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Operator
Operator
Good afternoon. And welcome to the ADMA Biologics fourth quarter and full-year 2024 financial results and business update conference call on Monday, March 3, 2025. (Operator Instructions)
午安.歡迎參加 2025 年 3 月 3 日星期一舉行的 ADMA Biologics 第四季和 2024 年全年財務表現和業務更新電話會議。(操作員指示)
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. At this time, I would like to introduce the company. Please go ahead.
請注意,應公司要求,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。現在我想向大家介紹一下這家公司。請繼續。
Skyler Bloom - Corporate Strategy, Business Development
Skyler Bloom - Corporate Strategy, Business Development
Welcome, everyone. And thank you for joining us this afternoon to discuss ADMA Biologic's financial results for the fourth quarter and full-year 2024 in recent corporate updates. I'm joined today by Adam Grossman, President and Chief Executive Officer; and Brad Tade, Chief Financial Officer and Treasurer.
歡迎大家。感謝您今天下午加入我們,在最近的公司更新中討論 ADMA Biologic 第四季度和 2024 年全年的財務業績。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)。
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 fourth quarter and full-year 2024 financial results. Finally, Adam will then provide some brief summary remarks before opening up the call for your questions.
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,布拉德將概述該公司 2024 年第四季和全年財務表現。最後,亞當將在開始回答大家的提問之前,先提供一些簡短的總結性發言。
Earlier today, we issued a press release, detailing the fourth quarter and full-year 2024 financial results and summarized certain achievements in recent corporate updates. The release is available on our website at www.admabiologics.com.
今天早些時候,我們發布了一份新聞稿,詳細介紹了第四季度和2024年全年的財務業績,並總結了最近公司更新中的某些成就。新聞稿可在我們的網站 www.admabiologics.com 上查閱。
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.
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上做出前瞻性的斷言,這些斷言代表了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。
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 any such statements.
所有前瞻性陳述均受各種因素、風險和不確定性的影響,例如今天的新聞稿、宣布此次電話會議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、風險和不確定性,這些因素、風險和不確定性可能導致實際結果與任何此類陳述所表達或暗示的結果存在重大差異。
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.
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。
We specifically disclaim any obligations to update any such statements except as required by federal securities laws. We refer you to the disclosure notice section in our earnings release we issued today in the risk factor section of our previously issued SEC filings and our annual report on 10-K for the year ended December 31, 2024.
我們明確表示不承擔更新任何此類聲明的義務,除非聯邦證券法要求。請您參閱我們今天發布的收益報告中的揭露通知部分,該部分位於我們先前發布的 SEC 文件的風險因素部分,以及我們截至 2024 年 12 月 31 日的年度報告 10-K 中。
Once filed on or before March 18, 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 EBITDA and adjusted net income.
曾在 2025 年 3 月 18 日或之前提交,用於討論可能導致實際結果與這些前瞻性陳述有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,包括調整後的 EBITDA 和調整後的淨收入。
A reconciliation of these non-GAAP financial measures to the most directly comparable GAAP metric is available in our earnings release. With that said, I would now like to turn the call over to Adam Grossman. Adam, go ahead.
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。話雖如此,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, Interim Chief Financial Officer, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
Thank you, Skyler. And welcome everyone to today's call. 2024 was a year of exceptional performance for ADMA, marked by significant financial growth and operational achievements. Total revenues reached $426.5 million, reflecting an increase of 65% year over year.
謝謝你,斯凱勒。歡迎大家參加今天的電話會議。 2024 年是 ADMA 表現卓越的一年,財務成長顯著,營運成就斐然。總收入達4.265億美元,年增65%。
Adjusted EBITDA grew to $164.6 million, representing a growth rate of 309% from the previous year. These results are a testament to the real-world benefits. Our biologic therapies continue to deliver to immune-compromised patients throughout the United States, as well as the dedication and expertise of our leadership team and exceptional staff.
調整後 EBITDA 成長至 1.646 億美元,較上年成長 309%。這些結果證明了現實世界的利益。我們的生物療法繼續為美國各地的免疫功能低下患者提供服務,我們的領導團隊和優秀員工的奉獻精神和專業知識也將繼續發揮作用。
Our commitment to financial and operational excellence continues to drive strong performance, allowing us to once again revive our financial guidance upwards. We now expect total revenue to exceed $490 million in 2025 and $605 million in 2026, with adjusted EBITDA projected to surpass $225 million and $305 million respectively in 2025 and 2026.
我們對財務和營運卓越的承諾繼續推動強勁的業績,使我們能夠再次提高財務指導。我們現在預計,2025 年總營收將超過 4.9 億美元,2026 年將超過 6.05 億美元,預計 2025 年和 2026 年調整後的 EBITDA 將分別超過 2.25 億美元和 3.05 億美元。
Adjusted net income guidance for 2025 and 2026, is now raised to more than $175 million and $235 million, respectively. We anticipate continued margin expansion as our revenue mix shift towards incentives, which we believe represents a potential billion dollar or more opportunity with lasting growth and brand durability through at least 2035 and likely beyond.
2025 年和 2026 年的調整後淨收入預期分別上調至 1.75 億美元和 2.35 億美元以上。隨著我們的收入結構向激勵措施轉變,我們預計利潤率將繼續擴大,我們相信這代表著潛在的數十億美元或更多的商機,並且至少在 2035 年甚至更久以後,我們的成長和品牌持久性都將持續下去。
In anticipation of a potential mid-year regulatory approval for our enhanced yield production process, we increase medical education and marketing efforts at key scientific conferences in the fourth quarter while preparing for an increase in high tide or plasma supply, work in process, and finished set of inventories.
由於預期我們的增產生產工藝可能在年中得到監管部門的批准,我們將在第四季度加大在主要科學會議上的醫學教育和營銷力度,同時為增加高潮或血漿供應、在製品和成品庫存做好準備。
Throughout commercialization, we have strategically managed new patients start to ensure continuity of patient care and maintain an uninterrupted drug supply. And we have accordingly taken a conservative and thoughtful approach to onboarding new ascent of patients.
在整個商業化過程中,我們對新患者的開始進行了策略性管理,以確保患者護理的連續性並保持不間斷的藥物供應。因此,我們採取了保守而周到的方式來接收新患者。
A set of forward-looking demand metrics are making new all-time highs into 2025, which has resulted in a queue of identified new patients, waiting to initiate a set of treatment. Having currently penetrated what we believe is just over 3% of incentives targeted, complex, and refractive PI markets.
一組前瞻性的需求指標將在 2025 年創下歷史新高,這導致大量新患者排隊等待開始接受治療。我們認為,目前我們已滲透到激勵目標、複雜性和折射性 PI 市場中超過 3%。
We have strong visibility into scaling new patients starts in the coming periods. And we believe we can address the significant unmet needs within this PI patient population. We believe our recently executed third-party high tide or plasma supply contracts mark a transformative milestone, paving the way for what should be long-term, top-tier growth for ADMA.
我們對未來一段時間擴大新患者人數有著清晰的認知。我們相信,我們可以滿足 PI 患者群體中尚未滿足的重大需求。我們相信,我們最近簽署的第三方高潮或血漿供應合約標誌著一個變革性的里程碑,為 ADMA 的長期頂級成長鋪平了道路。
These long-term agreements allow the company to source high tide or plasma from approximately 250 US-based, third-party plasma collection centers, representing approximately a five-fold increase in total collection capacity.
這些長期協議使該公司能夠從大約 250 個美國第三方血漿採集中心購買高潮血漿或血漿,這意味著總採集能力提高了約五倍。
While we continue to ramp up these third-party high tide procurement contracts at a rapid pace, we've also grown internal high tider collections to record levels. These third-party supply contracts combined with the robust internal plasma collection trends are expected to sustain incentives revenue growth and position us to potentially exceed $1 billion in total annual revenue prior to 2030, with anticipated growth headroom, thereafter.
在我們繼續快速增加這些第三方高潮採購合約的同時,我們的內部高潮收集量也增長到了創紀錄的水平。這些第三方供應合約加上強勁的內部血漿收集趨勢預計將維持激勵收入的成長,並使我們在 2030 年之前有可能實現超過 10 億美元的年總收入,此後預計還有成長空間。
We deeply appreciate the commitment of our plasma supply partners to our company and to the immuno-deficient patients we all collectively serve. We believe the anticipated approval of our enhanced yield production process represents a transformative opportunity for the company.
我們深深感謝血漿供應合作夥伴對我們公司以及我們共同服務的免疫缺陷患者的承諾。我們相信,我們提高產量生產流程的預期批准對公司來說代表著一個轉型的機會。
This innovative process has demonstrated an ability to increase production output by approximately 20% from the same starting plasma volume, potentially driving meaningful increases to financial guidance if approved.
這項創新流程已證明能夠在相同的起始血漿量下將產量提高約 20%,如果獲得批准,則有可能推動財務指導的大幅成長。
Our scientific, technical operations and regulatory teams have been instrumental in advancing this novel process. And our ongoing regulatory dialogue reinforces the confidence and timely potential approval by mid-year 2025.
我們的科學、技術營運和監管團隊在推動這項新流程方面發揮了重要作用。我們正在進行的監管對話增強了信心,並有望在 2025 年中期及時獲得批准。
Upon approval, we are well prepared to swiftly implement the new process enhancements, which would drive commercial sales and financial upside, beginning potentially in the second half of 2025.
獲得批准後,我們已做好充分準備迅速實施新的流程改進,這將推動商業銷售和財務成長,可能從 2025 年下半年開始。
Consistent with our conservative guidance approach, any revenue generated from immune globulin produced using this enhanced production process would represent potential upside to our current 2025 and 2026 financial projections.
與我們的保守指導方針一致,使用這種增強生產過程生產的免疫球蛋白所產生的任何收入都將對我們目前的 2025 年和 2026 年財務預測帶來潛在的上升空間。
We believe the anticipated increase in available high tide or plasma supply will enable us to meet incentives growing demand in the coming quarters, accelerate revenue and earnings growth, and further build on incentives still developing growth curve.
我們相信,預期可用的高潮或血漿供應的增加將使我們能夠滿足未來幾季不斷增長的激勵需求,加速收入和獲利成長,並進一步鞏固仍在發展的成長曲線。
A set of robust intellectual property estate, covering proprietary screening assays, plasma pooling formulas, methods of immune globulin use, secures brand protection through at least 2035 with potential extensions extending beyond.
一套強大的智慧財產權,涵蓋專有篩選試驗、血漿匯集配方、免疫球蛋白使用方法,確保品牌保護至少到 2035 年,並可能延長至更久。
Regulatory barriers and proprietary know-how further safeguard our franchise. Our comprehensive IP portfolio, encompassing immune globulin treatment for all virally induced respiratory infections, supports our expectations that a Senate alone could surpass $1 billion in total annual revenue.
監管壁壘和專有技術進一步保護了我們的特許經營權。我們全面的智慧財產權組合涵蓋了針對所有病毒引起的呼吸道感染的免疫球蛋白治療,這支持了我們的預期,即僅參議院的年總收入就可能超過 10 億美元。
With strong intellectual property and regulatory protections ensuring a long runway of profitable growth, we are building what we believe will be among the most durable earning streams in the biotech and pharmaceutical sector.
憑藉強大的智慧財產權和監管保護,確保長期獲利成長,我們正在打造我們認為將成為生物技術和製藥領域最持久的獲利來源之一。
We continue to advance our lead R&D pipeline program SG-001, targeting strep pneumonia, representing an additional upside lever to currently provided $1 billion total annual revenue guidance, expected to be realized prior to 2030.
我們繼續推進我們的主要研發管線計畫 SG-001,該計畫針對鏈球菌性肺炎,這為目前提供的 10 億美元年度總收入指導帶來了額外的上行槓桿,預計將在 2030 年之前實現。
If approved, SG-001 could contribute $300 million to $500 million or more in high margin annual revenue. Issued IP protecting SG-001 ensures branded protection through at least 2037 with the potential for extensions.
如果獲得批准,SG-001 每年可帶來 3 億至 5 億美元甚至更多的高利潤收入。已頒發的 IP 保護 SG-001 可確保品牌保護至少持續到 2037 年,並且有可能延長。
We are confident in our ability to advance this program through development and potential regulatory approval in a highly capital efficient manner. We believe the strength of our balance sheet and our increasing net cash position provide a solid foundation to execute from a position of strength, with the flexibility to act opportunistically should market conditions shift.
我們有信心以高度資本高效的方式推進該計劃的開發和潛在的監管批准。我們相信,我們強勁的資產負債表和不斷增長的淨現金狀況為我們以強勢地位執行提供了堅實的基礎,並且能夠在市場條件發生變化時靈活地採取機會行動。
At year-end 2024, total cash holdings exceeded $103 million, representing a net cash surplus relative to the $75 million of total debt currently outstanding with Ares Capital. This strong financial position should enable us to continue executing our strategic initiatives while maintaining disciplined capital allocation.
截至 2024 年底,現金總持有量超過 1.03 億美元,相對於 Ares Capital 目前未償還的 7,500 萬美元總債務而言,為淨現金盈餘。強勁的財務狀況使我們能夠繼續執行策略舉措,同時保持嚴格的資本配置。
With our fully-US domiciled operations and supply chain, coupled with our growing portfolio of life-changing medicines which continue to address clinical unmet needs for the immune compromised, we believe that we're well positioned to continue to execute on our business plan in the current political and economic backdrop.
憑藉我們完全在美國註冊的業務和供應鏈,再加上我們不斷增長的改變生活的藥物組合,這些藥物將繼續滿足免疫功能低下患者的臨床未滿足需求,我們相信,在當前的政治和經濟背景下,我們完全有能力繼續執行我們的業務計劃。
We take great pride in the impact our work has on patients, plasma donors, and public health. The achievements outlined here are a direct result of our team's dedication and commitment to excellence. We extend our sincere appreciation to our employees for their hard work and determination, qualities that define our company. And we believe set us apart in the industry.
我們對我們的工作對患者、血漿捐贈者和公共健康的影響感到非常自豪。這裡概述的成就直接源自於我們團隊的奉獻和對卓越的追求。我們向員工表達誠摯的感謝,感謝他們的辛勤工作和決心,這些都是我們公司特有的品質。我們相信,我們在行業中脫穎而出。
Finally, prior to turning the call over to Brad, who will speak to the matter in additional detail, I'd like to address the ongoing KPMG audit process. The successful consolidation of reporting ADMA's financial results is an important milestone for the company as ADMA's financial profile continues to rapidly grow and improve.
最後,在將電話轉給布拉德(他將更詳細地談論此事)之前,我想談談正在進行的畢馬威審計流程。隨著 ADMA 的財務狀況持續快速成長和改善,成功合併 ADMA 的財務業績報告對於公司來說是一個重要的里程碑。
Management and our audit committee have met with KPMG prior to releasing the financial results today. And we feel confident that our reported financials are accurate. And we do not anticipate any changes to these financials once the 10-K is filed on or before March 18, 2025.
管理階層和我們的審計委員會在今天發布財務結果之前已經與畢馬威進行了會面。我們相信,我們報告的財務狀況是準確的。我們預計,在 2025 年 3 月 18 日或之前提交 10-K 報表後,這些財務狀況不會發生任何變化。
As previously disclosed, KPMG was engaged by ADMA as the company's new independent registered public accounting firm in the fourth quarter of 2024. The company graduating to a big-four, independent accounting firm and releasing our reported financials today, should instill confidence in the accuracy and quality of our financial statements for our stockholders.
如前所述,畢馬威已被 ADMA 聘為該公司 2024 年第四季新的獨立註冊會計師事務所。公司晉升為四大獨立會計師事務所之一,並在今天發布財務報告,這應該會讓股東對我們財務報表的準確性和品質充滿信心。
With that said, I'd now like to turn the call over to Brad for a review of the fourth quarter and full-year 2024 financials.
話雖如此,我現在想把電話交給布拉德,讓他回顧 2024 年第四季和全年的財務狀況。
Brad Tade - Chief Financial Officer & Treasurer
Brad Tade - Chief Financial Officer & Treasurer
Thank you, Adam. We issued a press release earlier today, outlining our fourth quarter and full-year 2024 financial results. And as Adam mentioned, we expect to be filing our full year 10-K on or before March 18, 2025, which we would encourage you to read when filed.
謝謝你,亞當。我們今天早些時候發布了一份新聞稿,概述了我們第四季度和 2024 年全年的財務業績。正如亞當所提到的,我們預計將於 2025 年 3 月 18 日或之前提交全年 10-K 報表,我們鼓勵您在提交時閱讀。
I'll now discuss some of the key financial highlights from our fourth quarter and full year. Total revenue was $117.5 million for the quarter ended December 31, 2024, as compared to $73.9 million for the quarter ended December 31, 2023, an increase of $43.6 million or 59%.
我現在將討論我們第四季和全年的一些關鍵財務亮點。截至 2024 年 12 月 31 日的季度總收入為 1.175 億美元,而截至 2023 年 12 月 31 日的季度總收入為 7,390 萬美元,增加 4,360 萬美元,增幅為 59%。
Total revenue for the year ended December 31, 2024, was $426.5 million as compared to $258.2 million for the year ended December 31, 2023, an increase of $168.2 million or 65%.
截至 2024 年 12 月 31 日止年度的總收入為 4.265 億美元,而截至 2023 年 12 月 31 日止年度的總收入為 2.582 億美元,增加 1.682 億美元,增幅為 65%。
This increase is primarily related to increased sales of incentives as we continue to experience increased acceptance and utilization by physicians, payers, and patients for this product. Gross profit was $219.6 million for the year ended December 31, 2024, as compared to $88.9 million for the prior year, which represents a gross margin for fiscal year 2024 of 51.5% as compared to 34.4% for fiscal year 2023.
這一增長主要與激勵產品銷售額的增加有關,因為我們不斷看到醫生、付款人和患者對該產品的接受度和利用率不斷提高。截至 2024 年 12 月 31 日止年度的毛利為 2.196 億美元,而上一年為 8,890 萬美元,這意味著 2024 財年的毛利率為 51.5%,而 2023 財年的毛利率為 34.4%。
The improvement in gross margin is primarily driven by a significantly more favorable mix of higher margin IG sales in 2024 as compared to 2023. Along with operating efficiencies achieved resulting in a reduction in manufacturing costs, adjusted EBITDA was $48.3 million for the quarter ended December 31, 2024, as compared to adjusted EBITDA of $18.6 million for the quarter ended December 31, 2023.
毛利率的提高主要得益於 2024 年與 2023 年相比,IG 銷售額利潤率更高的組合更有利。隨著營運效率的提高導致製造成本的降低,截至 2024 年 12 月 31 日的季度的調整後 EBITDA 為 4830 萬美元,而截至 2023 年 12 月 31 日的季度的調整後 EBITDA 為 1860 萬美元。
Adjusted EBITDA for the quarter includes all non-GAAP reconciliation items including stock-based compensation, depreciation, amortization, interest expense, and loss-on-debt extinguishment.
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。
Adjusted EBITDA was $164.6 million for the year ended December 31, 2024, as compared to $40.2 million for the year ended December 31, 2023, an improvement of $124.4 million. The increase was primarily due to the substantial increase in operating income.
截至 2024 年 12 月 31 日止年度的調整後 EBITDA 為 1.646 億美元,而截至 2023 年 12 月 31 日止年度的調整後 EBITDA 為 4020 萬美元,增加了 1.244 億美元。成長的主要原因是營業收入大幅增加。
GAAP net income was $111.9 million for the quarter ended December 31, 2024, compared to a net loss of $17.6 million for the quarter ended December 31, 2023. The increase was primarily due to higher operating income, lower interest expense, a reduced loss on the extinguishment of debt, and an income tax benefit.
截至 2024 年 12 月 31 日的季度,GAAP 淨收入為 1.119 億美元,而截至 2023 年 12 月 31 日的季度淨虧損為 1,760 萬美元。成長主要歸因於營業收入增加、利息支出減少、債務清償損失減少、所得稅優惠。
GAAP net income was $197.7 million for the year end on December 31, 2024, as compared to a net loss of $28.2 million for the year ended December 31, 2023, an increase of $225.9 million. The increase was primarily due to an increase in operating income, lower interest expense, a reduced loss on the extinguishment of debt, and an income tax benefit as compared to fiscal year 2023.
截至 2024 年 12 月 31 日止年度,GAAP 淨收入為 1.977 億美元,而截至 2023 年 12 月 31 日止年度的淨虧損為 2,820 萬美元,增加了 2.259 億美元。與 2023 財年相比,成長的主要原因是營業收入增加、利息支出降低、債務清償損失減少以及所得稅優惠。
Adjusted net income was $33.4 million for the quarter ended December 31, 2024, as compared to an adjusted net income of $8.5 million for the quarter ended December 31, 2023. Adjusted net income was $119.2 million for the year ended December 31, 2024, as compared to adjusted net income of $0.7 million for the year ended December 31, 2023, an increase of $118.5 million.
截至 2024 年 12 月 31 日的季度調整後淨收入為 3,340 萬美元,而截至 2023 年 12 月 31 日的季度調整後淨收入為 850 萬美元。截至 2024 年 12 月 31 日止年度的調整後淨收入為 1.192 億美元,而截至 2023 年 12 月 31 日止年度的調整後淨收入為 70 萬美元,增加了 1.185 億美元。
As Adam mentioned, we opportunistically and strategically increase medical education and promotion activities during the fourth quarter in advance of anticipated increases in high tide or plasma supply. Accordingly, we would expect the normalized OpEx run rate to be lower than spend reported in the fourth quarter.
正如亞當所提到的,我們在第四季度抓住機會,策略性地增加了醫學教育和推廣活動,以應對預期的高潮或血漿供應增加。因此,我們預計標準化的營運支出運行率將低於第四季度報告的支出。
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.
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。
Based on the robust $48 million of operating cash flow generated during the fourth quarter and significant adjusted EBITDA growth, the company has currently reached a net cash surplus position relative to the $75 million in total debt, outstanding with Ares Capital.
基於第四季度產生的 4,800 萬美元強勁營運現金流和顯著的調整後 EBITDA 成長,該公司目前相對於 Ares Capital 未償還的 7,500 萬美元總債務已達到淨現金盈餘狀況。
Over the course of 2025 and beyond, we anticipate significant growth in our cash balance, which lends optionality to continue to reduce ADMA's weighted average cost of capital and advance all-growth initiatives from a position of strength.
在 2025 年及以後,我們預計現金餘額將大幅增長,這為我們繼續降低 ADMA 的加權平均資本成本和從優勢地位推進全增長計劃提供了選擇權。
Expounding on Adam's earlier comments regarding the auditor transition, we are pleased to have engaged and onboarded a new, big-four, independent audit firm KPMG.
闡述亞當先前關於審計師過渡的評論,我們很高興能夠聘用並加入一家新的四大獨立審計公司畢馬威 (KPMG)。
Given the relatively accelerated window for the audit process, following KPMG's onboarding in the fourth quarter of 2024, the delay in the filing of the Form 10-K is due to a combination of factors relating to the company's need for additional time to test and document the company's controls associated with its use of and reliance upon certain third-party service providers and to complete its assessment of the effectiveness of internal controls over financial reporting as of December 31, 2024.
鑑於畢馬威於 2024 年第四季度加入後審計流程相對較快,10-K 表格提交的延遲是由於多種因素造成的,這些因素包括公司需要更多時間來測試和記錄公司在使用和依賴某些第三方服務提供商方面的控制措施,並完成對截至 2024 年 12 月 31 日財務報告內部控制有效性的評估。
As a result of the foregoing, KPMG has not yet completed its audit procedures. We look forward to our next chapter with KPMG. And we thank the KPMG audit team for their efforts to date and for their dedication to their review of our financials which we reported today. With that, I will now turn the call back over to Adam for closing remarks.
鑑於上述情況,畢馬威尚未完成其審計程序。我們期待與畢馬威攜手開啟新的篇章。我們感謝畢馬威審計團隊迄今為止的努力以及他們對我們今天報告的財務狀況的審查。現在,我將把電話轉回給亞當,請他作最後發言。
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
Thank you, Brad. Our unwavering commitment to patient care, innovation, and operational excellence should continue to drive meaningful growth and long-term value creation. Positioned for anticipated both near and long-term success, we are focused on sustaining revenue growth, expanding margins, and accelerating earnings throughout 2025 and beyond.
謝謝你,布拉德。我們對病患照護、創新和卓越營運的堅定承諾應繼續推動有意義的成長和長期價值創造。我們致力於實現預期的近期和長期成功,專注於在 2025 年及以後維持收入成長、擴大利潤率和加速獲利。
We believe our strong balance sheet, growing net cash position, and robust intellectual property estate provide the financial strength and flexibility to support this trajectory while ensuring reliable access to our life-saving biologic therapies.
我們相信,我們強勁的資產負債表、不斷增長的淨現金狀況以及強大的知識產權資產將提供財務實力和靈活性來支持這一發展軌跡,同時確保可靠地獲得我們拯救生命的生物療法。
Looking at the current political and corporate borrowing backdrop and ADMA's net cash surplus compared to our gross debt, coupled with our top-tier revenue and earnings growth outlook, we believe the company is reasonably insulated and well positioned to continue to outperform and execute on its robust strategies, focus on delivering innovative and life-saving therapies for patients, ultimately delivering stockholder value.
縱觀當前的政治和企業借貸背景以及 ADMA 相對於我們總債務的淨現金盈餘,再加上我們頂級的收入和盈利增長前景,我們相信該公司具有合理的保護能力,並有能力繼續表現出色並執行其強勁的戰略,專注於為患者提供創新和拯救生命的治療方法,最終實現股東價值。
We believe we have established a durable and diversified raw material plasma supply, anchored by long-term agreements and record internal collections. This critical plasma supply footprint underpins our commercial expansion and strengthens our growth outlook.
我們相信,我們已經建立了持久且多樣化的原料血漿供應,並以長期協議和創紀錄的內部收集為基礎。這關鍵的血漿供應足跡支撐了我們的商業擴張並增強了我們的成長前景。
The potential mid-year regulatory approval of our enhanced yield IG manufacturing process could further amplify efficiencies and deliver additional increases to our currently reported financial guidance.
我們的高收益 IG 製造流程可能在年中得到監管部門的批准,這可能會進一步提高效率,並進一步提高我們目前報告的財務指導。
Increased availability of high tide or plasma should position us to broaden patient access, accelerate the pace of new patient starts among the growing perspective ascent of patient Q, deepen market penetration, as well as advance our capital efficient R&D pipeline with the utmost confidence.
高潮或血漿供應量的增加使我們能夠拓寬患者的治療管道,在 Q 患者日益增長的前景中加快新患者的開始速度,深化市場滲透,並以最大的信心推進我們資本高效的研發管道。
Looking ahead, we aim to leverage our innovative US-based business model, agile production platform, and in-house R&D to unlock new growth opportunities and maximize long-term stockholder value.
展望未來,我們旨在利用我們創新的美國商業模式、敏捷的生產平台和內部研發來釋放新的成長機會並最大化長期股東價值。
Our strategic focus on donor retention, third-party plasma procurement partnerships, and scalable production capabilities support our expected path toward a $1 billion plus revenue milestone as rapidly as possible, positioning us to meet growing demand while creating lasting value for patients, providers, and stockholders.
我們的策略重點是捐贈者保留、第三方血漿採購合作夥伴關係和可擴展的生產能力,支持我們盡快實現 10 億美元以上的收入里程碑,使我們能夠滿足不斷增長的需求,同時為患者、供應商和股東創造持久的價值。
Thank you, all, for your continued support and dedication. Together, we will continue to build on ADMA's success. Operator, we'd now like to open up the call for questions.
謝謝大家一直以來的支持與奉獻。我們將共同努力,繼續鞏固 ADMA 的成功。接線員,我們現在想開始提問。
Operator
Operator
Thank you. Today's question and answer session will be conducted electronically. (Operator Instructions)
謝謝。今天的問答環節將以電子方式進行。(操作員指示)
Kristen Kluska, Cantor Fitzgerald.
克里斯汀·克魯斯卡,坎托·菲茨杰拉德。
Kristen Kluska - Analyst
Kristen Kluska - Analyst
Hi. Good afternoon, everybody. Hey, Adam, so thanks for taking the questions. I have a few. I guess first of the third-party supply contracts you have, can you give us a sense of how many are currently up and running today and and the cadence we should expect in 2025?
你好。大家下午好。嘿,亞當,謝謝你回答這些問題。我有幾個。我想首先,在您擁有的第三方供應合約中,您能否告訴我們目前有多少合約正在運行,以及我們應該在 2025 年預期的節奏是多少?
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
So we are advancing very, very rapidly, Christen. We are certainly more than 50% of the way there. We're beating internal estimates. Our testing throughput is increasing rapidly.
所以,我們正在非常非常迅速地前進,克里斯汀。我們已經完成了超過 50% 的路程。我們超出了內部預期。我們的測試吞吐量正在快速增加。
We've really done a great job. My scientific and technical ops team is burning the midnight oil. We've onboarded some more staff, running more shifts to turn around testing faster. The more testing we can handle, the faster we can onboard these collection centers.
我們確實做得很好。我的科學技術操作團隊正在加班。我們招募了更多員工,安排了更多輪班,以更快地完成測試。我們能夠進行的測試越多,我們就能越快啟用這些收集中心。
So, as to the number, I don't have the exact number handy. But it's certainly well more than 50% of the centers that we were looking to add. It's conservative in our guidance estimates. We are to like -- I saw some data today. We are collecting more plasma. At this stage of the year, it's actually quite remarkable what the team and our third-party suppliers have been able to do.
所以,至於數字,我手邊沒有確切的數字。但我們想要添加的中心數量肯定遠遠超過 50%。我們的指導估計是保守的。我們喜歡——我今天看到了一些數據。我們正在收集更多的血漿。今年以來,我們的團隊和第三方供應商所取得的成就確實令人矚目。
So if these trends hold, I think that there could be upsides to guidance certainly for 2026. With more plasma, we can make more drug. And we believe that the demand trends are continuing into the first quarter of this year. And we're really seeing great uptake in a set of utilization, so far.
因此,如果這些趨勢持續下去,我認為 2026 年的指引肯定會有上行空間。有了更多的血漿,我們就可以生產更多的藥物。我們相信,這種需求趨勢將持續到今年第一季。到目前為止,我們確實看到了利用率的巨大提升。
Kristen Kluska - Analyst
Kristen Kluska - Analyst
Thank you, appreciate that. And then maybe just help us to understand, I know in the press release you made a comment you expect new patients to start on incentive in line with this. So can you characterize -- is there a waiting list of patients that we know are qualified for the treatment, just waiting?
謝謝,非常感謝。然後也許只是幫助我們理解,我知道在新聞稿中您發表了評論,您希望新患者能夠按照此方式開始獲得激勵。那麼,您能否描述一下——是否有一份我們知道符合治療條件的患者候診名單,只是在等待?
Because I know in the past, all the supply on hand was essentially making sure the patients on drug would continue to receive it. So how might that change now that you have more supply, potentially?
因為我知道,過去,所有現有的供應基本上都是為了確保服藥的患者能夠繼續得到藥物。那麼,現在有了更多的供應,情況可能會發生怎樣的變化呢?
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
So the queue is growing. I mean plain and simple. I said it. Brad said it in the prepared remarks.
因此排隊的人越來越多。我的意思很簡單。我說了。布拉德在準備好的發言稿中說了這番話。
The queue of prospective patients is growing. And we are onboarding more of these patients than we were, previously. And you're going to see that start to accelerate over the coming months as we're collecting more plasma, putting more pools into the tanks for incentive.
排隊等待治療的患者人數正在增加。與以前相比,我們接收了更多的此類患者。隨著我們收集更多的血漿,將更多的血漿池放入儲罐中以提供激勵,你會看到這一進程在未來幾個月內開始加速。
You're going to see us rapidly increasing this. The demand KPIs are growing at accelerated rates. We feel really, really good about this. I mean, look, we make a good drug that helps people. And it's continuing to help people pay our coverage, still is robust and everything looks positive, Kris.
您會看到我們正在快速增加這一數字。需求 KPI 正在加速成長。我們對此感到非常非常好。我的意思是,你看,我們生產出了一種可以幫助人們的好藥。它繼續幫助人們支付我們的保險費用,仍然很強勁,一切看起來都很積極,克里斯。
We feel really good about new patients being identified, new patients starts and the ability to ensure the continuity of supply for the duration of their treatment.
我們對新患者的發現、新患者的開始以及確保治療期間供應的連續性的能力感到非常高興。
Kristen Kluska - Analyst
Kristen Kluska - Analyst
Thanks. And last question from me, if I may, just do you have a sense of when a new doctor treats a patient with incentive, how many more on average under their care do they end up recommending the therapy to once they see the benefits firsthand themselves? Thanks again.
謝謝。我的最後一個問題,如果可以的話,您是否知道,當一位新醫生以激勵的方式治療患者時,在他們親眼看到這種療法的好處後,平均有多少位接受他們治療的患者會向他們推薦這種療法?再次感謝。
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
So great question. And again, it's practice dependent. But the majority of the docs who our sales force and our medical affairs team calls upon roughly about 10% of their patient population has the criteria and the comorbidities and other risk factors that could trend, that incentive could provide benefits to them.
這個問題問得真好。再次強調,這取決於實踐。但是,我們的銷售人員和醫療事務團隊所拜訪的大多數醫生大約佔其患者總數的 10%,他們符合相關標準,並且患有合併症和其他可能出現的風險因素,這種激勵措施可以為他們帶來好處。
We feel that many docs now, who have experience with one or two patients are queuing up. You know, patients 3,4,5 plus. Depth and breadth are going to continue to grow at the same institutions, at the same clinics.
我們感覺現在很多有治療一兩個病人經驗的醫生都在排隊。您知道,患者 3、4、5 以上。在相同的機構、相同的診所,深度和廣度將持續成長。
And we really do believe that there's a lot of white space in front of us. I mean we see the demand out there. We still have the engagement at the scientific and medical conferences. This is coming from a data-driven place. The data is being analyzed through our analytic system. And we feel really good about forward-looking opportunities here.
我們確實相信,我們的面前還有很大的空白空間。我的意思是我們看到了那裡的需求。我們仍然參與科學和醫學會議。這是來自數據驅動的地方。數據正在透過我們的分析系統進行分析。我們對這裡的前瞻性機會感到非常滿意。
I mean we wouldn't be increasing guidance if we didn't think we could collect the plasma or have the patients in queue, waiting for therapy. So everything looks good.
我的意思是,如果我們認為無法收集血漿或讓患者排隊等待治療,我們就不會增加指導。所以一切看起來都很好。
If demand trends continue, I think that you could expect the same cadence from us. And you know, we're taking the same conservative approach to guidance as we always have. And we feel really good about our positioning to exceed the numbers that we're putting in front of stockholders today.
如果需求趨勢持續下去,我認為您可以期待我們保持同樣的節奏。你知道,我們一如既往地採取保守的指導態度。我們對我們的定位感到非常滿意,我們能夠超越今天向股東提出的數字。
Kristen Kluska - Analyst
Kristen Kluska - Analyst
Thanks. And congrats on a great year.
謝謝。恭喜您度過了美好的一年。
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
Thank you, Kristen, very much. We appreciate your support.
非常感謝你,克里斯汀。感謝您的支持。
Operator
Operator
Anthony Petrone, Mizuho.
瑞穗的安東尼‧佩特羅內 (Anthony Petrone)。
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
How are you?
你好嗎?
Anthony Petrone - Analyst
Anthony Petrone - Analyst
Thanks and doing well, Adam. Thank you very much. Good afternoon, everyone on the call. And I echo that congratulations on a great 2024. Maybe Adam will start with the long-term guidance, what's in there and what's not in there? My understanding is the $605 million for '26, $495 million-plus this year and the billion target.
謝謝,亞當,你做得很好。非常感謝。各位來賓,大家下午好。我也祝賀 2024 年圓滿成功。也許亞當會從長期指導開始,其中有什麼,其中沒有什麼?我的理解是,26 年的投資額為 6.05 億美元,今年的投資額將超過 4.95 億美元,最終目標是 10 億美元。
Is at least somewhat inclusive of the extended supply agreements but does not include yield enhancement? So maybe, I'll start there. And I'll have a couple of follow-ups.
是否至少在一定程度上包括延長供應協議但不包括產量提高?所以也許我會從那裡開始。我也會進行一些後續跟進。
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
That is certainly fair, Anthony. We're conservative on the third-party supply. As I mentioned earlier, we are seeing accelerated collections at the present time. This may ebb and flow. There may be some seasonality. But at the end of the day, the numbers for '25 certainly do exclude yield enhancement.
這當然很公平,安東尼。我們對第三方供應持保守態度。正如我之前提到的,我們目前正在看到收集速度加快。這種情況可能會有所起伏。可能存在一些季節性。但最終,25 年的數據肯定不包括收益率的提高。
If at all, we've said back half of the year, we could see some accretion. Assuming a mid-year approval, there are some levers to pull where that could potentially be the earlier. 2026 yield enhancement is heavily-risk adjusted.
如果有的話,我們已經說過,今年上半年,我們可能會看到一些成長。假設該法案能夠在年中得到批准,那麼就有一些因素需要利用,而且批准時間可能會提前。 2026 年收益率提升受到嚴格風險調整。
So we do think that for 2026 if you factor in yield enhancement with the collection volume at its current pace, there could be some significant upside.
因此,我們確實認為,到 2026 年,如果將殖利率的增加與目前的收款量結合起來,可能會出現顯著的上漲空間。
Anthony Petrone - Analyst
Anthony Petrone - Analyst
Yeah, that would be my -- the follow up there on yield enhancement, maybe just explore that opportunity a little bit? My understanding is the effort here is in and around 3/4 of a gram per liter, is that number right?
是的,那將是我的——關於收益率提高的後續行動,也許只是稍微探索一下這個機會?我的理解是這裡的努力大約是每公升 3/4 克,這個數字對嗎?
And when you run that math on current BIVIGAM and incentive pricing on an annualized basis, not saying this is what the upside is, but the math sort of points to something in the [100 to 300 million] range, depending on what that mix between a cent of and BIVIGAM is.
當您按年化方式對當前 BIVIGAM 和激勵定價進行計算時,並不是說這就是好處,而是計算結果指向 [1 億到 3 億] 範圍內的某個數字,具體取決於一分錢和 BIVIGAM 之間的組合。
So is 3/4 of a gram, the right way to think about it? And if that is the case, how do you think that new yield coming out will be split between ASCENIV and BIVIGAM and NABI?
那麼 3/4 克是正確的思考方式嗎?如果是這樣的話,您認為新的收益將如何在 ASCENIV、BIVIGAM 和 NABI 之間分配?
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
So, well, the first thing I'll say is it's excluded from NABI. NABI's process isn't changing. We're not utilizing yield enhancement for NABI. It is a 20% effective incremental bulk product yield. So on the back of an envelope, I know you're using a number of about 3.8 is how I'm backing into your math. So in theory, yes, it's close.
所以,嗯,我要說的第一件事是它被排除在 NABI 之外。NABI 的流程沒有改變。我們不會利用 NABI 的收益增強。這是有效增量散裝產品產量的 20%。因此,在信封背面,我知道您使用的數字大約是 3.8,這就是我對您的數學計算的支持。所以從理論上來說,是的,很接近。
That would be a fair estimate from a bulk-drug increase. Again, no incremental FTEs required. The infrastructure is in place.
從原料藥成長量來看,這是合理的估計。同樣,不需要增加 FTE。基礎設施已經到位。
We spent a large portion of our shutdown time period over the Christmas holiday, New Year's holidays, upgrading the facility. And we feel in a great position for regulatory approval mid-year. And the ability to hit the switch on day one when we're ready to produce these yield, enhanced batches.
我們利用聖誕節和新年假期等停工期間的大部分時間來升級設施。我們感覺在年中獲取監管部門批准方面處於有利地位。當我們準備好生產這些產量並提高批次時,第一天就可以按下開關。
The FDA dialogue has been constructive. We feel good about timing for approval. But again, for your question concerning guidance for this year.
FDA 的對話是建設性的。我們對獲得批准的時機感到滿意。但再次,對於您關於今年指導的問題。
It's certainly conservative. You asked about mix. I mean, look, BIVIGAM continues to be the majority of the plant's throughput. But as we collect more high tide or plasma, we are seeing additional incentive batches being added to the production schedule all the time.
這當然是保守的。您詢問的是混合。我的意思是,BIVIGAM 繼續佔據該工廠產量的大部分。但隨著我們收集更多的高潮或血漿,我們看到額外的激勵批次不斷被添加到生產計劃中。
I know I probably sound like a broken record when I'm saying that, but that's how it's working right now. When we get enough plasma that meets a pool, we're putting another batch of ASCENIV into the tank. So we're borrowing from BIVIGAM slots. to make a more incentive as we collect more plasma.
我知道我這麼說可能聽起來像在重複老話,但現在情況就是這樣的。當我們獲得足夠的血漿以滿足血漿池的要求時,我們會將另一批 ASCENIV 放入儲存槽中。因此我們借鏡了 BIVIGAM 插槽。當我們收集更多的血漿時,我們會獲得更大的誘因。
But the mix is continuing to shift from a production throughput standpoint, certainly the top line mix incentive continues to outpace BIVIGAM, dramatically.
但從生產吞吐量的角度來看,產品組合不斷轉變,毫無疑問,頂線產品組合誘因持續大幅超過 BIVIGAM。
Anthony Petrone - Analyst
Anthony Petrone - Analyst
Excellent. And I'll hop back in into this shift to Brad. And Brad, just your high-level views as you get yield enhancement to come in, new supply coming in, how do you think about working capital?
出色的。我將重新回到布拉德的轉變中。布拉德,從您的高層次觀點來看,隨著收益率的提高和新供應的湧入,您如何看待營運資金?
How much of that gets caught in the inventory process and just your latest thoughts on the cap structure, particularly you have high-yield debt? Just thinking about your thoughts there on potentially when you could see a refinance. Thanks again, guys. Congrats.
其中有多少是在庫存過程中被捕獲的,您對上限結構有什麼最新想法,特別是對於高收益債務?只是想問您關於何時可能進行再融資的想法。再次感謝大家。恭喜。
Brad Tade - Chief Financial Officer & Treasurer
Brad Tade - Chief Financial Officer & Treasurer
Sure, thanks. Thanks, Anthony. I mean going talking about yield enhancement first, right? I mean what Adam is saying is we're going to get 20% more IG from the same starting point. So we will carry a little higher inventory as we continue to produce when we start producing yield enhancing materials.
當然,謝謝。謝謝,安東尼。我的意思是先談談提高產量,對嗎?我的意思是亞當所說的是,我們將從同一起點獲得 20% 以上的 IG。因此,當我們開始生產提高產量的材料時,我們會在繼續生產的同時保留稍高的庫存。
So that -- it's not going to put a lot of pressure. But it'll put slight pressure upwards on our inventory levels. In terms of the cap structure, right, we have always said we are going to generate cash this year. We feel very confident in our ability to continue to generate significant cash, especially coming into 2025.
所以——它不會帶來太大壓力。但這會對我們的庫存水準造成輕微的壓力。就上限結構而言,我們一直說我們今年將會產生現金。我們對自己繼續產生大量現金的能力非常有信心,尤其是進入 2025 年。
And we are going to be opportunistic with that cash and we are going to look for continue to look for ways as we've always said to maximize shareholder value, whether that's paying down debt or doing other things. But again, we will, we are going to be very opportunistic with the cash that we're generating. And our goal is to continue to generate shareholder value.
我們將利用這些現金,並將繼續尋找方法,正如我們一直所說的那樣,實現股東價值最大化,無論是償還債務還是做其他事情。但我們會再這樣做,我們會非常珍惜我們創造的現金。我們的目標是繼續為股東創造價值。
Anthony Petrone - Analyst
Anthony Petrone - Analyst
Thanks again.
再次感謝。
Operator
Operator
Gary Nachman, Raymond James.
蓋瑞納赫曼、雷蒙詹姆斯。
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
Hi, Gary. I look forward to seeing you.
你好,加里。我期待見到你。
Gary Nachman - Analyst
Gary Nachman - Analyst
Yeah, definitely. So, thank you. My congrats as well on the progress. So Adam, first, just I'm curious, how big is that queue for new patients, waiting to get treated with ASCENIV?
是的,確實。所以,謝謝你。我也對所取得的進展表示祝賀。那麼亞當,首先,我很好奇,等待接受 ASCENIV 治療的新患者團隊有多大?
So how much has it been growing, relative to the current patients that are getting treated. And what do they do in the meantime while they're waiting? Any risk that you lose them if that cue builds too long?
那麼相對於目前接受治療的患者來說,成長了多少呢?那麼他們在等待的同時會做什麼呢?如果球桿太長,是否有失去球桿的風險?
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
So all great questions. I can say that the queue is robust. And there are more patients than I'm able to supply today. What are these patients doing? I mean, they are on their standard IG therapy. They continue to maintain on the same drug that they've been receiving. And That's the way that that it's been going.
這些都是很棒的問題。我可以說,這個隊列很強大。而且病人的數量也超出了我今天能夠照顧的範圍。這些病人在做什麼?我的意思是,他們正在接受標準的 IG 治療。他們繼續服用他們一直在服用的相同藥物。事情就是這樣發生的。
These patients are on regular immunoglobulin which currently is pretty well supplied right now in the marketplace. So there's no risk that these patients are going to switch off to something else. I mean, there is no other alternative for these patients, besides IVIG replacement therapy.
這些患者正在接受常規免疫球蛋白治療,目前市面上的免疫球蛋白供應充足。因此,這些患者不會有轉而使用其他藥物的風險。我的意思是,除了 IVIG 替代療法之外,這些患者沒有其他選擇。
So they typically stay on the immune globulin that they're currently on. And when we have product supply availability, coupled with reimbursement approval, we're switching them to incentives. So these patients are at various stages. I mean we have doctors who identify these patients.
因此他們通常會繼續使用目前使用的免疫球蛋白。當我們有產品供應並且獲得報銷批准時,我們就會將其轉化為激勵措施。這些患者處於不同的階段。我的意思是我們有醫生可以辨識這些病人。
And we work back and forth with the payer to iron out any letter of medical necessity and Debate and argue there with some of the commercial payers. But at the end of the day, if the patients meet the criteria that we've been talking about, have [coped] significant comorbidities, have chronic persistent, infections, are in and out of the hospital.
我們反覆與付款人溝通,解決醫療必要性問題,並與一些商業付款人進行辯論和爭論。但最終,如果患者符合我們一直在談論的標準,患有嚴重的合併症,患有慢性持續性感染,就可以入院或出院。
We're seeing these patients added without too much pushback. So we're really super pleased with access right now. We're super pleased with the reimbursement profile throughout 2024 and into 2025. The calendar flip has not thrown up any flags for us at this point. And we continue to make progress.
我們看到這些患者的增加並沒有遇到太多阻力。所以我們對目前的訪問感到非常滿意。我們對 2024 年至 2025 年的報銷情況非常滿意。到目前為止,日曆翻頁還沒有為我們帶來任何警告。我們還在不斷取得進步。
I mean, look, we're pretty bullish. I mean increasing guidance again, we just gave guidance to JPMorgan. Now, we're increasing guidance again a couple of weeks later.
我的意思是,你看,我們非常樂觀。我的意思是再次增加指導,我們剛剛向摩根大通提供了指導。現在,幾週後我們再次提高了指導。
And I think that that has to do with the confidence of number 1, we're getting more plasma than we anticipated. Number 2, demand trends continue to increase and improve, and I mean, every Monday, I get my distribution data.
我認為這與第一名的信心有關,我們獲得的血漿比我們預期的要多。第二,需求趨勢持續增加和改善,我的意思是,每個星期一,我都會獲得分發資料。
And I've been a happy guy every Monday, which is very rare for me having to come back to the office. So hopefully, that answers your question.
我每個星期一都很開心,這對我來說很少需要回到辦公室。希望這能回答你的問題。
Brad Tade - Chief Financial Officer & Treasurer
Brad Tade - Chief Financial Officer & Treasurer
Yeah. In addition to the two points that Adam just called out in his level of confidence, I mean, the other key point is we are extremely confident in the ADMA's team's ability to continue to execute and continue to execute at a high level.
是的。除了亞當剛才在信心層面提到的兩點之外,另一個關鍵點是我們對 ADMA 團隊繼續執行並繼續高水準執行的能力非常有信心。
And when that happens, and it will, we will continue to drive year-over-year revenue growth and expanded margins. So the confidence not only in collecting plasma and the payer situation, but we are extremely confident in our team's ability to execute at a high level.
當這種情況發生時,我們將繼續推動營收年增和利潤率擴大。因此,我們不僅在收集血漿和付款人情況方面有信心,而且對我們團隊的高水平執行能力也非常有信心。
Gary Nachman - Analyst
Gary Nachman - Analyst
Okay. Great. And then, as the mix is obviously shifting a lot more to incentive, where do you expect growth margins to be for this year? And I mean if you could give us some high-level guidance for next year as well, and how much do the supply agreements impact that? And how will those, I guess, be staggered over the course of the next one to two years within your guidance?
好的。偉大的。然後,由於組合顯然更多地轉向激勵,您預計今年的成長幅度會是多少?我的意思是,如果您能為我們提供明年的一些高層指導,供應協議對此有多大影響?我想,在您的指導下,未來一到兩年內這些措施將如何分階段實施?
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
I mean incentive -- incentives gross margins, Gary, are you know 80%, 85%-plus this side of yield enhancement. The impact of the supply agreements, you know, it's not tremendous at all. I mean it's really -- we're paying market prices for what we've been paying for this plasma.
我的意思是激勵——激勵毛利率,蓋瑞,你知道 80%、85% 以上是收益提升的這一方面。你知道,供應協議的影響根本不大。我的意思是,我們為這種等離子體支付的價格確實是市場價格。
All along, I mean there is not much added from a cost perspective. Brad can correct me if I'm wrong there, but we feel really good about this. You're going to see a Senate continue to drive to become a substantial overwhelming majority.
一直以來,我的意思是從成本角度來看並沒有增加太多。如果我錯了,布拉德可以糾正我,但我們對此感覺很好。你會看到參議院繼續努力爭取壓倒性多數。
It is the overwhelming majority. It's going to continue to grow. It's going to continue to grow because number 1, we're not producing as much BIVIGAM and we're producing ASCENIV. And we believe that all-demand indicators that it's going to pull through at a rapid pace.
這是絕大多數。它還將繼續增長。它將繼續成長,因為第一,我們生產的 BIVIGAM 不多,而我們生產的是 ASCENIV。我們相信,所有需求指標都顯示它將快速度過難關。
Number 2, when you bolt on yield enhancement, which we anticipate should occur. I mean, the FDA dialogue has had been pretty good. We feel very confident about the likelihood of approval, albeit people still stay employed at FDA.
第二,當你提高產量時,我們預期會發生這種情況。我的意思是,FDA 的對話一直都很順利。儘管仍有人員留在 FDA 工作,但我們對獲得批准的可能性非常有信心。
But we really are looking at gross margins from the standpoint of they're only going to expand. There is nothing that we see in the foreseeable near term that's going to impact our ability to deliver these 80%-plus gross margins on incentive as we continue to go forward.
但我們確實是從毛利率只會擴大的角度來看毛利率的。在可預見的短期內,我們認為沒有任何事情會影響我們繼續前進並實現 80% 以上的激勵毛利率的能力。
Brad Tade - Chief Financial Officer & Treasurer
Brad Tade - Chief Financial Officer & Treasurer
And just furthermore, I mean the 20% additional yield going with yield enhancement significantly outpaces any investments that we make in RSV, any investments that we make in the yield enhancement process itself. So that 20% extra IG from yield enhancement is going to be very favorable and accretive to margins going forward.
此外,我的意思是,收益率提高所帶來的 20% 的額外收益率大大超過了我們在 RSV 上所做的任何投資,以及我們在收益率提高過程本身上所做的任何投資。因此,收益率提高帶來的 20% 額外 IG 將非常有利,並有助於提高未來的利潤率。
Gary Nachman - Analyst
Gary Nachman - Analyst
Okay. Great. And then just two more quick ones just on the FDA review here, for the enhanced yield process, do they have to do any sort of inspection? I mean, you -- you're very confident with this major timeline, so I just want to make sure of that.
好的。偉大的。然後,關於 FDA 的審查,我們再快速問兩個問題,對於提高產量的過程,他們是否必須進行任何形式的檢查?我的意思是,你——你對這個主要時間表非常有信心,所以我只是想確保這一點。
And then just on 001, when do you think you're going to have that animal data? And how soon could it potentially enter the clinic? Thanks.
那麼就在 001,您認為什麼時候可以獲得這些動物數據?它什麼時候才有可能進入臨床應用?謝謝。
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
All great questions. So we're not aware of a requirement for a pre-approval inspection for this submission. We haven't been notified at all from FDA yet, that they're going to do a PAI. And we're well into the review cycle here, so we feel pretty good about our positioning.
這些都是很棒的問題。因此我們不知道此項提交是否需要預先批准檢查。我們尚未收到 FDA 的任何通知,他們將進行 PAI。我們已經進入審查週期,因此我們對自己的定位感到非常滿意。
I don't think that they're going to come, but you never know. Maybe they're going to listen to this and they're going to show up. But we feel good about the ability to pass any FDA inspections, Gary. And we wouldn't be this confident and my compliance team and regulatory team wouldn't let me say the things that I'm saying today.
我不認為他們會來,但誰也不知道。也許他們會聽到這個並且會出現。但是我們對通過任何 FDA 檢查的能力感到很滿意,加里。我們不會這麼有自信,我的合規團隊和監管團隊也不會允許我說今天這些話。
If we didn't feel like we were having a robust, active, positive dialogue with the agency. So they've got all the data. They've been reviewing data. We've been fielding information requests in the normal course back and forth all year, so far. And we feel very confident for an approval on time.
如果我們感覺沒有與該機構進行有力、積極、正面的對話。所以他們獲得了所有數據。他們一直在審查數據。到目前為止,我們全年都在正常地來回處理資訊請求。我們非常有信心能夠按時獲得批准。
With respect to SG-001, I had a meeting last week that made me very excited. We are moving very rapidly. We produced some bench scale lots of product at different potencies. And I've seen some preliminary testing data with those batches.
關於 SG-001,我上週參加了一次會議,這讓我非常興奮。我們的進展非常迅速。我們生產了一些不同效力的實驗室規模產品。我已經看到了這些批次的一些初步測試數據。
We hope to have the animal data, later this year. We haven't guided to the development timelines. But we do think that the contribution to revenue, which is the $1 billion dollar revenue target prior to 2030. We certainly do think that it's reasonably likely, that SG-001 could enter the clinic substantially, before then, and potentially be contributing revenue, and that's excluded from that $1 billion-plus revenue target.
我們希望今年稍後能夠獲得動物數據。我們還沒有指導開發時間表。但我們確實認為,這將對收入做出貢獻,即 2030 年之前實現 10 億美元的收入目標。我們確實認為,SG-001 很有可能在此之前大規模進入臨床階段,並可能帶來收入,但這不包括在 10 億美元以上的收入目標中。
So again, it's an additional upside lever. I have not been this excited about this opportunity. I've had blinders on for a while. I think our stockholders and staff knows that I've been pounding the desk, saying more plasma, more high tide or plasma, more incentive.
所以,這又是一個額外的上行槓桿。我從未對這個機會如此興奮過。我已經戴上眼罩一段時間了。我想我們的股東和員工都知道,我一直在敲桌子,說要更多的血漿,更多的高潮或血漿,更多的激勵。
This is the first time that I'm really super excited about the potential opportunity we have with our in-house R&D engine here. I really think that it's capital efficient. I think that there's a substantial unmet medical need.
這是我第一次對我們內部研發引擎的潛在機會感到非常興奮。我確實認為這是資本效率高的。我認為存在大量未滿足的醫療需求。
And if everything that the team is hypothesizing, if half of what the team is hypothesizing comes to fruition, we've got another winner on our hands here. So I'm really positive about the product. Let me get the animal data done. Let me get the donors vaccinated. Let me get plasma collected. And I promise you later this year we will update you with respect to the development timeline.
如果團隊的所有假設都得以實現,如果團隊假設的一半都得以實現,那麼我們就會再次獲得勝利。所以我對產品非常有信心。讓我把動物數據弄完。讓我給捐贈者接種疫苗。讓我去採集血漿。我向你們保證,今年稍後我們將向你們通報開發時間表。
Gary Nachman - Analyst
Gary Nachman - Analyst
Great. Thanks for all that color. Appreciate it.
偉大的。感謝所有這些色彩。非常感謝。
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
Thanks, Gary. I look forward to talking on Wednesday.
謝謝,加里。我期待週三的談話。
Operator
Operator
And ladies and gentlemen, this will conclude our question-and-answer portion of the call. I'd like to turn it back 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。我想把話題轉回給亞當,請他做最後的補充發言。
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
Adam Grossman - President, Chief Executive Officer, Co-Founder, Interim Chief Financial Officer, Director
I just want to thank the ADMA Biologics team. 2024 was a year that will go down in our history for writing our book. It's one hell of a chapter. And I appreciate you all for showing up and giving your best every day. To our stockholders, thanks for trusting us.
我只想感謝 ADMA Biologics 團隊。 2024 年是我們撰寫書籍並載入史冊的一年。這真是一個精彩的章節。我感謝你們所有人的到來並每天盡全力。對於我們的股東,感謝你們對我們的信任。
And we appreciate your investment in ADMA because it allows us to keep doing what we're doing. So thank you, everybody. Have a great evening.
我們感謝您對 ADMA 的投資,因為它使我們能夠繼續做我們正在做的事情。謝謝大家。祝您有個愉快的夜晚。
Operator
Operator
Ladies and gentlemen, this concludes the conference call for today. We appreciate your participation. 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。您現在可以斷開連線。