ANI Pharmaceuticals Inc (ANIP) 2025 Q1 法說會逐字稿

Good day, everyone, and welcome to today's ANI Pharmaceuticals Inc first quarter 2025 earnings results call. Please note this call is being recorded. (Operator Instructions) It is now my pleasure to turn the conference over to Lisa Wilson.

大家好，歡迎參加今天的 ANI Pharmaceuticals Inc 2025 年第一季財報結果電話會議。請注意，本次通話正在錄音。（操作員指示）現在我很高興將會議交給麗莎威爾森。

Thank you, operator. Welcome to ANI Pharmaceuticals Q1 2025 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 Chris Mutz, Senior Vice President and Head of ANI's Rare Disease Business. You can also access the webcast of this call through the Investor section of the ANI website at anipharmaceuticals.com.

謝謝您，接線生。歡迎參加 ANI Pharmaceuticals 2025 年第一季收益結果電話會議。我是 ANI 投資者關係部的 Lisa Wilson。參加今天電話會議的還有總裁兼執行長 Nikhil Lalwani、財務長 Stephen Carey 和 ANI 高級副總裁兼罕見疾病業務負責人 Chris Mutz。您也可以透過 ANI 網站 anipharmaceuticals.com 的投資者部分存取本次電話會議的網路直播。

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.

在我們開始之前，我想提醒大家，今天的電話會議上所作的任何表達對未來事件和公司未來業績的信念、期望、預測、預報、預期或意圖的陳述都可能被視為《私人證券訴訟改革法案》所定義的前瞻性陳述。這些前瞻性聲明是基於 ANI Pharmaceuticals 管理層截至今天所掌握的信息，涉及風險和不確定性，包括我們今天上午發布的新聞稿和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。

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 archived webcast 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 May 9, 2025. Since then, ANI may have made announcements related to the topics discussed, so please reference the company's most recent press releases and SEC filings.

此類前瞻性陳述並不能保證未來的表現。實際結果可能與前瞻性陳述中的預測有重大差異。ANI 明確否認有任何更新這些前瞻性聲明的意圖或義務，除非法律要求。已存檔的網路直播將在我們的網站 anipharmaceuticals.com 上保留 30 天。為了方便那些可能正在收聽重播或已存檔的網路直播的觀眾，本次電話會議於 2025 年 5 月 9 日舉行並錄製。從那時起，ANI 可能已經發布了與討論主題相關的公告，因此請參考該公司最新的新聞稿和 SEC 文件。

And with that, I'll turn the call over to Nikhil Lalwani.

現在，我將把電話轉給尼基爾·拉爾瓦尼 (Nikhil Lalwani)。

Thank you, Lisa. Good morning, everyone, and thank you for joining us. I'll start by discussing our first quarter performance and highlights, along with our updated 2025 guidance. Chris will provide additional color on our rare disease business, including our lead asset, Cortrophin Gel and our retina assets, ILUVIEN and YUTIQ. Finally, Steve will review our first quarter results and updated 2025 guidance in more detail. Following our remarks, we'll take your questions.

謝謝你，麗莎。大家早安，感謝大家的收看。我將首先討論我們的第一季業績和亮點，以及我們更新的 2025 年指引。Chris 將為我們的罕見疾病業務提供更多詳細信息，包括我們的主要資產 Cortrophin Gel 和我們的視網膜資產 ILUVIEN 和 YUTIQ。最後，史蒂夫將更詳細地回顧我們的第一季業績和更新的 2025 年指引。在我們發言之後，我們將回答您的問題。

We had a very strong start to the year with record revenue, adjusted EBITDA and adjusted EPS. The first quarter reflected particularly strong performance for our generics business, continued solid demand for Cortrophin Gel and increased demand for our brands portfolio. The top line upside was partially offset by near-term factors impacting our retina products that I will expand on in a moment. We were pleased with the strength across our overall company. Based on our first quarter performance and favorable demand trends across generics, Cortrophin Gel and brands, we are raising our 2025 guidance for total revenues and adjusted non-GAAP EBITDA.

我們今年開局非常強勁，營收、調整後 EBITDA 和調整後 EPS 均創下新高。第一季反映出我們的仿製藥業務表現尤為強勁，對 Cortrophin Gel 的需求持續強勁，對我們品牌組合的需求增加。營收成長部分被影響我們視網膜產品的近期因素所抵消，稍後我將對此進行詳細說明。我們對整個公司的實力感到滿意。根據我們第一季的業績以及仿製藥、Cortrophin Gel 和品牌藥的良好需求趨勢，我們提高了 2025 年總收入和調整後非 GAAP EBITDA 的預期。

We now expect 2025 revenues of $768 million to $793 million, which represents growth of 25% to 29% over 2024 versus our prior guidance of $756 million to $776 million. We expect adjusted non-GAAP EBITDA of $195 million to $205 million -- sorry, $205 million, which reflects growth of 25% to 31% over 2024 versus our prior guidance of $190 million to $200 million. Steve will provide more specifics on our updated guidance later in the call.

我們現在預計 2025 年的營收為 7.68 億美元至 7.93 億美元，比 2024 年成長 25% 至 29%，而我們先前預測的營收為 7.56 億美元至 7.76 億美元。我們預計調整後的非 GAAP EBITDA 為 1.95 億美元至 2.05 億美元——抱歉，是 2.05 億美元，這反映出 2024 年的成長率為 25% 至 31%，而我們先前預測的數字是 1.9 億美元至 2 億美元。史蒂夫將在稍後的電話會議中提供有關我們更新指南的更多細節。

Turning now to our first quarter results. Total revenues were $197 million, $197.1 million, representing a year-over-year increase of 43% on an as-reported basis and 32% on an organic basis, driven by exceptional performance for generics, continued strong growth for Cortrophin Gel and continued demand for our brands portfolio. Adjusted non-GAAP EBITDA was $50.7 million and adjusted non-GAAP EPS was $1.70.

現在來看看我們的第一季業績。總收入為 1.97 億美元，同比增長 1.971 億美元，按報告基礎計算同比增長 43%，按有機基礎計算增長 32%，這得益於仿製藥的出色表現、Cortrophin Gel 的持續強勁增長以及對我們品牌組合的持續需求。調整後非 GAAP EBITDA 為 5,070 萬美元，非 GAAP EPS 調整後為 1.70 美元。

Cortrophin Gel generated $52.9 million in revenues during the quarter, up 43% over the first quarter of 2024. We continue to see growth across our targeted specialties, urology, nephrology, rheumatology, ophthalmology and pulmonology. Notably, we had a record number of new patient starts and new cases initiated despite the insurance resets that typically impact branded drugs in the first quarter.

Cortrophin Gel 本季營收為 5,290 萬美元，比 2024 年第一季成長 43%。我們繼續看到我們所針對的專業領域，即泌尿科、腎臟科、風濕病科、眼科和肺科的成長。值得注意的是，儘管第一季的保險重置通常會影響品牌藥物，但我們的新患者數量和新病例數仍創下了歷史新高。

We continue to believe that Cortrophin Gel remains on a strong multi-year growth trajectory. Based on reported sales of Cortrophin Gel and the other ACTH product on the market, the overall ACTH category grew 27% to approximately $684 million in 2024. While the overall ACTH category returned to strong growth in 2024, the number of patients on ACTH therapy today is still substantially lower than several years ago, providing plenty of room for plenty of headroom for expansion.

我們仍然相信 Cortrophin Gel 將保持多年強勁的成長軌跡。根據 Cortrophin Gel 和市場上其他 ACTH 產品的銷售報告，2024 年 ACTH 整體類別的銷售額將成長 27%，達到約 6.84 億美元。儘管 ACTH 整體類別在 2024 年恢復了強勁增長，但目前接受 ACTH 治療的患者數量仍遠低於幾年前，為擴張提供了充足的空間。

It is worth noting that approximately 40% of Cortrophin Gel prescribers are new to the ACTH category, which illustrates the need for our therapy and our ability to expand the market. We expect 2025 Cortrophin Gel revenues to increase 34% to 38% to $265 million to $274 million for the year. Our retina products, ILUVIEN and YUTIQ generated revenues of $16.1 million in the first quarter.

值得注意的是，大約 40% 的 Cortrophin Gel 處方者都是 ACTH 類藥物的新患者，這說明了我們這種療法的必要性以及我們拓展市場的能力。我們預計 2025 年 Cortrophin Gel 的營收將成長 34% 至 38%，達到 2.65 億美元至 2.74 億美元。我們的視網膜產品 ILUVIEN 和 YUTIQ 在第一季創造了 1,610 萬美元的收入。

Performance of our retina assets outside the US was in line with our expectations, but performance in the US was impacted by several factors, including market access challenges for Medicare patients, typical first quarter dynamics for branded drugs and turnover in our sales force as we optimized our field team to sell our complete rare disease ophthalmology portfolio. As we discussed on our fourth quarter call at the end of February, we saw an impact in the first quarter due to reduced access for Medicare patients. Patient support foundation such as Good Days did not receive sufficient funding in the first quarter of 2025, affecting their ability to assist patients with co-pay support.

我們在美國以外的視網膜資產的表現符合我們的預期，但在美國的表現受到多種因素的影響，包括醫療保險患者的市場准入挑戰、品牌藥物的典型第一季度動態以及我們銷售人員的流動率，因為我們優化了現場團隊以銷售我們完整的罕見疾病眼科產品組合。正如我們在二月底的第四季度電話會議上所討論的那樣，由於醫療保險患者的就醫機會減少，我們看到第一季受到了影響。Good Days 等病患支援基金會在 2025 年第一季沒有獲得足夠的資金，影響了他們協助病患支付共同費用的能力。

This change broadly impacted products reimbursed under Medicare Part B and has been particularly important for ILUVIEN's indication for diabetic macular edema or DME, as also reflected by other players with therapeutics in DME. After working with [HCPs] to understand their response to the market access challenges, we've refined our commercial approach. We're also exploring pathways to improve access for appropriate patients through a specialty pharmacy and Medicare Part D.

這項變更廣泛影響了醫療保險 B 部分報銷的產品，對於 ILUVIEN 治療糖尿病性黃斑水腫或 DME 的適應症尤其重要，其他 DME 治療藥物的參與者也反映了這一點。在與 [HCP] 合作了解他們對市場准入挑戰的反應後，我們改進了我們的商業方法。我們也正在探索透過專科藥局和醫療保險 D 部分為合適的病患改善就醫途徑。

We have also had some turnover in our US ophthalmology sales force as we took steps to optimize and elevate the quality of our team. We are adding best-in-class talent to our sales team and expect to be back to full strength during the second quarter.

隨著我們採取措施優化和提高團隊素質，美國眼科銷售團隊也出現了一些人員流動。我們正在為我們的銷售團隊增添一流的人才，並期望在第二季度恢復全部實力。

Our plans to address the near-term challenges in retina are yielding positive results. In April, end-user demand was higher than any month in the first quarter and almost back to fourth quarter 2024 end-user demand levels. Given the recent promising trends we've seen, we are maintaining our 2025 outlook for ILUVIEN and YUTIQ revenues of $97 million to $103 million. Our commitment and confidence in the value of our retina portfolio is further reflected in our recent buyout of our royalty obligation on ILUVIEN and YUTIQ.

我們應對視網膜近期挑戰的計劃正在取得積極成果。4月份，終端用戶需求高於第一季的任何一個月份，幾乎回到了2024年第四季的終端用戶需求水準。鑑於我們看到的近期良好趨勢，我們維持對 2025 年 ILUVIEN 和 YUTIQ 收入 9,700 萬美元至 1.03 億美元的預期。我們最近收購了 ILUVIEN 和 YUTIQ 的專利使用費義務，這進一步反映了我們對視網膜產品組合價值的承諾和信心。

Turning next to our generics business. We delivered an exceptionally strong first quarter revenues of $98.7 million, an increase of 41% over the first quarter of 2024 and 26% over the fourth quarter of 2024, which had previously been our highest quarter ever for generics. The robust growth was driven by contribution from new product launches, including our first-to-market launch of prucalopride tablets with 180 days of exclusivity that runs to late June, coupled with strong execution in the base business.

接下來談談我們的仿製藥業務。我們第一季的營收異常強勁，達到 9,870 萬美元，比 2024 年第一季成長 41%，比 2024 年第四季成長 26%，而第四季曾是我們仿製藥收入最高的一個季度。強勁的成長得益於新產品發布的貢獻，包括我們首次向市場推出的普卡洛普利片，其獨佔期為 180 天，持續到 6 月底，再加上基礎業務的強勁執行。

With a strong start, we now expect mid-double-digit growth from our generics business for the full year, up from our prior estimate of low double-digit growth. Our Brands portfolio continued to perform well. As discussed on our last earnings call, we were able to identify and capture increased demand in the first quarter for certain products, as we have done periodically for three consecutive years. Our revised full year guidance reflects a return to a more normalized level of demand during the second quarter.

由於開局強勁，我們目前預計全年仿製藥業務將實現中兩位數成長，高於我們先前估計的低兩位數成長。我們的品牌組合持續表現良好。正如我們在上次收益電話會議上所討論的那樣，我們能夠在第一季識別並抓住某些產品的需求成長，就像我們連續三年定期做的那樣。我們修訂的全年指引反映出第二季需求水準恢復到了更正常的水準。

Finally, I will say a few words on the evolving tariff situation. While we await the administration's pharmaceutical industry-specific framework, it is worth highlighting ANI's long-standing commitment to the US pharmaceutical industry and our positive and unique positioning relative to our peers. We are a US domiciled pharmaceutical company with over 90% of total company revenues coming from finished goods manufactured in the US. Less than 5% of our total company revenues has a direct reliance on China. In addition, we have a strong balance sheet that enables us to carry healthy levels of finished goods and raw material inventories, and we look forward to maintaining our strong commitment to the US pharmaceutical industry.

最後，我想就不斷變化的關稅情勢講幾句話。在我們等待政府推出針對製藥業的框架的同時，值得強調的是 ANI 對美國製藥業的長期承諾以及我們相對於同行的積極和獨特的地位。我們是一家美國製藥公司，公司總收入的 90% 以上來自美國生產的成品。我們公司總收入中不到5%直接依賴中國。此外，我們擁有強大的資產負債表，使我們能夠保持健康的成品和原材料庫存水平，我們期待保持對美國製藥業的堅定承諾。

I'll now turn the call over to Chris Mutz to discuss our Rare Disease business in more detail. Chris?

現在我將把電話轉交給克里斯·穆茨 (Chris Mutz)，更詳細地討論我們的罕見疾病業務。克里斯？

Thank you, Nikhil, and good morning, everyone. As Nikhil mentioned, we were pleased with the strong demand trends for Cortrophin Gel during the first quarter, which included continued momentum adding new prescribers and robust growth among existing prescribers. We saw demand growth across all of our targeted specialties. And in particular, in ophthalmology, we saw the highest growth driven by the efforts of our expanded dedicated ophthalmology sales team. Notably, the number of new initiated cases and new patient starts for Cortrophin Gel reached record levels in the first quarter, which is not typically a seasonally strong quarter for Cortrophin Gel or rare disease drugs in general.

謝謝你，尼基爾，大家早安。正如尼基爾所提到的，我們對第一季 Cortrophin Gel 的強勁需求趨勢感到滿意，其中包括新處方者的持續成長和現有處方者的強勁成長。我們發現所有目標專業領域的需求都在成長。特別是在眼科領域，我們見證了最高的成長，這得益於我們擴大的專業眼科銷售團隊的努力。值得注意的是，Cortrophin Gel 的新病例和新患者數量在第一季度達到了創紀錄的水平，而對於 Cortrophin Gel 或一般罕見疾病藥物來說，這通常不是一個季節性強勁的季度。

We completed the expansion of our portfolio sales team, which cover indications across neurology, nephrology and rheumatology. Our new team members are quickly building momentum in both new prescriber adds and patient starts in their sales territories. The indication for acute gouty arthritis flares, which is unique to Cortrophin Gel among ACTH therapies remained a strong driver, contributing to growth in the prescriber base and patients on therapy. We're also to new affordability options under the Medicare Part D redesign under the Inflation Reduction Act or IRA.

我們完成了產品組合銷售團隊的擴展，涵蓋神經病學、腎臟病學和風濕病學等領域。我們的新團隊成員正在各自的銷售區域內迅速累積新處方和新患者。急性痛風性關節炎發作的適應症是 Cortrophin Gel 在促腎上腺皮質激素 (ACTH) 療法中獨有的，它仍然是一個強勁的驅動力，有助於擴大處方醫生群體和接受治療的患者數量。我們也將在《通貨膨脹削減法案》（IRA）下對醫療保險 D 部分進行重新設計，提供新的可負擔性選擇。

As Nikhil noted, we continue to see Cortrophin Gel on a strong multiyear growth trajectory. We believe the number of patients on ACTH therapy now is approximately half the level of patients on therapy when the category previously peaked in 2017. We also believe the addressable patient population for ACTH therapy could be many times larger than the previous high of eight years ago. Keeping the significant unmet medical need in mind, we continue to invest in and make progress on initiatives to strengthen and grow the Cortrophin Gel franchise. Part of these efforts include improving patient and physician convenience.

正如尼基爾所指出的，我們繼續看到 Cortrophin Gel 呈現強勁的多年成長軌跡。我們認為，目前接受 ACTH 治療的患者數量大約是 2017 年該類別達到高峰時接受治療的患者數量的一半。我們也相信，ACTH 治療的目標患者群可能比八年前的最高水平高出許多倍。考慮到尚未滿足的龐大醫療需求，我們將繼續投資並推動加強和發展 Cortrophin Gel 特許經營權的舉措。這些努力包括提高患者和醫生的便利性。

In March, we announced FDA approval of our prefilled syringe and recently launched the new presentation. The prefilled syringe will benefit patients and physicians by reducing the steps needed for self-administration. So far, we've been pleased with early feedback on this important new offering. We're also continuing to invest in evidence generation for Cortrophin Gel. Earlier this week, at the Association for Research in Vision and Ophthalmology or ARVO Annual Meeting, we presented preclinical data on the use of Cortrophin Gel for uveitis.

今年三月，我們宣布 FDA 批准我們的預充式註射器，並於近期推出了新產品。預充式註射器將減少自我給藥所需的步驟，使患者和醫生受益。到目前為止，我們對這項重要新產品的早期回饋感到滿意。我們也將繼續投資 Cortrophin Gel 的證據生成。本週早些時候，在視覺和眼科研究協會或 ARVO 年會上，我們展示了使用 Cortrophin 凝膠治療葡萄膜炎的臨床前數據。

We are also excited to announce that we plan to initiate a Phase IV clinical trial for the treatment of acute gouty arthritis flares. The study is planned to enroll approximately 150 patients, and we expect to complete the study in approximately one year following initial patient initiation. While Cortrophin Gel has seen significant use in gout, results of this study will provide physicians with valuable insight into the treatment of acute gouty arthritis flares with Cortrophin Gel and could ultimately support inclusion in the American College of Rheumatology treatment guidelines. Overall, we're pleased to see the growing recognition of Cortrophin Gel as a safe and effective treatment option for appropriate patients and look forward to delivering strong multiyear growth for the product.

我們也很高興地宣布，我們計劃啟動治療急性痛風性關節炎發作的 IV 期臨床試驗。該研究計劃招募約 150 名患者，我們預計在初始患者開始研究後約一年內完成研究。雖然 Cortrophin 凝膠在治療痛風方面有著廣泛的應用，但這項研究的結果將為醫生提供關於使用 Cortrophin 凝膠治療急性痛風性關節炎發作的寶貴見解，並最終支持將其納入美國風濕病學會治療指南。總體而言，我們很高興看到 Cortrophin 凝膠越來越受到認可，成為適合患者的安全有效的治療選擇，並期待該產品在未來多年實現強勁增長。

Turning now to our retina products, ILUVIEN and YUTIQ. As Nikhil mentioned, during the first quarter, there was a significant change in market access dynamics for Medicare patients. HCPs took some time to understand the change, whether it would persist and how they needed to modify their approach and practice, while keeping patients first always. The impact of these market access changes has varied across regions and how HCPs have responded to these changes has also varied.

現在來談談我們的視網膜產品，ILUVIEN 和 YUTIQ。正如尼基爾所提到的，在第一季度，醫療保險患者的市場准入動態發生了重大變化。醫療專業人員花了一些時間來了解這種變化，了解這種變化是否會持續下去，以及他們需要如何修改他們的方法和實踐，同時始終將患者放在第一位。這些市場准入變化的影響因地區而異，醫療保健提供者對這些變化的反應也各不相同。

It's important to note that prescribing for NIUPS has been impacted to a much lesser degree relative to prescribing for DME. Our team has spent time understanding HCP responses and the granular impact to their workflows. With that understanding, we are for the impacted DME population. For example, Medicare patients with a pharmacy benefit can avail of the affordability options that Part B offers. Under this approach, retina physicians can access ILUVIEN through a specialty pharmacy. Taking all the above into account, our team has deployed a bespoke commercial approach customized by region and territory, which is already paying off as we've seen in our April results.

值得注意的是，NIUPS 處方受到的影響比 DME 處方受到的影響要小得多。我們的團隊花費了大量時間來了解 HCP 的回應及其對其工作流程的具體影響。基於這樣的理解，我們為受影響的 DME 族群提供支援。例如，享有藥房福利的醫療保險患者可以享受 B 部分提供的可負擔選項。透過這種方式，視網膜醫生可以透過專科藥房獲得 ILUVIEN。考慮到以上所有因素，我們的團隊部署了根據地區和領土量身定制的商業方法，正如我們在四月份的業績中所看到的那樣，這種方法已經獲得了回報。

We've taken several additional steps to enhance our commercial effectiveness. We're strengthening our sales team with top talent from leading retina and ophthalmology organizations, an approach that served us well when we built the Cortrophin team. To drive greater awareness and adoption of ILUVIEN and YUTIQ, we are launching new peer-to-peer educational programming and new refreshed marketing materials.

我們已採取多項額外措施來提高我們的商業效率。我們正在從領先的視網膜和眼科組織中引進頂尖人才來加強我們的銷售團隊，這種方法在我們組建 Cortrophin 團隊時發揮了很好的作用。為了提高人們對 ILUVIEN 和 YUTIQ 的認識和採用，我們正在推出新的點對點教育計劃和新的行銷材料。

Early response to these materials have been very positive. The multipronged commercial approach I described earlier is yielding results. In April, end-user demand was higher than any month in the first quarter and almost back to fourth quarter 2024 end-user demand levels. We've also made significant progress over the last few months to enhance supply security for our retina franchise. In March, we received FDA approval for an expanded label for ILUVIEN that includes an indication for the treatment of chronic NIUPS, which is the indication for YUTIQ.

這些材料的早期反應非常積極。我之前描述的多管齊下的商業方法正在取得成果。4月份，終端用戶需求高於第一季的任何一個月份，幾乎回到了2024年第四季的終端用戶需求水準。在過去的幾個月裡，我們還在增強視網膜特許經營的供應安全方面取得了重大進展。3 月份，我們獲得了 FDA 批准，可以擴大 ILUVIEN 的適應症，包括治療慢性 NIUPS，這也是 YUTIQ 的適應症。

We plan to begin marketing ILUVIEN for both chronic NIUPS and DME under the new combined label this quarter. We expect the transition to be relatively seamless for physicians who have prescribed both ILUVIEN and YUTIQ in the past. These physicians who have prescribed both products account for approximately 90% of prescriptions for ILUVIEN and YUTIQ.

我們計劃本季開始以新的組合標籤行銷用於治療慢性 NIUPS 和 DME 的 ILUVIEN。我們預計，對於過去同時開過 ILUVIEN 和 YUTIQ 處方的醫生來說，過渡會相對順利。這些同時開出這兩種產品的醫生佔了 ILUVIEN 和 YUTIQ 處方的約 90%。

We are engaged in discussions with commercial payers to expand coverage of ILUVIEN for the new indication of chronic NIUPS. We believe this process will be relatively straightforward for plans that cover YUTIQ, as we are simply transitioning patients to ILUVIEN and discontinuing YUTIQ. As a reminder, ILUVIEN is already approved for both DME and chronic NIUPS outside the US, including in 17 European countries.

我們正在與商業付款人進行討論，以擴大 ILUVIEN 對慢性 NIUPS 新適應症的覆蓋範圍。我們相信，對於涵蓋 YUTIQ 的計劃而言，這個過程相對簡單，因為我們只是將患者轉向 ILUVIEN 並停止使用 YUTIQ。提醒一下，ILUVIEN 已在美國以外地區（包括 17 個歐洲國家）獲準用於治療 DME 和慢性 NIUPS。

Moving to the NEW DAY and SYNCHRONICITY clinical trials, we are in the process of analyzing the data from the completed NEW DAY study and the SYNCHRONICITY study at the six month time point. We look forward to updating you on the results of both studies in the near term. Overall, we continue to expect our rare disease business to be our largest revenue growth driver in 2025.

轉向 NEW DAY 和 SYNCHRONICITY 臨床試驗，我們正在分析已完成的 NEW DAY 研究和 SYNCHRONICITY 研究在六個月時間點的數據。我們期待近期向您通報這兩項研究的結果。總體而言，我們仍預期罕見疾病業務將成為 2025 年最大的營收成長動力。

With that, I'll turn the call over to Steve for the financial update. Steve?

說完這些，我將把電話轉給史蒂夫，讓他報告財務最新情況。史蒂夫？

Thanks, Chris, and good morning to everyone on the call. I'll review our first quarter results and then discuss our updated 2025 guidance. ANI had a very strong start to the year, and our first quarter results form a strong foundation for the achievement of our increased full year financial goals. We generated first quarter revenues of $197.1 million, up 43% over the prior year period. Revenues from rare disease and brands were $94.1 million in the first quarter, up 50% from the prior year period as reported and 25% on an organic basis, driven by growth in our rare disease franchise.

謝謝，克里斯，各位電話裡的大家早安。我將回顧我們的第一季業績，然後討論我們更新後的 2025 年指引。ANI 今年開局非常強勁，第一季的業績為實現全年財務目標的提高奠定了堅實的基礎。我們第一季的營收為 1.971 億美元，比去年同期成長 43%。第一季罕見疾病和品牌營收為 9,410 萬美元，較去年同期成長 50%，有機成長 25%，這得益於我們罕見疾病特許經營業務的成長。

Rare Disease revenues were $69 million, up 87% from the prior year period. Revenues from Cortrophin Gel were $52.9 million, up 43% from the prior year period, driven primarily by increased volume on a record number of new patient starts. Revenues from ILUVIEN and YUTIQ were $16.1 million for the reasons that Nikhil and Chris just discussed. Revenues for brands were $25.1 million in the quarter, a decrease of 2% from the prior year period.

罕見疾病收入為 6,900 萬美元，比去年同期成長 87%。Cortrophin Gel 的營收為 5,290 萬美元，比去年同期成長 43%，主要由於創紀錄的新病患數量導致銷量增加。ILUVIEN 和 YUTIQ 的收入為 1,610 萬美元，原因正如 Nikhil 和 Chris 剛才所討論的。本季品牌營收為 2,510 萬美元，較去年同期下降 2%。

The first quarter benefited from continued elevated demand consistent with what we have periodically achieved with this portfolio in the past and similar to prior year levels of revenue achievement. Revenues for our Generics and other segment were $103 million, an increase of 38% over the prior year period. Revenues for Generics were $98.7 million, an increase of 41% over the prior year period and 26% over the fourth quarter of 2024, due to increased volumes from new product launches such as prucalopride and the impact of 2024 product launches.

第一季受惠於持續成長的需求，這與我們過去透過該投資組合所取得的階段性成果一致，也與去年的營收水準相似。我們的仿製藥和其他部門的收入為 1.03 億美元，比去年同期成長 38%。仿製藥收入為 9,870 萬美元，比去年同期成長 41%，比 2024 年第四季成長 26%，這歸因於普卡洛普利等新產品上市帶來的銷售成長以及 2024 年產品上市的影響。

Now moving down the P&L. As a reminder, when I speak to our operating expenses for the purposes of this earnings call, I will be referring to our non-GAAP expenses, which are detailed on Table 3 in our press release. Generally, our non-GAAP operating expenses exclude depreciation and amortization, stock-based compensation and certain costs related to litigation and M&A activity. Please refer to Table 3 for a reconciliation to our GAAP expenditures.

現在向下移動損益表。提醒一下，當我在本次收益電話會議上談到我們的營運費用時，我將參考我們的非 GAAP 費用，這些費用在我們的新聞稿中的表 3 中有詳細說明。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費用。請參閱表 3 以了解我們的 GAAP 支出的對帳情況。

Non-GAAP cost of sales, excluding depreciation and amortization increased 49% to $72.7 million in the first quarter of 2025 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 63.1%, a decrease of approximately 130 basis points from the prior year period, principally driven by mix and significant growth of royalty-bearing products.

2025 年第一季度，非公認會計準則銷售成本（不包括折舊和攤銷）較去年同期增長 49% 至 7,270 萬美元，這主要歸因於醫藥產品銷售量的淨增長和特許權使用費產品的顯著增長。非公認會計準則毛利率為 63.1%，較去年同期下降約 130 個基點，主要由於產品組合和特許權使用費產品的大幅成長。

Non-GAAP research and development expenses of $10 million in the first quarter was relatively in line with the prior year period. Non-GAAP selling, general and administrative expenses increased 56.5% to $63.7 million in the first quarter, driven by costs related to our acquisition of Alimera in the form of spend for our new larger ophthalmology sales team promoting Cortrophin Gel, ILUVIEN and YUTIQ and continued investment in rare disease sales and marketing activities, including the new purified Cortrophin Gel sales representatives that we added in the quarter.

第一季非公認會計準則研發費用為 1,000 萬美元，與去年同期基本持平。第一季非公認會計準則銷售、一般和行政費用成長 56.5% 至 6,370 萬美元，主要原因是我們收購 Alimera 的相關成本，這些成本用於我們新的更大的眼科銷售團隊推廣 Cortrophin Gel、ILUVIEN 和 YUTIQ，以及繼續投資於罕見疾病銷售和營銷活動，包括我們在本季度增加的新純化銷售代表。

Adjusted non-GAAP diluted earnings per share was $1.70 for the first quarter, compared to $1.21 per share in the prior year period. Adjusted non-GAAP EBITDA for the quarter was $50.7 million compared to $37.6 million in the prior year period. We ended the quarter with $149.8 million in unrestricted cash, reflective of $35 million of cash flow from operations and net of $17.3 million of cash used during the quarter to buy out our royalty obligation to SWK on net revenues of ILUVIEN and YUTIQ and the payout of annual 2024 incentive compensation.

第一季調整後非公認會計準則稀釋每股收益為 1.70 美元，去年同期為每股 1.21 美元。本季調整後非 GAAP EBITDA 為 5,070 萬美元，去年同期為 3,760 萬美元。本季末，我們的非限制性現金為 1.498 億美元，其中包括 3500 萬美元的經營活動現金流和本季度用於買斷我們對 SWK 就 ILUVIEN 和 YUTIQ 淨收入支付的特許權使用費義務以及 2024 年度激勵薪酬支出的 1730 萬美元現金淨額。

As of March 31, we have $637.2 million in principal value of outstanding debt, inclusive of our senior convertible notes and term loan. Our gross leverage was 3.5 times and our net leverage was 2.7 times. Our trailing 12-month adjusted non-GAAP EBITDA of $181.4 million, which is pro forma for the Alimera acquisition. Utilizing the midpoint of our revised 2025 adjusted non-GAAP EBITDA guidance, our net leverage is approximately 2.4 times on a forward basis.

截至 3 月 31 日，我們的未償還債務本金價值為 6.372 億美元，其中包括優先可轉換票據和定期貸款。我們的總槓桿率為3.5倍，淨槓桿率為2.7倍。我們過去 12 個月調整後的非 GAAP EBITDA 為 1.814 億美元，這是 Alimera 收購的預測。利用我們修訂後的 2025 年調整後非 GAAP EBITDA 指引的中點，我們的淨槓桿率預計約為 2.4 倍。

Turning to our updated 2025 financial guidance. We are raising our guidance for total revenue, adjusted non-GAAP EBITDA and adjusted non-GAAP EPS based upon higher estimates for our Generics business and higher first quarter demand for our brands portfolio. Updated guidance is as follows. Full year 2025 net revenue of $768 million to $793 million, up from our prior guidance of $756 million to $776 million, representing year-over-year growth of approximately 25% to 29%.

轉向我們更新的 2025 年財務指引。基於我們對仿製藥業務的更高估計以及第一季對我們品牌組合的更高需求，我們提高了對總收入、調整後非 GAAP EBITDA 和調整後非 GAAP EPS 的預期。更新後的指南如下。2025 年全年淨收入為 7.68 億美元至 7.93 億美元，高於我們先前預測的 7.56 億美元至 7.76 億美元，年成長約 25% 至 29%。

Cortrophin Gel net revenue of $265 million to $274 million, representing growth of 34% to 38% and in line with our prior estimate. We continue to expect quarterly sequential growth of Cortrophin revenues throughout the year. Combined ILUVIEN and YUTIQ net revenue of $97 million to $103 million, in line with our prior estimate, and we continue to expect quarterly sequential growth throughout the year.

Cortrophin Gel 淨收入為 2.65 億美元至 2.74 億美元，成長 34% 至 38%，符合我們先前的估計。我們繼續預期 Cortrophin 全年營收將逐季持續成長。ILUVIEN 和 YUTIQ 的合併淨收入為 9,700 萬美元至 1.03 億美元，與我們先前的估計一致，我們預計全年季度將繼續保持連續成長。

Generics revenue growth in the mid-double digits, driven by strength in our base business and contributions from new product launches versus our prior assumption of low double-digit growth. Note that in terms of phasing, we expect the first quarter to be our highest revenue quarter for this year for generics and the first half of the year to be higher than the second half of the year due to our late December 2024 first-to-market launch of prucalopride and its corresponding six months of exclusivity.

仿製藥收入成長率達到兩位數中段，這得益於我們基礎業務的強勁增長以及新產品發布的貢獻，而我們之前假設的增長率僅為兩位數的低段。請注意，就分階段而言，我們預計第一季將成為我們今年仿製藥收入最高的季度，並且由於我們將於 2024 年 12 月下旬率先上市普卡洛普利並享有相應的六個月獨家經營權，因此上半年的收入將高於下半年。

For Brands, we expect to return to more normalized performance during the second quarter as compared to a full quarter's worth of incremental market share achieved in the first quarter. Putting all the revenue elements together, we expect our second quarter revenues to be lower by a modest amount as compared to the first quarter, followed by a return to sequential revenue growth in the third and fourth quarters.

對於品牌而言，我們預計第二季的業績將比第一季實現的整個季度的增量市場份額恢復到更正常的狀態。綜合考慮所有收入因素，我們預計第二季的營收將比第一季略有下降，隨後第三季和第四季的營收將恢復連續成長。

Adjusted non-GAAP EBITDA of $195 million to $205 million, up from our prior guidance of $190 million to $200 million, representing growth of approximately 25% to 31%. From a quarterly perspective, we anticipate second quarter adjusted EBITDA to be lower as compared to the first quarter followed by a return to sequential growth in the third and fourth quarters.

調整後非 GAAP EBITDA 為 1.95 億美元至 2.05 億美元，高於我們先前預測的 1.9 億美元至 2 億美元，成長約 25% 至 31%。從季度角度來看，我們預計第二季調整後的 EBITDA 將低於第一季度，但第三季和第四季將恢復連續成長。

Adjusted non-GAAP earnings per share between $6.27 and $6.62, up from our prior guidance of $6.12 and $6.49. We continue to anticipate a US GAAP effective tax rate of approximately 25%. And consistent with prior quarters, we will tax effect non-GAAP adjustments for computation of adjusted non-GAAP diluted earnings per share using our estimated statutory rate of 26%. We also continue to anticipate between 20.1 million and 20.4 million shares outstanding for the purpose of calculating diluted EPS.

調整後非公認會計準則每股收益在6.27美元至6.62美元之間，高於我們先前預期的6.12美元至6.49美元。我們繼續預期美國公認會計準則有效稅率約為25%。與前幾季一致，我們將使用估計的 26% 的法定稅率對非 GAAP 調整進行徵稅，以計算調整後的非 GAAP 稀釋每股收益。為了計算稀釋每股盈餘，我們也繼續預期流通股數在 2,010 萬至 2,040 萬股之間。

Finally, I will highlight that the company continues to prepare for its upcoming trial with CG Oncology. As a reminder, on March 4, 2024, ANI commenced a civil action against CG Oncology in the Superior Court of the State of Delaware. ANI's complaint alleges that under an assignment and technology transfer agreement dated as of November 15, 2010, DG Oncology is liable to pay ANI a running royalty on 5% of the worldwide net sales of their lead product candidate, cretostimogene, and that in February 2024, CG Oncology wrongfully repudiated its royalty obligation to ANI. The jury trial is set to commence on July 21st, 2025, and ANI intends to pursue this matter vigorously.

最後，我要強調的是，該公司正在繼續為即將與 CG Oncology 進行的試驗做準備。提醒一下，2024 年 3 月 4 日，ANI 在特拉華州高等法院對 CG Oncology 提起民事訴訟。ANI 的投訴稱，根據 2010 年 11 月 15 日簽訂的轉讓和技術轉讓協議，DG Oncology 有義務向 ANI 支付其主要候選產品 cretostimogene 全球淨銷售額的 5% 的運行特許權使用費，但 2024 年 2 月，CG Oncology 錯誤地拒絕了對 ANI 義務的特許權使用義務的特許權使用費。陪審團審判將於 2025 年 7 月 21 日開始，ANI 打算大力推動此事。

With that, I'll turn the call back to Nikhil.

說完這些，我就把電話轉回給尼基爾。

Thank you, Steve. We're pleased with the strong start to '25 and would like to thank you, our customers, suppliers, partners, investors and the entire ANI team for their collaboration and significant contributions in delivering on our company's purpose of serving patients improving lives.

謝謝你，史蒂夫。我們對 25 年的強勁開局感到高興，並想感謝您、我們的客戶、供應商、合作夥伴、投資者和整個 ANI 團隊的合作和重大貢獻，以實現我們公司服務患者、改善生活的宗旨。

With that, operator, I turn it over to you for questions.

接線員，現在我把問題交給您了。

(Operator Instructions)

（操作員指示）

Gary Nachman, Raymond James.

蓋瑞納赫曼、雷蒙詹姆斯。

Congrats on the strong quarter. So first on Cortrophin, how much should the prefilled syringe help you? Do you think it could open up use a lot more because of the convenience? And what sort of benefit are you seeing from the additional 20 reps across the indications? Are you considering adding some more for any indications? And Mallinckrodt announced a good quarter for Acthar. It seems like there's good market growth. What else can you do to try and differentiate Cortrophin? I thought the Phase IV study for acute gouty flares is really interesting. So are there other studies that you're considering to potentially do with either the existing indications or maybe some others down the road? And then I have a follow-up.

恭喜本季業績強勁。那麼首先關於 Cortrophin，預充式註射器對您有多大幫助？您認為它因為方便而可以有更多用途嗎？您從額外的 20 次重複訓練中看到了什麼樣的好處？您是否考慮添加更多內容以適應任何情況？Mallinckrodt 宣布 Acthar 本季業績表現良好。看起來市場成長良好。您還可以做什麼來嘗試區分 Cortrophin？我認為針對急性痛風發作的 IV 期研究確實很有趣。那麼，您是否考慮針對現有適應症或未來其他適應症進行其他研究？然後我有一個後續問題。

Thank you, Gary, for your questions. So first on the prefilled syringe, as Chris mentioned in the prepared remarks, the early response from HCPs is positive as this reduces one step in the administration process for Cortrophin Gel, and we look forward to updating you on the progress. We have just launched the product in the market. While we got the approval or announced the approval in March, we just launched the product a couple of weeks ago. So look forward to updating you on the progress.

謝謝加里提出的問題。首先關於預充式註射器，正如克里斯在準備好的發言中提到的那樣，HCP 的早期反應是積極的，因為這減少了 Cortrophin 凝膠給藥過程中的一個步驟，我們期待向您通報進展情況。我們剛剛將該產品推向市場。雖然我們在三月就獲得了批准或宣布了批准，但我們幾週前才推出了該產品。因此期待向您通報進度。

Your next question was on the 20 reps and how that's going. They're doing well. They have started getting traction with getting both new patient starts and new prescribers and enrollments, and we'll continue to build momentum as the year progresses. We keep evaluating high ROI efforts from -- in the commercial side. So with regards to adding more, there's no intent to do that this year at this time, we, again, keep evaluating high ROI commercial initiatives to keep growing Cortrophin, which we believe is on a strong multiyear growth franchise as we've talked about several times.

您的下一個問題是關於 20 次重複以及進展如何。他們做得很好。他們已經開始在吸引新患者、新處方和新註冊方面取得進展，隨著時間的推移，我們將繼續增強這一勢頭。我們不斷從商業角度評估高投資報酬率的努力。因此，關於增加更多產品，今年目前沒有打算這樣做，我們再次繼續評估高投資回報率的商業計劃，以保持 Cortrophin 的增長，我們相信，正如我們多次談到的那樣，Cortrophin 擁有強勁的多年增長潛力。

You're right that the third point was on the competitor. You're right, the competitor did announce a strong quarter, as well as increased their guidance to high single digits. So if you add their guidance and our guidance, the combined market is growing approximately 16%. If you take -- they said high single digits, if you take that at 7.5%, the combined market will grow at about 16%. And we think that that's great for patients and for prescribers because the number of patients on therapy today are still half of what it was at its peak. And from an epidemiological perspective, the number of patients that can benefit or the addressable market is 6 to 8 times higher than the number of patients that were even being treated at its peak.

您說得對，第三點是關於競爭對手的。你說得對，競爭對手確實宣布了一個強勁的季度業績，並將其預期提高到了高個位數。因此，如果將他們的指導和我們的指導相加，合併後的市場將成長約 16%。如果你採取 - 他們說的是高個位數，如果你以 7.5% 的速度成長，那麼合併後的市場將會成長約 16%。我們認為這對患者和處方者來說都是一件好事，因為今天接受治療的患者數量仍然只有高峰時的一半。從流行病學角度來看，受益的患者數量或潛在市場比高峰期接受治療的患者數量高出 6 到 8 倍。

So it's good for the category to have two players bringing options for patients and for prescribers. You then asked about differentiation. So, we continue to invest to strengthen the franchise. You will remember that we launched the 1 ml vial. Now we've launched the prefilled syringe to increase convenience -- enhance convenience for patients and prescribers. And we continue to evaluate additional steps that we can take to enhance the convenience for patients and for physicians, and we'll look forward to updating you on that progress.

因此，對於該類別而言，擁有兩家公司為患者和處方者提供選擇是件好事。然後你問到差異化。因此，我們將繼續投資以加強特許經營權。您會記得我們推出了 1 毫升小瓶。現在我們推出了預充式註射器，以提高便利性——為患者和處方者提供更多便利。我們將繼續評估可以採取的其他措施，以增強患者和醫生的便利，我們期待向您通報進展。

And as Chris detailed some of the efforts on the evidence generation area, right, and the gout clinical study that we're initiating later this year. And that those are -- as well as the data that we presented at ARVO on uveitis, I think that those are indications of the multiple different steps across commercial evidence generation and bringing new presentations to the market that we're investing in to continue strengthening and growing the Cortrophin Gel franchise that we believe is on a strong multiyear growth trajectory.

克里斯詳細介紹了證據生成領域的一些努力，以及我們今年稍後將啟動的痛風臨床研究。而且這些——以及我們在 ARVO 上展示的有關葡萄膜炎的數據，我認為這些都表明了我們在商業證據生成和向市場推出新產品方面採取了多個不同步驟，我們正在投資這些步驟以繼續加強和發展 Cortrophin Gel 特許經營權，我們相信該特許經營權將處於強勁的多年增長軌跡。

Okay. Great. And then just regarding ILUVIEN and YUTIQ, just given some of the challenges in the first quarter, just what gives you confidence you can accelerate the sales to get up into the guidance range for the full year? That's a pretty big step up. And I appreciate the steps that you're taking, but how long you think for those to really take hold over the course of the year? And then just talk about the turnover in the ophtha sales team. It actually didn't seem to impact Cortrophin in that segment, which you said was really strong in ophtha and I'm curious why that wasn't the case. And just going forward, your outlook for ophtha.

好的。偉大的。然後就 ILUVIEN 和 YUTIQ 而言，考慮到第一季面臨的一些挑戰，是什麼讓您有信心加速銷售，使其達到全年的指導範圍？這是一個相當大的進步。我很欣賞你們所採取的措施，但你們認為這些措施需要多長時間才能在今年真正發揮作用？然後只談眼科銷售團隊的營業額。實際上，它似乎並沒有對 Cortrophin 在該領域產生影響，您說 Cortrophin 在眼科方面確實很有效，我很好奇為什麼事實並非如此。展望未來，我們對眼疾的前景有何展望？

Thank you again for your question, Gary. So first, ILUVIEN and YUTIQ guidance for this year is $97 million to $103 million, of which 30% is outside the US. Therefore, ILUVIEN and YUTIQ in the US accounts for under 10% of total company 2025 revenue guidance. So just to dimensionalize that, and that's what the different topics, the factors we spoke about. But when it comes to the guidance, our confidence in reiterating the guidance for ILUVIEN and YUTIQ at $97 million to $103 million is based on five factors. First, the performance outside the US, which is roughly 30% is largely on track across the markets with direct -- the four markets with direct commercial operation and the 17 markets where we work with partners.

再次感謝您的提問，加里。首先，ILUVIEN 和 YUTIQ 今年的指導金額為 9,700 萬至 1.03 億美元，其中 30% 在美國以外。因此，美國的 ILUVIEN 和 YUTIQ 占公司 2025 年總收入預期的 10% 以下。因此，只是為了將其維度化，這就是我們所討論的不同主題和因素。但談到指導，我們有信心重申對 ILUVIEN 和 YUTIQ 的指導金額為 9,700 萬至 1.03 億美元，這基於五個因素。首先，美國以外的業績約為 30%，在直接經營的市場中基本上符合預期——四個直接商業運營的市場和我們與合作夥伴合作的 17 個市場。

Next, the factors driving our confidence related to US performance for the rest of the year. So first quarter results were low due to seasonality seen for most branded drugs. The remaining three quarters will not have this. In fact, it will reverse in the fourth quarter. So that's one. Second, we've made significant strides in working through the turnover and strengthening our sales force with best-in-class talent. As of today, only four vacancies remain and we'll be back to full strength during the second quarter, which will create additional momentum.

接下來，推動我們信心的因素與美國今年剩餘時間的表現有關。因此，由於大多數品牌藥物的季節性，第一季的業績較低。其餘四分之三不會出現這種情況。事實上，第四季情況將出現逆轉。這就是其中之一。其次，我們在解決人員流動問題和引進一流人才加強銷售團隊方面取得了重大進展。截至今天，只剩下四個空缺職位，我們將在第二季度恢復全部實力，這將創造額外的動力。

Third, we're already seeing positive impact in April results from the bespoke commercial approach by region that we deployed given the Medicare dynamics. And then last, we expect to see positive impact from a combination of our efforts exploring alternatives for Medicare patients through the Part D pathway and restart in the back half of the year of some level of foundation support for Medicare patients. So I think that -- I think you also asked about more about turnover.

第三，考慮到醫療保險的動態，我們根據地區部署的定製商業方法已在 4 月份的業績中產生了積極影響。最後，我們期望看到透過 D 部分途徑為醫療保險患者探索替代方案的努力以及在今年下半年重新開始為醫療保險患者提供一定程度的基礎支持所產生的積極影響。所以我認為——我想您也詢問了更多有關營業額的問題。

Well, look, we believe we have a high-performance culture and in the initial integration time frame, it is typical to have a cross-calibration leading to organizational changes. We're adding best-in-class talent for -- from top ophthalmology and retina organization as we approach we followed in Cortrophin. And we expect our sales team to be back to full strength during the second quarter.

嗯，我們相信我們擁有高績效文化，並且在最初的整合時間範圍內，通常會進行交叉校準以導致組織變革。我們正在從頂級眼科和視網膜組織中招募最優秀的人才，正如我們在 Cortrophin 中提到的那樣。我們預計我們的銷售團隊將在第二季恢復全部實力。

So that's the sales force turnover dynamic that we have had in our combined ophthalmology sales force. And then you asked about impact on PCG and ophthalmology. While on a smaller base, Q1 volume for PCG for Cortrophin in ophthalmology was 50% higher than in Q4. And we believe that the momentum will continue, right, as we have our full strength combined ophthalmology, rare disease ophthalmology sales force in action. So -- and we feel confident about the continued growth and the outlook for Cortrophin in ophthalmology.

這就是我們合併後的眼科銷售團隊的銷售人員流動動態。然後您詢問了對 PCG 和眼科的影響。儘管基數較小，但眼科用 Cortrophin 的 PCG 第一季銷量比第四季高出 50%。我們相信，這一勢頭將會持續下去，因為我們擁有強大的眼科和罕見疾病眼科銷售團隊。因此，我們對 Cortrophin 在眼科領域的持續成長和前景充滿信心。

Faisal Khurshid, Leerink Partners.

Faisal Khurshid，Leerink Partners。

I just want to ask, can you kind of drill in a little bit more to kind of the details on the commercial and access challenges that impacted ILUVIEN in the first quarter? And can you just explain a little bit, help us understand what you're -- or kind of how you're thinking about like working around that with like getting the spec pharmacy and like Part D over Part B. Can you just like help us understand that a little bit?

我只是想問一下，您能否更詳細地介紹一下第一季影響 ILUVIEN 的商業和訪問挑戰的細節？您能否稍微解釋一下，幫助我們了解您的情況 - 或者您如何考慮解決這個問題，例如獲得規範藥房並將 D 部分置於 B 部分之上。您能否幫助我們稍微理解一下？

Thank you for your question. So the challenge is that there's a subset of patients that are on Medicare that require co-pay support to get therapy under Part B as an boy. And due to lack of funding and they get the support from foundations and due to lack of funding, these foundations have not been able to provide co-pay support, right? And this is a dynamic that emerged in Q1. So HCPs, physicians took some time and retina practices took some time to understand the change, whether it would persist and how they would need to modify their approach and practice while keeping patients first always. And so their response has varied across regions, and we've spent the time to understand how they're responding.

感謝您的提問。因此，挑戰在於，有一部分享有醫療保險的患者需要共同支付支持才能作為男孩接受 B 部分的治療。由於缺乏資金，他們得到了基金會的支持，由於缺乏資金，這些基金會無法提供共同支付支持，對嗎？這是第一季出現的動態。因此，HCP、醫生和視網膜實踐者花了一些時間來了解這種變化，了解這種變化是否會持續下去，以及他們需要如何修改他們的方法和實踐，同時始終將患者放在第一位。因此，不同地區的反應有所不同，我們花時間了解他們的反應。

One other thing to clarify is that this dynamic impacts ILUVIEN and the DME market more and therapeutics in the DME market more and as has been laid out by other therapeutics in the DME market and to a much lesser degree, NIUPS or noninfectious uveitis in the posterior segment of the eye patients. So our team has spent the time understanding the ACP responses and granular impact to their workflows.

還有一點需要澄清的是，這種動態對 ILUVIEN 和 DME 市場的影響更大，對 DME 市場的治療藥物的影響更大，正如 DME 市場中的其他治療藥物所指出的那樣，對眼後段患者的 NIUPS 或非感染性葡萄膜炎的影響則要小得多。因此，我們的團隊花了很多時間來了解 ACP 的回應及其對其工作流程的具體影響。

And with that understanding, we're exploring alternate path to improve the access for the DMA population. So for example, the Medicare patients with pharmacy benefit, they can avail the affordability options where there's a cap on the co-pay and smoothing offer that the Part D offers. So under that approach, we're exploring how to have retina physicians accessing ILUVIEN through a specialty pharmacy. Does that give you sufficient color, Faisal?

基於這種認識，我們正在探索替代途徑來改善 DMA 人口的訪問。例如，享有藥房福利的醫療保險患者可以享受可負擔性選項，其中對 D 部分提供的共同支付和平滑優惠設有上限。因此，在這種方法下，我們正在探索如何讓視網膜醫師透過專科藥局獲得 ILUVIEN。這能給你足夠的說明嗎，費薩爾？

Yes, that's helpful. And then I had one on Cortrophin Gel. So you've done well in this acute gouty arthritis if you include to see kind of exploring some additional evidence generation there. Are there other opportunities for you to kind of like recreate this sort of like carve-out success in like other indications or disease segments?

是的，這很有幫助。然後我使用了 Cortrophin 凝膠。因此，如果您想探索一些額外的證據生成，那麼您在急性痛風性關節炎方面做得很好。您是否還有其他機會在其他適應症或疾病領域重現這種類似的成功？

Yes, absolutely. I think across -- it goes back to the epidemiology across disease, across indications, the number of patients that can benefit from the therapy are significantly higher than what we -- that are availing of this option are being treated today. And as we've shared, 40% of our prescribers on Cortrophin were naive to ACTH and then never prescribed ACTH before. So we have confidence in our ability to get this treatment and this treatment option to more patients and prescribers. And so going back to your question, yes, there is an opportunity to bring more focused commercial efforts in other therapeutic areas as we have done in ophthalmology.

是的，絕對是。我認為——這可以追溯到跨疾病、跨適應症的流行病學，能夠從該療法中受益的患者數量明顯高於我們今天利用該療法治療的患者數量。正如我們所分享的，40% 的 Cortrophin 處方者對 ACTH 一無所知，並且之前從未開過 ACTH 處方。因此，我們有信心讓更多的患者和醫生享受這種治療和治療選擇。回到你的問題，是的，我們有機會在其他治療領域投入更有針對性的商業努力，就像我們在眼科領域所做的那樣。

Vamil Divan, Guggenheim Securities.

瓦米爾·迪萬，古根漢證券公司。

Congrats on the quarter. And maybe one question, sticking to the ophthalmology side and then one on the Generics. So on ophthalmology, appreciate all the color you provided. You did mention the NEW DAY trials completed now and I think you said you finished six months. Maybe can you just share your perspectives on sort of what you're hoping to see from those trials as we wait for the results here? And then what sort of impact did those have commercially on that business? And then on Generic side, you mentioned the prucalopride 180 days. I'm just wondering if you can comment on how much of a contribution that was to the generics performance in the first quarter. So we have a sense for the second quarter as well?

恭喜本季取得佳績。也許有一個問題，堅持眼科方面，然後一個問題關於仿製藥。因此，在眼科方面，感謝您提供的所有資訊。您確實提到了現在已經完成的 NEW DAY 試驗，而且我認為您說過您已經完成了六個月。當我們等待結果時，您能否分享一下您希望從這些試驗中看到什麼？那麼這些對該業務產生了什麼樣的商業影響呢？然後在通用方面，您提到了 180 天的普卡洛必利。我只是想知道您是否可以評論一下這對第一季仿製藥的表現有多大貢獻。那我們對第二季也有了解嗎？

So on NEW DAY, we are in the process of analyzing the data from the completed NEW DAY study. And if successful, it will allow physicians to consider ILUVIEN earlier in the treatment of DME. As we've described before, epidemiologically, today, we have less than 5,000 patients annually on ILUVIEN, whereas the addressable market is even before NEW DAY is at 53,000, right, which is patients for whom multiple rounds of anti-VEGFs are not showing optimal response and then they show positive response to steroid trial and can be considered for -- they're then being considered for ILUVIEN. So that's the addressable market of 53,000 versus the 5,000 patients that are currently annually being treated on ILUVIEN.

因此，在 NEW DAY 中，我們正在分析已完成的 NEW DAY 研究的數據。如果成功的話，醫生將能夠更早考慮使用 ILUVIEN 治療 DME。正如我們之前所描述的，從流行病學角度來看，今天，每年使用 ILUVIEN 的患者不到 5,000 名，而 NEW DAY 之前的潛在市場就已經達到 53,000 名，對吧，這些患者在經過多輪抗 VEGF 治療後沒有顯示出最佳反應，然後他們對類固醇試驗顯示出積極反應，可以考慮使用 ILUVIEN 然後他們被考慮使用 ILUVIEN。因此，潛在市場為 53,000 人，而目前每年接受 ILUVIEN 治療的患者數量為 5,000 人。

So the opportunity as it currently stands even before NEW DAY is pretty substantial. What NEW DAY will do is that much earlier in the treatment paradigm, right? So instead of 53,000, there are 400,000 additional patients that are being treated with multiple rounds of anti-VEGFs. And so if NEW DAY is successful, it could -- HCPs could consider using ILUVIEN earlier in the treatment paradigm. So it would open up a broader patient population for ANI -- sorry, for ILUVIEN.

因此，就目前情況而言，即使在 NEW DAY 之前，機會也相當可觀。NEW DAY 所做的是在治療模式中更早的階段，對嗎？因此，接受多輪抗 VEGF 治療的患者不再是 53,000 人，而是 40 萬人。因此，如果 NEW DAY 成功的話，HCP 可以考慮在治療模式的早期使用 ILUVIEN。因此，它將為 ANI（抱歉，是 ILUVIEN）開闢更廣泛的患者群體。

Next, to your question on prucalopride. Look, we don't comment on product level net revenues for the generics business. But what we can say is that our estimates show genericization levels significantly higher than the IQVIA reported TRx share of 62% to 63%. And we're pleased with the execution of the ANI team on this product from R&D and regulatory to win the CGT approval against numerous competitors to the sales and marketing team's ability to launch this product and maximize the opportunity. We anticipate that Q2 prucalopride revenues will be down as compared to the first quarter as the team will need to manage trade inventory levels down in advance of the end of 180 days of exclusivity on June 26.

接下來，回答您關於普卡洛普利的問題。瞧，我們不對仿製藥業務的產品級淨收入發表評論。但我們可以說的是，我們的估計顯示仿製藥的通用化水平明顯高於 IQVIA 報告的 TRx 份額 62% 至 63%。我們對 ANI 團隊在該產品上的執行情況感到滿意，從研發和監管方面，在眾多競爭對手中贏得 CGT 批准，到銷售和行銷團隊推出該產品並最大限度地利用機會的能力。我們預計第二季度普卡洛普利的收入將與第一季相比有所下降，因為團隊需要在 6 月 26 日 180 天獨佔期結束之前管理貿易庫存水準。

So generics will be in Q2 will be slightly lower, as Steve pointed out, on the phasing perspective, will be lower than the first quarter and then return to growth in the subsequent quarters from a total company perspective.

因此，正如史蒂夫指出的那樣，從分階段的角度來看，仿製藥在第二季度的銷售額將略有下降，但從整個公司的角度來看，仿製藥的銷售額將在接下來的幾個季度恢復成長。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆、派珀·桑德勒。

So just a couple for me. First, on Cortrophin Gel. As the category returns to growth, do you anticipate the payer landscape becoming more challenging over time compared to where it is now? Just talk about payer dynamics and what you're anticipating with the category returning to growth. So that's number one. And then number two is regarding ILUVIEN. I appreciate all the color on the headwinds. But I'm just wondering out loud, how you're feeling about the underlying acquisition of Alimera and what has surprised you most in terms of the challenges that you faced with the asset?

對我來說只有幾個。首先，關於 Cortrophin 凝膠。隨著該類別恢復成長，您是否預期付款人格局會比現在變得更具挑戰性？只需談論付款人的動態以及您對該類別恢復成長的預期。這是第一點。第二個是關於 ILUVIEN 的。我欣賞逆風中的所有色彩。但我只是想問，您對收購 Alimera 有何感想，以及就您在資產方面面臨的挑戰而言，最讓您感到驚訝的是什麼？

So on Cortrophin payer landscape, remember, this category had not seen competition for many, many decades. And the payers and PBMs, they definitely see us as the -- they appreciate the fact that we brought competition to this category, and we went to go and collaborate and partner with them from day one. So they appreciate that. And as the category has evolved and as we've grown, we've continued to collaborate with them and see that continuing. I mean, at the end of the day, we all put the patients first and ensure that we're bringing this therapeutic -- this much needed therapeutic to patients in need. So that's on the payer landscape dynamics.

因此，在 Cortrophin 付款人格局中，請記住，這個類別已經很多很多年沒有出現過競爭了。付款人和 PBM 肯定將我們視為 - 他們欣賞我們為這個類別帶來競爭，我們從第一天起就與他們合作並成為合作夥伴。所以他們對此表示感謝。隨著產品類別的發展和我們的成長，我們將繼續與他們合作並期待這種合作能持續下去。我的意思是，歸根結底，我們都把病人放在第一位，並確保為有需要的病人提供這種急需的治療方法。這就是付款人格局的動態。

And then on where do we -- where is our head on the overall acquisition of ILUVIEN? I think the simplest answer to that is, we just bought out a royalty obligation from SWK on ILUVIEN. And so we believe in the continued long-term opportunity for ILUVIEN and YUTIQ. So actually both in DME as well as in NIUPS, where the addressable markets are substantially higher in DME, 5,000 out of 53,000 in NIUPS, less than 5,000 out of 78,000 to 112,000. So large addressable markets. We're fully confident of our ability to solve problems. Even when we acquired Novitium, we had to work through certain challenges. And you can see the value that the Novitium acquisition has brought to us.

那麼，我們對 ILUVIEN 的整體收購處於什麼位置？我認為最簡單的答案是，我們剛剛從 SWK 購買了 ILUVIEN 的特許權使用費義務。因此，我們相信 ILUVIEN 和 YUTIQ 仍將擁有長期的機會。因此實際上無論是在 DME 還是 NIUPS，DME 的可尋址市場都高得多，在 53,000 人中佔 5,000 人，在 78,000 到 112,000 人中佔不到 5,000 人。潛在市場如此龐大。我們對自己解決問題的能力充滿信心。即使我們收購了 Novitium，我們也必須克服一些挑戰。您可以看到收購 Novitium 帶給我們的價值。

So this is a team that thrives on capturing opportunities and addressing challenges and has a very strong orientation towards problem solving. Last quarter, when we were speaking, we were talking about the supply challenges related to the CMO for YUTIQ, and we've worked through that challenge, right? We're later this quarter, we're going to start selling the combined label. So I think it's -- as an operating team, we have a strong orientation towards problem solving. And as I said at the beginning, our belief in ILUVIEN is best highlighted by our recent, I think, weeks ago, buyout of the royalty obligation from SWK.

因此，這是一支善於抓住機會、應對挑戰並且具有強大的解決問題能力的團隊。上個季度，當我們交談時，我們談到了與 YUTIQ 的 CMO 相關的供應挑戰，我們已經解決了這個挑戰，對嗎？我們將在本季稍後開始銷售合併後的品牌。所以我認為——作為一個營運團隊，我們非常注重解決問題。正如我在一開始所說的，我們對 ILUVIEN 的信任最好地體現在我們最近（我想是幾週前）從 SWK 收購特許權使用費義務上。

Ekaterina Knyazkova, JPMorgan.

葉卡捷琳娜·克尼亞茲科娃，摩根大通。

Congrats again on the quarter. So first question is just on Cortrophin. Can you elaborate a bit about which indications are driving most of the growth at this point? How much of the growth is coming from neuro versus rheumatology versus nephrology versus some of the new areas like ophthalmology? And just any changes you're seeing from a competitive standpoint on an indication-by-indication basis? And then second question is just around tariff. Do you think there's an opportunity for you to leverage your US manufacturing footprint if we do see these pharma tariff enacted? And just how much spare capacity do you have that you could potentially leverage to capture additional market share?

再次恭喜本季取得的成績。第一個問題是關於 Cortrophin 的。您能否詳細說明目前哪些指標推動了大部分成長？有多少增長來自神經病學、風濕病學、腎臟病學以及眼科學等一些新領域？從競爭角度來看，您認為每個適應症有什麼改變嗎？第二個問題是關於關稅。如果我們確實看到這些藥品關稅頒布，您是否認為您有機會利用美國製造業的足跡？您有多少閒置產能可以利用來奪取額外的市場份額？

Thank you, Katrina, for your questions. So on the first question on the indication, we were fortunate. We see growth across all specialties. Our core specialties, the ones that we launched with nephrology, rheumatology and neurology, we see strong growth across those indications. We talked about the -- more than 15% of our usage of our Cortrophin usage is coming from gout. So we see growth -- significant growth there, too. Obviously, we invested in the expansion of our field force that focuses on nephrology, rheumatology and neurology and they do that together as a portfolio sales team. So that team -- that expansion is yielding results.

謝謝卡特里娜的提問。因此，對於第一個問題，我們很幸運。我們看到所有專業領域都在成長。我們的核心專業，即腎臟病學、風濕病學和神經病學，我們在這些適應症中看到了強勁的成長。我們談到——我們所使用的 Cortrophin 中超過 15% 是用於治療痛風的。因此，我們也看到了成長——那裡的顯著成長。顯然，我們投資擴大了專注於腎臟病學、風濕病學和神經病學的現場隊伍，他們作為投資組合銷售團隊共同努力。因此，該團隊的擴張正在取得成果。

And then ophthalmology, while on a smaller base, showed the highest growth with almost 15 -- 50% increase in volumes versus the fourth quarter and pulmonology also continues to show growth. So really, we have opportunities growth across indications. And in terms of competitive dynamics, look, they've raised their guidance mid to high single digits, and they spoke about four therapeutic areas that they're focusing their efforts on. And the category, the number of patients that can benefit is just much, much larger than what either competitor is treating at this time. So yes, I think both competitors can continue getting the ACTH therapeutics to more patients and continue to grow the market.

然後，眼科雖然基數較小，但成長最快，與第四季相比，其數量增加了近 15-50%，肺病學也持續呈現成長。因此，我們確實有機會在各個方面實現成長。就競爭動態而言，他們已將指導價格提高了中到高個位數，並談到了他們正重點關注的四個治療領域。並且，該類別中受益的患者數量比任何競爭對手目前治療的患者數量都要多得多。所以是的，我認為這兩個競爭對手都可以繼續讓更多的患者獲得 ACTH 療法，並繼續擴大市場。

And then your second question on tariffs and do we have spare capacity? Absolutely. We do have spare capacity across our plants in East Windsor, New Jersey as well as in Bonnett, Minnesota. We are positively and relative to our peers, well positioned with over 90% of our revenues coming from finished goods manufactured in the US and less than 5% direct reliance on China. And we'll play our role in -- as we have done in the past of if there is supply challenges that arises out of the tariff situation to provide therapeutics to patients in need.

然後你的第二個問題是關於關稅，我們是否有閒置產能？絕對地。我們在新澤西州東溫莎和明尼蘇達州博內特的工廠確實有閒置產能。與同業相比，我們處於有利地位，因為我們 90% 以上的收入來自美國製造的成品，而對中國的直接依賴不到 5%。我們將發揮我們的作用——就像我們過去所做的那樣，如果關稅情況出現供應挑戰，我們將為有需要的患者提供治療。

Les Sulewski, Truist Securities.

Les Sulewski，Truist Securities。

So, Nikhil, perhaps I'll start on Cortrophin. You mentioned the 40% naive patient adoption. Do you have a sense how those scripts for naive patient pool have been trending over time? And I guess, what point do you expect that figure to turn? And then as for the prefilled syringe, is this driven by switches or naive patients? And what's the impact to margin profile from that product? And I guess, more broadly, gross margin looked favorable in 1Q. How do you expect that to trend throughout 2025? And I have a follow-up.

所以，尼基爾，也許我應該開始使用 Cortrophin。您提到了 40% 的初次患者採用率。您是否知道這些針對天真患者群體的處方隨著時間的推移趨勢如何？我想，您認為這個數字會轉變到什麼程度呢？那麼對於預充式註射器，這是由轉換還是由天真的患者推動的？該產品對利潤率有何影響？我想，從更廣泛的角度來看，第一季的毛利率看起來不錯。您預計 2025 年的趨勢如何？我還有一個後續問題。

Yes. Thank you for your questions, Les. So Cortrophin having 40% of prescribers that are -- that were naive to the category, that number keeps growing as we reach with a larger addressable market and reaching more HCPs. So we'll keep you updated on the progress on that. On the prefilled syringe, we see the prefilled syringe as another alternative, right, as we had the 5 ml vial and the 1 ml vial. So we're introducing the prefilled syringe, which comes in two presentations, 1 ml and the 0.5 ml.

是的。謝謝你的提問，萊斯。因此，Cortrophin 有 40% 的處方者對該類別藥物一無所知，隨著我們進入更大的目標市場並接觸到更多的 HCP，這個數字還在不斷增長。因此，我們會隨時向您通報進度。在預充式註射器上，我們將預充式註射器視為另一種選擇，對吧，因為我們有 5 毫升小瓶和 1 毫升小瓶。因此我們推出了預充式註射器，有兩種規格：1 毫升和 0.5 毫升。

And it's really for patients that have a that the reduction in the number of steps of administration will be helpful to them. So it's for a subset of patients. It's early days in the launch of the prefilled syringe. So we'll update you regarding your question on switches and is it new patients or switches. We see this as another option for patients by reducing one step -- for enhancing patient convenience by reducing one step in the administration in the step of -- in the steps for administration.

對於患者來說，減少給藥步驟確實對他們有幫助。所以它適用於一部分患者。預充式註射器的推出尚處於早期階段。因此，我們將向您更新有關轉換的問題，以及是新患者還是轉換。我們認為這是患者的另一種選擇，透過減少給藥步驟中的一個步驟來提高患者的便利性。

And then in the near-term, we see limited impact on the margin profile. It's priced at a slight premium to the 1 ml on a per ml basis, so -- but limited impact. And then on gross margin evolution through the year, I'll turn it over to Steve to take that question.

短期內，我們認為利潤率受到的影響有限。它的價格以每毫升計算比 1 毫升略高，所以——但影響有限。然後，關於全年毛利率的變化，我將把這個問題交給史蒂夫來回答。

Thanks, Nikhil. Yes, as we cited on the call today, Les, we continue to anchor in overall company gross margin between 63% and 64% throughout the course of the year. And obviously, there's numerous mix elements as the year progresses. And we expect, right, as rare disease becomes a bigger portion of the overall part of the total company revenues in the second half of the year and as the quarters progress, that will be a favorable margin input as compared to in the first quarter, strong margins in Generics, driven by prucalopride, as well as the persistent of market -- persistence of market share gains in the brand business, which helped margins in the first quarter.

謝謝，尼基爾。是的，正如我們今天在電話會議上提到的，萊斯，我們全年繼續將公司整體毛利率穩定在 63% 至 64% 之間。顯然，隨著時間的推移，會出現許多混合元素。我們預計，隨著罕見疾病在下半年占公司總收入的比例越來越大，並且隨著季度的進展，與第一季度相比，這將帶來有利的利潤投入，在普卡洛普利的推動下，仿製藥的利潤率很高，而且市場持續增長——品牌業務的市場份額持續增長，這些都有助於提高第一季度的利潤率。

Great. That's helpful. As a follow-up on the ILUVIEN, YUTIQ, Nikhil, do you have a sense of what portion of that subset is Medicare Part B? And is there a potential that cohort, I guess, of patients does not come back given that appears unlikely the third party will come back with funding, the assistance and co-pays? And then I guess the second portion, the sales force turnover within ophthalmology, does that have any impact on Cortrophin? Or perhaps asked in another way, is that a potential for an increased opportunity for Cortrophin given the new team that's in place now?

偉大的。這很有幫助。作為對 ILUVIEN、YUTIQ、Nikhil 的後續詢問，您是否知道該子集的哪一部分屬於 Medicare B 部分？我猜想，是否有可能這群病人不會再回來，因為第三方似乎不太可能提供資金、援助和共同支付？然後我想第二部分，眼科銷售人員的流動率，這對 Cortrophin 有影響嗎？或者換個方式問，考慮到現在的新團隊，這是否會為 Cortrophin 帶來更多機會？

Yes. So thank you for your questions, Les. So I'll take your second question first, which is on the turnover. Yes, I think you framed it correct appropriately that if we had the full team staff, you would have seen more growth in Cortrophin. So yes, we will see the impact of the top talent that we bring in on both ILUVIEN and Cortrophin going forward. So that's the answer on the turnover and the positive impact on Cortrophin. And then your question on Medicare. So there's a subset of Medicare patients, right, that don't have co-pay support through various mechanisms that are available, and that's the -- the population that's impacted by the funding not being available.

是的。謝謝你的提問，萊斯。我先回答你的第二個問題，關於營業額。是的，我認為您的表達非常正確，如果我們擁有完整的團隊人員，您將看到 Cortrophin 取得更大的成長。所以是的，我們將看到我們引進的頂尖人才對 ILUVIEN 和 Cortrophin 未來的影響。這就是關於營業額和對 Cortrophin 的正面影響的答案。然後是關於醫療保險的問題。因此，有一部分醫療保險患者無法透過各種可用的機制獲得共同支付支持，而這些人口就是受到資金短缺影響的人口。

And look, from our perspective, from everything that we've heard from major contributors to the relevant foundation, say, in the public domain and the discussions with several stakeholders in retina, we believe that some level of foundation support will return in the second half of the year. And if the foundation support does not come back, we are likely to trend towards the lower end of our guidance range as far as the ILUVIEN and YUTIQ is concerned. And remember, ILUVIEN and YUTIQ in the US is about 70% of our total ILUVIEN and YUTIQ guidance, right?

從我們的角度來看，從我們從相關基金會的主要捐助者那裡聽到的一切，例如在公共領域以及與視網膜的幾個利益相關者的討論中，我們相信一定程度的基金會支持將在下半年恢復。如果基金會支持沒有恢復，就 ILUVIEN 和 YUTIQ 而言，我們可能會趨向於指導範圍的低端。請記住，美國的 ILUVIEN 和 YUTIQ 約占我們 ILUVIEN 和 YUTIQ 總指導的 70%，對嗎？

So from a total company basis, again, just a reminder, it's less than 10% of total company 2025 revenues. And so our guidance for total company and the raised guidance factors in the puts and takes across different business lines. And we have high confidence in the overall total company revenues and total company adjusted non-GAAP EBITDA and adjusted non-GAAP EPS guidance that we have given, and we continue to retain that confidence.

因此，從整個公司的角度來看，再次提醒一下，這還不到該公司 2025 年總收入的 10%。因此，我們對整個公司的指導和提高的指導因素考慮了不同業務線的投入和收益。我們對我們給出的公司總收入、公司總調整後非 GAAP EBITDA 和調整後非 GAAP EPS 指引充滿信心，並且我們將繼續保持這種信心。

This does conclude today's question-and-answer session. I will now turn the program back over to Nikhil Lalwani for any additional or closing remarks.

今天的問答環節到此結束。現在我將節目交還給尼基爾·拉爾瓦尼 (Nikhil Lalwani)，請他發表補充意見或結束語。

Thank you, everybody, for joining our call this morning. We look forward to updating you on further progress as the year unfolds, and we look forward to seeing many of you at the Jefferies Conference in New York in June. Thank you.

感謝大家今天上午參加我們的電話會議。我們期待今年向您通報進一步的進展，並期待在六月紐約的 Jefferies 會議上見到你們。謝謝。

This does conclude today's program. Thank you for your participation. You may disconnect at any time.

今天的節目到此結束。感謝您的參與。您可以隨時斷開連線。