SI-BONE Inc (SIBN) 2022 Q4 法說會逐字稿

Good afternoon, and welcome to SI-BONE's Fourth Quarter Earnings Conference Call. (Operator Instructions) As a reminder, this call is being recorded for replay purposes.

下午好，歡迎來到 SI-BONE 的第四季度收益電話會議。 （操作員說明）作為提醒，正在錄製此通話以供重播。

I would now like to turn the conference over to Saqib Iqbal, Director of Investor Relations at SI-BONE for his introductory comments. Sir, you may begin.

現在，我想將會議轉交給 SI-BONE 投資者關係總監 Saqib Iqbal 作介紹性評論。先生，您可以開始了。

Thank you for participating in today's call.

感謝您參加今天的電話會議。

Joining me are Laura Francis, Chief Executive Officer; and Anshul Maheshwari, Chief Financial Officer. Earlier today, SI-BONE released financial results for the quarter ended December 31, 2022. A copy of the press release is available on the company's website.

加入我的是首席執行官 Laura Francis；和首席財務官 Anshul Maheshwari。今天早些時候，SI-BONE 發布了截至 2022 年 12 月 31 日的季度財務業績。新聞稿的副本可在公司網站上獲取。

Before we begin, I would like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results or performance are forward-looking statements. These forward-looking statements are based on the company's current expectations and inherently involve risks and uncertainties. These risks include the duration of secondary impacts of the COVID-19 pandemic, such as facility staffing shortages, whether the COVID-19 pandemic will recur in the future and our ability to effectively commercialize new products going forward.

在我們開始之前，我想提醒您，管理層將在本次電話會議期間發表聲明，其中包括聯邦證券法含義內的前瞻性聲明，這些聲明是根據 1995 年《私人證券訴訟改革法案》的安全港條款作出的. 本次電話會議中包含的任何與未來事件、結果或業績的預期或預測相關的陳述均為前瞻性陳述。這些前瞻性陳述基於公司當前的預期，並且固有地涉及風險和不確定性。這些風險包括 COVID-19 大流行的二次影響的持續時間，例如設施人員短缺、COVID-19 大流行是否會在未來再次發生以及我們未來有效地將新產品商業化的能力。

Other forward-looking statements include our examination of operating trends and our future financial expectations, such as expectations for hiring, surgeon training and adoption, active surgeons, new products, clinical trial enrollment and reimbursement decisions and are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements.

其他前瞻性陳述包括我們對運營趨勢和我們未來財務預期的審查，例如對招聘、外科醫生培訓和採用、現役外科醫生、新產品、臨床試驗註冊和報銷決定的預期，並基於我們目前的估計和各種假設.這些陳述涉及重大風險和不確定性，可能導致實際結果或事件與這些前瞻性陳述預期或暗示的結果或事件存在重大差異。因此，您不應過分依賴這些陳述。

For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our most recent Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. SI-BONE disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, February 27, 2023.

有關與我們業務相關的風險和不確定性的列表和描述，請參閱我們最近向美國證券交易委員會提交的 10-K 表格和 10-Q 表格的風險因素部分。 SI-BONE 不承擔任何更新或修改任何財務預測或前瞻性陳述的意圖或義務，除非法律要求，無論是因為新信息、未來事件還是其他原因。此電話會議包含時間敏感信息，僅截至 2023 年 2 月 27 日今天的現場直播準確無誤。

With that, I'll turn the call over to Laura.

有了這個，我會把電話轉給勞拉。

Thanks, Saqib. Good afternoon, and thank you for joining us.

謝謝，薩奇布。下午好，感謝您加入我們。

For today's call, I'll provide a business update, and Anshul will provide additional detail regarding our financial results. I'm pleased with our strong finish in 2022 as we effectively navigated some macro challenges, drove steady reacceleration of the business and delivered record performance. As you may recall, our worldwide year-over-year revenue growth in 2022 went from 10% in Q1 to 15% in Q2 to 19% in Q3 and finally 27% in Q4. Our growth was driven by both our core SI joint fusion business as well as new products targeted toward adult deformity and trauma applications.

對於今天的電話會議，我將提供業務更新，Anshul 將提供有關我們財務業績的更多詳細信息。我對我們在 2022 年的強勁表現感到滿意，因為我們有效地應對了一些宏觀挑戰，推動了業務的穩步再加速，並創造了創紀錄的業績。您可能還記得，我們在 2022 年的全球收入同比增長從第一季度的 10% 到第二季度的 15% 再到第三季度的 19%，最後是第四季度的 27%。我們的增長是由我們的核心 SI 關節融合業務以及針對成人畸形和創傷應用的新產品推動的。

2022 was a milestone year for the company as we extended our market leadership, expanded our addressable market with the launch of iFuse Bedrock Granite, a breakthrough product and received expanded FDA clearance for applications of iFuse-TORQ in fragility fractures and spino-pelvic fixation. Our comprehensive portfolio allowed us to achieve record U.S. active surgeon growth, which we believe is crucial to deliver strong and sustainable growth in 2023 and beyond. As we progressed through 2022, we delivered substantial operating leverage and significantly reduced our adjusted EBITDA loss and cash usage while investing in our long-term growth initiatives.

2022 年對公司來說是具有里程碑意義的一年，因為我們擴大了市場領導地位，通過推出突破性產品 iFuse Bedrock Granite 擴大了我們的潛在市場，並獲得了 FDA 對 iFuse-TORQ 在脆性骨折和脊柱骨盆固定中應用的擴大許可。我們全面的產品組合使我們能夠實現創紀錄的美國活躍外科醫生增長，我們認為這對於在 2023 年及以後實現強勁和可持續增長至關重要。隨著我們在 2022 年取得進展，我們在投資於長期增長計劃的同時，實現了可觀的經營槓桿，並顯著減少了調整後的 EBITDA 損失和現金使用量。

Before I discuss the details of our performance, I'd like to thank our employees for their dedication and focus to achieve these major milestones. You supported over 1,300 U.S. surgeons who perform the procedure using our solutions in 2022. Most importantly, you helped improve the quality of life for over 13,000 patients worldwide.

在我討論我們的業績細節之前，我要感謝我們的員工為實現這些重大里程碑所做的奉獻和專注。您在 2022 年支持了 1,300 多名使用我們的解決方案執行手術的美國外科醫生。最重要的是，您幫助改善了全球 13,000 多名患者的生活質量。

Now moving to our performance. For the fourth quarter of 2022, our worldwide revenue was $32 million, reflecting 27% growth compared to the fourth quarter of 2021 and 21% growth compared to the third quarter of 2022. Our U.S. revenue in the fourth quarter grew 28% compared to the prior-year period to a record $30 million, driven by a 33% procedure volume growth in the quarter. For the full year 2022, we generated worldwide revenue of $106.4 million, reflecting 18% growth compared to the full year 2021. Our U.S. revenue grew over 19% compared to full year 2021 to $98.8 million. The sequential acceleration in our U.S. revenue growth in each quarter of 2022 reaffirmed strong demand for our solutions in a normalizing operating environment.

現在開始我們的表演。 2022 年第四季度，我們的全球收入為 3200 萬美元，與 2021 年第四季度相比增長 27%，與 2022 年第三季度相比增長 21%。我們第四季度在美國的收入比去年同期增長 28%在本季度手術量增長 33% 的推動下，去年同期達到創紀錄的 3000 萬美元。 2022 年全年，我們的全球收入為 1.064 億美元，與 2021 年全年相比增長了 18%。與 2021 年全年相比，我們在美國的收入增長了 19% 以上，達到 9880 萬美元。 2022 年每個季度我們美國收入增長的連續加速再次證實了在正常化的運營環境中對我們的解決方案的強勁需求。

Now let me provide some details on our key initiatives as we look to expand our leadership position and drive strong long-term growth. Starting with sales infrastructure. Our dedicated direct sales force and agent partners are an important driver of growth as we develop our core markets and grow our presence in trauma and adult deformity. We ended 2022 with 88 territory managers and 73 clinical support specialists. In 2022, the average annual revenue per territory manager increased to $1.2 million, reflecting double-digit percentage growth compared to 2021. We believe there is significant opportunity for operating leverage in 2023, given the potential for average territory productivity to be in the range of $1.5 million to $2 million over time. With our expanded portfolio, we're leveraging our growing network of agents for case coverage and selectively evaluating consignment strategies at high-volume hospitals. We're confident that this hybrid approach will help the territory manager drive surgeon engagement, ensure high-quality support for a surgeon and deliver strong productive top line growth.

現在讓我詳細介紹一下我們的關鍵舉措，因為我們希望擴大我們的領導地位並推動強勁的長期增長。從銷售基礎設施開始。隨著我們開發核心市場並擴大我們在創傷和成人畸形領域的影響力，我們敬業的直銷團隊和代理合作夥伴是增長的重要推動力。到 2022 年底，我們擁有 88 名區域經理和 73 名臨床支持專家。到 2022 年，每位區域經理的平均年收入增至 120 萬美元，與 2021 年相比實現了兩位數的百分比增長。我們認為，鑑於平均區域生產力可能達到隨著時間的推移 150 萬到 200 萬美元。隨著我們擴大的產品組合，我們正在利用我們不斷增長的代理網絡來覆蓋病例，並有選擇地評估大容量醫院的寄售策略。我們相信，這種混合方法將幫助區域經理推動外科醫生的參與，確保為外科醫生提供高質量的支持，並實現強勁的生產性收入增長。

Moving on to surgeon engagement. Surgeon adoption is one of the best leading indicators of long-term procedure demand. We exited the fourth quarter with a record 920 active surgeons. This equates to over 33% growth in our active surgeon base over the fourth quarter of 2021 and approximately 15% sequential growth compared to the third quarter of 2022. This is the eighth consecutive quarter of double-digit year-over-year growth in our active surgeon base and the highest growth rate in active surgeon base since we've been a public company. This growth enacted surgeon base is a testament to our focus on surgeon engagement, education and outreach over the last several years.

繼續外科醫生的參與。外科醫生採用率是長期手術需求的最佳領先指標之一。我們以創紀錄的 920 名活躍外科醫生退出了第四季度。這相當於我們活躍的外科醫生人數在 2021 年第四季度增長了 33% 以上，與 2022 年第三季度相比環比增長了約 15%。這是我們的外科醫生連續第八個季度實現兩位數的同比增長自我們成為上市公司以來，活躍的外科醫生基數和活躍外科醫生基數的最高增長率。這種增長的外科醫生基礎證明了我們在過去幾年中對外科醫生參與、教育和外展的關注。

The increase in surgeons in the fourth quarter came from those who performed a minimally invasive SI joint fusion procedure as well as adult deformity or trauma procedures. Additionally, it's exciting to see a growing surgeon overlap across our various procedures. In 2022, over half of our active surgeons who performed an adult deformity procedure also performed a minimally invasive SI joint fusion procedure using our solutions. We believe our complementary portfolio provides a significant opportunity to drive deeper engagement with their active surgeon base and increase the procedures per surgeon.

第四季度外科醫生的增加來自那些進行微創 SI 關節融合手術以及成人畸形或創傷手術的人。此外，很高興看到越來越多的外科醫生在我們的各種手術中重疊。到 2022 年，超過半數進行過成人畸形手術的在職外科醫生也使用我們的解決方案進行了微創骶髂關節融合手術。我們相信，我們的互補產品組合提供了一個重要的機會，可以推動與他們活躍的外科醫生基礎進行更深入的接觸，並增加每位外科醫生的程序。

With the trauma indication expansions for iFuse-TORQ, the launch of iFuse Bedrock Granite and the growing interest in spino-pelvic fixation and fusion, surgeon education is crucial to drive engagement and activation. Additionally, we're experiencing great success with our academic programs that are focused on residents and fellows. Since the inception of the program, we've held training events in over 200 academic facilities in the United States and trained approximately 1,300 surgical residents as fellows. We're encouraged by the steady adoption of our procedures by these previously trained fellows and residents when they began practicing. In 2022, the number of fellows and residents who did their first case increased nearly threefold compared to 2021, while their procedure volumes increased fourfold.

隨著 iFuse-TORQ 創傷適應症的擴展、iFuse Bedrock Granite 的推出以及對脊柱-骨盆固定和融合的興趣日益增長，外科醫生教育對於推動參與和激活至關重要。此外，我們以住院醫生和研究員為重點的學術課程取得了巨大成功。自該計劃啟動以來，我們已在美國 200 多個學術機構舉辦了培訓活動，並培訓了大約 1,300 名外科住院醫師作為研究員。這些以前受過培訓的研究員和住院醫師在開始執業時穩步採用我們的程序，這讓我們感到鼓舞。與 2021 年相比，到 2022 年完成首個病例的研究員和居民人數增加了近三倍，而他們的手術量增加了四倍。

Turning to products and solutions. The key tenet of our strategy has been to expand our platform of sacropelvic solutions to a direct SI joint pain, adult deformity and trauma. With iFuse-3D, iFuse-TORQ and now iFuse Bedrock Granite, we believe it's the value of our innovative, versatile and complementary product portfolio provides surgeons with a comprehensive set of alternatives and positions us as the top choice for surgeons for sacropelvic solutions. iFuse-TORQ continues its strong growth and has become an important addition to the portfolio. TORQ provides an alternative to iFuse-3D for our existing surgeons and has allowed us to convert users of competitive screw systems as well as engage new surgeons performing minimally invasive SI joint fusion. Following the FDA clearance for iFuse-TORQ to include fusion in conjunction with spino-pelvic fixation, we're seeing a steady uptake in the use of the product to complement iFuse Bedrock Granite as a second point of fixation as a joint. From a biomechanical perspective, having 2 points of fixations is important to attain fusion.

轉向產品和解決方案。我們戰略的主要宗旨是將我們的骶骨盆解決方案平台擴展到直接的 SI 關節疼痛、成人畸形和創傷。憑藉 iFuse-3D、iFuse-TORQ 和現在的 iFuse Bedrock Granite，我們相信這是我們創新、多功能和互補產品組合的價值，為外科醫生提供了一套全面的替代方案，並使我們成為外科醫生的骶骨盆腔解決方案的首選。 iFuse-TORQ 繼續保持強勁增長，並已成為產品組合的重要補充。 TORQ 為我們現有的外科醫生提供了 iFuse-3D 的替代方案，並使我們能夠轉換具有競爭力的螺釘系統的用戶，並聘請新的外科醫生進行微創 SI 關節融合。在 FDA 批准 iFuse-TORQ 將融合與脊柱骨盆固定相結合後，我們看到該產品的使用穩步增長，以補充 iFuse Bedrock Granite 作為關節的第二固定點。從生物力學的角度來看，擁有 2 個固定點對於實現融合很重要。

In trauma, we're in the early stages of market development and are encouraged by the progress in the use of iFuse-TORQ for sacral insufficiency fracture. Based on our market analysis, many of our spine surgeons routinely see fragility fracture patients, providing us an opportunity to leverage existing relationships as we build this market. With approximately 120,000 of these injuries per year in the U.S., most of which are currently not treated surgically, the fragility fracture market is a recognized unmet clinical need. The trauma opportunity is of strategic importance to us as the sacropelvic solutions leader and will be an important avenue for growth over the long term.

在創傷方面，我們正處於市場發展的早期階段，並且對使用 iFuse-TORQ 治療骶骨功能不全骨折的進展感到鼓舞。根據我們的市場分析，我們的許多脊柱外科醫生經常會診治脆性骨折患者，這為我們提供了一個在建立這個市場時利用現有關係的機會。在美國，每年約有 120,000 起此類傷害，其中大部分目前未接受手術治療，脆性骨折市場是公認的未滿足的臨床需求。創傷機會對我們作為骶骨盆解決方案的領導者俱有戰略重要性，並將成為長期增長的重要途徑。

Moving to iFuse Bedrock Granite, the reception of iFuse Bedrock Granite has been exceptional, driven by strong surgeon and hospital interest in adopting the product. Based on our early interest, we believe that Granite may become a standard of care for stabilizing the base long construct in adult deformity procedures and in certain degenerative spinal fusion cases. As I indicated earlier, we're seeing several surgeons using some combination of our products to achieve 2 points of fixation across the SI joint on either side, resulting in a significant pull-through opportunity for the overall portfolio and higher procedure average selling price. This launch, nearly 2,500 hospitals across the U.S. have added iFuse Bedrock Granite to their approved products list. Additionally, with the recent FDA clearance to allow the use of iFuse Bedrock Granite with a variety of pedicle spring rod systems, surgeons can now have confidence using their preferred system with iFuse Bedrock Granite as the foundation for the construct. We believe both these milestones will be additional catalysts to drive future growth.

轉向 iFuse Bedrock Granite，iFuse Bedrock Granite 受到了強烈的外科醫生和醫院採用該產品的興趣的推動。基於我們早期的興趣，我們認為 Granite 可能成為在成人畸形手術和某些退行性脊柱融合病例中穩定基長結構的護理標準。正如我之前指出的那樣，我們看到幾位外科醫生使用我們產品的某種組合在兩側的 SI 關節上實現 2 個固定點，從而為整個產品組合帶來重要的拉動機會和更高的手術平均售價。此次發布，美國近 2,500 家醫院已將 iFuse Bedrock Granite 添加到其批准的產品列表中。此外，最近 FDA 批准允許將 iFuse Bedrock Granite 與各種椎弓根彈簧桿系統一起使用，外科醫生現在可以放心地使用他們首選的系統，將 iFuse Bedrock Granite 作為構造的基礎。我們相信這兩個里程碑將成為推動未來增長的額外催化劑。

Given the positive experience with iFuse Bedrock Granite, we're seeing surgeons expand the use of the product to stabilize the base of shorter multilevel constructs as part of their treatment for degenerates spinal conditions. Approximately 1/3 of our iFuse Bedrock Granite cases have been in these degenerative procedures. There are over 100,000 short multilevel spinal fusion procedures per year in the U.S. While still early, the expanded use of iFuse Bedrock Granite in the shorter multilevel spinal fusion procedures for fixation could be an exciting opportunity for us and could expand our total addressable market beyond our initially estimated $250 million.

鑑於 iFuse Bedrock Granite 的積極經驗，我們看到外科醫生擴大了該產品的使用範圍，以穩定較短的多級結構的基礎，作為他們治療退化脊柱疾病的一部分。我們大約 1/3 的 iFuse Bedrock Granite 案例都經過了這些退化程序。美國每年有超過 100,000 例短的多節段脊柱融合手術。雖然還早，但在較短的多節段脊柱融合手術中擴大使用 iFuse Bedrock Granite 進行固定對我們來說可能是一個令人興奮的機會，並且可以將我們的總目標市場擴大到我們的市場之外最初估計為 2.5 億美元。

Before I hand it over to Anshul, I'd like to provide a reminder on the CMS rule for hospital outpatient and ASC payments that went effective January 1. In 2023, Medicare facility fees and minimally invasive procedures performed using CPT code 27279 and hospital outpatient or ASC settings increased by 33% to approximately $22,000 and 26% to approximately $17,000, respectively. Today, 80% of our minimally invasive SI joint procedures are performed in an outpatient setting or at surgery centers. We expect more of our minimally invasive procedures to move to ASCs over time. While it is too early to assess the business impact of this significant increase in facility fees, we believe it could be a tailwind for demand and ASP stabilization at these sites serve.

在我將其移交給 Anshul 之前，我想提醒一下 1 月 1 日生效的醫院門診和 ASC 付款的 CMS 規則。2023 年，使用 CPT 代碼 27279 和醫院門診執行的醫療保險設施費用和微創手術或 ASC 設置分別增加 33% 至約 22,000 美元和 26% 至約 17,000 美元。今天，我們 80% 的微創骶髂關節手術是在門診或手術中心進行的。隨著時間的推移，我們希望更多的微創手術轉向 ASC。雖然現在評估設施費用大幅增加對業務的影響還為時過早，但我們認為這可能是這些站點服務的需求和 ASP 穩定的順風。

I'll now turn the call over to Anshul to provide more detail on our financial results.

我現在將電話轉給 Anshul，以提供有關我們財務業績的更多詳細信息。

Thanks, Laura. Good afternoon, everyone.

謝謝，勞拉。大家下午好。

My comments today will be focused on fourth quarter revenue growth, operating leverage and liquidity. Starting with revenue growth. Our fourth quarter total revenue was $32 million, representing growth of approximately 27% compared to the prior-year period and 21% sequentially. U.S. revenue was $30 million, increasing 28% compared to the prior-year period. Growth in the U.S. was driven by strong demand for our solutions, which resulted in approximately 33% procedure volume growth versus the prior-year period and 23% growth sequentially. ASC procedure volumes were in the low-20% range, consistent with the prior year period. International revenue was $2 million, reflecting growth of approximately 3% in U.S. dollars compared to the prior-year period. Across Europe, France maintained strong performance offset by underperformance in Germany and the U.K.

我今天的評論將集中在第四季度的收入增長、經營槓桿和流動性上。從收入增長開始。我們第四季度的總收入為 3200 萬美元，較上年同期增長約 27%，環比增長 21%。美國收入為 3000 萬美元，比上年同期增長 28%。美國的增長受到對我們解決方案的強勁需求的推動，導致手術量較上年同期增長約 33%，環比增長 23%。 ASC 程序量處於低 20% 的範圍內，與去年同期一致。國際收入為 200 萬美元，按美元計算較上年同期增長約 3%。在整個歐洲，法國保持強勁的表現，但被德國和英國的表現不佳所抵消。

Gross margins for the fourth quarter of 2022 was 84%, in line with our third quarter gross margin. The fourth quarter gross margin reflects a low single-digit percentage impact from lower average selling price, increase in freight cost and higher cost of new products as well as the increase in depreciation from the ongoing deployment of instrument trades to support strong new product demand.

2022 年第四季度的毛利率為 84%，與我們第三季度的毛利率一致。第四季度毛利率較低的個位數百分比受到較低的平均售價、運費增加和新產品成本較高的影響，以及為支持強勁的新產品需求而正在進行的儀器交易部署導致的折舊增加。

Moving to operating leverage. Operating expenses increased 7% to $38.2 million in the fourth quarter of 2022 as compared to $35.8 million in the prior-year period. The increase was driven by higher commissions associated with the revenue growth, increased travel and freight costs and higher investments in R&D. On a sequential basis, operating expenses increased approximately 6%, driven by higher commissions associated with the higher revenue in the quarter. We're pleased with the acceleration in operating leverage as our revenue growth rate was 4x the operating expense growth rate in the fourth quarter. The operating leverage was driven by strong top line performance and across-the-board productivity gains from investments we have made to scale our platform over the last few years.

轉向經營槓桿。與去年同期的 3580 萬美元相比，2022 年第四季度的運營費用增長了 7%，達到 3820 萬美元。這一增長是由與收入增長相關的更高佣金、增加的差旅和貨運成本以及更高的研發投資推動的。在連續的基礎上，運營費用增加了約 6%，這是由於與本季度收入增加相關的佣金增加所致。我們對運營槓桿的加速增長感到滿意，因為我們的收入增長率是第四季度運營費用增長率的 4 倍。過去幾年，我們為擴展平台所做的投資帶來了強勁的頂線性能和全面的生產力收益，從而推動了運營槓桿。

Our net loss was $11.2 million or $0.32 per diluted share for the fourth quarter of 2022 as compared to a net loss of $14.5 million or $0.43 per diluted share in the prior-year period. Our adjusted EBITDA loss improved significantly in the second half of 2022 with fourth quarter adjusted EBITDA loss of negative $4.2 million, an improvement of over 50% over the prior-year period.

2022 年第四季度，我們的淨虧損為 1120 萬美元或攤薄後每股 0.32 美元，而去年同期為淨虧損 1450 萬美元或攤薄後每股 0.43 美元。我們調整後的 EBITDA 虧損在 2022 年下半年顯著改善，第四季度調整後的 EBITDA 虧損為負 420 萬美元，比去年同期改善了 50% 以上。

Turning to liquidity. We exited 2022 with $97.3 million in cash and marketable securities. Our cash outflow steadily declined as we progressed through 2022. Our total cash outflow in the fourth quarter was $7 million, an improvement of approximately 51% compared to the prior-year period and an improvement of over 34% compared to the third quarter of 2022. While we plan to make additional investments in instrument trades and implants to support our growth, we expect continued progress in operating leverage to moderate cash usage in 2023. In January of 2023, we refinanced the outstanding $35 million term loan with a new $51 million credit facility with Silicon Valley Bank, including a $36 million term loan and a $15 million revolving line of credit. The new credit facility includes a $15 million accordion that is available to the company subject to the credit approval of the bank. The refinancing allows us to lower our borrowing costs, delay amortization by nearly 2 years and have access to additional liquidity, if needed.

轉向流動性。我們以 9730 萬美元的現金和有價證券退出了 2022 年。隨著我們在 2022 年的進展，我們的現金流量穩步下降。我們第四季度的總現金流量為 700 萬美元，與去年同期相比增長了約 51%，與 2022 年第三季度相比增長了 34% 以上. 雖然我們計劃對儀器交易和植入進行額外投資以支持我們的增長，但我們預計 2023 年經營槓桿將繼續取得進展以適度現金使用。2023 年 1 月，我們用新的 5100 萬美元為未償還的 3500 萬美元定期貸款再融資與硅谷銀行的信貸額度，包括 3600 萬美元的定期貸款和 1500 萬美元的循環信貸額度。新的信貸額度包括價值 1500 萬美元的手風琴，在獲得銀行的信貸批准後可供公司使用。再融資使我們能夠降低借貸成本，將攤銷時間推遲近 2 年，並在需要時獲得額外的流動性。

Finally, moving to our outlook for 2023. We continue to experience demand momentum for our comprehensive portfolio of solutions as well as elevated surgeon engagement. However, we are being thoughtful in our approach to annual guidance given the early phase of reacceleration of the U.S. business and the pace of recovery in our international business. Considering these factors, we expect 2023 worldwide revenue of approximately $124 million to $127 million, implying year-over-year growth of approximately 17% to 19%. In 2023, we expect gross margin to stabilize at approximately 80%. Our gross margin assumptions incorporate low single-digit ASP degradation as well as additional depreciation expense from the deployment of iFuse Bedrock Granite and iFuse-TORQ trades in the back half of 2022 and throughout 2023. Turning to operating expenses. We anticipate operating expenses will grow at a mid-single-digit percentage rate in 2023. We foresee a reduction in adjusted EBITDA loss compared to the full year 2022 based on the strong top line growth and continued operating leverage.

最後，轉向我們對 2023 年的展望。我們繼續感受到對我們全面的解決方案組合的需求勢頭以及外科醫生參與度的提高。然而，考慮到美國業務重新加速的早期階段和我們國際業務的複蘇步伐，我們在製定年度指導方針時會慎重考慮。考慮到這些因素，我們預計 2023 年全球收入約為 1.24 億美元至 1.27 億美元，這意味著同比增長約為 17% 至 19%。 2023年，我們預計毛利率將穩定在80%左右。我們的毛利率假設包括低個位數的平均售價下降以及 2022 年下半年和整個 2023 年部署 iFuse Bedrock Granite 和 iFuse-TORQ 交易產生的額外折舊費用。轉向運營費用。我們預計 2023 年運營費用將以中等個位數百分比增長。我們預計，基於強勁的營收增長和持續的運營槓桿，與 2022 年全年相比，調整後的 EBITDA 虧損將減少。

With that, I will turn the call over for questions. Operator?

有了這個，我會把電話轉過來提問。操作員？

(Operator Instructions) Our first question comes from the line of Kyle Rose with Canaccord.

（操作員說明）我們的第一個問題來自 Kyle Rose 與 Canaccord 的合作。

I just want to kind of dig in just on the gross margin guidance for a second here. 80%, I appreciate the commentary about the ASP decline and some higher depreciation costs. Maybe just talk a little bit more about the ASP stabilization that you're seeing there? And just how we should interpret that from a long-term perspective when we think about the gross margin profile of the company?

我只想在這裡深入了解一下毛利率指導。 80%，我很欣賞關於平均售價下降和一些更高的折舊成本的評論。也許只是多談談您在那裡看到的 ASP 穩定性？當我們考慮公司的毛利率狀況時，我們應該如何從長期的角度來解釋這一點？

Kyle, this is Anshul. From a gross margin perspective, as you've seen over the last couple of years since we've introduced 2 new products, we have been putting a lot of investment in instrument trays to support what we see as strong demand for both TORQ and for Granite. And if you look at the PP&E line in our balance sheet, you will see that have gone up from about, say, $4 million-ish at the end of 2020 to north of $15 million at the end of 2022. Now these trays get depreciated over a 3-year period. They obviously have a much longer lifespan that they are used for. But that's about $4 million to $5 million of depreciation that goes to your gross margin line, which will equate to about 3 to 4 points of gross margin deterioration. A lot of the Granite investment came about in the second half of 2022. We expect to continue to roll out additional Granite trays throughout 2023. So we took that into account as well. So I'd say a lot of the gross margin impact is driven by the depreciation of those instrument trays.

凱爾，這是安舒爾。從毛利率的角度來看，正如你在過去幾年中看到的那樣，自從我們推出 2 種新產品以來，我們一直在儀器托盤上投入大量投資，以支持我們認為對 TORQ 和花崗岩。而且，如果您查看我們資產負債表中的 PP&E 線，您會發現它已經從 2020 年底的大約 400 萬美元上升到 2022 年底的 1500 萬美元以上。現在這些托盤已經折舊了在 3 年的時間裡。它們顯然具有更長的使用壽命。但這大約是 400 萬至 500 萬美元的折舊會影響您的毛利率，這相當於毛利率下降約 3 至 4 個百分點。很多 Granite 投資發生在 2022 年下半年。我們預計將在 2023 年繼續推出更多 Granite 托盤。因此我們也考慮到了這一點。所以我想說很多毛利率的影響是由這些儀器托盤的折舊造成的。

Now on the ASP side, Kyle, we tend to make assumptions around based on what we've seen historically and sort of in the low-to-mid single-digit range ASP decline is what we always look at to sort of the 3% to 5%. And it's still early days in the year, but we are seeing sort of be on the lower side of that ASP trend than we have historically been. So that's how we've sort of framed our gross margin guidance.

現在在 ASP 方面，Kyle，我們傾向於根據我們在歷史上看到的情況做出假設，並且在中低個位數範圍內 ASP 下降是我們一直關注的 3%到 5%。現在還處於今年的早期階段，但我們看到的平均售價趨勢比以往任何時候都低。這就是我們如何構建我們的毛利率指導。

Okay. Very helpful. And I appreciate the commentary about the new product launches. And I have to put the cart before the horse, so to speak, given you're still early in the Granite and the TORQ launch. But what should we be expecting from a new product development perspective as the company focuses on being a larger pelvic reconstruction or pelvic ring focused company? What are the other areas that you think are underserved in the market that you think would be worth allocating R&D resources moving forward?

好的。很有幫助。我很欣賞有關新產品發布的評論。我必須本末倒置，可以這麼說，因為你還處於 Granite 和 TORQ 發布的早期階段。但是，隨著公司專注於成為一家更大的骨盆重建或骨盆環公司，我們應該從新產品開發的角度期待什麼？您認為市場上還有哪些其他領域服務不足，您認為值得在未來分配研發資源？

Yes, Kyle, thanks for the question. And when we went public, we were a single product company focused on SI joint fusion. We're the pioneer in that market. We've built that market, and we are, by far, the market leader in the space. And -- but what we've been doing over the last few years is capturing the broader opportunity in sacropelvic solutions. And so we have launched products that provide us with opportunities in adult deformity as well as in trauma as well. So we're seeing that strategy play out very well for us, and we do certainly have an additional pipeline of products that we'll be speaking to at future dates. But right now, what we're really focused on is market development of our core market and SI joint fusion, and we're really pleased about the reacceleration that we've seen in our core market. Also, we do believe that we have a near-term opportunity to capture our opportunity with granite in adult deformity with spino-pelvic fixation infusion.

是的，凱爾，謝謝你的提問。當我們上市時，我們是一家專注於 SI 聯合融合的單一產品公司。我們是那個市場的先驅。我們已經建立了這個市場，到目前為止，我們是該領域的市場領導者。而且 - 但我們在過去幾年一直在做的是抓住骶骨盆腔解決方案的更廣泛機會。因此，我們推出的產品為我們提供了治療成人畸形和外傷的機會。因此，我們看到該策略對我們來說效果很好，而且我們確實有一個額外的產品線，我們將在未來的日期討論這些產品線。但現在，我們真正關注的是我們核心市場的市場開發和 SI 聯合融合，我們對我們在核心市場看到的重新加速感到非常高興。此外，我們確實相信，我們有一個近期的機會來抓住我們的機會，用花崗岩治療成人畸形，並進行脊柱骨盆固定輸注。

And then the trauma market is really more of that longer term opportunity because this is an identified unmet clinical need, but it is an area where these patients typically are not surgically treated. So in a lot of ways, it reminds us of our core market in primary SI joint fusion. And as we've always done, we're focused on using clinical data, education and reimbursement support in order to develop that particular market. So more on new products coming in the future, I would say that the message that we really have today is we have an extraordinary opportunity in our core and adjacent markets, and we're focused on market development in those areas.

然後創傷市場實際上更多的是長期機會，因為這是一個確定的未滿足的臨床需求，但這是一個通常不對這些患者進行手術治療的領域。所以在很多方面，它讓我們想起了我們在初級 SI 聯合融合中的核心市場。正如我們一直所做的那樣，我們專注於使用臨床數據、教育和報銷支持來開發該特定市場。因此，關於未來新產品的更多信息，我想說的是，我們今天真正得到的信息是，我們在核心和鄰近市場擁有非凡的機會，我們專注於這些領域的市場開發。

(Operator Instructions) Our next question comes from the line of David Rescott with Truist.

（操作員說明）我們的下一個問題來自 David Rescott 與 Truist 的對話。

Maybe just starting off better then on the fourth quarter. It seems like the quarter came in essentially ahead of where the guidance essentially was prior to lower end in Q3. So just wondering maybe what went right in the second part of the quarter to essentially beat the guidance you set out there and then how we should be thinking about the way you're thinking about the guidance for 2023?

也許只是比第四節開始得更好。似乎本季度基本上領先於第三季度低端之前的指導。所以只是想知道本季度第二部分可能發生了什麼事情，基本上擊敗了你在那裡制定的指導，然後我們應該如何考慮你對 2023 年指導的思考方式？

David, your questions are spot on. We are really pleased with what we saw in the fourth quarter, 27% growth year-over-year. That was 21% sequential growth and to just see the continued acceleration throughout the year, it shows the normalization of the operating environment. It shows the reacceleration of our primary SI joint fusion business and then it shows the adoption curve with our Granite product in pelvic fixation. So pleased with everything that we saw there.

大衛，你的問題很正確。我們對第四季度的情況感到非常滿意，同比增長 27%。這是 21% 的環比增長，並且僅看到全年的持續加速，就表明了運營環境的正常化。它顯示了我們主要的 SI 關節融合業務的重新加速，然後它顯示了我們的 Granite 產品在骨盆固定方面的採用曲線。對我們在那裡看到的一切感到非常滿意。

In terms of getting into a little more detail for you, October results were solid. But what we saw is this very nice acceleration in November and December. So taking us back into that original range of what we had anticipated for the year of $106 million to $108 million in sales. And what we've seen actually is that has continued into the first quarter as well. So just continued indicators that the business is continuing to accelerate. And so our expectations for the first quarter from a revenue perspective is growth of approximately 30% in the first quarter based upon the continued acceleration of the business.

就為您提供更多細節而言，10 月份的結果非常可靠。但我們看到的是 11 月和 12 月的這種非常好的加速。因此，讓我們回到最初預期的 1.06 億美元至 1.08 億美元銷售額範圍內。我們實際上看到的是，這種情況也一直持續到第一季度。因此，只有持續的指標表明業務正在繼續加速。因此，從收入的角度來看，我們對第一季度的預期是，基於業務的持續加速，第一季度的增長率約為 30%。

And I probably would say that the last point I would focus on here is the active surgeon numbers were ecstatic about those numbers at this point, 33% increase year-over-year, up to 920 surgeons who did at least 1 case in the fourth quarter of 2022. That's 15% sequential growth in that metric. And for us, it's a great forward-looking indicator for that future demand.

我可能會說，我在這裡要關注的最後一點是活躍的外科醫生數量對這些數字欣喜若狂，同比增長 33%，多達 920 名外科醫生在第四季度至少做了 1 例2022 年季度。該指標連續增長 15%。對我們來說，這是未來需求的一個很好的前瞻性指標。

And then, David, on your question around the guidance for the year, I sort of break it down into a few different tranches from a guidance perspective. Laura just highlighted our expectations for where 1Q would be at the 30% year-over-year growth. We've got a couple of months behind us now. And as you know, our visibility is pretty strong, and we look out in the next 30 days or so. So we feel good about how the business is set up in the near term. And then as we think about -- and even on the 30% growth, right -- that's due to COVID, but when you think about it, even sequentially, you're looking at high single-digit Q4 to Q1 decline, which if you look at the last 4 years, it's been low double digits. So again, you're seeing a nice acceleration in the business coming into Q1.

然後，大衛，關於你關於今年指導的問題，我從指導的角度將其分為幾個不同的部分。勞拉剛剛強調了我們對第一季度同比增長 30% 的預期。我們現在已經落後幾個月了。如您所知，我們的知名度非常高，我們會在未來 30 天左右的時間裡保持警惕。因此，我們對近期的業務建立方式感到滿意。然後，正如我們所考慮的那樣——甚至是 30% 的增長，對吧——這是由於 COVID，但當你考慮它時，即使是連續的，你也會看到第四季度到第一季度的高個位數下降，如果你看看過去 4 年，它一直是低兩位數。因此，您再次看到進入第一季度的業務出現了很好的加速。

And then when we think about annual guidance, we thought it was appropriate to take a prudent stance here and sort of look at a risk-adjusted view of all the tailwinds that Laura highlighted in the preliminary remarks around procedure ASP trends, the pace of Granite adoption, how we think about OUS recovery from a business coming back perspective. And some of these factors could play out better than we anticipate. But given that we're this early in the year and several of the tailwinds are in the nascent stages, like Granite is still being rolled out and the facility fees that went into effect in January, right, it's too early to see what the potential impact of that could be. So we thought our guidance appropriately bracketed some of the risks and opportunities there.

然後，當我們考慮年度指導時，我們認為在這裡採取謹慎的立場是適當的，並在某種程度上審視勞拉在關於程序 ASP 趨勢的初步評論中強調的所有順風的風險調整觀點，花崗岩的步伐採用，我們如何從業務回歸的角度考慮 OUS 恢復。其中一些因素可能會比我們預期的更好。但考慮到今年年初，一些有利因素還處於初期階段，比如 Granite 仍在推出，設施費在 1 月份生效，現在判斷潛力還為時過早的影響可能是。因此，我們認為我們的指南適當地包含了那裡的一些風險和機遇。

And then the other aspect of our guidance was just a continuous focus on operating leverage that we expect to see as we progress through the year into 2023. Kyle asked the question around the gross margin. And look, our gross margin is at sort of that stabilizing at about 80% are still industry-leading and really dear to us, and we will continue to make sure we stay at pretty elevated gross margin levels. But we are increasingly focused on seeing that adjusted EBITDA leverage as well and feel good about that to go up coming into this year.

然後，我們指導的另一個方面就是持續關注我們預計在進入 2023 年的過程中會看到的經營槓桿。凱爾問了有關毛利率的問題。看，我們的毛利率穩定在 80% 左右，仍然處於行業領先地位，對我們來說真的很重要，我們將繼續確保我們保持在相當高的毛利率水平。但我們也越來越關注調整後的 EBITDA 槓桿率，並對今年的槓桿率上升感到滿意。

Okay. Great. So that just leads to the next question then. So I'm wondering, one, if the 80% gross margin in 2023 assumes that there is stabilization of gross margins brought on by that improved reimbursement rate or perhaps there may be is upside just as you progress through the year? And then the second part of that, just based on kind of our initial estimates, gross margins, a little bit lower than we were anticipating, but still expecting improving EBITDA through the year. So just wondering what the biggest driver of that improving profitability is and maybe how we should think about the cadence of that coming on through the rest of the year, especially since Q1 seems to be maybe a higher top line growth rate than the rest of the year?

好的。偉大的。這樣就引出了下一個問題。所以我想知道，一個，如果 2023 年 80% 的毛利率假設報銷率的提高帶來了毛利率的穩定，或者隨著你在這一年的進展，可能會有上升空間？然後是第二部分，僅基於我們的初步估計，毛利率略低於我們的預期，但仍預計全年 EBITDA 會有所改善。所以只是想知道提高盈利能力的最大驅動力是什麼，也許我們應該如何考慮今年餘下時間的節奏，特別是因為第一季度的收入增長率似乎高於其餘時間年？

Yes. David, that's a great question. So let me just take the question on what's going to drive operating leverage and EBITDA acceleration first and then go back to the gross margin side. So as we came into last year, David, we had talked about the business being at a natural inflection point to harvest all the investments that we made since going public and throughout the pandemic. And now we've had 3 consecutive quarters where revenue growth has exceeded operating expenses. And we're really pleased with that trajectory. And it's been pretty linear to revenue growth, right? So as our revenue growth accelerated, you sort of saw the leverage accelerate as well because we've got the foundational infrastructure in place.

是的。大衛，這是一個很好的問題。因此，讓我首先回答什麼將推動運營槓桿和 EBITDA 加速的問題，然後再回到毛利率方面。因此，當我們去年進入時，大衛，我們談到了業務正處於一個自然的轉折點，以收穫我們自上市以來和整個大流行期間所做的所有投資。現在我們已經連續 3 個季度收入增長超過運營支出。我們對這一軌跡非常滿意。它與收入增長呈線性關係，對吧？因此，隨著我們的收入增長加速，你會看到槓桿率也在加速增長，因為我們已經有了基礎設施。

And as we get into 2023, we do not think that, that trend is going to change. We are still going to make investments in R&D. We're still going to make investments in trades, which will go as depreciation on the P&L. And we are going to selectively grow our sales force, but the foundational infrastructure is there to support a much higher level of revenue, right. So when you think about the year, as the revenue accelerates or as we progress through the year, you will see the leverage accelerate, and we expect year-over-year adjusted EBITDA to continue to improve. You might have some seasonality sequentially, but year-over-year, we should see an improvement.

隨著我們進入 2023 年，我們認為這種趨勢不會改變。我們仍將在研發方面進行投資。我們仍將對交易進行投資，這將作為損益表的折舊。我們將有選擇地擴大我們的銷售隊伍，但基礎設施可以支持更高水平的收入，對吧。因此，當你考慮這一年時，隨著收入的加速增長或我們在這一年中的進步，你會看到槓桿率加速增長，我們預計經調整的 EBITDA 同比將繼續改善。您可能會連續出現一些季節性，但與去年同期相比，我們應該會看到有所改善。

(Operator Instructions) Our next question comes from the line of Craig Bijou with Bank of America.

（操作員說明）我們的下一個問題來自美國銀行的 Craig Bijou。

So I wanted to start with the active surgeon increase, and I appreciate Laurie, your comments on the acceleration of the core procedure. So I wanted to see what -- if any, information you'd be willing to share on the mix of surgeons of those active surgeons doing SI joint fusions and those doing adult deformity procedures. Is it evenly split? And then kind of in the same line of questioning, how much of -- or how much of the increase in active surgeons from SI joint fusions were new to you guys versus previously trained, but inactive surgeons?

所以我想從活躍外科醫生的增加開始，感謝勞裡，你對核心程序加速的評論。所以我想看看你願意分享哪些信息——如果有的話，你願意分享那些從事 SI 關節融合術的活躍外科醫生和那些從事成人畸形手術的外科醫生的組合。是平分的嗎？然後在同一個問題中，與以前受過訓練但不活躍的外科醫生相比，SI 關節融合術增加的活躍外科醫生中有多少 - 或者有多少對你們來說是新的？

Yes. Craig, I think you are highlighting a really important metric that we have here, given how rapidly we're seeing an increase in the active surgeon base. If you look at all of 2021, I believe that we had 1,000 surgeons in total that did procedures for us in 2021, whereas in the fourth quarter alone, we had 920 surgeons doing procedures. So it really is pretty extraordinary progress that we've seen just in a 12-month period. So a 33% increase year-over-year and then even a 15% increase, if you look sequentially quarter-over-quarter. And quite frankly, it's the highest that I've seen since we've been a public company. So it's really exciting from my perspective.

是的。克雷格，我認為你強調了我們在這裡擁有的一個非常重要的指標，因為我們看到活躍的外科醫生基數增長的速度有多快。如果你看看整個 2021 年，我相信 2021 年我們總共有 1,000 名外科醫生為我們做手術，而僅在第四季度，我們就有 920 名外科醫生做手術。因此，我們在 12 個月的時間裡就看到了非常非凡的進步。因此，如果按季度環比來看，同比增長 33%，甚至增長 15%。坦率地說，這是自我們成為上市公司以來我所見過的最高水平。所以從我的角度來看，這真的很令人興奮。

We usually don't give out a lot of information about the different parts of our business in terms of the product differentiation because we really do see this as one segment of our business or sacropelvic solutions company and all of these different areas, be it the primary market or adult deformity or trauma really fall into the same category. With that said, we recognize that there is a need to at least provide some information. And just -- we want to be clear that the core market is reaccelerating. It's not just the new markets. It's not just the adjacent markets that are driving the growth of our business.

我們通常不會在產品差異化方面提供有關我們業務不同部分的大量信息，因為我們確實將其視為我們業務或骶骨盆解決方案公司以及所有這些不同領域的一個部分，無論是初級市場或成人畸形或創傷確實屬於同一類別。話雖如此，我們認識到至少需要提供一些信息。只是 - 我們想明確核心市場正在重新加速。不僅僅是新市場。推動我們業務增長的不僅僅是鄰近市場。

And if you look at the surgeon adds, it's interesting that you made that comment, it is nearly even if you look at those just doing minimally invasive SI joint fusion versus those that are in our adjacent markets of adult deformity and trauma, if you look at the adds, it's around 50-50 between the core market versus the new products. And so we're seeing it come from all different ends. And what we're also pleased with is that we're seeing this growing overlap where surgeons are performing procedures across these different areas of SI joint fusion, adult deformity and trauma. So in summary, it's really a testament to how focused we've been on execution and education outreach over the last few years. And we really think that we have a terrific portfolio of products. We are the leader in the safer pelvic space. We have this favorable reimbursement tailwind in 2023 in our core market. And we think that surgeon engagement and density is going to accelerate this year.

如果你看看外科醫生補充說，你發表這樣的評論很有趣，即使你看看那些只做微創 SI 關節融合的人與那些在我們鄰近的成人畸形和創傷市場中的人，如果你看另外，核心市場與新產品之間的比例約為 50-50。所以我們看到它來自各個不同的目的。我們還感到高興的是，我們看到這種越來越多的重疊，外科醫生在 SI 關節融合、成人畸形和創傷等不同領域進行手術。因此，總而言之，這確實證明了我們在過去幾年中對執行和教育推廣的關注程度。我們真的認為我們擁有很棒的產品組合。我們是更安全的骨盆空間的領導者。 2023 年，我們的核心市場將迎來有利的報銷順風。我們認為外科醫生的參與度和密度將在今年加速。

Got it. That's helpful. Laura, you've mentioned it a couple of times you've had a couple of reimbursement positives over the last 6 months, call it. So one, I wanted to see -- get a little bit of color from you on the NTAP for Granite and how much of that is -- are hospitals realizing or getting the payment that they expected that you guys had kind of outlined, how much of that is driving that growth in Q4 and then how to think about it in '23? And then also on the actual SI joint fusion procedure, I know it's early, but any anecdotal feedback on the reimbursement win there?

知道了。這很有幫助。勞拉，你已經提到過幾次，在過去的 6 個月裡你有幾次報銷積極，稱之為。所以，我想看看——從你們那裡得到一些關於花崗岩的 NTAP 的顏色，其中有多少——醫院是否意識到或得到了你們所概述的他們期望的付款，有多少這推動了第四季度的增長，然後如何在 23 年考慮它？然後還有關於實際的 SI 聯合融合程序，我知道現在還早，但是有關於那裡的報銷勝利的軼事反饋嗎？

Yes. On the NTAP, very good question on that. And as you recall, the NTAP went into effect on October 1, 2022. So we really have just a little over a quarter of experience on that NTAP, but we think that this is a really important factor for Granite and the adoption of our product here in adult deformity. I was recently at a conference with adult deformity surgeons. And one of the questions that was asked on a panel was how our companies in our industry thinking about these issues of additional cost without additional reimbursement. And so something like the new technology add-on payment is definitely critical to making sure that a disruptive technology like Granite is adopted.

是的。關於 NTAP，這是一個很好的問題。正如您所記得的那樣，NTAP 於 2022 年 10 月 1 日生效。所以我們在 NTAP 方面確實只有四分之一多一點的經驗，但我們認為這對於 Granite 和採用我們的產品來說是一個非常重要的因素這裡是成人畸形。我最近參加了一個與成人畸形外科醫生的會議。在一個小組中被問到的問題之一是我們行業中的公司如何考慮這些沒有額外報銷的額外成本問題。因此，諸如新技術附加支付之類的東西對於確保採用像 Granite 這樣的顛覆性技術絕對是至關重要的。

And we are seeing that play out at this point. We are starting to see cases where the NTAP has been paid, and this is going to be important, obviously, to the surgeons and as importantly, to the hospitals as well. So we think that while the additional economics are meaningful, we believe the strong surgeon interest in the product is also due to Granite's unique design. It seamlessly fits into the surgeon workflow and it actually allows them to drive fusion and fixation to address this major unmet clinical need, and that is the securing of a long construct. So that's the NTAP.

我們現在看到了這一點。我們開始看到已支付 NTAP 的案例，這顯然對外科醫生很重要，對醫院也同樣重要。因此我們認為，雖然額外的經濟效益很有意義，但我們相信外科醫生對該產品的強烈興趣也是由於 Granite 的獨特設計。它無縫融入外科醫生的工作流程，實際上允許他們推動融合和固定，以滿足這一主要未滿足的臨床需求，這就是長結構的固定。這就是NTAP。

In terms of the increase in the facility fee for procedures that are quoted to 27279 minimally invasive SI joint fusion, we talked a little bit about how things are going in terms of the first quarter and what we're anticipating. It's not clear whether the reimbursement is driving some of the continued acceleration or if it's really just entering into a normalized environment at this point, but we are certainly pleased with what we're seeing how to begin it in the first quarter.

關於引用 27279 微創 SI 關節融合手術的設施費用增加，我們談到了第一季度的進展情況以及我們的預期。目前尚不清楚報銷是否正在推動一些持續加速，或者它是否真的只是在此時進入正常化環境，但我們當然對我們在第一季度看到的如何開始它感到滿意。

(Operator Instructions) Our next question comes from the line of Ross Osborn with Cantor.

（操作員說明）我們的下一個問題來自 Ross Osborn 與 Cantor 的對話。

Just starting off, has there been any progress in turning around your business in Germany and the U.K., following the new leadership team there? And as a follow-up, do you plan to have more resources to the U.S. business this year?

剛剛起步，在德國和英國的新領導團隊之後，您在扭轉您在德國和英國的業務方面是否取得了任何進展？作為後續行動，您是否計劃今年為美國業務提供更多資源？

Ross, we certainly are pleased with how Neville is stabilizing that business. He is focusing very specifically on the businesses in Germany and the U.K., while helping to support the growth that we're seeing in France and in the rest of Europe. So I think given that Neville is in the U.K., it gives him a very specific opportunity to get his arms very much around that business. There was also a kickoff meeting in January with the senior leadership team, plus the entire EMEA team. And a lot of this is just very basic blocking and tackling in these countries. It is focusing on the sales force and training of surgeons, getting the surgeons the first case and regularly diagnosing and treating patients. So that takes time with us. On average, it usually takes 12 months to see the impact of those sorts of moves. And so those things were considered as we were giving information on guidance, but we think the right things are happening there under new leadership.

羅斯，我們當然對內維爾穩定該業務的方式感到滿意。他非常專注於德國和英國的業務，同時幫助支持我們在法國和歐洲其他地區看到的增長。所以我認為，鑑於內維爾在英國，這給了他一個非常具體的機會，讓他能夠非常關注這項業務。 1 月份還與高級領導團隊以及整個 EMEA 團隊召開了啟動會議。在這些國家，其中很多只是非常基本的封鎖和應對。它專注於銷售人員和外科醫生的培訓，讓外科醫生成為第一個病例，並定期診斷和治療患者。所以這需要我們花時間。平均而言，通常需要 12 個月才能看到這些舉措的影響。因此，我們在提供有關指導的信息時考慮了這些事情，但我們認為在新的領導下正在發生正確的事情。

Yes. What I would say, Ross, is our expectation is any improvement that we see OUS will be at best back half loaded.

是的。羅斯，我要說的是，我們的期望是我們看到 OUS 的任何改進最多只能恢復一半。

Okay. Got it. And then one more from me. Would you be able to share the latest enrollment numbers from your SAFFRON study?

好的。知道了。然後我又來了一個。您能否分享 SAFFRON 研究的最新註冊人數？

I don't think we're actually giving out enrollment numbers. I think our plan is to actually provide information at key points in time. And I think that it actually probably will be 2024 before we give a detailed report out on SAFFRON.

我不認為我們實際上是在分發註冊人數。我認為我們的計劃是在關鍵時間點實際提供信息。而且我認為實際上可能要到 2024 年我們才能給出有關 SAFFRON 的詳細報告。

(Operator Instructions) Our next question comes from the line of Dave Turkaly with JMP Securities.

（操作員說明）我們的下一個問題來自 JMP 證券公司的 Dave Turkaly。

Laura, given the numbers that you saw in the fourth quarter, the 30% plus procedure volume growth, I'm just trying to reconcile with what we've heard from some of the, let's say, some of the other competitors in the ortho spine world, but in terms of where you think we are coming out or the rebound from COVID, I mean it seems like your U.S. might be all the way back and maybe you still have some lingering OUS things to tackle, but I heard you mentioned freight, but I didn't hear you say anything about staffing shortages. I know you said depreciation as well, but I'd just like to get your thoughts on domestically, do you feel like we're back?

勞拉，考慮到你在第四季度看到的數字，超過 30% 的手術量增長，我只是想與我們從一些，比方說，其他一些競爭者那裡聽到的情況保持一致脊椎世界，但就您認為我們正在走出去的地方或 COVID 的反彈而言，我的意思是您的美國似乎已經一路回歸，也許您仍有一些揮之不去的 OUS 事情需要解決，但我聽說您提到過運費，但我沒聽到你說任何關於人員短缺的事情。我知道你也說過折舊，但我想听聽你對國內的看法，你覺得我們回來了嗎？

It's an interesting question. We're looking at this as a normalized operating environment. And if anything, I was frustrated at the fact that it took 4 quarters in order to really see it. But we're pretty excited about where we're at. I do think that if I think about our procedures, Dave, our procedure is a relatively straightforward procedure in the operating room. For the most part, it's done outpatient or in a surgery center. And I think that even with a squeeze on labor in some cases, the sites of service and the surgeons are able to squeeze in these procedures. I do think that some of these improvements that we've seen in reimbursement will have an impact on the procedure being prioritized as well. And so I think all of those things are working in our favor.

這是一個有趣的問題。我們將其視為標準化的操作環境。如果有的話，我很沮喪，因為我花了 4 個季度才真正看到它。但我們對我們所處的位置感到非常興奮。我確實認為，如果我考慮我們的程序，Dave，我們的程序在手術室中是一個相對簡單的程序。大多數情況下，它是在門診或手術中心完成的。而且我認為，即使在某些情況下會壓縮勞動力，服務站點和外科醫生也能夠壓縮這些程序。我確實認為，我們在報銷方面看到的其中一些改進也會對優先考慮的程序產生影響。所以我認為所有這些事情都對我們有利。

Got it. And then maybe a quick follow-up just on the M&A landscape. We've seen some things start to happen again, which is nice, but it's been a little bit of a delay there. I guess I'd sort of like to hear your thoughts on where you're getting some of the new reps and where you plan to bring that force to this year? And if you think any of the transactions might help you gain some competitive folks?

知道了。然後可能只是對併購領域的快速跟進。我們已經看到一些事情又開始發生了，這很好，但它有一點延遲。我想我有點想听聽你對你在哪裡獲得一些新代表以及你計劃在今年將這支部隊帶到哪裡的想法？如果您認為任何交易可能會幫助您獲得一些有競爭力的人？

It's definitely interesting to watch what's going on at this point. It does seem like the M&A environment has come back to life because 2022 was pretty quiet at least in our particular space. So we're actually happy to see it. We -- there's a couple of things from a rep perspective. We've done a very good job of retaining our key reps within SI-BONE. And then we've also done a good job of growing our reps, too. So hiring these more junior clinical support specialists in 50% of cases when we do split a territory, we actually promote a clinical support specialist into a territory manager. So we try and promote from within wherever we can does it provide additional opportunity for us to hire new. Our focus is more on getting leverage of the sales force in 2023. So growing that $1.2 million of productivity up to the $1.5 million to $2 million range depending upon whether there's a junior rep in the territory or not. And so I would say that our thoughts are more on productivity increases and growing our own sales force versus trying to pull from other places given some of these changes in the M&A landscape.

觀察此時發生的事情絕對很有趣。併購環境似乎已經恢復生機，因為 2022 年至少在我們的特定領域非常安靜。所以我們真的很高興看到它。我們——從代表的角度來看有幾件事。我們在保留 SI-BONE 的關鍵代表方面做得非常好。然後我們在增加銷售代表方面也做得很好。因此，當我們拆分區域時，在 50% 的案例中僱用了這些更初級的臨床支持專家，我們實際上將臨床支持專家提升為區域經理。因此，我們盡可能地嘗試從內部提拔，這為我們提供了更多招聘新人的機會。我們的重點更多是在 2023 年利用銷售人員。因此，將 120 萬美元的生產力提高到 150 萬到 200 萬美元的範圍，具體取決於該地區是否有初級代表。因此，我想說的是，考慮到併購領域的一些變化，我們的想法更多地放在提高生產力和發展我們自己的銷售隊伍上，而不是試圖從其他地方拉動。

(Operator Instructions) Our next question comes from the line of Drew Ranieri with Morgan Stanley.

（操作員說明）我們的下一個問題來自 Drew Ranieri 與摩根士丹利的合作。

Maybe just on the overall environment. I mean, a few companies have talked about softness in the fourth quarter. This may go back to a question that was already asked. But as you are seeing about rolling out Granite through '23, can you just maybe talk about any factors that you are seeing in terms of growth rate and adoption? Are you seeing these incremental headwinds affecting the Granite launch? And then just from a set perspective, do you think -- or at this point, do you have adequate supply to meet all demand in the marketplace right now? And I have a follow-up.

也許只是在整體環境上。我的意思是，一些公司談到了第四季度的疲軟。這可能會回到已經提出的問題。但是正如您所看到的那樣，通過 23 年推出 Granite，您能否談談您在增長率和採用方面看到的任何因素？您是否看到這些影響 Granite 發布的逆風？然後從一個固定的角度來看，你認為 - 或者在這一點上，你現在有足夠的供應來滿足市場上的所有需求嗎？我有一個後續行動。

Yes. Drew, in terms of the environment, as you can see, we weren't necessarily seeing an impact or any softness in any particular part of the market in the fourth quarter. And as I also shared for Q1, our expectation is to see even further acceleration of our year-over-year growth in Q1. And I do think, though, that the last part of your question is the right question. Our opportunity with Granite is quite unique, at least for us here at SI-BONE. With our core market and SI joint fusion and also the opportunity in trauma with fragility fracture, those are really markets that take time to develop versus in the case of Granite and adult deformity, it's really more -- is very surgeon that's going to perform a long construct procedure and are they looking to use Granite for spino-pelvic fixation and fusion. So there's a much more potential opportunity for rapid uptake in our Granite product than there have been in our previous products.

是的。德魯，就環境而言，正如你所看到的，我們不一定在第四季度看到市場任何特定部分的影響或任何疲軟。正如我在第一季度分享的那樣，我們的期望是看到我們在第一季度的同比增長進一步加速。不過，我確實認為你問題的最後一部分是正確的問題。我們與 Granite 的合作機會非常獨特，至少對我們 SI-BONE 而言是這樣。憑藉我們的核心市場和 SI 關節融合以及脆性骨折外傷的機會，與花崗岩和成人畸形相比，這些市場確實需要時間來發展，它真的更多 - 非常外科醫生將要進行長的構建過程，他們是否希望使用 Granite 進行脊柱骨盆固定和融合。因此，與我們以前的產品相比，我們的 Granite 產品有更多的潛在機會可以快速吸收。

But the -- what's important here is that we have enough implants in the field. We have enough instrument trays in the field. And then also that we're on the approved list at the various hospitals where these procedures are going to be performed. And I can tell you, we've made extraordinary progress just in the last few months when we spoke in November, that was a rate-limiting factor for us. But we started to -- so even towards the middle of Q4, we were bringing in more implants, more trays and it's giving us the ability to try and keep up with some of this demand. And so I'm feeling pretty confident that we can meet the demand for both implants and trade for our Granite product, but it's definitely the -- probably the primary point of focus on fully recognizing the opportunity that we have in front of us with Granite.

但是——這裡重要的是我們在該領域有足夠的植入物。我們在現場有足夠的儀器托盤。然後我們也在將要執行這些程序的各個醫院的批准名單上。我可以告訴你，就在過去幾個月裡，我們在 11 月的談話中取得了非凡的進展，這對我們來說是一個速度限制因素。但我們開始了——所以即使在第四季度中期，我們也引入了更多的植入物、更多的托盤，這讓我們有能力嘗試滿足其中的一些需求。因此，我非常有信心我們能夠滿足對植入物和 Granite 產品貿易的需求，但這絕對是 - 可能是充分認識到 Granite 擺在我們面前的機會的主要關注點.

In addition, we've made great progress on making sure that Granite is on the approved list at these various hospitals. So we have approximately 2,500 hospitals now that have Granite on their approved list and we continue to tick through a few of them that are remaining at this point. But overall, we're in a good spot there. So I think that, hopefully, that answers your question.

此外，我們在確保 Granite 在這些不同醫院的批准名單上取得了很大進展。因此，我們現在大約有 2,500 家醫院將 Granite 列在他們的批准名單上，我們將繼續篩選目前仍保留的一些醫院。但總的來說，我們在那里處於有利地位。所以我認為，希望這能回答您的問題。

Yes. Great color. And maybe for Anshul, we've talked about guidance a few times tonight, but can you help us maybe frame volume growth, your expectations for volume growth in 2023, just coming off the strong fourth quarter and just help us kind of better contextualize what acceleration means in terms of volume growth? And then second, just any framework you can provide on CapEx for '23?

是的。很棒的顏色。也許對於 Anshul，我們今晚已經討論過幾次指導，但你能否幫助我們構建銷量增長，你對 2023 年銷量增長的預期，剛剛結束強勁的第四季度，並幫助我們更好地了解什麼加速意味著銷量增長？其次，您可以在 23 年的資本支出上提供任何框架嗎？

Yes. So in terms of our breakdown between volume and volume growth from a revenue growth perspective, Drew, our ASP assumptions are sort of having an ASP degradation that's similar to what we've had sort of last 12 months, which is between that 4% to 5% ASP degradation is what's put in there. So if you do the math of 17 to 19, that will give you an estimate of where the volume growth should be to be able to hit the low end or the high end of the range. And even within the U.S. and OUS, our expectation is that growth is going to be faster in the U.S., the OUS growth, like I said previously to an earlier question, would be a lot more muted and more back-half loaded as well. So that's sort of on the volume side.

是的。因此，就我們從收入增長的角度來看銷量和銷量增長之間的細分而言，德魯，我們的平均售價假設有點類似於我們過去 12 個月的平均售價下降，即 4% 到5% 的 ASP 降級就是其中的內容。因此，如果您對 17 到 19 進行數學運算，您就會估算出銷量增長應該達到該範圍的低端或高端的位置。甚至在美國和 OUS 內部，我們的預期是美國的增長會更快，就像我之前對一個較早的問題所說的那樣，OUS 的增長將更加溫和，並且後半部分的負荷也會增加。所以這是在數量方面。

Now in terms of the trend and acceleration, that's something that we've talked about internally a lot on how should the sequencing be as you progress through the year and unfortunately, when you look at the first half of the last 3 years, it's been significantly disported by COVID. So it's really difficult to say what a normal sequential trend would look like going from Q1 to Q2. And then you layer on some of the new products that we've launched in the last 2 years, that makes it even a little bit more difficult to say what the trending would look like. But like Laura said, we expect Q1 to be at about 30% growth year-over-year. Seasonally, you think Q2 is a little bit higher than that. Q3, we think will be more flattish and then you have sort of that Q4 ramp again. And we think that's the same trajectory you'll see now.

現在就趨勢和加速而言，這是我們內部討論過的很多事情，關於隨著你一年的進展應該如何排序，不幸的是，當你回顧過去 3 年的上半年時，它一直被 COVID 顯著驅散。所以很難說從第一季度到第二季度的正常連續趨勢是什麼樣的。然後再加上我們在過去兩年推出的一些新產品，這讓我們更難判斷趨勢會是什麼樣子。但正如勞拉所說，我們預計第一季度同比增長約 30%。季節性的，你認為第二季度比那個高一點。 Q3，我們認為會更加平穩，然後你會再次看到 Q4 的斜坡。我們認為這與您現在看到的軌跡相同。

Got it. And then CapEx for the year?

知道了。然後是今年的資本支出？

I would say from a CapEx perspective, the trend should be very similar to what you saw last year from a CapEx spend perspective because we'll still continue to introduce more TORQ trays, but the focus on continuing to put out more Granite trays is going to be key for us to be able to capture the opportunity Laura talked about.

我想說，從資本支出的角度來看，趨勢應該與去年從資本支出支出的角度看到的非常相似，因為我們仍將繼續推出更多的 TORQ 托盤，但重點是繼續推出更多的 Granite 托盤成為我們能夠抓住勞拉談到的機會的關鍵。

(Operator Instructions) Our next question comes from the line of David Saxon with Needham & Company.

（操作員說明）我們的下一個問題來自 David Saxon 與 Needham & Company 的合作。

Maybe I'll start on active surgeons, really strong into the year. Obviously, maybe I was wondering what your expectations are for 2023 in terms of active surgeon count? And then I think you said in the past, the quarterly average procedures per doc is in the 3 to 4 range. So I would love to hear where you think that could go over the next 12 to 24 months as you see some pull-through across the portfolio?

也許我會從積極的外科醫生開始，到今年真的很強大。顯然，也許我想知道您對 2023 年活躍外科醫生人數的期望是什麼？然後我想你過去說過，每個醫生的季度平均程序在 3 到 4 個範圍內。所以我很想听聽您認為在接下來的 12 到 24 個月內，當您看到整個投資組合中的一些突破時，這可能會發生什麼？

Yes, David, happy to take that question. In terms of active surgeon growth, again, we've had 8 quarters of double-digit growth. So I feel really good about it. Coming into this year, our expectation is growth in the mid-teens range at the end of Q4 2023 when you compare it to Q4 of 2022. Just to give you points of reference there. And if you think about the guidance range of 17 to 19, the delta of the guidance range versus that surgeon base would come from increase in productivity. We have better control on making sure we are reaching out to surgeons, creating them and getting them to first case.

是的，大衛，很高興回答這個問題。就活躍的外科醫生增長而言，我們再次實現了 8 個季度的兩位數增長。所以我感覺很好。進入今年，我們的預期是，與 2022 年第四季度相比，到 2023 年第四季度末將實現十幾歲左右的增長。只是為了給你提供參考點。如果你考慮 17 到 19 的指導範圍，指導範圍與外科醫生基礎的增量將來自生產力的提高。我們可以更好地控制確保我們接觸到外科醫生，創建他們並將他們帶到第一個案例中。

And then the sales team works really closely with the surgeons to get them to do repeat cases. But that's why we focus more on how many surgeons can retrain and get the first case. But with the broader portfolio, we expect that the number of procedures where we think about adult the 4 million SI joint fusion, because even the limited time period that we've been doing adult deformity as an example for 2022 of the surgeons that did an adult deformity procedure, also then an SI joint fusion procedure. So there is low-hanging fruit there that we can go after with this existing surgeon base and stop having them diagnose patients and postpone SI fusion procedures as well. But we want to be conservative on sort of that density per surgeon at this point.

然後銷售團隊與外科醫生密切合作，讓他們做重複病例。但這就是為什麼我們更關注有多少外科醫生可以重新培訓並獲得第一個病例。但是隨著更廣泛的投資組合，我們預計我們考慮成人 400 萬 SI 關節融合的程序數量，因為即使是我們一直在做成人畸形的有限時間，例如 2022 年的外科醫生做了一個成人畸形手術，然後是 SI 關節融合手術。因此，我們可以通過這個現有的外科醫生基地來實現一些容易實現的目標，並停止讓他們診斷患者並推遲 SI 融合手術。但我們希望在這一點上對每個外科醫生的密度保持保守。

Okay. That's super helpful. And then maybe I just wanted to follow up on the gross margin guidance. Anshul, I think in the script, you said gross margin stabilized at that 80%. So does that mean you're exiting the year at 80%? Or is that a full year guide kind of implying you're exiting slightly below that?

好的。這非常有幫助。然後也許我只是想跟進毛利率指導。 Anshul，我想在劇本中，你說毛利率穩定在 80%。那麼這是否意味著您將以 80% 的成績結束這一年？或者這是一個全年的指南，暗示你的退出略低於該指南？

I'm glad you caught that word stabilized, right. So our expectation is similar to what you saw in 2022, the gross margin will end the year at around that 80% mark because we will continue to roll trays out. And then we expect it to stabilize at that 80% level, which, again, look, they're industry-leading, gross margins is a huge competitive differentiator for us. So we will continue to work hard to maintain those gross margins going forward. And there are a couple of things that will play out as you get beyond 2023 from a gross margin perspective.

我很高興你發現這個詞穩定了，對吧。因此，我們的預期與您在 2022 年看到的類似，毛利率將在年底達到 80% 左右，因為我們將繼續推出托盤。然後我們預計它會穩定在 80% 的水平，再次看，它們是行業領先的，毛利率對我們來說是一個巨大的競爭優勢。因此，我們將繼續努力保持未來的毛利率。從毛利率的角度來看，隨著 2023 年以後的發展，有幾件事情會發生。

One is, when you launch a product, you see the market with significant capacity to be able to capitalize on the demand, and we've done that with TORQ starting in 2021. We're starting to do that with Granite in 2022. And what you have is a roll-off effect, right? So some of the older trays roll off, the newer trees that come on are more replacement capacity. So you have some stabilization on gross margin there. That's number one. Number two is as these products gain scale in the market, you start seeing the cost per implant potentially also improving over time, right? So we haven't taken that into account yet because it's still early for both those products.

一是，當你推出一款產品時，你會看到市場有很大的能力可以利用需求，我們已經從 2021 年開始用 TORQ 做到了這一點。我們在 2022 年開始用 Granite 做到這一點。而且你有什麼是滾降效應，對吧？因此，一些較舊的托盤滾落，出現的較新的樹具有更多的替代能力。所以你在那裡的毛利率有一些穩定。這是第一。第二，隨著這些產品在市場上的規模擴大，您開始看到每個植入物的成本也可能隨著時間的推移而提高，對吧？所以我們還沒有考慮到這一點，因為這兩種產品都還為時過早。

I'm showing no further questions in the queue. I would now like to turn the call back over to Laura Francis for closing remarks.

我不會在隊列中顯示更多問題。我現在想將電話轉回給 Laura Francis 作結束語。

Thanks, Towanda, and thank all of you for joining the call today.

謝謝 Towanda，也感謝大家今天加入電話會議。

As I'm sure you've heard in our voices, we're bullish about the opportunity ahead of us in 2023. Based on the demand momentum, we're seeing growing surgeon interest and also a favorable health economic environment, I'm optimistic that we're entering a period of strong and sustained procedure growth in the U.S. Just also wanted to say that we're going to be attending the upcoming AAOS meeting in Las Vegas, and I hope to see some of you there as well as at upcoming investor events.

正如我確定您已經從我們的聲音中聽到的那樣，我們看好 2023 年擺在我們面前的機會。根據需求勢頭，我們看到外科醫生的興趣越來越大，而且健康經濟環境也很有利，我樂觀地認為我們正在進入美國程序強勁和持續增長的時期。我還想說我們將參加即將在拉斯維加斯舉行的 AAOS 會議，我希望能見到你們中的一些人以及在即將舉行的投資者活動中。

Thank you. Goodbye.

謝謝。再見。

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。您現在可以斷開連接。