Novavax Inc (NVAX) 2022 Q4 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to the Novavax Fourth Quarter and Full Year 2022 Financial Results and Operational Highlights Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded.

女士們，先生們，感謝你們的支持，歡迎來到 Novavax 第四季度和 2022 年全年財務業績和運營亮點電話會議。 （操作員說明）請注意，今天的會議正在錄製中。

I would now like to hand the conference over to your speaker today, [Erica Schultz]. You may begin Ma'am.

我現在想把會議交給今天的演講者 [Erica Schultz]。女士，您可以開始了。

Good afternoon, and thank you all for joining us today to discuss our fourth quarter and full year 2022 operational highlights and financial results.

下午好，感謝大家今天加入我們，討論我們第四季度和 2022 年全年的運營亮點和財務業績。

A press release announcing our results is currently available on our website at novavax.com, and an audio archive of this conference call will be available on our website later today.

宣布我們結果的新聞稿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天晚些時候在我們的網站上提供。

Please turn to Slide 2. Before we begin with prepared remarks, I need to remind you that this presentation includes forward-looking statements, including information relating to the future of Novavax, its key strategic priorities, operating plans, objectives and prospects, its future financial or business performance, conditions or strategies, key commercial goals, future product demand trends, the ongoing development of our vaccine candidates, including strain selection, anticipating timing of trials and results, the scope, timing and outcome of future regulatory filings and actions, the efficacy, safety and intended utilization of our vaccine candidates, including against COVID-19 variants, the global market opportunities for our vaccine candidates, our manufacturing capacity and the future availability of our vaccine candidates and key upcoming milestones.

請轉到幻燈片 2。在我們開始準備好的評論之前，我需要提醒您，本演示文稿包含前瞻性陳述，包括與 Novavax 的未來、其關鍵戰略優先事項、運營計劃、目標和前景、其未來財務或業務績效、條件或戰略、關鍵商業目標、未來產品需求趨勢、我們候選疫苗的持續開發，包括毒株選擇、預期試驗時間和結果、未來監管文件和行動的範圍、時間和結果，我們候選疫苗的功效、安全性和預期用途，包括針對 COVID-19 變種的疫苗、我們候選疫苗的全球市場機會、我們的製造能力和我們候選疫苗的未來可用性以及即將到來的關鍵里程碑。

Each forward-looking statement contained in this presentation is subject to risks and uncertainties that could cause actual results to differ materially from those projected in such statements. Additional information regarding those factors appears under the heading Cautionary Note regarding forward-looking statements in the slide deck we issued this afternoon and under the heading Risk Factors in our most recent Form 10-K and subsequent Form 10-Q filed with the Securities and Exchange Commission and available at www.sec.gov and on our website at www.novavax.com, as well as subsequent filings with the SEC.

本演示文稿中包含的每項前瞻性陳述都存在風險和不確定性，這些風險和不確定性可能導致實際結果與此類陳述中預測的結果存在重大差異。有關這些因素的更多信息出現在我們今天下午發布的幻燈片中關於前瞻性陳述的警告性說明標題下，以及我們最近向證券交易委員會提交的 10-K 表格和隨後的 10-Q 表格中的風險因素標題下佣金和在 www.sec.gov 和我們的網站 www.novavax.com 上提供，以及隨後向美國證券交易委員會提交的文件。

The forward-looking statements in this presentation speak only as of the original date of this presentation, and we undertake no obligation to update or revise any of these statements.

本演示文稿中的前瞻性陳述僅在本演示文稿的原始日期發表，我們不承擔更新或修改任何這些陳述的義務。

Please turn to Slide 3. Joining me today for the first time is John Jacobs our new President and CEO. John will provide an update on his first few weeks at Novavax as well as provide an overview of our near-term priorities as we plan for the long-term path to success. Additionally, John Trizzino, Chief Commercial Officer and Chief Business Officer, will provide an update on our commercial activities and Dr. Filip Dubovsky, President of Research and Development, will discuss our variant strategy and clinical development. Finally, Jim Kelly, Chief Financial Officer and Treasurer, will provide an overview of our financial results. Rick Crowley, Chief Operations Officer, will also be available for the Q&A section at the end of today's call.

請翻到幻燈片 3。今天第一次和我在一起的是我們的新總裁兼首席執行官 John Jacobs。 John 將提供他在 Novavax 的前幾週的最新情況，並概述我們在規劃長期成功之路時的近期優先事項。此外，首席商務官兼首席商務官 John Trizzino 將提供我們商業活動的最新信息，研發總裁 Filip Dubovsky 博士將討論我們的變體戰略和臨床開發。最後，首席財務官兼財務主管 Jim Kelly 將概述我們的財務業績。首席運營官里克克勞利 (Rick Crowley) 也將在今天的電話會議結束時出席問答環節。

I would now like to hand over the call to John Jacobs. Please turn to Slide 4.

我現在想把電話轉給 John Jacobs。請轉到幻燈片 4。

Thank you, Erica, and thank you, everyone, for joining us today.

謝謝 Erica，也謝謝大家今天加入我們。

I'm pleased to be together with all of you for my first earnings call with Novavax, and I'm excited to have the honor of helping to shape this new chapter in the company's history in partnership with our Board, our leadership team and all of our employees. After spending 25 years in the pharmaceutical industry and having led the growth of several different organizations to become mature commercial entities, there are a few key factors that drew me to Novavax, including their validated and innovative technology platform, which has produced a differentiated and effective COVID-19 vaccine, a pipeline of additional assets and their adjuvant Matrix-M, that together offer the potential to create significant value for the organization. Their fully integrated set of capabilities, ranging from discovery and manufacturing to commercial execution on a global scale; and finally, Novavax' people and company values, which have cultivated a mission-driven culture dedicated to improving global public health.

我很高興能和大家一起參加我與 Novavax 的第一次財報電話會議，我很高興有幸與我們的董事會、我們的領導團隊和所有人合作，幫助塑造公司歷史的新篇章我們的員工。在製藥行業工作了 25 年並領導了幾個不同的組織成長為成熟的商業實體之後，有幾個關鍵因素吸引了我到 Novavax，包括他們經過驗證的創新技術平台，它產生了差異化和有效的COVID-19 疫苗是一系列額外資產及其佐劑 Matrix-M，它們共同提供了為組織創造重大價值的潛力。他們完全集成的能力集，從發現和製造到全球範圍內的商業執行；最後，Novavax 的員工和公司價值觀培養了一種以使命為導向的文化，致力於改善全球公共衛生。

Today, I would like to share a few insights from my first 5 weeks of the company and outline our near-term priorities before handing it over to additional members of our leadership team to discuss our results from the previous quarter. So let's talk about my observations during the first 5 weeks.

今天，我想分享我在公司工作的前 5 週的一些見解，並概述我們的近期優先事項，然後再交給我們領導團隊的其他成員討論我們上一季度的業績。那麼讓我們談談我在前 5 週的觀察。

Since joining Novavax in late January, I've spent my time listening, learning about the business and gaining perspective from key stakeholders across our organization. Though I will certainly continue to listen and learn for months to come as I visit our global facilities and meet all of our amazing employees, customers and partners, I've had the chance in these initial weeks to gather some early insights and to gain an initial picture of our current business, our capabilities and our challenges. These early interactions have made it clear to me that we need to focus our entire organization on a few key priorities, which I believe will give us the best chance for success in 2023.

自 1 月下旬加入 Novavax 以來，我一直在傾聽、了解業務並從我們組織的主要利益相關者那裡獲得觀點。儘管在接下來的幾個月裡，當我參觀我們的全球設施並會見我們所有優秀的員工、客戶和合作夥伴時，我肯定會繼續傾聽和學習，但在最初的幾周里，我有機會收集一些早期的見解並獲得一個我們當前業務的初步概況、我們的能力和我們面臨的挑戰。這些早期的互動讓我清楚地知道，我們需要將整個組織的重點放在幾個關鍵的優先事項上，我相信這將為我們在 2023 年取得成功提供最佳機會。

Importantly, they have also reinforced to me the remarkable technology, capability set and talent that we have as a company and the opportunity we have to build long-term value by leveraging the foundation that has been laid to date. So let's take a moment and talk about our near-term priorities.

重要的是，它們還讓我更加了解我們作為一家公司所擁有的卓越技術、能力和人才，以及我們必須利用迄今為止奠定的基礎來建立長期價值的機會。因此，讓我們花點時間談談我們近期的優先事項。

While the significant investments made to build the company over the past 3 years were necessary for Novavax to deliver our first commercial product during a complex global pandemic, we are now seeing a more traditional commercial market emerging as the pandemic settles into an endemic phase. This new emerging commercial market will require the company to adjust our level of investment and our plant to better align our efforts with this opportunity. In fact, the leadership team and I have already taken decisive actions together during my first few weeks with this in mind. These actions are intended to focus our efforts on the things that we believe are most important to our near-term success, while at the same time, reducing our spend and our resource commitments in areas that may no longer be aligned with those goals.

雖然在過去 3 年中為建立公司而進行的重大投資對於 Novavax 在復雜的全球大流行期間交付我們的第一個商業產品是必要的，但隨著大流行進入地方流行階段，我們現在看到一個更傳統的商業市場正在出現。這個新興的商業市場將要求公司調整我們的投資水平和我們的工廠，以更好地配合這個機會。事實上，考慮到這一點，我和領導團隊在我上任的頭幾週就已經共同採取了果斷行動。這些行動旨在將我們的精力集中在我們認為對我們近期成功最重要的事情上，同時減少我們在可能不再與這些目標保持一致的領域的支出和資源承諾。

I'd like to take a few minutes to share with you these priorities and some of the actions we've already taken since my arrival. Priority 1, deliver a competitive product for the upcoming 2023 fall vaccination season. We are a global company, and our intention is to deliver an updated COVID vaccine that aligns with public health recommendations. Additionally, we intend to make this product available in smaller dose vials, which we know is important for our customers. Together, these factors are intended to help ensure we are well positioned to compete as markets move from an advanced purchase agreement to a commercial orientation over time.

我想花幾分鐘時間與大家分享這些優先事項以及自我上任以來我們已經採取的一些行動。優先事項 1，為即將到來的 2023 年秋季疫苗接種季節提供有競爭力的產品。我們是一家全球性公司，我們的目的是提供符合公共衛生建議的更新 COVID 疫苗。此外，我們打算將該產品裝在更小劑量的小瓶中，我們知道這對我們的客戶很重要。總之，這些因素旨在幫助確保我們在市場從高級採購協議轉變為商業導向的過程中處於有利地位。

Importantly, globally, we do not yet have full clarity on strain selection for the upcoming '23 full vaccination season, which will be an important factor for us as we update our vaccine. In the U.S., for example, we are working in partnership with the FDA to inform them about what we will need in order to deliver our product, including the timing of strain selection and the nuances of our own manufacturing process as a protein-based vaccine.

重要的是，在全球範圍內，我們還沒有完全清楚即將到來的 '23 全面疫苗接種季節的毒株選擇，這將是我們更新疫苗時的一個重要因素。例如，在美國，我們正在與 FDA 合作，告知他們我們需要什麼來交付我們的產品，包括毒株選擇的時間和我們自己作為蛋白質疫苗的製造過程的細微差別.

Let's move on to priority 2, reduce our rate of spend, manage our cash flow and evolve our scale and structure. Since my arrival, we have taken immediate steps to reduce our rate of spend, better align our investments with our near-term priorities and focus our efforts in energy with the intent of delivering a successful launch this fall. I have already taken an important initial step to evolve our structure by modifying the organization of our executive leadership team, which we discussed in our earnings press release. These changes will allow us to better align our internal resources, operate more efficiently and help to position us for long-term success.

讓我們繼續優先事項 2，降低我們的支出率，管理我們的現金流並發展我們的規模和結構。自從我上任以來，我們已立即採取措施降低開支率，更好地使我們的投資與我們的近期優先事項保持一致，並將我們的精力集中在能源上，以期在今年秋天成功推出。我已經採取了重要的初步步驟，通過修改我們在收益新聞稿中討論的執行領導團隊的組織來發展我們的結構。這些變化將使我們能夠更好地調整我們的內部資源，更有效地運作，並幫助我們為長期成功做好準備。

Highlights of these changes include the appointment of Elaine O'Hara as our new Chief Strategy Officer, who will focus on business and corporate development, portfolio strategy and alliance management. Elaine brings to the organization over 15 years of senior strategic and commercial leadership experience in vaccines and infectious disease, including Chief Commercial Officer North America for Sanofi Vaccines and senior roles at both Otsuka and Pfizer. In addition, Dr. Filip Dubovsky will assume the role of President, Research and Development following the retirement of Dr. Greg Glenn. Greg will move into a consulting role as a strategic R&D adviser to the company. Silvia Taylor, has been promoted to Chief Corporate Affairs and Advocacy Officer with expanded responsibilities, including government affairs, policy and advocacy. Troy Morgan, our Chief Compliance Officer, will remain in his role and now report directly to me as CEO in order to elevate our company's focus on compliance. And finally, Investor Relations will move under our CFO, Jim Kelly, among other changes.

這些變化的亮點包括任命 Elaine O'Hara 為我們的新首席戰略官，她將專注於業務和企業發展、投資組合戰略和聯盟管理。 Elaine 為該組織帶來了超過 15 年的疫苗和傳染病高級戰略和商業領導經驗，包括 Sanofi Vaccines 的北美首席商務官以及 Otsuka 和 Pfizer 的高級職位。此外，Filip Dubovsky 博士將在 Greg Glenn 博士退休後擔任研發總裁一職。 Greg 將擔任公司的戰略研發顧問，擔任諮詢職務。西爾維婭·泰勒 (Silvia Taylor) 已晉升為首席企業事務和宣傳官，職責範圍擴大，包括政府事務、政策和宣傳。我們的首席合規官特洛伊·摩根 (Troy Morgan) 將繼續擔任其職務，現在作為首席執行官直接向我匯報，以提升我們公司對合規性的關注。最後，投資者關係部門將在我們的首席財務官 Jim Kelly 的領導下進行調整，並進行其他調整。

In the coming months, we will be assessing our global structure in more detail with these priorities and long-term value creation in mind and look forward to sharing any additional potential changes with you during future calls. You will hear more today about how we are reducing and streamlining our investments from Jim Kelly later in the call.

在接下來的幾個月裡，我們將考慮這些優先事項和長期價值創造，更詳細地評估我們的全球結構，並期待在未來的電話會議中與您分享任何其他潛在變化。今天，您將在電話會議後期從吉姆·凱利那裡聽到更多關於我們如何減少和精簡我們的投資的信息。

And finally, priority 3, leverage our technology platform, our capabilities and our portfolio of assets to drive additional value beyond Nuvaxovid alone. Beyond our COVID-19 vaccine and the near-term opportunity for the fall '23 vaccination campaign, we have a differentiated technology platform, a global footprint with a fully integrated capability set and a portfolio of promising assets, including a COVID-19 influenza combination vaccine in Phase II with data expected midyear that presents significant opportunity for value creation.

最後，優先事項3，利用我們的技術平台、我們的能力和我們的資產組合來推動 Nuvaxovid 之外的附加價值。除了我們的 COVID-19 疫苗和 23 年秋季疫苗接種活動的近期機會外，我們還有一個差異化的技術平台、一個具有完全集成能力集的全球足跡和一系列有前途的資產，包括 COVID-19 流感組合II 期疫苗的數據預計在年中提供，這為創造價值提供了重要機會。

It is our intention to unlock the potential of these assets and capabilities, both in the near term and over time via different strategies, including but not limited to, business and corporate development. This could include the potential for route licensing, partnering, co-promotion and/or other related activities.

我們打算通過不同的戰略，包括但不限於業務和企業發展，在短期內和長期內釋放這些資產和能力的潛力。這可能包括路線許可、合作、共同推廣和/或其他相關活動的可能性。

To further align our resources against this objective, I have added the new role of Chief Strategy Officer to my executive team as mentioned earlier. As part of her new role, Elaine will be undertaking a strategic review of our pipeline, including an assessment of how we will prioritize our pipeline investments. We have already decided to pause clinical development on RSV which Filip will discuss in more detail.

為了進一步調整我們的資源以實現這一目標，如前所述，我在我的執行團隊中增加了首席戰略官這一新角色。作為新角色的一部分，Elaine 將對我們的管道進行戰略審查，包括評估我們將如何確定管道投資的優先順序。我們已經決定暫停 RSV 的臨床開發，Filip 將對此進行更詳細的討論。

As noted in my opening comments, I have been trying to learn as much as I can during my first few weeks at Novavax. And although I still have a lot to learn as I continue to get to know our business. What I can say for sure already is that I have truly been impressed with the energy and talent of this team. Impressed with our technology and the remarkable set of assets and capabilities we have built as an organization on a global scale and importantly, the significant opportunity for future growth and value that this represents.

正如我在開場白中指出的那樣，在 Novavax 的頭幾周里，我一直在努力學習盡可能多的東西。儘管隨著我繼續了解我們的業務，我還有很多東西要學。我可以肯定地說，這支球隊的活力和才華給我留下了深刻的印象。我們對我們的技術以及我們在全球範圍內作為一個組織建立的卓越資產和能力印象深刻，重要的是，這代表了未來增長和價值的重要機會。

At the same time, I'm aware that over the past few years along this journey, we have experienced both highs and lows. And although the company has achieved many successes along the way, we have also experienced some disappointments. I would like to take a moment today to pledge to you our commitment to be transparent about our opportunities as well as our challenges, to provide balance and perspective about the near-term and future priorities we are focusing on, and with humility to admit the challenges we face.

同時，我意識到在過去的幾年中，在這段旅程中，我們經歷了高潮和低谷。儘管公司一路走來取得了許多成功，但我們也經歷過一些失望。今天我想花點時間向你們保證，我們承諾對我們的機遇和挑戰保持透明，對我們關注的近期和未來優先事項提供平衡和觀點，並謙虛地承認我們面臨的挑戰。

I would like to say thank you to all of our investors, our partners and the consumers of our vaccine for your faith in us and in this opportunity and for your patience as we now lead Novavax down a path towards a new and exciting future. The road ahead will be filled with potential opportunity as well as some significant challenges, and it won't be easy. But we commit to give you all our energy and our effort with the goal of success. And we may falter along the way. But if we do, we'll work hard to correct our path and be continuously thankful for your belief in our potential.

我想感謝我們所有的投資者、我們的合作夥伴和我們疫苗的消費者，感謝你們對我們和這個機會的信任，感謝你們在我們現在帶領 Novavax 走上一條通往令人興奮的新未來的道路上的耐心。前面的道路充滿了潛在的機遇，也充滿了一些重大挑戰，而且不會一帆風順。但我們承諾為您提供我們所有的能量和努力，以取得成功。我們可能會在路上步履蹣跚。但如果我們這樣做，我們將努力糾正我們的道路，並不斷感謝您對我們潛力的信任。

So let me close my opening comments by saying in the coming months, we are committed to maintaining a strong focus on the priorities I shared with you today, with the goal of strengthening our position as a company in the near term and putting us in a good position for future growth and success.

因此，讓我結束我的開場白，在接下來的幾個月裡，我們致力於繼續高度關注我今天與大家分享的優先事項，目標是在短期內加強我們作為一家公司的地位，並使我們處於為未來的成長和成功做好準備。

With that, I would like to hand it over to the team to discuss our results in more detail, beginning with John Trizzino to provide an update on our commercial activities on Slide 5. John?

有了這個，我想把它交給團隊來更詳細地討論我們的結果，首先是 John Trizzino 在幻燈片 5 上提供我們商業活動的最新情況。約翰？

Thanks, John. Please turn to Slide 6 to discuss commercial updates.

謝謝，約翰。請轉到幻燈片 6 討論商業更新。

As John has discussed, we are beginning to see the COVID-19 market evolve and stabilize as we transition from the pandemic to endemic phase of COVID-19. We expect COVID vaccines will remain an important part of annual seasonal immunization schedules to address waning immunity and protect against emerging variants. It is generally accepted by public health policy advisers that there is an ongoing need for an annual seasonal vaccination, and we expect this will create long-term markets for COVID vaccines globally. We anticipate that these markets will take a slightly different shape country by country, similar to established markets for other vaccines like influenza.

正如 John 所討論的那樣，隨著我們從 COVID-19 的大流行階段過渡到流行階段，我們開始看到 COVID-19 市場的發展和穩定。我們預計 COVID 疫苗仍將是年度季節性免疫計劃的重要組成部分，以解決免疫力下降的問題並防止出現新的變種。公共衛生政策顧問普遍認為，每年都需要進行季節性疫苗接種，我們預計這將為全球 COVID 疫苗創造長期市場。我們預計這些市場在不同國家/地區的形態會略有不同，類似於流感等其他疫苗的成熟市場。

In the U.S., the government's decision to end the public health emergency in May signaled the intent to move away from government purchasing and toward a commercial market for the second half of this year. In regions such as the EU and Asia Pacific, the market is beginning to transition from pandemic APAs to a more traditional commercial market. We expect governments will continue to play a significant role in these tender and private markets by procuring a portfolio of vaccines and allocating those vaccines in country.

在美國，政府決定在 5 月份結束公共衛生緊急狀態，這表明有意在今年下半年從政府採購轉向商業市場。在歐盟和亞太地區等地區，市場開始從大流行性 APA 過渡到更傳統的商業市場。我們預計政府將通過採購疫苗組合併在國內分配這些疫苗，繼續在這些招標和私人市場中發揮重要作用。

Taken together, we believe these market dynamics create a significant long-term opportunity with a potential global market size of greater than $15 billion annually over time and we anticipate that the U.S. and EU, 2 of our priority markets make up approximately $10 billion per year of this total projected opportunity.

總而言之，我們相信這些市場動態創造了一個重要的長期機會，隨著時間的推移，全球潛在市場規模每年超過 150 億美元，我們預計我們的兩個優先市場美國和歐盟每年約佔 100 億美元這個總的預計機會。

Now let me outline our path to commercial success and please turn to Slide 7. To capture our share of this potential opportunity, we are leveraging the strong foundation we built in 2022 to advance key commercial goals that will support our path to long-term success. These activities for the 2023 full vaccination season include: one, working to enable reliable access to our vaccine; two, leveraging our commercial footprint in priority markets in the Americas and Europe to drive demand; three, utilizing our global manufacturing and supply network; and four, delivering a differentiated product profile.

現在讓我概述我們的商業成功之路，請轉到幻燈片 7。為了抓住這一潛在機會，我們正在利用我們在 2022 年建立的堅實基礎來推進關鍵商業目標，以支持我們走向長期成功之路. 2023 年完整疫苗接種季節的這些活動包括：一，努力確保可靠地獲得我們的疫苗；第二，利用我們在美洲和歐洲優先市場的商業足跡來推動需求；第三，利用我們的全球製造和供應網絡；第四，提供差異化的產品概況。

So now let me dive a little bit deeper into each. Number one, enable reliable access to our vaccine. We believe the relationships we've built with customers in key markets through the launch of Nuvaxovid will help facilitate a smooth transition to the commercial market. In the U.S. We recently updated our agreement with the U.S. government to deliver 1.5 million additional doses of our COVID vaccine, which maintains access throughout the country in advance of our intent to deliver an updated variant-specific vaccine for the fall season.

所以現在讓我更深入地探討每一個。第一，確保可靠地獲取我們的疫苗。我們相信，我們通過推出 Nuvaxovid 與主要市場的客戶建立的關係將有助於促進向商業市場的平穩過渡。在美國，我們最近更新了與美國政府的協議，額外提供 150 萬劑我們的 COVID 疫苗，在我們打算為秋季提供更新的變體特異性疫苗之前，該疫苗在全國范圍內保持可及性。

Outside the U.S., we currently have $2.1 billion in committed APAs remaining. We expect to deliver doses against this commitment through 2023 and 2024, and we remain in ongoing discussions with our customers on supply. In the EU, we finalized our revised delivery schedule for the remaining 20 million committed doses under our APA.

在美國以外，我們目前還有 21 億美元的已承諾 APA。我們希望在 2023 年和 2024 年之前根據這一承諾提供劑量，並且我們仍在與客戶就供應問題進行持續討論。在歐盟，我們根據 APA 確定了剩餘 2000 萬劑承諾劑量的修訂交付時間表。

Number two, leverage our commercial footprint in priority markets. Our focus is on positioning Nuvaxovid as a critical protein-based option as well as working to generate additional pull-through in all our target markets. In the priority regions where we have established commercial operations, Americas, Europe, U.K. and Asia Pacific, our efforts are focused on building brand awareness, improving access and differentiating our product to build demand and support pull-through efforts.

第二，利用我們在優先市場的商業足跡。我們的重點是將 Nuvaxovid 定位為一種關鍵的基於蛋白質的選擇，並努力在我們所有的目標市場產生額外的拉動效應。在我們建立商業運營的優先區域，美洲、歐洲、英國和亞太地區，我們的工作重點是建立品牌知名度、改善准入和差異化我們的產品，以建立需求和支持拉動式努力。

In the U.S., our team's near-term focus is on communicating with and educating consumers and health care professionals to drive demand. While in the EU and APAC, our efforts are focused on advancing policy recommendations for national immunization programs and private purchasers.

在美國，我們團隊的近期重點是與消費者和醫療保健專業人員進行溝通和教育以推動需求。在歐盟和亞太地區，我們的工作重點是為國家免疫計劃和私人購買者提出政策建議。

Number three, utilizing our global manufacturing network. As John discussed earlier, one of our key priorities is to align our structure and scale with the commercial market opportunity. This includes continuing to assess our manufacturing needs and modifying our global manufacturing footprint, consistent with our contractual obligations to supply and for anticipated demand, especially in the U.S. for our COVID vaccine. We are working to establish our strain chain capabilities as we seek to manufacture various specific vaccines in monovalent or bi-valent formulations. These efforts are intended to provide us with increased flexibility to supply our priority markets in line with seasonal demand.

第三，利用我們的全球製造網絡。正如約翰之前討論的那樣，我們的主要優先事項之一是使我們的結構和規模與商業市場機會保持一致。這包括繼續評估我們的製造需求和修改我們的全球製造足跡，以符合我們供應和預期需求的合同義務，特別是在美國的 COVID 疫苗。我們正在努力建立我們的菌株鏈能力，因為我們尋求以單價或雙價配方製造各種特定疫苗。這些努力旨在為我們提供更大的靈活性，以根據季節性需求供應我們的優先市場。

As part of these efforts, we have established our own internal drug substance manufacturing capabilities, which we see as a potential competitive advantage in the future. Our facility in the Czech Republic, Novavax CZ recently received authorization from EMA to supply antigen drug substance to the European Union. And just this month, we completed our filing to the FDA to add this facility to our supply network.

作為這些努力的一部分，我們建立了自己的內部原料藥製造能力，我們認為這是未來的潛在競爭優勢。我們在捷克共和國的工廠 Novavax CZ 最近獲得了 EMA 的授權，可以向歐盟供應抗原原料藥。就在這個月，我們完成了向 FDA 的備案，將這個設施添加到我們的供應網絡中。

Lastly, our differentiated product profile. We believe our top organizational priority to help us capture market share is delivering a competitive product for the upcoming 2023 full vaccination season in either a bi-valent or monovalent formulation. In addition to the U.S., the EU has also stated their goal to harmonize their product and strain recommendations for the 2023 full vaccination season. And with this in mind, we believe that EMA and potentially other regulatory bodies may also consider a variant strain approach for the fall season.

最後，我們差異化的產品概況。我們認為，我們幫助我們奪取市場份額的首要組織優先事項是以雙價或單價配方為即將到來的 2023 年完整疫苗接種季節提供有競爭力的產品。除美國外，歐盟還表示他們的目標是在 2023 年整個疫苗接種季節協調其產品和毒株建議。考慮到這一點，我們認為 EMA 和潛在的其他監管機構也可能會考慮在秋季採用變異菌株方法。

For all our customers, we plan to remain an ongoing dialogue and prepare to supply the product that is requested. To further differentiate our product among health care providers, we are seeking to develop a smaller dose vial presentation. Nuvaxovid's competitive product profile is based on our validated technology platform and our clinical data demonstrate our vaccines high efficacy, strong durability of immune responses, protection against infection and well-characterized safety and reactogenicity profile. These key characteristics, coupled with our favorable transportation and storage attributes, all contribute to our vaccines differentiated profile.

對於我們所有的客戶，我們計劃保持持續的對話並準備提供所要求的產品。為了進一步區分我們的產品在醫療保健提供者中的差異，我們正在尋求開發更小劑量的小瓶包裝。 Nuvaxovid 具有競爭力的產品概況基於我們經過驗證的技術平台，我們的臨床數據證明我們的疫苗具有高效能、免疫反應的強持久性、抗感染保護以及良好的安全性和反應原性概況。這些關鍵特徵，加上我們有利的運輸和儲存屬性，都有助於我們的疫苗差異化。

I'll now hand it over to Filip to discuss our strategy for developing our various strain vaccine and ongoing clinical development.

我現在將把它交給 Filip 來討論我們開發各種毒株疫苗和正在進行的臨床開發的策略。

Thanks, John. Please turn to Slide 8.

謝謝，約翰。請轉到幻燈片 8。

Today, we remain focused on developing our COVID-19 vaccine, including against variants, while also evaluating our influenza and combination vaccines. Beyond these 3 clinical assets, we are rationalizing our preclinical pipeline to align our resources with programs that we believe will drive significant value for our business. This includes pausing the planned clinical development for our adult RSC program until a strategic pipeline assessment is complete, and we are confident our other priorities are fully resourced.

今天，我們仍然專注於開發我們的 COVID-19 疫苗，包括針對變體的疫苗，同時還評估我們的流感疫苗和聯合疫苗。除了這 3 項臨床資產之外，我們正在合理化我們的臨床前管道，以將我們的資源與我們認為將為我們的業務帶來重大價值的計劃相結合。這包括暫停我們成人 RSC 計劃的計劃臨床開發，直到完成戰略管道評估，並且我們相信我們的其他優先事項已得到充分資源。

Let's turn to Slide 9 and look at a high-level overview of our ongoing COVID-19 studies. In line with the priorities that John Jacobs introduced, these studies are focused on 2 key areas. The first is to gather data to improve and expand our label as well as to strengthen our policy recommendations. The second is to prepare for the upcoming vaccine strain change. Study 301 is our original Phase III study in U.S. and Mexico. We've continued the study and have administered first and second homologous boosts to both adults and adolescents. The adolescents boost data has been submitted to the FDA and is being submitted to other global regulators. Study 505 is being conducted in South Africa and is evaluating different dosing schedules for both immunocompromised and immunocompetent participants.

讓我們轉到幻燈片 9，看看我們正在進行的 COVID-19 研究的高級概述。根據 John Jacobs 介紹的優先事項，這些研究集中在 2 個關鍵領域。首先是收集數據以改進和擴展我們的標籤以及加強我們的政策建議。二是為即將到來的疫苗變株做好準備。 Study 301 是我們最初在美國和墨西哥進行的 III 期研究。我們繼續這項研究，並對成人和青少年進行了第一次和第二次同源加強免疫。青少年促進數據已提交給 FDA，並正在提交給其他全球監管機構。 Study 505 正在南非進行，正在評估針對免疫功能低下和免疫功能正常的參與者的不同給藥方案。

This data will support a more flexible vaccination schedule and guide us on vaccine dosing in special populations. Study 312 is an extension of our Lot-to-lot consistency study that I reported on in the previous quarter and of the January of our pack.

這些數據將支持更靈活的疫苗接種計劃，並指導我們在特殊人群中進行疫苗給藥。 Study 312 是我在上一季度和 1 月份報告的批次間一致性研究的延伸。

In this extension, we are reboosting some participants to evaluate the breadth of immune response after a second boost with our vaccine. And Study 503 is our global pivotal pediatric study evaluating the safety and effectiveness of the vaccine in children as young as 6 months of age. We continue to enroll in the older cohort and began enrolling in children 2 to 5 years of age in January. All of these studies were designed to provide data that can be used to expand our label and support policy recommendations.

在此擴展中，我們正在重新加強一些參與者，以評估在使用我們的疫苗進行第二次加強後免疫反應的廣度。 Study 503 是我們的全球關鍵兒科研究，旨在評估該疫苗對 6 個月大的兒童的安全性和有效性。我們繼續招收年齡較大的隊列，並於 1 月開始招收 2 至 5 歲的兒童。所有這些研究都旨在提供可用於擴展我們的標籤和支持政策建議的數據。

Finally, Study 311 is our Strain-Change study that we've previously discussed. The study achieved its prespecified endpoint supporting a potential Strain-Change to BA.1. However, as discussed at the VRBPAC, the prototype strain vaccine, BA.1 vaccine and bi-valent vaccine overall performed comparably supporting the continued use of our prototype and ongoing boosting campaigns.

最後，研究 311 是我們之前討論過的應變變化研究。該研究達到了其預先指定的終點，支持對 BA.1 的潛在應變變化。然而，正如在 VRBPAC 上討論的那樣，原型毒株疫苗、BA.1 疫苗和雙價疫苗總體上表現相當，支持我們的原型疫苗的繼續使用和正在進行的加強活動。

Part 2 of the study will evaluate our prototype strain vaccine, a BA.5 variant vaccine in a bi-valent containing prototype plus BA.5. The study is being expanded to include a cohort of adolescents who will receive the same BA.5-containing formulations. It is unclear if the BA.5 will be a component of the '23, '24 updated vaccine composition. However, in discussion with regulators, this study is designed to support our regulatory file irrespective of which strain or strains are chosen for the final composition.

該研究的第 2 部分將評估我們的原型毒株疫苗，這是一種雙價的 BA.5 變體疫苗，包含原型和 BA.5。該研究正在擴大，以包括一組接受同樣含 BA.5 製劑的青少年。目前尚不清楚 BA.5 是否會成為 '23、'24 更新疫苗成分的組成部分。然而，在與監管機構的討論中，這項研究旨在支持我們的監管文件，而不管最終組合物選擇了哪種菌株。

[Maybe a] miss, if I didn't mention that with the exception of Study 505, these are all being planned and conducted in partnership with the U.S. government.

[也許] 想念，如果我沒有提到，除了 Study 505，這些都是與美國政府合作計劃和實施的。

Before I move to our influenza COVID combination vaccine, I want to update you on our approach on doing preliminary work on emerging variants, so we can be nimble once the string composition has been announced.

在我轉向我們的流感 COVID 組合疫苗之前，我想向您介紹我們對新出現的變體進行初步工作的最新方法，以便在宣布字符串組成後我們可以保持敏捷。

Let's move to Slide 10. We monitor public health platforms for the versions of new variants. When concerning variants emerge, they are placed into our variant development platform. Work begins with [closing renew] sequence and evaluating spike proteins in vitro, the immune responses are evaluated in animal models and monoclonal antibodies are developed for our structure function analysis. Concurrently, we developed (inaudible) that's required for commercial manufacturer. And we also manufacture monovalent vaccine bulk, which can be used for clinical evaluation or if that variant is part of the selected future composition, it can be blended as a monovalent or bi-valent vaccine and be available for initial commercial release. Although we cannot be assured any of the variants we are working on will be selected for the future composition, this approach may shorten the time between strain selection and deployment of vaccine.

讓我們轉到幻燈片 10。我們監控公共衛生平台以獲取新變種的版本。當出現相關變體時，它們會被放置到我們的變體開發平台中。工作從 [關閉更新] 序列開始，並在體外評估刺突蛋白，在動物模型中評估免疫反應，並開發單克隆抗體用於我們的結構功能分析。同時，我們開發了（聽不清）商業製造商所需的。我們還生產單價疫苗散裝，可用於臨床評估，或者如果該變體是選定的未來組合物的一部分，它可以混合為單價或雙價疫苗，並可用於初始商業發布。雖然我們不能保證我們正在研究的任何變體都會被選擇用於未來的組成，但這種方法可能會縮短菌株選擇和疫苗部署之間的時間。

Okay. Please move to Slide 11. For our COVID influenza combination and stand-alone influenza vaccines, we initiated our Phase II study in Australia and New Zealand in December. The study design is shown conceptually on this slide. We previously reported results from our initial Phase I, Phase II trial that confirmed the feasibility of the combination vaccine. The current trial enrolled approximately 1,500 participants and is evaluating different antigen and adjuvant dose ranges for our combination product as well as our stand-alone influenza vaccine. The immune responses will be compared to 2 licensed influenza vaccines. This study will determine the specific formulations that could be advanced into late-stage development for both influenza and the combination vaccine. We expect initial results from our Phase II trial midyear.

好的。請轉到幻燈片 11。對於我們的 COVID 流感組合疫苗和獨立流感疫苗，我們於 12 月在澳大利亞和新西蘭啟動了 II 期研究。本幻燈片概念性地展示了研究設計。我們之前報告了我們最初的 I 期、II 期試驗的結果，證實了聯合疫苗的可行性。目前的試驗招募了大約 1,500 名參與者，並且正在評估我們的組合產品以及我們的獨立流感疫苗的不同抗原和佐劑劑量範圍。免疫反應將與 2 種獲得許可的流感疫苗進行比較。這項研究將確定可以推進流感疫苗和聯合疫苗後期開發的具體配方。我們預計我們的 II 期試驗將於年中取得初步結果。

We will evaluate the results and make a data-driven decision on our go-forward plan for these candidates. If the data are positive and demonstrate this program, we have significant potential value, and we will expect to pursue options to continue advancing the program into a Phase III trial.

我們將評估結果，並根據數據為這些候選人制定下一步計劃。如果數據是積極的並證明該計劃，我們將具有巨大的潛在價值，我們將期望尋求繼續推進該計劃進入 III 期試驗的選擇。

With that, I'll hand over to Jim Kelly to discuss our financial results.

有了這個，我將交給吉姆凱利來討論我們的財務業績。

Thank you, Filip. Please turn to Slide 12.

謝謝你，菲利普。請轉到幻燈片 12。

This afternoon, we announced our financial results for the fourth quarter and full year 2022. Details of our results can be found in our press release issued today and in our 10-K filing.

今天下午，我們公佈了第四季度和 2022 年全年的財務業績。我們的業績詳情可以在今天發布的新聞稿和我們的 10-K 文件中找到。

I'll begin by providing an overview of our total revenue performance and cash position, then I will discuss our quarterly and full year results in additional detail. Finally, and will discuss our recent initiatives to reduce and control our spend with the intent of improving Novavax' cash runway and best position the company to deliver near- and long-term value.

我將首先概述我們的總收入表現和現金狀況，然後我將更詳細地討論我們的季度和全年業績。最後，將討論我們最近減少和控制支出的舉措，目的是改善 Novavax 的現金跑道，並使公司處於最佳位置，以實現近期和長期價值。

Please turn to Slide 13. For the fourth quarter of 2022, we recorded total revenue of $357 million, a 61% growth over the fourth quarter of 2021. For the full year 2022, we recorded total revenue of $2 billion, a 73% growth over prior year. The growth in each period resulted from our Nuvaxovid product sales, which offset a decline in grants, royalties and other revenue and reflect the transition of Novavax to a commercial stage company.

請轉到幻燈片 13。2022 年第四季度，我們的總收入為 3.57 億美元，比 2021 年第四季度增長 61%。2022 年全年，我們的總收入為 20 億美元，增長 73%超過上一年。每個時期的增長都源於我們的 Nuvaxovid 產品銷售，這抵消了贈款、特許權使用費和其他收入的下降，並反映了 Novavax 向商業階段公司的過渡。

Additionally, we ended 2022 with $1.3 billion in cash compared to $1.5 billion as of the end of 2021. In December 2022, we raised $250 million in gross proceeds through concurrent equity and convertible securities offerings. In January 2023 we funded the maturity of our $325 million convertible notes.

此外，截至 2022 年底，我們的現金為 13 億美元，而截至 2021 年底為 15 億美元。2022 年 12 月，我們通過同時發行股票和可轉換證券籌集了 2.5 億美元的總收益。 2023 年 1 月，我們為 3.25 億美元的可轉換票據的到期提供了資金。

Please turn to Slide 14. Taking a look at our full year financial performance, our cost of sales for the fourth quarter and full year 2022 were $182 million and $903 million, respectively. This includes (inaudible) million and $604 million, respectively, for expenses related to excess, obsolete and expired inventory and losses on future supply commitments. These write-offs are associated with the rationalization of our supply network in light of lower demand as we transition to an endemic COVID-19 market.

請轉到幻燈片 14。看看我們全年的財務業績，我們 2022 年第四季度和全年的銷售成本分別為 1.82 億美元和 9.03 億美元。這分別包括（聽不清）100 萬美元和 6.04 億美元，用於與過剩、過時和過期庫存相關的費用以及未來供應承諾的損失。隨著我們向流行的 COVID-19 市場過渡，鑑於需求下降，這些註銷與我們供應網絡的合理化有關。

Research and development expenses for the fourth quarter and full year 2022 were $258 million and $1.2 billion, respectively compared to $963 million and $2.5 billion for the comparable periods in 2021. The decrease in both periods was primarily due to a decrease in development activities related to coronavirus vaccines and an increase to capitalized manufacturing costs that previously were expensed to R&D.

2022 年第四季度和全年的研發費用分別為 2.58 億美元和 12 億美元，而 2021 年同期為 9.63 億美元和 25 億美元。這兩個時期的減少主要是由於與以下方面相關的開發活動減少冠狀病毒疫苗以及以前用於研發的資本化製造成本的增加。

Selling, general and administrative expenses for the fourth quarter and full year 2022 were $162 million and $489 million, respectively compared to $84 million and $298 million for the comparable periods in 2021. The increase in both periods relates to the commencement of our commercial sales operations in support of our Nuvaxovid product launch. We recorded a net loss of $182 million for the fourth quarter and $658 million for the full year 2022. This compares to a net loss of $846 million and $1.7 billion for the comparable periods in 2021.

第四季度和 2022 年全年的銷售、一般和管理費用分別為 1.62 億美元和 4.89 億美元，而 2021 年同期為 8400 萬美元和 2.98 億美元。這兩個時期的增加都與我們商業銷售業務的開始有關支持我們的 Nuvaxovid 產品發布。我們錄得第四季度淨虧損 1.82 億美元，2022 年全年淨虧損 6.58 億美元。相比之下，2021 年同期淨虧損分別為 8.46 億美元和 17 億美元。

Please turn to Slide 15. In our 10-K, you will see that we have added a going concern disclosure. While our current business plan and cash flow forecast estimate that we have sufficient capital available to fund our operations for the next 12 months, we recognize that this plan is subject to significant uncertainty related primarily to future revenue, funding from the U.S. government and are pending arbitration with Gavi.

請轉到幻燈片 15。在我們的 10-K 中，您會看到我們添加了持續經營披露。雖然我們目前的業務計劃和現金流量預測估計我們有足夠的可用資金來為未來 12 個月的運營提供資金，但我們認識到該計劃存在重大不確定性，主要與未來收入、美國政府的資金有關，並且正在等待與全球疫苗免疫聯盟進行仲裁。

I'd like to first discuss these uncertainties and then share with you immediate actions we have taken to mitigate these concerns and improve our financial position. Regarding our full year 2023 revenue, our performance will depend on our ability to deliver an updated version of our COVID-19 vaccine for the 2023 fall vaccination season. Key activities in support of this plan include our timely completion of the 311 study to demonstrate our strain-change capabilities, and delivering an updated COVID-19 vaccine consistent with public health recommendations for screen composition.

我想首先討論這些不確定性，然後與您分享我們為減輕這些擔憂並改善我們的財務狀況而採取的立即行動。關於我們 2023 年的全年收入，我們的表現將取決於我們為 2023 年秋季疫苗接種季節提供更新版 COVID-19 疫苗的能力。支持該計劃的主要活動包括我們及時完成 311 研究以證明我們的菌株變化能力，以及提供符合公共衛生建議的篩查成分更新的 COVID-19 疫苗。

Regarding our U.S. government funding, in February 2023, the U.S. government indicated our existing agreement would not be extended past December 2023, which may place a portion of the remaining [$460 million] of funding at risk. We are proactively discussing mitigation options with the U.S. government in an effort to realize the full amount outstanding.

關於我們的美國政府資金，2023 年 2 月，美國政府表示我們現有的協議不會延長到 2023 年 12 月之後，這可能會使剩餘 [4.6 億美元] 資金的一部分面臨風險。我們正在積極與美國政府討論緩解方案，以努力實現全部未償還金額。

And finally, regarding Gavi. We recognize that the outcome of our pending arbitration is inherently uncertain. We are taking immediate actions as we seek to address these concerns, with the intent of improving Novavax' cash runway and best position the company to deliver near- and long-term value.

最後，關於全球疫苗免疫聯盟。我們認識到我們未決仲裁的結果本質上是不確定的。我們正在立即採取行動，尋求解決這些問題，目的是改善 Novavax 的現金跑道，並使公司處於實現近期和長期價值的最佳位置。

Earlier this month, we initiated an organization-wide effort to assess our capabilities and more closely align our investments and activities with the top business priorities that John outlined at the start of today's call. Through this initiative, we have implemented multiple measures to reduce and control our operating spend. These include alignment on our key priorities for investment for 2023, cost containment measures to reduce spend and an immediate hold on noncritical hiring.

本月早些時候，我們發起了一項全組織範圍的工作，以評估我們的能力，並使我們的投資和活動更緊密地與約翰在今天的電話會議開始時概述的首要業務優先事項保持一致。通過這一舉措，我們實施了多項措施來減少和控制我們的運營支出。其中包括調整我們 2023 年投資的主要優先事項、減少支出的成本控制措施以及立即暫停非關鍵招聘。

Given the uncertainty of the 2023 fall vaccination strain selection process and implications on our full year 2023 revenues, we've decided not to provide full year 2023 financial guidance at this time. We will assess whether it is prudent to do so in the future based on the clarity provided by government agencies globally that will, in turn, inform our revenue and operating plans.

鑑於 2023 年秋季疫苗接種菌株選擇過程的不確定性以及對我們 2023 年全年收入的影響，我們決定目前不提供 2023 年全年財務指導。我們將根據全球政府機構提供的清晰度來評估未來這樣做是否謹慎，這反過來又會為我們的收入和運營計劃提供信息。

However, today, we are providing preliminary insights into our near-term financial performance expectations. In the first quarter of 2023, our intent is to lower our combined SG&A and R&D expense to $370 million or less. If achieved, this would reflect a $50 million reduction to our run rate when compared to the $420 million recorded in the fourth quarter of 2022 and is based on the anticipated impact of our enhanced spend controls, prioritization and gating of activities.

然而，今天，我們將提供對我們近期財務業績預期的初步見解。在 2023 年第一季度，我們的目標是將我們的綜合 SG&A 和研發費用降低到 3.7 億美元或更少。如果實現，與 2022 年第四季度記錄的 4.2 億美元相比，這將反映出我們的運行率減少了 5000 萬美元，這是基於我們加強支出控制、優先級排序和活動門控的預期影響。

Regarding pipeline investment, among other things, we are gating funding for our [flu kick] Phase III program, pending an assessment of our Phase II clinical results in mid-2023. This will include an evaluation of dilutive and non-dilutive options to fund this important program. On revenue, we are seeing an emerging seasonality for the demand for COVID-19 vaccines globally. Because of this, we do not anticipate any new vaccine sales for the first quarter of 2023. We do anticipate vaccine sales beginning in the second quarter and the majority of our Nuvaxovid sales to occur in the second half of 2023.

關於管道投資，除其他事項外，我們正在為我們的 [flu kick] III 期計劃籌集資金，等待 2023 年年中對我們的 II 期臨床結果進行評估。這將包括對為這一重要計劃提供資金的稀釋性和非稀釋性方案的評估。在收入方面，我們看到全球對 COVID-19 疫苗的需求正在出現季節性。因此，我們預計 2023 年第一季度不會有任何新的疫苗銷售。我們預計疫苗銷售將從第二季度開始，而我們的大部分 Nuvaxovid 銷售將發生在 2023 年下半年。

Outside the United States, we currently have $2.1 billion in committed APAs remaining. We expect to deliver doses against these commitments throughout 2023 and 2024. Regarding our U.S. government funding, we entered 2023 with $416 million of funding outstanding and expect to recognize the majority of this amount in 2023 and are proactively discussing mitigation efforts with the U.S. government in an effort to realize the full outstanding amount.

在美國以外，我們目前還有 21 億美元的已承諾 APA。我們預計將在 2023 年和 2024 年期間兌現這些承諾。關於我們的美國政府資金，我們進入 2023 年時有 4.16 億美元的未償資金，預計將在 2023 年確認這一數額的大部分，並積極與美國政府討論緩解措施努力實現全部未清金額。

With that said, I'd like to turn it back over to John for some closing remarks.

話雖如此，我想把它轉回給 John 做一些結束語。

Thank you, Jim. And please turn to Slide 16.

謝謝你，吉姆。請轉到幻燈片 16。

Looking ahead, I'm excited about our opportunity this year and also believe that we have a significant opportunity to create value over the long term in Novavax. We recognize that we'll face some significant challenges on our journey from here and that the near-term road ahead will be tough, as we work hard with the intent of updating our differentiated vaccine in line with emerging requirements around the globe for the fall season, reshape our ways of working, reduce our spend and refocus our time, energy and resources on our emerging priorities for the year.

展望未來，我對今年的機會感到興奮，也相信我們有一個重要的機會在 Novavax 長期創造價值。我們認識到，我們將在今後的旅程中面臨一些重大挑戰，並且近期的道路將是艱難的，因為我們努力工作以更新我們的差異化疫苗，以滿足秋季全球的新需求季節，重塑我們的工作方式，減少我們的開支，並將我們的時間、精力和資源重新集中在我們今年新出現的優先事項上。

The support of our shareholders, partners and customers has been instrumental in guiding us to where we are today. And this support will continue to be critical to our long-term success. Because of this, our commitment is to put forward our best effort in all that we do and to conduct our business with the highest standards of integrity.

我們的股東、合作夥伴和客戶的支持在引導我們取得今天的成就方面發揮了重要作用。這種支持將繼續對我們的長期成功至關重要。正因為如此，我們的承諾是盡最大努力做好我們所做的一切，並以最高的誠信標准開展我們的業務。

Over the coming months, I will continue to work with the executive leadership team and our Board of Directors with the intent of delivering strong results this year and to develop our long-term vision for growth, positioning our business to eventually become one of the leading global vaccine companies. We look forward to sharing updates and additional details on our execution of this plan and our emerging long-term vision on our first quarter 2023 earnings call.

在接下來的幾個月裡，我將繼續與執行領導團隊和我們的董事會合作，以期在今年取得強勁的業績，並製定我們的長期增長願景，使我們的業務最終成為領先的公司之一全球疫苗公司。我們期待在 2023 年第一季度財報電話會議上分享有關我們執行該計劃的更新和更多詳細信息，以及我們正在形成的長期願景。

I'll now turn it over to the operator for Q&A. Operator?

我現在將其轉交給運營商進行問答。操作員？

(Operator Instructions) Today's first question comes from Roger Song with Jefferies.

（操作員說明）今天的第一個問題來自 Jefferies 的 Roger Song。

Few ones from us. The first is about the liquidity. Maybe the team can give us a little bit more granularity in terms of the top line versus the OpEx spend. On the top line, we are hearing you have [USD 20 million] -- I don't know the EU kind of APA -- revised APA. And also, you have the 2.1 APA -- $2.1 billion APA remains to deliver in 2023 and '24. And how should we think about the 2023 revenue kind of in general? And also in terms of the OpEx, how flexible your OpEx will be based on the top line revenue, understanding you're cutting the costs overall? And I have a follow-up after that.

我們很少。首先是關於流動性。也許團隊可以在頂線與 OpEx 支出方面給我們更多的粒度。最重要的是，我們聽說您有 [2000 萬美元]——我不知道歐盟那種 APA——修訂後的 APA。而且，您還有 2.1 APA——21 億美元的 APA 仍有待在 2023 年和 24 年交付。我們應該如何看待 2023 年的總體收入？並且在運營支出方面，您的運營支出將如何靈活地基於頂線收入，了解您正在削減總體成本？之後我有一個跟進。

Roger, John Jacobs here. Thank you for joining, and thanks to everyone for joining our call today.

羅傑，這裡是約翰·雅各布斯。感謝您的加入，也感謝大家今天加入我們的電話會議。

Just a couple of comments, and I'll hand it over to Jim Kelly to add some additional context, our CFO. But as you mentioned, we have just over a $2 billion book of business globally outside of the U.S. that the company will be optimizing between 2023 and 2024. Discussions around that are ongoing right now.

只是一些評論，我會把它交給吉姆凱利來添加一些額外的背景，我們的首席財務官。但正如您所提到的，我們在美國以外的全球範圍內擁有超過 20 億美元的業務賬簿，該公司將在 2023 年至 2024 年之間對其進行優化。目前正在進行相關討論。

In addition, the U.S. represents an exciting and relatively new opportunity for Novavax as the company didn't fully penetrate the U.S. market in the past. We're working closely with [USG] who just put an order in for additional vaccines right now as well as the FDA to align on what we're going to bring forward for this fall season and are excited about the additional opportunity that the U.S. marketplace offers us regarding potential revenue.

此外，美國對 Novavax 來說是一個令人興奮且相對較新的機會，因為該公司過去並未完全滲透美國市場。我們正在與 [USG] 密切合作，後者現在剛剛訂購了額外的疫苗，同時還與 FDA 就我們將在這個秋季推出的產品達成一致，並對美國提供的額外機會感到興奮。市場為我們提供了潛在的收入。

And Jim, Roger also had some commentary about OpEx and maybe you want to add some more context to that answer for now.

Jim，Roger 也對 OpEx 發表了一些評論，也許你現在想為該答案添加更多背景信息。

Certainly. And thanks for your question, Roger. One of the things that we shared was our expectations around trajectory of spend into the first quarter. That's certainly something we provided. And one of the things you're seeing is that we do have leverage in our business. We're seeing the ability to reduce sequentially that number of SG&A plus R&D by $50 million, which is just over 12%.

當然。羅傑，謝謝你的問題。我們分享的其中一件事是我們對第一季度支出軌蹟的預期。這當然是我們提供的。你看到的一件事是我們在我們的業務中確實有影響力。我們看到有能力按順序將 SG&A 和 R&D 的數量減少 5000 萬美元，剛好超過 12%。

What you also heard is that we have an operating plan that we think provides sufficient capital for us to be successful this year although acknowledge it's not without risk. And for that reason, that's why we're not providing financial guidance. You are correct that there are certain variable aspects to our cost structure that do coincide with sales that would be avoided. But the reality is we look forward to delivering an updated vaccine in the fall in bringing that product to people around the world.

您還聽說我們有一個運營計劃，我們認為該計劃為我們今年的成功提供了足夠的資金，儘管承認它並非沒有風險。因此，這就是我們不提供財務指導的原因。您是正確的，我們的成本結構中有某些可變方面確實與可以避免的銷售一致。但現實情況是，我們期待在秋季推出更新的疫苗，將該產品帶給世界各地的人們。

And Roger, just to make sure we were crystal clear that 20 million doses in Europe is part of that $2.1 billion book of business outside the U.S.

羅傑，只是為了確保我們非常清楚，歐洲的 2000 萬劑是美國以外 21 億美元業務的一部分。

And you had a follow-up question, Roger?

你有一個後續問題，羅傑？

Great. Yes. Yes, I understand. In terms of the variant specific vaccines since the globally that the regulator and public health agency is looking for. Just curious about your current -- the CMC capacity or the speed of the production? What is the time frame you're looking for to be able to need the stream change? Specific U.S. seems looking for 3 months, but would you be able to meet that or you really need the 6 months to be able to make the stream change?

偉大的。是的。是的我明白。就監管機構和公共衛生機構正在全球範圍內尋找的變體特異性疫苗而言。只是對您目前的 CMC 產能或生產速度感到好奇？您正在尋找能夠需要流更改的時間範圍是什麼？特定的美國似乎需要 3 個月，但你能滿足嗎？或者你真的需要 6 個月才能改變流？

Great question, Roger. And obviously, everyone knows that it takes a little bit longer to develop a protein-based vaccine than an mRNA vaccine. But there are things we can do to speed up our time line, and we are taking decisive action with that intent in mind. First and foremost, that's partnering with the FDA very closely in conversations between our team and FDA senior leadership and FDA technical leadership to make sure that they understand what our requirements are and that we understand what their requirements are in a crystal clear fashion, so we can move forward together with the goal of offering our protein-based vaccine as an option for U.S. consumers.

好問題，羅傑。顯然，每個人都知道開發基於蛋白質的疫苗比開發 mRNA 疫苗需要更長的時間。但我們可以做一些事情來加快我們的時間表，我們正在採取果斷行動，牢記這一意圖。首先也是最重要的是，在我們的團隊與 FDA 高級領導層和 FDA 技術領導層之間的對話中，我們與 FDA 密切合作，以確保他們了解我們的要求，並且我們以非常清晰的方式了解他們的要求，因此我們可以與向美國消費者提供基於蛋白質的疫苗作為一種選擇的目標一起前進。

In addition to that, we, as an organization, have a fully integrated capability set that allows us to bring forward multiple variants at the same time and bring those variants to scale in our CMC process, so we can hedge our bets, if you will, ahead of the curve in anticipation of variants that may be selected.

除此之外，作為一個組織，我們擁有一個完全集成的能力集，使我們能夠同時提出多個變體，並在我們的 CMC 流程中擴展這些變體，因此我們可以對沖我們的賭注，如果你願意的話，領先於預期可能選擇的變體的曲線。

And what I'll do is turn it over to Mr. Rick Crowley, who runs our manufacturing organization for additional color and context. Rick?

我要做的是將它交給 Rick Crowley 先生，他負責管理我們的製造組織以增加色彩和背景。瑞克？

Roger, it's a good question. The -- as said, we are actively producing variants of interest, and we're identifying those through the public health authorities and our discovery team is developing the variants that we are then moving on into the large-scale manufacturing. And so we anticipate having a pool of inventory ready at the time of the decision being made. And that allows us even though it still takes about 6 months to go from inception to commercial, we are getting a jump start on that by creating this inventory and putting this material in stock ready to be delivered in the fall.

羅傑，這是個好問題。正如所說，我們正在積極生產感興趣的變體，我們正在通過公共衛生當局識別這些變體，我們的發現團隊正在開髮變體，然後我們將進入大規模生產。因此，我們預計在做出決定時準備好庫存池。這讓我們即使從開始到商業化仍然需要大約 6 個月的時間，我們正在通過創建這個庫存並將這些材料放入庫存準備在秋季交付來快速開始。

And our next question today comes from Alec Stranahan with Bank of America.

我們今天的下一個問題來自美國銀行的 Alec Stranahan。

Just a few from us. As a follow-up to the question that was just asked on the vaccine turnaround, do you have any additional info on the spring versus summer strain selection? I know this was sort of a topic of debate at the most recent VRBPAC meeting. And just from a technological perspective, how accurate would it be to have multiple, I guess, irons in the fire? What would sort of be the hit rate historically when you look back at prior flu seasons? And one more question on innovation outside of COVID. I know you mentioned that RSV might be -- be prioritized. Is this due to how crowded the space has gone? Or are there some other technological hurdles? And any color around sort of the first stops or best applications for your technology would be helpful.

就我們幾個。作為剛剛提出的有關疫苗周轉問題的後續問題，您是否有關於春季和夏季毒株選擇的任何其他信息？我知道這在最近的 VRBPAC 會議上是一個爭論的話題。僅從技術角度來看，我猜在火中放置多個熨斗會有多準確？當您回顧之前的流感季節時，歷史上的命中率是多少？還有一個關於 COVID 之外的創新的問題。我知道你提到 RSV 可能會被優先考慮。這是因為空間變得擁擠了嗎？或者還有其他一些技術障礙？圍繞您的技術的第一站或最佳應用的任何顏色都會有所幫助。

Filip, do you want to take the question on strain selection?

Filip，你想回答關於菌株選擇的問題嗎？

Sure. Let's start there. So I mean what we're hearing from all the regulators more or less globally is that they're moving toward annual vaccination schedule. And when we heard the VRBPAC that they're really trying to select strains around the summer time or a bit earlier to be deployed in the '23, '24 northern hemisphere season, which is really a fall, winter for us. So those are the time frames that Rick was talking about meeting by selecting the strain.

當然。讓我們從那裡開始。所以我的意思是，我們從全球範圍內或多或少地從所有監管機構那裡聽到的是，他們正在朝著年度疫苗接種計劃邁進。當我們聽到 VRBPAC 說他們真的試圖在夏季左右或更早一點選擇菌株以部署在 23、24 北半球季節時，這對我們來說真的是秋冬季節。所以這些就是 Rick 所說的通過選擇菌株來滿足的時間框架。

Now you had an add-on question, what's the hit rate? And I think you mentioned flu. Now flu is different from COVID. And we talked about that at VRBPAC is recognized that COVID is changing a lot faster than influenza. Now that being said, there are some of these that as we look at the landscape -- the global landscape appear to continue to be important variants in cause disease, and some of them appear to be quite stable. In the slides that I showed you, I outlined the ones that we're pushing forward actively now. But we have other ones that are further in the pipeline that we can move toward GMP manufacturing, if that's the way it looks.

現在您有一個附加問題，命中率是多少？我想你提到了流感。現在流感不同於 COVID。我們在 VRBPAC 談到，人們認識到 COVID 的變化比流感快得多。話雖這麼說，但當我們審視景觀時，其中有一些——全球景觀似乎繼續是導致疾病的重要變體，其中一些似乎相當穩定。在我向您展示的幻燈片中，我概述了我們現在正在積極推進的內容。但我們還有其他一些正在進一步開發中的產品，如果看起來是這樣的話，我們可以轉向 GMP 製造。

And I got to tell you, the public health authorities globally are aware of where it takes to take a vaccine to a market in the time frame they're talking about, and they're trying to be as helpful as they can.

我必須告訴你，全球公共衛生當局都知道在他們談論的時間範圍內將疫苗推向市場所需的時間，並且他們正在盡其所能提供幫助。

Thank you, Filip. And regarding RSV, we're in the process -- and good question. We're in the process of rationalizing our portfolio, our supply chain, our global footprint, et cetera, to better align that with the emerging opportunity. We see coming at a global level as these markets transition from APA to a commercial opportunity for the long run.

謝謝你，菲利普。關於 RSV，我們正在進行中——這是個好問題。我們正在合理化我們的產品組合、我們的供應鏈、我們的全球足蹟等，以更好地使其與新出現的機會保持一致。隨著這些市場從 APA 轉變為長期的商業機會，我們看到了全球層面的到來。

And as John Trizzino said, we see the market evolving eventually to over $15 billion global opportunity with about 2/3 of that opportunity in the U.S. and Europe. But in the short run, our goal is to deliver results in 2023 to focus our energy, our efforts, our resources and our investment on what matters most. And our top priority at Novavax is introducing a differentiated and competitive vaccine alternative for this fall season at a global level and in the U.S. market in alignment with what regulatory authorities are looking for.

正如 John Trizzino 所說，我們看到市場最終發展到超過 150 億美元的全球機會，其中約 2/3 的機會在美國和歐洲。但在短期內，我們的目標是在 2023 年取得成果，將我們的精力、努力、資源和投資集中在最重要的事情上。 Novavax 的首要任務是在全球和美國市場為這個秋季推出差異化和有競爭力的疫苗替代品，以符合監管機構的要求。

By channeling our resources on that priority as well as streamlining our business, we hope to have a very successful year in 2023. Filip, any additional color there?

通過將我們的資源用於該優先事項並精簡我們的業務，我們希望在 2023 年取得非常成功的一年。Filip，還有其他顏色嗎？

Yes. So we're aware of the competition in the RSV space. But there's no specific reason we can be competitive in that space as well. The construct we have now has been modified and improved as has the manufacturing process. Right now, we're just like John said, we're in the position of trying to decide which ones to push forward and make sure that the resources are available to cover the priorities before we go deeper into the pipeline.

是的。所以我們知道 RSV 領域的競爭。但我們也沒有特定的理由可以在該領域具有競爭力。我們現在的結構和製造過程都經過了修改和改進。現在，我們就像 John 所說的那樣，我們正處於努力決定推進哪些項目的位置，並確保在我們深入管道之前有可用的資源來涵蓋優先事項。

Thank you, Filip. And one other comment to add to that. One of the reasons I came to Novavax, and I'm so excited about being here is our portfolio of assets that we have and our differentiated technology. And as I said earlier in the call, Pillar 3, our top priorities, all 3 are equal in priority to us. And Pillar 3 was extracting value and leveraging that technology and that portfolio through business and corporate development opportunities, beginning in this year and in the future. And RSV could very well be part of that. So we look forward to sharing more updates with you in the future as that develops.

謝謝你，菲利普。還有一條要補充的評論。我來到 Novavax 的原因之一，我對來到這裡感到非常興奮，這是我們擁有的資產組合和差異化技術。正如我早些時候在電話會議中所說，支柱 3 是我們的首要任務，所有這三個支柱對我們來說都是同等優先的。從今年和未來開始，支柱 3 正在通過業務和企業發展機會提取價值並利用該技術和產品組合。 RSV 很可能成為其中的一部分。因此，我們期待在未來與您分享更多更新。

Our next question today comes from Georgi Yordanov with Cowen and Company.

我們今天的下一個問題來自 Cowen and Company 的 Georgi Yordanov。

John, congratulations on the new role. So maybe starting with you in general, you've talked about the opportunity to offer a differentiated product to the market. So maybe can you talk about what would be the key aspects of differentiation that you would like to market and communicate to consumers that being both the general population, but also prescribers? And then as part of that, also to talk to also like what is your ability to actually communicate and market these differentiating aspects given that we don't really have clear head-to-head studies? And then I have a couple of follow-ups.

約翰，祝賀你擔任新角色。因此，也許從一般情況下開始，您已經談到了向市場提供差異化產品的機會。那麼，也許您能談談您希望向既是普通人群又是開處方者的消費者推銷和傳達的差異化的關鍵方面是什麼？然後作為其中的一部分，考慮到我們沒有真正進行明確的頭對頭研究，您還可以談論您實際溝通和營銷這些差異化方面的能力是什麼？然後我有幾個後續行動。

John Trizzino, would you like to take that question?

John Trizzino，你願意回答這個問題嗎？

Yes, certainly. I think the differentiation takes many different kind of shapes and sizes. And so first of all, clearly, protein vaccine and the only other protein vaccine licensed in the U.S. is a key important differentiating characteristic of our vaccine, right? I think if you understand the comfort in dealing with the protein-based vaccine, the refrigerator stability of the vaccine, and I think the label right now, I think it puts us on a level playing field or will put us on a level playing field with mRNA vaccines are critical attributes today that make us competitive for the 2023 season.

是的，當然了。我認為差異化需要許多不同的形狀和大小。所以首先，很明顯，蛋白質疫苗和唯一在美國獲得許可的其他蛋白質疫苗是我們疫苗的一個關鍵的重要區別特徵，對吧？我想如果你了解處理基於蛋白質的疫苗的舒適性，疫苗的冰箱穩定性，我認為現在的標籤，我認為它讓我們處於一個公平的競爭環境或將使我們處於一個公平的競爭環境mRNA 疫苗是當今的關鍵屬性，使我們在 2023 賽季具有競爭力。

I think if you also consider the number of kind of market research studies that we've done up to this point, really clearly indicate that there's a need in the marketplace, not only with health care professionals, but also consumers who are looking for an option away from mRNA and looking to protein-based vaccines in order to provide that. I think as we go forward, there are a number of other studies that are underway, some of which Filip outlined that will look at some additional differentiating characteristics going into the future. So -- not only do we want to be competitive today, but we want to be clearly differentiated on a number of points going into the future.

我認為，如果您還考慮到我們到目前為止所做的各種市場調查研究的數量，那麼確實清楚地表明市場上存在需求，不僅是醫療保健專業人員，還有正在尋找選擇遠離 mRNA 並尋求基於蛋白質的疫苗以提供這種疫苗。我認為隨著我們的前進，還有許多其他研究正在進行中，Filip 概述了其中一些研究，這些研究將著眼於未來的一些額外的差異化特徵。所以 - 我們不僅希望今天具有競爭力，而且我們希望在未來的許多方面明顯不同。

Great. And then just a couple of follow-ups. The first one is specifically around what you mentioned in terms of the strategy of manufacturing multiple strain vaccine risk. Can you maybe talk about what would be the impact of that on your gross margins? And I guess, how suitable is this strategy in the longer term?

偉大的。然後只是一些後續行動。第一個是具體圍繞你提到的製造多株疫苗風險的策略。你能談談這對你的毛利率有什麼影響嗎？而且我想，從長遠來看，這種策略有多合適？

Filip, Rick, why don't you comment on how suitable that strategy is over the long term. And then we'll turn it over to Jim Kelly to comment on the cost.

Filip、Rick，你為什麼不評論一下這個策略從長遠來看有多合適。然後我們將把它交給 Jim Kelly 來評論成本。

This is Rick. As Filip has stated earlier, COVID is a very different animal than flu. And so the evolution of the strain changes is more rapid. I think the only way any vaccine manufacturer can keep up with that is to manufacture variants of interest at risk and have a stockpile. So I think we're no different than any of the mRNAs in that respect.

這是瑞克。正如 Filip 之前所說，COVID 是一種與流感截然不同的動物。因此，應變變化的演變更加迅速。我認為任何疫苗製造商都能跟上的唯一方法是製造有風險的利益變體並有儲備。所以我認為在這方面我們與任何 mRNA 沒有什麼不同。

And that's certainly a sustainable strategy, Rick, with our global supply chain that we've built over the last several years here at Novavax.

這當然是一個可持續的戰略，里克，我們的全球供應鍊是我們過去幾年在 Novavax 建立的。

That's correct.

這是正確的。

Jim, did you want to comment on the impact to the P&L there?

吉姆，你想評論對損益表的影響嗎？

Yes, sure. So that's a great question. When you think about the amount we'd be manufacturing at risk to enable this strain change strategy, it's not the full season is worth just an initial start that keeps us on track for the fall. And so in that way, I don't view it as being a meaningful impact on our long-term cost structure.

是的，當然。所以這是一個很好的問題。當您考慮我們為實現這種應變變化策略而面臨的生產風險時，整個季節都不值得僅僅作為一個讓我們在秋季步入正軌的初步開始。因此，我認為這不會對我們的長期成本結構產生有意義的影響。

Great. And then the final question is just on the COVID flu combination study. Clearly, your mRNA competitors recognize that as a major upside to the [ventral] COVID market. So maybe can you clarify specifically the regulatory path that you see ahead of that? The cities that you're running are specifically in adult -- sorry, in elderly patients and so do you expect that, that combination product would only be used in elderly patients? Like what is the path to actually getting that product on the market?

偉大的。最後一個問題是關於 COVID 流感聯合研究。顯然，您的 mRNA 競爭對手認識到這是 [腹側] COVID 市場的主要優勢。那麼，也許您能否具體說明您在此之前看到的監管路徑？你經營的城市專門針對成人——抱歉，針對老年患者，所以你認為這種組合產品只會用於老年患者嗎？比如實際將該產品推向市場的途徑是什麼？

Yes. And first, let me just make a comment here that we're excited in anticipation of those results midyear this year. The team has been working very hard on that. We're looking forward to getting those results. And those results will help inform our strategy moving forward on how we bring the product to the next stage of development.

是的。首先，讓我在這裡發表評論，我們對今年年中的這些結果感到興奮。團隊一直在努力工作。我們期待著得到這些結果。這些結果將有助於告知我們如何將產品帶入下一開發階段的戰略。

But why don't I turn it over to Filip to address that in more detail. Filip?

但為什麼我不把它轉交給 Filip 來更詳細地解決這個問題。菲利普？

Yes. I mean, you're right. The studies are being done in older adults, and that's actually where we see the maximum value for this product. That's the place where differentiated products are being used globally, and that's where we want to play, compete and win. The studies are designed to choose the optimal dose for both the COVID combo product as well as the flu product.

是的。我的意思是，你是對的。這些研究是在老年人中進行的，這實際上是我們看到該產品最大價值的地方。這是差異化產品在全球範圍內使用的地方，也是我們想要發揮、競爭和獲勝的地方。這些研究旨在為 COVID 組合產品和流感產品選擇最佳劑量。

I remember from our previous work that we've demonstrated that we're able to induce a very long-lived T-cell response with our adjuvant. And we're even trying to see if we can get a bit more juice out of going to higher doses of matrix in these studies. That, along with what we're going to see from the (inaudible) response is going to give us some assurance whether we have a product that can really compete in that high cost space.

我記得從我們之前的工作中我們已經證明我們能夠用我們的佐劑誘導非常長壽的 T 細胞反應。我們甚至試圖看看在這些研究中我們是否可以從更高劑量的基質中獲得更多的果汁。那，連同我們將從（聽不清）響應中看到的內容，將給我們一些保證，我們是否擁有能夠真正在高成本領域競爭的產品。

Yes. Let me just add additional comment there, if I may. Let's be clear here. And as we've seen from some of the data that's already come out from Moderna that they're coming up with a very effective influenza vaccine is no small task. And recall that we already have some experience with our flu candidate in a very successful Phase III clinical trial.

是的。如果可以的話，讓我在那裡添加額外的評論。讓我們在這裡說清楚。正如我們從 Moderna 已經發布的一些數據中看到的那樣，他們想出一種非常有效的流感疫苗並非易事。回想一下，我們已經在一項非常成功的 III 期臨床試驗中對我們的流感候選藥物有了一些經驗。

So you're taking an already demonstrated successful flu vaccine candidate and combining it with our already demonstrated successful COVID candidate on a common technology platform or recombinant protein nanoparticle plus the adjuvant. So I think you got a combination here that has the potential to be very strong. We have a little bit to learn, a lot to learn here about how they interact with one another. But we do know that we've got 2 strong components that we're taking forward.

因此，您正在採用一種已經證明成功的候選流感疫苗，並將其與我們已經證明成功的 COVID 候選疫苗在通用技術平台或重組蛋白納米顆粒加佐劑上結合起來。所以我認為你在這裡得到了一個有潛力非常強大的組合。關於它們如何相互作用，我們有一點點要學，還有很多要學。但我們確實知道我們有兩個強大的組件正在推進。

Let me just pile on because why not. So the other point is, remember, we've already done the combination study with our previous Phase I, Phase II. And there, we were successfully able to innovate our way around the logic interference that was seen just by adjusting dosage levels. We dropped the hemagglutinin and we jacked up the spike, and we were able to recapitulate the immune responses we want it. So this is really to fine-tune those and to start building initial safety databases as we move forward with the product, if the data says we need to do that.

讓我繼續說下去，因為為什麼不呢。所以另一點是，請記住，我們已經完成了與我們之前的第一階段、第二階段的聯合研究。在那裡，我們成功地以創新的方式解決了僅通過調整劑量水平就可以看到的邏輯干擾。我們放下血凝素，然後頂起尖峰，我們能夠重現我們想要的免疫反應。因此，這實際上是為了微調這些並在我們推進產品時開始建立初始安全數據庫，如果數據表明我們需要這樣做的話。

So we see this as a key potential value driver for the organization by midyear. We look forward to sharing results with you when we get them.

因此，我們認為這是到年中組織的關鍵潛在價值驅動因素。我們期待在獲得結果時與您分享結果。

And our next question today comes from Eric Joseph with JPMorgan.

我們今天的下一個問題來自摩根大通的埃里克約瑟夫。

Just wanted to get a sense of where you might see operating efficiencies on the R&D side? You noted the health of the RSV program but are you -- I'm wondering if you're appropriately sized on the manufacturing side of things? It sounds like there's support for Novavax CZ going forward? I guess, how should we be thinking about where products -- being sourced over the long term and, in particular, the relationship with the Serum Institute? And then as a couple of follow-ups.

只是想了解一下您可能會在研發方面的哪些方面看到運營效率？您注意到 RSV 計劃的健康狀況，但您是否——我想知道您在製造方面的規模是否合適？聽起來好像有對 Novavax CZ 的支持？我想，我們應該如何考慮產品的來源——從長遠來看，尤其是與血清研究所的關係？然後作為幾個後續行動。

Secondly, I would like to get a sense of whether there is a sunset period for the $2.1 billion remaining in APAs, whether they're is potential for them to stay in place beyond the 2024 horizon? And then finally, I also just wanted to get clear on John T.'s role within the executive leadership team with Elaine coming in as Chief Strategy Officer?

其次，我想了解 APA 中剩餘的 21 億美元是否有日落期，它們是否有可能在 2024 年之後繼續存在？最後，我還想弄清楚 John T. 在執行領導團隊中的角色，Elaine 將擔任首席戰略官？

Let me address -- you have a lot of smiles in the room here. Thank you for your question. I'll address John T. first as he sits right across from me. John Trizzino is an outstanding Chief Commercial Officer and will remain so here in at Novavax by my side as the new CEO and with the executive team moving forward. Elaine's focus will be as a Chief Strategy Officer on Business and Corporate Development, which is a new role for the executive leadership team.

讓我來談談——你們在這裡的房間裡笑容滿面。謝謝你的問題。我會先向 John T. 講話，因為他就坐在我對面。約翰·特里齊諾 (John Trizzino) 是一位傑出的首席商務官，他將作為新任首席執行官繼續留在 Novavax，與我並肩作戰，並帶領執行團隊向前發展。 Elaine 的重點將是擔任業務和企業發展首席戰略官，這是執行領導團隊的新角色。

And it speaks to Pillar #3 that I spoke to about in my opening comments that we see an opportunity to begin to unlock more of the value from our extensive pipeline, our differentiated technology, and you alluded to already, our global footprint. We have a fully integrated infrastructure here from discovery through to manufacturing, through to full commercialization across several continents. And that in and of itself is a very important feature that Novavax has to offer potential partners. So Elaine will be leading those efforts for the organization to expand our efforts around business and corporate development. John will remain in his very important role as our Chief Commercial Officer and help lead the launch of our Nuvaxovid vaccine this fall. That's our intention.

它談到了我在開場白中談到的第三支柱，我們看到了一個機會，可以開始從我們廣泛的管道、我們的差異化技術中釋放更多的價值，你已經提到了我們的全球足跡。我們在這裡擁有從發現到製造，再到跨越幾大洲的完全商業化的完全集成的基礎設施。這本身就是 Novavax 必須為潛在合作夥伴提供的一個非常重要的功能。因此，Elaine 將領導組織的這些努力，以擴大我們圍繞業務和企業發展的努力。 John 將繼續擔任我們的首席商務官這一非常重要的角色，並幫助領導今年秋天推出我們的 Nuvaxovid 疫苗。這是我們的意圖。

When it comes to the supply chain, we're in the process of rationalizing our global supply chain as well as our portfolio and our global footprint as a company to make sure that it's aligned with the emerging opportunity we see now in the short run for COVID and also potential future opportunities as there are long lead times involved here, as you know as we expand our portfolio and continue to move those assets forward.

在供應鏈方面，我們正在合理化我們的全球供應鏈以及我們的產品組合和我們作為一家公司的全球足跡，以確保它與我們現在在短期內看到的新興機會保持一致COVID 以及潛在的未來機會，因為這裡涉及很長的交貨時間，正如您所知，我們正在擴大我們的產品組合併繼續推動這些資產向前發展。

And why don't I hand it over to John Trizzino for some additional context.

為什麼我不把它交給 John Trizzino 來了解一些額外的背景信息。

I think -- Yes, thanks, John. I think that regarding the $2.1 billion of remaining APA, it's important to understand that we're retaining the value of that through '23 and '24, as we mentioned during the script. Right now, we see a pathway towards satisfying those APAs during the course of '23 and '24 and don't see a sunsetting of any of the value of those contracts.

我認為-- 是的，謝謝，約翰。我認為，對於剩餘的 21 億美元 APA，重要的是要了解我們在 23 和 24 年保留了它的價值，正如我們在腳本中提到的那樣。現在，我們看到了在 23 年和 24 年期間滿足這些 APA 的途徑，並且沒有看到這些合同的任何價值下降。

And one last point, and I'll ask Rick Crowley, if he wants to comment as well on the CZ plant in Europe. That's an important asset for Novavax. And the company has built out that asset over the last few years as we got ready to take on the global pandemic, and we see it as a competitive advantage for us to have that level of quality and that manufacturing capacity in-house.

最後一點，我會問里克克勞利，他是否也想對歐洲的 CZ 工廠發表評論。這是 Novavax 的一項重要資產。在過去的幾年裡，隨著我們準備應對全球大流行病，公司已經建立了這項資產，我們認為擁有這種質量水平和內部製造能力對我們來說是一種競爭優勢。

Rick, did you want to comment any more on CZ?

Rick，你想對 CZ 發表更多評論嗎？

Yes. I was just going to say that we've utilized the CZ facility and staff there to become our global center of excellence for both manufacturing and quality. The -- additionally, it is our license holder for our EU license. So it's an important role in the facility.

是的。我只是想說，我們已經利用 CZ 設施和那裡的員工成為我們在製造和質量方面的全球卓越中心。 - 此外，它是我們的歐盟許可證的許可證持有者。所以它在設施中扮演著重要的角色。

Now you'd also asked about Serum. And by having Serum and CZ operating and approved, we're able to be very flexible in terms of how we manufacture our future variants because we're not dependent on just one facility. And so we can split our variant risks across both facilities and be able to supply the market appropriately at that point.

現在您還詢問了血清。通過讓 Serum 和 CZ 運營並獲得批准，我們能夠非常靈活地製造未來的變體，因為我們不僅僅依賴於一個設施。因此，我們可以將不同的風險分散到兩個設施中，並能夠在那時適當地供應市場。

And one final note is that we have gone through a serious analysis of our footprint and what it really needs to be to meet the demand as we currently see it. And that is -- has been executed and that resulted in CZ being as important as it is to us at this point.

最後要注意的是，我們已經對我們的足跡進行了認真的分析，以及滿足我們目前看到的需求真正需要的是什麼。那就是 - 已經執行，這導致 CZ 在這一點上對我們來說同樣重要。

And our next question comes from Mayank Mamtani with B. Riley Securities.

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

Welcome aboard to John and Elaine. I appreciate the helpful level of detail on many fronts, including having your 10-K also that just came out.

歡迎加入約翰和伊萊恩。我很欣賞在許多方面提供的有用的詳細信息，包括剛剛發布的 10-K。

So maybe just a quick big picture strategy question. Is there a particular scale, R&D, SG&A CapEx that you're working towards? And if there's like a medium to long-term time line you may have put out for that? And what could be the adjacent pipeline opportunities you could pursue? I know you talked about rationalization and discontinuation of RSV, but could you look to in-license something that you may see interesting out there? And then I have a couple of follow-ups.

所以也許只是一個快速的大局戰略問題。您是否正在努力達到特定的規模、研發、SG&A 資本支出？如果您可能為此制定了中長期時間表？您可以追求的相鄰管道機會是什麼？我知道您談到了 RSV 的合理化和停產，但您是否可以尋求一些您可能會感興趣的東西的許可？然後我有幾個後續行動。

Jim Kelly, would you like to take the first question?

吉姆·凱利，你願意回答第一個問題嗎？

Well, certainly. And thanks for the question. The assessment that you're hearing us discuss today really began over the past year with respect to our manufacturing network. We have scale that network down, especially the external participants that enabled us a great deal of flexibility to get to where we are today. And I think Rick highlighted the significance of, of course, our check plan with respect to not just [DS] production, but so much happening at that site. And then we'll also emphasize the importance of our Swedish site for matrix.

嗯，當然。謝謝你的提問。您今天聽到我們討論的評估實際上是在過去一年中針對我們的製造網絡開始的。我們縮小了該網絡的規模，尤其是外部參與者，這使我們能夠非常靈活地達到今天的水平。我認為 Rick 強調了我們的檢查計劃的重要性，當然，我們的檢查計劃不僅涉及 [DS] 生產，而且涉及該站點發生的許多事情。然後我們還將強調我們的瑞典站點對矩陣的重要性。

So of course, we'll move forward. And as a company, we'll continue to be thoughtful about how we scale to the opportunity. We're really looking forward to this fall season. I think that's going to give us a great opportunity to see how our vaccine competes globally, and we'll continue to update you from there.

所以當然，我們會繼續前進。作為一家公司，我們將繼續深思熟慮如何擴大規模以抓住機遇。我們真的很期待這個秋季。我認為這將為我們提供一個很好的機會來了解我們的疫苗如何在全球範圍內競爭，我們將繼續從那里為您更新。

And regarding your question on adjacencies and the pipeline, what I can say is that we intend to pursue a range of potential options from partnerships to co-promotion to out-licensing and even other opportunities that could be much larger in scale. Business development is complex and takes a lot of thought and care strategically for us to frame around these opportunities and bring them forward. So I won't speculate on timing or scale at the moment, but we'll say that we're -- we're opening the door for a much more opportunity to leverage the technology, the capabilities that we've got as a potential partner at a global level, our manufacturing scope and scale and the assets that we have in our pipeline to mine more value from those things over time and grow the potential of Novavax to become a leading vaccine company on the global stage.

關於你關於鄰接和管道的問題，我可以說的是，我們打算尋求一系列潛在的選擇，從合作夥伴關係到共同推廣到對外許可，甚至其他規模可能更大的機會。業務發展是複雜的，需要我們在戰略上進行大量思考和關注，才能圍繞這些機會構建框架並推動它們向前發展。所以我現在不會推測時間或規模，但我們會說我們 - 我們正在為更多機會利用技術打開大門，我們作為一個全球範圍內的潛在合作夥伴、我們的製造範圍和規模以及我們在管道中擁有的資產，以便隨著時間的推移從這些東西中挖掘更多價值，並提高 Novavax 成為全球舞台上領先的疫苗公司的潛力。

Got it. And just a quick follow-up on the regulatory and commercialization discussion on the strain change vaccine. How important is securing the full BLA to your partners, private or public? Just maybe clarify what steps remain there? And a related question that often comes up, why not pursue NanoFlu monotherapy, where you did have both influenza A and B strain specific potency? Could you just sort of clarify that?

知道了。只是快速跟進關於變株疫苗的監管和商業化討論。確保完整的 BLA 對您的私人或公共合作夥伴有多重要？也許只是澄清還剩下哪些步驟？還有一個經常出現的相關問題，為什麼不採用 NanoFlu 單一療法，因為您確實具有 A 型和 B 型流感病毒株的特異性效力？你能澄清一下嗎？

John Trizzino, would you like to take the first question?

John Trizzino，你願意回答第一個問題嗎？

The BLA first and then hand it back over to Filip. I think it's worth clarifying that the U.S., in particular, the U.S. government's action to suspend the public health emergency will not affect our ability to sell under emergency use authorization during the 2023 season. Of course, we'll be filing our BLA in the second half of the year. And of course, we'll have -- see expectations of BLA approval probably by late this year or early next year. But there's no -- in conversations with FDA, there's no concern at this point relative to operating under an emergency use authorization.

首先是 BLA，然後將其交還給 Filip。我認為值得澄清的是，美國，特別是美國政府暫停公共衛生緊急事件的行動，不會影響我們在 2023 賽季的緊急使用授權下銷售的能力。當然，我們將在今年下半年提交 BLA。當然，我們可能會在今年年底或明年初看到 BLA 批准的預期。但是沒有 - 在與 FDA 的對話中，目前沒有關於在緊急使用授權下操作的擔憂。

And let me try to unwind the influenza stand-alone. So first of all, the study we're doing now does, in fact, include stand-alone influenza. And a couple of things to remember about the study that you referenced previously. One of them is that to compete in the elderly market with a differentiated product. We really need clinical data, that would be difficult to do without it. And the other thing is we've learned up a lot about manufacturing COVID vaccine over the past couple of years and those learnings were brought into the flu stand-alone product. And that means we have a much more efficient process going forward. So in a sense, we were a black shoe of the Phase II study, which we're doing now and it opens the doors to pursue either the stand-alone (inaudible) flu or the combination.

讓我嘗試單獨解除流感。因此，首先，我們現在正在進行的研究實際上包括了獨立的流感。關於您之前提到的研究，有幾點需要記住。其中之一就是以差異化產品競爭老年市場。我們真的需要臨床數據，沒有它就很難做到。另一件事是，我們在過去幾年中學到了很多關於製造 COVID 疫苗的知識，這些知識被帶入了流感獨立產品中。這意味著我們有一個更有效的流程向前推進。因此，從某種意義上說，我們是 II 期研究的黑鞋，我們現在正在進行這項研究，它為研究獨立（聽不清）流感或聯合研究打開了大門。

Got it. And final question. In your 10-K, there is some level of detail on your Gavi arbitration. It looks like a response might be due next week, as early as next week. Could you maybe just touch on that -- what your argument sort of seems like? And just broadly, any comments on the deferred revenue of I think, $700 million? Or how should we think about that going forward?

知道了。最後一個問題。在您的 10-K 中，有一些關於您的 Gavi 仲裁的詳細信息。看起來可能會在下週做出回應，最早是在下週。你能不能談談這個——你的論點是什麼樣的？總的來說，對我認為的 7 億美元遞延收入有何評論？或者我們應該如何考慮未來的發展？

Thank you for your question. Yes, in late January, we did receive a request for arbitration from Gavi and while Novavax stands by its prior statements regarding that matter, we don't comment any further on legal matters and arbitration is inherently uncertain. So it is possible that we could be required to refund all or a portion of those advanced payments.

謝謝你的問題。是的，在 1 月下旬，我們確實收到了 Gavi 的仲裁請求，雖然 Novavax 堅持其之前關於此事的聲明，但我們不會就法律問題發表任何進一步評論，仲裁本質上是不確定的。因此，我們可能需要退還全部或部分預付款。

Look, we share Gavi's goal of improving global health via providing vaccines to consumers in low-income countries. And we intend to work to economical resolution for both parties, and we'll keep you posted as the situation unfolds appropriately.

看，我們與 Gavi 的目標一致，即通過向低收入國家的消費者提供疫苗來改善全球健康。我們打算努力為雙方找到經濟的解決方案，我們會在情況適當發展時及時通知您。

And if I could, one, you brought up the point of where exactly would this fall on our balance sheet. What you'll notice in our 10-K is that $700 million has shifted from deferred revenue to other current liabilities. And it just captures the inherent uncertainty associated with that arbitration.

如果可以的話，你提到了這究竟會落在我們資產負債表上的哪個位置。您會在我們的 10-K 中註意到，7 億美元已從遞延收入轉移到其他流動負債。它只是捕捉了與該仲裁相關的固有不確定性。

Thank you. And ladies and gentlemen, this concludes our question-and-answer session. I'd like to turn the conference back over to John for closing remarks.

謝謝。女士們，先生們，我們的問答環節到此結束。我想將會議轉回給 John 作閉幕詞。

I want to thank everyone for joining us today. Really appreciate your time and your energy, and we look forward to providing additional updates as the year pursues. Thank you.

我要感謝大家今天加入我們。非常感謝您的時間和精力，我們期待在新的一年中提供更多更新。謝謝。

Thank you. The conference call has now concluded. You may disconnect your lines at this time, and have a wonderful day.

謝謝。電話會議現已結束。此時您可以斷開線路，度過美好的一天。