Dynavax Technologies Corp (DVAX) 2022 Q3 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Dynavax Technologies Third Quarter 2022 Financial Results. (Operator Instructions). I would now like to turn the call over to Nicole Arndt, Senior Manager, Investor Relations. You may now begin.

女士們先生們，美好的一天，歡迎閱讀 Dynavax Technologies 2022 年第三季度財務業績。 （操作員說明）。我現在想把電話轉給投資者關係高級經理 Nicole Arndt。你現在可以開始了。

Thank you. Good afternoon, and welcome to the Dynavax Third Quarter 2020 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. 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 impact, market trends, growth perspective, seasonality, 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.

謝謝你。下午好，歡迎參加 Dynavax 2020 年第三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。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 影響、市場趨勢、增長前景、季節性、財務指導和趨勢，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 results 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, Senior Vice President of Commercial; Rob Janssen, Senior 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。這些結果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 表格季度報告。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；商業高級副總裁 Donn Casale； Rob Janssen，高級醫務官；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。

Thank you, Nicole, and thank you all for joining us today. I'm delighted to have the opportunity to discuss the progress we've made this quarter and to review how far we've come over the last few years. It was just 3 years ago, we made a strategic pivot to focus on building a leading vaccine company by committing to drive value through HEPLISAV-B commercialization and leveraging our CpG 1018 Adjuvant to develop new vaccines. At that time, HEPLIZAV-B's revenue for the full year of 2019 ended up at $35 million. Since then, we have seen significant growth as a result of strong execution from our commercial team. HEPLISAV-B generated nearly $38 million in revenue in this third quarter alone, keeping us on track for record HEPLISAV-B revenues for the full year of 2022 and providing us confidence in the expected continued revenue growth for the future. Also in 2019, we began to focus on broadening utilization of CpG 1018 for the development of new vaccines.

謝謝你，妮可，感謝大家今天加入我們。我很高興有機會討論我們本季度取得的進展，並回顧我們在過去幾年取得的進展。就在 3 年前，我們通過致力於通過 HEPLISAV-B 商業化推動價值並利用我們的 CpG 1018 佐劑開發新疫苗，實現了戰略重點，專注於打造一家領先的疫苗公司。當時，HEPLIZAV-B 2019 年全年的收入最終為 3500 萬美元。從那時起，由於我們商業團隊的強大執行力，我們看到了顯著的增長。僅在第三季度，HEPLISAV-B 就產生了近 3800 萬美元的收入，使我們有望在 2022 年全年實現創紀錄的 HEPLISAV-B 收入，並使我們對未來預期的持續收入增長充滿信心。同樣在 2019 年，我們開始專注於擴大 CpG 1018 在新疫苗開發中的應用。

Today, in addition to HEPLISAV-B, CpG-1018 is used globally in 5 COVID-19 vaccine programs, which have generated over $800 million in cumulative revenues for Dynavax through the third quarter of this year. Additionally, CpG 1018 is the foundation based of our expanding development pipeline. Currently, including adjuvanted [vacinate candidate] [shingles]. This is tremendous progress through short-term time to a testament as strategic plan and the team's ability to successfully execute it. As we near the end of 2022, we continue to expect between $550 million and $600 million in revenue from our CpG 1018 business for the full year. Our success in navigating the pandemic highlights the organization's execution abilities underscores the scientific rationale supporting the use of CpG 1018 for broader vaccine development and has transformed our financial profile. As we look to our future, our strong financial position supports continued investment in the commercialization of HEPLISAV-B and expanding and advancing our clinical programs.

如今，除了 HEPLISAV-B 外，CpG-1018 還在全球範圍內用於 5 個 COVID-19 疫苗項目，截至今年第三季度，這些項目為 Dynavax 帶來了超過 8 億美元的累計收入。此外，CpG 1018 是我們不斷擴展的開發管道的基礎。目前，包括佐劑[候選疫苗] [帶狀皰疹]。這是通過短期時間取得的巨大進步，證明了戰略計劃和團隊成功執行它的能力。隨著我們接近 2022 年底，我們繼續預計全年 CpG 1018 業務的收入將在 5.5 億美元至 6 億美元之間。我們在應對大流行病方面的成功凸顯了該組織的執行能力，強調了支持使用 CpG 1018 進行更廣泛疫苗開發的科學依據，並改變了我們的財務狀況。展望未來，我們強大的財務狀況支持繼續投資於 HEPLISAV-B 的商業化，並擴大和推進我們的臨床項目。

With the recent data from our Tdap Phase I trial and data from the Phase I shingles clinical trial anticipated before year-end, we believe we have the opportunity to highlight the value of our pipeline and strategy to produce best-in-class products targeting large markets. Additionally, we are advancing efforts to build on our vaccine portfolio by leveraging our capabilities in commercialization, development and manufacturing through the addition of late-stage or commercial assets. We are beginning the process of carefully identifying and evaluating opportunities with a high bar for potential transactions that we may consider. We believe this approach will further enable our success by leveraging our core organizational capabilities to strengthen our financial profile.

根據我們的 Tdap I 期試驗的最新數據和預計在年底前獲得的 I 期帶狀皰疹臨床試驗的數據，我們相信我們有機會強調我們的管道和戰略的價值，以生產針對大型人群的一流產品市場。此外，我們正在通過增加後期或商業資產，利用我們在商業化、開發和製造方面的能力，努力構建我們的疫苗產品組合。我們正在開始仔細識別和評估我們可能考慮的潛在交易的高門檻機會。我們相信，這種方法將通過利用我們的核心組織能力來加強我們的財務狀況，從而進一步使我們取得成功。

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'm thrilled to share the third quarter results for HEPLISAV-B. The dedication and perseverance of our commercial team has resulted in another record quarter of product revenue and market share 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. Serious 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. In the third quarter, HEPLISAV-B generated net product revenue of just under $38 million, its highest single revenue quarter since launch and an increase of 65% from $23 million in Q3 of last year. This significant revenue growth in the U.S. was largely driven by our continued gains in market share. We estimate HEPLISAV-B's total market share increased to 32% compared to 25% during the same period last year, while field targeted market share increased to 43%, up from 32% during the third quarter of last year. Strong performance in Q3 was driven by 2 critical segments: retail pharmacy and integrated delivery networks, or IDNs.

謝謝你，瑞安。我很高興分享 HEPLISAV-B 第三季度的業績。我們商業團隊的奉獻精神和毅力使 HEPLISAV-B 的產品收入和市場份額再創歷史新高。 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。認真完成對於高水平的保護至關重要。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更快地保護更多患者。第三季度，HEPLISAV-B 產生的淨產品收入略低於 3800 萬美元，這是自推出以來最高的單季度收入，比去年第三季度的 2300 萬美元增長了 65%。美國收入的顯著增長主要是由於我們市場份額的持續增長。我們估計 HEPLISAV-B 的總市場份額從去年同期的 25% 增加到 32%，而現場目標市場份額從去年第三季度的 32% 增加到 43%。第三季度的強勁表現是由兩個關鍵部分推動的：零售藥店和綜合配送網絡 (IDN)。

In Q3, retail pharmacy had significant increases in the number of new ordering and reordering locations. We are encouraged by this trend and the positive feedback we are receiving from customers about the ACIP universal recommendation. During the quarter, several top retail chains expressed a desire to make hepatitis B vaccine a priority focus for their immunization strategies moving forward. In addition to our success in retail, there has been considerable progress in the IDN segment. Many of our customers have expanded their use and increased reordering of HEPLISAV-B. Like in retail, we have received positive feedback from customers about the ACIP universal recommendation and their desire to enter this new era with a 2-dose vaccine for hepatitis B. In Q3, several large IDN customers updated their vaccine protocols and capabilities to reflect the policy change. 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 receive or should be vaccinated against hepatitis B. We continue to believe that the universal 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.

在第三季度，零售藥店新訂購和重新訂購地點的數量顯著增加。我們對這一趨勢以及我們從客戶那裡收到的關於 ACIP 普遍建議的積極反饋感到鼓舞。在本季度，幾家頂級零售連鎖店表示希望將乙型肝炎疫苗作為其未來免疫戰略的優先重點。除了我們在零售領域的成功之外，IDN 領域也取得了長足的進步。我們的許多客戶擴大了 HEPLISAV-B 的使用範圍並增加了重新訂購。與零售業一樣，我們收到了客戶對 ACIP 普遍推薦的積極反饋，以及他們希望通過 2 劑乙型肝炎疫苗進入這個新時代的願望。在第三季度，一些大型 IDN 客戶更新了他們的疫苗方案和能力，以反映政策變化。 ACIP 建議所有 19 至 59 歲的成年人都應該接種乙型肝炎疫苗，這大大增加了美國應該接種或應該接種乙型肝炎疫苗的成年人的數量。我們仍然相信，普遍的建議將是一個重要的催化劑增長，並估計到 2027 年，乙型肝炎市場機會可能增長到約 8 億美元，隨著時間的推移， HEPLISAV-B 處於有利地位，可以確保大部分市場份額。

In Q3, we continue to see positive trends in hepatitis B market recovery. During the quarter, the market was down only 7% from pre-pandemic levels. This positive recovery was due to the market continuing its return to normal pre-pandemic operations, coupled with expanded growth from customers implementing the universal recommendation.

在第三季度，我們繼續看到乙肝市場復甦的積極趨勢。在本季度，市場僅比大流行前水平下降了 7%。這種積極的複蘇是由於市場繼續恢復到大流行前的正常運作，再加上實施普遍建議的客戶擴大了增長。

Looking ahead to this quarter, we anticipate the hepatitis B market will remain flat or slightly below the levels seen in Q3. This likely outcome is due to the typical Q4 seasonality, which has historically reduced the market by 10% to 15% quarter-over-quarter. With a proven clinical profile and our team's strong commercial execution, we expect further market share gains and continued annual revenue 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.

展望本季度，我們預計乙肝市場將保持平穩或略低於第三季度的水平。這一可能的結果是由於典型的第四季度季節性，從歷史上看，該季度市場環比下降了 10% 至 15%。憑藉經過驗證的臨床資料和我們團隊強大的商業執行力，我們預計 HEPLISAV-B 的市場份額將進一步增加，年收入將持續增長。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 recently completed a Phase I clinical trial evaluating an improved tetanus, diphtheria, and pertussis or TDP vaccine that utilizes our CPG 1018 adjuvant. Adult and adolescent safety data from this study demonstrated the vaccine candidate was well tolerated without safety concerns. Adult immunogenicity results were consistent with our expectations and support continued advancement of the vaccine candidate. 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.

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 佐劑與已建立的抗原相結合，專注於針對大型市場的一流產品。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 TDP 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。我們還在進行一項非人類靈長類動物百日咳挑戰研究，以評估其對預防疾病症狀和百日咳細菌鼻腔定植的影響。

Our second development area is the shingles vaccine program. The last participant visit has been completed in the Phase I study evaluating safety, tolerability and immunogenicity compared with Shingrix, a commercially available shingles vaccine in the U.S. and other countries. We believe that our vaccine candidate adjuvanted with CpG 1018 has the potential to elicit strong CD4 T cell responses, which are key in controlling reactivation of the zoster virus, while also providing improved tolerability compared to the current marketed product. Data from this proof-of-concept clinical trial are anticipated by year-end. 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.

我們的第二個發展領域是帶狀皰疹疫苗項目。最後一次參與者訪問已在第一階段研究中完成，該研究與美國和其他國家/地區的市售帶狀皰疹疫苗 Shingrix 相比，評估了安全性、耐受性和免疫原性。我們相信，我們的候選疫苗輔以 CpG 1018 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，還提供更高的耐受性。該概念驗證臨床試驗的數據預計將在年底前公佈。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 third-quarter financial results.

我現在將電話轉給凱利審查我們第三季度的財務業績。

Thank you, Rob. I'm happy to report on another quarter of strong financial performance. I'll touch on some key financial items and then review our 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 additionally refer to our press release and 10-Q for detailed financial information. Starting with revenue. Total revenue for the third quarter was $168 million, up 55% year-over-year. This quarter marked another record-breaking quarter for HEPLISAV-B with total net sales of $38 million, representing 65% year-over-year growth. What is equally impressive for the brand is the continued improvement in gross margin, which was approximately 69% for the third quarter and 70% year-to-date compared to 56% for the full year 2021. Turning to CpG 1018 Adjuvant revenue. Revenue recognized under our commercial supply agreements for COVID-19 vaccines totaled $126 million for the third quarter, bringing CpG 1018 adjuvant revenues to $440 million year-to-date.

謝謝你，羅布。我很高興地報告另一個季度的強勁財務業績。我將談及一些關鍵的財務項目，然後回顧我們的 2022 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。請另外參閱我們的新聞稿和 10-Q 了解詳細的財務信息。從收入開始。第三季度總收入為 1.68 億美元，同比增長 55%。本季度標誌著 HEPLISAV-B 的又一個創紀錄的季度，總淨銷售額為 3800 萬美元，同比增長 65%。該品牌同樣令人印象深刻的是毛利率的持續提高，第三季度毛利率約為 69%，今年迄今為 70%，而 2021 年全年為 56%。轉向 CpG 1018 Adjuvant 收入。第三季度根據我們的 COVID-19 疫苗商業供應協議確認的收入總計 1.26 億美元，使 CpG 1018 佐劑收入今年迄今達到 4.4 億美元。

We had 2 unique items to highlight in the third quarter relating to our CpG 1018 COVID-19 partnerships. We have recently amended our commercial supply agreements with both Clover Biopharmaceuticals as well as Biological E to reflect the reduction in demand as the COVID landscape evolves. During the third quarter, in connection with the Clover amendment, we recognized approximately $24 million in one-time revenue for cancellation fees covering the cost of raw materials and CMO-related fees incurred. Additionally, we wrote down approximately $14 million in corresponding inventory in connection with the reduction in demand. We are working closely with our CpG 1018 adjuvant commercial supply customers as they manage their initial stockpiling of CpG 1018 with forward-looking demand as the global pandemic evolves. We continue to expect between $550 million and $600 million in full-year 2022 CpG 1018 revenue with corresponding gross margin approximately 60% and are very proud of the collective efforts with our collaborators to be an important part of the response to the COVID-19 pandemic during a very dynamic period. As we look ahead to 2023, we believe our customers will likely have sufficient adjuvant stockpile as of the end of 2022 to service their initial commercial agreements, translating to substantially lower adjuvant sales expected in 2023. Beyond 2023, we expect to provide additional guidance as we execute future commercial supply agreements and gain better line of sight into the endemic demand of COVID-19 vaccines for our customers.

在第三季度，我們有 2 個與 CpG 1018 COVID-19 合作夥伴關係相關的獨特項目需要強調。我們最近修改了與 Clover Biopharmaceuticals 和 Biological E 的商業供應協議，以反映隨著 COVID 形勢的發展需求減少。在第三季度，根據 Clover 修正案，我們確認了約 2400 萬美元的一次性收入，用於取消費用，包括原材料成本和產生的 CMO 相關費用。此外，由於需求減少，我們減記了大約 1400 萬美元的相應庫存。我們正在與我們的 CpG 1018 佐劑商業供應客戶密切合作，因為隨著全球大流行的發展，他們會根據前瞻性需求管理 CpG 1018 的初始庫存。我們繼續預計 2022 年全年 CpG 1018 收入將在 5.5 億美元至 6 億美元之間，相應的毛利率約為 60%，我們為與我們的合作者共同努力成為應對 COVID-19 大流行的重要組成部分而感到自豪在一個充滿活力的時期。展望 2023 年，我們相信到 2022 年底，我們的客戶可能會有足夠的佐劑庫存來滿足他們最初的商業協議，這意味著 2023 年的佐劑銷售額預計會大幅下降。2023 年之後，我們預計會提供額外的指導，因為我們執行未來的商業供應協議，並更好地了解客戶對 COVID-19 疫苗的地方性需求。

Now turning to expenses. Our research and development expenses for the third quarter of 2022 were $13 million compared to $6 million in the same period last year, 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 [adjuvant to play] vaccine. Selling, general and administrative expenses for the third quarter of 2022 increased to $32 million compared to $27 million for the third quarter of last year, primarily driven by increased headcount, cross-field sales, and G&A, coupled with focused marketing investments to drive growth in HEPLISAV-B.

現在轉向費用。我們 2022 年第三季度的研發費用為 1300 萬美元，而去年同期為 600 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項目的持續推進，以及我們與國防部的資助的第二階段合同【佐劑打法】疫苗。 2022 年第三季度的銷售、一般和管理費用從去年第三季度的 2700 萬美元增加到 3200 萬美元，這主要是由於員工人數增加、跨領域銷售和 G&A，以及為推動增長而進行的集中營銷投資在 HEPLISAV-B 中。

Moving on to profitability. For the third quarter of 2022, we generated GAAP net income of $64 million or $0.50 per share basic and $0.43 per share diluted. Turning to the balance sheet. We ended the third quarter with cash, cash equivalents, and investments of $587 million, and we continue to believe this level of capital is sufficient to support our core business, including our R&D portfolio without the need to raise additional funds. Lastly, I'm pleased to reiterate our 2022 full-year financial guidance, including CPG 1018 adjuvant revenues expected to be between $550 million and $600 million with approximately 60% gross margin for the year, reflecting the economics associated with the remaining firm orders under our [conical] supply agreements, 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 interest expense of approximately $7 million. In summary, with another quarter of strong commercial and financial performance, we remain on track for another great year with anticipated record revenues, continued progress and meaningful catalysts across our clinical portfolio, positive cash flow, and a second consecutive year of profitability. Our strong balance sheet position, combined with a disciplined approach to capital allocation enables us to focus on selective investments to drive growth in HEPLISAV-B and thoughtfully advance our clinical pipeline to drive long-term shareholder value.

繼續盈利。 2022 年第三季度，我們的 GAAP 淨收入為 6400 萬美元或每股基本收入 0.50 美元，稀釋後每股收入 0.43 美元。轉向資產負債表。我們在第三季度末擁有 5.87 億美元的現金、現金等價物和投資，我們仍然相信這一水平的資本足以支持我們的核心業務，包括我們的研發組合，而無需籌集額外資金。最後，我很高興重申我們的 2022 年全年財務指導，包括 CPG 1018 佐劑收入預計在 5.5 億美元至 6 億美元之間，全年毛利率約為 60%，反映了與以下剩餘確定訂單相關的經濟效益我們的 [錐形] 供應協議、5000 萬至 6000 萬美元的研發費用、1.3 億至 1.4 億美元的 SG&A 費用和大約 700 萬美元的利息費用。總而言之，憑藉又一個季度強勁的商業和財務業績，我們有望迎來又一個偉大的一年，預期創紀錄的收入、持續的進步和我們臨床產品組合的有意義的催化劑、正現金流和連續第二年的盈利。我們強大的資產負債表狀況，加上嚴格的資本分配方法，使我們能夠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。

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 Roy Buchanan from JMP Securities.

（操作員說明）。我們的第一個問題來自 JMP Securities 的 Roy Buchanan。

I guess the first one is on HEPLISAV. Good quarter. Do you know the market share in retail segment specifically? And if you do, is it consistent across the top 10 retailers where you have the contracts? Or is there a variation between the retailers?

我猜第一個是在 HEPLISAV 上。好季度。您是否具體了解零售領域的市場份額？如果你這樣做，它在你有合同的前 10 大零售商中是否一致？還是零售商之間存在差異？

Donn, do you want to go ahead and take that?

唐恩，你想繼續接受嗎？

Yes. So market share across the segment is just under 50% for the entire segment. We do see different market shares across the different retail chains with a few of them where we have majority market share. So it's a blend. But overall, we like the momentum we have seen as it relates to our market share as well as growth within that segment.

是的。因此，整個細分市場的市場份額略低於整個細分市場的 50%。我們確實看到不同零售連鎖店的市場份額不同，其中一些我們擁有大部分市場份額。所以它是一個混合物。但總的來說，我們喜歡我們所看到的勢頭，因為它與我們的市場份額以及該細分市場的增長有關。

Okay. Great. And then the improvements in gross margin is impressive, given all that we've heard about inflation. I guess any thoughts on the impact of inflation, may we see that impact the gross margins going forward?

好的。偉大的。考慮到我們所聽說的通貨膨脹，毛利率的提高令人印象深刻。我想對通貨膨脹的影響有什麼想法，我們可以看到這會影響未來的毛利率嗎？

Thanks, Roy. Kelly, do you want to take that one?

謝謝，羅伊。凱利，你要拿那個嗎？

Sure. So thanks, Roy, for the question. I appreciate it. We've made substantial improvements in investments in our manufacturing facility in Germany and are really excited to be able to pull through some of the financial benefits of those investments over the last couple of years. We don't expect inflation to have a meaningful impact to our gross margins. And in fact, in the 70% range is where we expect gross margins to settle in at this level of volume for HEPLISAV.

當然。羅伊，謝謝你提出這個問題。我很感激。我們在德國製造工廠的投資方面取得了重大進展，並且非常高興能夠在過去幾年中從這些投資中獲得一些經濟利益。我們預計通貨膨脹不會對我們的毛利率產生重大影響。事實上，在 70% 的範圍內，我們預計毛利率將穩定在 HEPLISAV 的這一銷量水平。

Great. And then I had a quick one on the shingles data coming up later in the year. Are you going to have T-cell data for all the patients? And then I know you're looking at the CD4 cells as a secondary endpoint. Are you also going to look at CD8 cells?

偉大的。然後我快速了解了今年晚些時候出現的帶狀皰疹數據。您要獲得所有患者的 T 細胞數據嗎？然後我知道您正在將 CD4 細胞視為次要終點。您是否也打算研究 CD8 細胞？

Rob, you want to take that?

羅伯，你要拿那個嗎？

CD4s are what are associated with protection against reactivation of zoster, so we'll be predominantly focusing on CD4s.

CD4 與防止帶狀皰疹重新激活有關，因此我們將主要關注 CD4。

For all patients...

對於所有患者...

For all patients in the study.

對於研究中的所有患者。

Our next question comes from Matthew Phipps of William Blair.

我們的下一個問題來自威廉·布萊爾的馬修·菲普斯。

And congrats on continued great momentum with [HEPLISAV]. I guess on the shingles update in comparison to Shingrix, I know it may be tough to answer this, but how much better do you want to be in the tolerability your new deck has [effect on] Shingrix side effect profile? And are there any particular side-effects you think are more impactful than others when you think about patient preference and adoption?

並祝賀 [HEPLISAV] 繼續保持強勁勢頭。我想在與 Shingrix 相比的帶狀皰疹更新中，我知道這個問題可能很難回答，但你希望你的新套牌對 Shingrix 副作用的耐受性提高多少？當您考慮患者偏好和採用時，是否有您認為比其他副作用更具影響力的特定副作用？

Thanks, Matt. Why don't have Rob answer that one?

謝謝，馬特。為什麼不讓 Rob 回答那個問題？

Yes. So what I anticipate is that we would be able to demonstrate statistically significantly lower rates of postinjection reactions in Shingrix. We're currently in the process of evaluating if any of the individual reactions would be more important than any other or whether we would use essentially a composite term, which is any of either local or systemic postinjection reactions. But it's something that we're looking into right now.

是的。因此，我預計我們將能夠在統計學上證明 Shingrix 中註射後反應的發生率顯著降低。我們目前正在評估是否有任何個別反應比其他反應更重要，或者我們是否會使用一個複合術語，即局部或全身注射後反應中的任何一種。但這是我們現在正在研究的事情。

Interesting. A question about the IRA inflation reduction. Obviously, it's some headaches for other drug development companies, but there is some benefit for adult vaccine coverage as far as co-pays and things like that. Does that impact any of your development calculus for pipeline programs?

有趣的。關於 IRA 通脹降低的問題。顯然，這讓其他藥物開發公司有些頭疼，但就共同支付和類似費用而言，成人疫苗覆蓋面有一些好處。這會影響您對管道程序的任何開發計算嗎？

Yes. Well, I mean, the benefits are relative compared to other products. I mean the reality is for [HEP-B] for example, it's incredibly favorable because of the impacts on Part D coverage. But with HEP-B specifically being called out on the Medicaid rebate program is not having to participate. We do not expect, given the level of Medicare spend on hepatitis B vaccine that it would ever be a negotiated drug. So from a relative perspective, I think our long-term revenue potential is comparatively strong compared to other products possibly. Different -- the calculus would be different depending on the product. If you had a product that was focused on the over-65 population that could result in a larger spend for Medicare, then it might be -- it might have an impact. But I will say that one of the benefits is that it's somewhat limited given the IRA limited the negotiation down to a 25% impact, which is less for vaccines, which is less than what you could see in other classes. So ultimately, I think being a vaccine manufacturer, the IRA doesn't have the same level of impact as other parts of our industry.

是的。嗯，我的意思是，與其他產品相比，好處是相對的。我的意思是現實是 [HEP-B]，例如，由於對 D 部分覆蓋範圍的影響，它非常有利。但由於 HEP-B 在醫療補助回扣計劃中被特別召集，因此不必參加。考慮到乙型肝炎疫苗的醫療保險支出水平，我們預計它永遠不會成為一種談判藥物。因此，從相對的角度來看，我認為與其他產品相比，我們的長期收入潛力可能比較強。不同——微積分會因產品而異。如果您的產品專注於 65 歲以上的人群，可能會導致醫療保險支出增加，那麼它可能會產生影響。但我要說的是，其中一個好處是它在某種程度上是有限的，因為 IRA 將談判限制在 25% 的影響，這對疫苗來說要小一些，這比你在其他類別中看到的要少。因此，最終，我認為作為一家疫苗製造商，IRA 的影響程度與我們行業的其他部分不同。

And I guess maybe lastly, obviously, mentioning a significant maybe slowdown in CpG revenues next year. But I guess it implies at least there is still some you expect next year. Is that flow through of currently signed contracts? Or is that you do see potential for some contracts in 2022?

我想也許最後，很明顯，提到明年 CpG 收入可能會顯著放緩。但我想這意味著至少明年還有一些你期待的。這是當前簽署的合同的流轉嗎？還是您確實看到了 2022 年某些合同的潛力？

Yes. I think the way -- what we're trying to provide is an overview of what we know now and what we know now is the market's changed pretty significantly over the last year as it relates to demand. And there's a decent amount of stockpile of adjuvant within our collaborators. And so it really would come down to how do we need shipments from the end of this year roll into next year, which would be minor. And then how will the market evolve towards the end of next year, which we don't have a ton of visibility into now. And so there is a potential for additional revenue in the second half of the year depending on how the market evolves, which we currently are not contracted for at the moment. So we would have to let you know as we know, as those contracts evolve and which will be dependent on the line of sight as far as demand for our collaborative vaccines.

是的。我認為方式 - 我們試圖提供的是我們現在所知道的概述，我們現在所知道的是市場在過去一年中發生了相當大的變化，因為它與需求有關。我們的合作者中有相當數量的佐劑儲備。所以這真的會歸結為我們如何需要從今年年底到明年的出貨量，這將是次要的。然後到明年年底市場將如何發展，我們現在還沒有太多的了解。因此，根據市場的發展情況，下半年有可能增加收入，目前我們還沒有簽訂合同。因此，我們必須讓您知道我們所知道的，隨著這些合同的發展，這將取決於對我們合作疫苗的需求的視線。

Our next question comes from [Madhu Kumar] from Goldman Sachs.

我們的下一個問題來自高盛的 [Madhu Kumar]。

This is Rob on for [Madhu]. I guess we were just wondering, from a high level, how should we think about the year-end shingles beta. And then also, I guess, how should we be thinking about modeling the adjuvant revenues in 2023 and on the forward?

這是 [Madhu] 的 Rob。我想我們只是想知道，從更高的層面來看，我們應該如何考慮年終帶狀皰疹測試版。然後，我想，我們應該如何考慮為 2023 年及以後的輔助收入建模？

So for the shingles data, we expect to have the data in hand by the end of the year, and we will be -- we expect to issue a top-line press release shortly thereafter with more robust reporting of the data to follow at a scientific meeting or publication. And then the other question as far as how to think about the long-term adjuvant revenue, I mean I think Rob, the key is you got to watch the market. What we keep saying is there's been significant evolution of the COVID market during the course of this year. We think we're well positioned as it relates to the global need, recognizing that we have collaborators targeting many different markets around the globe. But as far as what that ultimate demand will be, I think that's still left to be determined as we move into this investment. So we're very pleased with how we positioned ourselves to be able to participate in the long-term demand. Being able to quantify it at this moment is difficult.

因此，對於帶狀皰疹數據，我們預計將在今年年底之前掌握數據，我們將 - 我們預計此後不久將發布一份頂級新聞稿，並在之後發布更可靠的數據報告科學會議或出版物。然後是關於如何考慮長期輔助收入的另一個問題，我的意思是我認為 Rob，關鍵是你必須觀察市場。我們一直在說的是，今年 COVID 市場發生了重大變化。我們認為我們在滿足全球需求方面處於有利地位，認識到我們有合作者針對全球許多不同的市場。但至於最終需求是什麼，我認為在我們進行這項投資時仍有待確定。因此，我們對我們如何定位自己能夠參與長期需求感到非常滿意。此刻能夠量化，很難。

And the next question comes from Ernesto Rodriguez-Dumont from Cowen.

下一個問題來自 Cowen 的 Ernesto Rodriguez-Dumont。

Congrats in the quarter. You highlighted the progress that you've had on the retail space and with hospital systems. And they seem to be aware of their Universal clinical recommendation and seems that that's going to be a curator growth. What do you expect them to be the hurdle there? Is it the logistics of them applying their recommendation? Or are they going to wait for the demand to assess? Or are they going to try to push it? Or what is, I guess, the next step there? And if you -- my second question, if you could give also any color on the launch in Europe? Any progress on other markets outside of Germany?

祝賀本季度。您強調了您在零售空間和醫院系統方面取得的進展。他們似乎意識到了他們的通用臨床建議，並且似乎這將成為策展人的成長。你認為他們在那裡的障礙是什麼？是他們應用他們的建議的後勤工作嗎？還是他們要等待需求評估？還是他們會嘗試推動它？或者，我猜，下一步是什麼？如果你 - 我的第二個問題，你是否也可以在歐洲發佈時給出任何顏色？德國以外的其他市場有什麼進展嗎？

Okay. Donn, why don't you take that? The hurdle – spoken on the hurdle of the uptake from Universal, I think it was a question not spokes on market share, but let's start with the uptick in Universal.

好的。唐恩，你為什麼不接受那個？障礙——談到從環球影業吸收的障礙，我認為這是一個問題，而不是關於市場份額的問題，但讓我們從環球影業的上升開始。

So right now, as I mentioned, before nurse, we see quite a few of our hospitals that have implemented a flag within their EMR systems. So at the passive flag, that's a first great step. It gives us quite a bit of confidence as we think about the market opportunities. We communicated $800 million opportunity. Those types of signs or signs that we like to see, and we will continue to see that happening throughout the marketplace. Our role will be to pull that through with the customer for those age 30 to 50 to use a plus 1 strategy, especially going into 2023. So they've been gauging us around opportunities to go after that patient population and really see it as a strategic priority moving forward. So that's why we're really excited about the opportunities as it relates to Universal, both in Retail and IDN.

所以現在，正如我提到的，在護士之前，我們看到很多醫院在他們的電子病歷系統中實施了一個標誌。所以在被動旗幟下，這是偉大的第一步。當我們考慮市場機會時，它給了我們相當大的信心。我們傳達了 8 億美元的機會。我們喜歡看到的那些類型的標誌或標誌，我們將繼續在整個市場上看到這種情況發生。我們的職責是幫助 30 至 50 歲的客戶使用加 1 策略，尤其是進入 2023 年。因此，他們一直在評估我們是否有機會追逐該患者群體，並真正將其視為一種戰略重點向前推進。這就是為什麼我們對與 Universal 相關的機會感到非常興奮，無論是在零售還是在 IDN 領域。

Yes. If I can just add a little bit of color. That seems obvious, but that is a hurdle to clear that when physicians do have the prompts in front of them, patients are actually accepting the recommendation. And we've already seen evidence that that's taking place. So I would argue that we've cleared the first hurdle in expanding the market. Now obviously, we have to -- that has to be done much more broadly, as Donn highlighted. But we are seeing evidence that patients so that's an important step in the journey. Then, Donn, do you want to provide some commentary on the launch in Germany?

是的。如果我可以添加一點顏色。這似乎是顯而易見的，但要清除當醫生面前確實有提示時，患者實際上是在接受建議，這是一個障礙。我們已經看到了這種情況正在發生的證據。所以我認為我們已經清除了擴大市場的第一個障礙。很明顯，正如 Donn 強調的那樣，我們必須更廣泛地開展這項工作。但是我們看到了患者的證據，所以這是旅程中的重要一步。那麼，Donn，你想對在德國的發布發表一些評論嗎？

Yes. The launch is going well. As you would expect with most launches, it takes time. But we're excited about the progress that's been made thus far. We'll continue to update as we get more information. But thus far, the launch is going as we expect (technical difficulty).

是的。發射進展順利。正如您對大多數發布所期望的那樣，這需要時間。但我們對迄今為止取得的進展感到興奮。當我們獲得更多信息時，我們將繼續更新。但到目前為止，發布正如我們預期的那樣進行（技術難度）。

Our next question is from Roy Duane from JMP Securities.

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

I had a couple more. So what's the status of HEPLISAV in dialysis patients?

我還有幾個。那麼HEPLISAV在透析患者中的現狀如何呢？

Focused on COVID over the last few years. But we are working on the SBLA for dialysis, which we expect to file probably early next -- very early next year and to get that data into the label upon approval of the SBLA.

在過去的幾年裡專注於 COVID。但我們正在研究用於透析的 SBLA，我們預計可能會在明年初提交——明年年初，並在 SBLA 批准後將這些數據放入標籤中。

Okay. Great. And then back to the shingles. I guess it's a little earlier just finishing up the Phase 1, you're going to need to talk to the FDA, et cetera.

好的。偉大的。然後回到帶狀皰疹。我想現在完成第一階段的時間有點早，你將需要與 FDA 等進行交談。

95% efficacy ahead to head trial, just doesn't make sense. You'll never be able to seasonally demonstrate actual efficacy. And so we still obviously need to continue to advance our engagement with the agency, given that we're in Phase I to really fine-tune what the expectations are for the full regulatory plan. But we do not expect -- it's just not feasible to do a head-to-head efficacy study in this case.

95% 的療效提前到頭試驗，只是沒有意義。您永遠無法按季節展示實際功效。因此，我們顯然仍然需要繼續推進與該機構的合作，因為我們正處於第一階段，以真正微調對完整監管計劃的期望。但我們並不期望——在這種情況下進行頭對頭療效研究是不可行的。

Ex-U.S., do you see that as a -- I mean Shingrix does pretty well ex-U.S., especially this last quarter. How are you guys thinking about the opportunity there?

除美國外，你認為這是——我的意思是 Shingrix 在美國以外的地區做得很好，尤其是最後一個季度。你們如何看待那裡的機會？

Well, any product, we would expect we want to launch it broadly into all markets that would support the infrastructure cost of bringing the product into that region. So that's part of the -- the strategy is a global strategy for shingles.

好吧，任何產品，我們都希望我們希望將其廣泛投放到所有市場，以支持將產品引入該地區的基礎設施成本。所以這是 - 該戰略是帶狀皰疹的全球戰略的一部分。

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

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)，請他作結束語。你可以開始了。

Thank you, operator, and thank you all for your attention today. As we have reiterated on multiple occasions, we believe that the combination of our revenue-generating assets, 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. Our success this year and opportunities we see ahead are made possible by the dedicated team here at Dynavax. Our people are everything, and I would 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.

謝謝接線員，也謝謝大家今天的關注。正如我們多次重申的那樣，我們相信，我們的創收資產、經驗豐富的團隊、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 Dynavax 的未來奠定了堅實的基礎. Dynavax 敬業的團隊使我們今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。