Pacira Biosciences Inc (PCRX) 2024 Q3 法說會逐字稿

Good day, and welcome to the third-quarter 2024 Pacira BioSciences, Inc., earnings conference call. (Operator Instructions) As a reminder, this call may be recorded.

美好的一天，歡迎參加 Pacira BioSciences, Inc. 2024 年第三季財報電話會議。（操作員說明）謹此提醒，此通話可能會被錄音。

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

我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 third-quarter 2024 financial results. Joining me are Frank Lee, Chief Executive Officer; and Shawn Cross, Chief Financial Officer. Kristen Williams, Chief Administrative Officer; Lauren Riker, Senior Vice President, Finance; and Jonathan Slonin, Chief Medical Officer are 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 年第三季的財務表現。與我一起的還有執行長弗蘭克李 (Frank Lee)；和肖恩·克羅斯，首席財務長。克里斯汀威廉斯，首席行政官； Lauren Riker，財務資深副總裁；首席醫療官 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, subject to the Safe Harbor provisions of federal securities laws. Such statements represent our judgment as of today and may involve risks and uncertainties, which may cause our actual results, performance, or achievements to differ materially.

在我們開始之前，讓我提醒您，本次電話會議將包含前瞻性陳述，並遵守聯邦證券法的安全港條款。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，可能導致我們的實際結果、績效或成就有重大差異。

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. Lastly, as a reminder, we will be discussing non-GAAP financial measures on today's call. A description of these metrics along with our reconciliation to GAAP can be found in the news release we issued earlier this afternoon.

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。最後，提醒一下，我們將在今天的電話會議上討論非公認會計準則財務指標。有關這些指標的描述以及我們與公認會計原則（GAAP）的調整可以在我們今天下午早些時候發布的新聞稿中找到。

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。

Well, thank you, Susan and good afternoon, everyone. As you know, our top priority in 2024 is to ensure that as an organization, we're well positioned to deliver accelerated growth in 2025 and beyond. Since our last call, we've continued to make important progress in three key areas.

好的，謝謝你，蘇珊，大家午安。如您所知，我們 2024 年的首要任務是確保作為一個組織，我們能夠在 2025 年及以後實現加速成長。自上次通話以來，我們繼續在三個關鍵領域取得重要進展。

First, we're now aligned and committed to a refreshed, clear mission to deliver innovative, non-opioid pain therapies to transform the lives of patients. It is a straightforward yet compelling mission that personally resonates with me and our Pacira employees. Underpinning our mission are three guiding principles that we uphold every day: keep the patient at the center, follow the science, and treat our people well.

首先，我們現在一致致力於一項新的、明確的使命，即提供創新的非鴉片類止痛療法，以改變患者的生活。這是一項簡單而引人注目的使命，與我和我們的 Pacira 員工產生了個人共鳴。我們每天堅持的三個指導原則支撐著我們的使命：以病人為中心、遵循科學、善待我們的員工。

Second, we've completed a comprehensive portfolio review and defined a growth-oriented, long-term plan and therapeutic-area strategy focused on musculoskeletal pain and adjacencies. These are all significant and growing markets of high unmet need that are poised for innovation. Our portfolio of products and expertise in the space leaves us well positioned to drive innovation and create value.

其次，我們完成了全面的投資組合審查，並確定了以成長為導向的長期計劃和治療領域策略，重點關注肌肉骨骼疼痛和鄰近疾病。這些都是重要的、不斷成長的市場，其需求未被滿足，並且為創新做好了準備。我們在該領域的產品組合和專業知識使我們能夠很好地推動創新和創造價值。

Third, we've established the foundation for a modernized, best practice commercial market access and medical powerhouse. In parallel, we continue to advance our commercial initiatives as we lay the groundwork for expanded EXPAREL utilization ahead of the implementation of NOPAIN. As you know, this important reimbursement policy will begin providing separate outpatient reimbursement at ASP plus 6% in 2025.

第三，我們為現代化、最佳實踐的商業市場准入和醫療強國奠定了基礎。同時，我們繼續推進我們的商業計劃，為在實施 NOPAIN 之前擴大 EXPAREL 使用率奠定基礎。如您所知，這項重要的報銷政策將於 2025 年開始以 ASP 加 6% 的價格提供單獨的門診報銷。

We've completed another round of market research among hospital C suite and key stakeholders. Similar to our original findings, awareness and understanding around NOPAIN and its potential impact on patient care is growing among these hospital decision makers and key stakeholders. We expect it will take time for customers to implement this new reimbursement across their organizations.

我們已經完成了醫院高階主管和主要利害關係人的另一輪市場研究。與我們最初的發現類似，這些醫院決策者和主要利益相關者對 NOPAIN 及其對患者護理的潛在影響的認識和理解正在不斷增強。我們預計客戶需要一段時間才能在其組織中實施這項新的報銷。

We're also pleased to report EXPAREL will have its own product-specific J-code beginning in January of 2025. In addition to streamlining the reimbursement billing and coding process, a J-code is more likely to be recognized and covered by commercial payers. This combined with impending reimbursement from NOPAIN is particularly important to expanding access across different types of care and types of payers.

我們也很高興地報告 EXPAREL 將從 2025 年 1 月開始擁有自己的產品特定 J 代碼。除了簡化報銷計費和編碼流程之外，J 代碼更有可能被商業付款人認可和覆蓋。這與 NOPAIN 即將推出的報銷相結合，對於擴大不同類型的護理和付款人類型的覆蓋範圍尤其重要。

As you know, we're also partnering with GPOs of broad use and paved the way for NOPAIN. Through these preferential pricing programs, healthcare systems can afford the opportunity to be at the forefront of opioid-sparing pain management.

如您所知，我們還與廣泛使用的 GPO 合作，為 NOPAIN 鋪平了道路。透過這些優惠定價計劃，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。

We recently launched a new partnership with [Visian], whose significant network covers approximately 30% of EXPAREL-relevant market procedures. We're on track for our third and final GPO partnership to go live at the end of this year or early next year. This agreement will cover another 20% of the market. Once completed, more than 80% of EXPAREL business will be under contract.

我們最近與 [Visian] 建立了新的合作夥伴關係，其重要網絡涵蓋了 EXPAREL 相關市場流程的約 30%。我們的第三個也是最後一個 GPO 合作夥伴關係預計將在今年年底或明年初上線。該協議將涵蓋另外20%的市場。建成後，EXPAREL 80%以上的業務將簽約。

Turning to ZILRETTA and iovera, both products are performing according to plan with solid third-quarter sales. Our Phase 3 registrational study for ZILRETTA and shoulder OA is progressing with top-line results expected in 2026. If successful, the study could make ZILRETTA the first and only long-acting steroid approved for use in shoulders. Shoulder OA represents a sizable market opportunity with approximately 1 million intraarticular injections administered each year.

至於 ZILRETTA 和 iovera，這兩款產品均按計劃運行，第三季銷售穩定。我們針對 ZILRETTA 和肩部 OA 的 3 期註冊研究正在取得進展，預計將於 2026 年獲得頂線結果。如果成功，該研究將使 ZILRETTA 成為第一個也是唯一一個被批准用於肩部的長效類固醇。肩部 OA 代表著龐大的市場機會，每年進行約 100 萬例關節內注射。

As for iovera, on Friday, CMS issued their final hospital outpatient and ASC prospective payment system rule for 2025. We're pleased to see that the rule includes a newly created, product-specific code for iovera, C9809.

至於 iovera，週五，CMS 發布了 2025 年最終醫院門診和 ASC 預期支付系統規則。我們很高興看到該規則包含新建立的 iovera 產品特定代碼 C9809。

In its final rule, CMS concluded that iovera meets the statutory requirements of NOPAIN and qualifies for separate reimbursement in both the hospital and ASC settings. Importantly, the rule adopts a consistent add-on payment of up to $255 in addition to the standard iovera procedural rates in the hospital outpatient and ASC sites of care.

在其最終規則中，CMS 得出結論，iovera 符合 NOPAIN 的法定要求，並且有資格在醫院和 ASC 環境中單獨報銷。重要的是，除了醫院門診和 ASC 護理機構的標準 iovera 程序費率外，該規則還採用了高達 255 美元的一致附加付款。

Our registrational study for iovera for the treatment of spasticity is also underway with top-line results expected in 2026. Given the significant lack of innovation and patient unmet need in this debilitating condition, we believe iovera may offer a novel approach for patients with moderate to severe spasticity who are seeking treatment.

我們用於治療痙攣的 iovera 註冊研究也在進行中，預計將於 2026 年獲得頂線結果。鑑於這種令人衰弱的疾病嚴重缺乏創新且患者需求未得到滿足，我們相信 iovera 可能為尋求治療的中度至重度痙攣患者提供一種新方法。

The iovera team is also preparing to file for approval of a new iovera Smart Tip later this year. This tip is specifically designed for use in chronic low back pain, which impacts millions of Americans and often leads to poor quality of life, disability, and prescription opioid use.

iovera 團隊也準備在今年稍後申請批准新的 iovera 智慧提示。此技巧專為治療慢性下背痛而設計，這種疼痛影響著數百萬美國人，並常常導致生活品質不佳、殘疾和處方阿片類藥物的使用。

Switching gears for early stage pipeline, we continue to be encouraged by the potential of PCRX-201, our novel gene therapy for the treatment of osteoarthritis of the knee. It's innovative high-capacity adenovirus or HCAD design manufacturing process and local administration solve for many of the challenges that have made gene therapy inaccessible for common diseases.

切換到早期管道，我們繼續對 PCRX-201 的潛力感到鼓舞，PCRX-201 是我們用於治療膝骨關節炎的新型基因療法。其創新的高容量腺病毒或 HCAD 設計製造流程和本地管理解決了許多導致常見疾病無法進行基因治療的挑戰。

Key attributes of 201 include the following: The HCAD viral vector is more efficient at delivering genes to cells than other vectors. This means less medication is needed to achieve the desired effect.

201 的主要特性包括： HCAD 病毒載體比其他載體更有效地將基因傳遞到細胞。這意味著需要更少的藥物來達到預期的效果。

PCRX-201 is delivering medicine where it matters. It's injected locally into the knee joint capsule and contained there, leading to a robust clinical effect and favorable safety profile. Smaller doses, local administration, and scalable manufacturing result in an attractive cost of goods profile.

PCRX-201 正在向重要的地方提供藥物。它被局部注射到膝關節囊中並容納在那裡，從而產生強大的臨床效果和良好的安全性。較小的劑量、本地管理和可擴展的生產導致了具有吸引力的商品成本。

PCRX-201 has already exceeded expectations in an early-stage clinical trial in this large Phase 1 study of 72 patients with moderate to severe knee OA. A single intraarticular injection of PCRX-201 demonstrated pain relief and durability across all levels of disease severity as measured by the WOMAC scores. The study enrolled two three-dose cohorts, a co-administered steroid cohort, and a cohort that did not receive a steroid.

在這項大型 1 期研究中，PCRX-201 已經超越了早期臨床試驗的預期，該研究有 72 名中度至重度膝關節 OA 患者參與。根據 WOMAC 評分，單次關節內注射 PCRX-201 可以緩解所有疾病嚴重程度的疼痛並具有持久性。該研究招募了兩個三劑量隊列、一個共同施用類固醇隊列和一個未接受類固醇隊列。

Earlier this year, we presented one year data. PCRX-201 was well tolerated with efficacy observed across all doses studied. The greatest efficacy was observed in a steroid pre-treated group with 75% of patients achieving at least 50% improvement in pain and stiffness versus baseline for all three doses.

今年早些時候，我們提供了一年的數據。PCRX-201 具有良好的耐受性，在所有研究劑量中觀察到療效。在類固醇預處理組中觀察到了最大的療效，與基線相比，所有三種劑量的 75% 的患者的疼痛和僵硬程度均得到至少 50% 的改善。

A 20% improvement is considered clinically meaningful. So these results are highly encouraging. We continue to follow these patients and look forward to reporting exciting new two-year data at the American College of Rheumatology's annual meeting next week.

20% 的改善被認為具有臨床意義。所以這些結果非常令人鼓舞。我們將繼續追蹤這些患者，並期待在下週的美國風濕病學會年會上報告令人興奮的新的兩年數據。

While other therapies typically provide relief for three to six months. PCRX-201 has set a new standard with a year or more of sustained pain relief from a single injection. PCRX-201 is the first gene therapy to achieve these results and the only OA gene therapy to earn the FDA's RMAT designation, a testament to its promise and potential to revolutionize the treatment of knee OA.

而其他療法通常可以緩解三到六個月的時間。PCRX-201 設立了新標準，單次注射可持續緩解一年或更長時間的疼痛。PCRX-201是第一個實現這些結果的基因療法，也是唯一獲得 FDA RMAT 指定的 OA 基因療法，證明了其徹底改變膝關節 OA 治療的承諾和潛力。

As a premier to PCRX-201 presentation at ACR, we made an educational webinar available in the investor section of our website. We invite you to watch and learn more about this exciting asset.

作為 ACR 上 PCRX-201 演示的首次展示，我們在網站的投資者部分舉辦了一次教育網路研討會。我們邀請您觀看並了解有關此令人興奮的資產的更多資訊。

The last item I'll quickly touch on before closing is the District Court's recent ruling on our 495 patent litigation. While this was, of course, not the outcome we didn't hope for, it is important to remember that this was only the first case.

在結束之前我要快速提及的最後一個項目是地方法院最近對我們的 495 專利訴訟的裁決。當然，這並不是我們不希望的結果，但重要的是要記住這只是第一個案例。

Our legal strategy that's comprehensive includes pursuing an appellate review with respect to an injunction based on any information received through ongoing court proceedings. We do not believe irreparable harm from an at-risk launch is eminent at this time. If this changes, we're prepared to adjust our legal strategy accordingly. As a reminder, in order to be commercially successful, we believe eVenus will need to have overcome all of our patents.

我們全面的法律策略包括根據正在進行的法庭訴訟中收到的任何資訊對禁令進行上訴審查。我們認為目前風險發射不會造成無法挽回的損害。如果這種情況發生變化，我們準備好相應調整我們的法律策略。提醒一下，為了取得商業上的成功，我們相信 eVenus 需要克服我們所有的專利。

Importantly, the team continues to innovate and additional patents are forthcoming. We're also waiting a trial date for the second lawsuit that's progressing in the New Jersey District Court. This case involves our 574 patent, which we believe represents a higher hurdle for defendants to clear. The 574 patent claims composition of EXPAREL but includes the volume limitation that judge found lacking in the 495 case.

重要的是，該團隊不斷創新，更多專利即將推出。我們還在等待新澤西地方法院正在進行的第二起訴訟的審判日期。本案涉及我們的574專利，我們認為這對被告來說是更高的障礙。574 號專利要求保護 EXPAREL 的成分，但包括法官認為 495 號案件中缺乏的體積限制。

We will continue to take the necessary steps to protect the interests of our business, shareholders, patients, and other stakeholders. We firmly believe we built a strong portfolio of intellectual property and that the EXPAREL franchise is well protected on multiple levels.

我們將繼續採取必要措施保護我們的企業、股東、病患和其他利害關係人的利益。我們堅信，我們建立了強大的智慧財產權組合，並且 EXPAREL 特許經營權在多個層面上得到了良好的保護。

Before I turn the call over, I'd like to formally welcome our new Chief Financial, Officer Shawn Cross. Shawn is a seasoned industry veteran with more than 25 years of global experience as a biotechnology executive, Board member, and investment banker. And I'm confident he'll be a great steward of our financials and provide valuable insights and strategies as we advance our plan for long-term growth and value creation.

在轉接電話之前，我要正式歡迎我們新任財務長 Shawn Cross。Shawn 是一位經驗豐富的業界資深人士，擁有超過 25 年的全球生技主管、董事會成員和投資銀行家經驗。我相信他將成為我們財務的優秀管家，並在我們推進長期成長和價值創造計劃的過程中提供寶貴的見解和策略。

I'd like to thank Lauren Riker, our Senior Vice President of Finance who served as our interim CFO. Lauren has been with us here for 13 years, during which time she has demonstrated exceptional leadership and financial acumen. I'm grateful to Lauren for ongoing dedication and willingness to accept this responsibility during this transitional period.

我要感謝擔任我們臨時財務長的財務高級副總裁 Lauren Riker。Lauren 已經在我們這裡工作了 13 年，在此期間她展現了卓越的領導能力和財務頭腦。我感謝勞倫在這個過渡時期的持續奉獻和願意接受這項責任。

With that, I'll turn the call over to Shawn for review our financials.

這樣，我會將電話轉給肖恩，以審查我們的財務狀況。

Thank you, Frank, for that warm welcome and good afternoon to all on the call. I'm excited to join Pacira at this important juncture, because I'm strongly aligned with the company's important mission to deliver innovative, non-opioid pain therapies.

弗蘭克，謝謝您的熱烈歡迎，並祝所有與會人員下午好。我很高興能在這個重要時刻加入 Pacira，因為我強烈支持該公司提供創新的非鴉片類疼痛療法的重要使命。

Pacira is on strong financial footing with a business that is generating significant cash flow driven by three best-in-class, market-leading products. I'm excited to work alongside the talented and dedicated Pacira leadership team as we invest in our next phase of growth and beyond.

Pacira 擁有強大的財務基礎，其業務在三種同類最佳、市場領先的產品的推動下產生了大量現金流。我很高興能與才華橫溢、敬業的 Pacira 領導團隊一起工作，投資下一階段及以後的發展。

Turning now to the financials, I'll start with an update on sales and margin trends. Third-quarter EXPAREL sales increased to $132 million versus $128.7 million in 2023. Volume growth and a January 2024 price increase were largely offset by a shift in vial mix and discounting associated with the launch of our Premier and Visian partnerships.

現在轉向財務狀況，我將從銷售和利潤趨勢的最新情況開始。第三季 EXPAREL 銷售額增至 1.32 億美元，而 2023 年為 1.287 億美元。銷售成長和 2024 年 1 月的價格上漲在很大程度上被我們與 Premier 和 Visian 合作夥伴關係的推出相關的小瓶組合和折扣的變化所抵消。

Third-quarter's OA sales of $28.4 million were essentially flat versus the $28.8 million reported in 2023. For iovera sales were $5.7 million compared to $5.3 million in the third quarter of 2023.

第三季 OA 銷售額為 2,840 萬美元，與 2023 年報告的 2,880 萬美元基本持平。iovera 的銷售額為 570 萬美元，而 2023 年第三季為 530 萬美元。

Turning to gross margins. On a consolidated basis, our third-quarter. non-GAAP gross margin was 78%. This was driven by strong margins for all three products. For Non-GAAP R&D expense, the third-quarter decreased to $17.3 million from $18.6 million reported last year. This decrease relates to declines in product development and manufacturing capacity expansion costs as well as regulatory expenses.

轉向毛利率。在合併的基礎上，我們的第三季。非公認會計準則毛利率為 78%。這是由所有三種產品的強勁利潤所推動的。對於非 GAAP 研發費用，第三季從去年報告的 1,860 萬美元減少至 1,730 萬美元。這一下降與產品開發和製造產能擴張成本以及監管費用的下降有關。

These declines were partially offset by clinical study start-up costs. As a reminder, our pre-commercial scale of activities are now complete and the 200-liter EXPAREL manufacturing suite in San Diego began producing commercial inventory in July.

這些下降被臨床研究啟動成本部分抵消。提醒一下，我們的預商業規模活動現已完成，位於聖地牙哥的 200 公升 EXPAREL 製造套件已於 7 月開始生產商業庫存。

Non-GAAP SG&A expense came in at $65.0 million for the third quarter, which is up from $58.9 million last year. This increase is largely due to litigation costs as well as the investments we are making in our commercial, medical, and market access organizations. All of this resulted in another quarter of significant adjusted EBITDA of $54.7 million.

第三季非 GAAP SG&A 費用為 6,500 萬美元，高於去年的 5,890 萬美元。這一增長主要歸因於訴訟成本以及我們對商業、醫療和市場准入組織的投資。所有這些導致另一個季度調整後的 EBITDA 達到 5,470 萬美元。

One last item to note on our GAAP P&L is $163.2 million non-cash, non-recurring charge related to goodwill impairment. This was assessed following the New Jersey District Court's decision on our first EXPAREL for patent lawsuit.

我們的 GAAP 損益表中需要注意的最後一項是與商譽減損相關的 1.632 億美元非現金、非經常性費用。這是在新澤西地方法院對我們的第一個 EXPAREL 專利訴訟做出裁決後進行評估的。

As for the balance sheet, we exited the third quarter in a position of strength with more than $450 million of cash and investments. With a business that is producing significant cash flow, we are well equipped to advance our long-term growth strategy and drive long-term shareholder value.

至於資產負債表，我們在第三季結束時處於強勢地位，擁有超過 4.5 億美元的現金和投資。憑藉產生大量現金流的業務，我們有能力推進長期成長策略並推動長期股東價值。

Turning to guidance today, we are reiterating our full-year guidance for 2024 as follows. Total revenue of $680 million to $705 million. Non-GAAP gross margins 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.

今天談到指導，我們重申 2024 年全年指引如下。總收入為 6.8 億至 7.05 億美元。非 GAAP 毛利率為 74% 至 76%。非 GAAP 研發費用為 7,000 萬至 8,000 萬美元。非 GAAP SG&A 費用為 2.45 億美元至 2.65 億美元，股票薪酬為 5,000 萬美元至 5,500 萬美元。

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

說完，我會把電話轉回給弗蘭克。

Well, thank you Shawn. In closing, I'm proud of the significant strides the Pacira team has made this year, including important progress on the market access front. This includes new J-code for EXPAREL and separate CMS coverage for both EXPAREL and iovera under no pain.

嗯，謝謝你肖恩。最後，我對 Pacira 團隊今年的重大進步感到自豪，包括在市場准入方面取得的重要進展。這包括 EXPAREL 的新 J 程式碼以及 EXPAREL 和 iovera 的單獨 CMS 覆蓋，毫無痛苦。

I'm energized by the potential for what's yet to come. All of the work completed today positions us well to enter 2025 from a renewed place of focus on execution, commitment to our mission, and strategic clarity on musculoskeletal pain and adjacencies. We're confident the investments we're making will support and expand our leadership position in non-opioid pain management and ensure we are positioned for long-term growth and success.

我對未來的潛力感到充滿活力。今天完成的所有工作使我們在進入 2025 年時處於有利位置，重新關注執行、對使命的承諾以及對肌肉骨骼疼痛和鄰接問題的戰略明確性。我們相信，我們正在進行的投資將支持和擴大我們在非鴉片類藥物疼痛管理領域的領導地位，並確保我們能夠實現長期成長和成功。

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

透過該接線員，我們準備好開始提問。

Thank you. (Operator Instructions)

謝謝。（操作員說明）

Oren Livnat, HC Wainwright.

奧倫·利夫納特，HC 溫賴特。

Thanks for taking the questions. I have a couple. Just first, I think you mentioned in the script that it would take customers a little bit of time to implement NOPAIN changes. I'm just curious, can you just talk about how comfortable you are with your ability to hit the ground running there with all the investments and improvements you've made in the last six months?

感謝您提出問題。我有一對。首先，我認為您在腳本中提到客戶需要一些時間來實作 NOPAIN 變更。我只是很好奇，您能否談談您對自己在過去六個月中所做的所有投資和改進的能力感到滿意嗎？

And I'm not expecting guidance, but can you just put a little more color around what kind of ramp and implementation on your customer-end you expect and maybe how long it would take customers to follow on the commercial side? Thanks. And then I have a follow-up.

我並不期待指導，但您能否就您期望的客戶端的斜坡和實施方式以及客戶在商業方面遵循的時間需要多長時間提供更多資訊？謝謝。然後我有一個後續行動。

Well. Thanks for the question, Orin. And as you mentioned, I'm super proud of the team and what we've accomplished. And as you know, when we set out and provided our strategic direction in JP Morgan earlier this year, we talked about investing to grow on the business and solidifying our mission, our long-term strategy, and importantly, the commercial market access and medical organization. And you can see that those efforts are actually paying off if you take a look at the progress we've made now on for the first time, having a J-Code for EXPAREL and now expanded reimbursement and inclusion, and they'll pay for both EXPAREL and iovera, and this is really a testament to the team's efforts this year.

出色地。謝謝你的提問，奧林。正如您所提到的，我對我們的團隊和我們所取得的成就感到非常自豪。如您所知，當我們今年稍早在摩根大通制定並提供我們的策略方向時，我們談到了投資以實現業務成長並鞏固我們的使命、我們的長期策略，以及重要的是商業市場准入和醫療組織。如果您第一次查看我們現在所取得的進展，您會發現這些努力實際上正在得到回報，擁有 EXPAREL 的 J 代碼，現在擴大了報銷和包容性，他們將支付無論是EXPAREL還是iovera，這確實是團隊今年努力的證明。

So I'm super proud and confident about the direction we're headed. As it relates to no pain, I do believe that it will take our customers some time as I mentioned. So it won't be immediate. It will take some time for the customers to incorporate this into their sometimes large and complex organizations. And we're doing a lot now, but I would suspect that it's more second half of the year, next year, etcetera and onward, where we'll start to see some real signs that is taking hold.

因此，我對我們前進的方向感到非常自豪和自信。由於它與無痛有關，因此我確實相信，正如我所提到的，這將需要我們的客戶一些時間。所以這不會是立竿見影的。客戶需要一些時間才能將其納入他們有時龐大而複雜的組織中。我們現在正在做很多事情，但我懷疑是在今年下半年、明年等等以後，我們才會開始看到一些真正的跡象正在顯現。

Okay. And I guess just speaking of NOPAIN, the big picture, certainly a lot of us have on our mind, the results of the election last night. And you guys -- the company and with your consultants, obviously have a lot of experience working in Washington. And I assume we're instrumental in maybe getting NOPAIN done in the first place.

好的。我想，就 NOPAIN 而言，我們很多人肯定都在考慮昨晚的選舉結果。你們——公司和你們的顧問，顯然在華盛頓有很多工作經驗。我認為我們可能在首先完成 NOPAIN 方面發揮了重要作用。

Can you help us understand your -- what are your expectations longer term for implementation of that plan? Do you expect it to go beyond the three years? Obviously, the constituencies in the Republican Party are very much affected by opioid dependence issues also. But on the other hand, we've got presumably some budgetary pressures on the other side. So I'm just curious if you guys have a take or a confidence level in the long-term coverage for non-opioid therapies?

您能否幫助我們了解您對實施該計劃的長期期望是什麼？您預計會超過三年嗎？顯然，共和黨的選民也深受鴉片類藥物依賴問題的影響。但另一方面，我們可能也面臨一些預算壓力。所以我很好奇你們對非阿片類藥物療法的長期覆蓋是否有看法或有信心？

Yeah, it's a good question. And you know what, we're really encouraged by a couple of things. First, in the seven-plus years that it's taken to get this NOPAIN legislation across the line with a tremendous amount of support and advocacy from patient advocacy organization, like Voices for Non-Opioid Choices, in that process, what we found is that there's strong bipartisan support for really tackling this opioid issue that's out there still and amongst patients.

是的，這是一個好問題。你知道嗎，有幾件事讓我們深受鼓舞。首先，在七年多的時間裡，在非阿片類藥物選擇之聲等患者倡導組織的大力支持和倡導下，NOPAIN 立法得以全面通過，在此過程中，我們發現，兩黨大力支持真正解決患者中仍然存在的鴉片類藥物問題。

And so we don't expect that to change, and we're going to work very closely with advocacy as we always do. And that I believe that over the coming years, based on the data that we'll collect, I'm very, very confident that these investments that came through bipartisan support will pay off and will be recognized.

因此，我們預計這一點不會改變，我們將一如既往地與倡導者密切合作。我相信，在未來幾年中，根據我們將收集的數據，我非常非常有信心，這些來自兩黨支持的投資將獲得回報並得到認可。

Gregory Renza, RBC Capital Markets.

格雷戈里·倫扎（Gregory Renza），加拿大皇家銀行資本市場部。

Hey, guys. It's [Anish] on for Greg. Thanks for the updates this quarter and for taking our questions. Just a couple. Firstly, just to drill down a bit more on the ordering, over the next year, year and a half. Just on the GPO contracting, how should we be thinking about the onboarding process ordering and stocking within each organization?

嘿，夥計們。格雷格的[安尼什]上場了。感謝您本季的更新並回答我們的問題。只是一對。首先，我們要進一步深入了解未來一年半的訂購情況。就 GPO 合約而言，我們應該如何考慮每個組織內的入職流程訂購和庫存？

And then on NOPAIN and reimbursement, how can this be leveraged to keep centers ordering and using EXPAREL over the generic? Is ASP plus 6% enough? How are you messaging and educating on this? Thanks so much.

然後在 NOPAIN 和報銷方面，如何利用這一點來保持中心訂購和使用 EXPAREL 而不是通用藥物？ASP加6%就夠了嗎？您如何就此進行訊息傳遞和教育？非常感謝。

So, thanks for the question, Anish. And these are early days obviously for the GPOs. And so we're going to work very closely with our customers to make sure that they understand the GPO contracts, and we can help them pull it through at the low local level in a way that helps patients and the organization the most. So stay tuned on that. We think that this is important as we said before to not only providing access but fully leveraging NOPAIN and providing access to these kinds of innovative treatments.

所以，謝謝你的提問，安尼什。對 GPO 來說，現在顯然還處於早期階段。因此，我們將與客戶密切合作，以確保他們了解 GPO 合同，並且我們可以幫助他們以最有利於患者和組織的方式在基層實現這一目標。所以請繼續關注。我們認為，正如我們之前所說，這一點很重要，不僅要提供可及性，而且要充分利用 NOPAIN 並提供此類創新治療的可及性。

When we think about -- so the whole generic situation, and I'm going to come back to -- we shouldn't jump too far ahead. As we've mentioned, we believe that in order for a generic to be successful, there are multiple layers of patents that need to be overcome. And as we mentioned, we not only have the 495, the 574, but we are continuing to innovate as I mentioned earlier. So stay tuned on that.

當我們考慮整個一般情況時，我會回頭考慮，我們不應該跳得太遠。正如我們所提到的，我們相信，為了讓仿製藥成功，需要克服多層專利。正如我們所提到的，我們不僅有 495、574，而且正如我之前提到的，我們正在繼續創新。所以請繼續關注。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆，派珀·桑德勒。

Thanks. So I know there's not much you can really say beyond what you've already said about a generic entrant, but maybe I'll ask about it a little bit differently, which is that to the extent that an entrant materializes, I guess the question is, how do you think about the cost structure? How do you think about the potential for significant cost savings? How do you think about managing your margins in the context of a single generic entrant? So that's one set of questions.

謝謝。所以我知道除了你已經說過的關於通用進入者的內容之外，你真的沒有什麼可說的，但也許我會以稍微不同的方式問這個問題，也就是說，就進入者實現而言，我想問題是，您如何看待成本結構？您如何看待顯著節省成本的潛力？您如何看待在單一仿製藥進入者的背景下管理您的利潤？這是一組問題。

And then I guess the next question is as it relates to generic, is it something that we should be worried about on the competitive front regarding another filer or multiple filers emerging since there is one approved? It's one thing regarding a potential launch, but how are you thinking about the potential risk of other filers on liposomal bupivacaine emerging? Thanks.

然後我想下一個問題是，因為它與仿製藥相關，我們是否應該在競爭方面擔心另一個或多個申請者的競爭，因為有一個申請者已獲得批准？關於潛在的上市是一回事，但您如何看待其他申請者對脂質體布比卡因的潛在風險？謝謝。

David, just maybe a few things. First, as we've articulated previously to the extent, if and when there is a single generic entrant, there are a number of analogs. And I believe that Susan has a study here that she can forward you that shows that typically there's some price erosion, 15%, 20%. In that case, as we've said before, we consider that competition, and we'll compete in that space. We don't believe as I mentioned earlier that an at-risk launch is imminent.

大衛，也許只是一些事。首先，正如我們之前所闡述的那樣，如果有一個通用的進入者，就會有許多類似的產品。我相信蘇珊在這裡有一項研究，她可以轉發給您，該研究表明通常會出現一些價格侵蝕，15%、20%。在這種情況下，正如我們之前所說，我們會考慮這種競爭，並且我們將在該領域進行競爭。正如我之前提到的，我們不認為即將推出有風險的產品。

So we continue to drive this business and move it forward. We are certainly paying attention to the competitive environment, but we don't have visibility into any new -- and the filers, there's always some potential out there, but there have been no new filings that we've been noticed about.

因此，我們將繼續推動這項業務並向前發展。我們當然正在關注競爭環境，但我們沒有看到任何新的申請，而申報者總是有一些潛力，但我們還沒有註意到任何新的申請。

Gary Nachman, Raymond James.

加里·納赫曼，雷蒙德·詹姆斯。

Hey, guys. This is Tejas on for Gary. Congrats on the quarter. Can you guys talk just a bit more about the margin, where things went right there? You guys are kind of above your full-year guidance. Was that coming from the new EXPAREL facility?

嘿，夥計們。這是加里的光輝號。恭喜本季。你們能多談談邊際嗎？你們有點超出了全年指導。那是來自新的 EXPAREL 設施嗎？

And then now with the second GPO contract in place, things are starting to maybe firm up on the price going into NOPAIN. How do you see that dynamic just playing out in the last quarter and then into 2025?

現在，隨著第二份 GPO 合約的簽訂，NOPAIN 的價格可能開始變得堅挺。您如何看待上個季度以及 2025 年的這種動態？

Yeah. So that's a good question. We're certainly pleased about the margin improvement, but maybe I'll turn to Lauren here for some additional comment.

是的。這是一個好問題。我們當然對利潤率的提高感到高興，但也許我會在這裡向勞倫尋求一些額外的評論。

Sure, sure. Over time, we will improve gross margins by driving volume growth and certainly the 200 leader coming online is impacting those favorable margins. We are very pleased with our strong third-quarter margins, and it exceeded our guided range from 74% to 76%.

當然，當然。隨著時間的推移，我們將透過推動銷售成長來提高毛利率，當然，200 家領先企業的上線正在影響這些有利的利潤率。我們對第三季強勁的利潤率感到非常滿意，它超出了我們 74% 至 76% 的指導範圍。

But on a year to date, we believe we'll still land within that guided range. If you look at it, we came in at 75% on a year-to-date basis. The first half was negatively impacted by ZILRETTA and iovera. So EXPAREL has been -- continued to be strong, and we think that will that trend will continue?

但今年迄今為止，我們相信我們仍將落在該指導範圍內。如果你看一下，我們今年迄今的比例是 75%。上半年受到 ZILRETTA 和 iovera 的負面影響。因此，EXPAREL 一直保持強勁，我們認為這種趨勢會持續下去嗎？

Thanks Lauren.

謝謝勞倫。

And then I just had another follow-up kind of pivoting a little bit to 201 and what comes next for that program? Just kind of with the difficulties on EXPAREL, are you going to try to advance that program any quicker? Is there anything you want to do to kind of bring that program front and center just with everything that's been going on?

然後我又進行了另一種後續行動，稍微轉向 201，該計劃的下一步是什麼？只是考慮到 EXPAREL 上的困難，你會嘗試更快地推進該計劃嗎？您想做些什麼來將該計劃與正在發生的一切一起放在首位和中心嗎？

Well, that's a good question. I have to tell you, I'm personally excited about the program. I've seen a number of Phase 1 data sets in my time and this one, I get excited about. And I get excited about some of the data that we'll share next week. And I guess I'll turn to our Chief Medical Officer; Jonathan could talk a little bit about what's ahead. But certainly, we're very much excited about this locally administered gene therapy for common diseases like OA. So Jonathan, maybe we can talk about what's ahead for us.

嗯，這是個好問題。我必須告訴你，我個人對這個計劃感到很興奮。我看過許多第一階段的資料集，而這個資料集讓我感到興奮。我對我們下週將分享的一些數據感到興奮。我想我會求助於我們的首席醫療官；喬納森可以談談未來的發展。但當然，我們對這種針對 OA 等常見疾病的局部基因療法感到非常興奮。所以喬納森，也許我們可以談談我們的未來。

Thanks, Frank. As Frank articulated, we are really excited to be able to present our 104-week data at ACR and to talk about the potential to bring gene therapy to treat common diseases affecting millions of people. We're also really excited about our clinical program as that advances and we kick-off the next study at the beginning of next year. Along those lines, our CMC process is progressing as well ahead of schedule. So we are full steam ahead, and we're very excited about the potential of 201.

謝謝，弗蘭克。正如 Frank 所闡述的，我們非常高興能夠在 ACR 上展示我們的 104 週數據，並討論基因療法治療影響數百萬人的常見疾病的潛力。隨著臨床計畫的進展，我們也感到非常興奮，我們將在明年初啟動下一項研究。沿著這些思路，我們的 CMC 流程的進展也比計劃提前。所以我們正在全速前進，我們對 201 的潛力感到非常興奮。

And let me add on to that sometime next year, we'll provide better visibility into this next phase of the program. And we think it holds a lot of potential, not only for OA, osteoarthritis but perhaps other common diseases as well.

讓我在明年的某個時候補充一點，我們將為該計劃的下一階段提供更好的可見性。我們認為它具有很大的潛力，不僅可以治療骨關節炎、骨關節炎，還可以治療其他常見疾病。

Les Sulewski, Truist Securities.

Les Sulewski，Truist 證券公司。

Good evening. Thank you for taking my questions. Just a few for me. First, has eVenus provided you with a sample of their end product. I believe you mentioned that they're -- you're working through some logistics on the process of getting that worked out with the magistrate judge. Just want to get the latest on that.

晚安.感謝您回答我的問題。對我來說只有幾個。首先，eVenus 是否向您提供了他們的最終產品樣本。我相信你提到過，你正在與地方法官一起解決這個問題，並進行一些後勤工作。只是想了解最新情況。

Second, can you just remind us on the average out-of-pocket cost for iovera treatment? Now that you've got reimbursement, how much does that $255 reimbursement cover of the total cost?

其次，您能否提醒我們 iovera 療程的平均自付費用？現在您已經得到了報銷，那 255 美元的報銷金額佔總費用的多少？

And then a third on ZILRETTA, we're still seeing kind of a script deterioration continuing from second quarter. What do you think is driving this and at what point do we see stability on the front? Thank you.

然後是 ZILRETTA 的第三個，我們仍然看到劇本從第二季開始持續惡化。您認為是什麼推動了這個趨勢？謝謝。

Well, thanks for the question, Les. First on your question about the sample of product. No, we have not received the sample of the commercial product, and of course, we keep an eye on that. As I mentioned, we don't believe the launch is imminent as I mentioned earlier. Second, out of pocket is around 450 for iovera and of course, for the physician now and ASC and hospital, outpatient departments, the value equation is quite improved -- as I mentioned, another $255 on top of the current reimbursement. So we're super pleased about that.

好吧，謝謝你的提問，萊斯。首先關於你關於產品樣品的問題。不，我們還沒有收到商業產品的樣品，當然，我們會密切注意。正如我所提到的，我們認為發布不會像我之前提到的那樣迫在眉睫。其次，iovera 的自付費用約為450 美元，當然，對於現在的醫生、ASC 以及醫院、門診部門來說，價值等式已得到相當大的改善——正如我提到的，在當前報銷的基礎上，還需要另外255 美元。所以我們對此感到非常高興。

Just to give a shout out to the team, EXPAREL and iovera are among 2 of the 11 products that were approved. So many were not. So it's really a testament to the product and the team's efforts.

值得一提的是，EXPAREL 和 iovera 是獲得批准的 11 種產品中的 2 種。很多人都沒有。所以這確實是對產品和團隊努力的證明。

And finally, what I'll say about ZILRETTA is that historically, I think, we've focused quite a bit on EXPAREL and iovera. But what we recognize now is that there's quite a bit of potential for ZILRETTA. It's a very good product. Patients are very satisfied with this product, and we believe that ZILRETTA is promotionally responsive.

最後，關於 ZILRETTA，我認為從歷史上看，我們相當多地關注 EXPAREL 和 iovera。但我們現在認識到 ZILRETTA 具有相當大的潛力。這是一個非常好的產品。患者對產品非常滿意，我們相信 ZILRETTA 的促銷反應良好。

So going forward, you'll start to see the -- some of the changes that we've made and how we're going to promote ZILRETTA in the field and the kinds of things that we'll do on the marketing side. But we are bullish on Zetta growth going forward.

因此，展望未來，您將開始看到我們所做的一些改變以及我們將如何在該領域推廣 ZILRETTA 以及我們將在行銷方面做的事情。但我們看好 Zetta 未來的成長。

Thank you. There are no further questions. At this time, I'd like to turn the call back over to Susan Mesco, Head of Investor Relations for closing remarks.

謝謝。沒有其他問題了。此時，我想將電話轉回投資者關係主管蘇珊·梅斯科 (Susan Mesco) 進行結束語。

Thank you, Michelle, 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 remainder 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 be well.

謝謝米歇爾，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全國性危機，凸顯了我們使命的至關重要性。謝謝你，祝你一切順利。

Thank you for your participation. This does conclude the program, and you may now disconnect. Good day.

感謝您的參與。這確實結束了程序，您現在可以斷開連接。再會。