Dynavax Technologies Corp (DVAX) 2024 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Dynavax Technologies' second quarter 2024 financial results conference call.

女士們、先生們，美好的一天，歡迎參加 Dynavax Technologies 2024 年第二季財務業績電話會議。

As a reminder, this call is being recorded.

提醒一下，此通話正在錄音。

At the end of the company's prepared remarks, we will open the call for questions and provide specific participation instructions at that time.

在公司準備好的發言結束時，我們將開放提問並屆時提供具體的參與說明。

I would now like to turn the call over to Paul Cox, Vice President, Investor Relations and Corporate Communications.

我現在想將電話轉給投資者關係和企業傳播副總裁 Paul Cox。

You may begin.

你可以開始了。

Thank you for participating in today's call.

感謝您參加今天的電話會議。

Joining me 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.

與我一起來自 Dynavax 的還有首席執行官 Ryan Spencer；唐恩‧卡塞爾 (Donn Casale)，首席商務官；羅布‧詹森，首席醫療官；以及我們的財務長凱莉麥克唐納 (Kelly MacDonald)。

Earlier today, Dynavax released financial results for the second quarter ended June 30, 2024.

今天早些時候，Dynavax 發布了截至 2024 年 6 月 30 日的第二季財務業績。

Copies of the press release and the supplementary slide presentation are available on Dynavax's website.

新聞稿和補充幻燈片簡報的副本可在 Dynavax 網站上取得。

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, effective marketing efforts, future expected market share, and related growth rates and related ACIP recommendation impact on each financial guidance and 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 our CpG-1018 adjuvant.

在我們開始之前，我建議您，我們今天將根據我們當前的預期和信念做出前瞻性陳述，包括但不限於潛在市場規模、市場細分、有效的營銷努力、未來預期市場份額以及相關內容。成長率和相關ACIP 建議對每個財務指導和趨勢的影響，包括收入、盈利能力、現金流和當前資本充足性、 FDA 提交的時間和結果、臨床試驗開始和數據讀出以及我們的未來潛在用途或需求CpG-1018 佐劑。

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

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。

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.

這些風險在今天的新聞稿中進行了總結，並在我們向 SEC 提交的文件（包括今天的 10-Q 表格季度報告）的風險因素部分中進行了詳細介紹。

Our forward-looking statements speak as of today and we undertake no obligation to update such statements.

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。

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

現在，我將把電話轉給瑞安。

Thanks, Paul.

謝謝，保羅。

Good afternoon, everyone, and thank you for taking the time to join us to review our second quarter 2024 results.

大家下午好，感謝您抽空與我們一起回顧 2024 年第二季的業績。

We've achieved another record quarter for HEPLISAV-B net product sales as we strengthened our leadership position in the U.S. adult hepatitis B vaccine market, marking continued year-over-year market share gains for the total market and in key market segments.

隨著我們鞏固了在美國成人乙型肝炎疫苗市場的領導地位，我們的 HEPLISAV-B 淨產品銷售額再創歷史新高，標誌著整個市場和關鍵細分市場的市場份額持續同比增長。

Based on our strong results in Q2 and the continued strengthening of the hepatitis B vaccine market across Q2 and into early Q3, we are reaffirming our HEPLISAV-B product revenue guidance for the full year 2024.

基於我們在第二季的強勁業績以及第二季初乙型肝炎疫苗市場的持續走強，我們重申了 2024 年全年 HEPLISAV-B 產品收入指引。

Longer-term, we are highly optimistic about the adult hepatitis B vaccine market of over 130 million eligible patients, which is one of the largest addressable patient populations for vaccines in the U.S.

從長遠來看，我們對擁有超過 1.3 億合格患者的成人乙型肝炎疫苗市場高度樂觀，該市場是美國最大的疫苗適用患者群體之一。

We expect the market opportunity for HEPLISAV-B to grow to over $800 million by 2027, with continued growth in both market share and market size through the end of the decade.

我們預計，到 2027 年，HEPLISAV-B 的市場機會將成長到超過 8 億美元，到本十年末，市場份額和市場規模將持續成長。

We also anticipate long-term demand for HEPLISAV-B beyond 2030 as a result of the continued penetration of the unvaccinated cohort as well as expanding market share, providing a substantial long-term revenue opportunity for HEPLISAV-B.

我們也預計，由於未接種疫苗人群的持續滲透以及市場份額的擴大，2030 年以後對 HEPLISAV-B 的長期需求將為 HEPLISAV-B 提供大量的長期收入機會。

For our pipeline development, we are pleased to have recently initiated our Phase I, II trial for our novel shingles vaccine program and remain excited for several upcoming milestones, including readouts from the single study as well as our Tdap and plague vaccine programs expected across 2024 and 2025.

對於我們的管道開發，我們很高興最近啟動了新型帶狀皰疹疫苗計劃的I、II 期試驗，並對即將到來的幾個里程碑感到興奮，包括單項研究的結果以及預計在2024 年推出的Tdap 和鼠疫疫苗計畫和 2025 年。

In addition to this progress and bolstered by our strong financial position, we continue to evaluate strategic opportunities to grow beyond our internal organic pipeline within the infectious disease space, which we believe would enable us to further diversify our product portfolio and create future commercial opportunities.

除了這一進展以及我們強大的財務狀況的支撐外，我們還將繼續評估在傳染病領域超越我們內部有機管道的戰略機會，我們相信這將使我們能夠進一步實現產品組合多元化並創造未來的商業機會。

We look forward to providing updates on these efforts in the future.

我們期待將來提供有關這些努力的最新資訊。

I'll now turn the call over to Donn and Rob, who will provide more details on the HEPLISAV-B results and our pipeline progress, respectively, before Kelly reviews our financial results for the second quarter.

現在我將把電話轉給 Donn 和 Rob，他們將在 Kelly 審查我們第二季度的財務業績之前分別提供有關 HEPLISAV-B 結果和我們的管道進展的更多詳細信息。

Donn?

唐恩？

Thank you, Ryan.

謝謝你，瑞安。

We are thrilled with the performance in record breaking sales for HEPLISAV-B in the second quarter.

我們對 HEPLISAV-B 第二季破紀錄的銷售表現感到非常興奮。

HEPLISAV-B achieved over $70 million in net product revenue in the quarter, supported by hepatitis B vaccine market growth and increases in HEPLISAV-B market share.

在乙型肝炎疫苗市場成長和 HEPLISAV-B 市場份額增加的支持下，HEPLISAV-B 本季實現了超過 7,000 萬美元的產品淨收入。

During our last earnings call, we said that the hepatitis B vaccine market began to strengthen in early Q2 as the focus of healthcare providers and retail pharmacy shifted back to prioritizing non-respiratory vaccines.

在我們上次的財報電話會議上，我們表示，隨著醫療保健提供者和零售藥房的重點重新轉向優先考慮非呼吸道疫苗，乙型肝炎疫苗市場在第二季初開始走強。

That dynamic continue to play out throughout the quarter as customers reprioritize adoption of the ACIP universal recommendation to help protect their patients from hepatitis B.

隨著客戶重新優先考慮採用 ACIP 通用建議，以幫助保護患者免受乙型肝炎感染，這種動態在整個季度繼續發揮作用。

HEPLISAV-B continued to increase its total U.S. market share year-over-year, achieving an estimated 42% market share in the second quarter compared to 39% during the same period last year.

HEPLISAV-B 的美國總市佔率持續年增，第二季的市佔率預計為 42%，而去年同期為 39%。

HEPLISAV-B's strong performance continues to be driven by two critical segments: retail pharmacy and integrated delivery networks or IDM.

HEPLISAV-B 的強勁業績繼續受到兩個關鍵領域的推動：零售藥房和綜合配送網路或 IDM。

In retail, HEPLISAV-B's second quarter estimated market share increased to approximately 59% compared to approximately 45% during the same period last year.

在零售領域，HEPLISAV-B第二季度的預期市佔率增至約59%，去年同期約為45%。

For IDN, HEPLISAV-B's estimated market share increased to approximately 56% compared to approximately 53% for Q2 last year.

對於 IDN，HEPLISAV-B 的估計市佔率從去年第二季的約 53% 增加到約 56%。

During the quarter, several top national retail chains and many large IDN systems, established hepatitis B-focused initiatives and campaigns to increase hepatitis B vaccination.

本季度，幾家頂級全國零售連鎖店和許多大型 IDN 系統制定了以乙型肝炎為重點的措施和活動，以增加乙型肝炎疫苗接種。

We are encouraged by the focus and commitment of these customers and expect this momentum to continue into Q3 as healthcare providers continue to mobilize around the opportunity of hepatitis B vaccination.

我們對這些客戶的關注和承諾感到鼓舞，並預計隨著醫療保健提供者繼續圍繞乙型肝炎疫苗接種機會動員起來，這種勢頭將持續到第三季。

We remain confident in the long-term expansion of the U.S. hepatitis B vaccine market.

我們對美國乙型肝炎疫苗市場的長期擴張仍然充滿信心。

In early 2022, when the ACIP universal recommendation went into effect, we provided five-year guidance, and we expect the HEPLISAV-B market opportunity to be over $800 million by 2027, with HEPLISAV-B positioned to achieve a majority market share.

2022 年初，當 ACIP 普遍建議生效時，我們提供了五年指導，我們預計到 2027 年 HEPLISAV-B 的市場機會將超過 8 億美元，其中 HEPLISAV-B 預計將獲得多數市場份額。

We remain confident in that five-year guidance and expect continued hepatitis B market expansion and HEPLISAV-B market share gains through the end of the decade.

我們對該五年指導仍充滿信心，並預計乙型肝炎市場將持續擴張，HEPLISAV-B 市場份額將在本十年末持續成長。

Beyond 2030, we expect the market to be substantial due to the continued penetration of the remaining large unvaccinated adult cohort.

到 2030 年後，由於剩餘大量未接種疫苗的成年人群體的持續滲透，我們預計市場將會很大。

We look forward to providing more specific longer-term guidance by the end of this year.

我們期待在今年年底前提供更具體的長期指導。

In summary, we are reaffirming our confidence in the outlook for HEPLISAV-B both for 2024 and long-term.

總之，我們重申對 HEPLISAV-B 2024 年和長期前景的信心。

We expect HEPLISAV-B to strengthen this position as a clear market share leader in the expanding hepatitis B vaccine market.

我們預計 HEPLISAV-B 將鞏固其在不斷擴大的乙型肝炎疫苗市場中作為明顯市場份額領導者的地位。

We are very proud of our commercial team's success and are excited to help build on the momentum seen in Q2 for the remainder of 2024.

我們對商業團隊的成功感到非常自豪，並很高興能夠在 2024 年剩餘時間內幫助鞏固第二季度的勢頭。

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

我現在將把電話轉給 Rob，帶您了解我們的臨床流程。

Thank you, Donn.

謝謝你，唐恩。

I'm excited by the progress we're making with our innovative vaccine pipeline, starting with our shingles vaccine program, Z1018.

我對我們的創新疫苗系列所取得的進展感到興奮，首先是我們的帶狀皰疹疫苗計畫 Z1018。

As a reminder, we believe there's an opportunity to develop an improved shingles vaccine given the challenging tolerability profile of the current market-leading product.

提醒一下，鑑於當前市場領先產品的耐受性具有挑戰性，我們相信有機會開發改良的帶狀皰疹疫苗。

In the second quarter, we initiated a randomized active controlled dose escalation multicenter Phase I, II trial to evaluate the safety, tolerability and immunogenicity of Z1018 compared to an active control in approximately 440 healthy adults aged 50 to 69 years.

第二季度，我們在約440 名50 至69 歲健康成年人中啟動了一項隨機主動對照劑量遞增多中心I、II 期試驗，以評估Z1018 與主動對照相比的安全性、耐受性和免疫原性。

Key objectives of the trial include selecting the optimal glycoprotein E dose level and dosing schedule as well as adjuvant formulation for further clinical development.

本試驗的主要目標包括選擇最佳糖蛋白E劑量水平和給藥方案以及用於進一步臨床開發的佐劑配方。

The Phase I, II trial will be used to support validation of a patient-reported outcome measurement tool to differentiate Z1018 on tolerability and to support potential label claims.

I、II 期試驗將用於支持驗證患者報告的結果測量工具，以區分 Z1018 的耐受性並支持潛在的標籤聲明。

We anticipate reporting top line immunogenicity and safety data in the second half of 2025, including a comparison of CD4-positive T cells one month after the second of two vaccine doses.

我們預計在 2025 年下半年報告最重要的免疫原性和安全性數據，包括在兩劑疫苗中的第二劑接種後一個月內 CD4 陽性 T 細胞的比較。

Turning next to Tdap-1018 program.

接下來轉向 Tdap-1018 計劃。

This is an investigational vaccine candidate intended for active booster immunization against tetanus, diphtheria and pertussis or Tdap.

這是一種研究性候選疫苗，旨在針對破傷風、白喉和百日咳或 Tdap 進行主動加強免疫。

Current Tdap vaccines have limitations, including waning effectiveness, and we believe there's an opportunity to improve the duration of protection using our CPG-1018 adjuvant to generate a Th1-bias immune response.

目前的 Tdap 疫苗有其局限性，包括有效性減弱，我們相信有機會使用我們的 CPG-1018 佐劑產生 Th1 偏向免疫反應來延長保護持續時間。

We're evaluating the persistence of Tdap-1018-induced pertussis immunogenicity through a long-term follow-up study of participants who completed a Phase I trial of a booster dose of Tdap-1018 compared to an active control.

我們正在透過對完成 Tdap-1018 加強劑量與活性對照的 I 期試驗的參與者進行長期追蹤研究，評估 Tdap-1018 誘導的百日咳免疫原性的持久性。

The extension study will capture data for participants up to three years following initial vaccination.

擴展研究將收集參與者初次接種疫苗後三年內的數據。

Results from the Phase I extension study are expected in the fourth quarter of 2024.

第一階段擴展研究的結果預計將於 2024 年第四季公佈。

These data will provide us with a view of how the Tdap -1018 immune response over time compares to the active control and will help establish our views on the potential benefits that can be achieved with this vaccine candidate.

這些數據將使我們了解 Tdap -1018 免疫反應隨時間的變化與主動對照組相比如何，並將有助於建立我們對這種候選疫苗可以實現的潛在益處的看法。

For our plague vaccine program, which is in collaboration with and funded by the U.S. Department of Defense, we anticipate providing a program update based on results from both our Phase II clinical trial and the nonhuman primate challenge study in the fourth quarter of 2024.

對於我們與美國國防部合作並由其資助的鼠疫疫苗計劃，我們預計將在 2024 年第四季度根據 II 期臨床試驗和非人靈長類動物挑戰研究的結果提供計劃更新。

We're also focused on addressing FDA comments regarding our sBLA for HEPLISAV-B hemodialysis dosing regimen.

我們也致力於解決 FDA 關於 HEPLISAV-B 血液透析給藥方案 sBLA 的評論。

We intend to meet with the FDA in the second half of 2024 as part of the standard regulatory process to discuss pathways to amend our sBLA with additional data to support potential approval of the FORTIS regimen.

我們計劃在 2024 年下半年與 FDA 會面，作為標準監管流程的一部分，討論修改我們的 sBLA 的途徑，並提供更多數據來支持 FORTIS 方案的潛在批准。

We're pleased with this progress across our pipeline, and we look forward to executing on these upcoming milestones in the coming months.

我們對整個管道的進展感到滿意，並期待在未來幾個月內執行這些即將到來的里程碑。

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

我現在將把電話轉給凱利，以審查我們的財務表現。

Thank you, Rob.

謝謝你，羅布。

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

在開始之前，請注意，請參閱我們的新聞稿和今天早些時候提交的 10-Q 表格，以了解更詳細的財務資訊。

I'll walk through the financial highlights for another strong quarter, underscored by record HEPLISAV-B net sales of $70 million, a 24% year-over-year increase, and a 47% sequential increase compared to last quarter, putting us on track to achieve our guidance for the full year 2024.

我將介紹另一個強勁季度的財務亮點，其中最突出的是 HEPLISAV-B 淨銷售額創紀錄地達到 7000 萬美元，同比增長 24%，與上季度相比環比增長 47%，使我們步入正軌以實現我們對2024 年全年的指導。

We believe this progress is a testament to the effectiveness of our overall brand plan and highlights the strength of our sales deal team, combined with successful marketing campaigns across multiple channels, including retail.

我們相信這項進展證明了我們整體品牌計畫的有效性，並凸顯了我們銷售交易團隊的實力，以及跨多個管道（包括零售）的成功行銷活動。

HEPLISAV-B fee gross margin improved to 83% in Q2 2024 from 76% in the prior year quarter.

HEPLISAV-B 費用毛利率從去年同期的 76% 提高到 2024 年第二季的 83%。

This margin expansion is consistent with our guidance of approximately 80% for the full year 2024 and the result of highly efficacious capital investments in our manufacturing process combined with improved scale over time.

這項利潤率擴張符合我們對 2024 年全年約 80% 的指導，也是我們對製造流程進行高效資本投資以及隨著時間的推移規模不斷擴大的結果。

Other revenue was about $4 million for the second quarter, representing revenue related to the plague vaccine program in collaboration with and funded by the U.S. Department of Defense.

第二季的其他收入約為 400 萬美元，代表與美國國防部合作並由其資助的鼠疫疫苗計畫相關的收入。

Turning to our expenses, eesearch and development expenses were $15 million for Q2 2024 compared to $13 million for the prior year period, with the increase reflecting important progress throughout our discovery, preclinical, and clinical pipeline.

談到我們的費用，2024 年第二季的電子研究和開發費用為 1500 萬美元，而去年同期為 1300 萬美元，這一增長反映了我們在整個發現、臨床前和臨床管道方面的重要進展。

Selling, general, and administrative expenses for the second quarter of 2024 were $42 million compared to approximately $37 million for the prior year period.

2024 年第二季的銷售、一般和管理費用為 4,200 萬美元，而去年同期約為 3,700 萬美元。

The increase was primarily driven by sales by our sales force expansion in the second half of 2023 and other high ROI investments driving the growth of our HEPLISAV-B franchise.

這一成長主要是由於我們在 2023 年下半年銷售團隊的擴張以及其他高投資回報率投資推動了 HEPLISAV-B 特許經營權的成長。

Sublease income was $2 million in the second quarter of 2024 and as a reminder from last quarter's call, we expect to record approximately $5 million of net sublease income for the full year 2024.

2024 年第二季的轉租收入為 200 萬美元，作為上季電話會議的提醒，我們預計 2024 年全年將錄得約 500 萬美元的淨轉租收入。

These results generated net income of $11 million in the second quarter of 2024 compared to $3 million during the prior year period.

這些結果在 2024 年第二季產生了 1,100 萬美元的淨利潤，而去年同期為 300 萬美元。

Moving to the balance sheet.

轉向資產負債表。

We exited the second quarter of 2024 with cash, cash equivalents and marketable securities of approximately $736 million, which was a $12 million increase during Q2.

2024 年第二季結束時，我們持有約 7.36 億美元的現金、現金等價物和有價證券，比第二季增加了 1,200 萬美元。

We remain on track to achieve our cash guidance for the year and continue to believe that we have sufficient capital to prosecute our organic pipeline without the need to access the capital markets.

我們仍有望實現今年的現金指導，並繼續相信我們有足夠的資本來推進我們的有機管道，而無需進入資本市場。

Based on our strong execution year-to-date, we are also reiterating all of our full year 2024 financial guidance.

基於我們今年迄今的強勁執行力，我們也重申了 2024 年全年財務指引。

For our full guidance framework, please consult our press release earlier today.

有關我們的完整指導框架，請查閱我們今天早些時候的新聞稿。

In closing, we are excited to report another strong quarter, consisting of record quarterly revenue for HEPLISAV-B, improved product gross margins and advancing pipeline and a very robust balance sheet.

最後，我們很高興地報告另一個強勁的季度，包括 HEPLISAV-B 創紀錄的季度收入、產品毛利率的提高、管道的推進以及非常穩健的資產負債表。

I'd now like to turn the call back over to Ryan for closing comments.

我現在想將電話轉回瑞安以徵求結束意見。

Thanks Kelly.

謝謝凱莉。

I want to take a few moments to provide additional context and reflect on the progress we are making beyond the results from this quarter.

我想花一些時間提供更多背景信息，並反思我們在本季度結果之外所取得的進展。

I'm personally very proud of what this company has accomplished over the last few years and how that sets us up to drive the next leg of growth.

我個人對這家公司在過去幾年中所取得的成就以及這如何幫助我們推動下一階段的成長感到非常自豪。

We've demonstrated exceptional execution commercializing HEPLISAV-B and delivered a profitable brand with a long-term growth profile, which provides a strong foundation for us to continue to build on.

我們在 HEPLISAV-B 商業化方面展現了卓越的執行力，並打造了一個具有長期成長前景的獲利品牌，這為我們繼續發展奠定了堅實的基礎。

I'm proud of our team's success in a market that has long been dominated by big pharma.

我為我們的團隊在長期由大型製藥公司主導的市場中取得的成功感到自豪。

Beyond HEPLISAV-B, we have managed to stay both disciplined and agile, allowing us to respond to opportunities and manage our risks, while advancing new products into the clinic.

除了 HEPLISAV-B 之外，我們還設法保持紀律性和敏捷性，使我們能夠應對機會並管理風險，同時將新產品推向臨床。

We've been actively evaluating strategic opportunities for growth, but remain committed to applying disciplined business judgment, avoiding an implementation to take action for the sake of the perception of progress.

我們一直在積極評估策略成長機會，但仍致力於運用嚴格的商業判斷，避免為了取得進展而採取行動。

Beyond our financial position, we have built a high-performing team focused on strategic leadership and professionalism.

除了我們的財務狀況之外，我們還建立了一支專注於策略領導和專業的高績效團隊。

We believe this provides us the tools we need to grow our business and maximize our impact to benefit all of our stakeholders, including patients, investors, and employees as we aim to position Dynavax as a leading infectious disease company.

我們相信，這為我們提供了發展業務所需的工具，並最大限度地發揮我們的影響力，使我們的所有利益相關者（包括患者、投資者和員工）受益，因為我們的目標是將Dynavax定位為領先的傳染病公司。

Thank you, everyone.

謝謝大家。

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

接線員，我們現在要開始今天電話會議的問答部分。

(Operator Instructions)

（操作員說明）

Matthew Phipps at William Blair.

威廉布萊爾的馬修菲普斯。

Thanks for taking my questions and giving us the update here across the upside of the programs.

感謝您回答我的問題並向我們提供有關該計劃優點的最新資訊。

I was wondering maybe if you could give us a little bit of your expectations around market share, maybe by the end of this year or when you think you will break that kind of 50% mark in market share?

我想知道您是否可以向我們透露您對市場份額的預期，也許到今年年底，或者您認為您的市場份額何時會突破 50% 的大關？

And then as we think about some of the seasonality throughout the rest of the year, Kelly, maybe you can help us on should we assume a similar percentage of total year sales in Q3 and Q4 this year as we saw last year?

然後，當我們考慮今年剩餘時間的一些季節性因素時，凱利，也許您可以幫助我們，我們是否應該假設今年第三季和第四季的年度銷售額百分比與去年相似？

And Kelly welcome back.

凱莉歡迎回來。

Thanks, Matt.

謝謝，馬特。

I'll take the first one on market share.

我會選擇市佔率第一。

Obviously, we don't provide guidance at that level of detail.

顯然，我們不提供如此詳細的指導。

So, I'll just have to refer back to some of our general comments related to 2027 on the long-term guide that we expect to have a majority share at that period in time, but we haven't provided any guidance on market share that's more refined than that.

因此，我只需回顧一下我們對 2027 年有關長期指南的一些一般性評論，我們預計將在該時期佔據多數份額，但我們尚未提供任何有關市場份額的指南那比那更精緻。

And as it relates to seasonality, Kelly, do you want to take that?

由於它與季節性有關，凱利，你想接受嗎？

Sure.

當然。

Thanks for the warm welcome back, Matt.

感謝馬特回來的熱情歡迎。

So, as a reminder, we did reiterate our guidance, our net sales guidance for the year between $265 million to $280 million.

因此，提醒一下，我們確實重申了我們的指導意見，即我們今年的淨銷售額指導意見在 2.65 億美元至 2.8 億美元之間。

With respect to the seasonality that we've previously guided to and have sort of started to see throughout this year, we are still anticipating that Q4 contraction at the higher end of historical ranges.

就我們之前指導並在今年開始看到的季節性而言，我們仍然預計第四季度的收縮將處於歷史範圍的高端。

So, in that 15%, I think last year, we said we made 15% to 20%.

所以，在這 15% 中，我想去年我們說我們賺了 15% 到 20%。

We are expecting that to come into the about 15% range this year, again, that's sort of how we expect Q4 relative to Q3.

我們預計今年這一數字將達到 15% 左右，這也是我們對第四季相對於第三季的預期。

So hopefully, that's helpful.

希望這會有所幫助。

We do still, of course, expect Q3 to be a very strong quarter as well.

當然，我們仍然預計第三季也將是一個非常強勁的季度。

Okay, great.

好的，太好了。

Thanks for taking the questions.

感謝您提出問題。

Thanks, Matt.

謝謝，馬特。

Phil Nadeau from TD Cowen.

TD Cowen 的 Phil Nadeau。

Thanks for taking our questions.

感謝您回答我們的問題。

One commercial, one pipeline.

一個商業，一個管道。

On commercial, you reiterated your guidance for $800 million market in a few years.

在商業方面，您重申了對幾年內 8 億美元市場的指導。

Can you talk about the data points that are accumulating that continue to give you confidence in that market growth?

您能否談談不斷累積的數據點，這些數據點繼續讓您對市場成長充滿信心？

I think for most of us, it's a little hard given the noise around contraction in the market, some quarters and growth others.

我認為對於我們大多數人來說，考慮到市場、某些季度收縮和其他季度成長的噪音，這有點困難。

So, what gives you confidence that all is on track to hit that ultimate market size?

那麼，是什麼讓您相信一切都在朝著最終的市場規模邁進呢？

Yes, I'll make a couple of high-level points.

是的，我會提出一些高層次的觀點。

And Donn, if you have any other details to add, please do this.

Donn，如果您有任何其他詳細資訊需要添加，請這樣做。

Donn may reminded us that back in 2022, we projected out the market to be $800 million by 2027 based on our modeling of increasing coverage rates as a result of the ACIP universal recommendation.

Donn 可能提醒我們，早在 2022 年，我們就根據 ACIP 普遍建議提高覆蓋率的模型預測到 2027 年市場規模將達到 8 億美元。

And we continue to reiterate that because we're tracking towards those projections as we've progressed over the last few years.

我們繼續重申這一點，因為隨著過去幾年的進展，我們正在追蹤這些預測。

Donn, I don't know if you want to elaborate all on

Donn，我不知道你是否想詳細說明一下

I mean the only additional color would be those rates that we kind of put into our forecast are kind of in line with other vaccines and so other vaccine analogs.

我的意思是，唯一的額外顏色是我們在預測中所輸入的比率與其他疫苗和其他疫苗類似物一致。

So, as Ryan mentioned, we see that occurring, and that gives us the confidence to kind of reiterate that guidance long-term.

因此，正如瑞安所提到的，我們看到這種情況正在發生，這讓我們有信心重申這一長期指引。

But again, just looking at the market, looking at what happens with other vaccines, and we believe hepatitis B vaccination will follow that similar path.

但同樣，只要看看市場，看看其他疫苗的情況，我們相信B型肝炎疫苗接種也會遵循類似的路徑。

So, Phil, I think the data points you can look at are, one, the historical size of the Hep-B market and how it's grown since 2022 recommendation, along with analog being products that have recommendation changes and you'll see in those products point Tdap, for example, or flu that you'll have multiple years of progress made towards increasing vaccination coverage rates.

所以，Phil，我認為您可以查看的數據點是，第一，Hep-B 市場的歷史規模以及自 2022 年推薦以來的增長情況，以及推薦發生變化的模擬產品，您將在這些中看到例如，產品指出Tdap 或流感，您將在提高疫苗接種覆蓋率方面取得多年進展。

Got it.

知道了。

Okay.

好的。

Maybe actually one follow-up on commercial.

也許實際上是商業廣告的後續行動。

There's a lot of controversy in the COVID vaccine and RSV vaccine space because of recent trends there.

由於最近的趨勢，新冠疫苗和呼吸道合胞病毒疫苗領域存在著許多爭議。

COVID has been a little disappointing,.

新冠疫情有點令人失望。

RSV obviously had the recent recommendation or not recommendation for any more vaccination.

RSV 顯然最近建議或不建議進行更多疫苗接種。

So, there seems to be some concern that those vaccines won't be as heavily utilized next season as they had in this past.

因此，似乎有人擔心這些疫苗下個賽季不會像過去那樣大量使用。

How does that figure into your expectations for seasonality for HEPLISAV?

這如何影響您對 HEPLISAV 季節性的預期？

Is it too early to tell?

現在說還太早嗎？

Or is there some reason to think maybe 2024 to 2025, that respiratory virus season won't be as impacted on HBV vaccines as the past?

或者有理由認為，也許 2024 年至 2025 年，呼吸道病毒季節不會像過去那樣對B型肝炎疫苗產生影響？

Yes.

是的。

So, a couple of comments on the landscape.

所以，對景觀有一些評論。

One, COVID remains still a very large product.

第一，新冠病毒仍然是一個非常大的產品。

So, you're right, I think you could have some there's a comparison of expectation versus utilization, but it's still relatively highly utilized annually.

所以，你是對的，我認為你可以對期望與利用率進行一些比較，但每年的利用率仍然相對較高。

And RSV is going to be lower given the lack of recommendation for annual boost, those are both tailwinds for HEPLISAV.

由於缺乏年度提振建議，RSV 將會降低，這些都是 HEPLISAV 的有利因素。

Donn, do you want to maybe just provide a little bit of color on, in particular, the retail pharmacy trends that we have seen or could see as we progress as it relates to plus one options.

唐恩，您是否想提供一些信息，特別是我們在與加一選項相關的進展過程中已經看到或可能看到的零售藥房趨勢。

You're right.

你說得對。

I think it goes down to that, Phil, and the fact that it provides more vaccination opportunity, quite frankly, for patients as they originate in pharmacy this fall season into winter season.

菲爾，我認為這可以歸結為這一點，坦率地說，它為患者提供了更多的疫苗接種機會，因為他們從今年秋季到冬季從藥房開始。

So, again, to Ryan's point, the tailwind, it's an opportunity.

因此，對 Ryan 來說，順風車也是一個機會。

Our retail partners see it as such.

我們的零售合作夥伴也這麼認為。

And so for hep-B, it is an opportunity because, again, it provides additional origination vaccination opportunities this season, and we factored that in as we think about this year and beyond.

因此，對於乙型肝炎來說，這是一個機會，因為它再次在本季提供了額外的起源疫苗接種機會，我們在考慮今年及以後的情況時考慮了這一點。

So I get to Ryan's point the tailwind as an opportunity and our retail partners see it as such.

因此，我同意瑞安的觀點，順風是一個機會，我們的零售合作夥伴也認為這是一個機會。

And so we're happy it is an opportunity because again, it provides additional origination, vaccination opportunities this season, and we've factored that in as we think about this year and beyond.

因此，我們很高興這是一個機會，因為它再次在本季節提供了額外的起源和疫苗接種機會，並且我們在考慮今年及以後的情況時已將其考慮在內。

And to be clear, although RSV will be utilized less, that took an arm is someone originated for flu or COVID.

需要明確的是，儘管 RSV 的使用較少，但奪走手臂的是流感或新冠病毒感染者。

Now they have - there's an opportunity to be a different vaccine to be administered.

現在他們有機會注射不同的疫苗。

Got it.

知道了。

Okay.

好的。

And last question on the pipeline.

關於管道的最後一個問題。

You mentioned C-4 levels are going to be assessed in the Z-1018 trial.

您提到 C-4 水平將在 Z-1018 試驗中進行評估。

Can you give us some sense of what you hope to see?

您能否告訴我們您希望看到什麼？

What would you consider encouraging that will prompt further investment versus what would be discouraging in Dynavax's eye?

在 Dynavax 看來，什麼是令人鼓舞的，會促使進一步投資，什麼是令人沮喪的？

Sure, Rob, why don't you take that?

當然，羅布，你為什麼不接受呢？

Yes.

是的。

What we're looking at, we're looking at a number of different antigen levels in different combinations with adjuvants as well as different dosing regimens.

我們正在研究的是，我們正在研究與佐劑的不同組合以及不同的給藥方案中的許多不同的抗原水平。

And what we anticipate is identifying the best to move forward, which would be one that provides similar levels of CD4 accounts that we see with Shingrix.

我們期望找到最好的推進方案，即提供與 Shingrix 類似水準的 CD4 帳戶。

Got it.

知道了。

Thanks for taking our questions.

感謝您回答我們的問題。

Jon Miller from Evercore.

來自 Evercore 的喬恩·米勒。

Yes, thanks for taking my question.

是的，感謝您提出我的問題。

I guess one on market share here, and I know you sort of talked about this a little bit, but what drives the next leg of market share here?

我想這裡的一個是市場份額，我知道你稍微談論過這個問題，但是什麼推動了市場份額的下一階段呢？

Obviously, you've had good year-on-year growth for the past handful of quarters, but does it feel like it's stable, plus or minus a couple of percent, and the comps will year-on-year comps get tougher going into second half year?

顯然，過去幾季的同比增長良好，但感覺是否穩定，正負幾個百分點，並且同比比較將變得更加艱難下半年？

So, what drives the next level of HEPLISAV growth from here?

那麼，是什麼推動 HEPLISAV 進一步成長呢？

Yes.

是的。

So, a couple of things.

所以，有幾件事。

I'll hit at a high level again, Donn, if you want to add to it, please do.

我會再次打出高水平的球，Donn，如果你想補充的話，請做。

But we continue to have customers where we can expand utilization.

但我們仍然有可以擴大利用率的客戶。

So, customers don't move as a block necessarily in the IDN space, so you'll get the largest clinics and you can continue to expand there.

因此，客戶不一定會在 IDN 空間中作為一個整體移動，因此您將獲得最大的診所，並且可以繼續在那裡擴展。

I think the other element of this is a disproportionate share of growth.

我認為另一個因素是成長比例不成比例。

So we do believe the HEPLISAV will continue to capture a disproportionate share of the market expansion, which will also help overall market share.

因此，我們確實相信 HEPLISAV 將繼續在市場擴張中佔據不成比例的份額，這也將有助於提高整體市場份額。

Okay.

好的。

Okay, sure.

好吧，當然。

Then the other question, I guess, is it looks like from a gross margin perspective, you're more or less hitting your guidance this quarter.

我想，另一個問題是，從毛利率的角度來看，您本季或多或少達到了預期目標。

As I think quarter-to-quarter, how much noise is there in gross margin now that the big efforts to improve that over time are on board and you're reaching the realm you are hoping to get to?

正如我所認為的那樣，隨著時間的推移，隨著時間的推移，為提高毛利率做出了巨大的努力，並且您正在達到您希望達到的境界，因此毛利率有多少噪音？

Sure.

當然。

So, we'll continue to see some minor fluctuations quarter-to-quarter and some variability quarter-to-quarter just because of timing of just manufacturing processes.

因此，我們將繼續看到一些季度與季度之間的微小波動和一些季度與季度之間的變化，只是因為製造流程的時間表。

But I think in terms of order of magnitude, what we've seen these last couple of quarters is probably what we can expect to see going forward, which is why we provided the to your point, the 80% estimated gross margin for the year as our guidance.

但我認為就數量級而言，我們過去幾季所看到的可能是我們可以預期未來看到的，這就是為什麼我們提供了您的觀點，即今年預計毛利率為 80%作為我們的指導。

Great.

偉大的。

And then maybe last one for me.

然後也許是我的最後一個。

Just more about the phrasing of how you're some of your guidance reads.

更多關於您如何閱讀指南的措詞。

You're guiding for cash and equivalents at year end to be greater than it was at year-end 2023.

您預計年底的現金和等價物將高於 2023 年底。

And I noticed you're not talking about cash flow, you're not talking about particular profitability numbers.

我注意到你不是在談論現金流，也不是在談論特定的獲利能力數字。

It's specifically cash plus equivalents guidance.

它特別是現金加等價物指導。

Does that imply that BD is less likely before the end of the calendar year?

這是否意味著 BD 在年底前出現的可能性較小？

That guidance, Jon, just to be very clear, is on our current existing business, obviously, to the extent that we had significant deployment of capital for a BD opportunity that would impact that guidance.

喬恩，要非常明確的是，該指導意見是針對我們當前現有業務的，顯然，我們為 BD 機會部署了大量資本，這將影響該指導意見。

Yes, makes sense.

是的，有道理。

Thanks very much.

非常感謝。

Paul Choi from Goldman Sachs.

來自高盛的保羅崔 (Paul Choi)。

Hi, good afternoon and thank you for taking our questions.

您好，下午好，感謝您回答我們的問題。

My first question is also on the guidance and maybe directed to Kelly and Donn.

我的第一個問題也是關於指導，可能是針對凱利和唐恩的。

As you think about the guidance for the back half of the year, obviously, you've historically been weighted to 3Q versus 4Q.

當您考慮下半年的指導時，顯然，歷史上您一直在偏重第三季和第四季。

But I guess it seems like as we look at recent prescription trends through July, while up versus the tail end of 2Q, it seems like there's going to be a bit of a heavy lift to make the midpoint or upper end of your guidance.

但我想，當我們審視 7 月的近期處方趨勢時，雖然與第二季末相比有所上升，但似乎將有一些重大提升才能達到指導的中點或上限。

So, I guess the question is, based on what you're seeing in the marketplace right now, are you more comfortable with the lower end of the guidance you provided versus the midpoint?

所以，我想問題是，根據您現在在市場上看到的情況，您是否對您提供的指導的下限與中點更滿意？

That's my first question.

這是我的第一個問題。

And then second, with regard to the plague program, you guys did mention that you'll get provide an update in 4Q.

其次，關於瘟疫計劃，你們確實提到你們將在第四季度提供更新。

But assuming the data is positive there, can you maybe just remind us if that triggers any milestone with regard to that program?

但假設那裡的數據是積極的，您能否提醒我們這是否會觸發該計劃的任何里程碑？

And welcome back, Kelly as well.

也歡迎回來，凱利。

Thank you.

謝謝。

I'll take the first one and then Donn definitely will add in some details. which is as we think about guidance, I think we certainly believe that we have plenty of scenarios that will support the upper end of the range.

我會選擇第一個，然後唐肯定會添加一些細節。當我們考慮指導時，我認為我們當然相信我們有很多情景可以支持該範圍的上限。

So, we keep the guidance in terms of a range because there are uncertainties.

因此，由於存在不確定性，我們將指引保持在一定範圍內。

So, I think a couple of things that we're really excited about headed into Q3 and even Q4 have already been highlighted on this call.

因此，我認為我們對進入第三季甚至第四季感到非常興奮的一些事情已經在這次電話會議中得到了強調。

So, for example, some of the retail pull-through that we've seen, we continue to see that.

例如，我們已經看到了一些零售業的拉動，我們將繼續看到這種情況。

And we also have a really strong response to our personal promotion and then also, of course, some of the opportunity that was highlighted around the recent RSV recommendation, certainly, that opens up an opportunity for us.

我們對我們的個人晉升也有非常強烈的反應，當然，還有最近 RSV 推薦所強調的一些機會，這當然為我們提供了機會。

Maybe I'll hand it over to Donn to add any other color.

也許我會把它交給唐恩來添加任何其他顏色。

Yes, Paul, just regarding looking into Q3, I mean, to Kelly's point, we've said it's already -we're excited with what we see, especially with the new retail pharmacy segment, actually the behaviors that are happening and occurring by our partners, really save themselves up for a fairly robust back half of the year, taking advantage of opportunities and patient origination, as I mentioned before, with the RSV example, infrastructure is in place, communications in place.

是的，保羅，只是關於第三季度的調查，我的意思是，就凱利的觀點而言，我們已經說過了——我們對所看到的感到興奮，特別是新的零售藥房領域，實際上正在發生和正在發生的行為我們的合作夥伴確實為今年下半年的強勁表現做好了準備，利用機會和患者來源，正如我之前提到的，以 RSV 為例，基礎設施到位，溝通到位。

And so that's where we feel very good about where we're going at when we reaffirmed our guidance for 2024.

因此，當我們重申 2024 年的指導時，我們對我們的發展方向感到非常滿意。

And then Paul, on the plague program, there's no defined milestone structure as it relates to that program.

然後保羅，關於瘟疫計劃，沒有與該計劃相關的明確的里程碑結構。

That is a it's a duty-funded program that would the upside value there would be future product sales of either 1018 or if we ended up being responsible for the whole product.

這是一項關稅資助計劃，如果 1018 的未來產品銷售或我們最終負責整個產品，將會帶來上行價值。

So, we'll probably update on the program in Q4, which would include any future expectations around advancement and funding.

因此，我們可能會在第四季度更新該計劃，其中包括有關進展和資金的任何未來預期。

Got it.

知道了。

Okay, thanks for the clarity.

好的，謝謝你的澄清。

Thank you very much..

非常感謝..

Roy Buchanan from JMP Securities.

JMP 證券公司的 Roy Buchanan。

Follow-up on a lot of the guidance question.

跟進很多指導問題。

Just the longer term guidance that you mentioned providing later this year.

只是您提到的今年晚些時候提供的長期指導。

Can you maybe talk a little give us a preview maybe of what that's going to look like?

您能否稍微談談，讓我們預覽一下它會是什麼樣子？

Is that 2030, 2035, 2040, any granularity on when you might give us that guidance?

是 2030 年、2035 年、2040 年，您何時可以向我們提供該指導？

Yes, thanks.

是的，謝謝。

Yes.

是的。

Hi Roy.

嗨羅伊。

As you heard in some of the qualitative statements we made today around a little bit of an indication of what we expect beyond 2027 with continued market growth and continued market share, we are looking to be able to update longer term guidance to focus on providing color as to where we see the peak opportunity and then some context for the shape of the herd post peak.

正如您在我們今天所做的一些定性聲明中聽到的那樣，我們對 2027 年之後市場持續增長和市場份額的預期有所暗示，我們希望能夠更新長期指導，以專注於提供色彩關於我們在哪裡看到峰值機會，以及牛群後峰值形狀的一些背景。

So, we're refining that work right now, which is where we feel confident in continued growth on 2027, and we'll refine that a little bit more and provide a bit more quantitative update later this year.

因此，我們現在正在完善這項工作，這就是我們對 2027 年持續成長充滿信心的地方，我們將進一步完善這項工作，並在今年稍後提供更多定量更新。

Okay, great.

好的，太好了。

And did anything change?

有什麼改變嗎？

I guess not, but or have you just seen enough data at this point to be able to be confident in making these longer term projections?

我想不是，但是或您現在是否已經看到足夠的數據，能夠有信心做出這些長期預測？

Thanks.

謝謝。

Well, it kind of goes back to the discussion we had earlier in the Q&A session that we put out five-year guidance in 2022, and we wanted which we felt comfortable with at the time, and we think we need to continue to provide our view of the long-term opportunity as we have additional information to influence it.

嗯，這有點回到我們早些時候在問答環節中進行的討論，即我們在 2022 年提出了五年指導，我們希望當時感到滿意，我們認為我們需要繼續提供我們的指導意見。 ，因為我們有更多資訊可以影響它。

So, the last few years have provided us insight that we invite to reflect in our long-term guidance.

因此，過去幾年為我們提供了一些見解，我們邀請這些見解反映在我們的長期指導中。

Makes sense.

有道理。

Thanks.

謝謝。

We have no further questions at this time.

目前我們沒有進一步的問題。

I would now like to turn the call over to Ryan Spencer, CEO, for closing remarks.

現在我想將電話轉給執行長瑞安‧史賓塞 (Ryan Spencer)，讓其致閉幕詞。

You may begin.

你可以開始了。

Thank you, operator and thank you all for joining us today.

謝謝運營商，也謝謝大家今天加入我們。

We appreciate your interest in Dynavax.

我們感謝您對 Dynavax 的興趣。

We are excited about our recent accomplishments and the strength of our position.

我們對最近的成就和我們的地位感到興奮。

We look forward to updating you on our progress, focused on protecting the world against infectious diseases.

我們期待向您通報我們的最新進展，重點是保護世界免受傳染病的侵害。

Operator, you may end the call.

接線員，您可以結束通話了。

Ladies and gentlemen, thank you for joining us today.

女士們、先生們，謝謝你們今天加入我們。

This concludes today's conference call.

今天的電話會議到此結束。

You may now disconnect.

您現在可以斷開連線。