Assertio Holdings Inc (ASRT) 2023 Q2 法說會逐字稿

Good morning, and welcome to the Assertio Holdings, Inc. Second Quarter 2023 Financial Results Conference Call. (Operator Instructions). Please note, this event is being recorded. I would like to turn the conference over to Matt Kreps from Darrow Associates, Investor Relations for Assertio. Please go ahead.

早上好，歡迎參加 Assertio Holdings, Inc. 2023 年第二季度財務業績電話會議。 （操作員說明）。請注意，此事件正在被記錄。我想將會議交給 Assertio 投資者關係 Darrow Associates 的 Matt Kreps。請繼續。

Good afternoon, and thank you, everyone, for joining us today to discuss Assertio second quarter 2023 financials. The news release covering our earnings post 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.

下午好，感謝大家今天加入我們討論 Assertio 2023 年第二季度的財務狀況。有關我們財報發布期的新聞稿現已在我們網站的投資者頁面上提供：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 Dan Peisert, President and CEO; Paul Schwichtenberg, Senior Vice President and CFO; and Tom Riga, outgoing CEO of Spectrum Pharmaceuticals, for which we closed the acquisition earlier this week. Dan will open remarks to provide an overview of the business. Tom will provide additional comments on Spectrum's ROLVEDON progress, and Paul will review our financials. After that, we'll open the call for your questions.

今天與我在一起的有總裁兼首席執行官 Dan Pesert； Paul Schwichtenberg，高級副總裁兼首席財務官；以及 Spectrum Pharmaceuticals 即將離任的首席執行官 Tom Riga，我們於本週早些時候完成了對 Spectrum Pharmaceuticals 的收購。 Dan 將在開場致辭中概述業務情況。 Tom 將就 Spectrum 的 ROLVEDON 進展提供更多評論，Paul 將審查我們的財務狀況。之後，我們將打開電話詢問您的問題。

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 today's press release as well as 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. Our actual results may differ materially from those projected in the forward-looking statements, and Assertio specifically disclaims any intent or obligation to update those forward-looking statements, except as required by law.

在此通話期間，管理層將對我們未來的業績做出預測和其他前瞻性陳述。此類前瞻性陳述並不是對未來業績的保證，並且涉及風險和不確定性，包括今天的新聞稿以及 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 10-K 表年度報告的風險因素部分和其他部分中有更全面的描述。我們的實際結果可能與前瞻性陳述中預測的結果存在重大差異，Assertio 特別聲明不承擔任何更新這些前瞻性陳述的意圖或義務，除非法律要求。

And with that, I will now turn the call over to Dan.

現在，我將把電話轉給丹。

Thank you, Matt. Good afternoon, everyone, and welcome to our new shareholders and employees from Spectrum Pharmaceuticals. The acquisition of Spectrum marks a significant turning point for Assertio, providing immediate diversification of revenues, a sustainable near-term growth driver and long-term patent protection. The asset, the commercial infrastructure and sales model are also aligned with our vision of where we can effectively operate in this competitive pharmaceutical landscape, our intelligent contracting and market access are the foundation of the go-to-market model.

謝謝你，馬特。大家下午好，歡迎來自 Spectrum Pharmaceuticals 的新股東和員工。對 Spectrum 的收購標誌著 Assertio 的一個重要轉折點，可以立即實現收入多元化、可持續的近期增長動力和長期專利保護。資產、商業基礎設施和銷售模式也符合我們的願景，即我們能夠在競爭激烈的製藥領域有效運營，我們的智能合同和市場准入是進入市場模式的基礎。

I'm extremely proud of what we have accomplished here to Assertio and an internal employee memo following the shareholder meeting results. I reflected on our situation only 3.5 years ago, where Assertio had just invested 2 assets to pay off its debt and was left with an extremely concentrated portfolio of just CAMBIA and ZIPSOR. Today, those 2 assets together represent only 7% of our second quarter net product sales and only 4.6%, if you include ROLVEDON sales. In that time, we've acquired 2 businesses and 2 additional assets and paid off $195 million of debt. Our financial discipline and specifically our focus on cash flows is what has contributed to this success to date. Now with a healthier balance sheet and a growth asset, that discipline will still be there to help foster this company towards sustainable growth. We've proven we can manage through the ups and downs of loss of exclusivity, and we've built and now acquired a first-class commercial team from Spectrum that can only enhance our capabilities to grow assets and scale.

我對 Assertio 所取得的成就以及股東大會結果後的內部員工備忘錄感到非常自豪。我回顧了 3.5 年前我們的情況，Assertio 剛剛投資了 2 項資產來償還債務，剩下的投資組合極其集中，只有 CAMBIA 和 ZIPSOR。如今，這兩項資產合計僅占我們第二季度產品淨銷售額的 7%，如果將 ROLVEDON 銷售額計算在內，則僅佔 4.6%。在此期間，我們收購了 2 家企業和 2 項額外資產，並還清了 1.95 億美元的債務。我們的財務紀律，特別是我們對現金流的關注是迄今為止取得成功的原因。現在，有了更健康的資產負債表和增長型資產，該紀律仍將有助於促進該公司實現可持續增長。我們已經證明，我們能夠應對失去獨家經營權的起起落落，我們已經建立並現在從 Spectrum 收購了一支一流的商業團隊，這只會增強我們增加資產和擴大規模的能力。

Now I'd like to turn the call over to Tom Riga to talk about Spectrum's second quarter and why we are confident in its growth trajectory. Tom?

現在我想把電話轉給 Tom Riga，談談 Spectrum 第二季度的情況以及為什麼我們對其增長軌跡充滿信心。湯姆？

Thanks, Dan. And good afternoon, everybody. The launch trajectory of ROLVEDON continues to be extremely positive and that momentum has continued in the second quarter of 2023. Net sales for the second quarter were $21 million versus $15.6 million in Q1, an increase of 34%. This is the third consecutive quarter of exceptional performance. And it is a credit to the execution of our experienced team ensuring ROLVEDON continues to be clearly differentiated as the first novel product to enter the long-acting GCSF space in over 20 years that is not a biosimilar. This is a highly competitive market, and our people are proving to be one of the most valuable assets during this launch.

謝謝，丹。大家下午好。 ROLVEDON 的上市軌跡仍然非常積極，並且這種勢頭在 2023 年第二季度得到了延續。第二季度的淨銷售額為 2100 萬美元，而第一季度為 1560 萬美元，增長了 34%。這是連續第三個季度表現出色。這要歸功於我們經驗豐富的團隊的執行力，確保 ROLVEDON 繼續保持明顯的差異化，成為 20 多年來第一個進入長效 GCSF 領域的非生物仿製藥的新穎產品。這是一個競爭激烈的市場，事實證明，我們的員工是此次發布過程中最有價值的資產之一。

Beyond the strong Q2 revenue number, we made important progress on customer growth in terms of breadth, meeting the absolute number of customers using ROLVEDON and depth meeting same-store sales. Targeted accounts purchasing ROLVEDON increased 50% over Q1 2023 to about 300 in total. Additionally, we are seeing increased depth within accounts as customers become more comfortable with ROLVEDON's unique J-code and streamlined reimbursement process. Through Q1, customer demand was primarily driven by the largest community oncology GPO, which represents approximately 50% of the segment's business. In the second quarter, we initiated sales with the second largest GPO that represents approximately 40% of the Community Oncology business. This was very helpful in the second quarter, but more importantly, is a growth opportunity going forward.

除了強勁的第二季度收入數字之外，我們在客戶增長廣度、滿足使用 ROLVEDON 的客戶絕對數量以及滿足同店銷售深度方面取得了重要進展。購買 ROLVEDON 的目標客戶總數比 2023 年第一季度增加了 50%，達到約 300 個。此外，隨著客戶對 ROLVEDON 獨特的 J 代碼和簡化的報銷流程越來越滿意，我們看到賬戶的深度不斷增加。第一季度，客戶需求主要由最大的社區腫瘤學 GPO 推動，該 GPO 約佔該細分市場業務的 50%。第二季度，我們開始與第二大 GPO 進行銷售，該 GPO 約佔社區腫瘤業務的 40%。這對第二季度非常有幫助，但更重要的是，這是未來的增長機會。

Our focused launch strategy is hitting its stride and has played out largely as expected. The combined company, as it moves forward, there is additional opportunity to drive breadth and depth across the market. At this point ROLVEDON has approximately 2% market share of the overall long-acting GCSF market, which underscores the tremendous opportunity ahead. That said, we have been candid throughout that this marketplace is highly competitive and every share point gained requires market knowledge, a thoughtful and pointed strategy and exceptional execution.

我們的重點發布戰略正在大踏步前進，並且基本達到預期效果。合併後的公司隨著其向前發展，將有更多機會推動整個市場的廣度和深度。目前，ROLVEDON 在整個長效 GCSF 市場中佔有約 2% 的市場份額，這凸顯了未來的巨大機遇。儘管如此，我們始終坦誠地表示，這個市場競爭非常激烈，獲得的每一個份額都需要市場知識、深思熟慮和針對性的戰略以及卓越的執行力。

As Spectrum transitions to be a part of Assertio and take the next steps in ROLVEDON's growth trajectory, every one of our employees should take great pride in the excellent ROLVEDON performance to date. As I sign off and turn the reins over to Dan, I must say, I am extremely confident in the team he has acquired and have come to have respect for his leadership and the capabilities at Assertio.

隨著 Spectrum 成為 Assertio 的一部分並在 ROLVEDON 的發展軌跡上邁出下一步，我們的每一位員工都應該為 ROLVEDON 迄今為止的出色表現感到自豪。當我簽字並將領導權移交給 Dan 時，我必須說，我對他所收購的團隊非常有信心，並且開始尊重他在 Assertio 的領導力和能力。

With that, I'll turn the call back over to Dan.

這樣，我會將電話轉回給丹。

Thank you, Tom, and I share your enthusiasm for the future of ROLVEDON. Today, we're not able to provide guidance as we initially intended. We just learned a few hours ago the FDA has approved a generic indomethacin Suppositories. When we issued guidance, we like to have as much information at our disposal as possible. And now we believe it's prudent to withdraw our outlook until we know more information.

謝謝你，湯姆，我和你一樣對 ROLVEDON 的未來充滿熱情。今天，我們無法按照最初的預期提供指導。幾個小時前我們剛剛獲悉 FDA 批准了一種仿製藥吲哚美辛栓劑。當我們發布指導意見時，我們希望掌握盡可能多的信息。現在我們認為，在了解更多信息之前，撤回我們的觀點是謹慎的做法。

Today, all we know as a single competitor was approved and they received CGT status, which means no other generics can be approved for 180 days. We are not aware of their launch timing. What I can offer is that Assertio is not afraid of this nor are we hiding from this. It has been well known that indomethacin had no intellectual property nor exclusivity protecting it and generic entry risk was always in the background. So we have been preparing for it, and we are ready to defend it.

今天，據我們所知，單個競爭對手已獲得批准，並且他們獲得了 CGT 狀態，這意味著 180 天內沒有其他仿製藥可以獲得批准。我們不知道他們的發射時間。我可以提供的是，Assertio 並不害怕這一點，我們也不會逃避這一點。眾所周知，吲哚美辛沒有知識產權，也沒有排他性保護，仿製藥進入風險始終存在。所以我們一直在做準備，我們已經準備好捍衛它。

One example of how we can defend is evident in our financials this year. As many of you know, we lost exclusivity for CAMBIA in January of this year and 3 competitive generics entered the market in addition to 1 authorized generic. Normally, in these situations, the brands do not do well in the first 6 to 9 months following LOE. However, year-to-date, we've retained 36% to the prior year volumes and 34% of the prior year revenues, which is an outstanding result when many of the analogs in a competitive market like this would suggest retention rates near 10% of volume and between 0% to 10% of revenue, because of reduction in end customer inventory. This is all due to the outstanding execution of our commercial team, preparation for the LOE, and the early identification that patient refills were still being covered by commercial insurers and quickly utilizing the resources in our hub and our patient support programs to encourage a high refill rate. An example of our market access programs and strategy at work.

我們如何防禦的一個例子在我們今年的財務數據中很明顯。正如你們許多人所知，我們在今年 1 月失去了 CAMBIA 的獨家經營權，除了 1 種授權仿製藥外，還有 3 種競爭性仿製藥進入市場。通常，在這些情況下，品牌在 LOE 後的前 6 至 9 個月內表現不佳。然而，今年迄今為止，我們保留了上年銷量的 36% 和上年收入的 34%，這是一個出色的結果，因為在像這樣的競爭市場中，許多類似的產品都表明保留率接近 10由於最終客戶庫存減少，銷量的% 和收入的0% 到10% 之間。這一切都歸功於我們商業團隊的出色執行力、LOE 的準備，以及早期發現商業保險公司仍承保患者續藥，並迅速利用我們中心的資源和患者支持計劃來鼓勵高續藥速度。我們的市場准入計劃和戰略的實施示例。

We're confident that we can do something similar with INDOCIN. And in this case, we only have a single competitor and the analogs are far better than with 4 as was the case with CAMBIA. Paul will provide more details in his prepared remarks. But I want to comment on a few things as they relate to Assertio's core business and also the second quarter performance.

我們相信我們可以用 INDOCIN 做類似的事情。在這種情況下，我們只有一個競爭對手，而類似物比 4 個競爭對手要好得多，就像 CAMBIA 的情況一樣。保羅將在他準備好的講話中提供更多細節。但我想評論一些與 Assertio 核心業務以及第二季度業績相關的事情。

When we acquired Zyla, 1 of the products that came with the acquisition was a former Egalet product called OXAYDO, which is an abuse-deterrent opioid. While a small contributor, this product carries strong margins and cash flows because we put no marketing or sales support behind it. However, relative to its financial impact for this product from an operations viewpoint, it's been a challenge in both supply and DEA quota. So we've made the decision to stop sales of this product and have notified the FDA we will discontinue OXAYDO. As a result, the company is officially out of the opioid business. This decision will have a drag on our second half results. And for reference, we reported $1.7 million in OXAYDO sales in the second half of last year.

當我們收購 Zyla 時，收購帶來的產品之一是前 Egalet 產品，名為 OXAYDO，這是一種防止濫用的阿片類藥物。雖然貢獻很小，但該產品具有強勁的利潤和現金流，因為我們沒有為其提供任何營銷或銷售支持。然而，相對於從運營角度來看該產品的財務影響，它在供應和 DEA 配額方面都是一個挑戰。因此，我們決定停止銷售該產品，並通知 FDA 我們將停止使用 OXAYDO。因此，該公司正式退出阿片類藥物業務。這一決定將拖累我們下半年的業績。作為參考，我們報告去年下半年 OXAYDO 的銷售額為 170 萬美元。

I think this is an important decision for us as we mark this new turning point in our history. I'm very excited to announce that in the second quarter we've made notable progress in the opioid litigation, where we were dismissed from a significant minority of our NAS cases, or what is commonly referred to as the baby opioid cases. Now in aggregate, we've been dismissed from just shy of 40% of all of the opioid cases that have been filed against the company without paying a penny. I think this speaks volumes about the company's potential liability and that our patients and defense strategy is being awarded.

我認為這對我們來說是一個重要的決定，因為我們標誌著我們歷史上的這個新轉折點。我非常高興地宣布，第二季度我們在阿片類藥物訴訟方面取得了顯著進展，我們在 NAS 案件（即通常所說的嬰兒阿片類藥物案件）中被駁回。現在，總共有近 40% 的阿片類藥物案件被駁回，我們沒有支付一分錢。我認為這充分說明了公司的潛在責任以及我們的患者和防禦策略正在被授予。

Sympazan continues the trends I discussed last quarter, achieving new monthly and quarterly TRx count demand peaks, as measured by Symphony Health, as well as a mix shift towards the higher strengths, resulting in average -- higher average selling price, so that our quarterly net revenues grew 5% sequentially.

Sympazan 延續了我上季度討論的趨勢，實現了由 Symphony Health 衡量的新的月度和季度 TRx 計數需求峰值，以及向更高優勢的混合轉變，導致平均更高的平均售價，因此我們的季度淨收入環比增長5%。

Our first half of 2023 net revenues are just over $5.1 million for the product, which represents 7.1% growth over the prior year period reported by Aquestive. We're off to a good start so far and are starting to develop our longer-term strategic plans for the product and have reasons for optimism about its potential. We're starting to get back on track with Otrexup as we recover from the supply challenges we experienced last year. Our volumes are up 18% year-over-year and in the low single digits over last quarter. However, our net revenues were up 37% year-over-year and 27% sequentially as we focused on profitable volumes. A direct contrast to our primary competitor, who continues to report declining net revenues in ASPs as they keep bidding contract prices downward to maintain market share. This is just one small example of what I described as our business strategy overall.

我們的產品 2023 年上半年淨收入略高於 510 萬美元，比 Aquestive 報告的上一年同期增長 7.1%。到目前為止，我們已經有了一個良好的開端，並開始製定該產品的長期戰略計劃，並有理由對其潛力感到樂觀。隨著我們從去年經歷的供應挑戰中恢復過來，我們開始與 Otrexup 重回正軌。我們的銷量同比增長 18%，但較上季度低至個位數。然而，由於我們專注於盈利量，我們的淨收入同比增長 37%，環比增長 27%。這與我們的主要競爭對手形成鮮明對比，他們的平均售價淨收入繼續下降，因為他們不斷降低投標合同價格以維持市場份額。這只是我所描述的我們整體業務戰略的一個小例子。

We're smart, disciplined contracting and market access are the building box of everything we do and then allocate our sales and marketing dollars efficiently. Our efforts now shift to the integration of Spectrum and ensuring the continued launch trajectory of ROLVEDON. I will now turn the call over to Paul.

我們很聰明，遵守紀律的合同和市場准入是我們所做一切的基礎，然後有效地分配我們的銷售和營銷資金。我們現在的努力轉向 Spectrum 的整合，並確保 ROLVEDON 的持續推出軌跡。我現在將把電話轉給保羅。

Thank you, Dan. This afternoon, I will review the financial highlights from Assertio's second quarter of 2023. My comments on the second quarter, except for otherwise noted, will be on Assertio's stand-alone business, excluding Spectrum. For full details, please refer to the tables and financial statements in our earnings release and 10-Q.

謝謝你，丹。今天下午，我將回顧 Assertio 2023 年第二季度的財務亮點。我對第二季度的評論，除非另有說明，將針對 Assertio 的獨立業務，不包括 Spectrum。有關完整詳細信息，請參閱我們的收益報告和 10-Q 中的表格和財務報表。

Net product sales were $40.1 million for the second quarter of 2023, compared to net product sales of $35.4 million in the prior year quarter and $41.8 million last quarter. The increase in net sales versus the prior year quarter is primarily driven by INDOCIN and the addition of Sympazan, which more than offset the expected decline in CAMBIA. INDOCIN family net sales in the second quarter increased by 23% over the prior year, primarily due to a volume mix shift to more profitable channels. Otrexup and Sympazan combined net sales for the second quarter were $6.2 million, reflecting 17% sequential growth over the prior quarter due to strong volume and favorable channel mix for both products. Overall, portfolio net sales were up 13% versus the prior year quarter despite the CAMBIA loss of exclusivity on January 1.

2023 年第二季度的產品淨銷售額為 4010 萬美元，而去年同期的產品淨銷售額為 3540 萬美元，上一季度的產品淨銷售額為 4180 萬美元。與去年同期相比淨銷售額的增長主要是由 INDOCIN 和 Sympazan 的添加推動的，這遠遠抵消了 CAMBIA 的預期下降。 INDOCIN 系列第二季度淨銷售額比去年同期增長 23%，主要是由於銷量組合轉向利潤更高的渠道。 Otrexup 和 Sympazan 第二季度的淨銷售額合計為 620 萬美元，比上一季度環比增長 17%，這得益於兩種產品的強勁銷量和有利的渠道組合。總體而言，儘管 CAMBIA 在 1 月 1 日失去了獨家經營權，但投資組合的淨銷售額仍比去年同期增長了 13%。

Gross margin as a percentage of product net sales was 88.1% from the second quarter versus 87.2% in the prior year quarter. The increase in margin is due to a shift in product sales mix to INDOCIN, which carries a higher gross margin. Adjusted selling, general and administrative expenses in the second quarter were $11.4 million compared to $11.9 million last quarter and $8.6 million in the prior year quarter, which included a net benefit of $2 million from an insurance settlement. The increase versus the prior year quarter is primarily due to additional costs for both Sympazan and Otrexup, along with personnel costs due to new head count additions.

第二季度毛利率佔產品淨銷售額的百分比為 88.1%，而去年同期為 87.2%。利潤率的增加是由於產品銷售組合轉向毛利率較高的 INDOCIN。第二季度調整後的銷售、一般和管理費用為 1140 萬美元，上一季度為 1190 萬美元，去年同期為 860 萬美元，其中包括來自保險和解的 200 萬美元淨收益。與去年同期相比的增長主要是由於 Sympazan 和 Otrexup 的額外成本，以及由於新員工數量增加而產生的人員成本。

Adjusted EBITDA for the second quarter was $24.8 million compared to $25.6 million last quarter and $22.9 million in the prior year quarter. The year-over-year increase was driven by $4.7 million of additional product net sales and the SG&A spend changes previously mentioned. Adjusted EBITDA margin reflected as a percentage of total revenue and the second quarter was 60.4% versus 65.2% in the prior year quarter.

第二季度調整後 EBITDA 為 2480 萬美元，上一季度為 2560 萬美元，去年同期為 2290 萬美元。同比增長是由 470 萬美元的額外產品淨銷售額以及前面提到的 SG&A 支出變化推動的。調整後 EBITDA 利潤率反映為佔總收入的百分比，第二季度為 60.4%，而去年同期為 65.2%。

The second quarter non-GAAP adjusted earnings per share was $0.19, versus $0.29 in the prior quarter, and $0.28 in the prior year quarter. Again, please note that earnings per share is now calculated using diluted shares, including the if-converted impact of the convertible notes as is required under GAAP. There were $70.1 million total diluted shares in the second quarter, including the fully weighted additional diluted share impact of 9.8 million shares. The Spectrum merger will add approximately 38 million shares.

第二季度非 GAAP 調整後每股收益為 0.19 美元，上一季度為 0.29 美元，上年同期為 0.28 美元。再次請注意，每股收益現在是使用稀釋後的股票計算的，包括根據公認會計準則要求的可轉換票據轉換後的影響。第二季度稀釋股票總額為 7010 萬美元，其中包括 980 萬股完全加權的額外稀釋股票影響。 Spectrum 合併將增加約 3800 萬股。

Net income for the second quarter was $8.5 million compared to a net loss of $3.5 million last quarter and $7.8 million in the prior year quarter. The second quarter net income was impacted by $3.4 million in transaction costs associated with the acquisition of Spectrum Pharmaceuticals. Net cash provided by operating activities as reported in the company's statement of cash flows for the second quarter was $18.6 million versus $22.7 million last quarter and $14.4 million in the prior year quarter. The year-over-year increase in operating cash flow is due to increased net sales, partially offset by higher operating expenses versus the prior year.

第二季度淨利潤為 850 萬美元，而上一季度淨虧損為 350 萬美元，去年同期淨虧損為 780 萬美元。第二季度淨利潤受到與收購 Spectrum Pharmaceuticals 相關的 340 萬美元交易成本的影響。公司第二季度現金流量表中報告的經營活動提供的現金淨額為 1,860 萬美元，上一季度為 2,270 萬美元，去年同期為 1,440 萬美元。營業現金流量同比增長是由於淨銷售額增加，但部分被較上年增加的營業費用所抵消。

Ending cash on June 30, 2023, was $70.2 million, reflecting a $1.6 million increase versus the prior quarter. On June 30, 2023, our long-term debt balance was $38.2 million, reflecting the $40 million convertible debt balance less unamortized debt issuance costs. We did not take on any additional debt from the acquisition of Spectrum.

截至 2023 年 6 月 30 日，現金為 7,020 萬美元，較上一季度增加 160 萬美元。截至 2023 年 6 月 30 日，我們的長期債務餘額為 3820 萬美元，反映了 4000 萬美元的可轉換債務餘額減去未攤銷的債務發行成本。我們沒有因收購 Spectrum 而承擔任何額外債務。

Looking ahead, please note that the third quarter results will be impacted by purchase accounting, transaction costs and restructuring costs related to the Spectrum acquisition on July 31. And now I'll turn the call back over to Matt.

展望未來，請注意，第三季度業績將受到與 7 月 31 日收購 Spectrum 相關的採購會計、交易成本和重組成本的影響。現在我將把電話轉回給 Matt。

Thank you, Paul, Tom and Dan. At this time, we completed our prepared remarks, and we'll use the balance of our allotted time to take questions from our sell-side analyst community. Operator, can you please provide the instructions for Q&A from our listeners and launch the first question?

謝謝保羅、湯姆和丹。此時，我們已經完成了準備好的發言，我們將利用分配的剩餘時間來回答賣方分析師社區的問題。接線員，您能否提供一下聽眾問答的說明，並提出第一個問題？

(Operator Instructions) Our first question comes from Thomas Flaten at Lake Street Capital Markets.

（操作員說明）我們的第一個問題來自 Lake Street Capital Markets 的 Thomas Flaten。

Dan, given the uncertainty around INDOCIN. I was wondering if you could comment a little bit on the spectrum staff that's coming over. Did you have any vacancies in the field? How is kind of morale? Any kind of qualitative or quantitative for that matter, thoughts you could give us on the team that's coming over given that ROLVEDON now has become even more important, at least in the near term here.

丹，考慮到 INDOCIN 的不確定性。我想知道您是否可以對即將到來的頻譜工作人員發表一些評論。您該領域有空缺嗎？士氣怎麼樣？鑑於 ROLVEDON 現在變得更加重要，至少在短期內，您可以給我們關於即將到來的團隊的任何定性或定量的想法。

Yes. I'll provide some initial comments and then Tom, I'll open it up to you, too. So I've got to know a lot of this team, we're taking over the whole entire team intact as is. They're -- as far as I'm aware, there aren't -- there is no vacancies, there's 1 position that will be filled, it's a new position that will be filled in mid-August. But it's -- I'm sure the news today will be a little bit of a morale boost to third bump as it will be across the entire company. But that shouldn't dissuade anyone from the success that they're having with the launch of ROLVEDON. And as Tom said, the people here are the most valuable assets in the company. And that doesn't apply just to Spectrum, it applies to Assertio too. So the people are even more valuable now than they were yesterday. And we are going to put even more emphasis behind this launch, and it is just as important to this company as it was before. And Tom, any other comments about the commercial team?

是的。我將提供一些初步評論，然後湯姆，我也會向您開放。所以我必須了解這個團隊的很多內容，我們將完好無損地接管整個團隊。據我所知，沒有空缺職位，有 1 個職位需要填補，這是一個新職位，將於 8 月中旬填補。但我確信今天的消息將會對第三次沖擊的士氣有所鼓舞，因為這將影響到整個公司。但這不應該阻止任何人通過 ROLVEDON 的推出所取得的成功。正如湯姆所說，這裡的員工是公司最寶貴的資產。這不僅適用於 Spectrum，也適用於 Assertio。所以現在的人比昨天更有價值。我們將更加重視這次發布，它對這家公司來說和以前一樣重要。湯姆，關於商業團隊還有什麼其他評論嗎？

No. I think you said it. Thomas, first, performance speaks for itself. But outside of that, this is a rock solid group of people that know what they're doing. They're professionals, they're resilient, and they play to win. So I expect that will continue. And it really starts with leadership, and I think Dan is adopting an exceptional leadership team. And I think they will thrive.

不，我想你已經說過了。托馬斯，首先，表現不言而喻。但除此之外，這是一群堅如磐石的人，他們知道自己在做什麼。他們是專業人士，他們有韌性，他們為勝利而戰。所以我預計這種情況將會持續下去。這確實始於領導力，我認為丹正在組建一支出色的領導團隊。我認為他們會蓬勃發展。

And then, Dan, any thoughts on ROLVEDON for 2023 the calendar year? I know that sits kind of adjacent to the legacy business, but I think if -- any thoughts you can share on expectations for that? I know you're not providing guidance for the whole business, but maybe that product as a stand-alone.

那麼，Dan，您對 2023 年 ROLVEDON 有什麼想法嗎？我知道這與傳統業務有點相鄰，但我想，您可以分享對此的期望嗎？我知道您並沒有為整個業務提供指導，但也許該產品作為一個獨立的產品。

So I don't -- Thomas, we have -- there's a point estimate that Assertio put in the S-4. And I would tell you that I don't think our opinion of the launch has changed too terribly much from that estimate that we put out in the S-4 other than to say that it has been tracking slightly better than our original expectations.

所以我不知道——托馬斯，我們知道——Assertio 在 S-4 中加入了一個點估計。我想告訴你，我認為我們對 S-4 發射的看法與我們對 S-4 的估計相比沒有太大變化，只是說它的跟踪情況略好於我們最初的預期。

Got it. And then one final one, if I may. Given the INDOCIN news, any preliminary thoughts on how you might proceed with the planned study in moderate ERCP patients amount of risk?

知道了。如果可以的話，還有最後一篇。鑑於 INDOCIN 消息，您對如何在中等風險的 ERCP 患者中進行計劃中的研究有什麼初步想法嗎？

Yes. A very, very good question, and I think appropriate, and it's something that we're evaluating. We had been evaluating options as it regards to a regulatory strategy anyway. I think with the news today, we're going to -- so I'll be upfront. The life cycle management option that we had was a different dosage strength of this product that is more convenient for an ERCP procedure. I think with this news today, what we might be looking to do is find a way to accelerate that to market. And there are some backup options that we had before that did not bring an exclusivity option with them, and those might be something that we start to accelerate, but that's obviously something we as a management team and have to discuss and align with our Board before we make a decision.

是的。這是一個非常非常好的問題，我認為合適，我們正在評估這個問題。無論如何，我們一直在評估與監管策略有關的選項。我認為今天的新聞，我們將——所以我會坦率地說。我們擁有的生命週期管理選項是該產品的不同劑量強度，這對於 ERCP 程序來說更方便。我認為，根據今天的消息，我們可能希望找到一種方法來加速其上市。我們之前有一些備用選項，但沒有帶來排他性選項，這些可能是我們開始加速的事情，但這顯然是我們作為管理團隊的事情，必須在之前與我們的董事會進行討論和協調我們做出決定。

Your next question comes from Mayank Mamtani with B. Riley.

您的下一個問題來自 Mayank Mamtani 和 B. Riley。

This is (inaudible) on for Mayank. Congratulations on closing the Spectrum acquisition. So as you said, the ROLVEDON performance seems to be tracking ahead of plan. I just wanted to see if you could comment on the sort of long-term cash flow you anticipate on a stand-alone basis, recognizing there is a balanced mix of commercial and digital spend you intend to have. And what's the incremental OpEx we should expect, which is important in light of the uncertainty with the top line being pulled?

這是 Mayank 的（聽不清）。祝賀您完成對 Spectrum 的收購。正如您所說，ROLVEDON 的表現似乎超出了計劃。我只是想看看您是否可以對您單獨預期的長期現金流發表評論，並認識到您打算擁有商業和數字支出的平衡組合。考慮到營收拉動的不確定性，我們應該預期增量運營支出是多少，這一點很重要？

So Paul and I will have to -- yet another reason why we pulled guidance was what is going to be the operating expense in the base business. The -- what we anticipate bringing over now, we had originally assumed $60 million of operating expenses from Spectrum in our -- when we announced the deal. Now as we're through most of the integration work and planning process, we're now anticipating that, that's going to be $55 million of incremental operating expenses to operate that asset on our platform. So the big question that's still open now is, what is the base of Assertio's operating expenses. So I can't give you a go forward, but I know it's going to be incremental $55 million of ROLVEDON.

因此，保羅和我必須——我們取消指導的另一個原因是基礎業務的運營費用。我們現在預計會帶來的，當我們宣布這項交易時，我們最初從 Spectrum 承擔了 6000 萬美元的運營費用。現在，當我們完成大部分集成工作和規劃流程時，我們預計在我們的平台上運營該資產將需要 5500 萬美元的增量運營費用。因此，現在仍然懸而未決的一個大問題是，Assertio 的運營費用基礎是什麼。所以我不能給你一個前進的機會，但我知道 ROLVEDON 將會增加 5500 萬美元。

Sure. And maybe just following up on the question about integrating the 2 teams there. I know that you're sticking with Spectrum's game plan and the commercial team, then layering in the associated digital platform on top. Maybe can you just get some more color on how that integration is going?

當然。也許只是跟進有關整合兩支球隊的問題。我知道您會堅持 Spectrum 的遊戲計劃和商業團隊，然後在相關的數字平台上分層。也許您可以進一步了解整合的進展情況嗎？

I would tell you that the planning was, I would say, flawless. They did an amazing job in coordinating together to plan this integration. When it came to the commercial side, because we are pulling over the entire team, and we're not trying to disrupt anything, it's little things like how long do we get to keep our Spectrum e-mail address? And if we want to launch new marketing materials, which promotional review committee do we go to. So it's not massive disruption, it's minor disruption. So the commercial changes shouldn't be large and the overlay of the digital does not have to happen right away. That is going to be probably more towards late this quarter. The planning part of that is going to happen as we speak. And then later this quarter, early next quarter is when that will actually start taking place. So there's plenty of activity, as Tom said, that he just opened up a new GPO. So there's plenty of growth avenues open for that team right now before we start throwing more at them.

我可以告訴你，這個計劃是完美無缺的。他們在協調規劃這次整合方面做得非常出色。當談到商業方面時，因為我們正在拉動整個團隊，而且我們並不想破壞任何事情，所以我們會保留 Spectrum 電子郵件地址多長時間？如果我們想推出新的營銷材料，我們應該去哪個促銷審查委員會。所以這不是大規模的破壞，而是輕微的破壞。因此，商業變化不應很大，數字化的覆蓋也不必立即發生。這可能會在本季度末發生。就在我們說話的時候，計劃部分就要開始了。然後在本季度末、下個季度初，這將真正開始發生。正如 Tom 所說，有很多活動，他剛剛開設了一個新的 GPO。因此，在我們開始向他們投入更多資金之前，現在有很多增長途徑可供該團隊使用。

Okay, sure. Maybe just one quick follow-up. I think you mentioned in the past that -- so I guess we're going to expect the synergies from the digital platform being layered on top of later in 3Q, you said. Just wondering if you could comment on what kind of [scenes] you were looking at. I think previously, you mentioned, opening up new geographies for ROLVEDON. I'm wondering if there's anything additional to that.

好吧，當然。也許只是一個快速跟進。我想您過去曾提到過這一點，所以我想我們預計數字平台的協同效應將在第三季度晚些時候分層，您說。只是想知道你是否可以評論一下你正在看什麼樣的[場景]。我想您之前提到過，為 ROLVEDON 開闢新的地理區域。我想知道除此之外是否還有其他內容。

So just -- what I think might be correct something you said. I wouldn't look at the digital platform as a synergy, maybe a revenue synergy, but not an operating expense synergy. We're not going to be using the digital platform as a way to reduce the current spectrum, it's going to be add on to it and enhance it and hopefully go to areas or geographies, as you said, that they're currently not able to go to. So that is what our current vision of this is and to be able to possibly accelerate the launch in that manner.

所以，我認為你所說的可能是正確的。我不會將數字平台視為一種協同效應，也許是一種收入協同效應，但不是一種運營費用協同效應。我們不會使用數字平台作為減少當前頻譜的一種方式，而是會對其進行添加和增強，並希望能夠進入他們目前無法做到的地區或地區。要去。這就是我們目前的願景，並且能夠以這種方式加速發布。

Our next question comes from Hamed Khorsand with BWS Financial.

我們的下一個問題來自 BWS Financial 的 Hamed Khorsand。

So first off, I just wanted to see, how closely are you where this was happening? And what are your expectations of how this would be -- your competitor would be able to manufacture this generic and be successful in launching in the U.S.

首先，我只是想看看，你距離事情發生的地點有多近？您對此有何期望——您的競爭對手將能夠生產這種仿製藥並成功在美國上市。

I would say we were not aware of this at all. This came as a complete shock and surprise. So the last we had heard of this potential competitor, they were working on a 100-milligram dose and we had thought that they were done. So we were not aware that they were at the FDA. The fact that they had competitive generic therapy approval tells you it was an accelerated approval. So it was relatively quick. So this came as a complete surprise to us.

我想說我們根本不知道這一點。這完全令人震驚和驚訝。因此，我們最後一次聽說這個潛在競爭對手時，他們正在研究 100 毫克的劑量，我們原以為他們已經完成了。所以我們不知道他們在 FDA。他們獲得競爭性仿製藥批准的事實告訴您這是一個加速批准。所以相對來說還是比較快的。所以這對我們來說完全是一個驚喜。

And what preparations are you making as far as just being able to retain market share -- or close to the market share, just given the potential generic coming in?

考慮到潛在的仿製藥上市，您正在做哪些準備，以保持市場份額或接近市場份額？

We've been making preparations for that ever since I took over as CEO. So for the last 3 years, we've been making preparations for this. I'd rather not tell you on an open conference call what they are. I appreciate that you'd like to know what they are. But I don't want Zydus who is likely listening to be aware of what they are.

自從我接任首席執行官以來，我們一直在為此做準備。所以在過去的三年裡，我們一直在為此做準備。我不想在公開電話會議上告訴你它們是什麼。我很高興您想知道它們是什麼。但我不希望正在聽的 Zydus 知道他們是什麼。

Fair enough. I guess the other question I had was given the ASGE guideline changes, have you seen any -- the market expands. Where are you seeing the demand, if any?

很公平。我想我提出的另一個問題是 ASGE 指南發生了變化，您是否看到了任何變化——市場擴大了。您在哪裡看到需求（如果有）？

So we hadn't -- we hadn't seen it. So one of the things that we were going to talk about was some of the market research that we have been doing and some of the other awareness campaigns that we had launched. There was the continuing medical education program that we had funded just launched on July 26, and we had something like 1,000 viewers of it on day 1. So we are pretty excited about that. Some of the market research that we had done in the quarter, we surveyed a bunch of physicians, and we had what was it, (inaudible) 90% we're unaware of the ASGE changes. So that led us to believe that there were some good opportunity for awareness. So we believe that there's some good opportunity awareness and reasons to be hopeful, but that whole section of the prepared remarks was removed today.

所以我們沒有——我們沒有看到它。因此，我們要討論的一件事是我們一直在做的一些市場研究以及我們發起的其他一些宣傳活動。我們資助的繼續醫學教育項目於 7 月 26 日剛剛啟動，第一天就有大約 1,000 名觀眾。所以我們對此感到非常興奮。我們在本季度所做的一些市場研究，我們調查了一群醫生，我們得到的結果是，（聽不清）90% 我們不知道 ASGE 的變化。因此，這讓我們相信存在一些提高認識的好機會。因此，我們相信存在一些良好的機會意識和充滿希望的理由，但準備好的言論的整個部分今天被刪除了。

Our next question comes from Jim Sidoti with Sidoti & Company.

我們的下一個問題來自 Sidoti & Company 的 Jim Sidoti。

The $55 million of operating expenses that's coming on, can you break that out? Is that primarily SG&A? And can you just break out what's SG&A, what's R&D and other components?

即將到來的 5500 萬美元運營費用，您能透露一下嗎？這主要是SG&A嗎？您能否詳細說明什麼是 SG&A、什麼是研發和其他組成部分？

Yes. Sure, Jim. I can give you a breakdown of that. Breaking down the $55 million, about $40 million is going to be sales and marketing -- that's for the team that we brought over, as Dan mentioned. About $12 million is G&A, including a variety of functions, QA, manufacturing, other back office; and about $3 million is R&D.

是的。當然，吉姆。我可以給你一個詳細的說明。細分 5500 萬美元後，大約 4000 萬美元將用於銷售和營銷——正如 Dan 提到的，這是我們引進的團隊的費用。 G&A 約為 1200 萬美元，包括各種職能、QA、製造、其他後台；大約 300 萬美元用於研發。

And as you said earlier, you've been to this before with CAMBIA and products coming off of exclusivity. How good were you are predicting what happened with CAMBIA, and do you think you're better now? And do you think you'll get a better handle on what will happen with INDOCIN over the next few weeks? Or how long do you think it will take?

正如您之前所說，您之前已經通過 CAMBIA 和獨家產品經歷過這種情況。你對 CAMBIA 發生的事情的預測有多好？你認為你現在做得更好了嗎？您認為在接下來的幾週內您會更好地掌握 INDOCIN 的情況嗎？或者你認為需要多長時間？

In terms of timing, CAMBIA was a known LOE event. We had the Paragraph IV settlement. So we knew everyone was coming January 1 of this year. But we have been preparing, so basically running more games here internally as if it was coming tomorrow. So while I tell you this was a surprise in terms of timing. The team is ready and -- ready to go and responding as we speak.

就時間安排而言，CAMBIA 是一場眾所周知的 LOE 活動。我們達成了第四款和解協議。所以我們知道每個人都會在今年 1 月 1 日來。但我們一直在準備，所以基本上在內部運行更多遊戲，就好像明天就會到來一樣。所以，雖然我告訴你，這在時間上是一個驚喜。該團隊已準備就緒，隨時準備出發，並在我們發言時做出回應。

Our next question comes from Scott Henry from ROTH Capital.

我們的下一個問題來自羅斯資本的斯科特·亨利。

And I apologize I missed a lot of the call. Had some phone problems during travel. But Dan, I did want to ask you just about INDOCIN. When we think about potential generics, how do you think the distribution channel will impact this when we compare it to the potential competition relative to other more traditional products, if at all?

我很抱歉我錯過了很多電話。旅行期間手機出現一些問題。但是丹，我確實想問你有關 INDOCIN 的問題。當我們考慮潛在的仿製藥時，當我們將其與其他更傳統產品的潛在競爭（如果有的話）進行比較時，您認為分銷渠道將如何影響這一點？

I'll try and answer it with the best I can, Scott. The analogs that we look at, there's multiple ways that you can look at an analog in a generic erosion, and one of which is 1 entrant versus 4 in the case of CAMBIA. And it certainly erodes far faster in 1 versus 4 -- or in 4 versus 1. The other way is, it's the -- not just the distribution channel but where it's used. So if it's a retail setting as opposed to hospital -- and in a retail setting it erodes far faster than it does in a hospital, and that tends to be because of the retail pharmacies profit motivation to switch. So what we've seen is that single entrant hospital generics, the brand retains a far greater share and the pricing tends to be better.

我會盡力回答這個問題，斯科特。我們所研究的類似物，您可以通過多種方式來看待一般侵蝕中的類似物，其中之一是 1 個進入者與 4 個進入者（在 CAMBIA 的情況下）。在 1 對 4 或 4 對 1 中，它的侵蝕速度肯定要快得多。另一種方式是，它不僅是分銷渠道，而且是使用它的地方。因此，如果它是零售環境而不是醫院——並且在零售環境中，它的侵蝕速度比在醫院中快得多，這往往是因為零售藥店的利潤動機發生了轉變。因此，我們看到的是，在單一進入的醫院仿製藥中，該品牌保留了更大的份額，而且定價往往更好。

So that is what -- one of the things that gives us some optimism in this particular situation is we have 1 competitor -- it's the hospital setting. It's a difficult to manufacture dosage form, which we've been talking about for years. So supply may not be 100% readily available. So there are a number of factors that would say that this particular situation would lend itself to one where the brand could maintain a decent share of this market going forward.

所以這就是——在這種特殊情況下讓我們感到樂觀的事情之一是我們有一個競爭對手——那就是醫院環境。這是一種難以製造的劑型，我們多年來一直在談論這個問題。因此，供應可能並非 100% 可用。因此，有很多因素表明，這種特殊情況將有利於該品牌在未來保持該市場的可觀份額。

And one other question, and I do apologize if it's competitive. But the ROLVEDON revenues in the quarter $21 million. Was that a relatively same quarter in terms of stocking? I mean, is it fair to say that based on 2Q, was it a roughly $85 million run rate already? Or was there any give or take in the quarter?

還有一個問題，如果它具有競爭力，我深表歉意。但ROLVEDON該季度的營收為2100萬美元。就庫存而言，該季度是否相對相同？我的意思是，根據第二季度，運行費用是否已經達到大約 8500 萬美元，這樣說是否公平？或者本季度是否有任何讓步？

From what I've seen, it's a pretty clean quarter. Good quarter for demand, and they were able to turn on a new account, as Tom said, and it's off to the races from here on.

據我所知，這是一個非常乾淨的季度。正如湯姆所說，這個季度的需求很好，他們能夠開設一個新賬戶，從現在開始就可以開始競爭了。

Thank you. There are currently no further questions at this time. So this concludes our question-and-answer session. I would like to turn the conference back over to Dan Peisert, President and Chief Executive Officer, for the closing remarks.

謝謝。目前沒有進一步的問題。我們的問答環節到此結束。我想將會議轉回總裁兼首席執行官丹·佩塞特 (Dan Pesert) 致閉幕詞。

Thank you. While the news today wasn't as pomp and circumstances we had planned, and we certainly weren't aware that the generic was coming. But it does highlight our strategic need to diversify the business and why the merger of Spectrum was important. We will have some short-term obstacles to overcome, but we are a strong and committed team, and we will overcome them. We are a far stronger company now than we were a few years ago. And I believe that we are well positioned to come through this even stronger and create value for all shareholders. In addition, we've just made a large step in mitigating our legacy legal uncertainties. Thank you, and have a good evening.

謝謝。雖然今天的消息並不像我們計劃的那樣盛況和情況，而且我們當然不知道仿製藥即將上市。但這確實凸顯了我們業務多元化的戰略需求以及 Spectrum 合併的重要性。我們將需要克服一些短期障礙，但我們是一支強大而忠誠的團隊，我們將克服這些障礙。與幾年前相比，我們現在是一家更加強大的公司。我相信，我們有能力渡過難關，變得更加強大，並為所有股東創造價值。此外，我們剛剛在減輕遺留法律不確定性方面邁出了一大步。謝謝您，祝您晚上愉快。

This concludes today's call. You may now disconnect.

今天的電話會議到此結束。您現在可以斷開連接。