Dynavax Technologies Corp (DVAX) 2022 Q2 法說會逐字稿

Good day, and welcome to the Dynavax Technologies Second Quarter 2022 Financial Results Call. As a reminder, this conference call is being recorded. (Operator Instructions) I would now like to turn the call over to Nicole Arndt, Senior Manager for Investor Relations. You may begin.

美好的一天，歡迎參加 Dynavax Technologies 2022 年第二季度財務業績電話會議。提醒一下，正在錄製此電話會議。 （操作員說明）我現在想將電話轉給投資者關係高級經理 Nicole Arndt。你可以開始了。

Thank you. Good afternoon, and welcome to the Dynavax Second Quarter 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 in the Events section of our website.

謝謝你。下午好，歡迎參加 Dynavax 2022 年第二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”部分還提供了今天電話會議附帶的補充幻燈片演示。

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; market trends; impact of ACIP recommendations and timing of such impact; 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 CpG 1018 adjuvant.

在開始之前，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，包括但不限於潛在的市場規模和市場份額；市場走向; ACIP 建議的影響和這種影響的時間安排；財務指導和趨勢，包括收入、盈利能力和當前資本的充足性； CpG 1018 佐劑的臨床試驗開始時間和結果以及數據讀出和潛在的未來用途。

These statements involve risks and uncertainties, and our actual results may differ materially. These results -- 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.

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。這些結果——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的風險因素部分進行了詳細說明，包括今天關於表格 10-Q 的季度報告。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。

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. I will now turn the call over to Ryan.

今天和我一起參加電話會議的是首席執行官 Ryan Spencer； Donn Casale，商業高級副總裁； Rob Janssen，首席醫療官；和首席財務官凱利麥克唐納。我現在將把電話轉給 Ryan。

Thank you, Nicole, and thank you all for joining us today. I'm excited to have the opportunity to review the progress we have made during the second quarter. I'll start by providing a brief overview of our highlights before turning it over to Donn, Rob and Kelly, who'll provide a bit more insight to their respective areas.

謝謝你，妮可，謝謝大家今天加入我們。我很高興有機會回顧我們在第二季度取得的進展。我將首先簡要概述我們的亮點，然後將其交給 Donn、Rob 和 Kelly，他們將對各自領域提供更多見解。

The short summary of the quarter is that we continue to execute well on our core priorities, which has us on track for a second consecutive year of profitability with record revenues expected for HEPLISAV-B and our CpG 1018 adjuvant. Based on strong execution from the team, the total revenue for the quarter grew 386% compared to the second quarter of last year. Importantly, we continue to see market adoption of HEPLISAV-B driven by successful engagement across our customer segments, resulting in increased market share and revenue. We achieved over $32 million in HEPLISAV-B net product sales in the second quarter, supporting our expectations for another year of growth for HEPLISAV-B revenues.

本季度的簡短總結是，我們繼續在我們的核心優先事項上執行良好，這使我們連續第二年實現盈利，預計 HEPLISAV-B 和我們的 CpG 1018佐劑的收入將創紀錄。基於團隊的強大執行力，本季度的總收入與去年第二季度相比增長了 386%。重要的是，我們繼續看到 HEPLISAV-B 的市場採用受到我們客戶群的成功參與的推動，從而增加了市場份額和收入。我們在第二季度實現了超過 3200 萬美元的 HEPLISAV-B 淨產品銷售額，支持了我們對 HEPLISAV-B 收入再增長一年的預期。

We're also paying close attention to the evolving landscape for COVID-19 vaccines globally. New COVID-19 variants have driven increases in infections. However, vaccines continue to provide protection against severe disease that lead to hospitalization and death. Our collaborators have demonstrated that their COVID-19 vaccine platforms adjuvanted with CpG 1018 can provide a combination of high efficacy and immunogenicity with favorable safety and tolerability.

我們還密切關注全球 COVID-19 疫苗的演變前景。新的 COVID-19 變體導致感染增加。然而，疫苗繼續提供針對導致住院和死亡的嚴重疾病的保護。我們的合作者已經證明，他們以 CpG 1018 為佐劑的 COVID-19 疫苗平台可以提供高效和免疫原性的組合，並具有良好的安全性和耐受性。

In the second quarter, our global portfolio of CpG 1018 adjuvant supply agreements for COVID-19 vaccines generated over $220 million of revenue. We anticipate full year 2022 revenue for CpG 1018 to be between $550 million and $600 million, which represents the remainder of orders from our partners under our commercial supply agreements. We continue to work with each of our partners to understand and clarify potential demand for 2023 and beyond.

在第二季度，我們針對 COVID-19 疫苗的 CpG 1018 佐劑供應協議的全球組合產生了超過 2.2 億美元的收入。我們預計 CpG 1018 的 2022 年全年收入將在 5.5 億美元至 6 億美元之間，這代表了我們的合作夥伴根據我們的商業供應協議獲得的剩餘訂單。我們將繼續與每個合作夥伴合作，以了解和澄清 2023 年及以後的潛在需求。

Now beyond COVID-19, we are leveraging our proven CpG 1018 adjuvant to advance our pipeline of new and improved vaccines. Our current clinical programs are focused on delivering meaningful improvement over existing vaccines by adding our CpG 1018 adjuvant to establish antigen. We expect our Tdap and shingles program will generate initial Phase I data this year, which we anticipate will highlight the value of our pipeline and strategy to produce best-in-class products targeting large markets.

現在除了 COVID-19，我們正在利用我們經過驗證的 CpG 1018 佐劑來推進我們的新疫苗和改進疫苗的管道。我們目前的臨床項目專注於通過添加我們的 CpG 1018 佐劑來建立抗原，從而對現有疫苗進行有意義的改進。我們預計我們的 Tdap 和帶狀皰疹計劃將在今年產生初始的第一階段數據，我們預計這將突出我們的管道和戰略的價值，以生產針對大型市場的一流產品。

In reflecting on the past few years, we are extremely proud of the execution on our strategy to grow HEPLISAV-B revenue and broadly develop our CpG 1018 adjuvant to build a strong foundation for future growth. Over a relatively short period of time, we have drastically expanded the long-term opportunity for our CpG 1018 adjuvant, transformed our financial profile and have demonstrated our ability to successfully commercialize HEPLISAV-B.

回顧過去幾年，我們為實現 HEPLISAV-B 收入增長和廣泛開發 CpG 1018 佐劑為未來增長奠定堅實基礎的戰略的執行感到非常自豪。在相對較短的時間內，我們極大地擴大了 CpG 1018 佐劑的長期機會，改變了我們的財務狀況，並展示了我們成功商業化 HEPLISAV-B 的能力。

We are proud of our progress and equally excited for our future, where we will continue to provide advancements to benefit public health and drive value for our shareholders. I'll now turn the call over to Donn to provide more details on HEPLISAV-B performance.

我們為我們的進步感到自豪，對我們的未來同樣興奮，我們將繼續提供進步以造福公眾健康並為我們的股東創造價值。我現在將把電話轉給 Donn，以提供有關 HEPLISAV-B 性能的更多詳細信息。

Thank you, Ryan. I'm extremely proud of the hard work and dedication of our commercial team and thrilled to share the extraordinary second quarter results for HEPLISAV-B. 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. Unfortunately, most adults never complete a 3-dose hepatitis B vaccine series. 2-dose HEPLISAV-B can make series completion easier and protect more patients faster.

謝謝你，瑞安。我為我們商業團隊的辛勤工作和奉獻精神感到非常自豪，並很高興能分享 HEPLISAV-B 的非凡第二季度業績。 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，它允許在 1 個月內僅完成 2 劑系列疫苗。系列完成對於高水平的保護至關重要。不幸的是，大多數成年人從未完成 3 劑乙型肝炎疫苗系列。 2 劑 HEPLISAV-B 可以更輕鬆地完成系列並更快地保護更多患者。

In the second quarter, HEPLISAV-B generated net product revenue of $33 million, its highest single revenue quarter since launch and an increase of 139% from $14 million in Q2 of last year. This includes approximately $1 million in revenue from the launch in Germany by our commercialization partner, Bavarian Nordic. This significant revenue growth in the U.S. was driven by our continued gains in market share. We estimate HEPLISAV-B's total market share increased to 32%, up from 19% during the same period last year, while field targeted market share increased to 39%, up from 30% during the same period last year.

第二季度，HEPLISAV-B 產生了 3300 萬美元的淨產品收入，是自推出以來的最高單季度收入，比去年第二季度的 1400 萬美元增長 139%。這包括我們的商業化合作夥伴 Bavarian Nordic 在德國推出的約 100 萬美元收入。美國的這一顯著收入增長是由我們持續增長的市場份額推動的。我們估計 HEPLISAV-B 的總市場份額從去年同期的 19% 增加到 32%，而現場目標市場份額從去年同期的 30% 增加到 39%。

Total market share gains were supported by significant progress in the retail pharmacy segment. Quarter-over-quarter dose growth in this segment increased by approximately 167%. During Q2, we expanded our commercial engagement with top national retail chains and have now successfully executed purchase contracts with all of the top 10 retail pharmacy chains. These top 10 chains represent over 97% of the hepatitis B market opportunity in this segment.

零售藥房領域的重大進展支持了總市場份額的增長。該細分市場的季度劑量增長約 167%。在第二季度，我們擴大了與全國頂級零售連鎖店的商業合作，現已成功執行與所有前 10 家零售藥店連鎖店的採購合同。這些前 10 家連鎖店代表了該細分市場中超過 97% 的乙肝市場機會。

Additionally, we executed several sales and marketing initiatives and leveraged the ACIP universal recommendation to drive increased stocking across pharmacy chains. Retail customers view the ACIP universal recommendation as a significant lever for driving expanded vaccination and continue to express an interest in working with us to implement hepatitis B immunization initiative. We are very excited by our progress in this segment and believe that retail pharmacy will be a critical growth driver to expand the hepatitis B vaccine market.

此外，我們執行了多項銷售和營銷計劃，並利用 ACIP 通用建議來推動藥房連鎖店的庫存增加。零售客戶將 ACIP 普遍建議視為推動擴大疫苗接種的重要手段，並繼續表示有興趣與我們合作實施乙肝免疫計劃。我們對我們在這一領域的進展感到非常興奮，並相信零售藥店將成為擴大乙肝疫苗市場的關鍵增長動力。

Another important segment that led to significant increases in Q2 market share was the Integrated Delivery Network, or IDN, segment. In Q2, we were able to convert several top national hospital systems to HEPLISAV-B. We believe the unique clinical profile of HEPLISAV-B as the only 2-dose option in an era of universal recommendation is accelerating IDN adoption and conversion to HEPLISAV-B. We are encouraged by the uptake and anticipate continued positive momentum within this segment.

另一個導致第二季度市場份額顯著增加的重要部分是集成交付網絡（IDN）部分。在第二季度，我們能夠將幾個頂級的國家醫院系統轉換為 HEPLISAV-B。我們相信 HEPLISAV-B 作為普遍推薦時代唯一的 2 劑選擇的獨特臨床特徵正在加速 IDN 的採用和向 HEPLISAV-B 的轉換。我們對這一領域的吸收感到鼓舞，並預計該領域將繼續保持積極勢頭。

In addition to increases in market share, we continue to see a positive trend in the hepatitis B market returning from pandemic lows. In Q2, we estimate that the hepatitis B market utilization was down 19% from pre-pandemic levels. Looking ahead for the remainder of the year, Q3 market utilization will likely remain at or near the same levels seen in Q2 due to ongoing COVID-19 booster campaigns. We also anticipate some market utilization impact in the fourth quarter due to typical year-end seasonality.

除了市場份額增加外，我們繼續看到乙肝市場從大流行低點恢復的積極趨勢。在第二季度，我們估計乙肝市場的利用率比大流行前的水平下降了 19%。展望今年剩餘時間，由於正在進行的 COVID-19 助推器活動，第三季度的市場利用率可能會保持在或接近第二季度的水平。由於典型的年終季節性因素，我們還預計第四季度市場利用率會受到一些影響。

We are focusing our commercial efforts on driving awareness to the expanded ACIP recommendation, which we believe may result in significant market growth over the coming years. The ACIP's recommendation that all adults 19 to 59 years of age should receive hepatitis B vaccination significantly expands the number of adults in the U.S. who should be vaccinated against hepatitis B compared to the prior risk-based recommendation. We continue to believe that the ACIP recommendation will be a significant catalyst for growth and estimate the hepatitis B market opportunity could grow to approximately $800 million by 2027 with HEPLISAV-B well positioned to secure a majority market share over time.

我們的商業努力集中在提高人們對擴大的 ACIP 建議的認識，我們認為這可能會在未來幾年帶來顯著的市場增長。與之前基於風險的建議相比，ACIP 建議所有 19 至 59 歲的成年人都應接種乙型肝炎疫苗，這顯著增加了美國應接種乙型肝炎疫苗的成年人數量。我們仍然相信 ACIP 的建議將成為增長的重要催化劑，並估計到 2027 年，隨著 HEPLISAV-B 處於有利地位，隨著時間的推移，乙型肝炎市場機會將增長到大約 8 億美元。

With a proven clinical profile and our team's strong commercial execution, we expect further market share gains and continued annual growth for HEPLISAV-B. We remain confident in our ability to generate momentum and look forward to continuing to drive long-term growth for the brand. I will now turn the call over to Rob to take you through our clinical pipeline.

憑藉經過驗證的臨床概況和我們團隊強大的商業執行力，我們預計 HEPLISAV-B 的市場份額將進一步增長並持續每年增長。我們仍然對我們產生動力的能力充滿信心，並期待繼續推動該品牌的長期增長。我現在將把電話轉給 Rob，帶您了解我們的臨床管道。

Thank you, Donn. Our ongoing studies in Tdap and shingles are progressing nicely. These studies are expected to generate early clinical data later this year that we believe will begin to support meaningful differentiation from the existing vaccines. We're currently conducting a Phase I clinical trial evaluating an improved Tetanus, diphtheria and pertussis or Tdap vaccine that utilizes our CpG 1018 adjuvant. Previously, we reported interim adult data from this study that demonstrated the vaccine candidate was well tolerated without safety concerns and that immunogenicity results were consistent with our expectations and support continued advancement of the vaccine candidate.

謝謝你，唐恩。我們正在進行的 Tdap 和帶狀皰疹研究進展順利。這些研究預計將在今年晚些時候產生早期臨床數據，我們相信這些數據將開始支持與現有疫苗的有意義的差異化。我們目前正在進行一項 I 期臨床試驗，評估使用我們的 CpG 1018 佐劑的改良破傷風、白喉和百日咳或 Tdap 疫苗。此前，我們報告了該研究的中期成人數據，證明候選疫苗耐受性良好，沒有安全問題，免疫原性結果與我們的預期一致，並支持候選疫苗的持續發展。

Adolescent data from the same trial are expected in the fourth quarter of 2022. We're also conducting a nonhuman primate pertussis challenge study to assess the impact on prevention of disease symptoms and nasal colonization of the pertussis bacteria.

來自同一試驗的青少年數據預計將於 2022 年第四季度公佈。我們還在進行一項非人類靈長類動物百日咳挑戰研究，以評估對預防疾病症狀和百日咳細菌鼻腔定植的影響。

Now moving on to our shingles vaccine program. We recently completed enrollment in our ongoing Phase I study evaluating safety, tolerability and immunogenicity compared with Shingrix, a commercially available shingles vaccine in the United States and other countries. We believe that our vaccine candidate with CpG 1018 has the potential to elicit strong CD4 T cell responses, which are key in controlling reactivation of the zoster virus while providing improved tolerability compared to the current marketed product. Top line data from this clinical trial are anticipated in the fourth quarter of 2022.

現在繼續我們的帶狀皰疹疫苗計劃。我們最近完成了我們正在進行的 I 期研究的註冊，該研究評估了與美國和其他國家的市售帶狀皰疹疫苗 Shingrix 相比的安全性、耐受性和免疫原性。我們相信，我們的 CpG 1018 候選疫苗有可能引發強烈的 CD4 T 細胞反應，這是控制帶狀皰疹病毒再激活的關鍵，同時與目前上市的產品相比提供了更好的耐受性。該臨床試驗的一線數據預計將在 2022 年第四季度發布。

Lastly, we anticipate enrolling this month, the first participants in our Phase II clinical trial evaluating the immunogenicity, safety and tolerability of a plague vaccine candidate utilizing CpG 1018 adjuvant. The clinical trial is being conducted in collaboration with and funded by the U.S. Department of Defense.

最後，我們預計本月將招收第一批參與者，我們的 II 期臨床試驗評估了使用 CpG 1018 佐劑的鼠疫候選疫苗的免疫原性、安全性和耐受性。該臨床試驗是與美國國防部合作並由美國國防部資助進行的。

We are pleased with the advancement of our clinical candidates and confident in our strategy to leverage the proven profile of CpG 1018 to develop new and improved vaccine candidates that have potentially significant opportunities addressing important unmet medical needs. I'll now pass the call over to Kelly to review our second quarter financial results and our 2022 financial guidance.

我們對臨床候選藥物的進步感到高興，並對我們利用 CpG 1018 的成熟概況開發新的和改進的候選疫苗的戰略充滿信心，這些候選疫苗具有潛在的重大機會，可以解決重要的未滿足的醫療需求。我現在將電話轉給凱利，以審查我們的第二季度財務業績和我們的 2022 年財務指導。

Thank you, Rob. I'm very pleased to report on another quarter of strong financial performance. I'll highlight the key financial items and then review our updated full year 2022 guidance and provide a few closing thoughts. Please note that all financial comparisons are versus the prior year period, unless otherwise noted. Please refer additionally to our press release and 10-Q for the detailed financial information.

謝謝你，羅布。我很高興地報告另一個季度的強勁財務表現。我將重點介紹關鍵的財務項目，然後回顧我們更新的 2022 年全年指南並提供一些結束的想法。請注意，除非另有說明，否則所有財務比較均與去年同期相比。另請參閱我們的新聞稿和 10-Q 了解詳細的財務信息。

Beginning with our revenue performance. We delivered total revenue of $256 million for the second quarter of 2022, up 386% year-over-year. We are extremely excited about the commercial progress of HEPLISAV-B in the U.S. and now also in Germany. The second quarter marked another record-breaking quarter of total HEPLISAV-B net sales of $33 million, including approximately $1 million of sales associated with commercialization in Germany and represents significant year-over-year growth of 139% for the franchise.

從我們的收入表現開始。我們在 2022 年第二季度實現了 2.56 億美元的總收入，同比增長 386%。我們對 HEPLISAV-B 在美國以及現在在德國的商業進展感到非常興奮。第二季度是 HEPLISAV-B 總淨銷售額 3300 萬美元的又一個創紀錄的季度，其中包括與德國商業化相關的約 100 萬美元的銷售額，該特許經營權同比顯著增長 139%。

Additionally, we continue to execute across our global portfolio of CpG 1018 adjuvant commercial supply agreements for COVID-19 vaccines, achieving $223 million in CpG 1018 adjuvant revenues with a gross margin of 67%. Included in this amount is approximately $55 million in revenue at 100% gross margin associated with the final delivery under our commercial supply agreement with Valneva.

此外，我們繼續在全球範圍內執行 COVID-19 疫苗的 CpG 1018 佐劑商業供應協議組合，實現 2.23 億美元的 CpG 1018 佐劑收入，毛利率為 67%。根據我們與 Valneva 的商業供應協議，該金額中包括與最終交付相關的 100% 毛利率的約 5500 萬美元收入。

Now turning to expenses. Our research and development expenses for the second quarter of 2022 were $10 million, reflecting continued advancement of our ongoing pipeline programs in Tdap and shingles as well as our funded Phase II contract with the DoD for an adjuvanted plague vaccine. Looking ahead, we are very encouraged by the continued progress in our clinical pipeline and look forward to multiple potential data catalysts across our portfolio by the end of the year, as Rob highlighted.

現在轉向開支。我們在 2022 年第二季度的研發費用為 1000 萬美元，這反映了我們在 Tdap 和帶狀皰疹方面正在進行的管道計劃的持續推進，以及我們與國防部資助的鼠疫佐劑疫苗的 II 期合同。展望未來，正如 Rob 強調的那樣，我們對臨床管道的持續進展感到非常鼓舞，並期待在今年年底之前在我們的產品組合中出現多種潛在的數據催化劑。

Selling, general and administrative expenses for the second quarter of 2022 increased to $36 million compared to $22 million for the second quarter of last year, primarily driven by increased headcount across field sales and G&A, coupled with focused marketing investments to drive growth in HEPLISAV-B.

與去年第二季度的 2200 萬美元相比，2022 年第二季度的銷售、一般和管理費用增加到 3600 萬美元，這主要是由於現場銷售和 G&A 的員工人數增加，加上集中營銷投資以推動 HEPLISAV 的增長- B.

Moving on to profitability. For the second quarter of 2022, we generated GAAP net income of $129 million or $1.02 per share basic and $0.87 per share diluted compared to GAAP net income of $4 million or $0.04 per share basic and $0.02 per share diluted in the second quarter of 2021.

繼續盈利。對於 2022 年第二季度，我們產生的 GAAP 淨收入為 1.29 億美元或每股基本 1.02 美元和每股攤薄收益 0.87 美元，而 2021 年第二季度的 GAAP 淨收益為 400 萬美元或每股基本淨收益 0.04 美元和每股攤薄收益 0.02 美元。

Now turning to the balance sheet. We ended the second quarter with a robust balance sheet, including cash, cash equivalents and investments of $518 million. We believe this level of capital is sufficient to support our core business without the need to raise additional funds. Lastly, I'm pleased to refine our 2022 full year financial guidance, including: CpG 1018 adjuvant revenues of between $550 million to $600 million, with approximately 60% gross margin for the year, which reflects the economics associated with the remaining firm orders under our commercial supply agreements for 2022; R&D expenses in the range of $50 million to $60 million; SG&A expenses in the range of $130 million to $140 million; and we are reiterating our previously guided interest expense of approximately $7 million.

現在轉向資產負債表。我們以穩健的資產負債表結束了第二季度，其中包括 5.18 億美元的現金、現金等價物和投資。我們相信，這一水平的資本足以支持我們的核心業務，而無需籌集額外資金。最後，我很高興完善我們的 2022 年全年財務指導，包括： CpG 1018 輔助收入在 5.5 億美元至 6 億美元之間，全年毛利率約為 60%，這反映了與以下剩餘固定訂單相關的經濟性我們的 2022 年商業供應協議；研發費用在 5000 萬美元到 6000 萬美元之間； SG&A 費用在 1.3 億美元至 1.4 億美元之間；我們重申我們之前指導的大約 700 萬美元的利息支出。

These refinements to our operating expense guidance reflects our disciplined approach to capital allocation, focused on selective investments to drive growth in HEPLISAV-B and thoughtfully advance our clinical pipeline to drive long-term shareholder value. We remain on track for another great year with anticipated record revenues for both of our commercial assets, continued progress and meaningful catalysts across our clinical portfolio and a second consecutive year of profitability. Thank you, everyone, for your attention today. Operator, we would now like to open the Q&A portion of today's call.

我們對運營費用指導的這些改進反映了我們嚴格的資本分配方法，專注於選擇性投資以推動 HEPLISAV-B 的增長，並深思熟慮地推進我們的臨床管道以推動長期股東價值。我們仍有望迎來又一個偉大的一年，我們的商業資產預計收入將創紀錄，臨床投資組合的持續進展和有意義的催化劑以及連續第二年盈利。謝謝大家今天的關注。接線員，我們現在想打開今天電話的問答部分。

(Operator Instructions) Your first question comes from the line of Madhu Kumar from Goldman Sachs.

（操作員說明）您的第一個問題來自高盛的 Madhu Kumar。

This is Rob on for Madhu. Congrats on a good quarter. We were just wondering, to what extent were the HEPLISAV-B revenue gains driven by the CDC ACIP recommendation versus deeper use among prescribers? And additionally, just 1 more question, like what should we look for from the 4Q Tdap and shingles data in terms of like key markers of immunity?

這是Madhu的Rob。祝賀一個好季度。我們只是想知道，CDC ACIP 建議與處方者之間更深入的使用相比，HEPLISAV-B 的收入增長在多大程度上？此外，還有 1 個問題，比如我們應該從 4Q Tdap 和帶狀皰疹數據中尋找免疫關鍵標誌物方面的哪些內容？

Thanks, Rob. I'll answer the first 1 briefly, given -- the gains in HEPLISAV are primarily tied to market share. The ACIP recommendation will -- for market growth, we expect to take some more time. Donn, would you like to provide a little bit more commentary on how the ACIP recommendation has supported that increase in market share?

謝謝，羅伯。鑑於 HEPLISAV 的收益主要與市場份額相關，我將簡要回答前 1 個問題。 ACIP 建議將——為了市場增長，我們預計需要更多時間。 Donn，您想就 ACIP 建議如何支持市場份額的增加提供更多評論嗎？

Yes, absolutely. What the recommendation has done is really created a market event for the field sales team to leverage with customers. It's allowed us to get back, engage with critical stakeholders, decision-makers around driving market share. So at least right now, what that has done is provided that market event. And also it allows us to really highlight the true benefit of the 2-dose clinical profile of HEPLISAV-B. And many of our customers are starting to realize how that will be really important in a universal reality. So that's what's driving the market share and folks that are converting to HEPLISAV-B really using that market event universal right now.

是的，一點沒錯。該建議所做的實際上是為現場銷售團隊創造了一個市場事件，以利用客戶。它使我們能夠回歸，與關鍵利益相關者、決策者圍繞推動市場份額進行互動。所以至少現在，它所做的是提供了那個市場事件。而且它還使我們能夠真正突出 HEPLISAV-B 的 2 劑臨床特徵的真正益處。我們的許多客戶開始意識到這在普遍現實中的重要性。所以這就是推動市場份額的原因，以及正在轉換為 HEPLISAV-B 的人們現在真正使用該市場事件普遍。

And then, Rob, would you mind providing some context for what expectations around the data release is this year.

然後，Rob，您是否介意提供一些關於今年數據發布的期望的背景信息。

So for Tdap, what we'll be looking at is antibodies to pertussis antigens induced by our CpG 1018 adjuvanted vaccine compared to BOOSTRIX. In addition, we'll be looking at tolerability to be certain that the addition of 1018 induces similar tolerability to that of BOOSTRIX. And that's the first of a package of a comprehensive package of Tdap data that we'll be developing over time.

因此，對於 Tdap，我們將關注與 BOOSTRIX 相比，我們的 CpG 1018 佐劑疫苗誘導的百日咳抗原抗體。此外，我們將研究耐受性以確定添加 1018 會產生與 BOOSTRIX 相似的耐受性。這是我們將隨著時間的推移開發的全面的 Tdap 數據包中的第一個。

For shingles, what we expect to see will be immunogenicity data, but most importantly, CD4 data compared with SHINGRIX. In addition, what's going to be critical there and what we think will differentiate us from SHINGRIX is tolerability data. So SHINGRIX is notorious for having challenges with tolerability, and we're very confident that we'll be able to find a formulation that has equal efficacy to SHINGRIX but better tolerability.

對於帶狀皰疹，我們期望看到的是免疫原性數據，但最重要的是與 SHINGRIX 相比的 CD4 數據。此外，在那里至關重要的以及我們認為將我們與 SHINGRIX 區分開來的是耐受性數據。所以 SHINGRIX 因耐受性挑戰而臭名昭著，我們非常有信心找到與 SHINGRIX 具有同等功效但耐受性更好的配方。

Your next question is from the line of Ernesto Rodriguez from Cowen.

您的下一個問題來自 Cowen 的 Ernesto Rodriguez。

Congrats on the quarter. This is a follow up to Rob's question on HEPLISAV-B. Given that most of the gains are related to the market share that we should expect the adult vaccine utilization to remain flat for the rest of the year. Then how -- what would be the magnitude that you think that effect will have on the growth in the next couple of quarters?

祝賀本季度。這是 Rob 關於 HEPLISAV-B 的問題的後續。鑑於大部分收益與市場份額有關，我們應該預計成人疫苗的利用率將在今年剩餘時間內保持平穩。那麼，您認為這種影響對未來幾個季度的增長有何影響？

Thanks, Ernesto, for the question. Obviously, at this point, we're still not comfortable providing financial guidance for the second half of the year for HEPLISAV. I think you've got the point accurately, though, that the market is still a big driver of how we expect revenue to perform. And while we're pleased with the [return to date,] knowing there's the COVID-19 booster programs out there provides another variable in trying to predict the return to the previous levels.

謝謝，埃內斯托，提出這個問題。顯然，在這一點上，我們仍然不願意為 HEPLISAV 提供下半年的財務指導。不過，我認為你的觀點很準確，市場仍然是我們預期收入表現的主要驅動力。雖然我們對 [返回日期] 感到滿意，但知道那裡有 COVID-19 助推器計劃提供了另一個變量來嘗試預測返回到以前的水平。

Market share gains are -- were pretty sizable from Q1 to Q2. But we've tried to draw your attention to the trends we see annually where we focus on driving revenue annually for the brand. We do expect to continue to take market share each quarter, but obviously, the trend quarter-over-quarter can vary.

從第一季度到第二季度，市場份額的增長相當可觀。但我們試圖讓您關注我們每年看到的趨勢，我們專注於每年為品牌增加收入。我們確實希望每個季度繼續佔據市場份額，但顯然，季度環比趨勢可能會有所不同。

Okay, I see. That's helpful. And I know you're not -- also not providing guidance for next year for CpG. But do you have -- like thinking about how -- what do you know about your partners and their orders and how they've been progressing in their sales or in their filing or regulatory filings, do you have any sort of like directional prediction? Do you expect it to be more or less the same as this year or less or more?

好的，我明白了。這很有幫助。而且我知道你沒有 - 也沒有為明年的 CpG 提供指導。但是你有沒有——比如思考如何——你對你的合作夥伴和他們的訂單有什麼了解，以及他們在銷售或備案或監管備案方面的進展情況，你有任何類似的方向預測嗎？您預計它與今年或多或少相同還是更少或更多？

Yes. I can't give you prediction. I mean, I can give you the facts that we know and that I think we all can observe from the COVID landscape. And that is, obviously, the vaccine landscape continues to evolve, including policies around vaccination and government programs supporting boosters and how the future vaccines will evolve with the potential to eventually move to variant-based vaccines. And that's all very dynamic at the moment.

是的。我不能給你預測。我的意思是，我可以向您提供我們所知道的事實，並且我認為我們都可以從 COVID 環境中觀察到這些事實。也就是說，很明顯，疫苗領域在繼續發展，包括圍繞疫苗接種的政策和支持加強劑的政府計劃，以及未來疫苗將如何發展，並有可能最終轉向基於變體的疫苗。目前，這一切都非常活躍。

I think one thing I can draw your attention to is our -- and as we noted in our revenue guidance, that revenue guidance represents the orders that we have for '22 and the majority of our contracts, except for the one that we recently executed with PT Bio Farma were only for pandemic supply, which ended in 2022. So we're continuing to work with our collaborators to identify any potential demand in 2023.

我認為我可以提請您注意的一件事是我們的 - 正如我們在收入指南中指出的那樣，收入指南代表了我們在 22 年的訂單和我們的大部分合同，除了我們最近執行的合同與 PT Bio Farma 的合作僅用於 2022 年結束的流行病供應。因此，我們將繼續與我們的合作者合作，以確定 2023 年的任何潛在需求。

And I just -- directionally, another point to note is there's been a large amount of adjuvant supply in '22 that we do believe if you look across our partners' developments, which I'll get into a second, can carry them into supplying -- satisfying some demand for '23. So it's pretty dynamic across all those factors. But just briefly, Biological E continues to make advancements with their program. The WHO has opened up a pathway for prequalification based on immunogenicity, which Bio E has submitted for.

而且我只是 - 從方向上講，另一點需要注意的是，在 22 年有大量的佐劑供應，我們相信，如果你看看我們合作夥伴的發展情況，我將在第二個介紹，可以讓他們進入供應- 滿足 '23 的一些需求。因此，所有這些因素都非常動態。但簡而言之，Biological E 繼續在他們的計劃中取得進步。世界衛生組織已經開闢了一條基於免疫原性的資格預審途徑，Bio E 已經提交了該途徑。

And in addition to the progress they've made within India, where they have also recently got a recommendation to be approved for heterologous boosting. And then Clover Biopharmaceuticals also is continuing to move forward down the regulatory path in the second half of the year to obtain approval where they filed in both EU and China. And they also continue to develop clinical data to support long-term advancement of that program.

除了他們在印度取得的進展外，他們最近還獲得了一項建議，以批准異源促進。然後 Clover Biopharmaceuticals 也在今年下半年繼續沿著監管路徑前進，以獲得他們在歐盟和中國提交的批准。他們還繼續開發臨床數據，以支持該計劃的長期發展。

So there's definite movement across the collaborators and progress. I think the fact of the matter is it's a very dynamic environment around policy and innovation that will make '23 hard to predict. And I do think that we'll see more settling out of the endemic market as we move forward into '24 and '25.

因此，合作者之間有明確的運動和進展。我認為事實上這是一個圍繞政策和創新的非常動態的環境，這將使 23 年難以預測。而且我確實認為，隨著我們進入 '24 和 '25，我們會看到更多的地方性市場安定下來。

Your next question is from the line of Matthew Phipps from William Blair.

您的下一個問題來自 William Blair 的 Matthew Phipps。

Congrats on some great numbers in the quarter. Can you maybe just give us a sense of how much revenue in the quarter came from the DoD channel or at least if you expect a similar level of DoD activity in Q3 and then maybe that moderates in Q4 as typical seasonality?

祝賀本季度取得了一些不錯的數字。您能否告訴我們本季度有多少收入來自國防部渠道，或者至少如果您預計第三季度的國防部活動水平相似，然後可能在第四季度作為典型的季節性因素有所緩和？

Yes. We're not going to be able to break out revenue by channel. And then I want to make a quick comment. Donn, if you have anything to add, let me know. And Matt, I think some of the commentary is based on our historical trends where the DoD seasonality had a big impact in our numbers because we had early success in a couple of key accounts in DoD.

是的。我們將無法按渠道劃分收入。然後我想快速發表評論。 Donn，如果你有什麼要補充的，請告訴我。還有馬特，我認為一些評論是基於我們的歷史趨勢，在這些趨勢中，國防部的季節性對我們的數據產生了很大影響，因為我們在國防部的幾個關鍵客戶中取得了早期的成功。

As we grow the broad book of business, the DoD seasonality becomes a little less impactful than it had historically. So I think there is definitely the summer surge that could take place and drive up some volumes in our DoD accounts, but it won't be seen as discretely necessarily in our revenue numbers as it has historically when it made up a larger portion of the total percentage. Donn, is there anything that you'd like to add?

隨著我們擴大業務範圍，國防部的季節性影響變得比歷史上要小一些。因此，我認為肯定會出現夏季激增並推高我們國防部賬戶的一些數量，但在我們的收入數字中不會像歷史上那樣離散地看到它，當它占美國國防部賬戶的大部分時總百分比。 Donn，你有什麼要補充的嗎？

Matt, the only thing I'd add is regarding seasonality, it's not so much a DoD piece anymore. It's more so a market piece, a vaccine market piece in the sense of what you see in the fourth quarter, given the holidays, it's just a few weeks where you don't have as much health care utilization. So that would be the typical seasonality that we expect again for the heavy market going into Q4 but less so around the concept of a DoD to Ryan's point around the fact that it's just less as a contributor to the overall revenue moving forward.

馬特，我唯一要補充的是季節性，它不再是國防部的文章了。它更像是一個市場份額，一個疫苗市場份額，就你在第四季度看到的情況而言，考慮到假期，只有幾週你沒有那麼多的醫療保健利用率。因此，這將是我們對進入第四季度的重磅市場再次預期的典型季節性，但圍繞 DoD 的概念對瑞恩的觀點而言，它對整體收入的推動作用並不那麼大。

That's helpful. And then for the new biopharma CPG revenue source, is -- I guess, is the -- how much is committed for this [quarter]? And is really the upside potential from $550 million to $600 million, is that really coming from options from biopharma?

這很有幫助。然後對於新的生物製藥 CPG 收入來源，是 - 我猜，是 - 這個 [季度] 的承諾金額是多少？真的是從 5.5 億美元到 6 億美元的上行潛力，這真的來自生物製藥的選擇嗎？

No, that is not specific to biopharma, Matt. I mean, obviously, they're in their projection. The reason for that range, and Kelly, please add to this if needed is that still has -- there's still execution of manufacturing and shipments. And if anything were to slip quarter-over-quarter, we just have to be careful about making sure we have the right range, just to [handle] just general operations. But PT Bio Farma is included in that range. Kelly, is there anything you want to add to that? No, okay.

不，這不是特定於生物製藥的，馬特。我的意思是，很明顯，他們在他們的投影中。該範圍的原因，凱利，如果需要，請補充這一點是仍然有 - 仍然有製造和發貨的執行。如果有任何事情比季度下滑，我們只需要小心確保我們有正確的範圍，只是為了[處理]一般操作。但 PT Bio Farma 包含在該範圍內。凱利，你有什麼要補充的嗎？不，好吧。

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

我們的下一個問題來自 H.C. 的 Ed White。溫賴特。

Just a question on the plague study. The first patient is to be dosed this month. Perhaps you can give us your thoughts on the time line to data and the path forward to approval and any thoughts that you have on potential DoD stockpiling?

只是關於瘟疫研究的問題。第一位患者將於本月給藥。也許您可以向我們提供您對數據時間線和獲得批准的途徑的想法，以及您對潛在的國防部儲備的任何想法？

Sure, Ed. So the time line, there's a number of different readouts in this trial. The time line, I think there will be a potential interim readout towards the end of next year. There's multiple elements to this trial. There's a bedside mix component versus co-administration that we have to get through before we move into the next stage of the trial. So there's some operational elements.

當然，埃德。所以時間線，在這個試驗中有許多不同的讀數。時間線，我認為到明年年底會有一個潛在的中期讀數。這次試驗有多個要素。在進入試驗的下一階段之前，我們必須通過床邊混合成分與共同給藥。所以有一些操作元素。

I think more importantly is the utility of the overall data eventually for potential revenue for CpG 1018. And the way we would view this trial is enabling a discussion around a stockpile or a product purchase in conjunction with antigen for a stockpile plague vaccine. There's not a -- this is the first step in the process before we could figure out the exact path to what would probably be an Emergency Use Authorization, given that this is not going to necessarily be a commercial vaccine. This would be only used in certain settings where -- in response to a biothreat. So we would like to get through the data package first and then we can become more clear on the path forward to a potential line of revenue.

我認為更重要的是整體數據最終對 CpG 1018 潛在收入的效用。我們看待這項試驗的方式是圍繞庫存或產品購買與庫存鼠疫疫苗抗原進行討論。考慮到這不一定是商業疫苗，在我們弄清楚可能是緊急使用授權的確切途徑之前，這不是流程中的第一步。這只會在某些環境中使用——以應對生物威脅。因此，我們希望首先通過數據包，然後我們才能更清楚地了解通往潛在收入線的道路。

Okay. And then a second question, if I may, just on hepatitis B sales. You recorded sales in Germany. How should we be thinking about what's next stop in Europe as far as company rollouts go or any sales expectations or the market that you can tell us about?

好的。然後是第二個問題，如果可以的話，只是關於乙型肝炎的銷售。您在德國記錄了銷售額。就公司推出或任何銷售預期或您可以告訴我們的市場而言，我們應該如何考慮歐洲的下一站？

Sure. So obviously, Germany is the focus and our partnership with Bavarian Nordic is really getting underway now with this initial launch. We're very excited about that opportunity and their focus in Germany and with their sales team. So I think the best opportunity for us to continue to drive revenue is going to be through that collaboration.

當然。很明顯，德國是重點，我們與 Bavarian Nordic 的合作夥伴關係現在正在通過首次發布真正開始。我們對這個機會以及他們在德國和他們的銷售團隊的關注感到非常興奮。因此，我認為我們繼續推動收入增長的最佳機會將是通過這種合作。

Beyond that, Europe is challenging from a pricing perspective, which we've not -- we've been transparent about for a long time here. We do continue to look for opportunities to find new ways to bring the product into different countries. We think the United Kingdom is likely the next best opportunity, particularly because some of the other lower-priced countries within Europe would create a reference price challenge for our pricing strategy in Germany, whereas U.K. does not have that challenge. So we're actively looking at opportunities to move forward into the U.K. And like I said, excited to see Bavarian Nordic's progress with the brand in Germany.

除此之外，從定價的角度來看，歐洲面臨著挑戰，而我們沒有——我們在這裡已經透明了很長時間了。我們確實會繼續尋找機會，尋找將產品帶入不同國家的新方法。我們認為英國可能是下一個最佳機會，特別是因為歐洲其他一些價格較低的國家會給我們在德國的定價策略帶來參考價格挑戰，而英國則沒有這種挑戰。因此，我們正在積極尋找進軍英國的機會。就像我說的，很高興看到 Bavarian Nordic 在德國的品牌取得進展。

We have no further questions at this time. I would now like to turn the call over to Ryan Spencer, CEO, for closing remarks.

目前我們沒有其他問題。我現在想把電話轉給首席執行官瑞安·斯賓塞 (Ryan Spencer) 做閉幕詞。

Thank you, operator. We believe that the combination of our revenue-generating assets and a highly experienced team, our strong financial profile and an emerging pipeline of product candidates based on our proven adjuvant technology provide a solid foundation for Dynavax's future.

謝謝你，接線員。我們相信，我們的創收資產和經驗豐富的團隊、強大的財務狀況以及基於我們經過驗證的輔助技術的新興產品候選管線的結合為 Dynavax 的未來奠定了堅實的基礎。

Finally, while I may say this repeatedly, cannot be emphasized enough, our achievements, the opportunities we believe lie ahead are made possible by the hard work and dedication of the incredible Dynavax team. I'd like to highlight them and thank them for their commitment and effort towards our mission. We look forward to updating you on our progress throughout the remainder of the year. Thank you for joining us today. We appreciate your time and interest in Dynavax. Operator, you may end the call.

最後，雖然我可能會反復強調這一點，但無論怎麼強調都不過分，我們的成就和我們相信擺在面前的機會是由令人難以置信的 Dynavax 團隊的辛勤工作和奉獻精神實現的。我想強調他們並感謝他們對我們使命的承諾和努力。我們期待在今年剩餘時間內向您通報我們的進展情況。感謝您今天加入我們。感謝您對 Dynavax 的時間和興趣。接線員，您可以掛斷電話。

Thank you. Ladies and gentlemen, thank you for joining us today. This concludes today's conference call. You may now disconnect.

謝謝你。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。