Dynavax Technologies Corp (DVAX) 2023 Q1 法說會逐字稿

Good day, ladies and gentlemen, and welcome to Dynavax Technologies First Quarter 2023 Financial Results Conference Call. As a reminder, this conference is being recorded. (Operator Instructions) I would now like to turn the call over to Paul Cox, Vice President, Investor Relations and Corporate Communications. You may begin.

女士們先生們，美好的一天，歡迎來到 Dynavax Technologies 2023 年第一季度財務業績電話會議。提醒一下，這次會議正在錄製中。 （操作員說明）我現在想把電話轉給投資者關係和企業傳播副總裁 Paul Cox。你可以開始了。

Thank you, Norma. Good afternoon, and welcome to the Dynavax first quarter 2023 financial results and corporate update conference call. In addition to our press release issued today, a supplementary slide presentation that accompanies today's call is available in the Events section of our website.

謝謝你，諾瑪。下午好，歡迎來到 Dynavax 2023 年第一季度財務業績和公司更新電話會議。除了我們今天發布的新聞稿外，我們網站的“活動”部分還提供了伴隨今天電話會議的補充幻燈片演示。

Before we begin, I advise you that we will be making forward-looking statements today based on our current expectations and beliefs, including, but not limited to, potential market sizes, market segmentation, future expected market share and related growth rates and related ACIP recommendation impact on each financial guidance and trends, including revenue, profitability and sufficiency of current capitalization, timing and results of clinical trial starts and data readouts and potential future uses of or demand for our CpG 1018 adjuvant.

在我們開始之前，我建議您，我們今天將根據我們當前的預期和信念做出前瞻性陳述，包括但不限於潛在市場規模、市場細分、未來預期市場份額和相關增長率以及相關 ACIP推薦對每項財務指導和趨勢的影響，包括收入、盈利能力和當前資本化的充足性、臨床試驗開始的時間和結果、數據讀數以及我們 CpG 1018 佐劑的潛在未來用途或需求。

These statements involve risks and uncertainties, and our actual results may differ materially. These risks are summarized in today's press release and detailed in the Risk Factors section of our SEC filings, including today's quarterly report on Form 10-Q. Our forward-looking statements speak as of today, and we undertake no obligation to update such statements. Joining me on the call today are Ryan Spencer, Chief Executive Officer; Donn Casale, Chief Commercial Officer; Rob Janssen, Chief Medical Officer; and Kelly MacDonald, Chief Financial Officer.

這些陳述涉及風險和不確定性，我們的實際結果可能存在重大差異。這些風險在今天的新聞稿中進行了總結，並在我們提交給美國證券交易委員會的文件中的風險因素部分進行了詳細說明，包括今天的 10-Q 表季度報告。我們的前瞻性陳述截至今天，我們不承擔更新此類陳述的義務。今天和我一起參加電話會議的是首席執行官 Ryan Spencer；首席商務官 Donn Casale； Rob Janssen，首席醫療官；和首席財務官凱利·麥克唐納 (Kelly MacDonald)。

I'll now turn the call over to Ryan.

我現在將電話轉給瑞安。

Thank you, Paul, and thank you all for joining us today. We're excited to update you on our continued progress in the first quarter as we execute across our core strategic priorities. First and foremost, we are focused on driving growth for our commercial product, HEPLISAV-B, our adult vaccine for Hepatitis B. In the first quarter, we were pleased to achieve record quarterly net product revenue once again through HEPLISAV-B and continued market share gains, both in total market share and in the key market segments that are expected to drive the long-term growth.

謝謝你，保羅，感謝大家今天加入我們。我們很高興向您介紹我們在執行核心戰略優先事項時第一季度的持續進展。首先，我們專注於推動我們的商業產品 HEPLISAV-B 的增長，這是我們的乙型肝炎成人疫苗。第一季度，我們很高興通過 HEPLISAV-B 和持續的市場再次實現創紀錄的季度淨產品收入份額增長，包括總市場份額和預計將推動長期增長的關鍵細分市場。

The tremendous results this quarter even exceeded our own expectations. We are encouraged by the continued market adoption of HEPLISAV-B driven in part by the expanded ACIP recommendation for adult Hepatitis B vaccination and look forward to demonstrating continued revenue and market share growth this year. Last year, HEPLISAV-B revenue doubled compared to 2021, and we anticipate continued annual revenue growth for HEPLISAV-B in 2023 in the range of 30% to nearly 50%. The Q1 revenue increasing 109% compared to Q1 of last year. We are already on track to achieve a fourth year of record revenue for HEPLISAV-B.

本季度的巨大成果甚至超出了我們自己的預期。我們對 HEPLISAV-B 的持續市場採用感到鼓舞，部分原因是 ACIP 對成人乙型肝炎疫苗接種的擴大建議，並期待今年的收入和市場份額持續增長。去年，HEPLISAV-B 的收入比 2021 年翻了一番，我們預計 HEPLISAV-B 的年收入在 2023 年將繼續增長 30% 至近 50%。與去年第一季度相比，第一季度收入增長了 109%。我們已經有望實現 HEPLISAV-B 第四年創紀錄的收入。

Donn will review our commercial progress in more detail in a few minutes. We continue to build on the strong executional foundation late in 2022 through further advancement of our pipeline as we progress our three adjuvanted vaccine clinical stage candidates for Tdap, shingles and plague and continue to identify new opportunities to leverage CpG 1018 in our preclinical efforts, both internally and through our collaboration. Rob will walk through our expected progress for our clinical programs this year in detail later on in the call. Based on our strong execution, we are in a financial position that enables us to support our efforts to maximize the HEPLISAV-B opportunity while making the appropriate investments to advance our clinical stage portfolio.

Donn 將在幾分鐘內更詳細地回顧我們的商業進展。我們將繼續在 2022 年末通過進一步推進我們的產品線建立強大的執行基礎，因為我們正在推進針對 Tdap、帶狀皰疹和鼠疫的三種佐劑疫苗臨床階段候選藥物，並繼續尋找新的機會在我們的臨床前工作中利用 CpG 1018，兩者在內部和通過我們的合作。 Rob 將在稍後的電話會議中詳細介紹我們今年臨床計劃的預期進展。基於我們強大的執行力，我們的財務狀況使我們能夠支持我們努力最大化 HEPLISAV-B 機會，同時進行適當的投資以推進我們的臨床階段產品組合。

In addition, backed by the continued HEPLISAV-B growth and our strong cash position, we are actively working to identify and review strategic opportunities to accelerate our growth. Our initial prioritization of external opportunities include the following two categories: commercial or late-stage assets in the vaccine space to leverage our expertise in the field and our fully integrated capability and high synergy commercial assets within the infectious disease space that would broaden our focus to include therapeutic modalities outside of vaccines. We remain focused on a disciplined capital allocation strategy in our efforts to generate significant value and accelerate growth, and we look forward to providing updates on this front in the future.

此外，在 HEPLISAV-B 持續增長和我們強大的現金狀況的支持下，我們正在積極努力識別和審查戰略機會以加速我們的增長。我們最初對外部機會的優先排序包括以下兩類：疫苗領域的商業或後期資產，以利用我們在該領域的專業知識，以及我們在傳染病領域的完全整合能力和高協同商業資產，這將擴大我們的重點包括疫苗以外的治療方式。在我們努力創造重要價值和加速增長的過程中，我們仍然專注於嚴格的資本配置戰略，我們期待在未來提供這方面的最新信息。

I'll now turn the call over to Donn to provide more details on the tremendous HEPLISAV-B performance in the first quarter.

我現在將電話轉給 Donn，以提供有關第一季度 HEPLISAV-B 出色性能的更多詳細信息。

Thank you, Ryan. I'm excited to share more details about the very strong performance for HEPLISAV-B in the first quarter and our continued progress in capturing market share for the brand. As a reminder, HEPLISAV-B is the first and only FDA-approved adult Hepatitis B vaccine that allows series completion with only 2 doses in 1 month. Series completion is essential for high levels of protection. In an era of universal Hepatitis B recommendation, 2 dose HEPLISAV-B can make series completion easier and protect more patients faster than a 3-dose regimen. As Ryan stated, HEPLISAV-B's performance in the first quarter exceeded our expectations.

謝謝你，瑞安。我很高興與大家分享有關 HEPLISAV-B 在第一季度非常強勁的表現以及我們在為該品牌奪取市場份額方面持續取得進展的更多細節。提醒一下，HEPLISAV-B 是第一個也是唯一一個獲得 FDA 批准的成人乙型肝炎疫苗，只需在 1 個月內接種 2 劑即可完成系列接種。系列完成對於高水平保護至關重要。在普遍推薦乙型肝炎的時代，2 劑 HEPLISAV-B 可以使系列更容易完成，並比 3 劑方案更快地保護更多患者。正如 Ryan 所說，HEPLISAV-B 在第一季度的表現超出了我們的預期。

In the quarter, net product revenue for HEPLISAV-B grew 109% year-over-year. This significant revenue growth in the U.S. was driven by several factors. First, the Hepatitis B market continues to grow in the U.S. following the ACIP universal recommendation for Hepatitis B vaccination. The ACIP's recommendation that all adult age 19 to 59 receive Hepatitis B vaccination significantly expands the number of adults in the U.S. who are recommended to be vaccinated. Hepatitis B now has the second highest addressable adult population for vaccination in the U.S., more than shingles and pneumococcal vaccination and a second only to flu.

本季度，HEPLISAV-B 的淨產品收入同比增長 109%。美國收入的顯著增長是由多種因素推動的。首先，根據 ACIP 對乙肝疫苗接種的普遍建議，乙肝市場在美國繼續增長。 ACIP 建議所有 19 至 59 歲的成年人都接種乙型肝炎疫苗，這大大增加了美國建議接種疫苗的成年人人數。乙型肝炎現在在美國擁有第二高的疫苗接種可尋址成人人口，超過帶狀皰疹和肺炎球菌疫苗接種，僅次於流感。

This represents a large and growing market opportunity. We continue to believe this recommendation will be a significant catalyst for growth and estimate the Hepatitis B market opportunity in the U.S. could grow to over $800 million by 2027. During the first quarter, we observed Hepatitis B vaccine market growth of approximately 45% year-over-year. This significant market growth was due to a return to routine healthcare operations plus market expansion as a result of the ACIP universal recommendation. The second factor underlying HEPLISAV-B's performance is the continued positive trend towards securing a majority market share within the expanding Hepatitis B market.

這代表著巨大且不斷增長的市場機會。我們仍然相信這一建議將成為增長的重要催化劑，並估計到 2027 年美國乙型肝炎市場機會可能增長到超過 8 億美元。在第一季度，我們觀察到乙型肝炎疫苗市場年增長率約為 45%-超過一年。這一顯著的市場增長是由於恢復了常規醫療保健業務以及 ACIP 普遍建議導致的市場擴張。 HEPLISAV-B 業績背後的第二個因素是在不斷擴大的乙型肝炎市場中確保多數市場份額的持續積極趨勢。

We continue to demonstrate gains in market share quarter-over-quarter and estimate that HEPLISAV-B's total market share increased to approximately 37% compared to approximately 26% at the end of the first quarter last year and only 14% in Q1 of 2021. The 37% market share in Q1 also demonstrated sequential market share growth from Q4 of last year where HEPLISAV-B had a 35% share. We continue to be very encouraged by this positive trend towards capturing a majority market share by 2027. The third factor driving growth for HEPLISAV-B is strong performance in two critical market segments: retail pharmacy and integrated delivery networks, or IDNs.

我們繼續證明市場份額環比增長，並估計 HEPLISAV-B 的總市場份額增加至約 37%，而去年第一季度末約為 26%，2021 年第一季度僅為 14%。第一季度 37% 的市場份額也顯示了與去年第四季度相比連續的市場份額增長，其中 HEPLISAV-B 擁有 35% 的份額。這一到 2027 年佔據大部分市場份額的積極趨勢繼續令我們感到非常鼓舞。推動 HEPLISAV-B 增長的第三個因素是在兩個關鍵市場領域的強勁表現：零售藥房和綜合配送網絡，或 IDN。

For the Retail segment, HEPLISAV-B's market share increased to approximately 49% in Q1 compared to approximately 28% at the end of the first quarter of last year. We have made tremendous progress with the top 10 retail pharmacy chains in the U.S., characterized by increases in initial purchases and reordering at higher volumes with several large national chains making HEPLISAV-B their preferred adult Hepatitis B vaccine. Additionally, during the quarter, we initiated collaborative marketing initiatives with 3 of the top 4 national retail chains, demonstrating the continued excitement around HEPLISAV-B and the ACIP universal opportunity.

在零售領域，HEPLISAV-B 在第一季度的市場份額從去年第一季度末的約 28% 增加到約 49%。我們與美國前 10 大零售藥店連鎖店取得了巨大進展，其特點是初始購買量增加和重新訂購量增加，幾家大型全國連鎖店使 HEPLISAV-B 成為他們首選的成人乙型肝炎疫苗。此外，在本季度，我們與全國 4 大零售連鎖店中的 3 家發起了協作營銷計劃，展示了圍繞 HEPLISAV-B 和 ACIP 普遍機會的持續興奮。

For IDN, at the end of the first quarter, HEPLISAV-B's market share increased to approximately 49% compared to approximately 33% at the end of the first quarter last year. Similar to retail in the IDN segment, we are continuing to see strong conversion from large customers that adopted the ACIP universal recommendation, driving meaningful increases in their Hepatitis B purchases that continue to exceed 2019 pre-pandemic levels. We believe the retail and IDN segments will see most of the anticipated market growth from the ACIP universal recommendation.

對於 IDN，在第一季度末，HEPLISAV-B 的市場份額從去年第一季度末的約 33% 增加到約 49%。與 IDN 細分市場的零售類似，我們繼續看到採用 ACIP 普遍建議的大客戶的強勁轉化，推動他們的乙型肝炎購買量顯著增加，繼續超過 2019 年大流行前的水平。我們相信零售和 IDN 細分市場將從 ACIP 通用建議中看到大部分預期的市場增長。

Both segments have required institutional control, infrastructure, capabilities and patient volumes that can drive universal uptake. We expect these two segments will represent approximately 60% of the Hepatitis B market by 2027 compared to approximately 44% in 2022. We are well-positioned in both segments with HEPLISAV-B now making up approximately 50% of the market share across these two segments. We have established long-term relationships with key vaccine decision makers, along with a deep understanding of the buying process and operational levers that can help us drive ACIP universal recommendation uptake.

這兩個細分市場都需要能夠推動普遍接受的機構控制、基礎設施、能力和患者數量。我們預計到 2027 年這兩個細分市場將佔乙型肝炎市場的約 60%，而 2022 年約為 44%。我們在這兩個細分市場都處於有利地位，HEPLISAV-B 現在約佔這兩個市場份額的 50%段。我們與關鍵的疫苗決策者建立了長期關係，並且對購買流程和運營槓桿有深刻的了解，這可以幫助我們推動 ACIP 普遍推薦的採納。

This exciting progress has supported our shift in strategy from a market share-only approach to increasing our focus on market expansion in the retail and IDN segments. In summary, we are very encouraged by our continued progress and momentum in the key segments of retail and IDN, both of which significantly contributed to the performance of HEPLISAV-B exceeding our expectations in the first quarter. In 2023, we forecast the Hepatitis B market opportunity will grow 15% to 25% from 2022 levels and exceed 2019 utilization, showing not only a complete rebound from pandemic-related disruptions of the market but continued further growth being driven by the ACIP universal recommendation.

這一激動人心的進展支持我們將戰略從僅關注市場份額的方法轉變為更加關注零售和 IDN 領域的市場擴張。總而言之，我們對我們在零售和 IDN 關鍵領域的持續進步和勢頭感到非常鼓舞，這兩個領域都對 HEPLISAV-B 在第一季度超出我們預期的表現做出了重大貢獻。到 2023 年，我們預測乙型肝炎市場機會將從 2022 年的水平增長 15% 至 25%，並超過 2019 年的利用率，這不僅顯示出從大流行相關的市場中斷中完全反彈，而且在 ACIP 普遍建議的推動下繼續進一步增長.

In addition to total market growth, we expect HEPLISAV-B will continue to increase its market share across all segments, most notably in retail and IDN. I continue to be proud of our team's strong commercial execution, and we remain very confident in our ability to continue this momentum as we strive to capture a majority market share for HEPLISAV-B.

除了總體市場增長外，我們預計 HEPLISAV-B 將繼續增加其在所有領域的市場份額，尤其是在零售和 IDN 領域。我繼續為我們團隊強大的商業執行力感到自豪，並且我們對繼續保持這一勢頭的能力充滿信心，因為我們努力為 HEPLISAV-B 爭取大部分市場份額。

I will now turn the call over to Rob to take you through our clinical pipeline.

我現在將電話轉給 Rob，帶您了解我們的臨床管道。

Thank you, Donn. We're focused on advancing an innovative and diversified vaccine pipeline, leveraging our CpG 1018 adjuvant with proven antigens. Our goal is to build an adult vaccine portfolio of best-in-class products. We're currently advancing clinical programs for 3 adjuvanted vaccines, Tdap, shingles and plague. We're also exploring multiple innovative preclinical and discovery efforts with leading collaborators. Starting with our Tetanus, diphtheria and pertussis or Tdap program we believe our CpG 1018 adjuvant has the potential to improve the durability of protection against pertussis by redirecting T cells and enhancing protective antibody responses in a booster vaccine.

謝謝你，唐恩。我們專注於推進創新和多樣化的疫苗管道，利用我們的 CpG 1018 佐劑和經過驗證的抗原。我們的目標是建立一流產品的成人疫苗組合。我們目前正在推進 3 種佐劑疫苗、Tdap、帶狀皰疹和鼠疫的臨床計劃。我們還與領先的合作者一起探索多項創新的臨床前和發現工作。從我們的破傷風、白喉和百日咳或 Tdap 計劃開始，我們相信我們的 CpG 1018 佐劑有可能通過重定向 T 細胞和增強加強疫苗中的保護性抗體反應來提高對百日咳保護的持久性。

Last year, we completed a Phase I clinical trial, evaluating an improved Tdap vaccine that utilizes our CpG 1018 adjuvant. Adult and adolescent safety data from this study demonstrated the vaccine candidate was well tolerated without observed safety concerns. Adult immunogenicity results were consistent with our expectations and support continued advancement of the vaccine candidate. This year, we plan to make important progress with the Tdap program. We're completing a non-human primate pertussis challenge study that was designed to assess the impact on prevention of disease and nasal colonization as well as T cell responses.

去年，我們完成了 I 期臨床試驗，評估了一種使用我們的 CpG 1018 佐劑的改進型 Tdap 疫苗。這項研究的成人和青少年安全數據表明，候選疫苗耐受性良好，沒有觀察到安全問題。成人免疫原性結果與我們的預期一致，支持候選疫苗的持續發展。今年，我們計劃在 Tdap 計劃方面取得重要進展。我們正在完成一項非人類靈長類動物百日咳挑戰研究，該研究旨在評估對預防疾病和鼻定植以及 T 細胞反應的影響。

Data are anticipated in mid-2023. We also plan to discuss the clinical and regulatory pathways with the FDA this year. We expect to provide an update on the next steps for this program, including our planned human challenge study following that interaction. Now we also continue to advance our shingles vaccine program. We believe the CpG 1018 adjuvant mechanism of action is ideal for an improved shingles vaccine due to its demonstrated good tolerability and its ability to generate high levels of both antibodies and CD4-positive T cells, which are key in controlling reactivation of the zoster virus and preventing shingles.

數據預計在 2023 年年中。我們還計劃在今年與 FDA 討論臨床和監管途徑。我們希望提供有關該計劃後續步驟的最新信息，包括我們計劃在該交互之後進行的人類挑戰研究。現在我們還繼續推進我們的帶狀皰疹疫苗計劃。我們認為 CpG 1018 佐劑作用機制是改進帶狀皰疹疫苗的理想選擇，因為它表現出良好的耐受性以及產生高水平抗體和 CD4 陽性 T 細胞的能力，這是控制帶狀皰疹病毒再激活的關鍵，預防帶狀皰疹。

In January, we reported topline results from our Phase I clinical trial designed to evaluate our investigational shingles vaccine utilizing different regimens of CpG 1018 adjuvant. The Phase I results have been accepted for an oral presentation at the 2023 Annual Conference on Vaccinology Research or ACVR on June 6. With these data in hand, we plan on discussing the regulatory path forward with the FDA this year. Now over the course of the year, we expect to complete GMP manufacturing of GE antigen to support initiation of a Phase I/II study in early 2024. This study will evaluate various dose levels of GE plus CpG 1018 adjuvant.

1 月，我們報告了 I 期臨床試驗的主要結果，該試驗旨在評估我們使用不同 CpG 1018 佐劑方案的研究性帶狀皰疹疫苗。 I 期結果已在 6 月 6 日的 2023 年疫苗學研究年會或 ACVR 上接受口頭報告。有了這些數據，我們計劃今年與 FDA 討論監管路徑。現在，在今年的過程中，我們預計將完成 GE 抗原的 GMP 製造，以支持在 2024 年初啟動 I/II 期研究。該研究將評估 GE 加 CpG 1018 佐劑的各種劑量水平。

Moving on to the plague program; we're conducting a Phase II trial evaluating the immunogenicity, safety and tolerability of a 2-dose rF1V-plague vaccine candidate adjuvanted with CpG 1018. This is a collaboration with and funded by the U.S. Department of Defense or DoD. The CpG 1018 adjuvanted vaccine candidate's mechanism of action has the potential to speed up time to protection with fewer doses compared to the 3-dose vaccine under development by the DoD. In January, we successfully completed Part 1 of the clinical trial. Both CpG 1018 adjuvanted arms met the Part 1 primary endpoint by demonstrating a greater than twofold increase in antibodies over the alum adjuvanted control arm after 2 doses.

繼續進行瘟疫計劃；我們正在進行一項 II 期試驗，評估以 CpG 1018 為佐劑的 2 劑 rF1V 鼠疫候選疫苗的免疫原性、安全性和耐受性。這是與美國國防部或 DoD 合作並由其資助的。與 DoD 正在開發的 3 劑疫苗相比，CpG 1018 佐劑候選疫苗的作用機制有可能以更少的劑量加快保護時間。一月份，我們成功完成了臨床試驗的第 1 部分。兩個 CpG 1018 佐劑組都達到了第 1 部分的主要終點，證明在 2 劑後抗體比明礬佐劑對照組增加了兩倍以上。

The DoD approved continuing to Part 2 of the Phase II program, and we're pleased to announce today that we recently completed enrollment in Part 2. Topline data are anticipated in 2024. The advancement of our clinical candidates is a core priority. We're confident in our strategy to leverage the proven profile of CpG 1018 to develop new and improved vaccine candidates that provide significant opportunities to address important unmet medical needs.

國防部批准繼續進行第二階段計劃的第 2 部分，我們今天很高興地宣布，我們最近完成了第 2 部分的註冊。頂線數據預計在 2024 年獲得。我們的臨床候選人的進步是一個核心優先事項。我們對我們的戰略充滿信心，即利用 CpG 1018 的成熟特徵開發新的和改進的候選疫苗，為解決重要的未滿足醫療需求提供重要機會。

I'll now turn the call over to Kelly to review our financial results.

我現在將電話轉給凱利來審查我們的財務業績。

Thank you, Rob. I'm pleased to report on another quarter of strong financial execution. I'll review the key financial results from the first quarter and then review our full year 2023 guidance and provide a few closing thoughts. Please note that all financial comparisons are versus the prior year period unless otherwise noted. Please also refer to our press release and Form 10-Q for detailed financial information. Starting with revenue; total revenues for the first quarter of 2023 were $47 million, driven by HEPLISAV-B net product revenue of $44 million. Compared to the first quarter of last year, HEPLISAV-B net product revenue represented an increase of 109%. We are excited about the continued growth of the brand, which is tracking to the higher end of our revenue expectations for the full year.

謝謝你，羅布。我很高興地報告另一個季度強勁的財務執行情況。我將回顧第一季度的主要財務業績，然後回顧我們的 2023 年全年指引並提供一些結束語。請注意，除非另有說明，否則所有財務比較均與上一年同期相比。另請參閱我們的新聞稿和 10-Q 表，了解詳細的財務信息。從收入開始； 2023 年第一季度的總收入為 4700 萬美元，這主要受 HEPLISAV-B 產品淨收入 4400 萬美元的推動。與去年第一季度相比，HEPLISAV-B 淨產品收入增長了 109%。我們對該品牌的持續增長感到興奮，該品牌正朝著我們全年收入預期的高端邁進。

We are also pleased with the continued trend in the margin profile for HEPLISAV-B with gross margins expected to exceed 70% for the year despite certain onetime charges related to improvement projects at the Germany manufacturing facility in the first quarter. Other revenue was $4 million for the first quarter, representing revenue related to the plague vaccine program in collaboration with and fully funded by the U.S. Department of Defense. We continue to be pleased with the progress of this program and the collaboration with the DoD.

我們還對 HEPLISAV-B 利潤率的持續趨勢感到滿意，儘管第一季度與德國製造工廠的改進項目相關的某些一次性費用預計全年毛利率將超過 70%。第一季度的其他收入為 400 萬美元，代表與美國國防部合作並由其全額資助的鼠疫疫苗計劃相關的收入。我們繼續對該計劃的進展以及與國防部的合作感到高興。

Turning to CpG 1018 adjuvant supply for COVID-19 vaccine; as expected, we did not record any COVID-19-related revenue this quarter. As we have previously indicated, we believe our customers have sufficient adjuvant stockpile to fulfill their near-term demand, translating to minimal to as little as zero COVID-19-related adjuvant sales for Dynavax in 2023. As we progress throughout the year and as we gain clarity around the endemic demand of COVID-19 vaccines for our customers, we will provide updates around any potential future commercial supply agreements for 2024 and beyond.

轉向 COVID-19 疫苗的 CpG 1018 佐劑供應；正如預期的那樣，本季度我們沒有記錄任何與 COVID-19 相關的收入。正如我們之前所指出的，我們相信我們的客戶有足夠的佐劑庫存來滿足他們的近期需求，這意味著 2023 年 Dynavax 與 COVID-19 相關的佐劑銷售額最少甚至為零。隨著我們全年的進展和我們清楚地了解了客戶對 COVID-19 疫苗的地方性需求，我們將提供有關 2024 年及以後任何潛在的未來商業供應協議的最新信息。

We continue to collect on amounts outstanding from our COVID-19 CpG 1018 adjuvant supply customers. As a reminder, early in the pandemic, CEPI provided funding to Dynavax in the form of a fully forgivable loan to support CpG 1018 adjuvant supply to CEPI partners, including Biological E., who has developed and supplied its COVID-19 vaccine CORBEVAX to the Government of India. During the first quarter, the credit profile for Biological E. was negatively impacted as its cash collections from the Government of India for CORBEVAX has been significantly reduced and delayed.

我們繼續向我們的 COVID-19 CpG 1018 佐劑供應客戶收取欠款。提醒一下，在大流行初期，CEPI 以完全可免除貸款的形式向 Dynavax 提供資金，以支持向 CEPI 合作夥伴（包括 Biological E.）供應 CpG 1018 佐劑，後者開發了 COVID-19 疫苗 CORBEVAX 並將其提供給印度政府。在第一季度，Biological E.的信用狀況受到負面影響，因為其從印度政府收取的 CORBEVAX 現金已大幅減少和延遲。

Accordingly, in April 2023, we entered into agreements with Biological E. and CEPI to resolve the remaining amounts due from biologically and to fully forgive the corresponding CEPI advanced payments. This resolution resulted in approximately $12 million in bad debt expense during the first quarter, reflecting uncollectible amounts. And we used only $1 million outstanding as of today from Biological E., which we expect to collect later this year. Overall, we continue to be very proud of the way we've navigated such a complex and dynamic environment and our meaningful role in the global response to the pandemic, delivering CpG 1018 adjuvant for nearly 1 billion COVID-19 vaccine doses across all five of our commercial supply partnerships.

因此，2023年4月，我們與Biological E.和CEPI達成協議，解決Biological E.的剩餘欠款，並完全免除相應的CEPI預付款。該決議在第一季度導致約 1200 萬美元的壞賬支出，反映出無法收回的金額。截至今天，我們僅使用了 Biological E. 的 100 萬美元，我們預計將在今年晚些時候收回。總的來說，我們繼續為我們在如此復雜和多變的環境中航行的方式以及我們在全球應對大流行中發揮的重要作用感到自豪，為所有五個國家的近 10 億劑 COVID-19 疫苗提供 CpG 1018 佐劑我們的商業供應夥伴關係。

Now turning to our research and development expenses for the quarter; these increased to $14 million compared to $11 million in the prior period. This increase was driven by continued advancement in our clinical pipeline programs, as Rob mentioned. Selling, general and administrative expenses for the first quarter increased to $37 million compared to $32 million in the prior period. The increase was primarily driven by higher personnel-related costs and an overall increase in targeted marketing efforts to drive HEPLISAV-B market share and drive market expansion in key segments that we believe will disproportionately benefit HEPLISAV-B.

現在轉向我們本季度的研發費用；與上一期間的 1 100 萬美元相比，這些增加到 1 400 萬美元。正如 Rob 所提到的，這一增長是由我們臨床管道計劃的持續進步推動的。第一季度的銷售、一般和管理費用從上一季度的 3200 萬美元增加到 3700 萬美元。這一增長主要是由於與人員相關的成本增加，以及為推動 HEPLISAV-B 市場份額和推動關鍵領域市場擴張而進行的針對性營銷工作的整體增加，我們認為這將使 HEPLISAV-B 不成比例地受益。

Now turning to net loss; we recorded GAAP net loss of $24 million or $0.19 per share basic and diluted in Q1. This is compared to GAAP net income of $33 million or $0.26 per share basic and $0.22 per share diluted for the prior year period. Turning to the balance sheet; we ended the first quarter with cash, cash equivalents and marketable securities of approximately $652 million, an increase compared to our year-end balance of $624 million. Based on our current operating plans, we expect to finish 2023 with positive free cash flow for the year. We continue to believe that this level of capital is sufficient to support our core business, enabling us to drive sustainable growth in HEPLISAV-B to capture a majority market share and bring our R&D portfolio of vaccine candidates forward without needing to return to the capital markets.

現在轉向淨虧損；我們在第一季度錄得 GAAP 淨虧損 2400 萬美元或每股 0.19 美元基本和稀釋。相比之下，去年同期的 GAAP 淨收入為 3300 萬美元或每股基本收入 0.26 美元，稀釋後每股收入 0.22 美元。轉向資產負債表；第一季度結束時，我們的現金、現金等價物和有價證券約為 6.52 億美元，比年末餘額 6.24 億美元有所增加。根據我們目前的運營計劃，我們預計到 2023 年全年將實現正自由現金流。我們仍然相信，這一水平的資本足以支持我們的核心業務，使我們能夠推動 HEPLISAV-B 的可持續增長，以佔據大部分市場份額，並將我們的候選疫苗研發組合向前推進，而無需返回資本市場.

We are also pleased to reaffirm our full year 2023 financial guidance, which includes the following expectations: HEPLISAV-B net product revenue to be between $165 million to $185 million, research and development expenses of between $55 million to $70 million; and selling, general and administrative expenses to be between $135 million to $155 million. In closing, we continue to execute on our core priorities across the entire organization.

我們也很高興重申我們的 2023 年全年財務指導，其中包括以下預期：HEPLISAV-B 淨產品收入在 1.65 億美元至 1.85 億美元之間，研發費用在 5500 萬至 7000 萬美元之間；銷售、一般和管理費用在 1.35 億美元至 1.55 億美元之間。最後，我們將繼續在整個組織內執行我們的核心優先事項。

We are focused on strong operational and financial performance as well as being extremely thoughtful in how we allocate our capital to accelerate growth. Our strong capital position and commercial execution has provided us with strategic flexibility to identify and pursue external opportunities to complement our organic growth as we strive to deliver long-term value to our shareholders. We are excited about our progress to date, and we look forward to continuing to deliver on our goals for 2023.

我們專注於強勁的運營和財務業績，並在如何分配資本以加速增長方面非常周到。我們強大的資本狀況和商業執行力為我們提供了戰略靈活性，可以在我們努力為股東創造長期價值的過程中識別和尋求外部機會，以補充我們的有機增長。我們對迄今為止取得的進展感到興奮，並期待繼續實現 2023 年的目標。

Thank you, everyone, for your attention today. Operator, we would now like to open the Q&A portion of today's call.

謝謝大家今天的關注。接線員，我們現在想打開今天電話會議的問答部分。

(Operator Instructions) Our first question comes from the line of Matthew Phipps with William Blair.

（操作員說明）我們的第一個問題來自 Matthew Phipps 和 William Blair 的台詞。

Congrats on continued great launch and growth of HEPLISAV. GSK noted in their quarter an increase in Hepatitis vaccine sales due to purchasing patterns in the CDC. And I wondered if any of that might have applied to you all? And then Donn, I'd like to focus on the retail and the IDN and seeing that grow as a way to grow the brand. If you got 20% market share and continue to grow market share in those brands, would that spill over into some of the rest of the markets?

祝賀 HEPLISAV 的持續推出和發展。 GSK 在他們的季度中指出，由於 CDC 的採購模式，肝炎疫苗的銷售額有所增加。我想知道這些是否適用於你們所有人？然後是 Donn，我想專注於零售和 IDN，並將其視為發展品牌的一種方式。如果您獲得 20% 的市場份額並繼續增加這些品牌的市場份額，這會不會波及到其他一些市場？

Sure, Matt. Okay. No, go ahead, Donn, go ahead and take it away.

當然，馬特。好的。不，去吧，唐恩，去吧，把它拿走。

So Matt, regarding your first question on CDC purchasing, that really wasn't something that impacted our revenue from a HEPLISAV-B perspective, we sell typical CDC purchasing in the public sector. So that wasn't really nothing that was of note for Q1 for HEPLISAV-B. Regarding kind of that spillover impact as it relates to retail and IDN, we are seeing that impact, quite frankly, in some of the other segments where we don't put as much promotional resources. We're seeing market momentum across various other segments. And we do believe as we continue to take market share, it will certainly have an impact in these other segments as well.

所以馬特，關於你關於 CDC 採購的第一個問題，從 HEPLISAV-B 的角度來看，這真的不是影響我們收入的東西，我們在公共部門銷售典型的 CDC 採購。所以對於 HEPLISAV-B 的第一季度來說，這並不是什麼值得注意的事情。關於與零售和 IDN 相關的溢出影響，坦率地說，我們在其他一些我們沒有投入太多促銷資源的領域看到了這種影響。我們看到了其他各個領域的市場勢頭。我們確實相信，隨著我們繼續佔據市場份額，它肯定也會對這些其他領域產生影響。

Great. I guess maybe just one last question. On the kind of synergy commercial assets that are not vaccines, would that still be something prophylactic or it could be therapeutic as well. And I don't know if there's any other thoughts you can give around the size of the market for those things.

偉大的。我想也許只是最後一個問題。關於不是疫苗的那種協同商業資產，它仍然是預防性的還是也可以是治療性的。我不知道你是否可以就這些東西的市場規模給出任何其他想法。

Thanks, Matt. No, not necessarily prophylactic. The point is recognizing that we want to broaden the aperture a little bit to have access to valuable transactions that can leverage our capabilities from a business platform perspective. I mean going beyond peak prophylactic interventions, we still feel that we can leverage our corporate capability within infectious disease. So the focus is on high synergies accretive deals that for commercial products.

謝謝，馬特。不，不一定是預防性的。關鍵是要認識到我們希望稍微擴大範圍以訪問有價值的交易，這些交易可以從業務平台的角度利用我們的能力。我的意思是，除了高峰期的預防干預，我們仍然認為我們可以利用我們在傳染病領域的企業能力。因此，重點是針對商業產品的高協同增效交易。

Our next question comes from the line of Josh Schimmer with Evercore ISI.

我們的下一個問題來自 Evercore ISI 的 Josh Schimmer。

Great and congrats on the strong quarter. I guess given how strong it was ahead of expectations, what are the uncertainties that have kept you from raising your guidance for the year?

太好了，祝賀這個強勁的季度。我想鑑於它超出預期的程度，有哪些不確定因素阻止你提高今年的指導？

Josh, really just the first quarter, we did see really good growth in the market. We recognize we're sort of tracking up to Q1 to the midpoint and expect to be in the higher end of the range, but it's just too early in the year. We'd like to have another quarter or so to be able to relate to the final market trends around growth before we change any guidance.

喬什，真的只是第一季度，我們確實看到了市場的良好增長。我們認識到我們正在追踪到第一季度的中點，並期望處於該範圍的高端，但今年還為時過早。在我們更改任何指導之前，我們希望再有一個季度左右的時間能夠與圍繞增長的最終市場趨勢相關聯。

Got it. And what kind of seasonality are you expecting over the course of the year in terms of the overall market considering some of the various forces, including the impact of the ACIP recommendations.

知道了。考慮到一些不同的力量，包括 ACIP 建議的影響，您對整個市場在一年中的季節性有什麼樣的預期。

Yeah. We know there's traditional seasonality. But Donn, you want to comment on how the ACIP growth could play into the typical seasonality that we see?

是的。我們知道有傳統的季節性。但是 Donn，您想評論 ACIP 增長如何影響我們看到的典型季節性？

Yeah, Josh, to Ryan's point, we're going to see the seasonality we've seen in years past and in particular Q4 given the holiday season. The one thing that certainly is on our radar, and we'll continue to monitor is the launch of the rF1V vaccine certainly in the retail segment. But that being said, rF1V's going to be for 65-plus. And when we think about retail and HEPLISAV-B and Hepatitis B vaccination, there's a tremendous focus on 30 to 50 year-old patients. So we'll have to continue to monitor that. But we'll see certainly that typical seasonality that we would have seen in the past, particularly in Q4. As it relates to ACIP, I don't know if that's going to impact seasonality per se. I think ACIP is going to continue to be a catalyst for continued growth, as we said before, both in retail and in IDN.

是的，Josh，就 Ryan 的觀點而言，我們將看到我們在過去幾年看到的季節性，特別是考慮到假期的第四季度。肯定在我們雷達上的一件事，我們將繼續監測，當然是在零售領域推出 rF1V 疫苗。但話雖這麼說，rF1V 將適用於 65 歲以上的人群。當我們考慮零售以及 HEPLISAV-B 和乙型肝炎疫苗接種時，人們非常關注 30 至 50 歲的患者。因此，我們必須繼續對此進行監控。但我們肯定會看到我們過去會看到的典型季節性，尤其是在第四季度。由於它與 ACIP 相關，我不知道這是否會影響季節性本身。正如我們之前所說，我認為 ACIP 將繼續成為零售和 IDN 持續增長的催化劑。

Got it. And then last question for me (inaudible) asset line increased by about $70 million in the quarter. What drove that?

知道了。然後我的最後一個問題（聽不清）資產線在本季度增加了約 7000 萬美元。是什麼驅使它？

Sure, Joshua, I can take that. So that's simply a reclassification of amounts associated with the Clover and CEPI arrangement from current to noncurrent.

當然，約書亞，我可以接受。因此，這只是將與 Clover 和 CEPI 安排相關的金額從流動重新分類為非流動。

And our next question comes from the line of Madhu Kumar with Goldman Sachs.

我們的下一個問題來自 Madhu Kumar 與高盛的合作。

This is Rob on for Madhu. Maybe I could just ask a question about what do you expect the cadence to be of the entire market growing versus your market share growth? You guys saw a good market share growth over the past few years, and I was wondering how much of the future growth is going to be that versus the entire market growth with the ACIP recommendation now in place?

這是馬杜的羅布。也許我可以問一個問題，你認為整個市場增長的節奏與你的市場份額增長的節奏是什麼？你們在過去幾年看到了良好的市場份額增長，我想知道未來的增長與現在採用 ACIP 推薦的整個市場增長相比有多少？

Rob, I think ultimately, market growth is critically important. I mean we already reported that we're at 37% now on market share. We will continue to advance that to take a majority share. But as you noted by some of our prior kind of disclosure of the market size being growing from $400 million to $800 million by 2027, that gives you a pretty good clear order of magnitude of how important growth is. And I think the point that you make is we're not -- we're not at the point now where we would sort of project slowing market share growth. But as you get more and more share, the next point does get harder to capture. So right now, '23 is going to be pretty balanced. But over the long term, market growth can be critical.

Rob，我認為最終，市場增長至關重要。我的意思是我們已經報告說我們現在的市場份額為 37%。我們將繼續推進這一進程以取得多數份額。但正如您在我們之前的一些披露中指出的那樣，到 2027 年，市場規模將從 4 億美元增長到 8 億美元，這為您提供了一個非常清晰的增長重要性順序。而且我認為你提出的觀點是我們不是 - 我們現在還沒有達到我們可以預測市場份額增長放緩的地步。但隨著你獲得越來越多的份額，下一點確實變得更難捕捉。所以現在，'23 將會非常平衡。但從長遠來看，市場增長可能至關重要。

Our next question comes from the line of Roy Buchanan with JMP Securities.

我們的下一個問題來自 JMP Securities 的 Roy Buchanan。

Great quarter. First one is on dialysis. And just can you review your views on the opportunity in that segment? Any reason to not expect a majority market share in the future? And then looking at slide 6, I mean, it looks like the total dollar amount doesn't really grow. The percent goes down by about half the market size goes up by about half. Why would HEPLISAV maybe not expand the dialysis opportunity?

偉大的季度。第一個是透析。您能否回顧一下您對該細分市場機會的看法？有什麼理由不期望在未來佔據多數市場份額？然後看幻燈片 6，我的意思是，看起來總金額並沒有真正增長。百分比下降約一半市場規模上升約一半。為什麼 HEPLISAV 可能不會擴大透析機會？

Sure. Just to be clear, we'd really -- are favorable on our profile dialysis with the adjuvanted vaccine. So we're excited to be able to give the sBLA and so we can begin to actively promote that segment. And we would expect to do pretty well there. The reality is that market doesn't grow because right now, it's solved with basically 8 doses of the traditional vaccine. And the patient population isn't expected to grow there like it is in other segments. And so HEPLISAV moves into that space, we think it will do very well, but it doesn't grow the market size because of the amount of doses used in that space compared to with the (inaudible) with HEPLISAV.

當然。需要明確的是，我們真的 - 有利於我們使用佐劑疫苗進行的個人資料透析。因此，我們很高興能夠提供 sBLA，因此我們可以開始積極推廣該細分市場。我們希望在那裡做得很好。現實情況是市場沒有增長，因為現在基本上用 8 劑傳統疫苗就可以解決這個問題。預計患者人數不會像其他部分那樣增長。因此，HEPLISAV 進入該領域，我們認為它會做得很好，但由於與 HEPLISAV 的（聽不清）相比，該領域使用的劑量數量，它並沒有擴大市場規模。

Okay, great. And then a few on the shingles; I'm not sure if you can tell us, but if you can, the dose of CpG 1018 that you're going to go with and what levels of GE that you're going to explore? And just any other details on the trial design, maybe the planned size of the Phase I/II?

好的，太好了。然後是帶狀皰疹上的一些；我不確定你是否可以告訴我們，但如果可以的話，你將使用的 CpG 1018 劑量以及你將探索的 GE 水平是多少？還有關於試驗設計的任何其他細節，也許是 I/II 期的計劃規模？

Sure. Rob, do you want to take that?

當然。羅伯，你要拿那個嗎？

Sure. So we haven't made final decisions on either CpG 1018 dose. We do anticipate doing a dose escalation of at least 3 or 4 levels of GE. But again, the final decisions on those aspects of the study design haven't been made yet.

當然。所以我們還沒有對 CpG 1018 的劑量做出最終決定。我們確實預計會增加至少 3 或 4 個 GE 水平的劑量。但同樣，關於研究設計的那些方面的最終決定尚未做出。

And we'll be also working with the FDA this year to clarify the regulatory path forward and finalize eventual trial designs.

今年我們還將與 FDA 合作，闡明監管路徑並最終確定最終的試驗設計。

Our next question comes from the line of Ed White with H.C. H.C. Wainwright.

我們的下一個問題來自 Ed White 和 H.C. H.C.溫賴特。

With the market share growth we saw in retail this quarter, were there any new retail initiatives in the first quarter of this year? And do you have any plan for the rest of 2023? And then I also wanted to get your thoughts on potential DTC advertising to drive retail sales.

隨著我們在本季度看到零售市場份額的增長，今年第一季度是否有任何新的零售舉措？您對 2023 年剩餘時間有什麼計劃嗎？然後我還想了解您對推動零售銷售的潛在 DTC 廣告的看法。

Donn, do you want to handle those?

唐恩，你想處理這些嗎？

Sure. Ed, yes, so regarding retail initiatives as you know, we've said this in the past. Initiatives are very critical in this segment. And so a lot of Q1 was setting up Q2 as it relates to initiatives. We are strategically placing our initiatives in the second quarter to get out ahead of the flu season. As I mentioned during my comments, we have various initiatives with 3 of the top 4 retail chains throughout the country. That gives us a lot of confidence, obviously, going into Q2 and the rest of the year. And so those initiatives are critical, but those initiatives also tied to the second part of your question, which is direct-to-consumer.

當然。 Ed，是的，所以關於零售計劃，如您所知，我們過去已經說過了。舉措在這一領域非常關鍵。因此，很多第一季度都在建立第二季度，因為它與計劃有關。我們在戰略上將我們的舉措放在第二季度，以便在流感季節之前擺脫困境。正如我在評論中提到的，我們與全國 4 大零售連鎖店中的 3 家採取了各種舉措。顯然，這給了我們很大的信心進入第二季度和今年剩餘時間。因此，這些舉措至關重要，但這些舉措也與你問題的第二部分有關，即直接面向消費者。

Part of our strategy with DTC is partnering with retail and leveraging their capabilities, their advertising capabilities to reach their customers and their consumers. We believe those channels bring much more credibility when we're talking about ACIP universal recommendation in HEPLISAV-B. So that's our strategy is to leverage retail and their infrastructure to get to their patients and their consumers throughout the year.

我們與 DTC 的部分戰略是與零售業合作，並利用他們的能力、他們的廣告能力來接觸他們的客戶和消費者。我們相信，當我們在 HEPLISAV-B 中談論 ACIP 普遍推薦時，這些渠道會帶來更多的可信度。因此，我們的策略是利用零售及其基礎設施全年接觸患者和消費者。

And the question in, and I mean -- and just to put a fine point on it, DTC is -- it's going to be very large. We have a very focused approach to DTC that we think will be very effective.

問題是，我的意思是 - 只是為了說明這一點，DTC 是 - 它會非常大。我們對 DTC 有一個非常集中的方法，我們認為它會非常有效。

Okay. And just a question on Europe. So you received marketing authorization in Great Britain in April. And I just wanted to get your thoughts on the opportunity in Europe for perhaps just 2023 and beyond that?

好的。只是一個關於歐洲的問題。因此，您在 4 月份獲得了英國的上市許可。我只是想了解您對 2023 年及以後歐洲機會的看法？

Yeah. I mean we're -- we did just receive the authorization and we're working to identify appropriate partners to commercialize to the private markets there. Wouldn't expect that the 2023 launch date for that product -- that will be out later into '24 and beyond after we establish the right partnership.

是的。我的意思是我們 - 我們確實剛剛獲得授權，我們正在努力確定合適的合作夥伴，以便將其商業化到那裡的私人市場。不會期望該產品的 2023 年發布日期——在我們建立正確的合作夥伴關係後，該日期將在 24 年後及以後發布。

Our next question comes from the line of Phil Nadeau with TD Cowen.

我們的下一個問題來自 Phil Nadeau 與 TD Cowen 的對話。

Rodriguez for Phil. Congratulation on a great quarter. I've got a couple of questions from us. On the shingles (inaudible) vaccine, what additional data from what has already been disclosed will be presented then if you can elaborate on that? And what do you think investors should focus on data?

羅德里格斯換菲爾。祝賀一個偉大的季度。我有幾個問題要問我們。關於帶狀皰疹（聽不清）疫苗，如果您可以詳細說明，那麼將提供哪些已經披露的額外數據？您認為投資者應該關注數據的哪些方面？

Ernie, thank you for the question. We think we've categorized the data pretty well with our initial top line results. But obviously, there will be a little bit more insight into the actual numbers in the poster presentation. And I think the key thing to focus on is we (inaudible) we provided the top line results of the vaccine response rates and our overall profile. And this also gives a great opportunity for us to present the data at (inaudible) forum. So I think that's what's so important about getting this out of just our initial press release to a poster at a meeting.

厄尼，謝謝你的提問。我們認為我們已經根據我們的初始頂線結果很好地對數據進行了分類。但顯然，海報展示中的實際數字會有更多的洞察力。我認為要關注的關鍵是我們（聽不清）我們提供了疫苗反應率和我們整體概況的最重要結果。這也為我們提供了在（聽不清）論壇上展示數據的絕佳機會。因此，我認為這就是將我們最初的新聞稿中的內容髮佈到會議海報上的重要性。

Got it. And on the bad debt expense, sounds like there's not much more at risk with Biological E. You have around $1 million more than you expect to collect. But is there any other uncollected receivables from other customers that you think may be at risk for similar circumstances risk on the dynamics of the market these days.

知道了。就壞賬支出而言，聽起來 Biological E 的風險並不大。您的收入比預期多出約 100 萬美元。但是，您認為這些天市場動態中是否存在您認為類似情況下可能面臨風險的其他未收賬款。

So I'll take that one, Ernie, thanks so much for the question. And yes, I think your characterization around the remaining exposure, as we sit here today for Bio E. is limited to only about $1 million, as we mentioned on the call. The other -- the only other customer where we have amounts remaining to be collected under the CEPI arrangement is Clover and what you'll see in the 10-Q in quite a bit of additional detail. But just by way of summary, we have about $71 million to be collected from Clover. Of that, though, about $60 million has already been received and is backed up by CEPI. So we expect to collect those amounts in the next few years as Clover collects on their commercial agreements with China and through other bilateral arrangements.

所以我會接受那個，厄尼，非常感謝你提出這個問題。是的，正如我們在電話會議上提到的，我認為您對剩餘風險的描述，正如我們今天坐在這里為 Bio E. 所做的那樣，僅限於大約 100 萬美元。另一個——根據 CEPI 安排，我們還有剩餘待收金額的唯一其他客戶是 Clover，您將在 10-Q 中看到更多詳細信息。但僅作為總結，我們有大約 7100 萬美元可以從 Clover 收集。不過，其中約 6000 萬美元已經收到並得到 CEPI 的支持。因此，我們預計在未來幾年內收集這些金額，因為 Clover 根據與中國的商業協議和其他雙邊安排收集。

And we have no further questions at this time. I would like to turn the call over to Mr. Ryan Spencer, Chief Executive Officer, for closing remarks. You may begin.

我們現在沒有其他問題了。我想將電話轉給首席執行官 Ryan Spencer 先生，請他作結束語。你可以開始了。

Thank you, operator, and thank you all for joining us today. We appreciate your interest in Dynavax. We're excited about the foundation we've built with our continued successful commercialization, execution and positive momentum for HEPLISAV-B, our advancing pipeline and our strong financial position. I'd like to thank our team at Dynavax for their continued dedication to patients and their families, caregivers and investigators who participate in our studies, along with our collaborators and customers for their continued partnership and support. We look forward to updating you on our progress. Operator, you may end the call.

謝謝接線員，感謝大家今天加入我們。感謝您對 Dynavax 的興趣。我們為 HEPLISAV-B 的持續成功商業化、執行和積極勢頭、我們不斷推進的管道和我們強大的財務狀況所建立的基礎感到興奮。我要感謝我們在 Dynavax 的團隊對參與我們研究的患者及其家人、護理人員和研究人員的持續奉獻，以及我們的合作者和客戶的持續合作和支持。我們期待著向您通報我們的最新進展。接線員，你可以掛斷電話了。

Ladies and gentlemen, thank you for joining us today. This concludes today's conference call. You may now disconnect. Everyone, have a wonderful day.

女士們，先生們，感謝你們今天加入我們。今天的電話會議到此結束。您現在可以斷開連接。每個人，祝你有美好的一天。