Dynavax Technologies Corp (DVAX) 2023 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to Dynavax Technologies, Second Quarter 2023 Financial Results. As a reminder, this conference is being recorded. At the end of the company's prepared remarks, we will open the call for questions and provide pacific instructions at that point. I would now like to turn the call over to Paul Cox, Vice President, Investor Relations and Corporate Communications. You may begin.

女士們、先生們，美好的一天，歡迎閱讀 Dynavax Technologies 2023 年第二季財務業績。提醒一下，本次會議正在錄製中。在公司準備好的發言結束時，我們將開始提問並提供和平指示。我現在想將電話轉給投資者關係和企業傳播副總裁 Paul Cox。你可以開始了。

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

感謝大家參加今天的電話會議。今天與我一起從 Dynavax 前來的有執行長 Ryan Spencer、首席商務官 Donn Casale、以及羅布‧詹森，首席醫療官；和財務長凱莉·麥克唐納。

Earlier today, Dynavax released financial results for the second quarter ended June 30, 2023. Copies of the press release and a supplementary slide presentation are available on Dynavax's 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, market segmentation, effective marketing efforts and future expected market share and related growth rates and related ACIP recommendation impact on each.

今天早些時候，Dynavax 發布了截至 2023 年 6 月 30 日的第二季財務業績。新聞稿和補充幻燈片簡報的副本可在 Dynavax 網站上取得。在開始之前，我建議您，我們今天將根據我們當前的預期和信念做出前瞻性陳述，包括但不限於潛在的市場規模、市場細分、有效的營銷努力以及未來預期的市場份額和相關增長費率和相關ACIP 建議對每個方面的影響。

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. These statements involve risks and uncertainties, and our actual results may differ materially. These risks are summarized in today's press release and detailed in the Risk Factors section of our SEC filings, including today's quarterly report on Form 10-Q.

財務指導和趨勢，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數以及我們的 CpG 1018 佐劑的未來潛在用途或需求。這些陳述涉及風險和不確定性，我們的實際結果可能存在重大差異。這些風險在今天的新聞稿中進行了總結，並在我們向 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. And with that, I will now turn the call over to Ryan.

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。現在，我將把電話轉給瑞安。

Thanks, Paul. Good afternoon, everyone, and thank you for taking the time to join us to review Dynavax's results for the second quarter of 2023. We are pleased to share the results of yet another impressive quarter for Dynavax, including outstanding progress for HEPLISAV-B, for adult hepatitis B vaccine, which delivered $56 million in quarterly net product revenue.

謝謝，保羅。大家下午好，感謝您抽出時間與我們一起回顧 Dynavax 2023 年第二季度的業績。我們很高興分享 Dynavax 又一個令人印象深刻的季度的業績，包括 HEPLISAV-B 的出色進展，成人乙型肝炎疫苗，季度淨產品收入為5,600 萬美元。

These results reflect our team's success in driving the expansion of the adult hepatitis B vaccine market and capturing market share. As a result of the strong HEPLISAV-B performance in the first half of 2023, along with the growing enthusiasm that we see in the market, we are significantly raising our revenue expectations for the full year. We now expect HEPLISAV-B net product revenue to be in the range of $200 million to $215 million compared to the prior range of $165 million to $185 million.

這些結果反映了我們團隊在推動成人乙型肝炎疫苗市場擴張並佔領市場份額方面的成功。由於 HEPLISAV-B 在 2023 年上半年表現強勁，加上我們看到市場熱情不斷高漲，我們大幅提高了全年的營收預期。我們現在預計 HEPLISAV-B 產品淨收入將在 2 億至 2.15 億美元之間，而先前的範圍為 1.65 億至 1.85 億美元。

Last year, HEPLISAV-B revenue doubled compared to 2021. And with our increased guidance range, we now expect growth of 58% to 70% this year. Based on our exceptional commercial execution, we have strengthened our financial position with cash and investments increasing to $682 million at quarter end. And we expect positive free cash flow for 2023 in total. This position enables us to support our efforts to maximize depose the opportunity while making the appropriate investments to advance our clinical portfolio.

去年，HEPLISAV-B 的營收比 2021 年翻了一番。隨著我們擴大指導範圍，我們現在預計今年的成長將達到 58% 至 70%。基於我們卓越的商業執行力，我們的財務狀況得到了加強，現金和投資在季度末增至 6.82 億美元。我們預計 2023 年自由現金流總額為正。這個職位使我們能夠支持我們最大限度地利用機會的努力，同時進行適當的投資以推進我們的臨床產品組合。

We continue to make progress in advancing our clinical pipeline of three vaccine candidates for Tdap, shingles and plague. Rob will walk through our achievements and expectations for our clinical programs in a few minutes.

我們在推動 Tdap、帶狀皰疹和鼠疫三種候選疫苗的臨床研發方面繼續取得進展。羅布將在幾分鐘內介紹我們的臨床計畫的成就和期望。

Additionally, we continue to identify and review strategic opportunities to help accelerate our growth and further diversify our product portfolio and future commercial opportunities. We are focusing on prioritizing external opportunities in the following two categories: first, commercial or late-stage assets in the vaccine space to leverage our expertise in the field and our fully integrated capabilities; and second, high synergy commercial assets within the infectious disease space that would broaden our focus to include therapeutic modalities outside of vaccines.

此外，我們繼續識別和審查策略機會，以幫助加速我們的成長並進一步使我們的產品組合和未來的商業機會多樣化。我們重點優先考慮以下兩類外部機會：第一，疫苗領域的商業或後期資產，以利用我們在該領域的專業知識和完全整合的能力；其次，傳染病領域內的高度協同商業資產將擴大我們的關注範圍，並將疫苗以外的治療方式納入其中。

We remain focused on disciplined capital allocation strategy and our efforts to generate significant value and accelerate growth. And we look forward to providing updates on this front in the future. I'll now turn the call over to Donn, so he can provide more details on the tremendous HEPLISAV-B performance in the second quarter.

我們仍然專注於嚴格的資本配置策略以及創造顯著價值和加速成長的努力。我們期待將來提供這方面的更新。我現在將把電話轉給 Donn，以便他可以提供有關第二季度 HEPLISAV-B 出色性能的更多詳細資訊。

Thank you, Ryan. I'm excited to share more details about another very strong quarterly performance for HEPLISAV-B and our continued progress in driving overall market growth as well as capturing market share within what we believe is the best-in-class hepatitis B vaccine. The hepatitis B market continues to grow in the U.S. following the ACIP universal recommendation for hepatitis B vaccination, which now represents a large and growing market opportunity.

謝謝你，瑞安。我很高興分享有關 HEPLISAV-B 另一個非常強勁的季度業績的更多細節，以及我們在推動整體市場成長以及在我們認為是同類最佳乙型肝炎疫苗中佔領市場份額方面的持續進展。在 ACIP 普遍建議乙型肝炎疫苗接種後，美國的乙型肝炎市場持續成長，這代表著一個巨大且不斷成長的市場機會。

We believe this recommendation will be a significant catalyst for growth and estimate the hepatitis B market opportunity in the U.S. could grow to over $800 million by 2027. We continue to see indicators of market expansion with hepatitis B vaccine market growth of approximately 40% year-over-year in Q2.

我們相信這項建議將成為成長的重要催化劑，並估計到2027 年美國乙型肝炎市場機會可能成長到超過8 億美元。我們繼續看到市場擴張的跡象，乙型肝炎疫苗市場每年增長約40% 。第二季年增。

HEPLISAV-B continues its positive trend towards securing a majority of market share within the expanding hepatitis B market. We are demonstrating gains in market share and estimate that HEPLISAV-B's total market share increased to approximately 39% compared to approximately 32% at the end of the second quarter last year.

HEPLISAV-B 繼續保持其在不斷擴大的乙型肝炎市場中獲得大部分市場份額的積極趨勢。我們正在展示市場份額的成長，並估計 HEPLISAV-B 的總市場份額從去年第二季末的約 32% 增至約 39%。

As Ryan stated, HEPLISAV-B's performance in the second quarter exceeded expectations. In the quarter, net product revenue for HEPLISAV-B grew 73% year-over-year. These quarterly results were once again driven by HEPLISAV-B's strong performance in two critical market segments, retail pharmacy and integrated delivery networks or IDNs. So IDNs, at the end of the second quarter, HEPLISAV-B's market share increased to approximately 53% compared to approximately 39% at the end of the second quarter last year.

正如Ryan所說，HEPLISAV-B第二季度的表現超出了預期。本季度，HEPLISAV-B 的產品淨收入年增 73%。這些季度業績再次受到 HEPLISAV-B 在兩個關鍵細分市場（零售藥房和綜合配送網絡或 IDN）的強勁表現的推動。因此，在第二季末的 IDN 中，HEPLISAV-B 的市佔率增至約 53%，而去年第二季末的市佔率約為 39%。

In the IDNs segment, we are seeing strong conversion from large customers that have started to adopt the universal recommendation driving meaningful increases in their hepatitis vaccine purchases and vaccination in appropriate patients that exceeded 2019 pre-pandemic levels. We are working with these large health systems and others to drive ongoing adoption of the universal recommendation during the second half of the year.

在 IDN 細分市場，我們看到大客戶的強烈轉變，他們已開始採用普遍建議，推動其肝炎疫苗購買量和適當患者的疫苗接種量顯著增加，超過了 2019 年大流行前的水平。我們正在與這些大型衛生系統和其他系統合作，推動下半年普遍建議的持續採用。

In the Retail Pharmacy segment, we continue to make tremendous progress. During the quarter, HEPLISAV-B dose volume increased 78% year-over-year. We are excited about this result as market growth is the #1 indicator that retail pharmacy customers are adopting the universal recommendation.

在零售藥局領域，我們持續取得巨大進步。本季度，HEPLISAV-B 劑量年增 78%。我們對這一結果感到興奮，因為市場成長是零售藥局客戶採用普遍建議的第一指標。

Driving market growth in retail will be our primary sales and marketing focus moving forward. Although our market share for the quarter remained consistent at 45% year-over-year as a result of buying patterns of several top retail chains, we are extremely confident in our ability to be the market leader within this critical segment. We have well-established strong collaborative relationships across the top retail chain and have launched key headquarter sponsored marketing initiatives and tactics across the segment.

推動零售市場成長將是我們未來的主要銷售和行銷重點。儘管由於幾家頂級零售連鎖店的購買模式，我們本季的市場份額同比保持在 45%，但我們對成為這一關鍵領域的市場領導者的能力非常有信心。我們在頂級零售連鎖店中建立了牢固的合作關係，並在整個細分市場推出了總部贊助的重要行銷計劃和策略。

Given this, we will be optimizing our sales force to expand our promotional reach in the segment to drive market expansion. This expanded salesforce reach will call on headquarters, divisional, regional and district leaders across the top retail chain.

有鑑於此，我們將優化我們的銷售隊伍，擴大我們在該領域的促銷範圍，從而推動市場擴張。擴大的銷售隊伍範圍將吸引頂級零售連鎖店的總部、部門、區域和地區領導者。

In addition to increasing our salesforce reach, we are also excited to see the full impact of the collaborative marketing initiatives launched at the end of the second quarter. We anticipate these headquarter sponsor initiatives plus our expanded salesforce reach will enable continued strong market growth and market leadership within this important segment.

除了擴大我們的銷售人員覆蓋範圍之外，我們還很高興看到第二季末推出的協作行銷計劃的全面影響。我們預計這些總部贊助商措施加上我們擴大的銷售隊伍範圍將在這一重要領域實現持續強勁的市場成長和市場領導地位。

We are focusing our efforts on the retail pharmacy and IDNs segment as we expect to see most of the anticipated market growth from the ACIP universal recommendation in these segments. Both segments have required institutional control, infrastructure, capability and patient volumes that can help drive universal uptake. We expect these two segments will represent approximately 60% of the HEPLISAV-B market by 2027 compared to approximately 44% in 2022.

我們將工作重點放在零售藥局和 IDN 細分市場，因為我們預計這些細分市場的大部分預期市場成長都來自 ACIP 普遍建議。這兩個細分市場都需要機構控制、基礎設施、能力和患者數量，以幫助推動普遍採用。我們預計到 2027 年，這兩個細分市場將佔 HEPLISAV-B 市場的約 60%，而 2022 年約為 44%。

We are well positioned in both segments with HEPLISAV-B now capturing approximately 50% of the market share in these segments combined. In summary, we had an outstanding quarter, reaffirming our confidence that HEPLISAV-B becoming the market leader in the expanding hepatitis B vaccine market. We are encouraged by our progress and momentum in the key segments of retail pharmacy and IBS, both of which significantly contributed to the performance of HEPLISAV-B exceeding expectations for the second quarter.

我們在這兩個細分市場都處於有利地位，HEPLISAV-B 目前佔據這些細分市場約 50% 的市場。總之，我們度過了一個出色的季度，重申了我們對 HEPLISAV-B 成為不斷擴大的乙型肝炎疫苗市場的市場領導者的信心。我們對零售藥局和 IBS 關鍵領域的進展和勢頭感到鼓舞，這兩個領域為 HEPLISAV-B 第二季度的業績超出預期做出了重大貢獻。

This quarter's record HEPLISAV-B revenue results reflects the continued expansion of the hepatitis B vaccine market and growing demand from physicians, pharmacists and patients for our best-in-class hepatitis B vaccine, both made possible by our team's strong commercial execution. I will now turn the call over to Rob to take you through our clinical pipeline.

本季創紀錄的HEPLISAV-B 收入結果反映了乙型肝炎疫苗市場的持續擴張以及醫生、藥劑師和患者對我們一流的乙型肝炎疫苗不斷增長的需求，這一切都得益於我們團隊強大的商業執行力。我現在將把電話轉給 Rob，帶您了解我們的臨床流程。

Thank you, Donn. Over the second quarter, we made important progress on our pipeline, and I'm pleased to provide our recent advancements and our plans for continued execution throughout 2023.

謝謝你，唐恩。第二季度，我們在管道方面取得了重要進展，我很高興提供我們最近的進展以及我們在 2023 年繼續執行的計劃。

I'll start with our shingles vaccine program in June '22. In June, we presented results from a Phase I randomized active controlled adjuvant dose escalation trial to evaluate the safety, tolerability and immunogenicity of the duty team at the 2023 Annual Conference on Bacteriology Research.

我將於 22 年 6 月開始我們的帶狀皰疹疫苗計劃。 6 月，我們在 2023 年細菌學研究年會上展示了 I 期隨機主動對照輔助劑量遞增試驗的結果，以評估值班團隊的安全性、耐受性和免疫原性。

In this study, we demonstrated that Deep Vitamins Team showed favorable tolerability without observed safety concerns in healthy adults ages 50 to 59 years. All the 10 groups demonstrated high antibody and CD4+ T cell responses. These results demonstrate the opportunity to develop the shingles vaccine with improved tolerability and comparable efficacy and they support the continued development of Z-1018.

在這項研究中，我們證明 Deep Vitamins Team 在 50 至 59 歲的健康成年人中表現出良好的耐受性，沒有觀察到安全性問題。所有 10 組均表現出較高的抗體和 CD4+ T 細胞反應。這些結果表明有機會開發具有改善的耐受性和可比較功效的帶狀皰疹疫苗，並支持 Z-1018 的持續開發。

In the second half of 2023, we plan to assess the regulatory pathway with the FDA to support the initiation of a Phase I/II trial in early 2024. So let's turn to our Tdap and Td program. It's an investigational vaccine intent intended for active booster immunization against Tetanus, Diphtheria and Pertussis or TDA. We're focused on improving the durability and protection against pertussis by leveraging our CpG 1018 adjuvant in a floatel Tdap vaccine.

2023 年下半年，我們計劃與 FDA 評估監管途徑，以支持在 2024 年初啟動 I/II 期試驗。所以讓我們轉向我們的 Tdap 和 Td 計劃。這是一種研究性疫苗，旨在針對破傷風、白喉和百日咳或 TDA 進行主動加強免疫。我們致力於透過在 floatel Tdap 疫苗中利用我們的 CpG 1018 佐劑來提高持久性和對百日咳的保護。

We recently completed a post-Peruse challenge study in the non-human primate floatel, which demonstrated protection from disease and robust Th1 responses. We also recently received Type B pre-leasing feedback from the FDA on the Tdap 1018 clinical development and regulatory pathways. Together, results from our Phase I study and our human primate study, nonhuman primate study as well as feedback from FDA support proceeding to a human challenge study.

我們最近在非人靈長類 floatel 中完成了一項 Peruse 後挑戰研究，該研究證明了其對疾病的保護作用和強大的 Th1 反應。我們最近也收到了 FDA 關於 Tdap 1018 臨床開發和監管途徑的 B 類預租賃回饋。綜合起來，我們的第一階段研究、人類靈長類動物研究、非人類靈長類動物研究的結果以及 FDA 支持進行人類挑戰研究的回饋。

We expect to submit an investigational new drug application to FDA in the fourth quarter of 2023 to support the initiation of the human challenge study. Moving on to the plan program. We're conducting a Phase II trial in evaluating the immunogenic safety and tolerability of a 2-dose plant vaccine candidate that is as demanded with CpG 1018. This is a collaboration with and funded by the U.S. Department of the sense.

我們預計在 2023 年第四季向 FDA 提交研究性新藥申請，以支持人體挑戰研究的啟動。繼續計劃。我們正在進行一項 II 期試驗，以評估 2 劑候選植物疫苗的免疫原性安全性和耐受性，該疫苗符合 CpG 1018 的要求。這是與美國衛生部合作並由其資助的。

This CpG 1018 adjuvant vaccine candidate mechanism of action has the potential to speed up time of protection with fewer doses compared to the 3-dose animal molded vaccine under development by the Department of Defense. Earlier this year, we completed enrollment into Part two of the Phase II program with top line data expected in 2024.

與國防部正在開發的 3 劑動物模製疫苗相比，這種 CpG 1018 佐劑疫苗候選作用機制有可能以更少的劑量加快保護時間。今年早些時候，我們完成了第二階段計畫第二部分的註冊，預計將於 2024 年獲得頂線數據。

In July, Dynavax and the Department of Defense executed a contract modification to support advancement into a nonhuman primate challenge study with the agreement now totaling $33.7 million through 2025. We look forward to continuing to make progress across these programs to the rest of this year.

7 月，Dynavax 和國防部執行了合約修改，以支持非人靈長類動物挑戰研究的進展，目前協議總額為3,370 萬美元，到2025 年為止。我們期待在今年剩餘時間內繼續在這些項目上取得進展。

In addition, we're excited to announce the establishment of our Scientific Advisory Board comprised of renowned leaders in vaccine research and development and infectious diseases. We look forward to working with this advisory board in advantaging our pipeline as well as supporting the evaluation of internal and external opportunities.

此外，我們很高興地宣布成立由疫苗研發和傳染病領域的知名領導者組成的科學顧問委員會。我們期待與該顧問委員會合作，推動我們的產品線發展，並支持對內部和外部機會的評估。

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. I'm thrilled to report on another strong quarter. I'll review the key financial results for the second quarter and then review our updated guidance for the full year. Please note that all financial comparisons are versus the prior year period, unless otherwise noted. Please also refer to our press release and Form 10-Q for the detailed financial information.

謝謝你，羅布。我很高興報告又一個強勁的季度。我將回顧第二季度的主要財務業績，然後回顧我們更新的全年指引。請注意，除非另有說明，所有財務比較均與上一年期間進行比較。另請參閱我們的新聞稿和表格 10-Q 以了解詳細的財務資訊。

Starting with revenue. Total revenues for the second quarter of 2023 were $60 million, driven by HEPLISAV-B net product revenue of $56 million. Compared to the second quarter of last year, HEPLISAV-B net product revenue grew by 73%. We are excited about the uptake trajectory for HEPLISAV-B, including our continued growth in key market segments and are therefore raising our HEPLISAV-B net product revenue guidance for the full year to $200 million to $215 million compared to the prior guidance of $165 million to $185 million. This represents an almost 20% increase at the midpoint, reflecting our confidence in the continued product growth this year.

從收入開始。 2023 年第二季的總收入為 6,000 萬美元，得益於 HEPLISAV-B 產品淨收入 5,600 萬美元。與去年第二季相比，HEPLISAV-B產品淨收入成長了73%。我們對 HEPLISAV-B 的採用軌跡感到興奮，包括我們在關鍵細分市場的持續成長，因此將全年 HEPLISAV-B 淨產品收入指引提高至 2 億至 2.15 億美元，而先前的指引為 1.65 億美元至1.85 億美元。這意味著中間值成長了近 20%，反映了我們對今年產品持續成長的信心。

We are also pleased with the continued trend in the margin profile for HEPLISAV-B to gross margins of approximately 76% in Q2 compared to about 69% last year, and we continue to expect gross margins to average in the mid-70s for the full year. Other revenue was $4 million for the second quarter, representing revenue related to the play vaccine program in collaboration with and fully funded by the U.S. Department of Defense.

我們也對 HEPLISAV-B 的毛利率持續保持趨勢感到滿意，第二季毛利率約為 76%，而去年約為 69%，我們繼續預計整個毛利率平均在 70 年代中期。年。第二季的其他收入為 400 萬美元，代表與美國國防部合作並由美國國防部全額資助的疫苗計畫相關的收入。

Now, turning to our research and development expenses for the quarter. These increased to $13 million compared to $10 million for the prior period. The increase was driven by continued advancement in our clinical pipeline programs. Selling, general and administrative expenses for the quarter were $37 million compared to $36 million for the prior period. The increase was primarily driven by higher personnel-related costs and an overall increase in targeted marketing efforts to drive helpless market share and drive market expansion in key segments that we believe will disproportionately benefit HEPLISAV-B.

現在，談談我們本季的研發費用。與上一期間的 1,000 萬美元相比，這一數字增加至 1,300 萬美元。這一增長是由我們的臨床管道項目的持續進步所推動的。本季的銷售、一般和管理費用為 3,700 萬美元，而上一季的銷售、一般和管理費用為 3,600 萬美元。這一增長主要是由於人員相關成本上升以及有針對性的營銷努力總體增加，以推動無可挽回的市場份額並推動關鍵細分市場的市場擴張，我們認為這將使 HEPLISAV-B 受益匪淺。

Now, turning to net income. We recorded GAAP net income of $3 million or $0.03 per share basic and diluted in Q2 compared to GAAP net income of $129 million or $1.02 per share basis and $0.87 per share diluted for the prior year period.

現在，轉向淨利。我們第二季的 GAAP 淨利潤為 300 萬美元，即基本和稀釋後每股 0.03 美元，而去年同期的 GAAP 淨利潤為 1.29 億美元，即每股 1.02 美元，稀釋後每股 0.87 美元。

Moving to the balance sheet. We ended the second quarter with cash, cash equivalents and marketable securities of approximately $682 million, an increase compared to our year-end balance of $624 million. Based on our current operating plans, we continue to expect to finish 2023 with positive free cash flow for the year.

轉向資產負債表。截至第二季末，我們的現金、現金等價物和有價證券約為 6.82 億美元，比年末餘額 6.24 億美元增加。根據我們目前的營運計劃，我們繼續預計 2023 年將實現正自由現金流。

Additionally, we continue to believe this level of capital is sufficient to support our core business, enabling us to drive sustainable growth in help to capture a majority market share and bring our R&D portfolio of vaccine candidates forward without needing to return to capital markets.

此外，我們仍然相信這一水平的資本足以支持我們的核心業務，使我們能夠推動永續成長，幫助佔領多數市場份額並推進我們的候選疫苗研發組合，而無需返回資本市場。

We are also pleased to update our full year 2023 financial guidance expectations. As mentioned, we are raising our HEPLISAV-B net product revenue expectations to be between $200 million and $215 million. We are maintaining our operating expense guidance of R&D expenses between $55 million and $70 million as well as SG&A expenses between $135 million and $155 million. We do expect to come in at the lower end of our R&D expense range due to the timing of Tdap program clinical trial startup activities taking place later this year and into early 2024.

我們也很高興更新 2023 年全年財務指引預期。如前所述，我們將 HEPLISAV-B 淨產品收入預期提高到 2 億美元至 2.15 億美元之間。我們將研發費用的營運費用指引維持在 5,500 萬美元至 7,000 萬美元之間，SG&A 費用維持在 1.35 億美元至 1.55 億美元之間。由於 Tdap 計畫臨床試驗啟動活動的時間安排在今年稍後和 2024 年初，我們確實預計研發費用範圍將處於較低水準。

In closing, we are proud of another successful quarter marked by continued HEPLISAV-B outperformance, further strengthening of our financial position and pipeline progress. We also continue to be extremely thoughtful on how we allocate our capital to accelerate growth and build beyond our current base business. Our strong capital position and commercial execution has provided us with strategic flexibility to identify and pursue external opportunities to complement our organic growth as we strive to deliver long-term value to our shareholders.

最後，我們對又一個成功的季度感到自豪，HEPLISAV-B 的表現持續出色，進一步加強了我們的財務狀況和管道進展。我們也繼續對如何分配資本以加速成長並超越當前的基礎業務進行深思熟慮。我們強大的資本地位和商業執行力為我們提供了策略靈活性，可以在我們努力為股東創造長期價值的同時，識別和尋求外部機會，以補充我們的有機成長。

We are excited about our progress to date, and we look forward to continuing to deliver on our goals for 2023. Thank you, everyone, for your attention today. Operator, we would now like to open the Q&A portion of today's call.

我們對迄今為止的進展感到興奮，並期待繼續實現 2023 年的目標。感謝大家今天的關注。接線員，我們現在要開始今天電話的問答部分。

To ask a question, '(Operator Instructions)'. One moment for our first question. Our first question comes from the line of Matthew Phipps with William Blair.

要提出問題，請「（操作員說明）」。請稍等一下我們的第一個問題。我們的第一個問題來自馬修·菲普斯和威廉·布萊爾的對話。

Just really congrats on a great quarter for you guys. Great to see. I guess, first for Donn, given what you -- some of the commentary you had around kind of the retail growth and just where your market share is, is the overall market expanding as you expected? Or is it maybe even a little bit faster than you expected to get to that $800 million? I guess I would have thought it'd be a little bit slower in this first year, picking up a little bit later. Curious where you think you are in that kind of trajectory to get to $800 million.

衷心祝賀你們度過了一個美好的季度。很高興看到。我想，首先對於唐恩來說，考慮到您對零售成長的一些評論以及您的市場份額，整個市場是否如您預期的那樣擴張？或者達到 8 億美元的速度是否比您預期的快一點？我想我會認為第一年會慢一點，稍後會加快一點。很好奇您認為自己處於達到 8 億美元目標的軌道上。

Matt, thanks for the question. Regarding market growth, as I mentioned on the comments, market growth is so critical. Obviously, retail and IDN, but specifically to answer your question, market growth is actually accelerating more so than we forecasted. We're really pleased to see the uptake with the recommendation in both segments, both retail and IDN. And so, that's something that we're really excited about in those segments.

馬特，謝謝你的提問。關於市場成長，正如我在評論中提到的，市場成長非常關鍵。顯然，零售和 IDN，但具體回答你的問題，市場成長實際上比我們預測的更快。我們非常高興看到零售和 IDN 這兩個領域的推薦都被採用了。因此，我們對這些領域感到非常興奮。

Great. And curious on the Tdap nonhuman challenge study, did that study include a control arm such as Boostrix.

偉大的。對 Tdap 非人類挑戰研究感到好奇，該研究是否包括像 Boostrix 這樣的控制臂。

It did.

它做了。

Can you comment on any of that? Or do you plan to present that at some meeting coming up?

您能對此發表評論嗎？或者您打算在即將舉行的某個會議上介紹這一點？

We don't have any plans to present that nonhuman primate data at a meeting on its own. But in general, we saw strong T cell responses, which with the adjuvant compared to these Boostrix, comparative control. So, we are pleased with the results compared to the comparator. And then just a final point on question before, Matt, just figure clear. As you mentioned, it's accelerated faster than we projected. We haven't, at this point, changed the overall time on our long-term guidance around the peak. So we're going to have to watch that and see how that kind of continues to evolve over time to see if this accelerated or the shape of the curve just got a little steep in the front end.

我們沒有任何計劃在會議上單獨展示非人類靈長類動物的數據。但總的來說，我們看到了強烈的T細胞反應，這與這些Boostrix佐劑相比，是對照。因此，與比較器相比，我們對結果感到滿意。然後是之前問題的最後一點，馬特，弄清楚吧。正如您所提到的，它的加速速度比我們預期的要快。目前，我們尚未改變峰值周圍長期指導的整體時間。因此，我們必須觀察這種情況，看看這種情況如何隨著時間的推移而繼續演變，看看這種情況是否加速，或者曲線的形狀在前端變得有點陡峭。

One moment for our next question, please. Our next question comes from the line of Ernesto Rodriguez-Dumont with Cowen.

請稍等一下我們的下一個問題。我們的下一個問題來自埃內斯托·羅德里格斯·杜蒙和考恩的對話。

Congratulations on a great quarter. So one question on HEPLISAV. You have guided previously for gross margins in the low 70s. Now you reported margins on the mid-high 70s. Is that something that we should consider looking forward, maybe improvement in your estimate in gross margin? Or is that something more short term?

恭喜您度過了一個美好的季度。關於 HEPLISAV 的一個問題。您之前曾指導毛利率在 70 左右。現在您報告的利潤率為 70 年代中高點。這是我們未來應該考慮的事情嗎？也許可以提高您對毛利率的估計？還是這是更短期的事情？

Thanks for the question. As you know, and as you've seen sort of the lumpiness over the last couple of years in COGS, we made pretty meaningful investments in our in our manufacturing facility over in Germany. So, we're really excited to see some of the yield improvement translating to improved margins, especially in this quarter.

謝謝你的提問。如您所知，正如您所看到的，過去幾年銷貨成本的波動性很大，我們對德國的製造工廠進行了相當有意義的投資。因此，我們非常高興看到一些產量的提高轉化為利潤率的提高，尤其是在本季。

To answer your question directly, we would expect margins in this level to continue here on out with mid-70s percent margin for the year on average.

為了直接回答您的問題，我們預計這一水平的利潤率將繼續保持在這一水平，全年平均利潤率將達到 70% 左右。

Got it. That's helpful. And if I may, on the shingles vaccine on the presentation, any feedback by you got from from the presentation from situations? And in particular, have you disclosed also the Grade three or Grade four AESI that were presented, in particular the one that led to the discontinuation of treatment?

知道了。這很有幫助。可以的話，關於帶狀皰疹疫苗的演示，您從演示中得到了任何反饋嗎？特別是，您是否也揭露了所提出的三級或四級 AESI，特別是導致治療停止的 AESI？

Yes, we did. The Grade three and four were similar between the two groups. And there was one that led to discontinuation in the lowest in 1018 group but it wasn't related to vaccine. It was thought to be related to vaccine from by the investigator by the sponsor that we would not consider to be related.

是的我們做了。兩組的三年級和四年級成績相近。 1018組中最低的有一個導致停藥，但與疫苗無關。研究者認為申辦者認為與疫苗有關，但我們認為不相關。

One moment for our next question, please. Our next question comes from the line of Roy Buchanan with JMP Securities.

請稍等一下我們的下一個問題。我們的下一個問題來自 JMP 證券公司的 Roy Buchanan。

Great quarter. First one, I guess, on the play, the new brand, just how much was left in the original part of the brand? Do you have access to that entire amount? And then how far does the new total get you? I think the PR says starting in nonhuman primate challenge trial, but it seems like it probably gets quite a bit beyond that. And then I guess, can you just help us understand what the low from the nonhuman primate challenge trial are, as far as getting you to an approval?

很棒的季度。第一個，我猜，在劇中，新的品牌，原來的品牌部分還剩下多少？您可以使用全部金額嗎？那麼新的總數能讓你走多遠呢？我認為公關說要從非人類靈長類動物挑戰試驗開始，但看起來它可能會超出這個範圍。然後我想，您能否幫助我們了解非人類靈長類動物挑戰試驗的低點是什麼，以便讓您獲得批准？

If you recall, the original contract was about $22 million. We have full access to that content. That was to focus on the completion of the Phase II trial. So there's a number of amendments that expanded the contract by about $11 million in total with the largest piece being the nonhuman primate study, which is I think to get your real -- the structural question, how far does that get us? That's one component of a longer-term pathway to support eventual approval that would leverage nonhuman primate challenge studies. And so, that's the first step in that process, which is covered by this particular contract expansion.

如果你還記得的話，最初的合約價值約為 2200 萬美元。我們可以完全存取該內容。那是為了集中精力完成第二階段試驗。因此，有一些修正案使合約總額增加了約 1100 萬美元，其中最大的一部分是非人類靈長類動物研究，我認為這是為了了解你真正的結構性問題，這能讓我們走多遠？這是支持最終批准的長期途徑的組成部分，該途徑將利用非人靈長類動物挑戰研究。因此，這是該過程的第一步，該特定合約擴展涵蓋了這一過程。

Okay. Great. And then just a quick one on shingles. I know you guys still need to talk to the FDA and probably will have more to say after that. But I guess I'm just curious your thoughts around if you have to go ex U.S. for the next trial, is that leverageable for U.S. approval? Or is it a base assumption that you might have to forego to the U.S. market? And if the latter is the case, does it make the most sense to license the candidate out?

好的。偉大的。然後快速了解一下帶狀皰疹。我知道你們仍然需要與 FDA 交談，之後可能會有更多話要說。但我想我只是好奇你的想法，如果你必須去美國進行下一次試驗，這是否可以得到美國的批准？或者這是您可能不得不放棄美國市場的基本假設？如果是後者，那麼授予候選人許可是否最有意義？

Our current strategy is definitely to include the U.S. market. So as you indicated, we'll have to still talk to the agency about our opportunities for a pathway in the U.S., but any sort of strategy that took us into ex U.S. markets for efficacy would be part of a plan to utilize that data to support U.S. licensure.

我們目前的策略肯定是包括美國市場。因此，正如您所指出的，我們仍然必須與該機構討論我們在美國開闢道路的機會，但任何將我們帶入美國以外市場以提高功效的策略都將是利用該數據來實現目標的計劃的一部分。支持美國許可。

One moment for our next question, please. Our next question comes from the line of Jon Miller with Evercore ISI.

請稍等一下我們的下一個問題。我們的下一個問題來自 Evercore ISI 的 Jon Miller。

I guess I'll join everybody else in congratulating you on a great quarter. As a new analysts covering the story, I can only assume every quarter will be as exciting as this one. I appreciate that. That's my question. No. Maybe just wanted -- from me, when you say you're optimizing your commercial efforts for retail IDN segments as the fastest-growing segment, can you maybe give me a little more color on what levers are available to you there versus other segments? And maybe the biggest drivers of share growth there will be? And given the rapid growth you've seen since the Ara -- are you seeing any signs that a pushback from payers, price sensitivity or anything like that in the retail segment that may be influencing further growth there?

我想我會和其他人一起祝賀你們度過了一個美好的季度。作為一名報導這個故事的新分析師，我只能假設每個季度都會像這個季度一樣令人興奮。我很感激。這就是我的問題。不。也許我只是想——當您說您正在優化零售IDN 細分市場的商業努力，將其作為增長最快的細分市場時，您能否給我更多關於您可以使用哪些槓桿（與其他細分市場相比）的資訊？細分？也許股票成長的最大動力是什麼？鑑於自 Ara 以來您所看到的快速增長 - 您是否看到任何跡象表明零售領域的支付者的抵制、價格敏感性或類似因素可能會影響那裡的進一步增長？

Let me break this up. I'll take the second question quickly and then let Donn provide some more insight around the optimization within retail. But in general, and this is really important as it relates to the vaccine business. There's very little payer involvement or engagement in the vaccine business. It's generally good medicine and seen as being -- it's welcomed by payers typically. So, we have not seen any pushback as it relates to the recommendation from a payer or a pricing perspective and we don't expect that would have any impact on the ability for the market to grow that really comes down to physician recommendation and patient acceptance. But as it relates to the operational changes within the field team and the marketing, I'm sorry, the retail segment I'll turn it over to Donn.

讓我來打破這個局面。我將快速回答第二個問題，然後讓 Donn 提供更多零售業優化的見解。但總的來說，這非常重要，因為它與疫苗業務有關。付款人很少參與疫苗業務。它通常是一劑良藥，通常受到付款人的歡迎。因此，我們沒有看到任何阻力，因為它與付款人或定價角度的建議有關，我們預計這不會對市場成長的能力產生任何影響，這實際上取決於醫生的推薦和患者的接受度。但由於它涉及現場團隊和行銷內部的營運變化，抱歉，零售部門我會將其交給 Donn。

Yes. Hi, Jon. So yes, regarding the optimizing of salesforce, not intact the sales force, mainly as it relates specifically to retail, as I mentioned on the call, the targets will be around not only headquarters, which is where we've been quite a bit for quite some time, establishing relationships that allows us to deploy marketing initiatives, but also engaging at the regional, the divisional and the district levels of these retail change, which is so critical to pull through initiatives and education, whatever may be to increase identification and recommendation of hepatitis B vaccine. So, the whole point there is to really engage the retailer at those different levels, and that's part of this process, ensuring we have the right sales force attack to allow us to drive forward the recommendations throughout the top chains. At the same time, within the hospital segment, IDN segment, we've gone to a more vertical structure that allows account executives to own the decision makers at the top as well as pull-through at the clinic level to drive the recommendation. So, we feel really good about where we're at. And a lot of it is based upon a lot of the learnings we've been able to gather over the last several years in launching HEPLISAV-B.

是的。嗨，喬恩。所以，是的，關於銷售人員的優化，而不是完好無損的銷售人員，主要是因為它與零售業具體相關，正如我在電話中提到的，目標不僅圍繞總部，這是我們長期以來一直關注的地方。在相當長的一段時間裡，我們建立了關係，使我們能夠部署行銷舉措，而且還參與這些零售變革的區域、部門和地區層面，這對於完成舉措和教育至關重要，無論是為了增加識別度和推薦乙型肝炎疫苗。因此，重點是真正讓零售商在不同層面上參與進來，這是這個過程的一部分，確保我們擁有正確的銷售人員攻擊，使我們能夠在整個頂級連鎖店中推動建議。同時，在醫院部門、IDN 部門，我們採用了更垂直的結構，允許客戶主管擁有最高層的決策者，並在診所層級拉動以推動推薦。所以，我們對自己所處的位置感覺非常好。其中很大一部分是基於我們在過去幾年推出 HEPLISAV-B 過程中收集到的大量經驗教訓。

Great. That makes sense. Maybe on the Tdap program, can you give any more color on that challenge study that you're planning on starting by the end of the year? How big it's going to be and how that will support further development of that program?

偉大的。這就說得通了。也許在 Tdap 計劃中，您能否為您計劃在今年年底開始的挑戰研究提供更多資訊？它會有多大？它將如何支持該計劃的進一步發展？

We haven't commented on actual size just yet. But as far as how it fits into the whole picture, obviously demonstrating that the product can be protected in humans is critical, and it will allow us to then have an immunogenicity endpoint that we can use to bridge back to in larger studies. So, this is an initial challenge study. It's likely and expected that we would have to do larger challenge studies in addition to this one as part of the longer-term development plan. It's important to also recognize this is a new study design that hasn't really been done before with a vaccine for Pertussis. So, we're working with an investigator now to help support his development of a challenged model where we can use a vaccine and allows disease to progress to identify and test efficacy from humans. And so, this pilot study is important on a number of fronts, one for our product and also to establish the model.

我們尚未評論實際尺寸。但就其如何適應整個情況而言，顯然證明該產品可以在人體中受到保護是至關重要的，這將使我們能夠獲得一個免疫原性終點，我們可以用它來進行更大規模的研究。所以，這是一項初步的挑戰研究。作為長期發展計畫的一部分，除了這項研究之外，我們很可能並且預計還必須進行更大規模的挑戰研究。重要的是要認識到這是一項新的研究設計，之前還沒有在百日咳疫苗上真正進行過研究。因此，我們現在正在與一名研究人員合作，幫助支持他開發一種具有挑戰性的模型，在該模型中我們可以使用疫苗並允許疾病進展，以識別和測試人類的功效。因此，這項試驗研究在許多方面都很重要，其中之一是對我們的產品而言，也是為了建立模型。

And we have no further questions at this time. I would like to hand the conference back over to Mr. Ryan Spencer, Chief Executive Officer, for closing remarks. You may begin.

目前我們沒有進一步的問題。我想將會議交回給執行長 Ryan Spencer 先生致閉幕詞。你可以開始了。

Thank you, Operator, and thank you all for joining us today. We appreciate your interest in Dynavax. We are very excited about our continued progress and the strength of our position, which we believe allows us to focus on executing our long-term objectives to drive value through advancement of meaningful products to help protect the world from infectious diseases. We look forward to updating you on our progress. Operator, you may end the call.

謝謝運營商，也謝謝大家今天加入我們。我們感謝您對 Dynavax 的興趣。我們對我們的持續進步和我們的地位感到非常興奮，我們相信這使我們能夠專注於執行我們的長期目標，透過開發有意義的產品來推動價值，幫助保護世界免受傳染病的侵害。我們期待向您通報我們的最新進展。接線員，您可以結束通話了。

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

謝謝。女士們、先生們，謝謝你們今天加入我們。今天的電話會議到此結束。您現在可以斷開連線。祝大家有美好的一天。