Dynavax Technologies Corp (DVAX) 2024 Q1 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Dynavax Technologies first quarter 2024 financial results conference call. As a reminder, this call is being recorded. At the end of the company's prepared remarks, we'll open the call for questions and provide specific participation instructions at that time.

女士們、先生們，美好的一天，歡迎參加 Dynavax Technologies 2024 年第一季財務業績電話會議。提醒一下，此通話正在錄音。在公司準備好的發言結束時，我們將開始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. Please begin, sir.

我現在想將電話轉給投資者關係和企業傳播副總裁 Paul Cox。請開始吧，先生。

Thank you for participating in today's call. Joining me from Dynavax are Ryan Spencer, Chief Executive Officer; Donn Casale, Chief Commercial Officer; Rob Janssen, Chief Medical Office; and our Interim Head of Finance, Rita O'Connor.

感謝您參加今天的電話會議。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； Rob Janssen，首席醫療辦公室；以及我們的臨時財務主管 Rita O'Connor。

Earlier today, Dynavax released financial results for the first quarter ended March 31, 2024. Copies of the press release and the supplementary slide presentation are available on Dynavax's website.

今天早些時候，Dynavax 發布了截至 2024 年 3 月 31 日的第一季財務業績。

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 of results of FDA submissions, clinical trial starts and data readouts, and potential future uses of or demand 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率以及相關ACIP 建議對財務指導和趨勢的影響，包括收入、盈利能力、現金流量和當前資本充足性、FDA 提交結果的時間表、臨床試驗開始和數據讀出，以及未來潛在的用途或需求我們的CpG 1018 佐劑。

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

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。現在，我將把電話轉給瑞安。

Thanks, Paul. Good afternoon, everyone. Thank you for taking the time to join us to review our Q1 2024 results. The first quarter of 2024 saw continued year-over-year growth in quarterly HEPLISAV-B net product revenue, despite a slight decrease in the US hepatitis B vaccine market during the first quarter. Due to an extended cough, cold, and flu season, which reduced the number of vaccination opportunities, a dynamic which was observed across other non-respiratory vaccine markets beyond hepatitis B.

謝謝，保羅。大家下午好。感謝您抽出寶貴時間與我們一起回顧 2024 年第一季的業績。儘管第一季美國乙型肝炎疫苗市場略有下降，但 2024 年第一季 HEPLISAV-B 季度淨產品收入持續年增。由於咳嗽、感冒和流感季節延長，疫苗接種機會減少，這種情況在乙型肝炎以外的其他非呼吸道疫苗市場上也觀察到。

Even with the slow start to the year, we remain very encouraged about the adult hepatitis B vaccine market opportunity, both in 2024 and over the longer term. We are seeing a pickup in the market in recent weeks as providers have begun to shift to non-respiratory vaccine campaign and as our retail pharmacy partners and top IDN systems launched new hepatitis B focus initiatives.

儘管今年開局緩慢，但我們仍然對 2024 年和更長期的成人乙型肝炎疫苗市場機會感到非常鼓舞。最近幾週，隨著供應商開始轉向非呼吸道疫苗接種活動，以及我們的零售藥房合作夥伴和頂級 IDN 系統推出新的乙型肝炎重點計劃，我們看到市場出現回升。

HEPLISAV-B became a market share leading hepatitis B vaccine for adults in the US last year, and we plan to build on that position in 2024. We continue to expect record HEPLISAV-B sales in 2024, with net product revenue expected in the range of $265 million to $280 million for the year. Longer term, the US adult hepatitis B vaccine opportunity remains significant with over $130 million patients eligible, one of the largest addressable type of patient populations in the US, with the vast majority remaining unvaccinated. We believe this translates to a market opportunity for HEPLISAV-B of over $800 million by 2027, with HEPLISAV-B poised to achieve a majority market share.

HEPLISAV-B 去年成為美國成人乙型肝炎疫苗市場份額領先的產品，我們計劃在 2024 年鞏固這一地位。 2.65 億至2.8 億美元。從長遠來看，美國成人乙型肝炎疫苗的機會仍然很大，有超過 1.3 億美元的患者符合資格，這是美國最大的可尋址患者群體之一，其中絕大多數尚未接種疫苗。我們相信，到 2027 年，這意味著 HEPLISAV-B 的市場機會將超過 8 億美元，而 HEPLISAV-B 預計將獲得多數市場份額。

We're also excited for several upcoming milestones from our novel vaccine pipeline, including the initiation of our Phase 1/2 trial for our shingles vaccine candidate, long-term follow-up data for our Phase 1 Tdap trial, and data readouts from our plate program. As a reminder, we look forward to our PDUFA action date on May 13 for HEPLISAV-B, supplemental BLA for vaccination of adults on hemodialysis, which is currently under review by the US FDA.

我們也對我們的新型疫苗管道即將實現的幾個里程碑感到興奮，包括啟動帶狀皰疹候選疫苗的 1/2 期試驗、我們的 1 期 Tdap 試驗的長期隨訪數據以及我們的數據讀出板程序。提醒一下，我們期待 5 月 13 日對 HEPLISAV-B 採取 PDUFA 行動日期，HEPLISAV-B 是成人血液透析疫苗接種的補充 BLA，目前正在接受美國 FDA 的審查。

In addition to this continued execution and bolstered by our strong financial position, we continue to assess 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. As we've discussed previously, we remain committed to disciplined capital allocation, focused on generating significant value and driving growth. We look forward to providing updates on these efforts in the future.

除了持續執行和強大財務狀況的支持外，我們還繼續評估在傳染病領域超越內部有機管道的成長機會，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。正如我們之前所討論的，我們仍然致力於嚴格的資本配置，專注於創造重大價值並推動成長。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 and Rob, who will provide more details on HEPLISAV-B results and our pipeline progress respectively, before Rita O'Connor reviews our financial results for the first quarter.

現在，我將把電話轉給 Donn 和 Rob，在 Rita O'Connor 審查我們第一季的財務業績之前，他們將分別提供有關 HEPLISAV-B 結果和我們的管道進展的更多詳細資訊。

As previously announced, our CFO, Kelly McDonald, is currently on maternity leave, as Rita has stepped in as interim Head of Finance, supporting me in my temporary appointment as Principal Financial Officer until Kelly's expected return in August. Donn, you take it away.

正如先前宣布的，我們的財務長凱莉·麥克唐納(Kelly McDonald) 目前正在休產假，麗塔(Rita) 已作為臨時財務主管介入，支持我臨時任命為首席財務官，直到凱利(Kelly McDonald) 預計於8 月回歸。唐恩，你把它拿走。

Thank you, Ryan. In the first quarter of 2024, HEPLISAV-B achieved strong net product sales despite headwinds that affected the non-respiratory vaccine market, including hepatitis B. On our last call, we said that growth in the US hepatitis B vaccine market was expected to be flat during the first quarter, due to an extended cough, cold, and flu season. As expected, these dynamics played out, ultimately, reducing the opportunity for adult vaccination in Q1, leading to a slight decrease in the hepatitis B vaccine market compared to the fourth quarter of last year, and a flat year-over-year growth compared to the first quarter of 2023. This dynamic has been observed across other non-respiratory vaccine markets as well.

謝謝你，瑞安。儘管存在影響包括乙型肝炎在內的非呼吸道疫苗市場的不利因素，但HEPLISAV-B 在2024 年第一季實現了強勁的產品淨銷售額。肝炎疫苗市場的成長預計將由於咳嗽、感冒和流感季節延長，第一季持平。如預期，這些動態最終導致第一季成人疫苗接種機會減少，導致B型肝炎疫苗市場較去年四季略有下降，較去年同期成長持平。

HEPLISAV-B continues to increase its total US market share year-over-year, achieving an estimated 41% market share in the first quarter compared to 37% during the same period last year. Net product revenue in the quarter grew 10% year-over-year compared to the first quarter of 2023. This sales growth continues to be driven by HEPLISAV-B's strong performance in two critical segments: retail pharmacy and integrated delivery networks or IDNs.

HEPLISAV-B 的美國總市佔率持續年增，第一季的市佔率預計為 41%，而去年同期為 37%。與 2023 年第一季相比，本季產品淨收入年增 10%。

We estimate these segments will drive significant growth and represent over 60% of the total adult hepatitis B market in the US by 2027. In both segments, HEPLISAV-B's first quarter, estimated market share increased to approximately 55% compared to approximately 49% during the same period last year. Despite the softness in the market in the first quarter, we continued to see indicators of US market expansion from the ACIP universal recommendation for adult hepatitis B vaccination, reaffirming our confidence in a sizable market opportunity and long-term revenue growth potential for HEPLISAV-B.

我們估計，到2027 年，這些細分市場將推動顯著成長，並占美國成人乙型肝炎市場總量的60% 以上。估計增至約55%，而2017 年約為49%。儘管第一季市場疲軟，但我們繼續看到 ACIP 成人乙型肝炎疫苗普遍推薦的美國市場擴張跡象，重申了我們對 HEPLISAV-B 巨大市場機會和長期收入成長潛力的信心。

Large health systems and providers are gaining awareness and agree they need to act on the ACIP universal recommendation. Many large systems have committed to launching new hepatitis B focus initiatives over the next several quarters to effectively implement the recommendation. Over half of our targeted IDN universe has increased hepatitis B dose volume year over year. While system level changes take time to enact, we are encouraged by the progress we see as our systems work to implement operational changes to support routine adoption of the ACIP universal recommendation.

大型衛生系統和提供者正在提高意識，並同意他們需要根據 ACIP 普遍建議採取行動。許多大型系統已承諾在未來幾季啟動新的乙型肝炎重點計劃，以有效實施該建議。我們的目標 IDN 群體中有一半以上的乙型肝炎劑量逐年增加。雖然系統級變更需要時間才能實施，但我們的系統努力實施營運變更以支援 ACIP 普遍建議的常規採用，所取得的進展令我們感到鼓舞。

In the retail pharmacy segment, we have made meaningful progress with several large national chains placing HEPLISAV-B in a preferred position among adult hepatitis B vaccines. Despite the slow start in Q1, retail customers are mobilizing around the opportunity of hepatitis B vaccination. Several customers have indicated a clear shift away from respiratory vaccines to a focus on non-respiratory vaccines such as hepatitis B.

在零售藥房領域，我們與幾家大型全國連鎖店取得了有意義的進展，使 HEPLISAV-B 在成人乙型肝炎疫苗中處於首選地位。儘管第一季開局緩慢，但零售客戶正在圍繞乙型肝炎疫苗接種的機會進行動員。一些客戶表示，他們明顯從呼吸道疫苗轉向了B型肝炎等非呼吸道疫苗。

Given these positive trends and customers' commitment to prioritize hepatitis B vaccination for the rest of the year, we are forecasting the retail segment to meet our annual expectations for 2024 and make a considerable impact to help HEPLISAV-B success this year.

鑑於這些積極趨勢以及客戶承諾在今年剩餘時間內優先接種乙型肝炎疫苗，我們預測零售部門將達到我們對 2024 年的年度預期，並為幫助 HEPLISAV-B 今年取得成功產生重大影響。

As Ryan noted, we are reaffirming our full-year 2024 net product revenue guidance for HEPLISAV-B to be in the range of $265 million to $280 million. As mentioned, we've already seen signs of the market strengthening early on in Q2, as the focus of health care providers and retail pharmacy shifts back to prioritizing non-respiratory vaccines.

正如 Ryan 指出的那樣，我們重申 HEPLISAV-B 2024 年全年淨產品收入指引為 2.65 億至 2.8 億美元。如前所述，我們在第二季初期就已經看到市場走強的跡象，因為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。

We are extremely confident in the long-term expansion of the US hepatitis B vaccine market and forecast annual market growth of approximately 10% to 15% over the next several years, with HEPLISAV-B gaining meaningful increases in total market share over that time. We continue to expect the hepatitis B vaccine market opportunity for HEPLISAV-B to grow to over $800 million in the US by 2027 from approximately $525 million in 2023.

我們對美國乙型肝炎疫苗市場的長期擴張非常有信心，並預測未來幾年市場年增長率約為 10% 至 15%，其中 HEPLISAV-B 在此期間的總市場份額將獲得有意義的增長。我們仍然預計，到 2027 年，美國 HEPLISAV-B 的乙型肝炎疫苗市場機會將從 2023 年的約 5.25 億美元增長到超過 8 億美元。

In summary, we are reaffirming our confidence that HEPLISAV-B will strengthen its position as a clear market share leader in the expanding hepatitis B vaccine market, and we expect 2024 will be another year of record sales and continued growth. We are very proud of our commercial team's execution in establishing HEPLISAV-B as the market share leader in the US, and we look forward to continuing this momentum in the remainder of 2024.

總而言之，我們重申，我們相信 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，我們預計 2024 年將是另一個創紀錄銷售和持續增長的一年。我們對我們的商業團隊將 HEPLISAV-B 打造成美國市場份額領先者的執行力感到非常自豪，我們期待在 2024 年剩餘時間內繼續保持這一勢頭。

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. We continue to make progress advancing our innovative vaccine pipeline, which is focused on leveraging our CpG 1018 adjuvant with proven antigens. Starting with our shingles vaccine program, Z1018.

謝謝你，唐恩。我們繼續在推進我們的創新疫苗管道方面取得進展，重點是利用我們的 CpG 1018 佐劑和經過驗證的抗原。從我們的帶狀皰疹疫苗計劃 Z1018 開始。

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. One of the unique advantages we believe of our CpG 1018 adjutant 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 the zoster virus.

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。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帶狀皰疹病毒重新活化至關重要。

We previously conducted a Phase 1 trial of Z-1018 in 150 subjects at clinical sites in Australia. We believe the results from this 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. Late last year, we received Type B meeting feedback from FDA on the Z-1018 program, which we believe is supportive of our proposed clinical development plan that includes a pivotal placebo-controlled efficacy study.

我們先前在澳洲臨床中心對 150 名受試者進行了 Z-1018 的 1 期試驗。我們相信該試驗的結果支持 Z-1018 的持續開發，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。去年年底，我們收到了 FDA 關於 Z-1018 計劃的 B 型會議回饋，我們相信這支持了我們提出的臨床開發計劃，其中包括一項關鍵的安慰劑對照療效研究。

During the second quarter of 2024, we plan to initiate a randomized active controlled Phase 1/2 trial to evaluate the safety, tolerability, and immunogenicity of Z1018 compared to the licensed recombinant vaccine. We plan to enroll approximately 440 healthy adults aged 50 to 69 years at trial sites in Australia. We will be evaluating escalating doses of our GE protein, our selected dose of CpG 1018 with or without [alam] in different vaccination schedules.

在2024年第二季度，我們計劃啟動一項隨機主動對照1/2期試驗，以評估Z1018與許可的重組疫苗相比的安全性、耐受性和免疫原性。我們計劃在澳洲的試驗地點招募約 440 名 50 至 69 歲的健康成年人。我們將在不同的疫苗接種計劃中評估 GE 蛋白的遞增劑量、我們選擇的 CpG 1018 劑量（有或沒有 [alam]）。

We anticipate top line immunogenicity and safety data in the second half of 2025, which will include a comparison of CD4 positive T cells one month after the last vaccine dose. In March, we received FDA clearance of our IND application for this trial.

我們預計在 2025 年下半年獲得最重要的免疫原性和安全性數據，其中包括最後一劑疫苗一個月後 CD4 陽性 T 細胞的比較。今年 3 月，我們獲得了 FDA 批准我們針對該試驗的 IND 申請。

Turning next Tdap-1018 program. 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 that a Th1 biased immune response.

轉向下一個 Tdap-1018 程式。這是一種在研候選疫苗，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 Th1 偏向免疫反應，有機會延長保護持續時間。

In 2022, Dynavax reported top line results from a Phase 1 clinical trial evaluating the immunogenicity and safety of a booster dose of Tdap-1018 compared to an active control. The results demonstrated that Tdap-1018 was generally well tolerated and induced similar or higher anti-pertussis antibodies and booster response rates than the active control.

2022 年，Dynavax 報告了一項 1 期臨床試驗的主要結果，該試驗評估了 Tdap-1018 加強劑量與活性對照組相比的免疫原性和安全性。結果表明，Tdap-1018 通常具有良好的耐受性，並且與活性對照組相比，可誘導相似或更高的抗百日咳抗體和加強反應率。

Prior to advancing Tdap-1018 into a previously announced Phase 2 human challenge trial, Dynavax plans to evaluate the persistence of pertussis immunogenicity of Tdap-1018 through a long-term follow-up study of participants who completed our Phase 1 trial. The extension study is expected to follow participants for up to approximately three years following vaccination. Top-line results are expected in the fourth quarter of 2024. These data will provide us with a view of how the Tdap-1018 immunogenicity response over time compares to the active control and will help establish our views on the potential benefits that can be achieved with our vaccine candidate.

在將 Tdap-1018 推進到先前宣布的 2 期人體挑戰試驗之前，Dynavax 計畫透過對完成 1 期試驗的參與者進行長期追蹤研究來評估 Tdap-1018 百日咳免疫原性的持久性。擴展研究預計將在接種疫苗後對參與者進行長達約三年的追蹤。預計將於2024 年第四季度獲得頂線結果。看法與我們的候選疫苗。

Moving on to the plague vaccine program, which is in collaboration with and funded by the US Department of Defense. In March, we executed a contract modification with DoD to add approximately $4 million to support CMC work for the plague vaccine candidate, with the agreement now totaling $38 million through 2025. We anticipate top line data from both the randomized active control Phase 2 clinical trial as well as the non-human primate challenge study of the plague vaccine candidate in the fourth quarter of 2024.

接下來是鼠疫疫苗計劃，該計劃與美國國防部合作並由其資助。 3 月份，我們與國防部執行了一項合約修改，增加了約400 萬美元，以支持鼠疫候選疫苗的CMC 工作，目前該協議到2025 年的總金額為3800 萬美元。 2 期臨床試驗的頂線數據以及2024年第四季鼠疫候選疫苗的非人靈長類動物挑戰研究。

These data will inform next steps for the program. We're pleased with this progress across our pipeline, and we look forward to executing on these upcoming milestones in the coming year. We also continue to identify new opportunities to leverage our CpG 1018 adjuvant through multiple innovative programs with biotech and academic collaborators.

這些數據將為該計劃的後續步驟提供資訊。我們對整個管道所取得的進展感到高興，並期待在來年實現這些即將到來的里程碑。我們也繼續透過與生物技術和學術合作者的多個創新項目尋找利用我們的 CpG 1018 佐劑的新機會。

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

我現在將把電話轉給麗塔，以審查我們的財務表現。

Thank you, Rob. I'll review the key financial results for the first quarter of 2024, as well as our financial guidance for the full year of 2024. Please note that all financial comparisons are versus the prior year period unless otherwise noted. Please refer to our press release and Form 10-Q for more detailed financial information.

謝謝你，羅布。我將回顧 2024 年第一季的主要財務業績，以及 2024 年全年的財務指引。請參閱我們的新聞稿和 10-Q 表以了解更詳細的財務資訊。

Starting with HEPLISAV-B, net product revenue grew 10% year over year to $48 million in the first quarter of 2024. Cost of product sales for HEPLISAV-B in the first quarter of 2024 decreased to $11 million compared to $15 million for the prior year periods. The decrease was primarily due to lower per unit manufacturing costs as a result of previous process improvements, partially offset by a $1 million inventory write-off charge recorded during the first quarter of 2024.

從 HEPLISAV-B 開始，2024 年第一季產品淨收入年增 10%，達到 4,800 萬美元。年期間。這一下降主要是由於先前的流程改善導致單位製造成本降低，但部分被 2024 年第一季記錄的 100 萬美元庫存沖銷費用所抵消。

We continue to be pleased with the HEPLISAV-B margin profile trend, with gross margin of about 77% in Q1 of 2024, a significant improvement over the 66% in the first quarter of 2023. We continue to expect gross margins of approximately 80% for the full year of 2024, which is consistent with our long-term expectations of margin profile for HEPLISAV-B. Other revenue was about $3 million for both the first quarter of 2024 and 2023, representing revenue related to the plague vaccine program in collaboration with and funded by the US Department of Defense.

我們仍然對 HEPLISAV-B 的利潤率趨勢感到滿意，2024 年第一季的毛利率約為 77%，比 2023 年第一季的 66% 顯著改善。全年的利潤率與我們對HEPLISAV-B 利潤率的長期預期一致。 2024 年第一季和 2023 年第一季的其他收入約為 300 萬美元，代表與美國國防部合作並由其資助的鼠疫疫苗計劃相關的收入。

Turning to our expenses. Research and development expenses were $14 million for both the first quarters of 2024 and 2023. Expenses in 2023 included the completion of clinical trials for our pipeline programs, whereas the first quarter of 2024 reflected activities for planned clinical trials as well as increases related to investments in our CpG 1018 preclinical and clinical collaborations.

轉向我們的開支。 2024 年和 2023 年第一季的研發費用均為 1,400 萬美元。在我們的CpG 1018 臨床前和臨床合作中。

Selling, general and administrative expenses for the first quarter of 2024 were $44 million compared to approximately $37 million for the prior year period. The increase was primarily driven by increased headcount and other investments supporting our strategic growth, including an overall increase in targeted commercial and marketing efforts designed to increase HEPLISAV-B the market share and maximize the opportunities presented by the ACIP's universal recommendation.

2024 年第一季的銷售、一般和管理費用為 4,400 萬美元，而去年同期約為 3,700 萬美元。這一增長主要是由於員工人數的增加和支持我們戰略增長的其他投資的推動，包括總體增加有針對性的商業和營銷工作，旨在增加HEPLISAV-B 的市場份額並最大限度地利用ACIP 普遍推薦所帶來的機會。

Sublease expense was $1.6 million in the first quarter of 2024 compared to sublease income of $1.6 million in the prior year period. This change reflected the termination of our original lease with a non-cash charge of $3.5 million, partially offset by income of $1.9 million during the period. Including this onetime non-cash charge, we expect to record approximately $5 million of net sublease income for the full year of 2024. These results generated a net loss of $9 million in the first quarter of 2024 compared to $24 million during the prior year period.

2024 年第一季的轉租費用為 160 萬美元，而去年同期的轉租收入為 160 萬美元。這項變更反映了我們原始租賃的終止，產生了 350 萬美元的非現金費用，部分被期間收入 190 萬美元所抵銷。包括這筆一次性非現金費用，我們預計2024 年全年將錄得約500 萬美元的淨轉租收入。萬美元。

Moving to the balance sheet. We ended the first quarter of 2024 with cash, cash equivalents, and marketable securities of $724 million, which we believe is sufficient to progress our current pipeline assets and support our organic based business without the need to raise additional capital.

轉向資產負債表。截至 2024 年第一季度，我們擁有 7.24 億美元的現金、現金等價物和有價證券，我們相信這足以發展我們當前的管道資產並支持我們的有機業務，而無需籌集額外資金。

And now to summarize our financial guidance. We are reaffirming our prior full year 2024 financial guidance as follows. HEPLISAV-B net product revenue expected to be between approximately $265 million and $280 million, including approximately $3 million in ex-US sales through our commercialization partnership in Germany. We expect HEPLISAV-B gross margin of approximately 80% for the full year of 2024.

現在總結我們的財務指導。我們重申先前 2024 年全年的財務指引如下。 HEPLISAV-B 產品淨收入預計約為 2.65 億至 2.8 億美元，其中包括透過我們在德國的商業化合作夥伴關係在美國以外的銷售額約 300 萬美元。我們預計 HEPLISAV-B 2024 年全年毛利率約為 80%。

We expect R&D expenses to be between approximately $60 million and $75 million. We expect SG&A expenses to be between approximately $160 million and $180 million. And we also expect cash, cash equivalents and marketable securities to be higher at the end of '24 as compared to December 31 of '23, reflecting our continued discipline towards allocating capital to drive top line revenue growth while thoughtfully advancing our research programs.

我們預計研發費用約 6,000 萬至 7,500 萬美元。我們預計 SG&A 費用約為 1.6 億至 1.8 億美元。我們也預期 24 年底的現金、現金等價物和有價證券將高於 23 年 12 月 31 日，這反映出我們在認真推進我們的研究項目的同時，繼續嚴格分配資本以推動收入成長。

I would now like to turn the call back over to Ryan before we start the Q&A section.

現在，在我們開始問答部分之前，我想將電話轉回給 Ryan。

Thanks, Rita. In closing, we believe that our strong financial position and proven ability to execute, we are well positioned to drive sustainable growth in our core HEPLISAV-B business by capturing majority US market share, and leading 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.

謝謝，麗塔。最後，我們相信，憑藉我們強大的財務狀況和經過驗證的執行能力，我們有能力透過佔領美國大部分市場份額並引領成人乙型肝炎疫苗市場的擴張，推動我們的核心HEPLISAV-B 業務的可持續增長。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 the call.

謝謝大家今天的關注。接線生，我們現在要開始通話的問答部分。

(Operator Instructions)

（操作員說明）

Matt Phipps, William Blair.

馬特·菲普斯，威廉·布萊爾。

Good afternoon, thanks for taking my questions. First, I guess, the retail market share looks like it did dip a little bit from Q4 to Q1, 58% to 55%. I realize one, these are somewhat assumptions. But just wondering if there's anything lumpy in there or did anything else change with any contracts that caused that to happen?

下午好，感謝您回答我的問題。首先，我猜零售市場佔有率看起來確實從第四季到第一季略有下降，從 58% 下降到 55%。我意識到，這些在某種程度上都是假設。但只是想知道其中是否有任何塊狀的東西，或者是否有任何合約發生了其他變化導致了這種情況的發生？

Hey, Matt. It is Donn. Nothing really change -- market share, there are always slight variations in market share, and it's related to purchasing patterns of some of our larger customers. But for us, we continue to expect to take market share both in retail and as well in IDM. So it is really more or so around these purchasing patterns with some of the larger customers.

嘿，馬特。是唐恩.沒有什麼真正改變——市場份額，市場份額總是有細微的變化，這與我們一些大客戶的購買模式有關。但對我們來說，我們仍然期望在零售和 IDM 領域佔據市場份額。因此，它實際上或多或少圍繞著一些大客戶的購買模式。

All right, thanks, Donn. Rob, a question on the shingles program, one, can you just maybe tell us how many total arms are in the trial?

好的，謝謝，唐恩。羅布，一個關於帶狀皰疹計劃的問題，第一，您能告訴我們試驗中總共有多少組嗎？

Just kind of wondering how many patients will be in these trials, to get a sense of powering you might have for the immunogenicity endpoint? And then also, did you -- I can tell if you confirm that a potential pivotal trial would be placebo-controlled or that's just kind of still the hope and you need to still have those conversations?

只是想知道有多少患者將參加這些試驗，以了解您可能對免疫原性終點有何支持？然後，我可以告訴你，你是否確認一項潛在的關鍵試驗將是安慰劑對照的，或者這仍然是希望，你仍然需要進行這些對話？

So Matt, we will be enrolling 10 arms to receive C1018, and then a Shingrix arm. So there will be 11 arms with 40 subjects in each arm, and which is a reasonably large number for a Phase 1 study. But it's really so we can get a good sense of what CD4 responses are. Now with respect to a placebo-controlled, we have communicated with the FDA and heard from them that placebo-controlled efficacy study would be acceptable for review for a license.

所以 Matt，我們將登記 10 個手臂來接收 C1018，然後是一個 Shingrix 手臂。因此，將有 11 個組別，每組有 40 名受試者，這對於第一階段研究來說是一個相當大的數字。但這確實是為了讓我們能夠更了解 CD4 反應是什麼。現在，關於安慰劑對照，我們已經與 FDA 進行了溝通，並從他們那裡得知，安慰劑對照的療效研究可以接受許可審查。

Great. And then maybe one last one for Ryan. Do you almost hesitate to make any real big decisions with regards to your cash balance until you see that immunogenicity data from the shingles program in the second half of next year? is that almost a -- you just kind of want to make sure you have all your options open until you get to that data or is that not the case?

偉大的。然後也許是瑞安的最後一件事。在明年下半年看到帶狀皰疹項目的免疫原性數據之前，您是否會猶豫是否要對現金餘額做出任何真正的重大決定？這幾乎是——你只是想確保在獲得該數據之前你有所有的選擇，或者情況並非如此？

No, it is certainly one of the elements on how we think about managing our capital position. One, we talked a lot about this, we're in a favorable position to be able to fund our development programs as well as the opportunity to settle or convert when it comes due in '26. And so we like to be able to maintain all of our optionality as it relates to being able to advance our pipeline. So it's definitely a factor in how we manage our capital structure overall.

不，這肯定是我們考慮如何管理資本部位的要素之一。第一，我們對此進行了很多討論，我們處於有利的地位，能夠為我們的開發計劃提供資金，並有機會在 26 年到期時進行結算或轉換。因此，我們希望能夠保持所有的選擇性，因為這與能夠推進我們的管道有關。因此，這絕對是我們如何管理整體資本結構的因素。

Great, thanks for taking my questions.

太好了，感謝您回答我的問題。

Thanks, Matt.

謝謝，馬特。

Paul Choi, Goldman Sachs.

保羅‧崔，高盛。

Hi, good afternoon, team, and thanks for taking my question. Also, I have a follow-up on shingles as well. And can you maybe comment on how you thought about the trial design for your study, particularly, in the context of recent data from [chirvo] which showed 100% immunogenicity. Any thoughts on patient selection and or trial design endpoints and such that you can comment on just where you can possibly show the most differentiation either on efficacy and or safety?

嗨，團隊下午好，感謝您提出我的問題。另外，我還有帶狀皰疹的後續行動。您能否評論一下您對研究試驗設計的看法，特別是在 [chirvo] 最近的數據顯示 100% 免疫原性的情況下。對患者選擇和/或試驗設計終點有什麼想法，以便您可以評論在哪裡可以在療效和/或安全性方面表現出最大的差異？

And secondly, just with regard to HEPLISAV-B, can you maybe just comment on just sort of retail chain behavior? The share gains continue to look good, but just curious if you're seeing more activity? If you could elaborate a little bit more on the activity levels in the retail channel in particular? Thank you very much.

其次，就 HEPLISAV-B 而言，您能否只評論一下零售連鎖店的行為？股票收益看起來仍然不錯，但只是好奇您是否看到了更多的活動？能否詳細說明零售通路的活動量？非常感謝。

Thanks, Paul. Rob, why don't you take the first question on shingles, Then, Donn, you can address the retail question.

謝謝，保羅。羅布，為什麼不回答關於帶狀皰疹的第一個問題，然後，唐恩，你可以解決零售問題。

Yeah. Right. So the study really is designed to identify the some antigen, the GE antigen. This is the first time, our GE antigen, this is the first in humans, first time it's been in people. So we are looking at different levels of antigen. So the trial is designed to look at different levels of antigen to increase CD4 counts. And we'll also be looking at different regimens. We're looking at a couple of different regimens in terms of time between doses, again, to increase CD4 counts.

是的。正確的。所以這項研究其實是為了辨識某種抗原，即 GE 抗原。這是第一次，我們的GE抗原，這是第一次出現在人類身上，第一次出現在人類身上。所以我們正在研究不同程度的抗原。因此，該試驗旨在觀察不同程度的抗原以增加 CD4 計數。我們也將研究不同的治療方案。我們正在研究幾種不同的治療方案，以增加 CD4 計數的劑量間隔時間。

Now to look at reactogenicity, we're developing and we've been communicating with FDA about it. And how to go about doing it, and that is reactogenicity and how can we design future studies that would be label-enabling to put reactogenicity data in the label. And we're looking at your sort of standard global impression of severity changes in symptoms, health related quality of life, those types of already -- instruments that already exists. But we'll also be looking to develop potentially our own instrument in this study and then to validate it for use in a Phase 3 study.

現在我們正在研究反應原性，並且我們一直在與 FDA 就此進行溝通。以及如何做，這就是反應原性，以及我們如何設計未來的研究，使標籤能夠將反應原性資料放入標籤中。我們正在研究您對症狀嚴重程度變化、健康相關生活品質以及已經存在的這些類型的標準全球印象。但我們也將尋求在這項研究中開發自己的儀器，然後驗證它是否可用於第三階段研究。

And Paul, just to put a finer point on it. When we think about the ways we measure immunogenicity, we've been very clear and transparent that we believe that CD4s are critical for this vaccine. And so we think about the way we've talked about our data, it's been very deliberate to be focused on what we think is the most critical -- some of the most critical endpoints. There is a variety of ways to measure immunogenicity with percentages of response to different measures. But for our trials, we've been very clear about the importance of CD4s, and that's what we will continue to focus on as we progress

保羅，只是為了更詳細地闡述這一點。當我們考慮衡量免疫原性的方法時，我們非常明確且透明地認為 CD4 對於這種疫苗至關重要。因此，我們思考我們談論數據的方式，我們非常刻意地將重點放在我們認為最關鍵的方面——一些最關鍵的端點。有多種方法可以透過對不同措施的反應百分比來衡量免疫原性。但在我們的試驗中，我們非常清楚 CD4 的重要性，這也是我們在進展過程中將繼續關注的重點

Got it. And on the retail front?

知道了。那麼在零售方面呢？

Hey, Paul. It's Donn. To put a bit more color on the retail behavior, there's been a dramatic shift, if you will, in the retail segment as it relates to non-respiratory vaccines and focus on those vaccines coming off the respiratory season.

嘿，保羅。是唐恩。為了讓零售行為增添更多色彩，如果你願意的話，零售領域發生了巨大的轉變，因為它與非呼吸道疫苗有關，並專注於呼吸道季節的疫苗。

You're seeing certainly a lot of focus by those retailers as it relates to various tactics to increase awareness, to continue to run initiatives, both not only awareness for the US pharmacists themselves, but also advertising out to the consumers, that are all rolling around the fact that, it may hepatitis B Awareness Month. But there's a lot of focus again on setting up infrastructure, if you will, to take advantage of that opportunity as well. So again, a drastic shift, if you will, a focus by the retail chains as it relates to hepatitis B vaccination.

您肯定會看到這些零售商非常關注，因為它涉及各種提高認識的策略，繼續開展舉措，不僅是提高美國藥劑師本身的認識，而且還向消費者做廣告，這些都在滾動圍繞這一事實，可能是乙型肝炎宣傳月。但如果你願意的話，人們再次將重點放在建立基礎設施上，以利用這個機會。因此，如果您願意的話，這又是零售連鎖店關注乙型肝炎疫苗接種的重大轉變。

Great, thanks for the color. I'll jump back in queue.

太好了，謝謝你的顏色。我會插回隊列。

Jon Miller, Evercore ISI.

喬恩·米勒，Evercore ISI。

Hi, [Jin chan] Jon. Thanks for taking our question. I guess first one on HEPLISAV, how do you see the seasonality profile developing as the market gets more penetrated? Do you expect to see - when do you expect to see the biggest growth for the remaining of the year? And I guess second on Tdap, I guess, quite delay in that to that Phase 2 trial and how will the Phase 2 design change based on learnings from the extension of Phase 1? Thanks.

嗨，[金燦]喬恩。感謝您提出我們的問題。我想關於 HEPLISAV 的第一個問題是，隨著市場滲透率的提高，您如何看待季節性特徵的發展？您預計今年剩餘時間內何時會出現最大成長？我猜想，Tdap 的第二階段，第二階段試驗相當延遲，第二階段設計將如何根據第一階段擴展的經驗進行改變？謝謝。

Let me comment on seasonality first, and then, Donn, you have anything to add, please feel free.

首先讓我評論一下季節性，然後，Donn，您有什麼要補充的，請隨意。

It's pretty clear that Q2 and Q3 will -- we expect will continue to be the largest quarters in the adult hepatitis B vaccine market for a variety of reasons. And I don't think -- I think the market growth doesn't really change, the belief that we still believe Q2 and Q3 will be the largest quarters of the year and the years in the future. Recognizing that, we do expect a little always be seasonality due to the fact the significant respiratory vaccine given in the Q4,Q1 time period. So we expect that seasonality to continue even as we see market growth. Donn, good?

很明顯，由於多種原因，我們預計第二季和第三季將繼續成為成人乙型肝炎疫苗市場最大的季度。我認為市場成長並沒有真正改變，我們仍然相信第二季和第三季將是今年和未來幾年最大的季度。認識到這一點，我們確實預計會有一定的季節性，因為在第四季度和第一季期間接種了重要的呼吸道疫苗。因此，即使我們看到市場成長，我們預計季節性仍將持續。唐恩，好嗎？

Yeah, it is good.

是的，這很好。

And then I think the other question, just at a high level on Tdap, I'll take that too. And Rob. please add any color that you feel is important. But the decision here to delay the Phase 2 challenge study was as a response to the regulatory feedback that we received related to the PRN positive versus PRN negative strain for pertussis. Recognizing that the FDA is interested in PRN negative strain that we would conduct in the future, we didn't need to conduct a positive pilot study now.

然後我認為另一個問題，只是 Tdap 的高等級問題，我也會接受。還有羅布。請添加您認為重要的任何顏色。但推遲 2 期挑戰研究的決定是對我們收到的與百日咳 PRN 陽性菌株和 PRN 陰性菌株相關的監管回饋的回應。認識到 FDA 對我們將來進行的 PRN 陰性菌株感興趣，我們現在不需要進行積極的試點研究。

And we decided to make the decision to focus on the PRN negative strain in the future when available, which also happened to allow us to see the results of this Phase 1 extension study. So it doesn't have an impact on the overall time line, but it does allow us to have insight into the durability of our product prior to advancing into any other clinical studies. All in all, I think a pretty -- it's actually a very favorable opportunity to be able to increase our understanding of product before investing further in additional clinical trials.

我們決定決定將來專注於 PRN 陰性菌株，這也恰好讓我們看到了這一階段 1 擴展研究的結果。因此，它不會對整體時間線產生影響，但它確實使我們能夠在進入任何其他臨床研究之前深入了解我們產品的耐用性。總而言之，我認為這實際上是一個非常有利的機會，能夠在進一步投資額外的臨床試驗之前增加我們對產品的了解。

All right, thank you.

好吧。

Ed White, H.C. Wainwright.

懷特，H.C.溫賴特。

Good evening. Thanks for taking my questions. Just to stay with the Tdap. So how is the timing of the Phase 2 going to be affected? When do you expect to start that study?

晚安.感謝您回答我的問題。只是為了留在Tdap。那麼第二階段的時間安排會受到怎樣的影響呢？您預計什麼時候開始這項研究？

The Phase 2 we started, it really is still kind of up in the air. We do need to have the PRN negative strain available and that's being developed. So it depends on the availability of that strain. I think the key point though is that study is one component of the overall development plan. The longer lead times in this development plan will be the immunogenicity data, which in our view, it is going to be critical to have that data develop over time to show durability, that can be part of our submission.

我們開始的第二階段，確實仍然懸而未決。我們確實需要 PRN 陰性菌株，並且正在開發中。所以這取決於該菌株的可用性。我認為關鍵是學習是整體發展計劃的組成部分之一。該開發計劃中較長的交付時間將是免疫原性數據，在我們看來，隨著時間的推移使數據發展以顯示耐久性至關重要，這可以成為我們提交的一部分。

So the Tdap challenge, I think, is not on the critical path, I think, is the way to think about it. It's a very valuable study, because it will show the antigens are efficacious, which we have a high confidence that they will be. And with the presence of our adjuvant, we expect to improve over existing vaccines. So ultimately, what will gate hate that timing will be the availability of the PRN negative strain.

因此，我認為 Tdap 挑戰並不在關鍵路徑上，我認為，這是思考它的方式。這是一項非常有價值的研究，因為它將表明抗原是有效的，我們對此充滿信心。由於我們的佐劑的存在，我們期望能夠改進現有的疫苗。因此，最終，抑制仇恨的時機將是 PRN 陰性菌株的可用性。

Okay. Thanks, Ryan. And I actually have the BLA -- excuse me, the PDUFA on May 13th for hemodialysis patients. I'm just wondering if you can quantify what that means to the -- what the impact could potentially be, not only this year, but going forward?

好的。謝謝，瑞安。我實際上有 5 月 13 日針對血液透析患者的 BLA——對不起，是 PDUFA。我只是想知道你是否可以量化這意味著什麼——不僅是今年，而且是未來可能產生的影響？

Yeah. I think we talked about this a little bit in the past that the -- you already noted that May 13 is the PDUFA date. It is too really too early to comment on the impact of any -- of revenue expectations. But we will know, as we said in the past, obviously, it does take time to engage customers. And merely having the PDUFA, It's the -- it gives us that license to hunt and actually engage them commercially. So we'd expect it would -- it's going to take time like with any other customer to be able to engage them in an effective manner. So we made no comment on the revenue expectations from this particular regulatory events, but we will continue to provide updates as we progress.

是的。我想我們過去曾討論過這個問題，您已經注意到 5 月 13 日是 PDUFA 日期。現在評論收入預期的影響還為時過早。但我們會知道，正如我們過去所說，顯然，吸引客戶確實需要時間。僅僅擁有 PDUFA，它就為我們提供了狩獵並實際與它們進行商業交易的許可。所以我們預計它會像其他客戶一樣需要時間才能以有效的方式吸引他們。因此，我們對這一特定監管事件的收入預期沒有發表任何評論，但我們將隨著進展繼續提供最新資訊。

Okay. Thanks for taking my questions.

好的。感謝您回答我的問題。

Phil Nadeau, TD Cowen.

菲爾·納多，TD·考恩。

Team, thanks for taking our questions. One follow-up question on seasonality. Appreciating -- it's probably a hard question since we're all dealing with imperfect information, but do you have a sense that this year, the seasonality was particularly bad, given that it was early and the availability of RSV vaccines and people are still getting shots for COVID? Is there any reason to think that the seasonality and the decline in HPV market in Q4 and Q1 won't be as bad in future years? Or is that just hard to know at this point?

團隊，感謝您提出我們的問題。關於季節性的一個後續問題。欣賞——這可能是一個很難回答的問題，因為我們都在處理不完美的信息，但你是否有一種感覺，今年的季節性特別糟糕，因為現在還很早，而且RSV 疫苗的可用性和人們仍在接種為新冠疫苗注射？有沒有理由認為 HPV 市場的季節性和第四季和第一季的下滑在未來幾年不會那麼糟？還是目前還很難知道？

Hey, Phil. It's Donn. I think it's a little hard to know, a little early to kind of call it. But certainly -- and the feedback we've been receiving from our retail customers in particular is learning new vaccines, RSV COVID, a lot was thrown at the retailers all at once. Now that they've gone through it once, going into this year, they will be better prepared to understand what is going to be in store for that respiratory season. So we sort of see that as an opportunity moving forward. But probably too early to tell how it looks every year thereafter. But certainly, we expect this year to be a little bit different because our customers are little bit more prepared for anticipating the onslaught of all these different vaccines in the space. (multiple speakers)

嘿，菲爾。是唐恩。我認為現在很難知道，現在就這樣稱呼還為時過早。但可以肯定的是，我們從零售客戶收到的回饋尤其是學習新疫苗、RSV COVID，零售商一下子就收到了許多回饋。既然他們已經經歷過一次，進入今年，他們將更了解該呼吸季節將會發生什麼。所以我們認為這是一個前進的機會。但現在判斷此後每年的情況可能還為時過早。但當然，我們預計今年會有所不同，因為我們的客戶對預期該領域所有這些不同疫苗的衝擊做好了更多準備。 （多個發言者）

And then on the hemodialysis -- sorry --

然後是血液透析——抱歉——

Just one -- just add on to that. I just also remembered the winter season and how cough, cold, and flu, COVID, other things, those are variables as well as. That is how they impact well this is opportunities for vaccinations. So that's going to always be variable across the season. So we just have to keep that in mind that it is not only market dynamics, there's also disease dynamics at play, that will be variable.

只有一個——只需添加即可。我還記得冬天，以及咳嗽、感冒、流感、新冠肺炎和其他事情，這些都是變數。這就是它們產生良好影響的方式，這是疫苗接種的機會。因此，整個賽季的情況總是會改變。因此，我們必須記住，這不僅是市場動態，還有疾病動態在起作用，這將是可變的。

Did the RSV vaccines have a requirement that patients not be vaccinated for something else like HPV for weeks before weeks after receiving RSV especially?

RSV 疫苗是否要求患者在接種 RSV 後數週內不得接種其他疫苗，例如 HPV？

The RSV -- Did you say the RSV vaccines? Is that what you --

RSV——你是說 RSV 疫苗嗎？這就是你——

Yeah, specifically for RSV, is there a required to be a window of no other vaccinations around that vaccine?

是的，特別是對於 RSV，是否需要在該疫苗周圍設置一個不接種其他疫苗的窗口？

No, not in particular. Just be aware, Phil, the common datas usually doesn't specific how it very -- it is very rare for there to be specific information around how to treat other vaccines within one vaccines label.

不，不是特別。請注意，菲爾，通用數據通常不會具體說明如何處理一種疫苗標籤中的其他疫苗，很少有具體資訊。

Phil, It is more around the operational hurdles quiet frankly. Just operationalizing a new vaccine and vaccine launches versus concomitant administration being the barrier for our retailers in particular.

菲爾，坦白說，更多的是圍繞著營運障礙。僅僅實施新疫苗和疫苗發布與同時管理對我們的零售商來說尤其是障礙。

Got it. In terms of hemodialysis, I think in the past, you've suggested that there is some use of HEPLISAV already in the market. If that's true and if you have any estimates of penetration in the hemodialysis market currently?

知道了。在血液透析方面，我認為過去您曾建議市場上已經有一些 HEPLISAV 的使用。如果這是真的，您對目前血液透析市場的滲透率是否有任何估計？

Yeah, no, there's definitely utilization in the marketplace. So -- and you're right, we have commented on that before. We have not commented on specific penetration or share other than our comments on retail and IDN, like we have said before. And so we have our PDUFA -- BLA approved, we're going to refrain from getting into too many details on the segment.

是的，不，市場上一定有利用。所以——你是對的，我們之前已經對此發表過評論。正如我們之前所說，除了對零售和 IDN 的評論之外，我們沒有對具體的滲透率或份額發表評論。因此，我們的 PDUFA - BLA 已獲得批准，我們將避免涉及該細分市場的太多細節。

Great. Thanks for talking my questions.

偉大的。謝謝你說出我的問題。

Thanks, Phil.

謝謝，菲爾。

Thank you, Phil.

謝謝你，菲爾。

Roy Buchanan, Citizens JMP.

羅伊·布坎南，公民 JMP。

Hey, thanks for taking the questions. Just a quick follow-up on Tdap. I guess how many patients are you expecting in the extension trial? And it says in the press release versus active control. So you're going to be able to enroll the Tdap-1018 and the boostrix arms -- seems like a lot of patients have probably been off the trial for a while. Maybe gone on to other things. Are you going to look at both the adults and the adolescents?

嘿，感謝您提出問題。只是 Tdap 的快速跟進。我猜你預計有多少患者參加擴展試驗？它在新聞稿中提到與主動控制。因此，您將能夠註冊 Tdap-1018 和 boostrix 手臂——看來許多患者可能已經退出試驗一段時間了。也許繼續做其他事情了。你要同時看成人和青少年嗎？

We'll just be looking at the --

我們只會看看——

Rob will handle that.

羅布會處理這件事。

Yeah, we'll just be looking at the young adults, Roy. We won't be looking at adolescents who are too few. The number of subjects we were looking to try to enroll was up to 50. And we will be comparing Tdap-1018 to Boostrix.

是的，我們只關注年輕人，羅伊。我們不會關注數量太少的青少年。我們想要嘗試招募的受試者數量最多為 50 名。

Got it, Thanks.

知道了謝謝。

And Roy, just a couple of elements there. You already noted, the trial was conducted a while ago. Sp we'll have two to three years of follow-up in these patients. And the ultimate number is going to be depending on how many we can get to return, given some of the challenging factors you noted. But we expect that we'll be able to have some interesting data from the follow up.

羅伊，只是其中的幾個要素。你已經注意到，審判是不久前進行的。我們將對這些患者進行兩到三年的追蹤。考慮到您提到的一些具有挑戰性的因素，最終的數字將取決於我們能返回多少人。但我們希望後續能得到一些有趣的數據。

Okay. Very good, thank you.

好的。非常感謝。

Thank you. We have no further questions at this time. I would now like to turn the call over to Mr. Ryan Spencer, Chief Executive Officer, for closing remarks.

謝謝。目前我們沒有進一步的問題。現在我想請執行長 Ryan Spencer 先生致閉幕詞。

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

謝謝您，接線生，也謝謝大家今天加入我們。我們感謝您對 Dynavax 的興趣。我們對最近在我們的地位上所取得的成就感到興奮。我們期待向您通報我們在保護世界免受傳染病侵害方面的最新進展。接線員，您可以結束通話了。

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

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。