Novavax Inc (NVAX) 2014 Q4 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Novavax Fourth Quarter and Full Year 2014 Earnings Conference Call. (Operator Instructions) As a reminder, this conference is being recorded. I would now like to introduce your host for today's call, John Herrmann, General Counsel. Sir, you may now begin.

女士們先生們，美好的一天，歡迎來到 Novavax 2014 年第四季度和全年收益電話會議。 （操作員說明）作為提醒，本次會議正在錄製中。我現在想介紹今天電話會議的主持人，總法律顧問 John Herrmann。先生，您現在可以開始了。

Thank you. Good afternoon, everyone. This is John Herrmann, General Counsel of Novavax. I'd like to thank everyone for joining today's call to discuss our fourth quarter and full year 2014 financial results. Today's earnings release is currently available on our website at novavax.com, and an audio archive of this conference call will be available on our website later this evening. Joining me on today's call is Novavax's President and CEO, Stan Erck; along with Buck Phillips, our CFO; and Dr. Greg Glenn, our Senior Vice President of Research and Development.

謝謝你。大家下午好。我是 Novavax 的總法律顧問 John Herrmann。我要感謝大家參加今天的電話會議，討論我們 2014 年第四季度和全年的財務業績。今天的收益發布目前可在我們的網站 novavax.com 上獲取，本次電話會議的音頻檔案將於今晚晚些時候在我們的網站上提供。和我一起參加今天電話會議的是 Novavax 的總裁兼首席執行官 Stan Erck；與我們的首席財務官 Buck Phillips 一起；和我們的研發高級副總裁 Greg Glenn 博士。

Before we begin our prepared remarks, I need to remind you that we will be making forward-looking statements during this teleconference that could include financial, clinical or commercial projections. Statements relating to future financial or business performance, conditions or strategies and other financial and business-related matters, including expectations regarding revenue, operating expenses, cash usage and clinical developments and anticipated milestones are all forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time.

在我們開始準備發言之前，我需要提醒您，我們將在本次電話會議期間發表前瞻性陳述，其中可能包括財務、臨床或商業預測。與未來財務或業務業績、條件或戰略以及其他財務和業務相關事項有關的陳述，包括對收入、運營費用、現金使用和臨床發展的預期以及預期的里程碑，均為私人證券含義內的前瞻性陳述訴訟改革法。 Novavax 告誡說，這些前瞻性陳述受許多假設、風險和不確定性的影響，這些假設、風險和不確定性會隨著時間而變化。

With the front over, I will now turn the call over to Stan Erck, President and CEO. Stan?

前面結束後，我現在將把電話轉給總裁兼首席執行官 Stan Erck。斯坦?

Thanks, John. Good afternoon, everyone. So our accomplishments during the fourth quarter culminated in a productive year for Novavax, as we delivered on all the key clinical and corporate objectives that we outlined at the beginning of the year. With the initiation of several important clinical trials during the second half of 2014, we anticipate announcing top line data from all of our key pipeline programs in 2015, making the upcoming year incredibly exciting for us.

謝謝，約翰。大家下午好。因此，我們在第四季度取得的成就為 Novavax 帶來了豐收的一年，因為我們實現了年初概述的所有關鍵臨床和企業目標。隨著 2014 年下半年幾項重要臨床試驗的啟動，我們預計 2015 年將公佈我們所有關鍵管道項目的一線數據，這將使來年對我們來說非常令人興奮。

As usual, I'll now ask Greg to review our recent clinical and scientific accomplishments. After that, I'll provide detail regarding key anticipated events in 2015. We'll finish the call with a financial overview by Buck and then open the line for questions.

像往常一樣，我現在請格雷格回顧一下我們最近的臨床和科學成就。之後，我將提供有關 2015 年主要預期事件的詳細信息。我們將以巴克的財務概述結束電話會議，然後打開電話提問。

With that agenda, let me hand the call over to Greg.

有了這個議程，讓我把電話交給格雷格。

Thanks, Stan, and good afternoon, everyone. During 2014, we announced a number of clinical and preclinical accomplishments. Our efforts have built a strong foundation for moving our key programs into later-stage development. As Stan mentioned, 2015 will be a busy and exciting year with several important clinical data readouts.

謝謝，斯坦，大家下午好。 2014 年，我們公佈了多項臨床和臨床前成就。我們的努力為我們的重點項目進入後期發展奠定了堅實的基礎。正如 Stan 所說，2015 年將是忙碌而激動人心的一年，有幾個重要的臨床數據讀數。

I'll start with a review of our accomplishments and focus first on our comprehensive RSV program. The first major achievement I'd like to highlight is the Phase II clinical trial of our RSV F vaccine in elderly adults that we initiated in the fourth quarter of 2014. This trial is a randomized, observer-blinded, placebo-controlled trial of 1,600 elderly adults over 60 years of age, which is being conducted at 10 U.S. based sites. The trial is designed to evaluate the safety and immunogenicity of 135-microgram dose of the RSV F vaccine compared with placebo and the incidence of all respiratory illnesses due to RSV, including medically attended respiratory illness due to RSV and hospitalizations for respiratory illness due to RSV in community-living elderly adults. The trial will also estimate the efficacy of the RSV F vaccine in reducing the incidence of respiratory illnesses due to RSV.

我將從回顧我們的成就開始，首先關注我們全面的 RSV 計劃。我想強調的第一個重大成就是我們在 2014 年第四季度啟動的針對老年人的 RSV F 疫苗的 II 期臨床試驗。該試驗是一項隨機、觀察者盲、安慰劑對照試驗，共有 1,600 人參與60 歲以上的老年人，正在美國的 10 個地點進行。該試驗旨在評估 135 微克劑量的 RSV F 疫苗與安慰劑相比的安全性和免疫原性，以及由 RSV 引起的所有呼吸道疾病的發生率，包括因 RSV 引起的呼吸道疾病和因 RSV 引起的呼吸道疾病住院在社區生活的老年人中。該試驗還將評估 RSV F 疫苗在降低 RSV 引起的呼吸道疾病發病率方面的功效。

Another major achievement occurred in the third quarter of 2014 when we initiated the Phase II trial of RSV F vaccine in pregnant women as the next step in our maternal immunization program. This trial is a randomized, blinded, placebo-controlled Phase II study enrolling 50 healthy women in their third trimester of pregnancy. The trial evaluates the safety of the vaccine in mothers and their infants. It also studies the transfer of RSV-specific antibodies from mother to infant and assesses the RSV antibody half-life in the infants of immunized mothers. This trial is continuing to enroll, and we expect to provide top line data in the third quarter of this year.

另一項重大成就發生在 2014 年第三季度，我們啟動了孕婦 RSV F 疫苗的 II 期試驗，作為我們孕產婦免疫計劃的下一步。該試驗是一項隨機、盲法、安慰劑對照的 II 期研究，招募了 50 名處於妊娠晚期的健康婦女。該試驗評估了疫苗對母親及其嬰兒的安全性。它還研究 RSV 特異性抗體從母親到嬰兒的轉移，並評估免疫母親的嬰兒中 RSV 抗體的半衰期。該試驗正在繼續招募，我們預計將在今年第三季度提供一線數據。

In addition, in November 2014, we initiated a Phase I clinical trial of our RSV F vaccine in children. The trial, which is being conducted in Canada, is a randomized, observer-blinded, dose-ranging Phase I study to evaluate the safety and immunogenicity of the RSV F vaccine with or without aluminum phosphate in children aged 2 to 6 years of age, who are seropositives to RSV.

此外，2014 年 11 月，我們啟動了我們的 RSV F 疫苗在兒童中的 I 期臨床試驗。該試驗在加拿大進行，是一項隨機、觀察者盲、劑量範圍的 I 期研究，旨在評估 RSV F 疫苗在 2 至 6 歲兒童中使用或不使用磷酸鋁的安全性和免疫原性，對 RSV 呈陽性反應的人。

In addition to the trial's primary goal of evaluating safety in this population, the trial is also designed to evaluate the immunogenicity as measured by concentrations of serum IgG antibodies to the RSV fusion or F-Protein, the palivizumab competing antibody titers and RSV microneutralizing titers. Importantly, in this Phase I trial, we're evaluating the immunogenicity of the vaccine outside the RSV season and obtaining safety data through the following season.

除了該試驗的主要目標是評估該人群的安全性外，該試驗還旨在評估免疫原性，該免疫原性是通過針對 RSV 融合或 F 蛋白的血清 IgG 抗體濃度、帕利珠單抗競爭抗體滴度和 RSV 微量中和滴度來測量的。重要的是，在這個 I 期試驗中，我們正在評估疫苗在 RSV 季節之外的免疫原性，並在下一個季節獲得安全數據。

We have found that enrolling children prior to the 2014/'15 RSV season proceeded more slowly than we have expected. It's unlikely that enrollment could be completed before the season, so we've elected to delay any further recruitment in this trial until after the end of the season in 2015 in Canada. Our plan is to restart recruitment later this year prior to the next RSV season and, in doing so, incorporate our learnings about pediatric recruitment to avoid some of the enrollment issues we have faced.

我們發現，在 2014/'15 RSV 季節之前招收兒童的進度比我們預期的要慢。在賽季前完成招募的可能性不大，因此我們選擇將本次試驗中的任何進一步招募推遲到 2015 年加拿大賽季結束之後。我們的計劃是在今年晚些時候在下一個 RSV 季節之前重新開始招募，並在此過程中結合我們對兒科招募的了解，以避免我們面臨的一些招募問題。

With respect to RSV program, I want to note that our clinical and preclinical data sets have continued to grow and garnered significant interest for the medical community. On our last quarter's call, I described in detail our presentations at the 8th International Society of Vaccine Congress and at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy known as ICAAC.

關於 RSV 計劃，我想指出，我們的臨床和臨床前數據集持續增長，並引起了醫學界的極大興趣。在我們上個季度的電話會議上，我詳細描述了我們在第八屆國際疫苗學會大會和第 54 屆抗菌藥物和化療跨科學會議（即 ICAAC）上的演講。

In addition to those conferences, we recently presented a number -- a variety of our clinical and preclinical data at the 9th International RSV Symposium held last November in South Africa. Our topics included immunization of pregnant baboons demonstrated placental transfer of functional anti-RSV antibodies in their infants, along with similar data in rabbit and guinea pig models; presentation of our clinical data from our Phase II trial in healthy women of childbearing age; preclinical studies demonstrating protection against RSV wild-type strain and palivizumab escape mutants; and the relevance of our RSV vaccine immunogenicity, including palivizumab competing antibodies. These presentations are all posted on our website for your review.

除了這些會議之外，我們最近還在去年 11 月於南非舉行的第 9 屆國際 RSV 研討會上展示了我們的各種臨床和臨床前數據。我們的主題包括對懷孕狒狒的免疫，證明其嬰兒的功能性抗 RSV 抗體在胎盤中轉移，以及在兔和豚鼠模型中的類似數據；介紹我們在健康育齡婦女中進行的 II 期試驗的臨床數據；臨床前研究證明對 RSV 野生型菌株和帕利珠單抗逃逸突變體具有保護作用；以及我們的 RSV 疫苗免疫原性的相關性，包括帕利珠單抗競爭抗體。這些演示文稿都發佈在我們的網站上供您查看。

Last quarter, I noted that RSV is increasingly being recognized in the past year with great importance. Globally, RSV is second only to malaria as a leading cause of death in children under 1 year of age. In the U.S., nearly all children become infected with RSV before they are 2 years of age, and it is the #1 cause of hospitalization of children 0 to 12 months old. It's estimated that as many as 17,000 elderly and high-risk adults die of RSV infection or its complications annually in the U.S. and up to 180,000 hospitalization for serious -- hospitalized for serious respiratory disease.

上個季度，我注意到 RSV 在過去一年中越來越受到重視。在全球範圍內，RSV 是 1 歲以下兒童死亡的主要原因，僅次於瘧疾。在美國，幾乎所有兒童都在 2 歲之前感染 RSV，這是 0 至 12 個月大的兒童住院的第一大原因。據估計，美國每年有多達 17,000 名老年人和高危成人死於 RSV 感染或其並發症，多達 180,000 人因嚴重呼吸系統疾病住院。

I want to note that in the New England Journal published today, there was a study that enrolled 2,638 children, 89% who all had -- who had radiographically evidence of pneumonia. Their annual incidence of pneumonia was 15 cases per 10,000. Children with the highest rates were younger than 2 years of age and had 62 cases per 10,000. And in this study, RSV was the most common pathogen detected and was with the greatest burden of hospitalization observed among children younger than 2 years of age. So that is in the 26 February New England Journal, today as I mentioned.

我想指出，在今天出版的《新英格蘭雜誌》上，有一項研究招募了 2,638 名兒童，其中 89% 的兒童都有肺炎的影像學證據。他們每年的肺炎發病率為每10,000人中有15例。發病率最高的兒童年齡小於 2 歲，每 10,000 人中有 62 例。在這項研究中，RSV 是檢測到的最常見病原體，並且在 2 歲以下兒童中觀察到的住院負擔最大。正如我所提到的，這是在 2 月 26 日的《新英格蘭日報》上。

Our view of the importance of RSV -- of an RSV vaccine has been recently validated also by the FDA who granted RSV vaccine Fast Track Designation for protection of infants by maternal immunization. We believe this reflects the agency's recognition of the importance of this unmet medical need, their support for maternal immunization as an approach to protect the infants from this respiratory pathogen and the potential of our RSV F vaccine.

我們對 RSV 重要性的看法——一種 RSV 疫苗最近也得到了 FDA 的驗證，FDA 授予 RSV 疫苗快速通道指定以通過母體免疫保護嬰兒。我們認為，這反映了該機構對這一未得到滿足的醫療需求的重要性的認識，他們對母體免疫接種作為保護嬰兒免受這種呼吸道病原體感染的一種方法的支持，以及我們的 RSV F 疫苗的潛力。

Now moving to our influenza program. Last -- in the fourth quarter, we initiated a Phase II clinical trial of a recombinant quadrivalent seasonal VLP vaccine. As a reminder, this trial has been conducted over the company's contract with BARDA, which was recently extended an additional 24 months through September 2016, and we were awarded with additional $70 million in funding. This Phase II trial is a randomized, observer-blinded, dose-ranging trial designed to evaluate the safety and immunogenicity of our quadrivalent seasonal VLP vaccine in 400 healthy adults. The primary outcomes of the trial will assess safety and tolerability of the seasonal VLP -- influenza VLP vaccine and quantify immune responses to each of the 4 influenza strains based on hemagglutinin inhibition titers. In addition, the secondary outcomes will evaluate neuraminidase inhibition antibody titers for all influenza strains.

現在轉到我們的流感項目。最後——在第四季度，我們啟動了重組四價季節性 VLP 疫苗的 II 期臨床試驗。提醒一下，這項試驗是根據公司與 BARDA 的合同進行的，最近又延長了 24 個月至 2016 年 9 月，我們獲得了額外的 7000 萬美元資金。這項 II 期試驗是一項隨機、觀察者盲、劑量範圍試驗，旨在評估我們的四價季節性 VLP 疫苗在 400 名健康成人中的安全性和免疫原性。該試驗的主要結果將評估季節性 VLP - 流感 VLP 疫苗的安全性和耐受性，並根據血凝素抑制效價量化對 4 種流感毒株中每一種的免疫反應。此外，次要結果將評估所有流感毒株的神經氨酸酶抑制抗體滴度。

We believe this vaccine has the potential to provide a differentiated immune response in the presentation of both hemagglutinin and the intact neuraminidase antigen, and that a differentiated immune response has the potential to deliver a more robust protection against infection.

我們相信這種疫苗有可能在血凝素和完整神經氨酸酶抗原的呈遞中提供差異化的免疫反應，並且差異化的免疫反應有可能提供更強大的抗感染保護。

Before we're moving on, I want to remind you that during this year, we were also pleased to receive word from the FDA that our pandemic H7N9 VLP vaccine was also granted FDA Fast Track Designation. Similar to RSV, we believe this designation underscores the FDA's recognition of the risk of H7N9 influenza, the lack of approved vaccines and the strength of our vaccine.

在我們繼續之前，我想提醒您，在今年，我們也很高興收到 FDA 的消息，我們的大流行 H7N9 VLP 疫苗也被授予 FDA 快速通道指定。與 RSV 類似，我們認為這一指定強調了 FDA 對 H7N9 流感風險的認識、缺乏批准的疫苗以及我們疫苗的強度。

So lastly, we announced a significant update in our Ebola program. Earlier this month, enrollment began in our Phase I clinical trial of our Ebola vaccine candidate, adjuvant with the Matrix-M in healthy adults. As a reminder, we initiated the development of our Ebola vaccine shortly after the publication of the genetic sequence of 2014 Ebola Makona strain responsible for the current Ebola epidemic in West Africa. The Ebola GP Vaccine clinical trial, which is being conducted in Australia, is a randomized, observer-blinded, dose-ranging Phase I trial to evaluate the safety and immunogenicity of the vaccine with and without Matrix-M adjuvant in 230 healthy adults between 18 to 50 years of age. In addition to the trial's primary goal of evaluating safety in this population, the study will also evaluate immunogenicity as measured by concentrations of serum IgG to the Ebola Makona strain glycoprotein.

最後，我們宣布了埃博拉病毒計劃的重大更新。本月早些時候，我們的埃博拉候選疫苗 I 期臨床試驗開始註冊，該疫苗在健康成人中使用 Matrix-M 佐劑。提醒一下，我們在 2014 年埃博拉馬科納病毒株的基因序列公佈後不久就開始了埃博拉疫苗的開發，該病毒株負責目前西非埃博拉病毒的流行。正在澳大利亞進行的埃博拉 GP 疫苗臨床試驗是一項隨機、觀察者盲、劑量範圍的 I 期試驗，旨在評估疫苗在 18 歲之間的 230 名健康成年人中使用和不使用 Matrix-M 佐劑的安全性和免疫原性到50歲。除了該試驗的主要目標是評估該人群的安全性外，該研究還將評估免疫原性，該免疫原性是通過對埃博拉馬科納病毒株糖蛋白的血清 IgG 濃度來測量的。

In less than 5 months, Novavax validated its Ebola vaccine with prevailing animal data, including 100% protection against the lethal Ebola challenge in nonhuman primates. In this study, nonhuman primates received 2 injections of a 5-microgram dose of the Ebola GP vaccine with Matrix-M, and they were challenged with a lethal dose of the Ebola virus. Predictably, the challenge is lethal for the control animal, while 100% of the immunized animals were protected.

在不到 5 個月的時間裡，Novavax 用流行的動物數據驗證了其埃博拉疫苗，包括 100% 保護非人類靈長類動物免受致命的埃博拉病毒挑戰。在這項研究中，非人類靈長類動物接受了 2 次 5 微克劑量的帶有 Matrix-M 的埃博拉 GP 疫苗的注射，並且它們受到了致命劑量的埃博拉病毒的攻擊。可以預見，挑戰對對照動物是致命的，而 100% 的免疫動物受到保護。

The rapid progression to a Phase I clinical trial was further supported by Novavax GMP process, which is detailed in the February online publication of the BioProcessing Journal.

Novavax GMP 流程進一步支持了向 I 期臨床試驗的快速進展，該流程在 2 月份的 BioProcessing Journal 在線出版物中有詳細說明。

So with that summary, I'll now turn the call back to Stan.

因此，有了這個總結，我現在將電話轉回給 Stan。

Thanks, Greg. Based on Greg's comments, I'm sure that you can appreciate how much we've accomplished in 2014 and how that momentum is continuing into 2015. At the risk of repeating some of what Greg mentioned, let me recap both where we are and update you on guidance of our expected progress in 2015. First, after initiating and completing our H7N9 pandemic flu trial last year with very positive results in the last months of 2014 and into February of this year, we've started 3 new Phase II clinical trials and 2 new Phase I clinical trials. We will use data from 3 of these trials, specifically the quadrivalent flu trial, the elderly RSV trial and the maternal RSV trial to help us design our pathway forward into Phase III trials, which are all targeted to start as early as the fourth quarter of this year or later in 2016. With Ebola, the pathway forward there will depend on both the progression of the epidemic and the opportunities for financial backing.

謝謝，格雷格。根據 Greg 的評論，我相信您會理解我們在 2014 年取得的成就以及這種勢頭如何持續到 2015 年。冒著重複 Greg 提到的一些內容的風險，讓我回顧一下我們的現狀並更新您對我們在 2015 年的預期進展提供指導。首先，在去年啟動並完成了我們的 H7N9 大流行性流感試驗並在 2014 年最後幾個月和今年 2 月取得了非常積極的結果之後，我們已經開始了 3 項新的 II 期臨床試驗和 2 項新的 I 期臨床試驗。我們將使用其中 3 項試驗的數據，特別是四價流感試驗、老年 RSV 試驗和母體 RSV 試驗來幫助我們設計進入 III 期試驗的途徑，這些試驗都計劃最早在今年第四季度開始。今年或 2016 年晚些時候。對於埃博拉，前進的道路將取決於疫情的發展和資金支持的機會。

Data from the Phase I RSV pediatric trial will help us determine what will be required for a Phase II trial and the timing thereof relative to the more advanced elderly and maternal trials. So let me update you on the timing of the data from these trials. We continue to expect data from the quadrivalent flu trial by the end of the second quarter. Our 1,600 elderly adult RSV trial remains on target to report on preliminary results in the third quarter. Our Phase II maternal immunization trial is also expected to report preliminary results in the third quarter. And as Greg mentioned, the Phase I pediatric trial is taking longer than originally planned, and while we still continue to target data in 2015, that could slip into 2016. And finally, from the startup of our Ebola program in September to the initiation of our Phase I trial this month, we expect data in mid-2015.

來自 I 期 RSV 兒科試驗的數據將幫助我們確定 II 期試驗所需的內容以及相對於更先進的老年人和孕產婦試驗的時間安排。因此，讓我向您介紹這些試驗數據的時間安排。我們繼續期待第二季度末四價流感試驗的數據。我們的 1,600 名老年人 RSV 試驗仍有望在第三季度報告初步結果。我們的第二階段產婦免疫試驗也有望在第三季度報告初步結果。正如 Greg 所提到的，I 期兒科試驗的時間比最初計劃的要長，雖然我們仍然在 2015 年繼續瞄準數據，但這可能會滑到 2016 年。最後，從 9 月我們的埃博拉病毒項目啟動到啟動我們本月的 I 期試驗，我們預計 2015 年年中的數據。

We've grown the company to over 300 very talented employees. This group now has the critical mass and capabilities to help us achieve our aggressive development goals in 2015. We continue to broaden our exposure in the RSV, flu and emerging virus communities, and I believe now command a great deal of respect for the breakthroughs we've made in all of these fields of vaccination. We see this recognition from academic, governmental and nongovernmental key opinion leaders as well as from our industrial colleagues.

我們已經將公司發展為擁有 300 多名才華橫溢的員工。這個小組現在擁有足夠的數量和能力來幫助我們在 2015 年實現我們積極的發展目標。我們繼續擴大我們在 RSV、流感和新興病毒社區的接觸，我相信現在我們對我們取得的突破感到非常尊重已經在所有這些疫苗接種領域取得了成功。我們從學術、政府和非政府的關鍵意見領袖以及我們的行業同事那裡看到了這種認可。

So with that, I'll turn the call over to Buck to review our fourth quarter 2014 financial results.

因此，我將把電話轉給巴克審查我們 2014 年第四季度的財務業績。

Thank you, Stan. Today, we announced results for both the 2014 fourth quarter and full year. The summary of financial statements can be found in today's press release.

謝謝你，斯坦。今天，我們公佈了 2014 年第四季度和全年的業績。財務報表摘要可在今天的新聞稿中找到。

For the fourth quarter of 2014, we recorded a net loss of $31.5 million or $0.13 per share. This compares to a net loss of $14.1 million or $0.07 per share for the prior year period. The increase in net loss for the fourth quarter is primarily the result of increased R&D expenses related to our successful RSV F vaccine program and the initiation of 3 RSV clinical trials in the third and fourth quarter of 2014. I will discuss those expenses in greater detail in the R&D section of my comments today.

2014 年第四季度，我們錄得淨虧損 3150 萬美元或每股 0.13 美元。相比之下，去年同期淨虧損 1410 萬美元或每股 0.07 美元。第四季度淨虧損的增加主要是由於與我們成功的 RSV F 疫苗計劃相關的研發費用增加以及 2014 年第三和第四季度啟動 3 項 RSV 臨床試驗。我將更詳細地討論這些費用在我今天評論的研發部分。

Revenue for the quarter was -- net loss for the year, excuse me, everyone. Net loss for the year of 2014 was $82.9 million or $0.37 per share. This compares to a net loss of $52 million or $0.31 per share for the period -- for the prior year period. The increase in net loss was primarily due to higher R&D expenses, specifically related to the initiation of the 3 clinical trials of our RSV vaccine, as well as higher employee-related expenses and the full year impact of our Novavax AB acquisition. The revenue for the quarter was $6.7 million compared to $8.7 million for the same period in 2013. The 23% decrease in fourth quarter 2014 relative to the same period in '13 is primarily related to revenues recognized under our past agreement for the fourth quarter of 2013 related to the initiation of the Phase II RSV trial in women of childbearing age.

本季度的收入是——今年的淨虧損，對不起，各位。 2014 年的淨虧損為 8290 萬美元或每股 0.37 美元。相比之下，去年同期淨虧損 5200 萬美元或每股 0.31 美元。淨虧損增加主要是由於研發費用增加，特別是與啟動我們的 RSV 疫苗的 3 項臨床試驗有關，以及員工相關費用增加以及我們收購 Novavax AB 的全年影響。本季度的收入為 670 萬美元，而 2013 年同期為 870 萬美元。與 13 年同期相比，2014 年第四季度下降了 23%，這主要與我們過去的第四季度協議中確認的收入有關。 2013 年涉及在育齡婦女中啟動 II 期 RSV 試驗。

Revenue for the year ended 2014 increased 47% to $30.7 million compared to $20.9 million in 2013. The increase in full year revenue results from the 2014 Phase I/II clinical trial of our H7N9 pandemic vaccine candidate and activities related to the preparation and initiation of the Phase II clinical trial of our quadrivalent seasonal influenza vaccine. Both programs are funded under our contract with BARDA.

與 2013 年的 2,090 萬美元相比，截至 2014 年的年度收入增長 47% 至 3,070 萬美元。全年收入的增長源於我們的 H7N9 大流行疫苗候選者的 2014 年 I/II 期臨床試驗以及與製備和啟動相關的活動我們的四價季節性流感疫苗的 II 期臨床試驗。這兩個項目都是根據我們與 BARDA 的合同資助的。

For the fourth quarter of 2014, cost of government contracts revenue increased 9% to $2.8 million compared to $2.6 million in the same period of 2013. This increase is primarily due to activities related to the preparation and initiation of the Phase II clinical trial of our quadrivalent seasonal influenza vaccine in the fourth quarter. For the full year of 2014, cost of government contracts revenue increased 82% to $15 million compared to $8.2 million in 2013. The increase in costs for the full year of 2014 were associated with the 2014 Phase I/II clinical trial of the H7N9 pandemic influenza vaccine and, again, the activities related to the preparation and initiation of the Phase II clinical trial of the seasonal influenza vaccine.

與 2013 年同期的 260 萬美元相比，2014 年第四季度的政府合同收入成本增加了 9% 至 280 萬美元。這一增長主要是由於與我們的 II 期臨床試驗的準備和啟動相關的活動第四季度四價季節性流感疫苗。與 2013 年的 820 萬美元相比，2014 年全年的政府合同收入成本增加了 82%，達到 1500 萬美元。2014 年全年成本的增加與 2014 年 H7N9 大流行的 I/II 期臨床試驗有關流感疫苗，以及與季節性流感疫苗 II 期臨床試驗的準備和啟動有關的活動。

R&D expenses increased 87% to $30.5 million in the quarter compared to $16.3 million in the same period of 2013. For those of you who have followed our progress throughout the year and our promise to initiate 3 RSV clinical trials in the second half of 2014, you'll recognize that the primary reason for this increase in R&D expenses is due to the preparation and initiation of the pediatric RSV vaccine trial and the elderly RSV vaccine clinical trial in the fourth quarter of 2014, as well as the ongoing costs related to the maternal immunization RSV trial, which was initiated in the third quarter of 2014.

與 2013 年同期的 1630 萬美元相比，本季度的研發費用增加了 87% 至 3050 萬美元。對於那些關注我們全年進展並承諾在 2014 年下半年啟動 3 項 RSV 臨床試驗的你們，您會認識到研發費用增加的主要原因是由於 2014 年第四季度兒童 RSV 疫苗試驗和老年 RSV 疫苗臨床試驗的準備和啟動，以及與2014 年第三季度啟動的孕產婦免疫 RSV 試驗。

As stated early in my comments, the increase in RSV critical trial expense was the main driver to the increase in net loss in the fourth quarter of 2014. I should note that the bolus of these clinical trial expenses typically occur in the weeks leading up to the initiation of enrollment and during the enrollment period. Therefore, we expect their expenses related to these clinical trials to decrease dramatically in the ensuing quarters.

正如我在前面的評論中所說，RSV 關鍵試驗費用的增加是 2014 年第四季度淨虧損增加的主要驅動力。我應該指出，這些臨床試驗費用的推注通常發生在幾週前入學開始和入學期間。因此，我們預計他們與這些臨床試驗相關的費用將在隨後幾個季度大幅下降。

G&A expenses increased 24% to $5.1 million in the quarter compared to $4.1 million in the same period in 2013. This increase is primarily due to an increase in employee-related expenses tied to the continued growth of the business here in Novavax. For the full year, G&A expenses increased 34% to $19.9 million compared to $14.8 million in 2013. Again, the increase in the G&A expenses for the year is the result of these increased employee-related costs tied to the growth of the business.

與 2013 年同期的 410 萬美元相比，本季度的 G&A 費用增長 24% 至 510 萬美元。這一增長主要是由於與 Novavax 業務的持續增長相關的員工相關費用的增加。與 2013 年的 1,480 萬美元相比，全年的 G&A 費用增加了 34% 至 1,990 萬美元。同樣，今年 G&A 費用的增加是由於與業務增長相關的員工相關成本增加的結果。

As of December 31, 2014, the company had $168.1 million in cash, cash equivalents and investments on the balance sheet.

截至 2014 年 12 月 31 日，公司在資產負債表上擁有 1.681 億美元的現金、現金等價物和投資。

With this, I'll conclude my review of the financial statements and turn the call back over to Stan.

至此，我將結束對財務報表的審查，並將電話轉回給 Stan。

All right. Thanks to all of you for participating today. I look forward to talking to you all in the next quarter. We will now open it up to Q&A.

好的。感謝大家今天的參與。我期待在下個季度與大家交談。我們現在將它開放給問答。

(Operator Instructions) Edward Tenthoff, Piper Jaffray.

（操作員說明）Edward Tenthoff，Piper Jaffray。

Well, firstly, I just have to say congrats on all the great progress, and it's great to see getting reflected in the stock price, too. Really exciting time for the company. First, I just -- I -- my hearing is going with my increase in age, so I wanted to make sure I heard something correctly. Did you say that the Phase III for seasonal flu could start as early as the fourth quarter of this year?

嗯，首先，我只想祝賀所有的巨大進步，很高興看到股價也得到反映。對公司來說真是激動人心的時刻。首先，我只是——我——我的聽力隨著年齡的增長而變化，所以我想確保我聽到的東西是正確的。你說季節性流感的第三階段最早可能在今年第四季度開始嗎？

So this is Stan. So we have 3 Phase II clinical trials. All will give us data that will help us design Phase IIIs for those programs that is: quadrivalent flu, elderly flu, maternal flu -- I'm sorry, elderly RSV and maternal RSV. Our expectation is the first trial to start a Phase III is likely to be the elderly. That could be by the end of this year. Flu, as we've been saying for quite some time, it's -- we have to go through in addition to the end of Phase II -- in getting the Phase II data, we have to go to an end of Phase II data with the FDA. We have an additional step of going through an in-process review with BARDA, and that will give us the input to design a Phase III to start in 2016. The maternal program Phase III will be somewhere around either the end of this year or beginning of next year, and that's to be determined.

這就是斯坦。所以我們有3個II期臨床試驗。所有這些都將為我們提供數據，這些數據將幫助我們為以下項目設計第三階段：四價流感、老年流感、孕產婦流感——對不起，老年 RSV 和孕產婦 RSV。我們的預期是第一個開始III期試驗的很可能是老年人。那可能是到今年年底。流感，正如我們很長一段時間以來一直在說的那樣，除了第二階段的結束，我們還必須經歷第二階段的數據——在獲取第二階段的數據時，我們必須通過食品和藥物管理局。我們還有一個與 BARDA 進行過程中審查的額外步驟，這將為我們提供設計 III 期計劃的投入，該計劃於 2016 年開始。孕產婦計劃 III 期計劃將在今年年底或開始左右進行明年，還有待確定。

Great, that's really helpful. And then if I may, just kind of digging into the sort of go, no-go on the RSV study. What do you guys kind of have as a threshold here? What do you need to see where this would make sense to proceed in maternal and/or the elderly? Do you have a specific immunogenicity levels that you think you need to achieve? Is there a time duration, for example, in the cord blood? Or how long do you think you need to see protection in the infants?

太好了，這真的很有幫助。然後，如果可以的話，只是深入研究 RSV 研究的那種去，不去。你們這裡有什麼門檻？您需要了解哪些情況下這對產婦和/或老年人有意義嗎？您是否有您認為需要達到的特定免疫原性水平？例如，臍帶血中是否存在持續時間？或者您認為您需要在嬰兒身上看到保護多久？

Thanks. Those are good questions. This is Greg here. So I think we'll see -- maternal immunization, we're looking for 3 factors here. First of all, this is a trial we're learning to execute, and I think recruitment there is very important and I'm very confident what we're doing will deliver on our milestones. Then presuming that we will look at the transfer of cord blood and, generally speaking, the antibody level found in the mother and the infant in that setting has shown concentration. Now as you know, in our Phase II trials of women of childbearing age, we have shown antibody titers as measured by palivizumab competing antibodies that would be what we would consider tenfold greater than what would be the protected level.

謝謝。這些都是好問題。這是格雷格。所以我想我們會看到——孕產婦免疫，我們在這裡尋找三個因素。首先，這是我們正在學習執行的試驗，我認為那裡的招聘非常重要，我非常有信心我們正在做的事情將實現我們的里程碑。然後假設我們將研究臍帶血的轉移，一般來說，在該環境中發現母親和嬰兒的抗體水平已經顯示出濃度。如您所知，在我們對育齡婦女進行的 II 期試驗中，我們已經展示了通過帕利珠單抗競爭抗體測量的抗體滴度，我們認為該滴度是保護水平的十倍。

So we're looking to see that kind of level show up in the infant, and so it's our expectation that it will, at least, be similar -- quite similar to what you see in the mother. Now a very, I'd say, positive additional win on that would be to see relative concentration, which you do see with some vaccines, for example, tetanus. So I think that's the kind of data we're looking for, and we will be able to make an estimate of the half-life of the antibodies in an infant.

所以我們希望看到這種水平出現在嬰兒身上，所以我們期望它至少會與你在母親身上看到的相似——非常相似。現在，我想說，一個非常積極的額外勝利將是看到相對集中，你確實看到了一些疫苗，例如破傷風。所以我認為這就是我們正在尋找的數據，我們將能夠估計嬰兒抗體的半衰期。

And again, this is a relatively small sample size, but we're looking for -- as we go forward, we're looking at the two in our primary endpoints prevent severe RSV infection in the infants at least to 3 months.

再一次，這是一個相對較小的樣本量，但我們正在尋找——隨著我們的前進，我們正在研究主要終點中的這兩個，以防止嬰兒嚴重 RSV 感染至少到 3 個月。

So we're looking for a significant level of antibody that would exceed what we think is a protective level in the general population, at least out to 3 months. And again, a very big win would be to see that level of antibody extend beyond 3 months of age. So I think those are how we'll look at the data for maternal immunization.

因此，我們正在尋找一種顯著水平的抗體，這種抗體水平將超過我們認為的普通人群的保護水平，至少在 3 個月內。再一次，一個非常大的勝利將是看到抗體水平超過 3 個月大。所以我認為這就是我們將如何看待孕產婦免疫數據的方式。

So I think there, the biological risk of the immune response being protected is -- or biological chance the immune response will be protected is quite high because we've been able to bridge so well to the side II palivizumab/Synagis data that exists in the randomized clinical trial. So that's how we look at maternal immunization. With the elderly, there, we are in the Phase II trial, 1,600 subjects.

所以我認為，免疫反應受到保護的生物學風險是——或者免疫反應受到保護的生物學機會相當高，因為我們已經能夠很好地連接到存在於隨機臨床試驗。這就是我們看待孕產婦免疫接種的方式。對於老年人，我們正在進行 II 期試驗，有 1,600 名受試者。

And in this trial, we're doing something very important. We're going to define the disease burden. We have 10 sites across different geographic areas in the United States where we're going to assess using PCR and, I think, very close follow-up, the type of respiratory symptoms you see associated with RSV. If you look at the literature, the attack rate in this population is a fairly wide range based on the study design, in my opinion.

在這次試驗中，我們正在做一些非常重要的事情。我們將定義疾病負擔。我們在美國不同地理區域有 10 個站點，我們將使用 PCR 進行評估，並且我認為，非常密切的跟進，您看到的與 RSV 相關的呼吸道症狀類型。如果您查看文獻，我認為根據研究設計，該人群的發病率範圍相當廣泛。

Here, we have a prospective surveillance, so that typically gets you a better attack rate. But if you look at the literature, somewhere between 2% and 5% of all the 60-plus elderly have a significant RSV infection. So that's our -- that's going to be important. If we can define an attack rate and it's within that range, I think that makes us confident, and there's -- the RSV trial would be feasible. So we're looking to reproduce the attack rate in the -- in that population and that kind of range.

在這裡，我們有一個前瞻性的監視，因此通常可以讓您獲得更好的攻擊率。但是，如果您查看文獻，在所有 60 多歲的老年人中，大約有 2% 到 5% 的人患有嚴重的 RSV 感染。所以這就是我們的 - 這將很重要。如果我們可以定義一個攻擊率並且它在那個範圍內，我認為這會讓我們充滿信心，而且——RSV 試驗是可行的。因此，我們希望在該人群和該範圍內重現攻擊率。

As far as the vaccine effect, I think we have a little less to say. I think if you look at influenza, those vaccines range between 50% to 70%, roughly, in terms of protective efficacy.

至於疫苗的效果，我想我們還有點要說的。我認為，如果您看一下流感，就保護效果而言，這些疫苗的範圍大致在 50% 到 70% 之間。

And so that would be, I think, a very satisfactory range, and our study is designed to detect somewhere between 60% to 80% of protective efficacy with our vaccine. So those are very rough parameters.

因此，我認為這將是一個非常令人滿意的範圍，我們的研究旨在檢測我們疫苗的 60% 到 80% 的保護效力。所以這些是非常粗略的參數。

That is the secondary or exploratory endpoint. As you know, we would use that then to power a study to show the vaccine effect in a Phase II trial. So that's sort of general guidance, I think, on what we're looking for in this Phase II trial.

那是次要或探索性終點。如您所知，我們將使用它來支持一項研究，以在 II 期試驗中顯示疫苗效果。我認為，這就是我們在 II 期試驗中尋找的一般指導。

Kevin DeGeeter, Ladenburg.

凱文·德吉特，拉登堡。

Could you just give us an update on your current thinking on the pentavalent program, combining -- potentially combining RSV and quadrivalent influenza?

您能否向我們介紹一下您目前對五價計劃的最新想法，結合——可能結合 RSV 和四價流感？

Yes. Kevin, this is Stan. We're -- we think it's as important as we did with the last time we talked to you. We don't have it on the schedule officially yet. We're trying to get it in this year. It's -- we're -- we have the 5 different strains available to go in and then have bandwidth to do it. I'm hoping that we get it started in the second half of this year, but we don't have it officially [plugged] up.

是的。凱文，這是斯坦。我們 - 我們認為這與我們上次與您交談時所做的一樣重要。我們還沒有正式將它列入日程表。我們正努力在今年實現它。這是 - 我們是 - 我們有 5 種不同的菌株可供使用，然後有帶寬去做。我希望我們能在今年下半年啟動它，但我們還沒有正式[插入]。

Great. That's helpful. And could you maybe provide or share an updated thinking on business development? Obviously, a very busy year on the clinical side. Just what makes sense in terms of BD? And is that a high priority here, just given the volume of clinical development over the next 12 months?

偉大的。這很有幫助。您能否提供或分享有關業務發展的最新想法？顯然，臨床方面非常忙碌的一年。就 BD 而言，什麼是有意義的？考慮到未來 12 個月的臨床開發量，這是否是一個高度優先事項？

Yes. Again, we just have a potful of data coming out in the third quarter, fourth quarter of this year, and those data are going to give us a really good look at how we're going to try to design and execute Phase III clinical trials toward licensure, but it will also give us an idea of -- we'll start thinking about how we want to develop global sales and marketing plans and how we develop partners for those programs. And I think, as you know, we hired -- last year, we hired a Senior Vice President for Commercial Operations. We've now hired a couple other senior people, and we're starting the process of planning our way into these markets. And so I think data dependent, second half of this year, we'll design our BD strategy as well.

是的。同樣，我們剛剛在今年第三季度和第四季度發布了大量數據，這些數據將使我們能夠很好地了解我們將如何嘗試設計和執行 III 期臨床試驗走向許可，但它也會讓我們了解——我們將開始思考我們希望如何制定全球銷售和營銷計劃，以及我們如何為這些計劃發展合作夥伴。而且我認為，如您所知，我們聘請了 - 去年，我們聘請了一位負責商業運營的高級副總裁。我們現在已經聘請了其他幾位資深人士，我們正在開始規劃進入這些市場的方式。所以我認為數據依賴，今年下半年，我們也將設計我們的 BD 戰略。

And then maybe just one more, if I could sneak this in. I get a fair number of questions up from clients trying to appreciate some of the work that's being done on potential pre-fusion vaccine approaches versus the Novavax post-fusion approach. Greg, could you just kind of give us your thoughts as to your just sort of -- or what's sort of understood in terms of some of these alternative approaches and just kind of more, generally, how you think about the competitive landscape out there?

然後也許只是一個，如果我可以偷偷溜進去的話。我從客戶那裡得到了很多問題，他們試圖了解在潛在的融合前疫苗方法與 Novavax 融合後方法方面所做的一些工作。格雷格，你能不能給我們你的想法，或者你對這些替代方法的理解，一般來說，你如何看待那裡的競爭格局？

Okay. So let's dive a little technical for a minute. So the -- some of this work has come from defining the crystal structure for the RSV F-protein. Now when that's done, you have to solubilize it and make changes. So the changes were made such that you truncate the protein, and so you don't have the portion that sticks into the membrane.

好的。因此，讓我們潛入一點技術層面。所以——其中一些工作來自於定義 RSV F 蛋白的晶體結構。現在完成後，您必須將其溶解並進行更改。所以做出了改變，你截斷了蛋白質，所以你沒有粘在膜上的部分。

So lots of that to say that, that I think the crystal structural work is extremely exciting. It's very interesting. There is conclusions about the structure that I think many people accept that, that would be -- that would represent a form that would be in the pre-fusion or the form that you would find before the fusion process occurs. So that's been extended then to try to replicate that in vaccines on the assumption that it may provide a type of construct that would work.

說了這麼多，我認為晶體結構工作非常令人興奮。這很有趣。關於結構的結論，我認為很多人都接受，那就是 - 這將代表一種在融合前的形式或在融合過程發生之前你會發現的形式。因此，這已經擴展到嘗試在疫苗中復制它，假設它可能提供一種可行的結構。

I think where I have some critiques of that approach is that the -- I think the general consensus of the self antibodies you see to the F-protein in the general population will be considered pre-fusion for the most part, and I would just point out that natural immunity is not highly effective. And so you have these, of course, infants who were born with very high levels of antibodies from mothers, and yet they continue to have RSV infection. Healthy adults have RSV infection and the elderly, despite the fact the presence of these pre-fusion-type antibodies. So I believe if you take that vaccine and push the antibodies high enough, they could be protected.

我認為我對這種方法的一些批評是——我認為你在普通人群中看到的對 F 蛋白的自身抗體的普遍共識將在很大程度上被認為是預融合，我只想指出自然免疫不是很有效。當然，這些嬰兒出生時母親的抗體水平非常高，但他們仍繼續感染 RSV。健康成人和老年人有 RSV 感染，儘管存在這些融合前型抗體。所以我相信，如果你服用這種疫苗並將抗體推到足夠高的水平，它們就可以得到保護。

So in our case, we don't make real claims about the pre- or post-fusion nature of our vaccine. I would say we have a full-length nanoparticle trimeric F vaccine. It displays the palivizumab epitope in a very efficient manner, and as you know, we get the Synagis-like antibodies at a very robust level. To me, that is the most critical feature to consider. We also know from the work done on palivizumab or Synagis about the mechanism by which it blocks RSV infection. So I think we have a mechanism of action. If you induce these type of antibodies that you should consider that work.

因此，在我們的案例中，我們不會對疫苗的融合前或融合後的性質做出真正的聲明。我想說我們有一種全長納米顆粒三聚體 F 疫苗。它以非常有效的方式顯示帕利珠單抗表位，如您所知，我們獲得了非常強大的 Synagis 樣抗體。對我來說，這是要考慮的最關鍵的功能。我們還從對帕利珠單抗或 Synagis 所做的工作中了解到它阻止 RSV 感染的機制。所以我認為我們有一個行動機制。如果您誘導這些類型的抗體，您應該考慮這項工作。

Our preclinical data supports that it's very protective, and then you look at our clinical data and we have robust antibodies to this that result in functional immune response. So I think that is a very interesting debate. I think some of the bets have been made now, and we have what I would consider a modified near full-length RSV F-protein, and I don't think we can make any claims about the nature, whether it's pre- or post-fusion, our vaccine does induce these site II antibodies.

我們的臨床前數據支持它非常具有保護性，然後您查看我們的臨床數據，我們有強大的抗體來產生功能性免疫反應。所以我認為這是一個非常有趣的辯論。我認為現在已經打了一些賭注，我們有我認為經過修飾的近全長 RSV F 蛋白，我認為我們不能對性質提出任何主張，無論是前期還是後期-融合，我們的疫苗確實會誘導這些 II 位點抗體。

I think that is really an absolutely novel story for a new vaccine like this to have 5 randomized clinical trials where that type of vaccine was evaluated. The levels are known. It's extremely compelling story to follow, and we felt that, that is the most clinically relevant information to follow. So I know that was kind of a deep dive a bit for this call, but hope I answered your question.

我認為對於像這樣的新疫苗進行 5 次隨機臨床試驗來評估這種類型的疫苗，這確實是一個絕對新穎的故事。水平是已知的。這是一個非常引人入勝的故事，我們認為這是與臨床最相關的信息。所以我知道這對這次電話來說有點深入，但希望我回答了你的問題。

Heather Behanna, Wedbush.

韋德布什的希瑟·貝漢娜。

This is [Allison] in for Heather. I was hoping you could give us an update on the next steps for the pandemic flu program and then maybe some ideas on the timing of Ebola -- the Ebola funding that might come? Does that have to wait until after the data midyear?

這是Heather的[Allison]。我希望你能給我們提供有關大流行性流感計劃下一步的最新信息，然後可能對埃博拉病毒的時間提出一些想法——埃博拉病毒的資金可能會到來嗎？這是否必須等到年中數據之後？

Yes, so this is Stan again. So pandemic, we have on the schedule a pandemic trial to start in the -- right around the beginning of the fourth quarter of this year. That would be a trial that would include healthy adults and elderly, leading to what we presume would be a Phase III clinical trial. We don't have a time table for that. It's probably some time around mid next year, but that's the steps toward Phase III and licensure. With respect to -- and as you know, the pandemic's going to be licensed based upon an immune response rather than efficacy.

是的，所以這又是斯坦。因此，大流行，我們計劃在今年第四季度初左右開始大流行試驗。這將是一項包括健康成人和老年人的試驗，導致我們認為將是一項 III 期臨床試驗。我們沒有時間表。可能是明年年中左右的某個時間，但這是邁向第三階段和許可的步驟。關於 - 如你所知，大流行將根據免疫反應而不是功效獲得許可。

So it's a simple immunogenicity trial. And with Ebola, so we got into the clinic. So what we're doing right now is we are collaborating with NIH with our vaccine they're using in advanced nonhuman primate studies. There's a lot of interest in this vaccine. It solves a lot of the potential problems of the other vector-based vaccines that are there and so people are really interested in. We are -- we started a Phase I trial.

所以這是一個簡單的免疫原性試驗。有了埃博拉病毒，我們就進了診所。所以我們現在正在做的是我們正在與 NIH 合作開發我們的疫苗，他們在先進的非人類靈長類動物研究中使用。人們對這種疫苗很感興趣。它解決了許多其他基於載體的疫苗的潛在問題，因此人們真的很感興趣。我們 - 我們開始了 I 期試驗。

We did this, and the timing of this was so fast because we decided to do it without seeking government support first because we thought timing was a real important aspect to this. So we started the Phase I trial, I think, 2 weeks ago now. It's -- step-wise, you do a low dose and then you wait for safety evaluation, and then you step it up in a higher dose. I think data from the trial will be in the, what we advertised, midyear, I guess, but it'll probably early third quarter. And during that time, we're not going to sit on our hands. We're talking with all of the interested parties, which include people like BARDA, people like NIH.

我們這樣做了，而且時間如此之快，因為我們決定在不首先尋求政府支持的情況下這樣做，因為我們認為時間是一個真正重要的方面。所以我們開始了第一階段的試驗，我想，現在是兩週前。這是 - 逐步，你做一個低劑量，然後你等待安全評估，然後你以更高的劑量逐步增加。我認為試驗數據將在我們宣傳的年中，我猜，但可能會在第三季度初。在那段時間裡，我們不會坐以待斃。我們正在與所有相關方進行交談，其中包括像 BARDA 這樣的人，像 NIH 這樣的人。

The military are involved. The nongovernmental agency, such as Gates and others, [Gobi], who have expressed interest. At least, who have expressed interest in funding, the purchase of Ebola vaccines.

軍方參與其中。非政府機構，如蓋茨和其他人，[戈壁]，表示有興趣。至少，誰表示有興趣資助購買埃博拉疫苗。

We're talking to them all and plus our pharmaceutical colleagues as well. So we're going to try to figure out what to do as a next step to get this into a larger trial, so that it can get licensed. Probably now under what's known as the animal rule, where you do 2 species of animals efficacy and then you do a large -- larger safety trial in humans.

我們正在與他們所有人以及我們的製藥同事交談。因此，我們將嘗試弄清楚下一步該做什麼，以便將其納入更大的試驗中，以便獲得許可。可能現在在所謂的動物規則下，您可以在其中對 2 種動物進行功效，然後在人類身上進行更大規模的安全性試驗。

The goal is to get -- there are 4 customers, I think, for this Ebola vaccine. One, of course, are the citizens in West Africa. This -- with this outbreak, it's not like it has been over the last 40 or 50 years. This has a threat of becoming endemic with 27-some-odd-thousand people having been exposed so far. I think there's going to be a call to have a vaccine that can be distributed widely among the population.

目標是獲得——我認為，這種埃博拉疫苗有 4 個客戶。其中之一當然是西非的公民。這 - 這次爆發，它不像過去 40 或 50 年那樣。這有成為地方病的威脅，迄今為止已有 27 萬多人受到感染。我認為將會有人呼籲研製一種可以在人群中廣泛分發的疫苗。

There is clearly a vaccine that's required for first responders as well and, not just in West Africa, but as we saw in the U.S. and Europe. And there are plenty of people who would like to have gotten vaccinated before dealing with the actual victims. And then there's the U.S. military and other military that have sent thousands of troops down to Africa.

顯然，急救人員也需要一種疫苗，不僅在西非，而且正如我們在美國和歐洲看到的那樣。有很多人希望在與實際受害者打交道之前接種疫苗。然後是美國軍隊和其他軍隊，他們向非洲派遣了數千名士兵。

There's a call for a military purchase. And then finally, there's a real need to have a stockpile purchase of Ebola vaccine for future outbreaks, and we have reason to believe that our vaccine can -- is going to be effective against a wide, broad range of strains of Ebola, and so it could be useful as a potent stockpile vaccine.

有人呼籲進行軍事採購。最後，確實需要為未來的爆發購買埃博拉疫苗，我們有理由相信我們的疫苗能夠——將有效對抗廣泛、廣泛的埃博拉病毒株，所以它可以用作有效的儲備疫苗。

David Lebowitz, Janney Montgomery

大衛·勒博維茨，珍妮·蒙哥馬利

I have a question on the Phase III program for the seasonal influenza. Given that the vaccine represents a kind of a unique vaccine versus what is currently out there and what's been historically submitted, are there any unique aspects to this Phase III program and the ultimate submission afterwards that might need to be different because it's a newer type of vaccine?

我有一個關於季節性流感第三階段計劃的問題。鑑於疫苗代表了一種獨特的疫苗，與目前已有的疫苗和歷史上提交的疫苗相比，這個 III 期計劃和之後的最終提交是否有任何獨特的方面，可能需要有所不同，因為它是一種更新的類型疫苗？

No, but I like your question because I do think our vaccine has advantages over the current vaccines out there, and I'm happy to be able to tell anybody who's willing to listen about them. But we have a nanoparticle. We have a virus-like-particle vaccine that is -- should have high immune response to the standard hemagglutinin antigen. We have a vaccine that we think might have immunogenic sites that are more conserved across a broader range of strains, that's possible, that we would like to show on a Phase III. And third, and maybe very important, is we have neuraminidase. We have active neuraminidase that -- and we've shown high levels of neuraminidase antibodies when we vaccinate animals and people. To demonstrate the effect of all 3 of those, we need to do an efficacy trial and as opposed to just an immunogenicity trial, and so we look forward to conducting an efficacy trial to show the benefit -- the combined benefit of all these aspects of our vaccine, so.

不，但我喜歡你的問題，因為我確實認為我們的疫苗比目前的疫苗有優勢，我很高興能夠告訴任何願意聽他們的人。但是我們有一個納米粒子。我們有一種病毒樣顆粒疫苗，它應該對標準血凝素抗原具有高免疫反應。我們有一種疫苗，我們認為它可能具有在更廣泛的菌株中更保守的免疫原性位點，這是可能的，我們希望在第三階段展示。第三，也許非常重要的是，我們有神經氨酸酶。我們有活躍的神經氨酸酶——當我們為動物和人接種疫苗時，我們已經顯示出高水平的神經氨酸酶抗體。為了證明所有這三個方面的效果，我們需要進行功效試驗，而不是僅僅進行免疫原性試驗，因此我們期待進行功效試驗以顯示益處 - 所有這些方面的綜合益處我們的疫苗，所以。

And with the ultimate submissions, how broad an array of different types of viral strains would ultimately need to be encompassed in a submission?

對於最終的提交，最終需要在提交中包含多廣泛的不同類型的病毒株？

Well, it would just be a standard -- our standard quadrivalent vaccine, whatever the strains are recommended for next year I suppose, and -- but with -- and -- but you never can predict, just like this year, you can't predict what the circulating strains are all going to be. And so we'll have the potential, the ability to show that it works on strains that may not be contained in the vaccine itself.

好吧，這只是一個標準——我們的標準四價疫苗，無論我想明年推薦什麼毒株，而且——但是有——而且——但你永遠無法預測，就像今年一樣，你可以' t 預測循環菌株將是什麼。因此，我們將有潛力，有能力證明它對疫苗本身可能不包含的菌株起作用。

(Operator Instructions). George Zavoico.

（操作員說明）。喬治·扎沃伊科。

I just had a quick follow-on from previous question regarding the Ebola. You said it could be effective in many different strains of Ebola. Have you tested it in other strains beside the guinea strain? I'm not sure if I heard you discuss that before or not.

我剛剛對上一個關於埃博拉的問題進行了快速跟進。你說它可能對許多不同的埃博拉病毒株有效。您是否在幾內亞菌株之外的其他菌株中測試過它？我不確定我是否聽說過你之前討論過這個問題。

Greg, here. As you probably know, since people have been working on Ebola vaccine for quite a while, most of the assays and the challenge models are done with previous strains. So for example, the mouse challenge data where we showed 100% protection was done with Mayinga strain, which is from 1976, and the macaques strain was done with Kikwit, which was a 1996 strain.

格雷格，這裡。您可能知道，由於人們研究埃博拉疫苗已經有一段時間了，所以大多數檢測和挑戰模型都是用以前的毒株完成的。例如，我們顯示 100% 保護的小鼠挑戰數據是使用 1976 年的 Mayinga 菌株完成的，而獼猴菌株是使用 1996 年的 Kikwit 菌株完成的。

So just by definition in our challenge studies, we are showing cross-protection. Also that's true of the way the neutralization is assessed because, again, those assays and challenges have been historic and getting the assays up-to-date have been challenging for investigators. So our collaborators at [Sayusamad] are just beginning to have the neutralization assay for the current strain available.

因此，根據我們的挑戰研究的定義，我們正在展示交叉保護。評估中和作用的方式也是如此，因為同樣，這些檢測和挑戰是歷史性的，使檢測更新對研究人員來說是一個挑戰。因此，我們在 [Sayusamad] 的合作者才剛剛開始提供針對當前菌株的中和試驗。

And by the way, it's circulating in Guinea, but they've renamed the sequence of the strain word to Makona. So our 2014 Makona vaccine represents the circulating sequence currently in Africa. Maybe I'd just add a little bit. I would have -- you would expect with Matrix-M that you get some additional presentation of conserved antigens, and I think what we see with this relative cross-protection would be at least in part explainable by the very, very robust response we see to the protein in the Matrix-M.

順便說一句，它在幾內亞流傳，但他們已將應變詞的序列重命名為 Makona。因此，我們的 2014 Makona 疫苗代表了目前在非洲的流行序列。也許我只是添加一點。我會 - 你會期望使用 Matrix-M，你會得到一些額外的保守抗原呈遞，我認為我們看到的這種相對交叉保護至少可以部分解釋為我們看到的非常、非常強大的反應Matrix-M 中的蛋白質。

And you probably noticed, but we posted some of that data with a WHO presentation. But you can see we have very, very high immune responses, and I think that would explain -- they're also high affinity. If you see in that table there, we did a competitive ELISA. We measured the affinity. These antibodies are very, very high affinity antibodies. So typically, that also should add to cross-protection.

您可能注意到了，但我們在世衛組織的演示文稿中發布了其中一些數據。但是你可以看到我們有非常非常高的免疫反應，我認為這可以解釋——它們也具有高親和力。如果您在該表中看到，我們進行了競爭性 ELISA。我們測量了親和力。這些抗體是非常非常高親和力的抗體。所以通常情況下，這也應該增加交叉保護。

Now the customers for the Ebola strain -- I'm sorry, for the Ebola vaccine, you mentioned the 4 main customers. That's all government, and so what -- and it's probably too early to predict or to project what the costs may be, but the intent would be to -- for broad application through government purchasing, would it be like cost plus? Or is it just early to talk about it?

現在是埃博拉病毒株的客戶——對不起，對於埃博拉病毒疫苗，您提到了 4 個主要客戶。這都是政府，那又如何——現在預測或預測成本可能還為時過早，但其意圖是——通過政府採購進行廣泛應用，會不會像成本加成一樣？還是現在談論它還為時過早？

Well, I think it's a little early to talk about it. We don't rule out doing this with a pharmaceutical partner as well, so someone who might have more weight in getting distribution where the vaccine needs to be done. So we're open to a lot of things. We think we have a unique vaccine right now, and we've worked hard to get data to back up that statement. But it's hard to say what the nature -- the kind and nature of the contract might be different for different customers as well with different uses.

好吧，我認為現在談論它還為時過早。我們不排除也與製藥合作夥伴一起這樣做，因此在需要進行疫苗分發的地方可能有更大的權重。所以我們對很多事情持開放態度。我們認為我們現在有一種獨特的疫苗，我們一直在努力獲取數據來支持這一說法。但是很難說本質是什麼——合同的種類和性質對於不同的客戶以及不同的用途可能會有所不同。

Okay. Switching over to the RSV and the flu. You mentioned you want to start one of these trials in the fourth quarter of this year. At least, in the northern hemisphere, the flu season actually starts maybe in September, just before the fourth quarter starts. Are you constrained?

好的。切換到 RSV 和流感。您提到您希望在今年第四季度開始其中一項試驗。至少，在北半球，流感季節實際上可能在 9 月開始，就在第四季度開始之前。你有約束力嗎？

Or are you going move part of the trial to the southern hemisphere? How -- and then with regard -- the same thing with the RSV and the maternal immunization, do you immunize the women in the third trimester with the birth expected during the RSV seasons? Do you have to time the trials to match the seasons, in other words?

或者你打算將部分試驗轉移到南半球？與 RSV 和孕產婦免疫一樣，您如何在 RSV 季節預期分娩時為妊娠晚期的婦女接種疫苗？換句話說，您是否必須為試煉計時以匹配季節？

I'll let Greg do that.

我會讓格雷格這樣做。

Yes, so we're aware of that. It's possible we may use the southern hemisphere trial for combo, as you described. And in maternal, we do want to immunize women in the season, so the women that -- so throughout the season, so infants are born and exposed, so which is that be real life. So the trial is designed to have births going on during RSV season at various time points.

是的，所以我們知道這一點。正如您所描述的，我們可能會使用南半球試驗進行組合。在孕產婦方面，我們確實希望在這個季節為女性接種疫苗，所以女性——在整個季節裡，嬰兒出生和暴露，這就是現實生活。因此，該試驗旨在在 RSV 季節的不同時間點進行分娩。

Okay. And George, it's Stan. So the trial that we have, the most confidence that we can target the fourth quarter on to see elderly RSV vaccine, but a lot of stars have to line up. We have to get data. We have to get a timely end of Phase II meeting with the FDA. We have to get product available by the time and get a response from the FDA at that time, and then vaccinate them just before the RSV season, and we think we can do that. It's possible to do that in the fourth quarter in the northern hemisphere. If we don't, then you'd be looking for us to try southern hemisphere. So that's the advantage of our hemispheric epidemics, and so we have more flexibility to go north or south.

好的。還有喬治，是斯坦。所以我們有的試驗，最有信心可以瞄準第四季度看老年RSV疫苗，但是很多明星要排隊。我們必須獲取數據。我們必須及時結束與 FDA 的第二階段會議。我們必須及時獲得產品，並在那時得到 FDA 的回應，然後在 RSV 季節之前給它們接種疫苗，我們認為我們可以做到這一點。在北半球的第四季度有可能做到這一點。如果我們不這樣做，那麼你會找我們去嘗試南半球。所以這就是我們半球流行病的優勢，所以我們有更多的靈活性去往北或往南。

And just a quick question, the flu and RSV seasons, do they overlap? Or do they -- is RSV a little bit later than the flu in when it starts?

一個簡單的問題，流感和 RSV 季節，它們重疊嗎？還是他們——RSV 比流感開始時要晚一點？

You're right. RSV is typically a little bit later.

你是對的。 RSV 通常稍晚一些。

Did you hear that? RSV is a little bit later.

你聽到了嗎？ RSV 稍晚一些。

They overlap, but RSV is a little bit later.

它們重疊，但 RSV 稍晚一些。

Okay. And finally, you didn't mention this at all in your prepared remarks, because of all the focus and attention to the RSV and flu, but you have a terrific collaboration going with Cadila in India on rabies and everything. If you could just give me a -- give us a brief update on where that stands and the potential milestones and timelines in 2015 for that might be?

好的。最後，您在準備好的發言中根本沒有提到這一點，因為所有的焦點和注意力都集中在 RSV 和流感上，但是您與印度的 Cadila 在狂犬病和其他方面進行了出色的合作。如果你能給我一個 - 給我們一個簡短的更新關於它的立場以及 2015 年的潛在里程碑和時間表可能是什麼？

Yes, great question. You're right. We have a lot to talk about, and I think you'll hear more about our progress in India with the CPLB, Cadila Pharmaceuticals Ltd. Biologicals joint venture that we have. They've been making a lot of progress both on developing a seasonal flu vaccine, and the rabies vaccine has been in the clinic. Both are in the clinic now. We'll report on data from both of those and give you some timelines. Certainly, during 2015, we'll give you timelines on when we think we can have either Phase III clinical trial data or approvals. And so be patient on that one, but it's going quite well.

是的，很好的問題。你是對的。我們有很多話要談，我想你會聽到更多關於我們在印度與 CPLB、Cadila Pharmaceuticals Ltd. Biologicals 合資企業取得的進展。他們在開發季節性流感疫苗方面取得了很大進展，狂犬病疫苗已經進入臨床。兩人現在都在診所。我們將報告這兩個方面的數據，並為您提供一些時間表。當然，在 2015 年，我們會為您提供我們認為何時可以獲得 III 期臨床試驗數據或獲得批准的時間表。所以請耐心等待，但進展非常順利。

This concludes our Q&A portion of the call. I would now like to turn the call back over to CEO, Stan Erck, for closing remarks.

我們的電話問答部分到此結束。我現在想將電話轉回給首席執行官斯坦·厄克（Stan Erck），以致閉幕詞。

Yes, so whoever's still on the line, thank you very much for calling in. We've had -- for the last year, we've been talking about -- we've been making projections about doing all the things necessary through process development and manufacturing and QA and QC and regulatory and clinical to get new trials started.

是的，所以無論誰仍然在線，非常感謝您的來電。我們已經 - 去年，我們一直在談論 - 我們一直在預測通過流程做所有必要的事情開發和製造以及質量保證和質量控制以及監管和臨床，以開始新的試驗。

I think we projected to get 4 started by the end of the year, and we actually got 4 plus a little surprise, which is Ebola, a couple of weeks ago. So we've executed on our promises, and what I'm really looking forward to is seeing the data. This is going to be a full data year, and it's really going to give us some subsequent data to tell us how we're going to get into Phase IIIs and give us more visibility into our product marketing timeline. So thank you. That's it.

我認為我們預計到今年年底將啟動 4 個，實際上我們得到了 4 個，加上幾個星期前的埃博拉病毒。所以我們已經兌現了我們的承諾，我真正期待的是看到數據。這將是一個完整的數據年，它真的會給我們一些後續數據，告訴我們如何進入第三階段，讓我們對產品營銷時間表有更多的了解。所以謝謝。而已。

Ladies and gentlemen, thank you for attending today's conference. This does conclude today's program. You may now disconnect.

女士們，先生們，感謝你們出席今天的會議。今天的節目到此結束。您現在可以斷開連接。