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Operator
Operator
Good afternoon, and welcome to ADMA Biologics first-quarter 2025 financial results and business update conference call on Wednesday, May 7, 2025. (Operator Instructions) Please be advised that, this call is being recorded at the company's request and will be available on the company's website approximately two hours following the end of the call.
下午好,歡迎參加 2025 年 5 月 7 日星期三 ADMA Biologics 2025 年第一季財務業績和業務更新電話會議。(操作員指示)請注意,應本公司要求,本次通話將被錄音,並將在通話結束後約兩小時在公司網站上公佈。
At this time, I would like to introduce the company. Please go ahead.
現在我想向大家介紹一下這家公司。請繼續。
Skyler Bloom - Senior Director of Corporate Strategy and Business Development
Skyler Bloom - Senior Director of Corporate Strategy and Business Development
Welcome, everyone, and thank you for joining us this afternoon to discuss ADMA Biologics' financial results for the first quarter of 2025 and recent corporate updates.
歡迎大家,感謝您今天下午加入我們,討論 ADMA Biologics 2025 年第一季的財務表現和最新的公司動態。
I'm joined today by Adam Grossman, President and Chief Executive Officer; and Brad Tade, Chief Financial Officer and Treasurer. During today's call, Adam will provide some introductory comments, and provide an update on corporate progress, and then Brad will provide an overview of the company's first quarter 2025 financial results. Finally, Adam will then provide some brief summary remarks before opening up the call for questions. Earlier today, we issued a press release detailing the first-quarter 2025 financial results and summarized certain achievements and recent corporate updates.
今天與我一起出席的還有總裁兼執行長亞當‧格羅斯曼 (Adam Grossman);以及財務長兼財務主管布拉德‧塔德 (Brad Tade)。在今天的電話會議中,亞當將提供一些介紹性評論,並提供公司進展的最新情況,然後布拉德將概述公司 2025 年第一季的財務表現。最後,亞當將在開始提問之前提供一些簡短的總結性演講。今天早些時候,我們發布了一份新聞稿,詳細介紹了 2025 年第一季的財務業績,並總結了某些成就和最近的公司動態。
The release is available on our website at www.admabiologics.com. Before we begin our formal comments, I'll remind you that, we will be making forward-looking assertions during today's call that represent the company's intentions, expectations or beliefs concerning future events, which constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. All forward-looking statements are subject to factors, risks and uncertainties such as those detailed in today's press release announcing this call and in our filings with the SEC, which may cause actual results to differ materially from the results expressed or implied by such statements. In addition, any forward-looking statements represent our views only as of the date of this call and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update any such statements, except as required by the federal securities laws.
新聞稿可在我們的網站 www.admabiologics.com 上查閱。在我們開始正式評論之前,我要提醒您,我們將在今天的電話會議中做出前瞻性的斷言,代表公司對未來事件的意圖、期望或信念,這些斷言構成了 1995 年《私人證券訴訟改革法案》安全港條款所指的前瞻性陳述。所有前瞻性陳述均受各種因素、風險和不確定因素的影響,例如今天宣布此次電話會議的新聞稿中以及我們向美國證券交易委員會提交的文件中詳細說明的因素、風險和不確定因素,這些因素、風險和不確定因素可能導致實際結果與此類陳述表達或暗示的結果存在重大差異。此外,任何前瞻性陳述僅代表我們截至本次電話會議之日的觀點,不應被視為代表我們在任何後續日期的觀點。我們明確表示不承擔更新任何此類聲明的義務,除非聯邦證券法另有要求。
We refer you to the disclosure notice section in our earnings release we issued today in the Risk Factors section in our SEC filings and our quarterly report on Form 10-Q for the quarter ended March 31, 2025, for a discussion of important factors that could cause actual results to differ materially from these forward-looking statements. Please note that the discussion on today's call includes certain non-GAAP financial measures, including adjusted total revenue, adjusted EBITDA and adjusted net income. A reconciliation of these non-GAAP financial measures to the most directly comparable GAAP metric is available in our earnings release. With that, I would now like to turn the call over to Adam Grossman. Adam, go ahead.
請您參閱我們今天發布的收益報告中提交給美國證券交易委員會 (SEC) 的文件中「風險因素」部分的揭露通知部分以及截至 2025 年 3 月 31 日的 10-Q 表季度報告,以了解可能導致實際結果與這些前瞻性陳述存在重大差異的重要因素。請注意,今天電話會議的討論包括某些非 GAAP 財務指標,包括調整後總收入、調整後 EBITDA 和調整後淨收入。我們的收益報告中提供了這些非 GAAP 財務指標與最直接可比較的 GAAP 指標的對帳表。說完這些,我現在想把電話轉給亞當‧格羅斯曼。亞當,繼續吧。
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
Thank you, Skyler. Good afternoon, everyone. ADMA's momentum has carried strongly into the first quarter of 2025, demonstrating robust execution across all aspects of our business. The advantages of our vertically integrated US-based supply chain, along with our domestic commercial footprint have proven critical in the current geopolitical and trade landscape. This strategic positioning has enabled uninterrupted operations and consistent fulfillment of demand even in the face of escalating global tariff tensions.
謝謝你,斯凱勒。大家下午好。ADMA 的強勁發展勢頭延續到了 2025 年第一季度,展現出我們業務各個方面的強勁執行力。事實證明,我們在美國垂直整合的供應鏈以及國內商業足跡的優勢在當前的地緣政治和貿易格局中至關重要。這項戰略定位使得即使在全球關稅緊張局勢不斷升級的情況下,也能不間斷地運作並持續滿足需求。
With our focus solely on the US healthcare ecosystem and completely domestic plasma sourcing, production and distribution operations, we believe ADMA is uniquely insulated from the tariff and trade volatility potentially affecting our multinational competitors. The recent approval of our innovative yield enhancement production process marks a pivotal achievement for ADMA and is anticipated to provide 20% more bulk IG from the same starting plasma volumes. As the first US producer of plasma-derived products to achieve regulatory approval for a novel yield enhancement process, ADMA continues to demonstrate its leadership in modernizing and advancing plasma fractionation through agile, forward-thinking scientific development and execution.
由於我們只專注於美國醫療保健生態系統和完全國內的血漿採購、生產和分銷業務,我們相信 ADMA 能夠獨特地抵禦可能影響我們跨國競爭對手的關稅和貿易波動。我們創新的產量提高生產流程最近獲得批准,這標誌著 ADMA 取得了一項關鍵成就,預計將從相同的起始血漿量中提供多 20% 的批量 IG。作為第一家獲得新型產量提高製程監管部門批准的美國血漿衍生產品生產商,ADMA 繼續透過靈活、前瞻性的科學開發和執行,展示其在現代化和推進血漿分餾方面的領導地位。
We commend our team for advancing this new production process from concept to approval with speed and capital efficiency, and we thank the FDA for its thorough and timely review, as well as the agency's commitment to expanding IG access for immunocompromised patients throughout the US. With our innovative, capital-efficient and robust internal R&D engine, we believe -- which we believe has been further validated with this FDA approval, we look forward to confidently advancing our R&D platform, further optimizing production capabilities and progressing novel pipeline programs, most notably SG-001, which exemplify our commitment to product and process innovation and meeting the unmet medical needs for immunocompromised patients. Our financial results for the first quarter reflect substantial growth and operational achievements. Total revenues reached $114.8 million on a reported basis, representing an impressive $32.9 million year-over-year increase and marking a growth rate of approximately 40%. Adjusting for the one-off voluntary product withdrawals during the quarter, total first quarter 2025 revenues would have been $118.6 million, representing approximately 45% year-over-year growth.
我們讚揚我們的團隊以快速和資本效率推進這一新生產流程,從概念到批准,我們感謝 FDA 的全面和及時的審查,以及該機構致力於擴大全美免疫功能低下患者獲得 IG 的機會。我們相信,憑藉我們創新、資本高效且強大的內部研發引擎——我們相信此次 FDA 批准進一步驗證了這一點——我們期待滿懷信心地推進我們的研發平台,進一步優化生產能力並推進新的管道項目,尤其是 SG-001,它體現了我們對產品和工藝創新的承諾,並滿足免疫功能低下患者未滿足的醫療需求。我們第一季的財務表現反映了顯著的成長和營運成就。據報道,總收入達到 1.148 億美元,比去年同期增加了 3,290 萬美元,成長率約 40%。經調整本季一次性自願產品撤回後,2025 年第一季總營收將達到 1.186 億美元,年增約 45%。
Illustrating ADMA's still nascent operating leverage, first quarter 2025 adjusted net income and adjusted EBITDA grew by approximately 87% and 81% year-over-year, respectively. These results underscore the efficacy of our biologic therapies for immunocompromised patients across the US as well as the dedication and expertise of our leadership team and exceptional staff. Driven by our commitment to financial and operational excellence, we are yet again raising guidance for both 2025 and 2026. For 2025, we are increasing total revenue guidance to $500 million or more, increasing adjusted EBITDA guidance to at least $235 million and reaffirming adjusted net income guidance of $175 million or more.
這顯示 ADMA 的經營槓桿仍處於萌芽階段,2025 年第一季調整後淨收入和調整後 EBITDA 分別年增約 87% 和 81%。這些結果強調了我們的生物療法對美國免疫功能低下患者的療效,以及我們的領導團隊和優秀員工的奉獻精神和專業知識。在我們對財務和卓越營運的承諾的推動下,我們再次提高了 2025 年和 2026 年的指導。到 2025 年,我們將總收入預期提高至 5 億美元或更多,將調整後的 EBITDA 預期提高至至少 2.35 億美元,並重申調整後的淨收入預期為 1.75 億美元或更多。
This upwardly revised 2025 guidance excludes potential accretion from the monetization of products sold using the now approved enhanced yield process, which is a function of conservatively contemplating assumptions around timing of the production ramp-up and lot release timing. We are additionally increasing top and bottom line guidance for 2026, enabled by recent FDA approval of our enhanced yield production process as well as our ongoing commercial momentum. This increased 2026 guidance, consistent with historically provided financial targets, reflects assumptions of continued margin expansion as our revenue mix shifts towards ASCENIV. Accordingly, for 2026, we are increasing total revenue guidance to $625 million or more, adjusted EBITDA to $340 million or more and adjusted net income guidance to at least $245 million. Further yet, we are increasing our total annual revenue expected to be realized prior to 2030 to $1.1 billion or more, up from the prior guidance of $1 billion.
此次上調的 2025 年指引不包括使用現已批准的增強產量流程銷售的產品貨幣化帶來的潛在增值,這是對產量提升時間和批次發佈時間進行保守考慮的結果。此外,由於 FDA 最近批准了我們的增產生產流程以及我們持續的商業發展勢頭,我們還提高了 2026 年的頂線和底線指導。這一 2026 年指引的提高與歷史上提供的財務目標一致,反映了隨著我們的收入結構向 ASCENIV 轉變,利潤率將繼續擴大的假設。因此,我們將 2026 年的總營收預期提高至 6.25 億美元或更多,調整後的 EBITDA 預期提高至 3.4 億美元或更多,調整後的淨收入預期提高至至少 2.45 億美元。此外,我們預計 2030 年前實現的年度總收入將從先前預測的 10 億美元增加到 11 億美元或更多。
On ADMA's pathway to reach this rapid revenue growth, the company expects meaningfully outsized margin expansion during the same periods prior to 2030. Through the first quarter of 2025 and subsequent periods, we have driven outsized demand for our commercial products, including both BIVIGAM and ASCENIV, with demand consistently exceeding our prior supply capabilities. New patient starts continue to grow and forward-looking demand indicators remain robust. Furthermore, we believe recent expansions in both third-party and internal high-titer plasma supply have markedly derisked our growth trajectories and enhanced our visibility for continued revenue growth and margin expansion. All told, we are increasingly confident in our ultimate ability to drive total ASCENIV annual revenues alone to potentially $1 billion or more with lasting growth and branded durability at least through 2035.
ADMA 在實現快速收入成長的道路上,預計在 2030 年之前的同一時期,利潤率將大幅成長。在 2025 年第一季及以後,我們的商業產品(包括 BIVIGAM 和 ASCENIV)的需求量龐大,需求量持續超過我們先前的供應能力。新患者數量持續成長,前瞻性需求指標依然強勁。此外,我們相信,近期第三方和內部高滴度血漿供應的擴張已顯著降低我們的成長軌跡風險,並提高了我們持續收入成長和利潤率擴大的可見性。總而言之,我們越來越有信心,我們最終有能力推動 ASCENIV 的年總收入達到 10 億美元或更多,並且至少到 2035 年保持持續成長和品牌持久性。
We believe our strong balance sheet, capital flexibility and growing cash and receivables provide a robust buffer against volatility in the current credit and equity market backdrops. Cash on hand and accounts receivable grew to a combined $171 million at the end of the first quarter, and we anticipate significant sequential operating cash flow growth throughout 2025. As detailed in our recently announced debt reorganization with Ares Capital Management, ADMA paid down all but $2.5 million of the term loan using available proceeds from the revolving credit facility. Due to the lower interest rate spread for the revolving credit facility compared to the term loan, this reorganization provides for a 1.1% nominal reduction in ADMA's total cost of debt. ADMA remains committed to optimizing its capital structure and continuing to organically pay down its total debt over the near term.
我們相信,我們強勁的資產負債表、資本靈活性以及不斷增長的現金和應收帳款為當前信貸和股票市場背景下的波動提供了強有力的緩衝。第一季末,現金和應收帳款合計成長至 1.71 億美元,我們預計 2025 年全年的經營現金流將實現顯著的連續成長。正如我們最近宣布的與 Ares Capital Management 的債務重組中所述,ADMA 使用循環信貸額度的可用收益償還了除 250 萬美元之外的所有定期貸款。由於循環信貸額度的利差低於定期貸款,此次重組將使 ADMA 的總債務成本名義上減少 1.1%。ADMA 仍致力於優化其資本結構並在短期內繼續有機償還其總債務。
Additionally, we are pleased to announce that our Board of Directors has recently authorized a stock repurchase program that will allow ADMA to purchase up to $500 million of its common stock or approximately 8% of the company's total current market cap. We will be opportunistic in deploying these repurchases, which will be enabled by the anticipated strong balance sheet and forecasted earnings and cash generation moving forward. The collective impact of these assertive initiatives are intended to instill confidence in our stockholder base that ADMA's management team and Board of Directors are aligned with you, our stockholders, and we are committed to generating durable stockholder value. We believe ADMA is executing from a position of strength, delivering durable branded growth in underserved markets and building what we expect will be one of the most resilient and scalable earnings streams in the biopharma complex. In addition, ADMA is pursuing capital-efficient initiatives to further diversify its uniquely leverageable business model, particularly through the advancement of its lead pipeline program, SG-001, a novel and proprietary hyperimmune globulin targeting strep pneumonia.
此外,我們很高興地宣布,我們的董事會最近批准了一項股票回購計劃,該計劃將允許 ADMA 購買高達 5 億美元的普通股,或占公司當前總市值的約 8%。我們將抓住機會部署這些回購,這將得益於預期強勁的資產負債表以及預測的未來收益和現金產生。這些積極措施的集體影響力旨在讓我們的股東相信,ADMA 的管理團隊和董事會與您(我們的股東)保持一致,並且我們致力於創造持久的股東價值。我們相信,ADMA 正憑藉其優勢地位,在服務不足的市場中實現持久的品牌成長,並打造出我們預期的生物製藥領域最具彈性和可擴展性的盈利來源之一。此外,ADMA 正在推行資本高效舉措,以進一步實現其獨特的可利用業務模式多樣化,特別是透過推進其領先管道項目 SG-001,這是一種針對鏈球菌性肺炎的新型專有高免疫球蛋白。
We anticipate generating proof-of-concept animal data by year-end. And if successful, we believe we will be able to rapidly advance the program into a registrational trial. Crucially, we remain materially non-reliant on near-term regulatory catalysts, and we believe that we are largely insulated from potential disruptions at the FDA. As we continue to advance what we believe is a top-tier growth profile within the sector, it's important to highlight that in the current health care backdrop that ADMA's product portfolio remains insulated from government price negotiations that affect other sectors of the pharmaceutical industry. This differentiation further underscores ADMA's strong reimbursement profile and growth durability.
我們預計到年底將產生概念驗證動物數據。如果成功的話,我們相信我們將能夠迅速推進該計劃進入註冊試驗階段。至關重要的是,我們仍然實質上不依賴近期的監管催化劑,我們相信我們基本上不會受到 FDA 潛在幹擾的影響。隨著我們繼續推動我們認為的該行業頂級成長前景,必須強調的是,在當前的醫療保健背景下,ADMA 的產品組合仍然不受影響製藥業其他部門的政府價格談判的影響。這種差異進一步凸顯了 ADMA 強大的償付能力和成長持久性。
As we reflect on our successes and upwardly revised projections, we do want to take a moment to express our sincere congratulations and appreciation to our phenomenal staff. Your unwavering commitment, dedication and hard work have been instrumental in driving ADMA's progress and achievements. It is your passion and resilience that enable us to navigate the challenges and seize opportunities in this dynamic environment. Collectively, we look forward to continuing our journey of innovation and excellence in service of our mission. With that, I'd now like to turn the call over to Brad to review first quarter financials in more detail.
當我們回顧我們的成功和上調的預測時,我們確實想花點時間向我們出色的員工表示誠摯的祝賀和感謝。您堅定的承諾、奉獻和辛勤工作對推動 ADMA 的進步和成就起到了重要作用。正是你們的熱情和韌性使我們能夠在這個充滿活力的環境中應對挑戰並抓住機會。總的來說,我們期待繼續我們的創新和卓越之旅,以實現我們的使命。有了這些,我現在想把電話轉給布拉德,讓他更詳細地回顧一下第一季的財務狀況。
Brad Tade - Chief Financial Officer and Treasurer
Brad Tade - Chief Financial Officer and Treasurer
Thank you, Adam. We issued a press release earlier today outlining our first quarter 2025 financial results. I'll now discuss some of the key financial highlights from the first quarter. Total reported revenue was $114.8 million for the quarter ended March 31, 2025, as compared to $81.9 million for the quarter ended March 31, 2024, an increase of $32.9 million, translating to 40% year-over-year growth. Adjusting for the aforementioned voluntary product withdrawals during the first quarter, total first quarter 2025 revenues would have been $118.6 million, representing approximately 45% year-over-year growth.
謝謝你,亞當。我們今天早些時候發布了一份新聞稿,概述了我們 2025 年第一季的財務表現。我現在將討論第一季的一些關鍵財務亮點。截至 2025 年 3 月 31 日的季度,報告總收入為 1.148 億美元,而截至 2024 年 3 月 31 日的季度為 8,190 萬美元,增加了 3,290 萬美元,年成長 40%。調整第一季上述自願產品撤回後,2025 年第一季總營收將達到 1.186 億美元,年增約 45%。
This increase in total revenue is primarily related to increased sales of ASCENIV as we continue to experience increased acceptance and utilization by physicians, payers and patients for this product. Gross profit was $61.1 million for the quarter ended March 31, 2025, as compared to $39.1 million for the quarter ended March 31, 2024. This gross profitability for the first quarter of 2025 translates to 53.2% compared to 47.8% for the comparable 2024 quarter. Adjusting for the aforementioned voluntary product withdrawals, first quarter 2025 adjusted gross margins would have been 54.7%. The improvement in gross margin is primarily driven by a significantly more favorable mix of higher-margin IG sales in the first quarter of 2025 as compared to the first quarter of 2024, along with the operational efficiencies achieved resulting in a reduction in manufacturing costs.
總收入的成長主要與 ASCENIV 銷售額的成長有關,因為我們持續看到醫生、付款人和患者對該產品的接受度和使用率不斷提高。截至 2025 年 3 月 31 日的季度毛利為 6,110 萬美元,而截至 2024 年 3 月 31 日的季度毛利為 3,910 萬美元。2025 年第一季的總獲利能力為 53.2%,而 2024 年同期為 47.8%。經上述自願性產品撤回調整後,2025 年第一季調整後的毛利率將達到 54.7%。毛利率的提高主要得益於 2025 年第一季與 2024 年第一季相比,IG 銷售額利潤率更高的組合更加有利,以及營運效率的提高導致製造成本的降低。
Adjusted EBITDA was $47.9 million for the quarter ended March 31, 2025, as compared to adjusted EBITDA of $26.4 million for the quarter ended March 31, 2024. Adjusted EBITDA for the quarter includes all non-GAAP reconciliation items, including stock-based compensation, depreciation, amortization, interest expense and loss on debt extinguishment. The 81% year-over-year growth of adjusted EBITDA was primarily due to the substantial increase in operating income. GAAP net income was $26.9 million for the quarter ended March 31, 2025, compared to a GAAP net income of $17.8 million for the quarter ended March 31, 2024. The increase was primarily due to the increase in operating income and lower interest expense.
截至 2025 年 3 月 31 日的季度,調整後 EBITDA 為 4,790 萬美元,而截至 2024 年 3 月 31 日的季度,調整後 EBITDA 為 2,640 萬美元。本季度調整後的 EBITDA 包括所有非 GAAP 對帳項目,包括股票薪酬、折舊、攤提、利息支出和債務清償損失。調整後EBITDA年增81%主要得益於營業收入的大幅增加。截至 2025 年 3 月 31 日的季度,GAAP 淨收入為 2,690 萬美元,而截至 2024 年 3 月 31 日的季度,GAAP 淨收入為 1,780 萬美元。成長主要由於營業收入增加和利息支出減少。
Adjusted net income was $33.3 million for the quarter ended March 31, 2025, as compared to adjusted net income of $17.8 million for the quarter ended March 31, 2024, translating to an 87% year-over-year growth. As Adam mentioned, we have continued to opportunistically and strategically increase medical education and promotion activities during the first quarter in advance of anticipated increases in high titer plasma supply provided by the recently secured long-term supply agreements, supporting ASCENIV's revenue growth trajectory. Accordingly, we would expect the normalized OpEx run rate to be lower than the spend reported in the first quarter as we progress through 2025. We believe we are just beginning to generate financial results that demonstrate the distinct operating leverage that our business can realize if our revenue continues to grow as planned and fixed expenses are tightly managed. Based on the robust $171 million in combined cash and receivables at the end of the first quarter of 2025, in combination with the significant adjusted EBITDA growth, we believe the company's balance sheet strength largely insulates ADMA from broader credit and equity market volatility.
截至 2025 年 3 月 31 日的季度調整後淨收入為 3,330 萬美元,而截至 2024 年 3 月 31 日的季度調整後淨收入為 1,780 萬美元,年增 87%。正如亞當所提到的,我們在第一季繼續抓住機會,策略性地增加醫學教育和推廣活動,以應對最近達成的長期供應協議帶來的高滴度血漿供應預期增加,從而支持 ASCENIV 的收入成長軌跡。因此,我們預計,隨著 2025 年的到來,標準化營運支出運行率將低於第一季報告的支出。我們相信,我們剛開始產生財務業績,這表明如果我們的收入在計劃和固定支出得到嚴格管理的情況下繼續增長,我們的業務可以實現獨特的經營槓桿。基於 2025 年第一季末 1.71 億美元的強勁現金和應收帳款總額,加上調整後的 EBITDA 的大幅成長,我們認為該公司的資產負債表實力在很大程度上使 ADMA 免受更廣泛的信貸和股票市場波動的影響。
Accordingly, as Adam mentioned, we have recently taken measures to meaningfully reduce the company's cost of debt, and we are pleased to have a newly authorized $500 million stock repurchase program, enabling us to be opportunistic in the periods ahead. Over the course of 2025 and beyond, we anticipate significant growth in our cash balance, which should allow ADMA to continue to reduce the company's weighted average cost of capital and advance all growth initiatives from a position of strength. With that, I'll now turn the call back over to Adam for closing remarks.
因此,正如亞當所提到的,我們最近採取了一些措施,大幅降低了公司的債務成本,並且我們很高興獲得新授權的 5 億美元股票回購計劃,這使我們能夠在未來一段時間內抓住機會。在 2025 年及以後,我們預計現金餘額將大幅成長,這將使 ADMA 能夠繼續降低公司的加權平均資本成本,並從優勢地位推進所有成長計畫。說完這些,我現在將電話轉回給亞當,請他作最後發言。
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
Thank you, Brad. ADMA is building on its robust momentum with significant financial growth and operational achievements driven by our uniquely positioned US-based supply chain. Our end-to-end controlled and agile business model allows us to operate independently of global trade volatility while maintaining substantial control of our integrated supply chain. We believe this is a critical advantage for ADMA in the current geopolitical climate. With recent FDA approval of our yield enhanced production process further strengthening our market position, unlocking potential opportunities for accelerated revenue and earnings growth.
謝謝你,布拉德。ADMA 憑藉其強勁的發展勢頭,憑藉其獨特的美國供應鏈實現了顯著的財務成長和營運成就。我們端到端控制且靈活的業務模式使我們能夠獨立於全球貿易波動進行運營,同時保持對整合供應鏈的實質控制。我們認為,這是 ADMA 在當前地緣政治氣候下的關鍵優勢。隨著 FDA 最近批准我們的產量提高生產工藝,進一步加強了我們的市場地位,釋放了加速收入和獲利成長的潛在機會。
Successfully bringing our innovative yield enhancement process from concept through development and ultimate FDA approval, we believe further validates the robust and capital-efficient internal R&D engine at ADMA, advancing both product and production innovations. As we anticipate continued demand for our commercial products and a favorable shift in our revenue mix, we remain confident in our ability to achieve sustainable revenue and earnings growth and deliver long-term value to our stockholders. Looking ahead, we are excited about the potential impact of our development initiatives and the resilience of our business model, positioning ADMA as a leader in the rapidly evolving biopharma landscape. With upwardly revised 2025 and 2026 financial guidance, we see a clear path to expanding our market presence and capitalizing on the opportunities within our pipeline. Together, we believe we are poised to drive meaningful advancements in healthcare, underscoring our commitment to innovation and excellence and ultimately unlocking continued stockholder value.
我們相信,成功地將我們的創新產量提高流程從概念階段推進到開發階段並最終獲得 FDA 批准,進一步驗證了 ADMA 強大且資本高效的內部研發引擎,從而推動了產品和生產創新。由於我們預計我們的商業產品的需求將持續增長,並且我們的收入結構將發生有利的變化,我們仍然有信心實現可持續的收入和盈利增長,並為股東帶來長期價值。展望未來,我們對我們的發展計劃的潛在影響和我們的商業模式的彈性感到興奮,這使 ADMA 成為快速發展的生物製藥領域的領導者。隨著 2025 年和 2026 年財務指引的上調,我們看到了擴大市場份額和利用我們產品線內的機會的清晰途徑。我們相信,我們已準備好共同推動醫療保健領域的有意義的進步,強調我們對創新和卓越的承諾,並最終釋放持續的股東價值。
With that, I'd now like to open up the call for your questions. Operator?
好了,現在我想開始回答大家的提問。操作員?
Operator
Operator
(Operator Instructions)
(操作員指示)
Anthony Petrone, Mizuho.
瑞穗的安東尼‧佩特羅內 (Anthony Petrone)。
Anthony Petrone - Analyst
Anthony Petrone - Analyst
Congrats here on a really strong start to the year and the recent FDA clearance on yield enhancement. I know it was a big lift for the team.
恭喜我們今年取得了非常強勁的開局,並且最近獲得了 FDA 對產量提高的批准。我知道這對球隊來說是一個巨大的啟發。
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
Absolutely. Thanks, Anthony.
絕對地。謝謝,安東尼。
Anthony Petrone - Analyst
Anthony Petrone - Analyst
Intrigued by the guidance here, Adam, raising the range once again here, $10 million in 2025, $20 million next year, but importantly, not including yield enhancement. Our understanding is you needed to manufacture, I think, at least several batches at the higher yield run rate to secure FDA clearance and that with FDA clearance, you could release those into the marketplace. So maybe just a recap on, how much was prepared to secure FDA clearance -- and when do you think those lots could actually begin contributing to revenue? And I'll have a couple of follow-ups.
亞當對此指導很感興趣,他再次提高了範圍,2025 年為 1000 萬美元,明年為 2000 萬美元,但重要的是,不包括收益率的提高。我們的理解是,我認為您需要以更高的產量運行率生產至少幾批產品,以確保獲得 FDA 批准,並且在獲得 FDA 批准後,您就可以將它們投放到市場上。因此,也許只是回顧一下,為了獲得 FDA 批准準備了多少——以及您認為這些批次何時才能真正開始為收入做出貢獻?我也會進行一些後續跟進。
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
Sure. Thanks, Anthony, very much. We appreciate the support. So you're exactly right. In order to have this FDA prior approval supplement approved, we manufactured 3 conformance lots at the commercial scale, 2 were BIVIGAM, are ASCENIV.
當然。非常感謝,安東尼。我們感謝您的支持。所以你說得完全正確。為了獲得 FDA 事先批准的補充劑,我們以商業規模生產了 3 個符合要求的批次,其中 2 個是 BIVIGAM,1 個是 ASCENIV。
We've expressly excluded this from 2025 guidance altogether. We take the same conservative approach to guidance that we always have. I feel confident that we should be able to have these lots labeled, packaged and released, but we are looking at this conservatively. We want to sell down all of the, call it, the old process, the 4,400-liter scale produced product first. We want to make sure that all of that product is out of inventory.
我們已明確將其排除在 2025 年指導範圍之外。我們一如既往地採取保守的指導態度。我相信我們能夠為這些批次貼上標籤、包裝並放行,但我們對此持保守態度。我們想先把所有我們稱之為舊工藝的、4,400 公升規模生產的產品全部賣掉。我們要確保所有該產品都缺貨。
And based on forward-looking demand trends for ASCENIV and BIVIGAM, we feel confident that we certainly have a good shot on goal. And you could see us take the same approach that we've always taken, which is when we have that visibility, we'll increase guidance. And we feel very, very good about our position right now. We are currently manufacturing at the yield improvement scale. So we feel really good about that.
基於對 ASCENIV 和 BIVIGAM 的前瞻性需求趨勢,我們有信心一定能實現目標。您可以看到我們採取了與以往相同的方法,即當我們擁有這種可見性時,我們就會增加指導。我們對自己目前的狀況感到非常非常滿意。我們目前正在按照產量改進規模進行生產。所以我們對此感到非常高興。
We're implementing that extremely rapidly and hats off to the team here for getting it done. But same conservative approach, Anthony. We'd rather under promise and over deliver, and we feel really good about where guidance is for '25 and '26, we've taken a conservative approach to yield enhancement, again, coupled with the fact that we want to make sure that we sell out all the inventory at the old process, and you will see margins start to certainly expand rapidly throughout 2026. If everything goes well, 100% of what we're going to sell in 2026 will be manufactured at the yield improvement scale. So if my commercial team is listening, get it on, pull it through the channel.
我們正在非常迅速地實施這一目標,並向這裡的團隊表示敬意。但同樣的保守態度,安東尼。我們寧願少承諾多交付,我們對 25 年和 26 年的指導方針感到非常滿意,我們採取了保守的方法來提高收益,再加上我們希望確保在舊流程中銷售所有庫存,你會看到利潤率在 2026 年肯定會開始迅速擴大。如果一切進展順利,我們將在 2026 年銷售的所有產品都將以良率提升規模生產。因此,如果我的商業團隊正在聽,那就將其發布,並透過管道傳播。
Anthony Petrone - Analyst
Anthony Petrone - Analyst
Lovely. Totally understood and a good approach there. Quick follow-ups, I'll hop in and let others jump in here. One is -- and Brad, you mentioned this in your remarks, Adam, you alluded to it. So there is going to be some investment here, I think, in demand generation for ASCENIV now that you have increased supply visibility.
迷人的。完全理解,這是一個很好的方法。快速跟進,我會跳進去並讓其他人跳進去。一是——布拉德,你在你的評論中提到了這一點,亞當,你也暗示了這一點。因此,我認為,既然現在已經提高了供應可見性,那麼就會對 ASCENIV 的需求產生進行一些投資。
The question on this is how much backlog right now is there, if you will, on ASCENIV that you can fill sort of near term? And then how much do you think demand generation can generate? And the last quick one would be, you now have a multidisciplinary capital allocation selection. You're talking about recapitalization of debt. You have an R&D program, pneumococcal pneumonia, and now we have a $500 million authorization.
問題是,如果您願意的話,ASCENIV 目前有多少積壓工作可以在短期內填補?那麼您認為需求產生能產生多少呢?最後一點是,您現在可以進行多學科資本配置選擇。您正在談論債務資本重組。您有一個研發項目,肺炎球菌性肺炎,現在我們獲得了 5 億美元的授權。
So maybe just the priorities for capital allocation going forward? Again, congratulations.
那麼也許這只是未來資本配置的優先事項?再次恭喜你。
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
Sure. Anthony, we feel that the OpEx is going to come down sequentially. You're going to see the OpEx line start to normalize starting in the second quarter. We're already halfway through the second quarter and the demand indicators for all of our products look very, very healthy and strong. We anticipate sequential growth from the top and bottom line as we progress throughout this year.
當然。安東尼,我們覺得營運支出將會逐步下降。您將會看到營運支出線從第二季開始恢復正常。我們已經進入第二季的一半,我們所有產品的需求指標看起來都非常非常健康和強勁。我們預計,隨著今年的進展,營收和利潤將持續成長。
Regarding our capital allocation, I mean, look, we feel really, really good about our forecasted forward-looking cash generation and profitability outlook. The free cash flow that we're planning to generate here, especially with yield enhanced produced product, will provide us with substantially enough cash to do all the things that you mentioned, pay down debt, fund our commercial strategy and growing the demand queue for our products, fund our R&D with SG-001 as well as we should have the money on the balance sheet to start repurchasing stock. I mean, we're looking at this from a position of strength. The forward-looking cash generation that we've seen, I mean, it's very exciting to be in this position. I've never felt this good about being the CEO of ADMA Biologics ever.
關於我們的資本配置,我的意思是,我們對預測的前瞻性現金產生和獲利前景感到非常非常滿意。我們計劃在這裡產生的自由現金流,特別是透過提高產量生產的產品,將為我們提供足夠的現金來完成您提到的所有事情,償還債務,資助我們的商業戰略和增加我們產品的需求隊列,資助我們使用 SG-001 的研發,並且我們應該在資產負債表上有錢開始回購股票。我的意思是,我們是從實力的角度來看這個問題的。我們看到的前瞻性現金創造,我的意思是,處於這個位置是非常令人興奮的。我從來沒有對擔任 ADMA Biologics 的執行長感到如此高興。
And things are humming along here, and we really feel good about this. The priorities to put them in an order, I mean, it's all a priority. And I think we feel, Brad, that we've got the cash generation outlook that with the share repo in place that will be under a 10b5-1 plan. So we'll put that in place. But we plan to start that in the near term.
現在一切進展順利,我們對此感到非常高興。按優先順序排列它們,我的意思是,這都是優先順序。布拉德,我認為,我們擁有現金生成前景,即在 10b5-1 計劃下實施股票回購。所以我們會將其落實到位。但我們計劃近期開始實施。
You see that we are looking at novel ways to reduce our cost of debt, saving 1.1%, we think is fantastic in this backdrop. And depending upon how the financial markets play out, we'll make the decisions in real-time. Do we pay down more debt? We buy back shares, but we certainly have enough cash that we are looking at generating in the forward-looking periods to support everything that we want to do with the business and more.
您會發現,我們正在尋找新穎的方法來降低債務成本,節省 1.1%,我們認為在這種背景下非常棒。根據金融市場的走勢,我們將即時做出決策。我們要償還更多債務嗎?我們回購股票,但我們肯定有足夠的現金,我們希望在未來時期內產生足夠的現金來支持我們想要開展的所有業務以及更多業務。
Brad Tade - Chief Financial Officer and Treasurer
Brad Tade - Chief Financial Officer and Treasurer
Yes, Anthony, again, we're going to continue to see revenue growth and the evolving mix shift from BIVIGAM to ASCENIV in addition to the yield enhancement resulting in margin expansion. And that, coupled with the OpEx normalization that will translate into net income and EBITDA expansion. To Adam's point, we feel like we are entering second quarter and the second half of 2025 from a position of strength from the balance sheet. And with the bolus of expenses associated with yield enhancement and promotional activities and medical education behind us, we feel great with those investments, and we feel, again, like we are entering Q2 and the second half from a position of strength, both on the balance sheet and P&L.
是的,安東尼,我們將繼續看到收入成長和從 BIVIGAM 到 ASCENIV 的組合轉變,此外收益率還將提高,從而導致利潤率擴大。再加上營運支出正常化,這將轉化為淨收入和 EBITDA 擴張。正如亞當所說,我們感覺從資產負債表來看,我們將以強勁的勢頭進入第二季和 2025 年下半年。隨著與提高收益、促銷活動和醫學教育相關的大量支出的支出,我們對這些投資感到非常滿意,我們再次感覺到,無論是在資產負債表還是在損益表上,我們都將以強勢地位進入第二季度和下半年。
Operator
Operator
Kristen Kluska, Cantor Fitzgerald.
克里斯汀·克魯斯卡,坎托·費茲傑拉。
Rick Miller - Analyst
Rick Miller - Analyst
This is Rick Miller on for Kristen. Earlier this year, you were talking about the ability through some of the new supply agreements to access around 250 centers for collection. Can you help us understand what percentage of these centers are currently contributing to the source plasma mix? And then we'll have another one after that.
我是里克米勒 (Rick Miller),為克里斯汀 (Kristen) 表演。今年早些時候,您談到透過一些新的供應協議可以進入大約 250 個收集中心。您能否幫助我們了解這些中心目前對源頭血漿混合物的貢獻比例是多少?然後我們還會再有一個。
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
Thanks, Rick, very much. We appreciate your and interest support. With respect to the onboarding of these centers, I think substantially all of the centers are now sending in samples and we are screening from them. We've really done a great job here internally. Again, hats off to our laboratory testing team for this.
非常感謝,里克。我們感謝您的支持與關注。關於這些中心的入職情況,我認為基本上所有中心現在都在發送樣本,我們正在對它們進行篩選。我們在內部確實做得非常出色。再次向我們的實驗室測試團隊致敬。
But we are collecting more plasma than our forecast, and we feel real good about this. That's partially contributing to our increasing guidance for this year and next year. But we're running on all cylinders. We are collecting more plasma than we anticipated. We're making more ASCENIV batches.
但我們收集的血漿比預期的多,我們對此感到非常高興。這在某種程度上促使我們提高今年和明年的指導。但我們正在全力運作。我們收集的血漿比我們預期的要多。我們正在生產更多批次的 ASCENIV。
The first yield enhanced batch is an ASCENIV batch. So we feel real good about this. We are very, very pleased with how the supply is coming from our third-party partners. And these contracts have really derisked the historical bottleneck and supply constraints, and we feel that we're going to be able to hit all the targets that we're putting out there. And we certainly have shots on goal, easy shots, I think, to exceed what we are forecasting and guiding to today.
第一個產量提高批次是 ASCENIV 批次。所以我們對此感到非常高興。我們對來自第三方合作夥伴的供應感到非常非常滿意。這些合約確實降低了歷史瓶頸和供應限制的風險,我們認為我們將能夠實現我們設定的所有目標。我認為,我們確實有射門的機會,輕鬆的射門,可以超越我們今天的預測和指導。
Rick Miller - Analyst
Rick Miller - Analyst
Okay. Then one more from us. As thinking about scaling ASCENIV, do you have any updated color on kind of how the strategy is going for retaining high tighter donors? Any change in strategy there, how you're going about it?
好的。然後我們再說一個。在考慮擴大 ASCENIV 規模時,您是否對如何制定策略來保留高純度捐贈者有任何最新見解?那裡的策略有任何改變嗎?您打算如何實施?
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
Strategy seems to be working. I mean, if you compensate your donors and you make them feel good and you treat them like VIPs, they keep coming back. So we're seeing great donor retention. We are identifying new donors all the time, and the program seems to be working extremely well. So we don't see any need to change strategy right now.
該策略似乎正在發揮作用。我的意思是,如果你對捐贈者進行補償,讓他們感覺良好,並像對待貴賓一樣對待他們,他們就會不斷回來。因此,我們看到捐贈者的保留率很高。我們一直在尋找新的捐贈者,而且該計劃似乎運作得非常順利。因此我們認為目前沒有必要改變策略。
The margins for ASCENIV are still in that mid-80% gross margin range, and that is with the increased donor fees. So when you couple that with the 20% increase in bulk IG output from yield enhancement, margins for 2026 are going to grow exponentially. We're really excited about the opportunity.
ASCENIV 的利潤率仍然在 80% 左右,而且這是在捐贈費用增加的情況下。因此,如果再加上產量提高帶來的批量中空玻璃產量 20% 的增長,那麼 2026 年的利潤率將呈指數級增長。我們對這個機會感到非常興奮。
Operator
Operator
Gary Nachman, Raymond James.
蓋瑞納赫曼、雷蒙詹姆斯。
Gary Nachman - Analyst
Gary Nachman - Analyst
Congrats on getting the manufacturing process approval. So knowing that, you'll be able to generate 20% more yield with your plasma, are you able to release more new patients from the queue at a faster pace? Or do you need to have the finished product on hand before you do that? So, how do you envision managing that in terms of the patient queue? And maybe you could just speak more generally, Adam, just following on this about, how that queue has been building in terms of demand for ASCENIV?
恭喜您獲得製造流程核准。那麼,了解了這一點,您將能夠利用血漿產生 20% 以上的產量,您是否能夠以更快的速度從隊列中釋放更多新患者?或者在執行此操作之前您是否需要先準備好成品?那麼,您設想如何管理病患排隊問題呢?亞當,也許您可以更籠統地談談這個問題,就 ASCENIV 的需求而言,排隊情況如何?
And how long before you think you'll be able to get to most of those patients? Like is it 1 year, 2 years? How do you think that's going to evolve?
您認為多久之後才能夠救治多數患者?例如是 1 年,2 年?您認為事情會如何發展?
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
Well, my first gut reaction to that part of it is, is I hope we get to a place where there is so much demand that we can never meet it, and we're talking about expanding capacity and growing even bigger than we are today and that we think with new revised top line guidance prior to 2030 of $1.1 billion, if we can get there and we believe that there are more patients out there, we're very excited for that opportunity. I can tell you that we are releasing more product than ever before. We made more product late last year, as we said on previous calls. And we have that product available starting now basically. And we've seen some great, great demand trends as we enter the second quarter and ended the first quarter.
嗯,我對這部分的第一個反應是,我希望我們能達到一個需求如此之大以至於我們永遠無法滿足的地步,我們正在談論擴大產能,發展得比現在更大,我們認為,在 2030 年之前,新修訂的頂線指導值為 11 億美元,如果我們能夠實現這一目標,並且我們相信會有更多的患者,我們對這個機會感到非常興奮。我可以告訴你,我們發布的產品比以往任何時候都多。正如我們在之前的電話會議上所說的那樣,我們在去年年底生產了更多產品。基本上我們現在就可以開始供應該產品。進入第二季並結束第一季時,我們看到了一些非常好的需求趨勢。
And we're releasing more drug. The patient queue still exists. There are still patients waiting in line for therapy. We're seeing robust continuation of patients on drug, and we feel very good about our ability to have more supply in the market for ASCENIV and getting more patients on therapy. You're going to see the accounts receivable grow, and you see that number as we end the first quarter.
我們正在推出更多藥物。患者隊列仍然存在。仍有患者在排隊等待治療。我們看到患者繼續服用該藥物的勢頭強勁,我們對能夠在市場上提供更多 ASCENIV 供應並讓更多患者接受治療感到非常滿意。您會看到應收帳款成長,並且在第一季結束時您會看到這個數字。
I think cash and receivables were about $171 million, just about $100 million of receivables. And the majority of our sales continue to be from ASCENIV. As Brad said earlier, the mix shift continues to expand with ASCENIV being the overwhelming majority of the revenue that we are generating. And we feel really, really good. AR grew, because of the timing of lot releases.
我認為現金和應收帳款約為 1.71 億美元,應收帳款約為 1 億美元。我們的大部分銷售額仍然來自 ASCENIV。正如布拉德之前所說,組合轉變持續擴大,ASCENIV 佔據了我們所創造收入的絕大部分。我們感覺真的非常好。由於批次發佈時間的安排,AR 有所增長。
We had a number of lot releases come in from FDA in the March time frame. And the product is being pulled through at a rapid clip. So hopefully, that answers your question. But the queue remains. We are adding more patients every single week, and we feel good about it.
在三月期間,我們收到了來自 FDA 的多個批次批次。產品正以極快的速度運送出去。希望這能回答你的問題。但排隊現象仍然存在。我們每週都會增加更多的病人,我們對此感到很高興。
Patients continue to do well on drug therapy, and they're staying on drug for long periods of time.
患者的藥物治療效果持續良好,且長期服藥。
Gary Nachman - Analyst
Gary Nachman - Analyst
Yes. That was definitely helpful. And then this is something that we've talked about in the past, but what's the status for you to be able to generate some HEOR data demonstrating the benefits of using ASCENIV compared to standard IG products for the more severe PI patients. I think, you've talked about maybe having that later this year. And then how would you expect to utilize that data with physicians and payers?
是的。這絕對是有幫助的。這是我們過去討論過的事情,但是您能否產生一些 HEOR 數據來證明對於更嚴重的 PI 患者使用 ASCENIV 與標準 IG 產品相比的益處。我想,您已經談到可能在今年稍後實現這一目標。那麼您希望如何與醫生和付款人一起利用這些數據呢?
So maybe one, talk about how many physicians are currently using the product and how many more you think you could tap into potentially? And then from a payer standpoint that you're comfortable that you're not going to get the headwinds as the product continues to grow?
那麼也許可以先談談目前有多少醫生正在使用該產品,以及您認為還有多少醫生可以潛在地利用該產品?那麼從付款人的角度來看,您是否確信隨著產品的持續成長,您不會遇到阻力?
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
So we're still on track, Gary. Health economic outcome data, pharmacoeconomic data is on track. The team is working diligently with statisticians calling all the ICD codes, and we feel good about being in a position to have something published later this year. This work that we're doing is really designed to demonstrate the real-world evidence and it's resonating amongst the government pay and the commercial payers. The key driver of this project internally is to ensure that access for the drug is available from government payers and commercial payers.
所以我們仍然在正軌上,加里。衛生經濟結果數據、藥物經濟學數據均進展順利。該團隊正在與統計人員密切合作,調用所有 ICD 代碼,我們很高興能夠在今年稍後發布一些內容。我們所做的工作實際上是為了展示現實世界的證據,並在政府支付和商業支付者之間產生共鳴。該專案內部的關鍵驅動力是確保政府付款人和商業付款人都能獲得該藥物。
And we expect that any publications that we put out will continue to drive home to the commercial payer mostly that this drug, while it is sold at a premium price to standard IGs is keeping patients out of the hospital, it's keeping them in work and school. It's allowing them to lead normal lives without the additional medical costs from other opportunistic infections and other complications that these patients experience. So we're on track to have this data published prior to year-end. And as soon as we've got something to announce, we will certainly put out a press release for the market.
我們希望,我們發表的任何出版物都將繼續讓商業付款人明白,這種藥物雖然以高於標準 IG 的價格出售,但卻讓患者無需住院,而是可以繼續工作和上學。它使他們能夠過上正常的生活,而無需承擔因其他機會性感染和其他併發症而產生的額外醫療費用。因此,我們預計在年底之前發布這些數據。一旦我們有消息要宣布,我們肯定會向市場發布新聞稿。
Gary Nachman - Analyst
Gary Nachman - Analyst
Okay. Excellent. And then just 2 more quick ones. Just explain the voluntary product withdrawals in 1Q, why that occurred? And does that product come back at some point or it's basically just gone?
好的。出色的。然後再快速問 2 個問題。請解釋一下第一季自願撤回產品的原因是什麼?該產品會在某個時候回來嗎,還是基本上消失了?
And then also just your comment on extending the IP of ASCENIV beyond 2035, just the type of, I guess, tools that you have to potentially do that. Is this new manufacturing process one of those tools? And when you think we might hear about that longer durability?
然後,還有您對將 ASCENIV 的 IP 延長至 2035 年以後的評論,我猜,您必須使用這種類型的工具才能做到這一點。這個新的製造流程是其中一種工具嗎?您認為我們什麼時候可能會聽到更長的耐用性?
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
Sure. So I'll touch your first question first. These are inherent adverse events that patients experience. It's labeled in the package insert. And these are known adverse events that you experience with IG.
當然。所以我先來回答你的第一個問題。這些都是患者所經歷的固有不良事件。包裝說明書上有標籤。這些都是您在使用 IG 時會遇到的已知不良事件。
We were not alone in the quarter. Other manufacturers of IG, you can see on the FDA website also had recalls. This was -- we look at it as a onetime nonrecurring occurrence here that in the interest of public safety, we voluntarily removed the product from the market. First and foremost, and I've said this since ADMA was founded, our mission here is to provide safe, efficacious product to patients to keep the FDA happy. And we're going to make tough decisions here that may impact our financials, but are going to ultimately do the right thing for the patients and show the FDA that we look at these things and we take them seriously.
本季我們並不是唯一遇到這種情況的人。您可以在 FDA 網站上看到,其他 IG 製造商也進行了召回。我們認為這是一次性事件,出於公共安全的考慮,我們自願將該產品從市場上撤下。首先,自 ADMA 成立以來我就一直強調,我們的使命是為病患提供安全、有效的產品,讓 FDA 滿意。我們將做出艱難的決定,這可能會影響我們的財務狀況,但最終我們會為患者做正確的事情,並向 FDA 表明我們關注這些事情並且認真對待它們。
So, onetime occurrence here. These lots have been voluntarily withdrawn from the market. Any inventory that we had, we will destroy. Credits have been issued to customers for that product. I think it was around $3.8 million in the quarter.
所以,這裡只發生過一次。這些地塊已自願退出市場。我們擁有的任何庫存都將被銷毀。已向客戶發放該產品的信用額度。我認為本季約為 380 萬美元。
Brad Tade - Chief Financial Officer and Treasurer
Brad Tade - Chief Financial Officer and Treasurer
Correct.
正確的。
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
And this is our sixth year of commercialization of our products. It's never happened to us before. I think pretty much all other producers, maybe say for one, have not experienced something like this throughout their manufacturing life. But we're dealing with plasma-derived biologics and sometimes things happen. And unfortunately, it happened here, but our products are safe.
這是我們產品商業化的第六年。我們以前從來沒有遇過這樣的事情。我認為幾乎所有其他生產商,也許可以這麼說,在其整個生產生涯中都沒有經歷過這樣的事情。但我們正在處理血漿衍生的生物製劑,有時會發生一些事情。不幸的是,這件事發生了,但我們的產品是安全的。
We've got tens of thousands of grams being infused all the time, and we do not expect any further go-forward impacts from the product withdrawals. Moving to your next question on IP. We've got a lot of science going on here. I think that's evidenced by the approval of yield enhancement. And we've got a lot of great things that our team has worked on with respect to our testing assay and the methods that they are using to identify these donors faster.
我們一直都有數萬克的藥物被注入,我們預計產品撤回不會帶來任何進一步的影響。轉到您關於 IP 的下一個問題。我們在這裡進行了很多科學研究。我認為收益率提高的批准就證明了這一點。我們的團隊在測試分析以及用於更快地識別這些捐贈者的方法方面取得了許多偉大的成就。
And I think there are some levers that we can pull where we'll be able to modify and amend the IP to include some of these novel methodologies to potentially extend beyond midyear 2035. Still, I'll say we've got over a decade of patent life protection here. And to the best of our knowledge, we're not aware of anybody doing what we're doing globally. And we feel really good about our IP position, and we feel it's highly defensible. And we're just going to keep doing what we do, Gary.
我認為我們可以利用一些手段來修改和修訂 IP,以納入一些新穎的方法,並有可能延續到 2035 年中期以後。不過,我要說的是,我們已經擁有十多年的專利壽命保護。據我們所知,我們不知道全球有誰在做我們所做的事情。我們對我們的智慧財產權地位感到非常滿意,我們認為它具有很強的防禦能力。我們將繼續做我們正在做的事情,加里。
But looking at being the first company in the US to have yield enhancement approved, we really -- I just feel great about what our team is doing here. We're showing the bigger companies that being a small, nimble, fast-moving company can really drive value creation for stockholders and get good products to patients more rapidly. And I'm pretty confident in our team's ability. I'm sure 1 or 2 of them are going to get nervous that I'm saying this, but I'm pretty sure that we'll be in a good position to extend this IP.
但作為美國第一家獲得增產批准的公司,我們真的——我對我們團隊在這裡所做的事情感到非常高興。我們向大公司證明,小型、靈活、快速發展的公司確實可以為股東創造價值,並更快地為患者提供優質產品。我對我們團隊的能力非常有信心。我確信他們中的一兩個人會因為我說這句話而感到緊張,但我很確定我們將處於一個良好的位置來擴展這個 IP。
But even without it, we've got another decade to go and the amount of cash that we're going to generate between here and there is substantial. I mean we could buy back substantially more than the $500 million share repo that we put up today.
但即使沒有它,我們還有十年的時間,從現在到將來,我們將產生的現金數量是相當可觀的。我的意思是,我們可以回購比今天提供的 5 億美元更多的股票。
Gary Nachman - Analyst
Gary Nachman - Analyst
Yes. No, that color is really helpful and that durability is really important.
是的。不,顏色確實很有用,而且耐用性非常重要。
Operator
Operator
Ladies and gentlemen, this will conclude our question-and-answer portion of the call. I'd like now to turn it back over to Adam for additional closing remarks.
女士們、先生們,本次電話會議的問答部分到此結束。現在我想把發言權交還給亞當,請他做最後的補充發言。
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder,, Director
I just want to say thank you. Thank you to the ADMA team. Thank you to our stockholders for your continued support and for dialing in. As a US domiciled company, we feel real good about being insulated from all of the tariff noise that's out there.
我只是想說聲謝謝。感謝 ADMA 團隊。感謝我們的股東一直以來的支持與通話。作為一家美國公司,我們很高興能夠免受外界關稅噪音的影響。
And hopefully, we'll be in a position to continue to deliver outstanding results. So thanks very much. Stay healthy. Enjoy spring wherever you are, and have a good evening.
希望我們能夠繼續取得優異的成績。非常感謝。保持健康。無論您身在何處,都能享受春天的氣息,祝福您有個愉快的夜晚。
Operator
Operator
Ladies and gentlemen, this does conclude the conference call for today. We appreciate your participation, and you may now disconnect.
女士們、先生們,今天的電話會議到此結束。感謝您的參與,您現在可以斷開連接了。