Dynavax Technologies Corp (DVAX) 2022 Q4 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Dynavax Technologies Fourth Quarter and Full Year 2022 Financial Results. As a reminder, this conference call is being recorded. (Operator Instructions)

女士們先生們，美好的一天，歡迎閱讀 Dynavax Technologies 第四季度和 2022 年全年財務業績。提醒一下，正在錄製此電話會議。 （操作員說明）

I would now like to turn the call over to Nicole Arndt, Senior Manager, Investor Relations. You may begin.

我現在想把電話轉給投資者關係高級經理 Nicole Arndt。你可以開始了。

Thank you, operator. Good afternoon, and welcome to the Dynavax Fourth Quarter and Full Year 2022 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 on the Events section of our website.

謝謝你，運營商。下午好，歡迎來到 Dynavax 第四季度和 2022 年全年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 and market share, ACIP recommendation impact, market trends, growth perspective and rates, manufacturing plans, seasonality, financial guidance and trends, including revenue, profitability and efficiency of current capitalization, timing and results of clinical trial starts and data readouts and potential future uses of 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和市場份額、ACIP 推薦影響、市場趨勢、增長前景和比率、製造計劃、季節性、財務指導和趨勢，包括收入、盈利能力和當前資本化效率、臨床試驗開始的時間和結果以及數據讀數和 CpG 1018 佐劑的潛在未來用途。

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 annual report on Form 10-K. Our forward-looking statements speak as of today and we undertake no obligation to update such statements.

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-K 表格年度報告。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。

Joining me on the call today are Ryan Spencer, Chief Executive Officer; Donn Casale, Senior Vice President of Commercial; Rob Janssen, Chief Medical Officer; and Kelly MacDonald, Chief Financial Officer.

今天和我一起參加電話會議的是首席執行官 Ryan Spencer；商業高級副總裁 Donn Casale； Rob Janssen，首席醫療官；和首席財務官凱利·麥克唐納 (Kelly MacDonald)。

I will now turn the call over to Ryan.

我現在將把電話轉給瑞安。

Thanks, Nicole, and thank you all for joining us today. We're excited to have the opportunity to discuss the tremendous progress we made in 2022 and with respect as we look to our future. We built a valuable and scalable company on the foundation of our first product, HEPLISAV-B, which continues to generate increasing revenue year-over-year.

謝謝，妮可，感謝大家今天加入我們。我們很高興有機會討論我們在 2022 年取得的巨大進步，並在展望未來時懷著敬意。我們在我們的第一個產品 HEPLISAV-B 的基礎上建立了一家有價值且可擴展的公司，該產品繼續產生逐年增加的收入。

In 2022, as a result of the overall market growth, and continued market adoption of the product, HEPLISAV-B revenue doubled compared to 2021. This continued progress reinforced our confidence in the product and our ability to capture additional market share.

到 2022 年，由於整體市場增長和產品的持續市場採用，HEPLISAV-B 收入比 2021 年翻了一番。這一持續進步增強了我們對該產品的信心，並增強了我們獲得更多市場份額的能力。

Looking forward to 2023, we anticipate HEPLISAV-B annual revenue growth in the range of 30% to nearly 50% with sustained and meaningful annual growth expected for the coming years. Additionally, throughout the pandemic, we delivered CpG 1018 adjuvant for nearly 1 billion COVID-19 vaccine doses across all 5 of our commercial supply partnerships, completing our obligations under our commercial supply agreement to support the pandemic response. Our efforts resulted in $588 million of revenue in 2022 and further validated the safety and efficacy of CpG 1018 adjuvant across a variety of protein-based vaccine platforms around the world.

展望 2023 年，我們預計 HEPLISAV-B 的年收入增長將在 30% 至近 50% 之間，預計未來幾年將實現持續且有意義的年增長。此外，在整個大流行期間，我們在所有 5 個商業供應合作夥伴中為近 10 億劑 COVID-19 疫苗提供了 CpG 1018 佐劑，完成了我們在商業供應協議下支持大流行應對的義務。我們的努力在 2022 年帶來了 5.88 億美元的收入，並進一步驗證了 CpG 1018 佐劑在全球各種基於蛋白質的疫苗平台上的安全性和有效性。

And then finally, for 2022, we made great progress in executing on our clinical development plans, delivering robust Phase I data for both our shingles and Tdap vaccine candidates and completing Part 1 of the Phase II plague trial that's funded by the DoD, which, as you'll hear from Rob shortly, met its primary endpoint.

最後，到 2022 年，我們在執行臨床開發計劃方面取得了巨大進展，為我們的帶狀皰疹和 Tdap 候選疫苗提供了可靠的 I 期數據，並完成了由國防部資助的 II 期鼠疫試驗的第 1 部分，其中，正如您很快就會從 Rob 那裡聽到的那樣，達到了它的主要終點。

We are now exiting the pandemic era in a stronger position than when it began, as a result of this team's commitment, resolve, agility and professionalism. During this period, HEPLISAV-B has made major market share gains, even though the health care system faced unprecedented disruption. Our success generating over -- of generating almost $1 billion of CpG 1018 adjuvant revenue during this time was made possible by the impressive teamwork and collaboration across the company.

由於這個團隊的承諾、決心、敏捷性和專業精神，我們現在以比剛開始時更強大的地位退出了大流行病時代。在此期間，HEPLISAV-B 取得了重大的市場份額增長，儘管醫療保健系統面臨著前所未有的破壞。我們在這段時間內取得了近 10 億美元的 CpG 1018 佐劑收入，這得益於整個公司令人印象深刻的團隊合作和協作。

We have successfully built a pipeline in preclinical and clinical assets, focused on leveraging our proven adjuvant to drive long-term value. All of our success was accomplished while also strengthening our corporate infrastructure, governance and overall capabilities across our fully integrated organization, allowing us to run a successful business while managing our growth.

我們已經成功地建立了臨床前和臨床資產管道，專注於利用我們經過驗證的佐劑來推動長期價值。我們在取得所有成功的同時，還加強了我們完全整合的組織的企業基礎設施、治理和整體能力，使我們能夠在管理增長的同時經營成功的業務。

I'm incredibly proud and confident in our team. And considering the results that have been delivered in this particularly challenging environment, I believe this organization's combined capability is a tremendous asset that we will leverage as we advance and grow our business.

我對我們的團隊感到無比自豪和自信。考慮到在這個特別具有挑戰性的環境中取得的成果，我相信這個組織的綜合能力是我們在推進和發展業務時將利用的巨大資產。

In 2023, we will build on a strong foundation laid in '22. With continued product revenue growth from HEPLISAV-B and advance of our clinical development and preclinical pipeline, leveraging our CpG 1018 adjuvant. Additionally, we are prioritizing our business development efforts with the goal of adding late-stage or commercial assets to further leverage our comprehensive organizational capability and to accelerate value creation.

2023 年，我們將在 22 年打下的堅實基礎上再接再厲。隨著 HEPLISAV-B 產品收入的持續增長以及我們臨床開發和臨床前管道的推進，利用我們的 CpG 1018佐劑。此外，我們正在優先考慮我們的業務發展工作，目標是增加後期或商業資產，以進一步利用我們的綜合組織能力並加速價值創造。

We will continue to take a highly disciplined approach to identifying opportunities that we believe can make an even greater impact on our mission to help protect the world against infectious diseases.

我們將繼續採取高度紀律的方法來尋找我們認為可以對我們幫助保護世界免受傳染病侵害的使命產生更大影響的機會。

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

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

Thank you, Ryan. I am thrilled to share the incredible progress and strong results for HEPLISAV-B and details about the exciting future and growth opportunities for the brand. 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.

謝謝你，瑞安。我很高興與大家分享 HEPLISAV-B 取得的令人難以置信的進步和強勁的成果，以及有關該品牌令人興奮的未來和增長機會的詳細信息。 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 劑即可完成系列疫苗。在乙型肝炎普遍推薦的時代，系列完成對於高水平保護至關重要 2 劑量 HEPLISAV-B 可以使系列完成更容易，並比 3 劑量方案更快地保護更多患者。

In 2022, full year net product revenue for HEPLISAV-B grew 104% from 2021. This significant revenue growth in the U.S. was driven by continued gains in market share. We estimate HEPLISAV-B's total market share increased to 35% compared to 25% during the same period last year, while prioritized Integrated Delivery Networks in clinics increased to 47%, up from 33% during the fourth quarter of 2021.

到 2022 年，HEPLISAV-B 的全年淨產品收入比 2021 年增長了 104%。美國收入的顯著增長是由市場份額的持續增長推動的。我們估計 HEPLISAV-B 的總市場份額從去年同期的 25% 增加到 35%，而優先考慮的診所綜合交付網絡從 2021 年第四季度的 33% 增加到 47%。

Strong performance in the fourth quarter was driven by 2 critical segments: retail pharmacy and Integrated Delivery Networks, or IDNs. Within the Retail segment, we continue to receive positive feedback from customers about the ACIP universal recommendation. Additionally, we saw increases in initial purchases and reordering across several large national chains.

第四季度的強勁表現是由兩個關鍵部分推動的：零售藥店和集成交付網絡 (IDN)。在零售領域，我們繼續收到客戶對 ACIP 普遍建議的積極反饋。此外，我們還看到幾家大型全國連鎖店的首次購買和重新訂購有所增加。

Likewise, in the IDN segment, several customers began implementing processes to adopt the ACIP universal recommendation, which led to meaningful increases in their hepatitis B purchases that far exceeded 2019 levels. The momentum in both segments led to our strong performance in the fourth quarter despite the typical end of year seasonality.

同樣，在 IDN 部分，一些客戶開始實施採用 ACIP 通用建議的流程，這導致他們購買的乙型肝炎顯著增加，遠遠超過 2019 年的水平。儘管存在典型的年末季節性，但這兩個領域的發展勢頭使我們在第四季度表現強勁。

The ACIP's recommendation that all adults 19 to 59 years of age received hepatitis B vaccination, significantly expands the number of adults in the U.S. who are recommended to be vaccinated against hepatitis B. In fact, hepatitis B vaccination now has the second highest addressable adult population across vaccines, more than shingles and pneumococcal vaccination and is second only to flu.

ACIP 建議所有 19 至 59 歲的成年人都接種乙型肝炎疫苗，這顯著增加了美國建議接種乙型肝炎疫苗的成年人數量。事實上，乙型肝炎疫苗接種現在是可尋址的第二大成年人群在疫苗中，超過帶狀皰疹和肺炎球菌的疫苗接種量僅次於流感。

We continue to believe this recommendation will be a significant catalyst for growth and estimate the hepatitis B market opportunity could grow to over $800 million by 2027, with HEPLISAV-B well positioned to secure a majority market share.

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 年乙型肝炎市場機會可能增長到超過 8 億美元，HEPLISAV-B 處於有利地位以確保大部分市場份額。

We believe the IDN and retail segments will see most of the market growth from the ACIP universal recommendation. Both segments have the required institutional control, infrastructure, capabilities and patient volumes that can drive universal uptake.

我們相信 IDN 和零售領域將從 ACIP 通用建議中看到大部分市場增長。這兩個細分市場都具有所需的機構控制、基礎設施、能力和患者數量，可以推動普遍採用。

We expect these 2 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 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 update.

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 年這一比例約為 44%。我們在這兩個細分市場都處於有利地位，與主要疫苗決策者建立了長期關係，並對可以幫助我們推動 ACIP 通用建議更新的購買流程和運營槓桿。

Additionally, HEPLISAV-B is approaching 50% market share across these 2 segments, with most of the nation's top IDN and several national retail chains making HEPLISAV-B their preferred hepatitis B vaccine.

此外，HEPLISAV-B 在這兩個細分市場中的市場份額接近 50%，美國大多數頂級 IDN 和幾家全國零售連鎖店都將 HEPLISAV-B 作為首選乙肝疫苗。

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 2023, we forecast the hepatitis B market opportunity will grow 15% to 25% from 2022 levels and exceed 2019 utilization.

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。到 2023 年，我們預測乙肝市場機會將比 2022 年增長 15% 至 25%，並超過 2019 年的利用率。

In addition to market growth, we expect HEPLISAV-B will continue to increase its market share across all segments, most notably, IDN and retail.

除了市場增長，我們預計 HEPLISAV-B 將繼續增加其在所有細分市場的市場份額，最顯著的是 IDN 和零售。

With a proven clinical profile and our team's strong commercial execution, we remain confident in our ability to generate momentum and look forward to continuing to drive long-term growth for the brand.

憑藉經過驗證的臨床資料和我們團隊強大的商業執行力，我們對我們產生動力的能力充滿信心，並期待繼續推動品牌的長期增長。

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 believe there's a tremendous amount of potential in our pipeline, focusing on best-in-class products targeting large markets by combining our CpG 1018 adjuvant with established antigens. We're currently advancing programs for 3 adjuvanted vaccines, Tdap, shingles and Plague. We believe CpG 1018 adjuvant has the potential to improve the durability of protection against pertussis by redirecting T cell responses and enhancing protective antibody responses in the booster vaccine. We recently completed a Phase I clinical trial, evaluating an improved tetanus, diphtheria and pertussis or Tdap vaccine that utilizes our CpG 1018 adjuvant.

謝謝你，唐恩。我們相信我們的管道有巨大的潛力，通過將我們的 CpG 1018 佐劑與既定抗原相結合，專注於針對大型市場的一流產品。我們目前正在推進 3 種佐劑疫苗、Tdap、帶狀皰疹和鼠疫疫苗的計劃。我們相信 CpG 1018 佐劑有可能通過重定向 T 細胞反應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。我們最近完成了一項 I 期臨床試驗，評估使用我們的 CpG 1018 佐劑的改進型破傷風、白喉和百日咳或 Tdap 疫苗。

Adult and adolescent safety from this study demonstrated the vaccine candidate was well tolerated without observed safety concerns. Adult immunogenicity results were consistent with our expectations and they support continued advancement of the vaccine candidate. This year, we're completing a nonhuman primate pertussis challenge study that we designed to assess the impact on prevention of disease symptoms and nasal colonization as well as T cell responses with data anticipated mid-2023.

這項研究的成人和青少年安全性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，它們支持候選疫苗的持續發展。今年，我們將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症狀和鼻腔定植以及 T 細胞反應的影響，預計數據將於 2023 年年中公佈。

At the same time, our collaborator in Canada is identifying the appropriate challenge dose of pertussis bacteria to be used in our human challenge study with planned initiation by the end of this year. This will be the first-ever vaccine pertussis human challenge study, and it's designed to assess the feasibility of such a study to evaluate vaccine prevention of pertussis symptoms, effect on nasal colonization and immune responses, including pertussis toxin neutralization and T cell responses.

與此同時，我們在加拿大的合作者正在確定適當的百日咳細菌攻擊劑量，以用於我們計劃於今年年底啟動的人類挑戰研究。這將是有史以來第一個百日咳疫苗人類挑戰研究，旨在評估此類研究的可行性，以評估疫苗對百日咳症狀的預防、對鼻腔定植和免疫反應的影響，包括百日咳毒素中和和 T 細胞反應。

In addition to Tdap, we 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 antibodies in CD4-positive T cells, which are key in controlling reactivation of the zoster virus in preventing shingles.

除了 Tdap，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和在 CD4 陽性 T 細胞中產生高水平抗體的能力，這是控制帶狀皰疹病毒重新激活以預防疾病的關鍵帶狀皰疹。

In January, we reported promising top line results from our Phase I clinical trial designed to evaluate our investigational shingles vaccine utilizing different regimens of CpG 1018 adjuvant. High antibody and CD4 positive T cell vaccine response rates were seen in all arms, and they were similar to the comparator. Robust increases in CD4-positive T cells were observed in all the CpG 1018 adjuvanted arms as well, although lower than comparator.

1 月，我們報告了第一階段臨床試驗的有希望的頂線結果，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。所有組均觀察到高抗體和 CD4 陽性 T 細胞疫苗反應率，並且與比較組相似。在所有 CpG 1018 佐劑組中也觀察到 CD4 陽性 T 細胞的強勁增加，儘管低於比較組。

In the first half of this year, we plan to submit an abstract with a full set of data for presentation at an upcoming medical meeting, and we plan on meeting with FDA to discuss the regulatory path forward. Over the course of the year, we expect to complete GMP manufacturing of GE antigen to support initiation of subsequent clinical trials.

今年上半年，我們計劃提交一份包含全套數據的摘要，以便在即將召開的醫學會議上進行展示，我們還計劃與 FDA 會面，討論未來的監管路徑。在這一年中，我們預計將完成 GE 抗原的 GMP 製造，以支持後續臨床試驗的啟動。

Based on our initial data, we plan to advance our shingles vaccine candidate with CpG 1018 adjuvant into a Phase I/II study in early 2024 to evaluate various dose levels of the GE antigen and further evaluate immune responses over a longer period of time.

根據我們的初步數據，我們計劃在 2024 年初將帶有 CpG 1018 佐劑的帶狀皰疹候選疫苗推進到 I/II 期研究，以評估 GE 抗原的各種劑量水平，並進一步評估較長時間內的免疫反應。

Now transitioning to our third program, we're conducting a Phase II trial evaluating the immunogenicity, safety and tolerability of an rF1V plague vaccine candidate adjuvanted with CpG 1018 in collaboration with and funded by the U.S. Department of Defense.

現在過渡到我們的第三個項目，我們正在與美國國防部合作並由其資助進行一項 II 期試驗，以評估以 CpG 1018 為佐劑的 rF1V 鼠疫候選疫苗的免疫原性、安全性和耐受性。

The CpG 1018 adjuvanted vaccine candidates 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.

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。

In January, we successfully completed part 1 of the clinical trial. Both CpG 1018 adjuvanted arms met the Part 1 primary endpoint and demonstrated a greater than twofold increase in antibodies over the alum adjuvanted control arm after 2 doses. COD has approved continuing to part 2 of the study using a bedside mix of CpG 1018 with the alum adjuvanted rF1V plague vaccine.

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，並證明在 2 劑後抗體比明礬佐劑對照組增加了兩倍以上。 COD 已批准繼續使用 CpG 1018 與明礬佐劑 rF1V 鼠疫疫苗的床邊混合物進行研究的第 2 部分。

The advancement of our clinical candidate is a core Dynavax priority. We're confident in our strategy to leverage the proven profile of CpG 1018 to develop new and improved vaccine candidates that provides significant opportunities to address important unmet medical needs.

我們臨床候選人的進步是 Dynavax 的核心優先事項。我們對我們的戰略充滿信心，即利用 CpG 1018 的成熟特性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 very happy to report another quarter and full year of strong financial performance. I'll highlight the key annual financial results and then share 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.

謝謝你，羅布。我很高興地報告又一個季度和全年的強勁財務業績。我將重點介紹關鍵的年度財務業績，然後分享我們 2023 年全年的指導意見並提供一些結束語。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。

Please also refer to our press release and Form 10-K for detailed financial information. Starting with revenue. Total revenue for 2022 was $723 million compared to $439 million for 2021, representing an annual increase of about 64% which was driven both by HEPLISAV-B as well as CpG 1018 adjuvant sales as we successfully executed all 5 of our COVID-19 pandemic commercial supply agreement.

另請參閱我們的新聞稿和 10-K 表格，了解詳細的財務信息。從收入開始。 2022 年的總收入為 7.23 億美元，而 2021 年為 4.39 億美元，年增長率約為 64%，這是由 HEPLISAV-B 和 CpG 1018 佐劑銷售推動的，因為我們成功執行了所有 5 個 COVID-19 大流行商業廣告供應協議。

Starting with HEPLISAV-B. We recorded a full year net product revenue of $126 million compared to $62 million in the prior year, representing annual growth of 104%. What is equally impressive for the brand is the continued improvement in gross margin, which was approximately 68% for the full year compared to 56% for 2021.

從 HEPLISAV-B 開始。我們的全年淨產品收入為 1.26 億美元，而上一年為 6200 萬美元，年增長率為 104%。該品牌同樣令人印象深刻的是毛利率的持續改善，全年毛利率約為 68%，而 2021 年為 56%。

Turning to CpG 1018 adjuvant revenue. Revenue recognized under our commercial supply agreements for COVID-19 vaccines totaled $588 million, gross margin of 62% for 2022, achieving the high end of our previously stated guidance range for both revenue and gross margin.

轉向 CpG 1018 佐劑收入。根據我們的 COVID-19 疫苗商業供應協議確認的收入總計 5.88 億美元，2022 年的毛利率為 62%，達到我們先前規定的收入和毛利率指導範圍的高端。

Looking ahead for our COVID-19 partnerships. Our customers are managing their initial stockpiling of CpG 1018 with forward-looking needs as the global pandemic evolves. Specifically for 2023, we believe our customers have sufficient adjuvant stockpiles to fulfill their near-term demand translating to minimal to as low as 0 COVID-19 related adjuvant sales for Dynavax in 2023. We expect to share additional insight as we execute future commercial supply agreements and gain better clarity around the endemic demand of COVID-19 vaccine for our customers for 2024 and beyond.

展望我們的 COVID-19 合作夥伴關係。隨著全球大流行的發展，我們的客戶正在根據前瞻性需求管理他們最初的 CpG 1018 庫存。具體到 2023 年，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，即 2023 年 Dynavax 的 COVID-19 相關佐劑銷售量最低甚至低至 0。我們希望在執行未來商業供應時分享更多見解達成協議，並更好地了解我們客戶在 2024 年及以後對 COVID-19 疫苗的地方性需求。

Now turning to expenses. Our research and development expenses for 2022 were $47 million compared to $32 million in 2021. The increase was primarily driven by continued advancement in our pipeline programs, Tdap and shingles through the completion of Phase I clinical trials, also successful top line data plus the continued advancement of our fully funded Phase II contract with the DoD for adjuvant and plague vaccines.

現在轉向費用。我們 2022 年的研發費用為 4700 萬美元，而 2021 年為 3200 萬美元。這一增長主要是由於我們的管道項目、Tdap 和帶狀皰疹在完成 I 期臨床試驗後取得的持續進展，以及成功的頂線數據以及持續的推進我們與國防部簽訂的佐劑疫苗和鼠疫疫苗全額資助的第二階段合同。

Selling, general and administrative expenses for 2022 were $131 million and at the low end of our previously stated guidance compared to $100 million for 2021. The increase was primarily driven by increased headcount across field sales and G&A, coupled with focused marketing investments, targeting growth in HEPLISAV-B market share as well as market expansion in key segments that we believe will benefit HEPLISAV-B.

與 2021 年的 1 億美元相比，2022 年的銷售、一般和管理費用為 1.31 億美元，處於我們先前所述指導的低端。增長的主要原因是現場銷售和 G&A 的員工人數增加，以及以增長為目標的集中營銷投資HEPLISAV-B 的市場份額以及我們認為將使 HEPLISAV-B 受益的關鍵領域的市場擴張。

Moving on to profitability. For the full year 2022, we generated GAAP net income of $293 million or $2.32 per share basic and $1.97 per share diluted compared to GAAP net income of $77 million or $0.62 per share basic and $0.57 per share diluted for the full year 2021.

繼續盈利。 2022 年全年，我們產生的 GAAP 淨收入為 2.93 億美元或每股 2.32 美元基本收入和每股稀釋收入 1.97 美元，而 2021 年全年的 GAAP 淨收入為 7700 萬美元或每股基本收入 0.62 美元和稀釋後每股收入 0.57 美元。

Turning to the balance sheet. We ended the year with cash and investments of approximately $624 million. We continue to believe this level of capital is sufficient to support our core business enabling us to drive sustainable growth in HEPLISAV-B and bring our R&D portfolio of vaccine candidates forward without needing to return to the capital markets.

轉向資產負債表。年底，我們的現金和投資約為 6.24 億美元。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，並在無需返回資本市場的情況下推進我們的候選疫苗研發組合。

For 2023 full year financial guidance, we anticipate the following. HEPLISAV-B net product revenue between $165 million and $185 million, R&D expenses to be between $55 million and $70 million and SG&A expenses to be between $135 million and $155 million.

對於 2023 年全年財務指導，我們預計如下。 HEPLISAV-B 產品淨收入在 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，SG&A 費用在 1.35 億美元至 1.55 億美元之間。

Lastly, and in closing before we turn to Q&A, we're very proud of the way that we executed on our priorities throughout 2022. Our strong balance sheet position combined with a disciplined approach to capital allocation enables us to focus on selective investments to drive sustainable top line growth in HEPLISAV-B, thoughtfully advance our clinical pipeline and support our business development objectives, all of which we believe will generate long-term shareholder value. Thank you, everyone, for your attention today.

最後，在我們轉向問答環節之前，我們對我們在整個 2022 年執行優先事項的方式感到非常自豪。我們強大的資產負債表狀況與嚴格的資本配置方法相結合，使我們能夠專注於選擇性投資以推動HEPLISAV-B 的可持續收入增長，深思熟慮地推進我們的臨床管道並支持我們的業務發展目標，我們相信所有這些都將產生長期股東價值。謝謝大家今天的關注。

Operator, we would now like to open the Q&A portion of today's call.

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 Phil Nadeau from Cowen and Company.

（操作員說明）我們的第一個問題來自 Cowen and Company 的 Phil Nadeau。

Congrats on the successful year. A couple of commercial questions from us and then one pipeline. On the commercial side, in your prepared remarks and in the press release, you mentioned that you are seeing signs that the ACIP guidelines are growing the market. Can you talk a little bit more detail about what those signs are? And what gives you confidence that you're beginning to see the impact of the guideline change?

祝賀你成功的一年。我們提出了幾個商業問題，然後是一個管道。在商業方面，在您準備好的評論和新聞稿中，您提到您看到了 ACIP 指南正在推動市場增長的跡象。你能更詳細地談談這些標誌是什麼嗎？是什麼讓您有信心開始看到指南變更的影響？

Phil, it's Donn. Absolutely. so within the Integrated Delivery Networks segment, so some of the signs we're seeing is just volume increases. We're looking at the volume increases in several of these customers that are exceeding 2019 levels. We're also monitoring implementation. And so it's around how they implement the guidelines. So are they communicating those guidelines out across the clinics? We're seeing signs of that. Are they evaluating progress against those communications, we're seeing signs of that as well within the IDN segment. So those are all positive signals as well as the growth, as I mentioned before.

菲爾，是唐恩。絕對地。所以在集成交付網絡部分，我們看到的一些跡像只是數量增加。我們正在研究其中幾個客戶的數量增長超過 2019 年的水平。我們也在監督實施。因此，這與他們如何實施指南有關。那麼他們是否在整個診所傳達這些指南？我們看到了這方面的跡象。他們是否在評估這些通信的進展，我們在 IDN 部分也看到了這種跡象。因此，正如我之前提到的，這些都是積極的信號以及增長。

Within retail, retail, we continue to engage at the headquarter level within retail and they continue to want to be willing to do different types of initiatives focusing on hepatitis B vaccination, so that's obviously a very positive sign. Retail fees, the recommendation as an opportunity, certainly, especially in the 30- to 50-year-old age cohorts as an opportunity to do a companion vaccination strategy. So that's been communicated to us by several of the less large national retailers. So all very positive signs as we head into '23.

在零售業，零售業，我們繼續在零售業的總部層面參與，他們繼續願意採取不同類型的舉措，重點是乙型肝炎疫苗接種，這顯然是一個非常積極的跡象。零售費用，建議作為一個機會，尤其是在 30 至 50 歲的年齡組中，作為一個機會來進行伴隨疫苗接種策略。因此，一些規模較小的全國性零售商已經向我們傳達了這一點。因此，當我們進入 23 年時，所有的跡像都非常積極。

That's really helpful. Then second commercial question on CpG 1018. Your guidance for 2023 is pretty clear. But I'm thinking longer term as the pandemic ends, in the past, Dynavax had suggested it was hoping to get 30% to 40% of the economics on vaccines sold using CpG 1018 vaccines commercially sold for -- using CpG 1018. Is that possible under your current supply contracts with the COVID manufacturers? Or do you need to renegotiate new contracts for the post-pandemic era, assuming some of those vaccines may eventually be available commercially?

這真的很有幫助。然後是關於 CpG 1018 的第二個商業問題。您對 2023 年的指導非常明確。但我認為，隨著大流行的結束，從長遠來看，在過去，Dynavax 曾表示，它希望在使用商業銷售的 CpG 1018 疫苗銷售的疫苗上獲得 30% 至 40% 的經濟效益——使用 CpG 1018。是嗎？根據您當前與 COVID 製造商的供應合同可能嗎？或者您是否需要重新談判後大流行時代的新合同，假設其中一些疫苗最終可以在市場上買到？

Well, I think it depends on what actually happens in the post-pandemic era, I think when you think of the low income countries, the economics post pandemic and during the pandemic are frankly, probably is similar. It's the middle income and upper middle income and high income countries and how our collaborators will fare in those primary markets that could be different than the way those markets existed during the pandemic government-sponsored purchasing.

嗯，我認為這取決於大流行後時代實際發生的情況，我認為當你想到低收入國家時，大流行後和大流行期間的經濟坦率地說，可能是相似的。這是中等收入和中高收入和高收入國家，以及我們的合作者在這些主要市場的表現可能與大流行政府贊助採購期間這些市場的存在方式不同。

So I actually don't think we would need to comment any differently on our -- [the ability of the value we can] capture. It seems consistent. I think what's more challenging to understand is how does the 1 billion dose of adjuvant supply get utilized over the next -- through the pandemic -- through '23 and '24 and '25 before there's additional supply to support the endemic market. And at that time, we'll be able to understand where the endemic pricing has settled out at and volumes to be able to negotiate the appropriate economics to figure out basically over the long term, but I don't think there's anything major change in how we position the economics part.

因此，我實際上認為我們不需要對我們的 - [我們可以獲取的價值的能力] 發表任何不同的評論。看起來是一致的。我認為，更難理解的是，在有額外供應來支持地方病市場之前，10 億劑量的佐劑供應如何在下一個——通過大流行——到 23 年、24 年和 25 年得到利用。到那時，我們將能夠了解地方性定價的確定位置和數量，以便能夠協商適當的經濟學，從長遠來看基本上弄清楚，但我認為沒有任何重大變化我們如何定位經濟學部分。

Okay. That is useful. And then last question on the pipeline. In terms of Z-1018, the press release that discussed the top line data noted that the CD4 positive T cells somewhat lower for Z-1018 than the comparator regimens. What -- any thoughts on the significance of that finding? And do you think those CD4 positive T cell levels could be related to glycoprotein E dose, and therefore, as you go to higher doses, perhaps you get more levels more similar to the competition?

好的。那很有用。然後是關於管道的最後一個問題。就 Z-1018 而言，討論頂線數據的新聞稿指出，Z-1018 的 CD4 陽性 T 細胞略低於比較方案。什麼 - 關於該發現的重要性的任何想法？您是否認為那些 CD4 陽性 T 細胞水平可能與糖蛋白 E 劑量有關，因此，當您使用更高劑量時，也許您會獲得更多與競爭產品更相似的水平？

Yes. I mean we're going to be looking at it with our gE protein in our Phase I/II trial. So we'll have to see. I mean we use a reasonably high dose in this one. So I don't think that we'd highlights that as an expectation, but we'd like to see it in the [next] Phase I/II trial. The first question is the importance of it. And as you can tell by our continued interest in the program, it's unknown, right? And we want to continue to work around that endpoint. But the bottom line is we saw a robust response. And recognizing that it's lower than the comparator, we still saw a very robust response and believe that, that has the opportunity to deliver high levels of efficacy. So we need to continue to do work and advance the program and think of ways to derisk that ultimate efficacy trial. But we can't really comment more than what we said around the fact that they were lower, but we did see robust responses. Rob, anything else you want to add to that?

是的。我的意思是我們將在 I/II 期試驗中用我們的 gE 蛋白來研究它。所以我們必須拭目以待。我的意思是我們在這個中使用了相當高的劑量。所以我不認為我們會強調這是一種期望，但我們希望在[下一個] I / II 期試驗中看到它。第一個問題是它的重要性。從我們對該計劃的持續興趣可以看出，它是未知的，對吧？我們希望繼續圍繞該端點進行工作。但最重要的是我們看到了強烈的反應。並且認識到它低於比較器，我們仍然看到了非常強大的響應，並相信它有機會提供高水平的功效。因此，我們需要繼續開展工作並推進該計劃，並想辦法降低最終療效試驗的風險。但我們不能真正評論更多關於它們較低這一事實的評論，但我們確實看到了強烈的反應。 Rob，你還有什麼要補充的嗎？

No, I think you've covered it. We certainly will be looking at higher doses of antigen in the new Phase I study and potentially other changes to look at how we can improve those CD4 responses.

不，我想你已經涵蓋了它。我們當然會在新的 I 期研究中研究更高劑量的抗原，並可能進行其他改變，以研究我們如何改善這些 CD4 反應。

Our next question comes from the line of Madhu Kumar from Goldman Sachs.

我們的下一個問題來自高盛的 Madhu Kumar。

So I think we'll start with a financial one kind of as you think about gross margins for HEPLISAV, as we mentioned gross margins of 68%. Should we expect further margin improvements in 2023 and on the forward for HEPLISAV?

所以我認為我們將從財務方面開始，就像您考慮 HEPLISAV 的毛利率一樣，正如我們提到的 68% 的毛利率。我們是否應該期待 2023 年和 HEPLISAV 的未來利潤率進一步提高？

Yes, we're really happy with the continued expansion in margin. We've been making some very such specific and disciplined investments in our manufacturing facility in Germany. So we're happy to see those yield improvements over time. We would like to continue to see some margin expansion through 2023 and 2024, namely, as scale continues to improve, I think in the low 70% is a fair -- sort of fair estimate for the next couple of years.

是的，我們對利潤率的持續擴張感到非常高興。我們一直在對我們在德國的製造工廠進行一些非常具體和有紀律的投資。所以我們很高興看到這些產量隨著時間的推移而提高。我們希望在 2023 年和 2024 年之前繼續看到利潤率有所擴大，也就是說，隨著規模的不斷擴大，我認為低 70% 是一個公平的——對未來幾年的公平估計。

Okay. And then a follow-up question on the CpG 1018 story. So really clear about kind of expectations for CpG 1018 sales in 2023. I guess also, as you think about the kind of long-term opportunities you mentioned in the endemic market, we hear some of your customers talking about plans for the endemic market. If they were to need more adjuvant and what kind of time frame would you expect them to need to be placing these orders? And when kind of would you have a sense of when that demand might emerge?

好的。然後是關於 CpG 1018 故事的後續問題。對 2023 年 CpG 1018 銷售的預期非常清楚。我想，當你考慮你在地方市場中提到的那種長期機會時，我們聽到你的一些客戶談論地方市場的計劃。如果他們需要更多的佐劑，您希望他們需要什麼樣的時間框架來下這些訂單？您什麼時候會知道這種需求何時會出現？

Thanks for the question, Madhu. Again, it depends on how fast they burn through their stockpile of adjuvant, but we are in very close contact with our collaborators recognizing that there is lead time needed to secure the manufacturing supply [for us]. We do have inventory. I think it's worth noting that we do have some inventory of adjuvants that we purposely maintained to be able to help navigate the transition from utilizing the stockpile and manage the time line to securing manufacturing spots so that we can be supportive of our collaborators broadly.

謝謝你的問題，馬杜。同樣，這取決於他們消耗佐劑儲備的速度有多快，但我們與我們的合作者保持著非常密切的聯繫，認識到需要提前期來確保 [為我們] 的製造供應。我們確實有庫存。我認為值得注意的是，我們確實有一些佐劑庫存，我們有意維護這些庫存，以幫助駕馭從利用庫存和管理時間線到確保生產地點的過渡，以便我們能夠廣泛支持我們的合作者。

So I think we'll be able to see it coming is the point as they use their -- as the endemic market becomes clearer, more clear as to what the volume and demand will be. And as our collaborators utilize their inventory, I think there will be plenty of time to see any future demand coming to be able to manage their needs for their endemic markets without having to run the risk of not having adjuvants (inaudible).

所以我認為我們將能夠看到它的到來是他們使用他們的點 - 隨著地方性市場變得更加清晰，對於數量和需求將會更加清晰。當我們的合作者利用他們的庫存時，我認為將有足夠的時間看到任何未來的需求能夠管理他們對地方性市場的需求，而不必冒沒有佐劑的風險（聽不清）。

Our next question comes from the line of Matthew Phipps from William Blair.

我們的下一個問題來自威廉·布萊爾的馬修·菲普斯。

Congrats on great into '22. Following up on Phil's question on the antigen dose of gE for shingles vaccine. GSK published a study in 2014 that looked at different doses of antigen and at least in that study, it looked like there was a dose response for the humoral response, but maybe not for the cellular response. Is that what you would expect when you're changing antigen? Or is there maybe differences in ranges being looked at or something different with the CpG 1018 adjuvant to change that?

祝賀你進入 22 年。跟進菲爾關於帶狀皰疹疫苗的 gE 抗原劑量的問題。 GSK 在 2014 年發表了一項研究，研究了不同劑量的抗原，至少在該研究中，體液反應似乎有劑量反應，但細胞反應可能沒有。當你改變抗原時，這是你期望的嗎？或者是否可能存在正在觀察的範圍差異或 CpG 1018 佐劑的不同之處以改變這種情況？

Bob, would you like to take that?

鮑勃，你願意接受嗎？

Yes. I think it's hard to know because the adjuvants work in very different ways. So yes, in that paper, GSK's paper, 50 and 100 looked the same for CD4s. I don't know that, that's going to be true for us. So the purpose of the Phase I that we completed was just looking at a fixed dose of antigen but various CpG 1018 formulations to see -- could we get close to the comparator. And I think at this point now, because now what we have to look at is, now we have to look at that antigen dose. I don't think we can assume that based on the GSK experience, that's what we're going to see with 1018.

是的。我認為很難知道，因為佐劑的作用方式非常不同。所以是的，在那篇論文中，GSK 的論文中，50 和 100 對於 CD4 看起來是一樣的。我不知道，這對我們來說是真的。因此，我們完成的第一階段的目的只是查看固定劑量的抗原，但要查看各種 CpG 1018 配方——我們能否接近比較器。我現在認為，因為現在我們要看的是，現在我們必須看抗原劑量。我不認為我們可以根據葛蘭素史克的經驗假設，這就是我們將在 1018 中看到的情況。

Got it. Okay, Bob. And you mentioned kind of the prioritizing of BD, which is good to hear, given the balance sheet. And I know you can't talk too much about it at this point, but should we be thinking about adult vaccines, pharmacist administered. I guess just where do you think there's the most overlap with kind of your current infrastructure?

知道了。好的，鮑勃。考慮到資產負債表，你提到了 BD 的優先級排序，這很高興聽到。我知道你現在不能談論太多，但我們應該考慮成人疫苗，藥劑師管理。我想您認為與您當前的基礎設施類型最重疊的地方在哪裡？

I think practically, Matt, the reality is it's the [sweep] opportunities in the industry that it's going to be more meaningful as opposed to the specific overlap. Well, it would be great to find something that overlaps perfectly with our commercial infrastructure. The reality is it's the whole combined entity that has value to leverage, including leadership high-quality manufacturing, pharmacovigilance, clinical development policy, commercialization, medical affairs, commercial leadership, distribution. So I think we're looking for ways to leverage that entire entity more so than just focusing on leveraging our field footprint, which can be augmented in many directions as needed depending on the products that are available.

我認為實際上，馬特，現實是，與特定的重疊相比，它是行業中的 [掃蕩] 機會，它將更有意義。好吧，找到與我們的商業基礎設施完美重疊的東西會很棒。現實情況是，整個聯合實體具有價值，包括領導高質量製造、藥物警戒、臨床開發政策、商業化、醫療事務、商業領導、分銷。因此，我認為我們正在尋找方法來利用整個實體，而不僅僅是專注於利用我們的現場足跡，這可以根據可用產品的需要在許多方向上進行擴展。

So you've heard in our comments, from a business perspective, we believe the best use of our capital as well as our capabilities, focusing on late-stage or commercial assets. That would be obviously within the vaccine business ideally, but we also might have to be open to a little bit broader purview as well. So we'll have to kind of manage through that over time as we consider all the opportunities.

所以你在我們的評論中聽到，從商業角度來看，我們相信最好利用我們的資本和我們的能力，專注於後期或商業資產。理想情況下，這顯然是在疫苗業務範圍內，但我們也可能必須對更廣泛的範圍持開放態度。因此，隨著我們考慮所有機會，我們必須隨著時間的推移進行管理。

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

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

Kind of handful on the shingles program. I just want to make sure I heard Rob correctly. I think you said meet with the FDA this half. Is that correct? And do you plan to announce the outcome of that meeting outside of, say, an earnings call? And then, if that's true, do you also think you can file the IND this half?

關於帶狀皰疹計劃的少數人。我只是想確保我沒聽錯 Rob。我想你說過這半年會見 FDA。那是對的嗎？您是否計劃在財報電話會議之外宣布該會議的結果？然後，如果那是真的，你是否也認為你可以在這一半提交 IND？

Roy, this is Ryan. Let me just take the cognitive communication. The meeting with the FDA is a pre-IND meeting to move into a clinical trial in the U.S. And so we will -- the outcome of that meeting will help dictate our future development program, which we will always be transparent about as we continue to refine it. I don't think you should expect that we have a specific announcement related to the completion of that meeting. So the communication of that outcome will be through how we talk about our programs and our traditional dialogue. So I think that's just to be very clear about that, Rob, you can comment on the timing of IND filing.

羅伊，這是瑞安。讓我來談談認知交流。與 FDA 的會議是在美國進行臨床試驗的前 IND 會議，因此我們將——那次會議的結果將有助於決定我們未來的發展計劃，我們將始終保持透明，因為我們將繼續完善它。我認為您不應該期望我們會發布與該會議結束相關的具體公告。因此，結果的交流將通過我們如何談論我們的計劃和我們的傳統對話來進行。所以我認為這只是為了非常清楚，Rob，你可以評論 IND 申請的時間。

Yes. Timing, so yes, we do anticipate that we'll be able to meet with FDA in the first half of the year. We certainly will be submitting our pre-IND meeting requests. And then we do anticipate submitting the IND later in the year, it will be the second half of the year.

是的。時間，所以是的，我們確實預計我們將能夠在今年上半年與 FDA 會面。我們當然會提交我們的 IND 會議前會議請求。然後我們確實預計在今年晚些時候提交 IND，這將是下半年。

Got it. Okay. Anything else you guys can say about the potential venue for the data this half. It sounds like maybe you haven't submitted the abstract, is that correct? Just any details you can give us on that. And then anything you can say about what you've seen as far as the adjuvants. I know you're looking at with and without alum. Anything you can say at this point whether you expect to go forward with alum or without.

知道了。好的。關於這半部分數據的潛在地點，你們還有什麼可以說的嗎？聽起來您可能還沒有提交摘要，對嗎？您可以就此向我們提供任何詳細信息。然後就佐劑而言，你可以說說你所看到的一切。我知道你在看有沒有明礬。在這一點上，無論您是否希望繼續使用明礬，您都可以說任何話。

Well, let me comment on the abstract. If we have to estimate the abstract, we have to be accepted before we can commit to where we're going to present. So I think, frankly, at this point, it's most appropriate for us to just explain our plan, which we will be submitting the abstract with expectations for a medical meeting that will be held in the first half of this year. I don't think we can really comment more on that because we don't -- won't control the ultimate acceptance for that abstract. And then we haven't commented on our decision around the adjuvant with or without alum yet. One thing that I will -- just to highlight some of the commentary you saw in our previous press release, all of our comments were around all dose groups. So there was -- we did see some differences, which will be highlighted in the eventual poster presentation, but they are not so significant to where there is necessarily an obvious decision. So we will continue to work through that decision as we progress towards our Phase I/II trial. There's just not a lot of urgency to make that decision yet, Roy. So we haven't prioritized it.

好吧，讓我評論一下摘要。如果我們必須估計摘要，我們必須先被接受，然後才能承諾我們將要展示的地方。所以我認為，坦率地說，在這一點上，我們只解釋我們的計劃是最合適的，我們將提交摘要並期望在今年上半年舉行的醫學會議。我不認為我們真的可以對此發表更多評論，因為我們不會 - 不會控制對該摘要的最終接受。然後我們還沒有評論我們關於有或沒有明礬的佐劑的決定。我會做一件事——只是為了強調您在我們之前的新聞稿中看到的一些評論，我們所有的評論都圍繞所有劑量組。因此，我們確實看到了一些差異，這些差異將在最終的海報展示中突出顯示，但它們對於必須做出明顯決定的地方來說並不那麼重要。因此，隨著我們向 I/II 期試驗取得進展，我們將繼續執行該決定。羅伊，現在還沒有太多的緊迫感來做出這個決定。所以我們沒有優先考慮它。

We have no further questions at this time. I'd like to now turn it back to Ryan Spencer, CEO, for closing remarks.

目前我們沒有其他問題。我現在想把它轉回給首席執行官瑞安斯賓塞，以作結束語。

Thank you, operator, and thank you all for your attention today. The important takeaway for you is that we believe the combination of our revenue-generating assets, a highly experienced and execution-focused team, our strong financial profile, and an emerging pipeline of product candidates based on our proven adjuvant technology provides a solid foundation for our future. .

謝謝接線員，也謝謝大家今天的關注。對您來說重要的一點是，我們相信我們的創收資產、經驗豐富且專注於執行的團隊、我們強大的財務狀況以及基於我們成熟的佐劑技術的新興候選產品管道的結合，為我們的未來。 .

Our success this past year and the opportunities we see ahead are made possible by the dedicated team of Dynavax. Our people are everything, and I'd like to thank them for their commitment and effort towards our mission. Thank you for joining us today. We appreciate your time and interest in Dynavax. Operator, you may end the call.

Dynavax 敬業的團隊使我們過去一年的成功和我們看到的未來機會成為可能。我們的員工就是一切，我要感謝他們對我們使命的承諾和努力。感謝您今天加入我們。感謝您抽出寶貴時間對 Dynavax 感興趣。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.

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。