Eagle Pharmaceuticals Inc (EGRX) 2023 Q2 法說會逐字稿

Good morning, everyone. My name is Shelby, and I will be your conference operator. At this time, I'd like to welcome everyone to Eagle Pharmaceuticals Second Quarter 2023 Financial Results. (Operator Instructions) As a reminder, this conference call is being recorded today, August 8, 2023. It is now my pleasure to turn the floor over to Ms. Lisa Wilson, Investor Relations for Eagle Pharmaceuticals. Please go ahead.

大家，早安。我叫謝爾比，我將擔任您的會議操作員。現在，我歡迎大家閱讀 Eagle Pharmaceuticals 2023 年第二季財務業績。 （操作員說明）謹此提醒，本次電話會議於今天（2023 年 8 月 8 日）進行錄音。現在我很高興將發言權交給 Eagle Pharmaceuticals 投資者關係部門的 Lisa Wilson 女士。請繼續。

Thank you, Shelby. Welcome to Eagle Pharmaceuticals' Second Quarter 2023 Earnings Call. This is Lisa Wilson, Investor Relations for Eagle Pharmaceuticals. With me on today's call are Eagle's President and Chief Executive Officer, Scott Tarriff; Chief Financial Officer, Brian Cahill; and Vice President of Medical Affairs, Dr. Michael Greenberg.

謝謝你，謝爾比。歡迎參加 Eagle Pharmaceuticals 2023 年第二季財報電話會議。我是 Eagle Pharmaceuticals 投資者關係部的 Lisa Wilson。與我一起參加今天電話會議的是 Eagle 總裁兼執行長 Scott Tarriff；財務長布萊恩·卡希爾；和醫學事務副總裁邁克爾·格林伯格博士。

This morning, Eagle issued a press release detailing its financial results for the 3 months ended June 30, 2023. This press release and a webcast of this call can be accessed through the Investors section of the Eagle website at eagleus.com.

今天上午，Eagle 發布了一份新聞稿，詳細介紹了截至2023 年6 月30 日的三個月的財務業績。可透過Eagle 網站eagleus.com 的投資者部分存取本新聞稿和本次電話會議的網路直播。

Before we get started, I would like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation or intent regarding future events and the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to Eagle Pharmaceuticals management as of today and involve risks and uncertainties, including those noted in this morning's press release and our filings with the SEC.

在我們開始之前，我想提醒大家，在今天的電話會議上發表的任何表達對未來事件和公司未來業績的信念、期望、預測、預測、期待或意圖的陳述都可能被視為前瞻性陳述。根據《私人證券訴訟改革法》。這些前瞻性聲明是基於 Eagle Pharmaceuticals 管理層截至目前所掌握的信息，涉及風險和不確定性，包括今天上午的新聞稿和我們向 SEC 提交的文件中指出的風險和不確定性。

Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements. Eagle Pharmaceuticals specifically disclaims any intent or obligation to update these forward-looking statements, except as required by law. A telephone replay will be available shortly after completion of this call. You'll find the dial-in information in today's press release.

此類前瞻性陳述並非對未來績效的保證。實際結果可能與前瞻性陳述中的預測有重大差異。除法律要求外，Eagle Pharmaceuticals 特別聲明不承擔任何更新這些前瞻性聲明的意圖或義務。本次通話結束後不久將提供電話重播。您將在今天的新聞稿中找到撥入資訊。

The archived webcast will be available for 30 days on our website at eagleus.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on August 8, 2023. Since then, Eagle may have made announcements related to the topics discussed, so please refer to the company's most recent press release and SEC filings.

存檔的網路廣播將在我們的網站 eagleus.com 上保留 30 天。為了那些可能正在收聽重播或存檔網路廣播的人的利益，本次電話會議於 2023 年8 月8 日舉行並進行了錄音。此後，Eagle 可能發布了與所討論主題相關的公告，因此請參閱該公司最新的新聞稿和 SEC 文件。

We will be discussing non-GAAP financial measures during this call in addition to financial information prepared in accordance with U.S. GAAP. These non-GAAP financial measures should be considered in addition to but not as a substitute for the information prepared in accordance with GAAP. A description of these non-GAAP financial measures and reconciliations of these non-GAAP financial measures to the most comparable GAAP measures are set forth in our earnings press release available on our website at eagleus.com.

除了根據美國公認會計原則所準備的財務資訊外，我們還將在本次電話會議中討論非公認會計原則財務措施。這些非公認會計原則財務指標應作為根據公認會計原則準備的資訊的補充而不是替代。這些非 GAAP 財務指標的描述以及這些非 GAAP 財務指標與最具可比性 GAAP 指標的調節，請參閱我們網站 eagleus.com 上發布的收益新聞稿。

And with that, I'll turn the call over to Eagle's President and CEO, Scott Tarriff.

接下來，我會將電話轉給 Eagle 的總裁兼執行長 Scott Tarriff。

Thank you, Lisa. Good morning, everyone, and thank you for joining our call today. We delivered a strong second quarter with impressive earnings and revenue, continuing the positive trajectory we've seen over the past 18 months. This morning, I will begin by discussing our financial and business highlights for the second quarter as well as our expectations for the remainder of the year, Brian will then provide a more detailed review of our second quarter financial performance and our updated guidance for 2023 before opening the call to Q&A.

謝謝你，麗莎。大家早安，感謝您今天加入我們的電話會議。我們第二季業績強勁，獲利和營收令人印象深刻，延續了過去 18 個月的積極發展軌跡。今天早上，我將首先討論我們第二季度的財務和業務亮點以及我們對今年剩餘時間的預期，然後布萊恩將對我們第二季度的財務業績進行更詳細的審查，並在 2023 年更新指導之前打開問答電話。

We entered '23 with a great deal of momentum from our outstanding performance in '22. And we built on that with strong PEMFEXY numbers in the first half, market share retention for BENDEKA and BELRAPZO and growing relaunch revenues for BARHEMSYS and Byfavo since our acquisition of these products from Acacia.

由於我們在 22 年的出色表現，我們帶著巨大的動力進入了 23 年。在此基礎上，我們上半年的 PEMFEXY 數據強勁，BENDEKA 和 BELRAPZO 的市佔率已保留，自從我們從 Acacia 收購這些產品以來，BARHEMSYS 和 Byfavo 的重新推出收入不斷增長。

First, we are obviously very pleased with the performance of our currently marketed drugs, both in oncology and in our hospital business. Once again, we posted strong earnings and revenue. And in fact, this is now the fourth consecutive quarter in which we have beaten consensus estimates. Reflecting on these and other positive factors that I'll discuss this morning, we recently raised our full year guidance and in July resumed repurchases under our existing share repurchase program.

首先，我們顯然對目前上市的藥物在腫瘤學和醫院業務方面的表現非常滿意。我們再次公佈了強勁的利潤和收入。事實上，這已經是我們連續第四個季度超出了普遍預期。考慮到我今天早上將討論的這些和其他積極因素，我們最近提高了全年指引，並於 7 月根據現有股票回購計劃恢復了回購。

Based on the higher guidance, we anticipate ending the year with over $100 million in net working capital. Let me provide some context here. We believe this expected working capital position is meaningful considering how much money we anticipate having invested by the end of '23 across our products and pipeline. For '22 and '23, we anticipate to have invested $38 million in direct R&D to fund our product candidates, EA-114 and CAL02. Additionally, we spent approximately $130 million mostly cash to acquire Acacia's shares and debt and $25 million to date for an equity position with an option to acquire Enalare.

根據更高的指引，我們預計今年底的淨營運資本將超過 1 億美元。讓我在這裡提供一些背景資訊。考慮到 23 年底我們預計在我們的產品和管道上投資了多少資金，我們相信這一預期營運資金狀況是有意義的。對於 22 年和 23 年，我們預計將投資 3,800 萬美元用於直接研發，以資助我們的候選產品 EA-114 和 CAL02。此外，我們還花了約 1.3 億美元（主要是現金）來收購 Acacia 的股票和債務，迄今為止還花費了 2,500 萬美元購買股權，並可選擇收購 Enalare。

This totals approximately $193 million, and we still find ourselves in this positive working capital position as we continue to generate positive cash flow. Over the past 12 months, we have also expanded our commercial teams both in the hospital and oncology segments. And we now have a significant commercial infrastructure of about 80 people, which is included in the earnings and cash flow just discussed and the revised upward guidance.

這總計約為 1.93 億美元，隨著我們繼續產生正現金流，我們仍然處於積極的營運資金狀況。在過去 12 個月中，我們也擴大了醫院和腫瘤領域的商業團隊。我們現在擁有約 80 人的重要商業基礎設施，這已包含在剛才討論的收益和現金流以及修訂後的向上指引中。

We view our 2 sales forces as strategic assets to the company, which we will discuss further shortly. What we believe this means for the future is that Eagle could bring in additional products through R&D and/or acquisition with minimal additional cost because of the commercial infrastructure we already have and therefore, most of the revenue generated would fall to the bottom line.

我們將我們的 2 支銷售隊伍視為公司的策略資產，我們很快就會對此進行進一步討論。我們認為，這對未來意味著，由於我們已經擁有商業基礎設施，Eagle 可以透過研發和/或收購以最小的額外成本引入更多產品，因此，產生的大部分收入將落入底線。

Now let's put everything in perspective for a moment. For fiscal year '22, we more than tripled non-GAAP earnings to just shy of $8 per share compared to '21, which was driven by approximately $230 million of gross profit in '22, excluding amortization expense. Adjusted non-GAAP EBITDA grew more than 350% to $132 million for the fiscal year '22 compared to '21. For '23, we expect nearly the same gross profit as we saw in '22, excluding amortization expense. Although we increased our spending, our gross margin continues to be strong. In fact, our gross margin percent, excluding amortization in the first half of this year was 83% compared to 74% in the first half of last year.

現在讓我們暫時正確地看待一切。與21 財年相比，我們的22 財年非GAAP 收益增加了兩倍多，每股略低於8 美元，這是由22 財年約2.3 億美元的毛利（不包括攤銷費用）推動的。與 21 財年相比，22 財年調整後的非 GAAP EBITDA 成長了 350% 以上，達到 1.32 億美元。對於 23 年，我們預計毛利與 22 年幾乎相同，不包括攤銷費用。儘管我們增加了支出，但我們的毛利率仍然強勁。事實上，今年上半年我們的毛利率（不包括攤提）為 83%，而去年上半年為 74%。

And when you remove vasopressin, which was discontinued, our gross profit actually increased for the second quarter of '23 compared to the second quarter of '22. We expect this trend to continue going forward. The year-over-year decline in earnings per share is mostly due to these continued investments in R&D and our commercial infrastructure, which we believe positions us well for the future upside and is not a function of gross profit decline.

當你除去已停產的加壓素時，與 22 年第二季相比，我們 23 年第二季的毛利實際上有所增加。我們預計這一趨勢將繼續向前發展。每股盈餘年減主要是由於對研發和商業基礎設施的持續投資，我們相信這使我們在未來的上漲中處於有利地位，而不是毛利下降的結果。

We have been highly focused on our R&D initiatives and are working hard to ensure that each asset has the best chance of success. We're just a couple of weeks away from an important Type C meeting with FDA for EA-114, our estrogen receptor antagonist project, which I'll discuss in more detail shortly. The investments we have made in our commercial infrastructure clearly paid off. We have more than tripled our market share of the non-340B pemetrexed market to approximately 21% leaving Q2 up from 6% at the end of last year.

我們一直高度關注我們的研發計劃，並努力確保每項資產都有最大的成功機會。距離我們與 FDA 就 EA-114（我們的雌激素受體拮抗劑計畫）舉行重要的 C 型會議僅剩幾週時間，我將很快對此進行更詳細的討論。我們對商業基礎設施的投資顯然得到了回報。我們在非 340B 培美曲塞市場的市佔率增加了兩倍多，達到約 21%，第二季的市佔率從去年年底的 6% 上升。

It's important here to look at our balance sheet and receivables as well. The bulk of our receivables relate to PEMFEXY at the end of the second quarter. For this product, we received the majority of our orders near the end of the quarter because contract pricing is mostly adjusted quarterly, large quantities of products are purchased near the end of the quarter producing this result. This trend is likely to continue into the near future.

在這裡查看我們的資產負債表和應收帳款也很重要。第二季末，我們的大部分應收帳款與 PEMFEXY 有關。對於該產品，我們在季末附近收到了大部分訂單，因為合約定價大多按季度調整，在季末附近購買了大量產品，從而產生了這一結果。這種趨勢很可能會持續到不久的將來。

Our quarter-over-quarter receivables balance is flat, indicating that we are in a normal cycle of payment and new revenue. Now turning our attention to the Acacia acquisition. We are also very pleased with the relaunch efforts of BARHEMSYS and Byfavo within our hospital acute care segment. We characterize and treat both products as relaunches. As a reminder, our acquisition of Acacia was effective June 9, 2022, about a year ago. Our fully trained and fully staffed sales force was first in action in Q1 of this year as we relaunched and Byfavo received its unique J-code in May. Now please review the following slide.

我們的季度應收帳款餘額持平，表示我們處於正常的付款和新收入週期。現在將我們的注意力轉向 Acacia 收購。我們也對 BARHEMSYS 和 Byfavo 在我們醫院急診護理領域的重新啟動努力感到非常高興。我們將這兩種產品視為重新推出的產品。提醒一下，我們對 Acacia 的收購於 2022 年 6 月 9 日生效，大約一年前。我們訓練有素、人員齊全的銷售團隊在今年第一季首次行動，我們重新啟動，Byfavo 於 5 月收到了其獨特的 J 代碼。現在請查看下面的幻燈片。

We now have 2 full quarters of sales data and growth has been about 30% quarter over consecutive quarter since the relaunch, and we anticipate a similar growth rate to continue for the foreseeable future. In the second quarter of this year alone, we estimate that approximately 19,000 patients were dosed with BARHEMSYS or Byfavo, a very impressive number, reflecting the fact that the drugs are being embraced by our customers.

我們現在擁有 2 個完整季度的銷售數據，自重新推出以來連續季度的成長率約為 30%，我們預計在可預見的未來將繼續保持類似的成長率。光是今年第二季度，我們估計就有大約 19,000 名患者服用了 BARHEMSYS 或 Byfavo，這是一個非常令人印象深刻的數字，反映出這些藥物正在受到我們客戶的歡迎。

In terms of penetration, 2 quarters in, approximately 275 health care facilities are purchasing product out of a targeted 4,000 entities in the United States. We see significant upside expansion potential here. I mentioned 19,000 patients a moment ago. Let me repeat this number. 19,000 patients were administered BARHEMSYS or Byfavo in our second quarter of relaunch.

就滲透率而言，兩個季度以來，美國約 275 家醫療保健機構正在從 4,000 家目標實體購買產品。我們在這裡看到了巨大的上行擴張潛力。我剛才提到了19,000名患者。讓我重複一下這個數字。在我們重新推出的第二季度，有 19,000 名患者接受了 BARHEMSYS 或 Byfavo 治療。

Imagine what happens if half of these entities are using our drugs, or if we increase our market share at each of these, you can see how the 19,000 could grow quickly. We'll see how the next several quarters go, but I hope you can feel the excitement we have about these 2 launches.

想像一下，如果這些實體中有一半正在使用我們的藥物，或者如果我們增加每個實體的市場份額，您就會看到這 19,000 個實體將如何快速成長。我們將看看接下來幾季的進展，但我希望您能感受到我們對這兩次發布的興奮。

Now let's discuss our oncology business. Gross profit, excluding amortization expense in our oncology business was $43.8 million in the second quarter of '23, up from $38.7 million in the second quarter of last year, representing an impressive gross margin of 84% and 72%, respectively.

現在我們來討論一下我們的腫瘤業務。 2023 年第二季度，我們腫瘤業務的毛利（不包括攤銷費用）為 4,380 萬美元，高於去年第二季度的 3,870 萬美元，毛利率分別高達 84% 和 72%，令人印象深刻。

Across the entire portfolio, our gross margin percentage, excluding amortization, has gone from 70% in the second quarter of '22 up to 83% in the second quarter of this year.

在整個投資組合中，我們的毛利率（不包括攤銷）已從 22 年第二季的 70% 上升到今年第二季的 83%。

We anticipate that these trends will hold in the near to medium term.

我們預計這些趨勢將在中短期內持續下去。

Hopefully, you can see that our gross profit and our gross profit margin continued to be very strong as it has for the past 1.5 years. We are strategically investing in our business for our future growth. Today, we have the largest commercial team that we've ever had which is prime now to be able to bring more products into the company with minimal incremental expense, thus accelerating the bottom line as products come into the portfolio.

希望您可以看到我們的毛利和毛利率繼續保持在過去 1.5 年的水平。我們正在對我們的業務進行策略性投資，以實現未來的成長。今天，我們擁有有史以來最大的商業團隊，現在能夠以最小的增量費用為公司帶來更多產品，從而隨著產品進入產品組合而加速盈利。

We have been investing heavily in R&D as well as a way to expand our portfolio. We believe we are poised for future earnings growth based on the strength of our business and our R&D. The question remains then how do we ensure growth going forward? The answer is simple. We need to add products through acquisition and/or through our R&D pipeline. Fortunately, as we've discussed this morning, we believe we can bring in products with minimal additional commercialization expense. One potential opportunity is EA-114, our estrogen receptor antagonist program, which we have invested in over the past several years.

我們一直在研發方面投入巨資，並尋求擴大我們的產品組合的方法。我們相信，基於我們的業務和研發實力，我們將為未來的獲利成長做好準備。問題仍然是我們如何確保未來的成長？答案很簡單。我們需要透過收購和/或透過我們的研發管道來新增產品。幸運的是，正如我們今天早上討論的那樣，我們相信我們可以以最小的額外商業化費用引入產品。一個潛在的機會是 EA-114，我們的雌激素受體拮抗劑項目，我們在過去幾年中對此進行了投資。

We believe we have compelling data from our recent study of EA-114, and we have a Type C meeting with FDA later this month. Once this meeting transpires, we will provide an update. Now turning to our hospital segment. We believe the hospital business is a great space with strong growth potential. We've already heard about the relaunch for BARHEMSYS and Byfavo and CAL02 and Enalare-001 could also have significant potential. As people familiar with this space, although hospital launches are slow, they are also generally rather sticky and profitable once well established.

我們相信我們從最近的 EA-114 研究中獲得了令人信服的數據，並且我們將於本月晚些時候與 FDA 舉行 C 型會議。這次會議召開後，我們將提供最新情況。現在轉向我們的醫院部門。我們認為醫院業務是一個巨大的空間，具有強大的成長潛力。我們已經聽說 BARHEMSYS 和 Byfavo 的重新推出，以及 CAL02 和 Enalare-001 也可能具有巨大的潛力。熟悉這個領域的人都知道，雖然醫院的啟動速度很慢，但一旦建立起來，它們通常也具有相當的粘性和盈利能力。

Now let's discuss CAL02. As we recently announced, our Phase II study is underway and our first patients have been randomized. The study is designed to assess the efficacy and safety of CAL02, which you may recall is the first, which is -- recall is a novel, first-in-class antitoxin drug candidate being developed to treat severe community-acquired bacterial pneumonia as an add-on to standard of care antibiotic therapy. CAL02 is a unique therapeutic agent that works differently from antibiotics, disarming the infectious pathogens' virulence factors to reduce damage and mitigate disease.

現在我們來討論CAL02。正如我們最近宣布的，我們的 II 期研究正在進行中，我們的第一批患者已被隨機分組。該研究旨在評估 CAL02 的有效性和安全性，您可能還記得這是第一個，即 - 召回是一種新型、一流的抗毒素候選藥物，正在開髮用於治療嚴重的社區獲得性細菌性肺炎標準護理抗生素治療的附加療法。 CAL02 是一種獨特的治療劑，其作用與抗生素不同，可以解除傳染性病原體的毒力因子，從而減少損害並減輕疾病。

It has been designed to neutralize a broad range of bacterial toxins to lessen the effect of virulence factors on disease progression and severity. We plan to enroll approximately 276 patients at more than 100 sites in over 20 countries worldwide. Our expectation is that we will have approximately 100 sites up and running before the year is over in readiness for the Northern Hemisphere's pneumonia season.

它旨在中和多種細菌毒素，以減輕毒力因子對疾病進展和嚴重程度的影響。我們計劃在全球 20 多個國家的 100 多個地點招募約 276 名患者。我們的預期是，在今年年底之前，我們將建立並運行約 100 個站點，為北半球的肺炎季節做好準備。

In addition, we expect to have our interim results within the first half of '24. In June, FDA granted CAL02 QIDP designation under the GAIN Act. QIDP stands for qualified infectious disease product. CAL02 also received Fast-Track designation. And let me briefly walk you through what this all means.

此外，我們預計將在 2024 年上半年公佈中期業績。 6 月，FDA 根據 GAIN 法案授予 CAL02 QIDP 頭銜。 QIDP代表合格的傳染病產品。 CAL02 也獲得了快速通道稱號。讓我簡要地向您介紹這一切意味著什麼。

QIDP designation entitles Eagle to an additional 5 years of marketing exclusivity on approval. Moreover, Eagle believes CAL02 qualifies as a new chemical entity, which would result in 5 years of marketing exclusivity upon approval or 3 years without NCE designation. In total, CAL02 may be eligible for a total of 8 to 10 years of marketing exclusivity upon approval. QIDP and Fast-Track designations underscore the significant unmet medical need in treating severe community-acquired bacterial pneumonia.

QIDP 指定使 Eagle 在獲得批准後獲得額外 5 年的行銷獨家經營權。此外，Eagle 認為 CAL02 符合新化學實體的資格，在獲得批准後將獲得 5 年的營銷獨家權，而無需獲得 NCE 指定則可享受 3 年的營銷獨家權。總的來說，CAL02 在獲得批准後可能有資格獲得總共 8 至 10 年的行銷獨家權。 QIDP 和快速通道指定強調了治療嚴重社區獲得性細菌性肺炎的巨大未滿足的醫療需求。

CAL02 also has patent protection through September of 2035 with filed patent applications that would extend to 2037 or later and may qualify for up to 5 additional years of patent term exclusivity as a new chemical entity up to 2040. CAL02 has the potential to be a significant opportunity for us and a true paradigm shift in how health care providers combat this complex disease. We look forward to providing updates as the CAL02 clinical program advances. Before I turn it over to Brian, let me reiterate once more how pleased I am that we were able to raise our guidance for the year, very excited about the health of the business.

CAL02 還享有截至2035 年9 月的專利保護，已提交的專利申請將延長至2037 年或更晚，並且可能有資格在2040 年之前作為新化學實體獲得最多5 年的專利期限獨佔權。CAL02 有潛力成為重要的我們的機會以及醫療保健提供者如何對抗這種複雜疾病的真正範式轉移。我們期待隨著 CAL02 臨床計劃的進展提供更新。在我將其交給布萊恩之前，讓我再次重申，我對我們能夠提高今年的指導感到非常高興，對業務的健康發展感到非常興奮。

And with that, I'll turn the call over to Brian Cahill to discuss our second quarter financials. Brian?

接下來，我將把電話轉給布萊恩·卡希爾 (Brian Cahill)，討論我們第二季的財務狀況。布萊恩？

Thank you, Scott, and good morning. Let me share a few highlights from the financials we published in our press release this morning. In the second quarter of 2023, total revenue was $64.6 million compared to $74.1 million in Q2 of 2022. Net product sales during the second quarter of '23 totaled $43 million compared to $49.2 million in Q2 of '22.

謝謝你，斯科特，早安。讓我分享我們今天早上在新聞稿中發布的財務數據的一些要點。 2023 年第二季度，總營收為 6,460 萬美元，而 2022 年第二季為 7,410 萬美元。23 年第二季的產品淨銷售額總計 4,300 萬美元，而 22 年第二季為 4,920 萬美元。

PEMFEXY net product sales were $19.4 million in the second quarter of 2023 compared to $16.5 million in the second quarter of 2022. The increase is driven by our continued growth in market share as Scott discussed earlier. BELRAPZO net product sales decreased to $6.8 million in the second quarter of 2023 compared to $8.1 million in Q2 of 2022. Second quarter RYANODEX net product sales were $10 million compared to $8.8 million in the prior year quarter.

PEMFEXY 2023 年第二季的產品淨銷售額為 1,940 萬美元，而 2022 年第二季為 1,650 萬美元。正如斯科特之前討論的那樣，這一增長是由我們市場份額的持續增長推動的。 BELRAPZO 的產品淨銷售額在 2023 年第二季下降至 680 萬美元，而 2022 年第二季為 810 萬美元。第二季 RYANODEX 產品淨銷售額為 1,000 萬美元，而去年同期為 880 萬美元。

Orders for RYANODEX are primarily driven by product expiry with few customers requiring dantrolene unless their stock is expiring. With this, our guidance considers Q3 to be lighter than the historical average. Second quarter BARHEMSYS and Byfavo sales totaled $1.2 million. Q2 2023 royalty revenue was $21.7 million compared to $24.9 million in the prior year quarter. Royalty revenues include royalties earned on the sales of BENDEKA in the U.S. and TREAKISYM in Japan.

RYANODEX 的訂單主要是由產品過期驅動的，很少有客戶需要丹曲林，除非他們的庫存即將過期。因此，我們的指導方針認為第三季的情況低於歷史平均。第二季 BARHEMSYS 和 Byfavo 銷售額總計 120 萬美元。 2023 年第二季的特許權使用費收入為 2,170 萬美元，去年同期為 2,490 萬美元。特許權使用費收入包括在美國銷售 BENDEKA 和在日本銷售 TREAKISYM 所獲得的特許權使用費。

Gross margin was 74% in Q2 2023 compared to 68% in the prior year quarter. The increase was primarily driven -- primarily, sorry, the result of increased PEMFEXY sales, the expiration of bendamustine royalty stream and the buydown of PEMFEXY royalties. This is partially offset by the inclusion of amortization expense of intangible assets related to the newly acquired products, BARHEMSYS and Byfavo, and our PEMFEXY royalty buydown, both of which we expect to continue going forward.

2023 年第二季的毛利率為 74%，而去年同期的毛利率為 68%。這一增長主要是由 PEMFEXY 銷售額增加、苯達莫司汀特許權使用費到期以及 PEMFEXY 特許權使用費減持所推動的。這被與新收購產品 BARHEMSYS 和 Byfavo 相關的無形資產攤銷費用以及我們的 PEMFEXY 特許權使用費收購所部分抵消，我們預計這兩項業務將繼續向前推進。

Gross margin, excluding amortization expense was 83% in the second quarter of 2023 compared to 70% in the prior year quarter. On the expense front, R&D expenses were $9.8 million for the second quarter of 2023 compared to $11.4 million in Q2 of '22. This decrease is largely attributable to the timing of our EA-114 program spend in '22 and is partially offset by continuing CMC and clinical trial spend on our CAL02 program (inaudible) increased internal costs.

2023 年第二季的毛利率（不含攤銷費用）為 83%，而去年同期為 70%。在費用方面，2023 年第二季的研發費用為 980 萬美元，而 2022 年第二季的研發費用為 1,140 萬美元。這一減少主要歸因於我們 22 年 EA-114 計劃支出的時間安排，並被我們 CAL02 計劃的持續 CMC 和臨床試驗支出（聽不清楚）增加的內部成本部分抵消。

Excluding stock-based compensation and under noncash and nonrecurring items, second quarter 2023 non-GAAP R&D expense was $9.2 million. SG&A expenses in the second quarter of 2023 were $27.7 million compared to $36.8 million in the second quarter of '22. This decrease was primarily driven by $17.6 million in costs related to the acquisition of Acacia, which will not recur. This is partially offset by incremental $2.9 million related to increased sales and marketing headcount, $2.4 million related to direct marketing support for BARHEMSYS, Byfavo and PEMFEXY, and $2.9 million in other general and administrative expenses partially related to these commercial efforts.

不包括股票薪酬以及非現金和非經常性項目，2023 年第二季非 GAAP 研發費用為 920 萬美元。 2023 年第二季的銷售管理及行政費用為 2,770 萬美元，而 2022 年第二季為 3,680 萬美元。這一下降主要是由於與收購 Acacia 相關的 1,760 萬美元成本造成的，該成本不會再發生。這部分被與銷售和行銷人員增加相關的增量290 萬美元、與BARHEMSYS、Byfavo 和PEMFEXY 的直接行銷支援相關的240 萬美元以及部分與這些商業努力相關的其他一般和管理費用290 萬美元所抵消。

Excluding stock-based compensation and other noncash and nonrecurring items, second quarter 2023 non-GAAP SG&A expense was $23.8 million. Net income for the second quarter of '23 was $5.2 million or $0.39 per basic and diluted share compared to a net loss of $9.5 million or $0.74 loss per basic and diluted share in the prior year quarter. Adjusted non-GAAP net income for the second quarter was $15.5 million or $1.18 per basic and diluted share. And our adjusted non-GAAP EBITDA was $20.7 million for the second quarter. For a full reconciliation of non-GAAP measures to the most comparable GAAP measures, please see the table at the end of our press release. As of June 30, '23, the company had $15.4 million in cash and cash equivalents, $115.1 million in net accounts receivable and $71.3 million in outstanding debt.

不包括股票薪酬和其他非現金和非經常性項目，2023 年第二季非 GAAP SG&A 費用為 2,380 萬美元。 2023 年第二季的淨利潤為 520 萬美元，或每股基本股和稀釋股虧損 0.39 美元，而去年同期淨虧損為 950 萬美元，或每股基本股和稀釋股虧損 0.74 美元。第二季調整後的非 GAAP 淨利潤為 1,550 萬美元，即每股基本股和稀釋股 1.18 美元。第二季調整後的非 GAAP EBITDA 為 2,070 萬美元。如需了解非公認會計準則衡量指標與最具可比性的公認會計準則衡量指標的全面對賬，請參閱我們新聞稿末尾的表格。截至23年6月30日，該公司擁有1,540萬美元的現金和現金等價物、1.151億美元的應收帳款淨額和7,130萬美元的未償債務。

With that, I'll ask the operator to open the call for questions. Operator, please go ahead.

之後，我將要求接線員打開提問電話。接線員，請繼續。

(Operator Instructions) And we'll take our first question from Tim Lugo with William Blair.

（操作員說明）我們將回答 Tim Lugo 和 William Blair 提出的第一個問題。

And I guess a few for Brian, you detailed some expectations around Q3. I think you mentioned some seasonality in the quarter. Can you kind of expand on that. And we've also seen gross margins expanding. Can you also discuss some of the drivers there?

我想布萊恩有一些，你詳細介紹了對第三季的一些期望。我認為您提到了本季度的一些季節性因素。能擴展一下嗎？我們也看到毛利率在擴大。您還能討論一下那裡的一些驅動程式嗎？

Sure, Tim. Thank you. So first on the seasonality question as you picked up, I'm highlighting RYANODEX, right? So RYANODEX has approximately 36-month shelf-life. The cycle in which we sell the product in and the expiry cycle really dictates most of when those sales will occur. Second quarter was an ebb and third quarter is expected to be a slight flow, right, so it will be a little bit lower.

當然，提姆。謝謝。首先，關於您提到的季節性問題，我強調的是 RYANODEX，對吧？因此 RYANODEX 的保存期限約為 36 個月。我們銷售產品的周期和到期週期實際上決定了這些銷售的大部分時間。第二季是低潮，第三季預計會有小幅流動，對吧，所以會低一點。

But that cycle kind of continues on the wave depending on when those lots are expiring.

但這種週期會持續下去，這取決於這些批次的到期時間。

And I tried to highlight, Tim, also some of the drivers around the margin differentials that we're experiencing in our business. And I'm trying to highlight for you ex amortization of what our real profitability looks like. And you'll recall, I hope that we had a few factors going into our gross margin. We were previously weighted down with royalties that we used to pay on our bendamustine franchise. Those have expired at the end of last year.

提姆，我試圖強調我們在業務中遇到的利潤差異的一些驅動因素。我試圖向您強調我們實際盈利能力的攤銷前情況。您會記得，我希望我們的毛利率受到一些因素的影響。此前，我們因支付苯達莫司汀特許經營權的特許權使用費而不堪重負。這些已在去年年底到期。

So it actually increases our profitability in that area of our business. And for PEMFEXY, we made a decision to buy down a large -- the majority of our royalty to another partner at the end of last year. And with that, we have better profitability, gross margin and gross profit. And that's the great decision as we look back on that what we did as far as looking at our forecast to buy down that royalty, it was really favorable for us I think.

因此，它實際上提高了我們在該業務領域的獲利能力。對於 PEMFEXY，我們決定在去年年底向另一個合作夥伴購買大量的特許權使用費。這樣，我們就有了更好的獲利能力、毛利率和毛利。這是一個偉大的決定，當我們回顧我們所做的事情以及我們對購買特許權使用費的預測時，我認為這對我們來說非常有利。

And I guess lastly, BARHEMSYS and Byfavo. We see the growth. However, they're obviously relatively still smaller compared to the total franchise. What are some of the expectations for that franchise over a 1 year and maybe even 3-year period? Is it going to be continued steady growth? Or will there be anything else swinging that?

我想最後是 BARHEMSYS 和 Byfavo。我們看到了成長。然而，與總特許經營權相比，它們顯然相對較小。對於該特許經營權在一年甚至三年內的一些期望是什麼？是否會持續穩定成長？或者還有其他東西會影響這個嗎？

Yes. Thanks, Tim. It's Scott. So look, we're just really very excited about it. And as far as we're concerned, we've only been fully marketing these drugs for 2 quarters, and you can see the 30% growth. Our expectation is that this growth rate that we see is going to continue into the foreseeable future. It's just going to keep growing. We're getting great feedback from our customers, great acceptance.

是的。謝謝，蒂姆。這是斯科特。所以看，我們對此感到非常興奮。就我們而言，我們只全面行銷這些藥物兩個季度，你可以看到 30% 的成長。我們的預期是，我們看到的這種成長率將持續到可預見的未來。它只會繼續增長。我們從客戶那裡得到了很好的回饋和認可。

If you think that there's 275 hospitals buying now or facilities that could buy at a 4,000, and we have our most seasoned and the highest number of people in our sales force in most number of territories, you can see what happens. And I don't know how you feel about, but the fact that 19,000 different patients used our drug in Q2 alone is very exciting. Our customers are obviously embracing it, they're reusing it or you wouldn't be able to get to this 19,000 number.

如果您認為現在有 275 家醫院在購買，或者設施可以以 4,000 美元的價格購買，並且我們在大多數地區擁有經驗最豐富、人數最多的銷售隊伍，那麼您可以看到會發生什麼。我不知道您有何感受，但僅在第二季度就有 19,000 名不同的患者使用我們的藥物這一事實非常令人興奮。我們的客戶顯然​​正在接受它，他們正在重複使用它，否則您將無法獲得這個 19,000 的號碼。

And we expect that it's just going to keep growing. And then if you just multiply it out where this is going to go in not that too far of a distant future, it's going to be a very meaningful part of our business. And I think we're going to look back and be very pleased with the acquisition and combine that, if we get good news on CAL02, we'll see what happens with Enalare. But in a few years, a couple of years, we can be one of the leading hospital businesses in the marketplace. And we still think it's a great place to be. So we're more than excited right now about how it's going.

我們預計它會繼續增長。然後，如果你把它乘以不遠的未來，這將是我們業務中非常有意義的一部分。我認為，當我們回顧過去時，會對這次收購感到非常滿意，如果我們在 CAL02 上得到好消息，我們就會看看 Enalare 會發生什麼。但幾年後，我們就可以成為市場上領先的醫院企業之一。我們仍然認為這是一個很棒的地方。所以我們現在對事情的進展感到非常興奮。

Understood. And you're actively buying back shares. But obviously, in the public markets, the share price has been weak year-to-date, and you're not the only one obviously. Can you just maybe discuss a little bit about where you think that disconnect is?

明白了。而且您正在積極回購股票。但顯然，在公開市場上，今年迄今股價一直疲軟，而且您顯然不是唯一一個這樣做的人。能否稍微討論一下您認為脫節的地方？

Well, Tim, that's a very good question. From our perspective, we've really had a remarkable 1.5 years, right? And we'll wind up with a strong '23. And the fact that we rebased the business, and we grew to $8 a share and this increase of 350% last year. And hopefully, the takeaway today when you go through our script and our release is that gross profit year-over-year is about the same, right?

嗯，提姆，這是一個非常好的問題。從我們的角度來看，我們確實度過了非凡的 1.5 年，對吧？我們將以強勁的 '23 結束。事實上，我們重新調整了業務基礎，去年成長至每股 8 美元，增幅為 350%。希望今天當您瀏覽我們的腳本和發布的內容時，您會發現毛利同比大致相同，對吧？

Our margins are growing in key segments of our business. We're bringing in quite a bit of profit. We've decided to spend some of that profit selectively and opportunistically into the future of the company. We're in a position to bring more products. And so for instance, when EA-114, if we're fortunate enough to bring that to the market, we don't need much more additional expense to add that product into the company.

我們業務關鍵領域的利潤正在成長。我們帶來了相當多的利潤。我們決定有選擇地、機會主義地將部分利潤用於公司的未來。我們有能力帶來更多產品。例如，當 EA-114 出現時，如果我們夠幸運地將其推向市場，我們就不需要更多額外費用來將該產品添加到公司中。

We're waiting for data on CAL02, we're waiting to come back from this FDA meeting. I don't know where the disconnect is per se from a stock standpoint. But from a company standpoint, it's just been a great 2 years, and we're very excited about the future. And the future looks great either through R&D. We'll see how the R&D works out. We're very hopeful that our balance sheet and our cash position just puts in a great position to bring another product or 2 into the company. And so we think the future looks incredibly bright, great 2 years. And hopefully, people figure it out, and the stock will take care of itself because the earnings certainly have and the R&D looks like it is, and these things have a tendency to work through.

我們正在等待 CAL02 的數據，我們正在等待 FDA 會議的結果。從股票的角度來看，我不知道脫節本身在哪裡。但從公司的角度來看，這只是美好的兩年，我們對未來感到非常興奮。透過研發，未來看起來很美好。我們將看看研發成果如何。我們非常希望我們的資產負債表和現金狀況能夠為公司帶來另一種或兩種產品。所以我們認為未來看起來非常光明，美好的兩年。希望人們能弄清楚這一點，股票會自行解決，因為獲利肯定會實現，研發看起來也是如此，而且這些事情都有解決的趨勢。

(Operator Instructions) And it appears that we have no further questions at this time. I will now turn the program back over to Scott Tarriff for any additional or closing remarks.

（操作員說明）目前我們似乎沒有其他問題了。我現在將把節目交還給斯科特·塔里夫（Scott Tarriff）以供補充或結束語。

Thank you again, everyone, for joining the call. I'm extremely proud of our performance this quarter. And as you've heard this morning, we have the foundation in place for another strong year in '23. Looking ahead, we intend to build our sales momentum to leverage our commercial infrastructure and working capital position to add complementary products either through R&D or acquisition to advance the pipeline. And as always, we appreciate your ongoing support, and thank you for being on the call. Stay well. We appreciate it.

再次感謝大家加入通話。我對我們本季的表現感到非常自豪。正如您今天早上所聽到的，我們已經為 23 年又一個強勁的一年奠定了基礎。展望未來，我們打算建立銷售勢頭，利用我們的商業基礎設施和營運資金狀況，透過研發或收購來增加補充產品，以推進管道。一如既往，我們感謝您持續的支持，並感謝您的接聽電話。保持良好。我們很感激。

And that concludes today's teleconference. Thank you for your participation. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。