Amphastar Pharmaceuticals Inc (AMPH) 2025 Q3 法說會逐字稿

Greetings, and welcome to the Amphastar Pharmaceuticals Inc. third quarter earnings call. (Operator Instructions) Please note that certain statements made during this call regarding matters that are not historical facts, including, but not limited to, management's outlook or predictions for the future periods, are forward-looking statements. These statements are based solely on information that is now available to us.

各位好，歡迎參加安普斯塔製藥公司第三季財報電話會議。（操作員說明）請注意，本次電話會議中就非歷史事實事項所作的某些陳述，包括但不限於管理階層對未來期間的展望或預測，均為前瞻性陳述。這些聲明僅基於我們目前掌握的資訊。

We encourage you to review the session entitled forward-looking statements in the press release issued today and the presentation on the company's websites. Also, please refer to our SEC filings, which can be found on our websites and the SEC's website, for a discussion of numerous factors that may impact our future performance.

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。

We will also discuss certain non-GAAP measures. Important information on our use of these measures and reconciliations to the US GAAP may be found in our earnings release. Please note that this conference is being recorded.

我們也將討論一些非GAAP指標。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。

Our speakers today are Mr. Bill Peters, CFO; Mr. Dan Dischner, 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. Please go ahead, sir.

今天的演講嘉賓有：財務長比爾‧彼得斯先生；企業傳播資深副總裁丹‧迪施納先生；以及監管事務和臨床營運執行副總裁東尼‧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。請繼續，先生。

Thank you, operator. Good afternoon, and thank you for joining Amphastar's third quarter 2025 earnings call. I'm pleased to share that the company delivered another strong quarter, underscoring the continued success of our vertically integrated strategy and steadfast commitment to science-driven innovation.

謝謝接線生。下午好，感謝各位參加安普斯塔公司2025年第三季財報電話會議。我很高興地宣布，公司又取得了強勁的季度業績，這凸顯了我們垂直整合策略的持續成功以及對科學驅動創新的堅定承諾。

Our performance this quarter was anchored by three core pillars: strong commercial execution, the strategic expansion of our pipeline, and focused regulatory progress, all reinforcing our long-term growth trajectory. For the third quarter, Amphastar achieved net revenues of $191.8 million, with GAAP net income of $17.3 million, or $0.37 per diluted share.

本季我們的業績主要得益於三大核心支柱：強勁的商業執行力、產品線的策略擴張以及監管方面的重點進展，所有這些都鞏固了我們的長期成長軌跡。第三季度，Amphastar 實現淨收入 1.918 億美元，以美國通用會計準則計算的淨利潤為 1,730 萬美元，即每股攤薄收益 0.37 美元。

On a non-GAAP basis, adjusted net income was $44.6 million, or $0.93 per diluted share. This performance was primarily driven by sustained momentum in our core products, BAQSIMI and Primatene MIST. BAQSIMI delivered $53.6 million in total sales, up 14% year-over-year.

以非GAAP準則計算，調整後淨收入為4,460萬美元，即每股稀釋收益0.93美元。這項業績主要得益於我們核心產品 BAQSIMI 和 Primatene MIST 的持續成長動能。BAQSIMI 的總銷售額為 5,360 萬美元，年增 14%。

This growth was driven by seasonal demand and expanded sales execution through our partnership with MannKind's salesforce. Additionally, total revenue from Primatene MIST increased by 11% year-over-year, validating persistent consumer engagement in the OTC respiratory space as the product consistently sees a positive growth trend.

這一增長是由季節性需求以及我們與 MannKind 銷售團隊合作擴大銷售執行力度所推動的。此外，Primatene MIST 的總收入年增 11%，證明了消費者對非處方呼吸系統藥物的持續關注，該產品也持續呈現積極的成長趨勢。

Turning to our proprietary pipeline, I'm excited to highlight a significant expansion this quarter, fueled by an exclusive in-licensing agreement with Nanjing Anji Biotechnology, securing US and Canadian rights to three early-stage novel peptide candidates, targeting high-growth markets across oncology and ophthalmology.

談到我們自主研發的產品線，我很高興地宣布本季度取得了重大進展，這得益於我們與南京安吉生物技術有限公司達成的獨家引進許可協議，該協議獲得了美國和加拿大對三種早期新型肽候選藥物的權利，這些藥物的目標是腫瘤學和眼科學領域的高增長市場。

The first candidate, AMP-105, is a first-in-class oncology peptide targeting tumor proliferation and metastasis, representing a novel mechanism of action with broad clinical potential. Early studies have shown anti-tumor activity across multiple cancer types.

第一個候選藥物 AMP-105 是一種首創的腫瘤勝肽，可針對腫瘤增生和轉移，代表了一種具有廣泛臨床潛力的全新作用機制。早期研究表明，該藥物對多種癌症類型具有抗腫瘤活性。

The second candidate, AMP-109, is a peptide-coupled doxycycline with improved selectivity and bioavailability, targeting lung, colorectal, gastric, and pancreatic cancers. It is designed to reduce doxycycline-induced toxicity and has the potential to improve the efficacy and safety of current taxane therapies.

第二個候選藥物 AMP-109 是一種勝肽偶聯的強力黴素，具有更高的選擇性和生物利用度，可針對肺癌、大腸直腸癌、胃癌和胰臟癌。它旨在降低多西環素引起的毒性，並有可能提高目前紫杉烷療法的療效和安全性。

Lastly, the third candidate is AMP-107, which is a non-invasive eye drop therapy for wet age-related macular degeneration and diabetic macular edema, offering a patient-friendly alternative to injectable treatments and the potential to improve treatment adherence and quality of life.

最後，第三個候選藥物是 AMP-107，它是一種用於治療濕性老年黃斑部病變和糖尿病黃斑水腫的非侵入性滴眼療法，為患者提供了一種注射治療之外的更友好的替代方案，並有可能提高治療依從性和生活品質。

AMP-107 has the potential to be the first non-injectable anti-vascular endothelial growth factor or anti-VEGFR eye drop in a $9.4 billion market. These newly added assets broaden our pipeline beyond diabetes and complex generics, unlocking a combined market opportunity of over $60 billion.

AMP-107 有潛力成為價值 94 億美元的市場上首個非注射型抗血管內皮生長因子或抗 VEGFR 眼藥水。這些新加入的資產使我們的產品線擴展到糖尿病和複雜仿製藥之外，釋放了超過 600 億美元的綜合市場機會。

To capitalize on this growth, our US manufacturing expansion will quadruple production capacity at our Rancho Cucamonga headquarters, strengthening operational agility and positioning us to capture greater value across our portfolio.

為了充分利用這一成長，我們將擴大在美國的生產規模，使位於蘭喬庫卡蒙加的總部產能翻兩番，從而增強營運靈活性，並使我們能夠從我們的投資組合中獲得更大的價值。

Our investment in domestic capacity reflects a strategic commitment to resilience and scalability as we navigate an increasingly dynamic landscape. We are delighted to share that we are well-positioned to reach our target of proprietary products comprising 50% of our pipeline by 2026.

我們對國內產能的投資體現了我們在應對日益動態的市場環境時，對韌性和可擴展性的策略承諾。我們很高興地宣布，我們已做好充分準備，到 2026 年實現自主研發產品占我們研發管線 50% 的目標。

Shifting our discussion to our regulatory initiatives, we made meaningful progress this quarter, highlighted by FDA approval of iron sucrose injection, or AMP-002, which is now commercially available as one of the generic options in the United States.

接下來，我們討論一下監管方面的舉措。本季我們取得了實質進展，其中最引人注目的是FDA批准了蔗糖鐵注射液（AMP-002），該藥物現已在美國作為仿製藥上市。

This milestone expands patient access to affordable therapies while contributing to our revenue growth. During this quarter, iron sucrose injection generated total sales of $2.4 million. Beyond these launches, we continue to advance several high-impact regulatory programs across our portfolio.

這項里程碑擴大了患者獲得價格合理療法的機會，同時也促進了我們的收入成長。本季度，蔗糖鐵注射液的總銷售額為 240 萬美元。除了這些新項目之外，我們還在持續推進我們投資組合中的多個具有重大影響力的監管項目。

For our AMP-007 inhalation filing, we are on track for a launch in mid-2026, with the potential to be the first to market generic in a $1.5 billion addressable market. We're also pleased to report that our generic teriparatide product, AMP-015, is also on track for a launch in the first half of 2026.

對於我們的 AMP-007 吸入劑申請，我們正按計劃於 2026 年年中推出，並有可能成為首個在 15 億美元潛在市場中推出仿製藥的公司。我們也很高興地宣布，我們的特立帕肽仿製藥 AMP-015 也正按計畫推進，將於 2026 年上半年上市。

Additionally, our GLP-1 AMDA, AMP-018, is on schedule for a 2027 launch. The obesity and diabetes markets continue to attract significant competition, and as a result, we expect the commercial opportunity to be limited, and we will focus on maintaining cost and quality leadership in this space.

此外，我們的 GLP-1 AMDA AMP-018 計劃於 2027 年上市。肥胖症和糖尿病市場持續面臨激烈的競爭，因此，我們預計商業機會有限，我們將專注於維持該領域的成本和品質領先地位。

And finally, our insulin aspart BLA, or AMP-004, is moving steadily towards a launch in 2027. The recent approval of biosimilars in this space helps de-risk the opportunity by establishing a proven pathway for market acceptance and adoption.

最後，我們的胰島素門冬生物製品許可申請（BLA），即 AMP-004，正穩步朝著 2027 年上市的目標邁進。該領域近期生物相似藥的核准有助於降低風險，因為它建立了一條已被市場接受和採用的成熟途徑。

Collectively, these programs position us to expand patient access and deliver sustainable growth across multiple high-demand therapeutic areas in the coming years. I will now turn the call over to Bill Peters, our CFO and Executive Vice President of Finance, for a more detailed financial review of the third quarter.

這些計畫共同為我們擴大患者就醫管道、並在未來幾年在多個高需求治療領域實現永續成長奠定了基礎。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，讓他對第三季的財務狀況進行更詳細的回顧。

Thank you, Dan. Revenues for the third quarter increased slightly to $191.8 million from $191.2 million in the previous year's period. BAQSIMI recorded its highest quarterly sales ever, growing to $53.6 million compared to the prior year period of $40.4 million.

謝謝你，丹。第三季營收略有成長，從去年同期的 1.912 億美元增至 1.918 億美元。BAQSIMI 創下有史以來最高的季度銷售額，達到 5,360 萬美元，而去年同期為 4,040 萬美元。

Amphastar assumed full commercialization responsibility globally at the beginning of 2025. Keep in mind that during the same period last year, Eli Lilly had BAQSIMI sales of $6.4 million. Therefore, total BAQSIMI sales for the period grew by 14%.

Amphastar 於 2025 年初承擔了全球範圍內的全部商業化責任。請記住，去年同期，禮來公司的 BAQSIMI 銷售額為 640 萬美元。因此，該期間 BAQSIMI 的總銷售額成長了 14%。

Primatene MIST sales grew 11% to $28.8 million in the third quarter compared to $26.1 million in the prior year period, primarily due to our increased marketing efforts. Glucagon injection sales declined 49% to $13.6 million from $26.8 million, primarily due to a decrease in unit volumes and increased competition and a shift to ready-to-use glucagon products such as BAQSIMI.

Primatene MIST 第三季銷售額成長 11%，達到 2,880 萬美元，而去年同期為 2,610 萬美元，這主要歸功於我們加大了行銷力度。胰高血糖素注射劑的銷售額從 2,680 萬美元下降了 49%，至 1,360 萬美元，主要原因是單位銷售下降、競爭加劇以及轉向即用型胰高血糖素產品（如 BAQSIMI）。

Epinephrine sales decreased 12% to $18.8 million from $21.3 million in the prior year period due to increased competition on our multi-dose vial product. This decrease was partially offset by an increase in unit volume for our epinephrine prefilled syringe as a result of increased demand caused by shortages from other suppliers during the quarter.

由於多劑量小瓶裝產品的競爭加劇，腎上腺素銷售額從去年同期的 2,130 萬美元下降了 12%，至 1,880 萬美元。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單位銷量增加，部分抵消了上述下降。

Sales of lidocaine decreased 19% to $12.9 million from $15.9 million in the prior year period, primarily due to a decrease in unit volumes as a result of other suppliers returning to historical distribution levels. Other pharmaceutical product sales increased to $64.1 million from $58.3 million, primarily due to a $4.7 million increase in sales of albuterol during the period, as well as $2.4 million in sales of iron sucrose injection, which we launched in August 2025.

利多卡因的銷售額從去年同期的 1,590 萬美元下降了 19%，至 1,290 萬美元，這主要是由於其他供應商恢復到歷史分銷水平，導致單位銷售下降。其他藥品銷售額從 5,830 萬美元增加到 6,410 萬美元，主要原因是該期間沙丁胺醇銷售額增加了 470 萬美元，以及我們在 2025 年 8 月推出的蔗糖鐵注射液銷售額增加了 240 萬美元。

This increase was partially offset by a decrease in unit volumes of enoxaparin and dextrose, primarily due to increased competition. Cost of revenues decreased -- increased to $93.2 million from $89.3 million, with gross margins declining to 51.4% from 53.3% in the previous year's period.

由於競爭加劇，依諾肝素和葡萄糖的單位體積減少，部分抵消了成長。營業成本下降—從 8,930 萬美元增至 9,320 萬美元，毛利率從去年同期的 53.3% 下降至 51.4%。

BAQSIMI sales made by Lilly in the prior year were recorded under the transition service agreement with Lilly and were booked at 100% gross margin. With the completion of the transition to Amphastar, cost of revenue for all products shipped are included in this line, which negatively impacts margin rates.

禮來公司上一年在 BAQSIMI 的銷售額是根據與禮來的過渡服務協議記錄的，並以 100% 的毛利率入帳。隨著向 Amphastar 的過渡完成，所有出貨產品的收入成本都包含在這一行中，這對利潤率產生了負面影響。

Additionally, pricing declines, as well as a decrease in unit volumes due to competition for both our glucagon kit and epinephrine multi-dose vial product, negatively impacted margins. Because of these trends, management implemented cost control measures across the business, mitigating the impact of pricing pressures.

此外，由於市場對我們的胰高血糖素試劑盒和腎上腺素多劑量小瓶產品的競爭，價格下降以及單位銷量減少，對利潤率產生了負面影響。由於這些趨勢，管理層在整個業務範圍內實施了成本控制措施，以減輕價格壓力的影響。

Selling, distribution, and marketing expenses increased 28% to $11.5 million from $9 million in the previous year's period due to the sales and marketing efforts related to BAQSIMI, including the co-promotion agreement with MannKind, as well as sales and marketing efforts related to Primatene MIST.

由於與 BAQSIMI 相關的銷售和行銷工作（包括與 MannKind 的聯合推廣協議）以及與 Primatene MIST 相關的銷售和行銷工作，銷售、分銷和行銷費用從上一年的 900 萬美元增長了 28%，達到 1150 萬美元。

General and administrative spending increased to $39.5 million from $14.8 million, primarily driven by a litigation provision related to a recent jury verdict in a civil case against the company. While we plan to appeal the decision, accounting standards require us to book provision for the full amount, net of applicable insurance coverage.

一般及行政支出從 1,480 萬美元增加到 3,950 萬美元，主要原因是與公司最近一起民事訴訟的陪審團裁決相關的訴訟準備金。雖然我們計劃對該決定提出上訴，但會計準則要求我們提列全額準備金，並扣除適用的保險賠償後。

Research and development expenditures increased 6% to $22.4 million from $21.1 million in the prior year period due to the $5.25 million upfront payment we made to Nanjing Anji Biotechnology to license three peptide products for our proprietary product portfolio. This increase was partially offset by a decrease in material and supply expenses.

由於我們向南京安吉生物技術有限公司支付了 525 萬美元的預付款，以獲得我們專有產品組合中三種勝肽產品的許可，因此研發支出從去年同期的 2,110 萬美元增長了 6%，達到 2,240 萬美元。這一增長被材料和供應費用的下降部分抵消。

Non-operating expenses decreased to $3.8 million from $9.4 million, primarily due to currency fluctuations. Net income decreased to $17.3 million or $0.37 per share in the third quarter, from $40.4 million or $0.78 per share in the third quarter of 2024.

非經營性支出從 940 萬美元減少到 380 萬美元，主要原因是匯率波動。第三季淨收入減少至 1,730 萬美元，即每股 0.37 美元，而 2024 年第三季淨收入為 4,040 萬美元，即每股 0.78 美元。

Adjusted net income decreased to $44.6 million or $0.93 per share, compared to an adjusted net income of $49.6 million or $0.96 per share in the third quarter of last year. Adjusted earnings exclude amortization, equity compensation, impairments of long-lived assets, and certain one-time events, including the aforementioned litigation provision that was recorded this quarter.

經調整後的淨利潤下降至 4,460 萬美元，即每股 0.93 美元，而去年第三季經調整後的淨利潤為 4,960 萬美元，即每股 0.96 美元。調整後的收益不包括攤銷、股權激勵、長期資產減損以及某些一次性事件，包括本季提列的上述訴訟準備金。

In the third quarter, we had cash flow from operations of approximately $52.6 million. We used a portion of our cash on hand to buy back $4.9 million worth of shares.

第三季度，我們的營運活動現金流約為 5,260 萬美元。我們動用了部分現金儲備，回購了價值 490 萬美元的股票。

I will now turn the call back over to Dan.

現在我將把通話轉回給丹。

Thank you, Bill, for the update. In summary, Amphastar's performance this quarter reflects the power of our integrated strategy and our commitment to long-term transformative growth. We demonstrated enduring commercial momentum with strong performance from our leading proprietary products, BAQSIMI and Primatene MIST.

謝謝你，比爾，提供最新消息。總而言之，Amphastar 本季的業績體現了我們一體化策略的力量以及我們對長期變革性成長的承諾。我們憑藉領先的專有產品 BAQSIMI 和 Primatene MIST 的強勁表​​現，展現了持久的商業發展勢頭。

We advanced our regulatory pipeline with the approval and launch of iron sucrose injection, alongside steady progress on our interchangeable insulin aspart BLA. Furthermore, we strategically enriched our proprietary portfolio with novel peptide candidates in high-growth indications across oncology and ophthalmology.

我們推進了監管管道的建設，獲得了蔗糖鐵注射液的批准和上市，同時，我們的可互換胰島素門冬生物製品許可申請也取得了穩步進展。此外，我們也策略性地豐富了我們專有的產品組合，納入了腫瘤學和眼科學等高成長適應症領域的新型勝肽類候選藥物。

These achievements underscore our unique combination of scientific innovation, US-based manufacturing capabilities, and deep commercial expertise. With a disciplined focus on proprietary product development and a robust R&D engine powered by our advanced technology, we believe we are positioned to accelerate into the next phase of sustainable growth and value creation.

這些成就凸顯了我們在科學創新、美國本土製造能力和深厚的商業專業知識方面的獨特優勢。憑藉對專有產品開發的專注和由先進技術驅動的強大研發引擎，我們相信我們已做好準備，加速進入永續成長和價值創造的下一個階段。

Thank you for your continued support and for joining us today. With that, we will now take your questions. Operator?

感謝您一直以來的支持，也感謝您今天蒞臨現場。接下來，我們將回答各位的問題。操作員？

(Operator Instructions) Serge Belanger, Needham & Co.

（操作說明）Serge Belanger，Needham & Co.

Hi, good afternoon. First one for Bill. Now that we're three quarters in for this year, any updated thoughts on your informal guide for a flat year-over-year top line and maybe more importantly, a double-digit growth for a --return to double-digit growth for next year?

您好，下午好。第一個是給比爾的。今年已經過了三個季度，對於您先前非正式預測的同比營收持平，以及更重要的，明年能否實現兩位數成長，您有什麼新的見解嗎？

Secondly, on iron sucrose, you've now been in the market for a couple of months, so maybe just highlight or give us an idea of how big the opportunity can be for you, given the competition and your manufacturing capacity for the product. Thank you.

其次，關於蔗糖鐵，你們已經進入市場幾個月了，所以或許可以重點介紹一下，或者讓我們了解一下，考慮到競爭情況和你們的產品生產能力，這個市場對你們來說機會有多大。謝謝。

Yeah. So we still believe that we can get to flat this year based on some outperformance by BAQSIMI and Primatene MIST and some other factors. And the next year, what we're looking at is probably either a high single-digit to low double-digit growth rates.

是的。因此，我們仍然相信，基於 BAQSIMI 和 Primatene MIST 的一些優異表現以及其他一些因素，今年我們可以實現持平。而明年，我們預期的成長率可能是接近兩位數的高個位數到接近兩位數的低個位數。

But we'll talk a little bit more about that in the next call-up. And on iron sucrose, I think the best way to look at that is that we had $2.4 million this quarter, which is about half a quarter, and that's probably a good run rate for the time being on a go-forward basis.

但我們會在下次徵召時再詳細談談這個問題。至於蔗糖鐵，我認為最好的看待方式是，我們本季營收為 240 萬美元，大約是半個季度，從長遠來看，這可能是一個不錯的成長速度。

Dennis Ding, Jefferies.

丹尼斯丁，傑富瑞集團。

Hi, thanks for taking the question. This is a Liwen Wang for Dennis Ding. We would like to ask if there's any updates on 007? And what about the communication with FDA? Has the shutdown impacted that process at all? And also, would you like to comment on the FDA bandwidth to handle these applications, especially given the shutdown situation?

您好，感謝您回答這個問題。這是李文王為丁丹尼創作的作品。我們想問007系列電影有什麼最新消息嗎？與FDA的溝通狀況如何？此次停工是否對此過程造成了任何影響？另外，您能否就FDA處理這些申請的能力發表一下看法，尤其是在目前政府停擺的情況下？

Sure. This is Tony for our AMP-007. We continue to have engagement with the agency on it. Given the nature of the combination and complex products like this, this is kind of the due course for these types of products.

當然。這是我們的 AMP-007 的 Tony。我們將繼續就此事與該機構進行溝通。考慮到這種組合和複雜產品的性質，這對這類產品來說算是必然的。

And as a result, we've aligned our guidance more precisely around the anticipated launch date, as you'll see there. And we've done this because we believe it offers a more meaningful and actionable reference point for the analyst.

因此，我們已將指導方針更加精確地調整為以預期發布日期為準，您將在那裡看到。我們這樣做是因為我們相信它能為分析師提供更有意義、更具操作性的參考點。

As far as the bandwidth from the agency, we have seen just slight delays in interaction, not necessarily directly related to any delays in products, just maybe taking a little bit longer to respond to questions. But this hasn't resulted directly to anything that we've seen as far as missed dates.

就代理商的頻寬而言，我們發現互動方面略有延遲，但這並不一定與產品延遲直接相關，只是回覆問題可能需要更長時間。但就目前來看，這還沒有直接導致任何錯過約會的情況。

Jason Gerberry, Bank of America.

傑森‧格伯里，美國銀行。

Hey, guys. This is Pavan Patel on for Jason Gerberry. Thanks for taking your questions. The first on generic Venofer, maybe can you just speak to the competitive dynamics? Just wondering why it seems like the competitor, generic Venofer that's launched, seems to have garnered a little bit more market share since the start of the launch. And what are the key pushes and pulls in working with these dialysis centers?

嘿，夥計們。這裡是帕萬·帕特爾，替傑森·格伯里為您報道。謝謝您回答問題。關於通用名Venofer，您能否談談其競爭格局？我只是好奇為什麼競爭對手推出的仿製藥Venofer似乎自上市以來獲得了更多的市場份額。與這些透析中心合作的關鍵推動因素和阻力因素是什麼？

I'm just trying to think through if there are any levers such as contracting or anything else that you can pull in order to increase the run rate headed into 2026. And then maybe as you look towards 2026, it sounds like high single-digit to double-digit growth is the new sort of commentary there.

我只是想弄清楚，有沒有什麼辦法，例如透過縮減規模或其他方式，來提高到 2026 年的運行率。展望 2026 年，或許可以預見，接近兩位數的成長率將成為新的預期。

And I'm just wondering, is that baking in all of the pipeline aspects that you've talked about in terms of AMP-007, generic Forteo, generic GLP-1, and maybe not the insulin aspart since that's 2027, but is that all on a nominal basis, or is there any risk adjusting that's going on there? Thank you.

我只是想知道，您提到的所有研發管線方面，例如 AMP-007、仿製藥 Forteo、仿製藥 GLP-1，以及可能不包括胰島素門冬（因為它要到 2027 年才能上市），是否都已考慮在內？這些都是以名目價格計算的，還是其中有任何風險調整？謝謝。

Yeah. So for the iron sucrose question, it's -- our goal is to launch it with a profitable price portfolio and hit it at hit points where we can have a nice margin on this. So we may not have gone as aggressively in some areas where there's some lower margin.

是的。所以關於蔗糖鐵的問題，我們的目標是以有利可圖的價格組合推出它，並在我們可以獲得良好利潤的價位上進行銷售。因此，在一些利潤較低的領域，我們可能不會採取那麼積極的策略。

Also, I think while we had some supply initially, I think that we were not, we didn't have enough supply at the beginning of the quarter, but we were by the end of the quarter. And I still think the initial guidance I gave a little while ago, which was we were in for half a quarter, that's probably the run rate to look at on a going forward basis. I think that's the best way to look at that.

另外，我認為雖然我們最初有一些供應，但我認為我們在季度初供應不足，但到季度末供應就充足了。我仍然認為我前段時間給出的初步指導意見，即我們預計完成半個季度，這可能是未來應該關注的運行速度。我認為這是看待這個問題的最佳方式。

As far as the guidance for next year, we do risk adjust our guidance. But I will say that the insulin product and also the GLP-1, we've assumed that those do not launch until 2027, so they're not in the guidance for next year.

至於明年的業績指引，我們會根據風險狀況進行調整。但我要說的是，胰島素產品以及 GLP-1，我們假設它們要到 2027 年才會上市，所以它們不在明年的指導方針中。

Ekaterina Knyazkova, JPMorgan.

葉卡捷琳娜·克尼亞茲科娃，摩根大通。

Hey. Thank you so much. Just on the licensing you did with Nanjing Anji, just elaborate a bit more on what brought you to that portfolio of assets initially and just your level of excitement, both about the science and the potential commercial opportunity.

嘿。太感謝了。關於您與南京安吉的授權合作，請您詳細說明最初是什麼讓您關注這些資產組合，以及您對其中的科學價值和潛在商業機會的興奮程度。

And kind of a related question, but just on business development more broadly, just level of appetite of doing more deals going forward, and maybe your preference between doing something with more clinical risk like you just did or something closer to BAQSIMI that's more commercial stage. Thank you.

還有一個相關的問題，但更廣泛地說是關於業務發展，例如您對未來進行更多交易的意願程度，以及您是更傾向於做像您剛剛做的那樣具有更高臨床風險的項目，還是更傾向於做像 BAQSIMI 這樣更商業化的項目。謝謝。

Yeah. When we looked at this opportunity in working with Anji and these products, this is something that's been a long part of our long-term plan. And that is to get more into branded products. As we've gone along over the years, we've had that toolbox has been very effective for us.

是的。當我們考慮與安吉及其產品合作的機會時，這其實是我們長期計劃中的一個重要組成部分。那就是要更多地銷售品牌產品。多年來，我們發現這套工具箱對我們來說非常有效。

Immunogenicity, preclinical, animal studies, doing a lot of work in these early development, has helped us considerably. And when we looked at this opportunity, it seemed like a very good fit. All of the pieces were in place for us to be able to actually do the development of these types of products.

免疫原性、臨床前研究、動物研究，以及在這些早期開發階段所做的大量工作，對我們幫助很大。當我們審視這個機會時，覺得它非常適合我們。所有條件都已具備，我們可以著手開發這類產品了。

And as far as business development on a going forward basis, I would say that now that we have some early-stage assets and some commercial assets, I think what we would be looking for primarily is either assets that are already commercialized or very late-stage R&D assets.

至於未來的業務發展，我認為，既然我們已經擁有一些早期資產和一些商業資產，我們主要尋找的要么是已經商業化的資產，要么是非常後期研發階段的資產。

And one other thing too, level of excitement about these products. We're very, very excited about them. And we've seen some early data for us on some of these animal models. It looks very encouraging for, as Dan had mentioned, some potentially broad applications for some of these cancer treatments. It seems very exciting for us to have this opportunity.

還有一點，就是大家對這些產品的興奮程度。我們對此感到非常非常興奮。我們已經看到了一些關於這些動物模型的早期數據。正如丹所提到的，這些癌症療法看起來非常令人鼓舞，它們可能具有廣泛的應用前景。能有這樣的機會，我們感到非常興奮。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆，派珀·桑德勒。

Thanks. Two for me. One on insulin aspart. What's the competitive landscape going to look like in your view once you're in a position to launch in 2027? And how are you thinking about just the size of that opportunity and how impactful that could be to your portfolio? So that's number one.

謝謝。我兩個。一例胰島素門冬。您認為到 2027 年產品上市時，競爭格局會是什麼樣子？您如何看待這個機會的規模以及它可能對您的投資組合產生的影響？這是第一點。

And then secondly, on Primatene MIST, noticed that your one R&D patent expires in 2026. Are you expecting competition there? How are you thinking about exclusivity for that product? Thank you.

其次，在 Primatene MIST 上，我注意到您的一項研發專利將於 2026 年到期。你預計那裡會有競爭嗎？您對該產品的獨家銷售有何考慮？謝謝。

As far as the insulin aspart goes, we do know we originally hoped that we'd be there first or second, but it's likely to be three or more competitors in that market. It's a large market and a lot of volume. There are a couple of things going for us there, which are we make the API ourselves, and we also make the finished product ourselves.

至於門冬胰島素，我們最初希望能夠名列第一或第二，但很可能這個市場上會有三家或更多競爭對手。這是一個龐大的市場，交易量也很大。我們在這方面有兩個優勢，就是我們自己開發 API，也自己生產最終產品。

And with a large volume market like that, it's going to really help our cost structure to get another high-volume product like that out here will affect our overall cost structure. So we still see that as being a good market that we can have strong sales, and it would be something that will move the needle for our company. It's not just another launch.

像這樣的大市場，如果能推出另一款大批量產品，將會對我們的成本結構產生正面影響，進而影響我們的整體成本結構。所以我們仍然認為這是一個不錯的市場，我們可以在這裡取得強勁的銷售業績，這將對我們公司的發展起到推動作用。這不僅是一次普通的記者會。

On Primatene MIST, yeah, the patent for the current product does expire next year. Two things on that. One, we do not know of any competition, but generic competition, but not that there will not be because there always could be.

關於 Primatene MIST，是的，目前產品的專利將於明年到期。關於這一點，有兩點需要說明。第一，我們目前還不知道是否有任何競爭，但一般意義上的競爭是不存在的，但這並不意味著不會存在，因為總是有可能存在。

But we also have been saying all along that we think it is unlikely that we get competition early on, because of this product being -- because it is an OTC product, a lot of the sales would stay with the brand. If there is a generic come in, we assume that the brand gets half the market anyway.

但我們一直以來也都認為，我們不太可能在早期就遇到競爭對手，因為這款產品是OTC產品，許多銷售都會留在品牌內。即使有仿製藥上市，我們也假設品牌藥無論如何都會佔一半的市佔率。

On the other half of the market, if there was generic, we would also launch our own generic version of it and probably capture half the generic market. And any competitor would be limited to one quarter of the market, and they would have to cut the price at half or more to get any of that market share.

在另一半市場，如果存在仿製藥，我們也會推出我們自己的仿製藥版本，並可能佔據一半的仿製藥市場。任何競爭對手都只能佔據四分之一的市場份額，而且他們必須將價格降低一半甚至更多才能獲得任何市場份額。

And we're talking maybe it's a $10 million, $12 million sales market, and it's also now not a high-margin product. It's a low-margin product. So spending $10 million-plus to get to that low-sales, low-margin product, we don't think is a great idea for most players. We don't see that as being a big opportunity for generics. We think it's not the most likely target for generics to go after.

我們現在說的是，這可能是一個價值 1000 萬美元到 1200 萬美元的銷售市場，而且它現在也不是一個高利潤產品。這是一款低利潤產品。因此，花費超過 1000 萬美元去開發一款銷量低、利潤低的產品，我們認為對大多數玩家來說並不是一個好主意。我們認為這對仿製藥來說並不是一個巨大的機會。我們認為它不太可能是仿製藥最有可能瞄準的目標。

And secondly, we've also discussed how we are working on a follow-on product that has an even lower global warming propellant. So we're working with EFDA right now. We've already filed one patent on that and are working on some others as we plan to get that product moving forward. We'll probably give some more information about timing of that next year.

其次，我們也討論了我們正在如何研發後續產品，該產品採用全球暖化效應更低的推進劑。所以我們目前正在與EFDA合作。我們已經就此申請了一項專利，並且正在申請其他一些專利，以便推進該產品的研發。我們可能會在明年公佈更多關於時間安排的資訊。

Ben Burnett, Wells Fargo

本·伯內特，富國銀行

Hey, thank you very much. I want to go back and ask a follow-up question around the in-license products that you just got. I wonder if you can maybe just kind of map out for us sort of the market or the regulatory and development path. Is there one of these -- could one maybe be developed before the other or have a shorter path to market? How do you see sort of the timing there?

嘿，非常感謝。我想就您剛剛獲得的授權產品再問一個後續問題。我想知道您是否可以為我們大致勾勒一下市場或監管和發展路徑。這兩者之間是否存在某種可能——其中一種能否先於另一種開發出來，或者能否擁有更短的上市路徑？你覺得時機把握如何？

Yeah. What I could say about these, these would be new chemical products. So these would be going through the routine new product, new chemical entity pathway from the agency. We do from a prioritization, we have some that we think might be a little bit easier than others.

是的。關於這些產品，我可以說，它們都是新型化學產品。因此，這些產品將依照監管機構的常規新產品、新化學實體審批流程進行審批。我們根據優先順序排序，認為有些事情可能比其他事情更容易一些。

And it's kind of early for us to give any kind of prioritization guidance on that. Other than it's going to be some animal studies that we'll have to do and followed by some human studies, obviously, kind of the normal pathway that you would expect.

現在就此給出任何優先順序方面的指導還為時過早。除此之外，我們還需要進行一些動物實驗，然後進行一些人體實驗，這顯然是正常的流程，也是你所預期的。

How much prioritization the agency gives in that remains to be seen. We're very encouraged by some of the early data, and we think perhaps the agency will too, which will help expedite the approval process of that. But we're still early in it, and we're still kind of evaluating some of the pre-clinical data that we're getting, although we're very encouraged by it.

該機構對此給予多大的重視，還有待觀察。我們對一些早期數據感到非常鼓舞，我們認為該機構可能也會如此，這將有助於加快審批過程。但我們仍處於早期階段，我們仍在評估我們所獲得的一些臨床前數據，儘管我們對此感到非常鼓舞。

And one thing I'd like to add to that is that this has been a plan of ours for a while. As we've illustrated in our presentation, our intent was always to get our pipeline to be 50% proprietary. We've staffed up. We have the resources to work on all of these independently at the same time. As we start hitting our stride with them, we'll have a better outlook on how we'll report it and when we'll report it and what we'll report going forward.

我還要補充一點，這其實是我們醞釀已久的計畫。正如我們在簡報中所展示的那樣，我們的目標始終是使我們的產品線 50% 專有化。我們已增派人手。我們有能力同時獨立進行所有這些工作。隨著我們與他們合作越來越得心應手，我們將對如何報告、何時報告以及未來報告的內容有更清晰的認識。

Okay. Great. Thank you very much for that. If I could just maybe follow up with a BAQSIMI question, I guess, what is your estimate for kind of the share of the ready-to-use market that you have? And I feel like in the past, you've talked about the glucagon market as potentially expanding. And curious if you're still seeing that, and if so, kind of what are sort of the drivers of that? Thank you.

好的。偉大的。非常感謝。如果我可以再問一個關於 BAQSIMI 的問題，我想問一下，您估計您在即用型市場中所佔的份額是多少？我覺得你過去曾談到胰高血糖素市場可能會擴張。我很好奇你是否仍然看到這種情況，如果是的話，造成這種情況的原因是什麼？謝謝。

Yeah. Right now, depending on the month, we usually have between 55% and 60% of the ready-to-use market, and that's how we're defining that segment of the market. And we have said that the glucagon market is expanding.

是的。目前，根據月份的不同，我們通常佔據即用型市場 55% 到 60% 的份額，這就是我們對該細分市場的定義。我們之前說過，胰高血糖素市場正在擴張。

And going back to the data on that, which was when we purchased BAQSIMI, only 10% of people who are on insulin were getting a glucagon script filled. And at that time, the Diabetes Association recommended that every person who is on insulin get a glucagon script filled.

回到我們收購 BAQSIMI 時的數據，當時只有 10% 的胰島素使用者獲得了升糖素處方。當時，糖尿病協會建議所有使用胰島素的人都應該去配一瓶胰高血糖素。

So we've seen that increase pretty steadily, and we're now up to 12% of people getting a glucagon script filled. So it has increased pretty significantly, but we think that there's a lot of opportunity for that number to keep increasing.

所以我們看到這一比例穩步上升，現在已有 12% 的人獲得了胰高血糖素處方。所以這個數字已經顯著成長，但我們認為這個數字還有很大的成長空間。

Therefore, we're very excited about the long-term cash flows from this product and the long-term growth of that product. We still have our forecast of peak sales of $250 million to $275 million. So -- and we think that, that's very achievable. We're still excited about this, and BAQSIMI is our number one growth product for next year.

因此，我們對該產品的長期現金流和長期成長前景感到非常興奮。我們仍預測銷售高峰將達到 2.5 億至 2.75 億美元。所以——而且我們認為，這是完全可以實現的。我們對此仍然感到興奮，BAQSIMI 是我們明年最重要的成長產品。

Thank you, Bill. There are no further questions at this time. I would now like to turn the floor back over to Dan Dischner for closing comments. Please go ahead, sir.

謝謝你，比爾。目前沒有其他問題了。現在我想把發言權交還給丹·迪施納，讓他做總結發言。請繼續，先生。

Thank you, operator. Thank you all for joining us today. We remain excited about closing 2025 on a positive trajectory, and remain focused on delivering innovation and value as we enter 2026. I look forward to sharing updates next year. Have a great day.

謝謝接線生。感謝各位今天蒞臨。我們對2025年能夠以積極的勢頭結束感到興奮，並將繼續專注於在2026年提供創新和價值。我期待明年與大家分享最新進展。祝你有美好的一天。

Thank you. Ladies and gentlemen, that then concludes today's conference. Thank you for joining us. You may now disconnect your lines.

謝謝。女士們、先生們，今天的會議到此結束。感謝您的參與。現在您可以斷開線路了。