Amphastar Pharmaceuticals Inc (AMPH) 2025 Q1 法說會逐字稿

Greetings, and welcome to the Amphastar Pharmaceuticals first-quarter earnings call. (Operator Instructions)

大家好，歡迎參加 Amphastar Pharmaceuticals 第一季財報電話會議。（操作員指示）

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 future periods are forward-looking statements. These statements are based solely on information that is now available to us. We encourage you to review the section entitled forward-looking statements in the press release issued today and the presentation on the company's website.

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）均屬於前瞻性陳述。這些聲明完全基於我們目前掌握的資訊。我們鼓勵您查看今天發布的新聞稿中題為「前瞻性陳述」的部分以及公司網站上的介紹。

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. Important information on our use of these measures and reconciliations to US GAAP may be found in our earnings release. Please note, this conference call is being recorded.

此外，請參閱我們的 SEC 文件，該文件可在我們的網站和 SEC 網站上找到，其中討論了可能影響我們未來業績的眾多因素。我們也將討論某些非公認會計準則衡量指標。有關我們使用這些指標以及與美國公認會計準則 (GAAP) 進行調節的重要資訊可在我們的收益報告中找到。請注意，本次電話會議正在錄音。

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.

今天的演講者是財務長比爾·彼得斯先生、企業傳播高級副總裁丹·迪施納先生和監管事務和臨床營運執行副總裁托尼·馬爾斯先生。

I will now turn the conference over to your host, Mr. Dan Dischner, Senior Vice President of Corporate Communications. Dan, you may begin.

現在我將會議交給主持人、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, and good afternoon, everyone. Before we begin our Q1 earnings call, I'd like to take a moment to acknowledge the incredible dedication demonstrated by our teams here at Amphastar.

謝謝你，保羅，大家下午好。在我們開始第一季財報電話會議之前，我想花點時間來感謝 Amphastar 團隊所展現的令人難以置信的奉獻精神。

Recently, in the first quarter of this year, we were honored to receive the Drug Shortage Assistance Award from the US FDA. This prestigious award recognizes our significant efforts in preventing and alleviating critical drug shortages, ensuring that patients have access to essential medications. We take great pride in how our employees understand the importance of consistent access to medicine and continue to work diligently to prevent shortages.

最近，今年第一季度，我們很榮幸獲得美國FDA頒發的藥品短缺援助獎。這項享有盛譽的獎項表彰了我們在預防和緩解嚴重藥物短缺、確保患者能夠獲得基本藥物方面所做的重大努力。我們為我們的員工理解持續獲得藥物的重要性並繼續努力工作以防止藥物短缺感到非常自豪。

The dedication of our teams is what strengthens our company, our company culture and fuels our drive for success. We appreciate your continued support of Amphastar and are excited to share our progress with you today. So let's get started.

我們團隊的奉獻精神增強了我們的公司、增強了我們的公司文化並激發了我們走向成功的動力。我們感謝您對 Amphastar 的持續支持，並很高興今天與您分享我們的進展。那麼就讓我們開始吧。

As anticipated, Amphastar's performance in the first quarter exhibited a mix of results. With our critical care products such as dextrose and epinephrine experiencing softened demand due to increased competition, similarly, the competitive landscape for glucagon has intensified. As a result, we reported net revenues of $170.5 million for the first quarter, reflecting a modest 1% decline compared to the same period last year. Despite this relatively flat performance, it underscores the enduring strength and resilience of our diversified portfolio in a dynamic market environment.

正如預期的那樣，Amphastar 第一季的業績表現好壞參半。由於競爭加劇，我們的重症監護產品（如葡萄糖和腎上腺素）的需求下降，同樣，胰高血糖素的競爭格局也加劇了。因此，我們報告第一季淨收入為 1.705 億美元，與去年同期相比小幅下降 1%。儘管表現相對平淡，但它凸顯了我們多元化投資組合在動態市場環境中的持久實力和韌性。

We recognize the cyclical nature of drug shortages and anticipate that the trends observed in the first quarter will continue throughout the year. As we marked the beginning of 2025, BAQSIMI achieved sales of $38.3 million in the first quarter. This figure is closely aligned with the combined BAQSIMI sales by Lilly and Amphastar of $38.7 million recorded in the first quarter of the previous year.

我們認識到藥品短缺的周期性，並預計第一季觀察到的趨勢將持續全年。2025年開始，BAQSIMI第一季的銷售額達到3,830萬美元。這數字與禮來公司和 Amphastar 公司去年第一季的 BAQSIMI 總銷售額 3,870 萬美元非常接近。

The first quarter of 2025 also represents the first in which Amphastar has taken full control of all BAQSIMI operations, including distribution in all countries following the successful conclusion of our transition from Lilly.

2025 年第一季也是 Amphastar 首次全面控制所有 BAQSIMI 業務，包括成功完成從禮來 (Lilly) 的過渡後在所有國家的分銷。

In January, we proudly launched our strategic partnership with MannKind, whose experienced sales force has enhanced our promotional reach for BAQSIMI. While this expansion positions us favorably for sustainable long-term growth, we remain focused on the fact that the majority of the benefits and returns from these initiatives are expected to materialize in the second half of 2025.

今年 1 月，我們很自豪地與 MannKind 建立了策略合作夥伴關係，其經驗豐富的銷售團隊增強了我們對 BAQSIMI 的推廣範圍。雖然此次擴張為我們實現可持續的長期成長創造了有利條件，但我們仍然關注的是，這些舉措的大部分收益和回報預計將在 2025 年下半年實現。

Primatene MIST continues to be a cornerstone of our branded portfolio, demonstrating remarkable performance with sales reaching $29 million this quarter, a 20% increase compared to $24 million in the same period last year. This growth can be attributed to significant increase in unit volumes and sustained demand across our distribution channels.

Primatene MIST 繼續作為我們品牌組合的基石，表現卓越，本季銷售額達 2,900 萬美元，較去年同期的 2,400 萬美元成長 20%。這一增長得益於銷售的大幅增長以及我們分銷渠道的持續需求。

In tandem with this success, we have expanded our physician sampling program, which was enhanced earlier this year by launching a pilot initiative aimed at improving outreach to primary care physicians. We are confident that these strategic efforts will further bolster the growth of market positions for Primatene MIST.

在這一成功的基礎上，我們擴大了醫生抽樣計劃，該計劃於今年早些時候得到加強，啟動了一項旨在改善初級保健醫生覆蓋範圍的試點計劃。我們相信，這些策略努力將進一步促進 Primatene MIST 市場地位的成長。

Together with BAQSIMI, we anticipate that both products will serve as key drivers of revenue growth throughout 2025, further solidifying our commitment to expanding our branded product portfolio. As we assess the glucagon and epinephrine markets, we recognize the ongoing competitive pressures influencing our performance.

我們預計，與 BAQSIMI 一起，這兩款產品將成為 2025 年全年營收成長的主要驅動力，進一步鞏固我們擴大品牌產品組合的承諾。當我們評估胰高血糖素和腎上腺素市場時，我們意識到持續的競爭壓力正在影響我們的表現。

This remains -- we remain committed to navigating these challenges while focusing on delivering quality and value to our customers and stakeholders. In the first quarter, our pipeline is strategically focused on capturing several promising near-term opportunities.

我們將繼續致力於應對這些挑戰，同時專注於為我們的客戶和利害關係人提供優質和有價值的服務。在第一季度，我們的策略重點是抓住幾個有前景的短期機會。

We are encouraged by the FDA's recent communication concerning our AMP-002 filing. While we typically refrain from providing details on FDA communication and do not intend to set a precedent in doing so, we feel it is important to share this exception due to the extended time since our filing has exceeded its original GDUFA date.

FDA 最近就我們的 AMP-002 申請發出的通知令我們感到鼓舞。雖然我們通常不會提供有關 FDA 溝通的詳細信息，也不打算開創先例，但我們認為分享這一例外情況非常重要，因為我們的申請已經超過了其原始的 GDUFA 日期。

We responded to a simple FDA request promptly within one day and maintain a positive outlook on the progress of AMP-002's submission. As we look ahead to our upcoming ANDA filings, we'd like to provide an update on the progress. For AMP-007, our inhalation product, we are on track to submit our response to the recently received Complete Response Letter, or CRL, in the second quarter.

我們在一天之內迅速回應了 FDA 的簡單請求，並對 AMP-002 的提交進展保持積極的態度。當我們展望即將提交的 ANDA 申請時，我們想提供最新進展。對於我們的吸入產品 AMP-007，我們將在第二季提交對最近收到的完整回覆函（CRL）的回覆。

Additionally, for AMP-015, our teriparatide product, we are pleased to report that the GDUFA goal date is still on schedule for the fourth quarter of this year. Furthermore, concerning AMP-018, our GLP-1 ANDA, we anticipate submitting our response to the recently received CRL in the second half of this year. We are pleased to announce that the FDA has accepted our Biologics License Application or BLA for insulin aspart, identified as AMP-004, with a Biosimilar User Fee Act or BsUFA goal date set in the first quarter of 2026.

此外，對於我們的特立帕肽產品 AMP-015，我們很高興地報告，GDUFA 目標日期仍將在今年第四季按計劃進行。此外，關於我們的 GLP-1 ANDA AMP-018，我們預計將在今年下半年提交對最近收到的 CRL 的回應。我們很高興地宣布，FDA 已經接受了我們的門冬胰島素生物製品許可申請 (BLA)，編號為 AMP-004，其生物相似藥用戶付費法案 (BsUFA) 目標日期定於 2026 年第一季。

This acceptance represents a significant milestone in our efforts to expand our portfolio of interchangeable biosimilar insulin offerings, demonstrating our commitment to enhancing patient access to vital treatments. In light of the current tariff discussions, we as a domestic manufacturer, are closely monitoring the evolving situation. We hope policymakers will take into account the distinctive aspects of the pharmaceutical sector and the vital role we play in the health care system as they attempt to level the playing field and shape trade policies.

此次認可代表著我們努力擴大可互換生物相似藥胰島素產品組合的一個重要里程碑，顯示了我們致力於提高患者獲得重要治療的機會的承諾。鑑於當前的關稅討論，作為國內製造商，我們正在密切關注形勢的發展。我們希望政策制定者在試圖創造公平競爭環境和製定貿易政策時，能夠考慮到製藥業的獨特之處以及我們在醫療保健系統中發揮的重要作用。

While we manufacture all of our finished products in the United States, we do import some components and API. As the tariffs currently stand, it will not materially impact our costs. We understand that transitioning from a generic-driven business model to a more diversified portfolio that includes proprietary and interchangeable biosimilar products is a process that requires time and strategic effort.

雖然我們的所有成品都在美國生產，但我們確實進口了一些零件和 API。按照目前的關稅，它不會對我們的成本產生重大影響。我們明白，從仿製藥驅動的商業模式轉變為包括專有和可互換的生物仿製藥產品的更加多樣化的產品組合是一個需要時間和戰略努力的過程。

Our expertise in critical care areas like immunogenicity and product characterization demonstrated through the successful development of complex products such as glucagon and enoxaparin underscores the robust capabilities of our R&D team. As we move forward, we remain optimistic about the potential to strengthen our commercial position and enhance our portfolio of products awaiting approval.

我們透過成功開發胰高血糖素和依諾肝素等複雜產品，證明了我們在免疫原性和產品特性等重症監護領域的專業知識，凸顯了我們研發團隊的強大能力。隨著我們不斷前進，我們仍然對加強我們的商業地位和增強等待批准的產品組合的潛力持樂觀態度。

We are particularly excited about the future of our pipeline within high-value therapeutic areas, which we believe will drive significant value for our stakeholders. Our commitment to operational excellence will be the cornerstone of our strategy as we navigate the path ahead. Thank you for your continued support, and we look forward to sharing our progress in the coming quarters.

我們對高價值治療領域的產品線未來感到特別興奮，我們相信這將為我們的利害關係人帶來巨大的價值。我們對卓越營運的承諾將成為我們未來道路上策略的基石。感謝您一直以來的支持，我們期待在未來幾季分享我們的進展。

Now I will turn our call over to our CFO and Executive Vice President of Finance, Bill Peters.

現在，我將把電話轉給我們的財務長兼財務執行副總裁比爾彼得斯 (Bill Peters)。

Thank you, Dan. Revenues for the first quarter decreased 1% to $170.5 million from $171.8 million in the previous year's period. BAQSIMI revenues for products shipped by Amphastar grew 177% to $38.4 million compared to $13.8 million in the prior year period. As we have now fully assumed responsibility for distribution in all countries around the world, we no longer have a net economic benefit booked to other revenues, which in the prior year period accounted for sales of $14.2 million.

謝謝你，丹。第一季的營收從去年同期的 1.718 億美元下降 1% 至 1.705 億美元。BAQSIMI 透過 Amphastar 出貨的產品收入成長了 177%，達到 3,840 萬美元，而去年同期的營收為 1,380 萬美元。由於我們現在已經完全承擔起在全球所有國家分銷的責任，我們不再將淨經濟利益記入其他收入，而去年同期的銷售額為 1,420 萬美元。

Primatene MIST sales grew to $29.1 million in the quarter, which represents sales growth of 20% from $24.2 million in the first quarter of last year. Glucagon injection sales declined 27% to $20.8 million from $28.5 million due to increased competition. Epinephrine sales decreased 29% to $18.6 million from $26.1 million due to increased competition for our multidose vial product. Other finished pharmaceutical product sales decreased $2.2 million to $50 million from $52.2 million due to competition for enoxaparin, naloxone, and dextrose.

Primatene MIST 本季銷售額成長至 2,910 萬美元，較去年第一季的 2,420 萬美元成長 20%。由於競爭加劇，胰高血糖素注射液的銷售額從 2,850 萬美元下降 27% 至 2,080 萬美元。由於多劑量小瓶產品競爭加劇，腎上腺素銷售額從 2,610 萬美元下降 29% 至 1,860 萬美元。由於依諾肝素、納洛酮和葡萄糖的競爭，其他成品藥品銷售額從 5,220 萬美元減少 220 萬美元至 5,000 萬美元。

This trend was partially offset by sales of albuterol, which we launched in August last year and increased unit sales of phytonadione. Cost of revenues increased to $85.3 million from $81.7 million. Gross margins declined to 50% of revenues in the first quarter of 2025 from 52.4% in the previous year.

這一趨勢被我們去年 8 月推出的沙丁胺醇的銷售和植物甲萘醌單位銷售額的成長部分抵消。收入成本從 8,170 萬美元增至 8,530 萬美元。毛利率從前一年的 52.4% 下降到 2025 年第一季營收的 50%。

The primary driver of the change was the shift in distribution of BAQSIMI from Lilly to Amphastar as BAQSIMI sales from Lilly were booked net of expenses, giving them a gross margin of 100%. Additionally, pricing declines for our Epinephrine multi-dose vial product, which is one of our higher-margin products, contributed to this change. These changes were partially offset by an increase in sales of Primatene MIST and phytonadione, both of which are higher-margin products.

造成這項變更的主要驅動因素是 BAQSIMI 的經銷從禮來公司轉向 Amphastar，因為禮來公司的 BAQSIMI 銷售額扣除費用後記入賬，毛利率達到 100%。此外，我們的高利潤產品之一腎上腺素多劑量瓶產品的價格下降也導致了這種變化。這些變化被 Primatene MIST 和 phytonodione 的銷售成長部分抵消，這兩種產品都是利潤率較高的產品。

Selling, distribution, and marketing expenses increased 27% to $11.9 million from $9.4 million in the previous year's period due to the expansion of our sales and marketing efforts related to BAQSIMI, particularly the co-promotion agreement with MannKind as well as increased marketing efforts for Primatene MIST.

銷售、分銷和行銷費用從去年同期的 940 萬美元增加 27% 至 1190 萬美元，這歸因於我們擴大了與 BAQSIMI 相關的銷售和營銷力度，特別是與 MannKind 的聯合推廣協議以及加大了對 Primatene MIST 的營銷力度。

General and administrative spending increased 2% to $16 million from $15.7 million. Research and development expenditures increased 18% to $20.1 million from $17 million due to the timing of clinical trials and FDA filing fees. Our nonoperating expense of $6.4 million compared to a nonoperating expense last year of $100,000, primarily due to foreign currency fluctuations.

一般及行政支出從 1,570 萬美元增加 2% 至 1,600 萬美元。由於臨床試驗的時間安排和 FDA 申請費用，研發支出從 1,700 萬美元增加 18% 至 2,010 萬美元。我們的非營業支出為 640 萬美元，而去年的非營業支出為 10 萬美元，這主要是由於外匯波動造成的。

Net income decreased to $25.3 million or $0.51 per share in the first quarter from $43.2 million or $0.81 per share in the first quarter of 2024. Adjusted net income decreased to $36.9 million or $0.74 per share to an adjusted net income of $55.3 million or $1.04 per share in the first quarter of last year.

淨收入從 2024 年第一季的 4,320 萬美元或每股 0.81 美元下降至第一季的 2,530 萬美元或每股 0.51 美元。調整後淨收入下降至 3,690 萬美元或每股 0.74 美元，而去年第一季調整後淨收入為 5,530 萬美元或每股 1.04 美元。

Adjusted earnings excludes amortization, equity compensation, impairments of long-lived assets, and onetime events. In the first quarter, we had cash flow from operations of approximately $35.1 million, and we used a portion of our cash to buy back $11 million worth of shares.

調整後的收益不包括攤銷、股權補償、長期資產減損和一次性事件。第一季度，我們的營運現金流約為 3,510 萬美元，我們使用部分現金回購了價值 1,100 萬美元的股票。

Before I turn the call back over to Dan, I wanted to address the first question on investors' minds this year, which is the potential impact of tariffs. While we don't know where tariffs will end up, we believe we are in a good position because we manufacture all of our finished products in the United States.

在我將電話轉回給丹之前，我想先回答今年投資者關心的第一個問題，那就是關稅的潛在影響。雖然我們不知道關稅最終會是多少，但我們相信我們處於有利地位，因為我們所有的成品都在美國生產。

Our current exposure is on certain active ingredients and components, which we import from various countries. At this time, we estimate that the impact to Amphastar under the current tariff situation is an increase in cost of about $500,000 per quarter. The impact in the first quarter was less than half of that amount.

我們目前關注的是某些活性成分和成分，這些成分和成分是從各國進口的。目前，我們估計，在當前關稅狀況下，對 Amphastar 的影響是每季增加約 50 萬美元。第一季的影響還不到該數字的一半。

I will now turn the call back over to Dan.

我現在將電話轉回給丹。

Okay, Paul, we'll take questions now.

好的，保羅，我們現在開始回答問題。

(Operator Instructions) David Amsellem, Piper Sandler.

（操作員指示）David Amsellem，Piper Sandler。

So just wanted to talk more about the expectation for the rest of the year as it relates to new launches. I think you cited at least the potential for a couple of launches before the end of this year. And with CRLs and just the multi-cycle nature of these filings, can you just talk about how you're thinking about impact from new launches this year and the extent to which that could cushion the impact of competition? So that's number one.

因此，我只是想多談談今年剩餘時間新產品發布的預期。我認為您提到了至少在今年年底之前進行幾次發射的可能性。鑑於 CRL 和這些申請的多周期性質，您能否談談您如何看待今年新產品發布的影響，以及這能在多大程度上緩解競爭的影響？這是第一點。

And then number two, on BAQSIMI, I'm just trying to better understand your commercial support initiatives here. And I guess I understand the focus or at least in part on primary care. But I guess, is the uptick in volumes that you're expecting also a function of you assuming full responsibility over the asset?

第二，關於 BAQSIMI，我只是想更了解你們在這裡的商業支援舉措。我想我理解重點，或至少部分理解重點是初級保健。但我想，您預期的交易量上升是否也是您對資產負完全責任的結果？

In other words, was there some disruption that muted volume growth and now assuming full responsibility gets you to a better place in terms of volume growth? I'm just trying to understand how you're getting there just beyond these commercial initiatives.

換句話說，是否存在一些幹擾因素導致銷售成長放緩，而現在承擔全部責任是否能讓您在銷售成長方面取得更好的成績？我只是想知道除了這些商業舉措之外，你們是如何實現這一目標的。

David, I'll take the first part of your question relating to approvals. We have our first cycle CRL for AMP-007. That's the one that we really feel very positive about. We plan to respond to that CRL in the second quarter of this year.

大衛，我將回答你關於批准的問題的第一部分。我們有 AMP-007 的第一個週期 CRL。這是我們真正感到十分樂觀的事。我們計劃在今年第二季對該 CRL 做出回應。

So I think from that perspective is giving us a lot of optimism. The second is the meetings that Dan referred to for AMP-002. I think that the meeting that we held, the IR that they engaged us with that we respond to the next day. I think that's pretty telling about the optimism about that product. We still have the action date for AMP-015 for the fourth quarter of this year.

所以我認為從這個角度來看這給了我們很多樂觀。第二個是 Dan 提到的 AMP-002 會議。我認為我們召開的會議以及他們與我們接觸的 IR 我們會在第二天做出回應。我認為這充分錶明了人們對該產品的樂觀態度。我們仍然有今年第四季 AMP-015 的行動日期。

And that one as far as a revenue driver, I think given that this would be the third generic in that space, although it's a decent-sized product and the timing of that, I think the revenue optimism wouldn't be too high for this year.

就收入驅動因素而言，我認為考慮到這將是該領域的第三種仿製藥，儘管它是一款體面的產品，而且時機成熟，但我認為今年的收入樂觀度不會太高。

And just to follow up on that. So going back to that again. So we think that 007, 002, and 015 are all things that have a possibility to be approved in time to get revenues this year. And our assumption to get to flat revenue for the year was based on sales from two of those products later on in the year. So at this time, I will say, even though you didn't ask it, but we're still comfortable with our flat revenue for the year guidance that we gave at the last conference call.

只是為了跟進這一點。所以再次回到那個話題。因此，我們認為 007、002 和 015 都有可能及時獲得批准，今年將獲得收入。我們假設全年營收持平，是基於其中兩款產品在年底的銷售量。所以現在，我想說，即使你們沒有問，我們仍然對上次電話會議上給出的全年收入持平預期感到滿意。

And then for your second question, the BAQSIMI support. So we took over all of the selling responsibilities for the promotional responsibilities for it at the end of 2023. So we've been doing that for more than one year now.

然後是您的第二個問題，BAQSIMI 支援。因此，我們在 2023 年底接手了所有銷售和促銷責任。我們已經這樣做了一年多了。

What's changed over the course of last year, we did increase the sales force size. And then this year, we also added the co-promote agreement with MannKind. So we, over time, have been increasing the outreach that we have. And most of that is focused on endocrinologists, not really on primary care. So just to clarify that as well.

去年發生的變化是，我們確實增加了銷售團隊的規模。今年，我們也增加了與 MannKind 的聯合推廣協議。因此，隨著時間的推移，我們一直在擴大我們的影響力。其中大部分都集中在內分泌學家身上，而不是初級保健。所以也只是為了澄清這一點。

And then additionally, with the script growth, we did see -- if you remember last year, as we transitioned from Lilly to Amphastar at the end of the first quarter, we did have a couple of hiccups that we mentioned in the second quarter call last year, where there was a couple pharmacies that showed the product is being discontinued, a couple of states, Medicare took a little longer to get us up online. So all of those things are past us now.

此外，隨著處方的增長，我們確實看到——如果你還記得去年，當我們在第一季末從禮來（Lilly）過渡到 Amphastar 時，我們確實遇到了一些我們在去年第二季度電話會議上提到的小問題，有幾家藥店顯示該產品已停產，幾個州的醫療保險花了更長的時間才讓我們上線。所以所有這些事情現在都已成為過去。

So we're still comfortable with the guidance that we gave on that product as well, which was the high single-digit unit growth for this year.

因此，我們對該產品的預期仍然感到滿意，即今年該產品的單位成長率將達到高個位數。

Cerena Chen, Wells Fargo.

Cerena Chen，富國銀行。

Congrats on the filing acceptance for AMP-004. Can you talk more about the insulin aspart opportunity specifically of the insulin pipeline? And what are some of the competitive dynamics to keep in mind? And also just wanted to ask what you think might be the challenges, but also benefits of pursuing interchangeability?

恭喜 AMP-004 申請獲得受理。能否具體談談胰島素管道中的門冬胰島素機會？有哪些競爭動態需要牢記？另外，您也想問一下，您認為追求互換性可能面臨哪些挑戰，又有哪些好處？

Yeah. So first of all, it's a large sales product. So when we take a look at the opportunities out there, it's one of the bigger products out there with sales of over -- the IQVIA level sales of over $1.4 billion.

是的。首先，它是一款銷售量很大的產品。因此，當我們審視現有的機會時，我們發現它是較大的產品之一，銷售額超過——IQVIA 水平的銷售額超過 14 億美元。

And it's also -- I think it's over [40 million] units. So it's a big unit draw as well. So what we're seeing is a really big market opportunity. Right now, there is the brand and there is one generic. However, the generic out there is not biostep -- is not an interchangeable biosimilar. So our goal is to become the first product that's interchangeable. And that's been our goal all along.

而且—我認為它超過了 [4000 萬] 台。所以這也是一次大型單位抽籤。因此，我們看到的是一個非常大的市場機會。目前，有一個品牌，還有一個通用品牌。然而，市面上的仿製藥並非Biostep，它不是可互換的生物相似藥。所以我們的目標是成為第一個可互換的產品。這一直是我們的目標。

And maybe Tony can elaborate on the interchangeability aspect.

也許托尼可以詳細說明可互換性方面。

Yeah, we see the value of interchangeability is being able to get an immediate replacement whenever the patient needs one, they don't have to write a script to a specific type of insulin. It would be just an equivalent of a generic. So from a sales force perspective, we wouldn't have to have any kind of branded name like the biosimilars that you see are.

是的，我們認為互換性的價值在於，當病人需要時，他們能夠立即得到替換，而不必為特定類型的胰島素寫處方。它只不過是通用的一個等價物。因此，從銷售人員的角度來看，我們不必擁有任何像您所看到的生物相似藥那樣的品牌名稱。

So it would be just a simple switch whenever a physician wrote the prescription for insulin as part, they would immediately just convert it over to ours. So we see that as a very big value to the interchangeability.

因此，這只是一個簡單的轉換，每當醫生開出胰島素處方時，他們就會立即將其轉換為我們的處方。因此，我們認為這對於互換性來說具有非常大的價值。

We're working with the FDA, our perspective is that we want to have the interchangeability only. And our targeted first approval for this would be for interchangeability rather than what we often see, which is companies get approved as a biosimilar and then later meet the threshold for the interchangeable.

我們正在與 FDA 合作，我們的觀點是，我們只希望實現互換性。我們對此的首次批准目標是可互換性，而不是我們經常看到的情況，即公司先獲得生物仿製藥的批准，然後再達到可互換性的門檻。

Jason Gerberry, Bank of America.

美國銀行的 Jason Gerberry。

Just wanted to come back to the outlook for sales to be flat in 2025. So on the pipeline comment, I just wanted to make sure I heard this right.

只是想回到 2025 年銷售額持平的前景。因此，關於管道評論，我只是想確保我聽到的是正確的。

So that assumes that there's some second half contribution from one or both 002, 007 and from time of like submitting a response. What's the turnaround time for getting a GDUFA? And then with BAQSIMI, I think you've mentioned, I think, high single-digit volume growth for the product and a little bit of the price benefit carrying over in '25.

因此，假設 002、007 中的一個或兩個以及提交回應時會做出一些後半部的貢獻。獲得 GDUFA 的周轉時間是多久？然後對於 BAQSIMI，我想您已經提到過，我認為該產品的銷售將呈現高個位數成長，並且價格優勢將在 25 年延續下去。

But if I'm looking at the $38 million this quarter, isn't the comparable year on year number roughly $38.5 million, so kind of flat growth on a year on year basis in 1Q? And so I'm just kind of -- and so we just need to kind of buy into the second half kind of uptick from the MannKind-driven promotion?

但如果我看本季的 3800 萬美元，那麼與去年同期相比的數字不是大約是 3850 萬美元嗎，所以第一季與去年同期相比是持平增長？所以我只是有點——所以我們只是需要從 MannKind 推動的促銷活動中購買下半年的上升趨勢？

Yeah. So just to clarify, the first thing is that we said we have the possibility of sales from AMP-002, AMP-015, and AMP7. So those are the three that we believe that we have the possibility and our forecast and what we said was that we would need sales from two products. And Tony can tell you a little bit more about the for the GDUFA, which right now would be really for 007, which we plan to respond to shortly.

是的。因此，需要澄清的是，首先我們說過我們有可能銷售 AMP-002、AMP-015 和 AMP7。因此，我們相信這三種產品都有可能實現，我們進行了預測，我們所說的是，我們需要兩種產品的銷售量。東尼可以向您詳細介紹《GDUFA》的情況，目前該法案實際上是針對 007 的，我們計劃很快對此做出回應。

Yeah. The turnaround depending on what categorization the agency would put these into would either be a minor or a major. If it's a major response, it would be 8 to 10 months. If it's minor, it would be 90 days.

是的。轉變取決於該機構將這些物品歸入哪個類別，可能是輕微的，也可能是重大的。如果出現重大反應，則需要 8 到 10 個月。如果是小事，則需要 90 天。

Got it. And then maybe just on the margin pressures that we see in 1Q on gross and net income, just are these good run rates in the absence of pipeline surprises or a major inflection in BAQSIMI when we look to the next couple of quarters?

知道了。那麼也許只是從我們在第一季看到的總收入和淨收入的利潤壓力來看，當我們展望未來幾個季度時，在沒有管道意外或 BAQSIMI 出現重大拐點的情況下，這些運行率是否良好？

So let me answer your previous BAQSIMI question first. So you're right, we were relatively flat year over year with the sales dollars. And what -- in the first quarter of last year, what we saw was that there was a little bit of a channel load as both Lilly was selling products in the United States and we launched.

因此，讓我先回答您先前關於 BAQSIMI 的問題。所以你說得對，我們的銷售額與去年同期相比基本持平。去年第一季度，我們發現，由於禮來公司在美國銷售產品，而我們又推出了產品，因此通路負載有點大。

So there was a little bit of extra inventory in the channel by the end of the first quarter. So that was part of the reason for that. And then we saw a little bit of weakness in the second quarter because of some of the software issues with certain pharmacies and some of the state Medicaid issues.

因此，到第一季末，通路中就會出現一些額外的庫存。這就是部分原因。然後，我們發現第二季度出現了一些疲軟現象，原因是某些藥局存在一些軟體問題，以及一些州醫療補助問題。

So what we've seen in the first quarter is from the IQVIA data is relatively low single-digit growth year over year. But so far in the second quarter, every week has shown a low double-digit growth rate so far this quarter. So I think we're getting back to that number. So I think you'll see some of those trends reverse and that we're still confident that we will get to this high single-digit growth.

因此，我們從 IQVIA 數據中看到，第一季的年比成長率相對較低。但第二季迄今為止，每週的成長率都保持在兩位數的低點。所以我認為我們會回到這個數字。因此，我認為你會看到其中一些趨勢發生逆轉，我們仍然有信心實現這一高個位數成長。

Now back to the margin question. There's a couple of things that are going against each other there. And one is we have not seen all of the price pressure on glucagon in the first quarter. That was something where the launch didn't happen at the end of the quarter. So the lower price for that product is only in there for maybe one month out of the quarter, not three.

現在回到保證金問題。那裡有幾件事是互相矛盾的。一是，我們在第一季還沒有看到胰高血糖素的全部價格壓力。也就是說，該產品未能在本季末推出。因此，該產品的低價可能只在每季的一個月內出現，而不是三個月。

So we will see margin pressure on that product and pricing pressure on that product as we go forward. But we're also -- as we mentioned, we're still growing Primatene MIST and BAQSIMI, which are higher-margin products. And we're taking some actions internally to make sure that we're cost competitive.

因此，隨著我們未來的發展，我們將看到該產品的利潤率和定價壓力。但正如我們所提到的，我們仍在成長Primatene MIST和BAQSIMI，它們是利潤率更高的產品。我們正在內部採取一些措施，以確保我們的成本競爭力。

So we're focusing on a lot of things that could help us operate the business a little bit more efficiency -- efficiently with a little bit less cost. So those are things that we're -- management is actively working on over the last several months and that we've already taken action on at this time.

因此，我們專注於許多可以幫助我們更有效率地經營業務的事情——以更低的成本高效地經營業務。所以這些都是我們管理階層在過去幾個月裡積極努力的事情，而且我們目前已經採取了行動。

Ekaterina Knyazkova, JPMorgan.

葉卡捷琳娜·克尼亞茲科娃，摩根大通。

So first is just on the regulatory landscape. There's obviously been a lot of changes at the FDA with the new administration. Do you see that kind of impacting review time lines or the approval process more broadly for kind of complex generics specifically?

首先是監管環境。新政府上台後，FDA 顯然發生了很多變化。您是否認為這會影響審查時間表或更廣泛意義上的複雜仿製藥的審批流程？

And then the second question is just around tariffs. Depending on what they end up looking like, is there an opportunity for you guys to leverage your US footprint to potentially pick up more share in certain markets? How much spare capacity do you potentially have that you could leverage for this?

第二個問題是關於關稅的。根據最終結果，你們是否有機會利用在美國的業務，在某些市場獲得更多的份額？您可能有多少閒置產能可以利用來達到這個目的？

Yeah. As far as the switches and the changes that we've seen at the FDA, we've seen some changes to some persons and some of those are public and we've seen it and some are at the project management level. And we really haven't seen an impact to our -- any of our timings for our applications.

是的。就我們在 FDA 看到的轉變和變化而言，我們看到一些人發生了一些變化，其中一些是公開的，我們已經看到了，還有一些是在專案管理層面。我們確實沒有看到對我們的應用程式時間的任何影響。

The only difference -- the only change we've seen are just minor. Sometimes it would take a few days for a project manager to get back to us with a question, and now it may be a week. But I would categorize that as really minor. It really hasn't affected. We've had a few action dates that the agency has met in responding to. So we haven't seen any impact with that.

唯一的區別——我們所看到的唯一變化只是微小的。有時專案經理需要幾天才能回覆我們問題，而現在可能需要一周時間。但我會將其歸類為非常小的事情。確實沒影響。我們已經設定了幾個行動日期，該機構也都按時完成了回應。因此，我們目前還沒有看到任何影響。

Second thing on tariffs is, yeah, because we are a US manufacturing company, I think we're in a much better place than a lot of companies are. So it really depends on how the tariffs are implemented. At the moment, with tariffs on certain components and APIs, right now, we are paying a tariff on the API that we bring in from our China facility. And so that's what's leading mostly to that cost increase that I mentioned.

關於關稅的第二件事是，是的，因為我們是一家美國製造公司，我認為我們的處境比許多公司好得多。所以這實際上取決於關稅如何實施。目前，由於對某些組件和 API 徵收關稅，我們現在正在為從中國工廠進口的 API 支付關稅。這就是我提到的導致成本增加的主要原因。

However, if we take a look at -- if those go away and they focus on the finished products, we're in a much better position. So we're definitely hoping that the government focuses more on where the finished product is made.

然而，如果我們放眼未來——如果這些限制取消，政府把重點放在成品上，我們的情況就會好得多。所以我們當然希望政府能更重視成品的生產地。

So -- but on the components and raw materials. The good thing is that we source from a variety of countries around the world. We make several of our APIs in the United States as well. So we're not really overexposed to any single country.

所以——但在組件和原料方面。好消息是，我們的採購來源來自世界各地的多個國家。我們也在美國生產多種 API。因此，我們實際上並沒有對任何一個國家過度關注。

Serge Belanger, Needham.

塞爾日·貝朗格，尼德漢姆。

This is John on for Serge today. Just want to touch on glucagon and epinephrine first. Currently, they're down about 29% year over year in this quarter. Is this something we should expect based on more competitive pressures on these products?

今天是 John，取代 Serge 的節目。首先我想先聊聊胰高血糖素和腎上腺素。目前，本季的銷售額較去年同期下降了約 29%。基於這些產品面臨的越來越大的競爭壓力，我們是否應該期待這種情況發生？

And is this more or less a full-time impact of the competition? And then with the remainder of the portfolio as well, you kind of touched on some external factors that are hitting those as well. If you can just give a little clarity on some of the dynamics going on there as well, that would be great.

這或多或少是比賽的全職影響嗎？然後對於投資組合的剩餘部分，您也提到了一些對其產生影響的外部因素。如果您能稍微澄清一下那裡正在發生的一些動態，那就太好了。

Yeah. So for epinephrine, we saw two new launches in that -- in our multi-dose file presentation last year. So with that the pricing impact is fully baked in there and our margin or our share loss is fully baked into the epinephrine. However, we also saw the prefilled syringe as well for epinephrine. So right now, we're still the only company making that in the United States. So there's always the possibility that someone returns to that. So that certainly is a risk to that.

是的。對於腎上腺素，我們在去年的多劑量文件演示中看到了兩種新產品的推出。因此，定價影響已完全反映在內，我們的利潤或股票損失也已完全體現在腎上腺素中。然而，我們也看到了裝有腎上腺素的預充注射器。所以目前我們仍然是唯一一家在美國生產這種產品的公司。所以總有可能有人會回歸到這種模式。所以這確實是一個風險。

On glucagon, as I mentioned earlier, the competitor on that product didn't launch at the beginning of the quarter. So we only have about a third of the quarter baked into that extra competition going from really a two-player to a three-player market. So I would expect that product to decline even faster.

關於胰高血糖素，正如我之前提到的，該產品的競爭對手並沒有在本季初推出。因此，我們只有大約三分之一的季度時間被納入額外的競爭中，從真正的雙人市場到三人市場。所以我預計該產品的衰退速度會更快。

And also keeping in mind that, as we've said, people are moving from -- for the people that are using the glucagon injection kit as an anti-hypoglycemic product, which is about 30% of our market now, those people are generally moving over to ready-to-use products like BAQSIMI.

還要記住，正如我們所說的，人們正在從使用胰高血糖素注射套件作為抗低血糖產品的人（目前約占我們市場的 30%）轉向使用即用型產品，例如 BAQSIMI。

So that was a declining market anyway. So we do expect that one to continue to decline. As far as the rest of the portfolio goes, we do see the growth in BAQSIMI and Primatene MIST. Most of our other -- we had some pressure on dextrose as a company return to competition there. Keep seeing competition on enoxaparin and naloxone, and we're expecting competition on phytonadione in the coming year as well.

無論如何，這是一個衰退的市場。因此我們確實預計該數字將繼續下降。就投資組合的其餘部分而言，我們確實看到了 BAQSIMI 和 Primatene MIST 的成長。我們的大部分其他業務——隨著公司重返競爭，我們在葡萄糖方面面臨一些壓力。我們將繼續看到依諾肝素和納洛酮的競爭，我們預計來年植物甲萘醌也將出現競爭。

So there's a handful of products with increased competition, a couple of products with where we think we're going to have growth and then the rest of the products should remain relatively flat.

因此，有少數產品的競爭加劇，有幾種產品我們認為將實現成長，其餘產品應該保持相對穩定。

There are no further questions at this time. I'd like to hand the floor back over to management for any closing comments.

目前沒有其他問題。我想將發言權交還給管理階層，請他們發表最後評論。

Thank you all for joining us today. We appreciate your support, and we look forward to sharing more updates in our next call. Have a great day.

感謝大家今天的參與。我們感謝您的支持，並期待在下次通話中分享更多更新。祝你有美好的一天。