Dynavax Technologies Corp (DVAX) 2025 Q1 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Dynavax Technologies first quarter 2025 Financial Results conference call. (Operator Instructions)

女士們、先生們，大家好，歡迎參加 Dynavax Technologies 2025 年第一季財務業績電話會議。（操作員指示）

I would now like to hand the call over to Paul Cox, Vice President, Investor Relations and Corporate Communications. You may now begin.

現在我想把電話交給投資人關係和企業傳播副總裁保羅‧考克斯 (Paul Cox)。現在你可以開始了。

Thank you for participating in today's call. Joining me from the from Dynavax are Ryan Spencer, Chief Executive Officer, Donn Casale, Chief Commercial Officer, Rob Janssen, Chief Medical Officer, and Kelly MacDonald, our Chief Financial Officer.

感謝您參加今天的電話會議。與我一起出席的還有來自 Dynavax 的首席執行官 Ryan Spencer、首席商務官 Donn Casale、首席醫療官 Rob Janssen 和首席財務官 Kelly MacDonald。

Earlier today, Dynavax released financial results for the first quarter ended March 30, 2025. Copies of the press release in a supplementary slide presentation are available on Dynavax's website.

今天早些時候，Dynavax 發布了截至 2025 年 3 月 30 日的第一季財務業績。補充幻燈片簡報中的新聞稿副本可在 Dynavax 的網站上找到。

Before we begin, I advise you that we will be making forward-looking statements today based on our current expectations and beliefs, including but not limited to potential market sizes, market segmentation.

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，包括但不限於潛在的市場規模、市場區隔。

Effective marketing efforts, future expected market share and related growth rates, and related ACIP recommendation impact on each financial guidance on trends including revenue, profitability, cash flow, and sufficiency of current capitalization, timing and results of FDA submissions, clinical trial starts, and data readouts, and potential future uses of or demand for CpG 1018 adjuvants.

有效的營銷努力、未來預期的市場份額和相關增長率以及相關的 ACIP 建議對每項財務指南趨勢的影響，包括收入、盈利能力、現金流量和當前資本的充足性、 FDA 提交的時間和結果、臨床試驗開始和數據讀數，以及 CpG 1018 佐劑的潛在未來用途或需求。

These statements involve risks and uncertainties, and our actual results may differ materially. These risks are summarized in today's press release and details 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.

這些聲明涉及風險和不確定性，我們的實際結果可能存在重大差異。這些風險已在今天的新聞稿和我們提交給美國證券交易委員會 (SEC) 的文件的風險因素部分中進行了總結，其中包括今天的 10-Q 表季度報告。我們的前瞻性陳述僅代表今日的觀點，我們不承擔更新此類陳述的義務。

Our earnings press release and this call will include discussion of certain non-GAAP information. You can find our earnings press release, including relevant non-GAAP reconciliations on the investor section of our corporate website at Dynavax.com.

我們的收益新聞稿和本次電話會議將討論某些非 GAAP 資訊。您可以在我們公司網站 Dynavax.com 的投資者部分找到我們的收益新聞稿，包括相關的非 GAAP 對帳。

And with that, I will now turn the call over to Ryan.

現在，我將把電話轉給瑞安 (Ryan)。

Thanks, Paul. Thank you all for joining us this afternoon. 2025 is off to a strong start, including delivering our highest ever first quarter net revenue for HEPLISAV-B of $65 million which was an increase of 36% compared to last year.

謝謝，保羅。感謝大家今天下午加入我們。 2025 年開局強勁，包括 HEPLISAV-B 實現了有史以來最高的第一季淨收入 6,500 萬美元，比去年增長了 36%。

We believe this performance early in the year puts us on track to achieve the top half of our full year HEPLISAV-B guidance range of net product sales between $305 million to $325 million.

我們相信，今年年初的這一表現將使我們預計將實現全年 HEPLISAV-B 指引範圍的上半年淨產品銷售額 3.05 億美元至 3.25 億美元之間。

We're also excited to advance our development pipeline which leverages our vaccine adjuvant technology CpG 1018. We have key clinical trial milestones this year for our shingles and plague vaccine programs while further broadening our pipeline with new programs announced today in pandemic influenza and Lyme disease.

我們也很高興能夠推進利用疫苗佐劑技術 CpG 1018 的開發流程。今年，我們的帶狀皰疹和鼠疫疫苗計畫在臨床試驗中取得了關鍵的里程碑，同時透過今天宣布的針對大流行性流感和萊姆病的新項目，進一步拓寬了我們的研發線。

All of our pipeline programs intentionally follow a similar philosophy of utilizing proven antigens and our CpG 1018 adjuvant, creating lower risk development pathways to advanced products with significant commercial potential.

我們所有的管道項目都刻意遵循類似的理念，即利用經過驗證的抗原和我們的 CpG 1018 佐劑，為具有巨大商業潛力的先進產品創造低風險的開發途徑。

So let's start with our shingles program, which is our most advanced clinical program. We see significant op opportunity for a differentiated shingles vaccine, which is currently a multi-billion dollar global annual market dominated by a single product. To be successful, a differentiated vaccine will require similar efficacy and meaningfully improved tolerability compared to the existing market leading products.

那麼讓我們從帶狀皰疹計畫開始吧，這是我們最先進的臨床計畫。我們看到差異化帶狀皰疹疫苗具有巨大的營運機會，目前該疫苗全球年市場規模達數十億美元，且主要由單一產品主導。要獲得成功，差異化疫苗需要具有與現有市場領先產品相似的功效和顯著改善的耐受性。

As a reminder, we've already completed a dose ranging phase 1 study where we saw comparable immunogenicity and meaningfully lower rates of post-injection reactions compared to Shingrix.

提醒一下，我們已經完成了劑量範圍第一階段研究，結果發現與 Shingrix 相比，其免疫原性相當，而且注射後反應發生率明顯較低。

For our ongoing phase 1/2 study, we expect to report our top line readout for part one of the study in the third quarter, which will be based on one month data following the last vaccine dose in the study for the 50- to 69-year-old patient cohort.

對於我們正在進行的 1/2 期研究，我們預計將在第三季報告研究第一部分的最高讀數，該讀數將基於研究中針對 50 至 69 歲患者群體的最後一劑疫苗接種後一個月的數據。

Turning to our new pandemic influenza adjuvant program. Pandemic influenza remains one of the most persistent and unpredictable global health threats. Yet while vaccine adjuvants play an central role in the pandemic response, the global supply of proven adjuvants remains limited compared to the global antigen production capacity.

談談我們新的大流行性流感佐劑計劃。大流行性流感仍然是最持久且最難以預測的全球健康威脅之一。儘管疫苗佐劑在應對疫情中發揮核心作用，但與全球抗原生產能力相比，全球已驗證的佐劑供應仍然有限。

Our goal is to generate clinical proof of concept data for pandemic influenza vaccines using CpG 1018. We believe this is an attractive opportunity for us to leverage our expertise and capabilities as a supplier of CpG 1018 in five COVID-19 vaccines used around the world.

我們的目標是使用 CpG 1018 為大流行性流感疫苗產生臨床概念驗證數據。我們相信，這是一個極具吸引力的機會，讓我們能夠利用我們的專業知識和能力，作為全球五種 COVID-19 疫苗的 CpG 1018 供應商。

We are on track to initiate a phase 1/2 trial combining third party source flu antigen with CpG 1018 in the coming weeks. This data will allow us to begin business development efforts with global flu manufacturers, government and non-government organizations focused on supplying our adjuvants to support global pandemic preparedness and response.

我們將在未來幾週內啟動將第三方來源流感抗原與 CpG 1018 結合的 1/2 期試驗。這些數據將使我們能夠與全球流感製造商、政府和非政府組織開展業務發展努力，並專注於提供佐劑，以支持全球大流行的防範和應對。

The second new program announced today is an investigational protein subunit vaccine for the prevention of Lyme disease, which is a bacterial infection that is the most common vector-borne illness in the northern hemisphere. We see a unique opportunity for Dynavax to develop a best-in-class Lyme disease vaccine.

今天宣布的第二個新項目是用於預防萊姆病的試驗性蛋白質亞單位疫苗，萊姆病是一種細菌感染，是北半球最常見的媒介傳播疾病。我們看到 Dynavax 開發一流萊姆病疫苗的獨特機會。

The mechanism of action for Lyme disease vaccines is well understood, in which high levels of antibodies are required for protection.

萊姆病疫苗的作用機制已被充分了解，即需要高水準的抗體才能提供保護。

Current vaccine candidates in late-stage clinical development require a challenging three to four dose series followed by annual boosters. A Lyme disease vaccine adjutant to the CpG 1018 offers the potential for a differentiated product requiring fewer doses or less frequent boosters.

目前處於後期臨床開發階段的候選疫苗需要三到四劑系列接種，然後每年加強接種。CpG 1018 的萊姆病疫苗佐劑有可能產生需要較少劑量或更少頻率加強劑的差異化產品。

We are excited to progress this program into (IND)-enabling studies to generate preclinical proof of concept data in nonhuman primates with plans to enter the clinic in 2027. Rob will speak in more detail about our clinical pipeline in a few minutes.

我們很高興將該計畫推進到（IND）研究階段，以便在非人靈長類動物中產生臨床前概念驗證數據，並計劃於 2027 年進入臨床階段。幾分鐘後，Rob 將更詳細地介紹我們的臨床流程。

We continue to focus on maintaining a disciplined approach to capital allocation, including executing on over 85% of our $200 million share repurchase program as of May fifth, while evaluating external opportunities that leverage our unique business platform, including our fully integrated commercial stage infrastructure and capabilities to generate additional long-term growth for our shareholders.

我們繼續致力於保持嚴謹的資本配置方法，包括截至 5 月 5 日執行 2 億美元股票回購計畫的 85% 以上，同時評估利用我們獨特業務平台的外部機會，包括我們完全整合的商業階段基礎設施和能力，為我們的股東創造額外的長期成長。

We are proud of the company we're building around our core assets of HEPLISAV-B and CpG 1018, which have together helped protect millions of people around the world. Our performance thus far sets us up for even greater success in 2025.

我們為圍繞 HEPLISAV-B 和 CpG 1018 核心資產建立的公司感到自豪，它們共同保護了全球數百萬人。我們迄今為止的表現為我們在 2025 年取得更大的成功奠定了基礎。

Which we expect to be a banner year for Dynavax. I look forward to providing you with updates on our progress along the way.

我們預計這將是 Dynavax 豐收的一年。我期待著向您提供我們一路以來的進展。

Next, I'd like to turn the call over to Donn.

接下來，我想把電話轉給唐恩。

Thanks, Ryan. At Dynavax, we are proud to be the leader in the US HEPLISAV-B vaccine market.

謝謝，瑞安。在 Dynavax，我們很自豪能夠成為美國 HEPLISAV-B 疫苗市場的領導者。

Since its launch in 2018, HEPLISAV-B disrupted the market due to what we believe is a differentiated investing class profile, securing its position as the market leader. In 2022, the ACIP universal recommendation transformed the US adult's HEPLISAV-B vaccine market. Expanding it into one of the largest addressable patient populations for vaccines in the US.

自 2018 年推出以來，HEPLISAV-B 憑藉其差異化的投資類別特徵顛覆了市場，鞏固了其市場領先地位。2022年，ACIP普遍推薦改變了美國成人HEPLISAV-B疫苗市場。將其擴展為美國最大的疫苗可尋址患者群體之一。

The market continues to adopt these expanded guidelines with Q1 total market dose volume increasing approximately 16% year over year.

市場繼續採用這些擴展的指導方針，第一季市場總劑量年增約 16%。

HEPLISAV-B's strong performance in this expanding market has resulted in record first quarter performance, with net revenue of $65 million a 36% year over year increase. This strong start to the year positions us well to achieve the top half of our annual revenue guidance range for 2025.

HEPLISAV-B 在這個不斷擴大的市場中的強勁表現帶來了創紀錄的第一季業績，淨收入達到 6500 萬美元，同比增長 36%。今年的強勁開局為我們實現 2025 年年度收入預期範圍的上半部分奠定了良好的基礎。

The retail segment delivered strong year over year growth in the first quarter, with market volume increasing approximately 70% compared to Q1 2024. This strong momentum has carried into the second quarter, with purchasing and utilization rates surpassing our expectations. Our commercial strategies are resonating with customers, and adoption is steadily expanding across the market.

零售業在第一季實現了強勁的同比增長，市場交易量與 2024 年第一季相比增長了約 70%。這一強勁勢頭一直延續到第二季​​度，採購率和利用率超出了我們的預期。我們的商業策略引起了客戶的共鳴，並且在整個市場上的採用率正在穩步擴大。

We anticipate additional upside during Hepatitis Awareness month in May as we activate targeted campaigns and collaborations to further accelerate Hepatitis-B vaccination.

我們預計，隨著我們啟動有針對性的活動和合作以進一步加速乙肝疫苗接種，五月的肝炎宣傳月期間將出現更多上漲。

He's estimated US market share rose to 43% in Q1, up from 41% in the same period last year. This growth was driven by broad-based gains, including consistent annual market share increases across all major retail customers. We expect to see similar year by year market share gains throughout the remainder of 2025 in line with our long-term expectations.

他估計，美國市佔率第一季將升至 43%，高於去年同期的 41%。這一增長是由廣泛的收益推動的，包括所有主要零售客戶的年度市場份額持續增長。我們預計，2025 年剩餘時間內市佔率將逐年成長，符合我們的長期預期。

Our positive outlook is supported by strong market growth and retail and other key customer segments where HEPLISAV-B holds a leading position.

強勁的市場成長以及零售和其他主要客戶領域的支持了我們的樂觀前景，其中 HEPLISAV-B 佔據領先地位。

We are encouraged by the ongoing adoption of HEPLISAV-B. Our progress continues to track with our long-term outlook for HEPLISAV-B market opportunity in the US, which we expect to peak to over $900 million by 2030, with HAB capturing at least 60% market share.

我們對 HEPLISAV-B 的持續採用感到鼓舞。我們的進展繼續與我們對美國 HEPLISAV-B 市場機會的長期展望保持一致，我們預計到 2030 年該市場規模將達到 9 億美元以上的峰值，其中 HAB 將佔據至少 60% 的市場份額。

This long-term guidance reflects our expectation of double-digit annual growth in product net sales through 2030.

這項長期指引反映了我們對 2030 年產品淨銷售額實現兩位數年成長的預期。

We expect the HEPLISAV-B be market opportunity to remain durable beyond 2030, driven by ongoing vaccination of the eligible adult population, observed re-vaccination practices by healthcare providers, and continued market share gains.

我們預計，HEPLISAV-B 市場機會將在 2030 年後保持持久，這得益於符合條件的成年人口的持續疫苗接種、醫療保健提供者觀察到的重新疫苗接種實踐以及市場份額的持續增長。

We are excited about the future for HEPLISAV-B. The strength we see across our business reinforces our belief in the long-term growth opportunity. The execution by our commercial team has been outstanding, and the momentum we have built in the 1st quarter sets a strong foundation for continued success this year and beyond.

我們對 HEPLISAV-B 的未來充滿期待。我們在整個業務中看到的實力增強了我們對長期成長機會的信心。我們的商業團隊的執行力非常出色，我們在第一季建立的勢頭為今年及以後的持續成功奠定了堅實的基礎。

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

現在我將把電話轉給 Rob，讓他向您介紹我們的臨床流程。

Thank you, Donn.

謝謝你，唐恩。

As Ryan summarized earlier, we're very pleased with how our clinical development pipeline continues to advance and expand as we focus on leveraging our core adjuvant technology to develop differentiated vaccines. Our internal R&D programs focus on well-established antigens in biology with clear regulatory pathways where CpG 1018 adjuvant can provide a meaningful improvement.

正如 Ryan 之前總結的那樣，我們非常高興我們的臨床開發管道能夠繼續推進和擴大，因為我們專注於利用我們的核心佐劑技術來開發差異化疫苗。我們的內部研發計畫專注於生物學中已建立的抗原，具有明確的調控途徑，CpG 1018 佐劑可以提供有意義的改進。

Additionally, we provide CpG 1018 to support external collaborations in a variety of programs. We believe this maximizes the opportunity for CpG 1018 to be utilized in novel vaccine development initiatives.

此外，我們也提供 CpG 1018 來支援各種專案的外部合作。我們相信這最大限度地增加了 CpG 1018 在新型疫苗開發計劃中的應用機會。

For a shingles vaccine program. We previously reported results from our phase one clinical trial evaluating our investigational shingles vaccine Z-1018 compared to Shingrix's in 150 participants.

針對帶狀皰疹疫苗計劃。我們先前報告了第一階段臨床試驗的結果，該試驗對 150 名參與者進行了帶狀皰疹疫苗 Z-1018 與 Shingrix 的比較評估。

We saw similar immunogenicity results and a favourable tolerability profile compared with Shingrix's. Importantly, this was an adjuvant dose ranging study that allowed us to select the dose of CpG 1018 to advance into phase 1/2. Now we're currently conducting part one of that phase 1/2 study in adults aged 50 to 69 years.

與 Shingrix 相比，我們看到了相似的免疫原性結果和良好的耐受性。重要的是，這是一項輔助劑量範圍研究，使我們能夠選擇 CpG 1018 的劑量以進入 1/2 期。目前，我們正在針對 50 至 69 歲的成年人進行第一階段半研究的第一部分。

We completed enrolment of 441 subjects in the trial at the end of last year, and we expect to report our top lying readout in the third quarter. It will be based on one month data following the last vaccine dose in the study.

我們在去年年底完成了 441 名試驗受試者的招募，我們預計將在第三季報告我們的最高讀數。它將基於研究中最後一劑疫苗接種後一個月的數據。

Now this is an antigen dose ranging study that's like the dose level to further optimize the formulation and schedule for our vaccine.

這是一項抗原劑量範圍研究，類似於劑量水平，可以進一步優化我們的疫苗配方和時間表。

Our goals for part one is, first, select the antigen dosing schedule to advance into part two of the phase 1/2 study by demonstrating similar immunogenicity in the Shing brooks based primarily on vaccine response rate measured by both antibody and CD4 positive T cells.

我們第一部分的目標是，首先，選擇抗原給藥方案，透過證明 Shing brooks 中的相似免疫原性，主要基於抗體和 CD4 陽性 T 細胞測量的疫苗反應率，進入第 1/2 階段研究的第二部分。

Second, demonstrate improved tolerability with lower rates of moderate and severe post-injection reactions compared to Shingrix's. And third, demonstrate the durability of CD4 T cells at six and 12 months follow up with data readouts expected next year in 2026.

其次，與 Shingrix 相比，其耐受性較好，注射後中度和重度反應發生率較低。第三，證明 CD4 T 細胞在六個月和十二個月的追蹤中的耐久性，預計明年（2026 年）會獲得數據讀數。

Now following positive one month data, we plan to advance the selected vaccine formulation and schedule into part two of this study, which is in adults 70 years of age and older. In the Shingrix Pivotal study, participants over 70 years of age had a lower vaccine efficacy than in a study in a younger age.

現在，根據一個月的正面數據，我們計劃將選定的疫苗配方和時間表推進到研究的第二部分，針對 70 歲及以上的成年人。在 Shingrix Pivotal 研究中，70 歲以上的參與者的疫苗效力低於年輕參與者的研究。

Thus, our study in adults over age 70 will provide a more stringent assessment of Z-1018 immunogenicity than in the younger age group.

因此，我們對 70 歲以上成年人的研究將比對年輕年齡組提供更嚴格的 Z-1018 免疫原性評估。

This portion of the trial will have a higher number of subjects to more fully support assessment of the vaccine response rate compared to Shingrix's.

與 Shingrix 相比，這部分試驗將有更多的受試者，以更全面地支持對疫苗反應率的評估。

We believe the part two data, along with the longer term follow up from Part one in the younger age group, that both of which are expected next year, will provide a comprehensive data package to provide confidence in advancing into a pivotal efficacy trial.

我們相信，第二部分的數據以及第一部分針對較年輕年齡組的長期追蹤數據（預計明年公佈）將提供全面的數據包，為推進關鍵療效試驗提供信心。

And regarding our plague vaccine program, it's in collaboration with and fully funded by the US Department of Defence. We continue to plan to initiate a phase two clinical trial in the third quarter of this year.

關於我們的鼠疫疫苗計劃，它是與美國國防部合作並由其全額資助的。我們繼續計劃在今年第三季啟動第二期臨床試驗。

Given that the program is focused on preventing the spread of pneumonic plague in a biological attack, our goal in the phase two study is to maximize a rapid antibody response through dose ranging of the CpG 1018 adjuvant and optimizing the dosing regimen.

鑑於該計劃的重點是防止生物攻擊中肺鼠疫的傳播，我們在第二階段研究中的目標是透過 CpG 1018 佐劑的劑量範圍和優化給藥方案來最大限度地提高快速抗體反應。

Now for the pandemic influenza a program, as Ryan mentioned, we expect to initiate the first in human clinical trial in the second quarter of this year. This will be a randomized active-controlled phase 12 study to evaluate the safety and immunogenicity of an investigational HEPLISAV-B avian pandemic influenza vaccine adjuvanted with CpG 1,018 and Allen.

現在對於大流行性流感 A 項目，正如 Ryan 所提到的，我們預計將在今年第二季啟動首次人體臨床試驗。這將是一項隨機、活性對照的 12 期研究，旨在評估以 CpG 1,018 和 Allen 為佐劑的試驗性 HEPLISAV-B 禽流感疫苗的安全性和免疫原性。

We believe this could enable us to generate clinical proof of concept in an efficient and low-cost manner.

我們相信這可以讓我們以高效且低成本的方式產生臨床概念驗證。

Part 1 of the Phase 1/2 trial will involve approximately 98 participants aged 18 year to 49 years to receive either a single dose or two doses of the investigational vaccine with the intent to select the optimal formulations of CpG 1018 for part 2 of the Phase 12 trial.

1/2 期試驗的第 1 部分將涉及約 98 名年齡在 18 歲至 49 歲之間的參與者，他們將接受單劑量或兩劑量的試驗疫苗，目的是為 12 期試驗的第 2 部分選擇最佳的 CpG 1018 配方。

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

現在我將把電話轉給凱利來審查我們的財務結果。

Thank you, Rob.

謝謝你，羅布。

Before I get started, a reminder to please refer to our press release in Form 10-Q you filed earlier today for more detailed financial information.

在我開始之前，請參閱我們今天早些時候提交的 10-Q 表中的新聞稿，以獲取更詳細的財務資訊。

Financial highlights for the first quarter included helpless at the net sales of $65 million for the first quarter, up 36% year over year, and $68 million in total revenues of 34% year over year. Additionally, HEPLISAV-B gross margin was 79% for the first quarter of 2025, an increase compared to 77% in the first quarter of 2024. We continue to expect HEPLISAV-B gross margin of approximately 80% for full year 2025.

第一季的財務亮點包括第一季淨銷售額 6,500 萬美元，年增 36%，總營收 6,800 萬美元，年增 34%。此外，HEPLISAV-B 2025 年第一季的毛利率為 79%，較 2024 年第一季的 77% 有所成長。我們繼續預計 2025 年全年 HEPLISAV-B 的毛利率約為 80%。

Turning to expenses, R&D expenses were $19 million for the first quarter, up compared to $14 million in the first quarter last year. Looking ahead for R&D expenses as we continue to progress our clinical stage pipeline through key milestones in 2025. Notably our shingles data readout in Q3, our pandemic influenza clinical initiation in Q2, and our plague program Phase 2 initiation in Q3,

談到費用，第一季的研發費用為 1,900 萬美元，高於去年第一季的 1,400 萬美元。展望研發費用，我們將繼續推動臨床階段研發，在 2025 年實現關鍵里程碑。值得注意的是，我們在第三季度讀取了帶狀皰疹數據，在第二季度啟動了大流行性流感臨床研究，並在第三季度啟動了鼠疫計畫的第二階段研究。

We expect R&D expenses to increase by at least high as a percentage compared in 2024. If our shingles program readout supports moving into part two of the Phase 1/2 trial, we would expect a further step up in R&D expenses in the second half of the year to reflect investments in launching that study.

我們預計，與 2024 年相比，研發費用將至少增加一定百分比。如果我們的帶狀皰疹計畫讀數支持進入第 1/2 階段試驗的第二部分，我們預計下半年研發費用將進一步增加，以反映啟動研究的投資。

SG&A expenses were $48 million in the first quarter, up from $44 million in the first quarter of last year, with the increase primarily due to incremental proxy-related expenses. Excluding any potential further proxy contest-related costs, we expect to we expect SG&A expenses to be roughly flat in 2025, reflecting our ongoing commitment to disciplinedense management.

第一季銷售、一般及行政費用為 4,800 萬美元，高於去年第一季的 4,400 萬美元，成長的主要原因是代理相關費用增加。排除任何潛在的進一步代理競賽相關成本，我們預計 2025 年銷售、一般及行政費用 (SG&A) 將基本持平，這反映了我們對嚴謹管理的持續承諾。

During the first quarter, we also recorded an allowance for doubtful accounts of $11 million relating to our legacy COVID-19 adjuvant commercial supply agreement with Clover Biopharmaceuticals. This bad debt expense reflects our assessment of heightened credit risks from Clover due to their recently reported liquidity position as of December 31, 2024.

在第一季度，我們還記錄了與 Clover Biopharmaceuticals 簽訂的 COVID-19 佐劑商業供應協議相關的 1,100 萬美元的壞帳準備金。這筆壞帳費用反映了我們對 Clover 信用風險上升的評估，因為 Clover 最近報告了截至 2024 年 12 月 31 日的流動性狀況。

We expect to continue to pursue these amounts from Clover in connection with our agreement with [SEPI], who, as a reminder, provided us with a fully forgivable funding to support this arrangement during the pandemic.

我們希望根據與 [SEPI] 達成的協議繼續向 Clover 追討這些款項，提醒一下，SEPI 為我們提供了一筆完全可免除的資金，以支持疫情期間的這一安排。

Moving to the bottom line, we had GAAP net loss of $96 million for the first quarter of 2025 compared to GAAP net loss of $9 million for the first quarter of 2024. The net loss in the first quarter of 2025 was primarily due to the GAAP accounting treatment of our debt refinancing, which required us to recognize the one-time adjustment reflecting the difference between fair value and far value in connection with the extinguishment of our 2026 convertible notes.

談到底線，2025 年第一季我們的 GAAP 淨虧損為 9,600 萬美元，而 2024 年第一季的 GAAP 淨虧損為 900 萬美元。2025 年第一季的淨虧損主要是由於我們的債務再融資的 GAAP 會計處理，這要求我們確認與 2026 年可轉換票據清償有關的反映公允價值與遠期價值之間差異的一次性調整。

Lastly, on the P&L, non-GAAP adjusted EBITDA improved to negative $4 million for the first quarter compared to negative $7 million in the first quarter of last year. Please see a press release issued earlier today for a reconciliation of GAAP to non-GAAP results and accompanying disclosure.

最後，在損益表方面，第一季非 GAAP 調整後 EBITDA 改善至負 400 萬美元，而去年第一季為負 700 萬美元。請參閱今天稍早發布的新聞稿，以了解 GAAP 與非 GAAP 結果的對帳情況及隨附揭露。

Transitioning to the balance sheet, we ended the first quarter with cash equivalents and marketable securities of $661 million compared to $714 million at the end of 2024. The decrease in our cash position reflects the continued execution of our stock repur program, which included aggressive execution in the open market during periods of significant market volatility during the quarter.

從資產負債表來看，第一季末我們的現金等價物和有價證券為 6.61 億美元，而 2024 年底為 7.14 億美元。我們現金狀況的下降反映了我們持續執行庫存回購計劃，其中包括在本季度市場大幅波動期間在公開市場積極執行。

To date, the company has repurchased over $172 million worth of com stock under the authorized $200 million share repurchase program, or over 85% of the program executed. And we anticipate completing the remaining purchases by the end of the year.

迄今為止，該公司已根據授權的 2 億美元股票回購計畫回購了價值超過 1.72 億美元的蘋果股票，佔計畫執行額的 85% 以上。我們預計在今年年底前完成剩餘的採購。

In March 2025, we opportunistically refinanced a majority of our outstanding 2026 convertible senior notes, which extended the maturity date of most of our existing debt to mid-2030s, also lowered our overall cost of capital with meaningfully improved terms, reduced basic and diluted shares outstanding, and accelerated the execution of our share buyback program.

2025 年 3 月，我們抓住機會對大部分未償還的 2026 年可轉換優先票據進行了再融資，將大部分現有債務的到期日延長至 2030 年代中期，同時透過顯著改善的條款降低了我們的總體資本成本，減少了基本和稀釋流通股，並加快了我們的股票回購計劃的執行。

Following this successful debt refinancing, we believe we have the right size capital structure to support our strategy to protect and deliver long-term value for shareholders.

在此次債務再融資成功後，我們相信我們擁有合適規模的資本結構來支持我們的策略，即保護股東並為他們提供長期價值。

Turning to our financial guidance for the full year 2025, we reiterate our expectation of help lessee net product revenue to be in the range of $305 million to $325 million representing 17% year over year growth at the midpoint. We do now expect to achieve the top half of that range due to our strong start to the year.

談到我們對 2025 年全年財務的指導，我們重申我們的預期，即幫助承租人淨產品收入在 3.05 億美元至 3.25 億美元之間，相當於中點同比增長 17%。由於今年開局強勁，我們現在確實有望實現該範圍的上半部分。

We also reiterate our expectation for adjusted EBITDA to be at least $75 million demonstrating our ability to grow adjusted EBITDA at more than two times the rate of product revenue and further strengthening our ability to deliver on our strategic priorities in 2025.

我們也重申對調整後 EBITDA 至少為 7,500 萬美元的預期，表明我們有能力使調整後 EBITDA 的成長速度達到產品收入的兩倍以上，並進一步增強我們在 2025 年實現戰略重點的能力。

In closing, we are very excited about our strong start to the year, consisting of a record first quarter for helpless FB, our advancing pipeline with key milestones and new programs this year, and our strong financial profile with a balanced capital allocation strategy. We are very proud of this progress, and we're also excited about our growth prospects as outlined on the call today.

最後，我們對今年的強勁開局感到非常興奮，包括無助的 FB 第一季創下的紀錄、今年我們憑藉關鍵里程碑和新計劃不斷推進的產品線，以及我們強勁的財務狀況和均衡的資本配置策略。我們對這一進展感到非常自豪，我們也對今天電話會議上概述的成長前景感到興奮。

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

感謝大家抽出時間。接線員，我們現在想開始今天電話會議的問答部分。

(Operator Instructions)

（操作員指示）

Matthew Phipps, William Blair

馬修·菲普斯、威廉·布萊爾

Hi, good afternoon. Thanks for taking my questions and to see the new programs announced. I guess first, just a quick question, talking about hitting the upper half of guidance, why not officially raise the lower end of guidance then if confidence in that hitting that upper half.

嗨，下午好。感謝您回答我的問題並看到新計劃的公佈。我想先問一個簡單的問題，談到達到指導的上半部分，為什麼不正式提高指導的下限，如果有信心達到上半部分呢？

Hey, thanks for the question.

嘿，謝謝你的提問。

At this point we're only one quarter through the year, so we think it's prudent to maintain our overall guidance range as our official official guidance and just threaten the color that we have seen good progress to start the year off is the intention with the commentary around the upper half of the range.

目前，我們只度過了一個季度，因此我們認為將整體指導範圍維持為官方指導範圍是明智之舉，並且只是威脅我們已經看到年初取得的良好進展，這是圍繞該範圍上半部分進行評論的意圖。

Yeah, okay, and it may be a higher picture picture question, Ryan. There's obviously been some investor debates on the best path to long term value creation for Dynavax, and I'm wondering just particularly if you could share your view around kind of capital allocation and business development now that you're almost to the first shingles readout, you obviously had previously discontinued the [TAP] program, but now announcing two new pre-clinical programs just.

是的，好的，這可能是一個更高級別的圖片問題，瑞安。顯然，投資者對 Dynavax 長期價值創造的最佳途徑存在一些爭論，我很想知道您是否可以分享您對資本配置和業務發展的看法，因為您現在幾乎已經獲得了第一個帶狀皰疹數據，您顯然之前已經停止了 [TAP] 計劃，但現在宣布了兩個新的臨床前計劃。

How do these all fit into the longer term play and particularly around does this signal maybe less appetite for or less interest in a near term external business development bringing forward kind of two new pre-clinical programs?

這一切與長期發展有何關係？特別是這是否顯示人們對近期外部業務發展（提出兩種新的臨床前項目）的興趣或興趣有所降低？

Yeah, I mean, look, I mean, starting with the capital allocation philosophy, we've been pretty clear about our view that we have a balanced strategy and what underpins that is our desire to create value by leveraging our core assets as you kind of Picked up on here, Matt with the preclinical programs focused on leveraging 1,018 and also fully leveraging our infrastructure and capabilities which plays into our commentary around value creation through corporate development focusing on late stage commercial assets.

是的，我的意思是，從資本配置理念開始，我們已經非常清楚地表明了我們的觀點，即我們有一個平衡的戰略，而支撐這一戰略的是我們希望通過利用我們的核心資產來創造價值，正如你在這裡提到的那樣，馬特的臨床前項目專注於利用 1,018，並充分利用我們的基礎設施和能力，這符合我們關於商業資產的評論來創造後期價值的評論。

So, and then the sort of the third leg of that is the picture around our capital allocation strategy is to Focus on our existing asset. In addition, we also do look for opportunities, as you noted, as we noted with our share buyback program to return capital to shareholders.

因此，第三點是圍繞我們的資本配置策略，重點關注我們現有的資產。此外，正如您所說，我們也在尋找機會，透過股票回購計畫向股東返還資本。

So, when we balance all these things out, we believe there's room, and we're actually quite proud of this fact that we've been able to return capital to shareholders while also creating enough room for us to advance. Our internal development programs and we still believe there's an opportunity for us to identify high value assets to leverage our full commercial capability so we're going to continue to run that strategy as we advance forward.

因此，當我們平衡所有這些因素時，我們相信還有空間，而且我們實際上對能夠向股東返還資本同時也為我們前進創造足夠的空間這一事實感到非常自豪。我們的內部開發計劃，我們仍然相信我們有機會識別高價值資產，以充分利用我們的商業能力，因此我們將在前進的過程中繼續執行此策略。

Thanks, Ryan. Okay, I'll hop back in the.

謝謝，瑞安。好的，我這就回去。

Philip Nado, TD Cowen

菲利普·納多（Philip Nado），TD Cowen

Good afternoon. Thanks for taking our questions. A couple from us too. First, on the quarterly performance, there definitely seemed to be less seasonality in the winter of '24, '25 than in the past.

午安.感謝您回答我們的問題。我們這裡也有一對。首先，從季度表現來看，2024、2025 年冬季的季節性似乎確實比過去還要小。

What are you seeing along those lines? Do you expect what we saw this year to be the new normal, or was there anything special about this past winter?

您從這些方面看到了什麼？您是否認為今年所見的將會成為新常態，或者過去的這個冬天有什麼特別之處？

Hey, so it's, yeah, thanks for the question.

嘿，是的，謝謝你的提問。

What we saw, particularly in retail, a pretty fast start with focus on non-flu vaccines, including hepatitis B vaccine this year versus in years past. So, it was very purposeful by our leading retailers to really prioritize these kinds of expanded vaccines for the first quarter. So, that really contributed to the growth we saw in Q1, as I mentioned, we saw 70% growth year over year. In the retail segment alone, so that helped kind of flatten out that seasonality that we typically saw in years past.

我們看到，特別是在零售業，與過去幾年相比，今年的重點開始相當迅速地轉向非流感疫苗，包括B型肝炎疫苗。因此，我們的主要零售商非常有目的地在第一季優先考慮這類擴大的疫苗。所以，這確實促成了我們在第一季看到的成長，正如我所提到的，我們實現了同比增長 70%。僅在零售領域，這有助於緩解我們在過去幾年中通常看到的季節性現象。

Perfect. Then two questions on the pipeline. First, on the upcoming shingles data release, it sounds like if I interpreted your prepared remarks correctly.

完美的。然後是關於管道的兩個問題。首先，關於即將發布的帶狀皰疹數據，聽起來我似乎正確地理解了您準備好的評論。

That the data we get Q3 will be informative but not necessarily sufficient to make a go no go decision you're looking more for the more fulsome data releases, the longer-term data releases in 2026. To fully inform that decision.

我們在第三季獲得的數據雖然具有參考價值，但不一定足以幫助我們做出是否繼續的決定，因此您需要更全面的數據發布，即 2026 年發布的長期數據。充分告知該決定。

Is that correct? That's the first question. And then the second question, just more broadly, there's a lot of debate on what's happening in Washington with vaccines and the regulatory environment for those. Given that you're starting or talking about starting the development of two new programs, presumably you're having interactions with the FDA. Can you characterize those meetings and whether there's been any issues due to the changes at the FDA and HHS? Thanks.

對嗎？這是第一個問題。第二個問題，更廣泛地說，關於華盛頓在疫苗及其監管環境方面的情況存在著許多爭論。鑑於您正在啟動或談論啟動兩個新項目的開發，想必您正在與 FDA 互動。您能否描述一下這些會議以及 FDA 和 HHS 的變化是否導致了任何問題？謝謝。

Alright, why don't I take the first first, Phil. So no, this this readout is important, but I think you're highlighting the difference between sort of a staged development decision making and then the ultimate decision making to move into a pivotal program.

好吧，菲爾，我先選第一個吧。所以，這個讀數很重要，但我認為你強調的是分階段開發決策和最終進入關鍵專案的決策之間的差異。

And so, what you can pick up on our remarks today was trying to provide the right clarity for what this initial readout does and then what the longer-term projection is to have a fulsome package to make a decision to go into a pivotal program. So, the first readout this year is important. We need, remember, we're using our developed antigen here and we're using it to determine the optimized schedule and formulation.

因此，您可以從我們今天的演講中了解到，我們試圖清楚地說明這項初步數據的作用，以及長期預測，以便制定全面的方案來決定是否啟動一項關鍵計劃。因此，今年的第一次讀數很重要。我們需要記住，我們在這裡使用我們開發的抗原，並用它來確定優化的時間表和配方。

We still are going to be looking at that data to ensure that we're delivering a comparable vaccine response rate and with that positive data that would unlock additional investment to advance CMC activities and clinical development into the next part of that study. So, I want to be very careful here. There is a decision to be made here based on the information like we've said in the past.

我們仍將關注這些數據，以確保我們提供可比較的疫苗反應率，並利用這些積極的數據來釋放額外投資，以推進 CMC 活動和臨床開發進入該研究的下一部分。所以，我在這裡要非常小心。正如我們過去所說的那樣，我們需要根據這些資訊做出決定。

What we've added to the discussion today is to help you understand the bigger picture and the longer term decision and the data required to support what I think is the ultimate decision around moving forward into a pivotal study and that information we're going to require more information, including long term durability of the [T] cell response which we've consistently highlighted the importance of.

我們今天在討論中添加的內容是為了幫助您了解更大的圖景和長期決策，以及支持我認為的最終決定所需的數據，即推進關鍵研究，而我們需要更多信息，包括 [T] 細胞反應的長期持久性，我們一直強調其重要性。

As well as a comparable vaccine response rate in the hardest to vaccinate population, which is over 70 years old, we think this provides the most stringent analysis that provides confidence in advancing to a pivotal trial. So, there's multiple stage gates in the program ahead of us.

我們認為，除了在最難接種疫苗的 70 歲以上人群中具有可比較的疫苗反應率之外，這還提供了最嚴格的分析，為推進關鍵試驗提供了信​​心。因此，我們面前的計劃有多個階段門。

Got it. That is very helpful. And then any issues with your discussions with the FDA?

知道了。這非常有幫助。您與 FDA 的討論有什麼問題嗎？

Yeah, so I'll call it generally and then Rob if you have any specifics to add, but we actually find ourselves somewhat insulated for some of the immediate changes right now. If you think about the order of magnitude of our engagement, the next big engagement with the FDA will be in the phase two on the shingles program, and that'll be in the back half of '26.

是的，所以我會籠統地講一下，然後 Rob 如果你有任何具體細節要補充，但實際上，我們發現自己現在對一些眼前的變化有些免疫。如果你考慮我們合作的數量級，那麼與 FDA 的下一次重大合作將是在帶狀皰疹計畫的第二階段，那將是在 26 年下半年。

So, I do think [that] is, for whatever reason falling into a good spot there and that the near term immediate kind of activities we'll have time to settle out by the time we're engaging with the agency, and we're going to have the benefit of engaging with this agency before we embark on critical pivotal programs as it relates to other I'll call more operational activities. Rob, do you have any comments?

因此，我確實認為，無論出於什麼原因，這都是一個好時機，而且在與該機構接觸時，我們將有時間解決近期的即時活動，並且在著手開展與其他我稱之為更具運營性的活動相關的關鍵樞紐項目之前，與該機構接觸將使我們受益匪淺。羅布，你有什麼意見嗎？

Yeah, just we haven't had a lot of interactions recently, but those interactions we've had with the review team really haven't been affected at this point.

是的，只是我們最近沒有進行太多互動，但我們與審查團隊的互動目前確實沒有受到影響。

That's helpful, thanks for taking our questions.

這很有幫助，感謝您回答我們的問題。

Thanks Phill.

謝謝菲爾。

John Miller, Evercore

約翰·米勒，Evercore

Hi guys. Congrats on progress. Thanks for taking my question. I'd love to follow up first on that FDA question. We've recently heard that the agency is considering requiring placebo-controlled trials for all new vaccines. Do you think that's going to be relevant to your programs, which obviously are mostly designed head-to-head versus existing vaccines, and what do you think those comments are specifically referring to?

嗨，大家好。恭喜取得進展。感謝您回答我的問題。我很樂意先跟進有關 FDA 的問題。我們最近聽說該機構正在考慮要求對所有新疫苗進行安慰劑對照試驗。您認為這與您的計劃有關嗎？您的計劃顯然主要是針對現有疫苗進行正面對抗設計的，您認為這些評論具體指的是什麼？

And then secondly, on the Lyme vaccine, which I am personally very interested in, how do you conceive of the relevance of the commercial benefits you're going to provide relative to the competitive vaccines given pivotal trials from the competitors are coming end of this year and obviously they're well ahead. What do you think that market looks like by the time you're approaching commercialization?

其次，關於萊姆疫苗，我個人非常感興趣，考慮到競爭對手的關鍵試驗將於今年年底進行，而且顯然他們遙遙領先，您如何看待您所提​​供的商業利益相對於競爭疫苗的相關性。您認為當您們的產品接近商業化時，市場會是什麼樣子？

Great, thanks, John.

太好了，謝謝，約翰。

I'll let me present framing comments on the FDA and trials and rob please feel free to jump in if there's more to add, but I think you have to go back to again our latest stage program is shingles, and if you recall some of our prior dialogue on shingles was the fact that we were proposing a placebo-controlled study which was viewed to be, a question mark. Will the agency accept it, which we did get positive feedback prior to the change in the administration around the opportunity to have a placebo-controlled efficacy study for shing for shingles.

我將就 FDA 和試驗提出一些框架性評論，如果還有更多要補充，請隨時加入，但我認為你必須再次回顧我們最新階段的帶狀皰疹項目，如果你還記得我們之前關於帶狀皰疹的一些對話，那就是我們提出了一項安慰劑對照研究，這被視為一個問號。該機構是否會接受它，在政府換屆之前，我們確實得到了積極的反饋，有機會對帶狀皰疹進行安慰劑對照療效研究。

So, I think ultimately. For that program there's really no change. It's supportive.

所以，我認為最終。對於該程式來說，確實沒有什麼變化。這是支持的。

We will also conduct a head to head study, but that's focused on tolerability and that's that's an endpoint that we're interested from a commercial labeling perspective, and we expect that to be supported as well as it relates to. Additional programs in the future it's too soon to tell. I think there was remarks shared on the intention of placebo-controlled trials, I do think there's other elements of development that we have to consider, especially ethical concerns. And so at this point we don't see it being a major challenge to any of our ongoing programs or future development, we might find ourselves in a situation where we're doing placebo controlled arms as well as head to head arms to support labeling and competition and just figuring out the right balancing act between those.

我們還將進行一項頭對頭研究，但重點是耐受性，這是我們從商業標籤角度感興趣的終點，我們希望它能夠得到支持以及與之相關的支持。目前還無法預測未來是否會有其他計劃。我認為有人就安慰劑對照試驗的意圖發表了評論，我確實認為我們必須考慮其他發展因素，特別是道德問題。因此，目前我們並不認為這會對我們正在進行的任何項目或未來發展構成重大挑戰，我們可能會發現自己處於這樣一種情況：我們正在進行安慰劑對照組以及頭對頭組以支持標籤和競爭，並找出它們之間的正確平衡行為。

Rob, anything to add to that?

羅布，還有什麼要補充的嗎？

Okay, and then the lines of these products, I'm glad you mentioned this honestly because while you know this is a very interesting evolution where the programs in late stage development are going to be demonstrating the ability for circulating antibodies to provide a protective response, you have to go through quite a challenging dosing regimen which could significantly limit uptake in the marketplace.

好的，然後是這些產品線，我很高興你誠實地提到了這一點，因為雖然你知道這是一個非常有趣的演變，後期開發的項目將展示循環抗體提供保護性反應的能力，但你必須經歷一個相當具有挑戰性的給藥方案，這可能會顯著限制市場吸收。

So, we believe there's a couple of elements of our program which is why we're so interested in advancing it. Not only do we believe we can establish the profile very early on in nonhuman primates to again provide a very valuable, very early stage step to demonstrate some level of proof of concept.

因此，我們相信我們的計劃有幾個要素，這就是我們如此感興趣推進它的原因。我們不僅相信我們可以在非人類靈長類動物的早期階段建立這一概況，而且可以再次提供非常有價值的、非常早期的步驟來證明某種程度的概念證明。

But additionally, we believe the product profile would support taking a leading market share position, but also actually grow the market because it creates an opportunity for a regimen that is much more approachable for the population.

但此外，我們相信該產品不僅能支持其佔據領先的市場份額，還能實際上擴大市場，因為它為一種更適合大眾的養生法創造了機會。

So, I think ultimately this is a perfect example of where having an adjuvant that is safe and well tolerated can be incredibly beneficial to augment a proven mechanism of action.

所以，我認為最終這是一個完美的例子，說明一種安全且耐受性良好的佐劑可以非常有益於增強已證實的作用機制。

Do you guys expect there to be the current to establish a reliable correlative protection, and would you expect then to be able to move forward with that sort of an endpoint in in your own program?

你們是否期望目前能夠建立一種可靠的相關保護，並且您是否期望能夠在自己的程序中推進這種端點？

No, we're not expecting that. We'll have to see how data plays out over time, but I do think even without a correlative protection, I do think it'll the ongoing data as well as our challenge work will provide an awareness of the level of antibodies needed to be effective or at least a threshold by which you would measure your early-stage studies with.

不，我們並沒有期待這一點。我們必須觀察數據隨時間的變化，但我確實認為，即使沒有相關的保護，持續的數據以及我們的挑戰工作將使人們認識到有效所需的抗體水平，或者至少是衡量早期研究的閾值。

Even though it might fall short of a regulatory approval, corral it. I do think it'll provide credible information on what that being able to measure whether or not we're having a meaningful impact with fewer doses.

即使它可能無法獲得監管部門的批准，也要控制住它。我確實認為它將提供可靠的信息，能夠衡量我們是否能以更少的劑量產生有意義的影響。

Makes sense, thank you for your question.

有道理，感謝您的提問。

Roy Buchanan, Citizens

羅伊·布坎南，公民

Thanks for taking the questions.

感謝您回答這些問題。

Just to make sure I'm clear on the shingles read out next quarter, you guys have previously said, 75% threshold median CD4-T cell level versus Shingrix's. If you do not see that in the one-month data next quarter, are you going to stop the program or what's the thinking there?

只是為了確保我清楚了解下個季度的帶狀皰疹數據，你們之前說過，與 Shingrix 相比，CD4-T 細胞水平中位數閾值為 75%。如果您在下個季度的單月數據中沒有看到這一點，您會停止該計劃嗎？或者您是怎麼想的？

Thanks for the question, Roy and Rob again please comment, but Roy, as we continue to evaluate the right way to think about the immunogenicity data to support the goal really here, which is identifying how we compare to shingles from an efficacy perspective, we've continued to work with leaders in the space and review the scientific.

感謝您的提問，請 Roy 和 Rob 再次發表評論，但是 Roy，隨著我們繼續評估思考免疫原性數據的正確方法以真正支持這裡的目標，即從功效角度確定我們與帶狀皰疹的比較，我們將繼續與該領域的領導者合作並審查科學。

Information available and now you've heard a promise T-cell frequency is very important. However, we believe the best measure of that is not at one month, but at six and 12 months where you have the opportunity to see the contraction of T cells back to a baseline level that's going to be maintained over time as opposed to the level of rapid expansion. And so our current plan.

現有資訊和現在您聽到的承諾表明 T 細胞頻率非常重要。然而，我們認為最好的衡量標準不是在一個月後，而是在六個月和十二個月後，您有機會看到 T 細胞收縮回到基線水平，並且該水平將隨著時間的推移而維持，而不是快速擴張的水平。這就是我們目前的計劃。

For this study is to focus on the vaccine response rate, including the CD4 vaccine response rate and frankly importantly, the CD4 vaccine response rate with ultimate T cell frequencies at one month being informative but not as critical as six months and 12 months. Rob, do you have any other comments around that because of the expansion and contraction and why this is--

本研究的重點是疫苗反應率，包括 CD4 疫苗反應率，坦白說，重要的是，一個月時的最終 T 細胞頻率的 CD4 疫苗應答率具有參考價值，但不如六個月和十二個月那麼重要。羅布，你對此還有其他評論嗎？這是因為擴張和收縮，以及為什麼會這樣——

So, Roy, CD4s expand very quickly after vaccination, but they also drop very quickly, especially over the first 12 months. And then the curve begins to flatten out over that period of time. An example is the shingles studies where CD4 counts dropped more than 50% over the 1st year, and at that time the efficacy was 97%. Over a three-year period, they dropped 2/3. [FFC] only dropped 5%.

因此，Roy，CD4 在接種疫苗後會迅速擴增，但也會迅速下降，尤其是在前 12 個月。然後曲線在那段時間開始趨於平緩。一個例子是帶狀皰疹研究，其中 CD4 計數在第一年下降了 50％ 以上，而當時的有效率為 97％。三年內，它們下跌了 2/3。 [FFC] 僅下跌了 5%。

So yeah, we're using CD4 frequency, but it's not a clear direct measure of what's happening with incidents, and it does drop fast, as I said, at 12 months it begins to stabilize and doesn't drop as fast. So, we think a 12-month measurement of CD4 frequency is probably more informative than the one month.

是的，我們使用 CD4 頻率，但它並不能直接衡量事件發生的情況，而且它確實下降得很快，正如我所說，在 12 個月時它開始穩定並且不會下降得那麼快。因此，我們認為 12 個月的 CD4 頻率測量可能比一個月的測量更有參考價值。

Okay, great. That's very helpful. Thanks. And then a couple on HEPLISAV, investors have said that the total market shares paused, maybe it's paused, maybe it's growing less quickly, but either way, is there an explanation for the potentially slower growth? It's definitely slower than the growth you've seen in previous quarters. The GSK pushing back anything there, and how much of the revenue is due to Medicare? Thanks.

好的，太好了。這非常有幫助。謝謝。然後，關於 HEPLISAV 的一些消息，投資者表示，總市場份額暫停了，也許是暫停了，也許是增長速度放緩，但無論如何，是否有可能解釋增長放緩的原因？它的成長速度肯定比前幾季慢。GSK 在那裡推遲了什麼，其中有多少收入來自醫療保險？謝謝。

Hey Roy, it's Donn. Regarding market share, obviously, when we think about market share, year over year comparisons is most appropriate given the seasonality of the hefty market versus, say a quarter over quarter assessment of market share. We continue to expect year over year growth every quarter in 2025 we're on track exactly how we had planned for market share growth.

嘿，羅伊，我是唐恩。關於市場份額，顯然，當我們考慮市場份額時，考慮到龐大市場的季節性，同比比較是最合適的，而不是按季度對市場份額進行評估。我們繼續預計 2025 年每季都會實現年比成​​長，我們的市佔率成長計畫正按計畫順利進行。

The supports not only 2025. A long-term view of achieving at least 60% market share and part of that is to be on the back of retail pharmacy. That could be the fastest growing segment where we have very high market share and continue to increase that market share. So, we feel very comfortable and very proud where we're at with market share and continue to expect that market share gain year every year.

支持的不僅是2025年。長期目標是實現至少 60% 的市場份額，其中一部分將依靠零售藥局。這可能是成長最快的領域，我們擁有很高的市場份額，並將繼續增加這一市場份額。因此，我們對目前的市場份額感到非常滿意和自豪，並繼續期望市場份額逐年增長。

Maybe let's add to, I mean, that's exactly the right answer that the year over year comparison, but Roy, just to give you some context why the quarterly, we don't do the quarterly comparison.

也許我們可以補充一點，我的意思是，這正是同比比較的正確答案，但是羅伊，只是為了給你一些背景信息，為什麼我們不做季度比較。

When we have different channels and different customers where we have different levels of share, and when we see the channel make change quarter over quarter, for example, retail dropping Q1 compared to Q4, where we have very high share, it impacts the overall share for that quarter when lower share parts of the market are more static.

當我們擁有不同的通路和不同的客戶時，我們的份額水平也不同，我們看到通路每個季度都會發生變化，例如，與第四季度相比，第一季的零售額有所下降，而我們的份額在第四季度很高，當市場份額較低的部分比較穩定時，這會影響該季度的整體份額。

And so, we've said this for the last, I don't know how many years, the quarterly fluctuations due to channel mix changes or one-off procurement dynamics in the beginning or end of a quarter are not appropriate comparisons, and we're going to continue to stand by that. But we are excited when we look at the annual growth each quarter.

所以，我們在過去不知道多少年裡一直強調，由於通路組合變化或季度初或末的一次性採購動態而導致的季度波動是不合適的比較，我們將繼續堅持這一點。但當我們看到每個季度的年度成長時，我們感到很興奮。

So, I'm happy to continue to show those kinds of details as we progress and sort of these things that aren't necessarily intuitive, but we do want to continue to draw the comparison to the prior quarter for the same period in the prior year.

因此，我很高興在我們取得進展的同時繼續展示這些細節，並對這些不一定直觀的事情進行分類，但我們確實希望繼續與去年同期的上一季進行比較。

And then regarding Medicare, it is an important part of the market. Retailers are very excited about having access now to [EPA] [Ave] as well as all HEPLISAV-B vaccines. It will take some time as it relates to Medicare access to Medicare Advantage plans. We anticipate probably the second half of the year.

關於醫療保險，它是市場的重要組成部分。零售商對現在可以獲得 [EPA] [Ave] 以及所有 HEPLISAV-B 疫苗感到非常興奮。這將需要一些時間，因為它涉及醫療保險訪問醫療保險優勢計劃。我們預計可能是在今年下半年。

There'll be open access for all [Hep B] vaccines, including HEPLISAV-B, and so we're continuing to work with our retailers around prioritizing patients, appropriate patients within the Medicare segment. But it will be an important part of our growth strategy. And the good news, obviously retail is a big part of that where we have a very strong footprint and engagement strategy.

所有 [B肝] 疫苗（包括 HEPLISAV-B）都將開放使用，因此我們將繼續與零售商合作，優先考慮醫療保險領域內合適的患者。但它將成為我們成長策略的重要組成部分。好消息是，零售顯然是其中的重要組成部分，我們擁有非常強大的足跡和參與策略。

Got it. Thank you.

知道了。謝謝。

Thank you for your question.

感謝您的提問。

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。現在，我想將電話轉給執行長瑞安·斯賓塞 (Ryan Spencer) 做最後發言。你可以開始了。

Thank you, operator, and thank you all for joining us today. We appreciate your interest in Dynavax. We're excited about our recent accomplishments and the strength of our position. We look forward to updating you on the progress and focused on protecting the world against infectious diseases. Operator, you may end the call.

謝謝接線員，也謝謝大家今天加入我們。感謝您對 Dynavax 的關注。我們對我們最近的成就和我們的地位優勢感到非常興奮。我們期待向您通報進展情況，並致力於保護世界免受傳染病的侵害。接線員，您可以結束通話了。

Ladies and gentlemen, thank you for joining us today. This does conclude today's conference. You may now disconnect.

女士們、先生們，感謝你們今天的出席。今天的會議到此結束。您現在可以斷開連線。

Goodbye.

再見。