ANI Pharmaceuticals Inc (ANIP) 2024 Q2 法說會逐字稿

Good day, everyone, and welcome to today's ANI Pharmaceuticals, Inc. second quarter 2024 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. Please go ahead, ma'am.

大家好，歡迎參加今天的 ANI Pharmaceuticals, Inc. 2024 年第二季財報電話會議。請注意，此通話正在錄音。（操作員指示）現在我很高興將會議交給麗莎威爾森。請繼續，女士。

Thank you, Katie. Welcome to ANI Pharmaceuticals Q2 2024 earnings results call. This is Lisa Wilson of Insight Communications, Investor Relations for ANI. With me on today's call are Nikhil Lalwani, President, and Chief Executive Officer; Steve Carey, Chief Financial Officer; and Chris Mutz, Senior Vice President and Head of ANI's rare disease business.

謝謝你，凱蒂。歡迎參加 ANI Pharmaceuticals 2024 年第二季財報電話會議。我是 ANI 投資者關係 Insight Communications 的 Lisa Wilson。與我一起參加今天電話會議的有總裁兼執行長 Nikhil Lalwani；史蒂夫‧凱裡，財務長；以及 ANI 罕見疾病業務資深副總裁兼負責人 Chris Mutz。

You can also access the webcast of this call through the investor 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.

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、預期或意圖的聲明都可能被視為前瞻性聲明，由《私人證券訴訟改革法》定義。

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.

這些前瞻性聲明是基於 ANI Pharmaceuticals 管理層截至目前所掌握的信息，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 SEC 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 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 is held and recorded on August 6, 2024. 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.

除法律要求外，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。存檔的網路廣播將在我們的網站 anipharmaceuticals.com 上保留 30 天。為了那些可能正在收聽重播或存檔網路廣播的人的利益，本次電話會議將於 2024 年 8 月 6 日舉行並進行錄音。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.

接下來，我會將電話轉給 Nikhil Lalwani。

Thanks, to Lisa. Good morning, everyone, and thank you for joining our second quarter earnings call. We are delighted with ANI's accomplishments in the second quarter. We achieved both record revenues and a major milestone in our ongoing efforts to expand the scope and scale of our rare disease business with our proposed acquisition of Alimera Sciences.

謝謝，麗莎。大家早安，感謝您參加我們的第二季財報電話會議。我們對 ANI 第二季度的成就感到高興。透過擬議收購 Alimera Sciences，我們實現了創紀錄的收入，也是我們不斷努力擴大罕見疾病業務範圍和規模的重要里程碑。

The company continues to rise to each challenge and goal, and I'm proud of the team's ability to drive sustained, long-term growth while never losing sight of our purpose of serving patients, improving lives. During the second quarter, ANI generated revenues of $138 million, an increase of 18% over the second quarter of 2023.

公司不斷迎接每一個挑戰和目標，我為團隊推動持續、長期成長的能力感到自豪，同時永遠不會忽視我們服務病患、改善生活的宗旨。第二季度，ANI 營收 1.38 億美元，比 2023 年第二季成長 18%。

Adjusted non-GAAP EBITDA was $33.2 million, and adjusted non-GAAP EPS was $1.02. Based on our strong second quarter results and the continued momentum that we're seeing across the business, we're pleased to raise our full year 2024 guidance, which Steve will discuss later in the call.

調整後的非 GAAP EBITDA 為 3,320 萬美元，調整後的非 GAAP 每股收益為 1.02 美元。基於我們強勁的第二季業績以及我們在整個業務中看到的持續勢頭，我們很高興提高 2024 年全年指引，史蒂夫將在稍後的電話會議中討論這一點。

Accelerating demand for our lead rare disease asset, purified Cortrophin gel, and solid growth for generics drove our robust top-line performance, which more than offset the expected established brand business performance.

對我們的主要罕見疾病資產、純化 Cortropin 凝膠的需求加速成長以及仿製藥的穩健成長推動了我們強勁的營收業績，這超出了預期的既定品牌業務業績。

Cortrophin gel generated $49.2 million in revenues during the quarter, up 102% over the prior year quarter and 33% over the first quarter of 2024. The second quarter represented the highest number of both new patient starts and unique prescribers since launch in January 2022. We continue to have momentum in the addition of new prescribers and robust growth from existing prescribers and volumes increased across all targeted specialties, urology, rheumatology, nephrology, pulmonology, and ophthalmology.

Cortropin 凝膠在本季創造了 4,920 萬美元的收入，比去年同期成長 102%，比 2024 年第一季成長 33%。自 2022 年 1 月推出以來，第二季度的新患者數量和獨特處方者數量均達到最高水準。我們繼續保持新處方醫師的增加和現有處方醫師的強勁增長，以及所有目標專科、泌尿科、風濕病學、腎臟病學、肺病學和眼科的數量增加。

We are pleased to report that the areas of strategic investment behind Cortrophin gel that we announced earlier this year and late last year, including expanding our pulmonology sales team, launching a targeted ophthalmology sales team, and actively promoting the acute gouty arthritis flares indication, have been yielding positive results.

我們很高興地報告，今年稍早和去年年底我們宣布的Cortropin 凝膠背後的策略投資領域，包括擴大我們的肺科銷售團隊、成立有針對性的眼科銷售團隊以及積極推廣急性痛風性關節炎發作適應症，已經已取得正面成果。

Our ophthalmology sales team has a strong start and drove significant growth in prescriptions and new patient starts in the second quarter. We also saw particularly strong year-over-year and quarter-over-quarter growth for acute gouty arthritis flares. Cortrophin gel is the only ACTH product approved for this indication.

我們的眼科銷售團隊開局強勁，推動第二季度處方量和新患者數量顯著增長。我們也看到急性痛風性關節炎發作的年比和環比增長特別強勁。Cortropin 凝膠是唯一核准用於此適應症的 ACTH 產品。

As a reminder, we began promotional activities for the acute gouty arthritis flares indication in late 2023. More than 9 million people in the US are affected by gout, and some of these experience acute gouty arthritis flares as a symptom of their underlying disease. For some of these patients, Cortrophin gel may be an appropriate additional treatment option for their flares.

謹此提醒，我們於 2023 年底開始針對急性痛風性關節炎發作適應症進行促銷活動。美國有超過 900 萬人受到痛風的影響，其中一些會出現急性痛風性關節炎，這是其潛在疾病的症狀。對於其中一些患者來說，Cortropin 凝膠可能是治療耀斑的合適的附加治療選擇。

We have seen increasing momentum in physicians adopting Cortrophin gel for patients with acute gouty arthritis flares who have not responded adequately to conventional therapies. We continue our efforts to enhance the convenience and remove pain points for patients starting on ACTH and the healthcare providers who treat them.

我們看到，醫生越來越多地採用 Cortropin 凝膠來治療對傳統療法沒有充分反應的急性痛風性關節炎患者。我們繼續努力為開始使用 ACTH 的患者和治療他們的醫療保健提供者提供便利並消除痛點。

In the fourth quarter of 2023, we introduced the 1-ML version of Cortrophin gel to meet the needs of physicians who desired a smaller configuration of ACTH for certain patients, such as those with acute gouty arthritis flares.

2023 年第四季度，我們推出了 1-ML 版本的 Cortropin 凝膠，以滿足醫生希望為某些患者（例如患有急性痛風性關節炎發作的患者）提供較小劑量 ACTH 的需求。

Today, we are pleased to report for the first time that we are nearing the completion of development of a 1-ML prefilled syringe, offering further benefits to patients and physicians. We plan to file for FDA approval of the prefilled syringe in the second half of 2024 and are excited about the potential of this product. We look forward to launching this product in the first half of 2025.

今天，我們很高興地首次報告，我們即將完成 1 毫升預充式註射器的開發，為患者和醫生提供更多好處。我們計劃在 2024 年下半年向 FDA 申請預充式註射器的批准，並對該產品的潛力感到興奮。我們期待在 2025 年上半年推出產品。

Turning now to our generics business, which delivered another strong quarter with revenue of $74 million, an increase of 17% over the second quarter of 2023, and 5% over the first quarter of 2024. The solid performance reflected strength in our base business, coupled with contribution from new product launches.

現在談談我們的仿製藥業務，該業務在本季度再次表現強勁，收入達 7,400 萬美元，比 2023 年第二季度增長 17%，比 2024 年第一季增長 5%。穩健的業績反映了我們基礎業務的實力，以及新產品發布的貢獻。

We launched four new products in the second quarter, each into limited competition markets in generics. We have launched three new products so far in the third quarter and have a number of products pending approval that we expect to launch in the second half. We made substantial progress on bringing online the significant capacity expansion at our New Jersey site and believe all 15 new manufacturing suites and the new QC lab will be fully operational in the second half of 2024. The New Jersey site expansion will support the future growth of our generics business.

我們在第二季推出了四種新產品，每種產品都進入競爭有限的仿製藥市場。到目前為止，我們在第三季已經推出了三款新產品，還有一些產品正在等待批准，我們預計將在下半年推出。我們在新澤西工廠的重大產能擴張方面取得了實質進展，並相信所有 15 個新製造套件和新 QC 實驗室將在 2024 年下半年全面投入運作。新澤西工廠的擴建將支持我們仿製藥業務的未來成長。

Revenue for established brands was $14.9 million during the quarter, a decrease of 49% from the prior year period. The performance was anticipated and in line with our expectations and guidance. As a reminder, we noted on the first quarter call in May that we did not expect the tailwinds arising from competitor supply dynamics to persist beyond the first quarter.

該季度知名品牌的營收為 1,490 萬美元，比去年同期下降 49%。該業績符合我們的預期和指導。提醒一下，我們在 5 月的第一季電話會議上指出，我們預計競爭對手供應動態帶來的有利影響不會持續到第一季之後。

In June, we delivered a major milestone in our growth strategy with announcing the proposed acquisition of Alimera Sciences. This highly synergistic transaction will add two commercial assets in ophthalmology to our rare disease portfolio and more than $100 million in highly durable branded revenue annually. The acquisition is aligned with the M&A strategy we laid out over the past several quarters.

6 月，我們宣布擬收購 Alimera Sciences，實現了成長策略的一個重要里程碑。這項高度協同的交易將為我們的罕見疾病投資組合增加兩項眼科商業資產，並每年帶來超過 1 億美元的高度耐用的品牌收入。此次收購符合我們過去幾季所製定的併購策略。

Specifically, this transaction will expand the scope and scale of our rare disease business and strengthen one of our priority therapeutic areas of ophthalmology, which is also a key specialty for our lead rare disease asset, Cortrophin gel, and the overall ACTH market.

具體而言，本次交易將擴大我們罕見疾病業務的範圍和規模，並加強我們的優先治療領域之一眼科，這也是我們領先的罕見疾病資產 Cortropin 凝膠和整個 ACTH 市場的關鍵專業。

The deal will provide ANI two durable assets with double-digit growth. With Alimera, ANI's rare disease segment would account for approximately 45% of the total company revenues on a pro forma 2024 basis. And we expect rare disease to be the largest driver of the company's future growth.

該交易將為 ANI 提供兩項具有兩位數成長的耐用資產。預計 2024 年，憑藉 Alimera，ANI 的罕見疾病業務將占公司總收入的約 45%。我們預計罕見疾病將成為公司未來成長的最大驅動力。

From a financial perspective, we expect high single-digit to low double-digit accretion in adjusted non-GAAP EPF in 2025, with substantial accretion thereafter. Integration planning is well underway, and the transaction remains on track to close later this quarter.

從財務角度來看，我們預計 2025 年調整後的非 GAAP EPF 將出現高個位數到低兩位數的成長，此後還會大幅成長。整合計劃正在順利進行，交易仍有望在本季稍後完成。

Now, I'd like to turn the call over to Chris Mutz, our head of rare disease, to discuss the Alimera products and transaction in more detail.

現在，我想將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 Alimera 產品和交易。

Thank you, Nikhil. We're excited about what Alimera brings to ANI, starting with two high-growth, durable commercial products. Alimera's first product, ILUVIEN, is used to treat diabetic macular edema, or DME, the leading cause of vision loss in diabetic patients. The company's second product, YUTIQ, is used to treat patients with chronic, non-infectious uveitis affecting the back of the eye.

謝謝你，尼基爾。我們對 Alimera 為 ANI 帶來的東西感到興奮，首先是兩款高成長、耐用的商業產品。Alimera 的首款產品 ILUVIEN 用於治療糖尿病性黃斑水腫 (DME)，這是糖尿病患者視力喪失的主要原因。該公司的第二種產品 YUTIQ 用於治療影響眼睛後部的慢性非感染性葡萄膜炎患者。

ILUVIEN and YUTIQ are both double-digit growth assets with high barriers to genericization and significant future upsides. With the acquisition of Alimera, ANI will have three commercial rare disease assets, Cortrophin, ILUVIEN, and YUTIQ, and an expanded rare disease commercial team covering the specialties of ophthalmology, neurology, nephrology, rheumatology, and pulmonology.

ILUVIEN 和 YUTIQ 都是兩位數成長的資產，具有很高的仿製藥壁壘和巨大的未來上升空間。透過收購 Alimera，ANI 將擁有 Cortropin、ILUVIEN 和 YUTIQ 三個商業罕見疾病資產，並擴大了涵蓋眼科、神經病學、腎臟病學、風濕病學和肺病學專業的罕見疾病商業團隊。

A nationwide sales force of approximately 45 sales representatives will be dedicated to ophthalmology alone, extending our reach and ability to promote all three products for difficult-to-treat, late-line patients with limited therapeutic options. Alimera will also increase ANI's geographic diversification with its established ex-US footprint, including direct marketing operations in Europe and partnerships in additional key geographical regions.

由約 45 名銷售代表組成的全國銷售團隊將專門致力於眼科領域，擴大我們的影響範圍和能力，為治療選擇有限的難以治療的晚期患者推廣所有三種產品。Alimera 也將利用其在美國以外的既定足跡，增加 ANI 的地理多元化，包括在歐洲的直接行銷業務以及在其他關鍵地理區域的合作夥伴關係。

Earlier this morning, Alimera reported second-quarter results. ILUVIEN and YUTIQ generated net revenue of $27 million in the second quarter, which represented year-over-year growth of 54%. Alimera's adjusted EBITDA increased to $6.7 million in the second quarter, up from $0.9 million in the prior year quarter and $1.8 million in the first quarter of 2024. ILUVIEN and YUTIQ are both high-growth products, and we are confident in our ability to unlock additional values through commercial synergies and execution.

今天早些時候，Alimera 公佈了第二季業績。ILUVIEN 和 YUTIQ 第二季淨收入為 2,700 萬美元，較去年同期成長 54%。Alimera 在第二季調整後 EBITDA 增至 670 萬美元，高於去年同期的 90 萬美元和 2024 年第一季的 180 萬美元。ILUVIEN 和 YUTIQ 都是高成長產品，我們對透過商業協同和執行釋放額外價值的能力充滿信心。

With that, I'd like to turn the call over to Steve, who will walk through our second-quarter financial results and revise 2024 guidance in more detail. Steve?

接下來，我想將電話轉給 Steve，他將詳細介紹我們第二季的財務業績，並更詳細地修改 2024 年指引。史蒂夫？

Thank you, Chris, and good morning to everyone on the call. ANI generated second-quarter revenues of $138 million, up 18% over the prior year period. Revenues from Cortrophin gel reported in our rare disease segment were $49.2 million, up 102% from the prior year period, driven primarily by increased volume on record number of new patient starts.

謝謝你，克里斯，祝所有參加電話會議的人早安。ANI 第二季營收為 1.38 億美元，比去年同期成長 18%。我們的罕見疾病部門報告的 Cortropin 凝膠收入為 4,920 萬美元，比去年同期增長 102%，這主要是由於新患者數量創紀錄的增長所致。

Based upon the continued strong execution of the rare disease team in driving growth, we are raising our full-year Cortrophin gel revenue guidance range by $15 million to $185 million to $195 million. And similar to last year, we expect fourth quarter to be the strongest revenue quarter of the year.

基於罕見疾病團隊在推動成長方面持續強勁的執行力，我們將全年 Cortropin 凝膠收入指引提高了 1,500 萬美元至 1.85 億美元至 1.95 億美元。與去年類似，我們預計第四季將是今年營收最強勁的季度。

Revenues of our generic, established brands, and other segments were $88.8 million, a decrease of 4% over the prior year period. Generic revenues for the quarter were $74 million, an increase of 17% over the prior year period, driven by continued strength in the base business and the contributions of new product launches.

我們的仿製藥、知名品牌和其他細分市場的收入為 8,880 萬美元，比去年同期下降 4%。該季度的一般收入為 7,400 萬美元，比上年同期增長 17%，這得益於基礎業務的持續強勁和新產品發布的貢獻。

Net revenues for established brands and other were $14.9 million in the quarter, a decrease of 49% over the prior year period. This performance was expected, as Nikhil noted in his earlier remarks, and second quarter performance is generally indicative of our quarterly expectation for the back half of 2024.

本季知名品牌和其他品牌的淨收入為 1,490 萬美元，比去年同期下降 49%。正如 Nikhil 在先前的演講中指出的那樣，這一業績是預期的，第二季的業績總體上反映了我們對 2024 年下半年的季度預期。

Cost of sales, excluding depreciation and amortization, increased 36% to $57.7 million in the second 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, including Cortrophin gel.

與去年同期相比，2024 年第二季的銷售成本（不包括折舊和攤提）增加了 36%，達到 5,770 萬美元。主要是由於藥品銷售的淨增長以及包括 Cortropin 凝膠在內的特許權使用費產品的顯著增長。

Non-GAAP gross margin was 58.4%, a decrease of approximately 570 basis points from the prior year period and 600 basis points from the first quarter of 2024, primarily due to product mix, driven by the reduction in established brand revenues, as well as expenses related to the capacity expansion at our New Jersey manufacturing site. We expect sequential improvement in gross margin in both the third and fourth quarter of this year.

非 GAAP 毛利率為 58.4%，較上年同期下降約 570 個基點，較 2024 年第一季下降 600 個基點，主要是由於老牌品牌收入減少以及與新澤西製造基地產能擴張相關的費用。我們預計今年第三季和第四季的毛利率將持續改善。

Research and development expenses decreased 1% to $7.3 million in the second quarter of 2024, compared to the prior year period, and 30% from the first quarter. The sequential decline was related to expense timing and the inherent variability of R&D expenditures on a quarter to quarter basis. We expect R&D to increase in the second half of 2024 relative to the first half of the year, due to the timing of R&D activities.

2024 年第二季研發費用較去年同期下降 1%，至 730 萬美元，較第一季下降 30%。環比下降與費用時間安排以及研發支出按季度的固有變化有關。由於研發活動的時間安排，我們預計 2024 年下半年的研發活動將較上半年增加。

Selling, general, and administrative expenses increased 36% to $52.8 million in the second quarter of 2024, due to increased employment-related costs, continued investment in rare disease sales and marketing activities, legal expenses, expenses related to the pending acquisition of Alimera, and an overall increase in activities required to support the growth of our business.

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、法律費用、與即將收購 Alimera 相關的費用，2024 年第二季的銷售、一般和管理費用增加了 36%，達到 5,280 萬美元，支持我們業務成長所需的活動整體增加。

On a GAAP basis, net loss available to common shareholders for the second quarter of 2024 was $2.7 million, as compared to net income of $5.8 million in the prior year period, driven by a $3.5 million of expenses related to the pending acquisition of Alimera, and a $2.7 million unrealized mark-to-market loss on the value of our investment in CG oncology. Both of these items are adjusted for in our non-GAAP metrics this morning.

根據 GAAP 基礎，2024 年第二季普通股股東的淨虧損為 270 萬美元，而去年同期的淨利潤為 580 萬美元，這是由於與即將收購 Alimera 相關的 350 萬美元費用所致，我們對CG腫瘤學的投資價值產生了270 萬美元的未實現以市價計價損失。今天早上我們的非公認會計準則指標中對這兩項進行了調整。

Second quarter diluted GAAP earnings per share was a loss of $0.14, as compared to income of $0.29 per share in the prior year period. On an adjusted non-GAAP basis, diluted earnings per share was $1.02 for the quarter, compared to $1.28 per share in the prior year period. Adjusted non-GAAP EBITDA for the second quarter of 2024 was $33.2 million, compared to $34.1 million in the prior year period.

第二季稀釋後 GAAP 每股盈餘虧損 0.14 美元，去年同期每股收益為 0.29 美元。以調整後的非公認會計原則計算，本季攤薄後每股收益為 1.02 美元，而去年同期為每股 1.28 美元。2024 年第二季調整後非 GAAP EBITDA 為 3,320 萬美元，去年同期為 3,410 萬美元。

We ended the quarter with $240.1 million in unrestricted cash, and have $292.5 million in face value of outstanding debt, which is due in November of 2027. At the end of the second quarter, our gross leverage ratio was 2.1 times, and our net leverage ratio was well under half a turn of our trailing 12-month adjusted non-gap EBITDA of $137.5 million.

截至本季末，我們擁有 2.401 億美元的非限制性現金，面額 2.925 億美元的未償債務將於 2027 年 11 月到期。截至第二季末，我們的總槓桿率為 2.1 倍，淨槓桿率遠低於過去 12 個月調整後無缺口 EBITDA 1.375 億美元的半倍。

Finally, as Nikhil mentioned, and as outlined in this morning's press release, we are pleased to increase our full year 2024 guidance as follows. Full year 2024 net revenues of $540 million to $560 million, up from our prior guidance of $520 million to $542 million, representing year-over-year growth of approximately 11% to 15%. For Cortrophin Gel net revenues of $185 million to $195 million, up from our prior guidance of $170 million to $180 million, representing year-over-year growth of 65% to 74%.

最後，正如 Nikhil 所提到的，以及今天早上的新聞稿中概述的，我們很高興將 2024 年全年指導提高如下。2024 年全年淨收入為 5.4 億美元至 5.6 億美元，高於我們先前指導的 5.2 億美元至 5.42 億美元，年成長約 11% 至 15%。Cortropin Gel 的淨收入為 1.85 億至 1.95 億美元，高於我們先前指導的 1.7 億至 1.8 億美元，年增 65% 至 74%。

Adjusted non-GAAP EBITDA of $140 million to $150 million, up from our prior guidance of $135 million to $145 million, representing year-over-year growth of approximately 5% to 12%. And adjusted non-GAAP earnings per share between $4.38 and $4.82, up from our prior guidance of $4.26 and $4.67.

調整後的非 GAAP EBITDA 為 1.4 億美元至 1.5 億美元，高於我們先前指引的 1.35 億美元至 1.45 億美元，年成長約 5% 至 12%。調整後的非 GAAP 每股收益為 4.38 美元至 4.82 美元，高於我們先前指引的 4.26 美元至 4.67 美元。

We are reducing our estimate for total company non-GAAP gross margins by one point, to be between 61% and 62%, from our prior assumption of between 62% and 63%, due to a modest change in the timing of when the new manufacturing suites at our New Jersey site become fully operational.

我們將對公司非 GAAP 總毛利率的估計從之前 62% 至 63% 之間的假設下調 1 個百分點，至 61% 至 62% 之間，原因是新的我們新澤西工廠的製造套件已全面投入運營。

This factor is short-term in nature, as we anticipate achieving the full benefit and efficiency of the new suites in the second half of this year and beyond. Consisting with prior quarters, we will continue to tax-effect non-GAAP adjustments for computation of adjusted non-GAAP diluted earnings per share, using our estimated statutory rate of 26%.

這個因素本質上是短期的，因為我們預計在今年下半年及以後才能實現新套件的全部效益和效率。與前幾季一樣，我們將繼續使用我們估計的 26% 的法定稅率，對調整後的非 GAAP 稀釋每股盈餘進行稅收影響的非 GAAP 調整。

The company now anticipates between 19.4 million and 19.8 million shares outstanding for the purpose of calculating diluted EPS, and continues to expect its US GAAP effective tax rate to be between 22% and 25%. Please note that our updated 2024 full-year guidance does not include contribution from the pending acquisition of Alimera.

該公司目前預計用於計算攤薄每股收益的已發行股票數量將在 1,940 萬至 1,980 萬股之間，並繼續預計其美國公認會計原則有效稅率將在 22% 至 25% 之間。請注意，我們更新的 2024 年全年指引不包括即將收購 Alimera 的貢獻。

With that, I will now turn the call back to Nikhil.

現在，我將把電話轉回尼基爾。

Thank you, Steve. We are extremely pleased with our performance in the second quarter, and the continued momentum that has allowed us to increase our full-year expectations. It's an exciting time at ANI, with a strong first half and the anticipated Q3 closing of the acquisition of Alimera.

謝謝你，史蒂夫。我們對第二季度的表現以及持續的勢頭感到非常滿意，這使我們能夠提高全年預期。對於 ANI 來說，這是一個激動人心的時刻，上半年業績強勁，預計第三季將完成對 Alimera 的收購。

By the end of this year, ANI will have three growing and durable commercial assets in rare disease, an expanded commercial team covering the specialties of ophthalmology, neurology, nephrology, rheumatology, and pulmonology, and a highly reliable global network of over 20 countries. We are thrilled to unite the two companies with a shared culture built around similar missions of serving patients, improving lives.

到今年年底，ANI 將在罕見疾病領域擁有三個不斷增長且持久的商業資產、涵蓋眼科、神經病學、腎病學、風濕病學和肺病學專業的擴大的商業團隊，以及覆蓋20 多個國家的高度可靠的全球網路。我們很高興能夠將兩家公司聯合起來，擁有共同的文化，圍繞著服務患者、改善生活的相似使命。

Thank you for your interest in ANI, and we look forward to keeping you updated throughout the rest of the year.

感謝您對 ANI 的興趣，我們期待在今年剩餘時間內為您提供最新資訊。

Operator, please open the line for questions.

接線員，請開通提問線。

(Operator Instructions) Les Sulewski, Truist Securities.

（操作員指示）Les Sulewski，Truist Securities。

Hi, this is Jeremy on for Les. Thanks for taking our questions. First for me is, what other drivers do you have for the guidance range, aside from Cortrophin? And then also on the pre-filled syringe, can you give us any more color and explain if there's anything similar to this in the marketplace? Thank you.

大家好，我是 Les 的 Jeremy。感謝您回答我們的問題。首先對我來說，除了 Cortropin 之外，你們在指導範圍內還有哪些其他驅動程式？還有關於預充式註射器，您能給我們更多的顏色嗎？謝謝。

Good morning, and thank you, Jeremy. Thank you for joining. I'll take your second question first, which is on the pre-filled syringe. Look, we continue our efforts to enhance the convenience and remove pain points for patients, starting on ACTH and the healthcare providers who treat them.

早安，謝謝你，傑瑞米。感謝您的加入。我先回答你的第二個問題，也就是關於預充式註射器的問題。看，我們將繼續努力提高患者的便利性並消除患者的痛點，從 ACTH 和治療患者的醫療保健提供者開始。

You will remember that in the fourth quarter of '23, we introduced the 1-ml version of Cortrophin gel to meet the needs of physicians who desire the smaller configuration of ACTH for certain patients. Now, we're nearing the completion of development of a 1-ml pre-filled syringe, offering further benefits, right?

您會記得，在 2023 年第四季度，我們推出了 1 毫升版本的 Cortropin 凝膠，以滿足希望為某些患者提供較小規格 ACTH 的醫生的需求。現在，我們即將完成 1 毫升預充式註射器的開發，提供更多好處，對吧？

Specifically, helping patients with the preparation and admission of the Cortrophin gel product. And as I said before, we plan to file for approval of the pre-filled syringe in the second half of 2024 and launch this in the first half of 2025.

具體來說，幫助患者準備和入院 Cortropin 凝膠產品。正如我之前所說，我們計劃在 2024 年下半年申請預充式註射器的批准，並在 2025 年上半年推出。

Then, going back to your question on guidance and what's driving the guidance increase. Look, overall, we've continued to see strong momentum across our rare disease and generics business lines. Both were a touch better than we had expected, and hence, we're raising the folio guidance. And established brands, royalties, and others were largely in line with our expectations.

然後，回到你關於指導的問題以及推動指導增加的因素。總體而言，我們的罕見疾病和仿製藥業務線繼續保持強勁勢頭。兩者都比我們預期的要好，因此，我們提高了對開本的指導。既定品牌、特許權使用費等基本上符合我們的預期。

Thank you, Jeremy.

謝謝你，傑瑞米。

Thank you.

謝謝。

Gary Nachman, Raymond James & Associates.

加里·納赫曼，雷蒙德·詹姆斯及其同事。

All right. Thanks. Good morning, guys, and nice quarter. So, regarding some of the key drivers of the strong Cortrophin growth, just elaborate how many new prescribers are you getting? Were you seeing that mostly in what therapeutic areas? And how much of the volume growth is share gain versus overall market growth?

好的。謝謝。早上好，夥計們，美好的季度。那麼，關於 Cortropin 強勁成長的一些關鍵驅動因素，請詳細說明您獲得了多少新處方者？您主要在哪些治療領域看到這種情況？與整體市場成長相比，份額成長佔銷售成長的比例有多少？

And you called out gouty flares and (inaudible) but those are still relatively small, right? So, which areas are driving most of the upside in absolute dollars? And how much upside potential is there with the gouty flares indication and the 1-ML vial that you were just talking about?

你也提到了痛風發作（聽不清楚），但這些仍然相對較小，對吧？那麼，以絕對美元計算，哪些領域推動了大部分上漲？您剛才談到的痛風發作指示和 1 毫升小瓶有多少上升潛力？

All right. Well, thank you for your questions, Gary. I will try and answer all of them. I think number one is on the overall ACTH category, and the question around, share growth versus category growth. Look and our competitor reported their results earlier this year, earlier today.

好的。好的，謝謝你的提問，加里。我會盡力回答所有問題。我認為第一是關於整個 ACTH 類別，以及圍繞份額增長與類別增長的問題。Look 和我們的競爭對手今年早些時候（今天早些時候）報告了他們的結果。

And what you'll see is, as we've been saying even in the prior quarters, that overall the number of patients that are being treated on with ACTH today are significantly lower than patients that were being treated many years ago. And with our efforts and the efforts of the competitor, you're seeing for the first time the category, after many years of decline, are seeing category growth. So, the decline slowed and now the category is seeing growth.

您將看到的是，正如我們在前幾個季度一直所說的那樣，今天接受 ACTH 治療的患者總體數量明顯低於多年前接受治療的患者數量。透過我們和競爭對手的努力，您將第一次看到該類別在經歷了多年的下滑之後，出現了成長。因此，下降速度放緩，現在該類別正在成長。

And in fact, if you add the revised guidance that they shared earlier today, and our raised guidance, we raised guidance, our competitor raised guidance, you'll see that what it implies for the ACTH category is a high teams growth.

事實上，如果你加入他們今天早些時候分享的修訂後的指導意見，以及我們提高的指導意見，我們提高的指導意見，我們的競爭對手提高的指導意見，你會發現這對ACTH 類別意味著團隊的高速成長。

And there is a significant runway for the category, right? So, again, we believe that the efforts of ourselves and the competitor will increase the awareness of the ACTH market or ACTH category and result in overall ACTH market growth. So, for us, it's not a share capture -- it's not about share capture, it's about getting ACTH to the appropriate patients in need. So, that was one of your questions.

該類別有一個重要的跑道，對吧？因此，我們再次相信，我們自己和競爭對手的努力將提高人們對 ACTH 市場或 ACTH 類別的認識，並導致整體 ACTH 市場的成長。因此，對我們來說，這不是份額捕獲——這不是份額捕獲，而是將 ACTH 提供給有需要的適當患者。所以，這是你的問題之一。

The next was, where did the growth come from? We saw growth across therapeutic areas, both the ones we focused on at launch, neurology, nephrology, and rheumatology, and the newer areas of ophthalmology, gout, and pulmonology. And I would highlight the, so, to your question on where did the majority of the growth, you know, on an absolute basis did come from the core indication that we launched with, which is neurology, nephrology, and rheumatology.

接下來是，成長從哪裡來？我們看到了各個治療領域的成長，包括我們在推出時重點關注的神經病學、腎臟病學和風濕病學，以及眼科、痛風和肺病學等新領域。我要強調的是，對於你的問題，你知道，大部分成長在絕對基礎上確實來自我們推出的核心適應症，即神經病學、腎臟病學和風濕病學。

Of course, as you're aware, the number of resources that we have out there talking about or detailing to these different specialties is lower than what we have for the newer indications. But, there is very strong growth, and I would highlight the particularly strong growth both on a quarter-on-quarter and year-over-year basis that we've seen in gout, which is proprietary to Cortrophin gel as the only ACTH product approved for this indication.

當然，如您所知，我們所擁有的討論或詳細介紹這些不同專業的資源數量少於我們針對新適應症所擁有的資源數量。但是，成長非常強勁，我想強調我們在痛風方面看到的環比和同比特別強勁的增長，痛風是 Cortropin 凝膠專有的唯一 ACTH 產品批准用於該適應症。

And then, in addition, our ophthalmology sales team is off to a very strong start and drove significant growth in prescriptions and new patient starts in the second quarter, right? And, obviously, we will build on that as we expand the ophthalmology franchise with the integration of the Alimera Sciences acquisition.

此外，我們的眼科銷售團隊有了一個非常強勁的開局，並推動了第二季度處方量和新患者數量的顯著增長，對嗎？顯然，我們將以此為基礎，透過收購 Alimera Sciences 來擴大眼科特許經營權。

And then your last question, I think, was around how much upside is there. I think, Gary, you're aware of how large the ACTH market was. Even when you add -- our raised guidance and the competitors' raised guidance, that's still, a touch over 50% of what peak sales of the category was a few years ago. So, yeah. Hopefully, I covered all your questions, Gary.

我認為你的最後一個問題是有多少上升空間。我想，加里，你知道 ACTH 市場有多大。即使加上我們提高的指導值和競爭對手提高的指導值，這仍然是幾年前該類別銷售額高峰的 50% 以上。所以，是的。希望我回答了你所有的問題，加里。

Most of it, just that last question, was really more on the gouty flare indication and the 1-ml vial and having that presentation. And I think in the prepared remarks, -- you just talked about how many of these patients are out there and how many could be candidates. And I'm also curious if that 1-ml vial could be used for other indications, not just the gouty flare, just having a smaller vial size.

其中大部分內容，即最後一個問題，實際上更多的是關於痛風發作指示和 1 毫升小瓶以及該演示。我認為在準備好的發言中，您剛才談到了這些患者中有多少人以及有多少人可能是候選人。我也很好奇這個 1 毫升的小瓶是否可以用於其他適應症，而不僅僅是痛風發作，只是有一個較小的小瓶尺寸。

Yeah. Thank you for your question. Look, the addition of the 1-ml vial has been additive. It has helped us to expand usage to ACPs who are new to prescribing Cortrophin. And their first experience with Cortrophinhas been, -- with the 1-ml vial. And the volume in the 1-ml vial has grown significantly quarter-over-quarter.

是的。謝謝你的提問。看，1毫升小瓶的添加已經是累加了。它幫助我們將使用範圍擴大到剛開始使用 Cortropin 處方的 ACP。他們第一次接觸 Cortropin 是使用 1 毫升小瓶。1 毫升小瓶中的體積較上季顯著成長。

And look, it just goes back to, our approach towards enhancing the convenience as well as addressing the pain points and needs of both the appropriate patients as well as the healthcare providers who treat them. So, the 1-ml vial was one step in that direction.

看，這又回到了我們提高便利性以及解決適當患者和治療他們的醫療保健提供者的痛點和需求的方法。因此，1 毫升小瓶是朝這個方向邁出的一步。

And now, as we, I was pleased to report earlier today, that we are nearing the completion of our prefilled syringe to help, appropriate patients. And that brings another option for enhancing the convenience and addressing the pain points of the patients as well as the healthcare providers who treat them.

現在，作為我們，我很高興今天早些時候報告，我們即將完成預充注射器的開發，以幫助合適的患者。這為提高便利性並解決患者以及治療他們的醫療保健提供者的痛點提供了另一種選擇。

Okay. That's helpful. And then just one more on Alimera. So, first, I just want to confirm that you're not factoring any benefit from the deal in the raised Cortrophin guidance for the ophthalmology segment. And then just talk about the planning for the close and integration. And are there any issues or hurdles you're expecting and anything that you need to build out beforehand just to make sure that you have a successful transition from day one? Thanks.

好的。這很有幫助。然後是 Alimera 的另一篇文章。因此，首先，我想確認一下，在眼科領域提高的 Cortropin 指導中，您並未考慮到該交易帶來的任何好處。然後就講一下緊密結合的規劃。是否有任何您預期的問題或障礙，以及您需要提前解決什麼問題，以確保您從第一天起就成功過渡？謝謝。

Yeah. Thank you. So, your first question, there is no benefit from increased Cortrophin sales from a expanded ophthalmology sales force baked into the guidance. As you know, we are yet to close the deal. So, this is for standalone ANI. And then your second question around integration planning, we're making very good progress on planning for the integration.

是的。謝謝。因此，你的第一個問題是，指南中納入的擴大眼科銷售隊伍所增加的 Cortropin 銷售並沒有帶來任何好處。如您所知，我們尚未完成交易。因此，這是針對獨立 ANI 的。然後是關於整合規劃的第二個問題，我們在整合規劃方面取得了非常好的進展。

First part of it is on working towards the close of the deal. And as I said, we look forward to closing the deal later this quarter. And then from a planning perspective, I think that we're making, again, good progress interacting appropriately with the Alimera leadership and team to understand what the organization systems and processes will look like after deal closure.

第一部分是努力完成交易。正如我所說，我們期待在本季晚些時候完成交易。然後從規劃的角度來看，我認為我們在與 Alimera 領導層和團隊適當互動方面取得了良好進展，以了解交易完成後組織系統和流程的情況。

And as you would expect, thinking about at the heart of this integration is the combined ophthalmology 45-plus sales team and how they are going to carry all 3D durable commercial assets that Chris spoke about. And so, thinking about how we will organize with them, what does the training program look like for the folks that have been selling ILUVIEN and YUTIQ, for them to sell Cortrophin and our team has been selling Cortrophin for them to sell ILUVIEN and YUTIQ.

正如您所期望的，這種整合的核心是考慮合併後的 45 名以上眼科銷售團隊，以及他們將如何承擔 Chris 談到的所有 3D 耐用商業資產。因此，考慮一下我們將如何與他們一起組織，對於那些一直在銷售ILUVIEN 和YUTIQ 的人來說，培訓計劃是什麼樣的，對於他們來說，他們是為了銷售Cortropin，而我們的團隊一直是為了他們銷售Cortropin 來銷售ILUVIEN 和YUTIQ。

And obviously, with the other sort of IC plan and other support that they need to be able in the hub distribution, all of those, integrating all of those, I think those are all the steps that we're working towards and we're making good progress in that area.

顯然，有了其他類型的 IC 計劃和他們需要在中心分佈中能夠提供的其他支持，所有這些，整合所有這些，我認為這些都是我們正在努力實現的步驟，我們正在並在該領域取得良好進展。

All right, great. Thanks, Nikhil.

好吧，太好了。謝謝，尼基爾。

Thank you, Gary.

謝謝你，加里。

Vimal Divan, Guggenheim Securities.

維馬爾·迪萬，古根漢證券。

Thanks for taking my question. So, maybe just a couple of things I just want to clarify here. One, on the Cortrophin side, you mentioned fourth quarter, you expect to be the largest quarter of the year. Again, I'm just curious, I assume you're expecting still sequential growth from 2Q to 3Q and then 3Q to 4Q, but if you could just confirm that, that'd be helpful.

感謝您提出我的問題。所以，也許我只想在這裡澄清幾件事。一，在 Cortropin 方面，您提到第四季度，您預計將是一年中最大的季度。再說一次，我只是很好奇，我假設您預計從第二季度到第三季度，然後從第三季度到第四季度仍然會出現連續增長，但如果您能證實這一點，那就會有所幫助。

And then on the established brand side, you mentioned the second quarter is sort of a good base to look at for the remainder of this year. I'm just curious if you can comment any further than that in terms of 2025. Is this sort of a nice sort of steady state or do you expect any sort of meaningful changes next year?

然後在成熟品牌方面，您提到第二季度是今年剩餘時間的一個良好基礎。我只是好奇你是否能就 2025 年發表更多評論。這是一種很好的穩定狀態嗎？

And then last question, just with Alimera, you mentioned now you have the Ex- US presence that they provide. I'm curious how you're thinking about that. Anything else for future business development priorities is expanding Ex-US, maybe turning into a little bit more of a focus given what Alimera provides you. Thank you.

最後一個問題，就 Alimera 而言，您提到現在您擁有他們提供的前美國業務。我很好奇你是怎麼想的。未來業務發展優先事項的任何其他事情都是擴大美國以外的地區，考慮到 Alimera 為您提供的服務，可能會成為更多的焦點。謝謝。

Thank you, Vimal, and good morning. So your question on Cortrophin, yes, we expect to see sequential growth and that the fourth quarter, as Steve mentioned in his prepared remarks, we do expect the fourth quarter to be the highest. Therefore, there will be sequential growth in 3Q and 4Q.

謝謝你，維馬爾，早安。所以你關於 Cortropin 的問題，是的，我們預計會看到連續增長，並且正如史蒂夫在他準備好的講話中提到的那樣，第四季度我們確實預計第四季度將是最高的。因此，第三季和第四季將會出現環比成長。

The second question was around, actually the third question was around the Ex-US Alimera business and what opportunities that gives us. But we're working through these and we will share updates as they're meaningful and as they develop. Nothing specific to report at this time. Obviously, we're currently focused on closing the deal, integrating the asset, the company, and continuing the great work that Nick and team have been doing. So that's on the Alimera Ex-US business and what opportunities that gives us.

第二個問題是，實際上第三個問題是關於美國以外的 Alimera 業務以及它為我們帶來了哪些機會。但我們正在解決這些問題，並且我們將分享有意義的更新以及它們的發展。目前沒有什麼具體可報告的內容。顯然，我們目前的重點是完成交易、整合資產、公司，並繼續尼克和團隊一直在做的偉大工作。這就是 Alimera 除美國以外的業務以及它給我們帶來的機會。

And then the third question on established brands -- On established brands, we are continuing. This is an important component of our portfolio of businesses in that it is low working capital, high gross margin, and strong cash flow generation part of the business. So we are working on a number of different things.

然後是關於知名品牌的第三個問題——關於知名品牌，我們正在繼續。這是我們業務組合的重要組成部分，因為它是低營運資本、高毛利率和強大的現金流生成業務的一部分。因此，我們正在做許多不同的事情。

Historically, as for established brands, we expand the portfolio by doing business development deals for established brands. We haven't done one since 2021 as we've found different pathways to growth, whether it's capturing the benefits of the supply tailwind or trying innovative commercial strategies.

從歷史上看，對於知名品牌，我們透過為知名品牌進行業務開發交易來擴大產品組合。自 2021 年以來，我們還沒有這樣做過，因為我們找到了不同的成長途徑，無論是抓住供應順風的好處還是嘗試創新的商業策略。

And so we'll deploy some combination of these three to work through the plans for established brands and we'll share more as we go along. But going back to your core question, the current portfolio, year on year, you'll see some marginal decline in them in the absence of one of these moves being made.

因此，我們將部署這三者的某種組合來完成知名品牌的計劃，並且我們將在進展過程中分享更多資訊。但回到你的核心問題，目前的投資組合，年復一年，如果沒有採取這些舉措，你會發現它們會出現一些邊際下降。

Thank you.

謝謝。

Oren Livnat, H.C. Wainwright & Co.

奧倫·利夫納特，H.C.溫賴特公司

Thanks. I have a few questions. I guess coincidentally this morning, along with your announcement of the prefilled syringe development work, Mallinckrodt also announced the availability of their single use prefilled auto injector. (technical difficulty)

謝謝。我有幾個問題。我想巧合的是，今天早上，在你們宣布預充式註射器開發工作的同時，Mallinckrodt 也宣布推出一次性預充式自動注射器。（技術難度）

Can you just tell us if you think that will have any material impact on the competitive ACTH landscape? Are there certain indications where patient self-administration and auto injector would be most relevant? And do you think that will have any different market access or coverage than the current relative coverage of your two products now? And I have a follow-up to that.

您能否告訴我們您認為這是否會對 ACTH 競爭格局產生任何實質影響？是否存在某些跡象表明患者自我給藥和自動注射器最相關？您認為這與您的兩種產品目前的相對覆蓋範圍相比，會有什麼不同的市場准入或覆蓋範圍嗎？我對此有後續行動。

Sure. Good morning, Oren, and thank you for your question. Look, the competitor's device, from what we can tell, is aimed at -- the competitor's efforts as well as ANI's efforts are aimed at enhancing the convenience and addressing pain points that a subset of patients have.

當然。早安，奧倫，謝謝你的問題。看，據我們所知，競爭對手的設備的目標是——競爭對手的努力以及 ANI 的努力都旨在提高便利性並解決部分患者的痛點。

So, for example, our prefilled syringe is used to address, patients that have -- that can be helpful for patients in preparing and administering the Cortrophin gel product, right -- in a one mL prefilled syringe. And I think the way I would think about it is both the competitor and us are working, are investing to increase the awareness and bring new options to patients and, therefore, increase awareness of the category and drive growth in the category, right?

例如，我們的預充式註射器用於解決那些擁有 1 mL 預充式註射器的患者，這有助於患者準備和施用 Cortropin 凝膠產品，對吧。我認為我的想法是競爭對手和我們都在努力、投資以提高意識並為患者帶來新的選擇，從而提高對該類別的認識並推動該類別的成長，對嗎？

We lost the 1- mL vial, which was also appreciated by, as I mentioned earlier, by healthcare providers, some of whom, initiated their, who were naive to ACTH and initiated their usage of ACTH by trying with the 1-mL vial.

我們丟失了 1 毫升小瓶，正如我之前提到的，醫療保健提供者也對此表示讚賞，其中一些人對 ACTH 很幼稚，並通過嘗試使用 1 毫升小瓶開始使用 ACTH。

So, again different options for patients as well as the healthcare providers who treat them. And, again, reiterate that, overall, this is great for the category given that there is a significant runway for the ACTH category with the number of patients being treated today being significantly lower than the number of patients being treated many years ago.

因此，患者以及治療他們的醫療保健提供者再次有不同的選擇。再次重申，總體而言，這對該類別來說是很好的，因為 ACTH 類別有一個重要的跑道，今天接受治療的患者人數明顯低於多年前接受治療的患者人數。

And I appreciate, different strokes, different folks on products and needs across the landscape. I'm just curious if you think, I don't know what dose their autoinjector is for, if it's adjustable. You know, do you think there are any particular areas where that will have any impact or do you think it's just that is, she goes with your growth trajectory?

我欣賞不同的風格、不同的人對產品和需求的看法。我只是好奇你是否認為，我不知道他們的自動注射器的劑量是多少（如果可以調節的話）。你知道，你認為這會在某些特定領域產生影響嗎？

Yeah, I think that -- that there are probably a subset of indications where a 1-mL or 0.5-mL dose may be more convenient, right, to have than taking a 5-mL vial. And it is with this understanding itself that we -- we invested to bring the 1-mL vial many months ago, right, and now are going to bring a pre-filled syringe. And, you would expect that the options from a dosing perspective that you can expect that that will not create sort of meaningful differentiation between the two -- between the two for now.

是的，我認為，在某些適應症中，1 毫升或 0.5 毫升的劑量可能比服用 5 毫升的小瓶更方便，對吧。正是基於這種理解，我們在幾個月前投資了 1 毫升的小瓶，現在準備購買預裝注射器。而且，您會期望從劑量角度來看，您可以期望的選項不會在兩者之間（目前兩者之間）產生某種有意義的差異。

Okay. And regarding Alimera, I know it hasn't closed yet, so I guess feel free to say no comments. But since you're clearly in the planning stages -- can you give us any color on potential synergies there? Maybe what sort of EBITDA margins you hope the business can contribute versus what I guess they are just reporting now.

好的。至於 Alimera，我知道它還沒有關閉，所以我想請不要發表評論。但既然你們顯然處於規劃階段，你能為我們介紹一下潛在的綜效嗎？也許你希望公司能夠貢獻什麼樣的 EBITDA 利潤率，而不是我猜他們現在剛剛報告的利潤率。

And I guess another question I have is you talk about these as rare disease. Obviously, DME is a much larger indication, but you're targeting a niche of it, and NIU is rare disease. Is there any opportunity to revisit pricing of these products? It seems to me that, the value is quite high there, and particularly in an orphan indication and the differentiation of the product. It's not super expensive in my view. Do you have freedom to make changes there, or are you limited in the IRA framework?

我想我的另一個問題是你將這些稱為罕見疾病。顯然，DME 是一個更大的適應症，但你的目標是它的一個利基市場，而 NIU 是一種罕見疾病。是否有機會重新檢視這些產品的定價？在我看來，那裡的價值相當高，特別是在孤兒適應症和產品的差異化方面。在我看來，這並不是非常昂貴。您可以自由地進行更改，還是受到 IRA 框架的限制？

Yeah, thank you for your questions, Oren. I think that the sort of financial outlook for the deal remains what we shared at when we announced the deal, in that from a synergies perspective, like we had announced in 2025, we expect to see about $10 million worth of synergies. And as we're doing the integration plan, we're seeing a runway into that. Or I guess there's no information that suggests that we couldn't capture that.

是的，謝謝你的提問，奧倫。我認為該交易的財務前景仍然是我們宣布該交易時所分享的，因為從協同效應的角度來看，就像我們在2025 年宣布的那樣，我們預計將看到價值約1000 萬美元的協同效應。當我們制定整合計劃時，我們看到了一條通往這一目標的道路。或者我想沒有任何資訊表明我們無法捕捉到這一點。

And then, again, from an EBITDA addition, we also gave guidance on how much adjusted EBITDA we expect to add. Steve, you can jump in, but I think it was in the $30 million plus range that we talked about. You can help me with that, Steve.

然後，從 EBITDA 的增加來看，我們也為我們預計增加多少調整後的 EBITDA 提供了指導。史蒂夫，你可以插話，但我認為它在我們討論過的 3000 萬美元以上的範圍內。你可以幫我，史蒂夫。

So that's in terms of EBITDA addition in pro forma in 2025. And that obviously is net of any additional corporate sales and revenue synergies. It's just the additional EBITDA that we would get from the Alimera acquisition.

這就是預計 2025 年 EBITDA 的增加。這顯然不包括任何額外的企業銷售和收入協同效應。這只是我們從 Alimera 收購中獲得的額外 EBITDA。

And then the third part regarding pricing, again, we try to strike a balance between sharing information that is helpful as well as competitively sensitive. And we're in the integration planning stage, so it allows us to come back to you with further information on that topic.

然後是關於定價的第三部分，我們再次嘗試在共享有用資訊和競爭敏感資訊之間取得平衡。我們正處於整合規劃階段，因此我們可以向您提供有關該主題的更多資訊。

Steve, could you just answer Oren's clarification regarding what we had said about additional EBITDA in 2025?

Steve，您能回答一下 Oren 關於我們所說的 2025 年額外 EBITDA 的澄清嗎？

Yeah, good morning, Oren. Yeah, and I think importantly, I would note in terms of our gross margin profile, right, it's going to be accretive to our gross margin. The Alimera products are in the low 80%. And in terms of EBITDA, you know, we would expect in the mid-30s as Nickhil mentioned.

是的，早安，奧倫。是的，我認為重要的是，我會注意到我們的毛利率狀況，對，這將增加我們的毛利率。Alimera 產品處於 80% 的低水平。就 EBITDA 而言，正如 Nickhil 所提到的，我們預計會在 30 多歲左右。

Okay. And just lastly, I noticed in your GAAP SG&A, you had some litigation expense in there. And I'm just wondering if you're able to give us any color. Is that just on the disclosed CG oncology dispute that we've known about? Or is there potential Paragraph IV or [505B2] IP-related stuff there? And I guess I should be hoping to hear any news on the 505B2 front in the foreseeable future.

好的。最後，我注意到在你們的 GAAP SG&A 中，你們有一些訴訟費用。我只是想知道你是否能給我們任何顏色。這只是我們所知道的 CG 腫瘤學爭議的揭露嗎？或者那裡是否存在潛在的第四段或 [505B2] IP 相關內容？我想我應該希望在可預見的將來聽到有關 505B2 的任何消息。

Thank you. Yeah. I mean, in terms of the incremental litigation, as you would expect, we're vigorously pursuing the defense of our rights in CG oncology. And so that is an element in terms of the increased spend that we have in litigation year-over-year on a GAAP basis. I think that's the only one that we would highlight today to you. And then what was the second part of your question? I'm sorry.

謝謝。是的。我的意思是，就增量訴訟而言，正如您所期望的那樣，我們正在積極捍衛我們在 CG 腫瘤學領域的權利。因此，根據公認會計準則計算，這是我們訴訟支出逐年增加的因素。我認為這是我們今天要向您強調的唯一一個。那你問題的第二部分是什麼？對不起。

(multiple speakers) I can take that. Yeah. So, Oren, on the 505B2s, we will share more when we have meaningful updates to give. But there's no linkage between the litigation spend and the launch of 505B2 products. But we will share updates on that when there are material.

（多個發言者）我可以接受。是的。因此，Oren，關於 505B2，當我們提供有意義的更新時，我們將分享更多資訊。但訴訟支出與 505B2 產品的推出之間沒有關聯。但當有材料時，我們將分享這方面的最新資訊。

All right. Thanks so much. Congrats on another upside quarter.

好的。非常感謝。恭喜又一個季度上漲。

Thank you, Oren.

謝謝你，奧倫。

Tim Chiang, Capital One.

蔣添明，第一資本。

Thanks. It seems like your generic segment revenues are actually exceeding your original targets. Can you just sort of comment on where you see expectations for growth from the generic segment in the back half of the year? Obviously, you've increased your guidance for rare disease and your total revenues. But so how do you sort of see your generic segment playing out in the back half?

謝謝。看來您的通用部門收入實際上超出了您最初的目標。您能否簡單評論一下您對下半年仿製藥市場成長的預期？顯然，您增加了對罕見疾病的指導和總收入。但是你如何看待你的通用部分在後半段的表現呢？

Yeah. Good morning, and thank you for your questions, Tim. For our generic business, the performance is really coming on the back of three things, right? Number one is our new product, the cadence of new product launches, right? We launched, as we talked about, four new products in the second quarter, two new already in the third quarter, so about 12 since the start of the year.

是的。早安，謝謝你的提問，提姆。對於我們的通用業務來說，業績確實取決於三件事，對嗎？第一個是我們的新產品，新產品發布的節奏，對吧？正如我們所說，我們在第二季推出了四種新產品，第三季已經推出了兩種新產品，所以自今年年初以來大約有 12 種新產品。

That combined with our operational excellence and being a reliable supplier with strong GMP status and US based manufacturing enables us to deliver, as we had shared before, on a full-year basis, high single-digit to low double-digit growth. And then you can expect towards your question, I think, sequential growth as we move to the subsequent quarters in 2025.

結合我們的卓越營運以及作為一家擁有強大 GMP 地位和美國製造的可靠供應商，我們能夠實現全年高個位數到低兩位數的增長，正如我們之前分享的那樣。然後，我認為，隨著我們進入 2025 年的後續季度，您可以期待您的問題持續成長。

And maybe just to follow up, I mean, you started this new facility in New Jersey. How much capacity are you actually going to be able to increase with that new facility?

我的意思是，也許只是為了跟進，您在新澤西州開設了這個新設施。新設施實際上能夠增加多少容量？

Yeah. We are adding about 15 new manufacturing suites and a new QC lab, so that's a substantial increase in capacity. We've also upgraded the equipment and added higher batch size equipment in there. So I don't have a specific percentage, but it's a meaningful addition to the volume that we can service out of the New Jersey site, and it will serve the growth of our genetics business for multiple years.

是的。我們將增加約 15 個新的製造套件和一個新的 QC 實驗室，因此產能將大幅增加。我們還升級了設備並在那裡添加了更大批量的設備。所以我沒有具體的百分比，但這是對我們在新澤西站點之外的服務量的有意義的補充，它將服務於我們遺傳學業務的多年增長。

Okay, great. Nice quarter. Thanks.

好的，太好了。不錯的季度。謝謝。

Thank you, Tim.

謝謝你，提姆。

Thank you. It appears we have no further questions at this time. And I'll turn the program back over to Nikhil Lalwani for closing remarks.

謝謝。目前看來我們沒有其他問題了。我將把節目交回尼基爾·拉爾瓦尼 (Nikhil Lalwani) 作閉幕致辭。

Thank you again for your interest in ANI and for joining our call this morning. We really appreciate it, and we look forward to updating you on our progress as we move forward. Thank you.

再次感謝您對 ANI 的興趣並參加我們今天早上的電話會議。我們非常感謝，並期待向您通報我們前進的最新進展。謝謝。

Thank you, ladies and gentlemen. This concludes today's event. You may now disconnect.

謝謝你們，女士們、先生們。今天的活動到此結束。您現在可以斷開連線。