Dynavax Technologies Corp (DVAX) 2023 Q3 法說會逐字稿

Good day, ladies and gentlemen, and welcome to Dynavax Technologies Third Quarter 2023 Financial Results Conference Call. As a reminder, this call is being recorded. (Operator Instructions)

女士們、先生們，美好的一天，歡迎參加 Dynavax Technologies 2023 年第三季財務業績電話會議。提醒一下，此通話正在錄音。 （操作員說明）

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

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。今天與我一起來自 Dynavax 的是首席執行官 Ryan Spencer；唐恩‧卡塞爾 (Donn Casale)，首席商務官；羅布‧詹森，首席醫療官；和財務長凱莉·麥克唐納。

Earlier today, Dynavax released financial results for the third quarter ended September 30, 2023. Copies of the press release and a supplementary slide presentation are available at Dynavax's website.

今天早些時候，Dynavax 發布了截至 2023 年 9 月 30 日的第三季財務業績。新聞稿和補充幻燈片簡報的副本可在 Dynavax 網站上取得。

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, the clinical trial starts and data readouts and potential future uses or demands for our CpG 1018 adjuvant.

在開始之前，我建議您，我們今天將根據我們當前的預期和信念做出前瞻性陳述，包括但不限於潛在市場規模、市場細分、有效的營銷努力、未來預期市場份額和相關增長費率和相關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CpG 的潛在未來用途或需求1018助劑。

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

這些陳述涉及風險和不確定性，我們的實際結果可能存在重大差異。這些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。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. Good afternoon, everyone, and thank you for taking the time to join us to review Dynavax's results for the third quarter of 2023. We're pleased to report yet another record quarter of HEPLISAV-B revenue as we progress toward our goal of establishing HEPLISAV-B as the leading adult hepatitis B vaccine in the U.S., a market opportunity which we believe will continue to expand to over $800 million by 2027.

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 年第三季度的業績。隨著我們朝著建立 HEPLISAV 的目標邁進，我們很高興報告 HEPLISAV-B 收入再創歷史新季度-B 作為美國領先的成人乙型肝炎疫苗，我們相信這個市場機會將繼續擴大到2027 年超過8 億美元。

HEPLISAV-B delivered $62 million in quarterly net product revenue, which is a 66% year-over-year increase. This record quarter was driven by market share gains in the overall adult hepatitis B vaccine market and in particular, by HEPLISAV-B gaining majority market share in both the key market segments of retail pharmacy and integrated delivery networks.

HEPLISAV-B 季度淨產品收入為 6,200 萬美元，較去年同期成長 66%。這一創紀錄的季度是由整個成人乙型肝炎疫苗市場的市場份額增長推動的，特別是 HEPLISAV-B 在零售藥房和綜合交付網絡的關鍵細分市場中獲得了多數市場份額。

As a result of the strong HEPLISAV-B performance in the first 9 months of the year, we are again raising our revenue expectations for the full year. We now expect HEPLISAV-B net product revenue to be in the range of $210 million to $220 million, representing up to 75% growth this year.

由於 HEPLISAV-B 在今年前 9 個月表現強勁，我們再次上調全年營收預期。我們目前預計 HEPLISAV-B 產品淨收入將在 2.1 億美元至 2.2 億美元之間，今年成長高達 75%。

Based on our commercial execution to-date, we continue to strengthen our financial position with cash and investments increasing to $720 million at quarter end. This position enabled us to support our efforts to maximize HEPLISAV-B opportunity in this growing market, while also advancing our clinical pipeline into the next stage of trials in 2024, which Rob will cover in a few minutes.

根據迄今為止的商業執行情況，我們的財務狀況繼續增強，現金和投資在季度末增至 7.2 億美元。這個職位使我們能夠支持我們在這個不斷增長的市場中最大化HEPLISAV-B 機會的努力，同時還將我們的臨床管道推進到2024 年的下一階段試驗，Rob 將在幾分鐘內介紹這一點。

In addition, as we've discussed on prior calls, we continue to evaluate strategic opportunities to diversify our product portfolio and create future commercial opportunities. We remain committed to disciplined capital allocation to generate significant value and accelerate growth. We look forward to providing updates on these efforts in the future.

此外，正如我們在先前的電話會議中所討論的那樣，我們將繼續評估策略機會，以使我們的產品組合多樣化並創造未來的商業機會。我們仍然致力於嚴格的資本配置，以創造巨大的價值並加速成長。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 to provide more details on the tremendous HEPLISAV-B performance in the third quarter.

現在，我將把電話轉給 Donn，以提供有關第三季 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 quarter for HEPLISAV-B. We achieved record net product sales and market share in the quarter. The HEPLISAV-B market continues to grow in the U.S. following the ACIP universal recommendation for hepatitis B vaccination, which now represents one of the largest vaccine market opportunities for adults.

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的更多細節。我們在本季度實現了創紀錄的產品淨銷售額和市場份額。在 ACIP 對乙型肝炎疫苗接種的普遍建議之後，HEPLISAV-B 市場在美國持續成長，乙型肝炎疫苗現在代表了成人最大的疫苗市場機會之一。

As a reminder, we believe this recommendation will be a significant catalyst for growth and estimate that hepatitis B vaccine market could grow to over $800 million by 2027, with HEPLISAV-B achieving a majority market share by that time. We continue to see indicators of market expansion from ACS Universal.

提醒一下，我們相信這項建議將成為成長的重要催化劑，並估計乙型肝炎疫苗市場到 2027 年可能會成長到 8 億美元以上，屆時 HEPLISAV-B 將佔據多數市場份額。我們繼續看到 ACS Universal 的市場擴張跡象。

In the third quarter, the total hepatitis B vaccine market grew by approximately 29% year-over-year. HEPLISAV-B continues to increase its total market share, achieving 41% in the quarter compared to 32% during the same period last year. Net product revenue grew 66% year-over-year to $62 million in the quarter. This sales growth continues to be driven by HEPLISAV-B's strong performance in 2 critical segments: retail pharmacy and integrated delivery networks or IDNs.

第三季度，B肝疫苗市場總量年增約29%。 HEPLISAV-B 的總市佔率持續增加，本季達到 41%，而去年同期為 32%。本季產品淨收入年增 66%，達到 6,200 萬美元。這種銷售成長繼續受到 HEPLISAV-B 在兩個關鍵領域的強勁表現的推動：零售藥房和綜合交付網路或 IDN。

We continue to focus our sales and marketing efforts on the retail pharmacy and IDN segment as we expect to see most of the anticipated market growth from the universal recommendation in these segments, estimating both will grow to represent approximately 60% of the total hepatitis B market by 2027.

我們繼續將銷售和行銷工作重點放在零售藥房和 IDN 領域，因為我們預計大部分預期市場增長來自這些領域的普遍推薦，預計這兩個領域將增長到佔乙型肝炎市場總量的約 60%到2027 年。

For IDN, at the end of the third quarter, HEPLISAV-B's market share increased to approximately 54% compared to approximately 43% at the end of the third quarter last year. We are focused on working with large health systems at the C-suite and clinic level to pull through ongoing adoption of the Universal recommendation. In this segment, we are seeing continued strong conversion and expansion from large customers that are adopting the Universal recommendation, driving meaningful increases in their hepatitis B vaccine purchases.

對於IDN，截至第三季末，HEPLISAV-B的市佔率增至約54%，而去年第三季末約為43%。我們專注於與大型衛生系統的高階管理層和診所層級合作，以推動普遍建議的持續採用。在這一細分市場中，我們看到採用通用建議的大客戶持續強勁的轉換和擴張，推動了他們的乙型肝炎疫苗購買量的顯著增加。

In the third quarter, year-over-year hepatitis B vaccine market growth in the IDN segment was approximately 40%. In the retail pharmacy segment, we have made significant progress year-to-date, including several large national chains making HEPLISAV B their preferred adult hepatitis B vaccine. In the third quarter, HEPLISAV B achieved a majority share in this important segment, which is expected to drive significant growth in the coming years.

第三季度，IDN 領域的乙型肝炎疫苗市場年增約 40%。在零售藥房領域，我們今年迄今取得了重大進展，包括幾家大型全國連鎖店將 HEPLISAV B 作為他們首選的成人乙型肝炎疫苗。第三季度，HEPLISAV B 在這一重要領域取得了多數份額，預計將在未來幾年推動顯著成長。

Year-over-year hepatitis B vaccine market growth in the retail pharmacy segment was 80%, with HEPLISAV-B's market share increasing to approximately 53% compared to approximately 43% at the end of the third quarter last year. During the third quarter, we completed the optimization of our sales force to expand our promotional reach in the retail pharmacy segment, which is intended to further drive market expansions. This expanded sales force reach will call on headquarters, divisional, regional and district leaders across the top retail chain.

零售藥局領域乙肝疫苗市場年增80%，HEPLISAV-B的市佔率從去年第三季末的約43%增至約53%。第三季度，我們完成了銷售團隊的優化，擴大了零售藥局領域的促銷範圍，旨在進一步推動市場擴張。擴大的銷售隊伍覆蓋範圍將吸引頂級零售連鎖店的總部、部門、區域和地區領導人。

We are also excited to see the impact of our collaborative marketing initiatives with top national retail chains that launched at the end of the second quarter. We expect the strong collaborative relationships across the top retail chain, plus our expanded sales force reach will enable continued strong market growth and market leadership within this important segment over the years to come.

我們也很高興看到我們與第二季末推出的全國頂級零售連鎖店合作行銷計劃的影響。我們預計，頂級零售連鎖店之間的牢固合作關係，加上我們擴大的銷售隊伍覆蓋範圍，將在未來幾年實現這一重要細分市場持續強勁的市場成長和市場領導地位。

As Ryan noted, based on our progress year-to-date and these strong results, we are raising our full year 2023 net product revenue guidance for HEPLISAV-B to be in the range of $210 million to $220 million. This updated guidance reflects our tremendous momentum in the market, while still factoring in expected fourth quarter seasonality and the impact from customer-focused vaccine efforts on the new RC vaccine, COVID revaccination and seasonal flu.

正如 Ryan 所指出的那樣，根據我們今年迄今為止的進展和這些強勁的業績，我們將 HEPLISAV-B 的 2023 年全年淨產品收入指引提高到 2.1 億美元至 2.2 億美元之間。這項更新後的指導反映了我們在市場上的巨大動力，同時仍然考慮了預期的第四季度季節性因素以及以客戶為中心的疫苗工作對新RC 疫苗、新冠疫苗重新接種和季節性流感的影響。

We believe the strain on customer bandwidth due to RC, COVID and flu vaccination will be temporary and limited to the fourth quarter. We remain extremely confident in the long-term growth of the hepatitis B market and are forecasting annual growth of approximately 10% to 50% over the next several years with HEPLISAV-B continue to gain meaningful increases in total market share over that time.

我們認為，由於 RC、新冠肺炎和流感疫苗接種而對客戶頻寬造成的壓力將是暫時的，並且僅限於第四季度。我們對B型肝炎市場的長期成長仍然充滿信心，並預測未來幾年的年增長率約為 10% 至 50%，HEPLISAV-B 在此期間將繼續獲得顯著的總市場份額成長。

In summary, we had an outstanding third quarter, reaffirming our confidence in HEPLISAV-B becoming the market leader in the expanding hepatitis B vaccine market. We are very proud of our commercial team's execution and encouraged by the progress and momentum for HEPLISAV-B, establishing a majority market share in the key segments of retail pharmacy and IDN.

總而言之，我們在第三季表現出色，再次堅定了我們對 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。我們對我們商業團隊的執行力感到非常自豪，並對 HEPLISAV-B 的進展和勢頭感到鼓舞，在零售藥房和 IDN 的關鍵領域建立了多數市場份額。

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. As a reminder, in our development pipeline, we're advancing innovative and diversified vaccines that leverage our CpG 1018 adjuvant with proven antigens. We also continue to identify new opportunities to leverage our CpG 1018 adjuvant through multiple innovative preclinical and discovery efforts with leading collaborators.

謝謝你，唐恩。提醒一下，在我們的開發管道中，我們正在開發創新和多樣化的疫苗，這些疫苗利用我們的 CpG 1018 佐劑和經過驗證的抗原。我們也透過與領先合作者的多項創新臨床前和發現工作，繼續尋找利用我們的 CpG 1018 佐劑的新機會。

Starting with our shingles vaccine program, Z-1018. Currently, there is a blockbuster vaccine on the market, but we believe that there's an opportunity to develop an improved vaccine given the challenging tolerability profile of the current market-leading product. One of the unique advantages we believe of our CpG 1018 adjuvant is its safety and tolerability profile, combined with its ability to induce strong CD4-positive T cell responses, which we believe are critical to preventing the reactivation of disaster virus.

從我們的帶狀皰疹疫苗計劃 Z-1018 開始。目前，市場上有一種重磅疫苗，但我們相信，鑑於當前市場領先產品的耐受性具有挑戰性，有機會開發改進的疫苗。我們認為 CpG 1018 佐劑的獨特優勢之一是其安全性和耐受性，以及誘導強烈 CD4 陽性 T 細胞反應的能力，我們認為這對於防止災難病毒重新活化至關重要。

Results from our Phase I trial support the continued development of Z-1018 as they demonstrate the opportunity to develop a shingles vaccine with an improved tolerability profile and comparable efficacy. Recently, we received Type B meeting feedback from FDA on the Z-1018 program. We believe this feedback is supportive of our proposed clinical development plan that includes a pivotal Phase III placebo-controlled efficacy study.

我們的 I 期試驗結果支持 Z-1018 的繼續開發，因為它們證明了開發具有改進的耐受性和可比較功效的帶狀皰疹疫苗的機會。最近，我們收到了FDA關於Z-1018計畫的B型會議回饋。我們相信這項回饋支持我們提出的臨床開發計劃，其中包括關鍵的 III 期安慰劑對照療效研究。

Based on this feedback, we plan to submit an IND application to the FDA to support the initiation of a Phase I/II trial of Z-1018 in the first half of 2024.

根據這項回饋，我們計劃向 F​​DA 提交 IND 申請，以支持在 2024 年上半年啟動 Z-1018 的 I/II 期試驗。

Turning next to the Tdap-1018 program. So this is an investigational vaccine candidate that's intended for active booster immunization against tetanus, diphtheria, and pertussis or Tdap. 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-biased immune response.

接下來轉向 Tdap-1018 計劃。因此，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。目前的 Tdap 疫苗有局限性，包括有效性減弱。我們相信，使用我們的 CpG 1018 佐劑產生偏向 Th1 的免疫反應，有機會延長保護持續時間。

We've completed both a Phase I clinical trial in adults and adolescents as well as a pertussis challenge study in nonhuman primates. We recently received Type B pre-IND meeting feedback from FDA on the Tdap-1018 clinical development and regulatory pathways. Together, results from our Phase I study, our nonhuman primate study and the feedback from FDA, all support proceeding to a human challenge study in mid-2024.

我們已經完成了成人和青少年的 I 期臨床試驗以及非人靈長類動物的百日咳攻擊研究。我們最近收到 FDA 關於 Tdap-1018 臨床開發和監管途徑的 B 型 IND 前會議回饋。我們的 I 期研究、非人類靈長類動物研究的結果以及 FDA 的回饋都支持在 2024 年中期進行人類挑戰研究。

Moving on to the plague program. This is in collaboration with and funded by the U.S. Department of Defense. We're conducting a Phase II trial evaluating the immunogenicity, safety and tolerability of a 2-dose plague vaccine candidate that's adjuvanted with CpG 1018. The CpG 1018 adjuvanted vaccine candidate's mechanism of action has the potential to speed up time to protection with fewer doses compared to the 3-dose alum-adjuvant regimen that has been previously evaluated by the DoD. Earlier this year, we successfully completed part 1 of the Phase II study and subject dosing in part 2 is now complete. We anticipate top line data in 2024.

繼續瘟疫計劃。這是與美國國防部合作並由其資助的。我們正在進行一項II 期試驗，評估以CpG 1018 為佐劑的2 劑候選鼠疫疫苗的免疫原性、安全性和耐受性。CpG 1018 佐劑候選疫苗的作用機制有可能以更少的劑量加快獲得保護的時間與國防部先前評估過的 3 劑量明礬輔助方案相比。今年早些時候，我們成功完成了 II 期研究的第一部分，第二部分的受試者給藥現已完成。我們預計 2024 年將出現頂線資料。

Dynavax and the U.S. Department of Defense recently executed a contract modification to support advancement of the plague vaccine candidate into a nonhuman primate challenge study, which was initiated in August. In addition to these development programs, we've also filed a supplemental BLA for HEPLISAV-B vaccination of adults on hemodialysis, which the FDA has accepted with a PDUFA action date in May of 2024.

Dynavax 和美國國防部最近執行了一項合約修改，以支持將鼠疫候選疫苗推進到 8 月啟動的非人類靈長類動物挑戰研究中。除了這些開發計劃之外，我們還提交了針對接受血液透析的成人接種 HEPLISAV-B 疫苗的補充 BLA，FDA 已接受該補充 BLA，並於 2024 年 5 月確定 PDUFA 行動日期。

Now if approved, this would allow us to promote a 4-dose regimen of HEPLISAV-B for the dialysis population, which comprised about 11% of the total U.S. hepatitis B vaccine market in 2022. We look forward to continuing to make progress across these programs in the months ahead and we're excited to initiate the next clinical trials for both our shingles and Tdap programs in the coming year.

現在，如果獲得批准，這將使我們能夠向透析人群推廣 4 劑 HEPLISAV-B 方案，到 2022 年，透析人群約占美國乙型肝炎疫苗市場總量的 11%。我們期待在這些方面繼續取得進展我們很高興能在未來一年啟動帶狀皰疹和Tdap 計畫的下一個臨床試驗。

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 excited to report on a strong third quarter. I'll review the key financial results and then share 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 detailed financial information.

謝謝你，羅布。我很高興地報告第三季的強勁表現。我將回顧主要財務業績，然後分享我們最新的全年指引。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 third quarter of 2023 were $70 million, driven by HEPLISAV-B net product revenue of $62 million. Compared to the third quarter of last year, HEPLISAV-B net product revenue grew by 66%. We continue to be excited about the uptick trajectory for HEPLISAV-B with consistent growth in key market segments.

從收入開始。 2023 年第三季的總收入為 7,000 萬美元，得益於 HEPLISAV-B 產品淨收入 6,200 萬美元。與去年第三季相比，HEPLISAV-B產品淨收入成長了66%。我們繼續對 HEPLISAV-B 的上升軌跡感到興奮，並在關鍵細分市場中持續成長。

Based on the strong results for the first 9 months of the year, we are raising our HEPLISAV-B net life revenue guidance for the full year to $210 million to $220 million compared to prior guidance of $200 million to $215 million, reflecting our confidence in HEPLISAV-B's continued growth for the full year. We are also pleased with the continued trend in the margin profile for HEPLISAV-B with gross margin of approximately 79% in Q3 compared to about 69% last year and we continue to expect gross margins to average in the mid-70%s for the full year.

基於今年前 9 個月的強勁業績，我們將全年 HEPLISAV-B 淨壽險收入指引提高至 2.1 億至 2.2 億美元，而先前的指引為 2 億至 2.15 億美元，這反映了我們對HEPLISAV-B全年持續成長。我們也對 HEPLISAV-B 利潤率的持續趨勢感到滿意，第三季毛利率約為 79%，而去年約為 69%，我們繼續預計今年毛利率平均在 70% 左右。全年。

HEPLISAV-B margin improvements have been driven by lower per unit manufacturing costs as a result of the previous investments to drive process development improvements.

HEPLISAV-B 利潤率的提高是由於先前投資推動製程開發改進而降低了單位製造成本。

Other revenue was $7 million for the third quarter compared to $4 million in the prior year period, representing revenue related to the plague vaccine program in collaboration with and funded by the U.S. Department of Defense. The increase is primarily driven by the advancement into a nonhuman primate challenge study.

第三季的其他收入為 700 萬美元，而去年同期為 400 萬美元，這是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。這一增長主要是由非人類靈長類動物挑戰研究的進展所推動的。

Now turning to our research and development expenses for the quarter, which increased to $14 million compared to $13 million for the prior year period. The increase was driven by continued advancement in our clinical and preclinical development programs and collaborations. Selling, general and administrative expenses for the quarter were $38 million compared to $32 million for the prior year period.

現在讓我們來談談本季的研發費用，該費用從去年同期的 1,300 萬美元增加到 1,400 萬美元。這一增長是由我們的臨床和臨床前開發計劃及合作的持續進步所推動的。本季的銷售、一般和管理費用為 3,800 萬美元，而去年同期為 3,200 萬美元。

The increase was primarily driven by higher compensation and related personnel costs and an overall increase in targeted commercial and marketing efforts designed to increase HEPLISAV-B market share and maximize the opportunities presented by the ACIP's universal recommendations. These results generated GAAP net income of $14 million or $0.11 per share basic and $0.10 per share diluted in Q3 compared to GAAP net income of $64 million or $0.50 per share basic and $0.43 per share diluted for the prior year period.

這一增長主要是由於薪酬和相關人員成本的提高以及旨在增加HEPLISAV-B 市場份額並最大限度地利用ACIP 普遍建議所帶來的機會的有對比性的商業和營銷工作的整體增加所推動的。這些業績在第三季產生的GAAP 淨利為1,400 萬美元，即基本每股收益0.11 美元，稀釋後每股收益為0.10 美元，而去年同期的GAAP 淨利潤為6,400 萬美元，即基本每股收益0.50 美元，稀釋後每股收益0.43 美元。

Moving to the balance sheet. We ended the third quarter with cash, cash equivalents and marketable securities of approximately $720 million, an increase compared to our year-end balance of $624 million at the end of 2022. Based on our current operating plans, we continue to expect to finish 2023 with a positive free cash flow for the year.

轉向資產負債表。截至第三季末，我們的現金、現金等價物和有價證券約為 7.2 億美元，比 2022 年底的年末餘額 6.24 億美元有所增加。根據我們目前的營運計劃，我們繼續預計到 2023 年底全年自由現金流為正。

We are revising our full year 2023 financial guidance expectations, including raising our HEPLISAV-B net product revenue expectations to be between approximately $210 million to $220 million and refining our operating expense guidance, including research and development expenses to be between $50 million to $60 million as well as selling, general and administrative expenses to be between $145 million and $155 million.

我們正在修訂2023 年全年財務指導預期，包括將HEPLISAV-B 淨產品收入預期提高至約2.1 億美元至2.2 億美元之間，並完善我們的營運費用指導，包括將研發費用提高至5,000 萬美元至6,000 萬美元之間以及銷售、一般和管理費用在 1.45 億美元至 1.55 億美元之間。

In closing, we believe that with our strong financial profile, we are well positioned to drive sustainable growth in our core HEPLISAV-B business, capture a majority market share and lead the expansion of the adult hepatitis B vaccine market. We look forward to progressing our R&D portfolio of vaccine candidates, while continuing to be extremely thoughtful in how we allocate our capital to accelerate growth and build beyond our current base business. We are excited about our progress to-date and we look forward to continuing to deliver on our goals for this year and beyond.

最後，我們相信，憑藉我們強勁的財務狀況，我們有能力推動核心 HEPLISAV-B 業務的可持續成長，佔據多數市場份額，並引領成人乙型肝炎疫苗市場的擴張。我們期待著推進我們的候選疫苗研發組合，同時繼續深思熟慮如何分配我們的資本以加速成長並超越我們當前的基礎業務。我們對迄今為止的進展感到興奮，並期待繼續實現今年及以後的目標。

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

謝謝大家今天的關注。接線員，我們現在要開始今天電話的問答部分。

(Operator Instructions) Our first question comes from the line of Matthew Phipps with William Blair.

（操作員說明）我們的第一個問題來自馬修·菲普斯和威廉·布萊爾的對話。

Congrats on another great quarter and great market share gains. Donn, real quick, you mentioned -- I think you said you expect that the total market to have 10% to 15% annual growth over the next several years. Just want to make sure you're referring to total market there and then you guys' ability to gain market share on top of that?

恭喜又一個出色的季度和巨大的市場份額增長。 Donn，很快，您提到——我想您說過您預計未來幾年整個市場的年增長率為 10% 到 15%。只是想確保您指的是那裡的總市場，然後您是否有能力在此基礎上獲得市場份額？

Yes, so my comments were around the entire hep B market would be, we expect around 10% to 15% year-over-year growth for the next couple of years, so total.

是的，所以我對整個乙肝市場的評論是，我們預計未來幾年的同比增長約為 10% 至 15%，所以總體而言。

Yes. Okay. In the shingles plans, now that you got the feedback, congrats on confirming a placebo-controlled study of Phase III. So is the next step still to evaluate multiple doses of the antigen that you are producing yourselves?

是的。好的。在帶狀皰疹計劃中，既然您收到了回饋，那麼恭喜您確認了第三階段的安慰劑對照研究。那麼下一步仍然是評估您自己生產的多劑量抗原嗎？

Matt, thank you for the question. Yes, that's the plan for the Phase I/II studies to evaluate a couple of different doses of antigen.

馬特，謝謝你的提問。是的，這就是評估幾種不同劑量抗原的 I/II 期研究計劃。

All right. And then lastly, Ryan, earlier this year, you talked a little more about potential for external business development as being a priority. But now I don't really see any mention of that. Is that due to more change in excitement on your end for the internal shingles and Tdap programs or maybe just a lack of attractive external opportunities?

好的。最後，瑞安，今年早些時候，您更多地談到了外部業務發展的潛力作為優先事項。但現在我真的沒有看到任何提及這一點。這是因為您對內部帶狀皰疹和 Tdap 計劃的興奮程度發生了更多變化，還是只是缺乏有吸引力的外部機會？

No, it's still a priority. I mean, we mentioned it in my opening remarks. It still continues to be a priority for us to find opportunities to accelerate growth.

不，這仍然是優先事項。我的意思是，我們在開場白中提到了這一點。尋找加速成長的機會仍然是我們的首要任務。

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

請稍等一下我們的下一個問題。它來自埃內斯托·羅德里格斯·杜蒙 (Ernesto Rodriguez-Dumont) 和考恩 (Cowen) 的血統。

Congratulations on another great quarter. So you gained market share in both segments, the IDN segment and the retail segment. But it seems like at least the quarter-over-quarter share gain was more pronounced in the retail segment than the IDN segment. I was wondering, is that noise or is that maybe reflects more difficulty to penetrate the IDN market at this moment or anything like that?

恭喜又一個偉大的季度。因此，您在 IDN 細分市場和零售細分市場這兩個細分市場中都獲得了市場份額。但零售領域的季度環比成長似乎比 IDN 領域更為明顯。我想知道，這種噪音是噪音還是反映了目前進入 IDN 市場更加困難或類似的情況？

This is Donn. I mean, I think the best way to think about the 2 segments, IDN is probably more consistent around buying purchases and buying patterns versus within the retail segment. You're going to see more either seasonality or different types of purchasing patterns that will drive more fluctuation in market share. So there's different types of segments as you think about the hep B market.

這是唐恩。我的意思是，我認為考慮這兩個細分市場的最佳方式是，與零售細分市場相比，IDN 在購買購買和購買模式方面可能更加一致。您將看到更多的季節性或不同類型的購買模式，這將導致市場份額出現更大的波動。因此，當您考慮乙肝市場時，會有不同類型的細分市場。

Okay. And then looking into 2024 and the [BLA] in the dialysis population, should we expect a sort of like an inflection point there? Or I guess what's your expectations on further acceleration if and when you get data, [table] expansion?

好的。然後展望 2024 年和透析人群的 [BLA]，我們是否應該期待那裡出現某種拐點？或者我猜當您獲得數據、[表]擴展時，您對進一步加速的期望是什麼？

This is Ryan. We haven't actually provided any guidance for '24. And we -- and I think I understand your point as far as when we're able to start promoting, but we'd like to first get through the approval, engage the customer before we're able to make any commentary around specific expectations in that segment.

這是瑞安。我們實際上還沒有為 '24 提供任何指導。我們 - 我想我理解您的觀點，就我們何時能夠開始促銷而言，但我們希望首先獲得批准，在我們能夠圍繞具體期望做出任何評論之前與客戶互動在那個部分。

Next question comes from the line of Jonathan Miller from Evercore ISI.

下一個問題來自 Evercore ISI 的 Jonathan Miller。

And I'll join everybody else in congratulating you on another great quarter. I would love to get some color maybe on gross margin trends. I know you announced earlier this quarter that you had better pricing in your manufacturing contracts.

我將與其他人一起祝賀您又一個偉大的季度。我很想了解一些有關毛利率趨勢的資訊。我知道你們本季早些時候宣布你們的製造合約有更好的定價。

How should we expect gross margin to evolve as volumes increase? And then maybe secondarily, as you're growing market share nicely overall and in those key segments that you've been talking about, is there anywhere that's proving challenging to grow, places where legacy contracting is slowing things down? Are there some other headwinds? And is there any dynamic related to that that we can expect to change going forward?

隨著銷量的增加，我們預計毛利率將如何變化？其次，隨著您總體上以及您一直在談論的那些關鍵領域中市場份額的良好增長，是否有任何地方證明增長具有挑戰性，遺留合約正在放慢速度的地方？還有其他一些阻力嗎？我們可以預期未來會發生什麼與此相關的動態變化嗎？

Thanks for the question. This is Kelly. I'll take the first one and then hand it over to Donn for the second question. We're really proud of the way that we've been able to execute some of the margin improvements. I mean, this is a result of many years of investments and efficiencies that we've made, not only in our Dusseldorf facility, but as we continue to engage with our CMOs for adjuvant manufacturers. You can see the improved trends throughout the year, as you noted.

謝謝你的提問。這是凱利。我將回答第一個問題，然後交給 Donn 回答第二個問題。我們對能夠實現一些利潤率改善的方式感到非常自豪。我的意思是，這是我們多年投資和提高效率的結果，不僅是在杜塞爾多夫工廠，而且是我們繼續與助劑製造商的 CMO 合作。正如您所指出的，您可以看到全年的改善趨勢。

Additionally, I mean just as a reminder, we did reissue our guidance or reiterate our guidance that we believe for the full year, we're going to have average gross margins in the mid-70%s. We would expect next year to continue to see strong margins, more or less consistent with what we've seen in this most recent quarter.

此外，我的意思是提醒一下，我們確實重新發布了我們的指導意見或重申了我們的指導意見，我們相信全年的平均毛利率將在 70% 左右。我們預計明年將繼續看到強勁的利潤率，或多或少與我們在最近一個季度看到的情況一致。

Yes. And John, regarding market share, obviously, you heard the numbers regarding retail pharmacy and IDN and we're really proud of the market share gains quarter-over-quarter. One of the areas that's difficult and always has been difficult is kind of this long tail of customer, which is approximately 40,000 locations that order very little hepatitis B vaccine. So penetrating that universe of customers has been challenging from a market share perspective.

是的。約翰，關於市場份額，顯然，您聽說過有關零售藥房和 IDN 的數據，我們對市場份額逐季度增長感到非常自豪。一直以來都很困難的領域之一就是客戶的長尾，大約有 40,000 個地點訂購的乙型肝炎疫苗很少。因此，從市場份額的角度來看，滲透到客戶群中一直是一個挑戰。

But certainly, that's why we focus our efforts back to retail, back to IDN, where we believe the vast majority of growth will happen in those 2 segments. So we feel very confident around our growth opportunities as we look ahead. But from a market share perspective, in that long tail, that's been difficult in the past for market share.

但當然，這就是為什麼我們將精力集中在零售、IDN 上，我們相信絕大多數成長將發生在這兩個細分市場。因此，展望未來，我們對我們的成長機會充滿信心。但從市佔率的角度來看，在長尾中，過去很難獲得市場佔有率。

Great. And then maybe if I can squeeze one more in there to piggyback on that earlier question about [BD]. Given that it's still a priority for you, how do you view the current market environment, valuations that are out there as a potential acquirer? I think we've been seeing some motion in that across the industry, but it does feel like there's opportunities from the valuation perspective. How do you view infectious disease relative to the rest of the market?

偉大的。然後也許我可以再擠進去一個，以配合之前關於 [BD] 的問題。鑑於這仍然是您的首要任務，您如何看待當前的市場環境以及潛在收購者的估值？我認為我們已經看到了整個行業的一些動向，但從估值的角度來看，確實存在機會。相對於市場的其他部分，您如何看待傳染病？

Yes. Thanks, Jon. We agree. I mean I think it's hard not to miss that point, but we have to really focus on staying disciplined and finding the right fit for us for our business and our plans going forward. I think the trap of a good deal is not something we're really going to fall into. We want to really make sure it's the right thing for our business and require us to continue to be disciplined.

是的。謝謝，喬恩。我們同意。我的意思是，我認為很難不錯過這一點，但我們必須真正專注於保持紀律，並為我們的業務和未來的計劃找到合適的人選。我認為我們不會真正陷入好交易的陷阱。我們希望真正確保這對我們的業務是正確的，並要求我們繼續遵守紀律。

Our next question comes from the line of Roy Buchanan with JMP Securities.

我們的下一個問題來自 JMP 證券公司的 Roy Buchanan。

Had a few follow-ups on the 1018. Just if you could give any more detail on what the FDA said. Do you have the actual minutes back from the meeting? Did they explicitly recognize the correlative protection for the pivotal trial? Is there any other details you can give us around a potential pivotal design?

對 1018 進行了一些跟進。如果您能提供有關 FDA 所說內容的更多詳細資訊。您有會議的實際記錄嗎？他們是否明確承認關鍵試驗的相關保護？您是否可以向我們提供有關潛在關鍵設計的任何其他細節？

Roy, this is Ryan. I will make a quick high-level comment. Rob, feel free to add to it. I think we still continue to believe that this is a placebo-controlled efficacy study, not a correlate protection for the Z-1018 program. And the engagement with the FDA and the written response indicated support for that approach. Rob, do you have any other comments to make on top of that?

羅伊，這是瑞安。我將快速發表高級別評論。羅布，請隨意添加。我認為我們仍然繼續相信這是一項安慰劑對照功效研究，而不是 Z-1018 項目的相關保護。與 FDA 的接觸和書面答覆表明了對這種方法的支持。羅布，除此之外您還有其他意見嗎？

Yes. No. It's an efficacy study. So there was no mention of correlates, nor did we really ask about correlates. And I think the design of the study is going to be pretty typical of GSK's old design for Shingrix in terms of size endpoints. We haven't finalized any of that, but don't be surprised if it looks a lot like that.

是的。不，這是一項功效研究。所以沒有提到相關性，我們也沒有真正詢問相關性。我認為研究的設計在規模終點方面將非常典型地採用葛蘭素史克 (GSK) 對 Shingrix 的舊設計。我們還沒有最終確定其中的任何內容，但如果它看起來很像那也不要感到驚訝。

Okay. Great. That seems like a pretty big win in my view. And then just a quick one for Kelly. I guess what's driving the decrease in R&D guidance for the year?

好的。偉大的。在我看來，這似乎是一個相當大的勝利。然後是凱利的快速介紹。我猜是什麼導致了今年研發指導的下降？

Thanks, Roy. So it's just timing of deployment of our spend here. That's all.

謝謝，羅伊。所以這只是我們在這裡部署支出的時機。就這樣。

We have no further questions at this time. I would like to turn the call 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。我想請執行長瑞安‧史賓塞 (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're excited about our recent accomplishments and the strength of our position. 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。我們對最近的成就和我們的地位感到興奮。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, this concludes today's conference call. Thank you for joining us. You may now disconnect. Everyone, have a wonderful day.

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