Amphastar Pharmaceuticals Inc (AMPH) 2024 Q3 法說會逐字稿

Greetings, and welcome to the Amphastar Pharmaceuticals Inc third quarter earnings call.

您好，歡迎參加 Amphastar Pharmaceuticals Inc 第三季財報電話會議。

(Operator Instructions)

（操作員說明）

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，本次電話會議期間所做的有關非歷史事實的某些陳述，包括但不限於管理階層的展望或對未來期間的預測，均為前瞻性陳述。這些陳述僅基於我們現在掌握的資訊。我們鼓勵您查看今天發布的新聞稿中標題為前瞻性陳述的部分以及公司網站上的簡報。

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 reconciliation to US GAAP may be found in our earnings release.

另外，請參閱我們的 SEC 文件，這些文件可以在我們的網站和 SEC 網站上找到，以了解可能影響我們未來業績的眾多因素的討論。我們還將討論某些非公認會計準則措施，有關我們使用這些措施以及與美國公認會計準則的調整的重要資訊可能會在我們的收益發布中找到。

Please note this conference call is being recorded.

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, EVP of Regulatory Affairs and Clinical Operations.

今天我們的演講者是財務長 Bill Peters 先生； Dan Dischner 先生，企業傳播部資深副總裁；以及監管事務和臨床營運執行副總裁 Tony Marrs 先生。

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

現在我將會議轉交給東道主企業傳播高級副總裁 Dan Dischner 先生。丹，你可以開始了。

Thank you, Zico. Good afternoon and thanks for joining us for our third quarter's earnings call of 2024. Today, I'm joined by Bill Peters, our CFO and Executive Vice President of Finance and Tony Marrs, Executive Vice President of Regulatory Affairs and Clinical Operations.

謝謝你，濟科。下午好，感謝您參加我們的 2024 年第三季財報電話會議。今天，我們的財務長兼財務執行副總裁比爾彼得斯 (Bill Peters) 以及監管事務和臨床營運執行副總裁 Tony Marrs 與我一起出席。

In the third quarter of 2024, Amphastar reported net revenues of $191.2 million marking a 6% increase year-over-year, reflecting the resilience and growing strength of our diversified product portfolio and the strategic initiatives. Despite facing challenges such as the impact of hurricane Helene which impacted our logistics and resulted in delays and delayed shipments. The core business of Amphastar remains robust, leading the path to end this year with a solid footing for the execution of our portfolio.

2024 年第三季度，Amphastar 淨收入為 1.912 億美元，年增 6%，反映了我們多元化產品組合和策略性舉措的彈性和不斷增長的實力。儘管面臨海倫颶風等挑戰，影響了我們的物流並導致延誤和發貨延遲。Amphastar 的核心業務仍然強勁，為我們投資組合的執行奠定了堅實的基礎，引領了今年年底的發展方向。

Our strategic initiatives regarding our regulatory filings and commercial portfolio execution remain on track and we are well positioned to continue the growth of our key revenue drivers with BAQSIMI, Primatene MIST and our core hospital and clinical use products in the critical care arena.

我們關於監管備案和商業投資組合執行的策略性舉措仍在按計劃進行，我們處於有利位置，可以透過BAQSIMI、Primatene MIST 以及我們在重症監護領域的核心醫院和臨床使用產品繼續增長我們的主要收入驅動因素。

A key highlight for the quarter was Primatene MIST which achieved its highest quarterly sales since the launch reaching $26 million in sales. This performance is a significant step toward our goal of $100 million in annual sales for this product by the end of 2024. We believe there are additional growth opportunities with Primatene MIST and therefore, in 2025 we will expand our current physician sampling program by initiating a pilot sales program targeting more primary care physicians.

本季的一大亮點是 Primatene MIST，它實現了自推出以來的最高季度銷售額，達到 2600 萬美元。這項業績是我們朝 2024 年底該產品年銷售額達到 1 億美元的目標邁出的重要一步。我們相信 Primatene MIST 有額外的成長機會，因此，到 2025 年，我們將透過啟動更多初級保健醫生的試點銷售計劃來擴大我們目前的醫生抽樣計劃。

The transition for BAQSIMI is progressing smoothly with sales performance meeting expectations BAQSIMI remains an essential part of our portfolio, and we are dedicated to expanding this market's presence. To enhance the brand's visibility in the United States, we plan to strengthen the sales force for BAQSIMI. This product exemplifies the kind of innovative, user-friendly solutions we strive to develop and serve as a benchmark for our impactful products we are committed to advancing through our pipeline.

BAQSIMI 的過渡進展順利，銷售表現達到預期。為了提高品牌在美國的知名度，我們計畫加強BAQSIMI的銷售團隊。該產品體現了我們努力開發的創新、用戶友好的解決方案，並作為我們致力於透過我們的管道推進的有影響力的產品的基準。

As anticipated competition in the Glucagon injection kit market has intensified leading to a 9% decline in sales from the previous year, seeing $26.7 million in sales for the third quarter. We believe the increased competition reflects the rising awareness of effective hypoglycemia management options and the attractiveness to the market.

由於預期胰高血糖素注射套件市場競爭加劇，導致第三季銷售額較上年下降 9%，銷售額為 2,670 萬美元。我們認為，競爭的加劇反映了人們對有效低血糖管理方案的認識不斷提高以及對市場的吸引力。

On a different note, we are pleased to announce the launch of our Albuterol MDI product occurring in the third quarter of 2024, marking a significant expansion of our respiratory portfolio and operations in our Armstrong facility. This launch positions us to meet the growing demand for affordable high quality asthma management options. Entering a competitive market, we continue to actively pursue business opportunities.

另一方面，我們很高興地宣布將於 2024 年第三季推出沙丁胺醇 MDI 產品，這標誌著我們的呼吸產品組合和阿姆斯壯工廠運營的顯著擴展。此次推出使我們能夠滿足人們對經濟實惠的高品質氣喘管理方案日益增長的需求。進入競爭激烈的市場，我們繼續積極尋求商機。

On a regulatory front, we have continued routine productive discussions with the FDA regarding AMP-002 and believe that a clear path forward for approval is near. The generic Teriparatide NDA AMP-015, we received the CRL for this filing and we are on track to submit our response by the end of this year.

在監管方面，我們繼續與 FDA 就 AMP-002 進行例行富有成效的討論，並相信明確的批准道路即將到來。通用特立帕肽 NDA AMP-015，我們收到了本次備案的 CRL，我們預計在今年年底之前提交我們的回應。

Turning to our diabetes portfolio, we are scheduled to refile our BLA for our first insulin product AMP-004 or Insulin Aspart in the fourth quarter of this year. For our GLP-1 ANDA, AMP-018 which was filed in the second quarter of 2024, we are pleased to announce that this filing was granted competitive generic therapeutic designation and priority review. As mentioned on our last call, this product remains on track for a GDUFA goal date in the second quarter of 2025.

談到我們的糖尿病產品組合，我們計劃在今年第四季重新提交我們的首款胰島素產品 AMP-004 或門冬胰島素的 BLA。對於我們於 2024 年第二季提交的 GLP-1 ANDA、AMP-018，我們很高興地宣布，該申請已獲得競爭性仿製藥指定和優先審查。正如我們在上次電話會議中所提到的，該產品仍有望在 2025 年第二季實現 GDUFA 的目標日期。

Regarding AMP-007, our second inhalation ANDA, as previously announced has experienced an extension in the GDUFA goal date to the second quarter of 2025. And there are currently no pending items with the agency regarding this application.

關於 AMP-007，我們的第二個吸入 ANDA，正如先前宣布的那樣，GDUFA 的目標日期已延長至 2025 年第二季。目前該機構沒有關於此申請的待處理項目。

On a separate note, we are proud to announce or introduce AMP-028, a new biosimilar addition to our pipeline. This product has [equivoques] sales of plus $2 billion with no current biosimilars.

另外，我們很自豪地宣布或推出 AMP-028，這是我們管道中的新生物相似藥。該產品[同等]銷售額超過 20 億美元，目前還沒有生物相似藥。

We believe our unique capabilities will limit the potential number of competitors in the market. And it marks our first BLA target outside of insulin. Additionally, it highlights the strategic transition towards more advanced therapeutic areas where we can maximize value and impact.

我們相信我們獨特的能力將限制市場上潛在競爭對手的數量。它標誌著我們在胰島素之外的第一個 BLA 目標。此外，它還強調了向更先進的治療領域的策略轉型，我們可以在這些領域中最大化價值和影響力。

This shift represents a deliberate move to focus our efforts on high value projects that have the potential to drive sustainable growth and utilize our in-house expertise and resources.

這一轉變表明我們有意將精力集中在有潛力推動永續成長並利用我們內部專業知識和資源的高價值項目。

As we close 2024 and look towards 2025, our focus remains on advancing our portfolio through proprietary filings and high value areas like biosimilars, positioning us for sustainable growth and reduced competitive pressures.

在 2024 年即將結束並展望 2025 年之際，我們的重點仍然是透過專有申請和生物相似藥等高價值領域來推進我們的產品組合，從而為我們的可持續增長和減少競爭壓力做好準備。

In the coming year, we plan to announce additional candidates in our proprietary and biosimilar pipelines aligning with our strategic direction. Our R&D expertise and self-funded investments continue to drive progress while strong sales from BAQSIMI and Primatene MIST provide a solid foundation.

來年，我們計劃在我們的專有和生物仿製藥管道中宣布更多符合我們策略方向的候選人。我們的研發專業知識和自籌資金投資持續推動進步，而 BAQSIMI 和 Primatene MIST 的強勁銷售奠定了堅實的基礎。

We're confident in the potential of our upcoming projects including AMP-002, teriparatide, AMP-007 and our first GLP-1 ANDA. With a clear strategy and an expanding pipeline, we're excited about the opportunities ahead and remain committed to delivering long term value. With that, I'd like to turn the call to our CFO and Executive Vice President of Finance, Bill Peters to discuss the second quarter's financial results.

我們對即將推出的項目的潛力充滿信心，包括 AMP-002、特立帕肽、AMP-007 和我們的第一個 GLP-1 ANDA。憑藉著清晰的策略和不斷擴大的產品線，我們對未來的機會感到興奮，並繼續致力於提供長期價值。在此，我想致電我們的財務長兼財務執行副總裁比爾彼得斯 (Bill Peters)，討論第二季的財務表現。

Thank you, Dan revenues for the third quarter increased 6% to $191.2 million from $180.6 million in the previous year's period. BAQSIMI sales through Amphastar totaled $40.4 million in the third quarter. Sales of vaccine by Eli Lilly totaled $6.4 million during the same period and we recorded a net economic benefit in our other revenues line of $2.4 million, net of their expenses of $4 million.

謝謝，Dan 第三季的營收從去年同期的 1.806 億美元成長了 6%，達到 1.912 億美元。第三季度，BAQSIMI 透過 Amphastar 的銷售額總計 4,040 萬美元。禮來公司同期的疫苗銷售額總計 640 萬美元，我們在其他收入項目中記錄的淨經濟效益為 240 萬美元，扣除了 400 萬美元的費用。

Our product sales have increased while the net economic benefit has decreased throughout the year, as we have taken over distribution responsibilities for BAQSIMI in various countries around the world. We will assume distribution of BAQSIMI in the remaining territories on a country-by-country basis through the end of this year.

由於我們接手了BAQSIMI在全球各國的分銷責任，全年我們的產品銷售量有所成長，而淨經濟效益卻有所下降。我們預計到今年年底，BAQSIMI 將在其餘地區逐一國家進行分發。

During the quarter, while this distribution transition was ongoing, we faced a temporary supply disruption in 14 European countries and ran out of Lilly labeled BAQSIMI before we were able to receive any Amphastar labeled product. This temporary disruption limited European sales of BAQSIMI by approximately $2 to $3 million.

在本季度，雖然這種分銷轉型正在進行，但我們在14 個歐洲國家面臨暫時的供應中斷，在我們能夠收到任何帶有Amphastar 標籤的產品之前，禮來公司貼有BAQSIMI 的產品就用完了。這種暫時的中斷限制了 BAQSIMI 在歐洲的銷售額約 200 至 300 萬美元。

Glucagon sales decreased 9% to $26.8 million from $29.5 million due to a decrease in units shipped, as more hypoglycemia patients move to ready to use products such as BAQSIMI.

由於越來越多的低血糖患者轉而使用 BAQSIMI 等即用型產品，導致出貨量減少，胰高血糖素銷售額從 2,950 萬美元下降 9%，降至 2,680 萬美元。

Primatene MIST sales grew to a new record of $26.1 million in the third quarter compared to $24.8 million in the third quarter of last year, which represented sales growth of 5%.

Primatene MIST 第三季銷售額成長至 2,610 萬美元，創下新紀錄，而去年第三季銷售額為 2,480 萬美元，銷售額成長了 5%。

Epinephrine sales increased 6% to $21.3 million from $20.2 million, primarily due to an increase in units of our prefilled syringe product as we entered the Canadian market this quarter.

腎上腺素銷售額從 2,020 萬美元成長 6% 至 2,130 萬美元，主要是由於本季進入加拿大市場後我們的預充式註射器產品數量增加。

Phytonadione sales increased 57% to $11.7 million from $7.4 million due to an increase in demand this quarter. Enoxaparin and Naloxone sales decreased primarily due to a decrease in unit volumes.

由於本季需求增加，植物油二酮銷售額從 740 萬美元成長 57% 至 1,170 萬美元。依諾肝素和納洛酮的銷售額下降主要是因為單位銷售量的減少。

Other finished pharmaceutical product sales decreased $2.2 million to $35.5 million from $37.7 million on lower sales of products such as Atropine and Calcium Chloride.

由於阿托品和氯化鈣等產品銷售額下降，其他成品藥品銷售額從 3,770 萬美元減少 220 萬美元至 3,550 萬美元。

These decreases were partially offset by higher unit volumes of sodium bicarbonate due to an increase in capacity at our international medication subsidiary, as well as the launch of our Albuterol MDI in August 2024.

這些下降被我們國際藥品子公司產能增加以及我們於 2024 年 8 月推出沙丁胺醇 MDI 導致碳酸氫鈉單位體積增加所部分抵消。

Overall sales were negatively impacted by hurricane Helene as between $2 million and $4 million in sales that were expected in the third quarter were not recognized due to delayed deliveries. Revenues for these shipments are expected to be recognized in the fourth quarter.

整體銷售額受到海倫颶風的負面影響，預計第三季的 200 萬至 400 萬美元銷售額因交貨延遲而未能確認。這些出貨量的收入預計將在第四季度得到確認。

Cost of revenues increased $89.3 million from $79.2 million. Gross margins declined to 53% of revenues from 60% in the prior year primarily because BAQSIMI sales in the prior year were made by Lilly and we booked net of cost of goods which contributed to higher gross margins in the previous year.

收入成本從 7,920 萬美元增加到 8,930 萬美元。毛利率從上一年的60% 下降至收入的53%，主要是因為去年的BAQSIMI 銷售是由禮來公司完成的，而我們扣除了商品成本，這導致了上一年毛利率的提高。

This year, most sales are made by Amphastar which books the cost of goods. Additionally, we had an increase in labor costs and certain component costs.

今年，大部分銷售由 Amphastar 完成，該公司負責記錄商品成本。此外，我們的勞動成本和某些零件成本也有所增加。

Selling, distribution and marketing expenses increased 40% to $9 million from $6.4 million in the previous year due to our BAQSIMI sales force expansion.

由於 BAQSIMI 銷售隊伍的擴張，銷售、分銷和行銷費用從上一年的 640 萬美元增加了 40% 至 900 萬美元。

General and administrative spending increased 17% to $14.8 million from $12.7 million primarily due to increased expenses related to BAQSIMI and the personnel. Research and development expenditures increased 26% to $21.1 million from $16.7 million due to increases in material expenses related to our insulin pipeline products.

一般及行政支出從 1,270 萬美元增加 17% 至 1,480 萬美元，主要是因為 BAQSIMI 和人員相關費用增加。由於與我們的胰島素管道產品相關的材料費用增加，研發支出從 1,670 萬美元增加了 26% 至 2,110 萬美元。

Our non-operating expense of $9.4 million compared to an operating expense of $9 million in the third quarter of last year. Net income decreased by 18% to $40.4 million or $0.78 per share in the third quarter from $49.2 million or $0.91 per share in the third quarter of 2023.

我們的非營運支出為 940 萬美元，而去年第三季的營運支出為 900 萬美元。第三季淨利為 4,040 萬美元，即每股 0.78 美元，較 2023 年第三季的 4,920 萬美元或每股 0.91 美元下降 18%。

Adjusted net income decreased to $49.6 million or $0.96 per share compared to an adjusted net income of $61.9 million or a $1.15per share in the third quarter of last year.

調整後淨利潤下降至 4,960 萬美元，即每股 0.96 美元，而去年第三季調整後淨利為 6,190 萬美元，即每股 1.15 美元。

Adjusted earnings excludes amortization, equity compensation, impairments of long-lived assets and one-time events.

調整後收益不包括攤銷、股權補償、長期資產減損和一次性事件。

In the third quarter, we had cash flow from operations of approximately $60 million. We used $35 million of this cash to repurchase 797,000 shares. We also announced today that our board has authorized an additional buyback program of $50 million.

第三季度，我們的營運現金流約為 6,000 萬美元。我們用其中 3500 萬美元的現金回購了 797,000 股股票。今天我們也宣布，董事會已批准一項額外 5,000 萬美元的回購計畫。

I will now turn the call back over to Dan.

我現在將把電話轉回給丹。

Thanks, Bill for the updates. With that, we'll now take your questions, Zico please open the lines for Q&A.

謝謝比爾的更新。現在，我們將回答您的問題，Zico 請打開問答線。

Thank you.

謝謝。

Ladies and gentlemen, we will now be conducting a question-and-answer session.

女士們、先生們，我們現在將進行問答環節。

(Operator Instructions)

（操作員說明）

The first question comes from Ekaterina Knyazkova with JP Morgan. Please go ahead.

第一個問題來自摩根大通的 Ekaterina Knyazkova。請繼續。

Thank you so much. So just two questions if I may, so first, just I see that you've had the asset for several quarters now, just any surprises in terms of where you're seeing uptake or the competitive dynamics you're seeing in the market, and I guess any updates as you're thinking about peak sale potential for that product.

太感謝了。所以，如果可以的話，我只想問兩個問題，所以首先，我看到您已經擁有該資產幾個季度了，在您看到的吸收情況或您在市場上看到的競爭動態方面是否有任何意外，當您考慮該產品的峰值銷售潛力時，我猜想有任何更新。

And, and the second question is just on the GLP-1 category, can you just talk a little bit about the role that the company can play in this category over time? You obviously have AMP-018 potentially coming in 2025, but more if we think about some of the bigger GLP-1 molecules eventually going generic. Just any color there would be appreciated. Thank you.

而且，第二個問題只是關於 GLP-1 類別，您能否簡單談談公司隨著時間的推移可以在該類別中發揮的作用？顯然，AMP-018 可能會在 2025 年上市，但如果我們考慮到一些更大的 GLP-1 分子最終會成為通用藥物，那麼可能會出現更多的情況。任何顏色都會受到讚賞。謝謝。

So as far as BAQSIMI, right now, it's going relatively smoothly other than what I mentioned in my comments, which was the slight disruption that we had in supply, going to Europe this quarter. So, we were expecting to get all of the BAQSIMI with Amphastar labeled products out to those countries in time before the Lilly labeled product ran. But unfortunately, that didn't happen, which left us short in 14 countries. So, we were unable to deliver anywhere between four weeks to six weeks for a lot of those countries.

因此，就 BAQSIMI 而言，目前進展相對順利，除了我在評論中提到的情況之外，即本季前往歐洲的供應略有中斷。因此，我們希望在禮來公司標籤產品運作之前將所有帶有 Amphastar 標籤的 BAQSIMI 產品及時運送到這些國家。但不幸的是，這並沒有發生，導致我們在 14 個國家/地區出現短缺。因此，我們無法為其中許多國家提供四到六週的交付服務。

So, that's unfortunate, but, these things happen when you're transitioning to a new product and a new distribution center. So, no real big surprises. And as far as peak sales, I'll say no right now, we're still on target for what we had said previously on peak sales which was $250 to $275 million in peak sales. So right now, our annual sales are trending, we believe really close to the, our say, our base case that we put in at that time.

所以，這很不幸，但是，當您過渡到新產品和新的配送中心時，這些事情就會發生。所以，沒有什麼真正的大驚喜。至於峰值銷售額，我現在會說不，我們仍然達到了之前所說的峰值銷售額目標，即 250 至 2.75 億美元的峰值銷售額。所以現在，我們的年度銷售趨勢，我們相信非常接近我們當時提出的基本情況。

And then on the GLP-1 strategy, that's a great question. As you know that it's getting to be a really crowded market, there's a lot of people coming up with new GLP-1 type products. We're not alone in thinking about it. It's probably a little too early to really discuss any potential things in that group for us right now. But we'll update people as we get closer.

關於 GLP-1 策略，這是一個很好的問題。如您所知，這將成為一個非常擁擠的市場，有很多人想出了新的 GLP-1 類型產品。我們並不是唯一一個有這個想法的人。現在為我們真正討論該小組中的任何潛在問題可能還為時過早。但當我們接近時，我們會向人們通報最新情況。

Yeah, maybe we'll have an update for you at your conference in January.

是的，也許我們會在一月份的會議上為您提供最新消息。

Perfect. Thank you so much.

完美的。太感謝了。

Thanks.

謝謝。

Thank you.

謝謝。

The next question comes from David Amsellem with Piper Sandler. Please go ahead.

下一個問題來自 David Amsellem 和 Piper Sandler。請繼續。

David. Are you there?

大衛.你在嗎？

David? May we request you to unmute your line from your side, please?

大衛？我們可以請求您從您這邊取消線路靜音嗎？

David, may we request that you unmute your line, please?

大衛，我們可以請求您取消線路靜音嗎？

I think he's gone. So, let's go on to the next one. Yeah.

我想他已經走了。那麼，讓我們繼續下一篇。是的。

The next question comes from Pavan Patel from Bank of America. Please go ahead.

下一個問題來自美國銀行的 Pavan Patel。請繼續。

Hey guys, thanks for taking my questions.

嘿夥計們，謝謝你回答我的問題。

First on Epinephrine, can you speak to the main driver of lower revenue in the quarter? Was it more the [BP IV] competition or Pfizer supply shortage that may start, becoming resolved and where should we look in other areas of the business to offset this going forward? Will it be competitor supply shortages and other products or is the focus going to be on driving back to me growth such that the fluctuations of base business are smoother?

首先關於腎上腺素，您能談談本季收入下降的主要驅動因素嗎？是否更多的是[BP IV]競爭或輝瑞供應短缺可能開始並得到解決，我們應該在業務的其他領域尋找哪些方面來抵消未來的這種影響？是競爭對手供應短缺和其他產品，還是重點是推動我的成長，使基礎業務的波動更加穩定？

And then the second question is on back to me, maybe the year-over-year decline relative to what Lilly booked in prior year, what's driving the competitive headwinds there? Is it other branded products or a generic group have gone?

然後第二個問題又回到了我身上，也許相對於禮來公司去年的預訂量而言，同比下降了，是什麼推動了那裡的競爭逆風？是其他品牌產品還是通用產品消失了？

And can you frame what the investment in sales force will look like and timing of onboarding those sales reps? Thank you.

您能否確定對銷售隊伍的投資以及這些銷售代表入職的時間安排？謝謝。

Sure. So, so the I think you're comparing the second quarter. So we did have a decrease in the multi dose file. As there's been two competitors that have launched multi dose file this year driving prices and some of our volumes down. However, that was partially offset this quarter and a year over year increase in Epinephrine sales as we began shipping the prefilled syringes to Canada this quarter.

當然。所以，我認為你正在比較第二季。所以我們確實減少了多劑量文件。由於今年有兩個競爭對手推出了多劑量文件，導致價格和我們的部分銷量下降。然而，隨著我們本季開始將預充式註射器運送到加拿大，這在本季被部分抵消，腎上腺素銷售額較去年同期成長。

As far as the BAQSIMI is the year-over-year decline, I wouldn't say it's related to any competitive issues, it's partially driven by what I mentioned earlier, which was, we were out of stock for several weeks in 14 countries in Europe, so that limited sales there.

至於 BAQSIMI 的同比下降，我不會說這與任何競爭問題有關，部分原因是我之前提到的，即我們在 14 個國家/地區缺貨了數週。

And what I had mentioned earlier this year, which is the pricing that we have in the US has a decline this year because of the increased fee that we have to pay to wholesalers. So, we had said that for the year that you should expect sales would be, up single digit or up high single digits in terms of units, but down low single digits in pricing.

我今年早些時候提到過，由於我們必須向批發商支付的費用增加，我們在美國的定價今年有所下降。因此，我們曾說過，今年的銷售額預計會出現個位數成長或單位數成長，但定價會下降個位數。

And if we look at it on a year-long basis, I think you get to something that's closer to what we said. So, I think this one quarter is more of an aberration than anything else.

如果我們以一年為基礎來看待它，我認為你會得到更接近我們所說的內容。因此，我認為這一季度比其他任何季度都更反常。

So, and as far as the investment goes, we have had a very small increase in our sales force in the third quarter of this year. But we're planning a larger sales force increase, beginning in January, but there'll be some expenses related to that, that will hit in the fourth quarter as well. And once again, that sales force will also be an outsourced one. And so, we haven't, we might be able to dispose a little bit more about that later, but this is a new initiative that we're just starting right now.

因此，就投資而言，今年第三季我們的銷售團隊略有增加。但我們計劃從一月開始擴大銷售隊伍，但也會有一些與此相關的費用，這也會在第四季度產生。同樣，該銷售團隊也將是外包團隊。所以，我們還沒有，我們可能會稍後對此進行更多處理，但這是我們現在才剛開始的新舉措。

And we, we've always said that by utilizing or outsourcing the sales force, it gave us some flexibility to expand if we identified opportunities where we thought it would make sense and so it allows us to keep more control over the sales force. So, yeah, we're excited about this opportunity of increasing that footprint.

我們總是說，透過利用或外包銷售隊伍，如果我們發現了我們認為有意義的機會，它會給我們一定的擴展靈活性，因此它使我們能夠對銷售隊伍保持更多的控制。所以，是的，我們對這個擴大足跡的機會感到興奮。

Thank you.

謝謝。

Thank you.

謝謝。

The next question is from David Amsellem with Piper Sandler, please go ahead.

下一個問題是 David Amsellem 和 Piper Sandler 提出的，請繼續。

Hey, thanks. I'm sorry about that.

嘿，謝謝。對此我很抱歉。

So, couple of questions. First, can you talk about the albuterol generic, albuterol HFA? And what kind of footprint sales wise do you envision for that as we move through '25? So, that's number one.

那麼，有幾個問題。首先，您能談談沙丁胺醇仿製藥沙丁胺醇 HFA 嗎？當我們進入 25 世紀時，您預計會實現什麼樣的足跡銷售？所以，這是第一。

Number two, I know I asked this a lot but AMP-002, just anything new there or any latest thoughts on the road ahead for that product?

第二，我知道我問了很多這個問題，但 AMP-002，有什麼新的東西嗎？

And then lastly, I don't know if you addressed this, I apologize if you did, on AMP-007. I know that your [doa] got extended out to the second quarter. But just wondering out loud, anything there that you can talk about that gives you confidence that you're going to get that across the finish line and then given that there are a couple of entrants in that market. How do you think about the opportunity for that product? Thanks.

最後，我不知道您是否在 AMP-007 上解決了這個問題，如果您解決了，我深表歉意。我知道你的[doa]被延長到了第二季。但只是大聲地想知道，任何你可以談論的事情都會讓你有信心你會衝過終點線，然後考慮到這個市場有幾個進入者。您如何看待該產品的機會？謝謝。

I'll start with the Albuterol the sales footprint. That is, we had said earlier that we thought would be a little bit of a slow start as we ramp up, we also had some capacity issues as we're bringing on capacity in that facility. So that should time up well. So, we do expect this to be a meaningful but not, not in the fourth quarter.

我將從沙丁胺醇的銷售足跡開始。也就是說，我們之前說過，我們認為隨著我們的增加，啟動會有點慢，在我們增加設施的容量時，我們也遇到了一些容量問題。所以時間應該很準。因此，我們確實預計這將是有意義的，但不是在第四季度。

So hopefully that's helpful for you. We haven't given specific sales guidance, and the reason is that when you launch in a new generic into an existing generic market, you're not there at market formation. We like to not disrupt the market too much and to try to take that market share effort slowly. So, I think that's what we're trying to do with that.

希望這對您有幫助。我們沒有給出具體的銷售指導，原因是當你向現有的仿製藥市場推出新的仿製藥時，你並不在市場形成階段。我們希望不要過度擾亂市場，並嘗試慢慢爭取市場份額。所以，我認為這就是我們正在努力做的事情。

Yeah, and I'll take for AMP-002, we continue to have the high-level meetings with FDA officials, and they've been encouraging, and I know it's kind of the repetitive statements that I make about it, but we feel more encouraged.

是的，我會選擇 AMP-002，我們繼續與 FDA 官員舉行高層會議，他們一直在鼓勵，我知道這是我對此所做的重複聲明，但我們覺得更加受到鼓舞。

We suspect that in the near future, we should be receiving some sort of action to move the application along. But the good news is that we continue to be engaged with the agency and in this dialogue and I think soon we should see some things shake free on that.

我們懷疑在不久的將來，我們應該會收到某種行動來推動應用程式的發展。但好消息是，我們將繼續與該機構進行對話，我認為很快我們就會看到一些事情得到解決。

For AMP-007, this is our first cycle, and the agency has simply provided a late cycle, IR and as a result of that, they've extended the action day, there's nothing in there that gives us any alarm. We talked to many of our colleagues, and it seems that this is a pattern that the agency has been taking a lot lately. But again, it would be our first cycle on this combination product. So, nothing alarming to us on the conversations that we've had with them. So, we're still optimistic as we usually are for the first cycle.

對於 AMP-007，這是我們的第一個週期，該機構只是提供了一個較晚的周期，IR，因此，他們延長了行動日，其中沒有任何東西給我們帶來任何警報。我們與許多同事交談過，這似乎是該機構最近經常採取的模式。但同樣，這將是我們對該組合產品的第一個週期。因此，我們與他們的對話並沒有什麼令人擔憂的。因此，我們仍然像往常一樣對第一個週期持樂觀態度。

And, and actually, if I may just sneak in a follow up, I think I asserted that there might be entrance in that market for 007 actually might have been mistaken there. But can you say if there already is competition?

而且，實際上，如果我可以偷偷地跟進一下，我想我斷言 007 可能會進入這個市場實際上可能是錯誤的。但你能說是否已經存在競爭了嗎？

And then secondly, when you say combination product, does that mean that it's a, what do you mean just drug device combo, or you mean actual like two compounds? Like, an advert, for instance, any color you can share there would be helpful. Thanks.

其次，當你說組合產品時，這是否意味著它只是藥物裝置組合，或者你的意思是實際上像兩種化合物？例如，就像廣告一樣，您可以在那裡分享的任何顏色都會有所幫助。謝謝。

I'll take the, the combination product question. So, it's just a device, drug combination, like the majority of our inhalation products.

我將回答組合產品問題。所以，它只是一種設備、藥物組合，就像我們大多數的吸入產品一樣。

And as far as we haven't really said about said competition or not on that one. So, we'd like to not answer that one at this time.

就我們而言，我們還沒有真正談論過上述競爭或沒有談論過這場競爭。所以，我們現在不想回答這個問題。

Okay, fair enough.

好吧，很公平。

(Multiple speakers) Thank you.

（多位發言者）謝謝。

Thank you.

謝謝。

(Operator Instructions)

（操作員說明）

Thank you. As there are no further questions. I would now like to hand the conference over to Dan Dischner for closing comments.

謝謝。因為沒有其他問題了。現在我想將會議交給 Dan Dischner 進行總結評論。

Thank you, everyone for joining us today. We remain confident in delivering on our pipeline while executing on BAQSIMI and Primatene MIST. We look forward to updating you all again next quarter and have a great day.

謝謝大家今天加入我們。我們仍然有信心在執行 BAQSIMI 和 Primatene MIST 的同時交付我們的產品線。我們期待下個季度再次向您通報最新情況，祝您有個愉快的一天。

Thank you.

謝謝。

(Operator Instructions)

（操作員說明）