SIGA Technologies Inc (SIGA) 2023 Q3 法說會逐字稿

Welcome to the SIGA business update call. Before we turn the call over to SIGA management, please note that any forward-looking statements made during this call are based on management's current expectations and observations and are subject to risks and uncertainties that could cause actual results to differ from the forward-looking statements. SIGA does not undertake any obligation to update publicly any forward-looking statements to reflect events or change circumstances after this call.

歡迎致電SIGA業務更新。在我們將電話轉交給SIGA 管理層之前，請注意，本次電話會議期間做出的任何前瞻性陳述均基於管理層當前的預期和觀察，並受到可能導致實際結果與前瞻性陳述不同的風險和不確定性的影響。 SIGA 不承擔公開更新任何前瞻性聲明以反映本次電話會議後發生的事件或情況變化的義務。

For a discussion of factors that could cause results to differ, please see the company's filings with the Securities and Exchange Commission, including, without limitation, the company's annual report on Form 10-K for the year ended December 31, 2022, and its subsequent reports on Form 10-Q and Form 8-K.

有關可能導致結果不同的因素的討論，請參閱該公司向美國證券交易委員會提交的文件，包括但不限於該公司截至 2022 年 12 月 31 日的 10-K 表格年度報告及其後續報告報告表格10 -Q 和表格8-K。

I would now like to turn the conference over to Phil Gomez, Chief Executive Officer. Thank you. Please go ahead.

我現在想將會議交給執行長菲爾戈麥斯 (Phil Gomez)。謝謝。請繼續。

Thank you for taking the time to join today's call. Today, I'm joined by Dennis Hruby, our Chief Scientific Officer; Jay Varma, our Chief Medical Officer; and Dan Luckshire, our CFO.

感謝您抽空參加今天的電話會議。今天，我們的首席科學官 Dennis Hruby 也加入了我的行列。 Jay Varma，我們的首席醫療官；和我們的財務長 Dan Lucshire。

We are pleased to have this opportunity to provide an update to our shareholders. We'll then be happy to take questions. I'd like to start this call by highlighting key financial targets for 2023. We expect orders for oral and IV TPOXX to be approximately $164 million in 2023, with a substantial percentage of those orders to be delivered in 2023.

我們很高興有機會向股東提供最新情況。然後我們將很樂意回答問題。我想在這次電話會議開始時強調 2023 年的主要財務目標。我們預計 2023 年口服和 IV TPOXX 的訂單約為 1.64 億美元，其中很大一部分訂單將在 2023 年交付。

As such, as previously disclosed, we are targeting 2023 pretax operating income of between $90 million and $100 million based on the timing of deliveries that are currently being coordinated among the company, our supply chain and our government customers. Target pretax operating income for 2023 is based on the following target revenues. Approximately $113 million of revenues from fourth quarter deliveries of oral TPOXX to the U.S. Strategic National Stockpile, approximately $5 million of revenue from fourth quarter deliveries of oral TPOXX to the U.S. Department of Defense, $15 million to $18 million of revenue from fourth quarter international deliveries of oral TPOXX to the 2 European countries in connection with the recently announced HERA joint-procurement framework contract, and up to $50 million of revenue from fourth quarter deliveries of IV TPOXX to the U.S. Strategic National Stockpile.

因此，正如先前所揭露的那樣，根據公司、供應鏈和政府客戶目前正在協調的交付時間，我們的目標是 2023 年稅前營業收入在 9,000 萬至 1 億美元之間。 2023 年目標稅前營業收入是根據以下目標收入。第四季向美國戰略國家儲備交付口服TPOXX 帶來約1.13 億美元收入，第四季向美國國防部交付口服TPOXX 帶來約500 萬美元收入，第四季國際交付帶來約1500 萬至1800 萬美元收入根據最近宣布的 HERA 聯合採購框架合同，向兩個歐洲國家提供口服 TPOXX，並從第四季度向美國國家戰略儲備交付 IV TPOXX 獲得高達 5000 萬美元的收入。

To the degree that any target deliveries and related target revenues and pretax operating income do not occur in the fourth quarter of this year due to any timing constraints in connection with our customers or our packaging vendor, we expect that such deliveries and revenue would occur in January of 2024.

由於與我們的客戶或包裝供應商有關的任何時間限制，任何目標交付和相關目標收入和稅前營業收入不會在今年第四季度實現，我們預計此類交付和收入將在2024 年 1 月。

In particular, one thing that could impact the timing of deliveries between fourth quarter 2023 and January 2024 is the packaging of final drug product. This step of the process has been taking longer this year than in prior years and longer than expected so far this year. Needless to say, we have been in daily contact with our packaging vendor, and we continue to work together on getting packaging done as soon as possible and with an eye toward making the remaining target deliveries in 2023. Beyond 2023, we will continue to execute on our strategic plan to maximize growth opportunities.

特別是，可能影響 2023 年第四季至 2024 年 1 月期間交付時間的一件事是最終藥品的包裝。今年這一過程的這一步花費的時間比往年更長，也比今年迄今的預期更長。不用說，我們一直與包裝供應商保持日常聯繫，我們將繼續共同努力盡快完成包裝，並著眼於在 2023 年完成剩餘的目標交付。20​​23 年之後，我們將繼續執行我們的戰略計劃，以最大限度地提高成長機會。

I will now ask Dennis to provide an update on the PEP and mpox programs for oral TPOXX. Dennis?

我現在請丹尼斯提供有關口服 TPOXX 的 PEP 和 mpox 計劃的最新資訊。丹尼斯？

Thanks, Phil. I'd like to provide a summary of the strategy for PEP as we received some questions on this topic after the last investor call.

謝謝，菲爾。我想提供 PEP 策略的摘要，因為我們在上次投資者電話會議後收到了一些有關此主題的問題。

Based on the studies and trials that have been conducted, we believe TPOXX will work for PEP. The FDA has not asked for any additional studies to prove the efficacy of TPOXX for PEP. They have asked for extended safety data in humans for treatment for 28 days, which we completed. In a smallpox outbreak, TPOXX would likely be used in combination with a smallpox vaccine. So the Jynneos plus TPOXX study we will discuss is designed to solely evaluate if TPOXX interferes with the generation of an immune response to the vaccine.

根據已進行的研究和試驗，我們相信 TPOXX 將適用於 PEP。 FDA 並沒有要求任何額外的研究來證明 TPOXX 對 PEP 的功效。他們要求提供為期 28 天的人體治療的擴展安全性數據，我們已完成該數據。在天花爆發時，TPOXX 可能會與天花疫苗結合使用。因此，我們將討論的 Jynneos 加 TPOXX 研究旨在僅評估 TPOXX 是否幹擾疫苗免疫反應的產生。

Let me now provide a quick recap of what was noted in the last investor call. Earlier this year, the company met enrollment targets for both the immunogenicity trial and the expanded safety trial. For the expanded safety trial, as expected, the clinical trial result did not show any drug-related serious adverse events.

現在讓我快速回顧一下上次投資者電話會議中提到的內容。今年早些時候，該公司實現了免疫原性試驗和擴大安全性試驗的招募目標。對於擴大的安全性試驗，正如預期的那樣，臨床試驗結果沒有顯示任何與藥物相關的嚴重不良事件。

For the Jynneos plus TPOXX immunogenicity trial as a quick reminder, the goal of this trial was to show that TPOXX did not reduce the immune response to the vaccine. This is supplemental and separate to our current approval for the treatment of smallpox. In the preliminary analysis of the trial data performed by our CRO, the results did not show a meaningful difference between the immunogenicity of those that received Jynneos vaccine while on placebo, compared with those that received Jynneos vaccine while in TPOXX, which is consistent with what we expected.

作為一個快速提醒，Jynneos 加 TPOXX 免疫原性試驗的目的是證明 TPOXX 不會降低對疫苗的免疫反應。這是對我們目前批准的天花治療的補充和獨立。在我們的 CRO 對試驗數據進行的初步分析中，結果並未顯示在安慰劑期間接受 Jynneos 疫苗的患者與在 TPOXX 期間接受 Jynneos 疫苗的患者之間的免疫原性沒有顯著差異，這與我們預計。

However, as noted on the last investor call, the CRO results indicated that a number of volunteers that had measurable immune response to the Jynneos vaccine in both placebo and TPOXX groups was lower than expected. Given this result, one, will prevent noninferior statistical determination from being the primary endpoint as originally planned. Two is unexpected. And three, it's scientifically odd. We've been investigating the CRO results over the past series of months. Since the last investor call, in addition to conducting many other investigations, we sent a subset of the Jynneos plus TPOXX samples for our colleagues at CDC. We performed their validated [TRMT] analysis on them. These samples show the expected immune responses.

然而，正如上次投資者電話會議所指出的那樣，CRO 結果表明，在安慰劑組和 TPOXX 組中，許多志願者對 Jynneos 疫苗產生了可測量的免疫反應，但低於預期。鑑於此結果，一將阻止非劣統計確定成為最初計劃的主要終點。二是意想不到。第三，這在科學上很奇怪。過去幾個月我們一直在調查 CRO 結果。自上次投資者電話會議以來，除了進行許多其他調查之外，我們還向 CDC 的同事發送了 Jynneos 和 TPOXX 樣本的子集。我們對它們進行了經過驗證的 [TRMT] 分析。這些樣本顯示了預期的免疫反應。

As such, we're now working on getting the entire said samples reanalyzed and in parallel, working toward a supplemental NDA submission in 2024. We are grateful to our colleagues at CDC for this collaboration and are pleased to have identified a path forward.

因此，我們現在正在努力重新分析整個上述樣本，並同時努力在 2024 年提交補充 NDA。我們感謝 CDC 的同事進行的此次合作，並很高興找到了前進的道路。

In terms of getting the maximum and most timely benefit from the immunogenicity trial in the context of stockpile expansion conversations with the government, we believe the stuff taken over the past series of months is worth the extra time and effort to ensure the highest quality data. To be clear, we're working on finalizing the immune response levels of volunteers in the vaccine, the analyses are not about the efficacy or safety of TPOXX nor are they about TPOXX's impact on those individuals who are showing an immune response.

在與政府進行庫存擴展對話的背景下，為了從免疫原性試驗中獲得最大和最及時的利益，我們相信過去幾個月採取的材料值得付出額外的時間和精力，以確保最高品質的數據。需要明確的是，我們正在努力最終確定疫苗中志願者的免疫反應水平，這些分析不是關於 TPOXX 的功效或安全性，也不是關於 TPOXX 對那些表現出免疫反應的個體的影響。

To reiterate contextual comments made on the prior investor call, we believe that in regard to the PEP program, the totality of the studies and trials that have been conducted, including the immunogenicity trial as well as previous animal challenge experiments and clinical trials are supportive of the use of TPOXX for PEP, pending discussions and review with the FDA. In the case of an orthopoxvirus epidemic, be it mpox or smallpox, the use of TPOXX for PEP will be important to reduce the morbidity and mortality in the population.

重申先前投資者電話會議的背景評論，我們認為，就 PEP 計劃而言，已進行的所有研究和試驗，包括免疫原性試驗以及之前的動物挑戰實驗和臨床試驗，都支持使用TPOXX 進行PEP，正在與FDA 進行討論和審查。在正痘病毒流行的情況下，無論是mpox還是天花，使用TPOXX進行PEP對於降低人群的發病率和死亡率非常重要。

Shifting gears, let me also provide an update on the current mpox trials involving TPOXX, which include 5 randomized controlled trials as well as multiple observational studies. As a general comment, these studies continue to enroll patients and collect data. To provide a couple of specific data points, in Africa, as of October 19, the NIAID PALM trial being conducted in the DRC, enrolled 314 patients, a big jump from the 188 patients noted in the last investor call.

換個主題，我還提供一下目前涉及 TPOXX 的 mpox 試驗的最新情況，其中包括 5 項隨機對照試驗以及多項觀察性研究。總而言之，這些研究繼續招募患者並收集數據。提供幾個具體數據點，截至 10 月 19 日，在非洲剛果民主共和國進行的 NIAID PALM 試驗招募了 314 名患者，比上次投資者電話會議中提到的 188 名患者大幅增加。

In the NIAID STOMP trial as of October 31, there were 169 patients. The increase in patient numbers in the aforementioned trials highlights that case counts continue to accumulate, especially in Africa. Importantly, it also provides a glimpse to the overall global health risk posed by orthopoxviruses, Jay will provide further comments on mpox and orthopoxviruses.

截至 10 月 31 日，NIAID STOMP 試驗共有 169 名患者。上述試驗中患者人數的增加突顯了病例數持續積累，特別是在非洲。重要的是，它也讓我們了解了正痘病毒造成的整體全球健康風險，Jay 將提供 mpox 和正痘病毒的進一步評論。

Before I turn the call over to Jay, I'd like to provide a quick update on our pediatric program for TPOXX. Having completed a clinical trial that demonstrates equivalence of drug exposure in volunteers given the TPOXX oral capsules or the powder for reconstitution liquid formulation, we are commencing advanced development. We have chosen a scale-up manufacturer to prepare clinical supplies, and we're in the process of designing a clinical development program, which would support licensure. We consider this program to be an exciting path for potentially providing protection to the pediatric population.

在將電話轉給 Jay 之前，我想快速介紹一下我們的 TPOXX 兒科計畫的最新情況。我們已經完成了一項臨床試驗，證明服用 TPOXX 口服膠囊或重建液體製劑粉末的志願者的藥物暴露是等效的，我們正在開始高級開發。我們已經選擇了一家規模化製造商來準備臨床用品，我們正在設計臨床開發計劃，該計劃將支援許可。我們認為該計劃是一條令人興奮的途徑，有可能為兒科人群提供保護。

At this point, I'll turn the call over to Jay.

此時，我會將電話轉給 Jay。

Thanks, Dennis. As Phil and Dennis had mentioned on this call in prior calls, mpox preparedness and more broadly orthopoxvirus preparedness are essential from a public health perspective. As such, I am glad to have joined SIGA as an officer. As the Chief Medical Officer, I am responsible for leading medical affairs. This means that I am providing support for the overall goals of SIGA and in particular, and leading our efforts to build broader awareness of the risk and public health impact of smallpox, mpox and other orthopoxvirus outbreaks and to promote strategies in procurement and treatment that can support the highest levels of public and individual safety.

謝謝，丹尼斯。正如菲爾和丹尼斯在之前的電話會議中提到的那樣，從公共衛生的角度來看，MPOX 防範和更廣泛的正痘病毒防範至關重要。因此，我很高興能夠作為官員加入 SIGA。身為首席醫療官，我負責領導醫療事務。這意味著我正在為SIGA 的總體目標提供支持，特別是領導我們努力提高人們對天花、mpox 和其他正痘病毒爆發的風險和公共衛生影響的更廣泛認識，並促進採購和治療戰略，這些戰略可以支援最高水準的公共和個人安全。

I will represent SIGA in engagement with leaders from patient advocacy, medical organizations, professional societies, global and regional health agencies and other public health and defense organizations around the world. As background, one of the key reasons that I was highly interested in joining the SIGA team was that I believe my experience and skills are a good fit with SIGA.

我將代表 SIGA 與患者權益倡導者、醫療組織、專業協會、全球和區域衛生機構以及世界各地其他公共衛生和國防組織的領導人接觸。作為背景，我對加入 SIGA 團隊非常感興趣的關鍵原因之一是我相信我的經驗和技能非常適合 SIGA。

As a quick introduction, let me provide a brief summary of my professional background. I'm a physician and epidemiologist who has led epidemic responses, developed global and national policies and the large-scale programs that have saved hundreds of thousands of lives in China, Southeast Asia, Africa and the United States. From 2001 to 2021, I worked for the U.S. Centers for Disease Control and Prevention with postings in Atlanta, Thailand, China, Ethiopia and New York City. And from April 2020 to May 2021, I served as a principal scientific spokesperson and lead for New York City's COVID-19 response.

作為快速介紹，讓我簡單介紹一下我的專業背景。我是一名醫生和流行病學家，領導了流行病應對工作，制定了全球和國家政策以及大規模項目，挽救了中國​​、東南亞、非洲和美國數十萬人的生命。 2001 年至 2021 年，我在美國疾病管制與預防中心工作，曾在亞特蘭大、泰國、中國、衣索比亞和紐約市服務。從 2020 年 4 月到 2021 年 5 月，我擔任紐約市 COVID-19 應對工作的主要科學發言人和負責人。

Before I turn the call over to Dan, I would like to make some brief remarks in connection with the smallpox and mpox threat. The risk of these threats is growing with many public health officials arguing that we have entered a new age of pandemics with development, urbanization, migration and climate change, humans are interacting with animals in the environment in new ways, accelerating the risk of new diseases spilling over into humans. Humans are also increasingly conducting research on pathogen using novel techniques in biology. This increases the risk of the accidental spillover of a dangerous pathogen in a lab or more worrisome the deliberate release of a dangerous pathogen as an act of bioterrorism.

在將電話轉給 Dan 之前，我想就天花和 MPOX 威脅發表一些簡短的評論。這些威脅的風險正在增加，許多公共衛生官員認為，隨著發展、城市化、移民和氣候變化，我們已經進入了流行病的新時代，人類正在以新的方式與環境中的動物互動，從而加速了新疾病的風險溢出到人類身上。人類也越來越多地利用生物學新技術對病原體進行研究。這增加了實驗室中危險病原體意外溢出的風險，或更令人擔憂的是作為生物恐怖主義行為故意釋放危險病原體。

Specifically with respect to smallpox, this threat has increased, armed conflict around the world, particularly involving countries that are believed to have developed a biological weapon increases the likelihood that a rogue actor or nation could deliberately release the virus.

特別是在天花方面，這種威脅增加，世界各地的武裝衝突，特別是那些被認為已經開發出生物武器的國家，增加了流氓行為者或國家故意釋放病毒的可能性。

For mpox, while cases have declined globally since the 2022 pandemic, outbreaks continue to occur in East and Southeast Asia and Latin America, particularly concerning are the high and rising cases in the Democratic Republic of Congo, involving a subtype of the virus known as Clade I, that causes more severe illness and death than the subtype that circulated around the world during the recent pandemic.

對於MPOX，雖然自2022 年大流行以來全球病例數有所下降，但東亞、東南亞和拉丁美洲的疫情仍在繼續發生，特別令人擔憂的是剛果民主共和國的病例數居高不下且不斷上升，涉及一種被稱為Clade 的病毒亞型I，與最近大流行期間在世界各地傳播的亞型相比，它會導致更嚴重的疾病和死亡。

In the May 2023 issue of the Medical Journal of the Lancet, several prominent public health experts flagged their concern that this subtype is more similar to smallpox and that failure to stop transmission in Central Africa could lead to a far worse mpox pandemic than the 2022 one. In response, as detailed by Dennis, we are working closely with NIH and other health agencies on randomized clinical trials to demonstrate whether TPOXX is safe and effective for treating mpox in Africa, the U.S. and other parts of the world. And I'm working with the team to get the best possible results from a public health and company perspective.

在2023 年5 月號的《柳葉刀醫學雜誌》中，幾位著名的公共衛生專家表達了他們的擔憂，即這種亞型與天花更相似，如果未能阻止中部非洲的傳播，可能會導致比2022 年那場嚴重許多的麻疹大流行。作為回應，正如 Dennis 詳細介紹的那樣，我們正在與 NIH 和其他衛生機構密切合作進行隨機臨床試驗，以證明 TPOXX 在非洲、美國和世界其他地區治療 MPOX 是否安全有效。我正在與團隊合作，從公共衛生和公司的角度獲得盡可能好的結果。

At this point, I would like to turn the call over to Dan for our financial update.

現在，我想將電話轉給丹，以了解我們的財務最新情況。

Thanks, Jay. For the 3- and 9-months ended September 30, 2023, SIGA's revenue was approximately $9 million and $23 million, respectively. For the third quarter, approximately $8 million of revenue relates to international sales of oral TPOXX and approximately $1 million relates to research and development activity. In connection with the international sales of oral TPOXX, it included a sale to a first-time customer.

謝謝，傑伊。截至2023年9月30日的三個月和九個月，SIGA的營收分別約為900萬美元和2,300萬美元。第三季度，約 800 萬美元的收入與口服 TPOXX 的國際銷售有關，約 100 萬美元的收入與研發活動有關。與口服 TPOXX 的國際銷售有關，其中包括對首次客戶的銷售。

For the 9-months ended September 30, approximately $15 million of revenue relates to product sales and supportive activities and approximately $8 million of revenue relates to research and development activity. In connection with product sales, $5 million of the sales were to the U.S. Department of Defense and approximately $9 million of sales are international. Pretax operating loss, which excludes interest income and taxes, was approximately $1 million for the 3-months ended September 30, 2023.

截至 9 月 30 日的 9 個月中，約 1,500 萬美元的收入與產品銷售和支援活動有關，約 800 萬美元的收入與研發活動有關。在產品銷售方面，其中 500 萬美元的銷售額來自美國國防部，約 900 萬美元的銷售額來自國際。截至 2023 年 9 月 30 日的三個月，稅前營業虧損（不含利息收入和稅費）約為 100 萬美元。

For the 9-months ended September 30, pretax operating loss was approximately $8 million. Net loss for the 3-months ended September 30, 2023, was less than $1 million. For the 9-months ended September 30, net loss was approximately $4 million. In time, fully diluted loss per share for the 3-months ended September 30 was $0.01 per share, and for the 9-months ended September 30, fully diluted loss per share was $0.06.

截至 9 月 30 日的 9 個月，稅前營運虧損約為 800 萬美元。截至 2023 年 9 月 30 日的三個月淨虧損不到 100 萬美元。截至 9 月 30 日的 9 個月，淨虧損約為 400 萬美元。截至 9 月 30 日的 3 個月，完全攤薄每股虧損為每股 0.01 美元；截至 9 月 30 日的 9 個月，每股完全攤薄虧損為 0.06 美元。

At September 30, 2023, the cash balance for the company was approximately $71 million. For the first 9-months of the year, SIGA spent approximately $43 million on capital management with a special cash dividend of approximately $32 million and share repurchases of approximately $11 million.

截至2023年9月30日，公司現金餘額約7,100萬美元。今年前 9 個月，SIGA 在資本管理上花費了約 4,300 萬美元，其中特別現金股利約 3,200 萬美元，股票回購約 1,100 萬美元。

As noted by Phil earlier in the call, we are targeting 2023 pretax operating income of between $90 million and $100 million based on the timing of deliveries that are currently being coordinated among the company, our supply chain and our government customers. Target pretax operating income for 2023 is based on the following target revenues. Approximately $113 million of revenues from fourth quarter deliveries of oral TPOXX, two, the U.S. Strategic National Stockpile, approximately $5 million of revenues for fourth quarter deliveries of oral TPOXX to the U.S. Department of Defense, $15 million to $18 million of revenues from fourth quarter international deliveries of oral TPOXX, 2 European countries in connection with the recently announced HERA joint-procurement framework contract and up to $15 million of revenues from fourth quarter deliveries of IV TPOXX to the U.S. Strategic National Stockpile.

正如菲爾早些時候在電話會議中指出的那樣，根據公司、供應鏈和政府客戶目前正在協調的交付時間，我們的目標是 2023 年稅前營業收入在 9,000 萬至 1 億美元之間。 2023 年目標稅前營業收入是根據以下目標收入。第四季口服TPOXX 交付帶來的收入約為1.13 億美元，兩個美國戰略國家儲備，第四季向美國國防部交付口服TPOXX 帶來的收入約為500 萬美元，第四季帶來的收入為1500 萬至1800 萬美元口服 TPOXX 的國際交付、與最近宣布的 HERA 聯合採購框架合約有關的 2 個歐洲國家以及第四季度向美國戰略國家庫存交付 IV TPOXX 帶來的高達 1500 萬美元的收入。

To the degree that any target deliveries and related target revenues and pretax operating income did not occur in the fourth quarter of this year due to any timing constraints in connection with our customers or our packaging vendor, we expect that such deliveries and revenues would occur in January of 2024. This concludes the financial update.

由於與我們的客戶或包裝供應商有關的任何時間限制，今年第四季度沒有實現任何目標交付和相關目標收入和稅前營業收入，我們預計此類交付和收入將在2024 年1 月。財務更新到此結束。

At this point, I'll turn the call back to Phil.

此時，我會將電話轉回給菲爾。

Thanks, Dan. Before we open the call for Q&A, I'd like to make a few concluding remarks.

謝謝，丹。在我們開始問答之前，我想做一些總結性發言。

First, mpox continues to be a worrisome disease with significant impact and potential to grow. As Dennis and Jay have highlighted, we continue to see cases though the global outbreak has receded. Second, our ongoing international sales growth initiative is progressing in a value-creating manner as evidenced by the recently announced pan-European joint procurement contract. We have a solid base of international customers through which we continue to pursue additional customers as well as follow-on orders.

首先，MPOX 仍然是一種令人擔憂的疾病，具有重大影響和成長潛力。正如丹尼斯和傑伊所強調的那樣，儘管全球疫情已經消退，但我們仍然看到病例。其次，我們正在進行的國際銷售成長計​​畫正在以創造價值的方式取得進展，最近宣布的泛歐洲聯合採購合約就證明了這一點。我們擁有堅實的國際客戶基礎，透過這些客戶我們可以繼續爭取更多客戶以及後續訂單。

Third, the PEP-based development program continues to represent a growth initiative and that it may provide scientific and regulatory support for any stockpile expansion. The team is working hard to complete the follow-on immunogenicity testing and file for FDA approval of PEP.

第三，基於 PEP 的發展計畫繼續代表著一項成長舉措，並且它可以為任何庫存擴張提供科學和監管支持。團隊正在努力完成後續免疫原性測試，並向 FDA 提交 PEP 批准申請。

Fourth, we continue to be focused on transitioning our U.S. government contract to a long-term SNS contract that focuses on appropriate size requirements for the TPOXX stockpile as well as smoothing the annual deliveries, which would be critical to supply chain planning and provide a higher degree of financial predictability.

第四，我們繼續致力於將我們的美國政府合約轉變為長期SNS 合同，該合約側重於TPOXX 庫存的適當規模要求以及平穩年度交付，這對於供應鏈規劃至關重要，並提供更高的供應鏈效率。財務可預測程度。

This concludes our prepared remarks, and we will now begin the Q&A session.

我們準備好的演講到此結束，現在我們將開始問答環節。

(Operator Instructions) And your first question comes from the line of Pooya Hemami from Edison Group.

（操作員說明）您的第一個問題來自愛迪生集團的 Pooya Hemami。

I have a question on the HERA aspect. You expect about $18 million worth of orders over the next 2 months. Given that there are several other EU nations under the guidance of HERA, do you except -- or do we expect to receive incremental countries or other countries that are not part of those 13 right now?

我有一個關於 HERA 方面的問題。您預計未來 2 個月的訂單價值約為 1800 萬美元。鑑於還有其他幾個歐盟國家在 HERA 的指導下，您是否排除——或者我們是否期望接收更多國家或目前不屬於這 13 個國家的其他國家？

We certainly do. This essentially provides a contract vehicle with price that's been negotiated for all EU countries, and this represents the first order. There is pricing that is based on volume, so there's an incentive to pool orders before they go forward. But the vehicle has the concept of quarterly review with customers and the ability to put in orders on a quarterly basis. I think that will be based on how many come in and the volume to make sure they feel they're getting the right volume discounts that they want to get.

我們當然這樣做。這實質上提供了一種合約工具，其價格已與所有歐盟國家協商一致，這代表了第一個訂單。定價是基於數量的，因此有動力在下訂單之前集中訂單。但該車輛具有與客戶進行季度審查的概念以及按季度下訂單的能力。我認為這將取決於進來的數量和數量，以確保他們覺得自己獲得了他們想要的正確的批量折扣。

But in essence, this is broadly a hunting license as well because now we can go to countries that haven't purchased and say there's a vehicle to do this. The terms have been negotiated, the price has been negotiated, so we do feel like this is a nice step. It is, I would say, our understanding is it's the first vehicle that has been ever put in place in Europe for chemical biological products like this. So we're excited that we've opened up this vehicle, and we look forward to talking now to customers directly about follow-on orders. So thank you for the question.

但從本質上講，這基本上也是一種狩獵許可證，因為現在我們可以去尚未購買的國家並說有一種工具可以做到這一點。條款已經談妥，價格已經談妥，所以我們確實覺得這是一個很好的步驟。我想說，我們的理解是，這是歐洲為此類化學生物產品投入使用的第一個工具。因此，我們很高興我們已經開放了這輛車，我們期待現在直接與客戶討論後續訂單。謝謝你的提問。

As a follow-up to that, and try on your last remarks, do you envision that this arrangement with HERA will develop into something similar into what you have with BARDA which covers a certain percentage of the U.S. population in theory, what kind of upsell venture do you foresee here?

作為後續行動，並嘗試一下你最後的評論，你是否設想與 HERA 的這種安排會發展成類似於你與 BARDA 的安排，理論上覆蓋了一定比例的美國人口，什麼樣的追加銷售你在這裡預見到冒險嗎？

So the mechanism that HERA is using is not the same as BARDA. In the U.S., the U.S. government determines what a stockpile size should be. They then procure product to meet that stockpile size on behalf of the entire U.S. population. It's evolving in Europe. But right now, HERA does not set a target for all of Europe. They do emergency small procurements. So people may remember last year, they did do a direct procurement for $10 million, roughly $10 million to get some initial courses.

所以HERA使用的機制與BARDA不一樣。在美國，美國政府決定庫存規模。然後，他們代表全體美國人口採購產品以滿足庫存規模。它正在歐洲不斷發展。但目前，HERA 並未設定針對整個歐洲的目標。他們進行緊急小額採購。所以人們可能還記得去年，他們確實進行了 1000 萬美元的直接採購，大約 1000 萬美元用於購買一些初始課程。

But really, what they're doing in this vehicle is allowing countries to procure under it, but each country ultimately is determining what their budget is what they're doing to start stockpiling in their behalf. There have been broader discussions at the European Commission level to set up targets central funding that just hasn't gotten to the point yet where they're making targets, but we're encouraged that there's a lot more conversation in Europe than there was historically and certainly as evidenced by this initial order under this contract, there is some opportunity here that we look forward to pursuing.

但實際上，他們在這個工具中所做的就是允許各國根據它進行採購，但每個國家最終都在決定他們的預算是什麼，以及他們正在做什麼來開始代表他們進行庫存。歐盟委員會層級就設定中央資金目標進行了更廣泛的討論，但尚未達到製定目標的程度，但令我們感到鼓舞的是，歐洲的對話比歷史上要多得多當然，正如本合約下的初始訂單所證明的那樣，我們期待著抓住一些機會。

And your next question comes from the line of Paul Saunders from Hutch Capital.

你的下一個問題來自 Hutch Capital 的 Paul Saunders。

First question is just on the buyback. I noticed that you didn't buy any shares back this quarter, so I was just curious if you had any thoughts or commentary on not buying any shares back.

第一個問題是關於回購。我注意到您本季沒有回購任何股票，所以我很好奇您是否對不回購任何股票有任何想法或評論。

Paul, thanks for the question. Good to hear your voice. So as we've said in our conference calls, any buyback decision is a multiyear and certainly multifaceted set of the circumstances around the cash flow, orders, other opportunities and the Board and management review that, so we don't comment on specific quarters or buybacks.

保羅，謝謝你的提問。很高興聽到你的聲音。因此，正如我們在電話會議中所說，任何回購決定都是一個多年的、肯定是多方面的，涉及現金流、訂單、其他機會以及董事會和管理層的審查情況，因此我們不會對特定季度發表評論或回購。

But as Dan highlighted, we did have the special dividend and the 11 million purchase. So we've certainly been active this year in capital management, but we don't comment on quarter-by-quarter buying decisions, but I appreciate the question.

但正如丹所強調的那樣，我們確實有特別股息和 1100 萬美元的購買。因此，我們今年在資本管理方面確實很活躍，但我們不會對逐季度的購買決策發表評論，但我很欣賞這個問題。

And one more for me, if you don't mind, just a question on the inventory. I know it sounds like this delivery got pushed back because of it sounds like packaging issues, so I know it's sort of inflated due to that. But just kind of running the rough math, if that were fully finished, it looks like it's like 1.5 million courses of inventory. I'm just kind of curious, that's obviously a lot more than what you're going to deliver in the next quarter or two. So just kind of can you provide any color on that inventory build in excess of what you're going to deliver this upcoming quarter?

如果你不介意的話，我還有一個關於庫存的問題。我知道這聽起來像是這次交貨被推遲了，因為聽起來像是包裝問題，所以我知道它因此而被誇大了。但粗略算一下，如果完全完成的話，看起來就像 150 萬個課程的庫存。我只是有點好奇，這顯然比您在下一兩個季度要交付的內容要多得多。那麼，您能否提供超出下個季度交付量的庫存量的任何顏色？

So for those that may not know, the cycle time for making our product is certainly given normal scheduling and proactive scheduling of batches and manufacturing. We have 4 different manufacturers. It takes well over a year to go through the cycle time of our product. With BARDA, we have pretty good visibility into how that replenishment is going to go. And historically, we had a long lead time but we are now at a more mature place in our business where we want to make sure that we're able to have a responsive supply chain that doesn't start from 0, but may have targeted active pharmaceutical ingredient in inventory.

因此，對於那些可能不知道的人來說，製造我們產品的周期時間肯定是按批次和製造的正常調度和主動調度進行的。我們有 4 個不同的製造商。我們產品的周期需要一年以上的時間。透過 BARDA，我們可以很好地了解補貨的進展。從歷史上看，我們的交貨時間很長，但現在我們的業務處於更加成熟的階段，我們希望確保我們能夠擁有一個不是從 0 開始的響應式供應鏈，而是可能有目標庫存中的活性藥物成分。

And so if we have an opportunity for a sale, we're able to translate that into product in months as opposed to over a year. So you will see in general, an increase on our balance sheet of inventory that we manage to make sure if we have an opportunity to accelerate orders with a customer, we can do that. If we ever had a disruption in our supply chain, we'll be ready to do that. And we have a lot of flexibility given the stability of our API.

因此，如果我們有銷售機會，我們就能在幾個月內將其轉化為產品，而不是一年多的時間。因此，總的來說，您會看到我們的庫存資產負債表增加，我們設法確保如果我們有機會加快與客戶的訂單，我們就能做到這一點。如果我們的供應鏈發生中斷，我們將做好準備。鑑於 API 的穩定性，我們擁有很大的靈活性。

And as you point out, we do have a bolus that's getting ready for a large delivery to BARDA. We also anticipate next year, as we've said many times, an expiry schedule that will have another $113 million option that would be exercised, and another IV option. So we're also building inventory to make sure we're ready for those orders, not just the next quarter.

正如您所指出的，我們確實有一個丸劑正在準備向 BARDA 大量交付。正如我們多次說過的那樣，我們還預計明年的到期時間表將有另一個 1.13 億美元的選擇權將被行使，以及另一個 IV 選擇權。因此，我們也在建立庫存，以確保我們為這些訂單做好準備，而不僅僅是下個季度。

And if you don't mind, just with the -- I assume it was the packaging, why that option exercise didn't get to live this quarter. Was that -- like can you also provide any more color on what happened there with the packaging and I guess maybe how to sort of avoid that in the future?

如果你不介意的話，我想這就是包裝的問題，為什麼這個選擇權練習沒有在本季實施。是不是——就像你能提供更多關於包裝上發生的事情的資訊嗎？我想也許將來如何避免這種情況？

Yes, it's a great question, Paul. We work with a lot of service providers. And as we said, we haven't run into any problems per se, but it's just taken longer to get into those facilities, get it packaged and get it out. We certainly plan in advance for that, but then we have a sprint once we get the order and have to do the packaging. Historically, that's actually been an area that's gone very smoothly and rapidly. It just turns out this year, we run into delays there, not any technical challenges, simply delays.

是的，這是一個很好的問題，保羅。我們與許多服務提供者合作。正如我們所說，我們本身沒有遇到任何問題，只是進入這些設施、包裝並運出需要更長的時間。我們當然會提前計劃，但一旦收到訂單，我們就會進行衝刺並必須進行包裝。從歷史上看，這實際上是一個進展非常順利和迅速的領域。事實證明，今年我們遇到了延誤，不是任何技術挑戰，只是延誤。

And I can assure everyone in our team has been working really hard to find ways to make sure we hit the target, but we wanted to highlight that as the challenge that we're focused on right now.

我可以向我們團隊中的每個人保證，我們團隊中的每個人都在非常努力地尋找方法來確保我們實現目標，但我們想強調這是我們現在關注的挑戰。

There are no further questions at this time. Please proceed.

目前沒有其他問題。請繼續。

I'd like to thank everybody for their time today. We really appreciate the update and look forward to talking to you again soon. Thank you, operator. Have a good day, everybody.

我要感謝大家今天抽出寶貴的時間。我們非常感謝您的更新，並期待很快再次與您交談。謝謝你，接線生。祝大家有美好的一天。

Thank you. Ladies and gentlemen, that does conclude our conference for today. Thank you all for participating. You may all disconnect.

謝謝。女士們、先生們，今天的會議到此結束。感謝大家的參與。你們都可以斷開連線。