Pacira Biosciences Inc (PCRX) 2024 Q1 法說會逐字稿

Thank you for standing by. My name is Hermione. And I will be your conference operator today. At this time, I would like to welcome everyone to Q1 2024 Pacira BioSciences Earnings Conference Call. (Operator Instructions)

謝謝你的支持。我的名字是妙麗。今天我將擔任你們的會議操作員。此時，我歡迎大家參加 2024 年第一季 Pacira BioSciences 財報電話會議。 （操作員說明）

I would now like to turn the call over to Susan Mesco, Head of Investor Relations. Please go ahead.

我現在想將電話轉給投資者關係主管蘇珊‧梅斯科 (Susan Mesco)。請繼續。

Thank you, and good afternoon, everyone. Welcome to today's conference call to discuss our first quarter 2024 financial results. Joining me are Frank Lee, Chief Executive Officer; and Charlie Reinhart, Chief Financial Officer. Jonathan Slonin, Chief Medical Officer, is also here for today's question-and-answer session.

謝謝大家，大家下午好。歡迎參加今天的電話會議，討論我們 2024 年第一季的財務表現。與我一起的還有執行長弗蘭克李 (Frank Lee)；和財務長查理·萊因哈特。首席醫療官喬納森·斯洛寧 (Jonathan Slonin) 也出席了今天的問答環節。

Before we begin, let me remind you that this call will include forward-looking statements based on current expectations. Such statements represent our judgment as of today and may involve risks and uncertainties. For information concerning risk factors that could affect the company, please refer to our filings with the SEC, which are available from the SEC or the Pacira website.

在我們開始之前，讓我提醒您，本次電話會議將包括基於當前預期的前瞻性陳述。此類陳述代表我們截至目前為止的判斷，可能涉及風險和不確定性。有關可能影響公司的風險因素的信息，請參閱我們向 SEC 提交的文件，這些文件可從 SEC 或 Pacira 網站獲取。

With that, I will now turn the call over to Frank Lee.

現在，我將把電話轉給弗蘭克李。

Thank you, Susan, and good afternoon, everyone. It's been an exciting and productive time since I joined the company earlier this year. And I'm pleased to say sales are off to a solid start and on track for all 3 of our trusted opioids-sparing products, which continue to make an important impact on patients' lives. This year, our priority is EXPAREL, which is we're all focused on today. I'll also touch briefly on PCRX-201.

謝謝你，蘇珊，大家午安。自從我今年早些時候加入公司以來，這是一段令人興奮且富有成效的時光。我很高興地說，我們所有 3 種值得信賴的阿片類藥物節約產品的銷售已經有了一個良好的開端，並且步入正軌，這些產品將繼續對患者的生活產生重要影響。今年，我們的首要任務是 EXPAREL，這是我們今天所關注的焦點。我還將簡要介紹 PCRX-201。

Let's start with EXPAREL. Our goals are centered on preparing the organization and marketplace to fully realize its long-term potential. Let me walk you through the progress we've made in advancing 3 key drivers for 2024: First, advancing the launch of EXPAREL in 2 new lower extremity nerve block indications; second, progressing our awareness and educational activities around separate Medicare reimbursement and average selling price, or ASP, plus 6% in outpatient settings beginning in 2025 with the implementation of NOPAIN; and third, expanding patient access to EXPAREL through 340B pricing and new GPO partnerships such as Premier.

讓我們從 EXPAREL 開始。我們的目標集中在讓組織和市場做好準備，以充分發揮其長期潛力。讓我向您介紹我們在 2024 年推進 3 個關鍵驅動因素方面取得的進展：首先，推進 EXPAREL 在 2 個新的下肢神經阻斷適應症中的上市；其次，隨著 NOPAIN 的實施，從 2025 年開始，圍繞單獨的醫療保險報銷和平均售價 (ASP) 提高門診機構的 6% 的意識和教育活動；第三，透過 340B 定價和 Premier 等新的 GPO 合作夥伴關係擴大患者對 EXPAREL 的訪問。

I'll start with lower extremity nerve block, where we're seeing positive market receptivity across all sites of care, delivering 4 days of opioid-sparing pain control with a single 10 ml EXPAREL dose is an attractive value proposition to the anesthesia and surgical community for knee, foot and ankle surgeries. Physicians are also reporting consistent results with some patients not taking any opioids following very painful lower extremity procedures. To remind you, we launched with a strong presence in the TKA segment.

我將從下肢神經阻斷開始，我們看到所有護理場所的市場接受度都很高，用單次10 毫升EXPAREL 劑量即可提供4 天的阿片類藥物緩解疼痛控制，這對於麻醉和手術來說是一個有吸引力的價值主張膝蓋、足部和踝關節手術社區。醫生也報告了一致的結果，一些患者在接受非常痛苦的下肢手術後沒有服用任何鴉片類藥物。提醒您一下，我們在 TKA 領域擁有強大的影響力。

We're also working to build relationships and advanced product uptake through education and training in other lower extremity procedures like ACL repair, foot and ankle procedures. We would expect a slower uptake in this segment of the market.

我們也致力於透過 ACL 修復、足部和腳踝手術等其他下肢手術的教育和培訓來建立關係並促進先進產品的採用。我們預計該細分市場的吸收速度會較慢。

Turning now to the opportunity ahead with the upcoming changes in EXPAREL reimbursement for outpatient procedures. Separate CMS reimbursement of EXPAREL across all outpatient settings marks an important milestone. It will eliminate the cost barrier by fully reimbursing EXPAREL at ASP plus 6% beginning in January of 2025. Given the market steady migration away from hospital inpatient care, we see ample room for expanding EXPAREL utilization in outpatient settings. We've allocated resources to drive education and help health care systems implement EXPAREL as best practice standard of care for CMS patients.

現在談談 EXPAREL 門診手術報銷即將發生的變化帶來的機會。所有門診機構對 EXPAREL 的單獨 CMS 報銷標誌著一個重要的里程碑。從 2025 年 1 月開始，它將以 ASP 加 6% 的價格全額報銷 EXPAREL，從而消除成本障礙。 鑑於市場穩步從醫院住院護理轉移，我們認為在門診環境中擴大 EXPAREL 的使用有足夠的空間。我們分配資源來推動教育並幫助醫療保健系統實施 EXPAREL 作為 CMS 患者護理的最佳實踐標準。

There are roughly 6 million annual CMS procedures in the outpatient settings with a split of roughly 3.5 million procedures in the hospital outpatient settings and 2.5 million procedures performed at ambulatory surgical centers.

每年約有 600 萬例 CMS 手術在門診進行，其中約 350 萬例手術在醫院門診進行，250 萬例手術在門診手術中心進行。

To maximize this important opportunity, we're enhancing our organization with new talent and capabilities to ensure operational excellence within critical functions such as marketing, strategic accounts, medical and market access. In parallel, we're advancing initiatives to drive awareness, education, action across key decision makers.

為了最大限度地利用這一重要機會，我們正在利用新的人才和能力來增強我們的組織，以確保行銷、策略客戶、醫療和市場准入等關鍵職能部門的卓越運作。同時，我們正在推進舉措，以提高關鍵決策者的意識、教育和行動。

We're also paving the way for NOPAIN through our participation in 340B pricing and new GPO partnerships. Earlier this year, we announced a partnership with Premier whose significant network of hospitals and health care systems covers nearly 20% of EXPAREL relevant market procedures. Through these preferential pricing programs, we're helping health care systems afford the opportunity to be at the forefront of opioid-sparing pain management.

我們還透過參與 340B 定價和新的 GPO 合作夥伴關係為 NOPAIN 鋪平道路。今年早些時候，我們宣布與 Premier 建立合作夥伴關係，Premier 的重要醫院和醫療保健系統網路涵蓋了 EXPAREL 近 20% 的相關市場程序。透過這些優惠定價計劃，我們正在幫助醫療保健系統有機會站在阿片類藥物緩解疼痛管理的最前線。

While still early days, we're pleased with the initial data we're seeing from our partnership with Premier. In the first 2 months of post-launch, EXPAREL volumes at Premier accounts are up with only a modest impact on net sales dollars. In short, this partnership is starting to do what we expect it to do. Importantly, we have 2 additional GPO partnerships in process.

雖然還處於早期階段，但我們對從與 Premier 的合作中看到的初步數據感到滿意。在推出後的前 2 個月，EXPAREL 在 Premier 帳戶的銷量有所上升，但對淨銷售額的影響不大。簡而言之，這種夥伴關係正開始達到我們預期的效果。重要的是，我們還有 2 個 GPO 合作夥伴正在進行中。

As for ZILRETTA and iovera°, I'm pleased to say both products are performing according to plan with solid sales growth for the quarter. With respect to margins, while EXPAREL landed in our guided range, ZILRETTA and iovera° margins weighed on consolidated margins for the quarter. Charlie will share more details on margins shortly, but I want to emphasize that our primary focus is on driving top line growth. As we grow the top line, margins will in turn benefit.

至於 ZILRETTA 和 iovera°，我很高興地說這兩種產品都按計劃執行，本季銷售成長強勁。就利潤率而言，雖然 EXPAREL 落在我們的指導範圍內，但 ZILRETTA 和 iovera° 的利潤率拖累了本季的綜合利潤率。查理很快就會分享更多有關利潤率的細節，但我想強調，我們的主要重點是推動營收成長。隨著我們收入的成長，利潤率也會隨之受益。

Switching gears to our research and development pipeline. I'd like to share a few quick updates on PCRX-201. This novel intra-articular helper-dependent adenovirus gene therapy product candidate that codes for interleukin-1 receptor antagonist, or IL-1Ra for the treatment of osteoarthritis, OA, of the knee. Here, we believe PCRX-201 has the potential to become a leading disease-modifying agent by turning the patient's own cells into therapeutic production sites of IL-1Ra.

切換我們的研發管道。我想分享一些有關 PCRX-201 的快速更新。這種新型關節內輔助依賴性腺病毒基因治療候選產品，編碼白細胞介素 1 受體拮抗劑或 IL-1Ra，用於治療膝骨關節炎 (OA)。在這裡，我們相信 PCRX-201 有潛力透過將患者自身的細胞轉化為 IL-1Ra 的治療生產位點，成為領先的疾病緩解劑。

As background, IL-1 is a known inflammatory cytokine with inflammation tied to the reduction in catabolic processes in the joint that contribute to OA of the knee and progression. Last month, we presented encouraging preliminary results from a 72-patient Phase I study of PCRX-201 at the Osteoarthritis Research Society International, or OARSI, 2024, World Congress in Vienna. The data will also be featured as a noncore podium presentation at the Annual Meeting of the American Society of Cell and Gene Therapy this week in Baltimore.

作為背景，IL-1 是一種已知的發炎細胞因子，發炎與關節分解代謝過程的減少有關，從而導致膝關節骨關節炎和進展。上個月，我們在國際骨關節炎研究協會 (OARSI) 2024 年維也納世界大會上展示了 PCRX-201 的 72 名患者 I 期研究的令人鼓舞的初步結果。這些數據也將在本週於巴爾的摩舉行的美國細胞與基因治療學會年會上作為非核心講台演示。

This data showed that a single intra-articular injection of PCRX-201 demonstrated sustained clinical effect as assessed by patient-reported outcomes at all dose levels for at least 1 year post-injection. Importantly, PCRX-201 was shown to be well tolerated with a favorable safety profile. We now have data through 2 years, and we are preparing to submit those data for presentation at a medical meeting in the fall.

這些數據表明，單次關節內注射 PCRX-201 表現出持續的臨床效果，根據注射後至少 1 年的所有劑量水平的患者報告結果進行評估。重要的是，PCRX-201 具有良好的耐受性和良好的安全性。我們現在擁有兩年的數據，並準備在秋季的醫學會議上提交這些數據。

Of the 14 million Americans suffering from symptomatic OA of the knee, 2 million are under the age of 45. The duration of effect for currently available treatments is limited to 3 to 6 months. Based on our market research and feedback from our Scientific Advisory Board, improving pain and function while potentially modifying the disease for a year or more would be considered transformative by both physicians and patients.

在 1,400 萬名患有症狀性膝骨關節炎的美國人中，有 200 萬人年齡在 45 歲以下。根據我們的市場研究和科學諮詢委員會的回饋，在一年或更長時間內改善疼痛和功能，同時可能改變疾病，將被醫生和患者認為是變革性的。

Furthermore, a year or more of durability would be clinically and economically meaningful for patients and the health care system. These promising preliminary findings earned PCRX-201 the FDA's first ever Regenerative Medicine Advance Therapy, or RMAT, Designation for gene therapy product in osteoarthritis. Lastly, unlike other gene therapies, we believe PCRX-201 will be able to be manufactured at large scale for a favorable cost of goods sold.

此外，一年或更長時間的耐久性對於患者和醫療保健系統具有臨床和經濟意義。這些有希望的初步研究結果為 PCRX-201 贏得了 FDA 首個再生醫學高級治療（RMAT）骨關節炎基因治療產品的稱號。最後，與其他基因療法不同，我們相信 PCRX-201 將能夠以有利的銷售成本大規模生產。

Before I turn the call over to Charlie for a review of the financials, I'd like to highlight today's announcement of our plans to implement a $150 million stock repurchase plan. This stock repurchase plan underscores our confidence that we have in our growth outlook, and the belief that Pacira shares offer an attractive investment opportunity given the significant value ahead.

在我將電話轉給查理審查財務狀況之前，我想強調一下今天宣布的我們計劃實施 1.5 億美元的股票回購計劃。這項股票回購計畫強調了我們對成長前景的信心，以及鑑於未來的巨大價值，Pacira 股票提供了有吸引力的投資機會。

With that, I'll turn the call over to Charlie for his financial report.

這樣，我就把電話轉給查理，索取他的財務報告。

Thank you, Frank, and good afternoon to all on the call. To remind you, I will be discussing non-GAAP financial measures this morning. A description of these metrics, along with our reconciliation to GAAP, can be found in the news release we issued this afternoon. I'll start with an update on sales and margin trends.

謝謝弗蘭克，祝所有與會人員下午好。提醒您一下，今天早上我將討論非公認會計準則財務指標。這些指標的描述以及我們對 GAAP 的調整可以在我們今天下午發布的新聞稿中找到。我將從銷售和利潤趨勢的最新情況開始。

Starting with EXPAREL. First quarter EXPAREL sales increased to $132.4 million versus $130.4 million in 2023, driven by volume growth of 3%, which was partially offset by contracted discounts with the rollout of our Premier partnership in January as well as a modest shift in vial mix. First quarter ZILRETTA sales increased to $25.8 million versus $24.3 million in 2023 and iovera° sales improved to $5 million compared to $4 million in the first quarter of 2023.

從 EXPAREL 開始。第一季 EXPAREL 銷售額增至 1.324 億美元，而 2023 年為 1.304 億美元，銷量增長 3%，部分增長被 1 月份推出 Premier 合作夥伴關係帶來的合同折扣以及小瓶組合的適度變化所抵消。 ZILRETTA 第一季的銷售額從 2023 年的 2,430 萬美元增至 2,580 萬美元，iovera° 的銷售額從 2023 年第一季的 400 萬美元增至 500 萬美元。

Turning to margins. On a consolidated basis, our first quarter non-GAAP gross margin percent was 72%. While first quarter EXPAREL margins landed within our full year guided range of 74% to 76%, ZILRETTA and iovera° margins were below our guided range and negatively impacted consolidated gross margins for the quarter. For non-GAAP R&D expense, the first quarter increased to $16.4 million from $15.3 million reported last year. This year-over-year increase primarily relates to the start-up activities for the ZILRETTA Phase III study in shoulder OA.

轉向邊緣。在合併基礎上，我們第一季的非 GAAP 毛利率為 72%。雖然第一季 EXPAREL 利潤率落在我們全年指引範圍 74% 至 76% 之內，但 ZILRETTA 和 iovera° 利潤率低於我們的指導範圍，並對本季度的綜合毛利率產生了負面影響。對於非 GAAP 研發費用，第一季從去年報告的 1,530 萬美元增加到 1,640 萬美元。這一同比增長主要與肩部 OA 的 ZILRETTA III 期研究的啟動活動有關。

Of note, the first quarter R&D expense includes $7.4 million of product development and manufacturing capacity expansion costs, which is down 4% from the prior year as we approach the completion of our pre-commercial scale-up activities for the recently approved 200-liter EXPAREL manufacturing suite in San Diego.

值得注意的是，第一季研發費用包括 740 萬美元的產品開發和製造產能擴張成本，比上年下降 4%，因為我們即將完成最近批准的 200 公升的商業前規模擴大活動位於聖地牙哥的EXPAREL 製造套件。

Non-GAAP SG&A expense came in at $63.8 million for the first quarter, which is up from $62.5 million last year. This increase is largely due to professional and legal fees associated with the Paragraph IV and other litigation, and to a lesser extent, costs associated with our transition to a new CEO. First quarter interest expense improved to $3.3 million versus $9.6 million reported last year.

第一季非 GAAP SG&A 費用為 6,380 萬美元，高於去年的 6,250 萬美元。這一增長主要是由於與第四段和其他訴訟相關的專業和法律費用，以及在較小程度上與我們向新首席執行官過渡相關的成本。第一季利息支出從去年報告的 960 萬美元增至 330 萬美元。

This was driven by the interest expense savings associated with the retirement of our term loan B on March 31, 2023, using a new term loan A and cash on hand. And lastly, we delivered another quarter of significantly positive adjusted EBITDA of $44.6 million. With respect to capital allocation strategy, we are focused on creating long-term shareholder value.

這是由於我們使用新的定期貸款 A 和手頭現金於 2023 年 3 月 31 日終止定期貸款 B，從而節省了利息費用。最後，我們又一個季度實現了 4,460 萬美元的調整後 EBITDA 顯著正值。在資本配置策略上，我們專注於創造長期股東價值。

Today, we announced a $150 million stock repurchase plan, which gives us the flexibility to opportunistically return capital to our shareholders. We believe that our stock is undervalued, and we view our share repurchase program as a productive use of capital that will generate favorable returns for our shareholders.

今天，我們宣布了一項 1.5 億美元的股票回購計劃，這使我們能夠靈活地向股東返還資本。我們認為我們的股票被低估，我們認為我們的股票回購計畫是對資本的有效利用，將為我們的股東帶來豐厚的回報。

Turning to guidance. Today, we reiterate our full year guidance for 2024 as follows: total revenue of $680 million to $705 million; non-GAAP gross margin of 74% to 76%; non-GAAP R&D expense of $70 million to $80 million; non-GAAP SG&A expense of $245 million to $265 million; and stock-based compensation of $50 million to $55 million.

轉向指導。今天，我們重申 2024 年全年指引如下：總收入為 6.8 億美元至 7.05 億美元；非公認會計準則毛利率為 74% 至 76%；非公認會計準則研發費用為 7,000 萬至 8,000 萬美元；非 GAAP SG&A 費用為 2.45 億至 2.65 億美元；以及 5,000 萬至 5,500 萬美元的股票薪酬。

With that, I'll turn the call back to Frank.

說完，我會把電話轉回給弗蘭克。

Thank you, Charlie. In closing, I'm very pleased with the progress we've made thus far in 2024, leveraging growth opportunities for EXPAREL, launching new indications, preparing for the significant reimbursement opportunity that lies ahead next year, and also growing ZILRETTA and iovera°. The progress we're making is setting the stage for us to further entrench our leadership position in providing non-opioid pain management solutions.

謝謝你，查理。最後，我對我們在 2024 年迄今取得的進展感到非常滿意，利用 EXPAREL 的成長機會，推出新的適應症，為明年即將到來的重大報銷機會做好準備，並發展 ZILRETTA 和 iovera°。我們所取得的進展為我們進一步鞏固我們在提供非鴉片類疼痛管理解決方案方面的領導地位奠定了基礎。

We're sharply focused on growth as we continue to execute our growth strategy will create value for shareholders, health care systems and most importantly, transform the lives of the patients we serve.

我們高度關注成長，因為我們繼續執行我們的成長策略，將為股東、醫療保健系統創造價值，最重要的是，改變我們所服務的患者的生活。

With that, operator, we're ready to open the call for questions.

接線員，我們就準備開始提問了。

(Operator Instructions) And your first question comes from the line of Gregory Renza with RBC Capital Markets.

（操作員說明）您的第一個問題來自加拿大皇家銀行資本市場部的 Gregory Renza。

Congrats on the progress. Frank, I appreciate all the updates and the color on EXPAREL for the quarter, especially on Premier and the GPO contract. So wondering if you and the team could just comment on how you view the cadence of the contracting that you alluded to with a couple more potentially coming online, how should we be thinking about that and its impact and the influence on EXPAREL performance over 2024?

祝賀取得的進展。 Frank，我很欣賞 EXPAREL 本季的所有更新和顏色，特別是 Premier 和 GPO 合約。因此，想知道您和團隊是否可以評論您如何看待您提到的與更多可能上線的合約的節奏，我們應該如何考慮這一點及其影響以及對 2024 年 EXPAREL 業績的影響？

Yes, thanks, Greg. Thanks for the question. We're excited about what we're seeing. It's still early days, right? Because we signed this thing in January, it's early days, but we're excited about what we're seeing per my comments. And we're working on a couple more, as you mentioned.

是的，謝謝，格雷格。謝謝你的提問。我們對所看到的感到興奮。現在還為時過早，對吧？因為我們在一月份簽署了這個協議，現在還為時過早，但我們對我的評論所看到的內容感到興奮。正如您所提到的，我們正在研究更多的內容。

Let me turn it over to Charlie to give a little bit more color on that.

讓我把它交給查理，讓他對此有更多的了解。

Hey, Greg, so the expectation from a rollout perspective is that we would likely have a second contract kind of later in the second quarter and maybe another one in the third quarter. So the contracts are rolling in throughout the year. And as Frank said, the first quarter of the activity probably isn't at its peak. So it takes a little time for them to get warmed up. But we anticipate by the end of this year that we'll have 3 active GPO relationships.

嘿，格雷格，所以從推出的角度來看，我們可能會在第二季度晚些時候簽訂第二份合同，也許在第三季度再簽訂一份合約。因此，合約全年都會滾滾而來。正如弗蘭克所說，第一季的活動可能還沒有達到頂峰。所以他們需要一點時間來熱身。但我們預計到今年年底，我們將擁有 3 個活躍的 GPO 關係。

And let me just add some additional color there in addition to the contracts, what this enables us to do is to partner with the GPOs to better educate their membership on what's coming with respect to outpatient reimbursement at ASP plus 6 starting in January 2025.

除了合約之外，讓我添加一些額外的內容，這使我們能夠與 GPO 合作，更好地教育他們的會員，了解 2025 年 1 月開始的 ASP plus 6 門診報銷的相關內容。

Got it. That makes sense. And maybe keeping with a similar theme for my question. And I know it's too early to tell when it comes to 2025, as you just mentioned. But when it comes to that, call it, a bolus of patients with NOPAIN, at what point would you have some comfort in talking about what that trajectory could look like, of course, with the 6 million patients at CMS?

知道了。這就說得通了。也許我的問題與類似的主題保持一致。我知道，正如你剛才提到的，現在判斷 2025 年的時間還為時過早。但說到這一點，稱之為 NOPAIN 患者的推注，在什麼時候您會放心地談論 CMS 的 600 萬患者的軌跡可能會是什麼樣子？

And then that additional as a double when it comes to the commercial opportunity, at what point should we start thinking about your comfort level as you prepare for kind of that trajectory of those patients and capturing that opportunity from 2025 and beyond?

然後，當涉及商業機會時，當您為這些患者的這種軌跡做準備並抓住 2025 年及以後的機會時，我們應該在什麼時候開始考慮您的舒適度？

Yes, that's a good question, Greg. And we're doing a lot of work now. So as you know, from prior discussions, we've reallocated our resources toward NOPAIN. And so a lot of folks are working on getting not only our sales prepared but the market prepared.

是的，這是個好問題，格雷格。我們現在正在做很多工作。如您所知，根據先前的討論，我們已將資源重新分配給 NOPAIN。因此，許多人不僅致力於為我們的銷售做好準備，而且為市場做好準備。

We're going to have a better view as we get closer to the end of the year. And I know that there's quite a bit of interest in terms of thinking about how we model the uptake of NOPAIN. And my sense is that the work that we're doing now with a number of partners and having discussions in various settings, along with some qualitative and quantitative research that we're doing in partnership with various parties, we're going to have much better insight into the uptake of NOPAIN come towards the end of the year. And we'll be able to provide some better clarity in terms of what segments we think are going to uptake earlier on versus later.

隨著年底的臨近，我們將會有更好的視野。我知道人們對思考如何模擬 NOPAIN 的吸收非常感興趣。我的感覺是，我們現在正在與許多合作夥伴一起做的工作，並在各種環境中進行討論，以及我們與各方合作進行的一些定性和定量研究，我們將有很多到今年年底，我們將更了解NOPAIN 的吸收情況。我們將能夠更清楚地說明我們認為哪些細分市場將在早期和後期採用。

And of course, as we mentioned, it will take some time for commercial payers to follow suit. And so we're focused on that as well. Broadly speaking, as we mentioned before, Susan Mesco, our Head of IR, will be hosting some information settings in the fall. And those -- that timing will release in due course, which will provide better clarity on some initial feedback that we're getting from the marketplace.

當然，正如我們所提到的，商業付款人需要一些時間才能效仿。所以我們也關注這一點。一般來說，正如我們之前提到的，我們的 IR 主管 Susan Mesco 將在秋季主持一些資訊會議。這些時間將在適當的時候發布，這將使我們從市場獲得的一些初步反饋更加清晰。

I think, Greg, if there are no other questions, we can move to the next caller.

我想，格雷格，如果沒有其他問題，我們可以轉到下一個來電者。

Your next question comes from the line of David Amsellem with Piper Sandler.

您的下一個問題來自 David Amsellem 和 Piper Sandler。

I have a couple of questions. First, I know you said, Frank, that it's going to take some time for commercial payers to follow suit as it relates to NOPAIN. I guess, my question here is, can you talk to your dialogue with commercial plans, and ultimately, your confidence that these commercial plans will indeed follow suit?

我有一些問題。首先，弗蘭克，我知道你說過，商業付款人需要一些時間才能效仿，因為這與 NOPAIN 有關。我想，我的問題是，你能談談你與商業計劃的對話，以及最終你對這些商業計劃確實會跟進的信心嗎？

And then secondly, when you talk about that lag time, if you will, with commercial plans, is that more of a 2026 event? Just help us understand how long it might take for them to follow the lead of CMS?

其次，當你談論滯後時間時，如果你願意的話，如果有商業計劃的話，這更像是 2026 年的事件嗎？請幫助我們了解他們可能需要多長時間才能跟隨 CMS 的步伐？

And then the last question is just on the cost structure. You talked about 201, and of course, allocating resources to NOPAIN. I'm wondering where ZILRETTA and iovera° fit in terms of the long-term strategy of the company going forward?

最後一個問題是關於成本結構的。你談到了201，當然還有分配資源給NOPAIN。我想知道 ZILRETTA 和 iovera° 在公司未來的長期策略中適合什麼？

David, thanks for the questions. First, let me just provide a little bit of context on the opportunity known as NOPAIN, but I think we're trying to really make sure we focused on this one as outpatient reimbursement at ASP plus 6 for CMS patients.

大衛，謝謝你的提問。首先，讓我簡單介紹一下被稱為 NOPAIN 的機會，但我認為我們正在努力真正確保我們將重點放在這一機會上，作為 CMS 患者的 ASP 加 6 門診報銷。

Initially, as you know, we've quantified that as approximately 4 million patients in the HOPD setting and about 4 million in the ASC setting, which is quite substantial. So we've got a fair amount of opportunity right in front of us that we need to make sure that we do a good job of education in the marketplace to provide those patients with access to EXPAREL.

如您所知，最初我們量化了 HOPD 環境中約 400 萬名患者，ASC 環境中約 400 萬名患者，這是相當可觀的。因此，我們面前有大量機會，我們需要確保做好市場教育，為這些患者提供 EXPAREL 的使用機會。

As we stand up the broader commercial organization, and I think you've heard me say before that we are bolstering our commercial resources, commercial, medical, and importantly, market access, so that's in progress. We've reallocated resources from other parts of the company to bolster that area. And as we start to further now make progress there, and again, I think that's going to be more towards the end of the year, we're going to have much better clarity in terms of specifically how we see NOPAIN playing out over the course of '25, '26 and '27. So that's where we are with that.

當我們建立更廣泛的商業組織時，我想你們之前已經聽過我說過，我們正在加強我們的商業資源，商業、醫療，最重要的是市場准入，所以這一切都在進步。我們重新分配了公司其他部門的資源來支持該領域。隨著我們現在開始在這方面取得進一步進展，我認為這將在今年年底時實現，我們將更清楚地了解 NOPAIN 在整個過程中的具體表現'25、'26 和 '27。這就是我們現在的情況。

With regard to ZILRETTA and iovera°, as you heard earlier, we're making good progress there. We're making good progress and sales are very solid in terms of what we've been able to deliver. And that will continue from what we can see. But as I've said before, we are sharply focused on growing EXPAREL. So in terms of disproportionate resourcing towards EXPAREL, we're doing that. We are treating this like a product launch. And so that's how we're approaching the situation.

關於 ZILRETTA 和 iovera°，正如您之前所聽到的，我們在這方面取得了良好的進展。我們正在取得良好的進展，就我們所能提供的產品而言，銷售也非常穩定。從我們所看到的情況來看，這種情況還會持續下去。但正如我之前所說，我們高度重視 EXPAREL 的發展。因此，就 EXPAREL 的不成比例的資源而言，我們正在這樣做。我們將其視為產品發布。這就是我們處理這種情況的方式。

David, this is Charlie. Just building on your comment of 201, please note, we are investing in clinical trials for both ZILRETTA and iovera° with the shoulder OA study and the spasticity study. So there is investment going on.

大衛，這是查理。請注意，基於您對 201 的評論，我們正在投資 ZILRETTA 和 iovera° 的肩部 OA 研究和痙攣研究的臨床試驗。因此，投資正在進行中。

Your next question comes from the line of Hardik Parikh, JPMorgan.

您的下一個問題來自摩根大通的 Hardik Parikh。

Just had a couple of questions on the 495 patent challenge from eVenus. I was just wondering if you guys could give us some latest kind of thinking you guys have in terms of where some of the more likely scenarios that could play out and what actions, kind of market actions eVenus could take in the meantime based on the ruling?

剛剛對 eVenus 的 495 專利挑戰有幾個問題。我只是想知道你們是否可以給我們一些最新的想法，即一些更有可能出現的情況，以及 eVenus 根據裁決同時可以採取哪些行動、類型的市場行動？

And I just wanted to confirm, is the expectation that the ruling from the judge comes -- still comes in July? Or is there any kind of change on that front?

我只是想確認一下，法官的裁決是否仍會在 7 月到來？或者這方面有什麼改變嗎？

Thanks for the question, Hardik. Just a little bit of background. And so we do expect the ruling on the first patent litigation sometime by end of June. And so that's what -- that's consistent with what we said before. And just to remind, we've got a number of other patents that will need to be litigated. In addition, of course, eVenus will need to get their product approved and eventually decide to launch the product at some point.

謝謝你的提問，哈迪克。只是一點背景知識。因此，我們確實預計第一起專利訴訟的裁決將於 6 月底的某個時候做出。這就是──這與我們之前所說的一致。提醒一下，我們還有許多其他專利需要提起訴訟。此外，當然，eVenus 還需要讓他們的產品獲得批准，並最終決定在某個時候推出該產品。

So there are a number of things ahead, but let me turn it over to Kristen to provide some additional color here.

所以還有很多事情要做，但讓我把它交給克里斯汀來提供一些額外的顏色。

Thanks. As Frank said, there really isn't an update since we talked to you all at the end of February on 495 trial. We still expect it to read out by July 1, which is when the 30-month stay is up. So we look forward to the court's opinion being issued before then.

謝謝。正如 Frank 所說，自從我們在 2 月底就 495 試用與大家交談以來，確實沒有更新。我們仍然預計它會在 7 月 1 日之前讀出，屆時 30 個月的居留期結束。所以我們期待法院在此之前發布意見。

And as Frank mentioned, and as we've reiterated and we actually put a little detail in our release, we continue to produce new IP around EXPAREL, Orange Book listed patents, and those are additional hurdles that eVenus would need to get through in order to eventually launch a product.

正如弗蘭克所提到的，正如我們所重申的，我們實際上在我們的發布中提供了一些細節，我們繼續圍繞 EXPAREL 製作新的 IP，橙皮書列出的專利，這些是 eVenus 需要克服的額外障礙最終推出產品。

So it's in our release, but we did just have in March 3 additional Orange Book listed patents, 2 method of use, and another composition of matter, and those are in addition to the other ones after 495. So there are quite a few patents that we still need to get through. But as I said, we're looking forward to getting resolution to 495 here in short order. And then we'll continue to produce new IP and they will continue to have to work through other patents that are all on the Orange Book here.

所以它在我們的發布中，但我們在3 月3 日剛剛獲得了橙皮書列出的額外專利、2 種使用方法和另一種物質成分，這些都是495 之後的其他專利的補充。有相當多的專利我們仍然需要克服。但正如我所說，我們期待盡快解決 495 問題。然後我們將繼續生產新的智慧財產權，他們將繼續研究橙皮書中的其他專利。

Great. And then just one more on -- you mentioned the EXPAREL gross margin was within the full year guidance range. I was wondering if you could give a little bit more kind of granular detail about how margins are progressing among the various facilities, for example, the one in the U.K. versus in San Diego?

偉大的。然後還有一個問題——您提到 EXPAREL 毛利率在全年指導範圍內。我想知道您是否可以提供更多關於各種設施之間的利潤率進展的詳細信息，例如英國的設施與聖地亞哥的設施的利潤率進展？

Yes. Thanks for that, Hardik. And I think, overall, we're progressing well. We haven't really broken it down specifically by site. As you know, the 200-liter facility is coming in -- is going to come online later on this year.

是的。謝謝你，哈迪克。我認為，總體而言，我們進展順利。我們還沒有真正按站點具體細分。如您所知，200 公升的設施即將投入使用，並將於今年稍後上線。

I don't know, Charlie, if you want to say a few words about margins.

我不知道，查理，你是否想就利潤說幾句話。

No, listen in the long term, the improvement in gross margins is going to be driven by two major factors for EXPAREL. One is the manufacturing equipment the vials manufactured on. So the 200-liter is generally less expensive than the 45s. But probably even more importantly is the total volume. So we're focused on expanding top line, driving vial volume and so that margins can follow.

不，從長遠來看，毛利率的改善將由 EXPAREL 的兩個主要因素推動。一是生產小瓶的生產設備。所以200公升的一般比45公升的便宜。但可能更重要的是總體積。因此，我們專注於擴大營收，提高瓶子銷量，從而確保利潤率的提高。

Your next question comes from the line of Gary Nachman with Raymond James.

你的下一個問題來自加里·納赫曼和雷蒙·詹姆斯的對話。

Frank, first, talk more about your progress with the modernization of the commercial organization. Do you think you'll have most of that in place by midyear as you prepare for NOPAIN next year? I think that's been the target that what big hires still need to take place?

Frank，首先，多談談您在商業組織現代化方面的進展。您認為在年中為明年的 NOPAIN 做準備時，您會完成大部分工作嗎？我認為這就是仍需要哪些大規模招募的目標？

And then how aggressive do you plan on being with the share buyback? How is that contemplated with the convert coming due next year? And you have to maintain a certain amount of cash for that. So maybe talk through that as well.

那麼您計劃如何積極地進行股票回購？明年到期的轉換者是如何考慮的？而你必須為此保留一定數量的現金。所以也許也談談這個問題。

Great. Thanks for the questions, Gary. First, on the commercial organization. As I mentioned earlier, we're making very good progress on modernizing and bolstering the commercial, medical, and market access organizations.

偉大的。謝謝你的提問，加里。第一，關於商業組織。正如我之前提到的，我們在商業、醫療和市場准入組織的現代化和加強方面取得了非常好的進展。

At a high level, we've talked about plans, and we're making good progress on plans to hire a Chief Commercial Officer, and that's on track. In addition, we're expanding the number of folks in our field reimbursement management team, payer team as well as market access strategy and operations. So those are all things that are on track. In addition, we're looking very carefully at the broader commercial organization, including bolstering our resourcing of our marketing teams and medical teams.

在高層，我們已經討論了計劃，並且我們在聘請首席商務官的計劃上取得了良好進展，而且一切都步入正軌。此外，我們正在擴大現場報銷管理團隊、付款人團隊以及市場准入策略和營運團隊的人員數量。所以這些都是正在步入正軌的事情。此外，我們正在非常仔細地研究更廣泛的商業組織，包括加強我們的行銷團隊和醫療團隊的資源配置。

So those things are right on track and again, supported by reallocating our resources away from certain areas of the company and investing them here, where we believe it's going to make a difference here for our NOPAIN launch. So that's a comment on our commercial organization, and I'd characterize it as we're making good progress. And largely speaking, we expect that to be in place sometime in the second half of the year.

因此，在我們將資源從公司某些領域重新分配並投資到這裡的支持下，這些事情一次又一次步入正軌，我們相信這將為我們的 NOPAIN 發布帶來改變。這是對我們商業組織的評論，我將其描述為我們正在取得良好進展。總的來說，我們預計這將在今年下半年的某個時候實施。

With respect to the share buyback, let me turn it to Charlie here. I'll just say that it really does underscore our confidence in our growth outlook. And it's an attractive investment given the value that we believe is ahead.

關於股票回購，讓我在這裡向查理求助。我只想說，這確實凸顯了我們對成長前景的信心。考慮到我們認為未來的價值，這是一項有吸引力的投資。

So Charlie, let me turn it over to you.

所以查理，讓我把它交給你。

Thank you, Frank. And Gary, thanks for the question. So listen, as you point out, that we have a business that's operationally cash flow positive, we generate cash every year. We just reported having roughly $326 million on the balance sheet.

謝謝你，弗蘭克。加里，謝謝你的提問。因此，正如您所指出的，我們的業務營運現金流為正，我們每年都會產生現金。我們剛剛報告資產負債表上約有 3.26 億美元。

As you point out, we do need a certain amount of money on the balance sheet to repay the $400 million of August '25 notes next year. And so we're going to balance priorities, and we're not going to make any commitments about whether we -- when we're going to spend the $150 million that we're going to use it opportunistically as we think benefits our shareholders. And we will balance all of the needs from a cash flow perspective over time.

正如您所指出的，我們的資產負債表上確實需要一定數量的資金來償還明年 25 年 8 月發行的 4 億美元票據。因此，我們將平衡優先事項，並且我們不會做出任何承諾，當我們要花費 1.5 億美元時，我們是否會機會主義地使用它，因為我們認為有利於我們的股東。隨著時間的推移，我們將從現金流的角度平衡所有需求。

All right. Great. Actually, maybe one follow-up for Frank. Just what are the next steps for 201? You seem pretty excited about the data you've seen there so far following the Phase I. What comes next? What sort of resources will you put behind it?

好的。偉大的。事實上，也許是弗蘭克的後續行動。 201 的下一步是什麼？您似乎對第一階段之後迄今為止看到的數據感到非常興奮。你會在背後投入什麼樣的資源？

Charlie, you mentioned before, you are investing a little bit in pipeline. So I'm curious, is that something that could start this year? Or will you likely wait until to see how things unfold next year?

查理，您之前提到過，您正在對管道進行一些投資。所以我很好奇，這可能是今年開始的嗎？或者你會等到明年看看事情會如何發展嗎？

Yes, Gary. So it's an important question. There will be certainly quite a bit more effort this year in terms of planning and thinking through what we need to do. But in terms of any sort of spend and investment, largely, that will be ahead of us in '25, '26 and '27. And so we're excited about it. As I mentioned, we have had an opportunity to review the data with the Scientific Advisory Board. We've also presented some of the data, as I mentioned, at OARSI, and this week at ASGCT.

是的，加里。所以這是一個重要的問題。今年在規劃和思考我們需要做的事情方面肯定會付出更多的努力。但就任何形式的支出和投資而言，在很大程度上，這將在 25 年、26 年和 27 年領先我們。所以我們對此感到興奮。正如我所提到的，我們有機會與科學顧問委員會一起審查數據。正如我所提到的，我們也在 OARSI 以及本週的 ASGCT 上展示了一些數據。

And so we continue to vet the data. We also continue to think through clinical development strategy going forward. But in terms of activity, a lot of it this year, we'll be vetting our strategy and planning and the investments will largely occur in '25 and beyond.

所以我們繼續審查數據。我們也持續思考未來的臨床開發策略。但就活動而言，今年有很多活動，我們將審查我們的策略和規劃，投資將主要發生在 25 年及以後。

Your next question comes from the line of Les Sulewski with Truist Securities.

您的下一個問題來自 Les Sulewski 與 Truist Securities 的電話。

This is Jeremy on for Les. How do you view the opportunity with PCRX-201? And how exactly does the recent designation help you?

這就是 Les 的 Jeremy。您如何看待 PCRX-201 帶來的機會？最近的任命究竟對您有何幫助？

Yes. It's a very interesting opportunity because this is the first RMAT designation for gene therapy in osteoarthritis. And what that means is that the FDA and the company will work closely as we think about further vetting the data and development strategy. So this is a wonderful opportunity to make sure that we stay close with the FDA. And to the extent that we develop this asset going forward, this could truly be transformational for patients.

是的。這是一個非常有趣的機會，因為這是骨關節炎基因治療的第一個 RMAT 指定。這意味著 FDA 和該公司將在我們考慮進一步審查數據和開發策略時密切合作。因此，這是確保我們與 FDA 保持密切關係的絕佳機會。就我們未來開發這項資產而言，這可能真正為患者帶來改變。

As I mentioned earlier, based on our market research and discussions with thought leaders, current treatments offer patients 3 to 6 months of benefit and durability, whereas we know that from market research, 12 months or more is considered transformational. And so to the extent that PCRX-201 can deliver that, this could be an important new treatment option for patients. So we'll continue to vet the data and put the development plan together, but we're very excited about the data, and obviously based on the RMAT designation FDA as well.

正如我之前提到的，根據我們的市場研究以及與思想領袖的討論，目前的治療方法可為患者提供3 至6 個月的益處和持久性，而我們從市場研究中知道，12 個月或更長時間被認為是變革性的。因此，就 PCRX-201 能夠實現的程度而言，這可能是患者的一個重要的新治療選擇。因此，我們將繼續審查數據並製定開發計劃，但我們對這些數據感到非常興奮，而且顯然也是基於 FDA 的 RMAT 指定。

Your next question comes from the line of Oren Livnat, H.C. Wainwright.

您的下一個問題來自 Oren Livnat, H.C.溫賴特。

Congrats on a pretty clean quarter. A couple of questions. Just to build on earlier questions about the commercial follow-on after NOPAIN kicks in. I just want to make sure I understand what we're talking about here. Like obviously, you have pretty small overall market share of the broader landscape of procedures. I think you've highlighted in the past about 12 million relevant outpatient commercial procedures.

恭喜這個季度非常乾淨。有幾個問題。只是為了建立早期關於 NOPAIN 啟動後的商業後續行動的問題。顯然，在更廣泛的程序領域中，您的整體市場份額相當小。我想您過去已經強調了大約 1200 萬個相關的門診商業程序。

And so I just want to understand, when you talk about following on, do you mean plans that are just not covering EXPAREL at all, hence your small market share now, and they'll make you feel compelled to cover it if CMS is? Or is it about improvement in terms and access with those plans? Just help me understand what we're even talking about (inaudible) And I do have a follow-up.

所以我只是想明白，當您談到後續時，您是否指的是根本不涵蓋 EXPAREL 的計劃，因此您現在的市場份額很小，如果 CMS 涵蓋的話，它們會讓您感到有必要涵蓋它？還是關於這些計劃的條款和訪問方面的改進？請幫我理解我們正在談論的內容（聽不清楚）我確實有後續行動。

Yes. So thanks for that question, Oren. What I'm talking about is oftentimes CMS will come out first with reimbursement, and commercial plans will take some time to evaluate when and if they'll cover the new therapy. And so our task at hand now is to work very closely with the commercial payers to accelerate that adoption on the commercial side of things.

是的。謝謝你提出這個問題，奧倫。我所說的是，CMS 通常會先提供報銷，而商業計劃需要一些時間來評估何時以及是否會涵蓋新療法。因此，我們現在手頭上的任務是與商業付款人密切合作，以加速商業方面的採用。

Now that said, we do have a C-code and oftentimes, that can be reimbursed in the ASC setting currently, but it's not straightforward as it could be. And so here, we have an opportunity with NOPAIN and CMS reimbursement to use this now to engage commercial payers to follow sooner than they normally would. And so that's really it.

話雖如此，我們確實有一個 C 程式碼，並且通常可以在當前的 ASC 設定中進行補償，但這並不簡單。因此，我們現在有機會利用 NOPAIN 和 CMS 報銷來吸引商業付款人比平常更早跟進。就是這樣。

But I'll remind you again that there's a substantial opportunity just with the CMS patients. But what we're trying to do now is to really make this even a broader impact. So that's the idea.

但我要再次提醒您，CMS 患者中蘊含著巨大的機會。但我們現在正在努力做的是真正使其產生更廣泛的影響。這就是我們的想法。

Okay. So just so I'm clear, I mean, you obviously have a lot of outpatient use now, like you said, I mean, it's a $500 million, $600 million product, not all in patients. So I just wanted to understand is how that's being done now suboptimal even across the entire board of your commercial outpatient reimbursement, and that could change meaningfully at some point afterwards?

好的。所以我要澄清的是，我的意思是，你現在顯然有很多門診使用，就像你說的，我的意思是，這是一個價值5 億美元、6 億美元的產品，並非全部用於患者。所以我只是想了解，即使在整個商業門診報銷範圍內，現在的情況也不是最理想的，並且在之後的某個時候可能會發生有意義的改變？

Yes. What's important with NOPAIN legislation is in the outpatient setting, it provides for ASP plus 6% reimbursement which, for example, in the HOPD is pulling that thing out of the bundle. So this is important. So the product will be reimbursed separately. So now if you add up favorable access through 340B or GPOs, and you add on top of that ASP plus 6 reimbursement, I think this provides for an attractive value proposition given what EXPAREL delivers in the clinical setting.

是的。 NOPAIN 立法的重要之處在於在門診環境中，它規定了 ASP 加 6% 的報銷，例如，在 HOPD 中，這就是從捆綁中取出的東西。所以這很重要。因此該產品將單獨報銷。因此，現在如果您透過340B 或GPO 添加有利的存取權限，並在ASP 加上6 報銷的基礎上添加，我認為考慮到EXPAREL 在臨床環境中提供的功能，這提供了一個有吸引力的價值主張。

And oftentimes, some of the cost issues have been a barrier. So this is important. So to the extent that, that sort of reimbursement formula is followed to any extent by commercial payers. This will be something that further accelerates launch.

通常，一些成本問題一直是一個障礙。所以這很重要。因此，在某種程度上，商業付款人在任何程度上都遵循這種報銷公式。這將進一步加速發射。

Okay. And then just to follow up. I don't want to parse your language too closely. I know that can be pretty irritating. But you said to the extent we develop this asset going forward, and I want to know if I should interpret that as just to the extent that there is developing going forward based on how the data turns out? Or maybe if you are looking to out-license this to another company for someone else to take it forward potentially?

好的。然後只是跟進。我不想太仔細地解析你的語言。我知道這可能非常令人惱火。但你說我們未來開發這項資產的程度，我想知道我是否應該根據數據結果將其解釋為未來的發展程度？或者，如果您希望將其許可給另一家公司，以便其他人有可能將其推進？

I'm sorry, which product are we talking about? 201?

抱歉，我們正在談論哪種產品？ 201？

Yes.

是的。

I see, I see. Look, first, we're very excited about 201. We're going to go through a lot of thinking here about our development strategy. We have no plans to do anything about that right now. So that's what I'd say to you.

我明白了，我明白了。首先，我們對 201 感到非常興奮。我們目前沒有計劃對此採取任何行動。這就是我要對你說的話。

Your next question comes from the line of Balaji Prasad with Barclays.

你的下一個問題來自巴克萊銀行的巴拉吉‧普拉薩德 (Balaji Prasad)。

So a couple from me. While I can understand the rationale for the (inaudible) I'm curious to know the capital allocation factors, which you went to deciding the quantum of $150 million? That's one.

這是我的一對。雖然我可以理解（聽不清楚）的基本原理，但我很想知道資本配置因素，您是根據這些因素來決定 1.5 億美元的金額的？這是一個。

And two, I'm not sure if you covered this already. So (inaudible) growth in the dynamics in the quarter and how it changed versus the previous quarter? And what sort of cadence that we expect for the year? And maybe just from EXPAREL (inaudible) on the 18 million procedures that are going to be covered, of these 18 million procedures fully incremental (inaudible).

第二，我不確定您是否已經介紹過這一點。那麼（聽不清楚）本季動態的成長以及與上一季相比有何變化？我們預計今年的節奏是怎麼樣的？也許只是來自 EXPAREL（聽不清楚）將要涵蓋的 1800 萬個程序，其中 1800 萬個程序完全增量（聽不清楚）。

Balaji, You were breaking up on me there a little bit. So I think your first question was related to the stock repurchase, if that's correct. And so again, yes, so what I'll underscore here is the confidence we have in our growth outlook and the fact that it's an attractive investment given that outlook going forward.

巴拉吉，你當時就跟我分手了。所以我認為你的第一個問題與股票回購有關，如果這是正確的。是的，所以我要在這裡強調的是我們對成長前景的信心，以及鑑於未來的前景，這是一項有吸引力的投資。

If your question is about sort of the cadence and the amount, maybe I can turn that over to Charlie.

如果你的問題是關於節奏和數量，也許我可以把它交給查理。

Balaji, it's Charlie here. And -- so I think one of your questions might have been about the amount. And so from our perspective, we looked at what typical first-time people size, and it was kind of 10% to 15% of market cap. And that's really how we came up with $150 million. We also note that we have between now and the end of 2026 to utilize it. But if we utilize it more quickly, we'll -- and it makes sense, we can go back to the well and get another authorization. So this is something we're going to try, we're going to use it opportunistically, and hopefully, to everybody's benefit.

巴拉吉，我是查理。而且——所以我認為你的問題之一可能是關於金額。因此，從我們的角度來看，我們研究了典型的首次創業者規模，它約佔市值的 10% 到 15%。這就是我們籌集 1.5 億美元資金的真正原因。我們也注意到，從現在到 2026 年底，我們都可以使用它。但如果我們更快地利用它，我們將——這是有道理的，我們可以返回井並獲得另一次授權。所以這是我們要嘗試的事情，我們將機會主義地使用它，並希望對每個人都有好處。

Thanks, Charlie. And I think, Balaji, your other question was about broadly NOPAIN and just some numbers. So 18 million total that we believe are outpatient procedures that could fall under NOPAIN. Now specifically with respect to the settings and patient populations, so out of that 18 million, 6 million CMS and 12 million commercial. And so inside that 6 million is roughly about 4 million that lie within the HOPD setting and 2 million that are within the ASC setting, whereas in the commercial, that 12 million in the commercial is roughly about 4 million in the HOPD setting and about 8 million in the ASC setting. So hopefully, that's clear.

謝謝，查理。我認為，巴拉吉，你的另一個問題是關於廣泛的 NOPAIN 和一些數字。我們認為總共 1800 萬例門診手術可能屬於 NOPAIN 的範圍。現在特別是在環境和患者群體方面，在這 1800 萬中，有 600 萬個 CMS 和 1200 萬個商業患者。因此，在這600 萬個數據中，大約400 萬個位於HOPD 設定中，200 萬個位於ASC 設定中，而在商業廣告中，廣告中的1200 萬個大約相當於HOPD 設定中的400 萬個，大約8 個ASC 環境中的百萬美元。希望一切都清楚了。

If I could ask a follow-up there, Frank. Just what percent of these 18 million procedures will be incremental to EXPAREL that is those or not an EXPAREL today through any pathway?

如果我可以問後續情況，弗蘭克。這 1800 萬個程式中到底有多少百分比將透過任何途徑增量到 EXPAREL（無論是否是今天的 EXPAREL）？

Yes. I think, by and large, this is going to be a very favorable impact. And particularly, if I think about the CMS patients right out of gate, 6 million CMS patients in the HOPD specifically and ASC, I can't give you a hard number right now about how much is incremental. But what I can say is that our penetration, largely speaking, is fairly low, and a lot of that is due to the cost barriers that have existed.

是的。我認為，總的來說，這將是一個非常有利的影響。特別是，如果我考慮一下 CMS 患者，特別是 HOPD 和 ASC 中的 600 萬 CMS 患者，我現在無法給您關於增量的確切數字。但我可以說的是，我們的滲透率在很大程度上是相當低的，這很大程度上是由於已經存在的成本障礙。

And hence, that was the thinking behind making sure that we drive NOPAIN legislation to passage. And so the company saw that early on and has worked over the past 7 years with our voices coalition in partnership and that's why this thing was passed. And so fundamentally, it's pulling the drug reimbursement or product reimbursement out of the bundle. So there's not a financial disincentive to use the best product for the patients. So hopefully, that's clear.

因此，這就是確保我們推動 NOPAIN 立法通過的背後的想法。因此，該公司很早就看到了這一點，並在過去 7 年裡與我們的聲音聯盟合作，這就是為什麼這件事得以通過的原因。因此從根本上講，它將藥品報銷或產品報銷從捆綁中剔除。因此，不存在經濟因素阻礙患者使用最好的產品。希望一切都清楚了。

So I think given our low share penetration in this marketplace, we've got substantial room to further penetrate where those cost barriers are the real issue.

因此，我認為，鑑於我們在這個市場的份額滲透率較低，我們有很大的空間進一步滲透那些成本障礙才是真正的問題。

Your last question comes from the line of Serge Belanger with Needham & Company.

你的最後一個問題來自於 Needham & Company 的 Serge Belanger。

This is John on for Serge. We have two questions regarding EXPAREL pricing for this year and beyond. First, can you provide some context on what the discount looks like right now to improve the user base? And what the strategy might look like for the rest of the year based on what you've seen so far? And then when NOPAIN comes into effect next year, what does the pricing strategy look like at that point with improved reimbursement?

這是謝爾蓋的約翰。我們對今年及以後的 EXPAREL 定價有兩個問題。首先，您能否提供一些有關目前折扣的背景資訊以改善用戶群？根據您迄今為止所看到的情況，今年剩餘時間的策略可能會是什麼樣子？那麼，當 NOPAIN 明年生效時，屆時報銷改善的定價策略會是什麼樣子？

Yes. So Charlie, maybe you want to talk a little bit about EXPAREL pricing strategy. What I'll say here is that, when you think about what we're doing with GPO and access to 340B, that's very favorable. So I'll say that. And with NOPAIN, obviously, the reimbursement then gets better as opposed to the pricing.

是的。查理，也許您想談談 EXPAREL 定價策略。我在這裡要說的是，當您考慮我們正在使用 GPO 和訪問 340B 所做的事情時，您會發現這是非常有利的。所以我會這麼說。顯然，有了 NOPAIN，報銷會比定價更好。

And so beyond that, Charlie, maybe you can provide a little bit of color.

除此之外，查理，也許你可以提供一點色彩。

Sure. So If we think about EXPAREL's total gross to net at this point, it's a hair under 84%, and that includes product returns and prompt-pay discount. It includes 340B, a series of individual customer contracts. And over time, it will also include the GPOs as well. I think that was probably your question.

當然。因此，如果我們考慮一下 EXPAREL 目前的總毛額與淨額之比，就不到 84%，其中包括產品退貨和即時付款折扣。它包括340B，一系列個人客戶合約。隨著時間的推移，它也將包括 GPO。我想這可能是你的問題。

If you're talking about pricing -- actually, price increases, we've been pretty modest in that regard. We did one in January. And we're really focused on expansion of the top line by volume, not so much price.

如果你談論的是定價——實際上，價格上漲，我們在這方面一直相當溫和。我們在一月做了一個。我們真正關注的是銷量的擴大，而不是價格的擴大。

Yes. I think really just for next year when NOPAIN comes to effect, do you see the pricing kind of taking a -- I don't know, a more lumpy change at the beginning of the year? Or do you see more of a gradual flip from a discount to a price increase?

是的。我認為，明年當 NOPAIN 生效時，您是否認為定價會在年初發生更不穩定的變化？或者您看到更多的是從折扣到價格上漲的逐漸轉變？

So ASP plus 6 is critically important in the outpatient setting to drive volume. ASP plus 6 has nothing to do with our WACC or the prices we'll charge. So I don't know that we will change our strategy in any way, shape or form. We're just going to try to educate our potential customers so that they can benefit from ASP plus 6 and we can benefit from volume.

因此，ASP+6 在門診環境中對於提高治療量至關重要。 ASP plus 6 與我們的 WACC 或我們收取的價格無關。所以我不知道我們會以任何方式、形式或形式改變我們的策略。我們將嘗試教育我們的潛在客戶，以便他們能夠從 ASP plus 6 中受益，而我們也可以從銷售中受益。

John, I want to go back to -- we're sharply focused on growth. Doing so solves a lot of things, including margin some of the questions earlier. And this is the opportunity for us to drive penetration and growth with this catalyst of NOPAIN. So that's where we're focused on.

約翰，我想回到——我們非常關注成長。這樣做可以解決很多問題，包括解決之前的一些問題。這是我們利用 NOPAIN 催化劑推動滲透和成長的機會。這就是我們關注的地方。

That concludes our Q&A session. I will now turn the conference back over to Susan Mesco, Head of Investor Relations, for closing remarks.

我們的問答環節到此結束。現在，我將把會議轉回投資者關係主管蘇珊·梅斯科 (Susan Mesco) 致閉幕詞。

Thank you, Hermione, and thanks to all on the call for your questions and time today. We are excited about the opportunities that lie ahead for us. Throughout the balance of the year, we will continue to ensure we are well positioned for long-term success. The opioid epidemic continues to be a national crisis, underscoring the vital importance of our mission. Thank you, and stay well.

謝謝你，妙麗，也感謝所有在電話中提出的問題和今天抽出的時間。我們對擺在我們面前的機會感到興奮。在今年剩下的時間裡，我們將繼續確保我們為長期成功做好準備。阿片類藥物流行仍然是一場國家危機，凸顯了我們使命的至關重要性。謝謝你，祝你一切順利。

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

女士們、先生們，今天的電話會議到此結束。感謝大家的加入。您現在可以斷開連線。