Amphastar Pharmaceuticals Inc (AMPH) 2025 Q4 法說會逐字稿

Greetings and welcome to the Amphastar Pharmaceuticals fourth quarter earnings call. (Operator instructions)These statements are based solely on information that is now available to us. We encourage you to review the session entitled forward-looking Statements in the Press Release issued today and the Presentation on the company's website. Also, please refer to our SEC filings, which can be found on our website and the SEC's website for a discussion of numerous factors that may impact our future performance. We will also discuss certain non-GAAP measures.

各位來賓，歡迎參加安普斯塔製藥公司第四季財報電話會議。（操作說明）這些聲明僅基於我們目前掌握的資訊。我們建議您查看今天發布的新聞稿中題為「前瞻性聲明」的部分以及公司網站上的簡報。此外，請參閱我們向美國證券交易委員會提交的文件，這些文件可以在我們的網站和美國證券交易委員會的網站上找到，其中討論了可能影響我們未來業績的許多因素。我們也將討論一些非GAAP指標。

Important information on our use of these measures and reconciliations to US GAAP may be found in our earnings release. Please note this conference is being recorded. Our speakers today are Mr. Bill Peters, CFO, Mr. Dan Disner, senior Vice President of Corporate communications, and Mr. Tony Marrs, executive Vice President of Regulatory Affairs and Clinical Operations. I will now turn the conference over to your host, Mr. Dan Dischner, Senior Vice President of Corporate communications. Dan, you may begin.

有關我們使用這些指標以及與美國通用會計準則的調節的重要信息，請參閱我們的盈利報告。請注意，本次會議正在錄影。今天的演講嘉賓有：財務長比爾·彼得斯先生、企業傳播高級副總裁丹·迪斯納先生以及監管事務和臨床營運執行副總裁托尼·馬爾斯先生。現在我將把會議交給主持人，企業傳播資深副總裁丹‧迪施納先生。丹，你可以開始了。

Thank you, Paul. Good afternoon, everyone, and thank you for joining Amphastar’s fourth quarter 2025 earnings call. 2025 was a pivotal year for the company, demonstrating the strength and balance of our business model with our continued focus on both commercial execution and scientific innovation.

謝謝你，保羅。各位下午好，感謝各位參加安普斯塔公司2025年第四季財報電話會議。 2025年是公司發展歷程中的關鍵一年，充分展現了我們業務模式的實力和平衡性，我們持續專注於商業執行和科學創新。

BAQSIMI maintained its strong double-digit growth trajectory, reinforcing the durability of our franchise and continued execution, while FDA approvals for iron sucrose and teriparatide highlighted our technical depth in complex generics. And just this week we achieved another major regulatory milestone with the FDA approval of our Ipratropium Bromide HFA Inhalation Aerosol.

BAQSIMI 保持了強勁的兩位數成長勢頭，鞏固了我們特許經營權的持久性和持續執行力，同時 FDA 對蔗糖鐵和特立帕肽的批准突顯了我們在複雜仿製藥方面的技術深度。就在本週，我們的異丙托溴銨 HFA 吸入氣霧劑獲得了 FDA 的批准，我們又取得了一個重要的監管里程碑。

Previously referenced as AMP-007, the FDA also confirmed that this product is eligible for 180 days of generic drug exclusivity as we were the first ANDA applicant with paragraph IV certification. This approval reinforces the strength of our integrated R&D and manufacturing model and represents a meaningful addition to our respiratory portfolio. We expect to launch this product commercially early in the second quarter of 2026, positioning it as a significant near-term growth driver.

該產品之前被稱為 AMP-007，FDA 也確認該產品有資格獲得 180 天的仿製藥獨佔權，因為我們是第一個獲得 IV 段認證的 ANDA 申請人。此次獲批鞏固了我們一體化研發和生產模式的優勢，並為我們的呼吸系統產品組合增添了重要內容。我們預計將於 2026 年第二季初正式推出該產品，使其成為近期重要的成長動力。

Across the pipeline, we advanced and expanded our proprietary portfolio with the addition of 3 novel peptides in oncology and ophthalmology, and a fully synthetic corticotropin program in immunology. These additions support our transition towards a portfolio increasingly anchored in high value proprietary and biosimilar assets.

在整個研發管線中，我們透過在腫瘤學和眼科學領域新增 3 種新型勝肽，以及在免疫學領域開展全合成促皮質素項目，推進並擴展了我們的專有產品組合。這些新增資產有助於我們轉型為高價值專有資產和生物類似藥資產為主的投資組合。

On the commercial side, we remain attentive to the competitive pressures in certain legacy products and continue to prioritize resources towards our strongest growth opportunities.

在商業方面，我們始終關注某些傳統產品的競爭壓力，並繼續優先將資源投入我們最強勁的成長機會。

Our performance this year was driven by three core pillars resilient commercial momentum, strategic pipeline progress, and disciplined operational execution supported throughout our US-based manufacturing advantage. For the full year, net revenues were $719.9 million. BAQSIMI remained a key contributor, generating $185.4 million in revenue, up 12% year over year. Driven by higher US unit volumes and the successful transition to direct global distribution, Primatene Mist also performed well, with sales rising 7% to $108.7 million, supported by strong consumer demand and continued marketing investment.

今年我們的業績主要得益於三大核心支柱：強勁的商業勢頭、戰略性產品線的推進以及嚴謹的運營執行，而這一切都得益於我們在美國本土的製造優勢。全年淨收入為 7.199 億美元。BAQSIMI 仍然是主要貢獻者，創造了 1.854 億美元的收入，年增 12%。在美國銷售成長和成功過渡到直接全球分銷的推動下，Primatene Mist 也表現出色，銷售額增長 7% 至 1.087 億美元，這得益於強勁的消費者需求和持續的營銷投入。

We saw additional contributions from newer and expanding products, including $4.4 million from iron sucrose following its August launch. And a strong growth in albuterol driven by market demand. These gains helped offset competitive pressures in epinephrine and glucagon. Full year revenue declined modestly by 2%, reflecting greater than expected headwinds in legacy products. Even so, we maintained strong operational discipline, tightening expenses, prioritizing long-term investments, and mitigating margin pressures in areas facing pricing challenges.

我們看到來自新興和不斷擴大的產品的額外貢獻，包括蔗糖鐵在 8 月推出後帶來的 440 萬美元收入。受市場需求驅動，沙丁胺醇銷量強勁成長。這些收益有助於抵消腎上腺素和胰高血糖素的競爭壓力。全年營收小幅下降 2%，反映出傳統產品面臨的不利影響超出預期。即便如此，我們仍然保持了嚴格的營運紀律，控制支出，優先考慮長期投資，並緩解面臨定價挑戰領域的利潤壓力。

Operating cash flow totalled $156.1 million demonstrating the resilience of our model and our ability to continue investing in strategic priorities. On the pipeline side, we achieved several major regulatory milestones with approvals for iron sucrose, teriparatide, and most recently Ipratropium bromide HFA. These achievements broadened our capabilities across complex injectables and inhalation products. We also expanded our proprietary pipeline with high-value assets including AMP 105, AMP 109, AMP 110, and AMP 107, programs that collectively open more than $60 billion in addressable market opportunity and strengthen the long-term foundation of our portfolio.

經營現金流總計 1.561 億美元，證明了我們模式的韌性以及我們繼續投資於策略重點的能力。在研發方面，我們取得了幾個重要的監管里程碑，包括蔗糖鐵、特立帕肽以及最近的異丙托溴銨HFA的批准。這些成就拓寬了我們在複雜注射劑和吸入劑產品方面的能力。我們也擴大了我們專有的產品線，新增了高價值資產，包括 AMP 105、AMP 109、AMP 110 和 AMP 107，這些項目合計創造了超過 600 億美元的潛在市場機會，並加強了我們投資組合的長期基礎。

We also continue to advance several high impact programs that remain on track for near term launches. Our insulin aspart BLA for AMP 004 and our GLP 1 ANDA for AMP 018 are moving steadily through regulatory proceedings with anticipated commercialization for each expected in 2027. Together these programs represent meaningful near and mid-term value drivers as we expand our presence across complex formulations and high demand therapeutics.

我們也持續推動幾個具有重大影響力的項目，這些項目仍按計劃在近期內啟動。我們的胰島素門冬生物製品許可申請 (BLA) 針對 AMP 004，我們的 GLP-1 簡略新藥申請 (ANDA) 針對 AMP 018，正在穩步推進監管程序，預計均將於 2027 年實現商業化。隨著我們在複雜製劑和高需求療法領域擴大業務，這些項目共同代表了近期和中期重要的價值驅動因素。

To support this expanding pipeline, our US manufacturing investment in Rancho Cucamonga remains a critical pillar of our long-term strategy. The expansion will quadruple production capacity at the site, significantly enhancing scalability and improving supply reliability.

為了支持這條不斷擴大的生產線，我們在蘭喬庫卡蒙加的美國製造投資仍然是我們長期策略的關鍵支柱。此次擴建將使該廠的產能翻兩番，顯著提高產能可擴展性並改善供應可靠性。

The upgraded footprint positions us to meet future demand as our proprietary programs and complex generics advance towards commercialization, ensuring we can execute with the speed and consistency required in these high growth markets. I will now turn the call over to Bill Peters, our CFO and executive Vice President of finance, for more detailed financial review of the fourth quarter and full year.

升級後的佈局使我們能夠滿足未來的需求，隨著我們的專有項目和複雜的仿製藥逐步走向商業化，確保我們能夠以這些高成長市場所需的速度和一致性執行。現在我將把電話交給我們的財務長兼財務執行副總裁比爾彼得斯，讓他對第四季和全年的財務狀況進行更詳細的回顧。

Thank you, Dan. And good afternoon, everyone. In my comments today, I will discuss the 4th quarter results and then our assumptions for 2026. Sales for the fourth quarter of 2025 decreased 2% to $183.1 million from $186.5 million in the previous year's period. BAQSIMI sales grew 12% to $46.7 million from $41.8 million in the prior year period as we continue our sales and marketing efforts in the United States.

謝謝你，丹。大家下午好。今天，我將討論第四季業績，以及我們對 2026 年的假設。2025 年第四季銷售額較上年同期下降 2%，至 1.831 億美元，而去年同期為 1.865 億美元。由於我們繼續在美國進行銷售和行銷活動，BAQSIMI 的銷售額從去年同期的 4,180 萬美元成長了 12%，達到 4,670 萬美元。

Primatene MIST sales dropped 3% to $27.9 million from $28.9 million in the prior year period. Glucagon sales declined 45% to $14.1 million from $25.6 million in the prior year period due to increased competition as well as a market move toward ready to use products such as vaccine. Epinephrine sales declined 9% to $17.1 million from $18.7 million in the previous period due to increased competition for epinephrine multi-dose vial products.

Primatene MIST 的銷售額較上年同期下降 3%，從 2,890 萬美元降至 2,790 萬美元。由於競爭加劇以及市場轉向疫苗等即用型產品，胰高血糖素的銷售額從去年同期的 2,560 萬美元下降了 45%，至 1,410 萬美元。由於腎上腺素多劑量小瓶產品的競爭加劇，腎上腺素銷售額從上一時期的 1,870 萬美元下降了 9%，至 1,710 萬美元。

This decrease was partially offset by an increase in unit volumes for our epinephrine prefilled syringe, driven by increased demand caused by shortages from other suppliers during the quarter. Other pharmaceutical product revenue grew 8% to $62.4 million from $57.5 million in the previous year's period, primarily due to increased sales of albuterol and iron sucrose, which we launched in August 2024 and August 2025 respectively.

由於本季度其他供應商的短缺導致需求增加，我們的腎上腺素預充式註射器的銷量有所增長，部分抵消了這一下降。其他藥品收入成長 8%，從去年同期的 5,750 萬美元增至 6,240 萬美元，主要原因是沙丁胺醇和蔗糖鐵的銷售量增加，我們分別於 2024 年 8 月和 2025 年 8 月推出了這兩種產品。

Gross margins remained flat at 47% of revenues as we saw increased sales of BAQSIMI and iron sucrose. This is offset by a decrease in pricing of glucagon and our epinephrine multidose vial products.

由於 BAQSIMI 和蔗糖鐵的銷量增加，毛利率保持在收入的 47% 不變。胰高血糖素和腎上腺素多劑量小瓶產品的價格下降抵消了這種影響。

Selling, distribution, and marketing expenses were essentially unchanged at $10.3 million in the fourth quarter of 2025 compared to $10.4 million in the previous year's period.

2025 年第四季的銷售、分銷和行銷費用基本上保持不變，為 1,030 萬美元，而去年同期為 1,040 萬美元。

General and administrative expenses increased 27% to $16.5 million compared to $12.9 million in the prior year, primarily due to increased legal expenses and expenses related to the implementation of a new ERP system. Research and development expenditures increased 29% in the quarter to $23.3 million from $18.1 million in the comparable quarter of 2024, primarily due to increased spending on our insulin and proprietary pipeline.

一般及行政費用較上年同期增加 27%，達到 1,650 萬美元，而去年同期為 1,290 萬美元，主要原因是法律費用增加以及與實施新的 ERP 系統相關的費用增加。本季研發支出成長了 29%，從 2024 年同期的 1,810 萬美元增至 2,330 萬美元，主要原因是我們在胰島素和專有產品管線方面的支出增加。

Non-operating expenses in the fourth quarter of 2025 were $3.7 million compared to $1.2 million in the prior year period, primarily as a result of foreign currency fluctuations, mark to market adjustments related to our interest rate swap contracts.

2025 年第四季非經營性支出為 370 萬美元，而去年同期為 120 萬美元，主要原因是外匯波動以及與利率互換合約相關的市值調整。

We reported net income of $24.4 million or $0.51 per share, compared to the previous year's fourth quarter net income of $38 million or $0.74 per share. Adjusted net income was $34.2 million or $0.73 per share, compared to an adjusted net income of $47.2 million or $0.92 per share in the fourth quarter of the previous year.

我們公佈的淨收入為 2,440 萬美元，即每股 0.51 美元，而去年同期的淨收入為 3,800 萬美元，即每股 0.74 美元。經調整後的淨利潤為 3,420 萬美元，即每股 0.73 美元，而去年同期經調整後的淨利潤為 4,720 萬美元，即每股 0.92 美元。

Adjusted earnings exclude amortization, equity compensation, and onetime events. In the fourth quarter we had cash flows provided by operations of approximately $32.9 million for the full year cash flow from operations.

調整後收益不包括攤銷、股權激勵和一次性事件。第四季度，我們經營活動產生的現金流約為 3,290 萬美元，與全年經營活動產生的現金流相比，約 3,290 萬美元。

For $156.1 million. As we look ahead to 2026, we are basing our outlook on several key financial assumptions. For vaccine, we expect mid-single-digit unit growth in the US, partially offset by a planned reduction in international volume as we exit a handful of unprofitable markets later in the year. We do not expect to take any price increases in 2026, as our primary focus is on unit growth.

1.561億美元。展望 2026 年，我們的展望是基於幾個關鍵的財務假設。對於疫苗，我們預計美國市場將實現個位數中段的銷售成長，但隨著我們在今年稍後退出一些無利可圖的市場，國際銷售計劃減少，這將部分抵消疫苗銷售的成長。我們預計 2026 年不會漲價，因為我們的主要重點是銷售成長。

For Primatene mists, we expect unit growth in the mid to high single-digits this year, and we don't plan, and we plan to take a 5% increase in price in the second quarter. We expect the largest driver of growth will be the launch of ipratropium bromide with a planned launch in early the second quarter. Our 3rd meter dose inhalation product is poised to be a meaningful contributor as sales ramp up.

對於 Primatene 噴霧劑，我們預計今年的銷售量將達到個位數中高段，我們不打算在第二季將價格提高 5%。我們預計最大的成長動力將是異丙托溴銨的上市，並計劃於第二季初上市。隨著銷售額的成長，我們的第三款米劑量吸入產品有望做出重要貢獻。

We also expect increased contributions from 3rd party API sales from our AP subsidiary. Offsetting these growth trends will be expected sales declines due to increased competition for glucagon and to a lesser extent epinephrine and tad. Overall, we expect these dynamics to drive consolidated revenue growth in the mid to high single-digit range for 2026.

我們也預期來自AP子公司的第三方API銷售額將有所成長。抵銷這些成長趨勢的是，由於胰高血糖素的競爭加劇，以及在較小程度上腎上腺素和Tad的競爭加劇，預計銷售額將下降。整體而言，我們預期這些因素將推動 2026 年合併收入實現中高個位數成長。

We expect gross margins to be lower, primarily driven by continued pricing pressure on glucagon, epinephrine and phytonadione, which are high margin products.

我們預期毛利率將會下降，主要原因是胰高血糖素、腎上腺素和維生素K1（一種高利潤產品）的價格持續承壓。

In addition, we are seeing higher input costs, including labour and supplier related increases, which will further impact margins.

此外，我們看到投入成本上升，包括勞動成本和供應商相關成本的增加，這將進一步影響利潤率。

Our selling and marketing expense will increase slightly the percentage of sales if you increase sales and marketing efforts for both BAQSIMI and Primatene MIST.

如果您增加對 BAQSIMI 和 Primatene MIST 的銷售和行銷力度，我們的銷售和行銷費用將略微增加銷售額的百分比。

General administrative spending will be flattened up as a percentage of sales to the one time of spending associated with the implementation of our new ERP system. Turning to research and development, we plan to ramp up spending on clinical trials and purchases of materials and supplies for inhalation and proprietary pipeline products.

一般行政支出佔銷售額的比例將調整為與實施新ERP系統相關的一次性支出。在研發方面，我們計劃增加對臨床試驗和吸入劑及專有在研產品所需的材料和用品的採購投入。

We also anticipate a significant increase in capital spending from the expansion project at our Rancho Cucamonga facility which we announced last year. Spending on this major project is slower than we anticipated in 2025, but we ramp up more significantly in 2026. We plan to finance this expansion of cash flow from operations.

我們也預計，去年宣布的蘭喬庫卡蒙加工廠擴建工程將大幅增加資本支出。2025 年，這項重大項目的支出速度比我們預期的要慢，但我們將在 2026 年大幅提高支出。我們計劃透過增加經營活動產生的現金流來為此次擴張提供資金。

As of today we have over $300 million in cash and short-term investments on our hands, and we plan to utilize a portion of our strong cash position to continue our stock buyback program. Additionally, we continue to look for business development opportunities which fit Amphastar's strategy. I will now turn the call back over to Dan

截至目前，我們手頭上擁有超過 3 億美元的現金和短期投資，我們計劃利用我們充裕的現金儲備的一部分來繼續我們的股票回購計劃。此外，我們將繼續尋找符合安普斯塔策略的業務發展機會。現在我將把通話轉回給丹。

Thank you, Bill.

謝謝你，比爾。

In summary, 2025 was a year of meaningful progress and disciplined execution. We strengthened our commercial foundation with resilient performance from BAQSIMI and Primatene MIST, advanced our regulatory pipeline with FDA approvals of iron sucrose, teriparatide, and most recently Ipratropium Bromide HFA inhalation aerosol. And made significant progress across our AMP 004 and AMP 018 near term commercial product candidates.

總而言之，2025 年是取得實質進展和嚴格執行的一年。我們憑藉 BAQSIMI 和 Primatene MIST 的穩健表現，鞏固了我們的商業基礎；透過 FDA 批准蔗糖鐵、特立帕肽以及最近批准的異丙托溴銨 HFA 吸入氣霧劑，推進了我們的監管研發管線。我們在 AMP 004 和 AMP 018 近期商業化候選產品方面取得了重大進展。

We also expanded our proprietary pipeline portfolio into high growth therapeutic areas through the addition of novel product candidates in oncology, ophthalmology, and immunology. These achievements reinforced the depth of our scientific capabilities, the strategic value of our US manufacturing footprint. And our commitment to delivering high-quality therapies that improve patient access and outcomes. The momentum we've built positioned campusar for significant long-term value creation through focused execution, innovation, and a robust pipeline designed to support sustainable growth. With that, we'll take your questions, Paul.

我們也透過在腫瘤學、眼科學和免疫學領域新增新型候選產品，將我們專有的產品線組合擴展到了高成長的治療領域。這些成就鞏固了我們的科學研究實力，以及我們在美國製造業佈局的戰略價值。我們致力於提供高品質的治療方案，以改善患者的就醫途徑和治療效果。我們已經建立起的勢頭，使 campusar 能夠透過專注的執行、創新和強大的產品線（旨在支持永續成長）創造重大的長期價值。那麼，接下來我們將回答你的問題，保羅。

(Operator Instruction)

（操作說明）

Ekaterina Knyazkova, JP Morgan.

葉卡捷琳娜·克尼亞茲科娃，摩根大通。

Thank you so much. So first question is just on AMP 110, the corticotrophin asset. Just have you had any conversations with the FDA on just what the development path could look like and if there's anything you can share on that would be helpful. And then the second question is just on business development, just latest thoughts on appetite and priorities, just what kind of assets are you most interested in and how big of a priority is BD for you guys, in, 2026.

太感謝了。所以第一個問題是關於 AMP 110，也就是促腎上腺皮質激素。您是否與FDA就研發路徑進行過任何溝通？如果您能分享一些相關信息，那就太好了。第二個問題是關於業務發展，關於你們的最新需求和優先事項，你們最感興趣的資產類型是什麼，以及在 2026 年，業務發展對你們來說有多重要。

Thank you.

謝謝。

Thank you. I'll take the first question for 110. We have not engaged the FDA with conversation on that. We're internally still having the discussion and putting our program on paper. We'll be doing that in the relative near future.

謝謝。我來回答第一個問題，答案是110。我們尚未就此事與美國食品藥物管理局（FDA）進行溝通。我們內部仍在進行討論，並將我們的方案落實到紙面上。我們將在不久的將來這樣做。

And the second one for business development, our focus will be on areas where we either have a presence or a planned presence, and that would include endocrinology because we're a vaccine, products and also, the oncology, ophthalmology, and immunology spaces in terms of the areas where we have, early stage proprietary pipeline products.

第二個面向是商業拓展，我們將重點放在我們已經涉足或計劃涉足的領域，包括內分泌學（因為我們是疫苗產品生產商），以及腫瘤學、眼科學和免疫學領域（因為我們在這些領域擁有早期專有研發管線產品）。

Thank you.

謝謝。

Serge Bellinger Needham and Company.

Serge Bellinger Needham and Company。

Hi, good afternoon. First question, around back seeing expectations for 2026. Bill, I think you mentioned, you expect mid-single-digit growth on units, but to be offset by some discontinuation of international sales. Just curious what the level of those international sales are and what that means if you expect growth from the franchise at all for the year. And then the second question around AMP 007.

您好，下午好。第一個問題，回顧一下對 2026 年的預期。比爾，我想你提到過，你預計銷量將實現個位數中段的成長，但國際銷售的中斷將抵消這一成長。我只是好奇國際銷售額的水平如何，以及如果你預期該特許經營業務今年會有任何成長，這意味著什麼。然後是關於 AMP 007 的第二個問題。

You know just how big of an opportunity is this, I guess, have you gotten any news whether there's an authorized generic coming on the market and whether you think the Atrovent market is now stabilized after a significant step down from, in 2025 from 2024. Thanks.

我想，您一定知道這是多麼大的機會。您有沒有收到任何關於授權仿製藥即將上市的消息？您認為在經歷了從 2024 年到 2025 年的大幅下滑之後，Atrovent 市場現在是否已經穩定下來了？謝謝。

Yes, so BAQSIMI, we do expect to see that mid-single-digit increase in units in the United States and the international decline will come in the second half of the year.

是的，BAQSIMI，我們預計美國銷售量將出現中等個位數的成長，而國際銷售的下降將在今年下半年出現。

We had a 3-year commitment to keep marketing the product in all countries where Lily was selling the product, and that commitment is up in July. So at that time we're likely to discontinue from a handful. Both countries, there's several countries where either the regulatory requirements are very hard and expensive, or the sales are just very minimal. So those are the two things that we're looking at, so that will offset some of the price, some of the growth in the US, but we do still see this as growing this year. Especially in the first half of the year, as, the international sales will keep going on until the third quarter.

我們曾承諾在莉莉銷售該產品的所有國家繼續推廣該產品，為期 3 年，但承諾將於 7 月到期。所以到那時我們可能會停止少數幾種產品的生產。兩國都有一些國家，不是監管要求非常嚴格且成本高昂，就是銷售額非常低。所以，這就是我們關注的兩件事，這將抵消美國的部分價格和成長，但我們仍然認為今年它會成長。尤其是在上半年，因為國際銷售將持續到第三季。

And for your A07 question, the Atrovent data last year was $112 million. We think that there's a meaningful Market Share for Being the first and having 180 days of exclusivity with the product is a meaningful op opportunity for us. We don't currently have any visibility into whether authorized generic. Could or will be launched, but, and as far as the decline, I think we saw that mostly as, a more of a pricing decline, last year and not so much in a demand, decline, demand driven, so we think it's fairly stable at this point.

至於你提出的 A07 問題，Atrovent 去年的數據是 1.12 億美元。我們認為，作為第一個推出該產品並擁有 180 天獨家銷售權的公司，能夠獲得可觀的市場份額，這對我們來說是一個意義重大的機會。我們目前無法得知是否已授權使用通用名藥物。可能會或將會推出，但是，至於下滑，我認為去年我們看到的主要是價格下滑，而不是需求下滑，所以我們認為目前市場相當穩定。

Usually when you see a market go generic, you'll see that tend to stabilize because of the price considerations and because of payers wanting to have people on a generic product so we think that this will lead to stabilization in terms of uses for the product.

通常情況下，當一個市場出現仿製藥時，你會發現它往往會趨於穩定，因為價格因素以及支付方希望人們使用仿製藥，所以我們認為這將導致該產品的用途趨於穩定。

Got it. So, I guess just a follow-up if there's no AG, would that be an upside to this mid to high single-digit growth expectation for this year?

知道了。所以，我想問的是，如果沒有 AG，這是否會對今年中高個位數的成長預期構成利好？

I'll say it's, potentially one of the differences between mid and high single-digit.

我認為這可能是個位數中段和個位數高段之間的區別之一。

Pavan Patel, Bank of America.

帕萬·帕特爾，美國銀行。

Hey guys, thanks for taking my questions. My first is on gross margins. I know you commented that you expected to be lower in 2026, but maybe if you can help me understand what to what degree, pricing pressure on glucagon, epinephrine, and in these legacy products can be offset by backs and the growth. Maybe if you could just frame the sizing between those pushes and pulls there. And then my second question is with regards to buybacks. I know you said that you plan to use a portion of your cash, and you have about $300 million of cash. So maybe if you're able to help me size what proportion of that is going to be used potentially for buybacks versus BD and if you can't speak in terms of like absolute value numbers totally fine if you could just frame which is a higher priority that would also be helpful thank you.

各位好，感謝你們回答我的問題。我的第一個問題是毛利率。我知道您曾表示預計 2026 年價格會下降，但如果您能幫我理解胰高血糖素、腎上腺素以及這些傳統產品的價格壓力在多大程度上可以被回購和增長所抵消，或許會有幫助。或許你可以把尺寸調整框在那些推拉之間。我的第二個問題是關於股票回購的。我知道你說過你打算動用一部分現金，而你大約有 3 億美元的現金。所以，如果您能幫我估算一下這筆資金中，用於股票回購和用於商業開發的比例，那就太好了。如果您不能提供絕對數值，也沒關係，如果您能告訴我哪個優先級更高，那就更有幫助了，謝謝。

Yeah, sure, so BAQSIMI, that will definitely help us grow our gross margins next year, because two things one, the growth in the United States of, the sales there, and two, in the second half of the year, the countries where we'll discontinue it have, negative gross margins, so we're actually losing. In those countries, so that will help our margins.

是的，當然，BAQSIMI 肯定有助於我們明年提高毛利率，因為有兩件事：一是美國市場的成長，那裡的銷售額成長；二是下半年我們將停止銷售該產品的國家的毛利率為負，所以我們實際上是在虧損。在這些國家，這將有助於提高我們的利潤率。

But however, the glucagon reduction is fairly large and so those products, the Epiviol and the finan, also are high margin products, and we're expecting to see the sales declines in those products as well as we're seeing these cost increases from our vendors or our suppliers at this time. So that's also eating into the margins. Also, another thing we didn't mention is that we did mention the higher API sales from our China business next year. That's going to be at a generally lower than corporate average gross margin as well, which will impact the overall margins.

但是，胰高血糖素的減少幅度相當大，因此 Epiviol 和 Finan 等產品也是高利潤產品，我們預期這些產品的銷售額也會下降，因為我們目前也看到供應商的成本增加。所以這也蠶食了利潤空間。另外，我們沒有提到的是，我們確實提到了明年中國業務的 API 銷售額將會更高。這也會導致其毛利率普遍低於公司平均水平，進而影響整體利潤率。

And then as far as buybacks go, we have about, last year we did about $75 million in buyback, so I think that would be like the high end of the range for what we are, what we have. We have about $15 million left on the current buyback as of today. So we did buy back some, stock in January and February as well, so we're likely to, authorize have another authorization later this year, but a lot of it will depend on, do we, have business development opportunities and how close are we to potentially executing on those, likely to slow the buyback down if we have a have a need for cash utilization.

至於股票回購，去年我們進行了大約 7,500 萬美元的回購，所以我認為這應該是我們目前規模和規模的上限了。截至今日，我們目前的回購計畫還剩下約 1,500 萬美元。因此，我們在一月和二月也回購了一些股票，所以我們很可能在今年稍後再次獲得授權，但這很大程度上取決於我們是否有業務發展機會，以及我們距離實現這些機會還有多遠。如果我們需要現金利用，可能會放慢回購速度。

David Amsalom, Piper Sandler.

大衛·阿姆薩洛姆，派珀·桑德勒。

Hi, thank you. This is now on for David. Just a couple from us. First, regarding Primatene MIST, how are you thinking about competition for the product considering that the patent expires this year? And can you also remind us about life cycle management activities for the product? So that's one.

您好，謝謝。現在輪到大衛了。我們兩個就說這兩點吧。首先，關於 Primatene MIST，考慮到其專利今年到期，您如何看待該產品的競爭？另外，能否提醒我們產品的生命週期管理活動？這是其中之一。

Number two, how should we think about the cadence of filings this year compared to prior years? And is your primary focus on inhalation products? Thank you.

第二，我們該如何看待今年的報稅節奏與往年的變化？你們的主要業務是吸入式產品嗎？謝謝。

So, pricing that the patent has already expired so we don't see any competition now. We think it's unlikely to give the economics for this. We think, it's a strong product.

所以，由於專利已經過期，定價方面目前沒有競爭。我們認為不太可能給出相關的經濟數據。我們認為，這是一款很棒的產品。

Yeah, I think with the OTC market it's a different dynamic when it comes to generics, Primatene MIST has 60 years of brand equity in it and so we feel like we're in a good position even if there was competition. We're in a good position of maintaining a large market share with that product and at the same time we're in the process of developing a new formulation of Primatene mist we've secured one patent and we're currently working on another that's kind of our strategy as we move to that brand patent.

是的，我認為非處方藥市場的情況與仿製藥市場有所不同，Primatene MIST 擁有 60 年的品牌資產，因此即使存在競爭，我們也感覺自己處於有利地位。我們目前處於有利地位，能夠憑藉該產品保持較大的市場份額，同時我們正在開發 Primatene 噴霧劑的新配方，我們已經獲得了一項專利，目前正在申請另一項專利，這可以說是我們向該品牌專利邁進的戰略。

The second question was about the Cadence of the filing. So, we expect late, this year, early next year to have, 2 filings, and then next year total 2 to 3 filings, and we think that should be the case moving forward.

第二個問題是關於文件提交的節奏。因此，我們預計今年底到明年年初會有 2 份申請，明年總共會有 2 到 3 份申請，我們認為未來應該會是這樣的情況。

Ben Burnett, Wells Fargo.

本·伯內特，富國銀行。

Hi, hello, this is Tianxi calling in for Ben. Thanks for taking our questions. So, I wanted to ask you about the Nanjing Anji in-licensed assets. Just see if you can have any updates on that. What kind of level of confidence do you have on these assets, and what does the clinical development path look like in their respective indications? Thank you very much.

你好，我是天曦，替Ben打電話。謝謝您回答我們的問題。所以，我想問您關於南京安吉的授權資產的情況。看看你能不能得到這方面的最新消息。您對這些資產有多大的信心？它們在各自適應症中的臨床開發路徑是怎麼樣的？非常感謝。

Yeah, we're very excited about those products we are currently in the pre-clinical stage of those we're getting the getting our packages together to have conversation early conversation with the agency on it. We think these products are very, exciting internally. We have a lot of positive excitement around them. We're building teams and coming up with priorities of these projects.

是的，我們對目前處於臨床前階段的這些產品感到非常興奮，我們正在準備相關資料，以便儘早與監管機構進行溝通。我們認為這些產品在內部非常令人興奮。我們對他們充滿期待和興奮。我們正在組建團隊，並確定這些項目的優先順序。

These will be new drugs, so they'll be going through the standard NDA process, whether we have expedited, pathways or not remains to be seen. We're optimistic that we should have some for those. We have some oncology products that that we think likely will have some of that, but we've not yet engaged the FDA with conversations of that, but we're just kind of in the pre-clinical evaluation of that and looking at the prioritization of that, but overall, I think we're very excited and encouraged by these products.

這些都是新藥，所以它們將經歷標準的NDA流程，至於我們是否已經加快了審批流程，還有待觀察。我們樂觀地認為應該可以有一些貨源。我們有一些腫瘤產品，我們認為它們可能具有這種特性，但我們還沒有就此與 FDA 進行討論，我們目前正處於臨床前評估階段，並考慮優先順序，但總的來說，我認為我們對這些產品感到非常興奮和鼓舞。

Thank you. If there are no further questions at this time. I would like to hand the floor back over to management for any closing remarks.

謝謝。如果目前沒有其他問題的話。我謹將發言權交還給管理階層，請他們作總結發言。

Thank you, Paul, and thank you all once again for joining us today. We appreciate your continued engagement and support and we look forward to keeping you updated on our progress throughout 2026. Have a wonderful evening.

謝謝保羅，也再次感謝各位今天蒞臨。我們感謝您一直以來的關注與支持，並期待在 2026 年繼續向您報告我們的進展。祝您有個美好的夜晚。

This concludes today's conference call. You may disconnect your lives at this time.

今天的電話會議到此結束。你們現在可以暫時斷絕彼此的生活連結了。

Thank you again for your participation.

再次感謝您的參與。