Amphastar Pharmaceuticals Inc (AMPH) 2023 Q3 法說會逐字稿

Greetings, and welcome to the Amphastar Pharmaceuticals' Third Quarter Earnings Conference Call. (Operator Instructions) 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.

您好，歡迎參加 Amphastar Pharmaceuticals 第三季財報電話會議。 （操作員說明）請注意，本次電話會議期間就非歷史事實的事項所做的某些陳述，包括但不限於管理層的展望或對未來時期的預測，均為前瞻性陳述。這些陳述僅基於我們現在掌握的資訊。

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 company -- on our website and the SEC's website for a discussion of numerous factors that may impact our future performance. We will also discuss certain non-GAAP measures. Important information on our use of these measures and reconciliations to U.S. GAAP may be found in our earnings release. Please note, this conference call is being recorded.

我們鼓勵您查看今天發布的新聞稿中標題為前瞻性陳述的部分以及公司網站上的簡報。另外，請參閱我們向 SEC 提交的文件，這些文件可以在我們公司的網站和 SEC 網站上找到，以了解可能影響我們未來業績的眾多因素的討論。我們也將討論某些非公認會計原則措施。有關我們使用這些措施以及與美國公認會計原則（U.S. GAAP）的調節的重要資訊可以在我們的收益報告中找到。請注意，本次電話會議正在錄製中。

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

現在我將會議轉交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 thank you all for joining us today on our third quarter earnings call of 2023. 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. 2023 has been characterized by maintaining the momentum of our key high-margin products, while fulfilling our commitment by advancing our portfolio's proprietary, biosimilar and complex product segments.

謝謝你，保羅。下午好，感謝大家今天參加我們的 2023 年第三季財報電話會議。今天加入我的是財務長兼財務執行副總裁 Bill Peters；以及監管事務和臨床營運執行副總裁 Tony Marrs。 2023 年的特點是保持我們主要高利潤產品的發展勢頭，同時透過推進我們的專有產品、生物相似藥和複雜產品領域來履行我們的承諾。

In terms of sales, the third quarter ended with $180.5 million in revenue, representing a 50% increase on an annualized basis with the added net sales of our recently acquired proprietary product BAQSIMI and the continued strength of our core products, specifically glucagon, Primatene Mist and epinephrine.

就銷售額而言，第三季營收為1.805 億美元，年化成長50%，這得益於我們最近收購的專有產品BAQSIMI 的淨銷售額以及我們核心產品（特別是胰高血糖素、Primatene Mist）的持續強勢和腎上腺素。

Since we closed the BAQSIMI acquisition on June 30, we've been working hard transferring operations in 27 countries worldwide. On October 1, we began marketing the product in the United States using a contract sales force combined with our internal sales team. Around the world, we have signed agreements with third-party logistics and local companies to help us set up the needed distribution networks.

自6月30日完成對BAQSIMI的收購以來，我們一直在努力轉移全球27個國家的業務。 10 月 1 日，我們開始使用合約銷售人員與內部銷售團隊結合的方式在美國行銷該產品。在世界各地，我們與第三方物流和當地公司簽署了協議，幫助我們建立所需的分銷網絡。

We have already transferred the NDA in the United States to Amphastar and we are working on transferring the marketing authorizations in other countries as quickly as possible.

我們已經將美國的 NDA 轉讓給 Amphastar，並正在努力盡快轉讓其他國家的營銷授權。

We plan to transfer distribution in the United States in the first quarter of next year and other countries as soon as possible after that. BAQSIMI recorded its highest sales ever this quarter, continuing a growth trend we expected. Due to the seasonality of the product, the third quarter represents approximately 31% of the annual sales.

我們計劃明年第一季在美國轉移發行，之後儘快轉移到其他國家。 BAQSIMI 本季銷售額創下歷史新高，延續了我們預期的成長趨勢。由於產品的季節性，第三季約佔全年銷售額的31%。

In addition to the commentary on our glucagon and Primatene Mist offerings, the sustained performance of these products from the previous financial quarters is notable, specifically glucagon, which generated $29.5 million in revenue, marking a substantial 107% increase over the same period last year. However, we note that glucagon sales peak in the third quarter was due to the increased back-to-school demand and will typically normalize after the seasonal period.

除了對我們的胰高血糖素和Primatene Mist 產品的評論之外，這些產品在上一個財務季度的持續表現也引人注目，特別是胰高血糖素，其收入達到2,950 萬美元，比去年同期大幅增長107%。然而，我們注意到，第三季胰高血糖素銷售高峰是由於返校需求增加所致，並且通常會在季節過後恢復正常。

As for Primatene Mist, the product realized an impressive $24.8 million in sales in the third quarter. This represents a noteworthy 35% increase compared to the corresponding period in the previous year, primarily due to restocking by retailers. We continue to see unit retail growth in the 5% to 6% range and still project that Primatene Mist will reach the milestone of $100 million in sales by the end of 2024.

至於 Primatene Mist，該產品第三季實現了令人印象深刻的 2,480 萬美元銷售額。與去年同期相比，這一數字顯著增加了 35%，這主要是由於零售商補貨所致。我們繼續看到單位零售量成長在 5% 至 6% 範圍內，並且仍然預計 Primatene Mist 的銷售額將在 2024 年底達到 1 億美元的里程碑。

Regarding our epinephrine and other finished pharmaceutical products, once again, we have been able to capitalize on competitor supply shortages, specifically epinephrine, which achieved a notable 19% increase in sales over the prior quarter and a 4% increase annually, amounting to $20.2 million in sales.

關於我們的腎上腺素和其他成品藥品，我們再次能夠利用競爭對手的供應短缺，特別是腎上腺素，其銷售額比上一季顯著增長 19%，每年增長 4%，達到 2020 萬美元促銷。

Our Lidocaine product also saw sales growth within our injectable products in shortage, registering a 10% increase over the last quarter. This performance reflects our agile response to market dynamics and the strategic positioning of our products to serve unmet market needs effectively.

我們的利多卡因產品在短缺的注射產品中也實現了銷售成長，比上季成長了 10%。這項業績反映了我們對市場動態的敏捷響應以及我們產品的策略定位，以有效滿足未滿足的市場需求。

Our commitment to providing continuity of supply during periods of competitor shortage exemplifies our role as a reliable provider in the pharmaceutical landscape and supports our projection for sustained performance. As we address our adaptive response to evolving market conditions, the launch of REXTOVY, our proprietary naloxone nasal spray is now scheduled for release in the first quarter of 2024 due to production needs for shortages projects -- products. Furthermore, due to the API supplier for our MPA injection, having discontinued manufacturing this API we will have minimal to no sales of MPA over the ensuing quarters.

我們致力於在競爭對手短缺期間提供連續性供應，這反映了我們作為製藥領域可靠供應商的角色，並支持我們對持續績效的預測。在我們應對不斷變化的市場條件時，我們推出了 REXTOVY，這是我們專有的納洛酮鼻噴霧劑，由於短缺項目（產品）的生產需求，目前計劃於 2024 年第一季發布。此外，由於我們的 MPA 注射劑的 API 供應商已停止生產該 API，因此我們在接下來的幾個季度中 MPA 的銷量將很少甚至沒有。

We plan to resume manufacturing MPA following the anticipated FDA approval for qualification of the new API, which will be produced at our ANP facility. The FDA authorization will enable us to leverage our in-house production capabilities, ensuring a steady supply to meet market demand.

我們計劃在 FDA 批准新 API 資格後恢復 MPA 生產，新 API 將在我們的 ANP 工廠生產。 FDA 的授權將使我們能夠利用我們的內部生產能力，確保穩定的供應以滿足市場需求。

I would now like to shift our dialogue on the progress within our pipeline and the regulatory endeavors related to our proprietary biosimilar and complex generic products. Regarding the regulatory progress of AMP 002, we acknowledge the delay beyond its initial PDUFA goal date. We are currently engaged in discussions with the agency. The agency remains committed to moving the application forward in the regulatory review process as quickly as possible. There remains a significant market demand for this product, which would represent itself as the first generic in the market niche exceeding $600 million according to IQVIA.

我現在想將我們的對話轉移到我們的管道內的進展以及與我們專有的生物仿製藥和複雜的仿製藥產品相關的監管工作上。關於 AMP 002 的監管進展，我們承認其延遲超出了其最初的 PDUFA 目標日期。目前我們正在與該機構進行討論。該機構仍然致力於盡快在監管審查過程中推進申請。該產品仍然存在巨大的市場需求，根據 IQVIA 的數據，該產品將成為該市場中第一個超過 6 億美元的仿製藥。

Recognizing the need for generic options, we are dedicated to advancing our dialogue with the FDA. For our teriparatide ANDA referenced as AMP-015, as previously stated, we have responded to the CRL. We have a goal date in the first quarter of 2024. This date adheres to the conventional schedule, allowing for an additional quarter's extension should a preapproval inspection be necessary.

認識到對仿製藥選擇的需求，我們致力於推進與 FDA 的對話。對於我們的特立帕肽 ANDA（編號為 AMP-015），如前所述，我們已對 CRL 做出了回應。我們的目標日期是 2024 年第一季。該日期符合常規時間表，如果需要預先批准檢查，可以再延長一個季度。

In reference to our AMP-008 inhalation ANDA, which received priority review status, we believe we have addressed the issues identified in the minor CRL. As a result, we have a PDUFA goal date set for the fourth quarter of this year. Concurrently, our AMP-007 application is progressing as planned and is scheduled for submission by the end of this year.

參考我們獲得優先審查資格的 AMP-008 吸入 ANDA，我們相信我們已經解決了次要 CRL 中發現的問題。因此，我們將 PDUFA 的目標日期定為今年第四季。同時，我們的 AMP-007 申請正在按計劃進行，預計今年年底提交。

Regarding our proprietary product, intranasal epinephrine identified as AMP-019, we are diligently advancing through the clinical development phases in collaboration with the FDA. In alignment with our strategic objectives for our biosimilars, I am pleased to report today steady progress with AMP-004, our insulin aspart biosimilar candidate. We are on track to submit the BLA for this product by the end of this year with the intent of securing interchangeable status.

關於我們的專有產品，鼻內腎上腺素（編號為 AMP-019），我們正在與 FDA 合作，努力推進臨床開發階段。根據我們生物相似藥的策略目標，我今天很高興地報告我們的門冬胰島素生物相似藥候選產品 AMP-004 取得了穩步進展。我們預計在今年年底前提交該產品的 BLA，以確保可互換狀態。

In summary, the solid performance and strategic advancement detailed today underscore the strength and adaptability of our product portfolio in response to the competitive and regulatory environments we operate within.

總之，今天詳述的穩健績效和策略進步突顯了我們產品組合的實力和適應性，以應對我們所處的競爭和監管環境。

Our strong sales growth, strategic pipeline advancements and regulatory foresight aligned with our company's sustained growth and value creation vision. We remain dedicated to advancing unmet medical needs as we continue to invest in our high-margin products and innovate in proprietary biosimilar and complex products. We are confident in our ability to capitalize on market opportunities and navigate industry challenges strategically.

我們強勁的銷售成長、策略管道進展和監管遠見與我們公司的持續成長和價值創造願景一致。我們持續投資高利潤產品並在專有生物相似藥和複雜產品方面進行創新，始終致力於推動未滿足的醫療需求。我們對利用市場機會和策略性應對產業挑戰的能力充滿信心。

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

我現在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)，討論第三季的財務表現。

Thank you, Dan. Revenues for the third quarter increased 50% and to $180.6 million from $120.1 million in the previous year's period. Glucagon sales increased 107% to $29.5 million from $14.2 million as 2 suppliers left the market, and we experienced seasonally strong back-to-school sales.

謝謝你，丹。第三季營收成長 50%，從去年同期的 1.201 億美元增至 1.806 億美元。由於 2 家供應商退出市場，胰高血糖素銷售額從 1,420 萬美元增長了 107%，達到 2,950 萬美元，我們經歷了季節性強勁的返校銷售。

Primatene Mist sales grew to a new record of $24.8 million in the third quarter which represents a sales growth of 35% from sales of $18.4 million in the third quarter of last year as retailers replenished their inventories.

隨著零售商補充庫存，Primatene Mist 第三季銷售額成長至新紀錄的 2,480 萬美元，較去年第三季的 1,840 萬美元成長 35%。

Lidocaine sales increased to $15.5 million from $12.6 million due to higher unit volumes as a result of continued supplier shortages during the quarter. Phytonadione saw increased competition as sales decreased 47% to $7.4 million from $14 million.

由於本季供應商持續短缺導致單位銷售增加，利多卡因銷售額從 1,260 萬美元增至 1,550 萬美元。植物油二酮的競爭加劇，銷售額從 1,400 萬美元下降到 740 萬美元，下降了 47%。

Other finished pharmaceutical product sales increased $14.1 million to $37.7 million on increased sales of legacy products such as dextrose, atropine, calcium chloride and sodium bicarbonate and on sales of newer launches, including regadenoson, ganirelix and vasopressin. This marks the first quarter of revenues from BAQSIMI.

由於葡萄糖、阿托品、氯化鈣和碳酸氫鈉等傳統產品的銷售增加以及雷加腺松、加尼瑞克和加壓素等新產品的銷售，其他成品藥品銷售額增加了1,410 萬美元，達到3,770 萬美元。這標誌著 BAQSIMI 第一季的營收。

We recorded net revenues of $28.7 million, which corresponds to Amphastar's net economic benefit from BAQSIMI. This net economic benefit was calculated based on Eli Lilly's sales of $48.7 million less their expenses of $20 million, which included cost of goods, selling expenses and research and development expenses. We will continue to book revenues on a net basis until we begin distributing BAQSIMI in 2024. This change will occur on a country-by-country basis.

我們記錄的淨收入為 2,870 萬美元，相當於 Amphastar 從 BAQSIMI 獲得的淨經濟效益。這項淨經濟效益是根據禮來公司 4,870 萬美元的銷售額減去 2,000 萬美元的費用計算的，其中包括商品成本、銷售費用和研發費用。我們將繼續以淨額為基礎記帳收入，直到 2024 年開始分銷 BAQSIMI。這項變更將按國家/地區進行。

Our insulin API business had sales of $4.2 million, up from $1.2 million last year, primarily due to the timing of orders. Cost of revenues increased to $72.2 million from $61.6 million. Gross margins improved to 60% of revenues from 49% on increased sales of higher-margin products such as glucagon, Primatene Mist, ganirelix and vasopressin. Additionally, revenues from BAQSIMI reported net of related expenses.

我們的胰島素 API 業務的銷售額為 420 萬美元，高於去年的 120 萬美元，這主要是由於訂單的及時性。收入成本從 6,160 萬美元增加到 7,220 萬美元。由於胰高血糖素、Primatene Mist、加尼瑞克和加壓素等高利潤產品的銷售增加，毛利率從佔收入的 49% 提高到 60%。此外，BAQSIMI 的收入已扣除相關費用。

Selling, distribution and marketing expenses increased 34% to $6.4 million from $4.8 million in the previous year's period due to sales force expansion expenses related to BAQSIMI and increased advertising expenses for Primatene Mist.

由於 BAQSIMI 相關的銷售隊伍擴張費用以及 Primatene Mist 的廣告費用增加，銷售、分銷和行銷費用從去年同期的 480 萬美元增加了 34% 至 640 萬美元。

General and administrative spending increased 6% to $12.7 million from $12 million due to increased compensation and expenses related to BAQSIMI, which were partially offset by lower legal expenses.

由於與 BAQSIMI 相關的薪資和費用增加，一般和行政支出從 1,200 萬美元增加了 6%，達到 1,270 萬美元，但部分被法律費用減少所抵消。

Research and development expenditures decreased 10% to $16.7 million from $18.5 million due to the timing of clinical trials and material expenses related to our insulin and inhalation pipeline products.

由於臨床試驗的時間安排以及與我們的胰島素和吸入管道產品相關的材料費用，研發支出從 1850 萬美元減少了 10% 至 1670 萬美元。

Our nonoperating expense of $9 million compared to a nonoperating expense last year of $600,000, primarily due to interest expense and costs incurred for the term loan we entered into to complete the BAQSIMI acquisition and convertible debt issued this quarter. These expenses were partially offset by mark-to-market adjustments related to our interest rate swaps.

我們的營業外支出為 900 萬美元，而去年的營業外支出為 60 萬美元，主要是由於我們為完成 BAQSIMI 收購而簽訂的定期貸款以及本季度發行的可轉換債務所產生的利息支出和成本。這些費用被與我們的利率掉期相關的按市價調整部分抵消。

Net income increased over 200% to $49.2 million or $0.91 per share in the third quarter from $15.9 million or $0.30 per share in the third quarter of 2022. Adjusted net income also increased significantly to $61.9 million or $1.15 per share compared to an adjusted net income of $20.2 million or $0.38 per share in the third quarter of last year. Adjusted earnings excludes amortization, equity compensation, impairment of long-lived assets and onetime events.

第三季淨利成長超過200%，從2022 年第三季的1,590 萬美元或每股0.30 美元增至4,920 萬美元或每股0.91 美元。與調整後淨利相比，調整後淨利也大幅成長至6,190 萬美元或每股1.15 美元去年第三季的營收為 2,020 萬美元，即每股 0.38 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 quarter, we had cash flow from operations of approximately $64.3 million. We issued $345 million of convertible notes in September and used $200 million of the proceeds to concurrently pay down our term loan and $50 million to buy back approximately 1.1 million shares of our common stock. Subsequent to the end of the quarter, we paid down an additional $50 million of our term loan.

本季度，我們的營運現金流約為 6,430 萬美元。我們在 9 月發行了 3.45 億美元的可轉換票據，並使用其中的 2 億美元來同時償還我們的定期貸款，並使用 5,000 萬美元回購了大約 110 萬股普通股。本季末後，我們又償還了 5,000 萬美元的定期貸款。

When we entered into the term loan, we hedged $250 million of the loan by swapping into a fixed rate for 5 years. At this point, we do not have any more floating rate debt, which will enable us to lower our interest expense in the coming years.

當我們簽訂定期貸款時，我們透過轉換為 5 年期固定利率來對沖 2.5 億美元的貸款。目前，我們不再有任何浮動利率債務，這將使我們能夠在未來幾年降低利息支出。

I'll 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'll 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。

(Operator Instructions) Our first question is from Glen Santangelo with Jefferies.

（操作員說明）我們的第一個問題來自 Jefferies 的 Glen Santangelo。

Bill, I want to start out talking about BAQSIMI because obviously, I think this is a bigger result than most of us were expecting. When you look at the sales generated by Lilly $48 million, $49 million. I mean, I thought at least in your most recent sort of marketing deck, where we're talking about closing out this year at $145 million to $155 million annualized with the potential to get the peak sales of $250 million to $275 million. I mean how do you think about those targets that you had previously laid out relative to the fact that Lilly almost did $49 million in [rex] this quarter?

Bill，我想先談論 BAQSIMI，因為顯然，我認為這比我們大多數人的預期要大。當你看看禮來公司的銷售額為 4800 萬美元、4900 萬美元。我的意思是，我至少在你最近的行銷計劃中想到了這一點，我們正在談論今年的年化收入為 1.45 億至 1.55 億美元，並有可能實現 2.5 億至 2.75 億美元的峰值銷售額。我的意思是，相對於禮來公司本季幾乎在 [rex] 中實現 4900 萬美元的收入這一事實，您如何看待您之前製定的那些目標？

Well, 2 things. One, first of all, thanks for noticing the projections and saying the updated slide deck because we did update the projections from previous number to increase that slightly. And the big thing about this is that this is a back-to-school quarter. So the third quarter has historically been the high point of the year. So we expect sales will drop going into the fourth quarter, and that's just been the trend.

嗯，有兩件事。首先，感謝您注意到預測並更新了幻燈片，因為我們確實更新了先前數字的預測，以稍微增加這一數字。最重要的是，這是一個返校季。因此，從歷史上看，第三季是全年的高點。因此，我們預計第四季度的銷售額將會下降，這只是趨勢。

If you take a look at the graph of the script there, IQVIA script data, you see it really does have a big peak in the August, September time frame. So we expect it to decrease. But that said, the $250 million to $275 million is still just the forecast that we have at this point, and we think we have a very good plan to get to that. Could we beat that forecast? I think we possibly could. So it's just right now, it's certainly something that we could do, and we didn't want to set a forecast that was something that we'd ever have to lower. So I'm glad to say that we did increase it once already.

如果您查看那裡的腳本圖表（IQVIA 腳本資料），您會發現它確實在 8 月、9 月時間範圍內出現了一個大峰值。所以我們預計它會減少。但話雖如此，2.5 億至 2.75 億美元仍然只是我們目前的預測，我們認為我們有一個非常好的計劃來實現這一目標。我們能超越這個預測嗎？我想我們可能可以。所以現在就是我們可以做的事情，我們不想設定一個我們必須降低的預測。所以我很高興地說我們已經增加過一次。

All right. That's helpful. I appreciate that. Maybe I just ask one other quick question. Maybe a high-level question. The quarter, it always benefits to some extent from shortages in one product or another, and it's always hard sitting in our seat to sort of forecast which ones. Is there anything specifically you'd call out going on in the market this quarter? Like obviously, lidocaine benefited again, epinephrine benefited, Primatene obviously, was the opposite. And we know that Pfizer had some manufacturing issues, some unfortunate issues. But is there anything specifically this quarter that you may call out that may have a little bit more sustained impact or something to the opposite might have a little bit of a shorter duration to it.

好的。這很有幫助。我很感激。也許我只是問另一個簡單的問題。也許是一個高層次的問題。這個季度，它總是在某種程度上受益於一種或另一種產品的短缺，而且我們總是很難坐在座位上來預測哪些產品。本季市場上有什麼特別值得您關注的事情嗎？顯然，利多卡因再次受益，腎上腺素受益，而靈長類顯然相反。我們知道輝瑞公司存在一些製造問題，一些不幸的問題。但是，本季有哪些具體的事情您可能會指出，可能會產生更持久的影響，或者相反的事情可能會產生更短的持續時間。

Yes. So you did mention the Lidocaine. One of our Lidocaine SKUs is on shortage and we're producing as much as that as possible. But there's 3 right now, where we're the only 1 in the country making them, and that's dextrose sodium carbonate and also the epi syringe -- prefilled syringe that's used in emergency rooms. So those 3 things are -- we're just making as much of those things as we can. And we don't know when our competition will be back on the market, but it looks like that's going to at least go into at least the second quarter of next year from what we understand for those products. So that's what we can garner out of that.

是的。所以你確實提到了利多卡因。我們的一種利多卡因 SKU 出現短缺，我們正在盡可能地生產。但現在有 3 種產品，我們是全國唯一生產這些產品的公司，那就是葡萄糖碳酸鈉和 Epi 注射器——急診室使用的預充式註射器。所以這三件事是──我們只是盡可能地製造這些東西。我們不知道我們的競爭對手何時會重新出現在市場上，但從我們對這些產品的了解來看，這種情況至少會持續到明年第二季。這就是我們可以從中獲得的。

And as -- I think we mentioned and also in the presentation because of our attempt to take care of the market for these shortages, we've had to delay once again, the launch of our intranasal naloxone because it runs on the same equipment at our IMS facility.

我想我們在演示中也提到過，由於我們試圖解決這些短缺問題，我們不得不再次推遲鼻內納洛酮的推出，因為它在相同的設備上運行我們的 IMS 設施。

So we had an opportunity to launch that or satisfy some of the demand for these shortage products and we decided it was more prudent to make more of the shortage products to try to help the market out of the situation that it's in right now.

因此，我們有機會推出產品或滿足對這些短缺產品的部分需求，我們認為更謹慎的做法是生產更多短缺產品，以幫助市場擺脫目前的狀況。

Our next question is from Tim Chiang with Capital One.

我們的下一個問題來自第一資本的 Tim Jiang。

Good quarter. Maybe you could talk just a little bit about the rebound in Primatene Mist sales, how that might have contributed to your higher gross margins this quarter as well?

好季度。也許您可以稍微談談 Primatene Mist 銷售的反彈，這可能如何為您本季更高的毛利率做出貢獻？

Yes. So 2 things. One, really, the biggest thing to the gross margin was the fact that BAQSIMI is on a net basis. So it's a 100% margin product right now. So all the expenses are taken out before we book that revenue because of the accounting guidance that we have to follow. So that's really the big driver to get to that 60%. But as far as Primatene Mist goes, it's basically what we've been seeing in the last 2 quarters is it was growing at the retail level in the first quarter, but our sales were down. It was growing at the retail level in the second quarter, but our sales were down. That indicated to us that there was a contraction in the level of inventory at retailers. It reversed this quarter. The growth has actually been relatively steady at about 5% or 6% a quarter this year, 5% or 6% every quarter this year. And -- but you've seen this big fluctuation in our volumes, and that's just really has to do with the inventory.

是的。所以有兩件事。事實上，對毛利率影響最大的是 BAQSIMI 是以淨值計算的。所以現在它是一個100%利潤的產品。因此，由於我們必須遵循會計指南，所以在我們登記收入之前，所有費用都會被扣除。所以這確實是達到 60% 的重要推手。但就 Primatene Mist 而言，基本上我們在過去兩個季度中看到的是，它在第​​一季度的零售水平上有所增長，但我們的銷售額卻下降了。第二季零售層面正在成長，但我們的銷售額卻下降了。這向我們表明零售商的庫存水準有所收縮。本季情況出現逆轉。事實上，今年的成長相對穩定，每季成長5%或6%左右，今年每季成長5%或6%。而且——但你已經看到我們的銷售出現了巨大的波動，這確實與庫存有關。

So this is, we believe, an inventory stocking ahead of what's usually the biggest 2 quarters of the year for Primatene Mist usually the fourth quarter and the first quarter. So I think we got a little bit of that carryover into the first quarter because the retailers had lowered their inventory levels going into this quarter.

因此，我們認為，這是 Primatene Mist 一年中最大的兩個季度（通常是第四季度和第一季）之前的庫存儲備。因此，我認為我們在第一季得到了一些結轉，因為零售商在本季度降低了庫存水準。

Got it. And I guess with BAQSIMI, you're still going to report net economic benefit from BAQSIMI in the fourth quarter. But obviously, that number probably will be less, right? Because the third quarter obviously was the strongest quarter for the year. Is that right?

知道了。我想對於 BAQSIMI，您仍然會在第四季度報告 BAQSIMI 的淨經濟效益。但顯然，這個數字可能會更少，對吧？因為第三季顯然是全年最強勁的季度。是對的嗎？

That's correct. The other thing -- well, there's going to be a couple of forces that kind of go in different directions for that because starting in the fourth quarter, we are doing our own marketing, our own selling for that. So that's going -- the expense of that will now be on our selling line and it will not be borne by Lilly. So they will have a lower expense that's used to deduct that. So there, as we saw the Lilly sales were close to $49 million. So we expect that, that -- their top line number to decrease. And as Dan had mentioned, it's historically been about 31% of the annual sales into the third quarter. So it's definitely higher than the other quarters. But the deductions will be a little bit lower as well. .

這是正確的。另一件事——嗯，將會有一些力量朝著不同的方向發展，因為從第四季度開始，我們正在做我們自己的行銷，我們自己的銷售。事情就是這樣——這筆費用現在將由我們的銷售部門承擔，而不會由禮來公司承擔。因此，他們用於扣除的費用將會降低。我們看到禮來公司的銷售額接近 4900 萬美元。所以我們預計他們的頂線人數會減少。正如 Dan 所提到的，從歷史上看，第三季的銷售額約佔年銷售額的 31%。所以肯定比其他季度高。但扣除額也會低一些。 。

So the selling expense that they deduct will not be as high. So we'll still have their cost of goods, their distribution expenses and a little bit of R&D work as they continue out a couple of the R&D studies that were ongoing. So those expenses will still be borne in that gross number. And I know it's a little bit confusing, but it's a moving piece.

所以他們扣除的銷售費用不會那麼高。因此，當他們繼續進行一些正在進行的研發研究時，我們仍然會有他們的商品成本、分銷費用和一些研發工作。因此，這些費用仍將計入該總額中。我知道這有點令人困惑，但這是一個感人的作品。

And as we've mentioned, we're going to -- we plan to take our distribution in the United States in the first quarter of next year. So -- and then the rest of the world will follow depending on the timing of signing of certain contracts and also the transfer of the marketing authorizations in various locales.

正如我們所提到的，我們計劃在明年第一季在美國進行發行。因此，世界其他地區也將效仿，具體取決於簽署某些合約的時間以及不同地區行銷授權的轉移。

Okay. Just one last question then, Bill. Is the 60% gross margin, is that sort of your new going forward type of run rate now that you have BAQSIMI?.

好的。那麼還有最後一個問題，比爾。 60% 的毛利率是您擁有 BAQSIMI 後新的未來運行率類型嗎？

No. Because remember, because BAQSIMI, that we had, our net economic benefit was at 100% margin. So the net economic benefit that we get next quarter will also be at 100% margin. But as we move forward, we will have -- we'll start incurring the revenues and the cost of goods. So in the future, our revenue number goes up, but our cost of goods number goes up as well.

不。因為請記住，因為我們擁有 BAQSIMI，我們的淨經濟效益為 100%。所以我們下個季度獲得的淨經濟效益也將達到 100% 的利潤率。但隨著我們前進，我們將開始產生收入和商品成本。因此，未來我們的收入數字會上升，但我們的商品成本數字也會上升。

So instead of BAQSIMI being 100% margin product, it's going to be something that's well above our corporate average, but it will still have a cost associated with it once we begin distributing in locales, around the world. And I know that's a little bit complicated and a little bit -- it's going to be country-by-country basis. So it's not all -- it doesn't all happen at once.

因此，BAQSIMI 不是 100% 利潤的產品，而是遠高於我們公司平均水平的產品，但一旦我們開始在世界各地的地區分銷，它仍然會產生與之相關的成本。我知道這有點複雜，而且會因國家而異。所以這不是全部——這一切並不是同時發生的。

Right. Got it. I think historically, what U.S. BAQSIMI sales had made up about, what, 80% of the total BAQSIMI high?

正確的。知道了。我想從歷史上看，美國BAQSIMI的銷售量佔了BAQSIMI總銷售量的80%，什麼？

That's correct.

這是正確的。

Our next question is from David Amsellem with Piper Sandler.

我們的下一個問題來自 David Amsellem 和 Piper Sandler。

This is Tim on for David. A few from us, and apologies if there's a little overlap here. So on BAQSIMI, I guess, stepping back, what's your overall view on the glucagon [rescue] market growth both near term and longer term. And with respect to your sales force, what are you thinking in terms of sizing? Is that going to be a contract sales organization? Or will it be internal? And when do you expect for them to hit the field?

這是大衛的提姆。我們提供了一些信息，如果有一點重疊，我們深表歉意。因此，關於 BAQSIMI，我想，退後一步，您對胰高血糖素 [救援] 市場近期和長期增長的總體看法是什麼。對於您的銷售隊伍，您在規模上有何想法？那會是一個合約銷售組織嗎？還是會是內部的？您預計他們什麼時候上場？

And then second, on the glucagon injection generic, could you speak to how penetrated you are in the institutional setting and the extent to which you've been able to leverage our expanded manufacturing capacity? And over time, how big do you think the opportunity is in that setting? And then last, on the shortage products, can you talk to the extent to which you'll continue to benefit from shortages in 2024? I know you called out those 3 products that the competitors aren't making right now, but beyond that, what is the impact of the shortage is going to look like next year relative to this year?

其次，關於胰高血糖素注射仿製藥，您能否談談您在機構環境中的滲透程度以及您能夠在多大程度上利用我們擴大的製造能力？隨著時間的推移，您認為在這種環境下的機會有多大？最後，關於短缺產品，您能否談談 2024 年您將在多大程度上繼續從短缺中受益？我知道你指出了競爭對手目前沒有生產的這 3 種產品，但除此之外，相對於今年，明年的短缺會產生什麼影響？

Okay. So the first one I got was overall glucagon growth. So as we've said, we think the BAQSIMI is going to grow for us going to be somewhere in the $250 million to $275 million revenue range product for us at peak. So that's a really strong growth from where we are today, but just some are annualizing around $150 million in revenues. We do think that some of that market share comes out of the traditional glucagon, the generic glucagon that we're selling today. However, our current glucagon generic is also used as a diagnosticate. And because it's used as a diagnosticate, that doesn't go away with the conversion to BAQSIMI because it's -- BAQSIMI is not indicated for that.

好的。所以我得到的第一個結果是胰高血糖素的整體成長。正如我們所說，我們認為 BAQSIMI 將為我們帶來成長，在高峰期產品收入將達到 2.5 億至 2.75 億美元。因此，與我們今天的情況相比，這是一個非常強勁的成長，但只有一些公司的年收入約為 1.5 億美元。我們確實認為，部分市佔率來自傳統胰高血糖素，也就是我們今天銷售的通用胰高血糖素。然而，我們目前的胰高血糖素仿製藥也用作診斷。因為它被用作診斷，所以這不會隨著轉換為 BAQSIMI 而消失，因為 BAQSIMI 沒有為此指定。

On the sales force, we haven't said how many sales people we have, but we do have said that we have a contract sales force that we did engage. They began selling on October 1, so they're out there right now marking the product, so that we'll have that expense in our P&L in the selling expense line in -- from now on. We've also repurpose some of our internal sales force to the BAQSIMI salespeople as well. So they're also on the job, but they're already doing this. They trained -- all of these people were trained during the third quarter and ready to hit the ground running at the beginning of the fourth quarter. So that's definitely something that's ongoing.

關於銷售隊伍，我們沒有透露我們有多少銷售人員，但我們確實說過我們確實聘用了一支合約銷售隊伍。他們於 10 月 1 日開始銷售，所以他們現在就在那裡標記產品，這樣我們就可以在銷售費用行中將這筆費用計入損益表中——從現在開始。我們也將部分內部銷售人員重新分配給 BAQSIMI 銷售人員。所以他們也在工作，但他們已經在這樣做了。他們接受了訓練——所有這些人都在第三節接受了訓練，並準備在第四節開始時投入工作。所以這肯定是持續進行的事情。

On the glucagon injection, they're segmented. I think the Glucagon injected sale is about 31% in the retail space and about 69% in the nonretail space. So that's the different breakup there.

在胰高血糖素注射時，它們被分段。我認為胰高血糖素注射液的銷售額在零售領域約佔 31%，在非零售領域約佔 69%。這就是不同的分手方式。

And then -- what was the last question, the shortage on -- the shortage products. We see shortage products every single quarter for as long as we've been reporting our sales. So somewhere -- some products somehow is always in need currently. Because of certain issues, we have a little more shortage products, and we're just happy that we planned accordingly and are able to meet those needs at this time.

然後 - 最後一個問題是什麼，短缺 - 短缺產品。只要我們報告銷售情況，我們每個季度都會看到短缺產品。所以在某個地方——某些產品目前總是需要的。由於某些問題，我們有更多的短缺產品，我們很高興我們做出了相應的計劃，並且能夠滿足此時的這些需求。

Yes. And then just going back to elaborate on what Dan said. I've been in this company now 9.5 years. And every quarter, we've had some benefit from other competitors having shortage problems. And it's frequently the dextrose and the sodium bicarbonate. Sometimes it's epinephrine, sometimes it's phytonadione, sometimes it's lidocaine, sometimes atropine or calcium chloride. But there's always something that's going on in the market. And because we've built that extra capacity about 3, 4 years ago, we've been able to capitalize it -- on it over the last several years. And it's something that we did as a strategic decision. And it's working out well for us.

是的。然後回過頭來詳細說明丹所說的話。我在這家公司已經工作9.5年了。每個季度，我們都會從其他面臨短缺問題的競爭對手那裡獲得一些好處。通常是葡萄糖和碳酸氫鈉。有時是腎上腺素，有時是植物萘二酮，有時是利多卡因，有時是阿托品或氯化鈣。但市場上總有一些事情在發生。因為我們在大約三、四年前建立了額外的產能，所以我們能夠在過去幾年中充分利用它。這是我們作為戰略決策所做的事情。這對我們來說效果很好。

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.

目前沒有其他問題。我想將發言權交還給 Dan Dischner 先生，請其發表結束意見。

I want to thank everyone for joining us today. We would like to characterize 2023 as a year of execution amongst our key high-margin products and the further enhancement of our company portfolio within the proprietary product segment, especially with BAQSIMI. We look forward to updating you all again. Have a great day.

我要感謝大家今天加入我們。我們希望將 2023 年描述為執行我們的關鍵高利潤產品以及進一步增強我們公司在專有產品領域的產品組合（尤其是 BAQSIMI）的一年。我們期待再次為大家更新最新消息。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。此時您可以斷開線路。感謝您的參與。