ADMA Biologics Inc (ADMA) 2024 Q3 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Thank you for standing by. My name is Celine and I will be your conference operator today. At this time I would like to welcome everyone to the ADMA Biologics Financial Results Third Quarter 2024. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer session. [Operator Instructions] Thank you.

    謝謝你的支持。我叫席琳,今天我將擔任你們的會議操作員。現在,我謹歡迎大家關注 ADMA Biologics 2024 年第三季財務業績。所有線路均已靜音,以防止任何背景噪音。演講者發言後,將進行問答環節。[操作說明] 謝謝。

  • I would now like to turn the call over to Skyler Bloom. Please go ahead.

    我現在想把電話轉給斯凱勒·布魯姆。請繼續。

  • Skyler Bloom - Senior Director

    Skyler Bloom - Senior Director

  • Welcome, everyone, and thank you for joining us this afternoon to discuss ADMA Biologics financial results for the third quarter of 2024 and recent corporate updates. 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 third quarter 2024 financial results. Finally, Adam will then provide some brief summary remarks before opening the call up for questions. Earlier today, we issued a press release detailing the third quarter 2024 financial results and summarized certain achievements in recent corporate updates. The release is available on our website at www.admabiologics.com.

    歡迎大家,感謝您今天下午加入我們,討論 ADMA Biologics 2024 年第三季的財務表現和最近的公司動態。今天,總裁兼執行長 Adam Grossman 也加入了我的行列。財務長兼財務主管 Brad Tade。在今天的電話會議中,Adam 將提供一些介紹性評論並提供有關公司進展的最新信息,然後 Brad 將概述該公司 2024 年第三季度的財務業績。最後,亞當將在開始提問之前提供一些簡短的總結評論。今天早些時候,我們發布了一份新聞稿,詳細介紹了 2024 年第三季的財務業績,並總結了最近公司更新中的某些成就。此版本可在我們的網站 www.admabiologics.com 上取得。

  • 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 SEC filings, 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.

    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聲明,這些聲明代表公司對未來事件的意圖、期望或信念,這些聲明就1995 年《私人證券訴訟改革法案》中的安全港條款而言。所有前瞻性陳述均受到因素、風險和不確定性的影響,例如今天宣布本次電話會議的新聞稿和我們向SEC 提交的文件中詳述的因素、風險和不確定性,這可能導致實際結果與此類陳述所明示或暗示的結果有重大差異。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。

  • We specifically disclaim any obligations to update any such statements except as required by the federal securities laws. We refer you to the Disclosure Notice section in our earnings release we issued today in the Risk Factors section of our quarterly report on Form 10-Q for the quarter ended September 30, 2024, 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. A reconciliation of these non-GAAP financial measures to the most directly comparable GAAP metric is available in our earnings release.

    除聯邦證券法要求外,我們明確不承擔更新任何此類聲明的義務。我們建議您參閱我們今天發布的收益報告中的披露通知部分,該部分位於截至2024 年9 月30 日的季度10-Q 表格季度報告的風險因素部分,其中討論了可能導致實際結果發生變化的重要因素。請注意,今天電話會議的討論包括某些非公認會計準則財務指標,包括調整後的 EBITDA。我們的收益報告中提供了這些非公認會計原則財務指標與最直接可比較的公認會計原則指標的調節表。

  • With that, I would now like to turn the call over to Adam Grossman. Adam, go ahead.

    現在,我想將電話轉給亞當·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.

    謝謝您,斯凱勒,歡迎大家參加今天的電話會議。

  • The third quarter has been another period of exceptional performance for ADMA. Total revenues reached $119.8 million reflecting an increase of 78% year-over-year. Adjusted EBITDA rose to $45.4 million, representing a growth rate of 256% from the previous year, while net income increased by 1,300% year-over-year to $35.9 million. We successfully achieved sequential growth from our second quarter financial baseline, both in revenue and earnings, further solidifying our position as one of the fastest growing and profitable companies in the biotech sector.

    第三季是 ADMA 又一個表現出色的時期。總營收達到 1.198 億美元,年增 78%。調整後 EBITDA 升至 4,540 萬美元,較上年增長 256%,淨利潤年增 1,300% 至 3,590 萬美元。我們在收入和利潤方面成功實現了第二季度財務基準的環比增長,進一步鞏固了我們作為生物技術領域增長最快和盈利最快的公司之一的地位。

  • These achievements are a testament to the dedication and hard work of our teams as well as the real world benefits that immunocompromised patients are experiencing on our therapies. We believe the future of ADMA has never been brighter and we are exceedingly optimistic about the opportunities that lie ahead. We believe our commitment to financial and operational excellence is reflected in these results. In turn, we are yet again revising our financial guidance upward for both 2024 and 2025.

    這些成就證明了我們團隊的奉獻和辛勤工作,以及免疫功能低下患者在我們的治療中所體驗到的現實益處。我們相信 ADMA 的未來從未如此光明,我們對未來的機會非常樂觀。我們相信,我們對卓越財務和營運的承諾反映在這些結果中。反過來,我們再次上調 2024 年和 2025 年的財務指引。

  • Based on current market trends, we now expect total revenues to exceed $415 million in 2024 and $465 million in 2025 with adjusted EBITDA projected to surpass $160 million and $215 million respectively in 2024 and 2025. We are also raising GAAP net income guidance for 2024 and 2025 to more than $120 million and $165 million respectively. As we expect to close out 2024 on a strong note and look forward to next year, we anticipate significant margin expansion driven by an ongoing revenue shift towards ASCENIV.

    根據當前市場趨勢,我們預計 2024 年總收入將超過 4.15 億美元,2025 年將超過 4.65 億美元,調整後 EBITDA 預計將在 2024 年和 2025 年分別超過 1.6 億美元和 2.15 億美元。我們也將 2024 年和 2025 年 GAAP 淨利潤指引分別提高至 1.2 億美元和 1.65 億美元以上。由於我們預計 2024 年將以強勁的勢頭結束,並展望明年,我們預計營收將持續轉向 ASCENIV,將推動利潤率大幅成長。

  • We see ASCENIV emerging as a potential billion dollar revenue opportunity with substantial growth headroom and branded durability potentially extending thereafter through the 2030s and beyond. Demand for ASCENIV is strengthening with forward-looking metrics broadly supporting sustained growth momentum. In response, we have strategically adjusted our production schedule providing for greater ASCENIV production throughput and as a result we anticipate an accelerating pace of earnings growth.

    我們認為 ASCENIV 正在成為一個潛在的數十億美元收入機會,具有巨大的成長空間和品牌耐久性,有可能延續到 2030 年代及以後。對 ASCENIV 的需求正在增強,前瞻性指標廣泛支持持續成長動能。為此,我們策略性地調整了生產計劃,以提高 ASCENIV 的生產量,因此我們預計獲利成長速度將加快。

  • To further bolster our supply availability, we’ve implemented plasma donor retention programs aimed at increasing high titer plasma collections within our network, which are already showing positive results. Additionally, we are actively partnering with third party plasma collectors to secure even more high titer plasma. These combined efforts reinforced our confidence in advancing ASCENIV’s rapid growth trajectory. We believe we are well prepared to meet the growing end user demand and deliver increasing units of ASCENIV to immunocompromised patients in need.

    為了進一步提高我們的供應可用性,我們實施了血漿捐贈者保留計劃,旨在增加我們網絡內的高滴度血漿採集量,該計劃已經顯示出積極的結果。此外,我們也積極與第三方血漿收集器合作,以確保獲得更高滴度的血漿。這些共同努力增強了我們推進 ASCENIV 快速成長軌蹟的信心。我們相信,我們已做好充分準備,可以滿足最終用戶不斷增長的需求,並向有需要的免疫功能低下患者提供越來越多的 ASCENIV 單位。

  • This quarter we also made significant progress with our yield enhancement production project as well as our strep pneumoniae hyperimmune globulin pipeline program, which we refer to as SG-001. We are pleased to announce that we successfully completed production of a pilot-scale batch of SG-001. Additionally, we’ve identified a prospective laboratory partner and we are engaged in discussions for their services in order to initiate animal model studies. Like with ASCENIV’s preclinical development, we believe the data obtained from animal model studies will provide an understanding of the potential for SG-001 and aid in identifying the appropriate development pathway for potential future human clinical evaluations.

    本季度,我們的增產生產計畫以及肺炎鏈球菌超免疫球蛋白管線計畫(我們稱之為 SG-001)也取得了重大進展。我們很高興地宣布,我們成功完成了 SG-001 批次的中試生產。此外,我們已經確定了一個潛在的實驗室合作夥伴,並且正在就他們的服務進行討論,以便啟動動物模型研究。與 ASCENIV 的臨床前開發一樣,我們相信從動物模型研究中獲得的數據將有助於了解 SG-001 的潛力,並有助於確定未來潛在人類臨床評估的適當開發途徑。

  • We remain confident that this program can be developed and brought to market in a highly capital efficient manner and if approved SG-001 could potentially generate $300 million to $500 million or more in high margin annual revenue. Also on the R&D front, I’m pleased to announce that all patients in ASCENIV’s post-marketing pediatric study have now successfully completed their treatment schedule and that the clinical trial database is on track to be locked during the fourth quarter of 2024. The successful enrollment and execution by our team further illustrates the strength of ADMA’s internal R&D engine and speaks to our highly capital efficient and nimble approach to the development of specialty biologics for patients in need.

    我們仍然相信,該計劃能夠以高度資本效率的方式開發並推向市場,如果獲得批准,SG-001 可能會產生 3 億至 5 億美元或更多的高利潤年收入。同樣在研發方面,我很高興地宣布 ASCENIV 上市後兒科研究中的所有患者現已成功完成治療計劃,並且臨床試驗數據庫預計將在第四季度鎖定2024 年。我們團隊的成功註冊和執行進一步說明了 ADMA 內部研發引擎的實力,並證明了我們為有需要的患者開發特殊生物製劑的高度資本效率和靈活方法。

  • ADMA now anticipates filing its efficacy supplement to ASCENIV’s biologic license application over the coming quarter quarters with potential label-expanding approval during the first half of 2026. ASCENIV’s pediatric label expansion, if approved, may further strengthen the product’s positioning and utilization in the immune compromised patient setting. Our immunoglobulin production yield enhancement initiative is also progressing as planned. We anticipate regulatory approval and the commencement of commercial sales of immunoglobulin produced from our innovative process during the second half of 2025, which could lead to a substantial increase in revenue and earnings growth beginning in the second half of 2025, with further acceleration projected into 2026 and beyond.

    ADMA 目前預計在未來幾季提交 ASCENIV 生物製品許可申請的功效補充,並可能在 2026 年上半年獲得標籤擴展批准。ASCENIV 的兒科標籤擴展如果獲得批准,可能會進一步加強該產品在免疫受損患者環境中的定位和利用。我們的免疫球蛋白產量提高計劃也按計劃進行。我們預計在2025 年下半年,我們的創新製程生產的免疫球蛋白將獲得監管部門的批准並開始商業銷售,這可能會導致從2025 年下半年開始收入和盈利增長大幅增加,預計到2026 年將進一步加速以及更遠的地方。

  • In the third quarter, we continued the implementation of ADMAlytics, our artificial intelligence and machine learning platform, across the commercial operations of the business. Since its staggered rollout began in February of 2024, ADMAlytics has delivered impressive outcomes including increased production efficiency, enhanced manufacturing visibility, optimized commercial planning, streamlined plasma pooling and reduced variability in FTE hours. We expect further optimization of our commercial growth strategy as ADMAlytics reaches full deployment, strengthening our rapidly growing earnings projections and aiding with the identification of organizational efficiencies.

    第三季度,我們繼續在整個業務的商業營運中實施我們的人工智慧和機器學習平台 ADMAlytics。自 2024 年 2 月開始分階段推出以來,ADMAlytics 取得了令人印象深刻的成果,包括提高生產效率、增強製造可視性、優化商業規劃、簡化血漿池以及減少 FTE 小時的變化。隨著 ADMAlytics 的全面部署,我們預計我們的商業成長策略將進一步優化,從而加強我們快速成長的獲利預測並幫助確定組織效率。

  • Our balance sheet continues to strengthen and we are confident in achieving net leverage neutrality during the fourth quarter driven by increasing organic cash flows and growing adjusted EBITDA. This strong financial position should provide us with substantial flexibility moving forward. In terms of capital allocation we are unwaveringly committed to deploying resources in a way that maximizes stockholder value and lowers ADMA’s cost of capital. Our commercial portfolio of life changing medicines continues to provide significant benefits to patients, addressing unmet medical needs for the immunocompromised. We take immense pride in the impact we make on patients, donors and public health. These accomplishments are a direct result of our team’s unwavering dedication and we extend our sincere appreciation for their goal oriented hard work. It is this collaborative spirit that sets our workplace apart.

    我們的資產負債表繼續增強,在有機現金流增加和調整後 EBITDA 成長的推動下,我們有信心在第四季度實現淨槓桿中性。這種強勁的財務狀況應該為我們的前進提供很大的靈活性。在資本配置方面,我們堅定不移地致力於以最大化股東價值並降低 ADMA 資本成本的方式配置資源。我們改變生活的藥物商業組合繼續為患者提供顯著的益處,解決免疫功能低下者未滿足的醫療需求。我們對我們對患者、捐贈者和公共衛生的影響感到非常自豪。這些成就是我們團隊堅定不移的奉獻精神的直接結果,我們對他們以目標為導向的辛勤工作表示衷心感謝。正是這種協作精神使我們的工作場所與眾不同。

  • Finally, prior to turning the call over to Brad, who will speak to this matter in additional detail, I would like to address the recent auditor transition. Although we received notice of CohnReznick transition sooner than we anticipated, we are pleased to announce that we have now engaged KPMG as our new independent audit firm. We thank CohnReznick for the 17 years of being our audit partner during which we had no disagreements at any point during our working tenure or any manner of accounting principles or practices, financial statement disclosure or auditing scope or procedure. We appreciate CohnReznick’s continued support and commitment to ADMA in ensuring a smooth transition to KPMG.

    最後,在將電話轉交給布拉德之前(他將進一步詳細討論此事),我想談談最近的審計師過渡。儘管我們收到 CohnReznick 過渡的通知比我們預期的要早,但我們很高興地宣布,我們現在已聘請畢馬威作為我們新的獨立審計公司。我們感謝 CohnReznick 17 年來擔任我們的審計合作夥伴,在此期間,我們在工作期間的任何時候都沒有對會計原則或實務、財務報表揭露或審計範圍或程序產生任何分歧。我們感謝 CohnReznick 對 ADMA 的持續支持和承諾,以確保順利過渡到畢馬威。

  • With this said, I’d now like to turn the call over to Brad for a review of the third quarter 2024 financials.

    話雖如此,我現在想將電話轉給 Brad,以審查 2024 年第三季的財務狀況。

  • Brad Tade - Chief Financial Officer and Treasurer

    Brad Tade - Chief Financial Officer and Treasurer

  • Thank you, Adam.

    謝謝你,亞當。

  • We issued a press release earlier today outlining our third quarter 2024 financial results. We will also be issuing our third quarter 10-Q report later this afternoon, which we would encourage you to read in conjunction with our comments and discussion points we’ll make during today’s call. I’ll now discuss some of the key financial highlights from the third quarter. As Adam mentioned, total revenues were $119.8 million for the quarter ended September 30, 2024, as compared to $67.3 million for the quarter ended September 30, 2023, an increase of $52.6 million, or approximately 78%.

    我們今天稍早發布了一份新聞稿,概述了 2024 年第三季的財務表現。我們還將在今天下午晚些時候發布第三季 10-Q 報告,我們鼓勵您結合我們將在今天的電話會議中提出的評論和討論要點來閱讀該報告。我現在將討論第三季的一些主要財務亮點。正如Adam 所提到的,截至2024 年9 月30 日的季度總收入為1.198 億美元,而截至2023 年9 月30 日的季度總收入為6,730 萬美元,增加了5,260 萬美元,增幅約為78% 。

  • Gross profits were $59.7 million for the quarter ended September 30, 2024 as compared to $24.7 million for the quarter ended September 30, 2023, an increase of$35 million. As a result, ADMA achieved a corporate gross margin of 50% in the third quarter of 2024 as compared to 37% in the third quarter of 2023. Third quarter 2024 corporate gross margins were adversely impacted due to an outsized spot sale of low margin normal source plasma. This normal source plasma available for sale is due to our designed shift of production throughput toward ASCENIV. Adjusting for this impact, corporate gross margins would have been in the mid-50s on a normalized basis for the third quarter.

    截至 2024 年 9 月 30 日的季度毛利為 5,970 萬美元,較截至 2023 年 9 月 30 日的季度的毛利為 2,470 萬美元,增加了 3,500 萬美元。因此,ADMA 在 2024 年第三季的企業毛利率為 50%,而 2023 年第三季為 37%。由於低利潤正常來源血漿的大量現貨銷售,2024 年第三季企業毛利率受到不利影響。這種可供出售的普通源血漿是由於我們設計的生產量向 ASCENIV 的轉變。調整這項影響後,第三季企業毛利率在標準化基礎上將在 50 多歲左右。

  • During the third quarter, adjusted EBITDA was $45.4 million as compared to adjusted EBITDA of $12.7 million for the quarter ended September 30, 2023, an increase of $32.6 million or approximately 256%.

    第三季調整後 EBITDA 為 4,540 萬美元,而截至 2023 年 9 月 30 日的季度調整後 EBITDA 為 1,270 萬美元,增加了 3,260 萬美元,增幅約為 256%。

  • GAAP net income was $35.9 million for the quarter ended September 30, 2024 compared to a GAAP net income of $2.6 million for the quarter ended September 30, 2023, an increase of 1300%.

    截至 2024 年 9 月 30 日的季度的 GAAP 淨利潤為 3,590 萬美元,而截至 2023 年 9 月 30 日的季度的 GAAP 淨利潤為 260 萬美元,增長了 1,300%。

  • As we expect to finish 2024 from a position of strength, 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.

    由於我們預計2024 年將處於強勢地位,因此我們相信我們才剛開始產生財務業績,這些業績表明,如果我們的收入繼續按計劃增長並且固定費用得到嚴格管理,我們的業務就可以實現獨特的運營槓桿。

  • Based on the robust $25 million of operating cash flow generated during the third quarter and the significant adjusted EBITDA growth, the company’s current net leverage ratio has organically improved to approximately 0.1x annualizing the third quarter results. We anticipate the balance sheet will continue to strengthen over the coming periods, augmented by forecasted free cash flow and growing adjusted EBITDA.

    基於第三季產生的 2,500 萬美元強勁營運現金流以及調整後 EBITDA 的顯著成長,該公司目前的淨槓桿率已有機改善至第三季業績年化的約 0.1 倍。我們預計未來一段時間資產負債表將繼續加強,預計自由現金流和調整後 EBITDA 的成長將進一步增強。

  • Expounding on Adam’s earlier comments regarding the auditor transition, we are pleased to have engaged and onboarded a new Big 4 independent auditor, KPMG. This transition to a Big 4 accounting firm is an important milestone as our organization matures and if earnings continue to rapidly expand as expected. We look forward to the next chapter with KPMG and we thank them for the timely and efficient completion of their new client onboarding process.

    根據 Adam 先前關於審計師過渡的評論,我們很高興聘請並任命了新的四大獨立審計師畢馬威 (KPMG)。隨著我們組織的成熟以及利潤繼續按預期快速增長,向四大會計師事務所的轉變是一個重要的里程碑。我們期待與畢馬威一起開啟新篇章,並感謝他們及時有效率地完成新客戶入職流程。

  • With that, I'll now turn the call back over to Adam for closing remarks.

    現在,我將把電話轉回給 Adam 進行總結發言。

  • 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.

    謝謝你,布拉德。

  • Our commitment to innovation and performance continues to drive substantial growth and value creation which we believe positions ADMA for both near term and long-term success. We expect to finish 2024 on a high note and embark on 2025 from a position of significant strength. In the periods ahead, we anticipate delivering sustained revenue growth and continuing to drive a favorable shift in our revenue mix and production schedule towards ASCENIV. We believe this would result in significant margin expansion and earnings growth.

    我們對創新和績效的承諾將繼續推動大幅成長和價值創造,我們相信這使 ADMA 能夠取得短期和長期的成功。我們預計 2024 年將取得優異成績,並以顯著優勢開啟 2025 年。在未來的時期,我們預計將實現持續的收入成長,並繼續推動我們的收入結構和生產計劃向 ASCENIV 方向有利的轉變。我們相信這將帶來顯著的利潤率擴張和獲利成長。

  • We are confident our strong balance sheet allows us to be capable stewards of stockholder capital and maximize equity value while supporting our rapid growth trajectory.

    我們相信,強大的資產負債表使我們能夠成為股東資本的有效管理者,並在支持我們快速成長軌蹟的同時實現股權價值最大化。

  • Looking beyond 2025, we aim to leverage our innovative commercial model, agile specialty biologics production platform and in house R&D engine to unlock revenue and earnings opportunities that could significantly exceed our current projections. The collective impact of our internal donor retention programs and third party high tighter plasma supply initiatives, positions us to potentially reach a $1 billion annual revenue milestone as rapidly as possible, with further growth opportunities extending thereafter.

    展望 2025 年以後,我們的目標是利用我們的創新商業模式、敏捷的特殊生物製劑生產平台和內部研發引擎來釋放可能大大超出我們目前預測的收入和獲利機會。我們的內部捐贈者保留計劃和第三方更嚴格的血漿供應計劃的集體影響,使我們有可能盡快達到 10 億美元的年收入里程碑,並在此後提供進一步的增長機會。

  • We are confident that these strategies will enable us to meet the rapidly growing demand for ASCENIV across both short term and peak periods.

    我們相信,這些策略將使我們能夠滿足短期和高峰時期對 ASCENIV 快速成長的需求。

  • Thank you all for your continued support and dedication. Together we will continue to build on ADMA’s successes. And with that we now like to open up the call for questions. Operator?

    感謝大家一直以來的支持與奉獻。我們將共同繼續鞏固 ADMA 的成功。現在我們開始提問。操作員?

  • Operator

    Operator

  • Thank you. We will now open the line for questions. (Operator Instructions) Your first question comes from the line of Kristen Kluska with Cantor Fitzgerald. Please go ahead.

    謝謝。我們現在將開通提問熱線。(操作員說明)您的第一個問題來自 Kristen Kluska 和 Cantor Fitzgerald 的對話。請繼續。

  • Kristen Kluska

    Kristen Kluska

  • Hi everyone. Thanks for taking the questions. And congrats again on a great quarter. I’m not sure if I’m familiar with any company raising guidance five times in a year, so you may have the record on that one.

    大家好。感謝您提出問題。再次恭喜這個季度的出色表現。我不確定我是否熟悉任何一年內五次提出指導意見的公司,所以你可能有那一次的記錄。

  • So, I saw in the press release this might be one of the first times, I think, you’ve put it in writing about the potential for this to be a $1 billion revenue opportunity. So I was hoping you can maybe give us a little bit more color around some of the work that you’ve been doing to get more hyperimmune plasma as that’s likely going to be the driver to get you to those numbers. Hello? Oh sorry.

    因此,我在新聞稿中看到,我認為這可能是您第一次以書面形式描述這可能帶來 10 億美元的收入機會。因此,我希望您能為我們提供更多關於您為獲得更多超免疫血漿而所做的一些工作的信息,因為這很可能是讓您達到這些數字的驅動力。你好?哦,對不起。

  • 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

  • Can you hear us?

    你聽得到我們說話嗎?

  • Kristen Kluska

    Kristen Kluska

  • Yes.

    是的。

  • 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

  • At the Cantor Conference we were talking about the potential opportunity. And we just have a lot of great visibility into what we think is a very compelling operating leverage trajectory. And as we look at the demand indicators they continue to remain strong. So I don’t have to reiterate the same thing I’ve been saying for the last couple of quarters. I mean, the patients are there and we’ve defined appropriate use. All that stuff still holds true. But we’ve been implementing a VIP donor program. We’ve been implementing methods with ADMAlytics to identify where we can optimize plasma collections and how we can build our pools. And when we just look at all of the factors that are going into this, we’re able to accelerate the identification of these donors and collect more plasma.

    在康托會議上,我們討論了潛在的機會。我們對我們認為非常引人注目的營運槓桿軌跡有很多深入的了解。當我們觀察需求指標時,它們繼續保持強勁。因此,我不必重申過去幾個季度我一直在說的同樣的話。我的意思是,病人就在那裡,我們已經定義了適當的用途。所有這些東西仍然適用。但我們一直在實施 VIP 捐贈者計畫。我們一直在實施 ADMAlytics 的方法,以確定我們可以在哪裡優化血漿採集以及如何建立我們的池。當我們只考慮所有影響因素時,我們就能夠加快對這些捐贈者的識別並收集更多血漿。

  • The real hampering to ASCENIV’s growth is really around the raw material supply. We’ve got production capacity, we’ve got the ability to switch from BIVIGAM to ASCENIV. Again, the plant doesn’t care what we make. It’s the same process for ASCENIV and BIVIGAM.

    真正阻礙 ASCENIV 成長的因素實際上是原材料供應。我們有生產能力,我們有能力從 BIVIGAM 切換到 ASCENIV。再說一遍,植物並不關心我們生產什麼。ASCENIV 和 BIVIGAM 的流程相同。

  • We’ve invested in some additional testing machines and equipment. Even more were delivered in the last couple of weeks that have been validated and turned on. And we’re working with our third party collectors and we’re currently negotiating with them on ways to potentially add some more centers. And we’ll provide updates to that in the future. But as we look at this right now, we believe that we’re going to identify high titer RSP plasma donors faster. We believe that we’re implementing strategies to retain these donors for longer periods of time, maximize the number of collections that we can get out of these donors.

    我們投資了一些額外的測試機器和設備。過去幾週交付了更多已驗證並啟用的產品。我們正在與第三方收藏家合作,目前正在與他們就可能增加更多中心的方式進行談判。我們將在未來提供更新。但當我們現在審視這一點時,我們相信我們將更快地識別高滴度 RSP 血漿捐贈者。我們相信,我們正在實施的策略可以更長時間地保留這些捐贈者,以最大限度地增加我們從這些捐贈者那裡獲得的收藏數量。

  • As I’m sure you recall, I’ve said it a bunch of times, plasma donors can donate twice a week, up to eight times per month. And we are implementing strategies to attract these donors and retain them for longer.

    我相信您還記得,我已經說過很多次了,血漿捐贈者可以每週捐獻兩次,每月最多捐獻八次。我們正在實施策略來吸引這些捐助者並長期保留他們。

  • So when you put all of this together, we believe that the demand is there. And if we find the plasma, we’re going to make more ASCENIV. And you heard in the prepared remarks that I said that we’ve strategically shifted more production from BIVIGAM to ASCENIV all throughout this year and we’re going to continue to do that. So as we look forward, I don’t know when it’s going to happen, Kristen, but I know that we’re all working very, very rapidly here.

    因此,當你把所有這些放在一起時,我們相信需求是存在的。如果我們找到等離子體,我們將製造更多的 ASCENIV。你們在準備好的發言中聽到我說過,今年我們已經策略性地將更多生產從 BIVIGAM 轉移到了 ASCENIV,並且我們將繼續這樣做。因此,當我們展望未來時,我不知道什麼時候會發生,克里斯汀,但我知道我們都在非常非常迅速地工作。

  • Is it ‘25? No. Is it ‘26? No. Could it be, ‘27, ‘28 ‘29? Sure. We really are very optimistic about the forward-looking outlook. And I think when you couple this with yield enhancements, which also in the prepared remarks, we put some brackets around timelines here. Certainly in the back half of ‘25, we expect to see accelerating revenue and certainly margin accretion. But you know, it’s going to expand rapidly in 2026. When you really look at the opportunity that we have with the ability to gain 20% more finished goods from the same starting material, 100% of what we’re going to sell in 2026 will be made from what we believe will be the then approved yield enhanced process. You’re going to see margins expand substantially 2026 forward.

    是 25 元嗎?不。是 26 嗎?不。會不會是, 27, 28 29?當然。我們對前瞻性前景確實非常樂觀。我認為,當你將其與產量提高結合起來時(也在準備好的評論中),我們在此處的時間表周圍加上了一些括號。當然,在 25 年下半年,我們預期營收將加速成長,利潤率也將增加。但你知道,它會在 2026 年迅速擴張。當你真正看到我們有能力從相同的原材料中獲得多 20% 的成品時,我們將在 2026 年銷售的 100% 的產品將由我們認為當時的產品製成批准的增產工藝。到 2026 年,您將看到利潤率大幅成長。

  • So we will give additional guidance like we always do in the beginning of the year around the JPMorgan Conference. But working to identify donors faster, retain these donors, keep them engaged at our plasma centers and incentivize our third party collectors, you put all those things together and we’re really encouraged by the durability of what we’re building here and we think it’s truly unique.

    因此,我們將像年初摩根大通會議期間所做的那樣提供額外的指導。但是,努力更快地識別捐贈者,留住這些捐贈者,讓他們參與我們的血漿中心並激勵我們的第三方收集者,將所有這些事情放在一起,我們對我們在這裡建造的東西的耐用性感到非常鼓舞,我們認為它確實是獨一無二的。

  • Kristen Kluska

    Kristen Kluska

  • Thank you.

    謝謝。

  • Brad Tade - Chief Financial Officer and Treasurer

    Brad Tade - Chief Financial Officer and Treasurer

  • And just just to add to Adam's point.

    只是為了補充亞當的觀點。

  • I was just going to say just to add to Adam’s point, we’re going to accelerate towards that $1 billion threshold as soon as possible to Adam’s earlier comments. But the key point is it’s not over there. There is growth headroom thereafter and we’re going to continue to chase it.

    我只是想說,只是為了補充 Adam 的觀點,我們將根據 Adam 先前的評論,盡快加速邁向 10 億美元的門檻。但關鍵是它並不在那裡。此後還有成長空間,我們將繼續追逐它。

  • Kristen Kluska

    Kristen Kluska

  • Thank you for that. Can you give a little bit more specific metrics behind this VIP donor program? Is this implemented in all 10 of your collection facilities? And just in general, can you speak to what you’re seeing once you initiated that in terms of footprint traffic, is it the same donors coming in one more time a month? Like what can you give us in terms of that and recognize it’s still early days for this program?

    謝謝你。您能否提供此 VIP 捐款計畫背後更具體的指標?您的所有 10 個收集設施都實施了這種做法嗎?總的來說,您能否談談您在發起足跡流量後所看到的情況,是否是同一位捐贈者每月多來一次?您能為我們提供什麼,並認識到該計劃還處於早期階段?

  • 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

  • It’s a program that we’ve kicked off earlier this year. I believe at this stage it is in all of our centers, all of our 10 centers. I mean, it’s a pretty simple formula, Kristen, but I’m not going to give all the details so my competitors know. But I can tell you that we treat our donors well. We’ve always believed that the donors are the – it’s a pun, but the lifeblood of our ability to impact and improve the lives of patients in need. We build nice centers, we keep clean centers, we are working on donor retention strategies and programs that certainly include compensation. But we are seeing donors donating more frequently, we are seeing donors donating longer.

    這是我們今年早些時候啟動的計劃。我相信現階段我們所有的中心,我們所有的 10 個中心都是如此。我的意思是,克里斯汀,這是一個非常簡單的公式,但我不會提供所有細節,以便我的競爭對手知道。但我可以告訴你,我們對待捐款者很好。我們始終相信,捐贈者是我們影響和改善有需要的患者的生活的能力的命脈——這是一個雙關語。我們建立了良好的中心,我們保持清潔的中心,我們正在製定捐贈者保留策略和計劃,當然包括補償。但我們看到捐贈者的捐贈更加頻繁,我們看到捐贈者的捐贈時間更長。

  • And I think that from the data that I’ve seen, and we had one of our RSV plasma meetings today, the trend is we are collecting more plasma than we ever have before, not only from our internal centers, but also from our third party collectors.

    我認為,從我所看到的數據以及我們今天舉行的一次 RSV 血漿會議來看,趨勢是我們正在收集比以往更多的血漿,不僅來自我們的內部中心,而且還來自我們的血漿中心。三方收藏家。

  • So you’re going to see – look, maybe I’ll just touch on this we had a one-off in the quarter where we sold some normal source plasma. We don’t really want to be in the very, very low margin, negative margin source plasma selling business anymore. But what we’re doing is we’re looking at our inventory, we’re taking a very, very hard look at all of this.

    所以你會看到——看,也許我會簡單談談這一點,我們在銷售一些普通源血漿的季度發生了一次性事件。我們真的不想再從事利潤非常非常低、負利潤的源頭血漿銷售業務。但我們正在做的是檢查我們的庫存,我們正在非常非常認真地審視這一切。

  • And we only want to keep inventory and plasma that we can use to make the products that we want to make. And that’s mainly – so these are all things that I think that investors and our analysts can look at to understand that, we’re positioning this business appropriately to Brad’s point, not only to do a billion, but we do believe that there is room and like I’ve said before, that if we could fill the whole plant, which again I’m not guiding to, I don’t know if it can happen, but we certainly want to try.

    我們只想保留可用於製造我們想要製造的產品的庫存和血漿。這主要是——所以我認為投資者和我們的分析師可以透過查看這些內容來了解,我們正在根據布拉德的觀點適當地定位這項業務,而不僅僅是做十億美元,但我們確實相信有空間,就像我之前說過的,如果我們能夠填滿整個工廠,我也沒有指導,我不知道這是否會發生,但我們當然想嘗試。

  • But if we were to fill the entire plant, all 500,000, 600,000 liters a year that we can process, you could be generating somewhere in the range of $2 billion annually. So we’re going to keep pushing hard. We’re going to keep treating our donors kindly. We’re going to keep paying them to come back. We’re going to keep explaining to them why the plasma that’s inside them is so powerful and so beneficial to immunocompromised patients that are at high risk of infectious diseases.

    但如果我們要填滿整個工廠,每年可以處理 500,000、600,000 公升,那麼每年可能會產生 20 億美元的收入。因此,我們將繼續努力推進。我們將繼續善待我們的捐助者。我們將繼續付錢讓他們回來。我們將繼續向他們解釋為什麼他們體內的血漿如此強大,並且對感染性疾病高風險的免疫功能低下的患者如此有益。

  • Kristen Kluska

    Kristen Kluska

  • Thanks. Thanks again and congrats again.

    謝謝。再次感謝並再次恭喜。

  • 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 for your support, Kristen.

    感謝您的支持,克莉絲汀。

  • Brad Tade - Chief Financial Officer and Treasurer

    Brad Tade - Chief Financial Officer and Treasurer

  • Thank you. Kristen.

    謝謝。克里斯汀.

  • Operator

    Operator

  • And your next question comes from the line of Anthony Petrone with Mizuho Group. Please go ahead.

    你的下一個問題來自瑞穗集團的 Anthony Petrone。請繼續。

  • Anthony Petrone

    Anthony Petrone

  • Oh, thanks and congratulations.

    噢,謝謝並祝賀。

  • 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 you are doing, Anthony?

    你好嗎,安東尼?

  • Anthony Petrone

    Anthony Petrone

  • Doing very well, Adam. Thanks again, and congratulations on another strong quarter here. Maybe I’ll stick on the supply end of the equation. Just a couple high level ones. When you think of just churn, is churn a big issue? Adam, are you actually losing any of these donors? It sounds like retention is actually quite high.

    做得很好,亞當。再次感謝,並祝賀本季又一個強勁的表現。也許我會堅持等式的供給端。只有幾個高水準的。當您想到流失時,流失是一個大問題嗎?亞當,你真的失去這些捐贈者了嗎?聽起來保留率實際上相當高。

  • So just a little bit on the churn. And then when you think of just how you’re managing that inventory, are you fully at a level where you have enough safety stock that you’re able to sort of supply these longer-term contracts? So that would be the first high level one and then I’ll have a follow-up. Thanks.

    所以只要一點點就可以了。然後,當您考慮如何管理庫存時,您是否完全擁有足夠的安全庫存,能夠供應這些長期合約?這將是第一個高級別會議,然後我將進行後續活動。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

  • So we’re always losing donors, Anthony. Unfortunately, naturally occurring antibody doesn’t stay around forever. Some donors it does, but the majority of donors stay on the program for a period of time, as I’ve always said, and then they fall off. We’re constantly testing these donors. We’re constantly adding new donors. Donors move, they have lives just like everybody else. But we’re doing absolutely everything that we possibly can to ensure that the donors who we do identify that have high titers to RSV antibodies come back as frequently as possible.

    所以我們總是在失去捐贈者,安東尼。不幸的是,天然產生的抗體不會永遠存在。有些捐贈者確實如此,但正如我一直說的那樣,大多數捐贈者會在該計劃中停留一段時間,然後就退出了。我們不斷測試這些捐贈者。我們不斷增加新的捐助者。捐助者搬家了,他們和其他人一樣有生活。但我們正在盡一切努力確保我們確定的具有高滴度 RSV 抗體的捐贈者盡可能頻繁地回來。

  • I’d be lying to you, Anthony, if I said to you, yes, sure, we’ve got all the safety stock we need from a plasma supply standpoint, because we don’t. If we did, then I’d be making much more incentive and I think you’d see revenues growing even faster. But we’ve got plenty of work in process material, we’ve got plenty of plasma in inventory to continue to producing a drug, to continue to drive that revenue mix shift towards placenta, which we’re seeing every single quarter, every single period for the last couple of quarters here.

    安東尼,如果我對你說,是的,當然,從血漿供應的角度來看,我們擁有所需的所有安全庫存,那我就是在騙你,因為我們沒有。如果我們這樣做,那麼我會提供更多的激勵,而且我認為您會看到收入成長得更快。但我們在加工材料方面有大量的工作,我們有大量的血漿庫存,可以繼續生產藥物,繼續推動收入組合向胎盤的轉變,我們每個季度都會看到這種情況,這裡是最後幾個季度的每個時期。

  • ASCENIV is the majority of our revenue. It continues to grow. And we’re doing everything we can, Anthony, to build that safety stock. I think if some of our negotiations prove successful and if some of our activities with some of our third-party suppliers prove to be successful, hopefully, we’ll have something to announce around J.P. Morgan. But our goal is to find as many centers around the country who are willing to sell us plasma and collect that plasma. So we’ll keep you posted there. But we certainly feel very, very optimistic or else our attorneys wouldn’t let me say, some of the things that I’ve said today.

    ASCENIV 是我們收入的大部分。它繼續增長。安東尼,我們正在盡一切努力建立安全庫存。我認為,如果我們的一些談判被證明是成功的,如果我們與一些第三方供應商的一些活動被證明是成功的,那麼我們有望在摩根大通周圍宣布一些事情。但我們的目標是在全國範圍內找到盡可能多的願意向我們出售血漿並收集血漿的中心。因此,我們會及時通知您。但我們確實感到非常非常樂觀,否則我們的律師不會讓我說出我今天所說的一些話。

  • Anthony Petrone

    Anthony Petrone

  • Fair enough. And then maybe a follow-up – go ahead, Brad.

    很公平。然後也許是後續行動——繼續吧,布拉德。

  • Brad Tade - Chief Financial Officer and Treasurer

    Brad Tade - Chief Financial Officer and Treasurer

  • Anthony, just real quick, just going back to the spot sale, I mean, you know Adam, you know ADMA, we’re opportunistic. If we need to do a spot buy, we will do a spot buy. If we need to do a spot sale, we’re going to do a spot sale. And of course, we do that to align our plasma inventory with our production needs. And in this case, we made a spot sale as we continue our designated or designed shift of production to ASCENIV. And we will continue to be opportunistic when it comes to plasma, whether it’s doing spot sales or spot buys.

    安東尼,很快,回到現貨銷售,我的意思是,你知道亞當,你知道 ADMA,我們是機會主義者。如果我們需要現貨購買,我們就會現貨購買。如果我們需要進行現貨銷售,我們就會進行現貨銷售。當然,我們這樣做是為了使血漿庫存與生產需求保持一致。在這種情況下,我們在繼續將指定或設計的生產轉移到 ASCENIV 時進行了現貨銷售。在血漿方面,無論是現貨銷售或現貨購買,我們將繼續保持機會主義。

  • Anthony Petrone

    Anthony Petrone

  • Very helpful. And then the quick follow-up, just again, high level, more of a macro question there. Obviously big events this week. There’s a change in administration coming, change at the Senate level. There’ll be new personnel at FDA here. So maybe just your thoughts on how administration influences FDA and what that potentially means just for the plasma space in general, and ADMA, specifically, thanks again.

    非常有幫助。然後是快速跟進,再次是高層,更多的是宏觀問題。本週顯然有大事件發生。政府即將發生變化,參議院層級也將改變。FDA 將會有新人員。所以,也許只是您對行政管理如何影響 FDA 的想法,以及這對整個血漿領域,特別是 ADMA 可能意味著什麼,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

  • Thank you, Anthony. I mean it’s – that’s quite a question. If you could see the smile on my face here. I mean, I don’t know how to answer that because I really don’t really have visibility yet into who’s going to be where. And I know that there’s a lot of conjecture out there, but what I think I can speak to are the facts.

    謝謝你,安東尼。我的意思是,這是一個很大的問題。如果你能看到我臉上的笑容就好了。我的意思是,我不知道該如何回答這個問題,因為我真的不知道誰會去哪裡。我知道外界有很多猜測,但我認為我能說的是事實。

  • And the facts are that, since Obama, Trump, Biden now going back to Trump, there’s been bipartisan agreement across the Board that plasma derived therapies have been excluded from price negotiations. They were covered under Obamacare. I anticipate that with another Trump administration, I wouldn’t anticipate that there would be a lot of changes there.

    事實是,自從歐巴馬、川普、拜登現在回到川普身邊,兩黨就全面達成一致,認為血漿衍生療法已被排除在價格談判之外。他們受到歐巴馬醫改的保護。我預計,如果川普再執政,我不會預期那裡會發生很多變化。

  • What I can speak to is, I think you know this for those who don’t. I am the current Chairman of the Plasma Protein Therapeutics Association, North American Board. The Plasma Protein Therapeutics Association is the industry association that advocates for access and availability of plasma-derived therapies for all patients that receive these therapies as well as for industry.

    我能說的是,我想對於那些不了解這一點的人來說,你也知道這一點。我是血漿蛋白治療協會北美委員會現任主席。血漿蛋白治療協會是一個行業協會,倡導為所有接受這些療法的患者以及行業提供血漿衍生療法。

  • And the association working with representatives from all the member companies, we formed a Plasma Caucus. So I believe, I think I’m right, There are about 38 sitting Congresspeople who are on the Plasma Caucus. I think Capitol Hill is pretty well versed in the scarcity of plasma, that you can only use plasma collected from U.S. citizens in the United States in order to make these products for the U.S. population.

    該協會與所有會員公司的代表合作,成立了 Plasma 核心小組。所以我相信,我認為我是對的,等離子核心小組中有大約 38 名現任國會議員。我認為國會山莊非常了解血漿的稀缺性,你只能使用從美國境內的美國公民收集的血漿來為美國人民生產這些產品。

  • And I really feel that, we, all of us in the plasma derivatives industry are in a good position here with the change of administration. Specifically regarding ADMA, I mean, something that I’ve been championing about our company for a long, long time, and I was shouting it from the rooftops a little bit during the last Trump administration is, we are the last of the Mohegans. We are the last 100% U.S. domiciled plasma-derived therapeutics producing company.

    我真的覺得,隨著政府的更迭,我們血漿衍生性商品產業的所有人都處於有利的地位。具體來說,關於 ADMA,我的意思是,我長期以來一直在為我們公司辯護,在上屆川普政府期間我曾在屋頂上大喊過,我們是最後的 Mohegans 。我們是最後一家 100% 註冊於美國的血漿衍生療法生產公司。

  • 100% of our manufacturing supply chain is in the United States. So we make our drug here in Boca Raton, Florida. We fill ASCENIV and BIVIGAM here in Boca Raton. We also have a third-party fill finish facility in Virginia. All of our finished goods distribution is out of Tennessee, I believe. We only sell our products in the United States.

    我們 100% 的製造供應鏈都在美國。因此,我們在佛羅裡達州博卡拉頓生產藥物。我們在博卡拉頓填寫 ASCENIV 和 BIVIGAM。我們還在維吉尼亞州擁有一家第三方填充工廠。我相信,我們所有的成品分銷均來自田納西州。我們只在美國銷售我們的產品。

  • So we feel really good about some of the noise out there. But I think it would be premature, Anthony, to really comment specifically. But I can tell you that if there is legislation passed that hey, if you make your goods in the [indiscernible] we would meet that criteria. So it’s been a mission of ours. It was one of our founding principles. I always felt it very important that the United States also control some of their manufacturing capabilities and that a U.S. company has some of this control.

    所以我們對外面的一些噪音感覺很好。但我認為,安東尼,現在做出具體評論還為時過早。但我可以告訴你,如果通過了立法,嘿,如果你在[音頻不清晰]中生產你的商品,我們就會滿足這個標準。所以這是我們的使命。這是我們的基本原則之一。我一直認為美國也控制他們的一些製造能力並且美國公司擁有一些這種控制權非常重要。

  • And here we are, we’re making good products, we’re putting more product into the market every single quarter. And we feel real good about it. But I don’t think the change in administration will provide any negative impacts whatsoever to ADMA or other plasma-derived drugs on the market. I know that you cover some other companies there, but from a business perspective, we feel very good about the opportunities that lie ahead.

    我們在這裡,我們正在生產優質產品,我們每季都會向市場推出更多產品。我們對此感覺非常好。但我認為管理方式的改變不會對 ADMA 或市場上其他血漿衍生藥物產生任何負面影響。我知道您也報道了那裡的其他一些公司,但從商業角度來看,我們對未來的機會感到非常滿意。

  • Anthony Petrone

    Anthony Petrone

  • Very good. Thank you so much. Congrats again. I’ll hope back in.

    非常好。太感謝了。再次恭喜。我希望能回來。

  • 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.

    謝謝。

  • Brad Tade - Chief Financial Officer and Treasurer

    Brad Tade - Chief Financial Officer and Treasurer

  • Thanks. Anthony.

    謝謝。安東尼.

  • Operator

    Operator

  • And your next question comes from the line of Gary Nachman with Raymond James. Please go ahead.

    你的下一個問題來自加里·納赫曼(Gary Nachman)和雷蒙德·詹姆斯(Raymond James)。請繼續。

  • Gary Nachman

    Gary Nachman

  • Good afternoon, guys. My congrats as well on the strong quarter. So just back to the ASCENIV supply availability, obviously the topic du jour. Adam, do you think you need any more plasma donor facilities of your own to have more plasma supply? Can those 10 facilities and then the third parties get you to the billion target? And is there any risk to you sharing the methods of screening for high RSV titers with third-parties?

    下午好,夥計們。我也祝賀季度的強勁表現。那麼,回到 ASCENIV 供應可用性,這顯然是當前的話題。Adam,您認為您是否需要更多自己的血漿捐獻設施來提供更多血漿?這 10 個設施和第三方能否幫助您實現 10 億美元的目標?您與第三方分享高 RSV 滴度篩檢方法是否有風險?

  • 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

  • Great questions. Thank you, Anthony. To your first part of the question, do we need more centers? No. Do we want more centers? No. 10 centers gives us a great base for which we can collect and have control over some of our internal collection for the high titer plasma. As I’ve said to you in the past, in our private conversations and also as I say publicly, we certainly care very much about what we do and our staff is certainly trained to maximize the number of collections that we’re getting from any specific donor that we identify as being high titer.

    很好的問題。謝謝你,安東尼。對於問題的第一部分,我們需要更多的中心嗎?不。我們需要更多中心嗎?10 號中心為我們提供了一個很好的基地,我們可以透過它收集並控制我們內部收集的一些高滴度血漿。正如我過去在我們的私人談話中以及公開場合所說的那樣,我們當然非常關心我們所做的事情,我們的員工也確實接受過培訓,可以最大限度地提高我們獲得的館藏數量來自我們確定為高滴度的任何特定供體。

  • Our 10 centers collect more on average than any of our third-party collectors. And I really think that’s because there are and we control who’s donating in the chair and we control what we compensate those donors with. So our 10 centers, from my perspective, collect more than say, one of our third-party centers can collect. And we’re going to continue to do that. So no, we’re not investing in any more centers. We’re not going to build centers at this time. We’re not buying any additional centers. 10 is enough. And that’s where it’s going to stay.

    我們 10 個中心的平均收藏量比我們任何第三方收藏家都多。我真的認為這是因為我們控制著誰在主席的捐贈,我們控制著我們補償這些捐贈者的方式。因此,從我的角度來看,我們的 10 個中心收集的數據比我們第三方中心之一收集的數據還要多。我們將繼續這樣做。因此,我們不會再投資任何中心。我們目前不打算建立中心。我們不會購買任何額外的中心。 10個就夠了。這就是它要停留的地方。

  • With respect to the methods of screening, I think that’s a great question and I want to make sure that you and others understand this. We don’t give away our secret sauce to anybody. First of all, it’s patented. Second of all, all the testing, all the science is done by ADMA. So what – one of our third-party collectors will do is we get a sample tube of every new donor that walk into their center in any given week. So typically, new centers have between 20, 50, 100 donors, depending upon the size of the center per week, some centers have more.

    關於篩選方法,我認為這是一個很好的問題,我想確保您和其他人理解這一點。我們不會向任何人透露我們的秘密武器。首先,它擁有專利。其次,所有的測試、所有的科學工作都是由 ADMA 完成的。因此,我們的一位第三方收集者會做的是,我們會獲取任意一周內走進他們中心的每位新捐贈者的樣本管。因此,新中心通常有 20、50、100 名捐贈者,具體取決於中心每週的規模,有些中心有更多。

  • So right now we’re collecting from, I want to say about 70, 80 centers, maybe a few more. But we’re getting, call it, hundreds to thousands of samples every week that we do testing on in either our laboratory here in Boca Raton or we have a laboratory who we partnered with for many, many years that does screening and titer testing for us as well. So all of the science is controlled by us, all the third-party collector will know is that we say, we want donor number, 14603. We want donor 14609. That’s all they know. They don’t know what the donor’s titers are. They don’t know whether their titers are super high or in the middle range or in the lower high range.

    所以現在我們正在從大約 70、80 個中心收集數據,也許還有更多。但我們每週都會收到數百個上千個樣本,我們可以在博卡拉頓的實驗室進行測試,也可以在我們合作多年的實驗室進行篩選和滴度測試對我們來說也是如此。所以所有的科學都由我們控制,所有第三方收集者都會知道我們說,我們想要捐贈者號碼,14603。我們需要捐贈者 14609。這就是他們所知道的全部。他們不知道捐贈者的滴度是多少。他們不知道自己的滴度是超高、中等還是較低。

  • All they know is that we’re going to pay them more money for that liter of plasma that they collect from that donor. So all the science is kept in house. Again, all of our testing methodologies are patent protected, as well as we have certain know-how and other trade secrets that we employ around the testing and the screening. But our third-party collectors love us, because essentially they’re collecting the same thing that they’re always collecting, which is just regular plasma, but we’re going to pay them more money for it. So the only thing that one of our third party collectors does differently is they collect an extra sample tube and they send us, I think, it’s 5 mLs of plasma per donor and we test it in our screening assay.

    他們所知道的是,我們將為他們從捐贈者收集的那公升血漿支付更多的錢。所以所有的科學知識都被保留在內部。同樣,我們所有的測試方法都受專利保護,並且我們擁有圍繞測試和篩選使用的某些專有技術和其他商業機密。但我們的第三方收藏家喜歡我們,因為本質上他們收集的東西和他們一直在收集的東西是一樣的,這只是普通的血漿,但我們將為此付給他們更多的錢。因此,我們的第三方收集者所做的唯一不同的事情是,他們收集了一個額外的樣本管,然後寄給我們,我認為,每個捐贈者5 毫升的血漿,我們在篩選分析中對其進行測試。

  • Gary Nachman

    Gary Nachman

  • All right, great. That color is very helpful and comforting. So, I mean, you had a really strong quarter, but I’m curious, why didn’t you take full year guidance up more than you did? Just when you look at what 4Q might be, could it be a sequentially down quarter in the fourth quarter and what might cause that? And I also want to confirm that the yield enhancement benefit in the second half of next year is not in the current 2025 guidance.

    好吧,太好了。這種顏色非常有幫助和安慰。所以,我的意思是,你們有一個非常強勁的季度,但我很好奇,為什麼你們沒有比全年指導更高一些?當你看看第四季可能是什麼時,第四季是否會出現環比下降,以及是什麼原因導致的?而且我還想確認,明年下半年的產量提升效益並不在目前的2025年指引中。

  • 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 let me take the second part of your question first. The yield enhancement benefit is not yet contemplated in our guidance number. Again, we don’t have FDA approval yet and we do take a conservative approach to guidance. We’re going to continue to take the same conservative approach that we’ve employed since the beginning. And maybe I’ll just start off and Brad, certainly add some more color. But yes, Gary, we’re talking already about that there was a one-time opportunistic plasma sale in the quarter. I think it was about $6 million to $7 million.

    讓我先回答你問題的第二部分。我們的指導數字中尚未考慮產量提高的好處。再次強調,我們尚未獲得 FDA 的批准,並且我們確實採取保守的指導方法。我們將繼續採取我們從一開始就採用的保守方法。也許我會開始,布萊德當然會添加更多的色彩。但是,是的,加里,我們已經在談論本季有一次機會性血漿銷售。我認為大約是 600 萬至 700 萬美元。

  • So we’re not going to have that next quarter. We are seeing growth of incentive. We are seeing growth of BIVIGAM. But again being conservative, we are not going to have $6 million worth of revenue generation from plasma sales in the quarter. Additionally, and maybe I’ll make mention of this here, we’ve also voluntarily stopped producing 1 ml NABI-HB from the market. We only now produce the 5 ml product.

    所以下個季度我們不會再出現這種情況。我們看到激勵措施的成長。我們看到 BIVIGAM 的成長。但同樣保守的是,本季我們不會從血漿銷售中獲得價值 600 萬美元的收入。此外,也許我會在這裡提到這一點,我們也自願停止在市場上生產 1 毫升 NABI-HB。我們現在只生產5毫升的產品。

  • The margins were not great on the 1 ml and candidly with the PDUFA fees where they were, it just didn’t make sense. So we’re not going to be selling any 1 ml NABI in the fourth quarter. We do hope that we pick up that business as 5 mL revenue, but that’s yet to be determined. But it would be a down corner on the top line. But I think that when you look at guidance, we’ve increased EBITDA and net income guidance for the quarter, because we do believe that the revenue mix is going to continue to shift towards ASCENIV and higher margin products.

    1 毫升的利潤並不大,而且坦白說,考慮到 PDUFA 的費用,這根本沒有意義。因此,我們不會在第四季度銷售任何 1 毫升 NABI。我們確實希望能夠以 5 mL 的收入接手該業務,但這尚未確定。但這將是頂線上的一個下角。但我認為,當你查看指導時,我們已經提高了本季的 EBITDA 和淨利潤指導,因為我們確實相信收入組合將繼續轉向 ASCENIV 和更高利潤率的產品。

  • So we feel very good about where we are ending the year. we feel really good about where next year is going to be. And again to your question about yield enhancement, 2026 is going to be gangbusters. I mean, we’re just so excited about what the future holds for us there. But Brad, if you want to…

    因此,我們對今年的結局感到非常滿意。我們對明年的情況感到非常滿意。再回答你關於產量提高的問題,2026 年將是大勢所趨。我的意思是,我們對那裡的未來感到非常興奮。但是布萊德,如果你願意的話…

  • Brad Tade - Chief Financial Officer and Treasurer

    Brad Tade - Chief Financial Officer and Treasurer

  • Yes. Gary, we’re focusing on BIVIGAM and the ASCENIV mix shift. We’re focusing on yield enhancement. We’re focusing on our high margin products. And when you think about it, ADMA’s next chapter will be defined by margin expansion and earnings growth. We are going to continue to leverage our operating structure. We’re going to continue to drive top line. We’re going to continue to focus on high margin products and make those margins even better with yield enhancement. And again by doing that, by leveraging our operating structure, we’re going to continue to drive margin expansion. We’re going to continue to drive net income. We’re going to continue to drive EBITDA and that’s our plan.

    是的。加里,我們正在關注 BIVIGAM 和 ASCENIV 混合轉變。我們專注於提高產量。我們專注於高利潤產品。仔細想想,ADMA 的下一章將由利潤率擴張和獲利成長來定義。我們將繼續利用我們的營運結構。我們將繼續推動營收成長。我們將繼續專注於高利潤產品,並透過提高產量來提高這些利潤。透過這樣做,透過利用我們的營運結構,我們將繼續推動利潤率擴張。我們將繼續推動淨利潤。我們將繼續推動 EBITDA,這就是我們的計劃。

  • 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

  • Margin expansion and earnings growth, I’m going to get a t-shirt.

    獲利成長和獲利成長,我要買一件 T 卹。

  • Gary Nachman

    Gary Nachman

  • Okay. That’s the mantra.

    好的。這就是口頭禪。

  • Okay, awesome. Just a couple more quick ones, just on the S. pneumoniae program, when could we see some animal data on it? Now that you – it looks like you’ve identified a lab to do that study. And then congrats on getting KPMG, you’ve contracted with them for 2024, the year-end audit. Just when do you think you’ll finalize 2025 with them? We’ve been getting some questions on that. Thank you.

    好吧,太棒了。就幾個快速的,就肺炎鏈球菌計畫而言,我們什麼時候可以看到一些動物數據?現在您—看起來您已經確定了一個實驗室來進行這項研究。然後恭喜你獲得了畢馬威會計師事務所,你已經與他們簽訂了 2024 年年終審計的合約。您認為您什麼時候能與他們一起完成 2025 年的工作?我們收到了一些關於此的問題。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

  • Wait. So okay. SG-001, I wrote down your last part of the question about KPMG is when will we finalize engaging them for 2025.

    等待。那麼好吧。SG-001,我寫下了您關於畢馬威的問題的最後一部分,即我們何時最終確定在 2025 年與他們合作。

  • Gary Nachman

    Gary Nachman

  • Yeah. Correct.

    是的。正確的。

  • 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

  • People obviously are excited to see that you engage them for this year. Just when we…

    人們顯然很高興看到您今年與他們合作。就在我們…

  • Gary Nachman

    Gary Nachman

  • Yes, before I ask you the same question. Okay, I just wanted to make sure it was the same crazy question that I’m getting from investors as well. Okay.

    是的,在我問你同樣的問題之前。好吧,我只是想確保這也是我從投資者那裡得到的同樣瘋狂的問題。好的。

  • 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 let’s start with SG-001. So we successfully produced a pilot scale batch of product. So excited our scientific team here, our scientific technical ops team. With doing everything that they’re doing for yield enhancement, Kaitlin and I said, hey, let’s push them even harder. And we’re very excited to be here.

    讓我們從 SG-001 開始。因此我們成功生產了一批中試產品。我們這裡的科學團隊、我們的科學技術操作團隊都非常興奮。在盡一切努力提高產量時,凱特琳和我說,嘿,讓我們更努力地推動他們。我們非常高興來到這裡。

  • We’re evaluating labs, we’re currently writing and drafting testing protocols. I don’t really have a timeline but I want everything done immediately. I would hope, in the third quarter of next year. I’m probably going to get yelled at when I walk out of this conference room. But my hope is, sometime in the back half of next year or early back half, we should have some data, but please don’t hold me to it. And if it comes earlier, great. But I want to answer your question, I want to be straight with you. We’re very excited about this opportunity but obviously the priority for us is yield enhancement.

    我們正在評估實驗室,目前正在編寫和起草測試協議。我確實沒有時間表,但我希望一切立即完成。我希望是在明年第三季。當我走出會議室時,我可能會被罵。但我希望,在明年下半年或下半年初的某個時候,我們應該會得到一些數據,但請不要讓我堅持下去。如果它早點到來,那就太好了。但我想回答你的問題,我想直接告訴你。我們對這個機會感到非常興奮,但顯然我們的首要任務是提高產量。

  • The priority for us is expanding our production capabilities here to ramp up to be in a position that as soon as rapidly possible we can be producing from the yield enhanced process next year. And the goal is to sell as much yield enhanced product as we can in the second half of 2024 – excuse me, second half of 2025 and certainly all of 2026 will be from yield enhanced produced drug.

    我們的首要任務是擴大我們的生產能力,以便明年能夠盡快透過提高產量的製程進行生產。我們的目標是在 2024 年下半年銷售盡可能多的增產產品——對不起,2025 年下半年,當然還有 2026 年全年都將來自增產藥物。

  • With respect to KPMG, I mean, they’re our new auditor and it’s so funny to me when people ask these questions. But no one ever asked me, well, is CohnReznick going to continue to be your auditor after they finish your year-end audit here? There are – they are our new audit firm, they’re our new independent registered accounting firm that we are going to be working with from now for the foreseeable future. So they’re currently actively working with Brad and his team. We are going to continue to work with them and we believe that we’re going to be filing our 2024 10-K on or before the filing deadline, which I believe is March 3, 2025. We’re working rapidly to meet or exceed that deadline. But I don’t think there’s any reason why anyone should doubt that KPMG is not going to be our auditor for 2025 and 2026 and 2027, 2028 all the way into the future.

    對於畢馬威,我的意思是,他們是我們的新審計師,當人們問這些問題時,我覺得很有趣。但沒有人問過我,科恩雷茲尼克在完成你的年終審計後是否會繼續擔任你的審計師?他們是我們新的審計公司,他們是我們新的獨立註冊會計師事務所,從現在開始,在可預見的未來,我們將與其合作。因此,他們目前正在與布拉德及其團隊積極合作。我們將繼續與他們合作,我們相信我們將在提交截止日期(我認為是 2025 年 3 月 3 日)或之前提交 2024 年 10-K。我們正在迅速努力,以滿足或超過該最後期限。但我認為沒有任何理由讓任何人懷疑畢馬威不會在 2025 年、2026 年、2027 年、2028 年一直擔任我們的審計師。

  • We spent 17 years with CohnReznick. I tell the partners at KPMG, I don’t know if I’m working another 17 years, because I’m not as young as I used to be, but if I am, we’re very loyal here. I don’t know, Brad, if you want to add anything to that.

    我們和 CohnReznick 一起度過了 17 年。我告訴畢馬威的合夥人,我不知道自己是否還能再工作 17 年,因為我已經不像以前那麼年輕了,但如果是的話,我們對這裡非常忠誠。布拉德,我不知道你是否想對此添加任何內容。

  • Brad Tade - Chief Financial Officer and Treasurer

    Brad Tade - Chief Financial Officer and Treasurer

  • Agreed. Completely agreed.

    同意。完全同意。

  • Gary Nachman

    Gary Nachman

  • Okay, fair enough. And thank you for clarifying that. Congrats again.

    好吧,很公平。感謝您澄清這一點。再次恭喜。

  • 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

  • No problem.

    沒問題。

  • No, thank you. Look, we're, we're, we're very proud of transitioning to a big four audit firm and I think it just really represents the growth of the business and the maturation of our processes and our operations. So we're, we're excited to be working with them.

    不,謝謝。看,我們,我們,我們非常自豪能夠過渡到四大審計公司,我認為這確實代表了業務的成長以及我們流程和營運的成熟。所以我們很高興能與他們合作。

  • Brad Tade - Chief Financial Officer and Treasurer

    Brad Tade - Chief Financial Officer and Treasurer

  • Absolutely. I mean, it's, it's an important milestone in our organization and, you know, we don't expect, you know, any go forward, impact on the numbers and, or the filing time lines, as Adam had said, and we are happy to have engaged KPMG and have their service.

    絕對地。我的意思是,這是我們組織的一個重要里程碑,正如亞當所說,我們不希望任何進展對數字和/或申請時間表產生影響,而且我們正在很高興與畢馬威合作並獲得他們的服務。

  • Gary Nachman

    Gary Nachman

  • Great. Thank you.

    偉大的。謝謝。

  • Operator

    Operator

  • That concludes our question and answer session. I will now talk during the conference back over to Adam Grossman for closing remarks.

    我們的問答環節到此結束。現在,我將在會議期間邀請亞當·格羅斯曼(Adam Grossman)發表閉幕詞。

  • 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 very much everybody. We really appreciate your continued support and partnership. We thank our donors, we certainly thank our staff and we’re here to make good products that help people. To our stockholders, we appreciate you putting up with some of the pain last quarter, but it’s behind us now and I think the forward looking outlook is nothing but bright for us. So thank you very much. Donate plasma. Help save lives and stay healthy and safe and have a Happy Thanksgiving.

    非常感謝大家。我們非常感謝您持續的支持與合作。我們感謝我們的捐款者,當然也感謝我們的員工,我們致力於製造能夠幫助人們的優質產品。對於我們的股東,我們感謝你們忍受上個季度的一些痛苦,但現在它已經過去了,我認為前瞻性的前景對我們來說只是光明的。非常感謝。捐獻血漿。幫助拯救生命,保持健康和安全,並祝感恩節快樂。

  • Operator

    Operator

  • Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

    女士們、先生們,今天的電話會議到此結束。感謝大家的加入。您現在可以斷開連線。