Assertio Holdings Inc (ASRT) 2024 Q3 法說會逐字稿

Thank you for standing by. My name is John, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Assertio Holdings third-quarter results conference call. (Operator Instructions)

謝謝你的支持。我叫約翰，今天我將擔任你們的會議操作員。此時此刻，我歡迎大家參加 Assertio Holdings 第三季業績電話會議。（操作員說明）

I would now like to turn the call over to Matt Kreps, Investor Relations. Please go ahead.

我現在想將電話轉給投資者關係部的 Matt Kreps。請繼續。

Thank you, John. Good afternoon and thank you all for joining us today to discuss Assertio's third-quarter 2024 financials. The news release covering our results for this period is now available on the investor page of our website at investor.assertiotx.com. I would encourage you to review the release and tables in conjunction with today's discussion.

謝謝你，約翰。下午好，感謝大家今天加入我們討論 Assertio 的 2024 年第三季財務狀況。有關我們這段時期業績的新聞稿現已發佈在我們網站的投資者頁面：investor.assertiotx.com。我鼓勵您結合今天的討論來查看該版本和表格。

With me today are Brendan O'Grady, our Chief Executive Officer; and Ajay Patel, Chief Financial Officer. In just a moment, Brendan will open the remarks and provide an overview of the business, then Ajay will cover our financial results. After that, we will take questions from our covering research analysts.

今天與我在一起的有我們的執行長布倫丹·奧格雷迪 (Brendan O'Grady)；和財務長 Ajay Patel。稍後，布倫丹將開始致詞並概述業務，然後阿賈伊將介紹我們的財務表現。之後，我們將回答我們的研究分析師的問題。

Please note that during this call, management will make projections and other forward-looking statements regarding our future performance. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties including those noted in this afternoon's press release, as well as the Assertio's filings with the SEC. These and other risks are more fully described in the risk factors section and other sections of our annual report on Form 10-K and in our Form 10-Q filings.

請注意，在這次電話會議中，管理層將對我們未來的業績做出預測和其他前瞻性陳述。此類前瞻性陳述並非對未來業績的保證，並且涉及風險和不確定性，包括今天下午的新聞稿以及 Assertio 向 SEC 提交的文件中指出的風險和不確定性。這些風險和其他風險在我們的 10-K 表年度報告和 10-Q 表文件的風險因素部分和其他部分中有更全面的描述。

Our actual results may differ materially from those projected in the forward-looking statements. Assertio specifically disclaims any intent or obligation to update these forward-looking statements except as required by law. And with that, I will now turn the call over to Brendan. Please go ahead.

我們的實際結果可能與前瞻性陳述中的預測有重大差異。Assertio 特別聲明不承擔任何更新這些前瞻性聲明的意圖或義務，除非法律要求。現在，我將把電話轉給布倫丹。請繼續。

Thanks, Matt. Welcome, everyone, to today's call and thank you for joining. I'd like to start by wishing you all a Happy Veterans Day, especially to our retired and active service members and their families. In addition to our usual quarterly performance, there are two other relevant issues that I would like to begin my remarks by addressing.

謝謝，馬特。歡迎大家參加今天的電話會議，感謝您的加入。首先，我謹祝大家退伍軍人節快樂，特別是我們的退休和現役軍人及其家人。除了我們通常的季度業績之外，我還想在開始發言時解決另外兩個相關問題。

The first is the unwarranted attack on Assertio stakeholders by Mr. Alex Parker of Buxton Hemsley Group that was launched this past Friday, November 8. I'm sure many if not, most of you have seen the letter I released this morning addressing Mr. Parker's rambling manifesto that he put out last Friday.

第一個是 Buxton Hemsley Group 的 Alex Parker 先生於上週五（11 月 8 日）發起的對 Assertio 利害關係人的無端攻擊。我相信，如果沒有的話，你們中的大多數人都已經看到了我今天早上發布的這封信，信中針對帕克先生上週五發表的漫無目的的宣言。

Normally, I would not validate such conduct by speaking about it, but because of the numerous falsehoods and baseless allegations that had such an impact on our share price, I want to use this opportunity to address this head on. While we have taken Mr. Parker's allegations seriously and have looked into every single one of them.

通常情況下，我不會透過談論來證實這種行為，但由於大量的謊言和毫無根據的指控對我們的股價產生瞭如此大的影響，我想利用這個機會正面解決這個問題。雖然我們認真對待帕克先生的指控並調查了每項指控。

We found them all to be without merit. We have communicated that to Mr. Parker on numerous occasions while at the same time refusing to bow to his demands of cash payments or a seat on Assertio's Board to which he would add zero and I stress zero value. And most importantly, neither of which would be in the best interest of shareholders.

我們發現他們全都沒有優點。我們已多次向 Parker 先生傳達了這一點，同時拒絕屈服於他的現金付款或 Assertio 董事會席位的要求，他將在其中添加零，我強調零價值。最重要的是，這兩者都不符合股東的最佳利益。

If you happen to take the time to read through his less than Cogent 24 page document, he's essentially making three baseless claims. Well, I do not want to rehash my entire letter. I do want to take a minute to set the record straight specifically on those claims.

如果你碰巧花時間閱讀了他不到 24 頁的文件，你會發現他實質上是在提出三個毫無根據的主張。好吧，我不想重複我的整封信。我確實想花一點時間來澄清這些說法。

First and foremost, ROLVEDON on is a safe and effective product. I am 100% confident in that. Assertio was aware of the whistleblower claims around ROLVEDON before the acquisition of Spectrum.

首先，ROLVEDON on 是一種安全有效的產品。我對此有100%的信心。在收購 Spectrum 之前，Assertio 就知道有關 ROLVEDON 的舉報人的指控。

In fact, those claims were investigated by three different professional outside firms. The experts involved in those investigations determined that the FDA was supplied with all relevant and required data that led to ROLVEDONs approval. ROLVEDON's has now been in the market in the US and South Korea for 2.5 years and has demonstrated its safety and efficacy in the clinic with patients in real world settings. It is well tolerated by patients and has been well received by providers.

事實上，這些說法是由三家不同的專業外部公司調查的。參與這些調查的專家確定 FDA 已提供了導致 ROLVEDON 獲得批准的所有相關和必需的數據。ROLVEDON 現已在美國和韓國上市 2.5 年，並​​在現實環境中的臨床患者中證明了其安全性和有效性。它受到患者的良好耐受，並受到醫療服務提供者的好評。

Second, the impairment charges had nothing to do with any purported role that on safety claims. Assertio simply followed clearly established accounting principles as we always do in regards to any asset. Our disclosures clearly explain the impairment and how any and why it was calculated the way that it was. It is that simple.

其次，減損費用與安全索賠中所謂的任何作用無關。Assertio 只是遵循明確制定的會計原則，就像我們對任何資產一貫所做的那樣。我們的揭露清楚地解釋了減損以及減損的方式和原因。就是這麼簡單。

Third, no payments to the alleged whistleblower were ever made. The proposed payments, Mr. Parker's is referring to related to -- is related to an employment claim that was raised by a disgruntled former employee. That employee brought claims forward about ROLVEDON as leverage to boost the value of a settlement or reverse their pending termination.

第三，從未向被指控的舉報人支付任何費用。帕克先生提到的擬議付款與一位心懷不滿的前員工提出的就業索賠有關。該員工提出了有關 ROLVEDON 的索賠，以此作為提高和解價值或扭轉待決解僱的籌碼。

After a thorough investigation, it was determined those claims and allegations were false and without merit. The employee was subsequently terminated as part of a reduction in force and the case was later dismissed without any payment ever being made.

經過徹底調查後，確定這些說法和指控是虛假且毫無根據的。作為裁員的一部分，該員工隨後被解僱，該案件後來被駁回，但從未支付任何費用。

Finally, Mr. Parker's rambling rehash of connecting dots where none exist or misrepresenting long past settled issues is right with false statements and mischaracterizations that we have pointed out to him numerous times including the circumstances and reasons for the departure of a Board member -- former Board member.

最後，帕克先生漫無邊際地重述那些不存在的點，或者歪曲過去早已解決的問題，這與我們多次向他指出的虛假陳述和錯誤描述是正確的，包括董事會成員（前任）離職的情況和原因。

Well, I don't expect his desperate attacks will stop. You should know that there is nothing here and we will vigorously defend our reputation using all legal and regulatory means at our disposal. Today will be my last comment on this matter as I turn 100% of my focus to the business.

好吧，我不認為他的絕望攻擊會停止。您應該知道，這裡沒有任何內容，我們將使用我們掌握的所有法律和監管手段大力捍衛我們的聲譽。今天將是我對此事的最後一次評論，因為我將 100% 的注意力轉向業務。

So now, with that out of the way, I'd like to focus my comments back to the business and the progress we are making in stabilizing the company and positioning it for transformational growth in the coming months.

因此，現在，解決這個問題後，我想將我的評論集中在業務上，以及我們在穩定公司並使其在未來幾個月實現轉型成長方面所取得的進展。

As noted in our earnings release today, I would like to announce that during the November 7, Board of Directors meeting, Chairman of the Board, Peter Staple retired from the Board after 21 years of dedicated service and leadership. Peter was instrumental in bringing me to Assertio and although our time together was short, I appreciated his calm demeanor, deep expertise and presence on the Board. I cannot thank him enough.

正如我們今天的財報中所指出的，我謹宣布，在 11 月 7 日的董事會會議上，董事會主席 Peter Staple 在奉獻了 21 年的奉獻服務和領導後從董事會退休。Peter 在將我帶到 Assertio 方面發揮了重要作用，儘管我們在一起的時間很短，但我很欣賞他冷靜的舉止、深厚的專業知識以及在董事會中的表現。我對他感激不盡。

In addition, Dr. Jeff Vacirca has stepped back from the Board to focus on his many other business interests. We thank Dr. Vacirca for his service and providing continuity through the acquisition and integration of Spectrum. His insights into the GCF, GCSF and oncology markets were invaluable and we will miss his contributions to the Board.

此外，Jeff Vacirca 博士已退出董事會，專注於他的許多其他商業利益。我們感謝 Vacirca 博士的服務以及透過收購和整合 Spectrum 提供的連續性。他對 GCF、GCSF 和腫瘤學市場的見解非常寶貴，我們將懷念他對董事會的貢獻。

Both of these departures and continued transition the board have long been in the planning. With that. I'm also happy to announce that Heather Mason, Independent Director has been appointed as Chairwoman of the Board. Heather has been on the Assertio Board for over five years serving as Interim CEO prior to my joining. And she has a wealth of industry experience. I look forward to continuing to work with Heather in her newly expanded role.

董事會的這兩次離職和持續過渡早已在計劃之中。就這樣。我還很高興地宣布，獨立董事希瑟梅森 (Heather Mason) 已被任命為董事會主席。在我加入之前，Heather 已在 Assertio 董事會任職五年多，擔任臨時執行長。而她擁有豐富的行業經驗。我期待著繼續與希瑟在她新擴展的角色中合作。

I am also excited to announce that David Stark has joined the Assertio Board effective November 7. David is an experienced litigator and senior pharmaceutical executive. Recently retiring from Teva as Chief Legal Officer. David brings a wealth of industry and relevant legal expertise from his 20 plus years at Teva. David and I were colleagues at Teva and I'm excited to be working with him again in this new capacity.

我還很高興地宣布 David Stark 已加入 Assertio 委員會，自 11 月 7 日起生效。David 是一位經驗豐富的訴訟律師和資深製藥主管。最近從 Teva 首席法務官的職位上退休。David 在 Teva 工作 20 多年，帶來了豐富的行業和相關法律專業知識。大衛和我是 Teva 的同事，我很高興能以新的身分再次與他合作。

Now on to the business. First and foremost, let me just say I'm very pleased with where we are today as a starting line for growth. As I've said previously, this year is about stabilizing the organization as we transition from INDOCIN is our lead product to roll it on.

現在開始說正事。首先，我想說的是，我對我們今天的發展起點感到非常滿意。正如我之前所說，今年是我們從主要產品 INDOCIN 過渡到繼續推進組織穩定的一年。

And at the same time, positioning ourselves for more transformational growth in the coming months. It is worth restating that we have a solid balance sheet, modest debt, unfavorable terms and a good stable of growth, core and legacy assets led by ROLVEDON.

同時，為未來幾個月實現更多轉型成長做好準備。值得重申的是，我們擁有穩健的資產負債表、適度的債務、不利的條款以及由 ROLVEDON 領導的良好穩定的成長、核心和遺留資產。

We also have an excellent team of dedicated professionals who know this industry extremely well, giving us the opportunity to add or enhance key capabilities as we grow.

我們還擁有一支由非常了解這個行業的敬業專業人士組成的優秀團隊，使我們有機會在發展過程中增加或增強關鍵能力。

Also important to note is that our capabilities and lean model will allow us to be relatively sector, agnostic, broadening the landscape for new assets and letting us focus on those that best fit our commercial parameters.

同樣需要注意的是，我們的能力和精實模型將使我們能夠相對產業、不可知論，拓寬新資產的視野，並讓我們專注於那些最適合我們商業參數的資產。

For all these reasons, we are well positioned to deliver value for patients and providers we serve as well as shareholders and employees as we build a significant branded specialty business through acquisition, integration and a focused go to market strategy.

基於所有這些原因，我們有能力為我們服務的患者和提供者以及股東和員工創造價值，因為我們透過收購、整合和專注的市場策略建立了重要的品牌專業業務。

As I said on my first call with you in August, our focus will remain on steady execution, driving cash flow and identifying new assets we could add to bring further scale to Assertio's platform.

正如我在 8 月第一次與您通話時所說的那樣，我們的重點仍然是穩定執行、推動現金流並確定可以添加的新資產，以進一步擴大 Assertio 平台的規模。

Now turning to performance and I'll first address ROLVEDON. ROLVEDON Q3 sales were essentially steady quarter over quarter showing continued solid demand. We continue to retain a stable share around 33% in the oncology community, a community oncology clinic space where we have primarily focused.

現在轉向性能，我將首先討論 ROLVEDON。ROLVEDON 第三季銷售額大致穩定，顯示需求持續強勁。我們在腫瘤學社區中繼續保持穩定的份額，約為 33%，這是我們主要關注的社區腫瘤學診所空間。

We did see a dip in demand due to some typical seasonality that could occur in the third quarter as well as some shift in the community oncology clinic space, specifically part B. This was offset by the addition of new customers enabling further expansion into the hospital space and community oncology clinics where we did not have a presence.

由於第三季可能出現的一些典型季節性因素以及社區腫瘤診所空間（特別是 B 部分）的一些變化，我們確實看到需求有所下降。我們沒有開設太空和社區腫瘤診所。

There are segments -- these are segments that will be important for further future growth.

有些細分市場對於未來的進一步成長非常重要。

We remain focused on using our position a safe and effective non biosimilar GCSF to offer stability to providers and patients positioning ourselves as a predictable, reliable solution at a more stable price. And of course, this is a market dynamic, but our message continues to resonate. Additionally, ROLVEDON same day dosing trial wrapped up in early Q2, and I'm excited to announce that the data will be presented as a poster exhibit at the San Antonio Breast Cancer Symposium in December.

我們仍然專注於利用安全有效的非生物相似藥 GCSF 的地位，為提供者和患者提供穩定性，將自己定位為以更穩定的價格提供可預測、可靠的解決方案。當然，這是一個市場動態，但我們的訊息繼續引起共鳴。此外，ROLVEDON 當天給藥試驗已於第二季初結束，我很高興地宣布，這些數據將在 12 月的聖安東尼奧乳癌研討會上作為海報展覽展示。

I'm excited about ROLVEDON is it's going to play a key role for us over the next several years. Both in our current clinic focused market, as well as hospital -- as well as the hospital market. As we prepare to expand into those additional opportunities. As the only available GCSF approved under BLA without biosimilar copies, there may also be opportunities for label expansion. We're in the very early phases of making that assessment.

我對 ROLVEDON 感到很興奮，因為它將在未來幾年中為我們發揮關鍵作用。無論是在我們目前以診所為重點的市場，還是醫院——以及醫院市場。當我們準備好擴展這些額外的機會時。作為根據 BLA 批准的唯一可用 GCSF，沒有生物仿製藥，因此也可能有標籤擴展的機會。我們正處於評估的早期階段。

Now a couple words about INDOCIN. INDOCIN, we continue to manage the life cycle process and drive cash flow generating from the asset. Although there is some compounding activity to date, we have only one generic competitor. Our share of the market is holding steady at our internal target levels, which is around 50% of the X compounding market.

現在簡單介紹一下 INDOCIN。INDOCIN，我們繼續管理生命週期流程並推動資產產生現金流。儘管迄今為止存在一些複合活動，但我們只有一個通用競爭對手。我們的市佔率穩定在內部目標水平，即 X 複利市場的 50% 左右。

We will compete to hold our rightful share of the market. And at the same time, we will work to maintain our share and optimize price. Having worked at Teva for more than 20 years, this is something I am very familiar with and know how to do. Looking at SYMPAZAN, while this is a smaller asset, we believe that has under penetrated the market and there is room for growth. We also understand that SYMPAZAN is especially responsive to key opinion leader awareness and support.

我們將競爭以保持我們應有的市場份額。同時，我們將努力維持我們的份額並優化價格。我在 Teva 工作了 20 多年，這是我非常熟悉並且知道該怎麼做的事情。看看 SYMPAZAN，雖然這是一項較小的資產，但我們認為它尚未滲透到市場，並且還有成長空間。我們也了解到，SYMPAZAN 對關鍵意見領袖的認識和支持特別敏感。

I think I mentioned on the last call that we're piloting and executing sales and marketing tactics designed to drive prescriber awareness and prescription growth in key markets. Although early we have seen record demand levels and SYMPAZAN prescriptions in July and August as a result of these activities.

我想我在上次電話會議中提到，我們正在試行和執行旨在提高關鍵市場處方者意識和處方成長的銷售和行銷策略。儘管早些時候，由於這些活動，我們在 7 月和 8 月看到了創紀錄的需求水準和 SYMPAZAN 處方。

This is a product I like from the beginning of my time at Assertio, it serves a specific unmet medical need. We have a broad coalition of growing support among patients caregivers and providers and look to expand both awareness and use of SYMPAZAN going forward.

這是我在 Assertio 工作之初就喜歡的產品，它滿足了特定的未滿足的醫療需求。我們在病患照護人員和醫療服務提供者之間建立了廣泛的支持聯盟，並不斷擴大支持，並希望未來擴大 SYMPAZAN 的認識和使用。

And then lastly just a quick word about some of our remaining assets. And I'd like to just talk a little bit about how to characterize the business. I see it really in three main buckets. I see a growth asset bucket. This is clearly rolled it out and I've spoken about it.

最後簡單介紹一下我們的一些剩餘資產。我想簡單談談如何描述該業務。我確實在三個主要方面看到了它。我看到了成長資產桶。這已經很明確地推出了，我也已經談過了。

I see a core asset bucket. This is SYMPAZAN and SPRIX. And while I discuss SYMPAZAN and our plan there, I've not said much about SPRIX. What I will say about SPRIX, is that it serves a significant unmet medical need by providing opioid level pain relief. In fact, our indication states that SPRIX is indicated in moderate to moderately severe pain that requires analgesia at the opioid level.

我看到了一個核心資產桶。這是 SYMPAZAN 和 SPRIX。雖然我在那裡討論 SYMPAZAN 和我們的計劃，但我並沒有談論太多 SPRIX。關於 SPRIX，我要說的是，它透過提供鴉片類藥物水平的疼痛緩解來滿足重大的未滿足的醫療需求。事實上，我們的適應症表明，SPRIX 適用於需要阿片類藥物水平鎮痛的中度至中度重度疼痛。

There continues to be a focus on non-opioid pain relief. And the NOPAIN Act which expands reimbursement for non-opioid post-surgical options starting January 2025, could be an opportunity. We are looking that -- we are looking at very seriously for SPRIX. If nothing else, it brings the need for non-opioid pain relief back to the forefront and reason to believe that SPRIX could be a bigger asset for us than it currently is.

非鴉片類止痛藥仍然是人們關注的焦點。從 2025 年 1 月開始，《NOPAIN 法案》擴大了非阿片類藥物術後選擇的報銷範圍，這可能是一個機會。我們正在非常認真地考慮 SPRIX。如果不出意外的話，它使非阿片類止痛藥的需求重新回到人們的關注焦點，並有理由相信 SPRIX 對我們來說可能比目前更重要。

The last bucket is our legacy assets. These are our tail products that have lost exclusivity or faced very difficult market dynamics. In this bucket, it's all about asset optimization and includes INDOCIN and CAMBIA among others. I understand how to extract maximum value out of assets like this, and we continue to focus on cash generation in this bucket.

最後一個桶子是我們的遺留資產。這些是我們的尾部產品，它們已經失去了排他性或面臨非常困難的市場動態。在這一領域，一切都與資產優化有關，包括 INDOCIN 和 CAMBIA 等。我了解如何從此類資產中獲取最大價值，我們將繼續專注於此領域的現金產生。

With that, I'll conclude my remarks. And I'll hand it over to Ajay Patel, our Chief Financial Officer.

我的發言就到此結束。我會將其交給我們的財務長 Ajay Patel。

Thanks, Brendan. Today. I would like to cover our financial results for the third quarter of 2024. Before I begin, I want to note that my commentary will focus on sequential comparisons to the prior quarter. Comparisons to the prior year are less relevant given the acquisition of spectrum and generic competition of Indocin that occurred in the prior year, third quarter.

謝謝，布倫丹。今天。我想介紹一下我們 2024 年第三季的財務表現。在開始之前，我想指出，我的評論將集中在與上一季的連續比較。鑑於上一年第三季發生的吲哚美辛頻譜收購和仿製藥競爭，與前一年的比較不太相關。

Also, I want to remind everyone that ROLVEDON is now our lead asset and brings with it the associated changes and margin operating cost structure and cash flows that you are seeing in our results throughout this year.

另外，我想提醒大家，ROLVEDON 現在是我們的主要資產，並帶來了相關的變化以及利潤營運成本結構和現金流，您可以在我們今年的業績中看到。

For the third quarter of 2024, our total product sales were $28.7 million down slightly from $30.7 million in the second quarter, primarily due to ROLVEDON sales being offset by the expected decline in INDOCIN. ROLVEDON sales were $15 million in the third quarter compared to $15.1 million in the second quarter. The change was driven by continued volume growth offset by lower net pricing. We continue to hold about one-third share in our served markets.

2024 年第三季度，我們的產品總銷售額為 2,870 萬美元，較第二季度的 3,070 萬美元略有下降，主要是由於 ROLVEDON 的銷售額被 INDOCIN 的預期下降所抵消。ROLVEDON 第三季銷售額為 1500 萬美元，而第二季銷售額為 1510 萬美元。這項變更是由於銷售量持續成長而淨定價下降所抵銷。我們繼續在我們所服務的市場中持有約三分之一的份額。

INDOCIN sales were $5.7 million in the third quarter, down from $6.9 million in the second quarter driven by lower net pricing as a result of generic competition. In terms of volume, we continue to target and hold an approximate market share split.

第三季 INDOCIN 銷售額為 570 萬美元，低於第二季的 690 萬美元，因為仿製藥競爭導致淨定價下降。就銷量而言，我們繼續瞄準並保持大致的市場份額分割。

Reported gross margin in the third quarter improved to 74% compared to 71% in the second quarter. Primarily due to level of inventory step up amortization and write downs from prior quarter not repeating. Turning to operating expenses. AS G&A expense was $16.7 million in the third quarter, decreased from $18.4 million in the second quarter.

第三季的報告毛利率從第二季的 71% 提高至 74%。主要是由於庫存水準逐步提高，攤銷和上一季的減記不再重複。轉向營運費用。第三季 AS G&A 費用為 1,670 萬美元，低於第二季的 1,840 萬美元。

R&D expense in the third quarter was relatively flat at approximately $1 million. On an adjusted basis excluding stock compensation D&A and change in fair value, adjusted operating expense was $16.4 million in the third quarter, down from $17.7 million in the second quarter. The decrease was primarily due to lower sales and marketing and other G&A costs partially offset by net higher legal related charges.

第三季的研發費用相對持平，約 100 萬美元。在不包括股票報酬、D&A 和公允價值變動的調整後基礎上，第三季調整後營運費用為 1,640 萬美元，低於第二季的 1,770 萬美元。下降的主要原因是銷售和行銷以及其他一般管理費用的減少，部分被淨法律相關費用的增加所抵消。

GAAP net income for the third quarter was a loss of $2.9 million, down from a loss of $3.7 million in the second quarter. Because GAAP net income includes a number of non-cash expenses. We also use adjusted EBITDA as a good indicator of the operating performance of core business.

第三季 GAAP 淨利虧損 290 萬美元，低於第二季的虧損 370 萬美元。因為公認會計原則淨利包括一些非現金費用。我們也使用調整後的 EBITDA 作為核心業務營運績效的良好指標。

Q3 adjusted EBITDA was a positive $5.3 million increased from $5 million in the second quarter due to lower operating expenses partially offset by lower product sales. Please refer to our press release for detailed reconciliation of our adjusted EBITDA results.

第三季調整後 EBITDA 為正 530 萬美元，較第二季的 500 萬美元增加，原因是營運費用下降被產品銷售額下降部分抵銷。請參閱我們的新聞稿，以了解調整後 EBITDA 結果的詳細對帳資訊。

Crossing over to cash flow and our balance sheet. As a reminder, we invest cash into short term investments. Therefore, our reference to total cash position includes both cash and cash equivalents and short term investments. Total cost cash at the end of the quarter was $88.6 million, effectively flat to the $88.4 million in the second quarter and debt remained unchanged at $40 million.

交叉到現金流和我們的資產負債表。提醒一下，我們將現金投資於短期投資。因此，我們提到的總現金部位包括現金和現金等價物以及短期投資。本季末現金成本總額為 8,860 萬美元，實際上與第二季的 8,840 萬美元持平，債務保持在 4,000 萬美元不變。

As we previously noted, quarterly operating cash flows will fluctuate due to timing of working capital in terms of cash receipts and payments due to shift in product mix from INDOCIN to ROLVEDON. Third quarter, operating cash flows were negligible and were impacted by timing of working capital from cash collection and lower product sales. Year-to-date, we have generated $15 million in cash flows from operations.

正如我們之前指出的，由於產品組合從 INDOCIN 轉變為 ROLVEDON，季度營運現金流將因現金收入和支付方面的營運資金時間安排而波動。第三季度，營運現金流可以忽略不計，並受到現金回收和產品銷售下降的營運資金時間的影響。年初至今，我們的營運現金流已達 1,500 萬美元。

With that, we will open the floor to questions from our covering research analysts. Operator, please go ahead with the instructions.

至此，我們將接受我們的研究分析師所提出的問題。操作員，請按照說明進行操作。

Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. (Operator Instructions)

謝謝。女士們、先生們，我們現在開始問答環節。（操作員說明）

Thomas Flaten, Lake Street Capital Markets.

托馬斯·弗拉頓（Thomas Flaten），湖街資本市場。

Hey, good afternoon, guys. Congrats on the good quarter. Ajay, you didn't mention anything about guidance. Any thoughts on that for us?

嘿，下午好，夥計們。恭喜季度表現良好。阿傑，你沒有提到任何關於指導的事情。我們對此有什麼想法嗎？

Yeah. Thanks for the question. Thomas. You're right, at this point, we would have liked to narrow the range, but we still see a flux in few key areas for the remainder of the year. Therefore, we're going to keep the remaining guidance range that's out there.

是的。謝謝你的提問。托馬斯.你是對的，在這一點上，我們本來希望縮小範圍，但我們仍然看到今年剩餘時間內一些關鍵領域的變化。因此，我們將保留剩餘的指導範圍。

Some of the areas we're continuing to focus on is first focus of stabilizing the business as we cross over from INDOCIN to ROLVEDON. Secondly, as we continue to monitor the generic competitive landscape of INDOCIN. And then third is the dynamic pricing and volume activity occurring in the GCF, GCSF market landscape.

我們繼續關注的一些領域是，當我們從 INDOCIN 過渡到 ROLVEDON 時，首先要穩定業務。其次，我們將持續監控 INDOCIN 的通用競爭格局。第三是 GCF、GCSF 市場格局中發生的動態定價和交易量活動。

Great and then as a follow up -- or not, not a follow up. Brendan, you had spoken in the last quarterly call and I think in some investor conferences about your desire to maybe do a smaller deal this year and then maybe something more transformative in 2025. Could you give us your updated thoughts on that?

很好，然後作為後續行動——或者不是，不是後續行動。Brendan，您在上一季的電話會議中曾說過，我想在一些投資者會議上，您希望今年可能進行規模較小的交易，然後可能在 2025 年進行更具變革性的交易。您能告訴我們您對此的最新想法嗎？

Yeah, I know. So we continue to look at the landscape of what's available and what's out there and there are assets that we think we could execute whether they're small or whether they're larger, but, the further we go, I'm starting to think maybe we do something a little bit more robust in the near term.

是的，我知道。因此，我們繼續關注可用的內容和現有的內容，我們認為我們可以執行一些資產，無論它們是小還是大，但是，我們走得越遠，我開始思考也許我們在短期內會做一些更有力的事情。

Then there may be a small tuck in. So it really kind of depends on what's out there, what the price is, what we can get and how we think it fits with our model. So, I'm optimistic. I, I think there's lots of doable deals out there.

然後可能會有一個小摺痕。所以這實際上取決於現有的產品、價格是多少、我們能得到什麼以及我們認為它如何適合我們的模型。所以，我很樂觀。我，我認為那裡有很多可行的交易。

But I said before, I want to make sure it's the right fit. So I don't want to jump into something just because we feel like we need to, I want to make sure that it's the right thing for Assertio and we're paying the right price for it.

但我之前說過，我想確保它合適。所以我不想僅僅因為我們覺得有必要就介入某些事情，我想確保這對 Assertio 來說是正確的事情，並且我們正在為此付出正確的價格。

Excellent. Appreciate you taking the questions. Thank you.

出色的。感謝您提出問題。謝謝。

Sure. Thanks.

當然。謝謝。

Naz Rahman, Maxim Group.

納茲·拉赫曼，馬克西姆集團。

Hi, thank you for taking my question. They're both ROLVEDON. I'll start with this in regards to pricing. Where do you think the pricing decline sort of stable out? Do you think we -- you see -- you've reached stable prices or do you think there's still room for the pricing that pricing to decline?

你好，謝謝你回答我的問題。他們都是羅夫登。我將從定價方面開始。您認為價格下降在哪裡趨於穩定？你認為我們——你看——你已經達到了穩定的價格，還是你認為定價仍有下降的空間？

Yeah. Hey, Naz. This is Ajay. Thanks for the question. I would say the GCSF landscape is very competitive, especially with the biosimilars and some of the more recent entrants in the last few years really driving pricing.

是的。嘿，納茲。這是阿傑。謝謝你的提問。我想說 GCSF 的競爭非常激烈，尤其是生物相似藥和過去幾年的一些新進者確實推動了定價。

Therefore, in this market, we are somewhat hindered by what the market competitors will continue to do. We have seen pricing declines over the last few quarters, which we anticipate the trend would continue as market share starts to equalize. But one of the things we're absolutely focused on is the market that we operate in from a Medicare Part B perspective and maintaining one of our leading market share position there.

因此，在這個市場上，我們在某種程度上受到市場競爭對手將繼續做什麼的阻礙。我們看到過去幾季的價格下降，我們預計隨著市場份額開始趨於平衡，這種趨勢將持續下去。但我們絕對關注的事情之一是我們從 Medicare B 部分的角度運營的市場，並保持我們在那裡的領先市場份額地位之一。

Got it. That was awful. And my follow up question is following the same day dosing data. Could you talk a little bit about the logistics and potential time line to get that into NCCN guidelines? Like what has to happen there and how long does that take?

知道了。那太糟糕了。我的後續問題是追蹤當天的劑量數據。您能否談談將其納入 NCCN 指南的後勤工作和潛在時間表？例如那裡必鬚髮生什麼以及需要多長時間？

Yeah. So thanks for the question. So, again, we'll make the data public here in December and then I think it is roughly about a six month window for us to work with NCCN for them to consider that doesn't mean that it would be mid-year. But I think the earliest it could potentially be as been is mid-year. So, we haven't had those discussions of those conversations yet, but I think it would be somewhere between the middle and the back end of next year.

是的。謝謝你的提問。因此，我們將在 12 月再次公開數據，然後我認為我們與 NCCN 合作的時間大約為六個月，讓他們考慮這並不意味著會是年中。但我認為最早可能是年中。所以，我們還沒有對這些對話進行討論，但我認為這將在明年年中和年底之間進行。

Got it. Thanks for taking the questions.

知道了。感謝您提出問題。

Sure.

當然。

(Operator Instructions) Scott Henry, AGP.

（操作員說明）Scott Henry，AGP。

Thank you and good afternoon. A couple questions. First on ROLVEDON, first quarter, roughly $14.5 million; second quarter, $15.1 million; third quarter, $15 million. Guidance, I assume is still in place of roughly $60 million for 2024.

謝謝你，下午好。有幾個問題。首先是 ROLVEDON，第一季度，約 1,450 萬美元；第二季度，1,510萬美元；第三季度，1500萬美元。我認為 2024 年的指導仍為大約 6000 萬美元。

So we've got about four quarters right around that $15 million mark. Do you think it's basing out here for future growth or, well, maybe the growth be slower, just trying to get your sense of, there's a lot of moving parts here in that market of how we should think about growth for ROLVEDON and 2025 and beyond? Thank you.

因此，我們有大約四個季度的資金都在 1500 萬美元左右。你認為它是為了未來的成長而立足於此，還是，好吧，也許成長會更慢，只是想讓你感覺到，這個市場中有很多變化的部分，我們應該如何考慮ROLVEDON 和2025 年的成長，超過？謝謝。

Yeah. No, it's a great question, so thank you. And you're right. You've seen about $15 million first quarter, second quarter, third quarter has been relatively stable. And I think, if you think about the year that roughly $60 million in sales is right about where we think we'll be. But as we enter 2025, I mean, in 2024, we've been very focused in the community oncology clinic space, as Ajay said, focusing in the Medicare Part B space where we maintain about a third of that market share.

是的。不，這是一個很好的問題，所以謝謝你。你是對的。你看到第一季大約1500萬美元，第二季、第三季一直相對穩定。我認為，如果你考慮這一年，大約 6000 萬美元的銷售額就符合我們的預期。但隨著我們進入2025 年，我的意思是，在2024 年，我們一直非常關注社區腫瘤診所領域，正如Ajay 所說，重點關注醫療保險B 部分領域，我們在該領域保持約三分之一的市場佔有率。

As we move into 2025, we do think that further growth is not only possible, but that's what we're planning for as we expand beyond that clinic space into hospitals and so forth. So we are planning for growth, and we're approaching this category, and we're approaching ROLVEDON is a long-term play.

當我們進入 2025 年時，我們確實認為進一步的成長不僅是可能的，而且這也是我們在將業務從診所領域擴展到醫院等領域時所規劃的。所以我們正在規劃成長，我們正在接近這個類別，我們正在接近 ROLVEDON 是一個長期的遊戲。

We're not looking for a dramatic spike in any one particular quarter. We're looking at this asset over the long term. So we do think that we'll see continued growth, and we have plans to drive continued growth with ROLVEDON.

我們並不希望在任何一個特定季度出現戲劇性的飆升。我們正在長期關注這項資產。因此，我們確實認為我們將看到持續成長，並且我們計劃與 ROLVEDON 一起推動持續成長。

Okay, great. And SG&A in the quarter was on the -- it seemed pretty low. It's a good thing. Do you think that's a fair number to extrapolate going forward? Is that kind of the run rate you have currently?

好的，太好了。本季的銷售及管理費用（SG&A）似乎相當低。這是一件好事。您認為這個數字可以用來推斷未來嗎？你們目前的運行速度是這樣的嗎？

Yeah, Scott. Good question. Yeah, I would say generally in our business, the second half of the year from an SG&A is generally lower as a lot of our S&M initiatives occur in the first half of the year. With that, we also additionally had an additional kind of restructuring and retransition we did with the company in the beginning -- in the first quarter of the year. So that kind of reflected a higher run rate. I would say the average of the last two quarters is sufficient for the remainder of the year.

是的，斯科特。好問題。是的，我想說，一般來說，在我們的業務中，下半年的 SG&A 通常較低，因為我們的許多 S&M 計劃都發生在上半年。除此之外，我們還在年初（即今年第一季）對公司進行了另一種重組和重新轉型。所以這反映了更高的運行率。我想說，最後兩季的平均值足以滿足今年剩餘時間的需求。

Okay, great. And the final question I just wanted to ask on the Board update. Yeah, I've covered the company for a while. I believe there was a retire -- a mandatory retirement age for Board members. Was that a factor in Peter Staple retiring, if I recall that correctly? And if you could give any color on Dr. Vacirca retiring, I think he said something earlier, but I might have missed it.

好的，太好了。我只想在董事會更新中提出最後一個問題。是的，我已經報道這家公司有一段時間了。我相信有一個退休年齡——董事會成員的強制退休年齡。如果我沒記錯的話，這是彼得‧史泰普爾退休的因素嗎？如果你能對 Vacirca 博士的退休給出任何解釋，我想他早些時候說過一些話，但我可能錯過了。

Yeah. Sure. I'd be happy to address both. So I mean, Peter has been on the Board for 21 years. You've seen a lot of different versions of Assertio and I think he's worked with six, seven or eight CEOs. So, while I think Peter was approaching the term age or had approached it. I think there was a plan for Peter to step back for a while and retire from the Board.

是的。當然。我很樂意解決這兩個問題。我的意思是，Peter 已經在董事會任職 21 年了。你已經見過很多不同版本的 Assertio，我認為他曾與六、七或八位執行長合作。所以，雖然我認為彼得已經接近或已經接近這個詞了。我認為彼得有計劃暫時退出董事會並退休。

He stayed on largely because there was the transition between the former CEO, Heather becoming the Interim CEO, to bring me on Board. And then after I was on Board, this transition between Peter and Heather was planned to take place.

他留下來主要是因為前首席執行官希瑟（Heather）成為臨時首席執行官，以讓我加入董事會。在我加入董事會後，彼得和希瑟之間的過渡計畫就發生了。

So this has been a while in the making. I think Peter has been phenomenal, and he served Assertio well over the years. He's -- as I said in my opening comments, very calm demeanor, very experienced professional and really, really what I believe, a great Board member, and I appreciate his contributions.

所以這已經醞釀了一段時間了。我認為彼得非常出色，多年來他為阿塞蒂奧服務得很好。正如我在開場白中所說，他舉止非常冷靜，經驗豐富，非常專業，正如我所相信的那樣，他是一位出色的董事會成員，我感謝他的貢獻。

In regards to Dr. Vacirca. Dr. Vacirca came from Spectrum, he was on the Spectrum Board, I believe, and I think what Dr. Vacirca did for Assertio was really help with that integration and provide continuity as we integrated Spectrum into Assertio and started to really understand the GCSF market and the oncology market and the oncology clinic space.

關於 Vacirca 博士。Vacirca 博士來自 Spectrum，我相信他是 Spectrum 董事會成員，而且我認為 Vacirca 博士為 Assertio 所做的事情確實有助於整合，並在我們將 Spectrum 集成到 Assertio 並開始真正了解 GCSF 市場時提供連續性以及腫瘤學市場和腫瘤學診所空間。

So I don't think -- and I don't want to speak for Dr. Vacirca, but I don't think it was ever his long-term intention to stay on the Assertio Board forever. In fact, he probably stayed longer than planned. But I think he's thinking that he has a lot of outside other business interest that he needs to pay attention to. So this is a good time for him to step back from the Board as well.

所以我不認為——我也不想代表 Vacirca 博士發言，但我不認為他的長期意圖是永遠留在 Assertio 董事會。事實上，他停留的時間可能比計畫的還要長。但我認為他認為他有很多需要關注的外部其他商業利益。因此，這也是他退出董事會的好時機。

Okay. Great. Thank you for that color and thank you for taking the questions.

好的。偉大的。謝謝你的顏色，也謝謝你問問題。

Sure.

當然。

Ram Selvaraju, HC Wainwright.

拉姆‧塞爾瓦拉朱 (Ram Selvaraju)，HC 溫賴特 (HC Wainwright)。

Thanks very much for taking my questions. I just wanted to ask first and foremost about what the underlying market dynamics are that you're seeing that are driving new customers to choose ROLVEDON. If you could comment on that in some additional granularity, please?

非常感謝您回答我的問題。我首先想問的是，您所看到的推動新客戶選擇 ROLVEDON 的潛在市場動態是什麼。您能否更詳細地對此發表評論？

Well, I'll just give you my take first, and then Ajay, if you want to jump in and say anything you're welcome to. But look, I think that ROLVEDON is -- competes, as we said, in a very dynamic marketplace. It competes with other six or seven or eight other GCSFs.

好吧，我先告訴你我的看法，然後阿傑，如果你想插話說點什麼，歡迎。但是，我認為 ROLVEDON 正在——正如我們所說，在一個非常活躍的市場中競爭。它與其他六、七、八個 GCSF 競爭。

And it depends upon the actual slice of the market that you're competing in, that we compete in the clinic Medicare Part B space. We've been successful there. I think physicians recognize, the providers recognize that ROLVEDON is a very safe and effective product. And I think that will be underscored when we see the results of the same day dosing.

這取決於您所競爭的實際市場份額，以及我們在診所 Medicare B 部分領域的競爭。我們在那裡取得了成功。我認為醫生認識到，供應商認識到 ROLVEDON 是一種非常安全有效的產品。我認為當我們看到當天給藥的結果時，這一點將會得到強調。

Having said that, a lot of this is a contract play. And a lot of it is about access and a lot of it is about, do you have the right ASP formula, how are you managing ASP erosion, all of those things. So I think at the end of the day, a lot of times this comes to a contract play that is largely sometimes not even a physician that is making that choice.

話雖如此，其中許多都是合約遊戲。其中許多都與訪問有關，其中許多與您是否有正確的 ASP 公式、如何管理 ASP 侵蝕等等有關。所以我認為歸根究底，很多時候這都是一種合約遊戲，有時甚至不是醫生在做這樣的選擇。

It might be a practice manager. So patients may be unaware of the particular GCSF they're getting. Some may be aware, some may not be aware. But overall, it's decided kind of at the clinical level a lot of times by decision makers that way. Ajay, anything else to add?

可能是實踐經理。因此，患者可能不知道他們正在接受的特定 GCSF。有些人可能知道，有些人可能不知道。但總體而言，決策者多次在臨床層面做出決定。阿傑，還有什麼要補充的嗎？

No, I think Brendan hit it spot on, right the form or in terms of the appeal of the product itself helps us get kind of into the door. And then the second on the contracting side, who helped us with the stickiness of sustaining our leading market share in the oncology space.

不，我認為布倫丹說得對，無論是形式還是產品本身的吸引力都幫助我們進入了大門。然後是合約方的第二個，他幫助我們保持了在腫瘤領域領先的市場份額的黏性。

And then just as a follow up, I just wanted to see if Ajay you wanted to comment on what you see as future trends on the gross margin front, if you think that sustainably maintaining gross margins in the sort of low to mid 70s is possible as the product and revenue mix evolves. Thanks.

然後，作為後續行動，我只是想看看 Ajay，您是否願意對您所認為的毛利率方面的未來趨勢發表評論，如果您認為可持續地將毛利率維持在 70 年代中低水平是可能的隨著產品和收入組合的發展。謝謝。

Yeah. No, thanks for that question. Yeah, I think, as I mentioned to Thomas, right, I think we're keeping our previously announced guidance for '24 in line. We're not ready yet to comment anything beyond kind of '24 here. So previously stated comments on gross margin that year-over-year, there will be a gross margin erosion as we shift from INDOCIN, which was a highly accretive gross margin product with very little commercial activity behind it, to ROLVEDON, which is a biologic and carries a higher COGS rate.

是的。不，謝謝你提出這個問題。是的，我認為，正如我向托馬斯提到的那樣，我認為我們將保持之前宣布的 24 小時指導方針。我們還沒有準備好評論 '24 之外的任何內容。因此，先前對毛利率的評論是，與去年同期相比，當我們從INDOCIN（一種毛利率增值性高、背後商業活動很少的產品）轉向ROLVEDON（一種生物製劑）時，毛利率將會受到侵蝕。

And additionally, we have the commercial spend behind it. So we do continue to see that shift occurring into Q4 as well. But we are absolutely focused on from a pricing standpoint, maintaining that blended between 70% and 75% gross margin rate for 2024.

此外，我們還有背後的商業支出。因此，我們確實繼續看到這種轉變也發生在第四季。但從定價的角度來看，我們絕對專注於將 2024 年的毛利率維持在 70% 至 75% 之間。

Thank you.

謝謝。

Thank you. As there are no further questions that concludes the Q&A session. I would like to turn the conference back over to Brandon O'Grady for any closing remarks.

謝謝。由於沒有其他問題，問答環節就結束了。我想將會議轉回布蘭登·奧格雷迪發表閉幕詞。

Thank you. And I appreciate everyone who has joined us today. I just want to reiterate that I believe we have a great platform, an excellent team and a sound strategy as well as a balance sheet that will help support further growth.

謝謝。我感謝今天加入我們的所有人。我只想重申，我相信我們擁有出色的平台、優秀的團隊、健全的策略以及資產負債表，將有助於支持進一步的成長。

I hope that today's call is continue to demonstrate our ability to deliver steady execution on the commercial business we have today as well as our commitment to finding the right assets to further grow the platform.

我希望今天的電話會議能繼續展現我們穩定執行現有商業業務的能力，以及我們對尋找合適資產以進一步發展平台的承諾。

If you'd like to arrange a meeting or at an upcoming event or an update call with management, please contact Matt Kreps directly using his information provided in the press release and we'd be happy to schedule a time to speak. And thank you all again for joining us today.

如果您想安排一次會議或即將舉行的活動，或與管理層進行最新情況通話，請使用新聞稿中提供的資訊直接聯絡 Matt Kreps，我們很樂意安排講話時間。再次感謝大家今天加入我們。

That could close today's meeting. Thank you for your participation. You may now disconnect.

這可能會結束今天的會議。感謝您的參與。您現在可以斷開連線。