Amphastar Pharmaceuticals Inc (AMPH) 2024 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 in 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在公司網站上發布的新聞稿中標題為前瞻性陳述的部分。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。

We will also discuss certain non-GAAP measures and for 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.

我們還將討論某些非公認會計原則措施，有關我們使用這些措施的資訊以及與美國公認會計原則的調節可以在我們的收益發布中找到。請注意，本次會議正在錄製中。

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 call over to your host Mr. Dan Dischner, Senior Vice President of Corporate Communications. Dan, you may begin.

我現在將把電話轉給東道主企業傳播部高級副總裁 Dan Dischner 先生。丹，你可以開始了。

Thank you, Paul. Good afternoon, and thanks for joining us for our second-quarter earnings call of 2024. Joining me today 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，感謝您參加我們的 2024 年第二季財報電話會議。今天加入我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。

It has now been over a year since the successful acquisition of BAQSIMI, underscoring Amphastar's strategic focus on expanding our portfolio with proprietary products, biosimilars and complex products. This quarter, BAQSIMI has emerged as a key driver, achieving impressive worldwide sales of $38.5 million for the quarter, representing a 10% increase compared to the same period last year and highlighting this product's growth.

自從成功收購 BAQSIMI 以來已經一年多了，這凸顯了 Amphastar 的戰略重點是透過專有產品、生物相似藥和複雜產品擴大我們的產品組合。本季度，BAQSIMI 已成為關鍵驅動力，該季度全球銷售額達到 3,850 萬美元，與去年同期相比成長 10%，凸顯了該產品的成長。

Overall, the quarter concluded with solid sales growth, driving total revenues to $182.4 million, representing an impressive 25% increase year-over-year. This revenue growth is strengthened by significant increases in sales of Primatene MIST and Epinephrine, which have risen by 38% and 67% on an annualized basis, respectively.

總體而言，本季的銷售成長強勁，總收入達到 1.824 億美元，年增 25%，令人印象深刻。Primatene MIST 和 Epinephrine 銷售額的顯著增長加強了這一收入增長，按年化計算分別增長了 38% 和 67%。

Specifically, in-store sales of Primatene MIST have continued to show a growth trend, experiencing a 14% increase from Q2 of 2023. We remain confident in Primatene MIST trajectory that it is on track to meet the $100 million sales target by the end of 2024.

具體來說，Primatene MIST的店內銷售額持續呈現成長趨勢，較2023年第二季成長14%。我們對 Primatene MIST 的發展軌跡仍然充滿信心，認為它有望在 2024 年底實現 1 億美元的銷售目標。

At our IMS facility, we have focused on enhancing efficiencies in the production of our Epinephrine and other products, leading to increased capacity. These improvements have strategically positioned us to meet current and future market demand. Our ongoing efficiency and enhancements have significantly boosted our manufacturing capabilities without the need of additional square footage.

在我們的 IMS 工廠，我們致力於提高腎上腺素和其他產品的生產效率，從而提高產能。這些改進使我們能夠滿足當前和未來的市場需求。我們持續的效率和改進顯著提高了我們的製造能力，而無需額外的面積。

Furthermore, we believe that the recent approval of our Albuterol product will improve our efficiencies at our Massachusetts manufacturing facility where currently Primatene MIST is manufactured, optimizing our capacity utilization with another product and a third one, AMP-007 on the horizon.

此外，我們相信最近批准的沙丁胺醇產品將提高我們目前生產 Primatene MIST 的馬薩諸塞州製造工廠的效率，優化我們的另一種產品和即將推出的第三種產品 AMP-007 的產能利用率。

Our glucagon injection sales have remained strong. However, we anticipate a decline from the peak levels due to increased availability of competitor products in the diagnostic market. This trend aligns with our strategic focus on the diabetes sector, particularly with the emphasis of BAQSIMI. We are dedicated to advancing our branded product strategy with BAQSIMI, which presents significant opportunities in the retail market. The current underutilization of glucagon amongst diabetics combined with BAQSIMI's advantages as an intranasal product positions us well for growth.

我們的胰高血糖素注射液銷售仍然強勁。然而，由於診斷市場上競爭對手產品的可用性增加，我們預計將從峰值水平下降。這一趨勢與我們對糖尿病領域的策略重點一致，特別是與 BAQSIMI 的重點一致。我們致力於透過 BAQSIMI 推動我們的品牌產品策略，這為零售市場帶來了重大機會。目前糖尿病患者對胰高血糖素的利用不足，加上 BAQSIMI 作為鼻內產品的優勢，使我們有利於成長。

We want to briefly address the lawsuit filed by Teva on July 25. The lawsuit was filed with respect to Armstrong's approval or approved ANDA for generic albuterol. At the time of Teva's filing of this lawsuit, Armstrong had already received FDA approval for its ANDA, and we have launched the product.

我們想簡要討論一下 Teva 於 7 月 25 日提起的訴訟。該訴訟是針對阿姆斯壯批准或批准仿製藥沙丁胺醇的 ANDA 提起的。在 Teva 提起訴訟時，Armstrong 的 ANDA 已獲得 FDA 批准，我們已經推出了該產品。

While we cannot comment further about the pending litigation, we are confident about our likelihood of prevailing against Teva. We will vigorously defend ourselves in this matter since we recognize the importance of providing patients with more access to affordable generic versions of albuterol inhalers.

雖然我們無法對未決訴訟進一步發表評論，但我們對戰勝 Teva 的可能性充滿信心。我們將在這一問題上大力捍衛自己，因為我們認識到為患者提供更多負擔得起的仿製沙丁胺醇吸入器的重要性。

Having now covered our key revenue drivers and significant events for the quarter, I would like to turn our attention to our pipeline and regulatory activities. On the topic of our filed ANDAs, we are engaged in positive and ongoing discussions with the FDA for AMP-002, with anticipated progress in the near future. For AMP-015, our teriparatide ANDA, we have submitted our response to address the minor CRL and the FDA has assigned the GDUFA goal date in the fourth quarter. Additionally, our second inhalation ANDA, AMP-007 remains on track for a fourth quarter GDUFA goal date.

現在介紹了我們本季的主要收入驅動因素和重大事件，我想將我們的注意力轉向我們的管道和監管活動。關於我們已提交的 ANDA，我們正在與 FDA 就 AMP-002 進行積極且持續的討論，預計在不久的將來會取得進展。對於 AMP-015（我們的特立帕肽 ANDA），我們已提交對輕微 CRL 的答复，FDA 已指定第四季度的 GDUFA 目標日期。此外，我們的第二個吸入 ANDA AMP-007 仍有望實現第四季度 GDUFA 的目標日期。

With regards to our diabetes products, I'm pleased to announce that we have filed our ANDA for AMP-018, which is a generic GLP-1 product, and the FDA has accepted review of with the GDUFA goal date in the second quarter of 2025. As for our BLA for Insulin As part or AMP-004, the product is expected to be refiled in the third quarter of 2024.

關於我們的糖尿病產品，我很高興地宣布，我們已經提交了 AMP-018 的 ANDA，這是一種仿製藥 GLP-1 產品，FDA 已接受審查，GDUFA 目標日期為 2019 年第二季。 。至於我們的胰島素部分或 AMP-004 的 BLA，該產品預計將於 2024 年第三季重新提交。

In closing, I'd like to note that Amphastar is well positioned for a promising second half of 2024 with the potential for three significant product approvals, teriparatide, AMP-015, AMP-007 and AMP-002. These anticipated approvals are expected to substantially contribute to our revenue growth and enhance our market presence.

最後，我想指出的是，Amphastar 在充滿希望的 2024 年下半年處於有利地位，有可能獲得特立帕肽、AMP-015、AMP-007 和 AMP-002 三個重要產品的批准。這些預期的批准預計將大大促進我們的收入成長並增強我們的市場地位。

Our efforts to further strengthen our operational efficiencies and manufacturing capabilities will improve the foundation for transitioning from generics to higher-value products, including branded offerings, biosimilars and complex products with significant barriers to entry.

我們進一步加強營運效率和製造能力的努力將為從仿製藥向更高價值產品的轉型奠定基礎，包括品牌產品、生物相似藥和具有重大進入障礙的複雜產品。

By continuing to optimize our resources while strategically advancing our product pipeline, along with our commitment to grow our current branded product offerings, BAQSIMI and Primatene MIST, we are confident in our ability to drive long-term growth and deliver value.

透過持續優化我們的資源，同時策略性地推進我們的產品線，以及我們對發展現有品牌產品 BAQSIMI 和 Primatene MIST 的承諾，我們對推動長期成長和創造價值的能力充滿信心。

With that, I would now like to turn the call over to our CFO and Executive Vice President of Finance, Bill Peters, to discuss the second quarter's financial results.

現在，我想將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)，討論第二季的財務表現。

Thank you, Dan. Revenues for the second quarter increased 25% to $182.4 million from $145.7 million in the previous year's period. Primatene MIST sales grew 38% to $22.9 million in the second quarter from $16.5 million in the second quarter of last year. Remember that in the second quarter of last year, we experienced a onetime inventory drawdown by retailers, which held back sales of Primatene MIST in that period.

謝謝你，丹。第二季營收從去年同期的 1.457 億美元成長 25% 至 1.824 億美元。Primatene MIST 銷售額從去年第二季的 1,650 萬美元成長了 38%，達到 2,290 萬美元。請記住，去年第二季度，我們經歷了零售商的一次性庫存削減，這抑制了該時期 Primatene MIST 的銷售。

Epinephrine sales increased 67% to $27.9 million from $16.7 million due to other supplier shortages in the quarter. Phytonadione sales decreased to $10.3 million from $17.9 million due to increased competition. Enoxaparin and Naloxone sales also saw a decline due to increased competition. Glucagon injection sales were flat as sales in Canada offset the decline in the United States during the quarter.

由於本季其他供應商短缺，腎上腺素銷售額從 1,670 萬美元成長 67% 至 2,790 萬美元。由於競爭加劇，植物油二酮銷售額從 1,790 萬美元下降至 1,030 萬美元。由於競爭加劇，依諾肝素和納洛酮的銷售額也出現下降。胰高血糖素注射液銷售額持平，因為加拿大的銷售額抵消了本季美國的下降。

Other finished pharmaceutical product sales decreased to $34.7 million from $37.5 million primarily due to a decrease in medroxyprogesterone sales of $4.6 million due to the discontinuation of the API by our previous supplier, which has caused us to temporarily stop selling the finished product. This was partially offset by increased sales in other products such as dextrose and sodium bicarbonate.

其他成品藥品銷售額從 3,750 萬美元減少至 3,470 萬美元，主要是由於我們先前供應商的停產 API，導致我們暫時停止銷售成品，導致甲羥孕酮銷售額減少 460 萬美元。這被葡萄糖和碳酸氫鈉等其他產品銷售量的增加部分所抵消。

BAQSIMI revenues fall into two categories as we begin shipping the product in the United States and a few European countries in the first quarter of this year. The first category relates to product we ship directly to our customers for which we recorded net revenues of $30.9 million. These revenues are recorded in our product revenues net line on the income statement.

隨著我們在今年第一季開始在美國和一些歐洲國家出貨，BAQSIMI 的營收分為兩類。第一類涉及我們直接運送給客戶的產品，我們錄得的淨收入為 3,090 萬美元。這些收入記錄在損益表的產品收入淨額中。

The second category relates to products sold by Lilly on our behalf under the transition service agreement totaling $7.6 million, which had a cost of sales and expenses of $4.6 million. This resulted in net revenues of $3 million in our other revenues category, which corresponds to Amphastar's net economic benefit for BAQSIMI. Total worldwide BAQSIMI sales were $38.5 million for the quarter, up 10% from $34.9 million in sales reported by Lilly in the second quarter of 2023.

第二類涉及禮來公司根據過渡服務協議代表我們銷售的產品，總額為 760 萬美元，其中銷售成本和費用為 460 萬美元。這使得我們其他收入類別的淨收入達到 300 萬美元，相當於 Amphastar 為 BAQSIMI 帶來的淨經濟效益。本季 BAQSIMI 全球總銷售額為 3,850 萬美元，比禮來公司報告的 2023 年第二季銷售額 3,490 萬美元成長 10%。

We will continue to book revenues on a net revenue basis for those countries where Lilly continues to distribute the product on our behalf. For our own distribution of BAQSIMI will increase throughout 2024 on a country-by-country basis based on local regulations as Lilly has wound down their inventory, and we have Amphastar label inventory available. This will result in an increase in product sales and a decline in the net economic benefit recognized in our other revenues.

對於禮來公司繼續代表我們分銷產品的國家，我們將繼續以淨收入為基礎記帳收入。對於我們自己的 BAQSIMI 分銷，由於禮來公司已經減少了庫存，並且我們有 Amphastar 標籤庫存，因此根據當地法規，BAQSIMI 的分銷量將在 2024 年逐個國家增加。這將導致產品銷售增加，而我們其他收入中確認的淨經濟效益下降。

We would like to note that we just completed the first contract year of the five contract year period for potential milestone payments to Lilly. The four potential milestone payments are based on annual and cumulative five year sales of BAQSIMI.

我們想指出的是，我們剛剛完成了五個合約年期間的第一個合約年，以向禮來公司支付潛在的里程碑付款。四項潛在的里程碑付款是基於 BAQSIMI 的年度和五年累積銷售額。

Cumulative BAQSIMI sales in the first quarter or the first year totaled $163.2 million, so none of these milestone payments were triggered. Our Insulin API business had sales of $3.5 million, up from $2.8 million last year as we have shipped RHI API to Mankind for the last time until they have qualified our updated material.

第一季或第一年的 BAQSIMI 累積銷售額總計 1.632 億美元，因此沒有觸發這些里程碑付款。我們的胰島素 API 業務銷售額為 350 萬美元，高於去年的 280 萬美元，因為我們最後一次將 RHI API 運送給 Mankind，直到他們對我們的更新資料進行了鑑定。

Cost of revenues increased to $87.2 million from $73 million and gross margins improved to 52.2% from 49.9% in the previous year. The benefit of increased sales of higher-margin products such as BAQSIMI, Primatene MIST and epinephrine were partially offset by increased depreciation and amortization related to BAQSIMI and increases in labor and certain component costs.

收入成本從 7,300 萬美元增加到 8,720 萬美元，毛利率從前一年的 49.9% 提高到 52.2%。BAQSIMI、Primatene MIST 和腎上腺素等高利潤產品銷售增加的好處被 BAQSIMI 相關折舊和攤銷的增加以及勞動力和某些零件成本的增加部分抵消。

Selling, distribution and marketing expenses increased 34% to $9 million from $6.7 million in the previous year's period due to sales force expansion and marketing expenses related to BAQSIMI. General and administrative spending increased 8% to $13.3 million from $12.3 million primarily due to increased expenses related to BAQSIMI.

由於銷售隊伍擴張以及與 BAQSIMI 相關的行銷費用，銷售、分銷和行銷費用從上一年期間的 670 萬美元增加了 34% 至 900 萬美元。一般及行政支出從 1,230 萬美元增加 8% 至 1,330 萬美元，主要是因為 BAQSIMI 相關費用增加。

Research and development expenditures increased 5% to $17.7 million from $16.8 million due to an increase in salary and personnel-related expenses, as well as the ANDA filing fee for AMP-018. These increases were partially offset by decreases in clinical trial expenses due to the timing of clinical trials.

由於薪資和人事相關費用以及 AMP-018 的 ANDA 申請費增加，研發支出從 1,680 萬美元增加了 5% 至 1,770 萬美元。這些增長被臨床試驗時間安排導致的臨床試驗費用減少部分抵消。

Non-operating expenses increased to $5 million from $4.1 million, primarily driven by increased interest expense on loans associated with the acquisition of BAQSIMI. Net income increased 45% to $37.9 million or $0.73 per share in the second quarter from $26.1 million or $0.49 per share in the second quarter of 2023.

非營運支出從 410 萬美元增加到 500 萬美元，主要是因為收購 BAQSIMI 相關貸款利息支出增加。第二季淨利從 2023 年第二季的 2,610 萬美元（即每股 0.49 美元）成長 45% 至 3,790 萬美元（即每股 0.73 美元）。

Adjusted net income increased to $48.7 million or $0.94 per share compared to an adjusted net income of $34.8 million or $0.65 per share in the second quarter of last year. Adjusted earnings exclude amortization, equity compensation, impairments of long-lived assets and onetime events.

調整後淨利潤增至 4,870 萬美元，即每股 0.94 美元，而去年第二季調整後淨利為 3,480 萬美元，即每股 0.65 美元。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 second quarter, we had cash flow from operations of approximately $69.1 million. During the quarter, we made the required $129 million payment to Lilly for the BAQSIMI acquisition. In addition, we used a portion of our cash to buy back $8.5 million worth of shares and to pay down a mortgage for $8 million.

第二季度，我們的營運現金流約為 6,910 萬美元。本季度，我們向禮來公司支付了收購 BAQSIMI 所需的 1.29 億美元款項。此外，我們還用部分現金回購了價值 850 萬美元的股票，並償還了 800 萬美元的抵押貸款。

I will now turn the call back over to Dan.

我現在將把電話轉回給丹。

Thank you, Bill for the update. With that, we will now take your questions. Operator, please open the line for Q&A.

謝謝比爾的更新。現在我們將回答您的問題。接線員，請開通問答線。

Thank you. We'll now be conducting a question-and-answer session. (Operator Instructions)

謝謝。我們現在將進行問答環節。（操作員說明）

Ekaterina Knyazkova, JPMorgan.

葉卡捷琳娜·克尼亞茲科娃，摩根大通。

Hi, thank you so much. Just two for me, if I may. So first, just on epinephrine seems like another very strong quarter for the product. Can you just maybe talk about expectations for that franchise over time, both from a competitor or a supply shortage standpoint, if you're seeing any changes there as well as with potentially other players, either entering or filing an application in that market?

你好，非常感謝你。如果可以的話，只給我兩個。因此，首先，腎上腺素似乎是該產品的另一個非常強勁的季度。如果您看到那裡以及潛在的其他參與者（進入該市場或在該市場提交申請）發生任何變化，您能否從競爭對手或供應短缺的角度談談隨著時間的推移對該特許經營權的期望？

And then just second question is generic ProAir. Can you just help us frame how you're thinking about the size of that opportunity? And how quickly you can launch as soon as you decide to do so and how quickly you can, I guess, get uptake for that product? Thank you so much.

第二個問題是通用的 ProAir。您能幫助我們了解您如何看待這個機會的大小嗎？一旦您決定這樣做，您可以多快推出該產品？太感謝了。

So for the Epi, we have two different presentations for that product. First of all, there's a multi dose vial in a prefilled syringe. And the prefilled syringe has been on the drug shortage supply list for almost a year now or about a year now based on a hurricane that hit one of our competitors. So that portion of the business has remained relatively robust.

因此，對於 Epi，我們對該產品有兩種不同的演示。首先，預裝注射器中有一個多劑量小瓶。預充式註射器在藥品短缺供應清單上已經有近一年的時間了，或者根據我們競爭對手遭受的颶風襲擊，已經有大約一年的時間了。因此，這部分業務仍相對強勁。

However, as Dan had mentioned in his comments, what we've done is we've taken some steps to increase the capacity of that plant by increasing some of the efficiency of some of the labor in the different packaging steps. So we've been able to increase the production of that product and pump out more sales as we showed this quarter.

然而，正如丹在評論中提到的那樣，我們所做的是採取一些措施，透過提高不同包裝步驟中某些勞動力的效率來提高該工廠的產能。因此，正如我們本季所展示的那樣，我們已經能夠增加該產品的產量並增加銷售量。

So we do expect that shortage for that product will be, we're seeing from the competitors that they're going to start returning to the market in the fourth quarter now. I think last quarter, they said the third quarter, this quarter they're saying the fourth quarter. So but returning to a regular supply sometime next year.

因此，我們確實預計該產品將會出現短缺，我們從競爭對手那裡看到他們將在第四季度開始重返市場。我想上個季度他們說的是第三季度，這個季度他們說的是第四季。因此，但明年某個時候將恢復正常供應。

So it's hard to say exactly, but right now, we're just preparing ourselves to make sure that we can take advantage of this and we can supply as much as needed to the industry. As far as the multi-dose vial, there is a new competitor to that one out there. So we do expect that the sales of that presentation will drop somewhat as the market has gone from two to three suppliers.

所以很難準確地說，但現在，我們只是做好準備，以確保我們可以利用這一點，並且我們可以向行業提供所需的東西。就多劑量小瓶而言，有一個新的競爭對手。因此，我們確實預計，隨著市場供應商從兩個增加到三個，該簡報的銷售額將會下降。

On the generic ProAir, as we mentioned in the call, we have launched the product. So we've already got it out there. Where we're going with that, obviously, there are other competitors in the market, and we're still working on securing business there. So right now, I don't know that we're really have a good idea, but we, it's been received well so far. So hopefully, we'll be able to give an update, a better update later.

在通用 ProAir 上，正如我們在電話中提到的，我們已經推出了該產品。所以我們已經把它拿出來了。顯然，市場上還有其他競爭對手，我們仍在努力確保那裡的業務。所以現在，我不知道我們是否真的有一個好主意，但到目前為止，我們的想法很受歡迎。所以希望我們以後能夠提供更新，更好的更新。

And one of the things with that one is that we're increasing the capacity of the packaging over time. So we might be off to, I don't want to say, a more moderate start, but then we expect to increase that the ability to meet the demand for that product over the course of the next few quarters.

其中之一是，隨著時間的推移，我們正在增加包裝的容量。因此，我不想說，我們可能會採取更溫和的開始，但隨後我們預計將在接下來的幾個季度內提高滿足該產品需求的能力。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆，派珀·桑德勒。

Thanks. So I got a couple of pipeline questions. So I know AMP-002 has kind of been beaten over the head, but is there anything new that you could add regarding your interactions with the FDA? Or more specifically, what they're hung up on. That's number one.

謝謝。所以我有幾個管道問題。所以我知道 AMP-002 有點被打敗了，但是關於您與 FDA 的互動，您有什麼新的可以補充的嗎？或者更具體地說，他們所關注的是什麼。這是第一名。

Number two, on the GLP-1, just remind us, is that P4 or a P3, is that a litigated filing and is there already generic competition? Or do you anticipate that there will be others when you're in a position to launch. So that's number two.

第二，關於 GLP-1，請提醒我們，是 P4 還是 P3，這是訴訟申請嗎？或者您是否預計當您能夠啟動時還會有其他人。所以這是第二個。

And then number three, on AMP-017, similar kind of question, is that a P4? Is that going to be a litigated filing and talk about the nature of competition in that market? Thanks.

第三，關於 AMP-017，類似的問題，那是 P4 嗎？這是否會成為一份訴訟文件並討論該市場競爭的性質？謝謝。

For AMP-002, we continue to have routine conversations with the agency. The last conversations we've had have been, and I guess maybe stepping back, the idea is just to kind of get a sense of what they're doing and the progress that they're making for the issue. We think we understand what their issue is.

對於 AMP-002，我們繼續與該機構進行例行對話。我們最近一次的談話是，我想也許退一步來說，這個想法只是為了了解他們正在做什麼以及他們在這個問題上的進展。我們認為我們了解他們的問題是什麼。

And based on those conversations, we feel that they're coming to an end to be able to resolve their issue. And so based on those calls that we routinely have with them is why we feel that we believe it will be a near future that they'll take action on the application.

根據這些對話，我們認為他們已經能夠解決他們的問題了。因此，基於我們經常與他們打交道的電話，我們認為他們將在不久的將來對申請採取行動。

For the AMP-018, the GLP, it is a paragraph four filing on that product. And we're still within the period of time where we have not been sued to date, but we still could be and that we do expect competition on this one when we're in a position to launch the product. And AMP-007, that is a paragraph four filing as well.

對於 AMP-018（GLP），這是該產品的第四段備案。到目前為止，我們仍處於尚未被起訴的時期，但我們仍然有可能被起訴，我們確實預計當我們能夠推出產品時，會出現競爭。AMP-007，也是第四段歸檔。

And do you expect competition?

您期望競爭嗎？

It's hard to say at this point. We'd rather not say at this point.

目前還很難說。我們現在不想說。

Jason Gerberry, Bank of America.

傑森‧格伯里，美國銀行。

Thank you for taking my questions. Two for me. First, with BAQSIMI, as long as presumably, it's going to grow in the second half of (technical difficulty) this overall company gross margins second half versus first half, we saw a little bit of margin degradation in 2Q versus 1Q. So just wondering how we think about the impact of mix and more BAQSIMI in the revenues dropping to the gross profit line?

感謝您回答我的問題。給我兩個。首先，對於 BAQSIMI，只要可以推測，它會在下半年（技術難度）成長，整個公司的毛利率下半年與上半年相比，我們看到第二季與第一季的利潤率略有下降。所以只是想知道我們如何看待混合和更多 BAQSIMI 對收入下降到毛利線的影響？

And then on business development, I'm wondering how you're thinking about that as something that might kickstart your goal of getting to pipeline, 50% proprietary programs by next year versus using BD more as a tool to maybe add a complementary market-ready asset like BAQSIMI? Thanks.

然後在業務開發方面，我想知道您如何看待這可能會啟動您明年進入管道、50% 專有計劃的目標，而不是更多地使用 BD 作為可能添加補充市場的工具 -準備好像BAQSIMI 這樣的資產了嗎？謝謝。

So first one on the BAQSIMI and the market trends there. Yes, third quarter is always the biggest quarter. So we're expecting it to certainly ramp up from the second quarter on that basis. And the other thing is that on the accounting, remember that when Lilly books the sale, when they're the distributor and we get the net economic benefit, that's at 100% gross margin. There's no cost of goods associated with that, so we're getting that net.

第一篇是關於 BAQSIMI 和那裡的市場趨勢。是的，第三季始終是最大的季度。因此，我們預計在此基礎上，它肯定會從第二季度開始上升。另一件事是，在會計方面，請記住，當禮來公司 (Lilly) 登記銷售時，當他們是分銷商時，我們獲得淨經濟效益，即毛利率為 100%。沒有與此相關的商品成本，所以我們得到了這個網路。

So when we move from having them sell a majority of BAQSIMI to having us sell the majority of BAQSIMI, that we start incurring a significantly more cost of goods for those revenues. Therefore, the gross margin trend has dropped. And so one of the things I want to make sure people realize is that trend will continue on into the next quarter as we start picking up more countries in the quarter.

因此，當我們從讓他們出售大部分 BAQSIMI 轉向讓我們出售大部分 BAQSIMI 時，我們開始為這些收入承擔更多的商品成本。因此，毛利率呈下降趨勢。因此，我想確保人們意識到的一件事是，隨著我們在本季開始選擇更多國家/地區，這種趨勢將持續到下個季度。

As far as the business development goes, yes, so we're actively looking for things, and we've actually looked at things that are both in development and more like BAQSIMI already on the market. So we've actually been in discussions with both of those things. There's nothing to announce at this time. And I don't want to say we're close on anything.

就業務發展而言，是的，所以我們正在積極尋找新的東西，我們實際上已經研究了正在開發中的東西以及更像市場上已經上市的 BAQSIMI 的東西。所以我們其實一直在討論這兩件事。目前沒有什麼可宣布的。我不想說我們已經接近任何事情了。

But we remain diligent and also want to make sure that we're paying the right price for these assets. So a couple of the processes that we've looked at this year have been competitive processes where we're not necessarily the highest bidder, but we're okay with that because we want to remain disciplined. We have a strong base in our R&D pipeline. So we really want to make sure that's our first number one focus. And if we do any business development on top of that, that's really just icing on the cake.

但我們仍然勤奮，也希望確保我們為這些資產支付合適的價格。因此，我們今年看到的一些流程都是競爭性流程，我們不一定是最高出價者，但我們對此表示同意，因為我們希望保持紀律。我們的研發管道擁有強大的基礎。所以我們真的想確保這是我們的首要關注點。如果我們在此基礎上進行任何業務開發，那真的只是錦上添花。

Tim Chiang, Capital One.

蔣添明，第一資本。

Just a couple. Could you just comment on how you think REXTOVY will do for you guys? I know you launched that in the second quarter? And then secondly, just sort of comment on how you expect selling and marketing costs to shape up in the back half of the year versus the first half as you fully take over BAQSIMI in the US and some of these other countries , well, not just in the US?

只是一對。您能評論一下 REXTOVY 會為你們帶來什麼好處嗎？我知道你在第二季度推出了它？其次，請評論一下，當您完全接管美國和其他一些國家的 BAQSIMI 時，您預計下半年的銷售和行銷成本與上半年相比將如何形成，嗯，不僅僅是在美國？

Thanks, Tim. REXTOVY, as you know, is a crowded field. And one thing, our focus is on more of the government first responders or municipalities and first responders. And as we've discussed before, our product is also is different. We're using our proprietary device. So it's still too early to really say how we're going to do there. It takes time to secure those contracts. But we don't really anticipate it being a big product for us just because of the competitive nature of that environment there.

謝謝，蒂姆。如您所知，REXTOVY 是一個擁擠的領域。有一件事，我們的重點更放在政府急救人員或市政府和急救人員身上。正如我們之前討論過的，我們的產品也是不同的。我們正在使用我們的專有設備。因此，現在真正說出我們將如何做還為時過早。獲得這些合約需要時間。但僅僅因為那裡環境的競爭性質，我們並不真正期望它成為我們的大產品。

And then on the sales and marketing trends, two things there. One is that for most of the foreign entities, we don't really have a significant sales and marketing trends, mostly a distribution agreement. So we will have distribution expense that's going to fall into the cost of goods category there.

然後關於銷售和行銷趨勢，有兩件事。一是對大多數外國實體來說，我們並沒有真正的重大銷售和行銷趨勢，主要是分銷協議。因此，我們的分銷費用將屬於那裡的商品成本類別。

However, as we look at the United States and we ramp up, we are planning to add some people to the sales force, so the sales force is slated to grow in the third quarter. And I'll say that's an incremental growth as we make sure that we cover some more territories that were not as well covered in the past.

然而，當我們放眼美國並加大力度時，我們計劃在銷售隊伍中增加一些人員，因此銷售隊伍預計在第三季度有所增長。我想說，這是一種增量增長，因為我們確保涵蓋更多過去未涵蓋的領域。

So we are growing that. And one way to think about it is that we're probably going to spend a similar percentage on sales as we did for BAQSIMI a year ago. So the sales are up about 10%. And so the sales and marketing expense should grow about 10% as well.

所以我們正在發展這一點。一種思考方式是，我們可能會在銷售上花費與一年前為 BAQSIMI 所做的類似百分比。所以銷售額成長了大約10%。因此，銷售和行銷費用也應該增加 10% 左右。

Serge Belanger, Needham & Company.

謝爾蓋貝蘭格 (Serge Belanger)，李約瑟公司。

Good afternoon. A couple of questions. First on BAQSIMI. I think you mentioned sales were up about 10% year-over-year this quarter. Just curious if that was volume and market share driven or there was a price increase involved in that growth?

午安.有幾個問題。首先是BAQSIMI。我想您提到本季銷售額年增約 10%。只是好奇這是否是銷量和市場份額驅動的，或者這種增長涉及價格上漲？

And then secondly, on the pipeline, you highlighted three ANDA approvals that you're expecting over the second half. Maybe just talk about the market opportunity for each and how they compare to the generic ProAir opportunity in terms of being impactful to Amphastar's top line? Thanks.

其次，在管道上，您強調了預計下半年將獲得三個 ANDA 批准。也許只是談談每個市場機會以及它們與通用 ProAir 機會相比對 Amphastar 營收的影響如何？謝謝。

Sure. So I'll take the first thing. The units were remember, the main thing in the United States is now that we're selling it there is that we actually had a net pricing decrease in the United States because we have higher fees that we have to pay to the wholesalers. So that's a gross to net items. So we actually see a price reduction in the United States this year for the second quarter.

當然。所以我會採取第一件事。請記住，這些單位現在在美國銷售的主要問題是，我們實際上在美國的淨價格有所下降，因為我們必須向批發商支付更高的費用。這是毛額與淨額的比值。因此，我們實際上看到美國今年第二季的價格有所下降。

So all of that and more is unit growth. And the pricing outside of the US really hasn't changed much at all other than maybe there's only one country that had a material change, and that's because it moved from a government pay to a non-government pay over some price negotiations. So the price went up and the units went down.

因此，所有這些以及更多都是單位增長。美國以外的定價實際上並沒有太大變化，除了可能只有一個國家發生了實質變化，這是因為在一些價格談判中，它從政府支付轉變為非政府支付。因此價格上漲，單位數量下降。

And as far as the ANDAs for the market share, so teriparatide, it's already a multiplayer market. So I think our expectations are that we'll get a reasonable market share of that product, but it's not going to be as big as we had thought at one point. AMP-002, I think what we've said in the past is that it's a relatively large market, but we're going to be somewhat capacity constrained for that market. So we're going to probably get a lower market share than what you would consider to normally have in a two player market, but we still see it as being a good market in a large market for us.

就 ANDA 的市佔率而言，特立帕肽已經是一個多人市場。因此，我認為我們的期望是我們將獲得該產品的合理市場份額，但它不會像我們曾經想像的那麼大。AMP-002，我認為我們過去說過這是一個相對較大的市場，但我們對該市場的容量會受到一定的限制。因此，我們可能會獲得比您在兩人市場中通常認為的更低的市場份額，但我們仍然認為這對我們來說是一個大市場中的一個很好的市場。

And then AMP-007, we haven't said because we've been somewhat consciously clouding the issue there because we don't want to let people know what the product is for competitive reasons. So I will say that we see this as a very good market opportunity for us though.

然後是 AMP-007，我們沒有說，因為我們一直有意識地掩蓋了這個問題，因為出於競爭原因，我們不想讓人們知道該產品是什麼。所以我想說，我們認為這對我們來說是一個非常好的市場機會。

Glen Santangelo, Jefferies.

格倫桑坦傑洛，傑弗里斯。

Hey, Will, I also wanted to unpack BAQSIMI a little bit because what's interesting is the results were probably better than I think we were expecting. Looking at some of the script data, it looked like the numbers were trending in negative territory for the first quarter based on your response to the previous question, you kind of made it sound like it was more volume driven than price driven. So could you maybe reconcile those data points and what drove the strength in the quarter?

嘿，威爾，我還想稍微打開一下 BAQSIMI，因為有趣的是結果可能比我想像的要好。看看一些腳本數據，根據您對上一個問題的回答，第一季的數字似乎呈負數趨勢，您聽起來像是數量驅動而不是價格驅動。那麼您能否將這些數據點與推動本季強勢的因素進行核對？

And then maybe related to that, as we look to the back half of the year, can you maybe give us a little more color on the country-by-country transition and when you think the transition to Amphastar will be fully complete?

然後，也許與此相關的是，當我們展望今年下半年時，您能否給我們更多關於各個國家/地區過渡的信息，以及您認為向 Amphastar 的過渡何時會完全完成？

Sure. So yes, so the units in the quarter, yes, I will say that we had a couple of hiccups as we transitioned from Lilly supply numbers to ours, NDC numbers in certain drug store chains and certain government programs. So we did have a hiccup and there was a little bit of a time during the second quarter where we weren't getting every script we should have been getting.

當然。所以，是的，所以本季的單位，是的，我會說，當我們從禮來公司的供應數字過渡到我們的供應數字、某些連鎖藥局的NDC 數字和某些政府計劃時，我們遇到了一些問題。所以我們確實遇到了一些問題，在第二季的一段時間內我們沒有得到我們應該得到的所有劇本。

But I think all of those problems were resolved by the end of the quarter. And so I think we're expecting the third quarter to tick back up the way it should be. To a certain extent, some of the units sold later in the quarter were, I think, more of some of the wholesalers trying to gear up to make sure they had enough inventory in the channel because they want to make sure that they had enough for the large back-to-school surge that's usually happening in August. So I think that's part of it. And ex-US, we still had some nice trends there. So that's been going well as well.

但我認為所有這些問題都在本季末得到了解決。因此，我認為我們預計第三季將以應有的方式回升。在某種程度上，我認為，本季晚些時候銷售的一些單位更多是一些批發商試圖做好準備，以確保他們在渠道中有足夠的庫存，因為他們想確保他們有足夠的庫存返校高峰期通常發生在八月。所以我認為這是其中的一部分。除美國外，我們仍然有一些不錯的趨勢。所以這也進展順利。

As far as the country-by-country basis, our goal is to get a majority of other countries that are not distributed by Amphastar over to our distribution by the end of this quarter. So we have a lot of countries planned for cutover in August and September. So this is going to be another one of those quarters. It's a little bit mixed and that there's going to be multiple countries that are cutting over throughout this. So our expectation is that by the fourth quarter, there will only be three countries that are still being distributed by Lilly.

就具體國家/地區而言，我們的目標是在本季結束前將 Amphastar 未分銷的大多數其他國家納入我們的分銷範圍。所以我們有很多國家計劃在八月和九月進行切換。因此，這將是其中的另一個季度。這有點複雜，並且將會有多個國家在整個過程中切換。因此，我們的預期是，到第四季度，禮來公司仍將在三個國家進行分銷。

Our goal is probably on those final three. They we might not take over distribution to them until January 1. So we're still -- looking at either a December transition for those final three countries or maybe January 1. So, but most countries should be our distribution by the end of the third quarter, which means that the fourth quarter will be a little cleaner from that standpoint. It will be a little truer.

我們的目標可能是最後三名。我們可能要到 1 月 1 日才會接手對他們的分配。因此，我們仍在考慮在 12 月或 1 月 1 日為最後三個國家進行過渡。所以，但大多數國家應該在第三季末完成我們的分配，這意味著從這個角度來看，第四季會更加乾淨。會更真實一些。

Perfect. I appreciate the details. Maybe you could just ask one quick follow-up. On some of the other product categories, like when we think about like lidocaine and phytonadione, we see the supply issues ebbing and flowing in the market and that creates sort of these big swings in the results. And so as you look to the back half, without maybe giving specific guidance, are there any sort of product areas you'd call out where you're seeing either shortages or competitors sort of coming back online that influence some of those product categories in the back half? And I'll stop there. Thanks.

完美的。我很欣賞細節。也許你可以快速詢問一下。在其他一些產品類別上，例如當我們考慮利多卡因和植物萘二酮時，我們看到市場上的供應問題起伏不定，這導致了結果的大幅波動。因此，當您查看後半部分時，可能不會給出具體指導，您會指出哪些產品領域出現短缺或競爭對手重新上線，從而影響了其中一些產品類別後半部分？我就到此為止。謝謝。

So as I mentioned the competitor that had the supply problems over the last year has said that they will begin distribution of some of these supply constrained products in the fourth quarter. So we do expect that some of the will be able to do that for their disclosures. So any of those things could drop off in the fourth quarter. We're not seeing that in the third quarter yet. So the third quarter is kind of holding steady.

正如我所提到的，去年遇到供應問題的競爭對手錶示，他們將在第四季開始分銷其中一些供應受限的產品。因此，我們確實希望其中一些人能夠在披露時做到這一點。因此，這些事情都可能在第四季下降。我們在第三季還沒有看到這一點。所以第三季保持穩定。

But and as Dan had mentioned, I'll just point out again, we have increased the capacity of the facility that makes all of those products so that we could better take advantage of those. And that was one of the reasons that drove epinephrine sales in this quarter. We think it probably should drive higher sodium bicarbonate and dextrose sales in the third quarter.

但是，正如丹所提到的，我再次指出，我們增加了生產所有這些產品的設施的產能，以便我們可以更好地利用這些產品。這是推動本季腎上腺素銷售的原因之一。我們認為這可能會推動第三季碳酸氫鈉和葡萄糖的銷售成長。

So with that, we can make more product out of that facility, hopefully taking advantage of these things as they come up. And so that we want to be in a position so that if there is a supply shortage by another competitor on these products that we're able to supply the entire market. So we're kind of gearing up to be able to do that.

這樣，我們就可以利用該設施生產更多產品，希望在這些東西出現時能夠利用它們。因此，我們希望能夠在這些產品的其他競爭對手出現供應短缺的情況下，我們能夠供應整個市場。因此，我們正在做好準備，以便能夠做到這一點。

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，以徵求結束語。

I want to thank everyone for joining us today. The second half of 2024 remains to be a highly anticipated period with three potential launches. We look forward to updating you all again and again. Thank you and have a great day.

我要感謝大家今天加入我們。2024 年下半年仍是備受期待的時期，可能會推出三款產品。我們期待著一次又一次地為大家更新。謝謝您，祝您有美好的一天。

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。此時您可以斷開線路。感謝您的參與。