Amphastar Pharmaceuticals Inc (AMPH) 2025 Q2 法說會逐字稿

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

您好，歡迎參加 Amphastar Pharmaceuticals 第二季財報電話會議。（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. 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.

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。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。

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 is being recorded.

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，本次會議正在錄製。

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. Good afternoon, and thank you for joining our second-quarter 2025 earnings call. I'm pleased to share that Amphastar delivered a solid performance in the second quarter of 2025, highlighting the continued strength of our commercial execution, the resilience of our diversified portfolio, and our strategic focus on long-term growth.

謝謝你，保羅。下午好，感謝您參加我們的 2025 年第二季財報電話會議。我很高興地告訴大家，Amphastar 在 2025 年第二季度取得了穩健的業績，突顯了我們商業執行的持續強勁、多元化投資組合的彈性以及對長期增長的戰略重點。

For the second quarter, we reported net revenues of $174.4 million and a GAAP net income of $31 million or $0.64 per diluted share. On a non-GAAP basis, adjusted net income was $40.9 million, or $0.85 per diluted share. The performance was primarily driven by the strong momentum of BAQSIMI, which has quickly established itself as a reliable top performer for Amphastar.

第二季度，我們報告的淨收入為 1.744 億美元，GAAP 淨收入為 3,100 萬美元，即每股攤薄收益 0.64 美元。以非公認會計準則計算，調整後淨收入為 4,090 萬美元，即每股稀釋收入 0.85 美元。這一業績主要得益於 BAQSIMI 的強勁成長勢頭，該公司已迅速成為 Amphastar 可靠的頂級表演者。

Total revenue for BAQSIMI increased by 21% year over year. The growth reflects our successful integration of global commercialization at the start of 2025 as well as an increase in unit volume and higher average selling prices. Additionally, we observed stable performance from Primatene MIST, indicating consistent consumer demand.

BAQSIMI 的總營收年增 21%。這一成長反映了我們在 2025 年初成功整合全球商業化，以及單位銷售的成長和平均售價的提高。此外，我們觀察到 Primatene MIST 的效能穩定，顯示消費者需求持續穩定。

Turning to our capital investment strategy. We recently announced a significant expansion at our California headquarters aimed at quadrupling domestic manufacturing capacity at that facility. In today's geopolitical environment, expanding our US manufacturing footprint is essential to mitigate risks associated with international supply chains. This investment not only strengthens our operational resilience, but also supports the advancement of our R&D pipeline.

談到我們的資本投資策略。我們最近宣布對加州總部進行大規模擴建，旨在將該工廠的國內製造能力提高四倍。在當今的地緣政治環境下，擴大我們的美國製造業足跡對於降低與國際供應鏈相關的風險至關重要。這項投資不僅增強了我們的營運彈性，也支持了我們研發管道的進步。

Our vertical integrated infrastructure backed by US-based production has long been a cornerstone of our operational excellence as we focus on maintaining control of quality and upholding high standards.

我們以美國生產為後盾的垂直整合基礎設施一直是我們卓越營運的基石，因為我們專注於維持品質控制和堅持高標準。

Shifting our discussion to our regulatory initiatives. Our product candidate, AMP-002, has been under FDA review for an extended period. We have engaged in productive and ongoing dialogue with the agency and value the collaborative nature of these interactions. Based on the progress of our discussions and the feedback received to date, we remain optimistic for a near-term approval and look forward to the opportunity to deliver this important product to patients as soon as possible.

將我們的討論轉向監管舉措。我們的候選產品 AMP-002 已經接受 FDA 的長期審查。我們與該機構進行了富有成效的持續對話，並重視這些互動的協作性質。根據我們討論的進展和迄今為止收到的回饋，我們對近期批准保持樂觀，並期待有機會盡快將這一重要產品交付給患者。

We continue to advance several additional key regulatory programs. For our AMP-007 inhalation filing, we have received additional feedback from the FDA and now expect a GDUFA date in the first half of 2026.

我們繼續推進幾個額外的關鍵監管項目。對於我們的 AMP-007 吸入劑申請，我們收到了 FDA 的額外回饋，現在預計 GDUFA 日期為 2026 年上半年。

We're pleased to report that our teriparatide product, AMP-015, remains on track and is expected to meet our previously communicated guidance with a GDUFA action date in the fourth quarter of this year.

我們很高興地報告，我們的特立帕肽產品 AMP-015 仍在按計劃進行，預計將滿足我們先前傳達的指導，即今年第四季度的 GDUFA 行動日期。

As for our GLP-1 ANDA, or AMP-018, we are on track to respond to the complete response letter in the second half of this year.

至於我們的 GLP-1 ANDA 或 AMP-018，我們將在今年下半年回覆完整回信。

Additionally, we're incredibly excited about the long-term potential of our insulin Aspart BLA, AMP-004, as we continue to advance this program with interchangeability as our ultimate goal. While the recent approval of the first interchangeable insulin aspart product triggers a marketing exclusivity period, we view this as a meaningful milestone for the entire category.

此外，我們對我們的胰島素 Aspart BLA、AMP-004 的長期潛力感到非常興奮，因為我們將繼續以互換性為最終目標推進該計劃。雖然最近批准的首個可互換門冬胰島素產品觸發了行銷獨佔期，但我們認為這對整個類別來說是一個有意義的里程碑。

The FDA's decision to grant interchangeability not only validates the regulatory pathway, but sets a strong precedent that supports the potential for future competing interchangeable biosimilars in the United States insulin market. This development underscores the growing importance of accessible and affordable insulin options, a trend we expect will accelerate beyond 2026.

FDA 授予互換性的決定不僅驗證了監管途徑，而且樹立了強有力的先例，支持了未來美國胰島素市場上競爭可互換生物相似藥的潛力。這一發展凸顯了可獲得且負擔得起的胰島素選擇日益增長的重要性，我們預計這一趨勢將在 2026 年後加速發展。

Amphastar is exceptionally well positioned to benefit from this shift. With all US-based finished product manufacturing and a deep expertise in developing and manufacturing complex injectables, we are confident in our ability to be a major contributor in this evolving market. We believe the long-term implications of this program could be transformative, both for Amphastar and for the millions of patients who depend on high-quality insulin therapies.

Amphastar 處於非常有利的位置，可以從這一轉變中受益。憑藉所有美國成品製造以及開發和製造複雜注射的深厚專業知識，我們有信心成為這個不斷發展的市場的主要貢獻者。我們相信，該計劃的長期影響可能會帶來變革，無論是對 Amphastar 還是對依賴高品質胰島素療法的數百萬患者而言。

As we look beyond our core pipeline and diabetes portfolio, we are actively driving Amphastar's evolution into a more diversified innovation-led company with a growing emphasis on branded and proprietary products. Operationally, we continue to balance fiscal discipline with strategic investment, ensuring our resources are allocated to high-impact opportunities.

當我們將目光投向核心產品線和糖尿病產品組合之外時，我們正在積極推動 Amphastar 發展成為一家更加多元化的創新公司，並越來越重視品牌和專有產品。在營運方面，我們繼續平衡財務紀律和策略投資，確保我們的資源分配給具有高影響力的機會。

Our R&D expense rose 14% year over year, driven primarily by increased material and clinical trial costs, reflecting our deliberate investment in future growth. We view R&D as a critical engine of long-term value creation that enhances and extends our commercial capabilities.

我們的研發費用年增 14%，主要原因是材料和臨床試驗成本增加，這反映了我們對未來成長的深思熟慮的投資。我們將研發視為長期價值創造的關鍵引擎，它可以增強和擴展我們的商業能力。

Looking ahead, our strategy remains firmly anchored in sustainable growth with a strong focus on advancing our pipeline, both through internal innovation and carefully selected external opportunities that align with our vision and expertise.

展望未來，我們的策略仍然堅定地紮根於永續成長，重點是透過內部創新和精心挑選的符合我們願景和專業知識的外部機會來推進我們的產品線。

In summary, Amphastar's unique blend of scientific innovation in developing high-quality complex products, operational excellence, and deep commercial expertise positions us as a standout leader in the pharmaceutical industry. We believe that our strategic shift towards proprietary product development, supported by an all US-based finished product manufacturing that bolsters supply chain resilience and our strong commercial franchise focused on sustainable shareholder value, collectively form the foundation of Amphastar's growth.

總而言之，Amphastar 在開發高品質複雜產品方面的獨特科學創新、卓越的營運和深厚的商業專業知識使我們成為製藥業的傑出領導者。我們相信，我們向專有產品開發的策略轉變，加上全美國成品製造的支持，增強了供應鏈的彈性，以及我們專注於可持續股東價值的強大商業特許經營，共同構成了 Amphastar 增長的基礎。

Driven by these unique strengths and disciplined execution, we are well positioned to confidently accelerate into the next phase of long-term transformative growth.

在這些獨特優勢和嚴謹的執行下，我們完全有能力自信地加速進入長期轉型成長的下一階段。

Thank you again for joining us today. With that, I'll turn the call over to Bill Peters, our CFO and Executive Vice President of Finance, to walk through the financials in more detail.

再次感謝您今天加入我們。接下來，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)，讓他更詳細地介紹一下財務狀況。

Thank you, Dan. Revenues for the second quarter decreased 4% to $174.4 million from $182.4 million in the previous year's period. We're proud to share that while revenue was impacted by increased competition in our legacy products, this was largely offset by BAQSIMI, which recorded its highest quarterly sales since the product's acquisition.

謝謝你，丹。第二季營收從去年同期的 1.824 億美元下降 4% 至 1.744 億美元。我們很自豪地告訴大家，雖然營收受到我們傳統產品競爭加劇的影響，但這在很大程度上被 BAQSIMI 所抵消，該產品創下了自收購以來的最高季度銷售額。

BAQSIMI sales grew to $46.7 million compared to the prior-year period of $30.9 million as Amphastar assumed full commercialization responsibilities globally at the beginning of 2025. Keep in mind that during the same period last year, Lilly had BAQSIMI sales of $7.6 million. Therefore, total BAQSIMI sales for the period grew by 21%.

由於 Amphastar 於 2025 年初在全球範圍內承擔起全部商業化責任，BAQSIMI 的銷售額從去年同期的 3,090 萬美元增長至 4,670 萬美元。請記住，去年同期，禮來公司的 BAQSIMI 銷售額為 760 萬美元。因此，該期間 BAQSIMI 的總銷售額成長了 21%。

Primatene MIST sales held steady at $22.9 million in the second quarter. And we are pleased to report that our year-to-date sales have grown by 10%.

Primatene MIST 在第二季的銷售額保持穩定，為 2,290 萬美元。我們很高興地報告，今年迄今為止我們的銷售額成長了 10%。

Glucagon injection sales declined 25% to $20.6 million from $27.4 million, primarily due to the increased competition and a move to ready-to-use glucagon products such as BAQSIMI.

胰高血糖素注射液的銷售額從 2,740 萬美元下降 25% 至 2,060 萬美元，主要原因是競爭加劇以及轉向 BAQSIMI 等即用型胰高血糖素產品。

Epinephrine sales decreased 42% to $16.2 million from $27.9 million due to increased competition on the multi-dose vial and the sales of the pre-filled syringe dropped due to another supplier returning to the market.

由於多劑量瓶的競爭加劇，腎上腺素銷售額從 2,790 萬美元下降 42% 至 1,620 萬美元，由於另一家供應商重返市場，預充式註射器的銷售額下降。

Sales of lidocaine increased 17% to $15 million from $12.8 million, primarily due to an increase in unit volumes as a result of an increase in demand caused by shortages from other suppliers during the quarter.

利多卡因的銷售額從 1,280 萬美元增長 17% 至 1,500 萬美元，這主要是由於本季度其他供應商的短缺導致需求增加，從而導致單位銷售增加。

Other pharmaceutical product sales decreased to $53.1 million from $57.6 million, primarily due to a decrease in sales of enoxaparin, dextrose, and sodium bicarbonate as a result of increased competition. This trend was partially offset by sales of albuterol, which we launched in August 2024.

其他藥品銷售額從 5,760 萬美元下降至 5,310 萬美元，主要原因是競爭加劇導致依諾肝素、葡萄糖和碳酸氫鈉的銷售額下降。這一趨勢被我們於 2024 年 8 月推出的沙丁胺醇的銷售部分抵消。

Cost of revenues increased to $87.9 million from $87.2 million, with gross margins declining to 49.6% from 52.2% in the previous year's period. (technical difficulty) sales in the prior-year period were recorded under a transition service agreement with Lilly and were booked at 100% gross margin. So now that the transition to Amphastar has been completed, cost of revenues for all products shipped are included in this line, which negatively impacts margin rate.

收入成本從 8,720 萬美元增至 8,790 萬美元，毛利率從去年同期的 52.2% 下降至 49.6%。 （技術難度）去年同期的銷售額是根據與禮來公司簽訂的過渡服務協議記錄的，毛利率為 100%。因此，現在向 Amphastar 的過渡已經完成，所有運送產品的收入成本都包含在這一項中，這對利潤率產生了負面影響。

Additionally, pricing declined due to competition for glucagon, and our epinephrine multi-dose vial product negatively impacted margins. Because of these trends, management focused on cost control efforts across the business, which mitigated the impact of these pricing declines.

此外，由於胰高血糖素的競爭，價格下降，我們的腎上腺素多劑量小瓶產品對利潤率產生了負面影響。由於這些趨勢，管理層專注於整個業務的成本控制工作，從而減輕了價格下跌的影響。

Selling, distribution, and marketing expenses increased 14% to $10.2 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 efforts related to Primatene MIST.

銷售、分銷和行銷費用從去年同期的 900 萬美元增加 14% 至 1,020 萬美元，這歸因於與 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 相關的銷售工作。

General and administrative spending increased 5% to $14 million from $13.3 million, primarily due to increased personnel-related expenses. Research and development expenditures increased 14% to $20.1 million from $17.7 million due to an increase in material and supply expenses for our inhalation pipeline products and expenses related to our proprietary projects.

一般及行政支出從 1,330 萬美元增加 5% 至 1,400 萬美元，主要原因是人員相關費用增加。由於吸入管道產品的材料和供應費用以及與我們的專有項目相關的費用增加，研發支出從 1,770 萬美元增加到 2,010 萬美元，增加了 14%。

Non-operating expenses decreased to $2.8 million from $5 million due to a decrease in interest expense and currency fluctuations. Net income decreased to $31 million, or $0.64 per share, in the second quarter from $37.9 million, or $0.73 per share, in the second quarter of 2024.

由於利息支出減少和貨幣波動，非營業支出從 500 萬美元減少至 280 萬美元。淨收入從 2024 年第二季的 3,790 萬美元（合每股 0.73 美元）下降至第二季的 3,100 萬美元（合每股 0.64 美元）。

Adjusted net income decreased to $40.9 million, or $0.85 per share, compared to an adjusted net income of $48.7 million, or $0.94 per share, in the second quarter of last year. Adjusted earnings exclude amortization, equity compensation, impairments of long-lived assets, and certain one-time events.

調整後淨收入下降至 4,090 萬美元，即每股 0.85 美元，而去年第二季調整後淨收入為 4,870 萬美元，即每股 0.94 美元。調整後的收益不包括攤銷、股權補償、長期資產減損和某些一次性事件。

In the second quarter, we had cash flow from operations of approximately $35.6 million. We used a portion of our cash on hand to buy back $39.2 million worth of shares. These purchases finished our previous authorization. So our Board of Directors approved an additional $50 million stock buyback program.

第二季度，我們的營運現金流約為 3,560 萬美元。我們利用部分庫存現金回購了價值 3,920 萬美元的股票。這些購買已完成我們先前的授權。因此，我們的董事會批准了額外 5000 萬美元的股票回購計畫。

I'll now turn the call back over to Dan.

我現在將電話轉回給丹。

Thank you, Bill, for the updates. We'll now turn the call over to questions. Operator?

謝謝比爾的更新。我們現在將電話轉入提問環節。操作員？

(Operator Instructions) Serge Belanger, Needham & Company.

（操作員指示）Serge Belanger，Needham & Company。

I guess the first one for Bill. I think in the past, you've indicated you expected the top line to be flat year over year. Just curious if those expectations have changed now that we're halfway through the year.

我想第一個是比爾的。我認為過去您曾表示預計營業收入將與去年同期持平。我只是好奇，現在已經過了半年，這些期望是否已經改變。

And secondly, maybe if you can highlight what we should expect from BAQSIMI over the second half of the year. And are you starting to see some of the MannKind collaboration impacts on those sales?

其次，您能否強調我們對今年下半年 BAQSIMI 的期望。您是否開始看到 MannKind 合作對這些銷售產生的一些影響？

Sure, yeah. We still are guiding to flat sales year over year and we still anticipate that two products could be approved and contribute to that level. So we're still comfortable with that flat sales.

當然，是的。我們仍然預計銷售額將與去年同期持平，並且我們仍然預計有兩種產品能夠獲得批准並為此水平做出貢獻。因此，我們對平穩的銷售額仍然感到滿意。

And secondly, BAQSIMI. We're still consistently saying that the guidance that we gave at the beginning of the year, which was high single-digit unit growth and a 3% price increase in the United States, we're right on track for that. And we're really pleased with the strong growth we had in the second quarter.

其次，BAQSIMI。我們仍然堅持年初給出的指導方針，即在美國實現高個位數的銷售增長和 3% 的價格上漲，我們正朝著這個目標前進。我們對第二季的強勁成長感到非常滿意。

And then I guess in terms of potential approvals. AMP-002, hate to ask again, but has your level of confidence increased or changed at all from the last quarterly update?

然後我想就潛在的批准而言。AMP-002，不想再問了，但是與上次季度更新相比，您的信心水平是否有所提高或有所改變？

We still remain optimistic about the approval of it. We continue to engage with high-level officials at the FDA and it keeps us optimistic about the approval.

我們對其批准仍持樂觀態度。我們繼續與 FDA 的高層官員接觸，這讓我們對批准感到樂觀。

Cerena Chen, Wells Fargo.

Cerena Chen，富國銀行。

I wanted to ask about AMP-018, the GLP-1. I saw that the IQVIA trailing 12-month sales used to be $1.1 billion at the start of the year, now that's moved down to $400 million. So I was wondering how you're thinking about this opportunity, especially with the recent CRL delaying approval timelines. Thank you.

我想問有關 AMP-018、GLP-1 的問題。我看到 IQVIA 過去 12 個月的銷售額在年初為 11 億美元，現在已經下降到 4 億美元。所以我想知道您是如何看待這個機會的，特別是在最近 CRL 延遲批准時間的情況下。謝謝。

Yeah. This is one where we think there's going to be a very crowded generic market. So we expect it to be a relatively small contributor to our sales.

是的。我們認為，仿製藥市場將會非常擁擠。因此我們預期它對我們的銷售貢獻相對較小。

Jason Gerberry, Bank of America.

美國銀行的 Jason Gerberry。

Hey, guys. This is Pavan Patel on for Jason Gerberry. Just two questions from us.

嘿，大家好。這是 Jason Gerberry 的 Pavan Patel。我們只想問兩個問題。

Maybe first, if you could walk us through the expected margin trajectory for the second half of the year. And then second, on epinephrine PFS competition. Maybe if you could speak to the competitive environment. Has pricing eroded significantly? Or is this primarily a market share issue? Just the latest there. Thank you.

首先，您能否向我們介紹一下今年下半年的預期利潤率走勢？其次，關於腎上腺素 PFS 競爭。也許您可以談談競爭環境。價格是否大幅下降？或者這主要是市佔率問題？那裡只是最新的。謝謝。

Sure. So the expected margin trajectory, we do expect that the new products that we have will either be at or above the corporate average margin that we have right now. But what we are expecting to see is increased price competition on glucagon on a go-forward basis. Therefore, we expect margins to contract absent the new approval launches.

當然。因此，預期利潤率軌跡，我們確實預期我們擁有的新產品將達到或高於我們目前的企業平均利潤率。但我們預期未來胰高血糖素的價格競爭將會加劇。因此，我們預計，如果沒有新的批准，利潤率將會下降。

And as far as epi pre-filled syringe goes, that competition is really baked into the current quarter numbers that we have there. So the pricing and the unit drop have both happened for that, we believe. And it's been both. It's been both pricing and unit drops that have contributed to this overall sales decline.

就 Epi 預充式註射器而言，競爭確實已融入我們本季的數據中。因此，我們認為價格和銷售量的下降都是由此產生的。並且兩者皆有。價格和銷售量的下降都是造成整體銷售下滑的原因。

Ekaterina Knyazkova, JPMorgan.

葉卡捷琳娜·克尼亞茲科娃，摩根大通。

So first question is just on glucagon. Just as you think about the revenues for the product from here, is Q2 kind of a good runway to think about going forward? Or would you expect to see some sequential erosion as we think about Q3 and Q4?

所以第一個問題是關於胰高血糖素的。正如您從這裡考慮產品的收入一樣，第二季是否是一個值得考慮繼續前進的好機會？或者當我們考慮第三季和第四季時，您是否預計會看到一些連續的侵蝕？

And then second question is just on your plans to expand the manufacturing capacity. Could you talk about what motivated the decision? I'm assuming some of that was probably tariffs. And just thoughts on how you could leverage your capacity over time. Thank you.

第二個問題是關於您擴大生產能力的計劃。您能談談是什麼促使您做出這項決定的嗎？我猜其中一部分可能是關稅。只是想思考一下如何隨著時間的推移發揮你的能力。謝謝。

Yeah, I'll take the first one. And no, glucagon is not at a run rate yet. So while we did have the competition come in from one competitor, a second or another competitor was recently approved.

是的，我會選擇第一個。不，胰高血糖素尚未達到運轉率。因此，雖然我們確實面臨來自一個競爭對手的競爭，但第二個或另一個競爭對手最近也獲得了批准。

So our expectation is that that launch in the near future, therefore, bringing down both our units and our pricing on that. So we expect to see glucagon drop on a go-forward basis. And not to mention the fact that the overall market on the anti-hyperglycemic side of that is shrinking as people move towards ready-to-use products like our BAQSIMI.

因此，我們預計該產品將在不久的將來推出，從而降低我們的銷售和價格。因此，我們預計胰高血糖素水平將會下降。更不用說隨著人們轉向像我們的 BAQSIMI 這樣的即用型產品，抗高血糖的整體市場正在萎縮。

As for the expansion, it's been in our plans for quite a while to expand here at our headquarters. Certainly, the geopolitical environment is right for us to do that at this time. But it is designed more to support our pipeline. All the products that are currently on file with the FDA are already supported with manufacturing here at our facilities that we already exist.

至於擴張，我們很久以前就計劃在總部擴張。當然，目前的地緣政治環境適合我們這樣做。但它的設計更多的是為了支持我們的管道。目前已向 FDA 備案的所有產品均已在我們現有的工廠內生產。

But for our pipeline and -- specifically our pipeline as we move more into proprietary products and stuff, that's where we're looking at expanding the manufacturing supporting that. So that's the reason behind it.

但對於我們的管道，特別是我們的管道，隨著我們更多地轉向專有產品和產品，我們正在考慮擴大支援它的製造能力。這就是背後的原因。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆、派珀·桑德勒。

Wanted to circle back on the informal revenue guide. Does that contemplate contribution from AMP-002? And as a follow-up to the question on revenues for the year, how many launches, or even if you can say this, which launches are you actually contemplating before the end of the year? So that's number one.

想要重新討論非正式收入指南。這是否考慮了 AMP-002 的貢獻？作為今年收入問題的後續問題，有多少個發射項目，或者即使您可以這麼說，您實際上在考慮在年底之前發射哪些項目？這是第一點。

And then number two, I wanted to get some more color on AMP-007, the extent to which, so that's going to be a crowded market. And how should we think about the size of that opportunity to the extent that you ultimately get approval next year? Thanks.

第二，我想對 AMP-007 進行更多的了解，了解它的程度，這樣它就會成為一個擁擠的市場。我們應該如何看待這個機會的規模，以便您最終在明年獲得批准？謝謝。

So for the revenue guide, it does include -- I'll say we weight the expectations of these products as we take a look at them. And so we risk-adjust them. And it includes two launches on a risk-adjusted basis, and those include 002 and 015. So right now, those are the only two that we believe could be approved this year.

因此，對於收入指南，它確實包括——我會說我們在查看這些產品時會權衡對這些產品的期望。因此，我們對它們進行風險調整。其中包括兩次風險調整後的發射，分別是002和015。因此，目前，我們認為今年僅有這兩項提案能夠獲得批准。

But could we get to that flat in other ways? We could, depending on competition on other products and also just the BAQSIMI growth if that exceeds our expectations as well. So that answers that question.

但是我們能透過其他方式到達那間公寓嗎？我們可以，這取決於其他產品的競爭情況，也取決於 BAQSIMI 的成長是否超出我們的預期。這就回答了這個問題。

And 007, as far as the contribution, we don't know of any other filer -- or anybody else working on it or close to it. We haven't seen anything about it. So as far as we know, we could be the first approval on that. And if we're the first approval, we think that this has the potential to be a significant market opportunity, potentially the biggest in the near term.

至於 007 的貢獻，我們不知道還有其他文件提交者 — — 或有其他任何人正在從事或接近這項工作。我們還沒有看到任何有關它的消息。據我們所知，我們可能是第一個批准法案的國家。如果我們獲得第一個批准，我們認為這有可能成為一個重大的市場機會，可能是短期內最大的市場機會。

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

謝謝。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。

Well, thank you, Paul, and thank you, everyone, for joining us today. We look forward to sharing more updates in the near future. Have a great day.

好吧，謝謝你，保羅，也謝謝大家今天加入我們。我們期待在不久的將來分享更多更新。祝你有美好的一天。

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

今天的會議到此結束。現在您可以斷開線路。感謝您的參與。