Amphastar Pharmaceuticals Inc (AMPH) 2024 Q4 法說會逐字稿

Greetings and welcome to the Amphastar Pharmaceuticals fourth quarter earnings call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. (Operator Instructions)

大家好，歡迎參加 Amphastar Pharmaceuticals 第四季財報電話會議。此時，所有參與者都處於只聽模式。正式演講結束後將進行問答環節。（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.

請注意，本次電話會議中涉及非歷史事實的某些陳述（包括但不限於管理階層對未來期間的展望或預測）屬於前瞻性陳述。這些聲明完全基於我們目前掌握的資訊。

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.

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，請參閱我們向美國證券交易委員會提交的文件，該文件可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眾多因素。

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. Please note, this conference call 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 GAAP 進行協調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.

我們今天的演講者是財務長 Bill Peters 先生；企業傳播資深副總裁 Dan Dischner 先生；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 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 us today for our fourth quarter earnings call of 2024. Joining me on the call will be Bill Peters, CFO and Executive Vice President of Finance; and Tony Marrs, Executive Vice President of Regulatory Affairs and Clinical Operations.

謝謝你，保羅。下午好，感謝您今天參加我們的 2024 年第四季財報電話會議。與我一起參加電話會議的還有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。

Earlier today, we announced our financial results for the 2024 fiscal year, achieving revenues of $732 million, a strong 14% increase compared to the prior year. For the fourth quarter alone, we recorded $186 million, demonstrating a solid 5% year-over-year growth.

今天早些時候，我們公佈了 2024 財年的財務業績，實現收入 7.32 億美元，比前一年強勁增長 14%。光是第四季度，我們的營收就達到 1.86 億美元，年增 5%。

This performance highlights the resilience of our portfolio, driven by contributions from key products such as Primatene MIST and the integration of BAQSIMI into our expanding diabetes franchise.

這項業績凸顯了我們產品組合的韌性，這得益於 Primatene MIST 等主要產品的貢獻以及 BAQSIMI 與我們不斷擴大的糖尿病特許經營權的整合。

As we concluded the fourth quarter, BAQSIMI operations have fully transitioned to Amphastar and distribution responsibility is now completely under our control. Building on this momentum, we are thrilled to announce a new strategic partnership with MannKind.

在第四季結束時，BAQSIMI 業務已完全過渡到 Amphastar，分銷責任現已完全由我們控制。基於這一勢頭，我們很高興宣布與 MannKind 建立新的策略合作夥伴關係。

Effective January 1 of this year, MannKind's experienced sales force has started promoting BAQSIMI, expanding our sales reach. This collaboration represents a strategic step towards -- forward in amplifying BAQSIMI's growth trajectory and strengthening our position in the diabetes care market.

自今年 1 月 1 日起，MannKind 經驗豐富的銷售團隊開始推廣 BAQSIMI，擴大我們的銷售範圍。此次合作代表著我們朝著擴大 BAQSIMI 的成長軌跡和加強我們在糖尿病照護市場的地位邁出了策略性的一步。

Primatene MIST, a cornerstone of our branded product offering has reached a significant milestone with annual sales of $102 million, representing a 14% increase from 2023. Continuing to build on that momentum, we are pleased to announce that as of late January, our physician sampling program has been expanded with the launch of our pilot sales program targeting primary care physicians and enhancing our market penetration and engagement with health care providers.

Primatene MIST 是我們品牌產品的基石，其年銷售額已達到重要里程碑，達到 1.02 億美元，比 2023 年成長 14%。為了繼續保持這一勢頭，我們很高興地宣布，截至 1 月底，我們的醫生抽樣計劃已經擴大，我們推出了針對初級保健醫生的試點銷售計劃，並提高了我們的市場滲透率和與醫療保健提供者的互動。

As we look to the future, we remain confident that Primatene MIST and BAQSIMI will continue to be key contributors to our revenue growth through 2025. These products highlight our ability to innovate and meet market demands, reinforcing our commitment to sustaining growth through branded products.

展望未來，我們堅信 Primatene MIST 和 BAQSIMI 將在 2025 年之前繼續成為我們營收成長的主要貢獻者。這些產品凸顯了我們的創新和滿足市場需求的能力，強化了我們透過品牌產品維持成長的承諾。

Turning to glucagon; we recorded annual sales of $108 million in 2024. While this represents a modest 5% decline in the previous year, we expect glucagon to face increasing competitive pressures. Nevertheless, we view this as a natural evolution in a dynamic market for a generic product.

轉向胰高血糖素； 2024 年我們的年銷售額達到 1.08 億美元。雖然這比前一年下降了 5%，但我們預計胰高血糖素將面臨越來越大的競爭壓力。儘管如此，我們認為這是通用產品動態市場中的自然演變。

Part of the market evolution in the glucagon space involves the shift to ready-to-use products such as BAQSIMI which we believe positions us to seize new opportunities in the coming year.

胰高血糖素領域的市場演變部分涉及向 BAQSIMI 等即用型產品的轉變，我們相信這將使我們在來年抓住新的機會。

Our hospital and clinic use products also experienced heightened competitive pressures in the fourth quarter. Despite these obstacles, we continue to benefit from ongoing drug shortages in other areas of our product portfolio.

我們的醫院和診所使用的產品在第四季也面臨加劇的競爭壓力。儘管存在這些障礙，我們仍然受益於產品組合中其他領域持續存在的藥品短缺。

Given the cyclical nature of these shortages, we anticipate that similar market dynamics will persist throughout the coming year. Our diverse product portfolio and proactive supply chain strategy supported by our vertically integrated business structure are designed to effectively navigate these fluctuations, ensuring a consistent supply and strong competitive positioning in the market.

鑑於這些短缺的周期性，我們預計類似的市場動態將持續到明年。我們多樣化的產品組合和積極的供應鏈策略，加上我們垂直整合的業務結構支持，旨在有效應對這些波動，確保穩定的供應和強大的市場競爭地位。

Shifting the discussion to our regulatory and pipeline developments, we are optimistic about the potential approval of four key products in 2025. AMP-002; AMP-007, an inhalation product; AMP-015 which is teriparatide; and AMP-018 marking our GLP-1 ANDA.

將討論轉向我們的監管和管道發展，我們對 2025 年四種關鍵產品的潛在批准感到樂觀。AMP-002； AMP-007，一種吸入產品； AMP-015 即特立帕肽；和 AMP-018 標誌著我們的 GLP-1 ANDA。

Regarding AMP-002, despite a delay in its GDUFA date since the second quarter of 2023, we continue to engage in proactive discussions with senior-level FDA officials. This product is still without a generic competitor and we expect further clarification on the optimal path forward in the coming months.

關於 AMP-002，儘管其 GDUFA 日期自 2023 年第二季以來有所推遲，但我們仍在繼續與 FDA 高層官員進行積極討論。該產品仍然沒有通用競爭對手，我們期待在未來幾個月內進一步明確最佳前進路徑。

For AMP-015 or teriparatide, we have completely responded to the CRL we received in the fourth quarter of this -- as of this month, with an anticipated GDUFA goal date in the second half of this year. Regarding our remaining ANDAs, both AMP-007 and AMP-018, both are progressing well with first cycle GDUFA goal dates in the second quarter of this year.

對於 AMP-015 或特立帕肽，截至本月，我們已完全回應了今年第四季收到的 CRL，預計 GDUFA 目標日期為今年下半年。關於我們剩餘的 ANDA，AMP-007 和 AMP-018，都進展順利，第一輪 GDUFA 目標日期為今年第二季。

Turning to our insulin BLA, AMP-004 or insulin aspart, we have refiled this application after further request from the FDA. Our commitment to achieving the highest technical standards remains firm, particularly as we work towards obtaining interchangeability status for insulin product.

談到我們的胰島素 BLA、AMP-004 或門冬胰島素，我們在 FDA 的進一步要求後重新提交了此申請。我們始終堅定地致力於實現最高的技術標準，特別是在我們努力獲得胰島素產品的可互換性地位時。

Turning beyond our ANDAs and diabetes portfolio, I'd like to offer brief comments on recent developments concerning international trade and Amphastar's current business strategy. Regardless of current or future US trade policies and trade balances, we believe our vertically integrated business model positions us exceptionally well to mitigate any significant impact. Moreover, our robust US based manufacturing footprint where 100% of our finished products are produced domestically shields us from tariffs on finished pharmaceutical goods.

除了我們的 ANDA 和糖尿病產品組合之外，我想就國際貿易和 Amphastar 當前業務策略的最新發展發表一些簡短的評論。無論當前或未來的美國貿易政策和貿易平衡如何，我們相信我們的垂直整​​合業務模式使我們能夠很好地減輕任何重大影響。此外，我們在美國擁有強大的製造基地，100％的成品均在國內生產，這使我們免受成品藥品關稅的影響。

This domestic production capacity ensures supply chain resilience and aligns with potential policy initiatives to bolster US manufacturing. As we look to the future, Amphastar is optimistic about our growth as we shift our focus towards our branded and proprietary portfolio and pipeline. The year 2024 was particularly significant for us as we achieved a milestone of $100 million in sales with our proprietary product, Primatene MIST.

這種國內生產能力確保了供應鏈的彈性，並與支持美國製造業的潛在政策措施一致。展望未來，Amphastar 對我們的成長持樂觀態度，因為我們將把重點轉向我們的品牌和專有產品組合和管道。2024 年對我們來說具有特別重要的意義，因為我們的專有產品 Primatene MIST 實現了 1 億美元銷售額的里程碑。

Additionally, BAQSIMI has shown the expected growth potential and we continue to see positive trends for these products. I'm also pleased to announce that we will introduce more proprietary pipeline products by the end of this year. We are eager to share recent developments regarding these products, along with updates on the progress of our current filings towards approval and launch.

此外，BAQSIMI 已顯示出預期的成長潛力，我們繼續看到這些產品的正面趨勢。我也很高興地宣布，我們將在今年年底推出更多專有管道產品。我們渴望分享這些產品的最新進展，以及我們目前申請批准和發布的進展。

I would like to hand the call over to our CFO and Executive Vice President of Finance, Bill Peters, to discuss the fourth quarter and year ending financial results.

我想將電話交給我們的財務長兼財務執行副總裁比爾彼得斯，討論第四季和年底的財務表現。

Thank you, Dan. Sales for the fourth quarter of 2024 increased 5% to $186.5 million from $178.1 million in the fourth quarter of 2023. Total BAQSIMI sales at the factory level grew 12%, with BAQSIMI contributing $41.8 million to Amphastar's net product sales. Lilly sales of BAQSIMI totaled $300,000 which led to a net economic benefit of negative $455,000 after a true-up of certain expenses.

謝謝你，丹。2024 年第四季的銷售額從 2023 年第四季的 1.781 億美元成長 5% 至 1.865 億美元。BAQSIMI 工廠層級的總銷售額成長了 12%，其中 BAQSIMI 為 Amphastar 的淨產品銷售額貢獻了 4,180 萬美元。禮來公司的 BAQSIMI 銷售額總計 30 萬美元，扣除某些費用後，淨經濟效益為負 45.5 萬美元。

Throughout the year, Amphastar's BAQSIMI sales have increased, while the net economic benefit has decreased as we have taken over distribution responsibilities of BAQSIMI in various countries around the world. As of January 1, 2025, we assume distribution responsibilities for BAQSIMI in the final 2 countries.

全年，安菲星的BAQSIMI銷售額有所成長，但由於我們接手了BAQSIMI在全球各國的分銷責任，淨經濟效益有所下降。自 2025 年 1 月 1 日起，我們將承擔最後 2 個國家的 BAQSIMI 經銷責任。

Primatene MIST continues to show strong sales growth during the quarter with sales of $28.9 million, up 18% from $24.5 million in the prior year period. For the year, Primatene MIST sales were $102 million, surpassing our $100 million annual goal we set three years ago. Glucagon sales declined to $25.6 million from $31.2 million in the prior year period due to increased competition and a market move to ready-to-use products such as BAQSIMI.

Primatene MIST 本季持續呈現強勁的銷售成長，銷售額達 2,890 萬美元，較去年同期的 2,450 萬美元成長 18%。今年，Primatene MIST 的銷售額為 1.02 億美元，超過了我們三年前設定的 1 億美元年度目標。由於競爭加劇以及市場轉向 BAQSIMI 等即用型產品，胰高血糖素銷售額從去年同期的 3,120 萬美元下降至 2,560 萬美元。

Epinephrine sales declined to $18.7 million from $24.6 million in the previous year's period due to increased competition for our epinephrine vial product. Gross margins decreased to 46.5% of revenues in the fourth quarter of 2024 compared to 54% of revenues in the fourth quarter of 2023, primarily due to BAQSIMI sales which were recorded net of Lilly's expenses in the prior year, so there was no associated cost of sales.

由於腎上腺素瓶產品競爭加劇，腎上腺素銷售額從去年同期的 2,460 萬美元下降至 1,870 萬美元。2024 年第四季毛利率下降至營收的 46.5%，而 2023 年第四季為 54%，這主要是由於 BAQSIMI 銷售額記錄在禮來公司上一年的支出淨額中，因此沒有相關的銷售成本。

We were also impacted by higher labor and component costs. Strong sales of higher-margin Primatene MIST partially offset this trend. Selling, distribution and marketing expenses increased 21% to $10.4 million from $8.6 million due to the expansion of our sales and marketing efforts for BAQSIMI. General and administrative expenses remained relatively unchanged at $12.9 million compared to $13.1 million in the prior year.

我們也受到勞動力和零件成本上漲的影響。利潤率較高的 Primatene MIST 的強勁銷售部分抵消了這一趨勢。由於我們擴大了對 BAQSIMI 的銷售和行銷力度，銷售、分銷和行銷費用從 860 萬美元增加了 21% 至 1,040 萬美元。一般及行政開支相對保持不變，為 1,290 萬美元，而上年同期為 1,310 萬美元。

Research and development expenditures decreased 11% in the quarter to $18.1 million from $20.4 million in the comparable quarter of 2023, primarily due to lower spending on clinical trials and materials and supplies.

本季研發支出從 2023 年同期的 2,040 萬美元下降 11% 至 1,810 萬美元，主要原因是臨床試驗以及材料和用品的支出減少。

Non-operating expenses in the fourth quarter of 2024 were $1.2 million compared to $12.6 million in the prior year period, primarily related to the accretion of the $129 million deferred cash payment to Lilly which was made in June 2024 as well as lower principal balance on our debt, foreign currency fluctuations and mark-to-market adjustments on our interest rate swaps.

2024 年第四季的非營業費用為 120 萬美元，而去年同期為 1,260 萬美元，主要與 2024 年 6 月向禮來公司支付的 1.29 億美元遞延現金的增加以及債務本金餘額的降低、外匯波動和利率互換的按市價計價調整有關。

Additionally, in 2023, we wrote off unamortized debt issuance costs related to one of our term loans. The company reported net income of $34 million or $0.74 per share compared to the previous year's fourth quarter net income of $36.2 million or $0.68 per share which was up 5% and 9%, respectively.

此外，2023 年，我們註銷了與一筆定期貸款相關的未攤銷債務發行成本。該公司報告淨收入為 3,400 萬美元或每股 0.74 美元，而去年第四季淨收入為 3,620 萬美元或每股 0.68 美元，分別成長 5% 和 9%。

The company reported an adjusted net income of $47.2 million or $0.92 per share compared with an adjusted net income of approximately $46.9 million or $0.88 per share in the fourth quarter of the previous year.

該公司報告調整後淨收入為 4,720 萬美元，即每股 0.92 美元，而去年同期調整後淨收入約為 4,690 萬美元，即每股 0.88 美元。

Adjusted earnings exclude amortization, equity compensation, impairments of long-lived assets and onetime events. In the fourth quarter, we had cash flow provided by operations of approximately $29 million and for the full year, cash flows from operations were $213.4 million.

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。第四季度，我們的營運活動現金流約為 2,900 萬美元，全年經營活動現金流為 2.134 億美元。

Let me take this time now to review a few of the financial assumptions we are using as we look forward to 2025 and beyond. We took a 3% price increase on BAQSIMI in the United States and we anticipate continued unit growth in the high single-digit range for this product.

現在，請容許我回顧我們展望 2025 年及以後所使用的幾個財務假設。我們對美國 BAQSIMI 的價格進行了 3% 的上調，並預計該產品的銷售將繼續保持高個位數成長。

For Primatene MIST, we expect sales to grow in the high single digits this year as we continue to expand our physician sampling program. We are forecasting two product launches later this year from products on file at the FDA.

對於 Primatene MIST，隨著我們繼續擴大醫生抽樣計劃，我們預計今年的銷售額將實現高個位數成長。我們預計今年稍後將推出兩款已在 FDA 備案的產品。

Offsetting these growth trends will be sales declines due to increased competition for glucagon, epinephrine, phytonadione and enoxaparin. This will lead sales to be relatively flat in 2025 before returning to double-digit growth rates in 2026.

抵消這些成長趨勢的將是胰高血糖素、腎上腺素、植物萘醌和依諾肝素競爭加劇導致的銷售下降。這將導致 2025 年銷售額相對持平，然後在 2026 年恢復兩位數成長率。

We expect gross margins to be lower due to pricing pressures on glucagon, epinephrine and phytonadione which are higher-margin products. Additionally, the portion of our BAQSIMI sales made by Lilly in 2024 did not have cost of sales associated with them and these sales will be recorded by Amphastar this year, so they will have cost of sales, thus lowering our gross margin.

我們預計毛利率會較低，因為胰高血糖素、腎上腺素和植物甲萘醌等高利潤產品面臨定價壓力。此外，禮來公司在 2024 年銷售的 BAQSIMI 部分沒有相關的銷售成本，而這些銷售將由 Amphastar 今年記錄，因此它們將有銷售成本，從而降低我們的毛利率。

Our selling and marketing expenses will increase slightly as a percentage of sales due to increased efforts related to BAQSIMI.

由於增加與 BAQSIMI 相關的努力，我們的銷售和行銷費用佔銷售額的百分比將略有增加。

Turning to research and development. We plan to ramp up spending on clinical trials and purchases of materials and supplies as we increased spending on our insulin portfolio, 2 inhalation candidates and our proprietary products.

轉向研究和開發。我們計劃增加臨床試驗和材料及耗材採購的支出，同時增加胰島素產品組合、2 種吸入劑候選藥物和專有產品的支出。

We also anticipate a significant increase in capital spending this year as we prepare to break ground on our expansion project that will significantly increase capacity at our Rancho Cucamonga facility as we look to commercialize major insulin and complex injectable opportunities.

我們也預計今年的資本支出將大幅增加，因為我們準備破土動工擴建項目，這將大大提高我們 Rancho Cucamonga 工廠的產能，因為我們希望將主要的胰島素和複雜注射劑商業化。

Spending on this major project began last year but will ramp up more significantly in 2025. We plan to finance this expansion with cash flow from operations. Additionally, we plan to utilize our strong cash position to continue to buy back our stock.

該重大項目的支出已於去年開始，但到 2025 年將大幅增加。我們計劃利用營運現金流來為此次擴張提供資金。此外，我們計劃利用我們強大的現金狀況繼續回購我們的股票。

I'll now turn the call back over to the operator for Q&A.

我現在將把電話轉回給接線員進行問答。

(Operator Instructions) Jason Gerberry with Bank of America.

（操作員指示）美國銀行的 Jason Gerberry。

I just -- I know you guys aren't offering any 2025 guidance but I was wondering if you could speak to your outlook on Primatene MIST and glucagon heading into the next year. Those seem like the key products to me. Thanks in advance.

我只是——我知道你們沒有提供任何 2025 年的指導，但我想知道你們是否可以談談對 Primatene MIST 和胰高血糖素明年的展望。對我來說，這些似乎是關鍵產品。提前致謝。

Yes. So Primatene MIST, we are going to -- we're expecting to see single-digit sales growth, high single-digit sales growth for that product. For BAQSIMI, as I mentioned, we took a 3% price increase in the United States. The United States is about 80% of the sales for that product.

是的。因此，Primatene MIST，我們預計該產品的銷售額將實現個位數成長，高個位數成長。對於 BAQSIMI，正如我所提到的，我們在美國漲價了 3%。美國約佔該產品銷量的80%。

Additionally, we're expecting to see high single-digit unit growth for that product. And glucagon, because of the increased competition, we're expecting both pricing and unit volume drops for that product.

此外，我們預計該產品的單位銷售將實現高個位數成長。對於胰高血糖素，由於競爭加劇，我們預期該產品的價格和單位銷售都會下降。

Cerena Chen with Wells Fargo.

富國銀行的 Cerena Chen。

Congrats on the solid quarter. I was wondering for the products with GDUFA dates coming up in Q2, AMP-007 and 018, how prepared are you to launch these products if they do get approved. And for the GLP-1, are you aware if competitors have generally been able to get first cycle approvals? Or do you think this product typically requires more review cycles?

恭喜本季業績穩健。我想知道，對於 GDUFA 日期將於第二季度公佈的產品 AMP-007 和 018，如果它們獲得批准，您做好了怎樣的準備來推出這些產品。對於 GLP-1，您是否知道競爭對手是否通常能夠獲得第一輪批准？或者您認為該產品通常需要更多的審核週期？

As far as preparing to launch with these products being on their first cycle, our thought is that we probably wouldn't be ready to launch until the following quarter. So if it's a second quarter approval, then we would launch it in the third quarter. I'll turn it over to Tony for the other portion of that question.

至於準備推出這些處於第一個週期的產品，我們認為我們可能要等到下個季度才能準備好推出。因此，如果第二季獲得批准，我們將在第三季推出它。我將把該問題的另一部分交給托尼來回答。

Yes. For the GLP-1s, we think first cycle reviews are possible. But given that these are peptide type products, I think it's optimistic for that for the majority of companies.

是的。對於 GLP-1，我們認為第一輪審查是可能的。但考慮到這些都是勝肽類產品，我認為對大多數公司來說這是樂觀的。

Ekaterina Knyazkova with JPMorgan.

摩根大通的 Ekaterina Knyazkova。

So first question is just on BAQSIMI. I know it's early but what kind of impact are you seeing from the expanded sales force and the collaboration with MannKind. Are you kind of seeing the kind of traction you're expecting?

所以第一個問題是關於 BAQSIMI 的。我知道現在還為時過早，但您認為擴大銷售團隊和與 MannKind 的合作會帶來什麼樣的影響？您是否看到了您所期望的那種牽引力？

And maybe latest thoughts of how you're thinking about the commercial footprint beyond 2025? And then, second question is just on AMP-004. Just can you remind us how you're thinking about the size of that opportunity? And just the latest on timing, is this something that could potentially launch later this year? Or is this more 2026?

您最近對 2025 年以後的商業足跡有何看法？然後，第二個問題是關於 AMP-004 的。您能否提醒我們一下，您如何看待這個機會的規模？關於時間的最新情況，這個產品有可能在今年稍後推出嗎？還是這更接近 2026 年？

I'll start with the BAQSIMI question. Obviously, it's still a little early to tell. They just started detailing it in the beginning of January. But because of the -- we haven't disclosed the exact number but it's quite large -- quite a larger number of sales reps than what we've been utilizing.

我將從 BAQSIMI 問題開始。顯然，現在下結論還為時過早。他們從一月初就開始詳細說明。但由於——我們尚未透露確切的數字，但這個數字相當大——銷售代表的數量比我們一直以來使用的數字要多得多。

So we do expect -- and I also want to point out that they actually have experience in the endocrinology space. So we really feel like it's a great fit for us that they can get in and promote the product. So we're looking forward to that. And we'll keep you updated as that goes on. For AMP-004, have Tony kind of address that issue.

所以我們確實期待——而且我還想指出，他們實際上在內分泌學領域有經驗。所以我們真的覺得他們能夠加入並推廣我們的產品對我們來說非常合適。所以我們對此充滿期待。我們會及時向大家通報最新進展。對於 AMP-004，讓 Tony 解決這個問題。

Yes. So as far as getting ready to participate in that market, we don't see that getting approved this year or probably it's unlikely to get approved until late next year. So that's something that we'll be prepared for at that time.

是的。因此，就準備參與該市場而言，我們認為今年不會獲得批准，或者可能要到明年年底才能獲得批准。所以我們到時候會為此做好準備。

David Amsellem with Piper Sandler.

大衛‧阿姆塞勒姆 (David Amsellem) 與派珀‧桑德勒 (Piper Sandler)。

So I'm going to come back to the informal guidance topic or question. So you've got two products that you expect to be launching and that's in your numbers and then there's competition from the products you called out. I guess, a couple of questions on that is, you got GDUFA is on three products this year.

因此我將回到非正式指導主題或問題。因此，您有兩款預計要推出的產品，而且這些產品都包含在您的數據中，但您提到的這些產品也會帶來競爭。我想，關於這一點有幾個問題，今年你們獲得了三種產品的 GDUFA。

Can you say which of the three is between 015, 018 and 007 you expect to launch? Are you factoring in risk-adjusted contribution from those products? And is there any way you can quantify how much in the way of new launches you're guiding to versus how much decline from competition you are expecting? I think that kind of color would be helpful.

您能說出您預計推出的015、018和007中的哪一款嗎？您是否考慮了這些產品的風險調整貢獻？有什麼方法可以量化您指導的新產品發布量與您預期的競爭下滑量嗎？我認為那種顏色會有幫助。

Sure. So we've got four candidates that could be approved. And we actually think that there's a possibility of any of them being approved and possibility having contribution from all of them. So this is a risk-adjusted basis for two. And what we've decided to do this year is as we took a look at the potential timing for these things, we're expecting, I'll say, fourth quarter sales from two products. So no new launches until then for our guidance and that's on a risk-adjusted basis.

當然。因此，我們有四位候選人可能獲得批准。我們確實認為其中任何一個都有可能獲得批准，而且都有可能得到所有人的貢獻。因此，這是兩個風險調整的基礎。我們今年決定要做的是，當我們考慮了這些事情的潛在時機後，我們預計，我會說，兩種產品的第四季銷售將會很好。因此，根據我們的指導，在此之前不會推出新產品，而且這是在風險調整的基礎上的。

So it's certainly possible that it happens and we get some in the third quarter or even all four by the fourth quarter. But on a risk-adjusted basis, we think based on the way we see things and some uncertainty for some of these products that two of them is what we're looking at for the fourth quarter.

所以這當然有可能發生，我們會在第三季獲得一些收益，甚至在第四季獲得全部收益。但在風險調整的基礎上，我們認為，基於我們對事物的看法以及其中一些產品的不確定性，其中兩種產品是我們在第四季度關注的。

Okay. And if I may follow up, just is one of those 4 AMP-002 which I know has kind of been in flux since the GDUFA came and went back in 2023?

好的。我可以繼續問一下嗎？據我所知，自從 2023 年 GDUFA 頒布和廢除以來，這 4 個 AMP-002 中的一個就一直處於變化之中？

So I'll say on a risk-adjusted basis, it's possible but we think it's probably more likely that, that's a first quarter of 2026 event.

因此，我認為從風險調整的角度來看，這是可能的，但我們認為更有可能的是，這是 2026 年第一季發生的事件。

Serge Belanger with Needham & Company.

Needham & Company 的 Serge Belanger。

Few questions. I guess, first on BAQSIMI and the MannKind collaboration. Can you just give us a little more color on what the collaboration represents in terms of additional sales force regarding what you previously had and if they'll be targeting a different set of prescribers.

幾個問題。我想，首先是關於 BAQSIMI 和 MannKind 的合作。您能否向我們詳細介紹一下此次合作對於增加您先前的銷售隊伍有何意義，以及他們是否會針對不同的處方人員。

And I guess, if it increases your peak sales estimates for the product? And secondly, just can you update us on the competitive overview of epinephrine and whether you expect Pfizer to come back in the market at some point? And when?

我猜，它是否會增加您對該產品的最高銷售預期？其次，您能否向我們介紹一下腎上腺素的競爭概況，以及您是否預期輝瑞公司會在某個時候重返市場？什麼時候？

Sure. So let me start with the sales force of MannKind. With their sales force, that more than doubles the number of salespeople that are going to be detailing the product. So it covers more of the country than it had previously. Now keep in mind that for the MannKind portion of this, it's a secondary product for them.

當然。那麼，讓我先從 MannKind 的銷售團隊開始。有了他們的銷售隊伍，負責詳細介紹產品的銷售人員數量將增加一倍以上。因此，它覆蓋的地區比以前更大。現在請記住，對於 MannKind 部分來說，這是他們的次要產品。

So they're detailing Afrezza first and BAQSIMI second but I think it's a really good product for them because it gets them -- gives them something else to talk about than Afrezza they've been talking about for a long while. I think it gets them into doctors' offices.

因此，他們首先詳細介紹了 Afrezza，然後介紹了 BAQSIMI，但我認為這對他們來說確實是一款好產品，因為它讓他們有了除了他們長期以來一直在談論的 Afrezza 之外的其他話題可談。我認為這會讓他們進入醫生辦公室。

So I think they're really excited about it and we're really excited about it, too. So we do think that it takes some time to get that ramp-up going and that going. So the way we're looking at it is that the sales should accelerate going into the latter half of the year as well. So that's another thing that we're looking at there.

所以我認為他們對此非常興奮，我們也對此感到非常興奮。因此，我們確實認為需要一些時間來實現這一目標。因此，我們認為下半年的銷售量也應該會加速成長。這是我們正在關注的另一件事。

As far as epi goes, remember, we sell both the prefilled syringe and the multi-dose vial. And now there's four or five players now in the multi-dose vial. That's why we saw the epinephrine sales drop in the fourth quarter of last year. But on the prefilled syringe, as of right now, we're still the only player in the United States that's selling that product.

就 Epi 而言，請記住，我們既銷售預充式註射器，也銷售多劑量小瓶。現在，多劑量藥瓶裡有四、五名球員。這就是我們看到去年第四季腎上腺素銷售下降的原因。但就預充式註射器而言，截至目前，我們仍然是美國唯一一家銷售該產品的公司。

So right now, it's us. Our competition there has repeatedly changed the date when they expect to get back into the market. So it's hard to say but I don't think it's the first quarter or probably not a second quarter event.

所以現在，輪到我們了。我們在那裡的競爭對手多次更改他們預計重返市場的日期。所以很難說，但我認為這不是第一季或可能不是第二季的事件。

Thank you. There are no further questions at this time. I would like to hand the floor back over to Mr. Dan Dischner for any closing comments.

謝謝。目前沒有其他問題。我想將發言權交還給丹·迪施納先生，請他發表最後評論。

Thank you all for joining us on today's call. We are excited about the opportunities ahead, especially with two upcoming GDUFA dates in the second quarter. We will also provide updates on our branded proprietary and pipeline products in the future quarters. We look forward to sharing more information with you on our next call. Thank you. Have a good day.

感謝大家參加今天的電話會議。我們對未來的機會感到興奮，特別是第二季即將到來的兩個 GDUFA 日期。我們還將在未來幾季提供有關我們品牌專有產品和管道產品的最新資訊。我們期待在下次通話中與您分享更多資訊。謝謝。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。