Pacira Biosciences Inc (PCRX) 2024 Q4 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Pacira BioSciences fourth-quarter 2024 conference call. (Operator Instructions) Please note that today's conference is being recorded.

您好，感謝您的支持。歡迎參加 Pacira BioSciences 2024 年第四季電話會議。（操作員指示）請注意，今天的會議正在錄音。

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

現在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, operator, and good afternoon, everyone. Welcome to today's conference call to discuss our fourth-quarter and full-year 2024 financial results. Joining me are Frank Lee, Chief Executive Officer; and Shawn Cross, Chief Financial Officer. Kristen Williams, Chief Administrative Officer; Tony Molloy, Chief Legal Officer; Jonathan Slonin, Chief Medical Officer; and Brendan Teehan, Chief Commercial Officer, are also here for today's question-and-answer session.

謝謝接線員，大家下午好。歡迎參加今天的電話會議，討論我們的第四季度和 2024 年全年財務業績。與我一起出席的還有執行長 Frank Lee；以及財務長 Shawn Cross。克里斯汀·威廉斯 (Kristen Williams)，首席行政官；托尼·莫洛伊（Tony Molloy），首席法律官；喬納森·斯洛寧（Jonathan Slonin），首席醫療官；以及首席商務官 Brendan Teehan 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. This may cause our actual results, performance, or achievements to differ materially. For information concerning risk factors that could affect the company, please refer to our filings with the SEC. These are available from the SEC or the Pacira website.

在我們開始之前，請允許我提醒您，本次電話會議將包括受聯邦證券法安全港條款約束的前瞻性陳述。此類聲明代表我們今天的判斷，可能涉及風險和不確定性。這可能會導致我們的實際結果、表現或成就產生重大差異。有關可能影響公司的風險因素的信息，請參閱我們向美國證券交易委員會提交的文件。這些可從 SEC 或 Pacira 網站取得。

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 issued earlier this afternoon.

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。這些指標的描述以及我們與 GAAP 的協調可以在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 (Frank Lee)。

Thank you, Susan, and good afternoon, everyone. The considerable progress we made in 2024 leaves us well positioned for 2025 and beyond.

謝謝你，蘇珊，大家午安。我們在 2024 年取得的巨大進步為我們為 2025 年及以後做好了準備。

Key highlights from last year include record revenues of $701 million, the high end of our guided range, separate CMS coverage, and product-specific reimbursement codes for both EXPAREL and iovera, RMAT designation from the FDA for PCRX-201 and the readout of compelling two-year data from our 72-patient Phase 1 study, and importantly, establishing a best-in-class commercial, market access and medical powerhouse to drive top-line growth.

去年的主要亮點包括創紀錄的 7.01 億美元收入、我們指導範圍的高端、單獨的 CMS 覆蓋範圍以及 EXPAREL 和 iovera 的產品特定報銷代碼、FDA 對 PCRX-201 的 RMAT 指定以及我們 72 名患者第 1 階段研究中令人信服的兩年數據讀出，重要的是準入健康、市場增長和市場增長的商業、市場增長。

Looking ahead, the year is off to a strong start. We're sharply focused on executing our 5x30 strategy and becoming an innovative biopharmaceutical organization. We believe executing on this strategy is the best way to achieve growth and value creation as a leader in musculoskeletal pain and adjacencies.

展望未來，新的一年開局強勁。我們專注於執行我們的 5x30 策略並成為創新生物製藥組織。我們相信，作為肌肉骨骼疼痛和鄰近疾病領域的領導者，執行這項策略是實現成長和價值創造的最佳方式。

The plan focuses on five key objectives that we intend to achieve by 2030. These objectives support two broad strategic imperatives: first, accelerating growth in our strong commercial based business; and second, advancing an innovative pipeline and potentially transformative assets like PCRX-201.

該計劃重點關注我們打算在 2030 年實現的五個關鍵目標。這些目標支持兩大策略要務：首先，加速我們強大的商業業務的成長；其次，推進創新管道和 PCRX-201 等具有潛在變革意義的資產。

To summarize our 5x30 goals. Patients -- we expect our products to be benefiting more than 3 million patients annually by 2030. Products -- we plan to grow product revenues by double-digit CAGR over the next five years. Profitability -- we expect to achieve a 5 percentage point expansion in gross margin over 2024. Pipeline -- we anticipate having five novel programs in our clinical development pipeline. In partnerships, we plan to establish at least five clinical or commercial partnerships.

總結一下我們的 5x30 目標。患者－我們預計到 2030 年，我們的產品每年將使超過 300 萬名患者受益。產品－我們計劃在未來五年內使產品收入達到兩位數的複合年增長率。獲利能力－我們預計到 2024 年毛利率將提高 5 個百分點。管道－我們預計在臨床開發管道中會有五個新項目。在合作方面，我們計劃建立至少五個臨床或商業合作夥伴關係。

When we look at Pacira's commercial-based business, we have a solid foundation. Our three best-in-class products are generating significant cash flow. Each of these franchises has ample room for increased penetration and market expansion with multiple key growth drivers starting to kick in this year.

當我們審視 Pacira 的商業業務時，我們擁有堅實的基礎。我們的三款同類最佳產品正在產生大量現金流。由於今年多個關鍵成長動力開始發揮作用，這些特許經營企業都擁有充足的滲透率和市場擴張空間。

For our flagship product, EXPAREL, the NOPAIN Act is now in effect. This means we have reimbursement pathway for 18 million outpatient surgical procedures. Approximately 6 million of these procedures have CMS coverage and 12 million had commercial coverage.

對於我們的旗艦產品 EXPAREL，NOPAIN 法案現已生效。這意味著我們擁有1800萬例門診手術的報銷途徑。其中約有 600 萬例手術有 CMS 覆蓋，1,200 萬例有商業覆蓋。

EXPAREL now has its own product-specific J-code with the reimbursement rate of average selling price plus 6%. Securing this code was particularly important milestone as it will expand patient access to best practice of opioid-sparing care. In addition, the J-code will streamline the reimbursement and billing process. It is also more likely to be recognized and covered by commercial figures.

EXPAREL 現在有自己的產品特定 J 代碼，其報銷率為平均售價加上 6%。獲得該代碼是一個特別重要的里程碑，因為它將擴大患者獲得阿片類藥物節約護理最佳實踐的機會。此外，J-code 將簡化報銷和計費流程。也更容易被商業人士認可和報道。

While it's still early days, our field teams are seeing evidence of progress since the rollout of NOPAIN on January 1. This includes the recent formulary wins as well as a rising level of awareness around the J-code. While we're pleased with the positive early indicators, it will take time for our customers to adopt this new reimbursement. In addition, our IQVIA claims data can take up to four months to process.

雖然現在還處於早期階段，但自 1 月 1 日推出 NOPAIN 以來，我們的現場團隊已經看到了進展的證據。這包括最近的處方集勝利以及圍繞 J 代碼的認識水平的提高。雖然我們對早期的正面指標感到滿意，但我們的客戶需要時間來適應這種新的報銷方式。此外，我們的 IQVIA 索賠資料可能需要長達四個月的時間來處理。

We look forward to sharing future updates as more data become available. On the payer front, we continue to highlight the EXPAREL value proposition with real-world evidence. In addition to CMS, we now have commercial payers beginning to recognize the importance of reimbursing EXPAREL outside of the bundled payment. Recent progress includes several national payers adopting NOPAIN-like policies. This represents roughly 40 million covered lives and more than doubles our previous commercial coverage map.

隨著更多數據的出現，我們期待分享未來的更新。在付款人方面，我們繼續用現實世界的證據強調 EXPAREL 的價值主張。除了 CMS 之外，現在商業付款人也開始認識到在捆綁付款之外償還 EXPAREL 的重要性。最近的進展包括幾個國家付款人採用了類似 NOPAIN 的政策。這意味著大約有 4000 萬人受到覆蓋，並且是我們之前商業覆蓋範圍的兩倍多。

Our teams will continue to focus on expanding coverage, and we'll keep you apprised on future calls. Along with favorable patient outcomes, separate reimbursement helps our customers navigate financial challenges. At the same time, it gives them the opportunity to be at the forefront of opioid-sparing pain management. This is especially relevant for those accounts receiving discounted pricing through 340B or GPO networks, and the benefit is mutual given the anticipated EXPAREL volume expansion.

我們的團隊將持續致力於擴大覆蓋範圍，並將隨時向您通報未來的通話狀況。除了良好的患者治療效果外，單獨的報銷還能幫助我們的客戶應對財務挑戰。同時，這也使他們有機會走在阿片類藥物節約疼痛管理的前沿。對於那些透過 340B 或 GPO 網路獲得折扣價的帳戶來說，這一點尤其重要，而且考慮到預期的 EXPAREL 數量擴張，這種利益是相互的。

We launched two GPO partnerships last year. Both are performing according to plan, with volumes up and only modest impact on net sales dollars. Our third and final GPO agreement is expected to go live in the first half of this year. And once completed, more than 80% of our current EXPAREL business will be under contract.

我們去年建立了兩個 GPO 合作夥伴關係。兩家公司都按照計畫進行，銷量上升，但對淨銷售額的影響卻很小。我們的第三個也是最後一個 GPO 協議預計將於今年上半年生效。一旦完成，我們目前 80% 以上的 EXPAREL 業務將透過合約的方式進行。

Given our progress on the market access front, along with our learnings from market research, we believe it's the right time to invest in targeted direct-to-consumer marketing. We expect this DTC investment to expand utilization by driving patient demand for EXPAREL to be a part of their treatment plan for postsurgical pain.

鑑於我們在市場准入方面取得的進展以及我們從市場研究中獲得的經驗，我們認為現在是投資有針對性的直接面向消費者的營銷的最佳時機。我們預計這項 DTC 投資將推動患者對 EXPAREL 的需求，使其成為其術後疼痛治療計劃的一部分，從而擴大利用率。

We will begin with targeted pilot programs in the first half of the year and adjust our investment accordingly based on the underlying data. These patient-focused programs augment the EXPAREL value proposition we are presenting to physicians and other key stakeholders.

我們將從上半年開始進行有針對性的試點，並根據基礎數據調整投入。這些以病人為中心的計劃增強了我們向醫生和其他主要利益相關者提出的 EXPAREL 價值主張。

Turning to ZILRETTA, a best-in-class product that is promotionally sensitive. This year, we are focusing on generating additional share of voice, increasing our reach and driving awareness around its key advantages. It is the first and only long-acting single-shot corticosteroid injections for osteoarthritis knee pain.

談到 ZILRETTA，這是一款具有促銷敏感性的一流產品。今年，我們專注於創造更多的話語權，擴大我們的影響力，並提高人們對其主要優勢的認識。這是第一個也是唯一一個用於治療骨關節炎膝關節疼痛的長效單次注射皮質類固醇藥物。

ZILRETTA has demonstrated high patient satisfaction, up to four months of reliable pain relief and fewer office visits. ZILRETTA also has a strong safety and pharmacokinetic profile as it remains localized in the knee. This allows for fewer systemic effects, including significantly lower blood glucose spikes and important benefit for diabetic patients. 40% of patients with osteoarthritis also have diabetes, so this represents a meaningful opportunity.

ZILRETTA 已證明患者滿意度高，可可靠緩解疼痛長達四個月，並減少就診次數。由於 ZILRETTA 僅局限於膝蓋，因此還具有很強的安全性和藥物動力學特性。這可以減少全身影響，包括顯著降低血糖峰值，並為糖尿病患者帶來重要益處。 40% 的骨關節炎患者也患有糖尿病，因此這是一個有意義的機會。

In parallel with our commercial efforts, our Phase 3 registrational study is advancing in shoulder OA and is on track for top-line results next year. If approved, ZILRETTA would be the first and only long-acting steroid approved for use in shoulders. This is a sizable market with approximately 1 million intra-articular injections administered each year.

在我們進行商業努力的同時，我們在肩部骨關節炎方面的 3 期註冊研究也在不斷推進，並預計在明年獲得頂線結果。如果獲得批准，ZILRETTA 將成為第一個也是唯一一個獲準用於肩部的長效類固醇。這是一個相當大的市場，每年大約有 100 萬次關節內注射。

Switching gears to iovera. We have a key growth driver kicking in this year with separate CMS reimbursement now in effect via the product-specific code, C-9809. This is important as physicians are eligible to receive up to $256 for iovera using this new code. This payment is in addition to the procedural fees they are receiving.

切換到 iovera。我們今年有一個關鍵的成長動力，即透過產品特定代碼 C-9809 生效的單獨 CMS 報銷。這很重要，因為醫生有資格使用此新代碼獲得高達 256 美元的 iovera 治療費用。這筆款項是他們收到的手續費以外的額外費用。

We're also launching a new iovera SmartTip. This innovative tip was approved late last year and is specifically designed for use as a medial branch block to relieve low back pain. Millions of Americans suffer from chronic low back pain, it often leads to poor quality of life, disability, lost wages, and persistent prescription opioid use.

我們也將推出一款新的 iovera SmartTip。這項創新技術已於去年年底獲得批准，專門設計用於內側支阻滯以緩解腰痛。數百萬美國人患有慢性下背痛，這常常導致生活品質下降、殘疾、工資損失和持續使用處方阿片類藥物。

Lastly, our registrational study of iovera for treatment of spasticity is advancing with top-line results expected next year. There is a significant lack of innovation and patient satisfaction in this debilitating condition. We believe iovera represents a novel approach for patients with moderate to severe spasticity seeking better treatment options.

最後，我們對 Iovera 治療痙攣的註冊研究正在推進，預計明年將獲得最終結果。在這種令人衰弱的狀況下，創新和病患滿意度嚴重缺乏。我們相信，iovera 為尋求更好治療方案的中度至重度痙攣患者提供了一種新方法。

Turning now to our second strategic imperative, advancing an innovative pipeline. Here, we're focused on becoming a therapeutic area leader in musculoskeletal pain and adjacencies. These are large markets, significantly lacking innovation. Nearly 1 in 4 Americans are living with chronic pain and seeking new interventions, addressing its underlying costs.

現在談談我們的第二個策略要務，推動創新管道。在這裡，我們致力於成為肌肉骨骼疼痛和鄰近疾病治療的領導者。這些都是龐大的市場，但嚴重缺乏創新。近四分之一的美國人患有慢性疼痛，並尋求新的干預措施來解決其潛在費用。

As we look to new product development, we'll prioritize mid- to late-stage de-risked opportunities. More specifically, product candidates with validated mechanisms and established reimbursement pathways. We'll also look to leverage our long-standing market leadership in treating pain in a precise, targeted ways.

當我們著眼於新產品開發時，我們將優先考慮中後期的去風險機會。更具體地說，候選產品具有經過驗證的機制和已建立的報銷途徑。我們還將利用我們長期以來的市場領導地位，以精確、有針對性的方式治療疼痛。

Our recently announced acquisition of the remaining ownership stake of GQ Bio is a perfect example. It directly aligns with our 5x30 strategy by adding an exciting first-of-its-kind, high-capacity, local delivery platform for genetic medicines. This transaction also brings us a pre-clinical portfolio with disease-modifying potential in prevalent musculoskeletal diseases and research and development talent. Further, it eliminates future milestones and builds upon the process development activities we've been advancing with GQ Bio since 2023.

我們最近宣布收購 GQ Bio 的剩餘所有權就是一個很好的例子。它與我們的 5x30 策略直接一致，增加了一個令人興奮的首創、高容量、本地基因藥物交付平台。這項交易也為我們帶來了在流行肌肉骨骼疾病領域具有疾病改良潛力的臨床前產品組合和研發人才。此外，它消除了未來的里程碑，並以我們自 2023 年以來與 GQ Bio 一起推進的流程開發活動為基礎。

In short, we know this technology very well. We believe there is a great potential for this platform to position us as a leading developer of novel treatments for underlying cause of chronic pain using a targeted molecular approach.

簡而言之，我們非常了解這項技術。我們相信，該平台具有巨大的潛力，可以使我們成為利用有針對性的分子方法治療慢性疼痛潛在病因的新型療法的領先開發商。

We have a clear understanding of the safety and tolerability of the high-capacity adenovirus or HCAd viral vector, which is based on Ad5. This is a well-understood serotype that is very common in community circulation. We also have strong data suggesting it is not susceptible to pre-existing neutralizing antibodies. This allows for the possibility of redosing.

我們對基於Ad5的高容量腺病毒或HCAd病毒載體的安全性和耐受性有清楚的認識。這是一種眾所周知的血清型，在社區傳播中非常常見。我們也有強而有力的數據顯示它不易受到預先存在的中和抗體的影響。這使得重新給藥成為可能。

This platform solves many of the challenges that have made gene therapy inaccessible for common diseases. the HCAd vector is much more efficient at delivering genes into cells compared to many other gene therapies that are -- that rely on the adeno-associated virus, AAV vectors. As a result, the direct effect can be achieved with much smaller doses.

該平台解決了許多導致常見疾病無法進行基因治療的難題。與許多依賴腺相關病毒 (AAV) 載體的其他基因療法相比，HCAd 載體在將基因傳遞到細胞方面效率更高。因此，只需較少的劑量便可達到直接的效果。

The vector used in the HCAd platform can carry up to 30,000 base pairs of DNA, which enables gene therapy with multiple or larger genes compared to AAV vectors. It's locally delivered and sustained. This differs from systemic approaches requiring much higher dosing to achieve the desired effect. Lower dose levels, coupled with efficient manufacturing support a favorable and commercially viable cost of goods profile, another key advantage of our other gene therapies.

HCAd平台中使用的載體可攜帶多達30,000個DNA鹼基對，與AAV載體相比，可實現多個或更多基因的基因治療。它是在當地交付和維持的。這與需要更高劑量才能達到預期效果的系統方法不同。較低的劑量水平，加上高效的製造支持了有利且商業上可行的商品成本狀況，這是我們其他基因療法的另一個主要優勢。

PCRX-201 is a lead program from this platform, which we believe underscores its promise given its encouraging data in osteoarthritis. Last year, we reported compelling results from a robust Phase 1 study of PCRX-201 in 72 patients with moderate to severe osteoarthritis. A single intra-articular injection demonstrated unprecedented pain relief and durability across all levels of disease severity for at least two years.

PCRX-201 是該平台的領先項目，我們相信，鑑於其在骨關節炎方面令人鼓舞的數據，該項目的前景十分光明。去年，我們報告了針對 72 名中度至重度骨關節炎患者的 PCRX-201 的穩健 1 期研究的令人信服的結果。單次關節內注射至少兩年內即可在所有嚴重程度的疾病中表現出前所未有的疼痛緩解和持久性。

The greatest efficacy was observed in the steroid pre-treated group. In all three doses, more than 70% of patients saw at least a 50% improvement in pain versus baseline at week 16 and 78. PCRX-201 was also well tolerated with no serious treatment-emergent adverse events.

在類固醇預處理組中觀察到了最強的療效。在所有三種劑量中，超過 70% 的患者在第 16 週和第 78 週的疼痛程度與基線相比至少改善了 50%。PCRX-201 耐受性良好，沒有出現嚴重的治療引起的不良事件。

We continue to follow these patients and look forward to reporting exciting three-year follow-up data later this year. While there's typically a placebo phenomenon within osteoarthritis pain studies, we are encouraged by our data. The magnitude and durability of efficacy far exceeds the placebo effect reported in published randomized studies.

我們將繼續追蹤這些患者，並期待在今年稍後報告令人興奮的三年追蹤數據。雖然骨關節炎疼痛研究中通常存在安慰劑現象，但我們的數據令我們感到鼓舞。其療效的大小和持久性遠遠超過已發表的隨機研究報告的安慰劑效應。

Patient enrollment is now open for our Phase 2 double-blind two-part study of PCRX-201. The study will include an active steroid comparator. We will share additional details on the study design in the coming weeks with top-line data from Part A expected late next year.

我們目前正在進行 PCRX-201 的第 2 期雙盲兩部分研究，患者招募現已開放。該研究將包括活性類固醇比較劑。我們將在未來幾週內分享有關研究設計的更多細節，並預計在明年稍後提供 A 部分的頂線數據。

Beyond PCRX-201, the GQ transaction brings us several exciting product candidates in preclinical development. We've also identified numerous well-validated cytokines for musculoskeletal pain and adjacencies that will be strong candidates for this platform. We're planning to share more details on the potential of this exciting platform through an educational webinar in the spring.

除了 PCRX-201 之外，GQ 交易還為我們帶來了幾種處於臨床前開發階段的令人興奮的候選產品。我們還發現了許多經過充分驗證的針對肌肉骨骼疼痛和鄰近症狀的細胞因子，它們將成為該平台的有力候選者。我們計劃在春季透過教育網路研討會分享有關這個令人興奮的平台的潛力的更多細節。

For those areas outside of our strategic focus, we see great potential for partnering. This could extend the HCAd platform into other conditions of high unmet need, where localized treatment with a therapeutic protein is warranted. Fittingly, this brings us to the last component of the 5x30 plan, forming five clinical or commercial partnerships over the next five years.

對於我們策略重點之外的領域，我們看到了巨大的合作潛力。這可以將 HCAd 平台擴展到其他高度未滿足需求的疾病領域，在這些疾病中，需要使用治療蛋白進行局部治療。恰如其分的是，這將我們帶到了 5x30 計劃的最後一個組成部分，即在未來五年內建立五個臨床或商業合作夥伴關係。

As you know, our products are currently only marketed in the US. We believe there is a meaningful opportunity in certain key markets outside of the US, where our products can be financially viable and deliver value to patients. We will be actively seeking commercial partners to realize that potential. In parallel, we will also look to identify ways we can partner on development programs to balance portfolio risk.

如您所知，我們的產品目前僅在美國銷售。我們相信，在美國以外的某些關鍵市場中存在著重大機遇，我們的產品在這些市場中既具有經濟可行性，也能為患者帶來價值。我們將積極尋求商業夥伴來實現這一潛力。同時，我們也將尋找合作開發專案的方式，以平衡投資組合風險。

Before I turn the call over to Shawn, I'd like to formally welcome two new additions to our executive team Brendan Teehan, our newly appointed Chief Commercial Officer; and Krys Corbett, who joined as our Chief Business Officer. These two executives bring extensive experience to Pacira at an important stage in our evolution.

在我將電話轉給 Shawn 之前，我想正式歡迎兩位新成員加入我們的執行團隊，即我們新任命的首席商務官 Brendan Teehan；以及加入我們擔任首席商務官的 Krys Corbett。這兩位高階主管在我們發展的重要階段為 Pacira 帶來了豐富的經驗。

The Board also recently appointed Laura Brege, as Chair of the Board, while former Chair, Paul Hastings, and Andreas Wicki, have both retired. As a reminder, our Board refreshment began 15 months ago with the appointment of five new directors. These changes also significantly reduced the average tenure of our Board for less than 5 years compared to the nearly 12 years in 2023.

董事會最近還任命 Laura Brege 為董事會主席，而前主席 Paul Hastings 和 Andreas Wicki 都已退休。提醒一下，我們的董事會更新始於 15 個月前，當時任命了五名新董事。這些變化也顯著縮短了我們董事會的平均任期，從 2023 年的近 12 年減少到不到 5 年。

We thank Paul and Andreas for the many contributions to the company. Moving forward, I have every confidence Laura, Brendan and Krys will be key contributors to our next phase of growth.

我們感謝 Paul 和 Andreas 為公司做出的許多貢獻。展望未來，我完全相信 Laura、Brendan 和 Krys 將成為我們下一階段成長的關鍵貢獻者。

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

說完這些，我會把電話轉給肖恩，讓他審查一下財務狀況。

Thank you, Frank. I'll start with an update on sales and margin trends. Fourth-quarter EXPAREL sales increased to $147.7 million versus $143.9 million in 2023. Volume growth and the 2024 price increase were partially offset by a shift in viral mix and discounting associated with GPO partnerships.

謝謝你，弗蘭克。我首先會介紹一下銷售和利潤趨勢的最新情況。第四季 EXPAREL 銷售額增至 1.477 億美元，而 2023 年為 1.439 億美元。銷售成長和 2024 年價格上漲被病毒式組合的變化和與 GPO 合作夥伴關係相關的折扣部分抵消。

Fourth-quarter ZILRETTA sales increased to $33.1 million versus the $28.7 million reported in 2023. For iovera, sales were $6.5 million compared to $6.0 million in the fourth quarter of 2023.

第四季 ZILRETTA 銷售額增至 3,310 萬美元，而 2023 年為 2,870 萬美元。Iovera 的銷售額為 650 萬美元，而 2023 年第四季的銷售額為 600 萬美元。

Turning to gross margins, on a consolidated basis, our fourth-quarter non-GAAP gross margin was 79%. This was driven by improved margins for EXPAREL and ZILRETTA. For non-GAAP R&D expense, the fourth-quarter increased to $22.0 million from $16.6 million reported last year. This increase relates to product development and clinical study costs.

談到毛利率，以合併口徑計算，我們第四季的非 GAAP 毛利率為 79%。這是由於 EXPAREL 和 ZILRETTA 利潤率的提高所致。就非公認會計準則研發費用而言，第四季從去年報告的 1,660 萬美元增加到 2,200 萬美元。這一增長與產品開發和臨床研究成本有關。

Non-GAAP SG&A expense came in at $78.6 million for the fourth quarter, which is up from $57.4 million last year. This increase is largely due to investments in our commercial, medical and market access organization as well as NOPAIN readiness.

第四季非公認會計準則銷售、一般及行政費用為 7,860 萬美元，高於去年的 5,740 萬美元。這一成長主要歸功於我們對商業、醫療和市場准入組織以及 NOPAIN 準備的投資。

All of this resulted in another quarter of significant adjusted EBITDA of $62.5 million. As for the balance sheet, we exited the fourth quarter in a position of strength with $485 million of cash and investments. With the business that is producing significant operating cash flow, we believe we are well equipped to advance our 5x30 strategy and create shareholder value.

所有這些因素使得本季的調整後 EBITDA 再次大幅成長，達到 6,250 萬美元。至於資產負債表，我們在第四季結束時保持強勁勢頭，擁有 4.85 億美元的現金和投資。憑藉產生大量經營現金流的業務，我們相信我們有能力推進我們的 5x30 策略並創造股東價值。

We are taking a disciplined approach to capital allocation where we are focusing on four areas: first, accelerating growth in our best-in-class base business; second, advancing innovative pipeline to becoming the leader in musculoskeletal pain and adjacencies; third, managing our balance sheet and planning for the repayment of debt -- we have a convertible note due in 2025, a term loan due in 2028, and the second convertible note due in 2029; and fourth, returning capital to shareholders -- we have $125 million remaining of our share buyback authorization, which we put in place last year and runs through the end of 2026.

我們採取嚴謹的資本配置方式，重點關註四個領域：首先，加速我們一流的基礎業務的成長；第二，推進創新管道，成為肌肉骨骼疼痛及鄰近疾病領域的領導者；第三，管理我們的資產負債表併規劃債務償還－我們有一張 2025 年到期的可轉換票據、一筆 2028 年到期的定期貸款以及第二張 2029 年到期的股東1.25 億美元，有效期至 2026 年底。

Going forward, we will continue to be highly strategic, balance favorable operating margins while advancing our 5x30 strategy. This includes carefully investing in a best-practice commercial, medical, and market access powerhouse and targeted direct-to-consumer marketing. In parallel, we will advance a pipeline of potentially transformative assets like PCRX-201 as we transition into an innovative biopharmaceutical organization.

展望未來，我們將繼續高度重視策略，在推進 5x30 策略的同時平衡有利的營業利潤率。這包括謹慎投資最佳實踐的商業、醫療和市場准入強國以及有針對性的直接面向消費者的營銷。同時，隨著我們向創新生物製藥組織轉型，我們將推進 PCRX-201 等具有潛在變革意義的資產的研發管線。

That brings us to our full year P&L guidance for 2025 as follows. Total revenue of $725 million to $765 million. As Frank mentioned, we are pleased with the positive early signs and growing levels of awareness around NOPAIN. That said, it will take time for our customers to integrate this new reimbursement. We expect more meaningful uptick to begin in the second half of the year.

這使我們得出了 2025 年全年損益預測如下。總收入為 7.25 億美元至 7.65 億美元。正如弗蘭克所提到的，我們對 NOPAIN 的早期積極跡象和不斷提高的認知度感到高興。也就是說，我們的客戶需要時間來適應這種新的報銷方式。我們預計今年下半年將出現更有意義的上漲。

Non-GAAP gross margins of 76% to 78%, non-GAAP R&D expense of $90 million to $105 million. At the midpoint, this represents an 11% increase over our fourth-quarter 2024 annualized run rate. The key drivers are increased costs associated with clinical studies. These include the following: our Phase 2 study of PCRX-201, investments to support the PCRX-201 and HCAd commercial manufacturing process as well as other activities related to our acquisition of GQ Bio, the new pilot study of ZILRETTA in hip OA and ramping costs for the ZILRETTA and iovera registration studies, which we anticipate will read out in 2026.

非公認會計準則毛利率為 76% 至 78%，非公認會計準則研發費用為 9,000 萬美元至 1.05 億美元。從中點來看，這比我們 2024 年第四季的年化運作率成長了 11%。關鍵驅動因素是與臨床研究相關的成本增加。這些包括：我們對 PCRX-201 的 2 期研究、支持 PCRX-201 和 HCAd 商業製造過程的投資以及與我們收購 GQ Bio 相關的其他活動、ZILRETTA 在髖關節 OA 中的新試點研究以及 ZILRETTA 和 iovera 註冊研究的成本增加，我們預計將於 2026 年公佈結果。

For non-GAAP SG&A expense, we are guiding to a range of $290 million to $320 million. At the midpoint, this represents an 8% increase over our fourth-quarter 2024 annualized run rate. Key drivers of this increase are new marketing initiatives, including our DTC pilot programs that are beginning in the first half of the year. As Frank mentioned, we believe these DTC investments will drive increased patient demand for EXPAREL. And as always, we will be prudent and adjust spend accordingly based upon the data.

對於非 GAAP 銷售、一般及行政費用，我們預計範圍為 2.9 億美元至 3.2 億美元。從中點來看，這比我們 2024 年第四季的年化運作率成長了 8%。這項成長的主要驅動力是新的行銷舉措，包括我們今年上半年開始的 DTC 試點計畫。正如弗蘭克所提到的，我們相信這些 DTC 投資將推動患者對 EXPAREL 的需求增加。和往常一樣，我們將謹慎行事，並根據數據相應地調整支出。

Stock-based compensation of $56 million to $61 million. And lastly, for those modeling adjusted EBITDA, we expect our 2025 depreciation expense to be approximately $30 million. This increase over 2024 is largely driven by our 200-liter suite in San Diego, which began producing commercial supply in mid-2024 and is a new ZILRETTA fill line.

股票薪酬為 5,600 萬美元至 6,100 萬美元。最後，對於那些調整後的 EBITDA 模型，我們預計 2025 年的折舊費用約為 3,000 萬美元。2024 年的成長主要得益於我們位於聖地牙哥的 200 公升套件，該套件於 2024 年中期開始生產商業供應，是一條新的 ZILRETTA 填充線。

With that, I will turn the call back to Frank.

說完這些，我就把電話轉回給弗蘭克。

Thanks, Shawn. In closing, 2024 was a tremendous year of progress across the organization. All the work completed has allowed us to enter 2025 sharply focused on 5x30 and our transition into an innovative biopharmaceutical organization. We are confident the steps are taking position us for sustainable growth and success as a leader in musculoskeletal pain and adjacencies.

謝謝，肖恩。最後，2024 年是整個組織取得巨大進步的一年。所有已完成的工作使我們能夠在 2025 年重點關注 5x30 以及向創新生物製藥組織的轉型。我們相信，這些措施將使我們成為肌肉骨骼疼痛及鄰近疾病領域的領導者，實現永續成長和成功。

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

接線員，現在我們可以開始回答問題了。

Thank you. (Operator Instructions)

謝謝。（操作員指示）

Oren Livnat, H.C. Wainwright.

奧倫·利夫納特（H.C.）溫賴特。

Thanks. I've got a couple of questions. Just big picture, can you just talk more about the assumptions for NOPAIN, both implementation on the customer side and uptake. You're obviously not trying to get ahead of yourself by talking about a second-half ramp. But I'm trying to understand what would be the impediments to sort of an aggressive rapid uptake on the customer side given hospitals? Certainly, would like to be making margins here? And I'll wait for follow-ups. Thanks.

謝謝。我有幾個問題。就整體情況而言，您能否多談談 NOPAIN 的假設，包括客戶端的實作和吸收。顯然，你並不是想透過談論下半場的進展來超越自己。但我想了解的是，對於醫院而言，客戶端積極快速採用的障礙是什麼？當然，想在這裡賺取利潤嗎？我將等待後續訊息。謝謝。

Well, thanks for your question, Oren. It is Frank Lee here. We're excited about NOPAIN. And as we've said consistently, it will take time for our customers to really get traction around NOPAIN, and we think that's going to be starting in the second half.

嗯，謝謝你的提問，奧倫。我是弗蘭克李。我們對 NOPAIN 感到非常興奮。正如我們一直所說的那樣，我們的客戶需要時間才能真正了解 NOPAIN，我們認為這將在下半年開始。

Some of the things that we've got to make sure we do with our customers has certainly raise awareness, get them comfortable with the J-code. And in many cases, our customers are trying out the code to make sure that they're getting reimbursed. And so there's a learning period there.

我們必須確保為客戶做的一些事情肯定會提高他們的意識，讓他們熟悉 J 程式碼。在很多情況下，我們的客戶都會嘗試程式碼以確保他們能夠獲得報銷。因此，這是一個學習期。

And so we have to go through that, and we have some encouraging signs that we're seeing in terms of the use of the J-code, the awareness of NOPAIN, and customers utilizing that code and starting to get reimbursed. So the early signs are good, but certainly, it takes time for us to get traction on something like this.

所以我們必須經歷這個過程，而且我們在 J 程式碼的使用、對 NOPAIN 的認識以及使用該程式碼並開始獲得報銷的客戶方面看到了一些令人鼓舞的跡象。因此，早期跡像是好的，但當然，我們需要時間才能在這樣的事情上取得進展。

All right. And I guess you sort of segued into my follow-up, which was about what experience people are already having. Are you seeing successful reimbursement such that any cautious approach to using it for fear of not getting paid back is already starting to make some headway there?

好的。我想你已經進入了我的後續話題，即人們已經擁有的體驗。您是否看到了成功的報銷，以至於任何因擔心得不到償還而謹慎使用它的方法已經開始取得一些進展？

And have you had more access or penetration into accounts or geographies already that you hadn't at all before where, obviously, there are many accounts that don't use EXPAREL at all for financial reasons, but I'm wondering if you've broken new ground with NOPAIN already with a broader set of customers?

並且，您是否已經獲得了以前從未有過的更多訪問或滲透到帳戶或地區的權限？顯然，由於財務原因，許多帳戶根本不使用 EXPAREL，但我想知道您是否已經透過 NOPAIN 開闢了新局面，並擁有了更廣泛的客戶群？

Oven, these are all really good questions. And as we get more and more data, we'll be able to answer them factually, right? So as we mentioned, the IQVIA claims data, it takes some time to true up over time that's lacking data. But you know what, we're seeing encouraging signs.

Oven，這些都是非常好的問題。隨著我們獲得越來越多的數據，我們將能夠根據事實回答這些問題，對嗎？正如我們所提到的，IQVIA 聲稱的數據需要一段時間才能證實缺乏的數據。但你知道嗎，我們看到了令人鼓舞的跡象。

And oftentimes, these revenue cycles take a little while. It could take a couple of weeks to six, seven, eight weeks to see the revenue cycle be completed. And so it's still very, very early days. And what I'd say is, anecdotally, we're seeing good traction. And as we mentioned, commercial payers, we've had some wins there.

通常，這些收入周期需要一段時間。可能需要幾週到六、七、八週的時間才能完成收入週期。所以現在還處於非常早期的階段。我想說的是，從傳聞來看，我們看到了良好的進展。正如我們所提到的，商業付款人，我們在那裡取得了一些勝利。

And so as you know, it's not only the accounts but also the payers that are very important. And we've always said that CMS is important certainly for the outpatient setting. But of course, they have a mix of CMS and commercial payers. And we find it encouraging that we've got some commercial payer wins out the gate.

所以如您所知，不僅帳戶非常重要，付款人也非常重要。我們一直說 CMS 對於門診環境來說確實很重要。但當然，他們有 CMS 和商業付款人。我們發現，我們已經贏得了一些商業付款人的青睞，這令人鼓舞。

All right. And if I could just change gears a bit, I don't know if you want to comment at all on litigation going forward. But just big picture, you've been very confident in your optimism for a long EXPAREL runway exclusive -- with exclusivity, especially after your new IP issued late last year.

好的。如果我可以稍微換個話題，我不知道您是否想對未來的訴訟發表評論。但從總體來看，您對長期 EXPAREL 時裝秀獨家性的樂觀態度非常有信心——具有獨家性，特別是在去年年底發布新 IP 之後。

I'm trying to reconcile your approach to capital allocation given your confidence there, especially with -- the market has only barely backed off its most dire concerns from earlier last year and bounced back a little bit, but there's a huge disconnect in my view between even the current business. and what it's worth, let alone major growth potential from NOPAIN and upside optionality from a pipeline. Why wouldn't you be much more aggressive with potential buyback at these levels?

鑑於您的信心，我試圖調和您對資本配置的方法，特別是——市場才剛剛擺脫去年年初最可怕的擔憂並略有反彈，但在我看來，即使是當前的業務也存在巨大的脫節。以及它的價值，更不用說 NOPAIN 帶來的巨大成長潛力和管道帶來的上行選擇權。為什麼你不在這些層面上更積極地進行潛在回購？

Yeah. So let me start by saying, as always, we value certainty as much or more than any other investor, right? And so that's an important part. We also value making sure that we have long-term value for our shareholders. And so that's our guiding principle.

是的。所以，首先我要說的是，一如既往，我們比其他投資人更重視確定性，對嗎？這是一個重要的部分。我們也重視確保為股東帶來長期價值。這就是我們的指導原則。

And in the background, we've been, as you mentioned, very active in making sure that we continue to innovate and drive forward with new patents and new IP. And I would expect that going forward. We continue to innovate, and we believe we'll be providing additional patent protections going forward.

正如您所說，在幕後，我們一直非常積極地確保我們繼續創新並推動新專利和新智慧財產權的發展。我希望這種情況能夠持續下去。我們不斷創新，並相信未來我們將提供更多的專利保護。

That said now, from a capital allocation, we're going through a very disciplined approach, as Shawn mentioned, a very disciplined approach to make sure that we're funding our current operations. And we have quite a few catalysts here as we just talked about.

話雖如此，從資本配置的角度來看，我們正在採取一種非常嚴謹的方法，正如肖恩所提到的那樣，一種非常嚴謹的方法來確保我們為當前的營運提供資金。正如我們剛才談到的，這裡有不少催化劑。

We also have some important pipeline additions with -- now the great news, I really believe about GQ Bio. We can talk about that a little bit, just a recent acquisition that we announced. And of course, managing the balance sheet, and we do have $125 million left on our buyback program. So all of those, we're going to be managing in a very disciplined and balanced way.

我們還增加了一些重要的管道——現在是好消息，我真的相信 GQ Bio。我們可以稍微談論一下，這是我們最近宣布的一項收購。當然，管理資產負債表，我們的回購計畫還剩下 1.25 億美元。因此，我們將以非常自律和平衡的方式管理所有這些。

And so that's our approach. And we think that's going to get us to where we need to get to over the next five years.

這就是我們的方法。我們認為這將使我們在未來五年內達到我們需要達到的目標。

Gregory Renza, RBC Capital Markets.

加拿大皇家銀行資本市場 (RBC Capital Markets) 的 Gregory Renza。

Great. Thanks. Good afternoon, Frank and team. Congrats on the progress. Thanks for taking my question. Frank, and maybe a question for Shawn, as you lay out the ranges and the guidance for 2025, just wondering if you could talk a bit about maybe the relative contributions of the product portfolio for '25 and how you're thinking about that across EXPAREL, ZILRETTA, and iovera? And also if there's anything sequentially over the year that we should be thinking about just above and beyond what you've described when it comes to NOPAIN. Thank you.

偉大的。謝謝。下午好，弗蘭克和團隊。恭喜你取得進展。感謝您回答我的問題。弗蘭克，也許我想問肖恩一個問題，當您列出 2025 年的範圍和指導方針時，我只是想知道您是否可以談談 25 年產品組合的相對貢獻，以及您如何看待 EXPAREL、ZILRETTA 和 iovera？此外，如果在談到 NOPAIN 時，我們在今年內也應該考慮一些超出您所描述的事情。謝謝。

Yeah, sure. I'll let Shawn speak to that in here a second. Obviously, the EXPAREL is our flagship product, and we have a good catalyst here with the J-code as well as NOPAIN. But certainly, we plan on putting a shoulder behind ZILRETTA and iovera as well. But Shawn, you can speak a little bit to how we're thinking about that.

是的，當然。我讓肖恩在這裡談一下這個問題。顯然，EXPAREL 是我們的旗艦產品，並且我們擁有 J-code 和 NOPAIN 等良好的催化劑。但當然，我們也計劃為 ZILRETTA 和 iovera 提供支援。但是肖恩，你可以稍微談談我們對此的看法。

Yeah. I think the relative mix, as Frank mentioned, ZILRETTA or -- EXPAREL is still, of course, the flagship product -- and we think that we fully expect the commercial investments we've made in 2024 to bear fruit and enable the top line to achieve double-digit CAGR really exiting the year and beyond following our 5x30.

是的。我認為相對組合，正如弗蘭克所提到的，ZILRETTA 或 - EXPAREL 當然仍然是旗艦產品 - 而且我們認為我們完全期望我們在 2024 年進行的商業投資能夠取得成果並使營收實現兩位數的複合年增長率，真正實現我們 5x30 之後的年度及以後的複合年增長率。

As mentioned, we are pleased by the positive early signs of NOPAIN. But just can't reiterate more that it will take time for the customers to integrate the new reimbursement and stay tuned for what we expect to be a more meaningful uptake to begin in the second half of the year.

如上所述，我們對 NOPAIN 的早期積極跡象感到高興。但我再次強調，客戶需要時間來適應新的報銷制度，我們預計今年下半年將會出現更有意義的應用，敬請期待。

Great. That's really helpful. And maybe just as a follow-up, as you've mentioned, the double-digit CAGR on product revenue with 5x30. And certainly, Frank, you mentioned of value certainty. Just help us understand maybe what some of the implications are and some of the competitive landscape that you're thinking about when you set those numbers through into 2030. Does it imply competitive entry with EXPAREL some degree of timeline and competitive dynamics there? Thank you.

偉大的。這真的很有幫助。也許只是作為後續，正如您所提到的，產品收入的複合年增長率達到兩位數，為 5x30。當然，弗蘭克，你提到了價值確定性。只是幫助我們理解當您將這些數字設定到 2030 年時，您可能會想到的一些影響和競爭格局。這是否意味著 EXPAREL 的競爭進入具有一定程度的時間表和競爭動態？謝謝。

Sure. Greg, that's a great question. And I have to tell you we're very thoughtful as we put the 5x30 path to growth together and specifically around compounded annual growth rates are in the double digits. So we've talked a little bit about this before, but we do not believe there will be [at risk launch] a generic this year or in the foreseeable future.

當然。格雷格，這個問題問得很好。我必須告訴你，我們在製定 5x30 成長路徑時非常周到，特別是年複合成長率達到兩位數。我們之前已經談論過這個問題，但我們不認為今年或在可預見的未來會有仿製藥的上市。

So on top of that, we continue to build on our IP estate. We continue to innovate, and that gave us confidence to put forth the 5x30 strategy. And as Shawn mentioned, picking up that growth rate as we exit the year with all the different catalysts that we have behind us.

因此，在此基礎上，我們將繼續拓展我們的智慧財產權資產。我們不斷創新，這給了我們提出5x30策略的信心。正如肖恩所提到的那樣，隨著我們年底的到來，我們憑藉各種不同的催化劑，實現了成長率的提高。

Gary Nachman, Raymond James.

蓋瑞納赫曼、雷蒙詹姆斯。

Hi, guys. Good afternoon. So back to the revenue guidance range, what are you assuming in terms of volume growth versus how much offsetting pressure you'll have on gross to net from the GPO contracts just when we think about the NOPAIN dynamic?

嗨，大家好。午安.那麼回到收入指引範圍，當我們考慮 NOPAIN 動態時，您對銷售成長有何假設，以及 GPO 合約對總收入和淨收入造成的抵銷壓力有多大？

And then for DTC, the pilot effort, just how much could EXPAREL utilization be consumer-driven versus targeting physicians and hospitals like you have done traditionally? And then I have a follow-up.

那麼對於 DTC 試點計畫來說，EXPAREL 的使用率在多大程度上可以由消費者驅動，而不是像傳統上那樣以醫生和醫院為目標？然後我有一個後續問題。

Sure. Let me address the targeted DTC question first, and then I'll hand it over to Shawn to talk a little bit more about the numbers. Typically, what we see in the industry is once you educate the healthcare providers, and when you lower the access barriers, that is reimbursement through payers, coding, et cetera, then it's the right time to consider a very targeted approach to activating the patient. And I want to underscore targeted, because as you might imagine, the level of education and level of access, level of billing savvy varies by customer across the various geographies.

當然。讓我先解決目標 DTC 問題，然後再交給 Shawn 進一步討論數字。通常，我們在行業中看到的是，一旦你教育了醫療保健提供者，並且當你降低訪問障礙時，即通過付款人報銷，編碼等，那麼現在是考慮採用非常有針對性的方法來激活患者的最佳時機。我想強調的是針對性，因為正如您可能想像的那樣，不同地區的客戶的教育水平、訪問水平和計費水平各不相同。

So we're going to be very, very targeted, and we're going to be ROI-driven. So these days, you can be very, very targeted with these kinds of approaches. And as Shawn mentioned, we'll pilot some of those approaches in the first half of the year. And depending on what we see, we'll adjust our investment accordingly.

因此，我們將非常有針對性，並且以投資回報率為導向。因此，現在你可以透過這些方法非常有針對性地實現目標。正如肖恩所提到的，我們將在今年上半年試行其中一些方法。根據我們所看到的情況，我們將相應地調整我們的投資。

So that's how we're thinking about it. So the great news here is that we've had a long history of educating health care providers about EXPAREL. With the J-code now and NOPAIN that's given us the opportunity to lower those access barriers. Now is the right time to start to pilot and understand how best we can activate patients in certain settings and certain geographies.

這就是我們的想法。因此，好消息是，我們在向醫療保健提供者普及 EXPAREL 方面有著悠久的歷史。現在有了 J 程式碼和 NOPAIN，我們就有機會降低這些存取障礙。現在是開始試點並了解如何在特定環境和特定地區最好地激活患者的最佳時機。

So that's our thinking there. And let me hand it over to Shawn to talk a little bit about the numbers.

這就是我們的想法。現在我把時間交給肖恩來談談這些數字。

Yeah. We'll just keep this brief. It's a pretty simple answer with regard to the forward guidance on the revenue side that it's effectively all volume growth. That's the way to think about it.

是的。我們就長話短說吧。關於收入方面的前瞻性指引，答案很簡單，那就是實際上所有收入都來自銷售成長。這就是思考這個問題的方式。

Okay. Great. But in terms of magnitude of just the gross to net, you're going to have a little bit of pressure this year when you have the additional GPO. That obviously would be offset, but is that a little bit of a headwind, Shawn?

好的。偉大的。但就總額與淨額的比例而言，今年當你有了額外的 GPO 時，你會面臨一點壓力。這顯然會被抵消，但肖恩，這是否有點不利？

Yeah. You got it spot on. So we take price increase and have a little bit of headwind there, and they'll offset each other. So just think about it as volume growth.

是的。你說得完全正確。因此，我們承受著價格上漲和一些阻力，但它們會相互抵消。所以就把它看成數量增長吧。

Okay. And then, Frank, just it is a notable step-up in terms of your R&D spend this year, and you have a few programs ongoing that sound pretty interesting. How comfortable are you with what you have in-house? And maybe you just want to comment quickly on the GQ Bio and just adding that to types of preclinical programs that you have?

好的。然後，弗蘭克，就今年的研發支出而言，這是一個顯著的進步，而且你正在進行的幾個項目聽起來非常有趣。您對公司內部現有的資源滿意嗎？也許您只是想快速評論 GQ Bio，並將其添加到您擁有的臨床前項目類型中？

And do think you need to still go outside the company maybe to expand the pipeline further? Or do you have enough now internally to generate the kind of innovation that you're looking for? Thanks.

您是否認為仍需要走出公司之外來進一步擴大管道？或者您現在內部有足夠的資源來產生您所尋求的那種創新？謝謝。

Yeah. That's a good question, Gary. So I want to step back and say, we're in the process of transitioning from more specialty pharma and innovative pharma. I don't think that transition is complete. We will be taking steps delivered -- that direction. That's number one.

是的。這是個好問題，加里。所以我想退一步說，我們正處於從專業製藥轉型為創新製藥的過程中。我認為這種轉變尚未完成。我們將朝著這個方向採取措施。這是第一點。

Number two, as a result of that now, we'll start to invest a little more in R&D, consistent with that kind of a company that we're talking about. That more -- a little bit more innovative pharma than specialty pharma. What's great here is we've got not only life cycle programs for our existing products, but now we're adding some truly innovative programs like PCRX-201 that we're very excited about. We're starting the Phase 2 study. In fact, the study is open now for enrollment. And as you know, that will read out sometime late next year in terms of Part A in that study.

第二，由於這個原因，我們現在將開始在研發方面投入更多，這與我們所談論的公司類型一致。與專業製藥相比，這是一種更具創新性的製藥。最棒的是，我們不僅有現有產品的生命週期計劃，而且現在我們還添加了一些真正創新的計劃，例如 PCRX-201，我們對此感到非常興奮。我們正在開始第二階段的研究。事實上，這項研究現已開放報名。如您所知，該研究的 A 部分將於明年晚些時候公佈。

So we're very excited about that. And we're going to carefully look at what else is in the non-clinical pipeline from GQ Bio. And of course, there's some very interesting things there. And this supports the idea in our 5x30 that we'd have five novel development programs by 2030. So how many of them will come from GQ Bio, I can't comment on now, but we do think there's some very interesting projects there.

所以我們對此感到非常興奮。我們將仔細研究 GQ Bio 的非臨床研發線中還有哪些內容。當然，那裡也有一些非常有趣的東西。這支持了我們 5x30 中的想法，到 2030 年我們將有五個新穎的發展計劃。那麼其中有多少來自 GQ Bio，我現在無法評論，但我們確實認為那裡有一些非常有趣的項目。

For the platform, the HCAd platform is something that comes with GQ Bio now. PCRX-201, we had that asset, but now we also have the platform that could also be a way to generate additional programs and molecules. So we're excited about it. And so how much of it will come from GQ Bio and external, I can't really speak to right now, but very excited about the acquisition of GQ Bio.

對於平台，HCAd 平台是現在 GQ Bio 自帶的。PCRX-201，我們擁有這項資產，但現在我們也有平台可以產生額外的程式和分子。所以我們對此感到很興奮。那麼其中有多少來自 GQ Bio 和外部，我現在還不能透露，但我對收購 GQ Bio 感到非常興奮。

And again, it brings with it this idea that now we have a platform, the preclinical assets. It gives us some really talented -- I think, talented researchers in the space. People make the difference here in capability. And historically, we haven't had a lot of that in terms of the research and early development.

再次，它帶來了這樣的想法，即我們現在有一個平台，即臨床前資產。它為我們帶來了一些真正有才華的——我認為是該領域的才華橫溢的研究人員。在這裡，人的能力是決定因素。從歷史上看，我們在研究和早期開發方面並沒有取得太多進展。

And finally, from a financial standpoint, I really think it's a no-brainer. We're taking care of the future milestones, some of which we would have to pay this year. So all in all, it's a great acquisition, and we look forward to welcoming the GQ Bio team next week as we make a trip to Germany.

最後，從財務角度來看，我確實認為這是一個顯而易見的事情。我們正在處理未來的里程碑，其中一些我們必須在今年支付。總而言之，這是一次偉大的收購，我們期待下週在德國之行中歡迎 GQ Bio 團隊。

Serge Belanger, Needham & Company.

塞爾日·貝朗格（Serge Belanger），Needham & Company。

Hi. This is John on Serge today. Thanks for taking our questions. First on iovera, with the implementation of iovera into NOPAIN, do you kind of see it taking on a similar trajectory kind of adjacent to EXPAREL regarding any potential increased uptake throughout 2025? And then second, on the generic front, although it looks like it's unlikely that we'll see a generic launch in the near term, just wanted to gauge your guys' appetite on a potential settlement agreement at this time. Thanks.

你好。今天我是 Serge 節目的 John。感謝您回答我們的問題。首先是 iovera，隨著 iovera 納入 NOPAIN，您是否認為它會呈現與 EXPAREL 類似的軌跡，並在 2025 年期間有潛在的成長？其次，在仿製藥方面，雖然看起來我們不太可能在短期內看到仿製藥的推出，但我只是想衡量一下你們對此時潛在的和解協議的興趣。謝謝。

Yeah. Let me speak to the generic first. And then we can chat a little bit about iovera. From a generic standpoint, as I mentioned earlier, we value certainty as much or more than any other investor out there. I think in terms of settlement, we really can't comment on those kind of discussions. And so I think whatever we do is going to be in the long-term best interest of our shareholders and patients.

是的。讓我先談談一般情況。然後我們可以聊一聊 iovera。從一般角度來看，正如我之前提到的，我們與其他投資者一樣重視確定性，甚至比他們更重視確定性。我認為就解決方案而言，我們確實無法對此類討論發表評論。因此我認為無論我們做什麼都將符合股東和患者的長期最佳利益。

So I'll just leave it at that. And again, I want to reiterate that we feel very good about our IP estate and that we continue to innovate and what you should expect are more patents to come later on this year.

所以我就這樣吧。我想再次重申，我們對我們的智慧財產權資產感到非常滿意，我們將繼續創新，您可以期待今年稍後將有更多的專利問世。

With regard to iovera, what I'd tell you here is, it's one where we're very excited about this additional reimbursement. I have to be very transparent to tell you that we didn't know if we were going to get it or not. We are fairly certain about EXPAREL for sure. But for iovera, this one was a bit of a jump (technical difficulty)

關於 iovera，我想告訴你的是，我們對這次額外的報銷感到非常興奮。我必須非常坦率地告訴你，我們不知道我們是否會得到它。我們對 EXPAREL 非常有信心。但對 iovera 來說，這是一個小小的飛躍（技術難度）

So we're very excited about iovera being included as part of the 11 products. So EXPAREL and iovera are 2 out of 11 and provide some additional reimbursement. And maybe, Brendan, you can speak to the additional reimbursement and situation about iovera.

因此，我們非常高興 iovera 被列入這 11 種產品之一。因此，EXPAREL 和 iovera 排名 11 家公司中的 2 家，並提供一些額外的報銷。也許，布倫丹，你可以談談有關 iovera 的額外報銷和情況。

Sure. Thanks for the question. Thanks, Frank. We do see this as a key growth driver kicking in this year. With separate CMS reimbursement for iovera with a product-specific C-code, again, 9809, that's important as physicians are going to receive up to $256 for iovera when it's administered in the ambulatory surgical center or an HOPD setting via the new code. And the payment is, importantly, in addition to procedural fees that they would get -- that they would currently be receiving.

當然。謝謝你的提問。謝謝，弗蘭克。我們確實認為這是今年的關鍵成長動力。由於 iovera 的 CMS 報銷單獨採用產品特定的 C 代碼 9809，這一點很重要，因為當醫生透過新代碼在門診手術中心或 HOPD 環境中使用 iovera 時，他們將獲得高達 256 美元的報銷。重要的是，這筆付款是除了他們目前收到的程序費用之外的額外費用。

So I think we see that as an untapped opportunity. As we're looking ahead, we're looking at selectively investing in iovera for accelerated growth. It's in a different stage of its life cycle than EXPAREL. And we'll look at that and try to capitalize on the improved reimbursement landscape.

所以我認為我們認為這是一個尚未開發的機會。展望未來，我們考慮選擇性地投資 iovera 以實現加速成長。它與 EXPAREL 處於不同的生命週期階段。我們將研究這一點，並嘗試利用改善的報銷狀況。

And then finally, as you probably know, we have an additional opportunity with the new SmartTip that is launching later this year for low back pain, and we'll continue our Phase 3 registration study in spasticity.

最後，正如您可能知道的，我們還有一個機會，那就是今年稍後將推出用於治療腰痛的新型 SmartTip，我們將繼續進行痙攣方面的 3 期註冊研究。

Leszek Sulewski, Truist Securities.

Leszek Sulewski，Truist Securities。

Hey, good evening. This is [Jeevan] on for Les. Just a quick one for me. So with ZILRETTA's Phase 3 data for shoulder OA expected in '26, just wondering how you view its potential contribution to revenue growth? And are there plans to maybe accelerate development timelines or expanded indications?

嘿，晚上好。這是 [Jeevan] 為 Les 主持的。對我來說只是一個快速的步驟。因此，ZILRETTA 的肩部骨關節炎第 3 階段數據預計將於 26 年公佈，您想知道您如何看待它對收入成長的潛在貢獻？是否有計劃加快開發進度或擴大適應症？

Yeah. Thanks for the question. I have to tell you, I'm excited about ZILRETTA. ZILRETTA, as I've always said, is maybe the -- of the three products that maybe hasn't gotten the attention it really deserves. It's a fantastic product, does a lot to help patients with pain. And now we're excited about this opportunity with ZILRETTA in the shoulder.

是的。謝謝你的提問。我必須告訴你，我對 ZILRETTA 感到非常興奮。正如我一直說的，ZILRETTA 可能是這三種產品中尚未得到應有關注的。這是一個非常棒的產品，對緩解疼痛患者有很大幫助。現在，我們很高興能有機會使用 ZILRETTA 治療肩部疾病。

And this opportunity in shoulder, we think this will be -- we'll see top-line data sometime probably mid to late next year. And this will be the first long-acting corticosteroid for shoulder. And it's roughly about 1 million intra-articular injections a year. So it's quite substantial.

我們認為，這個機會就在眼前——我們大概會在明年中後期看到營收數據。這將是第一個用於治療肩部疾病的長效皮質類固醇藥物。每年約有 100 萬次關節內注射。所以這是相當重要的。

So we're optimistic. We obviously have to conduct the studies and have good data. But those studies are now enrolling, and we feel very good about delivering that data late next year or mid to late next year.

所以我們很樂觀。我們顯然必須進行研究並獲得良好的數據。但這些研究現在正在招募，我們很高興能在明年年底或明年中後期提供這些數據。

Thank you. (Operator Instructions)

謝謝。（操作員指示）

Hardik Parikh, JPMorgan.

摩根大通的 Hardik Parikh。

Hey, Frank and team. Thanks for the call. Just had a few questions for you. First is a follow-up to the R&D and OpEx question that was asked earlier. So this was definitely a bit higher than the guide and I think we had expected. I was wondering, do you guys see this kind of level of year-over-year increase kind of being more the standard? Or is this mostly one-time because of the 201 enrollment in the DTC? So that's just the first question. And then I'll follow up with that.

嘿，弗蘭克和他的團隊。謝謝您的來電。我只是想問你幾個問題。首先是對先前提出的研發和營運支出問題的後續回答。所以這肯定比指南高一點，我想我們已經預料到了。我想知道，你們是否認為這種同比成長水準更符合標準？或者這主要是由於 201 年 DTC 註冊而導致的一次性事件？這只是第一個問題。然後我會跟進此事。

Yeah. Hardik, it's a good question. I don't want to go off the guide for too many years. What I'll do is I'll tell you about this year. This year, we've got some really important catalysts like we just talked about. And we believe that these investments are going to return against -- we'll have a good return on investment against these investments. So that's number one as it relates to what we're doing on the commercial medical market access side.

是的。Hardik，這是個好問題。我不想偏離指南太多年。我要做的就是向你們講述今年的情況。今年，我們遇到了一些非常重要的催化劑，就像我們剛才談到的。我們相信這些投資將會帶來回報——我們將獲得良好的投資回報。因此，這是我們在商業醫療市場准入方面所做的工作的第一點。

As it relates to the development programs, as I said, it's very exciting around these development programs. And in terms of how quickly we shift towards more innovative versus specialty pharma, we'll be opportunistic about that. We'll see how these non-clinical assets in GQ Bio pan out, and there are some other things we're looking at as well. And so we'll be very, very careful there in managing our growth.

正如我所說，就開發計劃而言，這些開發計劃非常令人興奮。就我們轉向更具創新性而非專業性的製藥的速度而言，我們將抓住機會。我們將觀察 GQ Bio 中的這些非臨床資產如何發揮作用，同時我們也關注其他一些事情。因此，我們將非常非常小心地管理我們的成長。

And so the key thing to take away is, let's focus on this year. And this year, we believe, because of the catalyst and investment opportunities in front of us, this is going to return in terms of the ROI that we expect.

因此，我們要記住的關鍵一點是，讓我們專注於今年。我們相信，由於我們面前的催化劑和投資機會，今年的投資報酬率將達到我們預期。

Okay. Great. And then you mentioned that you had some commercial payers that had adopted a NOPAIN-like reimbursement model. I was just wondering if you could give us some more insight into which payers made that switch and how close their models are to the NOPAIN model.

好的。偉大的。然後您提到，一些商業付款人採用了類似 NOPAIN 的報銷模式。我只是想知道您是否可以向我們提供更多見解，了解哪些付款人進行了這種轉變，以及他們的模型與 NOPAIN 模型的接近程度。

Yeah. It's a good question. Now it's a tricky thing sometimes to mention specific payers and these kinds of things because you have to get permission from those folks. But what I'll tell you, it is a national payer for sure. And we were also able to get -- a couple of other payers that are very important as well. And so I want to come back to -- we're probably sitting at about double where we were before in terms of commercial covered lives.

是的。這是個好問題。現在，提及具體的付款人和諸如此類的事情有時是一件棘手的事情，因為你必須獲得這些人的許可。但我要告訴你的是，它肯定是國家付款人。我們還能夠獲得其他幾個同樣重要的付款人。所以我想回到這個問題——就商業保險覆蓋人數而言，我們現在的水平可能比以前高出一倍。

So we've gone from about $20 million to about $40 million. And this is early out of the gate. It's early out of the gate, which is a good sign. And this is very consistent with how CMS is reimbursing. In some cases, it's north of that. So it's outside of the bundle and at least what CMS is reimbursing.

因此我們的金額從大約 2,000 萬美元增加到了大約 4,000 萬美元。這才剛開始。出發時間還早，這是個好兆頭。這與 CMS 的報銷方式非常一致。在某些情況下，它位於其北邊。因此它不在套餐範圍之內，至少不在 CMS 的報銷範圍之內。

And I did fail to mention that we also got TRICARE as well. So as you know, they service the military and their families. And so that was a great win right out of the gate.

我忘了說我們也得到了 TRICARE。正如你所知，他們為軍隊及其家人提供服務。所以這真是一場偉大的勝利。

So we're encouraged by what we're seeing. We're encouraged and -- but it's still early days. So I don't want to get ahead of ourselves. But as I mentioned in prior calls, we expected the commercial payers to lag significantly as they normally do. But having these kind of wins early on is encouraging.

我們對所看到的情況感到鼓舞。我們感到鼓舞——但現在還為時過早。所以我不想超越我們自己。但正如我在之前的電話會議中提到的那樣，我們預計商業付款人將像往常一樣大幅滯後。但早期取得這樣的勝利是令人鼓舞的。

Oren Livnat, H.C. Wainwright.

奧倫·利夫納特（H.C.）溫賴特。

Thanks. Just want to try and think about how conservative or not this guidance is. I did notice on the gross margin, the adjusted gross margin guidance, they're flat to down from where we were in the entire second half of this year. And I would think with the growth -- even conservative assumptions on growth above your fixed cost structure and the 200-liter skid in San Diego now online, I would have thought that would be even higher in 2025.

謝謝。只是想嘗試思考這個指導是否保守。我確實注意到毛利率、調整後的毛利率指引與今年整個下半年的水平相比持平甚至下降。我認為，隨著成長——即使是保守地假設固定成本結構之上的成長，以及聖地牙哥現在上線的 200 公升滑橇，我也會認為 2025 年的成長會更高。

So can you just talk at all about the gross margin trends, maybe cadence through the year? And is there anything new or something we might be missing on that front that is factoring into that guidance?

那麼，您能否簡單談談毛利率趨勢，也許是全年的節奏？在這方面，我們是否可能遺漏了一些新內容，並將其納入指導範圍？

Yeah. Gross margins can be a little lumpy as they were last year. But certainly, Shawn can speak to how kind of lumpy they were last year and where we wound up. And overall, what I'd say is that we expect these margins to improve over time because of the volume, right?

是的。與去年一樣，毛利率可能會有點不穩定。但可以肯定的是，肖恩可以說出去年他們的表現有多糟糕，以及我們最終的結局。總的來說，我想說的是，我們預計這些利潤率會隨著時間的推移而提高，因為銷量會增加，對嗎？

Shawn, you can comment a little bit about kind of where we were with margins last year and where we ended up.

肖恩，你可以稍微評論一下我們去年的利潤率以及最終的利潤率。

Sure. And thanks for the question. And I completely agree that over time, we'll improve margins by driving volume growth, but we were pleased to see strong fourth quarter margins that exceeded our guided range of 74% to 76%.

當然。感謝您的提問。我完全同意，隨著時間的推移，我們將透過推動銷售成長來提高利潤率，但我們很高興看到第四季度的利潤率強勁，超過了我們預期的 74% 至 76% 的範圍。

But as Frank did mention, we need to emphasize this. There can be quarter-over-quarter variability in our gross margins and full-year margins are a much better frame of reference. And that informed our guided range for 2025 for 76% to 78%.

但正如弗蘭克所提到的，我們需要強調這一點。我們的毛利率可能存在季度環比變化，而全年利潤率是更好的參考標準。由此我們得出的 2025 年指引範圍是 76% 至 78%。

Yeah. And I think as we start to see volume pick up more going into the second half and particularly quarter four, as we talked about, really running at that double digit, then kind of going into next year, it will start to improve quite a bit more, and 200-liter will become more and more part of our mix. And so all these things give us a good tailwind, but it's going to take us a little bit of time to get there.

是的。我認為，隨著我們開始看到下半年，特別是第四季度的銷量進一步回升，正如我們所討論的，銷量將真正達到兩位數，然後進入明年，銷量將開始大幅改善，200 公升將越來越多地成為我們產品組合的一部分。所有這些事情都為我們帶來了良好的順風，但我們需要一點時間才能實現這一目標。

Thank you, ladies and gentlemen, for your questions. I will now turn the call back over to Susan Mesco for any closing remarks.

女士們、先生們，謝謝各位的提問。現在我會把電話轉回給蘇珊‧梅斯科 (Susan Mesco)，請她做最後發言。

Thank you, Olivia, 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 by executing our 5x30 plan to advance our mission. Thank you, and be well.

謝謝你，奧利維亞，也感謝今天電話會議中所有人的提問和時間。我們對未來面臨的機會感到興奮。在今年剩餘的時間裡，我們將繼續執行 5x30 計畫來推進我們的使命，確保我們為長期成功做好準備。謝謝，祝您一切安好。

This concludes today's conference call. Thank you all for participating, and you may now disconnect.

今天的電話會議到此結束。感謝大家的參與，現在您可以斷開連線了。