's why we're not providing like specific numbers at this point in time. But we are really getting a lot of very positive feedback on the product itself, and we are seeing really nice traction once adoption occurs within a given account. So I look forward to giving additional metrics on that going forward once we have a bit more of experience under our belt. We're just now one quarter into a full market release.

現在還為時尚早。完整版本已經發布了四分之一。這就是為什麼我們目前不提供具體數字的原因。但我們確實得到了很多關於產品本身的非常積極的反饋，而且一旦在給定帳戶中採用，我們就會看到非常好的吸引力。因此，一旦我們有了更多的經驗，我期待著在未來提供更多的指標。我們現在剛剛進入全面市場發布的四分之一。

So -- and then just last question on the -- obviously, balance sheet remains pristine. Are you guys seeing any interesting assets? Are you being shown things? What's the valuations? I mean, what -- is there anything you can sort of talk about there?

因此，最後一個問題顯然是，資產負債表仍然保持原始狀態。你們看到什麼有趣的資產了嗎？有人向你展示東西嗎？估值是多少？我的意思是，你有什麼可以在那裡談論的嗎？

Yes. We continue to look at opportunities that we think are on strategy for us. We feel like there are things that we will continue to look at, valuations remain high. And I've seen other CEOs make the same comment in the last couple of weeks with earnings calls.

是的。我們將繼續尋找我們認為符合我們戰略的機會。我們覺得有些事情我們會繼續關注，估值仍然很高。我看到其他首席執行官在過去幾週的財報電話會議上也發表了同樣的評論。

And at the same time, I think we have a pretty significant pipeline that we've developed that we're pretty focused on driving commercially right now. And I'm always balancing distraction with what we've got right in front of us. So we'll stay focused on what we've got coming into the market right now and continue to look at things that might be available out there from an inorganic perspective.

與此同時，我認為我們已經開發了相當重要的管道，我們現在非常專注於商業化。我總是在分心和眼前的事情之間取得平衡。因此，我們將繼續關注目前進入市場的產品，並繼續從無機角度研究可能存在的產品。

And your next question comes from the line of Jim Sidoti from Sidoti.

您的下一個問題來自 Sidoti 的 Jim Sidoti。

The settlement you made with the -- related to Parcus and the shareholders too, those were both completed in April. So I was surprised to see that they were on the March quarter income statement. Why was that?

您與 Parcus 和股東達成的和解也與 4 月份完成。所以我很驚訝地看到它們出現在三月份季度的損益表上。為什麼會這樣？

Jim, we will see costs associated with both of those in the first quarter and in the second quarter because you're absolutely right, they were both resolved in April. For the arbitration settlement, that was an ongoing contingency. And under GAAP, you would record that in the current open period. And so we recorded a settlement there of $3.25 million in the first quarter. .

吉姆，我們將在第一季度和第二季度看到與這兩個問題相關的成本，因為你說得完全正確，它們都在四月份得到了解決。對於仲裁和解而言，這是一個持續的意外事件。根據公認會計原則，您可以在當前開放期間記錄這一點。因此，我們第一季度的和解金額為 325 萬美元。 。

And we've broken that out separately and are excluding that from a non-GAAP basis. Also, in the first quarter, we had our own legal costs associated with Parcus arbitration and otherwise. And so we've kind of taken that amongst other related nonrecurring costs and call that out as $1.7 million in the quarter and not related to those legal costs and others that we believe to be nonrecurring.

我們已將其單獨列出，並將其排除在非公認會計準則基礎之外。此外，在第一季度，我們還產生了與 Parcus 仲裁及其他相關的法律費用。因此，我們將其與其他相關的非經常性成本一起考慮，並將其稱為本季度的 170 萬美元，與那些法律成本和我們認為是非經常性的其他成本無關。

So you've got that. And then we also incurred $800,000 of costs associated with the activist matter. That was costs incurred in the first quarter. We will have -- we estimate another maybe $2.5 million of nonrecurring costs in the second quarter. And that would include on the activist side, our cost as well as the cost that we are going to cover under the cooperation agreement that were incurred by the activists.

所以你已經得到了。然後我們還承擔了與維權事件相關的 80 萬美元費用。這是第一季度產生的成本。我們估計第二季度可能還會有 250 萬美元的非經常性成本。這將包括活動人士方面的成本，以及我們將根據合作協議承擔的活動人士產生的費用。

And then we also have the costs that we -- our internal legal costs associated with the Parcus arbitration matter in the beginning of this quarter. So -- we've called them out as nonrecurring. We've got $5.8 million of those in the quarter, as I said, another $2.5 million in the second quarter. And we've broken out the settlement and the activist matter as non-GAAP adjustments. The ongoing legal costs, they've been in our run rate and haven't been material enough to call out before. We're calling them out now. Those are not excluded for non-GAAP because we're treating those consistent with how we've treated them before. But we wanted you to understand they were elevated in the quarter and that's why we called them out as nonrecurring.

然後我們還有與本季度初 Parcus 仲裁事項相關的內部法律費用。所以——我們稱它們為非經常性的。正如我所說，我們在本季度獲得了 580 萬美元，在第二季度還有 250 萬美元。我們已經將和解和激進主義事項分解為非公認會計準則調整。持續的法律費用，它們一直在我們的運行費用中，而且之前還沒有足夠大的程度來調用。我們現在正在召喚他們。這些不排除在非公認會計原則之外，因為我們對待這些的方式與我們之前對待它們的方式一致。但我們希望您了解它們在本季度有所上升，這就是為什麼我們將它們稱為非經常性的。

Okay. I got it. Now do you think you'll have an additional charge in the second quarter for Parcus as well?

好的。我得到了它。現在您認為第二季度還會對 Parcus 收取額外費用嗎？

Yes, that was included in what I was just describing. So I think there's $2.5 million. Again, this is our legal fee, how all the costs come in. But $2.5 million all in of nonrecurring costs. And I would say, a small amount of that is the finishing up of the Parcus arbitration from our internal spend.

是的，這包括在我剛才描述的內容中。所以我認為有 250 萬美元。再說一遍，這是我們的法律費用，所有費用都是這樣產生的。但一次性費用總共有 250 萬美元。我想說，其中一小部分是我們內部支出中完成帕庫斯仲裁的費用。

Got it. Got it. Okay. Now with regards to the rotator cuff patch. I think you filed to that last year. Are -- do you have the approvals to launch that at this point? Or is there still regulatory work to be done for that?

知道了。知道了。好的。現在關於肩袖補丁。我想你去年就提出過這個問題。目前您是否已獲得啟動該項目的批准？或者是否還需要為此進行監管工作？

Jim, yes, there were multiple 510(k)s that we filed. This is a -- it is a regenerative patch based on hyaluronic acid and also other elements of a full system. So that's why there are multiple 510(k)s. We are not announcing kind of the parts and pieces as they come along, but we will provide a more fulsome update once we have everything fully cleared through the FDA.

Jim，是的，我們提交了多份 510(k) 文件。這是一個基於透明質酸以及完整系統的其他元素的再生貼片。這就是為什麼有多個 510(k)。我們不會公佈具體的零部件，但一旦 FDA 完全批准了一切，我們將提供更全面的更新。

And because one element of that is a regenerative patch, that tends to take longer from a time frame perspective relative to how you might think about normal turnaround time for 510(k)s. If there's an element to it that's regenerative in nature, they tend to take longer.

因為其中一個要素是再生補丁，所以從時間框架的角度來看，相對於您對 510(k)s 正常周轉時間的看法，這往往需要更長的時間。如果其中存在本質上可再生的元素，則它們往往需要更長的時間。

So the timelines that we've provided, we still feel good about. And there -- that's what's in the update that we have communicated. And as soon as we have anything more fulsome to announce, we will do so. We'll look forward to that.

因此，我們仍然對我們提供的時間表感覺良好。這就是我們所傳達的更新內容。一旦我們有更充實的消息要宣布，我們就會這樣做。我們對此充滿期待。

We're very excited about the system. We think it really completes the full continuum of care on the rotator cuff side, and we see an awful lot of advantages of this system relative to the first-generation collagen patches that are in the market today. So we look forward to updating you further on that.

我們對該系統感到非常興奮。我們認為它確實完成了肩袖側的完整連續護理，並且我們看到該系統相對於當今市場上的第一代膠原蛋白貼片具有很多優勢。因此，我們期待向您提供進一步的最新消息。

Okay. And then with regards to HYALOFAST, I think you said you had 1 more patient to complete the enrollment. And I assume it's a 12-month follow-up on that. And then I guess you're giving yourselves time to submit the PMA and then to work with the FDA. Is that why you have a 2025 estimate for that?

好的。關於 HYALOFAST，我想您說過您還有 1 名患者需要完成登記。我認為這是 12 個月的後續行動。然後我想你們會給自己時間提交 PMA，然後與 FDA 合作。這就是您預計 2025 年實現這一目標的原因嗎？

Yes. So you're correct. We have 1 more patient to enroll, and we'll be as excited as anybody when we get that study fully enrolled. The team is working hard on that. That has a 2-year follow-up, which is why the PMA filing is 2025. So that will be the clinical module of that will be the last module filed. But we're still on track to file that in 2025. And as soon as we have the final enrollment to announce, we will do so.

是的。所以你是對的。我們還有 1 名患者需要入組，當我們完全入組該研究時，我們會像任何人一樣興奮。團隊正在為此努力。有 2 年的隨訪期，這就是為什麼 PMA 歸檔時間為 2025 年。因此，這將是最後一個歸檔的臨床模塊。但我們仍有望在 2025 年提交該文件。一旦我們宣布最終註冊情況，我們就會這樣做。

Okay. So if you file in 2025, I would think back and forth with the FDA, you anticipate a launch sometime in 2026.

好的。因此，如果你在 2025 年提交申請，我會與 FDA 反复考慮，你預計會在 2026 年的某個時候推出。

Yes. We haven't provided guidance on launch timing until we get a little closer. But suffice it to say that we'll get everything filed in 2025.

是的。直到我們更加接近時，我們才提供有關啟動時間的指導。但我只想說，我們將在 2025 年提交所有文件。

Okay. And then the last one for me. On Cingal, it sounds like you're pursuing strategic agreements. Would they be structured similar to the agreements you have in place now for your OA Pain Management products. Would you have milestone payments attached to that? Or would that just be a straight distribution agreement?

好的。然後是我的最後一個。在 Cingal 上，聽起來你們正在尋求戰略協議。它們的結構是否類似於您現在為 OA 疼痛管理產品製定的協議？您會為此支付里程碑付款嗎？或者這只是一個直接分銷協議？

Yes. I think you can think about especially the ones in select Asian markets to look more like kind of a biotech pharma type arrangement in terms of structure. And in terms of the one in the U.S., we haven't really talked much about how those would be structured. But the select Asian market type agreements are probably more how you would think about a strategic relationship that has structured payments in addition to supplying product.

是的。我認為你可以特別考慮一些亞洲市場的結構，它們在結構上看起來更像是生物技術製藥類型的安排。就美國而言，我們還沒有真正討論過這些將如何構建。但選定的亞洲市場類型協議可能更符合您對戰略關係的看法，除了供應產品之外，還包括結構性付款。

Thank you. There are no further questions at this time. And that does conclude our conference for today. Thank you for participating. You may now disconnect.

謝謝。目前沒有其他問題。我們今天的會議到此結束。感謝您的參與。您現在可以斷開連接。