SIGA Technologies Inc (SIGA) 2024 Q4 法說會逐字稿

Welcome to the SIGA business update call. Before we starting to 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 different materially from the forward-looking statements.

歡迎參加 SIGA 業務更新電話會議。在我們開始致電 SIGA 管理層之前，請注意，本次通話中做出的任何前瞻性陳述均基於管理層當前的預期和觀察。並受風險和不確定性的影響，可能導致實際結果與前瞻性陳述有重大差異。

SIGA does not undertake any obligation to update publicly any forward-looking statements to reflect events or change circumstances after this call. For a discussion of factors that could cause actual results to differ, please see the company's filings with Securities and Exchange Commission, including without limitation, the company's annual report on Form 10-K for the year ended December 31, 2024, and its subsequent reports on Form 10-Q and Form 8-K.

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事件或變更情況的義務。有關可能導致實際結果不同的因素的討論，請參閱本公司向美國證券交易委員會提交的文件，包括但不限於本公司截至 2024 年 12 月 31 日的 10-K 表年度報告以及後續的 10-Q 表和 8-K 表報告。

With that, I will now turn the call over to Diem Nguyen, Chief Executive Officer of SIGA. Diem, please go ahead.

現在，我將把電話轉給 SIGA 執行長 Diem Nguyen。Diem，請繼續。

Good afternoon, everyone, and thank you for joining today's call and review of our business results for the fourth-quarter and full year of 2024. I am joined by Dan Luckshire, our Chief Financial Officer, and we appreciate this opportunity to provide an update to our company. After the update, we'll be happy to answer your questions.

大家下午好，感謝您參加今天的電話會議並審查我們 2024 年第四季和全年的業務業績。我們的財務長 Dan Luckshire 也與我們一同出席，我們很高興有機會向大家通報公司的最新動態。更新後，我們將很樂意解答您的問題。

I'm pleased to share that 2024 was a year of impactful execution and strong financial performance for SIGA. In 2024 we also make considerable progress on several initiatives to drive shareholder value, including, one, continue our partnership with the US government; two, advancing regulatory approvals for TPOXX; and three, cultivating strategic partnerships to expand global access to TPOXX.

我很高興地告訴大家，2024 年對 SIGA 來說是執行力強、財務表現強勁的一年。2024年，我們還在推動股東價值的多項措施上取得了長足進展，其中包括：一、繼續與美國政府合作；二、推進TPOXX的監管批准；三是建立戰略合作夥伴關係，擴大TPOXX的全球覆蓋範圍。

With product sales of 133 million up approximately 2% from 2023, we deliver the second consecutive year of product sales growth, reinforcing the critical role that TPOXX and a comprehensive smallpox preparedness play in strengthening national security.

產品銷售額達 1.33 億，較 2023 年成長約 2%，我們連續第二年實現產品銷售成長，鞏固了 TPOXX 和全面天花防範在加強國家安全方面發揮的關鍵作用。

Additionally, our results highlight the strength of our financial division. Of the $133 million in product sales, about $80 million was generated in the fourth quarter from a diverse mix of revenue sources led by deliveries of oral and IV TPOXX to this US Strategic National Stockpile. This was followed by deliveries of both oral and IV TPOXX to the US Department of Defense and deliveries of oral TPOXX in our nearly international markets.

此外，我們的業績凸顯了我們金融部門的實力。在 1.33 億美元的產品銷售額中，約有 8,000 萬美元來自第四季度的多種收入來源，主要來自向美國國家戰略儲備庫交付口服和靜脈注射 TPOXX。隨後，我們向美國國防部交付了口服和靜脈注射 TPOXX，並向幾乎國際化的市場交付了口服 TPOXX。

The latter included a notable sale in East Asia for $11 million of oral TPOXX, which is more than double the size of the largest prior individual TPOXX sale in the region. This latest international milestone follows the first sale of TPOXX in Africa in the third quarter in response to a request from the Ministry of Health in Morocco.

後者包括在東亞地區達成的一項引人注目的銷售額為 1100 萬美元的口服 TPOXX 交易，該交易金額是該地區之前最大單一 TPOXX 銷售額的兩倍多。這是繼第三季應摩洛哥衛生部的要求在非洲首次銷售TPOXX之後的最新國際里程碑。

Beyond the 2024 topline financial results, we have taken important steps to advance our key initiatives and strengthen our company, which we believe will produce shareholder value over time. I would like to highlight some of these steps.

除了 2024 年的營收財務表現外，我們還採取了重要舉措來推進我們的關鍵舉措並加強我們的公司，我們相信這將隨著時間的推移為股東創造價值。我想強調其中的一些步驟。

We continue to make progress on our international markets. Two examples stand out. First, midway through 2024, our company assumed responsibility for promoting TPOXX outside the US from Meridian Medical Technologies. This action was brought us much closer to our current and potential future customers, thereby enabling us to better understand and meet their needs.

我們在國際市場上不斷取得進展。有兩個例子十分突出。首先，從 2024 年中期開始，我們公司從 Meridian Medical Technologies 接管了在美國以外推廣 TPOXX 的責任。此舉使我們與現有和潛在的未來客戶更加接近，使我們能夠更好地了解和滿足他們的需求。

We started to build an international sales and marketing infrastructure in 2024 and planned to continue to invest in that infrastructure to achieve our full potential in the international market. We believe our conversations and actions will yield positive results over time. Second, as announced earlier this year, we achieved another international regulatory approval when Japan's Pharmaceuticals and Medical Devices Agency, in collaboration with the Japan Ministry of Health, Labor and Welfare approved TPOXX for the treatment of a broad range of orthopoxviruses.

我們於 2024 年開始建立國際銷售和行銷基礎設施，並計劃繼續投資該基礎設施，以充分發揮我們在國際市場的潛力。我們相信，隨著時間的推移，我們的對話和行動將會產生正面的成果。第二，正如今年稍早宣布的那樣，我們獲得了另一項國際監管批准，日本藥品和醫療器材管理局與日本厚生勞動省合作批准 TPOXX 用於治療多種正痘病毒。

This approval marked another important milestone in our efforts to expand access to TPOXX. Additionally, it, coupled with a growing sales of TPOXX in East Asia, reinforces the value of antiviral stockpiling to ensure supply resilience during immediate crisis response to safeguard communities and individuals against smallpox.

此項批准標誌著我們擴大 TPOXX 使用管道的努力中的另一個重要里程碑。此外，再加上TPOXX在東亞地區的銷售量不斷增長，更凸顯了抗病毒藥物儲備的價值，以確保在緊急應對危機期間的供應彈性，保護社區和個人免受天花侵害。

To obtain this approval and in collaboration with our local partner, Japan Biotechno Pharma, we submitted a robust data package which included studies involving healthy human volunteers, non-human primates, and rabbits. No other drug approved to treat smallpox or any other orthopoxvirus is supported by such a comprehensive and extensive data package.

為了獲得此項批准，我們與當地合作夥伴日本生物技術製藥公司合作，提交了一個強大的資料包，其中包括涉及健康人類誌願者、非人類靈長類動物和兔子的研究。目前尚未有任何其他獲準用於治療天花或任何其他正痘病毒的藥物得到如此全面和廣泛的數據包的支持。

Shifting gears on cultivating strategic partnerships, in October, we announced an exclusive license to a portfolio preclinical, fully human, monoclonal antibodies from the Vanderbilt University that have the potential to create a broad range of orthopoxviruses, including smallpox and mpox.

在轉向培養策略夥伴關係方面，我們在十月宣布獲得范德堡大學一系列臨床前、全人源化單株抗體的獨家許可，這些抗體有可能用於製造多種正痘病毒，包括天花和痘苗病毒。

Leveraging our existing capabilities to create new opportunities over the long term, we believe this portfolio has the potential to complement our TPOXX franchise and provide patients with additional therapies in this space.

利用我們現有的能力來長期創造新的機遇，我們相信該產品組合有潛力補充我們的 TPOXX 特許經營權，並為患者提供該領域的額外治療方法。

While monoclonal antibodies represent an early-stage component of our pipeline, our TPOXX post-exposure prophylaxis program for smallpox or PEP is far more advanced. We continue to collaborate with the CDC in consultation with the FDA to complete the analysis of the samples collected support the study's immunogenicity objective.

雖然單株抗體代表了我們產品線的早期階段組成部分，但我們針對天花或 PEP 的 TPOXX 暴露後預防計畫卻更為先進。我們將繼續與 CDC 合作並與 FDA 協商，完成所收集樣本的分析，以支持研究的免疫原性目標。

As a reminder, the safety objective has already been successfully achieved. The CDC's work is underway and we believe they will complete their analysis around the middle of this year. Based upon their projected timeline, we are now [charving] an FDA submission for the PEP indication in early 2026.

提醒一下，安全目標已經成功達成。疾病預防控制中心的工作正在進行中，我們相信他們將在今年年中左右完成分析。根據他們預計的時間表，我們現在正在向 FDA 提交 PEP 適應症申請，申請將於 2026 年初完成。

In addition to our successes, we've also faced some challenges this year given the PALM 007 and STOMP clinical trial results in mpox. While the results of these trials were not a surprise given the mechanism action of TPOXX and the design of the trials, they have led to some important discussions about TPOXX that I'd like to address today.

除了我們的成功之外，鑑於 mpox 的 PALM 007 和 STOMP 臨床試驗結果，我們今年也面臨一些挑戰。雖然考慮到 TPOXX 的作用機制和試驗設計，這些試驗的結果並不令人意外，但它們引發了一些關於 TPOXX 的重要討論，我今天想就這些討論進行討論。

By the way of background, TPOXX was developed as a treatment for smallpox with the primary goal of reducing mortality and saving lives in an event of an outbreak. Approval under the FDA's rigorous animal rule, TPOXX is supported by extensive studies demonstrating its safety and efficacy in reducing mortality from smallpox.

背景是，TPOXX 被開發用於治療天花，主要目標是在疫情爆發時降低死亡率並挽救生命。TPOXX 在 FDA 嚴格的動物規則下獲得批准，並有大量研究證明其在降低天花死亡率方面的安全性和有效性。

Since smallpox vaccination programs were discontinued several decades ago, herd immunity has diminished, leaving populations vulnerable to its potential reintroduction. For example, in the US, approximately 190 million people were born after the end of the routine vaccination leaving these Americans vulnerable. Additionally, the robustness of the immune response in those vaccinated more than 50 years ago cannot be determined.

自從幾十年前停止天花疫苗接種計畫以來，群體免疫力已經下降，人群很容易受到天花再次爆發的威脅。例如，在美國，約有 1.9 億人口是在常規疫苗接種結束後出生的，這使得這些美國人容易受到感染。此外，50多年前接種疫苗的人的免疫反應是否強勁尚無法確定。

As such, the potential for intentional reintroduction remains a serious concern. For PALM 007 and STOMP, SIGA donated the product to trial sponsors to help advance mpox research and support response to the 2022 global mpox outbreak. Because mpox is a far milder and largely self-resolving disease with a much lower mortality rate than smallpox, these trials were designed to measure the time for all lesions to heal between patients receiving TEPOXX and those receiving placebo.

因此，故意重新引入的可能性仍然是一個嚴重的問題。對於 PALM 007 和 STOMP，SIGA 將產品捐贈給試驗贊助商，以幫助推進 mpox 研究並支持應對 2022 年全球 mpox 疫情。由於 mpox 是一種比天花症狀更輕微、基本上可以自行痊癒的疾病，死亡率也低得多，因此這些試驗旨在測量接受 TEPOXX 的患者和接受安慰劑的患者之間所有病變癒合的時間。

While these studies did not show statistical significance difference between tecovirimat and placebo at this primary endpoint, the PALM 007 results did signal potential benefits for patients treated early or with severe disease.

雖然這些研究並未顯示特考韋瑞瑪與安慰劑在這一主要終點上存在統計學顯著差異，但 PALM 007 的結果確實表明，對於早期治療或患有重症的患者有潛在的益處。

Generally speaking, viruses replicate faster in the initial stages of infection and administrating antivirals early helps curb virus replication before reaching its peak load, thereby reducing the severity of the disease. This principle is exemplified during the COVID-19 pandemic where timely administration of antivirals proved critical in improving patient outcomes.

一般來說，病毒在感染的初期複製較快，早期使用抗病毒藥物有助於在病毒複製達到高峰之前抑制其複製，從而減輕病情的嚴重程度。這項原則在 COVID-19 大流行期間得到了體現，及時使用抗病毒藥物對於改善患者預後至關重要。

The same principle applies to TEPOXX. Tecovirimat work to reduce viral relief from infected cells. Based upon tecovirimat mechanism of action, we believe treatment would be optimized when administered early in symptoms or ideally post-exposure prophylaxis. The early phase of disease includes viral implication and dissemination throughout the body. As a disease progresses, the immune system works to clear the virus already released from the cell after replication.

同樣的原則也適用於TEPOXX。Tecovirimat 的作用是減少受感染細胞的病毒釋放。根據替考韋瑪的作用機制，我們相信在症狀出現早期進行治療或理想情況下在暴露後進行預防將能達到最佳治療效果。疾病的早​​期階段包括病毒感染和全身播散。隨著疾病的進展，免疫系統會努力清除細胞複製後釋放的病毒。

In PALM 007, we saw the potential benefits for patients treated early or with severe disease. We're currently assessing viral load impact in mpox patients over time as we expect reduction in virus load with tecovirimat administration early, consistent with our non-human primate models.

在 PALM 007 中，我們看到了早期治療或重症患者的潛在益處。我們目前正在評估 mpox 患者中病毒量隨時間的變化，因為我們預計早期使用 tecovirimat 可以減少病毒量，這與我們的非人類靈長類動物模型一致。

Both PALM 007 and STOMP enrolled patients at later stages of disease, a medium about 5.9 and 8 days respectively after self-reported symptom onset. We believe these trials are not necessary or effective of how or when the drug should be used based on its mechanism of action and potential value in smallpox outbreak.

PALM 007 和 STOMP 都招募疾病後期的患者，中位數時間分別在自我報告的症狀出現後約 5.9 天和 8 天。我們認為，根據藥物的作用機制和在天花爆發中的潛在價值，這些試驗對於如何或何時使用該藥物是不必要的或無效的。

We believe TEPOXX remains a vital countermeasure for reducing mortality from smallpox. In a comprehensive preparedness plan, antivirus provided critical line of defense. Complementing vaccines, antivirus can be used to treat an infection in patients who have not been vaccinated or do not benefit from vaccination.

我們相信 TEPOXX 仍然是降低天花死亡率的重要措施。在全面的防範計畫中，防毒軟體提供了關鍵的防線。作為疫苗的補充，抗病毒藥物可用於治療未接種疫苗或無法從接種疫苗中受益的患者的感染。

During antivirals have the potential to prevent onset of viral illness after exposure to the virus. The relationship between vaccines and antivirals is particularly important as we face the growing challenge of emerging infectious diseases and the threat of bioterrorism. Strategic stockpiling of antivirals, it helps ensure a swift, coordinated response when disaster strike.

在接觸病毒後，抗病毒藥物有可能預防病毒性疾病的發生。當我們面臨新興傳染病和生物恐怖主義威脅日益嚴峻的挑戰時，疫苗和抗病毒藥物之間的關係尤其重要。策略性地儲備抗病毒藥物，有助於確保在災難發生時能夠迅速、協調地做出反應。

Looking forward, we believe securing a new contract for the continuing supply of TEPOXX to the Strategic National Stockpile or SNS represents an opportunity to enhance our company's long-term potential and help advance our national security through bioterrorism preparedness.

展望未來，我們相信獲得一份繼續向國家戰略儲備（SNS）供應 TEPOXX 的新合同，為我們提升公司的長期潛力提供了一個機會，並有助於透過生物恐怖主義防範提高我們的國家安全。

Since the new US administration took office, we have seen many bold initiatives launched and executive orders enacted with more changes expected as new leaders are nominated, confirmed, and put in place. With any change of administration, this takes time. While change can create uncertainty, it can also create long-term opportunities as priorities are clarified and new policies are enacted to enhance national security.

自美國新政府上任以來，我們看到許多大膽舉措出台、行政命令頒布，隨著新領導人的提名、確認和上任，預計還會有更多變化。任何政府的變動都需要時間。雖然變化會帶來不確定性，但隨著優先事項的明確和新政策的製定以加強國家安全，變化也能創造長期機會。

We will continue to monitor these developments and assess the potential impact, if any, on our company. Whatever transpires we believe we are well-positioned to engage with a new ASPR as well as other senior officials on the nature and timing of an RFP for a new contract for TEPOXX.

我們將繼續關注這些事態發展，並評估其對我們公司可能產生的影響（如果有）。無論結果如何，我們都相信我們有能力與新的 ASPR 以及其他高級官員就 TEPOXX 新合約的 RFP 的性質和時間進行接觸。

As a reminder, ASPRs within the US HHS and houses the center of the biomedical advanced Research and Development Authority, or BARTA and the SNS. More reference you guys been providing TEPOXX to the ASPR for more than a decade, and national security is an issue that transcends political considerations. We believe the new administration is committed to maintaining a robust preparedness strategy which includes a supply of anti-biotherapies to treat smallpox.

提醒一下，ASPR 隸屬於美國衛生與公眾服務部 (HHS)，是生物醫學高級研究與發展局 (BARTA) 和 SNS 的中心所在地。更多參考你們十多年來一直為 ASPR 提供 TEPOXX，國家安全是一個超越政治考慮的問題。我們相信新政府致力於維持強有力的緊急策略，其中包括提供治療天花的抗生物療法。

Furthermore, our current 19C contract was awarded under President Trump's leadership in 2018. With this in mind, we stand ready to negotiate with the new ASPR with the objective of completing a new contract in 2025.

此外，我們目前的 19C 合約是在 2018 年川普總統的領導下授予的。考慮到這一點，我們準備與新的 ASPR 進行談判，目標是在 2025 年完成新的合約。

In summary, this is a dynamic time for SIGA. We are strong, resilient, and profitable. Our strategies yielding results. Our discipline approach to capital management gives us the optionality. Our TEPOXX franchise meets a critical need for smallpox preparedness. And our team has the expertise to drive results over the long term in the best interest of our customers and shareholders. In short, with a strong foundation, we believe we are well-positioned for the future and the opportunities ahead.

總而言之，對於 SIGA 來說，這是一個充滿活力的時期。我們實力雄厚、富有韌性、獲利能力強。我們的策略已取得成果。我們對資本管理的紀律性方法為我們提供了選擇權。我們的 TEPOXX 特許經營滿足了天花防治的迫切需求。我們的團隊擁有專業知識，能夠長期推動成果，以滿足客戶和股東的最佳利益。簡而言之，有了堅實的基礎，我們相信我們為未來做好了準備，抓住了未來的機會。

With that, I'll turn it over to Dan to review the financial results in more detail.

說完這些，我會把責任轉交給丹，讓他更詳細地審查財務結果。

Thanks, Diem. As noted earlier in the call, biggest product sales for this year surpassed (technical difficulty) year sales. This represents the second straight year of sales growth and a new high watermark for annual sales since FDA approval of TEPOXX in 2018.

謝謝，Diem。正如早些時候在電話會議中提到的，今年最大的產品銷售量超過了（技術難度）年度銷售量。這是TEPOXX連續第二年實現銷售額成長，創下自2018年FDA核准TEPOXX以來年度銷售額的新高。

Product revenue for full year 2024 was $133 million. Of this amount, $80 million was recognized in the three months ended December 31, 2024. In the fourth quarter, $51 million of oral TEPOXX and $9 million of IV TEPOXX was delivered to the Strategic National Stockpile or SNS. $9 million in mostly oral TEPOXX, any small amount of IV TEPOXX was delivered to the US Department of Defense. And there was an $11 billion sale to international customer in the East Asia region.

2024 年全年產品收入為 1.33 億美元。其中，8000 萬美元是在截至 2024 年 12 月 31 日的三個月內確認的。第四季度，價值 5,100 萬美元的口服 TEPOXX 和價值 900 萬美元的靜脈注射 TEPOXX 被運送到國家戰略儲備（SNS）。價值 900 萬美元的大部分是口服 TEPOXX，任何少量的 IV TEPOXX 都被運送到了美國國防部。其中，向東亞地區國際客戶的銷售額達 110 億美元。

To reiterate the comment made earlier in the call, the international sale in the fourth quarter represents a milestone in that it is more than double the size of the largest prior individual TEPOXX sale in the East Asia region.

為了重申早些時候在電話會議上發表的評論，第四季度的國際銷售代表著一個里程碑，因為其規模是之前東亞地區最大的單一 TEPOXX 銷售規模的兩倍多。

With respect to product sales for the full year 2024, the $133 million amount comes from a diverse mix similar to the diversity in the fourth quarter. The revenue mix includes $74 million of oral TEPOXX sales to the SNS, $26 million of IV TEPOXX sales to the SNS, $10 million of oral and IV EPOXX sales to the US Department of Defense, and $23 million of oral TEPOXX sales to 13 international customers.

就 2024 年全年產品銷售額而言，1.33 億美元的金額來自與第四季類似的多元化組合。收入結構包括向 SNS 銷售的 7,400 萬美元口服 TEPOXX、向 SNS 銷售的 2,600 萬美元靜脈注射 TEPOXX、向美國國防部銷售的 1,000 萬美元口服和靜脈注射 EPOXX，以及向 13 個國際客戶銷售的 2,300 萬美元口服 TEPOXX。

In addition to product-related revenues, the company also had research and development revenues. For the 3 and 12 months ended December 31, 2024, research and development revenues were $1.6 million and $5.4 million respectively. Pre-tax operating income, which excludes interest income and taxes, was approximately $57 million for the three months ended December 31, 2024.

除了產品相關收入外，該公司還有研發收入。截至 2024 年 12 月 31 日的 3 個月和 12 個月，研發收入分別為 160 萬美元和 540 萬美元。截至 2024 年 12 月 31 日的三個月，稅前營業收入（不包括利息收入和稅金）約為 5,700 萬美元。

For the full year 2024, pre-tax operating income was approximately $70 million. In comparison, there's a pre-tax operating income for the 3 and 12 months ended December 31, 2023, of approximately $92 million and $84 million respectively.

2024 年全年稅前營業收入約 7,000 萬美元。相較之下，截至 2023 年 12 月 31 日的 3 個月和 12 個月的稅前營業收入分別約為 9,200 萬美元和 8,400 萬美元。

I would like to note that differences between pre-tax operating income margin in 2024 and 2023 reflects different product mixes in those periods. Net income for the 3 months ended December 31, 2024, was approximately $46 million. For the 12 months ended December 31, 2024, net income was approximately $59 million. In turn, fully diluted income per share for the 3 months ended December 31, 2024, was $0.63. And for the full year 2024, fully diluted income per share was $0.82.

我想指出的是，2024 年和 2023 年稅前營業收入利潤率之間的差異反映了這兩個時期不同的產品組合。截至 2024 年 12 月 31 日的 3 個月的淨收入約為 4,600 萬美元。截至 2024 年 12 月 31 日的 12 個月，淨收入約為 5,900 萬美元。反過來，截至 2024 年 12 月 31 日的 3 個月的每股完全攤薄收益為 0.63 美元。 2024 年全年每股攤薄收益為 0.82 美元。

Throughout 2024, the company continued to maintain a strong balance sheet to an abiding commitment to financial discipline. At December 31, 2024, the company had a cash balance of $155 million and no debt.

在整個 2024 年，公司繼續保持強勁的資產負債表，並堅持遵守財務紀律。截至 2024 年 12 月 31 日，該公司的現金餘額為 1.55 億美元，沒有債務。

Looking forward to 2025, I would like to note that we had a $70 million outstanding order balance at December 31, 2024, which we expect to deliver in 2025. This concludes the financial update.

展望 2025 年，我想指出的是，截至 2024 年 12 月 31 日，我們的未結訂單餘額為 7,000 萬美元，我們預計將在 2025 年交付。財務更新到此結束。

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

現在，我將把電話轉回給 Diem。

Thank you, Dan. With that, we would like to open the call for questions.

謝謝你，丹。現在，我們想開始提問。

Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. (Operator Instructions)

謝謝。女士們、先生們，我們現在開始問答環節。（操作員指令）

Jyoti Prakash, Edison Group.

喬迪‧普拉卡許 (Jyoti Prakash)，愛迪生集團。

Hi, thanks for taking my questions. My first question relates to oral TPOXX deliveries. We understand that around $60 million has been delivered from the most recently exercised BARDA option. Have there been any additional deliveries in 2025 to date, and can we expect the entire remaining order to be delivered in the first half, given the expected RFP timelines with the US authorities?

你好，謝謝你回答我的問題。我的第一個問題與口服 TPOXX 給藥有關。我們了解到，最近行使的 BARDA 選項已交付約 6,000 萬美元。到目前為止，2025 年是否有任何額外交付？考慮到美國當局的預期 RFP 時間表，我們是否可以預期整個剩餘訂單將在上半年交付？

Thanks, Jyoti. I'll let Dan answer that question.

謝謝，喬蒂。我請丹來回答這個問題。

Yeah, thanks for the question, Jyoti.

是的，謝謝你的提問，喬蒂。

As it in our prepared remarks, we had 70 million of outstanding orders at December 31, 2024. These -- most of these orders or these orders mostly consist of remaining deliveries of oral and IV TPOXX to the SNS under existing orders. We currently expect those deliveries to start in the second quarter based on coordination with the United States government. And we expect all 70 million of the outstanding orders to be delivered in 2025.

正如我們在準備好的評論中所說，截至 2024 年 12 月 31 日，我們有 7000 萬份未結訂單。這些 — — 這些訂單中的大部分或這些訂單主要包括根據現有訂單向 SNS 剩餘的口服和靜脈注射 TPOXX 交付。根據與美國政府的協調，我們目前預計這些交付將於第二季開始。我們預計所有 7,000 萬份未完成訂單將於 2025 年交付。

There's one -- at the very end, you mentioned the RFP and I guess just to, you know, make sure for clarity purposes just to highlight that the RFP process is a separate process from the delivery process under the 19C contract. In fact, the RFP timing is not impacted by the delivery timing, just wanted to make clear.

有一點——在最後，您提到了 RFP，我想只是為了清楚起見，要強調的是，RFP 流程與 19C 合約下的交付流程是分開的。事實上，RFP 時間並不受交貨時間的影響，只是想明確一點。

Thanks a lot, that that's really helpful. My second question relates to your cash position. So you ended the year with a strong cash balance of $155 million. Can we expect you to announce another special dividend this year as you've been doing every year since 2022.

非常感謝，這真的很有幫助。我的第二個問題與您的現金狀況有關。因此，你們以 1.55 億美元的強勁現金餘額結束了這一財年。我們是否可以期待您今年再次宣布特別股息，就像您自 2022 年以來每年都做的那樣？

So I'll also take that question too. Before I get into the direct answer, let me just give you some background. So as a starting point, our capital management strategy is meant to be dynamic and tailored to optimize positive outcomes for our shareholders. So in the short term, balancing the short term and the long term, this approach has been used over the past series of years.

所以我也會回答這個問題。在直接回答之前，我先介紹一些背景知識。因此，作為起點，我們的資本管理策略應該是動態的和量身定制的，以優化股東的正面成果。所以從短期來看，平衡短期和長期，這種方法在過去幾年一直被採用。

And so with that, the timing of a special cash dividend each year, it's influenced by several factors that which we regularly review. Some of the factors include cash flow performance, capital allocation priorities, external market conditions. So there's a series of factors that we're continually reviewing. And so when you look at prior years, there's really no specific timeline for when special cash dividends occur.

因此，每年特別現金股利的時間受到我們定期審查的幾個因素的影響。一些因素包括現金流量表現、資本配置優先順序、外部市場條件。因此，我們正在不斷審查一系列因素。因此，當您回顧前幾年時，實際上並沒有關於特別​​現金股息發生的具體時間表。

In '22 and '23, the Board of Directors declared special cash dividends in May which were paid in June. And then in '24, the special cash dividend was declared in March. And it was paid in April, so there's some movement in terms of timing.

在 22 年和 23 年，董事會於 5 月宣布派發特別現金股息，並於 6 月支付。然後在24年，3月宣布了特別現金股利。而且它是在四月支付的，所以時間上有一些變動。

So when you sort of bring all these things together, to your question, when you take all these things into account, we currently anticipate Making a capital management decision in the second quarter, which is sort of, which is consistent with the timing for most prior years.

因此，當您將所有這些因素綜合在一起時，對於您的問題，當您將所有這些因素都考慮在內時，我們目前預計將在第二季度做出資本管理決策，這與前幾年的時機一致。

Great. My next question relates to your international group. First of all, congratulations on receiving the regulatory approval in Japan for TPOXX. Can you provide some more details in terms of your distribution agreement with Japan Biotechno Pharma? And just to follow up on that, you made $11 million of international sales in the last quarter. Does that relate to delivery -- to Japan Strategic National Stockpile?

偉大的。我的下一個問題與你們的國際集團有關。首先，恭喜TPOXX獲得日本監管部門的批准。您能否提供與 Japan Biotechno Pharma 簽訂的經銷協議的更多細節？順便問一下，你們上個季度的國際銷售額為 1,100 萬美元。這與向日本國家戰略儲備交付有關嗎？

Right, right. So on the first part of the question, the terms of the distribution agreement with Japan Biotechno Pharma or JBP. Those terms have not been disclosed. What we can say though is that the distribution agreements with JBP or you know with other countries, they're different in nature than the promotion agreement we had with Meridian.

對，對。因此，關於問題的第一部分，與日本生物技術製藥公司 (JBP) 簽訂的分銷協議的條款。這些條款尚未披露。但我們可以說的是，與 JBP 或其他國家簽訂的分銷協議在本質上與我們與 Meridian 簽訂的推廣協議不同。

And the key point here is that distribution agreement will not have the same level of fees that were paid to Meridian. It's a much more efficient model and financially better for us.

這裡的關鍵點是分銷協議的費用不會與支付給 Meridian 的費用相同。這是一個更有效率的模式，而且對我們來說從財務角度來說也更有利。

On the second part of that question in terms of the $11 million international sale, right now at this time we're not currently disclosing that customer. As mentioned in the prepared remarks, customers located in East Asia area, but we're not disclosing the specific customer.

關於該問題的第二部分，即 1100 萬美元的國際銷售額，目前我們尚未透露該客戶的資訊。正如準備好的評論中所提到的，客戶位於東亞地區，但我們沒有透露具體客戶。

Thank you for that. I have another couple of questions. So the next one is related to the mpox opportunity. How do you see that evolving given the results from the PALM 007 and STOMP trials. We understand that they were subset of patients which who saw good results in the PALM 007 trial. So is there any plan to adjust the design of the remaining trials to focus on these particular subset of patients?

謝謝你。我還有幾個問題。下一個與 mpox 機會有關。根據 PALM 007 和 STOMP 試驗的結果，您認為將會如何發展。我們了解到他們是在 PALM 007 試驗中取得良好效果的患者的一部分。那麼是否有計劃調整剩餘試驗的設計以關注這些特定的患者群體？

Jyoti, thanks for that question. I'll take this one.

喬蒂，謝謝你提問。我要這個。

Just an overarching concept. We are continuing to work with NIAID, they are specifically the PALM 007 and STOMP-trial sponsors. We are working with them to fully analyze the clinical data including reviewing data from certain subgroups as you mentioned, to determine what types of patients may potentially benefit the most from tecovirimat as well as the optimal treatment regimen. Once its data analysis is complete, we will then be in a better position to determine the best path forward from both a clinical trial and regulatory perspective.

只是一個總體概念。我們將繼續與 NIAID 合作，他們是 PALM 007 和 STOMP 試驗的贊助商。我們正在與他們合作，全面分析臨床數據，包括審查您提到的某些亞群的數據，以確定哪些類型的患者可能從tecovirimat 中受益最多，以及最佳治療方案。一旦數據分析完成，我們將能夠更好地從臨床試驗和監管的角度確定最佳前進路徑。

I think it's important to note that while we learned a lot from these trials, they certainly had some limitations associated with the trial design. The primary objective was to provide access from a humanitarian perspective, that was particularly consistent in the PALM 007. These trials are not designed by SIGA and they were not designed with a drug development in mind.

我認為值得注意的是，雖然我們從這些試驗中學到了很多東西，但它們在試驗設計上肯定存在一些限制。主要目標是從人道主義角度提供存取權限，這與 PALM 007 特別一致。這些試驗不是由 SIGA 設計的，也不是以藥物開發為設計的。

As a result, we express some of the limitations associated with the mechanism action. Antivirals generally work based on how their mechanism action is executed. Tecovirimat specific mechanism action, the typical patient profile, the design of the trials, it's not unexpected these trials did not meet their primary endpoint to full resolution of all lesions. As with the case of STOMP and PALM 007, SIGA is not the sponsor of these ongoing trials, so we do not have the ability to modify the designs based on learning with current ongoing trials.

因此，我們表達了與機製作用相關的一些限制。抗病毒藥物通常根據其作用機制發揮作用。Tecovirimat 的特定作用機制、典型的病人概況、試驗的設計，這些試驗未能達到完全消除所有病變的主要終點並不意外。與 STOMP 和 PALM 007 的情況一樣，SIGA 不是這些正在進行的試驗的贊助商，因此我們無法根據目前正在進行的試驗的學習來修改設計。

However, saying that, Jyoti, we will continue to evaluate the potential benefit of tecovirimat treatment and mpox patients and then design and execute on further studies accordingly.

不過，喬蒂說，我們將繼續評估 tecovirimat 治療和 mpox 患者的潛在益處，然後據此設計和執行進一步的研究。

Great, that's super helpful and I have one final question. What do you think of the reason funding cuts for the NIH by the Trump administration, and do you see any sort of flow through impact on your expected RFP for TEPOXX.

太好了，這非常有幫助，我還有最後一個問題。您如何看待川普政府削減 NIH 資金的原因？您是否認為這會對 TEPOXX 的預期 RFP 產生任何影響？

Thanks, Jyoti, we can only speak on the behalf of SIGA. First and foremost, I would say that SIGA has a long history of collaboration with the US government agencies, including through four administrations that is inclusive of Biden, Trump, Obama and Bush, and these relationships naturally evolve following changes in leadership from an administration perspective.

謝謝，喬蒂，我們只能代表 SIGA 發言。首先，我想說的是，SIGA 與美國政府機構有著長期的合作歷史，包括拜登、川普、歐巴馬和布希等四屆政府的合作，而且從政府的角度來看，隨著領導層的變化，這些關係自然會發展。

For now, our focus remains on maintaining strong partnerships and continue to play an important role in supporting the US national security and public health initiatives. Based on our experiences and conversations today, we do believe national security is of utmost importance. And it does transcend part partisan politics and that the new administration is committed to maintaining a robust preparedness strategy, which does include supply of antiviral therapies to treat smallpox.

目前，我們的重點仍然是保持強有力的夥伴關係，並繼續在支持美國國家安全和公共衛生計畫方面發揮重要作用。根據我們今天的經驗和談話，我們確實認為國家安全至關重要。它確實超越了黨派政治，新政府致力於維持強有力的防範策略，其中包括提供治療天花的抗病毒療法。

Whatever transpires during this transition period, we believe we are well positioned to engage with the new ASPR, as well as other senior officials on the nature and timing of RFP for a new contract for TEPOXX. At this time, any further comment would be purely speculative in nature.

無論在此過渡期內發生什麼，我們都相信我們已做好準備，與新的 ASPR 以及其他高級官員就 TEPOXX 新合約的 RFP 的性質和時間進行接觸。目前，任何進一步的評論都純粹是推測性的。

Okay. Thank you so much. No further questions and congratulations again on the strong quarter.

好的。太感謝了。不再有其他問題，再次恭喜您本季的強勁業績。

Thanks, Jyoti.

謝謝，喬蒂。

(Operator Instructions)

（操作員指令）

Brian Adams, Parker and Terry.

布萊恩亞當斯、帕克和特里。

Thank you very much and a great year. Couple of quick questions, on the kind of the process of re-engaging with BARDA and potentially again blue skies, gray skies looking forward. If this were a baseball game and it's nine innings, and we're re-upping the contract for we all hope to be maybe a number that would be greater than the 55 from 75 million of the original contract six years ago.

非常感謝，祝您有美好的一年。我有幾個快速問題，關於與 BARDA 重新接觸的流程，以及未來可能再次迎來藍天和灰濛濛的天空。如果這是一場棒球比賽，有九局，我們重新簽訂合同，我們都希望這個數字能比六年前最初合同的 7500 萬美元中的 5500 萬美元更高。

Where do you think we stand on this? Are we you know, the fourth inning, fifth inning, you would kind of alluded to name a doctor win that would some kind of decision would be made this year. Would there be a COLA increase, maybe a number in the $700 million and $800 million range. That's my first question.

您認為我們對此持什麼立場？你知道，第四局、第五局，你會暗示醫生贏了，今年就會做出某種決定。生活費調整 (COLA) 會增加嗎？可能在 7 億到 8 億美元之間。這是我的第一個問題。

And then secondly, the inventory that's on the book shows $49 million. What exactly is that the value of the drug on you that can be deployed. And I'm assuming that will need a portion of the $70 million of the legacy contract that still needs to be filled. So those are my first two questions.

其次，帳面庫存顯示價值 4,900 萬美元。那這種藥物對你來說到底有多大的價值，可以部署呢？我估計這將需要填補遺留合約中 7,000 萬美元的一部分。這就是我的前兩個問題。

Hi, Brian, thanks for the thoughtful questions. I will target the first section and then let Dan talk you through with the inventory. First and foremost, I would start by saying that we have continued conversations with BARDA and SNS in terms of tecovirimat and its primary treatment of choice for smallpox.

你好，Brian，謝謝你提出這些深思熟慮的問題。我將針對第一部分，然後讓丹向您講解庫存。首先，我想說的是，我們一直在與 BARDA 和 SNS 就特可韋拉帕米特及其作為天花主要治療方法進行對話。

There is a continued reinforcement of this importance to the US government from a preparedness perspective. We have talked quite a bit about manufacturing strategies as well as potential volume.

從防範角度來看，美國政府不斷強調這一點的重要性。我們已經討論了很多關於製造策略以及潛在產量的問題。

However, Brian, we have not identified its specific range of volume to date. I can only say, based on the macro dynamics, that we're facing in our environment today the smallpox threat continues to increase. Now whether that be from geopolitical tensions or from naturally occurring concerns based on a vulnerable patient population that may not be vaccinated. We think that this is certainly an important time to reflect on the volume requirements, that discussion still remains to be executed or discussed. Dan.

然而，布萊恩，迄今為止我們還沒有確定其具體的音量範圍。我只能說，根據宏觀動態，我們今天所面臨的環境天花威脅持續增加。現在，無論是由於地緣政治緊張局勢，還是由於對可能未接種疫苗的脆弱患者群體自然產生的擔憂。我們認為，這無疑是一個反思數量需求的重要時刻，這一討論仍有待執行或討論。擔。

Yeah, so on the question about inventory and it ties a little bit into what I was saying in that, you know, given what's happening on the geopolitical front, which is, it keeps getting ratcheted up, but this has been something that's been building for a series of years in terms of risks.

是的，關於庫存的問題，這與我之前說的有點相關，你知道，考慮到地緣政治方面發生的事情，情況不斷升級，但就風險而言，這種情況已經持續了好幾年。

And with that, we've been trying to be proactive in terms of having a products throughout the supply chain. So within that inventory balance it does include product to be delivered on that 70 million of outstanding orders. But also, it includes a fair amount of API so that when there are future orders, we have the ability to be responsive and a very efficient way, and in this scale manner. So we are trying to be proactive, but that amount does also include costs of product to be delivered under existing orders.

為此，我們一直在努力主動確保產品在整個供應鏈中流通。因此，該庫存餘額中確實包括了 7,000 萬份未結訂單中需要交付的產品。而且，它還包含大量 API，以便當未來有訂單時，我們能夠以非常有效率的方式、以這種規模的方式做出回應。因此，我們正努力採取積極主動的態度，但該金額也包括根據現有訂單交付的產品成本。

Okay. And then just asking a very pointed question and not to make anybody difficult, but I want to ask this because it was a really significant, you know, company specific situation, What is the continued, if any, fallout from Doctor Varna in regards to, you know, question from your peers or from NIH or BARDA in regards to the efficacy of basically TEPOXX 2, 3, you know, the early stages of mpox and I mean, you are in -- have rightfully, you know, refuted it but has it impacted sales I guess from what you're hearing, you're seeing.

好的。然後問一個非常尖銳的問題，並不是要為難任何人，但我想問這個問題，因為這是一個非常重要的，你知道，特定於公司的情況，對於您的同行或 NIH 或 BARDA 提出的問題，如果有的話，Varna 博士對此有何影響，關於 TEPOXX 2,3 的有效性，你知道，mpox 的早期階段，我的意思是，你已經正確地駁斥了它，但它是否對銷售產生了影響，我想從你所聽到的和看到的來看。

So, Brian, thank you for asking. I want to start by saying that we have had over a decade of a relationship with BARDA as well as SNS from a US perspective. This started originally from the co-development of our product tecovirimat where we have been incredibly transparent and collaborative in terms of our science.

所以，Brian，謝謝你的提問。首先我想說，從美國的角度來看，我們與 BARDA 以及 SNS 已經有十多年的合作關係。這最初始於我們產品 tecovirimat 的共同開發，在科學方面，我們的合作非常透明且富有協作性。

This has then progressed to the procurement of the stockpile of tecovirimat. Jay had been at SIGA for less than a year. In terms of his contributions, I would say that it's minimal, if not none. He was not part of the development of tecovirimat and he's certainly not part of this clinical trial confusion.

隨後，這項工作進展到採購替考韋拉 (tecovirimat) 庫存。傑伊在 SIGA 工作不到一年。就他的貢獻而言，我會說他的貢獻很小，甚至沒有。他沒有參與 tecovirimat 的研發，當然也沒有參與這次臨床試驗混亂事件。

So we stand by our science, we stand by the data and so do our partners in terms of the importance of an antiviral like tecovirimat well as the preclinical and clinical data that shows its safety, and finally, the preclinical data that demonstrates efficacy.

因此，我們堅信科學，堅信數據，我們的合作夥伴也堅信特可韋拉等抗病毒藥物的重要性，堅信顯示其安全性的臨床前和臨床數據，以及最終證明其療效的臨床前數據。

Okay, great, and then my final question, and I applaud you for making the deal, I guess, with Vanderbilt a few months back, but with the cash war chest that you've got, I mean, it would be my recommendation as a shareholder and a portfolio manager that you and you're probably already looking at this, but to build out yourselves beyond arguably one or two trick ponies, so to speak, or stable.

好的，太好了，然後我的最後一個問題，我讚賞您幾個月前與范德比爾特達成的交易，但是考慮到您擁有的現金儲備，我的意思是，作為股東和投資組合經理，我建議您，您可能已經在考慮這個問題了，但要讓自己超越可以說是一兩匹小馬，或者說穩定。

Are there other, you know, either, you know, drugs or bioterrorism, prophylaxis portfolios or drugs that you're looking at right now that you could tuck into your portfolio that would be another source of potential revenue and or income for you down the line.

您現在是否正在考慮其他藥物、生物恐怖主義、預防性治療組合或藥物，將其納入您的投資組合中，這將成為您未來的另一個潛在收入來源？

So Brian, I would actually say that coming into SIGA almost a year ago, one of the priorities I have is to maximize the TEPOXX franchise, which includes global expansion from a registration perspective, but the second aspect is looking at potential diversification of the pipeline. You saw the active -- the degree of activity we had pursued in 2025 -- 2024. I'd like to continue to pursue in 2025, portfolio diversification exactly to your point.

所以 Brian，我實際上想說，大約一年前加入 SIGA 時，我的首要任務之一就是最大限度地擴大 TEPOXX 特許經營權，這包括從註冊的角度進行全球擴張，但第二個方面是考慮渠道的潛在多樣化。您看到了我們在 2025 年至 2024 年所追求的活躍程度。我想在 2025 年繼續追求投資組合多樣化，正如您所說。

Okay. Thank you very much. That's all I have. Appreciate it. Thank you very much.

好的。非常感謝。這就是我的所有了。非常感謝。非常感謝。

There are no further questions at this time. I will now turn the call back to Diem. Please continue.

目前沒有其他問題。現在我將把電話轉回給吳廷琰。請繼續。

So I wanted to thank everybody for their time today and joining us for today's call and for your ongoing interest in SIGA. We look forward to speaking to you again our first-quarter call. Have a good rest of your evening. Thank you.

所以我想感謝大家今天抽出時間參加今天的電話會議，並感謝大家對 SIGA 的持續關注。我們期待在第一季電話會議上再次與您交談。祝您晚上愉快。謝謝。

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

女士們、先生們，今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。