Dynavax Technologies Corp (DVAX) 2023 Q4 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Dynavax Technologies Fourth Quarter and Full Year 2023 financial results conference call.

女士們、先生們，美好的一天，歡迎參加 Dynavax Technologies 2023 年第四季和全年財務業績電話會議。

As a reminder, this call is being recorded at the end of the Company's prepared remarks will open the call for questions and for five Pacific instructions at that time.

提醒一下，本次電話會議是在公司準備好的發言結束時進行錄音的，屆時將開始電話會議詢問問題並徵求五位太平洋公司的指示。

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

我現在想將電話轉給投資者關係和企業傳播副總裁 Paul Cox。

You may begin.

你可以開始了。

Thank you for participating in today's call.

感謝您參加今天的電話會議。

Joining me from Dynavax are Ryan Spencer, Chief Executive Officer, Dan Caruso, Chief Commercial Officer, Rob Janssen, Chief Medical Officer, and Kelly MacDonald, Chief Financial Officer.

與我一起來自 Dynavax 的還有首席執行官 Ryan Spencer、首席商務官 Dan Caruso、首席醫療官 Rob Janssen 和首席財務官 Kelly MacDonald。

Earlier today, Dynavax released financial results for the fourth quarter and full year ended December 31st, 2023 copies of the press release and a supplementary slide presentation are available on Dynavax's website.

今天早些時候，Dynavax 發布了截至 2023 年 12 月 31 日的第四季度和全年財務業績，新聞稿和補充幻燈片演示文稿的副本可在 Dynavax 網站上獲取。

Before we begin, I advise you that we will be making forward-looking statements today based on our current expectations and beliefs, including but not limited to, potential market sizes, market segmentation, effective marketing efforts, future expected market share and related growth rates and related ACIP. recommendation impact on each financial guidance and trends, including revenue, profitability, cash flow and sufficiency of current capitalization, timing and results of FDA submissions, clinical trial starts and data readouts and potential future uses of order 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的ACIP。建議對每個財務指導和趨勢的影響，包括收入、盈利能力、現金流和當前資本充足性、FDA 提交的時間和結果、臨床試驗開始和數據讀出以及我們的CpG 1018 佐劑訂單需求的未來潛在用途。

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

這些陳述涉及風險和不確定性，我們的實際結果可能存在重大差異。

These risks are summarized in today's press release and detailed in the Risk Factors section of our SEC filings, including today's Annual Report on Form 10 K. Our forward-looking statements speak as of today, and we undertake no obligation to update such statements.

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 K 表格年度報告）的風險因素部分中進行了詳細介紹。我們的前瞻性聲明截至今天為止，我們不承擔更新此類聲明的義務。

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

現在，我將把電話轉給瑞安。

Thanks, Paul.

謝謝，保羅。

Good afternoon, everyone, and thank you for taking the time to join us to review Dynavax results for 2023. 2023 was characterized by record revenue growth for FY 17, delivering 69% growth year over year and becoming the market leader market share leader in the two largest growth segments, which are retail pharmacies and integrated delivery networks meeting that will be the leading vaccine in the U.S. adult hepatitis B vaccine market.

大家下午好，感謝您抽出時間與我們一起回顧 Dynavax 2023 年業績。2023 年的特點是 2023 財年創紀錄的收入增長，同比增長 69%，成為該領域的市場領導者和市場份額領先者。零售紀錄的收入增長，同比增長 69%，成為該領域的市場領導者和市場份額領先者。零售藥局和綜合交付網路這兩個最大的成長領域將成為美國成人乙型肝炎疫苗市場的領先疫苗。

We expect 2024 to be an important year in building our vaccine portfolio of best-in-class products, including further growing mental 70 brand and advancing our pipeline programs into clinical trial initiations and data readouts for SMB.

我們預計 2024 年將是建立我們一流產品疫苗組合的重要一年，包括進一步發展 mental 70 品牌，並將我們的管道計劃推進到臨床試驗啟動和中小企業數據讀出。

We are again forecasting continued growth with net product revenue in the range of $265 million to $280 million for the year.

我們再次預測今年淨產品收入將持續成長，介於 2.65 億美元至 2.8 億美元之間。

As you minutes, Don will provide some additional commentary on how the U.S. hepatitis B vaccine market is evolving due to an active winter respiratory disease season and why we continue to be very confident in another year of growth for the brand and in the long term prospects for EpiCept, the vaccine market with one of the largest total addressable populations in the United States for our development pipeline, we expect to achieve important milestones in the coming months, including our fifth action date.

在您的會議記錄中，Don 將提供一些額外的評論，介紹美國乙型肝炎疫苗市場因冬季呼吸道疾病活躍季節而如何發展，以及為什麼我們對該品牌的又一年增長和長期前景仍然充滿信心對於EpiCept 來說，該疫苗市場是美國開發管道中最大的可尋址人群之一，我們預計在未來幾個月內實現重要的里程碑，包括我們的第五個行動日期。

For the Apple said, the SBLA for hemodialysis expected in May clearing our shingles I&D currently being reviewed by FDA to begin our Phase one two trial, advancing our TTR program and delivery phase two clinical and nonhuman primate challenge study data for our play program under collaboration with the US Department of Defense.

Apple 表示，血液透析的SBLA 預計將於5 月批准我們的帶狀皰疹I&D 目前正在接受FDA 審查，以開始我們的第一階段二期試驗，推進我們的TTR 計劃，並為我們合作的遊戲計劃提供第二階段臨床與非人靈長類動物挑戰研究資料與美國國防部。

Importantly, our strong financial position of $742 million of cash provides us with the optionality to continue to build value across our business, such as through incremental investments to drive the SMB market opportunity, continuing to advance R&D efforts and pursuing new opportunities to accelerate our growth as we've discussed previously, we continue to evaluate strategic opportunities to further diversify our clinical and commercial product portfolio.

重要的是，我們擁有7.42 億美元現金的強大財務狀況為我們提供了繼續在整個業務中創造價值的選擇，例如透過增量投資來推動中小企業市場機會、繼續推進研發工作並尋求新的機會來加速我們的成長正如我們之前所討論的，我們將繼續評估策略機會，以進一步豐富我們的臨床和商業產品組合。

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.

我們仍然致力於嚴格的資本配置，以產生巨大的價值並加速成長，我們期待在未來提供這些努力的最新資訊。

I'll now turn the call over to Donn to provide more details on the SFP results and our guidance.

我現在將把電話轉給 Donn，以提供有關 SFP 結果和我們的指導的更多詳細資訊。

Looking forward.

期待。

Thank you, Ryan.

謝謝你，瑞安。

And 2023, we achieved a record net product sales and market share.

到 2023 年，我們的產品淨銷售額和市佔率將創下歷史新高。

Establishing hepatitis B is the leading adult hepatitis B vaccine in the U.S. marketplace.

建立乙型肝炎是美國市場上領先的成人乙型肝炎疫苗。

Additionally, we drove significant hepatitis B market growth by effectively pulling through the ACIP universal recommendation.

此外，我們透過有效落實 ACIP 普遍建議，推動了乙型肝炎市場的顯著成長。

Our success in 2023 reaffirms our confidence in the sizable market opportunity and long-term revenue growth potential for SMB, U.S. adult hepatitis B market continued to grow in 2023 following the SAP universal recommendation for hepatitis B vaccination, which now represents one of the largest vaccine market opportunities for adults.

我們在2023 年的成功再次證明了我們對中小企業巨大的市場機會和長期收入增長潛力的信心，繼SAP 乙型肝炎疫苗接種通用建議之後，美國成人乙型肝炎市場在2023 年繼續增長，乙型肝炎疫苗目前是最大的疫苗之一的成人市場機會。

We believe this recommendation will continue to be a significant catalyst for growth and estimate.

我們相信這項建議將繼續成為成長和預測的重要催化劑。

The hepatitis B vaccine market opportunity for M-Pesa grew to approximately $525 million in 2023 on a clear path to approximately $800 million by 2027, with MOCVD achieving a majority market share by that time.

M-Pesa 的乙型肝炎疫苗市場機會將在 2023 年增長至約 5.25 億美元，並預計在 2027 年達到約 8 億美元，屆時 MOCVD 將佔據多數市場份額。

During the fourth quarter, we continued to see indicators of U.S. market expansion from the ACX universal recommendations, despite softness in the market related to reduced wellness visits and an increased focus by health care providers on respiratory disease vaccines, including typical flu campaign and the launches of RC and endemic COVID-19 vaccines.

在第四季度，我們繼續從 ACX 普遍建議中看到美國市場擴張的跡象，儘管市場疲軟與健康就診減少以及醫療保健提供者更加關注呼吸道疾病疫苗（包括典型的流感疫苗和疫苗上市）有關RC 和局部COVID-19 疫苗。

Capital therapy continues to increase its total US market share, achieving 42% at the end of 2023 compared to 35% at the end of 2022.

資本療法的美國市場總份額持續增加，從 2022 年底的 35% 增加到 2023 年底的 42%。

Net product revenue in 2023 grew 69% year over year.

2023 年產品淨收入年增 69%。

The sales growth continues to be driven by helpful have these strong performance in two critical segments, retail pharmacy and integrated delivery networks or IDNs.

零售藥局和綜合配送網路（IDN）這兩個關鍵領域的強勁表現持續推動銷售成長。

We continue to focus our sales and marketing efforts on the retail pharmacy and IDS segments as they expect to see most of the anticipated market growth from the ACIP universal recommendation in these segments estimated both will grow to represent over 60% of the total hepatitis D market by 2027.

我們繼續將銷售和行銷工作重點放在零售藥局和IDS 領域，因為他們預計這些領域的大部分預期市場成長將來自ACIP 普遍建議，預計這兩個領域將成長到佔整個丁型肝炎市場的60%以上到 2027 年。

As I said, we have now the market share leader in both of these key segments Friday and at the end of the year, Tempo Savvis market share increased to approximately 56% compared to approximately 47% at the end of 2022.

正如我所說，週五和年底，我們在這兩個關鍵領域均佔據市場份額領先地位，Tempo Savvis 的市場份額從 2022 年底的約 47% 增至約 56%。

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.

我們專注於與大型衛生系統的高階主管和診所層級合作，以推動普遍建議的持續採用。

Customers continue to respond positively to the ACID. change and recognize the need to adopt and implement the recommendations.

客戶繼續對 ACID 作出正面反應。改變並認識到需要通過和實施這些建議。

Full-year hepatitis B vaccine market growth in the IT&S segment was 41% in the Retail Pharmacy Segment, we have made significant progress in several large national chains, making headless ABI, the preferred adult hepatitis B vaccine at the end of the year help us as we achieve approximately 58% market share in the retail pharmacy segment compared to approximately 42% at the end of 2022.

IT&S板塊全年乙肝疫苗市場增長41%，零售藥房板塊，我們在幾個大型全國連鎖店取得了重大進展，使得年底首選的成人乙肝疫苗Headless ABI幫助我們我們在零售藥房領域的市場份額約為58% ，而2022 年底約為42%。

We continue to see and expect significant growth from the retail pharmacy segments.

我們繼續看到並預計零售藥房領域將顯著增長。

Full-year hepatitis B vaccine market growth was 78%.

全年乙肝疫苗市場成長率為78%。

As Ryan noted, we are providing full year 2020 for net product revenue guidance for SMB to be in the range of $265 million to $280 million.

正如 Ryan 所指出的那樣，我們為 SMB 提供的 2020 年全年淨產品收入指引為 2.65 億至 2.8 億美元。

This guidance reflects our momentum in the market while factoring in the evolving market landscape and emerging quarterly patterns of non respiratory vaccination that we expect to see in 2024.

該指引反映了我們的市場勢頭，同時考慮了不斷變化的市場格局以及我們預計在 2024 年出現的非呼吸道疫苗接種季度模式。

Based on feedback from customers, cough, cold and flu season has extended much further into January than expected, reducing the number of wellness visits and vaccination opportunities due to softness in January, we anticipate little to no growth in the hepatitis B vaccine market for Q1 as compared to Q4 2023.

根據客戶回饋，咳嗽、感冒和流感季節比預期延長至 1 月份，由於 1 月份經濟疲軟，導致就診次數和疫苗接種機會減少，我們預計第一季度乙肝疫苗市場幾乎沒有增長與2023 年第四季度相比。

Encouragingly, we expect the market to strengthen for the remainder of Q1 into Q2 as the focus of health care providers and retail pharmacy shifted back to prioritizing non respiratory vaccines.

令人鼓舞的是，隨著醫療保健提供者和零售藥房的重點重新轉向優先考慮非呼吸道疫苗，我們預計第一季剩餘時間到第二季市場將走強。

As a result, we expect to recognize up to 60% of our full year revenue range in the second and third quarters with typical Q4 seasonality expected.

因此，我們預計第二季和第三季將實現全年收入範圍的 60%，預計第四季是典型的季節性。

We are extremely confident in the long-term expansion of the U.S. hepatitis B vaccine market and forecast annual market growth of approximately 10% to 15% over the next several years with SAP gaining meaningful increases in total market share over that time horizon.

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%，SAP 在此期間總市場份額將大幅增長。

In summary, we had a tremendous 2023 reaffirming our confidence that Hamilton Beach will strengthen this position as the clear market leader in the expanding hepatitis B vaccine market.

總而言之，我們在 2023 年取得了巨大的成功，這再次堅定了我們的信心，漢密爾頓海灘將鞏固其在不斷擴大的乙型肝炎疫苗市場中作為明確市場領導者的地位。

We are very proud of our commercial team's execution and encouraged by the progress and momentum for EpiCept, the establishing a majority market share in the key segments of retail, pharmacy and IDN.

我們對我們商業團隊的執行力感到非常自豪，並對 EpiCept 的進步和勢頭感到鼓舞，在零售、製藥和 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, Dan.

謝謝你，丹。

As a reminder, in our development pipeline, we're advancing innovative and diversified vaccines that leverage our CpG 1018 adjuvant with proven antigens.

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。

We also continue to identify new opportunities to leverage our CpG 10, 18 adjuvant through multiple innovative preclinical and discovery efforts with leading collaborators starting with our shingles vaccine program, Z. 1018.

我們也與領先的合作者從我們的帶狀皰疹疫苗計畫 Z. 1018 開始，透過多項創新的臨床前和發現工作，繼續尋找利用我們的 CpG 10、18 佐劑的新機會。

Currently, there's a successful licensed vaccine on the market, but we believe there's an opportunity to develop an improved vaccine given the challenging tolerability profile of the current market leading product.

目前，市場上有一種成功獲得許可的疫苗，但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進的疫苗。

One of the unique advantages we believe of our CpG 1018 agents is it 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 Zoster Virus results from our Phase one trials 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.

我們認為CpG 1018 藥物的獨特優勢之一是它的安全性和耐受性，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激活至關重要，這一點是我們第一階段試驗支持的結果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。

Late last year, we received Type B meeting feedback from the 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.

去年年底，我們收到了 FDA 關於 z 的 B 類會議回饋。 1018 年計劃，我們相信該計劃支持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。

We recently submitted an investigational new drug application or IND. to the U.S. FDA to support the initiation of a Phase one two trial of Z. 1018.

我們最近提交了一份研究性新藥申請或 IND。向美國 FDA 提交支持 Z.1018 一、二期試驗的啟動。

In the first half of 2024, we will be evaluating escalating doses of RG. protein, our selected dose of CpG 1018 with or without alum and different vaccination schedules.

2024 年上半年，我們將評估逐漸增加的 RG 劑量。蛋白質、我們選擇的 CpG 1018 劑量（含或不含明礬）以及不同的疫苗接種計劃。

We plan to enroll approximately 400 subjects and anticipate tight top line immunogenicity data in the second half of 2025 now Turning next to our TD. 2010 18 program.

我們計劃招募約 400 名受試者，並預計在 2025 年下半年獲得嚴格的免疫原性數據，現在轉向我們的 TD。 2010年18期節目。

This is an investigational vaccine candidate intended for active booster immunization against tetanus, diphtheria and pertussis or TDF guarantee that vaccines have limitations, including waning effectiveness.

這是一種研究性候選疫苗，旨在用於針對破傷風、白喉和百日咳的主動加強免疫，或 TDF 保證疫苗有局限性，包括有效性減弱。

We believe there's an opportunity to improve the duration of protection using our CpG 1018 management to generate a Th one biased immune response.

我們相信，利用我們的 CpG 1018 管理產生 Th 1 偏向免疫反應，有機會延長保護持續時間。

We've completed both a Phase one clinical trial in adults and adolescents as well as a pertussis challenge study in nonhuman primates.

我們已經完成了成人和青少年的第一階段臨床試驗以及非人靈長類動物的百日咳攻擊研究。

We recently received type the pre IND meeting phase feedback from the FDA on the teed up 10, 18 clinical development and regulatory pathways together results from our Phase one studies, our nonhuman primate study and the feedback from FDA all support proceeding to a human challenge study.

我們最近收到了 FDA 的 IND 會議前階段回饋，涉及我們的一期研究、非人類靈長類動物研究的 10、18 項臨床開發和監管途徑的結果，以及 FDA 的反饋都支持進行人類挑戰研究。

This year, we plan to submit an IND to the U.S. FDA to support the initiation of this Phase two human challenge study of TDF. 1018 in the second half of the year upon completion of the independent study being conducted by the Canadian center for vaccinology to establish the human challenge dose, which we will utilize in our Phase two study.

今年，我們計劃向美國 FDA 提交 IND，以支持啟動 TDF 的第二期人體挑戰研究。 1018 年下半年，加拿大疫苗中心完成了確定人體激發劑量的獨立研究，我們將在第二階段研究中使用該劑量。

Moving onto the plug program, this is a collaboration with and funded by the US Department of Defense.

轉向插頭計劃，這是與美國國防部合作並由其資助的項目。

We are conducting a Phase two trial evaluating the immunogenicity, safety and tolerability of a two-dose plague vaccine candidate that is adjuvanted with CpG 1018, the CpG 1018 adjuvanted vaccine candidates.

我們正在進行一項二期試驗，評估以 CpG 1018 為佐劑的兩劑鼠疫候選疫苗（CpG 1018 佐劑候選疫苗）的免疫原性、安全性和耐受性。

Mechanism of action has the potential to speed up time to protection with fewer doses compared to the three-dose alum adjuvanted vaccine previously developed by the Department of Defense.

與國防部先前開發的三劑量明礬佐劑疫苗相比，此作用機制有可能以更少的劑量加快獲得保護的時間。

We're currently conducting a randomized active controlled Phase two clinical trial evaluating immunogenicity, safety and tolerability of the plague vaccine candidate.

我們目前正在進行一項隨機主動對照二期臨床試驗，評估候選鼠疫疫苗的免疫原性、安全性和耐受性。

And in parallel, we're conducting a nonhuman primate challenge study.

同時，我們正在進行一項非人類靈長類動物挑戰研究。

We expect top line data from both of these studies by the end of 2024, and these data will inform next steps for the program.

我們預計這兩項研究將於 2024 年底前獲得頂線數據，這些數據將為該計劃的後續步驟提供資訊。

Now in addition to these development programs, we've also filed a supplemental BLA for hepatitis B vaccination of adults on hemodialysis, which the FDA has accepted with a PDUFA action date in May of 2024.

現在，除了這些開發計劃之外，我們還提交了一份針對接受血液透析的成人乙型肝炎疫苗接種的補充 BLA，FDA 已接受該補充 BLA，並於 2024 年 5 月確定了 PDUFA 行動日期。

If approved, this would allow us to promote a four dose regimen of teplizumab B to the dialysis population.

如果獲得批准，這將使我們能夠向透析族群推廣 teplizumab B 的四劑量方案。

We look forward to continuing to make progress across these programs in the months ahead, and we're excited to initiate the next clinical trial for both our shingles and TTR programs in the coming year.

我們期待在未來幾個月繼續在這些項目上取得進展，我們很高興能在來年啟動帶狀皰疹和 TTR 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.

謝謝你，羅布。

I'm pleased to report another quarter and full year of strong financial performance.

我很高興地報告又一個季度和全年強勁的財務業績。

I'll review the key financial results for 2023 as well as our financial guidance for 2024.

我將回顧 2023 年的主要財務表現以及 2024 年的財務指引。

Please note that all financial comparisons are versus the prior year period unless otherwise noted.

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。

Please also refer to our press release and Form 10-K for more detailed financial information.

另請參閱我們的新聞稿和 10-K 表格，以了解更詳細的財務資訊。

Starting with SAP net product revenue grew 69% year over year to $213 million, 2023, another record year for the franchise.

自 SAP 開始，到 2023 年，SAP 淨產品收入年增 69%，達到 2.13 億美元，創下該系列業務的另一個創紀錄年份。

We are also pleased with our continued trend in the margin profile for Atlas at the with gross margin of approximately 76% in 2023, consistent with our guidance of mid-70s percentage for the full year and significant improvement compared to about 68% in the prior year.

我們也對 Atlas 的利潤率持續保持趨勢感到滿意，2023 年毛利率約為 76%，與我們全年 70% 左右的指導一致，與之前的約 68% 相比有顯著改善年。

Looking forward, we expect gross margins of approximately 80% for the full year 2024, which is consistent with our long-term expectations and margin profile for this brand.

展望未來，我們預計 2024 年全年毛利率約為 80%，這與我們對該品牌的長期預期和利潤率狀況一致。

Other revenue was $19 million in 2023 compared to $9 million in the prior year period, representing revenue related to the plague vaccine program in collaboration with and funded by the US Department of Defense.

2023 年其他收入為 1,900 萬美元，而去年同期為 900 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。

The increase was primarily driven by the advancement into a nonhuman primate challenge study as well as continued progress throughout our Phase two clinical contract for the vaccine candidate.

這一增長主要是由於非人類靈長類動物挑戰研究的進展以及候選疫苗第二階段臨床合約的持續進展。

Turning to our expenses, research and development expenses for 2023 increased to $55 million compared to $47 million in the prior year period with the increases reflecting continued advancements in our clinical and preclinical development programs.

談到我們的費用，2023 年的研發費用增加至 5,500 萬美元，而去年同期為 4,700 萬美元，這一增長反映出我們的臨床和臨床前開發項目的持續進步。

Selling, general and administrative expenses for 2023 were $153 million compared to $131 million in the prior year period, with the increase primarily driven by higher compensation and related personnel costs and an overall increase in targeted commercial investments designed to drive help us at the market share and maximize the opportunities presented by the ACIP.s universal recommendation.

2023 年的銷售、一般和管理費用為 1.53 億美元，而去年同期為 1.31 億美元，成長的主要原因是薪酬和相關人員成本增加，以及旨在幫助我們提高市場份額的目標商業投資的整體增加並最大限度地利用ACIP 的普遍建議所帶來的機會。

These results generated a GAAP net loss of $6.4 million in 2023 compared to a GAAP net income of $293 million during 2022.

這些結果導致 2023 年 GAAP 淨虧損為 640 萬美元，而 2022 年 GAAP 淨利潤為 2.93 億美元。

Moving to the balance sheet.

轉向資產負債表。

We ended the year with cash, cash equivalents and marketable securities of approximately $742 million, which we believe is sufficient to progress.

截至年底，我們擁有約 7.42 億美元的現金、現金等價物和有價證券，我們相信這足以取得進展。

Our current pipeline assets and support our organic base business without the need to raise additional capital.

我們現有的管道資產支持我們的有機基礎業務，無需籌集額外資金。

Turning towards 2024, we are providing the following full year financial guidance.

展望 2024 年，我們提供以下全年財務指引。

Coupled with that, the net product revenue is expected to be between approximately $265 million and $280 million, including approximately $3 million in ex-US sales through our commercialization agreement with Bavarian Nordic in Germany, we expect to present the gross margin of approximately 80% for full year 2024.

除此之外，淨產品收入預計將在約2.65億美元至2.8億美元之間，其中包括透過我們與德國巴伐利亞北歐公司的商業化協議實現的約300萬美元的美國以外銷售額，我們預計毛利率約80% 2024 年全年。

We expect R&D expenses to be between approximately $60 million and $75 million.

我們預計研發費用約 6,000 萬至 7,500 萬美元。

We expect SG&A expenses to be between approximately $160 million and $180 million, and we also expect to be cash flow positive from the full year ended December 31st, 2024, reflecting our continued discipline towards allocating capital to drive top-line revenue growth while thoughtfully advancing our research programs.

我們預計SG&A 費用將在約1.6 億至1.8 億美元之間，我們也預計截至2024 年12 月31 日的全年現金流量將為正，這反映出我們在謹慎地推進資本分配以推動營收成長的同時持續遵守紀律。我們的研究計劃。

In closing, we believe that with our strong financial profile, we are well positioned to drive sustainable growth in our core headless as the business capture majority market share and lead the expansion of the adult hepatitis B vaccine market.

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無頭產品的可持續成長，因為該業務佔據了大部分市場份額，並引領成人乙型肝炎疫苗市場的擴張。

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.

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。

We are excited about our progress to date, and we look forward to continuing to deliver on our goals for this year and beyond.

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.

謝謝大家今天的關注。

And operator, we would now like to open the Q&A portion of today's call.

接線員，我們現在要開始今天電話會議的問答部分。

(Operator Instructions) Matthew Phipps, William Blair.

（操作員說明）馬修·菲普斯、威廉·布萊爾。

Good afternoon.

午安.

Thanks for taking my questions.

感謝您回答我的問題。

Congrats on a great 23 from last year.

恭喜您去年取得了出色的 23 分。

You just wanted a visit last year and you initially gave guidance of sort of what those lower [165, 185], Wondering if I don't like that and throughout the year, you raised it 20 -- over 20% with subsequent updates.

去年你只是想參觀一下，你最初給出了一些較低的指導 [165, 185]，想知道我是否不喜歡這樣，全年你將其提高了 20——在隨後的更新中超過 20%。

What were the factors you think that drove greater than expected sales from your initial point last year?

您認為是什麼因素推動了去年銷售額超出預期？

Was it greater growth of the total market or market share gains?

是整個市場的更大成長還是市場佔有率的成長？

Just kind of wondering what factors might influence where your guidance goes from today in 2024.

只是想知道哪些因素可能會影響您的指導從今天到 2024 年的走向。

And Matt, thanks for the question.

馬特，謝謝你的提問。

I think we have to remember 2023 was the 1st year first full year coming out of both reconciliation of pandemic demand as well as the ACIP universal recommendation.

我認為我們必須記住，2023 年是協調大流行需求和 ACIP 普遍建議的第一個完整年。

So one of the things we said, I think we were pretty clear about this that I recall from our prior earnings calls is that the market growth in 23 outpaced our original expectations when we originally provided guidance earlier in the year.

因此，我們說過的一件事，我認為我們對此非常清楚，我記得在之前的財報電話會議中，23 年的市場增長超出了我們最初在今年早些時候提供指導時的預期。

So we also had fairly successful growth in market share throughout the year.

因此，我們全年的市場份額也取得了相當成功的成長。

How much of those two factors pretty much dominated by have better market growth than originally projected.

這兩個因素在很大程度上決定了市場成長比最初預期的要好。

And does your guidance for this year include any contribution from the dialysis segment?

今年的指導是否包括透析領域的任何貢獻？

Yes, I mean, we don't really provide guidance segment by segment.

是的，我的意思是，我們並沒有真正逐一提供指導。

So we want to want to feature that our guidance for the year takes into account a lot of different puts and takes on how the year could evolve.

因此，我們想要強調的是，我們對今年的指導考慮了許多不同的看跌期權，並考慮了今年的發展。

And so we're not going to comment on one specific segment.

因此，我們不會對某一特定部分發表評論。

Jonathan Miller, Evercore ISI.

喬納森·米勒，Evercore ISI。

Hey, guys.

大家好。

Thanks for taking the question.

感謝您提出問題。

And also, congrats on 23 growth.

另外，恭喜你23歲了。

I wanted to drill down a little bit into that comment you made on little growth in the heavy market in Q one.

我想深入探討您對第一季重型市場成長緩慢的評論。

Do you still have an opportunity to grow share in Q. one to what extent is share growth tied to market overall market expansion, I guess?

在第一個問題中，您是否還有機會增加份額？我猜，份額成長與市場整體市場擴張的關聯程度如何？

And then secondly, what are your expectations on regular regulatory requirements for plague beyond the Phase two and the NHP. studies this year.

其次，您對第二階段和 NHP 以外的鼠疫常規監管要求有何期望。今年學習。

What are you spectrum regulators?

你們是什麼頻譜監理機構？

And what do you expect from DOJ?

您對司法部有何期望？

And while we take different, hey, thanks, John.

雖然我們採取不同的方式，嘿，謝謝，約翰。

Thanks for the questions.

感謝您的提問。

I'm going to have Dan talk to your first question and I'll pick up the second one.

我將讓丹談談你的第一個問題，然後我會回答第二個問題。

In earnings share, actually, we're excited about our ability to continue to take market share.

實際上，在收益份額方面，我們對繼續佔據市場份額的能力感到興奮。

This quarter is no different, but it's going to be consistent around is the ability to take market share.

本季也不例外，但在佔據市場份額的能力方面將保持一致。

So we like our position and our ability to take market share in the first quarter and even with market being where it is.

因此，我們喜歡我們的地位和我們在第一季佔據市場份額的能力，即使市場處於現狀。

And then the second question regarding the play plan.

然後是關於比賽計劃的第二個問題。

The regulatory plan.

監管計劃。

I think it's important to know the reason we're doing the nonhuman primate study is because that's a key part of the regulatory path for a product like this to utilize the animal.

我認為了解我們進行非人靈長類動物研究的原因很重要，因為這是此類產品利用動物的監管途徑的關鍵部分。

And so what we don't know yet is the specific path on whether or not there will be additional work required to satisfy the filing is under that under that pathway with the agency.

因此，我們還不知道是否需要根據該機構的該途徑進行額外工作來滿足備案的具體途徑。

But Rob, I don't know if you have any other comments you want to make around play?

但Rob，我不知道你對於比賽還有什麼其他的看法嗎？

No, I think you covered it or you don't.

不，我認為你涵蓋了它，或者你沒有。

I don't think I do.

我不這麼認為。

So we know what will be required to through E way versus a full approval, not at this point.

因此，我們知道透過 E 方式與完全批准需要什麼，但不是現在。

It makes sense

這說得通

--

--

a little bit what the data will also be an important aspect of that.

一點點什麼數據也將是其中一個重要的面向。

So we really need to see that data before we can confirm the pathway.

因此，在確認路徑之前，我們確實需要查看這些數據。

And then just one more on gross margin.

然後再談一談毛利率。

You said 80%-plus for hepatitis.

你說肝炎80%以上。

But how does that potential DOD collaboration revenue and other revenue line tie into that could total gross margin over overall gross margin still be in the mid 80s and higher.

但是，潛在的國防部合作收入和其他收入線如何與之掛鉤，總毛利率與整體毛利率之比仍可能在 80 年代中期或更高。

So the guidance, so there's no question.

所以指導，所以沒有問題。

The guidance is approximately 80% for the full year for Atlas as our other revenue line item is predominantly our plate our plate contract reimbursement, which doesn't carry significant margin per se sorry, significant cost of goods.

Atlas 全年的指引約為 80%，因為我們的其他收入項目主要是我們的板材合約報銷，這本身並沒有帶來很大的利潤，抱歉，商品成本很高。

It obviously doesn't carry any cost of goods.

它顯然不包含任何商品成本。

It also.

它也是。

Yes, to the extent we continue recognizing which we expect to continue recognizing other revenue through that contract and our total company gross margins would be slightly higher than that 80%.

是的，在我們繼續認識到這一點的情況下，我們預計將繼續透過該合約確認其他收入，並且我們公司的總毛利率將略高於 80%。

Paul Choi, Goldman Sachs.

保羅‧崔，高盛。

Good afternoon and congrats on the strong finish to 23 from us as well.

下午好，也祝賀我們以優異的成績進入第 23 名。

I want to maybe just ask on your thinking with regard to the guidance.

我想問一下您對指導的看法。

And as you think about the macro economic environment we're in and on people's price sensitivity and sensitivity in terms of thinking about health care spending versus the in a high-inflation environment, how do you think about maybe sort of the puts and takes of that in terms of demand growth over the course of the year?

當您考慮我們所處的宏觀經濟環境以及人們對醫療保健支出與高通膨環境的價格敏感度和敏感度時，您如何看待可能的看跌期權和索取期權就全年的需求增長而言？

And would that is that something you're thinking about in terms of freight, trimming your guidance?

這是否是您在貨運方面考慮的事情，從而調整您的指導？

And then I had a follow up on capital allocation.

然後我對資本配置進行了跟進。

Thanks for the question, Paul.

謝謝你的提問，保羅。

Um, you know, our guidance obviously is very specific to the market dynamics trend or vaccination, and it's we don't see some of those macro factors having a big impact here at all on the advertising market.

嗯，你知道，我們的指導顯然是針對市場動態趨勢或疫苗接種的，而且我們認為其中一些宏觀因素根本不會對廣告市場產生重大影響。

And it's a very the reimbursement for that segment is incredibly well.

這部分的報銷非常好。

There's first dollar coverage required under under the Affordable Care Act.

《平價醫療法案》要求提供第一筆美元保險。

So we think we're in a good position as it relates to some of those macro factors to continue to grow the vaccine market through 2024 and beyond.

因此，我們認為我們處於有利地位，因為這與一些宏觀因素有關，疫苗市場在 2024 年及以後繼續成長。

Okay, thanks for that.

好的，謝謝。

And then a follow up on I know you and the team have talked about BD and or partnering here, but I guess as you sort of survey the landscape and sort of where potential bid-ask spreads or is perhaps risk appetites are I guess as partnership or BD opportunities don't materialize in the let's say, the next 12 to 18 months, how would you think about then rank ordering on your capital allocation outside of investing in the outlet business?

然後是後續行動，我知道您和團隊已經在這裡討論過 BD 和/或合作，但我想當您調查一下情況以及潛在的買賣價差或風險偏好時，我想作為合作夥伴關係或BD 機會不會在接下來的12 到18 個月內實現，那麼除了投資直銷業務之外，您會如何考慮對資本配置進行排序？

Thanks so much for taking our questions.

非常感謝您回答我們的問題。

All right.

好的。

Thanks, Paul.

謝謝，保羅。

Yes.

是的。

No, I think I appreciate you highlighting the fact that there's a lot of flexibility and identifying the right asset for Dynavax.

不，我想我很感謝您強調 Dynavax 具有很大的靈活性並確定了正確的資產。

And so Kelly, why don't you provide some commentary on our overall capital allocation strategy share?

那麼凱利，您為什麼不對我們的整體資本配置策略份額提供一些評論呢？

So our exceptional commercial execution for Atlas SB., along with our hydrogen supply business, of course, has created this and this strengthening of our financial profile.

因此，我們對 Atlas SB. 的卓越商業執行力，以及我們的氫氣供應業務，當然增強了我們的財務狀況。

And we certainly believe that strong position will help us drive further further growth, including first and foremost, looking for opportunities to invest in driving growth in SMP as well as advancing our organic clinical stage assets as well as our preclinical portfolio kind of as we as we reflect on opportunities outside of that you know, to Ryan's comments around corporate development.

我們當然相信，強大的地位將幫助我們推動進一步的成長，包括首先也是最重要的，尋找投資機會來推動 SMP 的成長，以及推進我們的有機臨床階段資產以及我們的臨床前投資組合。我們反思瑞安關於企業發展的評論之外的機會。

We do continue to evaluate strategic opportunities to diversify our commercial and clinical product portfolio.

我們確實繼續評估策略機會，以使我們的商業和臨床產品組合多樣化。

And then beyond that, certainly we do we do evaluate and consider other opportunities to either return capital to shareholders as appropriate and when appropriate, as well as other ways to generate value for our shareholders.

除此之外，我們當然會評估並考慮其他機會，在適當的時候向股東返還資本，以及為股東創造價值的其他方式。

So that's sort of the rank ordering where we stand today and for Greg.

這就是我們今天對格雷格的排名順序。

Thank you.

謝謝。

Ernesto Rodriguez-Dumont, Cowen.

埃內斯托·羅德里格斯·杜蒙，考恩。

Hi, everybody.

大家好。

Thanks for taking our questions and congrats on a great year on.

感謝您提出我們的問題，並祝賀您度過了美好的一年。

I have a question about the on the effect that you described for from the longer than expected and respiratory vaccine season and the Q4 seasonality.

我對您所描述的呼吸道疫苗季節長於預期和第四季度季節性的影響有疑問。

Are those effects overcome during Q4 and Q3?

這些影響在第四季和第三季是否都已克服？

Or do you have to like internally adjust your estimates for 2024 based on that.

或者您是否必須在此基礎上內部調整您對 2024 年的估計。

And then second question regarding the the gross margins are on what's driving the improvement in gross margin.

關於毛利率的第二個問題是推動毛利率改善的因素。

You said on economies of scale and lower cost or are you expecting to have more pricing power?

您提到了規模經濟和降低成本，或者您期望擁有更大的定價權？

Thank you for asking the first one and Kelly, if you can handle the technologic down as far as I said, Japan, Ternium is thanks for the question.

謝謝你問第一個問題，凱利，如果你能像我說的那樣處理技術，日本，Ternium，謝謝你提出這個問題。

I interpreted the first part of the question to say because what we see in Q1 impact how we think about the rest of the year to the change.

我將問題的第一部分解釋為因為我們在第一季看到的情況會影響我們對今年剩餘時間的變化的看法。

We our general guidance.

我們的一般指導。

I mean, ultimately, we we've only drilled one guidance number when we're ready to provide it.

我的意思是，最終，當我們準備好提供指導數字時，我們只鑽探了一個指導數字。

So I don't it's kind of hard to think about how individual factors impacted.

所以我不認為很難思考個人因素是如何影響的。

But like we said in the call script, we know that Q2 and Q3 will continue to be the strongest quarters of the year are our continued interactions with our customers are incredibly positive.

但正如我們在通話腳本中所說，我們知道第二季度和第三季將繼續成為今年最強勁的季度，因為我們與客戶的持續互動非常積極。

So we're excited to get out of the respiratory season interest-free vaccine season and start working with our customers on the nonrespiratory part of the year to really drive growth in this market.

因此，我們很高興能夠擺脫呼吸道季節無息疫苗季節，並開始在一年中的非呼吸道部分與我們的客戶合作，以真正推動該市場的成長。

Kelly, can you hit on the gross margin pressure

凱利，你能解決毛利率壓力嗎

On gross gross margins for Atlas and the nice margin improvements have been driven by a couple of things, but and namely you noticed decreasing our per unit manufacturing costs.

關於阿特拉斯的毛利率和良好的利潤率改善是由幾個因素推動的，但也就是說，您注意到我們的單位製造成本降低了。

We made a number of investments in our manufacture antigen manufacturing facility in Germany on and really, really proud of the way that we've been able to pull through those on improving yields over time to realize, you know, sort of an estimate of approximately 80% gross margin for 2024.

我們對德國的抗原生產設施進行了大量投資，我們非常非常自豪我們能夠隨著時間的推移不斷提高產量，實現大約約2024 年毛利率為 80%。

On to reiterate another point that I made in the prepared remarks, we do expect that 80% gross margin range to represent it.

重申我在準備好的發言中提出的另一點，我們確實預計 80% 的毛利率範圍可以代表這一點。

And with levels that are consistent with our long-term expectations for this brand.

且其水準符合我們對該品牌的長期期望。

Edward White, H.C. Wainwright.

愛德華懷特，H.C.溫賴特。

Hey, this is Steve on for Ed. What A few questions for the shingles vaccine.

嘿，這是艾德的史蒂夫。關於帶狀皰疹疫苗的幾個問題。

Do you have a Factive timing to market?

您有 Factive 的上市時間嗎？

Well, we haven't commented on the long term, the specificity of our launch.

好吧，我們還沒有對我們發布的長期性和特殊性發表評論。

Obviously, it's a full clinical development program.

顯然，這是一個完整的臨床開發計劃。

So we're taking it could take multiple years to to move forward.

因此，我們認為可能需要多年的時間才能取得進展。

We have we have commented on the Phase one two trial and the expectation to have that data in 2025.

我們已經對一、二期試驗發表了評論，並期望在 2025 年獲得該數據。

And then we'll have to roll forward from there.

然後我們必須從那裡向前推進。

Steven, on expectations from the moving into the next study site in the study, looking at enrollment that dynamics to figure out or gotten when that would be able to to readout.

史蒂文，關於進入研究中的下一個研究地點的期望，請查看入學動態以確定或獲得何時能夠讀出。

So it's a little premature for us to predict the specific timing of filing and ultimate approval, but we have provided general commentary there and traditional vaccine development pathway.

因此，我們現在預測申請和最終批准的具體時間還為時過早，但我們已經提供了一般性評論和傳統的疫苗開發途徑。

And there's good reference points for prior trials conducted in this space to get a sense of timelines taken for those studies.

之前在這個領域進行的試驗有很好的參考點，可以了解這些研究的時間表。

Okay.

好的。

Thank you.

謝謝。

And so there were no adjuvant sales this year, right?

那麼今年沒有佐劑銷售，對吧？

I know that I didn't sell this year and we don't we don't contemplate additional asset sales for our COVID partnerships in 2024 at this time.

我知道我今年沒有出售，我們也沒有，目前我們不考慮在 2024 年為我們的新冠合作夥伴關係進行額外的資產出售。

Okay.

好的。

And what about in 2025 and going forward?

那麼 2025 年及以後呢？

It's unclear.

目前還不清楚。

Depends on how the market demand and how the markets evolve and how our individual collaborator's products are utilized and the efforts they put beyond behind keeping up with the shifting landscape, including stream managements.

取決於市場需求和市場如何發展，以及我們個人合作者的產品如何被利用，以及他們為跟上不斷變化的情況所付出的努力，包括串流管理。

So obviously, we'll be supportive of our partners and their initiatives.

顯然，我們將支持我們的合作夥伴及其舉措。

We believe COVID vaccination will continue globally for the years to come and is an important product in the marketplace.

我們相信，新冠疫苗接種將在未來幾年在全球範圍內持續存在，並且是市場上的重要產品。

And so we will be there to support them as needed.

因此，我們將根據需要為他們提供支援。

Roy Buchanan, Citizens JMP.

羅伊·布坎南，公民 JMP。

Hey, thanks for taking the questions.

嘿，感謝您提出問題。

A couple of quick ones on the play.

劇中的幾個快速的。

But are you going to announce the results of the non human challenge trial and the Phase two at the same time later this year may.

但你是否會在今年稍後同時公佈非人類挑戰試驗和第二階段的結果？

Can you remind me, are you making any cell-mediated immunity assessments in the FIGHT Phase two?

您能提醒我，您在「戰鬥」第二階段是否進行了任何細胞介導的免疫評估？

And do you think those might be important?

您認為這些可能重要嗎？

Any thoughts on that?

對此有什麼想法嗎？

Thanks.

謝謝。

I'll take the first one and then I'll ask Ron to follow up on the second one of the things you have to realize with the with this study with DM funded by the DOD is this is data that has we had Orbital or duty partners on on the release that data release.

我會採取第一個，然後我會請羅恩跟進第二個你必須意識到的事情，在這項由國防部資助的 DM 研究中，這是我們擁有軌道或任務的數據合作夥伴在發布該數據時。

And so that has not been clarified yet on exactly what the opportunity will be to show that data and what form for either trial.

因此，目前還沒有明確顯示這些數據的機會以及試驗的形式。

So we need to basically complete the trials.

所以我們需要基本完成試驗。

First, Roy and Phil will make some top line comments like we have in the past, but we don't have a data release plan across both trials together and that will we will work to be able to provide as much clarity on how that program is progressing in partnership with the DoD primary endpoint is antibodies that Rob, would you please read any other commentary you have around cell-mediated immunity in the play program?

首先，羅伊和菲爾將像我們過去一樣發表一些重要評論，但我們沒有跨這兩項試驗的數據發布計劃，我們將努力盡可能清晰地說明該計劃的方式與國防部合作取得進展的主要終點是抗體，羅布，請您閱讀遊戲程式中有關細胞介導免疫的任何其他評論嗎？

Yes, the primary endpoint is looking at antibodies because that's been that's what DOD has used in previously.

是的，主要終點是觀察抗體，因為國防部以前就使用過抗體。

They've developed this vaccine on, particularly with respect to looking at antibodies, non nonhuman primates and then applying those to humans.

他們開發了這種疫苗，特別是在非人靈長類動物身上觀察抗體，然後將其應用於人類。

We aren't looking at cell-mediated immune your T cells in our in this Phase two study.

在我們的第二階段研究中，我們並沒有關注 T 細胞的細胞介導免疫。

Thank you.

謝謝。

Thank you.

謝謝。

At this time, I'd like to hand the conference back over to Mr. Ryan Spencer for closing remarks.

現在，我想將會議交回給 Ryan Spencer 先生致閉幕詞。

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

謝謝運營商，也謝謝大家今天加入我們。

We appreciate your interest in Dynavax.

我們感謝您對 Dynavax 的興趣。

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

我們對最近的成就和我們的地位感到興奮。

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

總的來說，我們期待向您通報我們在保護世界免受傳染病侵害方面取得的最新進展。

Operator, you may end the call.

接線員，您可以結束通話了。

Ladies and gentlemen, thank you for joining us today.

女士們、先生們，謝謝你們今天加入我們。

And this concludes today's conference call.

今天的電話會議到此結束。

You may now disconnect.

您現在可以斷開連線。