Iterum Therapeutics PLC (ITRM) 2025 Q3 法說會逐字稿

Hello, and welcome, everyone, to the Interim Therapeutics third quarter 2025 financial results. My name is Becky and I will be your operator today. (Operator Instructions).

大家好，歡迎來到 Interim Therapeutics 2025 年第三季財務業績發表會。我叫貝基，今天將由我為您接聽電話。（操作說明）

I will now hand over to your host, Kevin Dalton, Senior Director of Legal Affairs, to begin. Please go ahead.

現在我將把發言權交給主持人，法律事務高級總監凱文·道爾頓，由他來開始。請繼續。

Thank you, speaker. Good morning, and welcome to Iterum Therapeutics' third quarter 2025 financial results. A press release with our third quarter results was issued earlier this morning and can be found on our website. We are joined this morning by our Chief Executive Officer, Corey Fishman; our Chief Financial Officer, Judy Matthews; and our Chief Commercial Officer, Christine Coyne. Corey and Christine will provide an update on the commercial launch of ORLYNVAH in the US.

謝謝發言人。早安，歡迎收聽 Iterum Therapeutics 2025 年第三季財務業績報告。今天早些時候，我們發布了包含第三季業績的新聞稿，您可以在我們的網站上找到該新聞稿。今天上午，我們的執行長 Corey Fishman、財務長 Judy Matthews 和商務長 Christine Coyne 也出席了會議。Corey 和 Christine 將介紹 ORLYNVAH 在美國的商業上市。

Corey will also give an update on the business generally, and Judy will provide details on our financial results. We will then open the lines for Q&A. Before we begin, I would like to remind you that some of the information presented on this conference call will contain forward-looking statements concerning our plans, strategies and prospects for our business.

Corey也將介紹公司整體業務的最新情況，Judy將提供我們的財務表現詳情。接下來我們將開放問答環節。在會議開始之前，我想提醒各位，本次電話會議中提供的一些資訊將包含有關我們業務計劃、策略和前景的前瞻性陳述。

Including our expectation that ORLYNVAH 2026 net product sales will be in a range between $5 million and $15 million, the sufficiency of our cash resources to fund our operating expenses into Q2 of 2026, our ability to continue the commercialization of ORLYNVAH in the US, our ability to expand into new territories and put additional resources in high prescribing geographies and to expand the payer coverage of ORLYNVAH in the US, our ability to raise funds either through a capital raise and/or revenue generated from sales of ORLYNVAH, the development, therapeutic and market potential of ORLYNVAH and the protection provided by our patents.

其中包括我們預計 ORLYNVAH 2026 年淨產品銷售額將在 500 萬美元至 1500 萬美元之間，我們現金資源是否足以支付 2026 年第二季度的運營費用，我們能否繼續在美國進行 ORLYNVAH 的商業化，我們能否拓展到新的市場，並在處方數量上投入更多處方量和美國的融資範圍的銷售收入籌集資金，ORLYNVAH 的開發、治療和市場潛力以及我們專利提供的保護。

Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors outside our control. These include our ability to build and maintain a sales force and continue the commercialization of ORLYNVAH in the US, the market opportunity for a potential market acceptance of ORLYNVAH, the actions of third-party suppliers, manufacturers and contract sales organizations, our ability to continue as a going concern, the accuracy of our expectations regarding how far into the future, our cash on hand will fund our ongoing operations and finally, other factors discussed under the caption risk factors in our annual report on Form 10-K -- 10-Q filed with the SEC this morning.

由於各種我們無法控制的因素，實際結果可能與這些前瞻性聲明所指出的結果有重大差異。這些因素包括我們建立和維持銷售隊伍以及繼續在美國商業化 ORLYNVAH 的行動、我們持續經營的能力、我們對未來多久手頭現金能夠為持續經營提供資金的預期是否準確，以及最後，我們在今天早上向美國證券交易委員會提交表格 1010-K 的數據

In addition, any forward-looking statements represent our views only as of the date of this call and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update such statements. We will also be referencing non-GAAP financial measures during the call we have provided reconciliation of GAAP reported to non-GAAP adjusted information in the press release issued this morning.

此外，任何前瞻性陳述僅代表我們截至本次電話會議之日的觀點，不應被視為代表我們截至任何後續日期的觀點。我們特此聲明，沒有義務更新此類聲明。在本次電話會議中，我們也將提及非GAAP財務指標。我們在今天早上發布的新聞稿中提供了GAAP報告與非GAAP調整資訊的調節表。

With that all said, I'll turn it over to you, Corey, for your opening remarks.

說了這麼多，現在就交給你，科里，請你做開場白。

Thank you, Kevin. Welcome to everyone, and thank you for joining us today. We're excited to be talking with you today and especially looking forward to sharing information about the early stages of the ORLYNVAH commercialization. Just to remind you, we launched ORLYNVAH into the market on August 20 of this year.

謝謝你，凱文。歡迎各位，感謝大家今天加入我們。我們很高興今天能與您交流，尤其期待與您分享有關 ORLYNVAH 商業化早期階段的資訊。再次提醒您，我們在今年 8 月 20 日將 ORLYNVAH 推向市場。

Now I'd like to turn the call over to our Chief Commercial Officer, Christine Coyne.

現在我想把電話交給我們的商務長克里斯汀‧科因。

Thank you, Corey, and good morning to everyone. As with nearly every new product launch, changing behaviors and old habits is paramount, particularly in a category where prescribing habit has been ingrained for decades, due to lack of innovation and limited new branded options. Changing health care provider behavior involves frequent office visits and getting time with those prescribers and their office staff.

謝謝你，科里，大家早安。與幾乎所有新產品上市一樣，改變行為和舊習慣至關重要，尤其是在處方習慣已經根深蒂固數十年的領域，這是由於缺乏創新和新品牌選擇有限造成的。改變醫療保健提供者的行為需要頻繁就診，並與開處方醫生及其辦公室工作人員進行充分的溝通。

Our field team has been calling on our providers and ensuring they remember that there is now a better way to help treat their uncomplicated urinary tract infection patients with ORLYNVAH. As with any promotion, message retention and behavior change increases over time and with frequency. That is our current focus with our customers. Each week has improved.

我們的現場團隊一直在拜訪我們的醫療服務提供者，並確保他們記住現在有一種更好的方法，可以使用 ORLYNVAH 來幫助治療他們的非複雜性泌尿道感染患者。與任何推廣活動一樣，資訊的記憶和行為改變會隨著時間的推移和頻率的增加而提高。這是我們目前為客戶提供的服務重點。每週都有進步。

Having said that, we made steady progress in educating providers about ORLYNVAH and driving early ORLYNVAH use among patients suffering from uncomplicated urinary tract infections especially in the most recent weeks. Our momentum with customers has been growing consistently. Through November 12, we generated more than 280 prescriptions which were driven by more than 100 unique prescribers.

儘管如此，我們在教育醫護人員了解 ORLYNVAH 以及推動非複雜性尿路感染患者儘早使用 ORLYNVAH 方面取得了穩步進展，尤其是在最近幾週。我們與客戶的互動勢頭一直在穩步增長。截至 11 月 12 日，我們產生了 280 多張處方，這些處方由 100 多位不同的處方醫生開立。

Nearly half of those prescribers have broadened their experience by prescribing ORLYNVAH to more than one patient. This is an important signal of both physician and patient experience with ORLYNVAH. As physician comfort with ORLYNVAH continues to grow, we have seen a number of these physicians broadening out their use especially in the most recent weeks.

近一半的處方醫生透過給不只一位患者開立 ORLYNVAH 處方來拓寬他們的經驗。這是醫生和患者在使用 ORLYNVAH 時體驗的重要訊號。隨著醫生對 ORLYNVAH 的接受度不斷提高，我們看到許多醫生，尤其是在最近幾週，擴大了其使用範圍。

Another important indicator, which we follow closely, is the fill rate of ORLYNVAH prescriptions through our specialty pharmacy partner. This step in the process has a few parts to it. With new product introductions in many instances, payers have yet to make their decisions on formulary inclusion, which provides coverage for patients.

我們密切關注的另一個重要指標是透過我們的專業藥局合作夥伴完成 ORLYNVAH 處方配藥的完成率。這步驟包含幾個部分。許多新產品上市後，支付方尚未決定是否將其納入健保目錄，而健保目錄的納入決定了病患的健保覆蓋範圍。

That said, there is usually a path forward to help these insured patients get their prescription, and we are working our way through all of this now. As with a large proportion of launches, once payer decisions are made and coverage and access are achieved, this still rate should improve. However, even during this period of launch, while awaiting payer coverage, we have found that approximately 40% of the ORLYNVAH prescriptions have gone through the payer approval processes and has been filled, which aligns with our expectations.

也就是說，通常會有辦法幫助這些投保患者獲得處方，我們現在正在努力解決所有這些問題。與大多數產品上市一樣，一旦支付方做出決定，獲得覆蓋和准入，這一比率應該會有所改善。然而，即使在上市初期，在等待支付方承保期間，我們發現大約 40% 的 ORLYNVAH 處方已經通過了支付方的審批流程並已完成配藥，這與我們的預期相符。

As for the patient's out-of-pocket exposure, we have a co-pay support program that helps defray the cost for appropriate commercial patients. While this may be of help to some patients, it is our intention to work with insurance carriers, including Medicare plans to gain access to and coverage of ORLYNVAH to help optimize this adjudication process and patient out-of-pocket exposure over time.

至於患者的自付費用，我們有共同支付支持計劃，可以幫助符合資格的商業保險患者減輕費用負擔。雖然這可能對一些患者有所幫助，但我們的目標是與保險公司（包括聯邦醫療保險計劃）合作，以獲得 ORLYNVAH 的治療和保險，從而優化這一裁決過程，並隨著時間的推移減少患者的自付費用。

We will discuss more on our progress here in just a moment. With the ORLYNVAH promotion gaining momentum each week, we have received a number of inquiries from physicians interested in obtaining ORLYNVAH to whom the specialty pharmacy distribution is outside of their business practice model. Given the number and frequency of inquiries, such as these, we have been working with two of the most widely used specialty distributors, McKesson and Syncora to tuck into these particular physicians ways of practicing.

我們稍後將詳細討論我們在這裡取得的進展。隨著 ORLYNVAH 的推廣活動每週都在取得進展，我們收到了許多醫生的諮詢，他們有興趣獲得 ORLYNVAH，但專科藥房的分銷不在他們的業務實踐模式之內。鑑於此類諮詢的數量和頻率，我們一直在與兩家最廣泛使用的專業經銷商 McKesson 和 Syncora 合作，深入了解這些特定醫生的行醫方式。

This specialty distribution model allows these physicians to purchase ORLYNVAH through their preferred distributor, and it supports how they like to practice. At this time, we have already shipped ORLYNVAH to McKesson, and we will be shipping ORLYNVAH to Syncora shortly. Customer feedback and insights continue to be received as our efforts expand weekly to a wider set of health care providers and as utilization deepens with those providers who have already prescribed ORLYNVAH.

這種專業分銷模式允許這些醫生透過他們喜歡的經銷商購買 ORLYNVAH，並且支援他們喜歡的行醫方式。目前，我們已經將 ORLYNVAH 發貨給 McKesson，並將很快把 ORLYNVAH 發貨給 Syncora。隨著我們每週將工作範圍擴大到更多醫療保健提供者，以及在已經開立 ORLYNVAH 處方的提供者中加深使用，我們不斷收到客戶的回饋和見解。

Some of the important learnings include physicians welcome ORLYNVAH as a new alternative for physicians to help treat their uncomplicated urinary tract infection patients effectively, but especially where resistance is a challenge. Physicians can clearly see a place for ORLYNVAH to help them break the cycle of patients being treated with multiple antibiotics, which have been resistant.

一些重要的經驗包括：醫生歡迎 ORLYNVAH 作為一種新的替代療法，可以幫助醫生有效地治療非複雜性泌尿道感染患者，尤其是在抗藥性是一個挑戰的情況下。醫生們清楚地看到 ORLYNVAH 在幫助他們打破患者接受多種抗藥性抗生素治療的惡性循環方面發揮著重要作用。

ORLYNVAH provides physicians with a new option. Additionally, our customers have reported the importance of ORLYNVAH helping them to keep their patients out of the hospital. Being able to treat with a new oral option that helps keep their patients at home has been reported of great importance by our physicians.

ORLYNVAH 為醫生提供了一種新的選擇。此外，我們的客戶也反映，ORLYNVAH 對他們幫助患者避免住院至關重要。醫生們表示，能夠使用一種新的口服治療方案來幫助患者在家中進行治療，這一點非常重要。

Also, physicians clinical experience with ORLYNVAH and their patients has and as expected. Lastly, customer feedback coming from our recent presence at the Infectious Disease Week Conference, which was held last month in Atlanta. Our efforts included a poster session a learning lab presentation, confirmed very high interest from both default leaders and large infectious disease group practices with requests for follow-up discussions.

此外，醫生在使用 ORLYNVAH 及其患者方面的臨床經驗也符合預期。最後，我們想分享一下客戶對我們最近參加上個月在亞特蘭大舉行的傳染病週會議的回饋。我們的努力包括海報展示和學習實驗室演示，證實了預設領導者和大型傳染病集團實踐機構對此表現出極大的興趣，並要求進行後續討論。

Overall, we are pleased with the steady progress we have made, particularly given the modest commercial infrastructure we currently have in place. The field team continues working with health care providers as trial and adoption of ORLYNVAH continues. Now regarding our field operations, we continually monitor an array of performance metrics to help us capitalize on opportunities quickly as we discover them as well as optimized areas where effectiveness needs to be improved.

整體而言，我們對取得的穩定進展感到滿意，尤其考慮到我們目前擁有的商業基礎設施還比較有限。隨著 ORLYNVAH 的試驗和推廣繼續進行，現場團隊將繼續與醫療保健提供者合作。關於我們的現場作業，我們會持續監控一系列績效指標，以便在發現機會時能夠迅速抓住它們，並優化需要提高效率的領域。

Based on these diagnostics, we reduced the in-person field team to 10 representatives from our original plan of 20 and are in the process of augmenting our efforts with both in-person and virtual sales representatives. Once fully in place, a combination of the existing resources and our new supplemental resources should provide Iterum the equivalent coverage in at least the initial 20 target geographies, if not more, and it will be done with greater efficiency.

根據這些診斷結果，我們將現場銷售團隊從原計劃的 20 名代表減少到 10 名代表，目前正在透過增加現場銷售代表和虛擬銷售代表來加強我們的工作。一旦全面到位，現有資源和我們新的補充資源相結合，應該能夠為 Iterum 在至少最初的 20 個目標地區提供同等的覆蓋範圍，甚至更多，而且效率會更高。

Now I'd like to spend a few moments and talk about managed care and market access. Overall, Iterum's coverage discussions are advancing well, with positive feedback from both pharmacy benefit managers and health plans across both their commercial and Medicare Part D formularies. Iterum national account managers continue to engage strategically with key stakeholders across the US payer landscape.

現在我想花幾分鐘時間談談醫療管理和市場准入。總體而言，Iterum 的承保範圍討論進展順利，藥房福利管理機構和健康計劃都對其商業和 Medicare Part D 處方集給予了積極的反饋。Iterum 的全國客戶經理繼續與美國支付方領域的關鍵利益相關者進行策略性互動。

ORLYNVAH's differentiated value proposition and ongoing formulary discussions with state, regional and national health plans, including the three-largest pharmacy benefit managers have been met with strong interest and positive feedback. Today, we are pleased to announce that we have a signed rebate agreement with one of the top three Medicare Part D pharmacy benefit managers.

ORLYNVAH 的差異化價值主張以及與州、地區和國家健康計劃（包括三大藥品福利管理公司）的持續處方集討論，都引起了強烈的興趣和積極的反饋。今天，我們很高興地宣布，我們已與排名前三的 Medicare Part D 藥房福利管理機構之一簽署了回扣協議。

This agreement enables ORLYNVAH to be added to their Medicare Advantage prescription drug plan and Medicare prescription drug plan formularies for coverage beginning in 2026 or '27 depending upon the individual plan structures. Also, Iterum has been invited to bid for formulary inclusion across commercial, Medicare Part D and government segments managed by these pharmacy benefit managers.

根據該協議，ORLYNVAH 將被添加到他們的 Medicare Advantage 處方藥計劃和 Medicare 處方藥計劃的藥品目錄中，從 2026 年或 2027 年開始提供保障，具體取決於各個計劃的結構。此外，Iterum 也受邀參與競標，爭取將這些藥品納入由這些藥品福利管理機構管理的商業、Medicare Part D 和政府部門的藥品目錄。

With submissions now complete, we are aiming to secure long-term formulary positioning later this year and into Q1 2026. ORLYNVAH's access continues to grow with or without prior authorization or medical exception pathways. Coverage now reaches 16% of insured lives with increasing adoption by employer groups and payer formularies integrating ORLYNVAH into their standard benefit design.

提交工作現已完成，我們的目標是在今年稍後以及 2026 年第一季確保長期藥品目錄地位。無論是否事先獲得授權或醫療豁免途徑，ORLYNVAH 的使用範圍都在不斷擴大。目前，ORLYNVAH 的覆蓋率已達 16% 的投保人，越來越多的雇主團體和支付方將 ORLYNVAH 納入其標準福利設計中。

We expect additional decisions in the coming quarters and continue to see an increase in patient access and early prescription growth, reinforcing our confidence in the commercial trajectory.

我們預計未來幾季會有更多決定出台，我們將繼續看到患者就醫機會增加和早期處方成長，這增強了我們對商業發展軌蹟的信心。

Now I'd like to turn it back over to Corey. Thank you.

現在我想把話題交還給科里。謝謝。

Thanks for the update on ORLYNVAH's commercialization Christine. I'll make a few additional remarks. With regard to our patent estate, we continue to expand our coverage. We've been granted a patent in China that covers a combination of sulopenem etzadroxil for benefit and valproic acid for treating specified diseases. This patent is expected to expire in March 2041, absent any patent term extensions.

克里斯汀，謝謝你提供的關於ORLYNVAH商業化的最新資訊。我再補充幾點。就我們的專利組合而言，我們將繼續擴大覆蓋範圍。我們已在中國獲得一項專利，該專利涵蓋了用於治療特定疾病的磺吡啶乙胺羥嗪和丙戊酸的組合。如無專利期限延長，專利預計將於 2041 年 3 月到期。

We have also been granted a patent in Mexico that covers a bilayer tablet comprising sulopenem etzadroxil and probenicid, methods of preparing the tablet and the bilayer tablet for use in treating specified diseases. This patent is projected to expire in December 2039, absent any patent term extensions. I now would like to provide some financial guidance.

我們還在墨西哥獲得了一項專利，該專利涵蓋一種包含舒洛培南艾司羥甲酯和丙磺舒的雙層片劑、製備該片劑的方法以及用於治療特定疾病的雙層片劑。如無專利期限延長，該專利預計將於 2039 年 12 月到期。現在我想提供一些財務方面的指導。

As you may have seen in our financial statements, Iterum generated net product sales of $400,000 in the third quarter, which included some stocking at our specialty pharmacy. We expect modest sales in the fourth quarter this year as well.

正如您可能在我們的財務報表中看到的那樣，Iterum 在第三季度實現了 40 萬美元的淨產品銷售額，其中包括我們專科藥房的一些庫存。我們預計今年第四季銷售額也將保持穩定。

As we look ahead to 2026 with our existing field organization continuing to call on their targets, the additional resources we plan to add that Christine mentioned earlier, as well as obtaining coverage in key pharmacy benefit manager insurance plans, we currently expect our full year 2026 net product revenue to be in a range between $5 million and $15 million.

展望 2026 年，隨著我們現有的現場組織繼續拜訪目標客戶，以及 Christine 先前提到的我們計劃增加的額外資源，再加上獲得主要藥房福利管理保險計劃的覆蓋，我們目前預計 2026 年全年淨產品收入將在 500 萬美元至 1500 萬美元之間。

It's important to note that if Iterum were to achieve this revenue guidance for next year, it will have done so with a modest field organization relative to other antibiotic launches in the US. As it relates to total operating expenses, we currently estimate these will be between $25 million and $30 million for the full year 2026. Our existing cash and cash equivalents provides an operating runway into the second quarter of 2026.

值得注意的是，如果 Iterum 能夠實現明年的收入預期，那麼相對於美國其他抗生素上市企業而言，其現場組織規模將相當有限。至於總營運費用，我們目前預計 2026 年將全年在 2,500 萬美元至 3,000 萬美元之間。我們現有的現金及現金等價物足以支撐公司營運至 2026 年第二季。

In order to continue commercialization throughout 2026 and we will need to raise more capital. We have and will continue to discuss potential financing opportunities with available sources of capital, including nondilutive funding options but to date, have yet to secure a viable transaction. As such, we will likely look to obtain approval from our shareholders at an extraordinary general meeting over the coming months to grant our Board of Directors' authority to issue additional shares.

為了在 2026 年繼續商業化，我們需要籌集更多資金。我們已經並將繼續與現有資金來源討論潛在的融資機會，包括非稀釋性融資方案，但迄今為止，尚未達成可行的交易。因此，我們可能會在未來幾個月召開的特別股東大會上尋求股東批准，以授予董事會發行額外股份的權力。

If we are successful in getting this approval and raising incremental capital we would use those funds to continue the ongoing ORLYNVAH commercialization as well as potentially putting additional resources against high-value territories or expand into other highly valuable territories not yet tapped by us or both.

如果我們成功獲得批准並籌集到額外的資金，我們將利用這些資金繼續推進 ORLYNVAH 的商業化進程，並有可能將更多資源投入到高價值領域，或擴展到我們尚未涉足的其他高價值領域，或者兩者兼而有之。

Of course, our goal over the next couple of years is to generate revenue in excess of the amount of expenses we have and be self-funding. In summary, the feedback from physicians, payers and patients have been very good for ORLYNVAH and we are encouraged by the results we've achieved to date. If we're successful in raising additional capital, we believe we can continue to drive revenue growth and position ORLYNVAH for broader market adoption.

當然，我們未來幾年的目標是創造超過支出的收入，並實現自給自足。總而言之，醫生、支付方和患者的回饋對 ORLYNVAH 都非常積極，我們對迄今為止的成果感到鼓舞。如果我們成功籌集到更多資金，我們相信我們可以繼續推動收入成長，並使 ORLYNVAH 獲得更廣泛的市場認可。

Now I'll turn the call over to Judy Matthews for a financial update.

現在我將把電話交給朱迪·馬修斯，請她介紹一下最新的財務狀況。

Thanks, Corey. Net product revenues were $0.4 million in the third quarter of 2025 with the launch of ORLYNVAH in the United States in August 2025 and included initial stocking at our specialty pharmacies locations serving our targeted territories. Total operating expenses were $8.1 million in the third quarter 2025 compared to $4.9 million in the third quarter 2024.

謝謝你，科里。2025 年第三季淨產品收入為 40 萬美元，ORLYNVAH 於 2025 年 8 月在美國上市，其中包括在我們服務於目標區域的專科藥房的初始庫存。2025 年第三季總營運支出為 810 萬美元，而 2024 年第三季為 490 萬美元。

Operating expenses include cost of sales, the amortization of an intangible asset, research and development expenses and selling, general and administrative expenses. Cost of sales expense for the third quarter 2025 was $0.02 million and primarily consisted of royalty payments pursuant to our license agreement with Pfizer.

營業費用包括銷售成本、無形資產攤提、研發費用及銷售、一般及行政費用。2025 年第三季的銷售成本費用為 0.02 億美元，主要包括根據我們與輝瑞的授權協議支付的特許權使用費。

Note that prior to approval in October 2024, costs incurred for the manufacturer of ORLYNVAH were recorded as research and development expenses. Amortization of intangible assets for the third quarter 2025 was $0.3 million and related to the finite-lived intangible assets recognized in relation to the regulatory milestone payments payable to Pfizer upon approval ORLYNVAH by the FDA.

請注意，在 2024 年 10 月獲得批准之前，ORLYNVAH 製造商發生的成本被記錄為研發費用。2025 年第三季無形資產攤銷額為 0.3 百萬美元，與 FDA 批准 ORLYNVAH 後應向輝瑞支付的監管里程碑付款相關的有限壽命無形資產有關。

R&D costs were $1.3 million for the third quarter compared to $3.1 million for the same period in 2024. The primary driver of the decrease in R&D expense for the third quarter with lower chemistry manufacturing and control or CMC related expenses. Following approval, costs incurred for the manufacture of ORLYNVAH have been capitalized to inventory.

第三季研發成本為 130 萬美元，而 2024 年同期為 310 萬美元。第三季研發費用下降的主要原因是化學製造和控製或CMC相關費用降低。獲得批准後，ORLYNVAH 的生產成本已資本化計入庫存。

SG&A costs were $6.5 million for the third quarter compared to SG&A costs of $1.8 million for the same period in 2024. The primary driver of the increase in SG&A expense for the third quarter was commercialization activities associated with the August 2025 launch of ORLYNVAH in the United States. Our net loss on a US GAAP basis was $9 million for the third quarter of 2025 compared to a net loss of $6.1 million for the third quarter of 2024.

第三季銷售、一般及行政費用為 650 萬美元，而 2024 年同期銷售、一般及行政費用為 180 萬美元。第三季銷售、一般及行政費用增加的主要原因是與 ORLYNVAH 於 2025 年 8 月在美國上市相關的商業化活動。根據美國通用會計準則，我們2025年第三季的淨虧損為900萬美元，而2024年第三季的淨虧損為610萬美元。

On a non-GAAP basis, which excludes certain noncash adjustments, our net loss of $7.3 million in the third quarter 2025 compared to our non-GAAP net loss of $4.8 million in the third quarter 2024. The $2.5 million increase in our non-GAAP net loss for the third quarter was primarily a result of commercialization activities for ORLYNVAH, partially offset by lower CMC-related expenses.

以非GAAP準則（不包括某些非現金調整）計算，我們2025年第三季的淨虧損為730萬美元，而2024年第三季的非GAAP淨虧損為480萬美元。第三季非GAAP淨虧損增加250萬美元，主要是由於ORLYNVAH的商業化活動，部分被CMC相關費用的減少所抵銷。

At the end of September, we had cash and cash equivalents of $11 million. Based on our current operating plan, which includes our forecasted sales, we expect that our cash and cash equivalents together with $2.6 million of net proceeds raised under our at-the-market offering program from October 1, 2025 through November 13, 2025 will be sufficient to fund our operations into the second quarter of 2026. As of November 13, 2025, we had approximately 52.8 million ordinary shares outstanding.

截至9月底，我們擁有現金及現金等價物1,100萬美元。根據我們目前的營運計畫（包括我們預測的銷售額），我們預計，我們的現金及現金等價物，加上從 2025 年 10 月 1 日至 2025 年 11 月 13 日期間透過市場發行計畫籌集的 260 萬美元直至淨收益，將足以支持我們的營運第二季。截至 2025 年 11 月 13 日，我們約有 5,280 萬股普通股流通在外。

Now we will open it up for questions.

現在我們開放提問環節。

(Operator Instructions) Ed Arce, WestPark Capital.

（操作員說明）Ed Arce，WestPark Capital。

Congrats on the initial launch here. A few questions. First of all, appreciate all the detail here with the launch metrics around the commercialization. Wondering if this is the specific numbers around patients and prescribers and reps and coverage are data points that you intend to report for the first few quarters of the launch for us to track.

恭喜你們在這裡成功上線。幾個問題。首先，非常感謝這裡提供的所有關於商業化啟動指標的詳細資訊。我想知道這是否是您打算在產品上市後的前幾季報告的患者、處方醫生、銷售代表和保險覆蓋範圍等具體數據點，以便我們進行追蹤。

And related to that, I was wondering if you could discuss the number of actual physician details and also the number of sales regions that you currently plan to continue? And I have a follow-up.

另外，我想請您介紹一下您目前計劃繼續合作的醫生人數和銷售區域數量？我還有一個後續問題。

Thanks for the questions, Ed. I'll cover this. The question around the metrics, yes, we do plan to report the kind of the prescriptions, the growth, the number of physicians, the general information so people have a sense of how the launch is going. I think at some point, if all goes well, and we're generating tons and tons of scripts, we'll do things like most other companies do, which is report the growth quarter-over-quarter, that kind of thing.

謝謝你的提問，艾德。我會解答的。關於指標方面的問題，是的，我們計劃報告處方類型、增長情況、醫生數量、一般信息，以便人們了解產品發布的情況。我認為，如果一切順利，我們能夠產生大量的劇本，那麼在某個時候，我們會像大多數其他公司一樣，按季度報告成長情況等等。

So we will be more specific in the first couple of quarters till we have some data behind us and then we'll probably branch out to providing the same information but maybe not quite as granular. With regard to details and territories, we're not talking about specific number of details. What I will tell you is what I think is important.

因此，在前幾個季度，我們會更加具體，直到我們累積了一些數據，然後我們可能會擴大範圍，提供相同的信息，但可能不會那麼細緻。至於細節和地域方面，我們指的不是具體的細節數量。我將告訴你們我認為重要的事。

We started out our initial thinking was having 20 territories with high-value targets and I think with this change in the organization, as Christine mentioned, as well as the supplemental resources we will be putting on we will be in a position to at least effectively cover 20 of those territories, maybe a little more, but ultimately more efficiently. So I think that's probably the range that we'll be in. And again, we'll continue to report that as we do going forward with regard to how our performance is.

我們最初的想法是設立 20 個高價值目標區域，我認為隨著組織結構的改變，正如 Christine 所提到的，以及我們將投入的補充資源，我們將能夠至少有效地覆蓋其中 20 個區域，也許更多一些，但最終會更有效率。所以我認為我們大概會處於這個範圍內。我們將繼續報告我們的業績表現，就像我們今後所做的那樣。

Great. Okay. And then around the guidance for net sales next year, you -- in your release, discussed two particular drivers. Payer coverage, which I think you said is currently at 16% of insured lives and uptake. I'm wondering if you could give a bit more color or details around those two drivers, and in particular, with uptake, if there's any initial feedback you've gotten from physicians around the product profile of being oral and keeping the patients at home and how that's driving their interest.

偉大的。好的。然後，在談到明年的淨銷售額預期時，您在新聞稿中討論了兩個特別的驅動因素。支付方覆蓋率，我想您之前說過，目前已達到投保人數的 16% 和投保率。我想知道您能否就這兩個驅動因素提供更多細節，特別是關於市場接受度，您是否從醫生那裡獲得了關於該產品口服特性以及讓患者待在家中如何引起他們興趣的初步反饋。

Sure. So I will cover the second part first, which is the feedback. Feedback from physicians has been very good. I think there's a variety of reasons that physicians are using the product, as Christine mentioned. One of them is certainly to keep those patients that are most at risk out of the hospital. One of them is when you have recurrent infections, you want to make sure you're treating that infection appropriately since these folks have been on potentially multiple drugs over a short period of time that haven't worked.

當然。那我先來講第二部分，也就是回饋部分。醫生們的回饋非常好。我認為醫生使用該產品的原因有很多，正如克里斯汀所提到的那樣。其中一項措施當然是讓那些風險最高的病人遠離醫院。其中之一是，當出現反覆感染時，你需要確保對感染進行適當的治療，因為這些人可能在短時間內服用過多種藥物，但這些藥物都沒有效果。

And also the folks who have those comorbidities and who are on that higher end of the risk spectrum, I think physicians see this as an excellent option and we will -- we'll continue to work with physicians to get that message across. Your other question, I think, was around access and coverage. We are, I think, in a good spot.

對於那些患有合併症且處於較高風險水平的人來說，我認為醫生也認為這是一個極好的選擇，我們將繼續與醫生合作，將這一訊息傳達給他們。我認為你的另一個問題是關於接入和覆蓋範圍的。我認為，我們目前處境不錯。

As most of the folks on this call know you really don't get coverage in the first six-months from any plan post launch. That is just something that the PBMs, the pharmacy benefit managers generally do not do. And so we're approaching that six-month time frame in kind of February time frame for us. And as mentioned, we have submitted bids to all of them.

正如本次電話會議中的大多數人所知，任何計劃在推出後的前六個月內實際上都不提供任何保障。這是藥品福利管理機構（PBM）通常不會做的事情。因此，我們差不多在二月左右就接近六個月的時間節點了。正如前面提到的，我們已經向所有這些公司提交了投標書。

So now it's just a question of being able to get on those plans and get coverage, which will make the process even more efficient. Even though there is a process in place, of course, where you can get those prescriptions filled, we can make it a more efficient process through the addition of ORLYNVAH to those formularies.

所以現在的問題只是能否加入這些計劃並獲得保障，這將使整個過程更有效率。當然，雖然目前已經有了可以配藥的流程，但我們可以透過將 ORLYNVAH 添加到這些處方集中，使這個過程更加有效率。

So I think we're really looking at that as an opportunity to have additional efficiency in the system, so more and more scripts can be filled while you're continuing to have strong uptake with these physicians who are prescribing. And again, we've got a lot of physicians that have written multiple scripts already. And I think that's really an important metric because oftentimes, especially in these places where you haven't had a new product for many, many years, and we know that this has been that place. 25, 30 years, docs are pretty ingrained in what they're writing.

所以我認為我們真的應該把這看作是一個提高系統效率的機會，這樣就可以開出更多的處方，同時還能繼續保持醫生們對處方藥的積極接受度。而且，我們有許多醫生已經編寫了多份劇本。我認為這確實是一個重要的指標，因為很多時候，尤其是在那些很多年都沒有推出新產品的地方（我們知道這裡就是這樣的地方，已經有25年、30年沒有推出新產品了），文檔的內容已經根深蒂固。

And so it does take a few visits to get them to right and the folks who have written, many of them have come back and written again and again and again. So I think we're feeling like we've got a real opportunity here to continue that momentum, and that's really the drivers for us of how we're arriving at the revenue guidance.

因此，確實需要幾次拜訪才能把它們弄好，而且那些寫過信的人，很多都反覆回來寫信。所以我覺得我們現在確實有機會繼續保持這種勢頭，而這正是我們得出營收預期的真正驅動因素。

Jason McCarthy, Maxim Group.

Jason McCarthy，Maxim集團。

Corey, nice job of getting things off the ground so far. So just a follow-up on the prior question. Did I catch it right? You expect formulary -- I guess you submitted this already with PBMs in February of 2026 or sometime in the first quarter?

Corey，目前為止，你做得很好，讓事情順利啟動。所以，我再補充一下之前的問題。我理解對了嗎？您預計藥品目錄－我猜您已經在2026年2月或第一季向藥品福利管理機構提交了？

Yes. We're hoping that's the case. Obviously, we don't have control of that, Jason. But all of our -- we're doing everything we can on our end to make that as feasible as possible by having our bids already submitted. So we have now submitted our bids to all the three big PBMs as well as the big Medicare Part D plans.

是的。我們希望情況確實如此。顯然，我們對此無能為力，傑森。但是，我們正在盡一切努力，透過提交投標書，使其盡可能地可行。所以我們現在已經向三大藥品福利管理機構以及各大聯邦醫療保險D部分計劃提交了投標書。

So as we said, we've secured on contract so far on the Medicare Part D side. And so these will hopefully be coming in over the end of this quarter and the first quarter, and that would give us that opportunity to really kind of give an extra boost to the efficiency of the process.

正如我們所說，到目前為止，我們在 Medicare Part D 方面已經簽訂了合約。因此，這些預計將在本季末和第一季陸續到貨，這將給我們一個機會，真正進一步提高流程效率。

Is there any effort by EVERSANA or strategy rather, in terms of advertising or using social media outlets to get the word out on ORLYNVAH to try to drive uptake?

EVERSANA 是否有任何努力或策略，例如廣告宣傳或利用社交媒體管道來宣傳 ORLYNVAH，以推動其普及？

Yes. It's definitely something we've thought about. We are -- at this stage, we have put the majority of our investment into the field organization and the materials necessary to support that. But it's definitely something that we continue to look at and think about the ways to optimize that social media presence and how we can get that message across, given that we've got that modest infrastructure.

是的。這確實是我們考慮過的問題。現階段，我們已將大部分投資投入到現場組織和支持該組織所需的材料中。但鑑於我們目前擁有的基礎設施有限，我們肯定會繼續關注並思考如何優化我們在社群媒體上的存在感，以及如何傳遞訊息。

Okay. Do you plan on -- and despite have been covered already, do you plan on, in addition to script data down the road, releasing any information on the types of patients that are being treated? I don't know if that data is being accumulated, meaning are they high risk or even further? Are there specific types of comorbidities and high-risk aspects to these patients that you will gain access to?

好的。儘管這個問題之前已經討論過，但您是否計劃，除了將來公佈處方數據之外，還會公佈有關正在接受治療的患者類型的任何信息？我不知道這些數據是否正在被收集，也就是說，它們是否屬於高風險甚至更高風險？您將接觸到哪些特定類型的合併症和高風險因素？

Yes. We're not going to have a lot of those specifics because that gets into the doctor-patient relationship. I think what we'll end up having is more anecdotal information from those prescribing physicians and we certainly will always be cognizant of who's writing, what information can we get from them about the patients and how it's working so we can optimize.

是的。我們不會透露太多細節，因為這涉及醫病關係。我認為最終我們會得到更多來自開處方醫生的軼事信息，而且我們當然會始終關注是誰在撰寫，我們可以從他們那裡獲得有關患者及其治療效果的信息，以便我們進行優化。

And to your point, if we find that a certain comorbidity has been really important for a number of doctors, we certainly can get that from them through the sales organization and then figure out a plan to optimize that. But if it's a little bit trickier just because of all the confidentiality around patient information and you can't really know any of the details on the name and anything like that of the patient, it would really have to be more just anecdotal from the docs.

正如您所說，如果我們發現某種合併症對許多醫生來說非常重要，我們當然可以透過銷售部門從他們那裡了解這一點，然後製定一個優化方案。但是，由於患者資訊的保密性，情況就有點棘手了，你無法真正知道患者的姓名等任何細節，那就只能更多地依靠醫生的軼事描述。

Got it. And lastly, and this is -- not really sure the type events that you expect from this. Is it more of a broad thinking question because I've been doing this for a long time, and I see a lot of one product companies and drug launches that they're slow to start, they're choppy. Some people question what that growth is going to look like.

知道了。最後，還有一點——我不太確定你期望從這裡發生什麼類型的事件。這更像是一個需要廣泛思考的問題，因為我從事這行很久了，我看到很多只專注於單一產品的公司和藥物上市，它們的起步都很慢，進展也很不順利。有些人質疑這種成長將會是什麼樣子。

But my pushback in this case has been an oral penem has been sought after for decades, and it's not just for community infections like urinary tract infections. Have you -- do you think people are going to want this oral penem for a variety of things? If you've got an inbound interest and getting access to the drug for any kind of infection.

但我對此的反對意見是，人們幾十年來一直在尋找口服培南類藥物，而且它不僅適用於泌尿道感染等社區感染。你認為人們會因為各種原因需要這種口服培南黴素嗎？如果您有興趣取得治療任何類型感染的藥物。

Yes. We've gotten a lot of inbound interest from people that aren't on our call list that people that we're not covering infectious disease, physicians, et cetera. So I think there's a lot of interest in that. We obviously have an indication that we will promote on, and that is -- that's the only thing we will be talking about, but to the extent that there are physicians who call us up and ask for the product, we will absolutely supply it simply because we believe that it's an important piece if a physician is asking for us.

是的。我們收到了很多來自不在我們電話名單上的人的諮詢，這些人包括我們沒有涵蓋的傳染病領域、醫生等等。所以我覺得大家對此很有興趣。我們顯然有推廣的重點，那就是——這是我們唯一要談論的，但如果有醫生打電話來詢問該產品，我們一定會提供，因為我們認為，如果醫生向我們索要，那它就是一件重要的產品。

And that's why we've gone to McKesson and Syncora because going through a specialty distributor like ours is out of the kind of their business model for these types of physicians who are giving us inbound calls. So we obviously are going to be very, very mindful out of an organization to stay within our approved indication, but we will certainly respond to physicians inquiries because that may very well be for uncomplicated UTI.

這就是為什麼我們選擇與 McKesson 和 Syncora 合作的原因，因為對於打電話給我們的這類醫生來說，透過像我們這樣的專業經銷商進行銷售並不符合他們的商業模式。因此，我們顯然會非常非常注意在組織內部遵守我們批准的適應症，但我們肯定會回應醫生的詢問，因為這可能與單純性泌尿道感染有關。

We just -- we don't know, and physician has the flexibility to write it for whatever it is they choose to write it for.

我們只是──我們不知道，醫生有權根據自己的意願開立任何診斷證明。

Antonio Arce, WestPark Capital.

安東尼奧·阿爾塞，WestPark Capital。

Great. I just wanted to ask about this effort to augment the now 10 reps with the virtual effort, especially because you've characterized this as at least replacing the other 10 from the original 20 that you had targeted and perhaps a bit more. And so I'm wondering if you could provide some more detail in terms of the capabilities and the ability to engage with physicians through these different virtual platforms.

偉大的。我只是想問一下，您是如何將現在的 10 次重複動作與虛擬訓練結合起來的，特別是因為您曾表示，這至少可以替代您最初設定的 20 次重複動作中的另外 10 次，甚至可能更多。所以我想知道您能否詳細介紹一下這些不同的虛擬平台的功能以及透過這些平台與醫生互動的能力。

So I want to be really clear. We will probably do a combination of both in field and virtual to get to that at least 28 effective territories, if not more. And so on the virtual side, I think what you have seen, and you've probably seen this in your experience as well, many companies have used virtual reps who tend to be very efficient because they are using the same target lists, but they're doing this all virtually.

所以我想把話說清楚。我們可能會採用實地和虛擬相結合的方式，以達到至少 28 個有效地區，甚至更多。所以在虛擬方面，我認為你已經看到了，而且你可能也從自己的經驗中看到了，許多公司都使用了虛擬代表，他們往往非常高效，因為他們使用相同的目標名單，但他們都是在虛擬環境中完成這一切的。

So it's all through a phone and computer as opposed to reps who are out there having to drive, having to wait, et cetera. They can schedule meetings. They can be quite a bit more efficient on the interactions with physicians simply because they're sitting at a desk, not trying to drive around and find people and/or get in through the office.

所以所有操作都透過電話和電腦完成，而不再需要銷售代表開車、等待等等。他們可以安排會議。他們與醫生互動時效率會高得多，因為他們只需坐在辦公桌前，而不用開車四處尋找病人或進入辦公室。

So those people tend to be based on the experience that EVERSANA has had as well as a lot of other companies that we've all spoken to have had a very good reputation of being efficient in terms of producing performance. So we believe that those virtual reps can be a very important part of our organization in addition to the in-field reps.

因此，這些人往往是根據 EVERSANA 的經驗以及我們交談過的許多其他公司的經驗得出的結論，這些公司在生產性能方面都享有很高的效率聲譽。因此，我們相信，除了現場銷售代表之外，這些虛擬銷售代表也可以成為我們組織中非常重要的一部分。

I don't want to minimize one or the other because they're both incredibly important. But we do think the combination of the two is really going to give us the opportunity to reach a lot of targets in an effective way and hopefully drive that performance to the place where we're talking about.

我不想輕視其中任何一方，因為它們都非常重要。但我們認為，這兩者的結合確實會為我們帶來有效實現許多目標的機會，並有望將業績提升到我們所談論的水平。

Okay. At this point, are you considering other marketing channels like medical journals or engagement via social media or other channels like that?

好的。目前，您是否考慮過其他行銷管道，例如醫學期刊、社群媒體或其他類似管道的互動？

Yes. I think what we've talked a lot about with our partners at EVERSANA is things like social media tend to be more effective nowadays than the traditional kind of journal ads and things like that but we will continue to look at them. We'll continue to look at historical return on investment for those types of investments over various companies like ours that have used them and we'll try to optimize those as best we can.

是的。我認為我們和 EVERSANA 的合作夥伴討論了很多，例如社群媒體如今往往比傳統的雜誌廣告等方式更有效，但我們會繼續關注它們。我們將繼續研究與我們類似的公司過去使用這類投資的報酬率，並盡力優化這些投資。

Again, we're trying to be as mindful as we can about the capital we have and putting it where we believe we're going to get the biggest bang for the buck. And right now, that tends to be the field organization Hopefully, we'll have a little more flexibility if we're successful in raising more capital to put some of those other things into play. And altogether, then it makes everything more efficient. It's just a question of having that flexibility.

再次強調，我們會盡可能謹慎地使用現有資金，並將其投入到我們認為能夠獲得最大回報的地方。目前，這往往是現場組織架構。希望如果我們能成功籌集更多資金，就能有更大的彈性來實施其他一些措施。總而言之，這樣一來，一切都會變得更有效率。關鍵在於是否具備這種靈活性。

This concludes our Q&A session. I'll hand back over to Corey Fishman for closing remarks.

問答環節到此結束。接下來我將把發言權交還給科里·菲什曼，請他作總結發言。

Thank you, Becky. In closing, we believe we've made some very solid progress in the first 10-weeks of ORLYNVAH commercialization. Physicians see a place in the market for ORLYNVAH, and many physicians have begun prescribing for multiple patients. We will continue to work tirelessly toward growing the ORLYNVAH patient base and driving incremental revenues.

謝謝你，貝基。最後，我們認為在 ORLYNVAH 商業化的前 10 周里，我們已經取得了非常紮實的進展。醫生們看到了 ORLYNVAH 在市場上的一席之地，許多醫生已經開始為多名患者開立這種藥。我們將繼續不懈努力，擴大 ORLYNVAH 的患者群體，並推動收入成長。

We really appreciate your support as we continue the ORLYNVAH commercialization and are looking forward to keeping you updated as our key milestones are met. Thanks again for joining us today, and have a good day.

我們非常感謝您在 ORLYNVAH 商業化進程中的支持，並期待在達到關鍵里程碑時及時向您報告最新進展。再次感謝您今天的參與，祝您有美好的一天。

This concludes today's call. Thank you for joining us. You may now disconnect your lines.

今天的電話會議到此結束。感謝您的參與。現在您可以斷開線路了。