ANI Pharmaceuticals Inc (ANIP) 2024 Q3 法說會逐字稿

Good day, everyone and welcome to today's ANI Pharmaceuticals Inc third quarter, 2024 earnings results call. Please note that this call is being recorded. After the speaker's opening remarks there will be a question and answer session. If you would like to ask a question during this time, simply press the star and the number one on your telephone keypad, if you would like to withdraw your question, please press star two. It is now my pleasure to turn the conference over to Lisa Wilson, please go ahead.

大家好，歡迎參加今天的 ANI Pharmaceuticals Inc 2024 年第三季財報電話會議。請注意，此通話正在錄音。演講者致開幕詞後，將進行問答環節。如果您想在此期間提問，只需按星號和電話鍵盤上的數字一即可，如果您想撤回問題，請按星號二。現在我很高興將會議交給麗莎威爾遜，請繼續。

Thank you, Todd. Welcome to ANI Pharmaceuticals Q3, 2024 earnings results call. This is Lisa Wilson Investor Relations for ANI, with me on today's call are Nikhil Lalwani, President and Chief Executive Officer, Stephen Carey, Chief Financial Officer, and Christopher Mutz, senior Vice President and head of ANI's rare disease business. You can also access the webcast of this call through the investors section of the ANI website at anipharmaceuticals.com. Before we get started, I would like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation or intent regarding future events and the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to ANI pharmaceuticals management as of today and involve risks and uncertainties including those noted in our press release issued this morning and our filings with the sec. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements. ANI specifically disclaims any intent or obligation to update these forward-looking statements except as required by law the archive webcast. We will be available for 30 days on our website anipharmaceuticals.com for the benefit of those who may be listening to the replay or archived webcast. This call was held and recorded on November 8th 2024 since then ANI may have made announcements related to the topics discussed so please refer the company's most recent press releases and sec filings, and with that, I'll turn the call over to Nikhil Lalwani.

謝謝你，托德。歡迎參加 ANI Pharmaceuticals 2024 年第三季財報電話會議。我是 ANI 投資者關係部門的麗莎·威爾遜 (Lisa Wilson)，參加今天電話會議的包括總裁兼首席執行官 Nikhil Lalwani、首席財務官 Stephen Carey 以及高級副總裁兼 ANI 罕見病業務負責人 Christopher Mutz。您也可以透過 ANI 網站 anipharmaceuticals.com 的投資者部分觀看本次電話會議的網路廣播。在我們開始之前，我想提醒大家，在今天的電話會議上發表的任何表達對未來事件和公司未來業績的信念、期望、預測、預測、期待或意圖的陳述都可能被視為前瞻性陳述。根據《私人證券訴訟改革法》。這些前瞻性陳述基於 ANI 藥品管理層截至目前為止掌握的信息，涉及風險和不確定性，包括我們今天早上發布的新聞稿和我們向美國證券交易委員會提交的文件中指出的風險和不確定性。此類前瞻性陳述並非對未來績效的保證。實際結果可能與前瞻性陳述中的預測有重大差異。ANI 特別聲明不承擔任何更新這些前瞻性聲明的意圖或義務，除非法律要求存檔網路廣播。我們將在我們的網站 anipharmaceuticals.com 上提供 30 天的服務，以便那些可能正在收聽重播或存檔網路廣播的人。這次電話會議於 2024 年11 月8 日舉行並進行了錄音，此後ANI 可能發布了與所討論主題相關的公告，因此請參閱該公司最新的新聞稿和SEC 文件，然後我會將電話會議轉交給Nikhil Lalwani。

Thank you, Lisa. Good morning everyone and thank you for joining us. Today I'll start by discussing our third quarter performance and highlights you'll then hear from Chris Mutz ANI's Head of Rare Disease, after Chris provides additional colour on the progress of this segment of our business, including the integration of Alimera, Steve will review the quarter and our updated guidance in more detail. Following our remarks. We'll take your questions. It's an exciting time here at ANI and we're continuing to execute well, this year against our purpose of serving patients improving lives. In addition, our team delivered record performance during the quarter for our lead Rare Disease asset Cortrophin Gel and our generics business. We also put a new more efficient and effective capital structure in place and completed the acquisition of Alimera on September 16th. As you've heard me outline previously, Alimera is highly synergistic to our rare disease business and we believe our proven commercial execution capabilities can further unlock the potential for Alluvian and UI to growing and durable assets as well as accelerate the growth of Cortrophin gel. In ophthalmology integration remains one of our key priority areas and I'm pleased with our progress to date. In particular, we have a 45% combined ophthalmology sales force who have been cross trained and promoting all three products since mid October. In addition, we have successfully retained talented Alimera employees and taken actions to ensure we are on track to capture over $10 million of synergies in 2025. The Alimera acquisition is transformative for our rare disease business we expect the transaction to create substantial shareholder value driving $35 to $38 million in adjusted non-GAAP EBITDA in 2025 inclusive of the approximately $10 million of identified cost synergies and high single digit to low double digit accretion in 2025 adjusted non-GAAP EPS. In addition, we expect our dedicated ophthalmology team to drive additional Cortrophin revenues in 2025. Turning to our third quarter financial performance, the company posted another strong quarter with total revenues of 148.3 million an increase of 13% over the third quarter of 2023 driven by accelerating demand for Cortrophin gel and continued strong growth for generics adjusted non-GAAP EBITDA was $35.1 million and adjusted non-GAAP EPS was $1.34. Cortrophin gel generated $52.6 million in revenues during the quarter of 77% over the third quarter of 2023. The third quarter represented continued momentum with the highest number of both quarterly new patient starts and unique prescribers since launch in January 2022 we saw increased demand across all targeted specialties, neurology, rheumatology, nephrology, pulmonology, and ophthalmology and are pleased to report that the prescribing momentum has continued in the fourth quarter with a number of monthly new cases initiated reaching a record high in October. Cortrophin remains on a strong multiyear growth trajectory as the overall ACTH category has returned to growth and is expected to deliver more than 20% year over year growth in 2024. In addition, the number of patients on ACTH therapy today is still substantially lower than a few years ago. Our generics business delivered another strong quarter with revenues of 78.2 million, an increase of 11% over the third quarter of 2023 and 5.4% over the second quarter of 2024. The solid performance reflected strength in our base business coupled with contribution from new product launches during the quarter, we launched five new generics including some into limited competition markets. Our R&D team continues to build momentum with one additional product launched already in Q4 in submission of several new ANDAS in the fourth quarter. Based on our strong third quarter results, the continued momentum across the business and the addition of illumine and unique we're pleased to raise our full year 2024 guidance which Steve will discuss later in the call. I'll now turn the call over to Chris Mutz, our head of Rare Disease to discuss Cortrophin and our new ophthalmology franchise in more detail, Chris.

謝謝你，麗莎。大家早安，感謝您加入我們。今天，我將首先討論我們第三季度的業績和亮點，然後您將聽到ANI 罕見疾病主管Chris Mutz 的發言，Chris 提供了有關我們業務這一領域進展的更多信息，包括Alimera 的整合，Steve將更詳細地查看本季度和我們更新的指導。以下是我們的發言。我們會回答您的問題。這是 ANI 令人興奮的時刻，今年我們將繼續良好執行，以實現服務患者改善生活的目標。此外，我們的團隊在本季為我們的領先罕見疾病資產 Cortropin Gel 和仿製藥業務創造了創紀錄的業績。我們也建立了新的更有效率的資本結構，並於 9 月 16 日完成了對 Alimera 的收購。正如您之前聽到我概述的那樣，Alimera 與我們的罕見疾病業務高度協同，我們相信我們經過驗證的商業執行能力可以進一步釋放 Alluvian 和 UI 增長和耐用資產的潛力，並加速 Cortropin 凝膠的增長。在眼科整合仍然是我們的關鍵優先領域之一，我對我們迄今為止的進展感到高興。特別是，我們擁有 45% 的眼科銷售隊伍，他們自 10 月中旬以來一直接受交叉培訓並推廣所有三種產品。此外，我們還成功留住了 Alimera 的優秀員工，並採取行動確保我們預計在 2025 年實現超過 1000 萬美元的協同效應。Alimera 收購對我們的罕見疾病業務具有變革性意義，我們預計此次交易將創造可觀的股東價值，推動2025 年調整後非GAAP EBITDA 達到35 至3800 萬美元，其中包括約1000 萬美元的已確定成本綜效以及高個位數到低兩位數的收益2025 年調整後的非 GAAP 每股收益將增加。此外，我們預計我們的專業眼科團隊將在 2025 年推動 Cortropin 的額外收入。談到我們第三季的財務業績，由於Cortropin 凝膠的需求加速以及仿製藥調整後的非GAAP EBITDA 的持續強勁增長，該公司再次公佈了強勁的季度業績，總收入為1.483 億美元，比2023年第三季成長13%。 Cortropin 凝膠本季營收為 5,260 萬美元，較 2023 年第三季成長 77%。第三季的勢頭持續強勁，自2022 年1 月推出以來，季度新增患者數量和獨特處方者數量均達到最高水平，我們看到所有目標專科、神經病學、風濕病學、腎臟病學、肺病學和眼科的需求都在增加，我們很高興地報告說，第四季繼續開藥勢頭，10 月每月新增病例數創歷史新高。隨著整個 ACTH 類別恢復成長，Cortropin 仍保持強勁的多年成長軌跡，預計 2024 年年成長將超過 20%。此外，如今接受 ACTH 治療的患者數量仍大大低於幾年前。我們的仿製藥業務在本季再次表現強勁，營收達到 7,820 萬美元，比 2023 年第三季成長 11%，比 2024 年第二季成長 5.4%。穩健的業績反映了我們基礎業務的實力，加上本季新產品推出的貢獻，我們推出了五種新仿製藥，其中一些是進入競爭有限的市場。我們的研發團隊繼續累積動力，在第四季度推出了另一款產品，並在第四季度提交了幾項新的 ANDAS。基於我們強勁的第三季業績、整個業務的持續成長勢頭以及光明和獨特的增加，我們很高興提高我們的 2024 年全年指引，史蒂夫將在稍後的電話會議中討論這一點。現在，我將把電話轉給我們罕見疾病部門的負責人 Chris Mutz，以更詳細地討論 Cortropin 和我們新的眼科特許經營權，Chris。

Thank you Nikhil and good morning everyone. I'm looking forward to telling you a bit more about the exciting things happening in our rare disease business. First, Cortrophin. We're pleased with the strong demand trends for Cortrophin gel during the third quarter which included continued momentum in adding new prescribers and robust growth of existing prescribers. Importantly, we saw demand growth across all targeted specialties of neurology, rheumatology, nephrology, pulmonology and ophthalmology. Our ophthalmology sales team in particular drove significant growth in prescriptions and new patient starts in the third quarter. Further reinforcing our confidence in the potential of the expanded team, which is now bolstered by the addition of the former Alimera reps and new reps. We hired to complete the 45% integrated ophthalmology sales force. As Nikhil mentioned, we believe Cortrophin gel remains on a strong multiyear growth trajectory and the company has been taking important steps to further strengthen the Cortrophin gel franchise. Over the past 18 months, we've launched dedicated sales teams in pulmonology and ophthalmology and with the Alimera acquisition, we now have an expanded sales team in ophthalmology. Moving now to our efforts toward improving patient and physician experience and convenience. We are pleased to announce that we've completed the development of a prefilled syringe offering for Cortrophin gel and submitted a supplemental NDA for FDA approval in late October. We believe the prefilled syringe will provide further benefits to patients and physicians by reducing the steps needed for self administration and are excited about the potential for this new offering that we plan to launch in the first half of 2025. We are also exploring other ideas to enhance the convenience for patients starting on Cortrophin gel and the health care providers who treat them. And as a reminder in the fourth quarter of 2023 we introduced the 1ml version of Cortrophin gel to meet the needs of physicians who desire a smaller configuration of ACTH for certain patients in particular those with acute gouty arthritis flares for which Cortrophin gel is the only approved ACTH therapy position demand for the 1ml via steadily ramped up including in the third quarter. We're also continuing to invest in scientific research that will provide additional support for the use of Cortrophin gel. At the end of October, we presented two abstracts at the American Society of Nephrology Annual meeting and earlier in Q3 research with Cortrophin Gel was published in frontiers in pharmacology, authored by Ruann Gong from the University of Toledo with collaborators overall and I believe in and remains committed to investing behind Cortrophin and delivering strong multiyear growth through purified Cortrophin gel.

謝謝尼基爾，大家早安。我期待著向您介紹更多有關我們罕見疾病業務中發生的令人興奮的事情。首先，Cortropin。我們對第三季 Cortropin 凝膠的強勁需求趨勢感到高興，其中包括增加新處方者的持續勢頭和現有處方者的強勁增長。重要的是，我們看到神經病學、風濕病學、腎臟病學、肺病學和眼科等所有目標專業的需求都在增加。我們的眼科銷售團隊尤其推動了第三季處方量和新患者數量的顯著成長。進一步增強了我們對擴大後的團隊潛力的信心，前 Alimera 代表和新代表的加入增強了我們的信心。我們聘請了 45% 的綜合眼科銷售人員。正如 Nikhil 所提到的，我們相信 Cortropin 凝膠仍保持強勁的多年成長軌跡，該公司一直在採取重要措施來進一步加強 Cortropin 凝膠特許經營權。在過去 18 個月裡，我們在肺科和眼科領域建立了專門的銷售團隊，隨著 Alimera 的收購，我們現在在眼科領域擁有了一支擴大的銷售團隊。現在我們致力於改善患者和醫生的體驗和便利性。我們很高興地宣布，我們已經完成了 Cortropin 凝膠預填充注射器產品的開發，並於 10 月底提交了補充新藥申請 (NDA) 以獲得 FDA 批准。我們相信，預充式註射器將透過減少自我給藥所需的步驟為患者和醫生帶來更多好處，並對我們計劃在 2025 年上半年推出的這項新產品的潛力感到興奮。我們也正在探索其他想法，以提高開始使用 Cortropin 凝膠的患者和治療他們的醫療保健提供者的便利性。作為提醒，我們在2023 年第四季推出了1ml 版本的Cortropin 凝膠，以滿足醫生的需求，他們希望為某些患者提供較小劑量的ACTH，特別是那些患有急性痛風性關節炎的患者，而Cortropin 凝膠是唯一核准用於治療的患者ACTH 治療部位對 1ml via 的需求穩定上升，包括第三季。我們也將繼續投資科學研究，為 Cortropin 凝膠的使用提供額外支援。10 月底，我們在美國腎臟病學會年會上提交了兩篇摘要，並在第三季早些時候發表了Cortropin Gel 的研究，該研究由托萊多大學的Ruann Kong 與合作者共同撰寫，發表在在《藥理學前沿》上，我相信並且仍然致力於投資 Cortropin，並透過純化的 Cortropin 凝膠實現多年的強勁成長。

Turning now to the Alimera products we are as excited as ever about the potential for our combined rare disease team to accelerate growth of Alluvian, UTI and Cortrophin with retina and uveitis specialists along with additional targeted ophthalmology subspecialties. As a reminder, Alluvian is used to treat diabetic macular oedema or DME the leading cause of vision loss in diabetic patients and UTI is used to treat chronic non-infectious uve affecting the posterior segment or NIUPS. Both products are differentiated as long term treatment options compared to other available products on the market. And I has continued to make progress on the clinical studies, New Day and synchronicity which are ongoing for Alluvian and UTI Newday has the potential to expand the utilization of Alluvian for patients with early DME by investigating combination therapy consisting of Alluvian and supplemental anti Zy treatment to improve patient outcomes. We expect top line data in the second quarter of 2025. The study is a multicentre single mass randomized and controlled trial designed to demonstrate the efficacy of Alluvian as baseline therapy in patients by comparing Alluvian plus supplemental anti veggies therapy to the current standard of care anti veggies therapy alone. The New Day study was initiated in 2020 it's fully enrolled with 306 treatment naïve or almost naïve VME patients and approximately 42 sites around the US. The planned treatment period in the study is 18 months with the last patient last visit in this study projected for next month. Having just attended the American Academy of Ophthalmology meeting in Chicago in mid October. It's very clear that this data is highly anticipated by the retina specialist community in chronicity. The study designed to provide retina and UVI specialists with a broader sense of the utility of UT in patients with chronic NIUTS. The study is a Multicentre open label study evaluating UTI and chronic inflammation study has enrolled 110 patients in approximately 25 sites around the US. With the last patient last visit for the study projected for November 2025. Overall, the integration has been relatively seamless and we're not only excited about the products but also impressed by the calibre of talent that we welcomed into ANI integration and cross training of the legacy ANI and Alimera ophthalmology sales reps is complete and the combined team of 45 began promoting Cortrophin gel Alluvian and UTI to physicians in mid October. We expect the enhanced team to drive greater awareness of all three products and the identification of more patients that can benefit from treatment. In 2025 we expect ANI as rare as these business will be both the company's largest business unit and the largest driver of growth and we look forward to keeping you updated on our progress with that. I'll turn the call over to Steve for the financial update. Steve.

現在轉向 Alimera 產品，我們一如既往地對我們的聯合罕見疾病團隊與視網膜和葡萄膜炎專家以及其他有針對性的眼科亞專科加速 Alluvian、UTI 和 Cortropin 的發展的潛力感到興奮。提醒一下，Alluvian 用於治療糖尿病性黃斑水腫或 DME（糖尿病患者視力喪失的主要原因），而 UTI 用於治療影響後段的慢性非感染性葡萄膜炎或 NIUPS。與市場上其他現有產品相比，這兩種產品作為長期治療選擇有所不同。我在 Alluvian 和 UTI 正在進行的臨床研究、New Day 和同步性方面繼續取得進展 Newday 有潛力通過研究由 Alluvian 和補充抗 Zy 治療組成的聯合療法，擴大 Alluvian 在早期 DME 患者中的使用以改善患者的治療效果。我們預計 2025 年第二季將公佈營收數據。該研究是一項多中心單一群體隨機對照試驗，旨在透過將 Alluvian 加補充抗蔬菜療法與目前單獨的護理標準抗蔬菜療法進行比較，證明 Alluvian 作為基線療法對患者的療效。New Day 研究於 2020 年啟動，已全面招募 306 名未接受過治療或幾乎未接受過治療的 VME 患者，涵蓋美國各地約 42 個研究中心。研究的計劃治療期為 18 個月，本研究中最後一位患者的最後一次就診預計為下個月。十月中旬剛參加了在芝加哥舉行的美國眼科學會會議。很明顯，慢性病視網膜專家界高度期待這些數據。該研究旨在讓視網膜和 UVI 專家更廣泛地了解 UT 在慢性 NUTS 患者中的效用。該研究是一項評估泌尿道感染和慢性發炎研究的多中心開放標籤研究，已在美國約 25 個地點招募了 110 名患者。研究的最後一位患者的最後一次訪視預計為 2025 年 11 月。總體而言，整合相對無縫，我們不僅對產品感到興奮，而且對我們歡迎加入 ANI 整合的人才素質印象深刻，對傳統 ANI 和 Alimera 眼科銷售代表的交叉培訓已經完成，合併後的團隊也已完成45 人於10 月中旬開始向醫生推銷Cortropin 凝膠Alluvian 和UTI。我們希望增強後的團隊能提高人們對這三種產品的認識，並發現更多可以從治療中受益的患者。到 2025 年，我們預計 ANI 業務將變得罕見，因為這些業務將成為公司最大的業務部門和最大的成長動力，我們期待向您通報我們在這方面的最新進展。我會將電話轉給史蒂夫，以了解最新的財務狀況。史蒂夫.

Thanks Chris and good morning to everyone on the call. I'll review our third quarter results and then discuss our updated 2024 guidance ANI generated third quarter revenues of 148.3 million up 13% over the prior year period. Revenues from Cortrophin Gel reported in our rare disease segment were 52.6 million up 77% from the prior year period driven primarily by increased volume on a record number of new patient starts based upon the continued strong execution of the rare disease team in driving growth. We are raising our full year Cortrophin gel revenue guidance to 196 million to 200 million. The acquisition of Alimera closed on September 16th and therefore, our third quarter financial statements reflect approximately two weeks of revenue and expense activity. We are reporting combined revenues from these products under the heading. Alluvian and UTI which contributed 3.9 million of revenues to our rare disease segment during the two week period. Revenues for our generics, established brands and other segment were 91.9 million a decrease of 10% over the prior year period. Generic revenues for the quarter were 78.2 million an increase of 11% over the prior year period driven by increased volumes on contributions from new product launches in 2024. And the full year impact of products launched in 2023, Net revenues for established brands and other were 13.7 million in the quarter a decrease of 57% over the prior year, which was in line with our expectations. Starting today when I speak to our operating expenses for purpose of this earnings call, I will be referring to our Non-GAAP expenses which are detailed on table three in our press release. Generally, our Non-GAAP operating expense excludes depreciation and amortization, stock based compensation and certain costs related to litigation and M&A activity. Please refer to table three for reconciliation to our GAAP expenditures. Non-GAAP cost of sales excluding depreciation and amortization increased 25% to 59.5 million in the third quarter of 2024 compared to the prior year period, primarily due to net growth in sales volumes of pharmaceutical products and significant growth of royalty bearing products. Non-GAAP gross margin was 60% a decrease of approximately 3.9 points from the prior year period, primarily driven by unfavourable product mix due to the reduction in established brand revenues. Non-GAAP research and development expenses decreased 20% to 8.7 million in the third quarter of 2024 principally due to the timing of spend, we continue to expect second half, 2024 R&D expenditures to be meaningfully higher than the first half of the year due to the timing of activities and the inherent phasing of R&D on a quarter by quarter basis. In addition, fourth quarter, R&D spend will include expenditures for Alluvian and UT driven primarily by the New Day and synchronicity studies. Expenditures related to these studies are expected to continue throughout 2025. Non-GAAP selling general and administrative expenses increased 23% to 45 million in the third quarter of 2024 due to increased employment related costs, continued investment in rare disease, sales and marketing activities and an overall increase in activities required to support the growth of our business. We expect these expenses to be meaningfully higher in the fourth quarter, reflecting a full quarter of our integrated ophthalmology sales force, promoting Cortrophin, Alluvian and UT. We expect continued investment in our business and corresponding expenses to support the expanded sales force to continue in 2025. Adjusted Non-GAAP earnings per share was $1.34 for the quarter compared to $1.27 per share in the prior year period. Adjusted Non-GAAP EBITDA for the third quarter was 35.1 million compared to 36.5 million in the prior year period. We ended the quarter with 145 million in unrestricted cash and have 641.3 million in principal value of outstanding debt inclusive of our senior convertible notes and term loan. At the end of the third quarter, our gross leverage was approximately 3.8 times and our net leverage was approximately three times our trailing 12 month adjusted Non-GAAP EBITDA of approximately 167.7 million, which is Pro Forma for the Alimera acquisition inclusive of run rate synergies. Turning to our updated 2024 outlook. We're pleased to have closed the acquisition of Alimera and are raising our full year 2024 guidance to reflect continued strength in purified Cortrophin gel and the contribution from the Alluvian and UT starting September 16th. Our updated guidance is as follows. Full year 2024 net revenues of 594 million to 602 million up from our prior guidance of 540 million to 560 million representing year over year growth of approximately 22% to 24%. Cortrophin net revenues of 196 million to 200 million up from our prior guidance of 185 million to 195 million representing growth of 75% to 78% combined, Alluvian and UT net revenues of 30 million to 32 million, which reflects revenues during the post close period of September 16th through December 31st adjusted Non-GAAP EBITDA of 149 million to 153 million up from our prior guidance of 140 million to 150 million representing growth of approximately 11% to 14% and adjusted Non-GAAP earnings per share between $4.90 and $5.05 up from our prior guidance of $4.38 and $4.82. We now expect total company Non-GAAP gross margin to be at the high end of our previously communicated range of between 61% and 62%. With the inclusion of SDNA and R&D associated with Alluvian and UT. We anticipate full year total adjusted Non-GAAP operating expenses for 2024 of between 219 million and 223 million. Consistent with previous quarters, we will continue to tax effect Non-GAAP adjustments for the computation of adjusted Non-GAAP diluted earnings per share using our estimated statutory rate of 26% unless the item being adjusted is non tax deductible in whole or part. The company now anticipates approximate approximately 19.7 million and 19.9 million shares outstanding for the purpose of calculating adjusted Non-GAAP diluted EPS for the full year 2024 and fourth quarter, 2024 respectively. The company also expects its annual US GAAP effective tax rate to be in the mid single digits as compared to our previous expectation between 22% and 25% driven by the non deductible nature of certain expenses incurred in conjunction with the acquisition of Alimera applied against an annual forecasted GAAP pre tax loss. With that, I'll turn the call back to Nikhil.

謝謝克里斯，祝所有參加電話會議的人早安。我將回顧我們的第三季業績，然後討論我們更新的 2024 年指引 ANI 第三季營收為 1.483 億美元，比上年同期成長 13%。我們的罕見疾病部門報告的Cortropin 凝膠收入為5,260 萬美元，比上年同期增長77%，這主要是由於罕見疾病團隊在推動增長方面持續強勁的執行力，導致新患者數量創紀錄的數量增加。我們將全年 Cortropin 凝膠收入指引提高至 1.96 億至 2 億。對 Alimera 的收購於 9 月 16 日完成，因此，我們第三季的財務報表反映了大約兩週的收入和支出活動。我們在標題下報告了這些產品的合併收入。Alluvian 和 UTI 在兩週內為我們的罕見疾病部門貢獻了 390 萬美元的收入。我們的仿製藥、知名品牌和其他部門的收入為 9,190 萬美元，比去年同期下降 10%。由於 2024 年新產品發布帶來的貢獻量增加，該季度的一般收入為 7,820 萬美元，比上年同期增長 11%。而2023年推出的產品對全年的影響，老牌品牌及其他的本季淨收入為1,370萬美元，比上年下降57%，符合我們的預期。從今天開始，當我在本次財報電話會議中談到我們的營運費用時，我將指的是我們的非公認會計原則費用，這些費用在我們的新聞稿中的表三中詳細說明。一般來說，我們的非公認會計準則營運費用不包括折舊和攤提、股票薪資以及與訴訟和併購活動相關的某些成本。請參閱表三了解我們的 GAAP 支出對帳狀況。2024 年第三季度，不計折舊和攤銷的非 GAAP 銷售成本較上年同期增長 25%，達到 5,950 萬美元，這主要是由於醫藥產品銷量的淨增長以及含特許權使用費產品的大幅增長。非 GAAP 毛利率為 60%，較上年同期下降約 3.9 個百分點，主要是因為老牌品牌收入減少導致產品組合不利。2024 年第三季非 GAAP 研發支出下降 20% 至 870 萬美元，主要是由於支出時間安排，我們繼續預計 2024 年下半年研發支出將顯著高於上半年，因為每季的活動時間安排和研發的固有階段。此外，第四季度的研發支出將包括主要由新一天和同步性研究驅動的 Alluvian 和 UT 支出。與這些研究相關的支出預計將持續到 2025 年。由於就業相關成本增加、對罕見疾病、銷售和行銷活動的持續投資以及支持我們的成長所需的活動總體增加，2024 年第三季非 GAAP 銷售一般和管理費用增加了 23% 至 4500 萬美元。商業。我們預計第四季度這些費用將顯著增加，反映出我們整個季度的綜合眼科銷售隊伍，推廣 Cortropin、Alluvian 和 UT。我們預計我們的業務和相應費用將繼續投資，以支持 2025 年繼續擴大銷售團隊。本季調整後的非公認會計準則每股收益為 1.34 美元，而去年同期為每股 1.27 美元。第三季調整後非公認會計準則 EBITDA 為 3,510 萬美元，去年同期為 3,650 萬美元。截至本季末，我們擁有 1.45 億美元的非限制性現金，未償債務本金價值為 6.413 億美元，其中包括我們的優先可轉換票據和定期貸款。截至第三季末，我們的總槓桿率約為3.8 倍，淨槓桿率約為過去12 個月調整後非公認會計準則EBITDA（約1.677 億）的三倍，這是收購Alimera 的預期數據，包括運行率協同效應。轉向我們更新的 2024 年展望。我們很高興完成了對 Alimera 的收購，並提高了 2024 年全年指導，以反映純化 Cortropin 凝膠的持續優勢以及從 9 月 16 日開始的 Alluvian 和 UT 的貢獻。我們的更新指南如下。2024 年全年淨收入為 5.94 億至 6.02 億美元，高於我們先前指導的 5.4 億至 5.6 億美元，年增約 22% 至 24%。Cortropin 淨收入為1.96 億至2 億美元，高於我們先前指引的1.85 億至1.95 億美元，合計成長75% 至78%，Alluvian 和UT 淨收入為3,000 萬至3,200 萬美元，反映了關閉後期間的營收9 月16 日至12 月31 日調整後的非GAAP EBITDA 為1.49 億至1.53 億美元，高於我們先前指引的1.4 億至1.5 億美元，成長約11% 至14%，調整後的非GAAP 每股收益成長4.90 至5.05 美元與我們之前的指導價 4.38 美元和 4.82 美元相比。我們現在預計公司非 GAAP 總毛利率將處於我們先前通報的 61% 至 62% 範圍的高端。納入 SDNA 以及與 Alluvian 和 UT 相關的研發。我們預計 2024 年全年調整後非 GAAP 營運支出總額將介於 2.19 億至 2.23 億美元之間。與前幾季一樣，我們將繼續使用我們估計的 26% 法定稅率對非 GAAP 調整進行稅收影響，以計算調整後的非 GAAP 稀釋每股收益，除非調整的項目全部或部分不可免稅。該公司目前預計，用於計算 2024 年全年和 2024 年第四季調整後非 GAAP 攤薄每股收益的流通股數量分別約為 1,970 萬股和 1,990 萬股。該公司還預計其年度美國公認會計原則有效稅率將在個位數中間，而我們先前的預期為 22% 至 25%，這是由於收購 Alimera 時產生的某些費用的不可扣除性質所致。預測GAAP 稅前虧損。這樣，我會將電話轉回尼基爾。

Thank you, Steve. The continued strong performance of our business in the third quarter underscores the strength of our strategy and highlights our solid execution and we're excited about the potential of the new expanded rare disease business. We now have multiple growing and durable commercial rare disease assets and an augmented sales team covering the specialties of ophthalmology, neurology, nephrology, rheumatology, and pulmonology. We look forward to seeing many of you in person later this month at Guggenheim's inaugural Healthcare Innovation Conference in Boston and the Jeffreys London Healthcare Conference. Thank you all for joining us today, operator. Please open the line for questions.

謝謝你，史蒂夫。第三季我們業務的持續強勁表現凸顯了我們策略的優勢，並凸顯了我們紮實的執行力，我們對新擴展的罕見疾病業務的潛力感到興奮。我們現在擁有多個不斷增長和持久的商業罕見疾病資產，以及一支涵蓋眼科、神經病學、腎病學、風濕病學和肺病學專業的增強銷售團隊。我們期待本月晚些時候在波士頓舉行的古根漢首屆醫療保健創新會議和傑弗里斯倫敦醫療保健會議上見到你們中的許多人。感謝大家今天加入我們，接線生。請打開提問專線。

The floor is now open for your questions. If you have a question or comment at this time, please press star one on your telephone keypad. You may remove yourself by pressing star two. Again to ask a question. Please press star one.

現在請大家提問。如果您此時有疑問或意見，請按電話鍵盤上的星號一。您可以透過按二號星來移除自己。又來問問題了。請按星號一。

Our first question will come from David Amsellem with Piper Sandler, please go ahead.

我們的第一個問題將由 David Amsellem 和 Piper Sandler 提出，請繼續。

Thanks. So I have a couple of questions. First, can you talk about the payer landscape for Cortrophin gel and how that has evolved if it has evolved at all and how that looks compared to Accra Gel? So that's number one. Number two. Is you, you talked about the, the ACTH market returning to growth. But, I'm wondering out loud how much of your, your business is coming from practitioners who are moving away from Accra gel versus practitioners who are just new to the category? So can you help us understand the mix there for your product? And then lastly, on the generics business, you've had a steady cadence of new launches. I guess my question here is, what does that mean for 25? How are you thinking about the pace of new launches? And the extent to which you can continue to grow your generics business moving forward. Thank you.

謝謝。所以我有幾個問題。首先，您能談談 Cortropin 凝膠的付款人情況嗎？所以這是第一。第二。您談到了 ACTH 市場恢復成長。但是，我很想知道，您的業務有多少來自於離開阿克拉凝膠的從業者，而不是剛接觸該類別的從業者？那麼您能幫助我們了解您產品的組合嗎？最後，在仿製藥業務上，新產品的推出節奏穩定。我想我的問題是，這對 25 意味著什麼？您如何看待新品發布的節奏？以及您可以在多大程度上繼續發展您的仿製藥業務。謝謝。

And good morning David and thank you for your questions. I'll try to take them one by one. So the first question on the payer landscape in for Cortrophin and the ACTH category. So we try to find the balance between sharing information that is for investors and not review competitively sensitive information. So we maintain strong relationship with our partners in the market access space and believe that there is recognition of the value that Cortrophin brings to this class and as you think about the payroll, I think the most important mark, impactful market access change next year will be the increased affordability for seniors to the Medicare out of pocket cap along with the smoothing mechanisms for that out of pocket and our patient support team is prepared to educate patients and physicians about these new options which we believe should improve. You know, patient access.

早安，大衛，謝謝你的提問。我會嘗試將它們一一呈現。關於 Cortropin 和 ACTH 類別的付款人情況的第一個問題。因此，我們試圖在共享投資者資訊和不審查競爭敏感資訊之間找到平衡。因此，我們與市場准入領域的合作夥伴保持著牢固的關係，並相信Cortropin 為這一類別帶來的價值得到了認可，當你考慮工資單時，我認為最重要的標誌，明年有影響力的市場准入變化將是老年人對自付費用醫療保險的負擔能力提高，以及自付費用的平滑機制，我們的患者支持團隊準備向患者和醫生介紹這些我們認為應該改進的新選擇。你知道，患者訪問。

When your second question regarding, you know, our growth and you know, where does it come from existing prescribers or new prescribers? I think the way I would look at it is, you know, when you look at total growth of ANI, we've been in the market for three years now and have achieved the growth that we have right most recently, growing from 112 million in 2023 to a guidance of 196 to 200 million in 2024. That growth has come from both overall market growth as well as share growth and so when you sort of bring that down to the prescriber level, we're seeing both, we're seeing growth which share with prescribers that used to use the competitive product as well as new prescribers that have been unique to PC, to Cortrophin gel. And the other thing to just highlight is there are indications that ANI has that the competitor does not have including acute gout arthritis flares. So as you think about, you know, the overall ACTH market, which you know, if you take our guidance and the competitor's guidance, you know, implies more than 20% growth year on year and what the the potential is and why we believe Cortrophin has a strong multiyear growth trajectory. There's also, you know, beyond just the, the existing or the number of patients that were there on therapy a few years ago and also the additional indications that we have that the competitor does not have. So that's on the, the second question on, you know, the drivers of our Cortrophin.

當你的第二個問題涉及我們的成長時，你知道，它來自現有的處方者或新的處方者？我認為我看待它的方式是，當你看到 ANI 的總成長時，我們已經進入市場三年了，並且實現了我們最近的成長，從 1.12 億成長到2023 年目標為2024 年196 至2 億。這種成長來自整體市場成長和份額成長，因此，當你將其降低到處方者水平時，我們看到了兩者，我們看到了與過去使用競爭產品的處方者分享的成長以及PC、Cortropin 凝膠獨有的新處方。另一件需要強調的事情是，有跡象表明 ANI 具有競爭對手沒有的特徵，包括急性痛風關節炎發作。因此，當您思考整個 ACTH 市場時，如果您採用我們的指導和競爭對手的指導，您就會知道，這意味著同比增長超過 20%，潛力是什麼以及我們為何相信Cortropin 具有強勁的多年增長軌跡。你知道，除了幾年前接受治療的現有患者或患者數量之外，還有我們掌握的競爭對手沒有的其他跡象。這就是第二個問題，關於 Cortropin 的驅動因素。

And then on your third question on the cadence of new launches for generics and what does that imply for the trajectory of our generics business? we are strong R&D team along with the operational excellence and our US space manufacturing footprint with a strong FDA compliance track record will continue to deliver a cadence of new launches and we believe that the combination of these different factors will enable the ANI generics business to grow in the high, single digit, low double digit range going forward as we have delivered over the past few years.

然後關於你的第三個問題，即仿製藥新上市的節奏，這對我們仿製藥業務的軌跡意味著什麼？我們是強大的研發團隊，卓越的營運能力以及我們在美國太空製造的足跡以及強大的 FDA 合規記錄將繼續推出新產品，我們相信這些不同因素的結合將使 ANI 仿製藥業務不斷增長正如我們過去幾年所交付的那樣，未來將在高位、個位數、低位兩位數範圍內。

Thank you, David.

謝謝你，大衛。

Thank you.

謝謝。

Thank you. Our next question will come from Gary Nachman with Raymond James. Please go ahead.

謝謝。我們的下一個問題將由加里·納赫曼和雷蒙德·詹姆斯提出。請繼續。

Thanks, good morning. So for Alluvian and UT, the guidance of 30 to 32 million is from the close of Alimera on September 16th. So if I back out 4 million in the third quarter, it's 26 to 28 million for the fourth quarter, is that a reasonable quarterly run rate to think about going into next year? And then just talk about with the integration in place, how you plan to accelerate those products. If we could see growth next year, and also how much you think the New Day data could help potentially if it's positive, I guess in terms of combination use?

謝謝，早安。因此，對於 Alluvian 和 UT 來說，3,000 至 3,200 萬的指導是從 9 月 16 日 Alimera 收盤開始的。因此，如果我在第三季度收回 400 萬美元，那麼第四季度將是 2600 至 2800 萬美元，考慮進入明年，這是一個合理的季度運行率嗎？然後討論整合到位後，您計劃如何加速這些產品。如果我們明年能看到成長，以及您認為新日數據如果是正面的，可能會有多大幫助，我想在組合使用方面？

Great, good morning Gary and thank you for your questions. Yes. So your first question on Alluvian and UT and the the Q4 implied guidance. But since the deal closing, the commercial organization has been in a period of transition we've hired and now have in place 45 ophthalmology dedicated sales reps across the country. Some representatives have seen realignment of their territories. In addition, we've invested the time to cross train this team across all three products. Alluvian, UT and Cortrophin and post training. The combined sales team has been in, has been promoting all three products since mid October. So the Q4 guidance reflects this period of transition and we are confident that the underlying demand for Alluvian and UT are aligned with our expectations and expect to achieve our growth goals for these assets. So you would, we would expect growth over this run rate in, you know in 2025 and we remain confident that the Alimera acquisition to add incremental, 35 to 38 million in incremental EBITA in 2025 and anticipated to drive a single digit to low double digit accretion in adjusted non-GAAP EPS. And then on the New Day study, I'll turn that over to Chris to answer your question regarding, you know, the impact of the New Day study. I will just say that from our perspective, the, the double digit growth that we've or the growth expectations that we have for Alluvian and UT have not hinge and, and neither did our deal model hinge on a positive readout of the New Day study. Having said that, you know, we look forward to updating you regarding, you know, as we get the top line results towards the end of quarter one and beginning of quarter two, the implications of that on, you know, the commercial implications of that on the growth trajectory for for Alluvian. But Chris, would you like to add anything?

太好了，早上好，加里，謝謝你的提問。是的。因此，您關於 Alluvian 和 UT 的第一個問題以及第四季度暗示了指導。但自交易完成以來，我們聘用的商業組織一直處於過渡期，目前在全國各地擁有 45 名眼科專業銷售代表。一些代表已經看到了他們的領土的重新調整。此外，我們也投入了時間對這支團隊進行所有三種產品的交叉訓練。Alluvian、UT 和 Cortropin 以及訓練後。自十月中旬以來，聯合銷售團隊一直在推廣所有三種產品。因此，第四季度的指導反映了這段過渡時期，我們有信心對 Alluvian 和 UT 的潛在需求符合我們的預期，並期望實現我們對這些資產的成長目標。因此，我們預計 2025 年將超過這個運行率，我們仍然有信心收購 Alimera 將在 2025 年增加 35 至 3800 萬的增量 EBITA，並預計將個位數推至低兩位數調整後的非公認會計原則每股收益增加。然後在新的一天研究中，我會將其轉交給克里斯來回答你關於新的一天研究的影響的問題。我只想說，從我們的角度來看，我們對 Alluvian 和 UT 的兩位數成長或成長預期並不取決於，而且我們的交易模式也不取決於新一天的正向讀數學習。話雖如此，您知道，當我們在第一季末和第二季初獲得頂線結果時，我們期待向您通報最新情況，以及其對商業影響的影響。但是克里斯，你想補充什麼嗎？

Yeah. So as mentioned previously, the the New day clinical trials designed to generate prospective data, evaluating Alluvian as baseline therapy and the treatment of DME and, and really compared to current standard of care with anti VEGF injections, you know, we, we think this study really has a significant opportunity for people to revisit how they're taking care of DME patients. Certainly, anti VEGF therapy has been the standard of care in, in, in early DME and patients generally receive multiple anti vegf treatments. Before physicians consider Alluvian for those patients and I think, you know, from the feedback we've been getting from the retina community is that this is going to be the data that has been needed really to, to reconsider the the way that has the approach that has been taken in and taking care of these patients and, and really that the combination therapy of Alluvian plus and could potentially have a role based on this data.

是的。因此，如前所述，新日臨床試驗旨在產生前瞻性數據，評估 Alluvian 作為基線療法和 DME 的治療，並與當前抗 VEGF 注射的護理標準進行真正的比較，你知道，我們認為這這項研究確實為人們提供了一個重要的機會來重新審視他們如何照顧DME 患者。當然，抗 VEGF 治療一直是早期 DME 的標準治療，患者通常接受多種抗 VEGF 治療。在醫生考慮對這些患者使用 Alluvian 之前，我認為，從我們從視網膜界得到的反饋來看，這將是真正需要的數據，以重新考慮使用 Alluvian 的方式。實際上，根據這些數據，Alluvian 加的聯合療法可能會發揮作用。

Okay, thank you and then just, yeah. No, and then just on Cortrophin, I know it's pretty early days, but are you seeing a real benefit yet within ophthalmology from the combined sales team with Alimera what sort of impact do you expect in the coming year? You know, specifically in ophthalmology and then just with the prefilled syringe available, I think you said in the first half of next year. How much of a benefit do you think that will be from a convenience standpoint to help Cortrophin overall? Thanks.

好的，謝謝你，然後，是的。不，然後就 Cortropin 而言，我知道現在還為時過早，但是您是否看到與 Alimera 合併的銷售團隊在眼科領域帶來的真正好處，您預計來年會產生什麼樣的影響？你知道，特別是在眼科領域，然後你可以使用預裝注射器，我想你在明年上半年說過。從方便的角度來看，您認為這對 Cortropin 整體有多大好處？謝謝。

Yes. Thank you for both those questions again. Gary regarding the prefill, I'll take your second question for us, which is the prefill syringe. You know, this is a new offering that we're bringing to the market for patients to make it easier for patients that have, you know, to increase the patient convenience versus when using the vial to make it easier from an administration standpoint to use our prefill syringe. So we do believe that this will be helpful for patients this new offering will have an impact for patients that have, you know, increase in convenience while us while using the while administering the vials so I think that's that's the first. So I guess that was your second question and then regarding your question on the impact of PCG and ophthalmology. Look, it's early days, right? We just said that the combined ophthalmology sales team is in the in the market since mid October promoting all three products and the early signs are positive and we remain confident that that there will be the growth of Cortrophin and ophthalmology with this combined salesforce and what the early signs are promising but again, it's it's been a few weeks and we look forward to sharing further updates as we guide towards 2025 and inform on the updates on the progress made in this part of the business.

是的。再次感謝您提出這兩個問題。蓋瑞關於預充式註射器，我會回答你的第二個問題，即預充填式註射器。您知道，這是我們向患者推出的一項新產品，目的是讓患者更容易使用，您知道，與使用小瓶相比，從管理的角度來看，增加患者的便利性，使其更容易使用我們的預充式註射器。因此，我們確實相信這將對患者有所幫助，這項新產品將對患者產生影響，您知道，當我們在使用小瓶時使用時會增加便利性，所以我認為這是第一個。所以我想這是您的第二個問題，然後是關於 PCG 和眼科影響的問題。瞧，現在還早，對吧？我們剛剛說過，聯合眼科銷售團隊自 10 月中旬以來一直在市場上推廣所有三種產品，早期跡像是積極的，我們仍然相信，透過這支聯合銷售隊伍，Cortropin 和眼科將會成長，以及早期跡像是有希望的，但同樣，已經過去了幾週了，我們期待在2025 年指引時分享進一步的更新，並通報這部分業務所取得的進展的最新情況。

Thank you. Our next question will come from Vamil Divan with Guggenheim Securities. Please go ahead.

謝謝。我們的下一個問題將來自古根漢證券公司的瓦米爾·迪萬。請繼續。

Great. Thanks for taking my questions. So two if I could. So one, a little bit of a different angle on the Cortrophin ,questions I asked before you've continued to sort of beat and raise on this product through the course of this year. Can you maybe just talk about what parts are doing better? You know, is it more from a certain segments? Is the volume of the price or so, what's been driving the upside over the course of 2024 just again? So I think about how to model it out for for next year and then the second question, I want to make sure I caught something you said in your prepared remarks correctly. You know, something around rare disease being the biggest, the biggest unit in 2025. If you can just clarify that, what you said and then when you're comparing that, are you comparing that to just generics on its own or are you comparing it to generics, established brands and other altogether as a segment? Thank you.

偉大的。感謝您回答我的問題。如果可以的話，就兩個吧。所以，我從一個不同的角度來問一下 Cortropin 的問題，然後你們在今年繼續對這個產品進行擊敗和提高。您能否談談哪些部分做得更好？你知道，更多的是來自某些細分市場嗎？是價格的成交量還是左右的因素再次推動了 2024 年的上漲？所以我考慮如何為明年制定模型，然後是第二個問題，我想確保我正確地理解了你在準備好的發言中所說的內容。你知道，到 2025 年，罕見疾病將成為最大的單位。如果你能澄清一下你所說的，然後當你進行比較時，你是將其與仿製藥本身進行比較還是將其與仿製藥、知名品牌和其他作為一個細分市場進行比較？謝謝。

Good morning Vamil and thank you for your question regarding growth in Control Fund. I think first you ask, is it volume versus price? It's a, you know, a majority of the growth, you know, almost all of the growth comes from from growth and volumes and where does that growth in volumes come from? We see growth across therapeutic areas. The both the ones we focused on at launch neurology, nephology, and rheumatology, as well as the newer areas of ophthalmology, gout and pulmonology and we also see robust prescribing demand across both existing prescribers and new prescribers as the, as I had answered in the question for data upfront. So that's where the, you know, we're seeing growth sort of pretty much across the board and then the second your clarification on rare disease, we see the rare disease as the largest driver of growth for ANI as a company going forward. So that clarifies that part of the question.

早安，Vamil，感謝您提出有關控制基金成長的問題。我想你會先問，是數量還是價格？你知道，大部分的成長，幾乎所有的成長都來自於成長和數量，而數量的成長來自哪裡？我們看到各個治療領域的成長。我們在推出神經病學、腎病學和風濕病學時重點關注的兩個領域，以及眼科、痛風和肺病學的新領域，我們也看到現有處方者和新處方者的強勁處方需求，正如我在預先資料的問題。因此，您知道，我們看到了幾乎全面的成長，然後在您對罕見疾病進行澄清後，我們將罕見疾病視為 ANI 作為一家公司未來成長的最大推動力。這樣就澄清了問題的這一部分。

Once again, if you would like to ask a question, please press star one at this time. Our next question comes from (inaudible) with Truist securities. Please go ahead.

再次強調，如果您想提問，請此時按星號一。我們的下一個問題來自（聽不清楚）Truist 證券。請繼續。

So as you look back on the recent Alimera acquisition and potentially consider future M&A I'm just curious what earnings you take away from the transaction. If any to prevent similar situations in regards to timely closure in the future Thank you.

因此，當您回顧最近的 Alimera 收購並可能考慮未來的併購時，我只是好奇您從交易中獲得了哪些收益。今後如有防止類似情況請及時關閉，謝謝。

Yeah, I think that's a, that's a great question regarding, you know, learning. I think that as we look to pursue other remedy activities, I think we, we, we sort of remain focused on what is strategically aligned and important for ANI. So the Alimera acquisition is a highly synergistic acquisition. It helps continue to expand the scope and scale of our rare disease business, which is right in line with. But what we've been saying from you know day one, actually for almost over a year and that's something that we have been pursuing. So sort of sticking to our strategy. That's one lesson that we want to continue gathering forward and then the second is, you know, as, as you do an acquisition, there are bumps along the way and to make sure that we can continue to stay and work through the challenges and what and you know, those challenges may vary from acquisition to acquisition and you know, to ensure that we understand the challenge that we have the capability, experience and expertise to address the challenge and to move forward from there, you know, and you know, we believe that with the Alimera acquisition, there is a you know, a challenge related to the supply of the heat that has come up and we are well positioned to address that challenge, right by what we have been working closely with Highpoint since the deal signing to address the issues on the warning letter and that the work with and the collaboration and engagement with I point has become even closer since we closed the deal and we remain confident that you know that there will be that I point will satisfactorily address the points raised by the FDA. In fact, they've been giving updates on the same as they've gone along and we anticipate no impact on continuity of unique supply to patients in need and look, it is standard practice for ANI to work towards creating redundancies in supply chain for high value products. Accordingly. We are taking steps to increase supply security for both Alluvian and UT. So, you know, going back to your question, you know, there will be bumps along the way as we do acquisitions and you know, make sure that the experience and expertise that we have, we bring that to bear, you know, in this case, it was related to supply it may be something else in a future acquisition and look, we have significant capability and expertise in this area. Given the three plants we run in the US with strong FDA compliance track records and our experience in addressing points like these jointly with our suppliers, so that those are the lessons that I would stick to our strategy and making sure that when bumps come along the way that we, you know, understand the bumps and address them.

是的，我認為這是一個關於學習的好問題。我認為，當我們尋求其他補救活動時，我認為我們、我們、我們仍然關注對 ANI 具有戰略意義和重要意義的事情。因此，Alimera 的收購是一項高度協同的收購。它有助於繼續擴大我們罕見疾病業務的範圍和規模，這正好符合。但我們從第一天起就一直在說，實際上幾乎一年多了，這就是我們一直在追求的目標。所以有點堅持我們的策略。這是我們希望繼續累積的一個教訓，然後第二個教訓是，你知道，當你進行收購時，一路上會遇到坎坷，並確保我們能夠繼續留下來並努力應對挑戰以及什麼你知道，這些挑戰可能因收購而異，你知道，為了確保我們了解挑戰，我們有能力、經驗和專業知識來應對挑戰並從那裡繼續前進，你知道，你知道，我們相信，隨著Alimera 的收購，出現了一個與​​熱量供應相關的挑戰，而我們已經準備好應對這一挑戰，正是通過自交易以來我們一直與Highpoint 的密切合作簽署以解決警告信中的問題，自我們完成交易以來，與I point 的合作和接觸變得更加密切，我們仍然相信，您知道I point 將令人滿意地解決這些問題由 FDA 提出。事實上，他們一直在提供更新，我們預計不會影響向有需要的患者提供獨特供應的連續性，並且看起來，ANI 的標準做法是努力在供應鏈中創造冗餘高價值產品。因此。我們正在採取措施增強 Alluvian 和 UT 的供應安全。所以，你知道，回到你的問題，你知道，在我們進行收購的過程中會遇到坎坷，你知道，確保我們擁有的經驗和專業知識，我們將其運用到，你知道，在這種情況下，它與供應有關，在未來的收購中可能是其他事情，看起來，我們在這一領域擁有重要的能力和專業知識。鑑於我們在美國運營的三家工廠擁有強大的FDA 合規記錄，以及我們與供應商共同解決此類問題的經驗，因此，這些都是我將堅持我們的策略並確保在遇到困難時的經驗教訓。

Thank you. At this time, I show no further questions in queue, I will turn the call back to Nikhil Lalwani for closing remarks.

謝謝。此時，我不再顯示隊列中的其他問題，我會將電話轉回尼基爾·拉爾瓦尼 (Nikhil Lalwani) 進行結束語。

Yeah. Thank you everybody for joining our call and thank you for your interest in ANI, we look forward to continue updating you on our progress and I look forward to seeing you at the conferences that we have coming up and engaging with you as we move forward. Thank you.

是的。感謝大家加入我們的電話會議，感謝您對 ANI 的興趣，我們期待繼續向您通報我們的進展情況，我期待在我們即將召開的會議上見到您，並在我們前進的過程中與您互動。謝謝。

Thank you. This does conclude the ANI Pharmaceuticals Inc third quarter, 2024 earnings results call. You may disconnect your line at this time and have a wonderful day.

謝謝。ANI Pharmaceuticals Inc 2024 年第三季財報電話會議就此結束。此時您可以斷開線路並度過美好的一天。