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Operator
Operator
Good day. Thank you for standing by. Welcome to the first-quarter 2025 Pacira Biosciences earnings conference call.
再會。感謝您的支持。歡迎參加 2025 年第一季 Pacira Biosciences 收益電話會議。
(Operator Instructions) Please be advised that today's conference is being recorded.
(操作員指示)請注意,今天的會議正在錄音。
I would now like to hand the conference over to our first speaker today, Susan Mesco, Head of Investor Relations. Please go ahead.
現在,我想將會議交給今天的第一位發言者,投資者關係主管蘇珊·梅斯科 (Susan Mesco)。請繼續。
Susan Mesco - Investor Relations
Susan Mesco - Investor Relations
Thank you. Good afternoon, everyone. Welcome to today's conference call to discuss our first-quarter 2025 financial results.
謝謝。大家下午好。歡迎參加今天的電話會議,討論我們 2025 年第一季的財務表現。
Joining me are Frank Lee, Chief Executive Officer; Jonathan Slonin, Chief Medical Officer; and Shawn Cross, Chief Financial Officer. Tony Molloy, Chief Legal & Compliance Officer; and Brendan Teehan, Chief Commercial Officer are also here for today's question-and-answer session.
與我一起出席的還有執行長 Frank Lee;喬納森·斯洛寧(Jonathan Slonin),首席醫療官;以及首席財務官肖恩·克羅斯 (Shawn Cross)。托尼·莫洛伊 (Tony Molloy),首席法律與合規官;和首席商務官 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.
在我們開始之前,請允許我提醒您,本次電話會議將包括前瞻性陳述,並受聯邦證券法安全港條款的約束。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。
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 Paciro website.
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。這些可以從 SEC 或 Paciro 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)。
Frank Lee - Chief Executive Officer, Director
Frank Lee - Chief Executive Officer, Director
Thank you, Susan. Good afternoon, everyone.
謝謝你,蘇珊。大家下午好。
I'm pleased to say 2025 is off to a solid start. We start the year by introducing our 5 by 30 path to value creation to advance our transition into an innovative biopharmaceutical company.
我很高興地說,2025 年已經有了一個好的開始。我們在年初推出了「5x30」價值創造計劃,以推動我們向創新型生物製藥公司的轉型。
To remind you: the plan supports two broad strategic imperatives. First, accelerating growth in our strong commercial-based business. And second, advancing an innovative pipeline of potentially transformative assets like PCRX-201.
提醒您:該計劃支援兩大戰略要務。首先,加速我們強大的商業業務的成長。其次,推動 PCRX-201 等具有潛在變革意義的資產的創新管道。
In just a few short months, we've achieved early and meaningful 5 by 30 milestones. With respect to growing our commercial-based business, we successfully settled our patent infringement litigation for EXPAREL. This agreement recognizes the strength of our IP and establishes an exclusivity runway extending to 2039.
在短短幾個月內,我們就實現了早期且有意義的 5x30 里程碑。在發展商業業務方面,我們成功解決了 EXPAREL 的專利侵權訴訟。該協議認可了我們智慧財產權的實力,並建立了延伸至 2039 年的獨家經營權。
We expanded our EXPAREL patent estate and listed our 18th patent in the FDA's Orange Book, with additional patents forthcoming.
我們擴大了 EXPAREL 專利範圍,並將第 18 項專利列入 FDA 橙皮書,並且即將推出更多專利。
Our legal team recently secured a favorable court ruling that eliminates our RDF royalty obligation for EXPAREL. This will benefit EXPAREL gross margins by a low-single-digit percentage.
我們的法律團隊最近獲得了一項有利的法院裁決,免除了我們對 EXPAREL 的 RDF 特許權使用費義務。這將使 EXPAREL 的毛利率提高低個位數百分比。
As for the pipeline: here, too, we saw strong progress. First, we added novel platform, a pre-clinical portfolio, and a talented research team, with the acquisition of GQ Bio.
至於管道:我們也看到了強勁的進展。首先,透過收購 GQ Bio,我們增加了新的平台、臨床前產品組合和優秀的研究團隊。
Second, multiple new PCRX-201 data sets are reading out this year. The new data continue to underscore the promise and disease-modifying potential of PCRX-201 and the HCAd platform.
其次,今年有多個新的PCRX-201資料集正在讀取。新數據繼續強調了 PCRX-201 和 HCAd 平台的前景和改善疾病的潛力。
Finally, patient dosing is officially underway in our phase 2 ASCEND study of PCRX-201 in osteoarthritis of the knee.
最後,我們針對 PCRX-201 治療膝關節骨關節炎的 2 期 ASCEND 研究已正式開始對患者進行給藥。
I'll start by expanding a bit more on the settlement of EXPAREL litigation. We believe this positive outcome recognizes the strength of our EXPAREL portfolio. It also provides important short- and long-term visibility to confidently advance our 5 by 30 plan and fortify our leadership in musculoskeletal pain.
我將首先進一步闡述 EXPAREL 訴訟的解決情況。我們相信這一積極成果證明了我們 EXPAREL 產品組合的實力。它還提供了重要的短期和長期可見性,以便自信地推進我們的 5 by 30 計劃並鞏固我們在肌肉骨骼疼痛領域的領導地位。
Importantly, the agreement is volume-limited, with no pricing restrictions, royalties, or technology transfer. Fresenius and its partners are solely responsible for the future manufacture and import of the generic product.
重要的是,該協議是數量限制的,沒有價格限制、特許權使用費或技術轉移。費森尤斯及其合作夥伴對仿製藥的未來生產和進口負全部責任。
As a reminder, this is a sole generic ANDA filer. Any future filer would have to overcome a significant number of legal hurdles, given our growing number of Orange Book-listed patents.
提醒一下,這是唯一的通用 ANDA 申請人。鑑於橙皮書所列的專利數量不斷增加,任何未來的申請人都必須克服大量的法律障礙。
In short, the agreement sets the stage for long-term EXPAREL growth and market expansion for the next 14 years. With only one generic and ample room for increased penetration, we expect EXPAREL to generate significant cash flow for the foreseeable future.
簡而言之,該協議為 EXPAREL 未來 14 年的長期成長和市場擴張奠定了基礎。由於只有一種通用藥物且滲透率還有很大的提升空間,我們預計 EXPAREL 將在可預見的未來產生大量現金流。
This provides a perfect segue to NOPAIN. We have an important opportunity to significantly expand EXPAREL utilization.
這為 NOPAIN 提供了完美的過渡。我們有一個重要的機會來大幅擴大 EXPAREL 的利用率。
As you know, NOPAIN provides a reimbursement pathway for 18 million out-patient surgical procedures. Approximately 6 million of these are CMS procedures, which are now covered under NOPAIN. The remaining 12 million procedures are covered by commercial plans, where we expect NOPAIN-like coverages and policies will be implemented, over time.
如您所知,NOPAIN 為 1800 萬例門診手術提供了報銷途徑。其中約有 600 萬是 CMS 程序,現在已納入 NOPAIN 的覆蓋範圍。其餘 1,200 萬項手術均由商業計劃承保,我們預計隨著時間的推移,類似 NOPAIN 的承保範圍和保單將會得到實施。
As a reminder, it will take time for the market to broadly adopt with the new reimbursement. That said, we're seeing encouraging leading indicators in this early phase of the launch.
提醒一下,市場需要時間來廣泛採用新的報銷制度。話雖如此,我們在發布的早期階段就看到了令人鼓舞的領先指標。
First -quarter average daily EXPAREL sales and volumes are up approximately 7% over 2024, after adjusting for two fewer selling days in 2025. This is more than double the low-single-digit year-over-year growth rate reported in the last two years.
經過 2025 年銷售日數減少兩天的調整後,第一季 EXPAREL 平均每日銷售量比 2024 年增加了約 7%。這一數字是過去兩年低個位數年增率的兩倍多。
Beyond EXPAREL sales, other positive early indicators include an increase of more than 30% in both new and deactivated EXPAREL accounts, with customer expansion across all sites of care.
除了 EXPAREL 的銷售額之外,其他積極的早期指標還包括新開和停用的 EXPAREL 帳戶數量均增加了 30% 以上,並且客戶範圍擴展到了所有護理站點。
Mounting utilization of the new EXPAREL J -code is indicating a rising level of awareness around enhanced reimbursement policies.
新 EXPAREL J 代碼的使用率不斷提高表明人們對增強報銷政策的認識程度不斷提高。
Growth within community hospitals and ambulatory surgical centers -- these accounts, which typically have fewer decision makers, are embracing the NOPAIN value proposition.
社區醫院和門診手術中心的成長——這些帳戶通常擁有較少的決策者,正在接受 NOPAIN 的價值主張。
We're incorporating best practices from these early winds into our discussions with larger health systems.
我們正在將這些早期的最佳實踐融入與更大的醫療系統的討論中。
Formulary wins are starting to come in for integrated delivery networks. We expect these wins to grow, as the year progresses, while we navigate the numerous stakeholders within these large-scale networks.
綜合配送網絡開始在處方集方面取得勝利。我們預計,隨著時間的推移,隨著我們在這些大型網路中引導眾多利益相關者,這些勝利將會不斷增長。
While we're encouraged by the early positive trends, it's important to keep in mind that we're driving change for more than a decade of established processes within complex delivery systems.
雖然我們對早期的正面趨勢感到鼓舞,但重要的是要記住,我們正在推動複雜交付系統中十多年來既定流程的變革。
As you know, claims data can take four more months to process. And we look forward to sharing quarterly updates, as more reliable market data become available in the second half of the year.
如您所知,索賠數據可能需要四個月的時間來處理。隨著下半年有更多可靠的市場數據可用,我們期待分享季度更新。
On the payer front, we continue to highlight EXPAREL's value proposition to commercial plans, with real-world evidence. We're pleased to see an increasing percentage of claims coming in from those plans that have adopted NOPAIN-like policies. This too indicates a rising level of awareness among healthcare providers and organizations about the enhanced reimbursement that's now available.
在付款人方面,我們繼續用現實世界的證據強調 EXPAREL 對商業計劃的價值主張。我們很高興看到採用類似 NOPAIN 政策的計劃提出的索賠比例不斷增加。這也表明醫療保健提供者和組織對於目前可用的增強報銷的認識水平正在提高。
Since our last call, additional commercial plans have adopted NOPAIN-like coverage. And we anticipate more to follow suit in the months ahead.
自從我們上次通話以來,其他商業計劃已採用了類似 NOPAIN 的覆蓋範圍。我們預計未來幾個月還會有更多國家效法。
Now, turning to our other products, ZILRETTA and ioveraº. As a reminder, late last year we restructured our field-based teams to prioritize EXPAREL and maximize the opportunity of NOPAIN.
現在,轉向我們的其他產品,ZILRETTA 和 ioveraº。提醒一下,去年年底我們重組了現場團隊,優先考慮 EXPAREL 並最大限度地利用 NOPAIN 的機會。
As part of our plan to establish a commercial, medical, and market access powerhouse, we pivoted our existing sales force to focus on EXPAREL. In parallel, we onboarded new sales teams to focus specifically on ZILRETTA and iovera, given specific capabilities required to service these customers.
作為我們建立商業、醫療和市場准入強大力量計劃的一部分,我們調整了現有的銷售隊伍,將重點放在 EXPAREL 上。同時,我們也組建了新的銷售團隊,專注於 ZILRETTA 和 iovera,以滿足為這些客戶提供服務所需的特定能力。
As a result, first-quarter sales were impacted by the transition, given that both products are promotionally sensitive. This should naturally subside with some time, as the team strengthens relationships and begins to hit its stride in the second quarter.
因此,由於這兩種產品都對促銷敏感,第一季的銷售受到了轉變的影響。隨著球隊關係的加強以及在第二季開始步入正軌,這種情況會隨著時間的推移而自然消退。
In addition, our three salesforce structure, now, has the capability and capacity to carry additional products.
此外,我們的三個銷售隊伍結構現在有能力和容量來承載額外的產品。
For ZILRETTA, we're rolling out several new programs this spring. Among these are:
對於 ZILRETTA,我們將於今年春季推出幾個新項目。其中包括:
Establishing value-based contracts with large accounts that have demonstrated interest and are capable of driving volume growth.
與表現出興趣並能夠推動銷售成長的大客戶建立基於價值的合約。
Broadening use within Medicare population, where we have a very good access and coverage. There is no prior authorization requirement for CMS patients, in contrast to those commercial plans. This allows a ZILRETTA treatment to be administered during the same office visit that a provider decides to treat.
擴大醫療保險人群的使用範圍,我們在這方面擁有非常好的可及性和覆蓋範圍。與商業計劃不同,CMS 患者無需事先授權。這使得 ZILRETTA 治療可以在醫療服務提供者決定治療的同一門診期間進行。
Driving awareness around ZILRETTA's unique delivery mechanism and strong safety and pharmacokinetic profile, this allows for fewer systemic effects, such as blood glucose spikes -- a key advantage for diabetic patients and their healthcare providers.
透過提高人們對 ZILRETTA 獨特的輸送機制和強大的安全性和藥物動力學特徵的認識,可以減少血糖峰值等全身影響——這對糖尿病患者及其醫療保健提供者來說是一個關鍵優勢。
And assessing strategic partnerships to expand our breadth and depth of customer coverage.
並評估策略夥伴關係以擴大我們的客戶覆蓋廣度和深度。
In parallel with our commercial activities, our phase 3 registrational study is advancing in shoulder OA and on track for top-line results next year.
與我們的商業活動同步,我們在肩部骨關節炎方面的 3 期註冊研究正在推進,並預計在明年獲得頂線結果。
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.
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 ioveraº. As you might recall, this year, we're launching an innovative SmartTip, specifically designed for use as a medial branch block to relieve low back pain.
切換到 ioveraº。您可能還記得,今年我們推出了一款創新 SmartTip,專門設計用於作為內側支阻滯來緩解腰痛。
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.
數百萬美國人患有慢性腰痛。它常常導致生活品質下降、殘疾、工資損失以及持續使用處方阿片類藥物。
We're pleased with what we're seeing from the first phase of the launch. Initially, we're focusing on a small group of spine Key Opinion Leaders to gather insights and feedback, before expanding to a broader targeted audience.
我們對發布第一階段的成果感到滿意。最初,我們專注於一小部分骨幹關鍵意見領袖來收集見解和回饋,然後擴展到更廣泛的目標受眾。
The medial branch SmartTip stands to grow the number of ioveraº procedures in the second half of the year and beyond.
內側支 SmartTip 將在今年下半年及以後增加 ioveraº 手術的數量。
Lastly, our registrational study of ioveraº for the treatment of spasticity is advancing with top-line results expected next year.
最後,我們對 ioveraº 治療痙攣的註冊研究正在取得進展,預計明年將獲得最終結果。
There is significant lack of innovation and patient satisfaction in this debilitating condition. We believe ioveraº represents a novel approach for patients with moderate-to -severe spasticity seeking better treatment options.
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 ioveraº 為尋求更好治療選擇的中度至重度痙攣患者提供了一種新方法。
In addition to our label extension studies for ZILRETTA and ioveraº, we're valuing other opportunities with near- and midterm path to revenue appreciation. We're also valuing commercial partnerships in certain key markets outside of the US, where we believe our products can deliver value.
除了對 ZILRETTA 和 ioveraº 進行標籤擴展研究之外,我們也正在評估其他具有近期和中期收入增值途徑的機會。我們也重視美國以外某些主要市場的商業合作夥伴關係,我們相信我們的產品能為這些市場帶來價值。
Turning now to our clinical pipeline, where we're focusing on becoming a therapeutic area leader in musculoskeletal pain and adjacencies.
現在談談我們的臨床管線,我們致力於成為肌肉骨骼疼痛和鄰近治療領域的領導者。
These are large markets, significantly lacking innovation. Nearly one in four Americans are living with chronic pain and are actively seeking new interventions that address its underlying cost.
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,並正在積極尋求解決其潛在成本的新幹預措施。
As we look at new product development, we're prioritizing mid- to late-stage de-risk opportunities. More specifically, product candidates with valid mechanisms and established reimbursement pathways.
在考慮新產品開發時,我們優先考慮中後期的去風險機會。更具體地說,候選產品具有有效的機制和既定的報銷途徑。
PCRX-201 is a great example that we believe has the potential to revolutionize the treatment of osteoarthritis.
PCRX-201 就是一個很好的例子,我們相信它有可能徹底改變骨關節炎的治療。
Before I turn the call over to Jonathan for a review of our PCRX-201 program, I'd like to highlight our recently announced stock repurchase program and continued focus on disciplined capital allocation.
在我將電話轉給喬納森審查我們的 PCRX-201 計劃之前,我想強調我們最近宣布的股票回購計劃以及對嚴格的資本配置的持續關注。
This $300 million dollar authorization doubles the amount authorized under the previous stock repurchase program. This decision underscores our commitment to delivering shareholder value and the confidence we have in our growth outlook.
這次 3 億美元的授權金額是先前股票回購計畫授權金額的兩倍。這項決定凸顯了我們致力於實現股東價值的承諾以及對成長前景的信心。
We believe the shares offer an attractive opportunity at the current valuation, particularly in light of the settlement of EXPAREL patent litigation. This settlement agreement solidifies the strong cash flow-generating profile of our business, with the certainty of an exclusivity runway to 2039.
我們認為,以目前的估值來看,這些股票提供了一個有吸引力的機會,特別是考慮到 EXPAREL 專利訴訟的和解。和解協議鞏固了我們業務強勁的現金流產生能力,並確定了至 2039 年的獨家經營權。
We believe this will drive significant growth and value as we advance 5 by 30.
我們相信,隨著我們實現 5by30 目標,這將推動顯著的成長和價值。
With that, I'd like to turn the call over to Jonathan to provide additional details on PCRX-201 and our recently acquired HCAd platform. Jonathan?
有了這些,我想將電話轉給喬納森,讓他提供有關 PCRX-201 和我們最近收購的 HCAd 平台的更多詳細資訊。喬納森?
Jonathan Slonin - Chief Clinical Officer
Jonathan Slonin - Chief Clinical Officer
Thank you, Frank. Good afternoon to all joining us today.
謝謝你,弗蘭克。大家下午好。
I'm excited to share a few highlights on the progress made with PCRX-201, which we believe has the potential to be an important disease -modifying therapy for osteoarthritis.
我很高興與大家分享 PCRX-201 取得的一些進展,我們相信它有可能成為治療骨關節炎的重要疾病改良療法。
PCRX-201 targets the IL-1 pathway, which triggers inflammation in response to pathogens and cellular stress. Importantly, this is a well-validated de-risk target.
PCRX-201 針對 IL-1 通路,此通路會因病原體和細胞壓力而引發發炎。重要的是,這是一個經過充分驗證的降低風險目標。
There are two FDA approved drugs targeting the IL-1 pathway that are effectively used to treat other inflammatory conditions. These drugs are not practical for osteoarthritis, as they would require very high doses for daily injections directly into the joints.
有兩種針對 IL-1 路徑的藥物獲得 FDA 批准,可有效治療其他發炎疾病。這些藥物不適用於治療骨關節炎,因為它們需要每天直接注射到關節中,劑量非常大。
IL-1Ra is a core regulator of this pathway and helps to keep inflammation in balance by turning it off when it's not needed.
IL-1Ra 是該通路的核心調節器,透過在不需要時關閉它來幫助維持發炎平衡。
As we get older, our bodies have a more challenging time maintaining that balance. As a result, we develop chronic IL-1-driven inflammation that eventually causes joint damage and pain.
隨著年齡的增長,我們的身體維持這種平衡變得越來越困難。結果,我們患上了慢性 IL-1 驅動的炎症,最終導致關節損傷和疼痛。
In PCRX-201, we are rebalancing the inflammatory scales by mimicking the body's natural response to inflammation at the cellular level. This targets the root cause of osteoarthritis, rather than just alleviating symptoms.
在 PCRX-201 中,我們透過在細胞層面模仿身體對發炎的自然反應來重新平衡發炎規模。這針對的是骨關節炎的根本原因,而不僅僅是緩解症狀。
We remain highly encouraged by the data from our large 72-patient study in OA of the knee. We continue to follow these patients and have multiple new data sets reading out this year.
我們針對 72 名膝關節骨關節炎患者所進行的大規模研究的數據讓我們深受鼓舞。我們將繼續追蹤這些患者,並在今年讀取了多個新的數據集。
Last month, we presented encouraging data at the Osteoarthritis Research Society International meeting. In this subgroup analysis, a single injection demonstrated two years of improvement in pain, stiffness, and function.
上個月,我們在骨關節炎研究學會國際會議上發表了令人鼓舞的數據。在這個亞組分析中,單次注射即可顯示出兩年內疼痛、僵硬和功能的改善。
Importantly, clinically meaningful efficacy was observed across all structural severity subgroups. This included the most severe, with a KL grade 4. Most osteoarthritis studies do not include KL grade 4 patients, as this advanced stage is particularly challenging to treat.
重要的是,在所有結構嚴重程度亞組中都觀察到了具有臨床意義的療效。其中包括最嚴重的一次,KL 等級為 4 級。大多數骨關節炎研究不包括 KL 4 級患者,因為這種晚期階段的治療特別具有挑戰性。
Next week, the team will be presenting at the annual meeting of the American Society of Gene and Cell Therapy. Our presence will include a podium presentation, where we will be sharing immunogenicity data.
下週,該團隊將在美國基因和細胞治療學會年會上發表演講。我們的出席將包括一個講台演示,我們將在會議上分享免疫原性數據。
These data will provide important insights into the potential for redosing. As you know, this would be a key feature, given that many OA patients have multiple joints impacted.
這些數據將為重複給藥的可能性提供重要見解。如您所知,由於許多 OA 患者的多個關節受到影響,因此這將是關鍵特徵。
We will also be hosting a clinical symposium to highlight the advantages of our high-capacity adenovirus or HCAd platform.
我們還將舉辦臨床研討會,重點介紹我們的高容量腺病毒或 HCAd 平台的優勢。
In June we will be at the annual meeting of the European Alliance of Associations for Rheumatology. Here, we will be presenting the three-year follow-up data from our phase 1 study.
六月我們將參加歐洲風濕病協會聯盟年會。在這裡,我們將展示第一階段研究的三年追蹤數據。
As we are advancing our phase 2 ASCEND study in new OA; and patient dosing is underway. We expect to report top -line data from Part A of the study late next year.
隨著我們在新型 OA 領域推進第二階段 ASCEND 研究;並且正在進行患者給藥。我們預計將於明年稍後報告該研究 A 部分的重要數據。
This study is generating a high level of interest from investigators, which underscores the significant unmet need and lack of innovation in osteoarthritis.
這項研究引起了研究人員的濃厚興趣,凸顯了骨關節炎領域存在著巨大的未滿足需求和缺乏創新。
To fully describe the ASCEND study design, we have made an educational webinar, available in the Investor section of our website. We invite you to watch and learn more about our development program for this exciting asset.
為了全面描述 ASCEND 研究設計,我們在網站的投資者部分製作了一個教育網路研討會。我們邀請您觀看並了解更多有關我們針對這項令人興奮的資產的開發計劃。
As you know, PCRX-201 is the lead program for our recently acquired HCAd gene therapy vector platform. This platform solves many of the challenges that have made gene therapy inaccessible for common diseases.
如您所知,PCRX-201 是我們最近收購的 HCAd 基因治療載體平台的領先計畫。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。
The HCAd vector is much more efficient at delivering genes into cells, compared to many other gene therapies that rely on adenovirus-associated virus or AAV vectors. As a result, the desired effect can be achieved with much smaller doses.
與許多依賴腺病毒相關病毒或 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,只需較少的劑量即可達到預期的效果。
The vector used in the HCAd platform can carry up to 30,000 base pairs of DNA. This enabled gene therapy with multiple or larger genes compared to AAV vectors.
HCAd平台中使用的載體最多可攜帶30,000個DNA鹼基對。與 AAV 載體相比,這使得使用多個或更大基因進行基因治療成為可能。
It is locally delivered and sustained. This differs from systemic approaches requiring much higher dosing to achieve the desired effects.
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。
Lower doses, covered with efficient manufacturing, support a favorable and commercially viable cost of goods profile. Another key advantage over other gene therapies.
較低的劑量,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。與其他基因療法相比的另一個主要優勢。
In addition to this novel local delivery platform, this transaction brings us key research talent and a promising pre-clinical portfolio. The team is carefully looking at these opportunities, which may have disease-modifying potential in other prevalent musculoskeletal diseases.
除了這個新穎的本地交付平台之外,這項交易還為我們帶來了關鍵的研究人才和有前景的臨床前產品組合。團隊正在仔細研究這些機會,這些機會可能對其他流行的肌肉骨骼疾病具有改變疾病的潛力。
We also have identified numerous well-validated cytokines that would be strong candidates for the HCAd platform.
我們還發現了許多經過充分驗證的細胞因子,它們將成為 HCAd 平台的有力候選者。
For those areas outside of our strategic focus, we see potential for partnering. This could extend the HCAd platform into other conditions of high unmet need for localized treatment, where a therapeutic protein is warranted.
對於我們戰略重點之外的領域,我們看到了合作的潛力。這可以將 HCAd 平台擴展到其他對局部治療有高未滿足需求的疾病領域,而這些疾病需要治療性蛋白質。
Bottom line, the HCAd platform directly aligns with our 5 by 30 objectives of having 5 novel development programs and 5 partnerships by 2030. It offers great potential to position us as a leading developer of novel treatments for the underlying cause of chronic pain.
總而言之,HCAd 平台與我們的「5 by 30」目標直接契合,即到 2030 年擁有 5 個新穎的發展計畫和 5 個合作夥伴關係。它為我們成為慢性疼痛根本原因新型療法的領先開發商提供了巨大的潛力。
It also presents the opportunity for Pacira to be a strategic partner of choice and drive value through future royalty revenue.
這也為 Pacira 提供了成為首選策略合作夥伴並透過未來的特許權使用費收入創造價值的機會。
We look forward to sharing more details on the advancement of PCRX-201 and other HCAd-based product development opportunities on future calls.
我們期待在未來的電話會議上分享有關 PCRX-201 和其他基於 HCAd 的產品開發機會的更多進展細節。
With that, I will turn the call over to Sean 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。
Shawn Cross - Chief Financial Officer
Shawn Cross - Chief Financial Officer
Thank you, Jonathan.
謝謝你,喬納森。
I'll start with an update on sales and margin trends. First-quarter EXPAREL sales increased to $136.5 million versus $132.4 million in 2024, driven by volume growth.
我首先會介紹一下銷售和利潤趨勢的最新情況。受銷量成長的推動,第一季 EXPAREL 銷售額從 2024 年的 1.324 億美元增至 1.365 億美元。
On an average daily basis, EXPAREL sales and volumes were both up by approximately 7%, after adjusting for two fewer selling days in 2025 versus 2024.
經過調整,2025 年的銷售天數比 2024 年減少了兩天,以平均每日計算,EXPAREL 的銷售額和銷量均成長了約 7%。
First-quarters ZILRETTA sales declined to $23.3 million versus $25.8 million reported in 2024. As Frank mentioned, this was largely attributable to transition to our new sales forces for ZILRETTA and ioveraº.
第一季 ZILRETTA 銷售額下降至 2,330 萬美元,而 2024 年為 2,580 萬美元。正如弗蘭克所提到的,這在很大程度上歸因於我們向 ZILRETTA 和 ioveraº 的新銷售團隊的過渡。
Looking ahead, we believe the foundation is set for a return to growth for the remainder of the year.
展望未來,我們相信今年剩餘時間恢復成長的基礎已經打好。
For ioveraº , sales were slightly up at $5.1 million, compared to $5.0 million in the first quarter of 2024.
ioveraº 的銷售額略有上漲,達到 510 萬美元,而 2024 年第一季的銷售額為 500 萬美元。
Turning to gross margins. On a consolidated basis, our first-quarter non-GAAP gross margin improved to 81% versus 72% last year. Gross margins continue to benefit from the improved costs and efficiencies of our enhanced larger scale manufacturing process that went live, last year, in San Diego.
談到毛利率。綜合來看,我們第一季非公認會計準則毛利率從去年的 72% 提高至 81%。毛利率繼續受益於我們去年在聖地牙哥投入使用的增強型大規模製造流程的成本和效率的改善。
As Frank noted, we got a recent win in the Nevada court that will benefit future EXPAREL growth gross margins by a low-single-digit percentage, by eliminating RDF royalties.
正如弗蘭克所指出的,我們最近在內華達州法院取得了勝利,透過取消 RDF 特許權使用費,這將使 EXPAREL 未來的毛利率增長低個位數百分比。
For non-GAAP R&D expense, the first quarter increased $23.1 million from $16.4 million reported last year. This increase relates to start-up activities for the phase 2 study of PCRX-201, expenses associated with the ZILRETTA shoulder study, and product development.
第一季非公認會計準則研發費用較去年同期的 1,640 萬美元增加了 2,310 萬美元。這一增長與 PCRX-201 第 2 階段研究的啟動活動、與 ZILRETTA 肩部研究相關的費用以及產品開發有關。
Non-GAAP SG&A expense came in at $76.2 million for the first quarter. This is up from $63.8 million last year. This increase is largely due to the investments in our commercial, medical, and market access organization; targeted marketing initiatives; and the expansion of our field force.
第一季非公認會計準則銷售、一般及行政費用為 7,620 萬美元。這一數字比去年的 6,380 萬美元有所增加。這項成長主要歸功於我們對商業、醫療和市場准入組織的投資;有針對性的行銷舉措;以及我們現場力量的擴大。
All of this resulted in another quarter of significant adjusted EBITDA of $44.1 million for the first quarter.
所有這些因素使得第一季的調整後 EBITDA 再次大幅成長,達到 4,410 萬美元。
As for the balance sheet, we continue to be in a position of strength, with $494 million in cash and investments.
至於資產負債表,我們繼續處於強勢地位,擁有 4.94 億美元的現金和投資。
The business is producing significant operating cash flow. We believe we are well equipped to advance our 5 by 30 growth strategy to create shareholder value.
該業務正在產生大量經營現金流。我們相信,我們有能力推進我們的「5x30」成長策略,為股東創造價值。
We're taking a discipline disciplined approach to capital allocation. And we're focusing on three areas. First, accelerating growth in our best-in-class base business. Second, advancing an innovative pipeline, becoming the leader in musculoskeletal pain and adjacencies. And, third, opportunistically returning capital to shareholders.
我們對資本配置採取了嚴謹的方法。我們專注於三個領域。首先,加速我們一流的基礎業務的成長。第二,推動創新管道,成為肌肉骨骼疼痛及鄰近疾病領域的領導者。第三,把握機會向股東返還資本。
As Frank highlighted earlier, the Board recently authorized a new share repurchase program of $300 million. Given what we believe to be a significant disconnect in our current market valuation, this buyback authorization will run through the end of 2026.
正如弗蘭克之前強調的那樣,董事會最近批准了一項價值 3 億美元的新股票回購計畫。鑑於我們認為當前市場估值存在重大脫節,此回購授權將持續到 2026 年底。
Going forward, we will continue to be highly strategic, balancing favorable operating margins while executing our 5 by 30 growth strategy.
展望未來,我們將繼續高度重視策略,在執行「5x30」成長策略的同時平衡良好的營業利潤率。
We expect to prioritize opportunities that benefit operating margins to further enhance value for shareholders. This includes carefully investing in a best-practice commercial, medical, and market access powerhouse; and targeted marketing initiatives.
我們希望優先考慮有利於營業利潤率的機會,以進一步提高股東價值。這包括謹慎投資最佳實踐的商業、醫療和市場准入強國;以及有針對性的行銷舉措。
In parallel, we will work to advance a pipeline of potentially transformative assets of PCRX-201, as we transition into an innovative biopharmaceutical organization.
同時,隨著我們向創新生物製藥組織轉型,我們將努力推進 PCRX-201 的潛在變革資產管道。
That brings us to our full year P&L guidance for 2025, which, today, we are reiterating as follows:
這為我們帶來了 2025 年全年損益預測,今天我們重申如下:
Total revenue of $725 to $765 million. As Frank mentioned, we are pleased with the positive early signs and growing level of awareness around NOPAIN. That said, it will take time for broad adoption. And we expect a more meaningful uptick to begin in the second half of the year.
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。儘管如此,其廣泛採用仍需要時間。我們預計今年下半年將出現更顯著的成長動能。
Non-GAAP gross margins of 76% to 78%. Non-GAAP R&D expense of $90 million to $105 million. Non-GAAP SG&A expense of $290million to $320 million. Stock-based compensation of $56 million to $61 million.
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。非公認會計準則銷售、一般及行政費用為 2.9 億至 3.2 億美元。股票薪酬為 5,600 萬美元至 6,100 萬美元。
Lastly, for those modeling adjusted EBITDA, we expect our full-year 2025 depreciation expense to be approximately $30 million.
最後,對於那些調整後的 EBITDA 模型,我們預計 2025 年全年折舊費用約為 3,000 萬美元。
Lastly, and not surprisingly, we've recently been asked several questions about the impact of potential tariffs.
最後,毫不奇怪,我們最近被問到幾個有關潛在關稅影響的問題。
As a reminder: all of our intellectual property is domiciled in the US. The majority of our manufacturing takes place in the US.
提醒一下:我們所有的智慧財產權都在美國。我們的大部分製造工作都在美國進行。
And we have the capacity to allocate more EXPAREL manufacturing to the US. Based upon everything proposed today, we do not expect a material impact on our operations.
我們有能力將更多的 EXPAREL 製造分配給美國。根據今天提出的所有建議,我們預計不會對我們的營運產生重大影響。
Recognizing this is an evolving situation, we're closely monitoring developments and committed to minimizing any potential impact on the business.
認識到這是一個不斷變化的情況,我們正在密切關注事態發展,並致力於將對業務的任何潛在影響降至最低。
With that, I'll turn the call back to Frank.
說完這些,我就把電話轉回給弗蘭克。
Frank Lee - Chief Executive Officer, Director
Frank Lee - Chief Executive Officer, Director
Thank you Shawn.
謝謝你,肖恩。
In closing, I want to emphasize the transformative journey our company has been undergoing. With our 5 by 30 strategy, we have a clear path for future growth and value creation.
最後,我想強調一下我們公司正在經歷的變革之旅。透過我們的「5 by 30」策略,我們為未來的成長和價值創造指明了清晰的道路。
We're on our way to becoming a pioneering biopharmaceutical company and a leader in the musculoskeletal pain adjacencies.
我們正在成為一家先鋒生物製藥公司和肌肉骨骼疼痛治療領域的領導者。
Our best-in-class commercial-based business is generating significant cash flow and is poised for accelerated top-line growth. This is anchored by EXPAREL, which is well positioned to continue to set new standards in patient care, in the near and long term.
我們一流的商業業務正在產生大量現金流,並有望加速營收成長。這是由 EXPAREL 支持的,它完全有能力在近期和長期繼續為患者護理設立新的標準。
PCRX-201 is are novel locally-administered gene therapy product candidate for common diseases like osteoarthritis. This exciting asset continues to demonstrate its potential to revolutionize the treatment of osteoarthritis.
PCRX-201 是一種針對骨關節炎等常見疾病的新型局部給藥基因治療候選產品。這一令人興奮的資產繼續展示其徹底改變骨關節炎治療的潛力。
Our phase 2 development program is enrolling and on track for the first data read-out next year.
我們的第二階段開發計畫正在招募人員,預計明年首次讀取資料。
And our proprietary first-of-its-kind HCAd platform has the potential to unlock gene therapies for common diseases affecting millions of patients.
我們專有的首創 HCAd 平台有可能為影響數百萬名患者的常見疾病開啟基因療法。
Thank you, again, for joining us today and for your continued support and trust in our mission to deliver innovative non-opioid therapies to transform the lives of patients.
再次感謝您今天加入我們,並感謝您對我們提供創新非鴉片類藥物療法以改變患者生活的使命的持續支持和信任。
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。
Operator
Operator
(Operator Instructions)
(操作員指示)
Gregory Renza, RBC Capital Markets.
加拿大皇家銀行資本市場 (RBC Capital Markets) 的 Gregory Renza。
Unidentified Participant
Unidentified Participant
Hi, Frank and team. It's [Anish], on for Greg. Thanks for the updates this quarter and for taking our questions.
嗨,弗蘭克和他的團隊。我是 [Anish],替換 Greg。感謝您本季的更新以及回答我們的問題。
Just a couple from us. First, if you could just provide some color on what proportion of patients, on average, are covered with Medicare and would NOPAIN be applicable for within each surgical segment? Are there any coverage trends within that you're taking notice of?
距離我們只有幾對。首先,您能否提供一些信息,說明平均有多少比例的患者享受醫療保險,以及 NOPAIN 是否適用於每個手術環節?您是否注意到其中的任何覆蓋趨勢?
And second, on 201, what are you hearing from docs and patients, with respect to what needs to be shown to encourage wide adoption, should a therapy such as it, enter the market?
其次,關於 201,您從醫生和患者那裡聽到了什麼,關於需要證明什麼才能鼓勵廣泛採用,這樣的療法是否應該進入市場?
Thanks so much.
非常感謝。
Frank Lee - Chief Executive Officer, Director
Frank Lee - Chief Executive Officer, Director
Thanks, (inaudible). It's Frank Lee, here. Thanks for the question.
謝謝,(聽不清楚)。我是弗蘭克李 (Frank Lee)。謝謝你的提問。
So your question was about the proportion of patients covered by Medicare. Let me turn it over, here, to Bren, our Chief Commercial Officer. and he can speak to that.
所以您的問題是關於醫療保險覆蓋的患者比例。現在,讓我把這個任務交給我們的首席商務官布倫 (Bren)。他可以談論這一點。
Brendan Teehan - Chief Commercial Officer
Brendan Teehan - Chief Commercial Officer
Sure. Thanks for the question.
當然。謝謝你的提問。
As you would expect, there is a little bit of a difference between in-patient and out-patient. We have more commercial coverage in the in-patient segment, a little over 50%.
正如您所料,住院病人和門診病人之間存在一些差異。我們在住院領域的商業覆蓋率更高,略高於 50%。
But in the hospital out-patient setting in ASC, it skews a little bit more towards the Medicare side, on the HOCD side. And then, for ASC, it's principally commercial; almost three quarters of our business would be found commercially covered in ASCs.
但在 ASC 的醫院門診環境中,它更偏向醫療保險方面,即 HOCD 方面。然後,對於 ASC 來說,它主要是商業性的;我們的業務中幾乎有四分之三是在 ASC 中得到商業覆蓋的。
Frank Lee - Chief Executive Officer, Director
Frank Lee - Chief Executive Officer, Director
The second question was around 201 and what we're hearing from clinicians on what we need to show for wide adoption: at a high level, what I'd say here is, based on our market research and speaking with the community, current standard of care provides roughly three to six months of benefit and to the extent that we can provide a year or more, that's considered transformative and game changing.
第二個問題與 201 有關,我們從臨床醫生那裡聽到了我們需要展示什麼才能被廣泛採用:從高層次來看,我想說的是,根據我們的市場調查和與社區的交流,目前的護理標準提供了大約三到六個月的益處,如果我們能夠提供一年或更長時間的益處,那就被認為是變革性的和改變遊戲規則的。
And so, that's why we're particularly enthusiastic about the two-year data we've been able to share, so far. And as Jonathan mentioned, we'll be sharing our three-year data, later on this year.
所以,這就是為什麼我們對迄今為止能夠分享的兩年數據特別熱衷。正如喬納森所提到的,我們將在今年稍後分享我們的三年數據。
Unidentified Participant
Unidentified Participant
Great. Thank you so much.
偉大的。太感謝了。
Operator
Operator
Gary Nachman, Raymond James.
蓋瑞納赫曼、雷蒙詹姆斯。
Gary Nachman - Analyst
Gary Nachman - Analyst
All right. Thanks. And good afternoon. So, first, regarding NOPAIN. You've talked about some of the logistical challenges with hospital systems benefiting from NOPAIN. What are you doing to help expedite that from your end? The review programs that you have in place? And are you working with any third parties to help you get hospitals online faster?
好的。謝謝。午安.首先,關於 NOPAIN。您談到了受益於 NOPAIN 的醫院系統所面臨的一些後勤挑戰。您正在採取什麼措施來加速這一進程?您已實施哪些審查計畫?您是否與第三方合作來幫助您更快地實現醫院上線?
And then, just talk a bit more about how overall education of NOPAIN is going for physicians and hospitals, in general; and where awareness is now versus, let's say, the start of the year.
然後,再多談談 NOPAIN 對醫生和醫院的整體教育進展如何;以及現在與年初相比人們的認識程度如何。
And then, I have a follow-up.
然後,我有一個後續問題。
Frank Lee - Chief Executive Officer, Director
Frank Lee - Chief Executive Officer, Director
Thanks the question, Gary. Just at a high level -- if I turn it over to Brent, here -- we've said very consistently that it's going to be more the second half of the year until we really see traction for all the reasons we described.
謝謝你的提問,加里。從高層次來看——如果我把它交給布倫特——我們一直非常一致地表示,由於我們所描述的所有原因,我們真正看到牽引力還需要到今年下半年。
We are seeing some good early indicators. And, certainly, the things that we see in the smaller institutions and other settings, we can apply, also, to these bigger institutions.
我們看到了一些良好的早期指標。當然,我們在較小的機構和其他環境中看到的東西也可以應用到這些較大的機構。
But let me turn it over to Bren to talk, here, a little bit more.
但是,讓我把話題交給布倫,讓他在這裡再多談一點。
Brendan Teehan - Chief Commercial Officer
Brendan Teehan - Chief Commercial Officer
Yeah. Thanks for the question. I think Frank did really address where we've seen our early progress, which I think we've translated into a path forward for larger IDNs.
是的。謝謝你的提問。我認為弗蘭克確實談到了我們早期取得的進展,我認為我們已經將其轉化為更大 IDN 的前進道路。
I think things are going largely as we expected. in the community hospital setting, in the ambulatory surgery centers, we're seeing significant growth in adoption. And the reason we're seeing that is there are fewer decision makers; easier to communicate the NOPAIN message, as well as the separate J-code.
我認為事情基本上是按照我們預期的進行。在社區醫院環境中,在門診手術中心,我們看到採用率顯著成長。我們之所以看到這種情況,是因為決策者越來越少;更容易傳達 NOPAIN 訊息以及單獨的 J 程式碼。
But, concurrently, we're also seeing formulary wins at IDNs, where they're expanding lines of use for EXPAREL as a function of these conversations.
但同時,我們也看到 IDN 在處方集方面取得了勝利,他們根據這些對話擴大了 EXPAREL 的使用範圍。
Now, obviously, a lot of that's taken place over the last 90 to 100 days. I think the momentum you'd expect to see in IDNs would come, as has been suggested, in the latter part of the year, as it works its way through the system.
現在,顯然很多事情都是在過去 90 到 100 天內發生的。我認為,正如有人建議的那樣,隨著 IDN 在系統中逐漸成型,其發展勢頭將在今年下半年出現。
Frank Lee - Chief Executive Officer, Director
Frank Lee - Chief Executive Officer, Director
So let me just add to that, Gary, that, as I mentioned in my comments, we have prioritized our resources to EXPAREL, field force, and other field-facing resources, as well as in-house resources.
因此,加里,讓我補充一點,正如我在評論中提到的那樣,我們已將資源優先用於 EXPAREL、現場人員和其他面向現場的資源以及內部資源。
And so this is how we're ensuring that we have focus on this. And, again, as more reliable market data become available, as we progress through the course of the year, we'll be able to share with you some data that we can trend over time, consistently.
這就是我們確保關注這一點的方法。而且,隨著一年中越來越多的可靠市場數據的出現,我們將能夠與您分享一些我們可以隨時間推移持續變化的數據。
So the bottom line, as Brent said, is we're, I think, right on track with where we expect it to be. And we expect that we'll continue to see the ramp, with respect to NOPAIN.
因此,正如布倫特所說,我認為,最重要的是,我們正朝著預期的方向前進。我們預計,NOPAIN 將繼續呈現成長動能。
Gary Nachman - Analyst
Gary Nachman - Analyst
Okay. Great. And then, just on the recent settlement agreement with Fresenius. Now, that you have line of sight of no generic EXPAREL through the end of the decade, discuss your priorities a bit more, in terms of allocating capital.
好的。偉大的。然後,談談最近與費森尤斯達成的和解協議。現在,您已經預見到本世紀末不會出現通用的 EXPAREL,請從資本分配的角度進一步討論您的優先事項。
So how much will you be spending on the commercial efforts to accelerate EXPAREL versus spending on the pipeline and, also, looking to expand the pipeline through in-licensing deals? And would you consider doing a larger transaction for on-market products and would you only focus on the pain space or potentially look at some adjacencies?
那麼,您將在加速 EXPAREL 的商業努力上花費多少錢,以及在管道上花費多少錢,同時還希望透過許可交易來擴大管道?您是否會考慮對市場上的產品進行更大規模的交易,並且只關注痛點領域或潛在地考慮一些鄰接關係?
Frank Lee - Chief Executive Officer, Director
Frank Lee - Chief Executive Officer, Director
Yeah. Thanks for the question, Gary.
是的。謝謝你的提問,加里。
Before I turn it over to Shwan, here, to talk about capital allocation, let me just say, at a high level, we're very pleased with the settlement. This is a volume-limited settlement, provides visibility out to 2039. That's number 1.
在我把話題交給 Shwan 來談論資本配置之前,我只想說,從高層來看,我們對和解感到非常滿意。這是一項數量限制的解決方案,可提供至 2039 年的可見性。這是第一點。
And as you know, even in the first year, it's high single digits and it gradually goes up from that. And the last few years, it's steady at a high-30%s -- is what we've stated publicly, right?
而且如你所知,即使在第一年,它的成長率只是一個高個位數,並且會逐漸上升。過去幾年,這一比例一直穩定在 30% 左右——這是我們公開聲明的,對嗎?
That, combined with the fact that, right now, as we've defined our market, our penetration is still relatively low. In fact, in the high single digits, if you aggregate it.
再加上目前我們已經定義了我們的市場,我們的滲透率仍然相對較低。事實上,如果你把它加起來,就會達到較高的個位數。
So we have plenty of room to grow. And we've got visibility, now, out to 2039.
因此我們還有足夠的成長空間。現在,我們已經可以預見 2039 年的情況。
So that says context. And, now, let me turn it over to Shawn for capital allocation priorities.
這就是背景。現在,讓我將資本配置優先事項交給 Shawn。
Shawn Cross - Chief Financial Officer
Shawn Cross - Chief Financial Officer
Yeah. Thanks for the question.
是的。謝謝你的提問。
Similar to the last time we all got together, just to reiterate: we regularly review the capital allocation strategy. As Frank mentioned, some key areas of focus: investing in the base business; capitalize on NOPAIN, with the goal of accelerating top-line growth, as we've articulated in the 5 by 30; advancing, very thoughtfully, an innovative pipeline, focused on musculoskeletal pain and adjacencies; and then, as we announced earlier, returning capital to shareholders -- Board authorized an increase in the share buyback, which is now at $300 million and it runs through the end of 2026.
與我們上次聚在一起時類似,只是重申:我們會定期檢視資本配置策略。正如弗蘭克所提到的,一些重點關注的領域是:投資基礎業務;利用 NOPAIN,目標是加速營收成長,正如我們在「5 by 30」中所闡述的那樣;非常周到地推進創新管道,重點關注肌肉骨骼疼痛和鄰近疾病;然後,正如我們之前宣布的那樣,向股東返還資本——董事會批准增加股票。
With regard to that particular decision, it was part of our capital allocation continued evaluation. We performed extensive analyses to that end to get to that $300 million number; and, also, believe, based upon this positive settlement, that there is a significant disconnect in the current valuation of the company.
關於該特定決定,它是我們資本配置持續評估的一部分。為此,我們進行了廣泛的分析,得出了 3 億美元這個數字;並且,基於這一積極的解決方案,我們也認為,該公司目前的估值存在顯著的脫節。
Frank Lee - Chief Executive Officer, Director
Frank Lee - Chief Executive Officer, Director
Thanks, John. Let me just bring it back to, maybe, adding just additional color on a couple of other elements here.
謝謝,約翰。讓我再說一遍,也許,只是在這裡為其他幾個元素添加一些顏色。
First is, as I mentioned, overall, we're low, in terms of penetration, as we define our TAM.
首先,正如我所提到的,總體而言,就滲透率而言,我們的 TAM 定義較低。
And just to be really very specific: we've got, I think, a lot of room to further penetrate, in lower extremity, GI, OB-GYN, OMFS, plastics; and much of which is out-patient, if you take a look at the latter few.
具體來說,我認為我們在下肢、胃腸道、婦產科、中耳炎、整形等領域還有很大的滲透空間;如果你看一下後面幾個,你會發現其中大部分是門診病人。
We're optimistic about the potential we have to further penetrate these markets and grow, as we get beyond 2030.
隨著 2030 年的到來,我們對進一步滲透這些市場並實現成長的潛力充滿信心。
That said, I think that in terms of the kind of capital allocation, you'll see how we progress in a very disciplined way: to focus on our growth and the GQ Bio acquisition that we completed this quarter.
話雖如此,我認為就資本配置而言,你會看到我們如何以非常自律的方式取得進展:專注於我們的成長和本季完成的 GQ Bio 收購。
I think it's a great sign of how we're being very disciplined with the capital that we deploy.
我認為這是一個很好的跡象,表明我們對所部署的資本非常自律。
Gary Nachman - Analyst
Gary Nachman - Analyst
Okay. But it sounds like you would consider on-market products. It sounds like you have some capacity, within the sales force, to potentially do that.
好的。但聽起來您會考慮市場上的產品。聽起來您的銷售團隊具備一定的潛力來做到這一點。
Frank Lee - Chief Executive Officer, Director
Frank Lee - Chief Executive Officer, Director
Yeah. Great point, Gary. As I made my comments, this restructuring of sorts -- we did prioritize EXPAREL but, also, what it did was provide capacity now for the three sales forces to not only carry our products but, perhaps, additional products that we bring into the bag -- new products.
是的。說得好,加里。正如我所評論的那樣,這種重組 - 我們確實優先考慮了 EXPAREL,但它也為三個銷售團隊提供了能力,不僅可以攜帶我們的產品,而且可能還可以攜帶我們帶入包中的其他產品 - 新產品。
So I would say that that's a possibility. We'll be very, I think, disciplined in the way we look for these kinds of opportunities. And given the current market environment, I think we're in very strong position, financially, to look for those kind of opportunities and find a deal in a very disciplined way.
所以我認為這是有可能的。我認為,我們會非常自律地尋找這類機會。鑑於當前的市場環境,我認為我們在財務上處於非常有利的地位,可以尋找此類機會並以非常自律的方式達成交易。
Gary Nachman - Analyst
Gary Nachman - Analyst
Okay. Great. Thank you.
好的。偉大的。謝謝。
Operator
Operator
Leszek Sulewski, Truist Securities.
Leszek Sulewski,Truist Securities。
Unidentified Participant 2
Unidentified Participant 2
Hi. This is [Jeevan], on for Leszek. Thanks for taking our questions.
你好。我是 [Jeevan],代替 Leszek。感謝您回答我們的問題。
Quick one for me. Are there any EXPAREL enhancements in your line of sight that could extend its life cycle or, perhaps, expand its label?
對我來說很快。在您的視線範圍內,是否有任何 EXPAREL 增強功能可以延長其生命週期或擴展其標籤?
Frank Lee - Chief Executive Officer, Director
Frank Lee - Chief Executive Officer, Director
Yeah. Thanks for the question, [Jeevan].
是的。謝謝你的提問,[傑文]。
What I'd say, at a high level, is we continue to innovate EXPAREL. And as you can see from the recent patents, we've Orange Book-listed the 18th one and we expect to continue that innovation, going forward. That's number 1.
我想說的是,從高層次上講,我們將繼續創新 EXPAREL。正如您從最近的專利中看到的,我們已經在橙皮書上列出了第 18 項專利,我們希望在未來繼續進行創新。這是第一點。
Number 2. Aas it relates to other, I would say, indications, we don't have plans for that. We currently do have some studies ongoing. but we don't have any new plans for additional indications for EXPAREL.
2號。至於其他方面,我想說,跡象表明,我們對此沒有計劃。我們目前確實正在進行一些研究。但我們還沒有針對 EXPAREL 的更多適應症制定新的計劃。
Operator
Operator
Hardik Parikh, J.P. Morgan.
Hardik Parikh,摩根大通。
Hardik Parikh - Analyst
Hardik Parikh - Analyst
Hey. Thank you very much for taking the question.
嘿。非常感謝您回答這個問題。
I just had a question about the gross margins -- and I apologize if I missed it in the middle. You mentioned about how the royalty to RDF is going to get eliminated. And, now, it's about low single digits. That should help improve the gross margins.
我只是對毛利率有疑問——如果我中間錯過了,我深感抱歉。您提到如何取消 RDF 的版稅。而現在,這數字已降至個位數以下。這應該有助於提高毛利率。
Just wondering how that was incorporated into the four-year guide, in terms of you reiterating it. Thank you.
我只是想知道,就您重申這一點而言,它是如何被納入四年指南的。謝謝。
Frank Lee - Chief Executive Officer, Director
Frank Lee - Chief Executive Officer, Director
Thanks for the question, Hardik. As you might know, this litigation has a long history. And our legal team did a great job, here, of getting to a favorable resolution.
謝謝你的提問,Hardik。大家可能知道,這場訴訟由來已久。我們的法律團隊做得很好,達成了有利的解決方案。
And as you mentioned, this is low single-digit impact for EXPAREL. This is, overall, for EXPAREL. And so, we're very pleased about this. Going forward, now, this will help us improve margins, for sure.
正如您所提到的,這對 EXPAREL 來說只是一個低個位數的影響。總體而言,這是針對 EXPAREL 而言的。因此,我們對此感到非常高興。展望未來,這肯定會幫助我們提高利潤率。
But I want to come back to we think that, overall, margins will improve, as we sell more product. As we drive volumes, small margins will continue to improve.
但我想回到我們認為的整體情況,隨著我們銷售更多產品,利潤率將會提高。隨著我們銷量的增加,小額利潤將會持續改善。
That said, Shawn, you can speak to a little bit about the impact this quarter versus going forward.
話雖如此,肖恩,你可以稍微談談本季和未來的影響。
Shawn Cross - Chief Financial Officer
Shawn Cross - Chief Financial Officer
Yeah. We were very pleased to see the strong first-quarter margins that exceeded our guided range of 76% to 78%.We're getting good volume output from both our EXPAREL sites in San Diego and the UK.
是的。我們非常高興地看到第一季的利潤率非常強勁,超過了我們 76% 至 78% 的指導範圍。我們我們位於聖地牙哥和英國的 EXPAREL 站點均獲得了良好的產量。
As we just discussed, the markets benefited from favorable RDF royalty ruling.
正如我們剛才討論的,市場受益於有利的 RDF 特許權使用費裁決。
But just as a reminder: there's a number of manufacturing variables that can result in a pretty significant quarter variability.
但需要提醒的是:有許多製造變數可能會導致相當大的季度變化。
But based upon the performance of this quarter and what we're seeing from the teams, we'll of course look at marks, again, after our second-quarter landing and determine if an update is needed for a fuller guidance range, at that point.
但根據本季的表現以及我們從各個團隊看到的情況,我們當然會在第二季度著陸後再次查看分數,並確定是否需要更新以獲得更全面的指導範圍。
Frank Lee - Chief Executive Officer, Director
Frank Lee - Chief Executive Officer, Director
Just to add: this quarter, it's a minor impact. This quarter is really more going forward -- will have a more significant impact and carry over.
補充一下:本季的影響很小。本季確實更具前瞻性——將產生更重大的影響和延續性。
(multiple speakers) It already was in core ratings.
(多位發言者)它已經進入核心評級了。
I think that was your question. Wasn't it, Hardik?
我想這就是你的問題。不是嗎,哈迪克?
Hardik Parikh - Analyst
Hardik Parikh - Analyst
Yeah. Correct. Basically, why not raise the guide?
是的。正確的。基本上,為什麼不提高指南?
And then, the second question is just more around (multiple speakers) --
第二個問題是關於(多位發言者)——
Frank Lee - Chief Executive Officer, Director
Frank Lee - Chief Executive Officer, Director
Just one other thing about that. Just for the guide.
關於這一點還有一件事。僅供參考。
The other thing is, obviously, there are number of headlines about tariffs these days. And so, of course, we've been diligent at looking at that, analyzing that.
另一件事是,顯然最近有很多關於關稅的頭條新聞。因此,我們當然一直在認真研究和分析這個問題。
And so, we're comfortable with the guidance that we provided. So we're not lowering guidance.
因此,我們對所提供的指導感到滿意。所以我們不會降低指導。
We're comfortable with the guidance that's provided.
我們對所提供的指導感到滿意。
And then, as we get better visibility on truly how these tariffs might -- if and how they might manifest, then we can sharpen guidance as needed.
然後,當我們真正更好地了解這些關稅可能如何實施——如果實施以及如何實施,那麼我們就可以根據需要加強指導。
Hardik Parikh - Analyst
Hardik Parikh - Analyst
Okay. Great. Thank you.
好的。偉大的。謝謝。
And the second question is just around pricing. If I understand your comments correctly, I'm interpreting it as pricing was mostly flat; maybe slightly down, when you adjust for those lower number of selling days.
第二個問題與定價有關。如果我理解正確您的評論,我將其解釋為定價基本上持平;當您調整那些較低的銷售天數時,可能會略有下降。
One, is that correct? And then, how do you see pricing progressing for the rest of the year, as GPO contracts come online?
一、這樣對嗎?那麼,隨著 GPO 合約上線,您認為今年剩餘時間的定價將如何發展?
Frank Lee - Chief Executive Officer, Director
Frank Lee - Chief Executive Officer, Director
Yeah. So let me turn this over to Shawn. We pursued price as we normally do. And, obviously, GPO contracts are slowly coming online. Shawn?
是的。那麼讓我把這個交給肖恩。我們一如既往地追求價格。而且,顯然,GPO 合約正在慢慢上線。肖恩?
Shawn Cross - Chief Financial Officer
Shawn Cross - Chief Financial Officer
Sure. Yeah. With regard to EXPAREL, it was gross filer volume growth for the period. So it was all volume, effectively.
當然。是的。就 EXPAREL 而言,這是該期間的總申報量增加。所以實際上,這都是音量問題。
And then, with regard to the GPOs, we've, again, talked about this previously: that there will be a mid-single-digit impact for the first year, when we bring on board -- knock on wood -- the final GPO agreement.
然後,關於 GPO,我們之前已經討論過這個問題:當我們引入最終的 GPO 協議時,第一年將會產生中等個位數的影響。
We'll be lapping the second one this coming fall. And that's how to think about it: a mid-single-digit impact.
我們將在今年秋天進行第二次測試。這就是我們應該考慮的問題:中等個位數的影響。
Hardik Parikh - Analyst
Hardik Parikh - Analyst
Thank you.
謝謝。
Operator
Operator
Serge Belanger, Needham.
塞爾日·貝朗格,尼德漢姆。
Serge Belanger - Analyst
Serge Belanger - Analyst
Good afternoon. Thanks for taking my questions. And apologies if you already covered this earlier in the call.
午安.感謝您回答我的問題。如果您在之前的通話中已經討論過這個問題,我們深表歉意。
Just regarding surgery volumes: Can you just give us a little color on what you're seeing, so far -- first quarter and the first month of the second quarter; and if the macros impacted those volumes.
關於手術量:您能否簡單介紹一下目前為止第一季和第二季第一個月的情況?以及巨集是否影響了這些卷。
And, secondly, regarding competitions: I you mentioned that you're still at low penetration on your overall TAM. Curious if you're seeing more competition, now, from other players, like (inaudible)?
其次,關於競爭:我提到,你們的整體 TAM 滲透率仍然很低。好奇的是,現在你是否看到了更多來自其他玩家的競爭,例如(聽不清楚)?
That's it. Thank you.
就是這樣。謝謝。
Frank Lee - Chief Executive Officer, Director
Frank Lee - Chief Executive Officer, Director
Well, thanks for the question. Let me take a little bit of the competition question. And then, turn the surgery volume to Bren.
嗯,謝謝你的提問。讓我來回答一下有關比賽的一些問題。然後,將手術音量轉向 Bren。
Right now, we don't see any new competition that's significant. We have a lot of room to grow. There's largely the (inaudible) -- short-acting (inaudible) -- and the various cocktails that are out there: pumps, et cetera.
目前,我們還沒有看到任何重大的新競爭。我們還有很大的成長空間。主要有(聽不清楚)-短效(聽不清楚)-以及各種雞尾酒:幫浦等等。
But all that said, we really think we have a lot of room for penetration, going forward.
但儘管如此,我們確實認為未來我們仍有很大的滲透空間。
So that's what I'll say to that. Nothing has changed, with respect to the competition and intensity.
這就是我要說的。就競爭和強度而言,一切都沒有改變。
Brendan Teehan - Chief Commercial Officer
Brendan Teehan - Chief Commercial Officer
Thanks for the question.
謝謝你的提問。
In the first quarter, we saw, nominally, a decline in surgery room hours -- low-single (technical difficulty) --
在第一季度,我們名義上看到手術室使用時間減少——低單次(技術難度)——
Frank Lee - Chief Executive Officer, Director
Frank Lee - Chief Executive Officer, Director
Hey, Serge. Anything more?
嘿,塞爾吉。還有什麼嗎?
Serge Belanger - Analyst
Serge Belanger - Analyst
No. That was it. Thank you.
不。就是這樣。謝謝。
Operator
Operator
Thank you.
謝謝。
Dear speakers, there are no further questions for today.
尊敬的發言者,今天沒有其他問題了。
I would now like to hand the conference over to Susan Mesco for any closing remarks.
現在,我想將會議交給 Susan Mesco 做結束語。
Susan Mesco - Investor Relations
Susan Mesco - Investor Relations
Thank you, operator. And thanks to all on the call for your questions and time today.
謝謝您,接線生。感謝今天所有參加電話會議的人提出的問題和抽出的時間。
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 5 by 30 plan to advance our mission.
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「5 by 30」計劃來推進我們的使命,確保我們為長期成功做好準備。
Thank you. Be well.
謝謝。保重。
Operator
Operator
That does conclude our conference for today. Thank you for participating.
今天的會議就到此結束了。感謝您的參與。
You may now all disconnect. Have a nice day.
你們現在都可以斷開連結了。祝你今天過得愉快。