Amphastar Pharmaceuticals, Inc. (AMPH) 2026 Q2 法說會逐字稿

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

各位好，歡迎參加 Amphastar Pharmaceuticals, Inc. 2026 年第二季財報電話會議。

(Operator Instructions)

(接線員指示)

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 session 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之事項所作的某些陳述（包括但不限於管理層對未來期間的展望或預測）屬於前瞻性陳述。這些陳述僅基於我們目前可取得的資訊。我們鼓勵您查閱今日發布之新聞稿中題為「前瞻性陳述」的章節，以及公司網站上的簡報。

Also, please refer to our SEC filings, which can be found on the company's 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 is being recorded.

此外，亦請參閱我們的 SEC 申報文件（可於公司網站及 SEC 網站查閱），其中討論了可能影響我們未來業績的多項因素。我們也將討論若干非 GAAP 指標；關於我們使用這些指標的重要資訊以及與美國 GAAP 的調節，請見我們的財報新聞稿。請注意，本次會議將被錄音。

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.

今日出席的講者包括：財務長 Bill Peters 先生；企業傳播資深副總裁 Dan Dischner 先生；以及法規事務與臨床營運執行副總裁 Tony Marrs 先生。

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

現在我將把會議交給企業傳播資深副總裁 Dan Dischner 先生。Dan，請開始。

Thank you, Paul, good afternoon everyone, and thank you for joining Amphastar's second quarter 2026 earnings call.

謝謝你，Paul。各位下午好，感謝各位參加 Amphastar 2026 年第二季財報電話會議。

Earlier today we reported the financial results for the second quarter ended June 30, 2026, which are available on the investors page of our website, the second quarter was marked by strong execution across each of our strategic growth pillars, we observe continued demand across our commercial portfolio, we expanded our manufacturing capabilities and advanced both our development pipeline and regulatory programs.

今天稍早我們公布了截至 2026 年 6 月 30 日止第二季的財務結果，相關資料可於我們網站的投資人專區取得。本季在我們各項策略性成長支柱上均展現強勁的執行力；我們觀察到商業化產品組合需求持續，我們擴充了製造能力，並推進了研發產品線與法規計畫。

As a result, we generated and improved financial performance during the second quarter. Revenue increased to approximately $184 million, reflecting both sequential and year-over-year growth. Profitability also improved significantly from the first quarter, driven by increased revenue, margin expansion, and enhanced operating performance.

因此，我們在第二季實現並提升了財務表現。營收增加至約 1.84 億美元，呈現季增與年增。在營收增加、毛利率擴張及營運表現提升的帶動下，獲利能力亦較第一季顯著改善。

Despite a dynamic operating environment, our strategic priorities have remained consistent. We continue to focus on building a diversified pharmaceutical company supported by 3 complementary growth pillars. First, expanding and optimizing our branded and differentiate differentiated commercial portfolio. Second, advancing our pipeline of complex generic and biosimilar products.

儘管營運環境多變，我們的策略重點仍保持一致。我們持續聚焦於打造一家多元化的製藥公司，並由三項互補的成長支柱所支持。第一，擴大並優化我們的品牌與差異化商業化產品組合。第二，推進我們的高複雜度學名藥與生物相似藥產品線。

And third, progressing our proprietary development programs that have the potential to create significant long-term value. We believe this diversified business model provides multiple avenues for growth, enhances resilience and reduces our dependence on any single product, market, or revenue stream.

第三，推動我們的自有研發計畫，這些計畫有潛力創造可觀的長期價值。我們相信，這種多元化的商業模式提供多條成長途徑、提升韌性，並降低我們對任何單一產品、市場或營收來源的依賴。

Turning to the first pillar of our growth strategy, expanding and optimizing our branded and differentiated commercial portfolio. We continued to make meaningful progress during the second quarter, products such as BAQSIMI and Primatene MIST remain central to our long-term strategy and continue to demonstrate strong consumer demand.

接著談我們成長策略的第一項支柱：擴大並優化品牌與差異化商業化產品組合。我們在第二季持續取得實質進展；BAQSIMI 與 Primatene MIST 等產品仍是我們長期策略的核心，並持續展現強勁的消費者需求。

BAQSIMI remained an important contributor to our business. Total prescriptions increased approximately 17% compared with the second quarter of last year. Demonstrated continued growth in patient demand. BAQSIMI's net sales were approximately $45.5 million, a decrease of approximately 3% compared to the prior year quarter.

BAQSIMI 仍是我們業務的重要貢獻來源。總處方量較去年第二季約增加 17%。顯示病患需求持續成長。BAQSIMI 的淨銷售額約為 4,550 萬美元，較去年同期約下降 3%。

The difference primarily reflects pricing, rebates, and commercial dynamics. Importantly, strong prescription growth continues to reinforce our confidence in the long-term strength of the franchise. In June, we also complete the third contract year following our acquisition of BAQSIMI from Eli Lilly.

差異主要反映定價、回扣與商業動態。重要的是，強勁的處方成長持續強化我們對該產品線長期實力的信心。6 月我們也完成了自 Eli Lilly 收購 BAQSIMI 後的第三個合約年度。

During the contract year, BAQSIMI generated $178.3 million in net sales. Exceeding the $175 million threshold and triggering our first milestone payment to Lily, achieving this of the franchise and the successful execution of our commercial strategy since acquiring the product. Our focus remains on expanding patient access, supporting continued prescription growth and managing the business with disciplined commercial execution to maximize long-term value.

在該合約年度中，BAQSIMI 產生 1.783 億美元的淨銷售額。超過 1.75 億美元門檻並觸發我們向 Lilly 支付第一筆里程碑款，這反映了該產品線的實力，以及我們自收購以來成功執行商業策略。我們仍將聚焦於擴大病患可近性、支持處方持續成長，並以嚴謹的商業執行管理業務，以最大化長期價值。

Primatene MIST continued to demonstrate strong consumer demand during the corner. Each in-store sales increased compared with both the prior year quarter and the first quarter of 2026, reflecting continued brand strength and market penetration. While reported net sales declined, the decrease was largely attributable to consumer ordering patterns and the timing of shipments associated with pricing discussion with certain retailers.

Primatene MIST 在本季持續展現強勁的消費者需求。各通路的店內銷售較去年同期及 2026 年第一季均有所增加，反映品牌力與市場滲透率持續提升。雖然申報的淨銷售額下降，但主要歸因於消費者訂購模式以及與部分零售商進行定價討論所致的出貨時點差異。

We believe these temporary channel related effects rather than a change in consumer demand. Retail performance remained healthy throughout the quarter, reinforcing our confidence in the Primatene MIST franchise and the effectiveness of our marketing investments and commercial execution.

我們認為這些是暫時性的通路相關影響，而非消費者需求的改變。本季零售端表現維持健康，進一步強化我們對 Primatene MIST 產品線的信心，以及對我們行銷投資與商業執行成效的肯定。

At the same time, performance across our broader portfolio reflected the competitive dynamics that are characteristic of the generic pharmaceutical market.

同時，我們更廣泛的產品組合表現也反映出學名藥市場典型的競爭動態。

Glucagon sales declined compared with the prior year as a result of increased competition. We believe this scores the importance of continuing to diversify our commercial portfolio and advance new products, which can create multiple sources of growth and enhance the resilience of our business over the long-term.

由於競爭加劇，Glucagon 的銷售較去年同期下降。我們認為這凸顯了持續多元化商業化產品組合並推進新產品的重要性，藉此創造多元成長來源並提升公司長期韌性。

Furthermore, during the quarter, our manufacturing facility, Armstrong, benefited from the successful launch of our ipratropium bromide product in April. The launch further demonstrates our ability to advance technically complex generic products from development through regulatory approval and into the commercial production, reinforcing a core capability that differentiates our platform.

此外，本季我們的 Armstrong 製造廠受惠於 4 月成功推出 ipratropium bromide（異丙托溴化物）產品。此次上市進一步展現我們將技術複雜的學名藥產品從研發推進至法規核准並導入商業化生產的能力，強化了使我們平台具差異化的核心能力。

Based on early demand and the current competitive landscape, we believe ipratropium bromide represents an attractive long-term opportunity for Amphastar.

基於初期需求與目前競爭態勢，我們認為 ipratropium bromide 對 Amphastar 而言代表具吸引力的長期機會。

We continue to invest strategically across our US manufacturing network to strengthen quality and efficiency, expand automation and capacity, and prepare for upcoming pipeline products. As policy makers and consumers place greater emphasis on domestic pharmaceutical manufacturing and supply chain resilience.

我們持續在美國製造網路進行策略性投資，以強化品質與效率、擴大自動化與產能，並為即將推出的研發產品線做好準備。同時，政策制定者與消費者也更加重視國內藥品製造與供應鏈韌性。

We believe our US-based manufacturing footprint combined with our vertically integrated development and commercialization capabilities represents a meaningful competitive advantage. These investments not only support our current commercial portfolio but also provide a strong foundation for future product launches and sustainable long-term growth.

我們相信，我們以美國為基地的製造佈局，結合垂直整合的研發與商業化能力，構成一項重要的競爭優勢。這些投資不僅支持我們現有的商業化產品組合，也為未來產品上市與可持續的長期成長奠定堅實基礎。

IMS, one of our subsidiaries, recently received an FDA warning letter related to the FDA inspection conducted in December 2025. Since the inspection, IMS has continued implementing corrective action. We have responded to the FDA in a timely manner regarding our remediation plan and continue to work closely with the agency to address the items identified in the warning letter. The warning letter does not require IMS to stop manufacturing or distributing its products.

我們的子公司之一 IMS 近期收到 FDA 的警告信，與 FDA 於 2025 年 12 月進行的查廠相關。自該次查廠以來，IMS 持續推動矯正措施。我們已就改善計畫及時回覆 FDA，並持續與主管機關密切合作，以處理警告信中所指出的事項。該警告信並未要求 IMS 停止製造或配送其產品。

While the remediation effort will require additional resources. At this time, we do not currently anticipate a material adverse effect on Amphastar's overall business operations, commercial portfolio, development pipeline, or sales. We remain committed to addressing the FDA's observations thoroughly and sustainably. Quality remains a fundamental responsibility throughout Amphastar, and we will continue strengthening the overall effectiveness of our quality systems.

雖然改善工作將需要額外資源，但目前我們不預期會對 Amphastar 的整體營運、商業化產品組合、研發產品線或銷售造成重大不利影響。我們仍致力於徹底且可持續地回應 FDA 的觀察事項。品質是 Amphastar 全體的基本責任，我們將持續強化整體品質系統的有效性。

Turning to our third pillar of growth strategy, advancing our development pipeline, we continue to achieve important regulatory and clinical milestones during the second quarter. For our insulin apart biosimilar and interchangeable program to continue preparing for potential commercial, commercialization in 2027, subject to regulatory approval.

轉到我們成長策略的第三大支柱——推進我們的研發管線——我們在第二季持續達成重要的法規與臨床里程碑。就我們的 insulin apart 生物相似藥與可互換性（interchangeable）計畫而言，我們將持續為可能於 2027 年商業化做準備，惟仍須取得監管核准。

We have also made meaningful progress with our proprietary pipeline during the second quarter, we initiated the phase 1 clinical program, AMP-101, our epinephrine nasal products. For AMP-109, our targeted oncology program, nonclinical studies are on their way. During the quarter we received constructive feedback from the FDA and our continuing preparations for regulatory interactions in the near future and an anticipated IND submission.

我們在第二季也於自有產品管線方面取得實質進展；我們已啟動第一期臨床計畫 AMP-101（我們的腎上腺素鼻用產品）。至於 AMP-109（我們的標靶腫瘤學計畫），非臨床研究正在進行中。本季我們收到 FDA 的建設性回饋，並持續為近期的法規互動與預期的 IND 申請提交做準備。

Development activities are ongoing for AMP-110, a synthetic human corticotropin program. And AMP-107, our eyedrop program for wet age-related macular degeneration and diabetic macular edema as we look to advance both towards a future IND submission.

AMP-110（合成的人類促腎上腺皮質激素 corticotropin 計畫）的開發活動仍在進行中。以及 AMP-107（我們用於濕性年齡相關性黃斑部病變與糖尿病黃斑水腫的滴眼液計畫），我們正推進兩者朝向未來的 IND 申請提交。

While these programs remain in early stages of development, we believe they represent meaningful long-term opportunities. Leveraging our scientific, regulatory, and manufacturing capabilities, these programs have the potential to expand our presence into the larger proprietary markets and create additional drivers of future growth and value creation.

雖然這些計畫仍處於開發早期階段，我們相信它們代表具意義的長期機會。藉由運用我們在科學、法規與製造方面的能力，這些計畫有潛力擴大我們在更大型自有產品市場的布局，並創造未來成長與價值創造的額外動能。

I will now turn the call over to Bill Peters, our CFO and Executive Vice President of Finance for more detailed financial review of the second quarter.

接下來我把電話交給我們的財務長暨財務執行副總裁 Bill Peters，為大家更詳細地回顧第二季財務表現。

Thank you, Dan, and good afternoon, everyone. In my comments today, I will discuss the second quarter results and then update some of our assumptions for 2026. Revenues for the second quarter increased 5% to $183.9 million from $174.4 million in the previous year's period. Ipratropium Bromide Inhalation, which we launched in April, led to growth with strong sales of $8.4 million.

謝謝你，Dan，各位下午好。我今天的說明將先討論第二季業績，接著更新我們對 2026 年的一些假設。第二季營收較去年同期的 1.744 億美元成長 5%，至 1.839 億美元。我們於 4 月上市的 Ipratropium Bromide Inhalation 帶動成長，銷售表現強勁，達 840 萬美元。

BAQSIMI revenues decreased 3% to $45.5 million compared to $46.7 million in the prior year, an increase in units sold contributing $6.9 million in sales was driven by our continued marketing efforts.

BAQSIMI 營收較去年同期的 4,670 萬美元下滑 3% 至 4,550 萬美元；在我們持續的行銷努力帶動下，銷售量增加貢獻了 690 萬美元的銷售額。

Lower average selling prices negatively impacted sales approximately $8.1 million primarily as a result of higher rebates and higher 340B pharmacy discounts, some of which may have been duplicated.

較低的平均售價對銷售造成約 810 萬美元的負面影響，主要是因為更高的回扣以及更高的 340B 藥局折扣，其中部分可能出現重複折扣。

In May, in response to these pricing dynamics, we had seen over the past few quarters, we engaged a third-party to support data-driven identification, validation, and resolution of potential 340B duplicate discounts, which led to a smaller impact than we saw in the first quarter.

5 月，因應我們在過去幾季所見的這些定價動態，我們聘請第三方支援以資料驅動方式辨識、驗證並解決可能的 340B 重複折扣問題，使其影響程度小於第一季。

Primatene MIST sales for $21 million in the second quarter, down 8% from $22.9 million in the second quarter of last year due to the timing of customer purchases. Epinephrine sales were relatively flat as weakness in the vile product was offset by increased demand for our prefilled syringe product.

Primatene MIST 第二季銷售額為 2,100 萬美元，較去年第二季的 2,290 萬美元下滑 8%，主要因客戶採購時點所致。腎上腺素（epinephrine）銷售大致持平，因小瓶（vial）產品走弱被我們預充式注射器產品需求增加所抵銷。

Glucagon sales declined 42% to $11.9 million from $20.6 million due to increased competition. Sales of other products increased 25% to $66.2 million from $53.1 million primarily due to recently launched products including iron sucrose with sales of $3.5 million and teriparatide with sales of $4.5 million which launched in August 2025 and December 2025 respectively.

Glucagon 銷售因競爭加劇而下滑 42%，由 2,060 萬美元降至 1,190 萬美元。其他產品銷售由 5,310 萬美元增加 25% 至 6,620 萬美元，主要受近期上市產品帶動，包括 iron sucrose 銷售 350 萬美元與 teriparatide 銷售 450 萬美元；兩者分別於 2025 年 8 月與 2025 年 12 月上市。

An increase in albuterol sales of $2.4 million which we launched in 2024, also contributed to the increase.

此外，我們於 2024 年上市的 albuterol 銷售增加 240 萬美元，也對成長有所貢獻。

Additionally, an increase in phytonadione and sodium bicarbonate sales driven by higher demand resulting from supplier shortages and an increase in sales of API from our subsidiary had a positive impact on sales. Cost of revenue increased 3% to $90.4 million from $87.9 million however, gross margins increased to 51% of revenues in the second quarter of 2026 compared to 50% in the previous year period.

另外，因供應商短缺導致需求提高，phytonadione 與 sodium bicarbonate 的銷售增加，以及我們子公司 API 銷售增加，也對銷售帶來正面影響。營收成本由 8,790 萬美元增加 3% 至 9,040 萬美元；然而，2026 年第二季毛利率提升至營收的 51%，高於去年同期的 50%。

The primary drivers of the change were sales of recently launched products with higher margins such as ipratropium bromide, teriparatide, and iron sucrose. This trend was partially offset by a lower average selling price for Vximine, Glucagon, and epinephrine multiple dose vile. Additionally, we had increased manufacturing costs at our Amphastar facility.

變動的主要驅動因素為近期上市且毛利較高的產品銷售增加，例如 ipratropium bromide、teriparatide 與 iron sucrose。此趨勢部分被 Vximine、Glucagon 與多劑量腎上腺素小瓶（multiple dose vial）較低的平均售價所抵銷。此外，我們在 Amphastar 廠區的製造成本也有所上升。

Selling, distribution, and marketing expenses increased 30% at $13.3 million from $10.2 million primarily due to an increase in marketing efforts for BAQSIMI and higher freight expenses. General and administrative spending increased 30% to $18.2 million from $14 million driven by higher legal expenses, salary and personnel related expenses, as well as expenses related to the implementation of the new ERP system.

銷售、配送與行銷費用由 1,020 萬美元增加 30% 至 1,330 萬美元，主要因 BAQSIMI 行銷投入增加以及運費上升。一般及行政費用由 1,400 萬美元增加 30% 至 1,820 萬美元，主要受較高的法律費用、薪資與人員相關費用，以及導入新 ERP 系統相關費用所推動。

Research and development expenditures increased 10% to $22.2 million from $20.1 million primarily due to an increase in clinical trial expense, largely for our insulin pipeline.

研發支出由 2,010 萬美元增加 10% 至 2,220 萬美元，主要因臨床試驗費用增加，且多數與我們的胰島素管線相關。

Our non operating expense of $1.2 million during the period compared to a non-operating expense of $2.8 million in the prior year period, primarily due to foreign currency fluctuations and mark-to-market adjustments related to our interest rate swap contract during the quarter.

本期非營業費用為 120 萬美元，較去年同期的 280 萬美元非營業費用為低，主要因外幣匯率波動，以及本季與利率交換合約相關的按市價評價（mark-to-market）調整。

Net income decreased slightly to $30.3 million but increased on a per share basis to $0.67 in the second quarter from $31 million or $0.64 per share in the second quarter of 2025.

淨利小幅下降至 3,030 萬美元，但以每股計則在第二季提升至 0.67 美元，較 2025 年第二季的 3,100 萬美元或每股 0.64 美元為高。

Adjusted net income was relatively flat at $40.8 million but increased on a per share basis to $0.91 in the second quarter compared to an adjusted net income of $40.9 million or $0.85 per share in the second quarter of last year. Adjusted earnings exclude amortization, equity compensation, and one-time events.

調整後淨利大致持平，為 4,080 萬美元，但以每股計在第二季提升至 0.91 美元；相較之下，去年第二季調整後淨利為 4,090 萬美元或每股 0.85 美元。調整後盈餘排除攤銷、股權補償以及一次性事件。

In the second quarter we had cash flow from operations of approximately $51.3 million. During the quarter we accelerated our share repurchase program and bought back approximately $45 million worth of shares. Separately, in June we achieved the first annual BAQSIMI net sales milestone under our asset purchase agreement with Eli Lilly, which triggers a $100 million payment due in the third quarter of 2026.

第二季我們的營運活動現金流約為 5,130 萬美元。本季我們加速執行庫藏股回購計畫，回購約 4,500 萬美元的股份。另外，6 月我們在與 Eli Lilly 的資產購買協議下達成 BAQSIMI 年度淨銷售額的第一個里程碑，將觸發於 2026 年第三季支付 1 億美元。

Before I turn the call back over to Dan, I would like to update some of our guidance for 2026. Due to remediation efforts at our IMS facility, we expect expenses there will increase by $2 million to $3 million per quarter for the next several quarters.

在我把電話交回給 Dan 之前，我想更新我們對 2026 年的部分財測指引。由於我們 IMS 廠區的改善（remediation）工作，我們預期未來數季該廠區費用每季將增加 200 萬至 300 萬美元。

Capital expenditures will also increase at this facility, but there will be no change to our previously communicated capital expenditure profile as we direct, we redirect spending from our Amphastar facility to our IMS facility.

該廠區的資本支出也將增加，但我們先前對外溝通的資本支出輪廓不會改變，因為我們將把支出自 Amphastar 廠區轉移至 IMS 廠區。

We also expect a slight slowing of sales from IMS as we concentrate on addressing corrective actions. Thus improving the quality and manufacturing systems. Importantly, even with this revised outlook, we maintain our overall corporate sales guidance. Of mid single-digit to high single-digit sales growth, reflecting the strength of our broader portfolio.

我們也預期，隨著我們專注於推動矯正措施，IMS 的銷售將略為放緩。從而提升品質與製造系統。重要的是，即使在此修訂後的展望下，我們仍維持整體公司銷售指引不變。維持中個位數至高個位數的銷售成長，反映我們更廣泛產品組合的實力。

I will now turn the call back over to Dan.

我現在把電話交回給 Dan。

Thank you, Bill. Looking ahead, our priorities remain clear. We are focused on supporting continued growth across our commercial portfolio, expanding our US manufacturing capabilities, completing the IMS remediation activities, advancing our near-term regulatory programs and continued continuing disciplined investment in our proprietary pipeline.

謝謝你，Bill。展望未來，我們的優先事項依然明確。我們專注於支持商業產品組合的持續成長、擴大我們在美國的製造能力、完成 IMS 的補救活動、推進近期的法規/監管計畫，並持續以紀律方式投資於我們的自有研發管線。

We believe the second quarter highlighted the strength and resilience of Amphastar's diversified business model faced with a dynamic operating environment, we delivered improved financial performance, generated continued demand across our key commercial brands and achieved important regulatory and development milestones.

我們認為，第二季凸顯了 Amphastar 多元化商業模式在動態營運環境下的強韌性與實力；我們交出更佳的財務表現，旗下主要商業品牌需求持續，並達成重要的法規/監管與研發里程碑。

These results reflect the benefits of our diversified growth strategy and the balanced foundation we have built across our commercial portfolio, development pipeline and manufacturing platform. We also believe Amphastar is well positioned for the evolving pharmaceutical landscape, our diversified product portfolio, a US-based Finished product manufacturing footprint, vertically integrated capabilities and growing development pipeline provide multiple avenues of growth and support long-term value creation.

這些成果反映了我們多元化成長策略的效益，以及我們在商業產品組合、研發管線與製造平台之間所建立的均衡基礎。我們也相信 Amphastar 已為不斷演變的製藥產業格局做好布局；我們多元的產品組合、以美國為基地的成品製造據點、垂直整合能力以及持續成長的研發管線，提供多重成長途徑並支持長期價值創造。

With that, we will now take your questions, Paul? Thank you.

接下來我們將開始回答各位的提問，Paul？謝謝。

(Operator Instructions)

(接線員指示)

Ekaterina Knyazkova, JPMorgan.

Ekaterina Knyazkova，摩根大通（JPMorgan）。

Thanks so much, so the question is just on operating cost. Can you just elaborate a bit on how we should think about spend from here and what both R&D and SG&A could look like over the next several quarters.

非常感謝，我的問題是關於營運成本。能否請你們再多說明一下，接下來我們應如何看待支出走勢，以及未來幾季研發（R&D）與銷售、一般及行政費用（SG&A）可能會呈現什麼樣的水準。

And then I really had a question just on adjusted gross margins, it seems like there's been quite a bit of volatility in that number over the past few quarters, just what's been driving that and what's a good baseline, to use for gross margins in the second half of the year? Thanks.

另外我也想問一下調整後毛利率；看起來這個數字在過去幾季波動相當大，想請教主要驅動因素是什麼，以及今年下半年毛利率可用來參考的合理基準為何？謝謝。

Yes, so there's a couple things driving the decrease in the first quarter, the primarily thing was the BAQSIMI, that we saw there that had a pretty negative impact, we had some better impacts, in the second quarter as we began, some procedures to, mitigate that and hire an independent party that's going to help, reduce that double discount.

是的，第一季下降主要有幾個因素；最主要的是 BAQSIMI，我們看到它對毛利率造成相當負面的影響。第二季我們開始採取一些程序來緩解此情況，並聘請第三方獨立機構協助降低所謂的「雙重折扣」。

The second thing in the second quarter was that, we had the launch of, Ipratropium Bromide HFA, which is a higher market. That that really helps out a lot, so on a going forward basis, I would expect to see the coming quarter similar to this quarter, because remember, we'll have higher BAQSIMI sales, next quarter, so the higher sales should offset some of the costs that we're expecting at, IMS.

第二個因素是在第二季，我們推出了 Ipratropium Bromide HFA，這是一個較高市場（規模/價值）的產品。這確實帶來很大幫助。因此往後看，我預期下一季會與本季相近；因為請記得，下一季 BAQSIMI 的銷售會更高，較高的銷售應可抵消我們在 IMS 預期發生的一些成本。

Additionally, on the G&A and selling expense, and I think the second quarter is also a good comp for those, but the R&D expense. Do expect that to tick up a little bit as the percentage of sales, on a going forward basis.

另外，就一般及行政費用與銷售費用而言，我認為第二季也是一個不錯的比較基準；但研發費用方面，預期往後以銷售百分比來看會小幅上升。

(Operator Instructions)

(接線員指示)

Dennis Ding, Jefferies.

Dennis Ding，Jefferies。

I have two questions. Number one, remind us what's going on with the IMS facility that got the warning letter, and if I recall you guys probably responded to it in late July, so remind us the revenue exposure here again from this, facility, what are the next steps from the FDA and when, and then would, remediation plans require shutting down some of the production lines, that's question number 1.

我有兩個問題。第一，請再提醒我們，收到警告信的 IMS 廠目前狀況如何？如果我沒記錯，你們大概在 7 月下旬回覆了該警告信；請再說明一次，這座廠的營收曝險有多大？FDA 接下來的步驟是什麼、時間點為何？另外，補救計畫是否需要關閉部分產線？這是第一個問題。

And then question number 2 on BAQSIMI. 340B dynamic, I think you said 80% of that pricing pressure can ultimately go away. Can you reiterate that number, on the call today, and how much of that 80% was recovered in Q2 and how much is left to recover in Q3? Thanks so much.

第二個問題關於 BAQSIMI。關於 340B 的動態，我記得你們說其中 80% 的定價壓力最終可以消除。能否在今天的電話會議上重申這個數字？以及這 80% 中有多少在第二季已經回收、第三季還剩多少待回收？非常感謝。

Okay, so let me start with the revenue, IMS makes, the sales, are probably about a third of our overall corporate sales, on a big picture, however, we are still, we still are producing, at the same rate that we've been, what we have taken some, all of these steps which have slowed down some of the releases of some of the batches right now, to make sure that they've gone through an extra quality review, so, that's led to a small delay, right now for that, but I'll turn it over to Tony for some of the other, next step that we have going on there.

好的，我先從營收談起。IMS 的銷售大約占我們整體公司銷售的三分之一，從大方向來看是如此；不過我們目前仍以與以往相同的速度在生產。我們採取了各項措施，導致目前部分批次的放行速度放慢，以確保它們經過額外的品質審查；因此目前造成了些微延遲。不過我會把其他後續步驟交給 Tony 說明。

Yeah, as you mentioned, we did respond to the warning letter in late July, and essentially the way these are is you have an interaction where you update the FDA on a routine basis. Generally every month or two, just to go over your plan and the program, we've hired a third-party independent consultant that has great experience in, helping to work with these kind of projects.

是的，如你提到的，我們在 7 月下旬回覆了警告信；基本上這類流程是與 FDA 持續互動，定期向 FDA 更新進度。通常每一到兩個月一次，檢視你的計畫與專案。我們已聘請第三方獨立顧問，具備豐富經驗，能協助推動這類專案。

And we'll continue to just work with them, and if there are any remediation efforts, we'll work with them and keep the FDA in the loop with that if there are any shutdowns as you mentioned, which is definitely a possibility, then we'll do those as needed, we routinely do those now, whether it's a little bit longer or not remains to be, depending on what they find during the remediation and during the assessments.

我們會持續與他們合作；若有任何補救工作，我們也會與他們一起執行，並讓 FDA 隨時掌握進度。至於你提到的是否需要停線，確實有這種可能性；若有需要我們會進行。我們現在也會例行性地做這些停線作業，至於是否需要更長時間，則取決於他們在補救與評估過程中發現的情況。

But we do routinely have those, so unlikely at this point, we don't have any expectation that that there'll be any of those, but again, it sort of remains to be seen based on the assessments.

不過我們確實例行會做這些，因此就目前而言不太可能；我們沒有預期會發生，但同樣地，仍需視評估結果而定。

And then, going back to the last question was BAQSIMI -- on the 340B, now we just implemented, that consultant, or that firm that helps us with this in May, so we only covered 2 months, and I'll say not all of their actions took place right away, so when we talked about, reducing 80% of the double dipping on the last call I'd say that we probably are halfway there at this point.

再回到上一個問題：BAQSIMI——關於 340B，我們在 5 月才導入那位顧問/那家協助我們處理此事的公司，因此只涵蓋了兩個月；而且我會說，他們並非所有措施都能立即生效。所以當我們在上一通電話中談到可降低 80% 的「雙重折扣」時，我會說目前大概已達到一半左右。

(Operator Instructions)

(接線員指示)

David Amsellem, Piper Sandler Companies

David Amsellem，Piper Sandler Companies。

Hi, this is Naoki Martin for David. Thank you for taking your questions. First, with respect to BD, is your priority acquiring immediately a creative commercial products, or would you accept some development spending for differentiated late stage asset, that's number one.

您好，我是代替 David 的 Naoki Martin。感謝讓我提問。第一個問題，關於 BD（商務拓展），你們的優先事項是立即收購具創造性（可帶來貢獻）的商業化產品，還是也能接受為具差異化的後期資產投入一些開發支出？這是第一點。

Number two, also with respect to BD, are you willing to establish a new commercial organization in a new vertical, or will any potential targets need to leverage existing, commercial instructor, thank you.

第二點，同樣關於 BD，你們是否願意在新的垂直領域建立新的商業組織？還是任何潛在標的都需要能夠利用既有的商業基礎設施？謝謝。

Yeah, good question, so, as far as the development goes, we have been looking at both, development programs and, things that would be accretive or soon to be a accretive things that are very late stage potentially filed, with the FDA would, so right now because we in licensed three products last year that are early stage, our real focus and what we prefer to look at are things that would be either immediately creative or accretive to earnings in (technical difficulty).

是的，這是個好問題。就開發而言，我們同時在看兩類：開發計畫，以及那些能增厚（accretive）或很快就能增厚的項目——也就是非常後期、可能已向 FDA 送件的項目。所以目前因為我們去年引進授權了三個仍在早期階段的產品，我們真正的重點、以及我們更偏好看的，是那些能夠立即帶來創造性貢獻或對盈餘具增厚效果的項目，(technical difficulty)。

So, that's the strong preference, however, we're looking at multiple things, and if we saw the right thing, that was the case, we'd probably do that, but I think the cost structure of those is very different, so for example, when we took a look at the four products that we in license last year, the upfront cost was $2 million each, a far, much lower than the BAQSIMI or something else that's already on the market.

所以，那是我們強烈的偏好。不過，我們也在看多個機會；如果我們看到合適的標的、符合那種情況，我們大概也會做。但我認為這些的成本結構差異很大。舉例來說，我們去年評估並引進授權的四個產品，每個的前期費用是 200 萬美元，遠遠、明顯低於 BAQSIMI 或其他已在市場上的產品。

And as far as new commercial verticals. We would consider new commercial verticals, but they would probably be in the areas where we have either, some kind of planned products such as the in licensed assets that are in oncology, ophthalmology, and immunology, so those are the three areas that we would consider new verticals. so, in addition to the endocrinology where we have BAQSIMI. I don't see us moving outside of those verticals.

至於新的商業垂直領域。我們會考慮新的商業垂直領域，但它們很可能會在我們已有某種規劃產品的領域，例如我們引進授權的資產所在的腫瘤、眼科與免疫學，所以這三個領域是我們會考慮的新垂直領域；此外還有我們擁有 BAQSIMI 的內分泌領域。我不認為我們會走出這些垂直領域之外。

(Operator Instructions) Serge Belanger, Needham & Company Inc

(Operator Instructions) Serge Belanger, Needham & Company Inc

Hi, this is (Inaudible) today.

嗨，我今天是（聽不清）。

Thanks for taking our questions, so just a couple on your current, product portfolio, the first being the generic Atrovent launch, that came about in mid-April, I believe you've highlighted previously that you see this product capturing as much as 50% to 80% of the market, so curious what the early stages of the launch have shown thus far and whether you've, narrowed, that market share goal at this time,

謝謝回答我們的問題。我有幾個關於你們目前產品組合的問題。第一個是學名藥 Atrovent 的上市，我記得是在 4 月中旬。你們先前提到你們認為這個產品可望拿下多達 50% 到 80% 的市場份額，所以想請教目前上市初期的表現如何，以及你們是否在此時已縮小或調整了該市場份額目標，

And then second on glucagon, you highlighted that still seeing some competitive pressures, although it increased a little bit in the second quarter of the first quarter, I'm curious if you think that this product is, now at a stabilization period and could return to growth, in the second half of the year. Thanks.

第二個是關於胰高血糖素（glucagon）。你們提到仍然看到一些競爭壓力，雖然第二季相較第一季略有增加。我想了解你們是否認為這個產品現在已進入穩定期，並可能在今年下半年恢復成長。謝謝。

Yeah, so Atrovent, the generic Atrovent, we've got a nice market share, and we are closing in on those that goal range that we have put out there, but we're not quite there yet but, we're really happy with where we are at this point, and that product launch has gone really well for us.

是的，關於 Atrovent、也就是學名藥 Atrovent，我們已取得不錯的市占率，而且正逐步接近我們對外提出的那個目標區間；但還沒完全達到。不過，我們對目前的進展非常滿意，而這次產品上市對我們來說進行得非常順利。

As far as glucagon goes, we saw several new, competitors come in over the, over about an 18 month period including all the way into late last year, so we year over year we haven't finished the decline on a go forward basis that rate of decline we think will diminished, so we the worst that decline is over.

至於胰高血糖素，我們在大約 18 個月期間看到好幾個新的競爭者進入，甚至一路到去年年底。因此以年對年來看，我們在往後的基礎上，尚未完全走完下滑；但我們認為下滑速度會減緩，所以最糟的下滑已經過去了。

However, we don't see this as becoming a growth product again, the in all likelihood it's something where, (technical difficulty) portion of the market that's for diagnostic has, will grow slightly, but the proportion that's for the anti-hypoglycemia will continue to decline somewhat, so we don't see this as being a growth thing, it's going to decline and the decline is more muted than it's been, over the last several quarters.

不過，我們不認為它會再次成為成長型產品。很可能會是這樣：用於診斷的那一部分市場（technical difficulty）會小幅成長，但用於抗低血糖的那一部分占比仍會持續有些下滑。因此我們不把它視為成長動能；它仍會下滑，只是下滑幅度會比過去幾季更為溫和。

(Operator Instructions)

(Operator Instructions)

Jason Gerberry, BofA Global Research.

Jason Gerberry，BofA Global Research。

Hi, this is Melanie on for Jason, thanks for taking our question, just on AMP-004, your insulin aspart. Based on current price levels and anticipated concessions, do you see the product gross margin being relative to corporate levels.

嗨，我是代 Jason 提問的 Melanie，謝謝回答我們的問題。想問一下 AMP-004，也就是你們的門冬胰島素（insulin aspart）。以目前的價格水準與預期的讓利（concessions）來看，你們認為該產品的毛利率會與公司整體水準相當嗎？

Yes, this is something that we think will probably be at or slightly below the current, corporate (technical difficulty) margin levels given the competition that we see in there today. However, it is still being something where we have, a fairly a large sales potential for us, so we think sales will be meaningful for us.

是的，我們認為在目前看到的競爭情況下，它的毛利率大概會與公司目前整體（technical difficulty）毛利率水準相當或略低。不過，這仍會是一個對我們而言具相當大銷售潛力的產品，因此我們認為銷售額對我們會是有意義的。

(Operator Instructions)

(Operator Instructions)

Benjamin Burnett, Wells Fargo.

Benjamin Burnett，Wells Fargo。

Hi, hello, Tianqi on for Ben, thanks for taking our questions. So the bioavailability study. Recently it's shown up as completed on clinical trial. So is this something that we can touch on, like what is the data look like, what's the path forward on this, thank you.

嗨，你好，我是代 Ben 提問的 Tianqi，謝謝回答我們的問題。關於生體可用率研究。最近在 clinical trial 上顯示已完成。所以這部分我們能否談一下，例如數據看起來如何、接下來的推進路徑是什麼？謝謝。

Oh, could you please repeat the question again? I think it was a little, we were having a little hard time understanding. Sorry, which is which products are you referring to?

喔，可以請你再重複一次問題嗎？我想剛剛有點，我們有點難以聽清楚。抱歉，你指的是哪一個產品？

So, yeah, sorry, let me repeat again, so yeah, it's insulin as part, bioavailability study showing up recently on clinicaltrial.gov as completed, so is this something that we can touch on? Have you seen the data with the path forward, in terms of, resubmitting, et cetera.

好的，抱歉，我再重複一次：是門冬胰島素（insulin aspart）的生體可用率研究，最近在 clinicaltrial.gov 上顯示已完成，所以這部分我們能否談一下？你們是否已看到數據，以及接下來的路徑，例如重新遞交等。

So the question is, the question is about the trial is, if you've seen on it, it's a bioequivalence PK-type trial, and it's just measuring the, AUC between the two products, the reference. So I think that's what it is, what I'll say about that product is we're on schedule for that to have our launch commercial launch of the product next year in 2027.

所以問題是關於那個試驗：如果你在上面看到的話，那是一個生體相等性（bioequivalence）的 PK 類型試驗，主要是量測兩個產品之間的 AUC，也就是與參考品之間的比較。所以我想它就是那樣。關於那個產品我能說的是，我們的時程如期，預計在明年、也就是 2027 年，進行該產品的商業上市。

(Operator Instructions)

(Operator Instructions)

Thank you, Paul, and thank you all for the questions today. As highlighted in our remarks today, we remain focused on executing our long-term strategy, strengthening our commercial portfolio and advancing our pipeline, and continuing to invest in our US manufacturing capabilities. Thank you for your continued interest in Amphastar. We appreciate your support and look forward to updating you on our progress next quarter.

謝謝你，Paul，也謝謝大家今天的提問。如同我們今天的發言重點所述，我們仍專注於執行長期策略、強化我們的商業產品組合並推進研發管線，同時持續投資於我們在美國的製造能力。感謝各位持續關注 Amphastar。我們感謝各位的支持，並期待在下個季度向各位更新我們的進展。

(Operator Instructions)

(Operator Instructions)