Spectrum Pharmaceuticals Inc (SPPI) 2022 Q4 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Spectrum Pharmaceuticals 4Q 2022 Earnings Call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Michael Grabow, Executive Vice President and Chief Financial Officer. Please go ahead.

美好的一天，謝謝你的支持。歡迎來到 Spectrum Pharmaceuticals 2022 年第四季度財報電話會議。 （操作員說明）請注意，今天的會議正在錄製中。我現在想把會議交給今天的演講者，執行副總裁兼首席財務官 Michael Grabow。請繼續。

Thank you, operator. Welcome to Spectrum Pharmaceuticals' Full Year 2022 Earnings Call. With me on today's call are Spectrum's President and Chief Executive Officer, Tom Riga; Executive Vice President and Chief Financial Officer, Nora Brennan; and Senior Vice President, Sales and Marketing, Erin Miller.

謝謝你，運營商。歡迎來到 Spectrum Pharmaceuticals 的 2022 年全年收益電話會議。 Spectrum 總裁兼首席執行官 Tom Riga 和我一起參加今天的電話會議；執行副總裁兼首席財務官 Nora Brennan；以及銷售和營銷高級副總裁 Erin Miller。

Earlier today, Spectrum issued a press release detailing its financial results for the year ended December 31, 2022. This press release and a webcast of this call can be accessed on the Investor Relations section of the Spectrum website at sppirx.com.

今天早些時候，Spectrum 發布了一份新聞稿，詳細介紹了截至 2022 年 12 月 31 日止年度的財務業績。可在 Spectrum 網站 sppirx.com 的投資者關係部分訪問本新聞稿和本次電話會議的網絡廣播。

Before we get started, I would like to reference the notice regarding forward-looking statements included in today's press release. This notice emphasizes the major uncertainties and risks inherent in the forward-looking statements that we will make this morning. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements.

在我們開始之前，我想參考今天新聞稿中包含的有關前瞻性陳述的通知。本通知強調了我們今天上午將做出的前瞻性陳述中固有的主要不確定性和風險。這些陳述不是未來業績的保證，不應過分依賴它們。此類前瞻性陳述必然涉及已知和未知的風險和不確定性，這可能導致未來期間的實際業績和財務結果與此類前瞻性陳述明示或暗示的未來業績或結果的任何預測存在重大差異。

We encourage you to review the company's past and future filings with the SEC, including, without limitation, the company's annual report on Form 10-K and quarterly reports on Form 10-Qs, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements. A telephone replay will be available shortly after completion of this call. The archived webcast will be available for 1 year on our website at sppirx.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held on March 22, 2023. Since then, Spectrum may have made announcements related to the topics discussed, so please refer to the company's most recent press releases and SEC filings.

我們鼓勵您查看公司過去和未來向美國證券交易委員會提交的文件，包括但不限於公司的 10-K 表格年度報告和 10-Q 表格季度報告，這些報告確定了可能導致實際結果或事件的具體因素與這些前瞻性陳述中描述的內容存在重大差異。電話重播將在本次通話結束後不久提供。存檔的網絡廣播將在我們的網站 sppirx.com 上提供 1 年。為了那些可能正在收聽重播或存檔網絡廣播的人的利益，本次電話會議於 2023 年 3 月 22 日舉行。此後，Spectrum 可能發布了與所討論主題相關的公告，因此請參閱公司最新的新聞稿和 SEC 文件。

And with that, I'll turn the call over to Spectrum's President and CEO, Tom Riga.

有了這個，我將把電話轉給 Spectrum 的總裁兼首席執行官湯姆裡加。

Thanks, Mike. Good morning, everybody, and thank you for joining us on today's call. As I begin the fourth quarter and full year 2022 review, I want to acknowledge the energy and enthusiasm we are experiencing within our company. Our early launch trajectory of ROLVEDON has provided a very positive end to the year, and the momentum has continued to build throughout the first quarter of 2023. The optimism within the company is certainly fueled by the launch of ROLVEDON.

謝謝，邁克。大家早上好，感謝您參加今天的電話會議。在我開始第四季度和 2022 年全年回顧之際，我想感謝我們在公司內部感受到的活力和熱情。我們 ROLVEDON 的早期發布軌跡為今年畫上了一個非常積極的句號，並且這種勢頭在整個 2023 年第一季度持續增強。ROLVEDON 的發布無疑助長了公司內部的樂觀情緒。

Additionally, the company experienced a significant amount of change as we pivoted from a development-focused company, into a fully operational commercial organization. A key point of strategic focus throughout 2022 has been to rightsize the company while still meeting our core business objectives and investing in our growth drivers. In 2021, our operating expenses were $147.7 million. And in '22, we are reporting operating expenses today of $81 million. The 45% reduction was intentional and necessary to focus our resources and capitalize on the launch of ROLVEDON. As we move into 2023, we are well-positioned to continue investing in the launch trajectory and life cycle management of the product while maintaining a very disciplined and lean operating structure.

此外，隨著我們從一家專注於發展的公司轉變為一家全面運營的商業組織，公司經歷了巨大的變化。整個 2022 年戰略重點的一個關鍵點是調整公司規模，同時仍然實現我們的核心業務目標並投資於我們的增長動力。 2021 年，我們的運營費用為 1.477 億美元。在 22 年，我們今天報告的運營費用為 8100 萬美元。 45% 的減少是有意且必要的，以集中我們的資源並利用 ROLVEDON 的推出。隨著我們進入 2023 年，我們有能力繼續投資於產品的發布軌跡和生命週期管理，同時保持非常有紀律和精益的運營結構。

The combination of financial discipline and maximizing ROLVEDON's launch will allow us to begin to realize our broader strategic vision. We're not complacent being a single product company and aspire to commercialize and develop a portfolio of cancer treatments for patients in need. However, we understand and are motivated by the fact that our future optionality is largely predicated on the success of ROLVEDON, both commercially and through life cycle management with our same-day dosing study to further differentiate the brand. Today, ROLVEDON's launch is our primary focus, but we are keeping our eye on the horizon, and we'll be ready to use the product's success as a springboard for future opportunities.

財務紀律與 ROLVEDON 上市最大化的結合將使我們能夠開始實現我們更廣泛的戰略願景。作為一家單一產品公司，我們並不自滿，我們渴望為有需要的患者商業化和開發一系列癌症治療方法。然而，我們理解並受到這樣一個事實的激勵，即我們未來的選擇在很大程度上取決於 ROLVEDON 的成功，無論是在商業上還是通過生命週期管理以及我們的當天劑量研究來進一步區分品牌。今天，ROLVEDON 的發布是我們的主要關注點，但我們仍將目光投向地平線，我們將準備好利用該產品的成功作為未來機會的跳板。

Regarding the launch, ROLVEDON is the first novel product to enter the long-acting G-CSF space in over 20 years that is not a biosimilar. We launched ROLVEDON with a disciplined strategy based on a thorough understanding of the oncology market and a team with significant experience in this exact space. In a few moments, you'll be hearing from Erin Miller, our Senior Vice President of Sales and Marketing, who will provide more color on the launch. Erin has extensive growth factor experience, has been in oncology for over 20 years and Spectrum is fortunate to have her leading the charge.

關於上市，ROLVEDON 是 20 多年來第一個進入長效 G-CSF 領域的非生物仿製藥新產品。我們基於對腫瘤學市場的透徹了解以及在該領域擁有豐富經驗的團隊，以嚴格的戰略推出了 ROLVEDON 。稍後，您將收到我們的銷售和營銷高級副總裁 Erin Miller 的來信，她將在發布會上提供更多色彩。 Erin 擁有豐富的生長因子經驗，從事腫瘤學工作 20 多年，Spectrum 很幸運能由她領導。

The fourth quarter of 2022 was the first quarter ROLVEDON was commercially available, and we are pleased with the early reception from our customers. Net sales for the quarter were $10.1 million. As we think about the business, an important indicator of early success is measured by both breadth and depth of use. To set a solid foundation for an oncology launch, it's important to see the largest customers being receptive to the product along with a systematic increase in breadth of overall users. That said, we saw a total of 70 targeted accounts purchasing ROLVEDON during the launch quarter, including the top 3 community oncology networks. Those 3 networks alone represent approximately 22% of the total clinic market.

2022 年第四季度是 ROLVEDON 上市的第一季度，我們對客戶的早期反響感到滿意。本季度的淨銷售額為 1010 萬美元。當我們考慮業務時，早期成功的一個重要指標是通過使用的廣度和深度來衡量的。要為腫瘤藥物的上市奠定堅實的基礎，重要的是要看到最大的客戶對產品的接受度，以及整體用戶範圍的系統性增加。也就是說，我們在發布季度看到總共有 70 個目標客戶購買了 ROLVEDON，其中包括排名前 3 位的社區腫瘤學網絡。僅這 3 個網絡就約佔整個診所市場的 22%。

While we are pleased with the early customer reception to ROLVEDON, we are also acutely aware that it's just that: Early. Our team is motivated by the opportunities in front of us and understand the importance of sustained success over time. For more details on our launch strategy, progress and key drivers of the results, let me turn the call over to Erin.

雖然我們對 ROLVEDON 的早期客戶接待感到滿意，但我們也敏銳地意識到它只是：早期。我們的團隊受到擺在我們面前的機會的激勵，並了解隨著時間的推移持續取得成功的重要性。有關我們的發布策略、進展和結果的主要驅動因素的更多詳細信息，請讓我將電話轉給 Erin。

Thank you, Tom. I'm very happy to be here today to discuss the progress of the ROLVEDON launch. We're launching with a focused strategy and maximizing market opportunities with a nimble and experienced team who are producing early results. As Tom mentioned, we had 70 target accounts at the end of Q4. That number has more than doubled in the first quarter, and the breadth of overall users continues to accelerate.

謝謝你，湯姆。我很高興今天能在這裡討論 ROLVEDON 發布的進展。我們正在推出一個有針對性的戰略，並通過一個敏捷和經驗豐富的團隊來最大化市場機會，他們正在產生早期結果。正如湯姆提到的，我們在第四季度末有 70 個目標客戶。這一數字在第一季度翻了一番多，整體用戶的廣度繼續加快。

Regarding depth, the top customers who began using ROLVEDON in Q4 have continued to appropriately grow utilization within their networks. A key factor in our early success is our highly knowledgeable and connected commercial team. There are 113 systems representing 50% of long-acting G-CSF sales and we knew that our experience navigating those systems would allow us to connect quickly and pull-through early sales. Many of our customers are already recognizing the ROLVEDON value proposition and have proven highly receptive to our messaging and the suite of services that we're offering.

關於深度，在第 4 季度開始使用 ROLVEDON 的頂級客戶在其網絡中的利用率繼續適當增長。我們早期成功的一個關鍵因素是我們知識淵博且聯繫緊密的商業團隊。有 113 個系統代表了長效 G-CSF 銷售額的 50%，我們知道我們在這些系統中的導航經驗將使我們能夠快速連接並推動早期銷售。我們的許多客戶已經認識到 ROLVEDON 的價值主張，並證明對我們的消息傳遞和我們提供的全套服務高度接受。

In a market with tremendous price instability, providers appreciate visibility. As a result, our strategy centers around a provider focus that delivers both short- and long-term predictable value, which creates a great foundation for early adoption and continued growth. As we critically evaluate the early launch metrics, we're finding that the results are aligned with our strategy. Prior to launch, we spent an extensive amount of time focused on understanding customer behavior in each of the 3 long-acting G-CSF segments: Community oncology clinics; 340B; and non-340B hospitals. Our team is engaged with all segments of the business, and is executed on our early pull-through strategy with community oncology clinics who can make product decisions and implement change quickly.

在價格極度不穩定的市場中，供應商重視可見性。因此，我們的戰略以提供短期和長期可預測價值的供應商為中心，這為早期採用和持續增長奠定了良好的基礎。當我們批判性地評估早期發布指標時，我們發現結果與我們的戰略一致。在推出之前，我們花費了大量時間專注於了解客戶在 3 個長效 G-CSF 細分市場中的行為：社區腫瘤診所； 340B;和非 340B 醫院。我們的團隊參與了業務的所有部門，並與社區腫瘤診所一起執行我們的早期拉動戰略，他們可以做出產品決策并快速實施變革。

Moving forward, our plan is to continue to increase utilization in the clinic space while also capitalizing on opportunities within the hospital segment. For instance, in the first quarter, we've been able to expand utilization across specialty distribution networks and group purchasing organizations. Additionally, we're in the process of contracting with our first hospital IDN system and anticipate expanded utilization across all segments.

展望未來，我們的計劃是繼續提高診所空間的利用率，同時利用醫院部門內的機會。例如，在第一季度，我們已經能夠擴大專業分銷網絡和團購組織的利用率。此外，我們正在與我們的第一個醫院 IDN 系統簽訂合同，並預計將擴大對所有部門的使用。

As a novel product that is not a biosimilar, one of the unique features of ROLVEDON is independent reimbursement, not tied to other products. This gives us greater flexibility on pricing and contracting, which allows us to offer customers much needed visibility to make short- and long-term business decisions. As I mentioned earlier, given the current market dynamics, customers are receptive to tailored contracting and value stability and predictability of pricing and reimbursement over time. Additionally, the long-acting G-CSF market requires customers to stock multiple growth factors and they're accustomed to doing so. We believe the unique features of ROLVEDON, combined with the current market dynamics, offer our team an opportunity to grow appropriate utilization and solidify ROLVEDON's position in the market.

作為一種非生物仿製藥的新型產品，ROLVEDON 的獨特之處之一是獨立報銷，不與其他產品掛鉤。這使我們在定價和合同方面具有更大的靈活性，使我們能夠為客戶提供做出短期和長期業務決策所需的可見性。正如我之前提到的，考慮到當前的市場動態，客戶願意接受量身定制的合同以及隨著時間的推移定價和報銷的價值穩定性和可預測性。此外，長效 G-CSF 市場要求客戶儲備多種生長因子，他們已經習慣了這樣做。我們相信 ROLVEDON 的獨特功能，結合當前的市場動態，為我們的團隊提供了增加適當利用率並鞏固 ROLVEDON 在市場中的地位的機會。

While early receptivity is positive, it's not without its challenges. In the long acting growth factor market, there are multiple options for customers to choose, and we knew there would be formidable competitors. One challenge we've encountered since approval is the fact that ROLVEDON claims are currently submitted with a miscellaneous J-code. Customers prefer a permanent J-code because claim submissions and documentation are simplified, offering more reimbursement certainty. In a competitive market, customers are more likely to choose the certainty of a permanent J-code.

雖然早期接受是積極的，但並非沒有挑戰。在長效生長因子市場，有多種選擇供客戶選擇，我們知道會有強大的競爭對手。自批准以來我們遇到的一個挑戰是 ROLVEDON 索賠目前提交時帶有雜項 J 代碼。客戶更喜歡永久性 J 代碼，因為索賠提交和文件簡化，提供更多的報銷確定性。在競爭激烈的市場中，客戶更有可能選擇永久性 J 代碼的確定性。

ROLVEDON was recently assigned its own unique J-code, which goes into effect April 1. This was an important milestone for the product, and it will be very welcomed by our current customers and also remove barriers to utilization with potential new customers.

ROLVEDON 最近獲得了自己獨特的 J 代碼，該代碼將於 4 月 1 日生效。這是該產品的一個重要里程碑，它將受到我們現有客戶的歡迎，並消除潛在新客戶的使用障礙。

In Q4, we announced another important milestone when ROLVEDON was added to the National Comprehensive Cancer Network supportive care guidelines. The NCCN guidelines are a standard resource for determining the best course of treatment and inclusion will go a long way in establishing brand awareness and building customer confidence. Approval in September, followed by the inclusion in NCCN guidelines in December and a permanent J-code on April 1, these are significant accomplishments for the brand and speak to the urgency and capability of our team.

在第四季度，我們宣布了另一個重要的里程碑，即 ROLVEDON 被添加到國家綜合癌症網絡支持性護理指南中。 NCCN 指南是確定最佳治療方案的標準資源，納入該指南將對建立品牌知名度和建立客戶信心大有幫助。 9 月獲得批准，隨後於 12 月被納入 NCCN 指南，並於 4 月 1 日成為永久性 J 代碼，這些都是該品牌的重大成就，也說明了我們團隊的緊迫性和能力。

It's been a very exciting quarter. We've executed our launch strategy and established a strong foundation. We understand that we're just at the beginning of our journey and look forward to building on our initial success. With that, I'll now turn the call over to Nora to discuss the 2022 financial results.

這是一個非常令人興奮的季度。我們已經執行了我們的發布戰略並建立了堅實的基礎。我們明白我們的旅程才剛剛開始，並期待在我們初步成功的基礎上再接再厲。有了這個，我現在將電話轉給諾拉，討論 2022 年的財務業績。

Thank you, Erin. Total net sales for the fourth quarter and for the year ended December 31, 2022, were $10.1 million. During the quarter and year ended December 31, 2022, the cost of sales was $1.8 million, consisting primarily of packaging costs, freight and royalties associated with the net sales of ROLVEDON and $1.1 million of start-up expenses associated with stability and bio-burden testing. This figure did not include any direct costs associated with the manufacturer of ROLVEDON, which were previously expensed in research and development.

謝謝你，艾琳。第四季度和截至 2022 年 12 月 31 日止年度的總淨銷售額為 1010 萬美元。在截至 2022 年 12 月 31 日的季度和年度內，銷售成本為 180 萬美元，主要包括與 ROLVEDON 淨銷售額相關的包裝成本、運費和特許權使用費，以及與穩定性和生物負荷相關的啟動費用 110 萬美元測試。該數字不包括與 ROLVEDON 製造商相關的任何直接成本，這些成本以前用於研發。

Selling, general and administrative expenses for the quarter and year were $11.3 million and $38.8 million, respectively, as compared to $18.9 million and $60.4 million for the comparable periods in 2021. The decrease was primarily due to lower costs associated with personnel-related expenses resulting from a reduction in workforce announced in January 2022 and decreases in professional services and other general expenses.

本季度和年度的銷售、一般和管理費用分別為 1130 萬美元和 3880 萬美元，而 2021 年同期為 1890 萬美元和 6040 萬美元。減少的主要原因是與人事相關費用相關的成本降低來自 2022 年 1 月宣布的裁員以及專業服務和其他一般費用的減少。

Total research and development expenses were $8.7 million and $42.2 million for the quarter and year, respectively, as compared to $18 million and $87.3 million for the comparable period in 2021. The decrease was due to lower program activities for ROLVEDON, poziotinib and early-stage compounds, personnel-related expenditures associated with the reduction in workforce during a strategic restructuring that began in January 2022, as well as a concession provided by Hanmi Pharmaceutical for drug substance, which have been accrued during 2021 and is no longer payable by us.

本季度和年度總研發費用分別為 870 萬美元和 4220 萬美元，而 2021 年同期為 1800 萬美元和 8730 萬美元。減少的原因是 ROLVEDON、poziotinib 和早期階段的項目活動減少化合物、在 2022 年 1 月開始的戰略重組期間與裁員相關的人員相關支出，以及 Hanmi Pharmaceutical 為原料藥提供的特許權，這些費用已在 2021 年產生，我們不再支付。

Net loss from continuing operations was $11.7 million or $0.06 per share for the quarter ended December 31, 2022, compared to a net loss from continuing operations of $39.8 million or $0.26 per share for the comparable period in 2021. Net loss from continuing operations for the year was $78.1 million or $0.43 per share compared to net loss from continuing operations of $158.4 million or $1.02 per share for the comparable period in 2021.

截至 2022 年 12 月 31 日止季度，持續經營淨虧損為 1170 萬美元或每股 0.06 美元，而 2021 年同期持續經營淨虧損為 3980 萬美元或每股 0.26 美元。持續經營淨虧損為2021 年同期的持續經營業務淨虧損為 1.584 億美元或每股 1.02 美元，而 2021 年同期為 7810 萬美元或每股 0.43 美元。

Operating cash burn was approximately $97 million in 2022 as compared to $119.5 million in 2021. The decrease in net cash used in operating activities was primarily due to the decrease in net loss, which was driven by our ongoing strategic efforts to reduce the overall cash burn of the company, offset by decreases in changes in working capital and noncash charges. We ended the fourth quarter with approximately $75.1 million in cash, cash equivalents and marketable securities. We have access to an additional $25 million of financing with SLR Capital Partners, assuming we achieve certain revenue milestones for ROLVEDON. The 2 remaining tranches are available for drawdown at our discretion at various points until November 15, 2023. With this financing and cash on hand, we believe that we have the reserves to fund company operations through 2024.

2022 年的經營現金消耗約為 9700 萬美元，而 2021 年為 1.195 億美元。經營活動中使用的現金淨額減少主要是由於淨虧損減少，這是由於我們為減少整體現金消耗而進行的持續戰略努力所推動的公司的減少被營運資本和非現金費用的變化所抵消。第四季度結束時，我們擁有大約 7510 萬美元的現金、現金等價物和有價證券。假設我們為 ROLVEDON 實現了某些收入里程碑，我們可以從 SLR Capital Partners 獲得額外的 2500 萬美元融資。在 2023 年 11 月 15 日之前，我們可以酌情決定在不同時間點提取剩餘的 2 筆資金。有了這筆融資和手頭現金，我們相信我們有足夠的儲備為公司運營提供資金到 2024 年。

With that, operator, please open the line for questions.

有了這個，接線員，請打開問題線路。

(Operator Instructions) And our first question will come from Maury Raycroft of Jefferies.

（操作員說明）我們的第一個問題將來自 Jefferies 的 Maury Raycroft。

Congrats on the progress. Just wanted to ask on what you're seeing pre J-code and what are post April 1 expectations on predictability of reimbursement? And do you think by having the J-code in place through all of second quarter, would that enable you to provide guidance on your second quarter earnings call?

祝賀進步。只是想問一下您看到的 J 代碼之前的內容以及 4 月 1 日之後對報銷可預測性的期望是什麼？您是否認為通過在整個第二季度實施 J 代碼，是否可以讓您為第二季度的收益電話會議提供指導？

Maury, I think a big accomplishment for the brand was achieving that J-Code in the time because I think that's the important measure here. Getting at April 1, I think, just removes a barrier to customers using the product. And I think ultimately, what that means at the customer level is the cycle time to payment, the clarity of the claim, avoids things like additional documents required and delays in their payments.

Maury，我認為該品牌的一項重大成就是當時實現了 J-Code，因為我認為這是這裡的重要衡量標準。我認為，在 4 月 1 日，只是消除了客戶使用該產品的障礙。我認為最終，這在客戶層面意味著付款的周期時間、索賠的清晰度、避免需要額外文件和延遲付款等事情。

So I think from our perspective, one, seeing the early customer receptivity with the sales we recorded in the fourth quarter despite the hurdle of the miscellaneous J-Code, I think it fuels our enthusiasm for customer receptivity. And we anticipate with a permanent J-Code going into effect April 1, that's just going to remove a barrier to utilization.

因此，我認為從我們的角度來看，第一，儘管存在雜項 J-Code 的障礙，但看到我們在第四季度記錄的銷售額的早期客戶接受度，我認為這激發了我們對客戶接受度的熱情。我們預計永久性 J-Code 將於 4 月 1 日生效，這將消除使用障礙。

It doesn't give us comfort giving guidance. We want to get a few quarters under our belt (inaudible) giving you guidance. But all the measures that we're seeing, whether it be the that we shared today on NCCN and the J-Code or the continued breadth and depth of our utilization are kind of fueling our excitement and our team's energy as they're out engaging with customers.

它並沒有給我們提供指導的安慰。我們希望有幾個季度（聽不清）為您提供指導。但是我們看到的所有措施，無論是我們今天在 NCCN 和 J-Code 上分享的措施，還是我們利用的持續廣度和深度，都在某種程度上激發了我們的興奮和我們團隊的能量，因為他們正在參與與客戶。

Got it. Makes a lot of sense. And with the visibility into pricing that accounts are getting, you mentioned longer-term decisions and tailored contracting. Can you elaborate on what those contracts and contract durations look like?

知道了。很有道理。通過了解客戶獲得的定價，您提到了長期決策和量身定制的合同。您能否詳細說明這些合同和合同期限是什麼樣的？

Yes. So I think the entire value proposition that's central here is the fact that we are an independent BLA, not a biosimilar. And I think what that means is once our ASP is established, we are in direct control of our own discount that we put into the market. So any impact to average selling price over time is at our sole discretion. We're not reliant on anybody else's decision.

是的。所以我認為這裡的核心價值主張是我們是一個獨立的 BLA，而不是生物仿製藥。我認為這意味著一旦我們的 ASP 建立，我們就可以直接控制我們投入市場的折扣。因此，隨著時間的推移對平均售價的任何影響均由我們自行決定。我們不依賴於任何其他人的決定。

For example, how we handle third-party payers, how we discount with end users, those decisions will be centrally made by us. And I think the early customer feedback is they appreciate the fact that we have a long view here to provide stability over time. And I think that's something that's been needed because this marketplace, if you track the ASP, has been anything but stable.

例如，我們如何處理第三方付款人，我們如何與最終用戶打折，這些決定將由我們集中做出。而且我認為早期的客戶反饋是他們很欣賞這樣一個事實，即我們在這裡有長遠的眼光，可以隨著時間的推移提供穩定性。而且我認為這是需要的，因為如果你跟踪 ASP，這個市場一直很不穩定。

Got it. Makes sense. And maybe the last question for me and then I'll hop back in the queue. But just wondering how initial conversations with payers have been going, and how you think about pricing versus biosimilars as you negotiate with customers?

知道了。說得通。也許是我的最後一個問題，然後我會跳回到隊列中。但只是想知道與付款人的初步對話進展如何，以及您在與客戶談判時如何考慮定價與生物仿製藥？

Yes. I think they're certainly an important stakeholder. Our strategy is centered around a provider-centric strategy, but recognizing the importance of third-party payers, we have engaged them. I'll let Erin give some color around the progress we've made.

是的。我認為他們當然是重要的利益相關者。我們的戰略以提供者為中心的戰略為中心，但認識到第三方支付者的重要性，我們已經讓他們參與進來。我會讓 Erin 對我們取得的進展給出一些顏色。

Thanks, Tom. It's a great question. And as Tom mentioned, payers are an important stakeholder in this market. We have engaged with 100% of our target payers, which represent 73% of total insured lives. What we've learned from that engagement is there will be payers that we will not do business with, because our strategic interests are not aligned.

謝謝，湯姆。這是一個很好的問題。正如湯姆所說，付款人是這個市場的重要利益相關者。我們與 100% 的目標付款人進行了接觸，這些付款人佔受保人總數的 73%。我們從這次合作中學到的是，我們不會與之開展業務的付款人，因為我們的戰略利益不一致。

That being said, we do understand they're an important stakeholder. We have 3 payer agreements in place. Those agreements align with our strategy and the goal of providing additional access to providers, while also ensuring that we're keeping our focus on predictability and stability within this market.

話雖如此，我們確實了解他們是重要的利益相關者。我們有 3 份付款人協議。這些協議符合我們的戰略和為提供商提供更多訪問權限的目標，同時也確保我們將重點放在這個市場的可預測性和穩定性上。

And our next question will come from Edward White.

我們的下一個問題將來自愛德華·懷特。

So the first question, Tom, is just as you're working your way through the launch, are you finding that your sales force is rightsized? Or do you see that you have to make any additions? And how should we be thinking about SG&A expenses perhaps directionally, following the fourth quarter results?

所以第一個問題，湯姆，就在您完成發布的過程中，您是否發現您的銷售人員規模合適？或者你看到你必須做任何補充嗎？在第四季度業績之後，我們應該如何定向考慮 SG&A 費用？

Thanks for the question. Let me handle those one at a time. In terms of right size, we had a pretty disciplined strategy out of the gate. It was driven by two things. One is our understanding of the market and what we believed was going to be necessary to achieve success. And I think largely the sales that we're seeing outside of the top line number really speak to on strategy sales. So I think the team is executing quite well.

謝謝你的問題。讓我一次處理這些。就合適的規模而言，我們一開始就制定了非常嚴格的策略。它是由兩件事驅動的。一是我們對市場的理解，以及我們認為取得成功所必需的條件。而且我認為，我們在頂線數字之外看到的銷售額在很大程度上真正說明了戰略銷售。所以我認為團隊執行得很好。

But to your point, we are lean. And as we expand into other parts of the business, and we continue to expand our tentacles, we'll evaluate it. I think as you think about 2023, we're pretty comfortable with the size of the sales force that it exists today, and I don't anticipate significant growth that I would draw your attention to on that particular aspect of the SG&A line.

但就您的觀點而言，我們很精簡。隨著我們擴展到業務的其他部分，並且我們繼續擴大我們的觸角，我們將對其進行評估。我想當你想到 2023 年時，我們對它今天存在的銷售隊伍規模感到非常滿意，而且我預計不會有顯著增長，我會提請你注意 SG&A 系列的那個特定方面。

As you look at expenses, I think what you're seeing here is the R&D line came in at $8.7 million in Q4. That's largely associated with the de-prioritization of poziotinib that is largely included in that number. So I would expect to see 2023 expense line continue to reduce at the level of R&D with offsetting increases in SG&A. I think those were your 2. And if there's something else, let me know.

當您查看費用時，我認為您在這裡看到的是第四季度的研發線收入為 870 萬美元。這在很大程度上與該數字中主要包含的 poziotinib 的優先級降低有關。因此，我預計 2023 年的支出線將在研發層面繼續減少，並抵消 SG&A 的增加。我認為那些是你的 2。如果還有其他事情，請告訴我。

Those were it, Tom. And then just speaking of R&D, what are your current goals in R&D and expectations? You had mentioned that you are looking at a portfolio of cancer treatments. Maybe you can just give us your thoughts on potential internal R&D efforts or business development opportunities?

就是這樣，湯姆。然後就研發而言，您目前在研發方面的目標和期望是什麼？您曾提到您正在研究一系列癌症治療方法。也許您可以告訴我們您對潛在的內部研發工作或業務發展機會的看法？

Yes. So through the change that we've driven in the company, we have maintained a lean and scalable R&D group. My expectation of their focus, as we move into '23, is really centered around 2 things: It's around the same-day dosing study; and the pediatric PMR for ROLVEDON. So those activities will be central to how we execute.

是的。因此，通過我們在公司推動的變革，我們保持了一個精簡且可擴展的研發團隊。當我們進入 23 年時，我對他們的關注重點的期望實際上集中在兩件事上：圍繞當天的劑量研究；和 ROLVEDON 的兒科 PMR。因此，這些活動將是我們執行方式的核心。

We intentionally kept this group scalable because we're obviously optimistic with ROLVEDON. And what I had mentioned in the prepared remarks, is we do aspire to not just be a single product company. And those decisions and discussions will happen over time. But I think it's all starting and stopping with ROLVEDON's success, which is our primary focus today.

我們有意保持這個小組的可擴展性，因為我們顯然對 ROLVEDON 持樂觀態度。我在準備好的發言中提到的是，我們確實渴望不只是一家單一產品公司。這些決定和討論會隨著時間的推移而發生。但我認為這一切都以 ROLVEDON 的成功開始和結束，這是我們今天的主要關注點。

And our next question comes from Reni Benjamin of JMP Securities.

我們的下一個問題來自 JMP Securities 的 Reni Benjamin。

Congratulations on the launch. Maybe just jumping straight in, I think in your prepared remarks, you mentioned that in the first quarter, the number of accounts has doubled. I guess 2 related questions, that is, that would make about 140 accounts. Is it -- can we think about this doubling of accounts translating to a potential doubling of revenues for the first quarter? Or if not, what are the different factors we should be considering?

恭喜上線。也許直接跳進去，我想在你準備好的發言中，你提到在第一季度，賬戶數量翻了一番。我猜想有 2 個相關問題，也就是說，大約有 140 個帳戶。是嗎 - 我們可以考慮將賬戶數量翻一番轉化為第一季度收入的潛在翻番嗎？或者如果不是，我們應該考慮哪些不同的因素？

And as we think about this doubling of accounts, what's the total number of accounts that you are targeting? And how much progress have we made towards that total number?

當我們考慮帳戶數量翻倍時，您的目標帳戶總數是多少？我們在這個總數上取得了多少進展？

Yes. Thanks for the question, Ren. I think the first one, I would not equate a doubling of accounts to a doubling of sales. Because as you know, Ren, an account is not an account. Some of them, just in the example, the top 3 networks within community oncology represent 22% of the sales. So I think the reason we wanted to share that particular metric it's, one, we really value and look at internally because to be successful for the long-term goals, you have to increase the breadth of utilization, both intra-customer and inter-segment and across segments for that matter.

是的。謝謝你的問題，任。我認為第一個，我不會將賬戶翻倍等同於銷售額翻倍。因為如你所知，Ren，賬戶不是賬戶。其中一些，僅在示例中，社區腫瘤學中排名前 3 位的網絡佔銷售額的 22%。因此，我認為我們想要分享該特定指標的原因是，第一，我們真正重視並在內部進行研究，因為要成功實現長期目標，您必須增加客戶內部和客戶間的使用範圍。細分市場和跨細分市場。

So we're seeing those metrics go in the direction that we want to go. So to your question, do we expect growth? Absolutely with those kinds of breadth increases. But I don't think you should be making revenue assessments based on those numbers.

所以我們看到這些指標朝著我們想要的方向發展。那麼對於你的問題，我們是否期望增長？絕對隨著這些寬度的增加。但我認為你不應該根據這些數字進行收入評估。

Okay. And I guess just as we're thinking about the various constituents, right, between community 340B and the non-340B. By the end of the year, how are you kind of viewing what the penetration might be into each of those segments?

好的。我想就像我們正在考慮社區 340B 和非 340B 之間的各種成分一樣。到今年年底，您如何看待每個細分市場的滲透率？

I think we're planning to be systematic. I think as we've -- we've been very consistent with our research leading up to the launch, and it's playing out largely as expected that our strategy was to really start with community oncology given the speed of decision-making and receptivity to the value proposition.

我認為我們計劃是系統化的。我認為我們已經 - 我們一直與我們在發布前的研究非常一致，並且它的結果很大程度上符合預期，我們的戰略是真正從社區腫瘤學開始考慮決策速度和接受度價值主張。

I think I'm encouraged, as Erin had mentioned in her prepared remarks, our first hospital IDN is coming online here in the first quarter. So we are engaging all 3 of those segments. I think the challenge, or the reality of launching a product is there's timing of within each of these segments. There's decisions to either engage or not engage.

正如 Erin 在準備好的發言中提到的那樣，我想我很受鼓舞，我們的第一個醫院 IDN 將在第一季度在這裡上線。因此，我們正在參與所有 3 個細分市場。我認為挑戰或推出產品的現實是每個細分市場都有時機。有參與或不參與的決定。

So what we've tried to do is set up our strategy to enable ourselves to: One, see if there's an opportunity to gain initial interest in a really core segment of the community. And while we work through the P&T process, the decision-making process within each of the other hospital segments, and you're starting to see some of that come to fruition.

因此，我們試圖做的是製定我們的戰略，使我們能夠：第一，看看是否有機會獲得對社區真正核心部分的初步興趣。當我們完成 P&T 流程時，每個其他醫院部門的決策流程，您開始看到其中一些成果。

As it relates to the end of the year, I would expect us to be infused through all 3 segments of the business. But I think the lead driver that's going to be the place of greatest success, early indicators are that's going to be in the community, followed by 340B. And then I think on the trail end would be the non-340B hospitals.

由於涉及到今年年底，我希望我們能夠融入業務的所有 3 個部分。但我認為，領先的驅動力將成為取得最大成功的地方，早期的跡象表明，這將出現在社區中，其次是 340B。然後我認為在尾端將是非 340B 醫院。

Got it. And then just, I guess, one final one from us. Is there anything -- I don't think stockpiling takes place in this particular segment with G-CSF, but maybe I'm wrong. But is there anything that took place in the fourth quarter that might be -- that might have impacted the revenues, obviously, in a positive way that we might not see in subsequent quarters?

知道了。然後，我想，我們的最後一個。有什麼——我不認為在 G-CSF 的這個特定部分會發生儲存，但也許我錯了。但是，第四季度是否有任何事情可能會影響收入，顯然，我們可能不會在隨後的幾個季度看到這種積極的方式？

I'm just trying to get if there was anything that -- if we should be thinking about the trajectory as up from the fourth quarter as opposed to any sort of seasonality or any sort of onetime things that have occurred in the first quarter of launch.

我只是想知道是否有什麼 - 如果我們應該考慮從第四季度開始的軌跡，而不是任何季節性或第一季度發布的任何一次性事件.

No. I think there's dynamics that I'd point out to you to, Ren, in that number. So there's always some initial stockpile, there's -- not stockpiling of -- there's initial purchases that happen at the wholesaler level product becomes available.

不，我想我要向你指出，Ren，在那個數字中有一些動態。因此，總會有一些初始庫存，而不是庫存 - 在批發商級別發生的初始購買產品變得可用。

To your point, it's not in the wholesalers interest or the customers' interest to stockpile product. So we don't see any abnormal purchasing patterns through that. There's tight governors at the wholesaler level and the customer level for that. But there's purchasing patterns in any buy-and-bill oncology product by just the pure mechanisms by which things happen.

就您而言，囤積產品不符合批發商或客戶的利益。因此，我們看不到任何異常的購買模式。為此，批發商層面和客戶層面都有嚴格的監管者。但在任何購買和賬單腫瘤學產品中都存在購買模式，僅僅是通過事情發生的純粹機制。

So let me explain. ASP comes out the second week of the third month of the quarter. I think that a lot of decisions get made in that timing. And I think when you're dealing with contracted oncology, you inevitably see that the third month of the quarter will be larger than the previous two. And that's a function of the mechanism of how rebates are paid and time cost of money. So I think this business, whether it be ROLVEDON or any growth factor, you would typically expect to see the third month of the quarter be higher than the first two.

所以讓我解釋一下。 ASP 在本季度第三個月的第二週發布。我認為很多決定都是在那個時候做出的。而且我認為當你處理合同腫瘤時，你不可避免地會看到本季度的第三個月會比前兩個月更大。這是返利支付機制和資金時間成本的函數。因此，我認為這項業務，無論是 ROLVEDON 還是任何增長因素，您通常都希望看到本季度的第三個月高於前兩個月。

And I think that will shrink over time. But I think the reality of the third month being the biggest will be across growth factor products, especially those that are contracted with a rebate component.

而且我認為這會隨著時間的推移而縮小。但我認為第三個月最大的現實將是所有增長因子產品，尤其是那些與回扣部分簽約的產品。

And our next question will come from Prakhar Agrawal of Cantor Fitzgerald.

我們的下一個問題將來自 Cantor Fitzgerald 的 Prakhar Agrawal。

Congrats on the quarter. So first question, following up on the access question. I think you noted 3 pair agreements in place. So what percentage of covered lives do these represent right now? And where do you expect to be by the end of the year? And I have a quick follow-up.

祝賀這個季度。所以第一個問題，跟進訪問問題。我想你注意到了 3 對協議。那麼這些覆蓋生命目前代表的百分比是多少？你預計到今年年底會在哪裡？我有一個快速的跟進。

Yes. So let me try. And Erin, if there's something you want to add. So I think the way we think about the payer coverage is in the geographies where the receptivity is high, and there is a want and a desire from the end user to increase the eligible population within their book that has a predominant payer, that is a driver for us to look to make those payer agreements.

是的。所以讓我試試。艾琳，如果你想補充什麼。因此，我認為我們考慮付款人覆蓋範圍的方式是在接受度高的地區，最終用戶希望並希望在他們的賬簿中增加有主要付款人的合格人口，這是我們尋求達成這些付款人協議的驅動程序。

So it's very much a provider-centric strategy that enables us to engage the third-party payer based on customer receptivity to the product. So in those agreements that Erin had mentioned that we signed for payer agreements, it actually followed that exact pattern. So customers who engage with the product, who have started using the product and aspire to use it in a deeper concentration of their business, but it may have had a hurdle with one of their predominant payers, that's our signal to engage those contract negotiations with those payers.

因此，這在很大程度上是一種以供應商為中心的戰略，使我們能夠根據客戶對產品的接受程度來吸引第三方付款人。因此，在 Erin 提到的那些我們為付款人協議簽署的協議中，它實際上遵循了那個確切的模式。因此，參與該產品的客戶，已經開始使用該產品並渴望將其用於更深入的業務集中，但可能與他們的主要付款人之一存在障礙，這是我們與他們進行合同談判的信號那些付款人。

So as it relates to where we'll end up with total covered lives at the end of the year, I think that's largely going to be dependent on strategy. So as we continue deepen our position within our customers, we will be critically evaluating the eligible population that have restrictions within that business, and then look to make payer agreements that are beneficial for the [customer of] us well as the stakeholders. In this case, the payer. Erin, anything else?

因此，由於它關係到我們將在年底獲得總覆蓋生命的地方，我認為這在很大程度上取決於戰略。因此，隨著我們繼續深化我們在客戶中的地位，我們將批判性地評估在該業務中有限制的合格人群，然後尋求制定對我們的 [客戶] 和利益相關者有利的付款人協議。在這種情況下，付款人。艾琳，還有什麼事嗎？

No, I'd just say that focus that we have is predictability and stability within this market. So with payers that are willing to engage, have that discussion and understand that focus, we are absolutely willing to engage.

不，我只想說我們的重點是這個市場的可預測性和穩定性。因此，對於願意參與、進行討論並理解重點的付款人，我們絕對願意參與。

Understood. And second question, what has been the receptivity in the hospital segment of 340B and non-340B based on your initial discussions? Is it mostly a timing issue on the uptick with decision from P&T committees, or any other barriers that you need to work through? And has there been any difference between 340B versus non-340B? Appreciate the questions.

明白了。第二個問題，根據您的初步討論，340B 和非 340B 醫院部分的接受度如何？這主要是 P&T 委員會決定上升的時間問題，還是您需要克服的任何其他障礙？ 340B 與非 340B 之間有什麼區別嗎？感謝這些問題。

Yes. Great question. I think one is timing. So that is very real, P&T is real. I think there's other practical strategic challenges that one faces. We are never going to be the least cost alternative. And there are hospital systems that a principal driver of decisions is least cost alternatives. I think those are going to be a challenge.

是的。很好的問題。我認為一個是時機。所以這是非常真實的，P&T 是真實的。我認為人們還面臨著其他實際的戰略挑戰。我們永遠不會成為成本最低的選擇。在一些醫院系統中，決策的主要驅動力是成本最低的替代方案。我認為這些將是一個挑戰。

I think there are also a segment of hospitals, both 340B and non that are more value-centric in their approach. Given the consolidation of many of the community clinics that have become hospitals over the years, I think that thinking has infiltrated many of the large IDN systems. So I think the initial uptake in the hospital segment, certainly today, is about timing. But I don't think we have delusions of grandeur of the challenge that we're going to face in that segment, and we're going to be strategic in how we engage.

我認為還有一部分醫院，包括 340B 和非 340B，在他們的方法中更以價值為中心。考慮到多年來許多已成為醫院的社區診所的合併，我認為這種想法已經滲透到許多大型 IDN 系統中。所以我認為醫院部門的最初接受，當然是今天，是關於時機的。但我不認為我們對我們將在該領域面臨的挑戰抱有幻想，我們將在如何參與方面具有戰略意義。

And our next question will come from Sahil Kazmi of (inaudible).

我們的下一個問題將來自（聽不清）的 Sahil Kazmi。

This Sahil Kazmi asking a couple of questions for Mayank. So congrats on the quarter, team, and I think a bunch of my questions have been addressed. But just curious on the same-day dosing study, if you could provide us an update on enrollment and when we might hear some data from the study, but either from the earlier expansion phase. I know this is open label. So any color you have from the initial signs would be great.

這位 Sahil Kazmi 向 Mayank 提出了幾個問題。所以恭喜這個季度，團隊，我想我的很多問題已經得到解決。但只是對同一天的劑量研究感到好奇，如果你能向我們提供有關註冊的最新信息，以及我們何時可以從該研究中聽到一些數據，但要么來自早期的擴展階段。我知道這是開放標籤。所以你從最初的跡像中得到的任何顏色都會很棒。

Yes, thanks for the question. We're optimistic about this one. That study is up and running. We have a prespecified interim review of safety and efficacy that's projected on the back half of this year. As you mentioned, we did do the expansion into the 30-minute only arm, so I think both the data and the practical realities of utilization fit that particular delivery mechanism. So 30 minutes post chemotherapy is the arm that we're expanding.

是的，謝謝你的提問。我們對此持樂觀態度。該研究正在進行中。我們預計在今年下半年對安全性和有效性進行預先指定的中期審查。正如您所提到的，我們確實擴展到了 30 分鐘的唯一手臂，所以我認為數據和實際使用情況都符合該特定的交付機制。所以化療後 30 分鐘是我們正在擴展的手臂。

We're expecting to have some visibility into that open-label study in the second half of the year, and I think that's going to largely inform if the product is performing in line with what we presented in Miami initially, and then the early data that was presented on what we believe how the drug could perform. So second half of the year.

我們希望在今年下半年對該開放標籤研究有一些了解，我認為這將在很大程度上說明該產品的表現是否與我們最初在邁阿密展示的一致，然後是早期數據這是關於我們認為該藥物如何發揮作用的內容。那麼下半年。

Very helpful. And maybe as a brief follow-up, assuming we see some positive data here. Can you talk about the impact across the different distribution channels, be it the community oncology setting or the 340B, non-340B hospitals?

很有幫助。也許作為一個簡短的後續行動，假設我們在這裡看到一些積極的數據。您能否談談不同分銷渠道的影響，無論是社區腫瘤學環境還是 340B、非 340B 醫院？

I think the first thing -- if your question is specific to same-day dosing, I think depending on the outcome, we would have more conviction on a path, whether that be going to chat with FDA about a regulatory path forward, whether it's publication, it's really contingent upon what we see in that data.

我認為第一件事——如果你的問題是特定於當天給藥的，我認為根據結果，我們會對一條道路更有信心，無論是與 FDA 討論監管的前進道路，還是出版物，這實際上取決於我們在該數據中看到的內容。

So I think as it relates to distribution, commercialization, today we are focused and really pleased with what we're seeing with what we have in the bag, and that is our non-inferiority label given 24 hours post chemo. So I think here in the near-term, we are executing that strategy and that strategy alone. And then once we have visibility to the performance on the back half of the year, we could make a decision on what the appropriate next step of that strategy would be.

所以我認為，因為它與分銷、商業化有關，今天我們專注於我們所看到的以及我們袋子裡的東西，這就是我們在化療後 24 小時給出的非劣效性標籤。所以我認為在短期內，我們正在單獨執行該戰略和該戰略。然後，一旦我們了解了下半年的業績，我們就可以決定該戰略的下一步是什麼。

And should the data be overwhelmingly positive, we would be aggressive in our approach. Should it be underwhelming, we'd obviously take action there, too. But we're obviously hoping that the data that's produced is representative of what we've seen in the earlier work.

如果數據非常積極，我們將採取積極進取的方法。如果它沒有給人留下深刻印象，我們顯然也會在那裡採取行動。但我們顯然希望產生的數據能夠代表我們在早期工作中看到的情況。

Excellent. Congratulations on all the progress.

出色的。祝賀所有的進步。

And I'm showing no further questions. I would now like to turn the conference back to Tom Riga, CEO, for closing remarks.

我沒有再提出任何問題。我現在想把會議轉回給首席執行官湯姆·裡加 (Tom Riga) 作閉幕詞。

Thank you, everybody, for your participation on the call today as well as your interest in Spectrum. On the heels of a strong launch quarter, enthusiasm is high at the company and with our customers, and we're looking forward to the future. As always, if you have questions, feel free to reach out. Thanks for joining.

謝謝大家今天參加電話會議以及您對 Spectrum 的興趣。在強勁的發布季度之後，公司和客戶的熱情高漲，我們對未來充滿期待。與往常一樣，如果您有任何疑問，請隨時與我們聯繫。感謝您的加入。

And this concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。