Novavax Inc (NVAX) 2022 Q1 法說會逐字稿

Good afternoon and welcome to the Novavax first quarter 2022 financial results and operational highlights conference call. (Operator Instructions)

下午好，歡迎參加 Novavax 2022 年第一季度財務業績和運營亮點電話會議。 （操作員說明）

Please note, this event is being recorded. I would now like to turn the conference over to Silvia Taylor, Senior Vice President of Global Corporate affairs and Investor Relations. Please go ahead.

請注意，此事件正在記錄中。我現在想將會議轉交給全球公司事務和投資者關係高級副總裁 Silvia Taylor。請繼續。

Good afternoon and thank you all joining us today to discuss our first quarter 2022 operational highlights and financial results. A press release announcing our results is currently available on our website at novavax.com. An audio archive of this conference call will be available on our website later today.

下午好，感謝大家今天加入我們，討論我們 2022 年第一季度的運營亮點和財務業績。宣布我們結果的新聞稿目前可在我們的網站 novavax.com 上獲得。本次電話會議的音頻檔案將於今天晚些時候在我們的網站上提供。

Before we begin with prepared remarks, I need to remind you that we will be making forward-looking statements during this teleconference which are based on our current expectations and beliefs. For example, statements related to 2022 financial guidance, future financial or business performance, conditions or strategy including expectations regarding revenues, product demand, operating expenses, gross margins, cash usage, clinical development of our vaccine candidates, timing of future regulatory filings, authorizations and actions and other anticipated milestones are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time, and actual results could differ materially from what is described in such statements.

在開始準備發言之前，我需要提醒您，我們將在本次電話會議期間根據我們當前的期望和信念做出前瞻性陳述。例如，與 2022 年財務指導、未來財務或業務業績、條件或戰略相關的報表，包括對收入、產品需求、運營費用、毛利率、現金使用、我們候選疫苗的臨床開發、未來監管備案時間、授權的預期和行動和其他預期的里程碑是前瞻性陳述。 Novavax 告誡說，這些前瞻性陳述受許多隨時間變化的假設、風險和不確定性的影響，實際結果可能與此類陳述中的描述存在重大差異。

Please turn to Slide 3. During this call, we will be referring to a non-GAAP financial measure, which is not prepared in accordance with U.S. generally accepted accounting principles. The most directly comparable financial measure calculated in accordance with GAAP and a reconciliation of GAAP to the non-GAAP measure is contained in the presentation and is available on our website at ir.novavax.com.

請轉到幻燈片 3。在本次電話會議中，我們將提及非 GAAP 財務指標，該指標未根據美國公認會計原則編制。根據 GAAP 計算的最直接可比的財務指標以及 GAAP 與非 GAAP 指標的對賬包含在演示文稿中，可在我們的網站 ir.novavax.com 上找到。

Please turn to Slide 4. Joining me today is Stan Erck, President and CEO, who will provide an overview of recent achievements and our upcoming strategic priorities. Additionally, John Trizzino, Chief Commercial Officer and Chief Business Officer, will provide an update on the status of our global COVID-19 vaccine rollout and our current regulatory progress. Dr. Filip Dubovsky, Chief Medical Officer, will discuss our clinical and regulatory strategy across our pipeline, and Jim Kelly, Chief Financial Officer and Treasurer, will provide an overview of our financial results. Dr. Greg Glenn, President of Research and Development, will also be available for the Q&A section at the end of today's call. I'd now like to hand the call over to Stan. Please turn to Slide 5.

請轉至幻燈片 4。今天加入我的是總裁兼首席執行官 Stan Erck，他將概述最近的成就和我們即將到來的戰略重點。此外，首席商務官兼首席商務官 John Trizzino 將提供有關我們全球 COVID-19 疫苗推出狀態和我們當前監管進展的最新信息。首席醫療官 Filip Dubovsky 博士將討論我們整個管道的臨床和監管戰略，首席財務官兼財務主管 Jim Kelly 將概述我們的財務業績。研發總裁 Greg Glenn 博士也將在今天電話會議結束時參加問答環節。我現在想把電話交給斯坦。請轉到幻燈片 5。

Thank you, Silvia, and thanks, everyone, for joining us today to discuss Novavax's first quarter results. We had a landmark start to 2022, reporting today a major milestone for Novavax, our first ever profitable quarter as a commercial stage company, reporting $203 million in net income and $704 million in total revenue. Establishments are the result of continued execution on our strategic objectives to deliver our COVID vaccine globally and advance our pipeline of new strains and combination vaccines. We're proud of our strong progress throughout the first quarter. Since the start of the year, we've increased our global impact, strengthened our capabilities as a commercial stage vaccine leader.

謝謝你，Silvia，也謝謝大家今天加入我們討論 Novavax 的第一季度業績。我們在 2022 年有了一個里程碑式的開端，今天報告了 Novavax 的一個重要里程碑，這是我們作為商業階段公司的第一個盈利季度，報告了 2.03 億美元的淨收入和 7.04 億美元的總收入。這些設施是我們繼續執行我們的戰略目標的結果，即在全球範圍內提供我們的 COVID 疫苗並推進我們的新毒株和聯合疫苗的管道。我們為整個第一季度的強勁進展感到自豪。自今年年初以來，我們提高了全球影響力，加強了我們作為商業階段疫苗領導者的能力。

I'd like to begin today's call by highlighting the key accomplishments since the start of the year that demonstrate the substantial progress we've made, continued the successful launch of Nuvaxovid globally with vaccinations underway in key markets around the world. We have an additional authorizations and full approvals for primary vaccination in adults further solidified in our global research -- global reach.

我想在今天的電話會議開始時強調自今年年初以來取得的重大進展，繼續在全球範圍內成功推出 Nuvaxovid，並在全球主要市場進行疫苗接種。我們在全球研究中進一步鞏固了成人初級疫苗接種的額外授權和完全批准——全球影響力。

In the U.S., we reached a major milestone in our pathway to EUA with a VRBPAC meeting now set for June 7, following the successful completion of an inspection of our manufacturing site at Serum Institute of India. Our expectation with the VRBPAC meeting is authorization for primary vaccination in adults. We have already submitted our adolescent data, and we will be submitting additional data for boosting to the FDA. For additional indications, the timing of review will be a decision the FDA will have to make in the coming weeks.

在美國，繼成功完成對印度血清研究所生產基地的檢查後，我們於 6 月 7 日召開了 VRBPAC 會議，在通往 EUA 的道路上達到了一個重要里程碑。我們對 VRBPAC 會議的期望是授權成人初次接種疫苗。我們已經提交了我們的青少年數據，我們將向 FDA 提交額外的數據。對於其他適應症，審查時間將是 FDA 在未來幾週內必須做出的決定。

We continue to execute an ambitious strategy to pursue an expanded label for our COVID-19 vaccine, including indications for pediatrics and boosting. We recognize variants continue to emerge, and we remain ready to pivot and bring the relevant vaccines to market. We are advancing an Omicron monovalent and bivalent option and expect it to be in the clinic later this month. We also advanced our COVID-19 influenza combination vaccine through a Phase I/II trial with the goal to advance this candidate into a Phase II trial before the end of the year. With strong execution of our commercial launch plan and clear line of sight into our opportunities, we are well positioned to achieve our guidance of full year 2022 total revenue between $4 billion and $5 billion.

我們繼續執行一項雄心勃勃的戰略，為我們的 COVID-19 疫苗尋求擴大標籤，包括兒科和加強的適應症。我們認識到變種不斷出現，我們仍然準備好轉向並將相關疫苗推向市場。我們正在推進 Omicron 單價和二價選項，並預計它將在本月晚些時候進入臨床。我們還通過 I/II 期試驗推進了我們的 COVID-19 流感聯合疫苗，目標是在年底前將該候選疫苗推進至 II 期試驗。隨著我們商業啟動計劃的有力執行和對我們機會的清晰視野，我們有能力實現我們對 2022 年全年總收入在 40 億美元至 50 億美元之間的指導。

With that, John Trizzino will now discuss the commercial launch of Nuvaxovid.

有了這個，John Trizzino 現在將討論 Nuvaxovid 的商業發布。

Thank you, Stan. Please turn to Slide 6. Today, I'd like to provide an update on our COVID-19 vaccine rollout. Then I'll touch on our ongoing efforts to ensure optimal supply and distribution of our vaccine as well as our regulatory progress. Following the successful initial delivery of our vaccine to Indonesia in the fourth quarter, we've continued the global rollout of Nuvaxovid, our COVID-19 vaccine and Covovax, the trade name for our COVID-19 vaccine manufactured and marketed by Serum Institute to additional key markets.

謝謝你，斯坦。請轉到幻燈片 6。今天，我想介紹一下我們推出的 COVID-19 疫苗的最新情況。然後，我將談到我們為確保疫苗的最佳供應和分配以及我們的監管進展所做的持續努力。在第四季度成功向印度尼西亞首次交付疫苗後，我們繼續在全球推出我們的 COVID-19 疫苗 Nuvaxovid 和 Covovax（由 Serum Institute 生產和銷售的 COVID-19 疫苗的商品名），以進一步增加關鍵市場。

Through the first quarter, over 42 million doses have been delivered globally, including to the European Union, Canada, South Korea, Australia, New Zealand and Indonesia. And as Stan mentioned, vaccinations with Nuvaxovid and Covovax are underway in all of these markets. We continue to receive positive feedback from our customers in market as doses of our vaccine are delivered. While we are pleased with the initial utilizations of our vaccine, we expect to see pull through within these markets in the coming months as demand continues with recent surges of COVID around the world.

截至第一季度，全球已交付超過 4200 萬劑疫苗，包括歐盟、加拿大、韓國、澳大利亞、新西蘭和印度尼西亞。正如 Stan 所提到的，所有這些市場都在進行 Nuvaxovid 和 Covovax 的疫苗接種。隨著疫苗劑量的交付，我們繼續收到市場客戶的積極反饋。雖然我們對我們疫苗的初步使用感到滿意，但隨著最近全球 COVID 激增的需求仍在繼續，我們預計在未來幾個月內將在這些市場中看到拉動。

As we look ahead to the second quarter, we expect our shipments to key markets to increase. This includes the European Union, where we are fulfilling at a previously disclosed $42 million dose order and as a result, we expect increased product revenue for Q2. We are collaborating with all of our partners on allocation and delivery schedules and stand ready to ship our vaccine to where it is needed most, ensuring that we reach our shared goal of global equitable access. With emergency use listing granted by the WHO, our vaccine is now available in upwards of 170 countries worldwide, and we have sufficient manufacturing capacity to meet all demand. We believe that our protein-based vaccines storage attributes, efficacy and safety make it ideal for most settings, including those where standard cold chain is preferred.

展望第二季度，我們預計我們對主要市場的出貨量將會增加。這包括歐盟，我們正在履行先前披露的 4200 萬美元的劑量訂單，因此，我們預計第二季度的產品收入將增加。我們正在與所有合作夥伴就分配和交付時間表進行合作，並隨時準備將我們的疫苗運送到最需要的地方，確保我們實現全球公平獲取的共同目標。憑藉世界衛生組織授予的緊急使用清單，我們的疫苗現已在全球 170 多個國家/地區上市，我們有足夠的製造能力來滿足所有需求。我們相信，我們基於蛋白質的疫苗的儲存屬性、功效和安全性使其成為大多數環境的理想選擇，包括那些首選標準冷鏈的環境。

In addition, we continue to see low vaccination rates across low-income countries, and although we are prepared to deliver the quantities of 2373 doses to Gavi under the terms of our supply agreement. To date, we have not yet received an order from Gavi and the timing and quantities of future orders to deliver 2373 to the COVAX facility are unclear. In the U.S., where we anticipate getting emergency use authorization in early June, we are engaged in ongoing dialogue with the government for how we will support demand if we are authorized.

此外，我們繼續看到低收入國家的疫苗接種率很低，儘管我們準備根據我們的供應協議條款向 Gavi 提供 2373 劑疫苗。迄今為止，我們尚未收到 Gavi 的訂單，未來向 COVAX 工廠交付 2373 的時間和數量尚不清楚。在美國，我們預計在 6 月初獲得緊急使用授權，我們正在與政府進行持續對話，討論如果獲得授權，我們將如何支持需求。

We continue to receive input from health care providers, health care organizations and consumers across the country who are awaiting new vaccine choices. And if authorized, ours would be the first protein-based vaccine authorized in the U.S. With this recent progress, we remain encouraged by the long-term prospects for our vaccine domestically, and we remain on track to pursue full approval by filing for BLA in the second half of 2022, setting the stage for commercialization in 2023. This anticipated timing will be further informed by a pre-BLA meeting with the FDA, where we would expect to gain additional insight into BLA requirements and timing.

我們繼續收到來自全國各地等待新疫苗選擇的醫療保健提供者、醫療保健組織和消費者的意見。如果獲得批准，我們的疫苗將成為美國第一個獲得批准的蛋白質疫苗。隨著最近取得的這一進展，我們仍然對我們疫苗在國內的長期前景感到鼓舞，我們仍有望通過在美國申請 BLA 來尋求全面批准2022 年下半年，為 2023 年的商業化奠定基礎。這一預期的時間安排將通過與 FDA 的 BLA 前會議進一步了解，我們希望在會上對 BLA 的要求和時間安排有更多的了解。

To ensure we are prepared to meet current and future global demand, we remain focused on optimizing our manufacturing activities. To that end, we have begun delivering against our commitment to add additional manufacturing sites into our network in addition to Serum Institute of India. At the end of April, we submitted manufacturing data from our partner, SK Bioscience to the European Medicine Agency as a supplement to our conditional marketing authorization. And later this quarter, we expect to file a variation to add our Czech Republic site, Novavax CZ as well.

為確保我們準備好滿足當前和未來的全球需求，我們將繼續專注於優化我們的製造活動。為此，我們已經開始兌現我們的承諾，即除了印度血清研究所之外，在我們的網絡中增加更多的生產基地。 4 月底，我們將合作夥伴 SK Bioscience 的製造數據提交給歐洲藥品管理局，作為我們有條件上市許可的補充。本季度晚些時候，我們希望提交一份變更以添加我們的捷克共和國網站 Novavax CZ。

With significant progress made in our commercial launch, we believe we are well positioned to continue this execution through the remainder of 2022 and beyond. To accomplish our objectives, we've rapidly scaled our commercial team with a variety of initiatives underway to support our product launch. Some of these include the following: implementing customer engagement programs to build product awareness, building out our European operations with a new office in Switzerland that opened this month, deploying our first ever unbranded campaign to improve educational awareness around COVID-19 vaccines and building strategic partnerships with governments and policymakers around the world to promote market access.

隨著我們的商業發布取得重大進展，我們相信我們有能力在 2022 年剩餘時間及以後繼續執行這項工作。為了實現我們的目標，我們迅速擴大了我們的商業團隊，並採取了各種舉措來支持我們的產品發布。其中包括以下內容：實施客戶參與計劃以建立產品知名度，在本月開設的瑞士新辦事處建立我們的歐洲業務，部署我們有史以來第一個無品牌活動以提高圍繞 COVID-19 疫苗的教育意識，並建立戰略與世界各地的政府和決策者建立夥伴關係，以促進市場准入。

Now please turn to Slide 7. On the regulatory front, we've made tremendous progress to expand the global reach of our vaccine. Since the start of the year, we have gained additional authorizations for both Nuvaxovid and Covovax. In total, our regulatory efforts to date reflect authorizations or approvals in 41 countries as well as emergency use listing from the WHO, which represents the potential for our vaccine to reach over 170 countries, encompassing over 6 billion lives.

現在請轉到幻燈片 7。在監管方面，我們在擴大疫苗的全球覆蓋範圍方面取得了巨大進展。自今年年初以來，我們已經獲得了 Nuvaxovid 和 Covovax 的額外授權。總的來說，我們迄今為止的監管工作反映了 41 個國家的授權或批准以及世界衛生組織的緊急使用清單，這代表了我們的疫苗有可能覆蓋 170 多個國家，涵蓋超過 60 億人的生命。

Now please turn to Slide 8. We have been leveraging data generated from our robust clinical development plan to expand our label around the world for boosting, additional pediatric populations and the additional populations for primary vaccinations such as the immunocompromised.

現在請轉到幻燈片 8。我們一直在利用我們強大的臨床開發計劃產生的數據，在全球範圍內擴大我們的標籤，用於加強、更多的兒科人群和額外的初級疫苗接種人群，如免疫功能低下的疫苗。

I will now turn it over to Filip for more on all of this. Filip?

我現在將把它交給 Filip 以了解更多關於這一切的信息。菲利普?

Thanks, John. Let's flip to Slide 9. I will cover 3 topics today. First, I want to talk about our approach to variants. Based on our antigen and adjuvant technology, our approach may be different from other vaccines. In our Phase III studies, our vaccines worked well against all variants that circulated. Furthermore, the vaccine induced high levels of variant-specific immune response. Although it isn't certain that an Omicron-based vaccine will be required, we're pursuing a strain-change study to gather clinical data on the utility of both an Omicron variant as well as the bivalent approach.

謝謝，約翰。讓我們翻到幻燈片 9。我今天將討論 3 個主題。首先，我想談談我們對變體的處理方法。基於我們的抗原和佐劑技術，我們的方法可能與其他疫苗不同。在我們的 III 期研究中，我們的疫苗對所有流通的變種都有效。此外，該疫苗誘導了高水平的變異特異性免疫反應。儘管不確定是否需要基於 Omicron 的疫苗，但我們正在開展一項毒株變化研究，以收集有關 Omicron 變體和二價方法效用的臨床數據。

Next, I'll touch base on our pediatric data. We feel that our vaccine may have a special role in the pediatric population based on the parent's familiarity with recombinant protein vaccines and our favorable tolerability and immunogenicity profile. I'll also share some data from our partners at the Serum Institute of India on how the vaccine performs in children as young as 2 years of age.

接下來，我將根據我們的兒科數據進行討論。基於父母對重組蛋白疫苗的熟悉程度以及我們良好的耐受性和免疫原性特徵，我們認為我們的疫苗可能在兒科人群中發揮特殊作用。我還將與我們在印度血清研究所的合作夥伴分享一些關於疫苗如何在 2 歲以下兒童中發揮作用的數據。

Finally, I'm going to go over some data we presented previously on the combination work and I'll lay the pathway forward for that. Okay. Let's give Slide 10, which is a transition slide and goes to Slide 11 to talk about variants. What's displayed here is the comparison of the clinical efficacy results from our 2 independent Phase III studies. As you can see, the vaccine performed well with an overall efficacy of 90% despite the majority of cases being caused by variants. For matched strains, efficacy was between 96% and 100%. And for variants strains, efficacy was 86% to 94% for alpha and for U.S. or Mexico study, 93% against a basket of all variants of interest and various of concern. We observed complete protection against severe disease, irrespective of which variant circulated.

最後，我將回顧一下我們之前提供的關於組合工作的一些數據，並為此鋪平道路。好的。讓我們給幻燈片 10，這是一個過渡幻燈片，並轉到幻燈片 11 來談論變體。這裡展示的是我們 2 項獨立 III 期研究的臨床療效結果的比較。如您所見，儘管大多數病例是由變異引起的，但該疫苗表現良好，總體功效為 90%。對於匹配的菌株，功效在 96% 和 100% 之間。對於變體菌株，α 和美國或墨西哥研究的療效為 86% 至 94%，針對一籃子所有感興趣的變體和各種關注的變體為 93%。我們觀察到對嚴重疾病的完全保護，無論傳播哪種變體。

The Adolescent expansion of the U.S. Mexico study, only Delta circulated and the efficacy was 82%. I should note that the study was powered for the immunologic effectiveness endpoint, so there were only a very few cases. The conference intervals overlap the point estimate of the bigger, more precise adult cohort.

美國墨西哥的青少年擴張研究，只有Delta流通，有效率82%。我應該指出，這項研究是針對免疫有效性終點的，所以只有極少數病例。會議間隔與更大、更精確的成人隊列的點估計重疊。

Okay, let's move to Slide 12, please. where I've detailed the variants that circulated and cause disease in the studies. In the U.K., Alpha was circulating and in the Adolescent expansion, Delta was an identified variant. In the biggest study conducted in the U.S. Mexico, we identified 7 different variants and despite the majority of these cases being caused by this broad range of variants, our efficacy was preserved.

好的，請轉到幻燈片 12。我詳細介紹了在研究中傳播並導致疾病的變體。在英國，Alpha 正在流行，而在青少年擴張中，Delta 是一種已確定的變體。在美國墨西哥進行的最大研究中，我們確定了 7 種不同的變體，儘管這些病例中的大多數是由這種廣泛的變體引起的，但我們的療效得以保留。

Okay. Let's go to Slide 13, please, and talk about what we know about how the vaccine works in the Omicron. Left hand side, we've detailed immune responses against the matched prototype strain as well as a broad range of variants after the initial 2-dose primary series. The 100% of participants generated an antibody response that recognized all variants, including Omicron BA.1 and BA.2.

好的。請轉到第 13 張幻燈片，談談我們對疫苗在 Omicron 中的工作原理的了解。左側，我們詳細介紹了針對匹配的原型菌株以及初始 2 劑主要係列後的廣泛變體的免疫反應。 100% 的參與者產生了識別所有變體的抗體反應，包括 Omicron BA.1 和 BA.2。

On the right-hand side, we have displayed the immune response to the variants after a single boost at 6 months. Here you can see a very large bump in antibody response to all variants, including the more contemporaneous Omicron BA.1, BA.2. In fact, the levels for BA.1, BA.2 after boost are higher than that's seen after 2 doses to the prototype strain on the left-hand side of the slide, -- and I want to remind you that those levels were associated with 96-100% protection in the Phase III studies.

在右側，我們展示了在 6 個月時單次加強後對變體的免疫反應。在這裡，您可以看到對所有變體（包括更同時期的 Omicron BA.1、BA.2）的抗體反應都出現了非常大的變化。事實上，加強後 BA.1、BA.2 的水平高於幻燈片左側原型菌株 2 劑後看到的水平，我想提醒你，這些水平是相關的在 III 期研究中具有 96-100% 的保護。

Okay. Let's move to Slide 14, please, where the functional immune responses are displayed. These are 99% neutralization responses against prototype delta and Omicron performed by the Matt Frieman Lab in the University of Maryland. On the left hand side, the response after 2 doses displayed and on right-hand side, after a 6-month boost. After 2 doses, the neutralizing response is 3-point fold lower for Omicron compared to prototype. This is a relatively small difference. In fact, for influenza, anything less than a fourfold difference could be considered a matched response.

好的。讓我們轉到幻燈片 14，這裡展示了功能性免疫反應。這些是馬里蘭大學馬特弗里曼實驗室對原型 delta 和 Omicron 的 99% 中和響應。左側顯示 2 劑後的反應，右側顯示 6 個月加強後的反應。 2 劑後，Omicron 的中和反應比原型低 3 倍。這是一個相對較小的差異。事實上，對於流感，任何小於四倍的差異都可以被認為是匹配的反應。

After a third dose on the right-hand side, the immune response has increased significantly, including for Omicron. It is important because pretty much everyone has been exposed to COVID or has been vaccinated, so these boosted responses have become even more relevant. So based on our variant protection and immune data, we are far from certain that Omicron-based vaccine is required or will provide material improvement in performance. However, this question can be answered with clinical data, so let's move to Slide 15.

在右側第三次給藥後，免疫反應顯著增加，包括 Omicron。這很重要，因為幾乎每個人都接觸過 COVID 或接種過疫苗，因此這些增強的反應變得更加相關。因此，根據我們的變異保護和免疫數據，我們遠不能確定是否需要基於 Omicron 的疫苗或將在性能上提供實質性改進。然而，這個問題可以用臨床數據來回答，所以讓我們轉到幻燈片 15。

We've previously announced we plan to conduct a strain-change study to allow us to advance an Omicron-based vaccine. Study will be conducted in previously primed individuals and determined if an Omicron-based vaccine induces better immune responses compared to the original prototype vaccine. It will be the basis of a spread change variation. We'll also take the opportunity to evaluate a bivalent format to determine if there is a benefit of that approach. Study is scheduled to start this month and top line data will be available in the third quarter.

我們之前曾宣布，我們計劃進行毒株變化研究，以使我們能夠推進基於 Omicron 的疫苗。研究將在先前引發的個體中進行，並確定與原始原型疫苗相比，基於 Omicron 的疫苗是否誘導更好的免疫反應。這將是價差變化變化的基礎。我們還將藉此機會評估二價格式，以確定該方法是否有好處。研究計劃於本月開始，第三季度將提供一線數據。

Now let's skip Slide 16 and move to Slide 17 to talk about our pediatric data. Slide describes our adolescent data, which was an expansion of the U.S. Mexico Phase III study. In a roll of total of 2,247, 12- to 17-year olds, and we randomized them 2:1 vaccine to placebo. The participants were subsequently crossed over, and we are now finishing up boosting these children.

現在讓我們跳過幻燈片 16 並轉到幻燈片 17 來討論我們的兒科數據。 Slide 描述了我們的青少年數據，這是美國墨西哥 III 期研究的擴展。在總共 2,247 名 12 至 17 歲的兒童中，我們將他們隨機分配為 2:1 接種安慰劑。參與者隨後被交叉，我們現在正在完成對這些孩子的提升。

Let me review the top line results. The licensure-enabling effectiveness endpoint was the demonstration of non-inferior immune responses in adolescents compared to young adults. And in fact, the adult neutralizing responses were 1.5 fold higher than adults. We were also able to measure clinical efficacy, including against delta and the tolerability was favorable compared to adults in the main part of the study. These data are the data that is the basis for approval in India for our vaccine and is the basis of the file we have submitted to the regulators in the EU, the U.K., Korea, Australia and New Zealand. The increased magnitude of immune response seen in adolescents is also relevant for the variants. So let's look at that on Slide 18.

讓我回顧一下最重要的結果。獲得許可的有效性終點是與年輕人相比，青少年的非劣效免疫反應的證明。事實上，成人的中和反應比成人高 1.5 倍。我們還能夠測量臨床療效，包括對 delta 的療效，並且在研究的主要部分與成人相比，耐受性是有利的。這些數據是我們的疫苗在印度獲得批准的依據，也是我們向歐盟、英國、韓國、澳大利亞和新西蘭監管機構提交的文件的依據。在青少年中觀察到的免疫反應幅度增加也與這些變異有關。所以讓我們在幻燈片 18 上看一下。

Here, we've displayed our antibody responses to variants after 2 doses in 12- to 17-year-olds. Overall, they are 2 to 3 fold higher than adults after 2-dose series. We believe these data hold promise for broad efficacy in the pediatric population. Okay. Let's go to Slide 19 and talk about data in younger children collected by our partners at Serum. Study conducted with an expansion of their Phase II/III adult study. It was a randomized, blinded placebo-controlled study and in the pediatric portion, they had 3 age groups, 12 to 17, 7 to 11 and 2 to 6 year old. We've given permission to share top line reactogenicity and antibody results with you today. The study was conducted with a full dose of vaccine in all age groups, 5 micrograms of antigen and 50 micrograms of matrix.

在這裡，我們展示了我們對 12 至 17 歲兒童接種 2 劑後對變異的抗體反應。總體而言，在 2 劑系列之後，它們比成人高 2 到 3 倍。我們相信這些數據有望在兒科人群中獲得廣泛的療效。好的。讓我們轉到幻燈片 19，談談我們在 Serum 的合作夥伴收集的年幼兒童的數據。研究擴展了他們的 II/III 期成人研究。這是一項隨機、盲法安慰劑對照研究，在兒科部分，他們有 3 個年齡組，12 至 17 歲、7 至 11 歲和 2 至 6 歲。今天，我們已獲准與您分享頂級反應原性和抗體結果。該研究在所有年齡組中使用全劑量疫苗、5 微克抗原和 50 微克基質進行。

Turn to Slide 20. This slide, we've compared the local solicited symptoms by age group, adult are in dark blue, 12- to 17-year-olds in white blue, 7 to 11 in purple and 2 to 6 year olds in yellow, dose 1 is displayed on the top and those 2 in the bottom. Expected more reactions were observed after dose 2 compared to dose 1. However, overall our vaccine was well tolerated at least as well as if not better than in adults.

轉到幻燈片 20。這張幻燈片，我們按年齡組比較了當地要求的症狀，成人為深藍色，12 至 17 歲為白色藍色，7 至 11 歲為紫色，2 至 6 歲為黃色，劑量 1 顯示在頂部，劑量 2 顯示在底部。與第 1 劑相比，第 2 劑後觀察到的預期反應更多。但是，總體而言，我們的疫苗耐受性良好，至少與成人一樣好。

(inaudible) slide is to Slide 21, which is the next slide, which shows the solicited systemic reactions. Once again, dose 2 is more reactogenic than dose 1. Overall, the tolerability profile is favorable compared to adults. The 1 symptom that increases with decreasing age is fever. In the youngest children about 1/3 reported a fever after the second dose. However, the fevers were short-lived with a median of approximately 2 days and the grade Three fevers occurred in only 1% of the 2 to 6-year-olds. Overall, the vaccine is considered to be well tolerated.

（聽不清）幻燈片是幻燈片 21，這是下一張幻燈片，它顯示了請求的全身反應。再一次，劑量 2 比劑量 1 更具反應性。總體而言，與成人相比，耐受性特徵是有利的。 1隨著年齡的增長而增加的症狀是發燒。在最年幼的兒童中，大約 1/3 在第二次給藥後報告發燒。然而，發熱是短暫的，中位時間約為 2 天，3 級發熱僅發生在 1% 的 2 至 6 歲兒童中。總體而言，該疫苗被認為具有良好的耐受性。

Now please turn to Slide 22. Here, we have displayed the IgG responses at baseline after 1 dose and after 2 doses, adults are on the left and the youngest children are on the right. The results are from a validated assay performed in the Novavax clinical immunology labs. You can see there's a stepwise increase in immune responses as the age cohort decreases in age. So overall, we're seeing a favorable tolerability profile and a very significant increase in antibody responses in children. This sort of profile makes us believe our vaccine may have a special role in children's vaccinations.

現在請轉到幻燈片 22。在這裡，我們展示了 1 劑後基線時的 IgG 反應，2 劑後，成人在左邊，最小的兒童在右邊。結果來自在 Novavax 臨床免疫學實驗室進行的經過驗證的測定。您可以看到隨著年齡組年齡的下降，免疫反應逐步增加。所以總的來說，我們看到了良好的耐受性和兒童抗體反應的顯著增加。這種概況使我們相信我們的疫苗可能在兒童疫苗接種中發揮特殊作用。

So what's next? -- agreed upon a pediatric investigational plan in the EU and U.K. and our iPSP with the FDA has also been agreed to. Our protocol has been reviewed by the FDA, and we anticipate starting the study this summer. The planned study is a HD escalation study looking at 6- to 11-year-olds and 2 to 5 year olds and finally, 6 months to -- Okay, let's give the transition slide, go through to Slide 24, please.

下一個是什麼？ -- 就歐盟和英國的兒科研究計劃達成一致，我們與 FDA 的 iPSP 也已達成一致。我們的方案已經過 FDA 審查，我們預計今年夏天開始這項研究。計劃中的研究是一項針對 6 至 11 歲和 2 至 5 歲兒童的 HD 升級研究，最後，在 6 個月後-- 好的，讓我們給出過渡幻燈片，請轉到幻燈片 24。

A couple of weeks ago, we presented data from our quadrivalent influenza COVID combination study. We conducted the study because in our U.K. Phase III study, we noted immunologic interference between influenza vaccine and the induction of anti-spike antibody with our COVID vaccine. Subsequently, data has emerged for other vaccine platforms that would even flu vaccine is given with a third boosting dose of COVID, the immune response to COVID may be reduced by up to 1/3. By modulating the dosage levels of influenza hemagglutinin and COVID spike antigen, we've innovated our way past this issue.

幾週前，我們提供了來自四價流感 COVID 組合研究的數據。我們進行這項研究是因為在我們的英國 III 期研究中，我們注意到流感疫苗與我們的 COVID 疫苗誘導抗尖峰抗體之間存在免疫干擾。隨後，出現了其他疫苗平台的數據，這些平台甚至會用第三劑 COVID 加強流感疫苗，對 COVID 的免疫反應可能會降低多達 1/3。通過調節流感血凝素和 COVID 刺突抗原的劑量水平，我們以創新的方式解決了這個問題。

Let's move to Slide 25 and briefly review the study and design. Study was a design of experiment approach, where we had 14 different dosage groups where we varied the hemagglutinin between 5 and 60 micrograms, and we vary the spike between 2.5 and 22.5 micrograms. Now the Matrix adjuvant level study at 50 micrograms compared to our standard COVID vaccine with 5 micrograms of spike and our standard quadrivalent influenza vaccine, which had 60 micrograms of each flu antigen. Since the competitor has 75 micrograms of Matrix-M because that was a formulation we used in our successful Phase III quadrivalent influenza study. Logic output as well as the other baseline characteristics were fed into a mathematical model, which predicted the [opto] combination antigens.

讓我們轉到幻燈片 25 並簡要回顧一下研究和設計。研究是一種實驗方法的設計，我們有 14 個不同的劑量組，我們在 5 和 60 微克之間改變血凝素，我們在 2.5 和 22.5 微克之間改變峰值。現在，50 微克的基質佐劑水平研究與我們的標準 COVID 疫苗（含 5 微克的刺突）和我們的標準四價流感疫苗（每種流感抗原各 60 微克）進行了比較。由於競爭對手有 75 微克的 Matrix-M，因為這是我們在成功的 III 期四價流感研究中使用的配方。邏輯輸出以及其他基線特徵被輸入到數學模型中，該模型預測了 [opto] 組合抗原。

Okay. The findings are on Slide 26. First of all, all the combinations who are tolerable and the immunogenicity profile was in line with the influenza vaccine comparator. From an immunogenicity perspective, we confirmed the immunologic interference between hemagglutinin and spike that we saw in our Phase III study. However, we were able to overcome the interference by increasing the spike antigen and (inaudible). Optimal dose for spike is between 20 and 30 micrograms while the hemagglutinin could be reduced to 24 to 40 micrograms per screen. Overall antigen dose may be reduced by up to 50% in the combination product.

好的。研究結果在幻燈片 26 上。首先，所有可耐受的組合和免疫原性譜均與流感疫苗比較器一致。從免疫原性的角度來看，我們證實了我們在 III 期研究中看到的血凝素和尖峰之間的免疫干擾。然而，我們能夠通過增加尖峰抗原和（聽不清）來克服干擾。峰值的最佳劑量在 20 到 30 微克之間，而血凝素可以減少到每個篩選 24 到 40 微克。在組合產品中，總抗原劑量可減少多達 50%。

It will be confirmed in the Phase II study that we have planned for later this year, we will select a couple of dosage levels using contemporaneous influenza strains and compare it to a licensed influenza vaccine will take an opportunity to evaluate 75 micrograms of Matrix. Subsequent plan includes demonstration of clinical efficacy for both a stand-alone influenza vaccine as well as the combination vaccine. Okay. Let me hand it over to Jim to talk about the financials.

我們計劃在今年晚些時候進行的 II 期研究將證實，我們將使用同時期的流感毒株選擇幾個劑量水平，並將其與許可的流感疫苗進行比較，並將藉此機會評估 75 微克的 Matrix。隨後的計劃包括證明獨立流感疫苗和聯合疫苗的臨床療效。好的。讓我把它交給吉姆談談財務。

All right. Thank you, Filip. Please turn to Slide 27. This afternoon, we announced our financial results for the first quarter of 2022. I'll begin by providing an overview of our first quarter 2022 total revenue performance, net income and cash position. Then I'll discuss our quarterly results in additional detail as well as provide an update on our full year 2022 revenue guidance.

好的。謝謝你，菲利普。請轉到幻燈片 27。今天下午，我們公佈了 2022 年第一季度的財務業績。我將首先概述我們 2022 年第一季度的總收入表現、淨收入和現金狀況。然後，我將更詳細地討論我們的季度業績，並提供我們 2022 年全年收入指導的最新信息。

First quarter of 2022 marked an important milestone for Novavax and as our initial profitable quarter as a commercial stage company. We recorded $704 million in total revenue, reflecting 57% growth compared to prior year and $203 million in net income. We ended the first quarter of 2022 with $1.6 billion in cash and had accounts receivable of over $400 million, which positions us well as we continue our global launch of Nuvaxovid.

2022 年第一季度是 Novavax 的一個重要里程碑，也是我們作為商業階段公司的第一個盈利季度。我們的總收入為 7.04 億美元，與去年相比增長了 57%，淨收入為 2.03 億美元。我們以 16 億美元的現金結束了 2022 年第一季度，應收賬款超過 4 億美元，這使我們在繼續在全球推出 Nuvaxovid 時處於有利地位。

Please turn to Slide 28, where we'll provide a comprehensive overview of our first quarter financial results. For the first quarter of 2022, Novavax recorded total revenue of $704 million compared to $447 million in the first quarter of 2021. Total Revenue for the period included $586 million in product sales by Novavax, $19 million of royalties and other revenue, which includes both royalties and adjuvant sales to our licensed partners and $99 million in grants from the U.S. government.

請轉到幻燈片 28，我們將在其中全面概述第一季度的財務業績。 2022 年第一季度，Novavax 的總收入為 7.04 億美元，而 2021 年第一季度為 4.47 億美元。該期間的總收入包括 Novavax 的 5.86 億美元產品銷售、1900 萬美元的特許權使用費和其他收入，其中包括特許合作夥伴的特許權使用費和輔助銷售，以及來自美國政府的 9900 萬美元贈款。

31 million of Nuvaxovid doses sold globally, marked the first commercial product sales for Novavax. We recorded lower grants revenue in the first quarter of 2022 compared to the prior year as we materially completed the activities under the CEPI agreement in 2021. We do not expect to record incremental revenue under that agreement in 2022. We continue to receive funding for our 2373 clinical programs from the U.S. government. We entered 2022 with approximately $800 million of funding outstanding under our U.S. government agreements and expect to record at least $400 million of this amount during 2022 and remainder in 2023.

全球銷售了 3100 萬劑 Nuvaxovid，標誌著 Novavax 的首次商業產品銷售。與上一年相比，我們在 2022 年第一季度錄得較低的贈款收入，因為我們在 2021 年實質性完成了 CEPI 協議下的活動。我們預計 2022 年不會根據該協議錄得增量收入。我們將繼續為我們的來自美國政府的 2373 個臨床項目。根據我們的美國政府協議，我們進入 2022 年時將有大約 8 億美元的未償資金，預計在 2022 年和 2023 年將記錄至少 4 億美元的這一數額。

Our cost of sales for the first quarter of 2022 were $15 million of product sales in the period. We would discuss this in the concept of reduced cost of sales in a bit more detail on the next slide. Research and development expenses for the first quarter of 2022 were $383 million compared to $593 million for the comparable period in 2021. The decrease was primarily the result of lower clinical development activities for 2373 and capitalization of 2373 manufacturing costs during the quarter. We expect our full year R&D expenses to be lower than 2021. And as noted, a significant portion of our 2022 R&D cost will continue to be funded by the U.S. government.

我們 2022 年第一季度的銷售成本為該期間產品銷售額 1500 萬美元。我們將在下一張幻燈片中更詳細地討論降低銷售成本的概念。 2022 年第一季度的研發費用為 3.83 億美元，而 2021 年同期為 5.93 億美元。減少的主要原因是本季度 2373 的臨床開發活動減少和 2373 製造成本資本化。我們預計我們的全年研發費用將低於 2021 年。如前所述，我們 2022 年研發費用的很大一部分將繼續由美國政府資助。

Additionally, we recorded selling, general and administrative expenses of $96 million in the first quarter of 2022 compared to $63 million in the first quarter of 2021. The increase quarter-over-quarter was a result of our commercial launch costs associated with Nuvaxovid. We expect SG&A costs to continue to rise as we move through 2022 and as we further enhance our commercial capabilities to bring Nuvaxovid to markets around the world.

此外，我們在 2022 年第一季度記錄了 9600 萬美元的銷售、一般和管理費用，而 2021 年第一季度為 6300 萬美元。環比增長是由於我們與 Nuvaxovid 相關的商業啟動成本。隨著我們進入 2022 年，以及我們進一步增強將 Nuvaxovid 推向全球市場的商業能力，我們預計 SG&A 成本將繼續上升。

Novavax continues to maintain its full tax valuation allowance as of the end of the first quarter of 2022 and Majority of the $3 million tax expense recognized in the period was for income tax expenses related to foreign withholding taxes on royalties. For the first quarter of 2022, we recorded net income of $203 million compared to a net loss of $223 million in the first quarter of 2021.

截至 2022 年第一季度末，Novavax 繼續保持其全額稅收估值津貼，該期間確認的 300 萬美元稅收費用中的大部分用於與外國特許權使用費預扣稅相關的所得稅費用。 2022 年第一季度，我們的淨收入為 2.03 億美元，而 2021 年第一季度的淨虧損為 2.23 億美元。

Finally, for our cash position, we ended the quarter -- first quarter of 2022, with $1.6 billion in cash. Resales of 2.2 million shares of Novavax's common stock from our at-the-market offerings we raised net proceeds of $179 million during the first quarter.

最後，對於我們的現金頭寸，我們以 16 億美元的現金結束了本季度——2022 年第一季度。從我們的市場發售中轉售了 220 萬股 Novavax 普通股，我們在第一季度籌集了 1.79 億美元的淨收益。

Please turn to Slide 29, where I'll discuss our cost of sales in more detail. During 2021 and prior to regulatory authorizations for Nuvaxovid, certain manufacturing costs were expensed to research and development that would otherwise have been capitalized the inventory. If not for the reduced cost of inventory for the period, full cost to sales for the first quarter would have been approximately $160 million or 27% of product sales based on our standard cost. We expect to utilize the majority of our reduced cost inventory during 2022. Our Nuvaxovid gross margins on sales to high-income countries are expected to be between 70% and 85% of our sales.

請轉到幻燈片 29，我將在其中更詳細地討論我們的銷售成本。在 2021 年期間以及在 Nuvaxovid 獲得監管授權之前，某些製造成本被用於研發，否則這些成本將被資本化。如果不是因為該期間庫存成本的降低，根據我們的標準成本，第一季度的全部銷售成本約為 1.6 億美元或產品銷售額的 27%。我們預計將在 2022 年利用我們降低成本的大部分庫存。我們向高收入國家銷售的 Nuvaxovid 毛利率預計將在我們銷售額的 70% 至 85% 之間。

Please turn to Slide 30, where we'll provide an overview for our financial guidance for 2022. I Today, we are reiterating our full year 2022 total revenue guidance of between $4 billion and $5 billion. As a reminder, total revenue reflects all sources, including sales at Nuvaxovid by Novavax, grants revenue, royalties and other revenue. As John mentioned previously, we're prepared to deliver doses of our vaccine to Gavi under the terms of our supply agreement. However, we were recently notified by Gavi of their intent to seek to revise the number and timing of doses. To date, Novavax has not received an order from Gavi, and the timing and quantities of future orders to deliver from COVAX facility is unclear.

請轉到幻燈片 30，我們將在其中概述 2022 年的財務指導。今天，我們重申 2022 年全年總收入指導在 40 億美元至 50 億美元之間。提醒一下，總收入反映了所有來源，包括 Novavax 在 Nuvaxovid 的銷售額、贈款收入、特許權使用費和其他收入。正如約翰之前提到的，我們準備根據我們的供應協議條款向 Gavi 提供我們的疫苗劑量。然而，我們最近收到 Gavi 的通知，他們打算修改劑量的數量和時間。迄今為止，Novavax 尚未收到 Gavi 的訂單，未來從 COVAX 工廠交付訂單的時間和數量尚不清楚。

Although we're not adjusting our full year 2022 revenue guidance, we note that our current guidance assumes successful delivery and conversion up to $700 million prepayment to product revenue in the event we deliver less, our resulting revenue expectations for the year could be affected.

雖然我們沒有調整我們的 2022 年全年收入指引，但我們注意到，我們目前的指引假設成功交付和轉換高達 7 億美元的產品收入預付款，如果我們交付的收入減少，我們對這一年的收入預期可能會受到影響。

We look forward to sharing our progress towards realizing this total written of future earnings calls. With that, I'd like to turn it over to Stan to discuss our upcoming strategic priorities.

我們期待分享我們在實現未來收益電話會議上的全部進展。有了這個，我想把它交給斯坦來討論我們即將到來的戰略重點。

Thanks, Jim and the team for all the presentation. So let's go to Slide 31, close it out. Again, I'm pleased to report our many achievements since the start of the year reflecting ongoing execution across all of our strategic priorities for 2020. Through the remainder of the year, we will build on this momentum to achieve all of our objectives across commercial, regulatory, manufacturing and our pipeline. For commercial, we plan to continue the global delivery of our vaccine in collaboration with our partners to drive additional progress toward our full year 2022 revenue targets.

感謝 Jim 和團隊的所有演示。所以讓我們轉到幻燈片 31，將其關閉。再次，我很高興地報告我們自今年年初以來取得的許多成就，反映了我們對 2020 年所有戰略重點的持續執行。在今年剩餘的時間裡，我們將在這一勢頭的基礎上實現我們在整個商業領域的所有目標、監管、製造和我們的管道。對於商業，我們計劃與我們的合作夥伴合作繼續在全球交付我們的疫苗，以推動實現我們 2022 年全年收入目標的更多進展。

For regulatory, we are focused on executing our robust clinical development plan to pursue additional authorizations that expand our vaccines label and policy recommendations. For our pipeline, we will seek to advance development of our other vaccine candidates, ensuring our pipeline has the potential to address today's and tomorrow's most pressing global health needs. For our Omicron variant strain vaccine, we will conduct a clinical trial to ensure we're prepared to deliver our variant-specific vaccine as it either monovalent or bivalent vaccine as required in the coming months. And for our COVID-19 influenza combination vaccine, we will initiate our Phase II trial.

在監管方面，我們專注於執行我們強有力的臨床開發計劃，以尋求額外的授權，以擴大我們的疫苗標籤和政策建議。對於我們的管道，我們將尋求推進其他候選疫苗的開發，確保我們的管道有潛力滿足當今和未來最緊迫的全球衛生需求。對於我們的 Omicron 變異株疫苗，我們將進行臨床試驗，以確保我們準備好在未來幾個月內提供我們的變異特異性疫苗，因為它是單價或二價疫苗。對於我們的 COVID-19 流感聯合疫苗，我們將啟動我們的 II 期試驗。

Thanks for your attention. I will now turn it over to the operator for Q&A.

感謝您的關注。我現在將其交給接線員進行問答。

(Operator Instructions)

（操作員說明）

The first question comes from Roger Song from Jefferies.

第一個問題來自 Jefferies 的 Roger Song。

Great. Thank you for the update and congrats for the 1Q revenues and the quality of EPS. A couple of questions from us. So the first 1 is for the U.S. EUA, this VRBPAC meeting schedule. So as you mentioned, you're still kind of submitting outstanding items requested by the FDA. Just curious what are those kind of additional data package you need to submit before they can have this VRBPAC and how confident you are, you will have this VRBPAC meeting on June 7?

偉大的。感謝您的更新，並祝賀第一季度的收入和每股收益的質量。我們提出了幾個問題。所以第一個是美國 EUA，這個 VRBPAC 會議時間表。因此，正如您所提到的，您仍然需要提交 FDA 要求的未完成項目。只是好奇你需要提交什麼樣的額外數據包才能擁有這個 VRBPAC 以及你有多大信心，你會在 6 月 7 日舉行這個 VRBPAC 會議？

This is Filip. I'll take that. So they're not waiting for any new data from us. I mean all the data has been submitted. And it's just part of their review process. They just are asking questions back and forth and preparing for the VRBPAC. As you know, it's a lift for them as well as for us to prepare for such an open public session. We're very confident. You've seen our clinical data. It's very strong, and that's the focus of the VRBPAC. Now that it's been scheduled, we have a high degree of confidence that we'll have a successful outcome.

這是菲利普。我會接受的。所以他們不會等待我們的任何新數據。我的意思是所有數據都已提交。這只是他們審核過程的一部分。他們只是來回提問並為 VRBPAC 做準備。如你所知，準備這樣一個公開的公開會議對他們和我們來說都是一種提升。我們非常有信心。你已經看到了我們的臨床數據。它非常強大，這是 VRBPAC 的重點。既然已經安排好了，我們對我們將取得成功的結果充滿信心。

Got it. Okay. That's great. And another question is for the -- that to-date administration of Novavax vaccine. We see the delivery is pretty strong. But since the real adoption is relatively lower compared to the delivery. So how do you expect the administration will match up for the delivery and sustain the delivery order as you guided?

知道了。好的。那太棒了。另一個問題是 - 迄今為止的 Novavax 疫苗管理。我們看到交付非常強勁。但由於與交付相比，實際採用率相對較低。那麼，您希望政府如何按照您的指導匹配交付並維持交付訂單？

Yes. So this is John. So yes, we're lagging just a bit, but I think what we're seeing is momentum pick up week by week. where we move this product into the European Commission as well as others through a variety of distribution locations on a country-by-country basis, and then they have the responsibility to get that product out to their health care providers for vaccination. We're 2 months in, and we're seeing some improvement in trajectory, although we have a bit of work to do from an education standpoint, some of the unbranded campaigns that we're engaging in Europe as well as pull-through mechanisms, I'm sure will allow us to catch up in that regard.

是的。這就是約翰。所以，是的，我們只是有點落後，但我認為我們看到的是勢頭逐週回升。我們通過各個國家/地區的各種分銷地點將該產品運送到歐盟委員會以及其他機構，然後他們有責任將該產品提供給他們的醫療保健提供者進行疫苗接種。我們已經 2 個月了，我們看到軌蹟有所改善，儘管從教育的角度來看，我們還有一些工作要做，我們在歐洲參與的一些無品牌活動以及拉動機制，我肯定會讓我們在這方面趕上來。

Let's keep in mind, we also have new orders coming from these countries. So they're accepting additional vaccine in the second quarter in addition to what they received in Q1 and particularly in Europe at the 42 million doses going into Europe in Q2. So I think that there is a confidence in the vaccine, we're seeing improved uptake, and we'll expect to see that through Q2 and Q3.

請記住，我們也有來自這些國家的新訂單。因此，除了他們在第一季度收到的疫苗外，他們在第二季度接受了額外的疫苗，特別是在歐洲，第二季度有 4200 萬劑疫苗進入歐洲。因此，我認為人們對疫苗充滿信心，我們看到疫苗的使用有所提高，我們預計會在第二季度和第三季度看到這一點。

And if I can chime in. I mean we really are anticipating the label to be expanded in the near future that might provide additional opportunity.

如果我能插話的話。我的意思是我們真的期待在不久的將來擴大標籤，這可能會提供額外的機會。

Yes, that's true. Because so far, still most of the country only approved for the prime, not even for the booster or pediatrician -- pediatric. Okay. Great. Maybe just 1 last one, if I may, is just clarifying for the upcoming Omicron related data in 3Q, would that be just to monovalent? Or you also will report data from bivalent in 3Q?

是的，這是真的。因為到目前為止，全國大部分地區仍然只批准了prime，甚至沒有批准booster或兒科醫生——兒科。好的。偉大的。如果可以的話，也許只有最後一個，只是為了澄清即將在 3 季度發布的 Omicron 相關數據，這是否只是單價的？或者你也將在第三季度報告二價的數據？

So we think we'll be delivering the monovalent for sure. The bivalent might lag by just a little bit or maybe not. It mostly depends on the speed of enrollment of the spike. I think we're ready to move forward with both the monovalent as well as the bivalent product.

所以我們認為我們肯定會提供單價的。二價可能會滯後一點，也可能不會。這主要取決於尖峰的註冊速度。我認為我們已經準備好推進單價和二價產品。

The next question comes from Georgi Yordanov from Cowen Company.

下一個問題來自 Cowen 公司的 Georgi Yordanov。

Congratulations on the progress in your first quarter of profitability. So maybe just a follow-up is, I guess, 1 of the questions that were asked. One question we've been getting is on the APAs, how can countries delay on setting up a delivery schedule? Is there like something in the contract that kind of like sets a timing until when country should set up a schedule and actually accept the doses that are part of the contract? And do you guys have any update on those schedules, for example, with the U.K.? And then I'll give the follow-up there.

祝賀您在第一季度的盈利方面取得了進展。因此，我想，也許只是後續行動是被問到的問題之一。我們得到的一個問題是關於 APA，各國如何延遲制定交付時間表？合同中是否有類似的東西設定時間，直到國家應該制定時間表並實際接受合同中的劑量？你們對這些時間表有什麼更新嗎，例如，與英國有關的？然後我會在那裡進行跟進。

Yes. So the way those APAs are set up, Georgi, is that we and they have some flexibility in scheduling how those doses are shifted to the country. And so we're speaking and coordinating with them on almost a daily basis and their demand patterns and how they want to bring product into their particular country is communicated amongst us, and then we set those delivery schedules based upon that. And some of those APAs, as we've talked about before, we'll be shipping throughout the year and then also into 2023 as well.

是的。所以這些 APA 的設置方式，Georgi，是我們和他們在安排如何將這些劑量轉移到該國時具有一定的靈活性。因此，我們幾乎每天都在與他們交談和協調，他們的需求模式以及他們希望如何將產品帶入特定國家的方式在我們之間進行溝通，然後我們根據此制定這些交付時間表。正如我們之前談到的，其中一些 APA 將全年發貨，然後也將在 2023 年發貨。

Got it. And is there any update on the U.K. shipments?

知道了。英國發貨有任何更新嗎？

We're still coordinating with the U.K. about what that delivery schedule is. We're still waiting on JCVI recommendations to come through on our product. And as we've talked about, these label expansions will help with all those efforts as well.

我們仍在與英國就交付時間表進行協調。我們仍在等待 JCVI 對我們產品的建議。正如我們所談到的，這些標籤擴展也將有助於所有這些努力。

That's great. And then maybe we can also talk about your preparedness to participate in an eventual booster market this fall. So do you believe you could potentially be able to participate in that market with an Omicron containing vaccine, just given the timing of results for the upcoming studies?

那太棒了。然後也許我們也可以談談你準備好參加今年秋天最終的助推器市場。那麼，只要考慮到即將進行的研究的結果時間，您是否認為您有可能使用含有 Omicron 的疫苗參與該市場？

Well, that's our goal. Our goal is to be ready for such a campaign. Now clearly, we need to have a boosting indication, and then we need to have the Omicron strain change to be in place before we can do that. As you know, some of our labels, for instance, in Japan, actually carry both a homologous and heterologous boosting. And there are a number of countries where the policy bodies have allowed us to be used in the boosting situation either homologously or heterologously. And we are bringing additional data to bear in that regard. So that's what we want to do, and that's what we're working towards.

嗯，這就是我們的目標。我們的目標是為這樣的活動做好準備。現在很明顯，我們需要有一個增強的指示，然後我們需要讓 Omicron 應變變化到位，然後才能做到這一點。如您所知，我們的一些標籤，例如在日本，實際上同時帶有同源和異源提升。在許多國家，政策機構允許我們在同源或異源的情況下使用。在這方面，我們正在提供額外的數據。所以這就是我們想要做的，也是我們正在努力的方向。

Great. And then finally on the COVID-flu combination opportunity. Congratulations on the data. And to us, given just your technology, you could really be first to market with this product that could provide a major differentiation compared to your competitors? So maybe could you talk about how aggressively do you plan to pursue this program? And do you see it as a priority for you in the near term?

偉大的。最後是 COVID-flu 組合的機會。祝賀數據。對我們而言，僅憑您的技術，您真的可以率先將這款產品推向市場，與您的競爭對手相比，該產品可以提供重大差異化嗎？那麼，也許你能談談你打算如何積極地追求這個項目？您是否認為它是您近期的優先事項？

I can take a crack at that and John can over, if I say something which isn't complete or incorrect. So yes, we're pushing as hard as we can. There are a number of innovations which we haven't talked about that we're bringing into this product. And the main issue is that flu is unpredictable. And the clinical efficacy study, we want to actually demonstrate that this product is better than a licensed comparator vaccine. For that we need food to circulate. So I think that's the 1 uncertainty as to the timing of when that pivotal clinical efficacy study will occur.

如果我說一些不完整或不正確的話，我可以對此進行破解，約翰可以結束。所以，是的，我們正在盡我們所能。有許多我們沒有談到的創新，我們正在將這些創新引入到這個產品中。主要問題是流感是不可預測的。而臨床療效研究，我們想實際證明該產品優於許可的比較疫苗。為此，我們需要食物來流通。所以我認為這是關鍵臨床療效研究何時發生的不確定性。

Regarding commercial opportunity here, it's becoming clear that the key opinion leaders are looking at COVID to be looking like a flu, a seasonal -- annual seasonal vaccination. And so the combination of these 2 and particularly on our technology platform, our recombinant protein as well as adjuvanted technology seems to fit real well. I think most people will prefer 1 shot over multiple shots. And so therefore -- and with the data that we have for both. So we've got solid efficacy data off of COVID, obviously, -- and we also have a successful Phase III on our flu vaccine that makes us a strong combination and would expect high demand for this in most high-income country markets.

關於這裡的商業機會，很明顯，主要意見領袖正在將 COVID 視為流感，一種季節性的 - 年度季節性疫苗接種。所以這兩者的結合，特別是在我們的技術平台上，我們的重組蛋白以及佐劑技術似乎非常適合。我認為大多數人會更喜歡 1 次拍攝而不是多次拍攝。因此 - 以及我們擁有的數據。因此，顯然，我們已經從 COVID 獲得了可靠的療效數據——而且我們的流感疫苗也取得了成功的第三階段，這使我們成為一個強大的組合，並預計在大多數高收入國家市場對此會有很高的需求。

The next question comes from George Duncan of Cantor Fitzgerald.

下一個問題來自 Cantor Fitzgerald 的 George Duncan。

Let's see. This is Charles. Stan and team, congratulations on a great quarter of progress. Let's see. I had a quick question for John. John, you mentioned in your prepared remarks that you've gotten some favorable feedback from the market regarding the response to the vaccine. And I guess I'm just kind of wondering what kind of favorable feedback you've gotten in terms of adopters thus far?

讓我們來看看。這是查爾斯。 Stan 和他的團隊，祝賀取得了巨大的四分之一進步。讓我們來看看。我有一個簡短的問題要問約翰。約翰，你在準備好的評論中提到，你已經從市場上得到了一些關於疫苗反應的積極反饋。我想我只是想知道到目前為止，您在採用者方面得到了什麼樣的好評？

So we continue to hear from our market research as well as anecdotally that there's a high demand for some -- a choice in the marketplace. They like the technology platform, they like the safety profile, they like the efficacy profile. And so we're seeing a commitment inquiry as to when product is available and where -- the availability to get the product. So far, it's a little bit early as far as follow-on to the people that have been vaccinated but again, we're hearing that they enjoy getting the vaccine. They've seen low rates of reactogenicity. And again, so this isn't a quantifiable approach but market research and some surveying that we're doing. So we're optimistic about the data inputs that we're getting already where the vaccine has been in this.

因此，我們繼續從我們的市場研究中聽到，並且傳聞說對某些產品的需求很高——市場上的一種選擇。他們喜歡技術平台，他們喜歡安全性，他們喜歡功效性。因此，我們看到了有關產品何時可用以及在何處獲得產品的可用性的承諾查詢。到目前為止，就接種疫苗的人的後續行動而言，這還為時過早，但我們再次聽說他們喜歡接種疫苗。他們已經看到低反應原性。再說一次，這不是一種可量化的方法，而是我們正在做的市場研究和一些調查。因此，我們對我們已經獲得的數據輸入持樂觀態度，因為我們已經獲得了疫苗所在的位置。

Do you think that, I'll call it, prescribers are aware of and have growing understanding of the kind of relative clinical as well as logistics profile and that may or may not give an advantage in, say, a future booster campaign?

你認為，我會稱之為，開處方者知道並越來越了解相關的臨床和後勤情況，並且可能會或可能不會在未來的助推器運動中產生優勢？

Well, so you have to keep in mind here that we're not in many markets able to promote directly. So there's -- what we are trying to do is get people familiar with the various vaccines that are out of the market, get familiar that we are in the market. But we're not in the normal commercial circumstances where we could be promoting more aggressively about all of the attributes and product profile that we believe are strengths of this product. And so we're doing this through the scientific presentations. We're doing it through any opportunity that we can to make sure people are fully aware of what the characteristics of our vaccine. As long as we're partly limited here, but I think we're gaining momentum as we're able to get more doses out into the marketplace.

好吧，所以你必須記住，我們在許多市場都不能直接推廣。所以有 - 我們試圖做的是讓人們熟悉市場上的各種疫苗，熟悉我們在市場上。但我們不是在正常的商業環境中，我們可以更積極地宣傳我們認為是該產品優勢的所有屬性和產品簡介。所以我們通過科學演示來做到這一點。我們正在盡一切可能確保人們充分了解我們疫苗的特性。只要我們在這裡受到部分限制，但我認為我們正在獲得動力，因為我們能夠將更多劑量推向市場。

Okay. That really makes the doses delivered even more impressive to me. Let me ask you a quick question regarding regulatory and you're probably not going to be able to answer these questions rigorously. But I guess I'm wondering, as you prepare for the upcoming June event, VRBPAC meeting, what kind of questions are you anticipating? Are there any key points of debate that you are looking forward to really being able to reconcile?

好的。這確實使我提供的劑量更加令人印象深刻。讓我問你一個關於監管的快速問題，你可能無法嚴格回答這些問題。但我想我想知道，當你為即將到來的六月活動 VRBPAC 會議做準備時，你期待什麼樣的問題？您是否期待真正能夠調和的辯論關鍵點？

I guess that's to me. And the short answer is no. I mean, we've been very open with our data. We've published all of our results, but it is very strong. It's compelling. And as the VRBPAC is really focused on clinical results, I think that's what we're going to try it out and share it with the advisers. We're feeling pretty confident about this one.

我想這對我來說。簡短的回答是否定的。我的意思是，我們對我們的數據非常開放。我們已經公佈了我們所有的結果，但它非常強大。這是令人信服的。由於 VRBPAC 真正專注於臨床結果，我認為這就是我們要嘗試並與顧問分享的內容。我們對此感到非常有信心。

But in your -- in the context we've been approved in 40 other countries and some of those regulatory agencies, for instance, Japan, MHRA, EU, Health Canada, TGA, I mean those are rigorous regulatory agencies that have scrutinized our files.

但是在您的情況下，我們已經在其他 40 個國家和一些監管機構獲得批准，例如日本、MHRA、歐盟、加拿大衛生部、TGA，我的意思是那些嚴格的監管機構已經審查了我們的文件.

Very good. Filip, sorry, to interrupt you. Last question is for Jim regarding the last kind of statement out of your presentation on Gavi. I guess, I'm wondering if they were to renegotiate to 0, I guess, kind of worst-case scenario, how could that change at least qualitatively, how could that change the guidance? Just help me think through that math.

很好。菲利普，對不起，打擾你了。最後一個問題是關於你關於 Gavi 的演講中最後一種陳述的問題。我想，我想知道他們是否要重新談判到 0，我想，這是最壞的情況，這怎麼可能至少在質量上發生變化，這怎麼會改變指導方針？幫我想想那個數學。

Charles, I think it's fair to say you've put forth a highly negative kind of negative scenario. What we're saying is that it's simply unclear right now. So before we go to perhaps something so negative, what we're simply highlighting is that we're committed to continue working with Gavi to ensure equitable access. And as we -- as this becomes clearer, we'll share more.

查爾斯，我認為可以公平地說你提出了一種非常消極的消極情景。我們要說的是，現在還不清楚。因此，在我們討論可能如此消極的事情之前，我們只是要強調的是，我們致力於繼續與 Gavi 合作，以確保公平獲取。隨著我們 - 隨著這一點變得更加清晰，我們將分享更多。

And (inaudible) to that a little bit. I think Jim is precisely right, right. We can take a disclosure issue that we have here, right, that I think it was important for us to be transparent about. But we haven't spent a whole lot of time talking about what upside potential is in multiple markets relative to either the variant strains or bivalent or upside in the U.S. market as we move forward and get introduced into the U.S. market post the VRBPAC meeting. And so I think that there's some pluses and minuses that we're doing here, and we're simply trying to be transparent with this particular disclosure.

並且（聽不清）一點點。我認為吉姆完全正確，對。我們可以解決我們在這裡遇到的披露問題，對，我認為保持透明對我們來說很重要。但是，隨著我們在 VRBPAC 會議後推進並進入美國市場，我們並沒有花很多時間談論多個市場相對於美國市場的變異株或二價或上行潛力有哪些上行潛力。所以我認為我們在這裡做的有一些優點和缺點，我們只是試圖對這個特定的披露保持透明。

Yes. And I'm not trying to set a negative tone. I'm just trying to make a very simple -- overly simplistic mathematical calculation regarding Gavi but I guess when you renegotiated could go the other direction as well.

是的。而且我並不是要設定負面的基調。我只是想對 Gavi 做一個非常簡單——過於簡單的數學計算，但我想當你重新談判時也可能會轉向另一個方向。

Our next question comes from Eric Joseph of JPMorgan.

我們的下一個問題來自摩根大通的 Eric Joseph。

Just a couple on Nuvaxovid commercial. Stan made a comment about the expectation of sales increasing over the course of the second quarter. Was that relative to Q1? I'm just trying to get a sense of where you see demand going relative to Q1? And from Q1, we also -- we can back into a dose of about $19 a dose. I guess should we anticipate that price point in our assumptions going forward, any fluctuation in mix, I guess, right, that might impact ASPs in subsequent quarters as it late in back to that.

只是 Nuvaxovid 廣告中的一對。斯坦對第二季度銷售額增長的預期發表了評論。這與第一季度有關嗎？我只是想了解您認為相對於第一季度的需求在哪裡？從第一季度開始，我們也可以恢復到每劑約 19 美元的劑量。我想我們是否應該在我們的假設中預測到這個價格點，任何組合的波動，我想，對，這可能會影響隨後幾個季度的平均售價，因為它稍後會回來。

Yes. Eric, it's Stan. So yes, we expect an increase in Q2 over Q1. And we already announced that we have a 42 million dose orders in Europe compared to, I think, 27 million in the first quarter. And so that in itself is an increase at the same pricing that we are doing in first quarter. So we expect a fairly substantial increase in the second quarter revenue.

是的。埃里克，是斯坦。所以是的，我們預計第二季度會比第一季度有所增長。我們已經宣布我們在歐洲有 4200 萬劑訂單，而我認為第一季度為 2700 萬劑。因此，這本身就是我們在第一季度所做的相同定價的增長。因此，我們預計第二季度收入將有相當大的增長。

Okay. Okay. Great. And just thinking through some of the scenarios that might take place with the VRBPAC meeting. Is the focus here solely going to be on primary vaccination indication in Delta. I'm wondering if there's kind of a potential upside case where the agency might be able to consider a broader application for pediatric use?

好的。好的。偉大的。只是想一想 VRBPAC 會議可能發生的一些場景。這裡的重點是否僅放在 Delta 的主要疫苗接種適應症上。我想知道是否有一種潛在的上行案例，該機構可能會考慮更廣泛地應用於兒科用途？

Yes. So they've announced that the -- it will be primarily in adults greater than 18 years of age. At the same time, they have our adolescent data in hand. And that's the identical package, which has been supplied to the other global regulatory agencies, so they have the data in hand. I think it's going to be up to them to decide specifically what questions they ask the advisory body. It was for boosting, they have are boosting data that we're pulling together to submit to the other regulators. We anticipate giving them additional data as well.

是的。因此，他們宣布——它將主要針對 18 歲以上的成年人。同時，他們掌握了我們的青少年數據。這是相同的軟件包，已提供給其他全球監管機構，因此他們手頭有數據。我認為他們將具體決定他們向諮詢機構提出哪些問題。這是為了提升，他們正在提升我們正在匯總以提交給其他監管機構的數據。我們預計也會給他們額外的數據。

I think it's fair to say that what gets asked officially during the VRBPAC meeting versus what we submit soon thereafter. There's not going to be a big time gap between...

我認為可以公平地說，在 VRBPAC 會議期間正式提出的問題與我們之後不久提交的問題相比。不會有很大的時間間隔...

That's right. I mean the package that we would submit to the FDA, for instance, our adolescents is pretty much identical other than the cover letter that we've submitted to EMA, MHRA et cetera. So whether it be addressed there or I think we're ready for both situations.

這是正確的。我的意思是我們將提交給 FDA 的包裹，例如，除了我們提交給 EMA、MHRA 等的求職信之外，我們的青少年幾乎相同。所以無論是在那裡解決還是我認為我們已經為這兩種情況做好了準備。

Okay. Great. And just circling back to the vaccinated sales, I guess for those who are tracked tracking them along side using third-party data sources to the extent that those are accurate. I mean can you just clarify where sort of the point of sale or sales recognition takes place? Is it at doses delivered to a central hub, is there consideration for a secondary delivery or shock administer that get factored into when sales are recorded.

好的。偉大的。回到接種疫苗的銷售，我猜對於那些被跟踪的人來說，他們使用第三方數據源跟踪他們，以確保這些數據是準確的。我的意思是你能澄清一下銷售點或銷售識別發生在哪裡嗎？是否以交付到中央樞紐的劑量，是否考慮在記錄銷售時考慮二次交付或衝擊管理。

Yes, that's a great question. You recognize revenue upon delivery to our customers at their warehouses. That's where they keep title.

是的，這是一個很好的問題。您在我們的客戶倉庫交貨時確認收入。那是他們保留頭銜的地方。

The next question comes from Mayank Mamtani from B. Riley Securities.

下一個問題來自 B. Riley Securities 的 Mayank Mamtani。

Congrats team on regarding your first profitable quarter. So maybe just a follow-up on the prior question, Jim. This process of how revenue is recognized in EU versus shipments that are exported there. Can you just help us understand, is there like a time line lag or an average percentage that needs to get to that facility before it could get to a subsequent country and recognize as revenue. And then a follow-up question I had on the revenue guidance. The full year guidance was on, how much of that $4 billion to $5 billion, the guidance you issued today has the U.S. product sales included in there either as uses primary vaccine series, in adults, adolescents or as boosters? It would be helpful to get some color on that.

恭喜團隊在您的第一個盈利季度。因此，吉姆，也許只是對上一個問題的跟進。這個過程是在歐盟確認收入與出口到那裡的貨物的比較。您能否幫助我們理解，是否存在時間線滯後或需要到達該設施的平均百分比，然後才能到達下一個國家並確認為收入。然後是我對收入指導的後續問題。全年指導方針是，在你今天發布的指導方針中，40 億美元到 50 億美元中，有多少將美國產品銷售作為初級疫苗系列、成人、青少年或助推器包括在內？在上面塗上一些顏色會很有幫助。

Sure, sure. both good questions. So the -- we have not disclosed a particular cadence of shipments into our facility in the Netherlands, which is warehouse units prior to distribution. So we haven't communicated a specific expected cycle time from arrival there to distribution out to our customers. Beyond that, we certainly wanted to be as quick as possible to have the best shelf life available for our customers.

一定一定。兩個好問題。因此，我們沒有透露進入我們荷蘭工廠的特定發貨節奏，即配送前的倉庫單元。因此，我們沒有傳達從到達那裡到分發給客戶的具體預期週期時間。除此之外，我們當然希望盡快為我們的客戶提供最好的保質期。

Then with respect to your question about the U.S. government and the delivery and the doses, our future delivery of doses post authorization are expected to be recognized under grant revenue. You might recall that under our $1.8 billion operation work speed agreement, A component of that is earmarked for doses to be delivered to the U.S. government. Now we haven't disclosed exactly what percent of the -- or a specific amount of greater than $400 million that I mentioned earlier will be recognized this year. but it does capture both the U.S. government's funding of our ongoing clinical work and delivery of doses. It includes both. A reminder is this quarter, we recognized $100 million.

然後關於你關於美國政府和交付和劑量的問題，我們未來在授權後交付的劑量預計將在贈款收入中確認。您可能還記得，根據我們 18 億美元的運營工作速度協議，其中一部分指定用於向美國政府提供的劑量。現在我們還沒有確切披露我之前提到的超過 4 億美元的百分比或具體金額將在今年得到認可。但它確實獲得了美國政府對我們正在進行的臨床工作和劑量交付的資助。它包括兩者。提醒一下，本季度，我們確認了 1 億美元。

Understood. And could you just give us an update on that incremental 100 million with Europe, that optional APA, where you are with that? And what's your expectation for this year versus next year?

明白了。您能否向我們提供有關歐洲增加的 1 億人的最新信息，那個可選的 APA，您在哪裡？您對今年和明年的預期是什麼？

Yes. So we're still working off the initial orders. And again Mayank, we're in constant communication with them, but there hasn't been a step into that expanded 100 million doses yet. But again, with the pediatric label with the booster label and improved policy support, I would reasonably expect that we'll continue to see orders coming out of Europe in '22 and of course, in '23.

是的。所以我們仍在處理最初的訂單。再說一次，Mayank，我們一直在與他們保持溝通，但還沒有邁向擴大 1 億劑的步驟。但同樣，隨著兒科標籤的加強標籤和改進的政策支持，我有理由預計我們將繼續看到 22 年歐洲的訂單，當然還有 23 年。

Got it. And then just a couple of quick ones for Filip. This new data coming out of India and pediatrics, how does that inform your dosing strategy for, obviously, this 5 to 11 year old that you're starting in third quarter but also going down the age group. Anything you learned from that? And then the final question is on your EUA package is so sort of comprehensive on both clinical modules and CMC. What are the incremental items that will be part of the BLA package that you look to submit in second half?

知道了。然後給菲利普幾個快速的。這些來自印度和兒科的新數據，對於您從第三季度開始的 5 至 11 歲兒童的給藥策略有何影響，而且該年齡組也在下降。你從中學到了什麼？最後一個問題是關於你的 EUA 包在臨床模塊和 CMC 方面是如此全面。您希望在下半年提交的 BLA 包中的增量項目是什麼？

So let me -- I'll take it sequentially. So the pediatric data, we found very reassuring. The study design allows for dose adjustments increase the reactogenicity is too significant in the children. This may not be required. I mean, what we saw -- what I shared with you today look very, very good to me from a tolerability perspective and the immunogenicity was also obviously very good. So it allows us to be reassuring both to the regulators, the IRBs as well as the participants in participating in the study. I think additionally, it may allow us to move a little bit faster through the HD escalation process that was really up to -- going to be up to the Safety Monitoring Committee as well as the regulatory agencies. So overall, I think it's good news and just derisks the entire endeavor.

所以讓我 - 我將按順序進行。所以兒科數據，我們發現非常令人放心。研究設計允許劑量調整增加兒童的反應原性太顯著。這可能不是必需的。我的意思是，我們所看到的——從耐受性的角度來看，我今天與你們分享的內容對我來說非常非常好，而且免疫原性顯然也非常好。因此，它讓我們能夠讓監管機構、IRB 以及參與研究的參與者放心。此外，我認為，它可以讓我們在 HD 升級過程中更快一點，這實際上取決於安全監測委員會以及監管機構。所以總的來說，我認為這是個好消息，只是對整個努力的冒險。

We're going to maintain the ability to do fractional dosing in case we do see some reactions, which are severe, especially in the youngest kids, Remember, our goal is to take it out to children of 6 months of age, which is another step down than the data I shared with you today. As far as what's required for the BLA from the clinical perspective, we need to come to an agreement, and this is why we would have the pre-BLA meeting, exactly how much safety data the agency wants before we file a BLA. And also in the U.S. uniquely, Lot consistency study needs to be conducted prior to the BLA. And these are very short studies, but we need to make sure that the agency is in agreement with our approach for doing that.

我們將保持進行分次給藥的能力，以防我們確實看到一些嚴重的反應，尤其是在最小的孩子中，記住，我們的目標是將其用於 6 個月大的孩子，這是另一個比我今天和你分享的數據下台。至於從臨床角度對 BLA 的要求，我們需要達成協議，這就是為什麼我們要召開 BLA 前會議，在我們提交 BLA 之前該機構需要多少安全數據。並且在美國也是獨一無二的，需要在 BLA 之前進行批次一致性研究。這些都是非常簡短的研究，但我們需要確保該機構同意我們這樣做的方法。

The next question comes from Vernon Bernardino from H.C. Wainright.

下一個問題來自 H.C. 的 Vernon Bernardino。溫萊特。

Congratulations on the first profitable quarter. Hopefully, you're celebrating that achievement because it has been some time for some of us who covered you for a long time. And my only other question really is a follow-up from Charles' question regarding Gavi, just wondering if you could share perhaps what Gavi is seeing out there and/or perhaps what you are seeing out there that could make you at least have a metric as far as decision-making on the rest of your guidance and perhaps what -- where Gavin might go?

祝賀第一個盈利季度。希望您正在慶祝這一成就，因為對於我們中的一些人來說已經有一段時間了，他們已經為您報導了很長時間。我唯一的另一個問題真的是查爾斯關於 Gavi 的問題的後續問題，只是想知道你是否可以分享 Gavi 在那裡看到的東西和/或你在外面看到的東西，這可以讓你至少有一個指標至於你的其他指導的決策，也許還有什麼——加文可能會去哪裡？

Yes. This is Stan. Yes, it's an unclear marketplace right now in the low and middle income countries, there appears to be lots of inventory that's been shipped to the main vaccine introduction side of the warehouse in many of these low and middle income countries and the difficulty appears to be getting it into the use in the country. And so I think that, that's something that I don't have a lot of visibility into, but that's what's been related to us. And so therefore, they -- that translates into uncertainty about the demand for our vaccine right now. And so it's, I think, characterized by uncertainty. So I don't know where it's going to go for the low middle income countries, and we're waiting on discussions with Gavi to see what we're going to do with our current contract. It's -- we disclosed that there's uncertainty that's been fairly recent, and that's what it is. (inaudible)

是的。這是斯坦。是的，目前在低收入和中等收入國家的市場尚不清楚，似乎有很多庫存被運送到這些低收入和中等收入國家的倉庫的主要疫苗引入側，困難似乎是在國內投入使用。所以我認為，這是我不太了解的事情，但這就是與我們有關的事情。因此，他們 - 這轉化為目前對我們疫苗需求的不確定性。所以，我認為，它的特點是不確定性。所以我不知道中低收入國家會去哪裡，我們正在等待與 Gavi 的討論，看看我們將如何處理我們目前的合同。這是 - 我們披露了最近存在的不確定性，這就是事實。 （聽不清）

As a follow-up, if I could. I know it's a separate disease influenza. But part of hesitation sometimes is that if you don't have a severe flu season and that includes in developing in third world countries, you have less uptake of a vaccine that could potentially protects you much less save your life. What are you seeing? I know you're working on a bivalent, but what you're seeing as far as marketing research you're seeing, whether some of this hesitancy is related to the fact that we've not had severe flu seasons for many years now, obviously, before the pandemic.

如果可以的話，作為後續行動。我知道這是一種單獨的疾病流感。但有時猶豫的部分原因是，如果您沒有嚴重的流感季節（包括在第三世界國家的發展中國家），那麼您對可能保護您的疫苗的攝取量就會減少，而挽救您生命的可能性也會大大降低。你在看什麼？我知道你正在研究一個二價的，但就你所看到的營銷研究而言，你所看到的這種猶豫是否與我們多年來沒有經歷過嚴重流感季節的事實有關，顯然，在大流行之前。

Well, let me comment on that. I think what you assessment is right. Fear is a great driver of vaccine use, right? You're preventing a disease not curing a disease. And so therefore, preparation is important. So I think the issue here, Vernon, is what is the best preparation in any particular season for both influenza and COVID. And I think the vaccine is that right prevention. You can't predict in any given year what the circulating virus rate will be. And so I think that's why you've seen flu vaccine, especially in the U.S., be universally recommended now for many years. and there are some years that are bad and there are some years that are as severe, but vaccination is important. And I think that's going to be true for COVID as well.

好吧，讓我對此發表評論。我覺得你的評價是對的。恐懼是疫苗使用的重要驅動力，對吧？你是在預防一種疾病而不是治愈一種疾病。因此，準備工作很重要。因此，弗農，我認為這裡的問題是，在任何特定季節，針對流感和 COVID 的最佳準備是什麼。我認為疫苗是正確的預防措施。您無法預測任何一年的病毒傳播率。所以我認為這就是為什麼你已經看到流感疫苗，特別是在美國，多年來被普遍推薦。有些年份很糟糕，有些年份很嚴重，但疫苗接種很重要。我認為這對 COVID 也是如此。

At the moment, you have COVID muting the circulation of influenza virus and that might not be the case. And so when will flu come back, it will likely come back with some vengeance, and we need to be prepared for that. And we think a combination influence vaccine is the right strategy.

目前，您有 COVID 抑制了流感病毒的傳播，但情況可能並非如此。所以流感什麼時候會捲土重來，它很可能會捲土重來，我們需要為此做好準備。我們認為聯合影響疫苗是正確的策略。

Just to pile on from an Epi perspective, I mean, really flu hasn't been around now for a couple of seasons, and that means that the population is really susceptible. So when it does flip over and some minor drift bearing comes into the population, I think we could see quite a severe year. I mean remember that the CDC estimated that the vaccine efficacy past year was based on our data, we believe that we have a better flu vaccine.

只是從 Epi 的角度來看，我的意思是，真正的流感已經有幾個季節沒有出現了，這意味著人口真的很容易受到影響。因此，當它確實翻轉並且一些輕微的漂移軸承進入人口時，我認為我們會看到相當嚴峻的一年。我的意思是請記住，疾病預防控制中心估計過去一年的疫苗效力是基於我們的數據，我們相信我們有更好的流感疫苗。

This concludes our question-and-answer session. I would like to turn the conference back over to Stan Erck for closing remarks.

我們的問答環節到此結束。我想把會議轉回給 Stan Erck 做閉幕詞。

Okay. Thanks, and thanks for everyone for joining in and listening. Just to close, we're proud of the significant milestones we've reached since the start of 2022, all of which have been made possible through the dedicated efforts of our Novavax team and ongoing collaboration with many of our partners globally. Year ahead, we look forward to continue to report on additional progress. We've talked about things that are going on there will be new data coming out this year. across our business as we continue the successful commercial launch of our vaccine. Thank you very much, and we'll close.

好的。謝謝，也感謝大家的加入和聆聽。最後，我們為自 2022 年初以來取得的重要里程碑感到自豪，所有這些都是通過我們 Novavax 團隊的不懈努力以及與我們全球許多合作夥伴的持續合作而實現的。展望未來，我們期待繼續報告更多進展。我們已經討論了正在發生的事情，今年將會有新的數據出現。隨著我們繼續成功地商業化我們的疫苗。非常感謝，我們會關閉的。

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

會議現已結束。感謝您參加今天的演講。您現在可以斷開連接。