Precigen Inc (PGEN) 2025 Q3 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to the Precigen Third quarter 2025 financial results and business updates conference call. (Operator Instructions)

女士們、先生們，下午好，歡迎參加 Precigen 2025 年第三季財務業績和業務更新電話會議。（操作說明）

I would now like to turn the conference over to Steve Harrison. Please go ahead.

現在我將把會議交給史蒂夫·哈里森。請繼續。

Thank you, operator, and thank you to all those joining us for our Third quarter 2025 update call. Joining me today are Helen Sabzevari, our President and CEO, Phil Tennant, our Chief Commercial Officer, Rutul Shah, our Chief Operating Officer, and Harry Thomasian, our CFO.

謝謝接線員，也謝謝所有參加我們2025年第三季更新電話會議的各位。今天與我一同出席的有：總裁兼執行長 Helen Sabzevari，商務長 Phil Tennant，營運長 Rutul Shah，以及財務長 Harry Thomasian。

Before we begin our prepared remarks, I remind everyone that we will be making certain forward-looking statements. These statements are based on our current expectations and beliefs. We encourage you to review the slide in this presentation and in our SEC filings, which include risks and uncertainties that could cause actual results to differ materially from today's forward-looking statements. With that,

在我們開始發言之前，我提醒大家，我們將發表一些前瞻性聲明。這些說法是基於我們目前的預期和信念。我們建議您查看本次簡報和我們提交給美國證券交易委員會的文件中的投影片，其中包含可能導致實際結果與今天的前瞻性聲明有重大差異的風險和不確定性。就這樣，

I will now turn the call over to Helen.

現在我將把電話轉給海倫。

Thank you, Steve, and thank you to all those joining us for our third quarterly update call. The approval of PAPZIMEOS in August marked a monumental turning point for all those impacted by recurrent respiratory papillomatosis or RRP.

謝謝史蒂夫，也謝謝所有參加我們第三次季度更新電話會議的各位。PAPZIMEOS 於 8 月獲得批准，對於所有受復發性呼吸道乳頭狀瘤病 (RRP) 影響的人來說，這是一個里程碑式的轉捩點。

Patients, families, physicians, and the RRP Foundation alike. We would like to welcome you to the new era of RRP treatment with PAPZIMEOS poised to become the standard of care. PAPZIMEOS is the first and only available treatment for adults with RRP and it represents the best data, and that's by a wide margin ever generated in adults with RRP.

患者、家屬、醫生以及 RRP 基金會都從中受益。我們誠摯地歡迎您來到 RRP 治療的新時代，PAPZIMEOS 預計將成為治療標準。PAPZIMEOS 是目前唯一可用於治療成人 RRP 的藥物，代表了迄今為止在成人 RRP 治療中獲得的最佳數據，而且數據優勢非常明顯。

Why is PAPZIMEOS a groundbreaking therapy? Let's look at the facts. First, PAPZIMEOS addresses underlying root cause of RRP by generating an immune response against HPV 6 and 11 infected papilloma cells.

PAPZIMEOS為何是一項突破性療法？讓我們來看看事實。首先，PAPZIMEOS 透過產生針對 HPV 6 和 11 感染的乳頭狀瘤細胞的免疫反應，解決 RRP 的根本原因。

Secondly, Pap smears have demonstrated transformative clinical benefit. What do I mean by that? 51% of patients achieved complete response, requiring no surgery for 12 months post-treatment. With the durability shown in 15 of 18 complete responders remaining surgery free at medium duration of 3 years without any additional treatment.

其次，子宮頸抹片檢查已證明具有變革性的臨床益處。我這話是什麼意思？51% 的患者達到完全緩解，治療後 12 個月內無需手術。18 位完全緩解者中有 15 位在 3 年的中期內無需手術治療，療效持久。

Also, overall, 86% of our patients had reduction in their surgical burden after PAPZIMEOS treatment. PAPZIMEOS has a very favourable safety profile with nothing greater than grade 2 TRAs which are similar to those of all. Receiving a flu vaccine, for instance. Also, the ease of administration of PAPZIMEOS. It's given as a subcutaneous administration that can be administered at any clinic or any of the physician offices.

此外，總體而言，86% 的患者在接受 PAPZIMEOS 治療後，手術負擔有所減輕。PAPZIMEOS 具有非常好的安全性能，沒有超過 2 級的 TRA，與其他所有藥物類似。例如，接種流感疫苗。此外，PAPZIMEOS 的給藥也十分方便。它是皮下注射給藥，可以在任何診所或任何醫生辦公室進行注射。

Furthermore, PAPZIMEOS is not associated with a painful device necessary for the administration. Let me be very clear here. We have treated the most severe RRP patients and demonstrated unmatched complete response rate, which has been durable with an excellent safety profile.

此外，PAPZIMEOS 無需使用給藥時必須配合的疼痛裝置。讓我把話說清楚。我們已經治療了病情最嚴重的 RRP 患者，並取得了無與倫比的完全緩解率，而且療效持久，安全性極佳。

Based on the RRP pathology, it is easy to extrapolate PAPZIMEOS results to a less severe patient population, which has been reflected in FDA's review and subsequent grant of a broad label for all adult RRP patients irrespective of severity of their disease. In contrast, it is very difficult to extrapolate the results achieved in a less severe patient population to a more severe RRP population, as is the case with the competitor.

根據 RRP 病理學，很容易將 PAPZIMEOS 的結果推廣到病情較輕的患者群體，這體現在 FDA 的審查和隨後授予的廣泛適應症上，適用於所有成年 RRP 患者，無論其病情嚴重程度如何。相較之下，很難將病情較輕的患者群體所取得的結果推廣到病情較重的 RRP 患者群體，就像競爭對手的情況一樣。

I would like to emphasize that PAPZIMEOS pivotal study is the first and to date the only clinical trial in RRP conducted with this robust prospectively defined statistical primary endpoint. PAPZIMEOS clinical data not only beat the highest statistical bar set for the pivotal study using the most robust clinical efficacy and points ever evaluated in RRP, it furthermore demonstrated the strongest data shown to date for RRP.

我想強調的是，PAPZIMEOS 關鍵性研究是迄今為止唯一一項採用這種可靠的前瞻性定義的統計學主要終點進行 RRP 臨床試驗。PAPZIMEOS 的臨床數據不僅打破了關鍵研究設定的最高統計標準，採用了 RRP 中評估過的最可靠的臨床療效和指標，而且還展示了迄今為止 RRP 中最強有力的數據。

In summary, PAPZIMEOS was granted full approval by the FDA with a broad label of adult RRP that does not include restriction on a number of prior surgeries. This is a testament to the transformative clinical data that include unmatched efficacy and a strong ongoing durable responses. From a pivotal study with the prospectively defined statistical primary efficacy and points of complete response rate.

總之，PAPZIMEOS 獲得了 FDA 的全面批准，其適應症範圍廣泛，適用於成人 RRP，且不限制既往手術次數。這證明了具有變革意義的臨床數據，包括無與倫比的療效和持續穩定的療效。一項具有前瞻性定義的統計學主要療效和完全緩解率的關鍵性研究。

In addition, due to the mechanism of action of PAPZIMEOS, there is an opportunity for re-dosing of PAPZIMEOS. And with the full approval, we have significantly raised the bar for clinical data for any competitor to enter the adult RRP space in the future. This approval also marks a pivotal transition for Precigen. Propelling the company into a commercial estate. Delivering this transformative therapy to market with exceptional speed and agility is a remarkable achievement.

此外，由於 PAPZIMEOS 的作用機制，PAPZIMEOS 可以再次給藥。獲得全面批准後，我們大大提高了未來任何競爭對手進入成人 RRP 領域的臨床數據門檻。此次獲批也標誌著 Precigen 公司邁入了關鍵的轉型期。推動公司進軍商業不動產領域。以如此驚人的速度和靈活性將這種變革性療法推向市場，是一項了不起的成就。

In the short time since approval, we have made great strides toward recognizing the robust commercial opportunity and building the strong foundation for Pap simus to be the newest standard of care treatment. As always, our dialogue with the FDA continues to be very productive, including the completion of a successful post-approval meeting.

自從獲批以來，我們在認識到其巨大的商業機會並為 Pap simus 成為最新的標準治療奠定堅實基礎方面取得了長足的進步。與以往一樣，我們與FDA的對話仍然非常有成效，包括成功完成了一次上市後會議。

We are currently working toward initiation of PAPZIMEOS clinical trial for the pediatric RRP population. In addition, we have initiated our efforts for geographic expansion of PAPZIMEOS. With that in mind, I'm pleased to announce that we have submitted marketing authorization application with the EMA.

我們目前正致力於啟動兒童復發性呼吸道乳頭狀瘤病患者的 PAPZIMEOS 臨床試驗。此外，我們已經開始努力拓展 PAPZIMEOS 的地域版圖。有鑑於此，我很高興地宣布，我們已向歐洲藥品管理局 (EMA) 提交了上市許可申請。

I will now turn the call over to our Chief Commercial Officer Phil to walk us through our commercial development, Phil.

現在我將把電話交給我們的商務長菲爾，讓他為我們介紹我們的商業發展。菲爾。

Thank you, Helen, and I am delighted to share with you all today the exciting progress we are making with the launch of PAPZIMEOS. We've achieved a lot in a relatively short space of time. As a reminder, the approval in mid-August was the trigger to bring the full sales team of 18 key account managers on, who were hired, onboarded and deployed in September. In the few weeks since full team deployment, we have made great progress towards our goal of quickly establishing PAPZIMEOS as the new standard of care for adults with RRP.

謝謝海倫，我很高興今天能與大家分享我們在 PAPZIMEOS 的發布方面取得的令人興奮的進展。我們在相對較短的時間內取得了巨大的成就。提醒一下，8 月中旬的批准促使我們組建了由 18 名重點客戶經理組成的完整銷售團隊，他們在 9 月完成了招募、入職和部署。自團隊全面部署以來的短短幾週內，我們在迅速將 PAPZIMEOS 確立為 RRP 成人新護理標準的目標上取得了巨大進展。

So let me highlight the key achievements to date. Firstly, the drug is available and has started shipping to prescribers in the US for the treatment of all adults with RRP. Our field team has now engaged with 90% of our target institutions which cover a significant portion of the 27,000 adult patients with RRP.

那麼，讓我重點介紹一下迄今為止的主要成就。首先，該藥物已經上市，並已開始向美國處方醫生發貨，用於治療所有患有復發性呼吸道乳頭狀瘤病 (RRP) 的成年人。我們的現場團隊目前已與 90% 的目標機構進行了接洽，這些機構涵蓋了 27,000 名 RRP 成年患者中的很大一部分。

These engagements are focused on supporting and expediting the formulary inclusion process, and we have been very impressed by the enthusiasm of the HCPs in accelerating that process. We have already seen multiple formulary approvals nationally. We're also working with HCPs in those institutions to enrol patients who are waiting for treatment.

這些活動旨在支持和加快藥品目錄納入流程，我們對醫療保健專業人員在加快流程方面的熱情印象深刻。我們已經看到多項藥品目錄獲得全國批准。我們也與這些機構的醫護人員合作，招募正在等待治療的患者。

To that end, we have over 100 patients registered in our Precigen patient services hub and a significantly larger number also being processed through institutions' own patient services teams. In line with our expectations, there is clearly pent-up demand that these hospital systems that is now being processed for treatment with PAPZIMEOS.

為此，我們在 Precigen 患者服務中心註冊了 100 多名患者，還有更多患者正在透過各機構自身的患者服務團隊進行處理。正如我們所預期的那樣，這些醫院系統顯然存在積壓的需求，目前正在處理使用 PAPZIMEOS 進行治療的病例。

[Pleasingly], it's not just the large academic sites or IDNs that are expressing an interest in PAPZIMEOS. We're also making good progress with a number of community practices to expedite product uptake, including some of the supergroups affiliated to ENT and oncology networks around the country. This clearly reinforces what we heard in our market research ahead of launch, and we're now seeing in practice there is strong preference for PAPZIMEOS due to its efficacy, durability, safety, and mode of administration.

[令人欣慰的是]，不只是大型學術網站或IDN對PAPZIMEOS表示興趣。我們與一些社區實踐也取得了良好進展，以加快產品推廣，其中包括一些隸屬於全國各地耳鼻喉科和腫瘤科網絡的超級小組。這清楚地印證了我們在上市前進行市場調查時聽到的內容，現在我們在實踐中也看到，由於 PAPZIMEOS 的療效、持久性、安全性和給藥方式，消費者對其有強烈的偏好。

The drug can be shipped anywhere as well as stored and forward easily. No device needed. No training on device needed, just a simple subcutaneous injection. And as Helen said, no need for painful electroporation. Payer coverage is advancing rapidly. As of last week, over 80 million lives are covered, and a number of other policy updates are expected to be announced in the near future. Importantly, PAPZIMEOS is also covered through Medicare and Medicaid. Suffice it to say we're extremely pleased with this momentum, which is in line with our expectations.

這種藥物可以運送到任何地方，也易於儲存和轉發。無需任何設備。無需接受設備操作培訓，只需進行簡單的皮下注射即可。正如海倫所說，無需進行痛苦的電穿孔。支付方的覆蓋範圍正在迅速擴大。截至上週，已有超過 8,000 萬人獲得保障，預計近期還將宣布一系列其他政策更新。值得注意的是，PAPZIMEOS 也包含在聯邦醫療保險和醫療補助計劃的承保範圍內。總之，我們對這一發展勢頭感到非常滿意，這符合我們的預期。

Finally, we're seeing strong support from physicians, whether from a large institution or a community practice, again reflective of the speed at which our teams have engaged with our target customers. We continue to see strong support and advocacy from the RRP Foundation. We have published important new data regarding the significant burden of RRP both at the individual level and to the healthcare system, including the data released this week at the ISO meeting in Europe. These data coupled with the impressive and evolving durability profile of PAPZIMEOS is helping to propel us forward as we look to establish a new treatment paradigm.

最後，我們看到了醫生的大力支持，無論是來自大型機構還是社區診所，這再次反映了我們的團隊與目標客戶互動的速度。我們持續看到 RRP 基金會的大力支持和倡議。我們發布了有關 RRP 對個人和醫療保健系統造成重大負擔的重要新數據，包括本週在歐洲舉行的 ISO 會議上發布的數據。這些數據，再加上 PAPZIMEOS 令人印象深刻且不斷發展的耐久性，正在幫助我們向前邁進，以期建立一種新的治療模式。

In summary, we are extremely pleased with the progress being made. The market is embracing PAPZIMEOS as expected, and we also expect to further build on this momentum throughout the rest of Q4 and into Q1 2026. I look forward to continuing to share further progress across key indicators of success as we complete Q4 and move into the new year.

總而言之，我們對目前的進展感到非常滿意。正如預期的那樣，市場對 PAPZIMEOS 表示歡迎，我們也希望在第四季度剩餘時間和 2026 年第一季繼續保持這一勢頭。我期待在第四季結束、邁入新的一年之際，繼續與大家分享各項關鍵成功指標的進一步進展。

I will now turn the call over to our Chief Operating Officer Rutul Shah to give a brief update on manufacturing. Rutul.

現在我將把電話交給我們的營運長魯圖爾·沙阿，讓他簡要介紹一下生產方面的情況。魯圖爾。

Thank you, Phil, and good afternoon, everyone. I'm excited to share PAPZIMEOS manufacturing operations updates today. As part of our strategic commitment to long-term value creation, we have made significant investments to have control over our CGMP manufacturing operations. We operate a dedicated in-house CGMP facility for commercial PAPZIMEOS drug substance manufacturing.

謝謝你，菲爾，大家下午好。今天我很高興與大家分享 PAPZIMEOS 生產營運的最新進展。作為我們對長期價值創造的策略承諾的一部分，我們進行了大量投資，以控制我們的 CGMP 生產營運。我們擁有專門的內部 CGMP 設施，用於商業化生產 PAPZIMEOS 藥物原料。

Our facility has been fully operational, had a successful pre-approval inspection by the FDA, and has been manufacturing PAPZIMEOS drug substance since prior to approval. With significant in-house expertise in the production of [adenovirral] vectors, we are executing on our operational plan to supply PAPZIMEOS to both current and anticipated future demand.

我們的工廠一直全面運轉，成功通過了FDA的批准前檢查，並且在獲得批准之前就一直在生產PAPZIMEOS藥物原料。憑藉在腺病毒載體生產方面豐富的內部專業知識，我們正在執行我們的營運計劃，以滿足當前和預期的未來需求，為 PAPZIMEOS 提供供應。

I'd like to take the opportunity today to briefly address the cold chain requirement of PAPZIMEOS. We have done our homework in detail regarding this topic, and our interactions indicate no impact on the adoption of PAPZIMEOS. In fact, post COVID, the significant majority of our target IDNs and community centers are equipped to handle frozen drug products like PAPZIMEOS. We have end to end validated logistics in place to distribute PAPZIMEOS efficiently and as Phil mentioned, PAPZIMEOS drug product is available on the shelf, is being ordered and shipped to our customers.

今天我想藉此機會簡單談談 PAPZIMEOS 的冷鏈要求。我們已經就此主題進行了詳細的研究，我們的互動表明，對 PAPZIMEOS 的採用沒有影響。事實上，在新冠疫情之後，我們絕大多數的目標IDN和社區中心都配備了處理冷凍藥品（如PAPZIMEOS）的設備。我們已經建立了端到端的、經過驗證的物流體系，可以有效率地分銷 PAPZIMEOS。正如 Phil 所提到的，PAPZIMEOS 藥品有現貨，正在訂購並運送給我們的客戶。

With that, I'd like to turn the call over to Harry, our Chief Financial Officer, for the, for a financial update. Harry.

接下來，我想把電話交給我們的財務長哈里，讓他為大家報告財務狀況。哈利。

Thank you, Ratul, and good afternoon to those participating in this call. Before touching on the quarter, I want to thank our long-term shareholders for providing us the support necessary through the development and ultimate approval of PAPZIMEOS. It has been less than 5 years for this drug to go from the lab to approval, and we could not have achieved this momentous feat without your support. In addition, I'd like to say that I am proud to be part of the team that has provided patients with the first and only therapy targeting the root cause of RRP.

謝謝你，拉圖爾，也祝參加本次電話會議的各位下午好。在談到本季之前，我要感謝我們的長期股東，感謝他們在 PAPZIMEOS 的開發和最終獲批過程中給予我們的必要支持。從實驗室研發到核准上市，這款藥物花了不到5年的時間，沒有你們的支持，我們不可能有如此巨大的成就。此外，我想說，我很自豪能成為這個團隊的一員，我們為患者提供了第一個也是唯一一個針對 RRP 根本原因的療法。

Turning to our quarterly financial statements, specifically starting with our balance sheet, on September 30th, 2025, we had $123.6 million in cash equivalents, and investments following our recent drawdown of the first tranche of our credit facility. Which was entered into during the quarter. We expect this balance plus our projected revenues from PAPZIMEOS to fund our operations to cash breakeven, which includes continuing PAPZIMEOS launch costs and further development of our pipeline.

再來看我們的季度財務報表，特別是從我們的資產負債表開始，截至 2025 年 9 月 30 日，在我們最近提取了第一筆信貸額度後，我們擁有 1.236 億美元的現金等價物和投資。該合約是在本季度簽訂的。我們預計，這筆餘額加上 PAPZIMEOS 的預期收入將足以支付我們的營運費用，實現現金收支平衡，其中包括 PAPZIMEOS 的持續啟動成本和我們產品線的進一步開發。

I want to pause and repeat this point. We expect that our cash and investment balance plus expected projected revenues from PAPZIMEOS to fund our operations to cash break even.

我想暫停一下，再重複一次這一點。我們預計，我們的現金和投資餘額加上 PAPZIMEOS 的預期收入足以支撐我們的運營，實現現金收支平衡。

We remain confident in Precigen's financial future as we continue to execute our upcoming milestones. Additionally, on the balance sheet, we ended the quarter with approximately $3 million in inventory, which represents the manufacturing costs that we have incurred subsequent to the approval of PAPZIMEOS. Costs incurred in manufacturing the product prior to the approval have been expensed as part of our R&D expenses. Lastly, during the quarter, all of our preferred shares were converted into common shares, providing a simplified capital structure going forward.

我們對 Precigen 的財務前景依然充滿信心，我們將繼續推進即將到來的里程碑目標。此外，在資產負債表上，我們本季末的庫存約為 300 萬美元，這代表了 PAPZIMEOS 獲得批准後我們產生的製造成本。在產品獲得批准之前，生產該產品所產生的成本已計入我們的研發費用。最後，在本季度，我們所有的優先股都轉換為普通股，簡化了未來的資本結構。

In regard to our statement of operations, the one item to note within our operating expenses is the increase to our SG&A costs of approximately $14 million between the quarter ended September 30, 2025 versus the same quarter in the prior period. The majority of this increase was driven by increased commercialization spending related to the PAPZIMEOS launch and to a lesser extent additional employee-related costs, most of which is attributable to the accounting for share-based awards.

就我們的經營報表而言，需要注意的是，在截至 2025 年 9 月 30 日的季度中，我們的銷售、一般及行政費用比上年同期增加了約 1,400 萬美元。這一成長主要由與 PAPZIMEOS 上市相關的商業化支出增加所驅動，其次是與員工相關的額外成本，其中大部分是由於基於股份的獎勵的會計處理所致。

Additionally, our net loss attributable to common shareholders for the quarter ended September 30th, 2025 includes two large accounting-related non-cash items a change in the warrant liability and a deemed dividend related to the conversion of our preferred shares. Those two items combined represent $0.95 per share of the $1.06 per share loss attributable to common shareholders. We do not expect these two items to recur in future periods.

此外，截至 2025 年 9 月 30 日止季度歸屬於普通股股東的淨虧損包括兩項與會計相關的重大非現金項目：認股權證負債的變動及與優先股轉換相關的視同股利。這兩項加起來佔普通股股東每股虧損 1.06 美元中的 0.95 美元。我們預計這兩個項目在未來不會再次發生。

For more information on our financial statements, I'll refer you to today's press release and our 10, which was filed with the SEC after market closed this afternoon. I do want to provide certain guidance relating to our gross to net revenue adjustment. We anticipate that this adjustment will be in the high 10s to low 20%, which is consistent with peers in our industry.

有關我們財務報表的更多信息，請參閱今天的新聞稿以及我們今天下午收盤後向美國證券交易委員會提交的第 10 號文件。我想就我們的毛收入與淨收入調整提供一些指導意見。我們預計此次調整幅度將在 10% 到 20% 之間，這與業界同行的情況一致。

Lastly, it has been quite a year of precedent. As we prepared for the approval of PAPZIMEOS, we made a number of infrastructure investments, including the implementation of a new ERP system this past year. With these investments we have positioned Precigen. With appropriate systems, personnel, and controls to manage the various processes of a commercial company.

最後，今年可謂是開創先例的一年。在準備 PAPZIMEOS 獲得批准的過程中，我們進行了一系列基礎設施投資，包括去年實施了新的 ERP 系統。透過這些投資，我們為Precigen奠定了基礎。擁有適當的系統、人員和控制措施來管理商業公司的各種流程。

With that, I'd like to turn it over to the operator for Q&A operator.

接下來，我將把答疑環節交給接線生。

(Operator Instructions) Jason Butler Citizens JMP Securities LLC - Analyst

（操作說明）Jason Butler，Citizens JMP Securities LLC - 分析師

Hi, thanks for taking the questions and congrats on the launch. I'm wondering if you can give us any color on whether patients, any patients have received, reimbursement approvals yet or whether any patients have been dosed with the first dose of PAPZIMEOS. And then the follow-up is how should we think about the cadence of the pull through from patients that are now, registered in the hub to getting reimbursed drug. Thank you.

您好，感謝您回答問題，並祝賀產品發布成功。我想知道您能否透露一下，是否有患者已經獲得報銷批准，或者是否有患者已經接受了第一劑 PAPZIMEOS 治療。接下來的問題是，我們應該如何考慮從現在已在中心註冊的患者到獲得藥品報銷的整個流程的節奏。謝謝。

Thank you, Jason, and I think for the first question, and I would refer to our Chief Commercial Officer, Phil. Phil.

謝謝傑森，關於第一個問題，我想請教我們的首席商務官菲爾。菲爾

Sure. Hi, Jason. Yes, Phil here. Good to speak to you. So, as we mentioned, we've started shipping PAPZIMEOS to institutions basically for patients who are being scheduled for treatment as we speak. And as I mentioned, we've got payer coverage coming through thick and fast, so those two things are coming together and we're not going to go into details about specific patients being dosed at the moment, but I think in Q4, we'll see that come through and we'll be, when we report our Q4 earnings, we'll be able to talk specifically to numbers of patients dosed and of course the earnings and the revenues that go along with that.

當然。嗨，傑森。是的，我是菲爾。很高興和你交談。正如我們之前提到的，我們已經開始向醫療機構運送 PAPZIMEOS，主要是為了那些正在接受治療的患者。正如我之前提到的，支付方的覆蓋範圍正在迅速擴大，這兩件事正在朝著同一個方向發展。目前我們不會透露具體接受治療的患者人數，但我認為在第四季度，我們會看到相關數據，屆時，當我們公佈第四季度收益時，我們將能夠具體討論接受治療的患者人數，當然還有相關的收益和收入。

Oh, the second question regarding patients in the hub, again, those, they're sitting there now ready for benefit verification and prior authorization. So, and we're also seeing a whole load of those patients who are not necessarily in our hub but are going through the institution's own patient services systems. So, that pull through will be institution. Institution, but we expect that to be starting to pick up the pace as we go through Q4 as these processes come together both on the institution side and the payer side. But we're very pleased with the number of patients that we're seeing coming into the top of the funnel ready to be activated and treated.

哦，關於中心患者的第二個問題，他們現在正坐在那裡等待福利核實和事先授權。所以，我們也看到很多患者不一定在我們中心接受治療，而是透過機構本身的患者服務系統接受治療。所以，這種推動作用將會體現在製度建構中。機構方面，我們預期隨著第四季的到來，隨著機構和支付方雙方流程的整合，這一進程將會加快。但我們很高興看到有這麼多患者進入治療漏斗的頂端，準備接受治療。

Sorry, can I just squeeze in a quick clarification point there? So, Phil, do you expect the majority of patients that go into one of the hubs to actually become, to pull through into receiving drug?

不好意思，我可以插一句澄清一下嗎？菲爾，你認為大多數前往這些中心接受治療的患者最終都能接受藥物治療嗎？

That would be our expectation, yes.

是的，這正是我們所期望的。

And Jason, maybe I can add on these patients, both the ones that are being registered at the PAPZIMEOS hub or at the centre's that they have their own registration hubs. Basically, they are various adults. RRP patients that through their physicians have been identified for the treatment and will be joining to receive. So that's very exciting. And I think prior to approval of Pap smears, our analysis had shown that there will be a large patient population and as you have seen it. The estimate is 27,000 in the United States and it's really important to say that we are seeing that kind of a demand coming through from the various centers.

傑森，或許我可以補充一下這些患者的信息，包括在 PAPZIMEOS 中心登記的患者，以及在他們自己設有登記中心的中心登記的患者。他們基本上都是各種各樣的成年人。經醫生確定適合接受治療的 RRP 患者將加入治療。那真是太令人興奮了。我認為在巴氏抹片檢查獲得批准之前，我們的分析表明，將會有大量的患者群體，正如你所看到的。據估計，美國的需求量為 27,000 人，而且非常重要的是，我們看到各個中心都出現了這種需求。

And just to reinforce, Jason, a lot of these centers, they prefer to use their own expertise and systems and patient services initially. Now, obviously if they want to explore co-pay support or free drug. Support where for appropriate patients they would need to ultimately come into our hub, so we've, as you said, sort of got these two hub components that are coexisting at the moment, but both of which suggest that the pent-up demand that we identified is absolutely there.

傑森，我再強調一下，很多這樣的中心，他們首先傾向於使用自己的專業知識、系統和病患服務。當然，如果他們想了解共同支付支持或免費藥物的情況，那就另當別論了。我們會為合適的患者提供支持，讓他們最終能夠來到我們的中心。正如你所說，我們目前有兩個中心組成部分並存，但這兩者都表明，我們發現的被壓抑的需求確實存在。

(Operator Instructions) Swayampakula Ramakanth H C Wainwright & Co LLC (Pre-Merger) - Analyst

（操作說明）Swayampakula Ramakanth H C Wainwright & Co LLC（合併前）- 分析師

Thank you and congratulations, everybody, everyone on the team there. It's a great moment and it's a transitory quarter for you guys. Excellent. So, for my one question, I want to, check with, Harry regarding, the statement saying that you are funded, to cash flow break even. Which is a, obviously a significant statement you're making. What sort of assumptions are you taking into this, in terms of, in terms of either revenue or patient penetration, how did, how should we think to get there.

謝謝大家，恭喜團隊裡的每一個人。這是一個重要的時刻，對你們來說也是一個過渡階段。出色的。所以，我的問題只有一個，我想向哈利確認一下，關於你們獲得資金以實現現金流收支平衡的說法。這顯然是你發表的一個意義重大的聲明。就收入或病患滲透率而言，你們做了哪些假設？我們該如何思考才能達到這個目標？

Yeah, okay, good to talk to you and appreciate the question. I would say at this point we're not guiding on revenue, so it's kind of difficult to say, when or how we get to, cash flow break even, but I think we're willing to state that by the end of 2026 we'll be cash flow break even.

好的，很高興和你聊天，感謝你的提問。目前我們不對收入做出預測，所以很難說我們何時或如何實現現金流收支平衡，但我認為我們可以肯定地說，到 2026 年底，我們將實現現金流收支平衡。

Okay. Thank you.

好的。謝謝。

(Operator Instructions) Michael DiFiore, Evercore ISI - Analyst

（操作說明）Michael DiFiore，Evercore ISI - 分析師

Hi guys, thanks so much for taking my question and a huge congrats on all the progress here.

大家好，非常感謝你們回答我的問題，也恭喜你們在這裡所取得的所有進展。

Number one, just given the obvious pent-up demand and bows of patients that are expected to go on therapy soon. Could you give us any color as to how long that bolus may last, just considering the reimbursement hurdles that any new therapy encounters during the 1st year, and I have a follow-up.

第一，考慮到顯而易見的積壓需求以及預計很快將接受治療的患者數量。能否告知我們該劑量的持續時間？考慮到任何新療法在第一年都會遇到的報銷障礙，我還有一個後續問題。

Well, we do, we've looked at analogs of rare diseases and the uptake, where you do have pent up demand. So we think that that's going to last for quite a while. The 27,000 adult patients that we've identified are already there in the system. Obviously some more severe than others, some see the healthcare practitioner more often than others, but those are the patients that are actually there in the treatment, and then you would have the incident population on top of that. So I think this bolus of patients is going to be there for quite a while to come.

是的，我們研究過罕見疾病的類似疾病及其治療效果，發現確實有被壓抑的需求。所以我們認為這種情況會持續相當長一段時間。我們已經確定的 27,000 名成年患者都已在系統中。顯然，有些病情比其他病情更嚴重，有些病情比其他病情更頻繁地就診，但這些是實際接受治療的患者，然後在此基礎上還有新發病例人群。所以我認為這群患者還會持續相當長一段時間。

And Michael, maybe I can also further add the importance of of broad label, which covers basically all adult RRP which means anyone who is also going to be diagnosed immediately or they had for instance, even one surgery, and it will be continuously added to these hubs for the treatment, and it's very clear, at least from what we are seeing from the patients' enthusiasm, as well as the physicians. That based on the data that has been published from Hopkins prior, that basically patients by fifth surgery, they have irreversible damages to their either trachea or vocal cords.

邁克爾，我還可以進一步補充「廣泛標籤」的重要性，它基本上涵蓋了所有成人復發性呼吸道乳頭狀瘤病（RRP），這意味著任何患者，無論是否接受過手術，都會立即被診斷出來，並且會不斷被添加到這些治療中心。這一點非常清楚，至少從病人和醫生的熱情來看是這樣的。根據約翰霍普金斯大學先前公佈的數據，基本上患者在接受第五次手術後，氣管或聲帶都會受到不可逆的損傷。

Clearly now the patients as early as their diagnosis, they will be joining. So the pent up demand, obviously all of the severe patients, but also now all of the patients that have been diagnosed or going, undergoing diagnosis, they are basically eligible to receive the Pap smears and their physician, actually, this is the importance and As for instance, if you look at our Press release today, Doctor Best, which is one of the renowned physicians for the treatment of RRP in the world, he refers to Papsius as Nothing short of remarkable data for these patients, treatment of adult RRP and then also positioning it, it's poised to become a standard of care, which then covers all that population, and I think that's very important.

顯然，現在患者一旦確診，就會加入。所以，積壓的需求顯然來自所有重症患者，但現在所有已確診或正在接受診斷的患者，基本上都有資格接受子宮頸抹片檢查，他們的醫生也應該了解這一點。這非常重要。例如，如果您查看我們今天的新聞稿，Best 醫生是世界上治療復發性呼吸道乳頭狀瘤病 (RRP) 的著名醫生之一，他稱 Papsius 為這些患者提供了卓越的數據，用於治療成人 RRP，並且它有望成為一種標準療法，涵蓋所有相關人群，我認為這非常重要。

Excellent, thank you for that, Helen. And just my quick follow-up is just for modelling purposes, how should we think about subsequent cycles of therapy and would pair even allow subsequent cycles beyond the 1st 4 doses?

太好了，謝謝你，海倫。我還有一個後續問題，僅用於建模目的，我們應該如何考慮後續的治療週期？配對治療是否允許在最初的 4 次給藥之後進行後續週期？

Yeah, I think this is an excellent question. First of all, it's very important, and this was one of the interesting concepts that FDA has encouraged us very much for the re-dosing of the PAPZIMEOS and for the expansion of that. And the reason has been based on the safety, obviously the efficacy and the durability of the response and results that we have seen. And at the moment, of course, in the label, it's at the discretion of the physician, in order to redose. So if they feel that the patient needs to be redosed, they can prescribe to that. And of course, as we are moving forward, we are further generating further data on re-dosing of the patients.

是的，我認為這是一個很好的問題。首先，這一點非常重要，這也是 FDA 非常鼓勵我們採用的關於 PAPZIMEOS 重複給藥和擴大其應用範圍的一個有趣概念。原因顯然是基於安全性、有效性以及我們所看到的療效和結果的持久性。當然，目前標籤上寫的是，是否需要追加劑量由醫師酌情決定。因此，如果他們認為病人需要追加劑量，他們就可以開藥。當然，隨著我們不斷推進，我們也在進一步收集有關患者再次用藥的數據。

So, I think there is a huge expansion from that side. And one of the other things that we have mentioned is that our partial responders, as I mentioned, 86% Of our patients, they reduced the number of surgeries. And it's very important. And that was part of the discussions along for our BLA that clearly they will benefit, it seems that from the re-dosing because their immune system is being enhanced to address the root cause of this disease, which is HPV 6. 2011. And I think this is one of the areas that we are also expanding besides our pediatric clinical trials. It's further generation of the data on the dosing of the patients, re-dosing of the patients, I should say, which is initiated in the next year.

所以，我認為那方面會有巨大的擴張。我們提到的另一點是，正如我之前提到的，我們的部分緩解者（占我們患者的 86%）減少了手術次數。而且這非常重要。這也是我們在生物製品許可申請 (BLA) 討論的一部分，很明顯，他們似乎會從再次給藥中受益，因為他們的免疫系統得到了增強，可以解決這種疾病的根本原因，即 HPV 6。2011年。我認為，除了兒科臨床試驗之外，這也是我們正在拓展的領域之一。這是對患者用藥劑量和再次用藥數據的進一步生成，應該說是患者的再次用藥數據，這項工作將於明年啟動。

And I would just add from a payer perspective, the one characteristic of the drug that really stands out for them and will support us in any re-dosing conversations is the durability. So we started off with the 1 year from our clinical registrational studies. We then get the 2 year follow-up in our label. We've just published our 3 year data. All of this is very important data for the payers, and obviously we share that with them, build that into our value proposition so that we can support the concept of re-dosing.

我還要從支付方的角度補充一點，這種藥物最突出的特點，也是在任何重新給藥的討論中支持我們的關鍵因素，就是它的持久性。因此，我們從臨床註冊研究的第一年開始。然後，我們的標籤上會顯示 2 年的後續數據。我們剛剛發布了過去三年的數據。所有這些對支付者來說都是非常重要的數據，顯然我們會與他們分享這些數據，並將這些數據融入我們的價值主張中，以便我們能夠支持重複給藥的概念。

(Operator Instructions) Brian Cheng, JPMorgan - Analyst

（操作說明）Brian Cheng，摩根大通分析師

Hey guys, thanks for taking our questions and congrats on your progress here. I just want to clarify how you record, PAPZIMEOS revenue on your financial statements. Do you recognize revenue following each injection or at the end of the 4 injections and as a follow-up? Thank you.

各位好，感謝你們回答我們的問題，也祝賀你們取得的進展。我只是想確認一下你們如何在財務報表中記錄 PAPZIMEOS 的收入。您是在每次注射後確認收入，還是在 4 次注射結束後確認收入並作為後續確認？謝謝。

Hey Brian, this is Harry. Thanks for the question. Yeah, we recognize revenue when title transfers to, we're either shipping through a specialty pharmacy or directly to the IDN or the community hospital, and we recognize revenue upon receipt by those entities, so we don't wait until the injection occurs, which generally is going to be, within a day of it being received.

嗨，布萊恩，這是哈利。謝謝你的提問。是的，我們在所有權轉移時確認收入，我們要么通過專科藥房發貨，要么直接發貨給IDN或社區醫院，我們在這些實體收到藥品時確認收入，所以我們不會等到注射發生時才確認收入，而注射通常會在收到藥品後的一天內發生。

And as we think about the registered patient population within your patient hub and also the institutional patient hub, I'm curious if you can help us think about, the size and the trajectory of of the registered patients. And then, is it safe to assume that all of the, all these registered patients will get Pepsiios within a defined period of time?

當我們考慮您患者中心和機構患者中心內的註冊患者群體時，我很想知道您是否可以幫助我們思考註冊患者的規模和發展軌跡。那麼，是否可以合理地假設所有這些已登記的患者都會在規定的時間內獲得百事可樂？

Yeah, I mean, look, our hub and the hubs that we're understanding are being set up and implemented at the institutions. They're recruiting patients rapidly. There's a lot of momentum there, and we would expect that to continue, obviously with the bolus of patients that we know is out there.

是的，我的意思是，你看，我們的中心以及我們了解到的其他中心正在各個機構中建立和實施。他們正在迅速招募病人。目前勢頭強勁，我們預計這種勢頭還會持續下去，顯然是因為我們知道有大量患者湧入市場。

They'll be worked through, as we said earlier, those patients are there for a reason because they've been identified for treatment with Pabsimios, and so we would expect the vast majority of those to ultimately then make it onto Pabsimios. The period of time is difficult to pin down, but there's a high sense of urgency. That we have picked up in our interactions with the physician community, whether it's at the IDNs but actually also at the community level with physicians approaching us and wanting to expedite access at the community level. So I do think there will be an expedited uptake from the initial pool of patients that we're seeing, but that will continue for quite a while.

我們會對他們進行評估，正如我們之前所說，這些患者之所以在這裡是有原因的，因為他們已被確定需要接受 Pabsimios 治療，因此我們預計其中絕大多數人最終都會接受 Pabsimios 治療。很難確定具體時間段，但時間非常緊迫。我們在與醫師群體的互動中發現了這一點，無論是在 IDN 層面，還是在社區層面，醫生們主動聯繫我們，希望加快社區層面的醫療服務取得。所以我認為，在我們目前看到的這群患者中，這種療法的接受度會很快提高，但這還需要相當長一段時間。

Yeah, and maybe Brian, I can add really to. Phil said, I think what we are seeing, especially with the broad label, that now we are going to be treating the patients that as early as having one surgery or actually just being diagnosed, and they have to go through the surgery, plus all the other severe patient population that exist there and they are being scheduled by the Physicians. And as we have already knew prior to the approval, but clearly have been seeing it post approval as well from the physicians do not want to do these surgeries, and they are trying to prevent having these surgeries as soon as possible for these patients because they know. That with every surgery, there is basically closer to that damage line of 5 surgeries that it causes irreversible damage for this patient. So I think collectively, when you look at all of that, there is a continuous patient addition and with the understanding that, of course, these patients not only are identified and they will be getting a treatment. And they are enrolling as we speak and actually the prescription is ongoing.

是的，也許布萊恩，我也可以補充一些。菲爾說：“我認為我們現在看到的，尤其是在這個寬泛的標籤下，意味著我們將要治療的患者，最早可能只需要一次手術，或者僅僅是被確診，他們就必須接受手術，此外還有所有其他病情嚴重的患者群體，他們正在由醫生安排手術。”正如我們在批准之前就已經知道的那樣，而且在批准之後也明顯看到了這一點，醫生們不想做這些手術，他們正試圖盡快阻止這些患者接受這些手術，因為他們知道。每次手術，基本上都會使病人更接近那條造成不可逆轉損害的「5次手術」的界線。所以我認為，總的來說，當你把所有這些因素考慮進去時，你會發現患者人數不斷增加，而且我們也明白，這些患者不僅會被識別出來，他們還會接受治療。他們現在正在報名，而且實際上這項計劃正在進行中。

There are no further questions at this time, so I'll turn the call over back to Helen Subzavari for closing comments. Please go ahead.

目前沒有其他問題了，我將把電話轉回海倫·蘇布扎瓦里，請她做總結發言。請繼續。

Thank you to all those participating in the call today. As you can see, times are very exciting for us at Precigen and for the RRP community as a whole. We look forward to providing you with further updates as our launch progresses. In closing, I would like to leave you with words from a PAPZIMEOS patient who is one of the complete responders from the clinical study.

感謝今天所有參加電話會議的人。正如您所看到的，對於 Precigen 和整個 RRP 社區來說，現在都是非常令人興奮的時刻。隨著產品發布的推進，我們將期待為您提供更多最新消息。最後，我想引用一位 PAPZIMEOS 患者的話語作為結尾，他是臨床研究中完全緩解的患者之一。

The sound of hope living with RRP the last 24 years has been the sound of my own voice when I have it. It's being heard, even when this virus is trying to destroy my vocal cords. RRP not only took away my voice physically but also emotionally. So hope for me has been the moments I've been able to speak, and others have been able to hear me. Power of voices is camaraderie and advocacy. Being part of a community that refuses to be silenced. When my voice is weak, others are standing beside me and if needed, speaking up for me. That's power and that's hope. Today, hope sounds different. It's a physician telling their longtime RRP patient, you don't need another surgery, there's something new.

過去 24 年裡，患有復發性呼吸道乳頭狀瘤病 (RRP) 的我，聽到自己的聲音，就如同聽到了希望的聲音。即使這種病毒正在試圖摧毀我的聲帶，我的聲音仍然能被聽到。RRP不僅奪走了我的聲音，也奪走了我的情感。所以對我來說，希望就是我能夠開口說話，別人也能聽到我說話的時刻。聲音的力量在於團結和倡導。成為一個拒絕沉默的社群的一份子。當我聲音微弱時，其他人會站在我身邊，並在必要時為我發聲。這就是力量，這就是希望。今天，希望的含義已經不同了。這是醫生告訴其長期患有復發性呼吸道乳頭狀瘤病 (RRP) 的患者，您不需要再次手術，因為有新的治療方法。

Today, the sound of hope is [Pat Zemios].

今天，希望之聲響起[帕特·澤米奧斯]

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

女士們、先生們，今天的電話會議到此結束。非常感謝您的參與。您現在可以斷開連線了。