LENZ Therapeutics Inc (LENZ) 2025 Q1 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to the LENZ Therapeutics first quarter 2025 Financial results conference call. (Operator Instructions) As a reminder, this call is being recorded.

女士、先生們，下午好，歡迎參加 LENZ Therapeutics 2025 年第一季財務業績電話會議。（操作員指示）提醒一下，此通話正在被錄音。

At this time, I would like to turn the call over to Dan Chevallard, Chief Financial Officer. Please go ahead.

現在，我想將電話轉給財務長 Dan Chevallard。請繼續。

Thank you. Good afternoon and thank you for joining us today. My name is Dan Chevallard, Chief Financial Officer of LENZ Therapeutics. We are joined today by Ev Schimmelpennink, our President and Chief Executive Officer; and Shawn Olsson, our Chief Commercial Officer; as well as Dr. Marc Odrich, Chief Medical Officer, who will join us for the question-and-answer session.

謝謝。下午好，感謝您今天加入我們。我叫 Dan Chevallard，是 LENZ Therapeutics 的財務長。今天，我們的總裁兼執行長 Ev Schimmelpennink、首席商務長 Shawn Olsson 以及首席醫療官 Marc Odrich 博士也將參加我們的問答環節。

Before we begin, I would like to remind you that this call will contain forward-looking statements regarding LENZ's future expectations, plans, prospects, corporate strategy, regulatory and commercial plans and expectations, cash runway projections and performance. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors and risks, including those discussed in our filings with the Securities and Exchange Commission, which can also be found on our website.

在我們開始之前，我想提醒您，本次電話會議將包含有關 LENZ 未來預期、計劃、前景、公司策略、監管和商業計劃和預期、現金跑道預測和業績的前瞻性陳述。由於各種重要因素和風險，包括我們向美國證券交易委員會提交的文件中討論的因素和風險（這些文件也可以在我們的網站上找到），實際結果可能與這些前瞻性陳述所示的結果有重大差異。

In addition, any forward-looking statements represent only our views as of the date of this webcast and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements. The company encourages you to consult the risk factors contained in our SEC filings for additional detail, including in our first quarter 2025 Form 10-Q, which was filed today.

此外，任何前瞻性陳述僅代表我們截至本次網路廣播之日的觀點，不應被視為代表我們在任何後續日期的觀點。我們明確否認有更新此類聲明的任何義務。本公司鼓勵您查閱我們提交給美國證券交易委員會 (SEC) 的文件中包含的風險因素以獲取更多詳細信息，包括我們今天提交的 2025 年第一季度 10-Q 表。

With that, I'll now turn the call over to Ev.

說完這些，我現在將發言權交給 Ev。

Thank you, Dan, and good afternoon, everyone. The first quarter of 2025 has been a focused and highly productive period for LENZ. With our PDUFA target action date for LNZ100 now just three months away, we are entering into what we believe will be a defining chapter in our company's growth. Back in January, I said that 2025 had the potential to be a transformational year and with each passing milestone that's proving to be the case. In prior quarters, we emphasized our commitment to disciplined execution as we are advancing LNZ100 to launch and I believe in its potential as a category-defining treatment for presbyopia.

謝謝你，丹，大家下午好。2025 年第一季對 LENZ 來說是一個專注且高產的時期。現在距離 LNZ100 的 PDUFA 目標行動日期僅剩三個月，我們即將進入公司發展的決定性篇章。早在 1 月份，我就說過 2025 年有可能成為改變的一年，而隨著每個里程碑的過去，事實也證明這一點。在前幾季度，我們強調了對嚴格執行的承諾，因為我們正在推進 LNZ100 的推出，我相信它有潛力成為老花眼治療的分類治療方法。

That focus hasn't wavered, and we've been doing all of this while maintaining a strong financial foundation to support our growth. The foundation in recent weeks has been further strengthened through a block trade as a result of an inbound from a high-quality investor eager to initiate a meaningful starting position in our stock. Their interest was, amongst others, triggered by our Commercial Day, which we hosted in April at the Nasdaq market site. Our objective was to provide a clear and comprehensive look at our commercial readiness and share our excitement for the upcoming potential launch of LNZ100. There was an outstanding event with many investors and sell-side analysts joining in person, hundreds more joining live online and many others who have watched the replay since.

這一重點從未動搖，我們一直在做這一切，同時保持強大的財務基礎來支持我們的成長。最近幾週，由於一位優質投資者渴望在我們的股票上取得有意義的起始位置，透過大宗交易，基礎得到了進一步加強。他們的興趣源自於我們四月在納斯達克市場舉辦的商業日活動。我們的目標是清晰全面地介紹我們的商業準備情況，並分享我們對即將推出的 LNZ100 的興奮之情。這是一場精彩的活動，許多投資者和賣方分析師親自參加，數百人在線上觀看直播，還有許多人觀看了重播。

The feedback has been extremely positive. We believe we accomplished what we set out to do, demonstrate the strength of our commercial strategy and instill confidence in our ability to execute. There are four key takeaways from that event I'd like to briefly touch on here. First, the perspective shared by eye care professionals. We heard from a number of prospective KOLs who all expressed genuine enthusiasm about the clinical potential of LNZ100, particularly on how it could enhance patient care.

反饋非常正面。我們相信，我們已經完成了既定目標，展現了我們商業策略的實力，並增強了人們對我們執行能力的信心。我想在這裡簡要談談那次活動的四個關鍵要點。首先，眼科護理專業人士的觀點。我們聽取了許多潛在 KOL 的意見，他們都對 LNZ100 的臨床潛力表達了真正的熱情，尤其是它如何增強患者護理。

As a reminder, while there are approximately 128 million Americans with presbyopia, few and half of them are believed to see an eye care doctor. That presents a substantial opportunity and ECPs are very interested in how our direct-to-consumer marketing will help drive awareness and engagement among this large population. Second, we outlined the progress we have made in preparing for launch. As you know, our commercial strategy is structured around three pillars: enabling doctors to recommend us, empowering patients to request us by name and ensuring a seamless path to access. On the first pillar, our unbranded EYEAMSELECTIVE campaign continues to generate strong engagement.

需要提醒的是，雖然大約有 1.28 億美國人患有老花眼，但據信其中只有很少一半的人去看眼科醫生。這代表著一個巨大的機遇，ECP 對我們的直接面向消費者的行銷如何幫助提高這一龐大群體的認知度和參與度非常感興趣。第二，我們概述了發射準備工作所取得的進展。如您所知，我們的商業策略圍繞著三大支柱構建：讓醫生推薦我們、讓患者能夠指名提出請求以及確保無縫的訪問途徑。在第一個支柱上，我們的非品牌 EYEAMSELECTIVE 活動繼續產生強烈的參與度。

More than 50 KOLs are part of the effort, helping their peers take a fresh look at emerging options in presbyopia treatment. The campaign has reached over 12,000 ECPs and has delivered more than 2 million impressions online. Furthermore, our all optometrist MSL team has been actively engaging with ECPs with thousands of meaningful interactions to-date. They are playing a key role in educating the community about Aceclidine's mechanism of action and the importance of pupil-selectivity. And in parallel, our sales force build-out is progressing as planned, and Shawn will speak to that shortly.

超過 50 位關鍵意見領袖參與了這項活動，幫助他們的同儕重新審視老花眼療程的新興選擇。該活動已覆蓋超過 12,000 個 ECP，線上展示量超過 200 萬次。此外，我們所有的驗光師 MSL 團隊一直積極與 ECP 合作，迄今為止已進行了數千次有意義的互動。他們在向社區宣傳 Aceclidine 的作用機制和選擇學生的重要性方面發揮關鍵作用。與此同時，我們的銷售團隊建設正在按計劃進行，肖恩很快就會談到這一點。

The second pillar, building brand awareness among patients post approval and launch is driven by a clear and targeted strategy. As shared at the Commercial Day, our goal is to establish a true category one. We have defined our consumer targets. We know how and where to reach them, and we are building a campaign that will incorporate the right mix of influencer and ambassador engagement to drive visibility and recognition. And third, we've laid the foundation for a strong product access strategy that includes an extensive sampling approach and broad distribution through both traditional retail pharmacies and existing e-pharmacy channels, ensuring convenience and accessibility from the start.

第二個支柱是在品牌獲批和上市後在患者中建立品牌知名度，這需要製定明確而有針對性的策略。正如商業日所分享的，我們的目標是建立真正的第一類。我們已經明確了我們的消費者目標。我們知道如何以及在哪裡接觸到他們，我們正在建立一個活動，將結合有影響力的人和大使的正確參與，以提高知名度和認可度。第三，我們奠定了強大的產品獲取策略的基礎，包括廣泛的抽樣方法以及透過傳統零售藥局和現有的電子藥局通路的廣泛分銷，從一開始就確保便利性和可及性。

We also provided an update on our interactions with the FDA. Given the current regulatory environment, we felt it was important to reiterate that we are continuing to see a high level of engagement from the agency with excellent continuity among the review team, which has seen no changes in personnel. In fact, our late cycle review meeting has been moved forward to later this month, and we remain on track for our August 8 PDUFA date. Finally, I want to briefly speak to the topic of tariffs, which for obvious reasons, continues to come up in conversations. As we shared at the Commercial Day, we are in a strong and well-defined position.

我們也提供了與 FDA 互動的最新情況。鑑於當前的監管環境，我們認為有必要重申，我們將繼續看到該機構的高度參與，審查團隊的連續性非常好，人員沒有改變。事實上，我們的後期週期審查會議已提前至本月晚些時候，我們仍按計劃於 8 月 8 日舉行 PDUFA 會議。最後，我想簡單談談關稅問題，由於顯而易見的原因，這個問題在談話中不斷出現。正如我們在商業日上所分享的，我們處於強大而明確的地位。

On November 7 of last year, US Customs and Border Protection issued a definitive ruling establishing the United States as the country of origin for LNZ100. Then on April 2, we received a second definitive ruling confirming that LNZ100 will be duty-free. Combined with the fact that our intellectual property is domiciled in the US, we are proud to say that LNZ100 is designated and made in the USA. Across the organization from medical and regulatory to manufacturing operations, quality, finance, HR and commercial, every team is operating with urgency and alignment as we approach our target action date in August. It is a truly cross-functional effort, and I'm incredibly proud of what we have accomplished so far.

去年11月7日，美國海關和邊境保護局發布最終裁決，認定美國為LNZ100的原產國。隨後在 4 月 2 日，我們收到了第二項最終裁決，確認 LNZ100 將免稅。再加上我們的智慧財產權在美國，我們很自豪地說 LNZ100 是在美國指定和製造的。隨著我們接近 8 月的目標行動日期，從醫療和監管到製造營運、品質、財務、人力資源和商業，整個組織的每個團隊都在緊急協調地開展工作。這是一次真正的跨職能努力，我為我們迄今為止所取得的成就感到無比自豪。

With that, I will turn the call over to Shawn, our Chief Commercial Officer, who will share more on the progress we are making in our pre-commercial planning. Shawn?

接下來，我將把電話轉給我們的商務長肖恩 (Shawn)，他將分享更多有關我們在商業化前規劃方面取得的進展的資訊。肖恩？

Thank you, Ev. Good afternoon, everyone. As we've discussed on previous calls, the commercial potential for an effective presbyopia treatment represents one of the largest eye care market opportunities in the United States. Presbyopia impacts an estimated 128 million people in the US, population nearly 4 times larger than those impacted by dry eye and nearly 6 times larger than those impacted by Demodex blepharitis. For further context, presbyopia impacts more than the combined US population suffering from dry eye, Demodex blepharitis, childhood myopia, macular degeneration, diabetic retinopathy and glaucoma.

謝謝你，Ev。大家下午好。正如我們在之前的電話會議中討論過的，有效老花眼治療的商業潛力代表著美國最大的眼部保健市場機會之一。據估計，老花眼影響美國 1.28 億人，這一數字幾乎是乾眼症患者的 4 倍，是蠕形蟎蟲瞼緣炎患者的 6 倍。進一步而言，老花眼影響的不僅是患有乾眼症、蠕形蟎性瞼緣炎、兒童近視、黃斑部病變、糖尿病視網膜病變和青光眼的美國人口總和。

The first eye drop treatment for presbyopia was approved in 2021 and confirmed that there is a strong consumer desire for an eye drop treatment as evidenced by initial paid new scripts of up to 6,000 per week. Long-term usage beyond the trial period of this product did not materialize as Pilocarpine even at the high concentration of 1.25% cannot deliver the consumer required performance.

第一款用於治療老花眼的眼藥水療法於 2021 年獲得批准，並證實了消費者對眼藥水治療的強烈需求，最初每週付費新處方高達 6,000 份就證明了這一點。該產品無法在試用期之後長期使用，因為即使濃度高達 1.25% 的毛果芸香鹼也無法滿足消費者所需的性能。

Extensive independent consumer market research suggests this category is wide open for an eye drop solution that can deliver what consumers desire, a once-a-day eye drop that provides seamless near vision for the full workday for the majority of presbyopes. Unlocking this market requires an ideal presbyopia eye drop, and we're excited for the prospect of Aceclidine-based LNZ100.

廣泛的獨立消費者市場研究表明，這一類別對於能夠滿足消費者需求的眼藥水解決方案有著廣闊的空間，每天只需滴一次眼藥水，即可為大多數老花眼患者提供全天工作中的無縫近視力。打開這個市場需要一種理想的老花眼藥水，我們對基於乙醯克利定的 LNZ100 的前景感到興奮。

We believe the commercial potential of LNZ100 was validated in our Phase III CLARITY study with 90% of participants noticing an improvement in near vision and 75% of participants indicating they would continue to use LNZ100 after the study, of which 81% plan to use the product 4 to 7 days per week. Together with our broad inclusion criteria, we believe this positions LNZ100 well for the estimated $3 billion-plus market, creating a potential category one.

我們相信 LNZ100 的商業潛力在我們的第三階段 CLARITY 研究中得到了驗證，90% 的參與者註意到近視力有所改善，75% 的參與者表示他們會在研究後繼續使用 LNZ100，其中 81% 的參與者計劃每週使用該產品 4 至 7 天。結合我們廣泛的納入標準，我們相信，這將使 LNZ100 在預計價值 30 多億美元的市場中佔據有利地位，並有可能成為第一類市場。

We continue to advance our commercial readiness as we progress towards August 8 PDUFA date, and I'd like to take just a moment to provide an update on the three pillars of our commercial strategy. The first pillar of our commercial strategy is doctors to recommend us. As Ev mentioned, our all optometrist MSL team is already engaging with ECPs on medical education and fielding questions on the Phase III data.

隨著 8 月 8 日 PDUFA 日期的臨近，我們將繼續推進商業準備工作，我想花一點時間介紹我們商業策略的三大支柱的最新情況。我們的商業策略的第一個支柱是醫生推薦我們。正如 Ev 所提到的，我們所有的驗光師 MSL 團隊已經與 ECP 就醫學教育進行接觸並回答有關第三階段數據的問題。

In addition, our unbranded campaign continues to drive awareness of an ideal presbyopia solution with over 2 million digital impressions. Following prudential NDA approval, our sales force will immediately begin branded calls on approximately 15,000 ECPs, and I'm pleased to report that we have made substantial progress on the sales force over the past quarter. As a reminder, we had already successfully hired our full sales leadership team, including both of our Regional Directors in 2024. In Q1, we expanded the team further with additional 10 district managers. Collectively, this core leadership group brings nearly 150 years of eye care experience and more than 300 years of total sales experience.

此外，我們的非品牌活動透過超過 200 萬個數位印象繼續提高人們對理想老花眼解決方案的認識。在獲得審慎的保密協議 (NDA) 批准後，我們的銷售人員將立即開始對大約 15,000 個 ECP 進行品牌呼叫，我很高興地報告，我們在過去一個季度的銷售人員隊伍方面取得了實質性進展。提醒一下，我們已經在 2024 年成功聘請了我們的完整銷售領導團隊，包括我們的兩位區域總監。在第一季度，我們進一步擴大了團隊，增加了 10 位地區經理。這個核心領導團隊總共擁有近 150 年的眼科護理經驗和超過 300 年的總銷售經驗。

In March, we launched job postings for all 88 sales territories nationwide. The interest to join LENZ's sales force has been tremendous with over 7,500 applications for the 88 physicians. The quality applicants have been very high, and we're excited to share that we've begun extending offers to our field-based sales representatives. As of today, we've extended and received accepted offers for over 40% of our field sales team. In addition, 97% of these new team members have prior eye care or pharma experience and on average, have over 10 years of sales experience.

3月份，我們在全國88個銷售區域發布了招募資訊。加入 LENZ 銷售團隊的興趣非常濃厚，88 位醫生收到了超過 7,500 份申請。申請者的素質非常高，我們很高興地告訴大家，我們已經開始向我們的現場銷售代表提供錄取通知。截至今天，我們已向超過 40% 的現場銷售團隊發出報價，並且這些報價已被接受。此外，97％的新團隊成員擁有眼科護理或製藥行業經驗，平均擁有超過10年的銷售經驗。

This marks a major milestone in our commercialization readiness and great progress towards our target to have the full field team in place by July 1. We're excited to progress our first pillar, doctors to recommend us. And as a reminder, our primary market research surveyed 426 eye care professionals, and it yielded an impressive 82% and 83% of ECPs already being likely to provide -- prescribe and sample LNZ100 if FDA approved, respectively, based on that Phase III data. Our second pillar of our commercial strategy is consumers to request us by name. We've taken a consumer-first approach, leaning heavily into lifestyle creative that reflects the aspirations and daily experiences of our future consumers.

這是我們商業化準備的一個重要里程碑，也是我們在 7 月 1 日前組建完整現場團隊的目標上取得的巨大進展。我們很高興能夠取得我們的第一個支柱——醫生的推薦。需要提醒的是，我們的主要市場研究調查了 426 名眼科護理專業人士，結果顯示，根據第三階段的數據，如果 FDA 批准，82% 和 83% 的 ECP 已經可能提供——處方和樣品 LNZ100。我們的商業策略的第二個支柱是消費者向我們提出姓名請求。我們採取了消費者至上的方法，大量依賴能夠反映未來消費者的願望和日常體驗的生活方式創意。

The brand we've built is empowering, desirable and has tested exceptionally well in market research. On April 15, we hosted our Commercial Day event in New York City, where we unveiled the visual identity of the brand, which is modern, clean and sophisticated. We heard from Phase III users of LNZ100, which highlighted the personal experience with the drop and the word-of-mouth potential. We shared our plan for advertising, including influencers and celebrities to drive awareness. We even facilitated a live discussion with Tiffani Thiessen, who many of you may know from Saved by the Bell, 90210 and White Collar.

我們打造的品牌充滿力量、令人嚮往，並且在市場調查中獲得了極高的評價。4 月 15 日，我們在紐約舉辦了商業日活動，揭開了品牌的視覺形象：現代、簡潔、精緻。我們聽取了 LNZ100 第三階段使用者的回饋，他們強調了個人使用體驗和口耳相傳的潛力。我們分享了我們的廣告計劃，包括利用有影響力的人和名人來提高知名度。我們甚至與 Tiffani Thiessen 進行了現場討論，你們中的許多人可能都透過《救命下課鈴》、《90210》和《妙警賊探》認識她。

As a presbyope herself, she shared her frustrations with presbyopia and desire for a better solution. All of this helped frame how we plan to ensure consumers will request us by name. Our brand creative is now fully locked and the majority of our launch promotional materials are ready, pending final product insert language. Once approved, we'll begin activating our eye care professional-facing materials to ensure providers are confident and well equipped. Following that and once the ECP education is firmly in place, we'll launch into our direct-to-consumer campaign with high-impact advertising, influencers and celebrities that we believe will powerfully introduce our brand to the market.

作為一名老花眼患者，她分享了自己對老花眼的苦惱以及對更好解決方案的渴望。所有這些都有助於我們制定計劃，以確保消費者能夠指名向我們提出請求。我們的品牌創意現已完全鎖定，大部分發布宣傳資料也已準備就緒，只等待最終產品插入語言。一旦獲得批准，我們將開始啟用眼科護理專業人士的材料，以確保服務提供者充滿信心並配備齊全。隨後，一旦 ECP 教育穩固到位，我們將啟動直接面向消費者的活動，採用高影響力的廣告、有影響力的人和名人，我們相信這將有力地向市場推出我們的品牌。

For more information from the Commercial Day, a replay of the event is available on our Investor Relations page under the IR calendar on our website. The third and final pillar, seamless journey to use will ensure ease of sample and product access for patients. This requires enabling the patient to experience the product and move from trial to usage as quickly as possible. To support this, our team has built out consumer sampling capabilities and commercial access across multiple channels, including the traditional retail pharmacy as well as e-pharmacy home delivery. In our clinical trials, 95% of patients noticed at least two lines of improvement on hour one, day one.

欲了解商業日的更多信息，可在我們網站的投資者關係日曆下的投資者關係頁面上觀看活動重播。第三個也是最後一個支柱是無縫使用過程，這將確保患者能夠輕鬆獲得樣品和產品。這需要讓患者能夠盡快體驗產品並從試用轉向使用。為了支持這一點，我們的團隊已經建立了消費者抽樣能力和跨多個管道的商業管道，包括傳統零售藥局以及電子藥局送貨上門。在我們的臨床試驗中，95％的患者在第一天的第一個小時就注意到了至少兩條改善線。

This immediate response and wow effect is incredibly important to product sampling. Our sample vendor has been contacted and after approval, samples will be rep delivered to eye care professionals, allowing consumers to try the product. Our team has developed a 5-day sample path similar to sample sizes for contact lenses, which following the initial trial can act like a bridge until product is picked up at the pharmacy or delivered to the consumer's home. We will continue to drive these three pillars as we continue to progress towards our PDUFA date, doctors to recommend us, consumers to request us by name and a seamless journey to use.

這種即時反應和令人驚嘆的效果對於產品抽樣來說非常重要。我們已聯繫樣品供應商，批准後，樣品將交付給眼科護理專業人員，讓消費者試用產品。我們的團隊開發了類似於隱形眼鏡樣品大小的 5 天試用路徑，在初次試用之後，它可以充當橋樑，直到產品在藥房領取或送到消費者家中。我們將繼續推動這三大支柱，繼續朝著 PDUFA 日期邁進，讓醫生推薦我們，讓消費者指名要求我們，並提供無縫使用體驗。

I'd now like to hand the call over to Dan Chevallard, our CFO, to highlight our financial results.

現在，我想將電話交給我們的財務長 Dan Chevallard，以重點介紹我們的財務表現。

Thank you, Shawn. As has been mentioned, the first quarter of 2025 has been a very productive and focused time for the company with our PDUFA target action date for LNZ100 just over 90 days from now. We ended Q1 2025 in a position of financial strength and funded for success with approximately $194.1 million in cash, cash equivalents and marketable securities. As you may have seen, now having passed the anniversary date of our merger in March 2024 and the corresponding Rule 145 shell limitations imposed upon us by the SEC, we became shelf eligible and filed our first S-3 shelf registration statement in early April. Subsequent to quarter end, we received a meaningful inbound inquiry from a high-quality investor on our ATM, which ultimately resulted in a single block trade of 600,000 shares and net proceeds of $16.3 million, further strengthening our financial position.

謝謝你，肖恩。如同前面所提到的，2025 年第一季對公司來說是非常有成效和高度集中的時期，我們的 LNZ100 的 PDUFA 目標行動日期距今僅 90 多天。截至 2025 年第一季度，我們財務狀況良好，並擁有約 1.941 億美元的現金、現金等價物和有價證券，為成功提供了資金。正如您可能已經看到的，現在已經過了 2024 年 3 月的合併週年紀念日以及美國證券交易委員會對我們施加的相應 145 規則空殼限制，我們獲得了擱置資格，並於 4 月初提交了第一份 S-3 擱置註冊聲明。在季度末之後，我們收到了一位優質投資者對我們 ATM 的有意義的入站詢價，最終促成了 60 萬股的單筆大宗交易和 1,630 萬美元的淨收益，進一步增強了我們的財務狀況。

As such, we have upwardly revised our projected cash at PDUFA from over $170 million, which we disclosed at our commercial day to now over $185 million and again, reiterated our cash on hand is anticipated to fund the company's cash runway to post-launch positive operating cash flow. Let's now turn to our first quarter results. As I noted on our most recent year-end call, we expected measured increases in our operating expenses as we exited 2024 between year-end and the time of our PDUFA date, which was exactly what we saw in the first quarter.

因此，我們將 PDUFA 的預期現金從我們在商業日披露的 1.7 億美元以上上調至現在的 1.85 億美元以上，並再次重申，我們預計手頭上的現金將為公司的現金跑道提供資金，以實現上市後的正營運現金流。現在讓我們來看看第一季的業績。正如我在最近的年終電話會議上所指出的，我們預計在 2024 年年末至 PDUFA 日期之間我們的營運費用將有所增加，這正是我們在第一季看到的情況。

Our total Q1 2025 operating expenses increased to $16.9 million, an 11% increase over Q4, but well within our operating plan. From a cash perspective, we had a total net cash burn of $15 million in Q1 2025, which included approximately $3 million in onetime annual cash costs and is really reflective of closer to $12 million in operating cash burn compared to our Q4 2024 net operating cash burn of approximately $8.1 million.

我們 2025 年第一季的總營運費用增加到 1,690 萬美元，比第四季成長 11%，但仍在我們的營運計畫之內。從現金角度來看，我們在 2025 年第一季的總淨現金消耗量為 1,500 萬美元，其中包括約 300 萬美元的一次性年度現金成本，與我們 2024 年第四季的淨營運現金消耗約 810 萬美元相比，這實際上反映了接近 1,200 萬美元的現金營運消耗。

Total SG&A expenses increased to $11.3 million for Q1 2025 compared to $5.6 million for the same period in 2024, driven primarily by an increase in commercial headcount and other prelaunch commercial planning activities. Sequentially, SG&A increased quarter-over-quarter by approximately 19% from $9.4 million in the fourth quarter, driven primarily by increases in personnel-related expenses due to a growth in commercial headcount, pre-commercial marketing, advertising and sales infrastructure and all continuing the pattern of a ramped commercial spend as we approach our potential August 2025 approval for LNZ100.

2025 年第一季銷售、一般及行政費用總額從 2024 年同期的 560 萬美元增至 1,130 萬美元，主要原因是商業員工數量增加以及其他商業發布前規劃活動。與上一季相比，銷售、一般及行政費用環比增長約 19%，較第四季度的 940 萬美元有所增加，這主要由於商業員工數量增加導致人員相關費用環比增長約 19%，較第四季度的 940 萬美元有所增加，這主要由於商業員工數量增加導致人員相關費用環比增長約 19%，較第四季度的 940 萬美元有所增加，這主要是由於商業員工數量增加導致人員相關費用增加，以及商業前營銷、廣告和銷售基礎設施增加，而且隨著我們接近 2025 年 8 月 LNZ100 的潛在批准，所有這些都延續了商業支出增加的模式。

As I have highlighted on previous calls and what will be a consistent objective, we will continue to be measured in our spend on the G&A side of the organization as we aim to remain a lean and efficient G&A team. Total research and development expenses decreased to $5.8 million in Q1 2025 compared to $10.5 million for the same period in 2024. Sequentially, however, R&D expenses were flat quarter-over-quarter with a 1% net decrease from the fourth quarter.

正如我在之前的電話會議中所強調的以及我們將始終如一的目標，我們將繼續衡量我們在組織的 G&A 方面的支出，因為我們的目標是保持一支精簡高效的 G&A 團隊。2025 年第一季總研發費用從 2024 年同期的 1,050 萬美元下降至 580 萬美元。但與上一季相比，研發費用持平，季減與第四季淨減少 1%。

The majority of our research and development expenses in Q1 were dedicated to our manufacturing operations efforts as we build pre-approval commercial product and sample inventory to support our launch, which will continue through the approval of LNZ100, at which time much of our manufacturing costs will be prospectively reflected in cost of sales.

我們第一季的大部分研發費用都用於製造營運工作，因為我們正在建立預先批准的商業產品和樣品庫存以支持我們的產品發布，這將持續到 LNZ100 的批准，屆時我們的大部分製造成本將預期反映在銷售成本中。

Finally, our net loss per share, both basic and diluted, was $0.53 per share in the first quarter of 2025 on a net loss of $14.6 million compared to a net loss per share of $3.53 per share in first quarter of 2024 on a net loss of $16.6 million. Q1 2025 net loss per share was calculated on approximately 27.5 million weighted average common shares outstanding compared to Q1 of last year, which was the quarter in which we completed our reverse merger and net loss was calculated on approximately 4.7 million weighted average common shares outstanding.

最後，2025 年第一季度，我們的每股淨虧損（基本虧損和稀釋虧損）均為 0.53 美元，淨虧損為 1,460 萬美元，而 2024 年第一季的每股淨虧損為 3.53 美元，淨虧損為 1,660 萬美元。 2025 年第一季每股淨虧損是根據約 2,750 萬股加權平均流通普通股計算得出的，而去年第一季（即我們完成反向合併的季度）的淨虧損是根據約 470 萬股加權平均流通普通股計算得出的。

In total, we ended Q1 2025 with approximately 27.5 million shares of common stock outstanding. In summary, we feel very good about where we stand financially as we approach the exciting period ahead and are pleased with the strength of our balance sheet and disciplined operating plan as we approach our August 8 PDUFA date.

整體而言，截至 2025 年第一季度，我們流通普通股約為 2,750 萬股。總而言之，隨著我們即將迎來激動人心的時期，我們對我們的財務狀況感到非常滿意，並且隨著我們即將迎來 8 月 8 日 PDUFA 日期，我們對我們的資產負債表的強勁和嚴謹的運營計劃感到滿意。

With that, I'll turn the call back over to Ev for final remarks.

說完這些，我將把電話轉回給 Ev 進行最後的發言。

Thanks, Dan. As you can see, we're off to a great start in 2025 and believe we have tremendous momentum as we are now about three months from our PDUFA target action date. We've never been more confident in our abilities to deliver once-daily, well-tolerated and rapidly acting treatment to 128 million individuals living with presbyopia in the United States. I'm looking forward to the exciting months ahead.

謝謝，丹。如您所見，我們在 2025 年有了一個良好的開端，並且相信我們擁有巨大的發展勢頭，因為我們現在距離 PDUFA 目標行動日期還有大約三個月的時間。我們從未像現在這樣有信心，能夠為美國 1.28 億老花眼患者提供每日一次、耐受性良好且起效迅速的治療。我期待著未來令人興奮的幾個月。

With that, I'd like to open up the call for questions.

現在，我想開始提問。

(Operator Instructions)

（操作員指示）

Stacy Ku from TD Cowen.

Stacy Ku 的 TD Cowen。

Hi, thanks so much for taking our questions and Congrats on the progress. So we have a few. First, as we think about the LNZ100 initial launch, we do think it makes a lot of sense to maximize the prescriber and patient relationship with high-volume sampling. So just curious, do you have the infrastructure in place to get samples to all interested offices as quickly as possible post launch? Can you discuss in more detail plans kind of right immediately after approval?

您好，非常感謝您回答我們的問題，並祝賀您的進展。所以我們有幾個。首先，當我們考慮 LNZ100 的首次發佈時，我們確實認為透過大容量採樣來最大限度地增進處方醫生和患者的關係是非常有意義的。所以只是好奇，您是否有基礎設施可以在產品發布後儘快將樣品送到所有有興趣的辦公室？批准後您能立即更詳細地討論計劃嗎？

That's the first question. And then the second is somewhat related. Maybe talk about the type of preparation the team is doing to drive continued use and refills of LNZ100 after that initial sample. How are you thinking about the level of stickiness of LNZ100 as it relates to setting expectations for the patient experience? And then last, if we could, as you approach the approval timing, what kind of metrics will you disclose to kind of show patient demand to The Street? Thank you so much.

這是第一個問題。第二點與此有些相關。也許可以談談團隊正在進行的準備類型，以推動在初始樣本之後繼續使用和補充 LNZ100。您如何看待 LNZ100 的黏性程度與設定患者體驗期望的關係？最後，如果可以的話，隨著批准時間的臨近，您將揭露哪些指標來向華爾街展示病患的需求？太感謝了。

Great. Thanks, Stacy. This is Shawn. So for your first question, you're asking about where are we in our readiness and ability to sample right out the gate for LNZ100. I think I got that right.

偉大的。謝謝，史黛西。這是肖恩。因此，對於您的第一個問題，您詢問的是我們的準備以及對 LNZ100 進行採樣的能力如何。我認為我是對的。

So we see sampling as a critical component to our commercial strategy. So we've been out in front of this for a long time. So we actually contracted our sampling distributor back in 2024. And what we're doing in terms of progress, obviously, internally, we're running all of our policies for how the reps deliver the samples. And then also, we're already coordinating between our sample distributor as well as our CRM system and actually smoke testing those systems to make sure it will be seamless upon those samples being available.

因此，我們將採樣視為我們商業策略的關鍵組成部分。所以我們在這方面已經努力很久了。因此，我們實際上早在 2024 年就與樣品分銷商簽訂了合約。就進展而言，我們所做的顯然是，在內部，我們正在執行有關銷售代表如何交付樣品的所有政策。此外，我們已在樣品分銷商和 CRM 系統之間進行協調，並對這些系統進行煙霧測試，以確保樣品可用時一切順利。

So once samples are available, we'll immediately begin shipping those samples to the reps. They'll receive those samples and be out distributing them to their 15,000 ECP targets. And really, our plan is to have the majority of our samples rep delivered, and we see that as very important. We see that opens the door to go and talk to the eye care professionals, and that allows us to have that conversation about LNZ100 with the eye care professional every time we show up. On your second question in terms of preparations for the field.

因此，一旦樣品可用，我們將立即開始將這些樣品運送給銷售代表。他們將收到這些樣本並將其分發給 15,000 個 ECP 目標。實際上，我們的計劃是交付大部分樣品，我們認為這非常重要。我們發現這為我們與眼科保健專業人士交談打開了大門，並且讓我們每次出現時都可以與眼科保健專業人士討論 LNZ100。關於你的第二個問題，關於賽場的準備。

So we have a lot of work going on already to ensure that we're ready to go. So as you can imagine, with over 40% of the sales force already accepting offers in the background ahead of that, we've been building out all the training modules for the sales team. Once the sales team comes on, they have about a 3-week training cycle where we take them through all those modules.

因此，我們已經開展了大量工作以確保我們已做好準備。因此，正如您所想像的，在此之前，已有超過 40% 的銷售人員在後台接受了報價，我們一直在為銷售團隊建立所有培訓模組。銷售團隊加入後，他們會接受大約 3 週的培訓週期，我們會帶他們完成所有模組。

All of them, except for the one on the product, are all ready to go and through the medical, legal and regulatory review process. So we need to get training them day one and in terms of preparations to make sure that appropriate information is passed along to the eye care professional, and we prepared our Q&A documents as well as key messages to have that conversation with the doctors.

除產品上的批准外，其他所有批准均已準備就緒，並通過了醫學、法律和監管審查程序。因此，我們需要在第一天對他們進行培訓，並做好準備工作，確保將適當的資訊傳遞給眼科保健專業人員，並且我們準備了問答文件以及與醫生進行對話的關鍵訊息。

Got it. And then the last comment on what type of metrics you might disclose?

知道了。最後，關於您可能會揭露什麼類型的指標，您有什麼看法？

Yeah. So in terms of the metrics, so what we see there is this product will be distributed both through the retail pharmacy as well as the e-pharmacy. So I think where most people will be looking for us in terms of metrics early on, everyone will be going to the IQVIA data, looking at that new script rates as well as that refill rate. I think early on, the focus of Q4 is going to be samples. Once we move into Q1, I think that focus is really going to be what are those new scripts per week.

是的。因此，就指標而言，我們看到的是，該產品將透過零售藥局和電子藥局進行分銷。因此我認為，大多數人會在早期就根據指標來尋找我們，每個人都會查看 IQVIA 數據，查看新腳本率以及補充率。我認為早期第四季的重點將是樣品。一旦我們進入第一季度，我認為重點將是每周有多少新劇本。

And then moving into Q2, it's going to be a lot about how are those refills coming through. Given the e-pharmacy, obviously, that's often not picked up in IQVIA. We'll make sure that we can provide some guidance on how that's going so the appropriate analysis can be made.

然後進入第二季度，重點將放在這些補充的進展。鑑於電子藥房的存在，顯然這一點通常不會被 IQVIA 發現。我們將確保能夠提供一些有關進展的指導，以便進行適當的分析。

Stacy, just adding to it, I think you had a question in there on how we would expect to go from samples to ultimately use. That's really that our idea is that, that sample will be confident with a script. At that moment, the patient can choose to fill that script, as Shawn mentioned, through e-pharmacy. This is the what we're getting very accustomed to now, leave the doctor's office and the text will pop up on your phone and that product will then be delivered to your doorstep or if you want to go to more traditional route, you can pick the actual product up at the retail pharmacy. And then the second part of that question was what we think about stickiness.

史黛西，我補充一下，我認為你有一個問題，即我們如何期望從樣本到最終使用。我們的想法確實是這樣的，樣本將對腳本充滿信心。此時，正如 Shawn 所提到的，患者可以選擇透過電子藥局來配藥。這就是我們現在已經非常習慣的，離開醫生辦公室，短信就會彈出到你的手機上，然後產品就會送到你家門口，或者如果你想走更傳統的方式，你可以在零售藥店領取實際產品。問題的第二部分是我們對黏性的看法。

Hard to say at the moment, I think what's different from our product and Shawn highlighted that sample use, and we know that 95% of patients hit at least two lines of near vision improvement to expect that people see that improvement on the sample. If they are converting to a script, they should be motivated to continue to use that. We would expect relatively high stickiness once people have converted into a script.

目前很難說，我認為這與我們的產品有什麼不同，Shawn 強調了樣本的使用，我們知道 95％ 的患者近視力至少有兩行改善，因此人們可以在樣本上看到這種改善。如果他們正在轉換為腳本，他們應該有動力繼續使用它。一旦人們轉換為腳本，我們預計其黏性就會相對較高。

Okay. Wonderful, incredibly thoughtful. Thank you.

好的。太棒了，非常周到。謝謝。

Pavan Patel with Bank of America.

美國銀行的 Pavan Patel。

Hey guys, This is Pavan on for Jason Gerberry. First question is related to the 5-day sample pack. I know that's a key part of the strategy. How will sample distribution be managed and tracked to ensure that they reach high potential prescribers and patients? And what's the expected conversion rate from sample to paid prescription?

大家好，我是 Jason Gerberry 的 Pavan。第一個問題與 5 天樣品包有關。我知道這是該戰略的關鍵部分。如何管理和追蹤樣本分發以確保它們能夠到達有巨大潛力的處方者和患者？從樣品到付費處方的預期轉換率是多少？

And then on the manufacturing and supply chain, with the start of manufacturing in February of 2025, can you help us understand what's the current inventory level? And what's the target inventory for launch? And then one follow-up, if I may.

然後關於製造和供應鏈，隨著 2025 年 2 月製造的開始，您能幫助我們了解目前的庫存水準嗎？推出的目標庫存是多少？如果可以的話，我還有一個後續問題。

Absolutely. Shawn, do you want to take the sample pack?

絕對地。肖恩，你想拿樣品包嗎？

Yes, great. Great to hear from you, Pavan. So the 5-day sample pack, when we think about how that will be managed and tracked, so what will happen is, obviously, our sample vendor will hold all of the actual bulk samples in their location. And then how that we manage every month, that product will be shipped to each rep, right? So every month, there will be a shipment that goes to the rep.

是的，太棒了。很高興收到你的來信，帕萬。因此，當我們考慮如何管理和追蹤 5 天樣品包時，顯然會發生的是，我們的樣品供應商會將所有實際的批量樣品保存在他們的位置。然後我們每個月如何管理，將產品運送給每個代表，對嗎？因此，每個月都會有一批貨物發給銷售代表。

They'll hold their products in their storage locker. And then that shipment will be dependent on the number of targets and then the expected amount of samples they'd be dropping off, so that will be replenished every single month. Once that rep goes to the actual doctor's office to the eye care professional, every time samples are dropped off, we will make sure that they're signed for and fully accounted for to make sure that it's a clear transfer of ownership to the eye care professional.

他們會將產品存放在儲物櫃中。然後，該批貨物的發貨量將取決於目標數量以及他們預計送來的樣品數量，因此每個月都會進行補充。一旦該代表前往實際的醫生辦公室與眼保健專業人員會面，每次送來樣品時，我們都會確保對其進行簽名並進行全面核算，以確保將所有權明確轉移給眼保健專業人員。

And then every subsequent visit, they'll be checking in on how many samples were written or sorry, how many samples were left and how many scripts were written to make sure it maintains the right ratio. In terms of the expected conversion from samples to full-time users, I think it's a little bit too early to tell on that.

然後，每次後續訪問，他們都會檢查寫了多少個樣本，或者抱歉，還剩下多少個樣本以及寫了多少個腳本，以確保保持正確的比例。至於從樣品到全職用戶的預期轉變，我認為現在下結論還為時過早。

But when we have more insight, we'll share more on that.

但當我們有了更多見解時，我們會分享更多。

Thanks, Shawn. Just to add to that before I go to the inventory question, we do the math on the 15,000 doctors and 88 reps you get to about a 3-week call cycle. So every three weeks, the rep's in that office. On top of that, there's a mechanism for doctors if they run out of samples in that period to request more. So on the inventory, you are right that we started production of our to be commercial products in Q1.

謝謝，肖恩。在我討論庫存問題之前，我想補充一點，我們對 15,000 名醫生和 88 名銷售代表進行了計算，得出大約 3 週的通話週期。因此，每三週，代表就會到那個辦公室。除此之外，如果醫生在這段時間內樣本用完，還可以透過一種機制要求提供更多樣本。關於庫存，您說得對，我們在第一季就開始生產商業產品了。

I don't think we're going to be sharing at this moment what our inventory levels are other than we're confident that we can supply what we believe will constitute a successful launch.

我認為我們現在不會分享我們的庫存水平，但我們有信心提供我們認為能夠成功推出的產品。

Great. And then just for a follow-up, maybe if you can elaborate on the mechanics of the e-pharmacy partnership and how that will strengthen the patient journey from prescription to refill, including data capture on script conversion and adherence? Thank you.

偉大的。然後只是為了後續問題，也許您可以詳細說明電子藥房合作的機制，以及它將如何加強患者從處方到續藥的旅程，包括腳本轉換和依從性的數據捕獲？謝謝。

Yes, absolutely. What we've really seen over the past few years are the growth of people that prefer their medicines to be delivered to their house, just like their Amazon packages, right? So there's really been this growth in the use of e-pharmacies. What's great about that is it really creates like a closed system, which is helpful. So our partner that we're going to be using for our e-pharmacy is already active in the eye care professional space.

是的，絕對是。過去幾年我們真正看到的是，越來越多的人喜歡把藥品送到家裡，就像亞馬遜的包裹一樣，對吧？因此，電子藥局的使用確實出現了成長。它的偉大之處在於它確實創造了一個封閉的系統，這很有幫助。因此，我們將要用於電子藥局的合作夥伴已經在眼科護理專業領域活躍起來。

What that means and why that's important means when we go to when a doctor goes to enter the scripts into their EMR system, that e-pharmacy should already be loaded up within that computer. So it should be seamless to send it on to e-pharmacy. Once the e-pharmacy actually receives the scripts, they then take over the ownership and relationship with the patient to get them the product. So the e-pharmacy shoots the text to the patient's phone, right? At that point, it's just a link to click in.

這意味著什麼以及為什麼這很重要意味著當醫生將處方輸入他們的 EMR 系統時，電子藥房應該已經加載到該計算機中。因此將其發送到電子藥房應該是無縫的。一旦電子藥局真正收到處方，他們就會接管所有權以及與患者的關係，以便為患者提供產品。那麼電子藥局會將文字傳送到患者的手機上，對嗎？此時，它只是一個可以點擊的連結。

And from that link, they put in their credit card information and shipping information and that product starts shipping to their door. Throughout that process also, what's great about it is the opportunity for auto refill, which means in terms of stickiness, right, that product showing up every single month to the door. If they didn't select the auto refill, of course, the e-pharmacy will also follow up once they're at the end of their first box or second box to follow up and say, hey, it's time to order again. So it definitely creates a nice close environment where you have a strong relationship with the consumer. And then one other question, which you asked earlier that I think I missed the spot on, you want to make sure the samples go to those high-volume prescribers.

透過該鏈接，他們輸入信用卡資訊和送貨信息，產品就會開始送貨上門。在整個過程中，它的優點在於可以自動補充，這意味著從黏性方面來說，產品每個月都會送到顧客門口。當然，如果他們沒有選擇自動補充，那麼當他們用完第一個盒子或第二個盒子時，電子藥房也會跟進並說，嘿，該再次訂購了。因此，它確實創造了一個良好而親密的環境，讓您與消費者建立了牢固的關係。還有一個問題，您之前問過，但我認為我沒有回答清楚，您想確保樣品送到那些開藥量很大的醫生手中。

Because our samples are rep delivered, they're targeting those eye care professionals that we've identified as high decile users of the VUITY products. So our reps are going to those practices, which have already shown a high volume of VUITY use early on, and therefore, that way the samples are going to the right accounts.

由於我們的樣品是透過代表處交付的，因此它們針對的是那些我們確定為 VUITY 產品高十分位使用者的眼科護理專業人士。因此，我們的銷售代表會前往那些早期已經顯示出大量使用 VUITY 的機構，這樣，樣品就會到達正確的帳戶。

Thanks guys.

謝謝大家。

Yigal Nochomovitz, Citi.

花旗銀行的 Yigal Nochomovitz。

Yeah, hi, thank you very much. Regarding the marketing plans, can you talk about when you're going to turn on the influencers and not who you're going to get, but kind of when that might happen and on what platforms? And then as far as the commercial model in terms of how you're thinking about the launch, obviously, VUITY got to 6,000 scripts per week, I believe, and then it peaked out. I'm just wondering if you get to that point, would that be breakeven for you or would you need to be higher or lower? And how quickly do you think you could get to that 6,000 script high watermark that VUITY got to and then presumably exceed that?

是的，你好，非常感謝。關於行銷計劃，您能談談什麼時候開始利用有影響力的人嗎？不是說會找誰，而是什麼時候、在什麼平台上進行？至於商業模式，就您如何考慮發布而言，顯然，我相信 VUITY 每週的腳本數量達到了 6,000 個，然後就達到了頂峰。我只是想知道，如果您達到這一點，那對您來說是否能達到收支平衡，還是需要更高或更低？您認為多久可以達到 VUITY 所達到的 6,000 個腳本的最高水位，然後大概會超過這個數字？

Hi Yigal, this is Shawn again. Thanks for that. I'll take the first question on the marketing plans and when to turn on the influencers. So when we think of -- when we go to market, immediately upon the August 8 PDUFA date, if approved, the field will go out and start training ECPs. Our main goal ahead of the influencer campaign is to make sure the ECPs are aware of the product and comfortable with it, right?

你好，Yigal，我又是 Shawn。謝謝。我將回答有關行銷計劃以及何時啟用影響者的第一個問題。因此，當我們想到——當我們進入市場時，如果在 8 月 8 日 PDUFA 日期獲得批准，該領域將立即開始培訓 ECP。我們在進行影響力活動之前的主要目標是確保 ECP 了解產品並對其感到滿意，對嗎？

So that's what we want to make sure is in place before we turn on the influencer campaign. That's important because what we heard about VUITY is if you turn on the influencers too quick, the doctors are caught off guard. So I think it's safe to assume Q4 is really a focus on the eye care professionals. What's also great about our product is it's a cash pay product. So we're not beholden to when we have coverage by the PDMs to turn on DTC.

因此，我們在進行影響力活動之前要確保這些準備就緒。這很重要，因為我們聽說 VUITY 的情況是，如果你太快啟動影響者，醫生就會措手不及。因此我認為可以安全地假設第四季度真正關注的是眼科護理專業人士。我們的產品的另一個優點是它是現金支付產品。因此，我們不會受制於 PDM 覆蓋時間來開啟 DTC。

So we can turn on faster than other products that are covered by insurance. So when we start turning on influencer campaigns and really promoting DTC, that's going to happen in early 2026, I would expect. I think by that time, we'll have had enough time to meet with the doctors a few times each, make sure they're comfortable with the products before turning on DTC. In terms of channels, we worked a lot on identifying the early adopters and where they spend their time. What we are finding these people over 45 they're spending the majority of time on Facebook, Instagram, YouTube and Pinterest.

因此我們可以比其他受保險覆蓋的產品更快啟動。因此，當我們開始進行有影響力的活動並真正推廣 DTC 時，我預計這將在 2026 年初發生。我認為到那時，我們將有足夠的時間與醫生會面幾次，確保他們在啟用 DTC 之前對產品感到滿意。在通路方面，我們花了很多精力來確定早期採用者以及他們花時間的地方。我們發現這些 45 歲以上的人大部分時間都花在 Facebook、Instagram、YouTube 和 Pinterest 上。

So those are really going to be the avenue that we focus to drive that awareness. We're not finding that they're spending their time on like linear TV, so your standard TV channels. So timing, early 2026 in channels, Facebook, YouTube, Pinterest and Instagram.

因此，這些確實將成為我們提高認識的重點途徑。我們發現他們並沒有把時間花在線性電視，也就是標準電視頻道。因此時間表是，2026 年初在 Facebook、YouTube、Pinterest 和 Instagram 等管道上。

Thanks, Shawn. I'll take a question on the modeling, Yigal, and thanks for dialing in. You'll appreciate that at this state in the company and prelaunch, we're not guiding on revenue or volume. What we have shared is that ultimately, we can see this being a $3 billion-plus market. And as we've shared previously, that's based upon 8 million ultimate users in the US alone using the product five refills a year at what would be yearly pricing. So with that in mind and the fact that we're guiding to be cash flow positive, I think many of the models, including yours, are actively at least giving a sense of when that could happen. But again, we're not guiding to what we have in our plans.

謝謝，肖恩。我將回答一個關於建模的問題，伊加爾，感謝您撥入電話。您會理解，在公司目前的這個階段和產品發布前，我們不會提供收入或銷售方面的指導。我們所分享的是，最終我們可以預見這是一個價值 30 多億美元的市場。正如我們之前所分享的，這是基於僅在美國就有 800 萬最終用戶每年使用該產品五次，按年定價計算。因此，考慮到這一點以及我們指導現金流為正的事實，我認為包括你們在內的許多模型至少都在積極地表明這種情況何時會發生。但再次強調，我們並沒有對我們的計劃做出指導。

Okay, got it, thank you.

好的，知道了，謝謝。

Lachlan Hanbury-Brown with William Blair.

拉克蘭·漢伯里·布朗 (Lachlan Hanbury-Brown) 和威廉·布萊爾 (William B

Hey guys, thanks for taking the questions. So Shawn, just on the DTC marketing, I mean, you've obviously had a pretty comprehensive unbranded campaign prior to approval. So I was curious how you think about the transition from that to branded campaign to DTC? Does that -- if DTC starts in early 2026, does the unbranded campaign continue until then or does it sort of slip over to something else upon approval or availability? And then second, you sort of touched on this a little earlier, but with the sales force expected to all be hired by July 1 and presumably at least some of them will have been through that 3 weeks training. What can they do in terms of the interactions with target ECPs before an approval, if anything?

嘿夥計們，感謝你們回答問題。肖恩，就 DTC 行銷而言，我的意思是，在獲得批准之前，你顯然已經開展了相當全面的非品牌行銷活動。所以我很好奇您如何看待從品牌行銷活動到 DTC 的轉變？如果 DTC 在 2026 年初開始，那麼無品牌活動是否會持續到那時，還是在獲得批准或可用後轉移到其他活動？其次，您之前提到過這一點，但預計銷售人員將在 7 月 1 日前全部受聘，並且大概其中至少一部分人將接受為期 3 週的培訓。如果有的話，他們在批准之前與目標 ECP 的互動方面可以做些什麼？

Because I know there are obviously a lot of restrictions around what they can and can't say and do. So could you just elaborate on what they can do in that, say, 5 weeks before the PDUFA?

因為我知道他們能說什麼、不能說什麼、做什麼顯然受到很多限制。那麼，您能否詳細說明一下他們在 PDUFA 生效前 5 週可以做些什麼呢？

Thanks, Lachlan. Great questions. Yes, happy to cover those topics. So first thing, when does the unbranded stop? So right now, the unbranded campaign, obviously, it's a disease state awareness and looking for what's the ideal solution look like in presbyopia.

謝謝，拉克蘭。很好的問題。是的，很高興討論這些主題。那麼首先，無品牌什麼時候會停止？因此，現在，非品牌活動顯然是一種疾病狀態意識，並尋找老花眼的理想解決方案。

Our plan is to continue to run that up until potential approval. And then we would sunset that campaign. So it's really what we can have out there so we can get the excitement going for future solutions in presbyopia. Once we can transition to speaking about the brand, we want to immediately transition to that and make that the focus of all messaging. And so what that transition will look like to DTC marketing.

我們的計劃是繼續執行該操作直至獲得批准。然後我們就會結束這個活動。所以這確實是我們可以做的，因此我們可以為老花眼的未來解決方案感到興奮。一旦我們可以轉向談論品牌，我們希望立即轉向這一點，並使其成為所有訊息傳遞的重點。那麼這種轉變對於 DTC 行銷來說會是什麼樣子呢？

So right now, in the unbranded campaign, a lot of that's focused on where do doctors spend their time as well as the conventions that they're going to in their publications. When we move over to DTC for the direct-to-consumer, we'll actually first start with direct to practitioner. So we'll actually bring on branded messaging to the doctors. So we'll just transfer everything we're doing on the unbranded side, flip it over to branded materials directly at the doctors to really drive their awareness and make sure they're comfortable with the product. And then as we transition to then DTC after that in early 2026, the whole game resets in terms of how we target them because now that we're targeting a consumer, we're moving off of the platforms where doctors are focused for information back to that Pinterest, YouTube, Facebook, Instagram.

因此，目前，在非品牌宣傳活動中，許多內容都集中在醫生的時間花在哪裡以及他們在出版物中要參加的會議。當我們轉向 DTC 直接面向消費者時，我們實際上首先會從直接面向從業者開始。因此，我們實際上會向醫生傳達品牌訊息。因此，我們將把在非品牌方面所做的一切轉移到品牌材料上，直接提供給醫生，以真正提高他們的認知度並確保他們對產品感到滿意。然後，隨著我們在 2026 年初過渡到 DTC，整個遊戲將在我們如何定位目標方面進行重置，因為現在我們的目標是消費者，我們將從醫生關注的資訊平台轉向 Pinterest、YouTube、Facebook、Instagram。

And to do that, we've brought on the right type of media buy agencies that have those relationships to make sure that we have hard hitting impactful messaging on those platforms. So that's how we're really going to transition to DTC. Now the sales force, as we shared, over 40% of them have already accepted offers. Some of them will be on before July 1, right? You spoke about the 3 weeks of training.

為了做到這一點，我們引入了擁有這些關係的合適的媒體購買機構，以確保我們在這些平台上傳遞具有強烈影響力的訊息。這就是我們真正向 DTC 過渡的方式。現在，正如我們所分享的，銷售人員中超過 40％ 的人已經接受了報價。有些會在 7 月 1 日之前上線，對嗎？您談到了三週的培訓。

So what can happen after their training before approval? So that's again where the unbranded campaign comes in. The unbranded campaign is fair game for sales force to talk about, so they can actually start their call cycles. So they can start to meet the eye care professionals, confirm routings, confirm e-mails, get to know the doctor, just the discussion will be limited to the EYEAMSELECTIVE campaign. And then upon approval, they can then immediately switch to the branded calls.

那麼，在獲得批准之前，經過訓練之後會發生什麼事？這就是無品牌行銷活動再次發揮作用的地方。非品牌活動對於銷售人員來說是公平的討論對象，因此他們實際上可以開始他們的呼叫週期。因此，他們可以開始與眼科護理專業人員會面，確認路線，確認電子郵件，了解醫生，只是討論僅限於 EYEAMSELECTIVE 活動。經批准後，他們就可以立即切換到品牌呼叫。

So that's how to think of that transition from hiring until product approved.

這就是從招募到產品核准的轉變過程。

Okay, thanks, that's.

好的，謝謝，就這樣。

Gary Nachman with Raymond James.

加里·納赫曼 (Gary Nachman) 和雷蒙德·詹姆斯 (Raymond James)。

This is Denis Reznik, on for Gary Nachman. Congrats on all the progress. First, could you provide an update on the work you're doing surrounding the additional patent protection for LNZ100? I believe you previously mentioned you had 10 currently under review. Just any additional color on what type of patents they are and your confidence in the overall IP estate?

我是丹尼斯‧雷茲尼克 (Denis Reznik)，代替加里‧納赫曼 (Gary Nachman)。祝賀你取得的所有進展。首先，您能否介紹一下圍繞 LNZ100 的額外專利保護所做的工作的最新進展？我相信您之前提到目前有 10 個正在審核中。您能否進一步說明這些專利是什麼類型，以及您對整體智慧財產權的信心？

And then can you talk a little bit more about the process that went into selecting the e-pharmacy you're working with? What specifically sets this e-pharmacy apart from others? And just elaborate a little bit more there. And then I've got one follow-up.

然後，您能否再多談談選擇與您合作的電子藥局的過程？這家電子藥局與其他電子藥局有何不同？再稍微詳細地闡述一下。然後我還有一個後續問題。

Absolutely. Great questions. If you think about the current patent estate, we have 7 granted patents that go out to 2039 already. This fall roughly in 2 buckets, one around the use of aceclidine to treat presbyopia, so very strong patents around that. Another suite of product formulation patents and very strong patents that go out to 2039.

絕對地。很好的問題。如果你考慮一下目前的專利狀況，我們目前已經有 7 項已授權專利，有效期至 2039 年。這大致分為兩類，一類是使用乙醯克利定治療老花眼，因此這方面的專利非常強大。另一套產品配方專利和非常強大的專利將持續到 2039 年。

And the patents that are currently under review, and I'm talking U.S. only here for the moment, that will extend that to at least 2044 further patents in those 2 categories as well as use patents in different use cases that we have seen in our product. That's going to be, again, a very broad, very strong patent estate just to complete that on the protection side for the products. Ahead of that sits because it is a new chemical entity for the U.S., at least 5 years of data exclusivity upon approval is what we expect to get. And on the back end, because it's a self-pay product, you'll never see your traditional generic switch for a product like this because there's no insurance involved.

目前正在審查的專利（我目前只談論美國）將擴展到這兩個類別中的至少 2044 項專利，以及我們在產品中看到的不同用例的使用專利。再次強調，這將是一個非常廣泛、非常強大的專利資產，只是為了在產品保護方面完成這一點。由於這對美國來說是一個新的化學實體，因此我們預計在獲得批准後至少可以獲得 5 年的資料獨佔權。而在後端，因為它是一個自付費產品，你永遠不會看到這樣的產品的傳統通用開關，因為它不涉及保險。

So there's no insurance pushing the pharmacists to switch a brand over to a generic. That we feel on the back end, and now we're talking 2044 and beyond, will provide a very strong and long-lasting life cycle for the product.

因此，沒有保險會迫使藥劑師將品牌藥轉換為仿製藥。我們感覺在後端，現在我們談論的是 2044 年及以後，將為產品提供非常強大和持久的生命週期。

And this is Shawn, for the second question on the process to select e-pharmacy. So we spend a lot of time making sure we chose the right partner for e-pharmacy. One of the most important criteria is we wanted to make sure we selected an e-pharmacy that already existed within the eye care professional EMR ecosystem. What we didn't want to select a pharmacy that's not already established in the eye care offices because obviously, that takes work to set up all their EMR systems. So that was a key criteria.

我是 Shawn，第二個問題是關於選擇電子藥局的流程。因此，我們花費大量時間來確保選擇正確的電子藥局合作夥伴。最重要的標準之一是，我們要確保選擇已經存在於眼科專業 EMR 生態系統中的電子藥局。我們不想選擇尚未在眼科診所建立的藥房，因為顯然，建立所有的 EMR 系統需要花費功夫。所以這是一個關鍵標準。

Another key criteria was actually the interface for the consumer, right? With this being consumer products, we want something that was sleek, easy to use and a partner that had good follow-up to ensure compliance. So other factors that were behind those 2, speed of delivery, ability to handle high volume of actual scripts and other partners, making sure that they work with other reputable partners as well, not necessarily in eye care, but other high-end pharma companies. What was not in the selection process that's different than many other companies is their ability for prior authorization or insurance claim adjudication, that was not something that we put into the factors as we were involved evaluating e-pharmacy given the fact that this is a cash pay product.

另一個關鍵標準實際上是消費者的介面，對嗎？由於這是消費產品，我們希望它外觀時尚、易於使用，並且擁有良好的後續跟進以確保合規性的合作夥伴。因此，這兩個因素背後的其他因素是交付速度、處理大量實際腳本的能力和其他合作夥伴，確保他們也與其他信譽良好的合作夥伴合作，不一定是眼科護理領域，而是其他高端製藥公司。在選擇過程中，與許多其他公司不同的是，他們的事先授權或保險索賠裁決能力，這不是我們考慮的因素，因為我們參與評估電子藥房，因為這是現金支付產品。

That's super helpful. And then just given there's been some previous rumblings of recession, perhaps consumer sentiment being worse than people had anticipated, if that does end up occurring where there is a recession, how does that kind of change your initial call points, if at all? And then would that cause you to focus on certain geographies over others? Congrats on all the progress.

這非常有幫助。然後，考慮到之前已經出現過一些經濟衰退的跡象，也許消費者情緒比人們預期的更糟糕，如果最終真的發生了經濟衰退，這會如何改變您最初的呼叫點呢？那麼這是否會導致您將注意力集中在某些地區而不是其他地區？祝賀你取得的所有進展。

Yes. So Denis, this is Dan Chevallard. I'll start the first part of that question, and then I'll pass it to Shawn to conclude it. So the topic of recession is one that we've certainly looked at. And as you think about relative risks for a product with our profile, we evaluated the medical aesthetics field, VUITY category, medical procedures like LASIK, dermatology and others.

是的。丹尼斯，這是丹·切瓦拉德。我將開始回答該問題的第一部分，然後將其交給 Shawn 來總結。因此，經濟衰退這個主題確實是我們一直在關注的。當您考慮我們產品的相對風險時，我們會評估醫學美容領域、VUITY 類別、LASIK 等醫療程序、皮膚病學等。

And I think reference time points where you could look back to, to say, well, gosh, how did those profiles or how do those categories behave. You don't have to go too far back to see how do these categories behave in the COVID era and then prior to that in the Global Financial Crisis era of 2007 through 2011. Key takeaways, I think we would be naive to say that we're not immune, but historical precedent really suggests that the medical aesthetics category and we'll use the neurotoxins and fillers as maybe the closest proxy to what we do are a bit more insulated from a recession risk than higher-priced elective procedures such as cosmetic surgery. So that's one way to look at it. I think that it's fair to say that discretionary spend will always potentially be impacted.

我認為，您可以回顧參考時間點，然後說，天哪，這些配置或這些類別的表現如何。您無需回顧太久，就能看到這些類別在 COVID 時代以及之前 2007 年至 2011 年全球金融危機時期的表現如何。關鍵要點是，我認為說我們沒有免疫力是天真的，但歷史先例確實表明，醫學美容類別（我們將使用神經毒素和填充劑作為可能與我們所做的最接近的替代品）比整容手術等價格更高的選擇性手術更能抵禦經濟衰退的風險。這是一種看待這個問題的方式。我認為可以公平地說，可自由支配的開支總是會受到影響。

But I think for a product like ours that impacts quality of life that has such a large addressable market and you could even kind of put it into a category like these medical aesthetics from the standpoint of consumerism, you could almost put this into a beauty-like view of this being -- becoming something that is viewed as an essential really, which I think could insulate us from significant downside risk. Just to quantify that, you could look at the categories that we're highlighting as the closest proxies and you get at the high end single-digit negative impacts from a growth perspective at the peak of recession years, but on balance coming through in an extremely strong way.

但我認為，對於我們這種影響生活品質的產品，它擁有如此巨大的潛在市場，你甚至可以從消費主義的角度把它歸入醫學美容之類的類別，你幾乎可以把它放在類似美容的觀點中——成為一種真正被視為必需品的東西，我認為這可以使我們免受重大的下行風險。為了量化這一點，您可以查看我們強調的最接近的代理類別，從成長角度來看，在經濟衰退高峰期，其負面影響為個位數高端，但總體而言，其影響卻極其強勁。

And adding on to that in terms of the targets and given what was just shared by Dan, in terms of if a recession were to happen, our 88 rep field force, we believe, is rightsized and it's really focused on 85% of all of VUITY scripts. So I wouldn't see that changing. Again, given that minimal potential impact that Dan just highlighted. We're already also focused -- when you look at those 88 reps in those territories, we're really focused in calling in those major metropolitan markets where you're focused on that higher-end consumer as well that has a little bit more resolve in those situations. So I don't see that call point changing.

除此之外，就目標而言，考慮到丹剛才分享的內容，如果發生經濟衰退，我們相信我們的 88 名代表現場隊伍規模合適，並且真正專注於 85% 的 VUITY 腳本。所以我認為這種情況不會改變。再一次，考慮到丹剛才強調的潛在影響很小。我們已經集中精力了——當你看到這些地區的 88 名代表時，你會發現我們真正專注於在那些大都市市場開展業務，在這些市場中，你也會關注那些在那些情況下更有決心的高端消費者。因此我認為呼叫點不會改變。

Super helpful. Thanks, guys.

超有幫助。謝謝大家。

Matthew Caufield from H.C. Wainwright.

H.C. Wainwright 的 Matthew Caufield。

So we were curious with the recent developments in the space regarding others NDA submission and a product launch. Do you foresee specific scenarios where a prescriber could ultimately suggest an alternative approved eye drop first prior to utilizing LNZ100 pending approval?

因此，我們對該領域其他 NDA 提交和產品發布的最新進展感到好奇。您是否預見到特定情況，即處方醫生最終可能會建議先使用其他已批准的眼藥水，然後再使用 LNZ100 等待批准？

Great question, Matt. I think Shawn and I might tag team a little bit on that. I think ultimately, with these products, it's all around does it work, yes or no? Do you achieve as a consumer what you're expecting, which is can you go with at least a very significant part of the thing. We've seen that with VUITY that was not the case, which was a high-dose that clearly did not deliver that expectation -- on that expectation.

問得好，馬特。我想肖恩和我可能會就此展開合作。我認為，最終，這些產品的關鍵在於它是否有效，是還是？身為消費者，您是否實現了自己的期望，也就是說，您是否可以接受至少其中非常重要的一部分。我們發現 VUITY 的情況並非如此，高劑量顯然沒有達到預期。

And therefore, after our initial good launch, people didn't refill because it didn't work. These are not products that you get people to say, use it for three months and maybe you notice an effect. It's on the very first day, you either like it or you don't like it. And the liking it truly comes down to does it work. So it's hard to believe how others currently on the market can achieve that.

因此，在我們最初成功推出之後，人們並沒有再補充，因為它沒有發揮作用。這些產品並不是人們說用三個月就能看到效果的。第一天，你要嘛喜歡它，要嘛不喜歡它。而真正喜歡它取決於它是否有效。因此很難相信目前市場上的其他公司如何能夠實現這一目標。

We'll see. We're very much focused on what we can deliver. And that's where we know, again, if you just look at our clinical data, but especially also at the patient feedback, and we shared some of that at the Commercial Day, how they're talking about the product and how they've experienced that very first drop that went into their lives. And because of that, what you see us do is very heavy sampling, which is different than what others are doing. So I'll leave it with that.

我們將拭目以待。我們非常關注我們能夠提供什麼。我們知道，如果你看一下我們的臨床數據，尤其是患者的反饋，我們在商業日分享了其中的一些信息，他們是如何談論產品的，以及他們是如何體驗進入他們生活的第一滴產品的。正因為如此，我們所做的是高度採樣，這與其他人所做的不同。所以我就這樣吧。

We -- it's hard to see that you'll step in with one product and then if you will graduate to something else. Sampling is going to be key and people pick the ones that they will like.

我們很難想像你會先推出產品，然後再轉向其他產品。採樣是關鍵，人們會選擇他們喜歡的。

Yes. And just to add on to that, Minor League. So again, I've been out there at the conferences. I've spoken to the eye care professionals. I've seen the data of the products you're talking about, and I continue to see this as a category of one.

是的。再補充一點，小聯盟。因此，我再次參加了這些會議。我已經和眼科保健專家談過了。我已查看過您所談論的產品的數據，並且我仍然將其視為一個類別。

Definitely looking forward to the PDUFA.

絕對期待 PDUFA。

That concludes our question-and-answer session as I am showing no further questions. Thank you for your participation, and we will now conclude today's conference call. You may now disconnect.

我們的問答環節到此結束，我沒有其他問題了。感謝您的參與，我們現在結束今天的電話會議。您現在可以斷開連線。