Phathom Pharmaceuticals Inc (PHAT) 2025 Q1 法說會逐字稿

Hello and welcome to the Phathom Pharmaceuticals' First Quarter 2025 Earnings Results Call. (Operator Instructions) Please be advised that today's conference is being recorded. With that, I would like to turn the conference over to Eric Sciorilli, Phathom's Head of Investor Relations. Please go ahead.

您好，歡迎參加 Phathom Pharmaceuticals 2025 年第一季財報結果電話會議。（操作員指示）請注意，今天的會議正在錄音。接下來，我想將會議交給 Phathom 投資者關係主管 Eric Sc​​iorilli。請繼續。

Thank you, operator. Hello, everyone and thank you for joining us this morning to discuss Phathom's first quarter 2025 results. This morning's presentation will include remarks from Steve Basta, our President and CEO and Molly Henderson, our Chief Financial and Business Officer. Robert Breedlove, our VP of Finance and Principal Accounting Officer will also be joining the team during the Q&A portion of today's call.

謝謝您，接線生。大家好，感謝您今天早上加入我們討論 Phathom 2025 年第一季的業績。今天早上的演講將包括我們的總裁兼執行長史蒂夫·巴斯塔 (Steve Basta) 和首席財務和業務官莫莉·亨德森 (Molly Henderson) 的演講。我們的財務副總裁兼首席會計長羅伯特·布里德洛夫 (Robert Breedlove) 也將在今天電話會議的問答環節加入團隊。

Just a couple of logistical items before we get started. Earlier this morning, we issued a press release detailing the results we will be discussing during the call. A copy of that press release can be found under the News Releases section of our corporate website. Further, the recording of today's webcast can be found under the Events and Presentation section of our corporate website.

在我們開始之前，還有幾個後勤事項需要注意。今天早些時候，我們發布了一份新聞稿，詳細介紹了我們將在電話會議中討論的結果。您可在我們公司網站的新聞稿部分找到該新聞稿的副本。此外，您可以在我們公司網站的「活動和演示」部分找到今天的網路廣播錄音。

Before we begin, let me remind you that we will be making a number of forward-looking statements throughout today's presentation. These forward-looking statements involve risks and uncertainties, many of which are beyond Phathom's control. Actual results can materially differ from the forward-looking statements and any such risks can materially adversely affect the business, the results of operations and the trading prices for Phathom's common stock. A discussion of these statements and risk factors is available on the current Safe Harbor slide as well as in the Risk Factors section of our most recent Form 10-K and subsequent SEC filings. All forward-looking statements made on this call are based on the beliefs of Phathom as of this date and Phathom disclaims any obligation to update these statements.

在我們開始之前，請允許我提醒您，我們將在今天的演示中做出一些前瞻性的陳述。這些前瞻性陳述涉及風險和不確定性，其中許多超出了 Phathom 的控制範圍。實際結果可能與前瞻性陳述有重大差異，任何此類風險都可能對 Phathom 普通股的業務、經營績效和交易價格產生重大不利影響。有關這些聲明和風險因素的討論可在當前安全港幻燈片以及我們最新的 10-K 表格和隨後的 SEC 文件中的風險因素部分中找到。本次電話會議中所做的所有前瞻性聲明均基於 Phathom 截至目前的看法，Phathom 不承擔更新這些陳述的任何義務。

With that, I will now turn the call over to Steve Basta, Phathom's President and CEO, to kick us off. Steve?

現在，我將把電話交給 Phathom 總裁兼執行長 Steve Basta，讓我們開始吧。史蒂夫？

Thank you, Eric and thank you to everyone joining the call today. I am pleased to be here speaking with you all today. As I considered my choice to join Phathom, the piece that was abundantly clear to me in all of my conversations was the tremendous impact VOQUEZNA is having on patients' lives.

謝謝你，艾瑞克，也感謝今天參加電話會議的所有人。我很高興今天能在這裡與大家交談。當我考慮加入 Phathom 的選擇時，在所有對話中我都非常清楚 VOQUEZNA 對患者生活的巨大影響。

My focus throughout my career has been helping patients by delivering products that improve patient care and outcomes. This journey with Phathom builds on that focus. There are tens of millions of patients in the US that suffer from GERD. And many of those patients are inadequately treated by current PPIs.

在我的整個職業生涯中，我的重點是透過提供改善患者護理和治療結果的產品來幫助患者。這次與 Phathom 的旅程正是建立在這一重點之上。美國有數千萬患者患有 GERD。而許多患者目前的 PPI 療法無法充分治療。

Based on our clinical data and the many, many patient testimonials and testimonials from prescribers, we know that VOQUEZNA delivers a meaningful improvement to the management of acid reflux. My first priority as CEO is to accelerate the launch of this great drug and build a profitable, successful company for our employees and our shareholders.

根據我們的臨床數據以及眾多患者的評估和處方醫生的評價，我們知道 VOQUEZNA 對胃酸逆流的治療有顯著的改善。作為首席執行官，我的首要任務是加速推出這種偉大的藥物，為我們的員工和股東打造一個盈利的、成功的公司。

Before I address the operational topics that were discussed in today's press release and that we are going to go into in more detail, just a quick background might help for those who don't know me. I've sat in CEO seat for over 20 years leading biopharma, medical device, and digital health companies.

在我討論今天的新聞稿中討論的營運主題以及我們將要更詳細地討論的營運主題之前，簡單介紹一下背景可能會對那些不認識我的人有所幫助。我擔任執行長已有 20 多年，領導生物製藥、醫療設備和數位健康公司。

Each of those experiences had unique challenges. A common theme across all of them has been my commitment to commercial creativity. I've built businesses and created value where others doubted the initial market opportunity.

每一次經驗都面臨獨特的挑戰。所有這些的共同主題是我對商業創造力的承諾。我在其他人懷疑最初的市場機會的地方創建了企業並創造了價值。

As I look at this new journey with Phathom, I can promise you that I will bring fresh perspective, a hands-on approach and a sense of urgency to growing this company. Phathom successfully developed a great drug and launched VOQUEZNA to already within the first 18 months, an annualized run-rate of $120 million in net revenues. That's a great start.

當我展望與 Phathom 一起踏上新的旅程時，我可以向你們保證，我將為公司的發展帶來新的視角、親力親為的方法和緊迫感。Phathom 成功開發出一種出色的藥物，並推出了 VOQUEZNA，在前 18 個月內，年淨收入已達到 1.2 億美元。這是一個很好的開始。

Our future success centers around growing sales to achieve VOQUEZNA's significant potential and managing costs to reach profitable operations in 2026, thus mitigating financing risk and overhang and ultimately building a durable business with VOQUEZNA as the foundation of that business.

我們未來的成功集中在增加銷售額以實現 VOQUEZNA 的巨大潛力和管理成本以在 2026 年實現盈利運營，從而降低融資風險和懸而未決的問題，並最終以 VOQUEZNA 為基礎建立持久的業務。

Our operating priorities represent a shift somewhat compared to the company's previous targets. We recognize that when the stock was trading near $20 per share, our access to capital was much more flexible than it is today.

與公司先前的目標相比，我們的營運重點有所轉變。我們認識到，當股票交易價格接近每股 20 美元時，我們獲取資金的管道比現在靈活得多。

The cost of capital, if we were to raise at $4 a share is more dilutive and thus we are taking steps that reflect that reality by responsibly managing expenses. I am working with our team to establish the disciplined approach to spending based on efficiency with rigorous consideration of leveraging the high leverage growth drivers.

如果我們以每股 4 美元的價格籌集資金，資本成本會更加稀釋，因此我們正在採取措施，透過負責任地管理費用來反映這一現實。我正在與我們的團隊合作，建立基於效率的嚴格支出方法，並嚴格考慮利用高槓桿成長動力。

We have four priorities for the remainder of 2025. First, and absolutely, our focus is on growing VOQUEZNA's sales to maintain our revenue ramp. Second is clarifying our exclusivity timeline hopefully through our pending Citizens Petition and getting a clear answer from FDA or if we don't get a clear answer from FDA by taking the appropriate next steps if necessary.

我們對 2025 年剩餘時間有四項優先事項。首先，當然，我們的重點是增加 VOQUEZNA 的銷售量以維持我們的營收成長。第二是希望透過我們正在審理的公民請願書來澄清我們的排他性時間表，並從 FDA 獲得明確的答复，或者如果我們沒有從 FDA 獲得明確的答复，則在必要時採取適當的後續步驟。

Third is implementing the cost savings that we are starting today and will be executing over the course of the coming months with vigilance on a number of our areas of spending to achieve profitable operations in 2026. And fourth is then charting a value-creating future for Phathom that leverages the extraordinary potential of VOQUEZNA and builds on that foundation to create a durable, sustaining company.

第三是實施我們今天開始的成本節約措施，並將在未來幾個月內執行，同時密切關注我們的一些支出領域，以在 2026 年實現盈利運營。第四，為 Phathom 規劃一個創造價值的未來，利用 VOQUEZNA 的非凡潛力，並在此基礎上創造一家持久、可持續發展的公司。

Today, we are announcing that we will be implementing cost savings initiatives to reach operating expenses, excluding interest, stock comp, and certain accruals, of less than $55 million per quarter in Q4 of this year. These spending reductions, in combination with the continued focus on revenue growth, are intended to enable us to achieve profit from operations in 2026.

今天，我們宣布，我們將實施成本節約計劃，以使今年第四季的營運費用（不包括利息、股票補償和某些應計項目）達到每季 5,500 萬美元以下。這些支出削減，加上對收入成長的持續關注，旨在使我們在 2026 年實現營運獲利。

Importantly, our target is to be able to achieve this with our current cash on the balance sheet, without the need to draw-down additional debt or raise additional equity. This reframing of our strategy does not imply a departure from our belief in VOQUEZNA's commercial opportunity. Rather, it just reflects the reality of the current capital markets and brings a much needed sense of urgency and cost control to our operations.

重要的是，我們的目標是能夠利用資產負債表上的現有現金來實現這一目標，而無需減少額外債務或增加額外股權。重新制定策略並不意味著我們放棄對 VOQUEZNA 商業機會的信念。相反，它只是反映了當前資本市場的現實，並為我們的營運帶來了急需的緊迫感和成本控制。

We remain focused on driving top line growth and we believe our sales organization represents the core means by which we can achieve that goal. Our prioritization on profitability will require notable changes across the business, many of which you likely already saw in this morning's press release.

我們仍然專注於推動營收成長，我們相信我們的銷售組織是我們實現這一目標的核心手段。我們對盈利能力的優先考慮將要求整個業務做出顯著的改變，其中許多改變您可能已經在今天早上的新聞稿中看到。

Let me start by addressing some of the personnel-related changes. In the context of our cost reduction initiatives, Azmi, Martin, and Molly will transition out of Phathom in the coming weeks. Azmi will continue to advise the company to support our Citizens Petition process, some of our regulatory activities and future potential product pipeline strategies.

首先，我想談談一些與人事相關的變動。在我們的成本削減計劃的背景下，Azmi、Martin 和 Molly 將在未來幾週內離開 Phathom。阿茲米將繼續建議公司支持我們的公民請願程序、我們的一些監管活動以及未來潛在的產品管道策略。

Robert Breedlove, who is currently our VP of Finance, joins us on today's call to address questions, has also been appointed Principal Accounting Officer. These transitions are aligned with our goal of streamlining operations.

現任我們財務副總裁的羅伯特·布里德洛夫 (Robert Breedlove) 參加了今天的電話會議來回答問題，他也被任命為首席會計官。這些轉變與我們精簡營運的目標一致。

Several key functional leaders will now report directly to me providing for greater operational efficiencies and a commercially focused leadership team. With the reduction of some marketing and development activities, we are also implementing a reduction of force that will reduce total staffing by approximately 6%.

現在，幾位關鍵職能領導將直接向我匯報，以提高營運效率並組建以商業為中心的領導團隊。隨著一些行銷和開發活動的減少，我們也將實施裁員，總員工人數將減少約 6%。

We have carefully assessed our commercial and development initiatives to consider the return on investment of our core strategies and investments. And we have decided to deprioritize certain initiatives and prioritize others.

我們仔細評估了我們的商業和發展計劃，以考慮我們的核心策略和投資的投資回報。我們已決定降低某些措施的優先級，並優先考慮其他措施。

Most notably, at the end of Q2, we are halting our broadcast cable and streaming television promotion, which are the largest DTC spend categories. We will be maintaining certain digital promotion activities, which are providing higher ROI. So we are choosing to invest in the areas with higher ROI and reducing spend in areas that may have lower returns.

最值得注意的是，在第二季末，我們將停止廣播有線和串流媒體電視的推廣，而這兩項是 DTC 支出最大的類別。我們將維持某些提供更高投資報酬率的數位推廣活動。因此，我們選擇在投資報酬率較高的領域進行投資，並減少在回報率較低的領域的支出。

As I mentioned earlier, the core driver of our revenue growth is in our field sales organization. We are maintaining the strength of that organization and have brought in new leadership, which we announced today. I am delighted to welcome to Phathom our new SVP of Sales, Jonathan Bentley, who joins us from Intra-Cellular Therapies following their successful acquisition by J&J.

正如我之前提到的，我們收入成長的核心驅動力在於我們的現場銷售組織。我們正在保持組織的實力，並引入了新的領導層，我們今天宣布了這一消息。我很高興歡迎新任銷售高級副總裁 Jonathan Bentley 加入 Phathom，他之前任職於 Intra-Cellular Therapies，該公司被強生公司成功收購。

Jonathan brings a wealth of knowledge and experience and a fresh perspective to our sales team, including prior GI experience when he was with Salix. Jonathan will be a key member of our leadership team and leads the largest component of our organization, which is our commitment to our field sales organization.

Jonathan 為我們的銷售團隊帶來了豐富的知識、經驗和新視角，包括他在 Salix 工作時的 GI 經驗。喬納森將成為我們領導團隊的關鍵成員，並領導我們組織的最大組成部分，這是我們對現場銷售組織的承諾。

In R&D, we have paused plans for our pending Phase 2 eosinophilic esophagitis study. That study had not yet begun to enroll patients. We will evaluate over the coming months whether to initiate this study in the future based on the outcome of the Citizens Petition decision and strategic and financial considerations. Shifting for a moment to our Citizens Petition, which I know our shareholders are focused on, the FDA's decision on this matter is of critical importance to our exclusivity runway.

在研發方面，我們暫停了正在進行的第二階段嗜酸性食道炎研究的計畫。該研究尚未開始招募患者。我們將在未來幾個月內根據公民請願決定的結果以及策略和財務考量來評估是否在未來啟動這項研究。暫時轉到我們的公民請願書，我知道我們的股東非常關注這個問題，FDA 對此事的決定對於我們的獨佔性跑道至關重要。

Since I joined the company, I've worked closely with the team to understand the situation and identify if there are any ways in which we can positively influence FDA's consideration. The FDA is due to respond to our Citizens Petition in early June.

自從我加入公司以來，我一直與團隊密切合作，了解情況並確定是否有任何方法可以積極影響 FDA 的考慮。FDA 預計將於 6 月初對我們的公民請願做出回應。

A positive response would confirm our regulatory exclusivity to 2032. If we receive a negative or indeterminate response, we are going to consider the appropriate next steps and expect to take action to pursue the objective of maintaining exclusivity into 2032.

正面的回應將確認我們的監理專營權有效期至 2032 年。如果我們收到否定或不確定的答复，我們將考慮適當的後續步驟，並期望採取行動實現在 2032 年保持獨家經營權的目標。

We continue to have confidence in our legal position. The FDA granted QIDP status and a 5-year exclusivity extension to our HP-VOQUEZNA treatment packs. Under established FDA practice, that same exclusivity period should appropriately apply to all forms of the new chemical entity, vonoprazan. Unfortunately, FDA decisions and timelines are not within our control.

我們對我們的法律地位仍然充滿信心。FDA 授予我們的 HP-VOQUEZNA 治療包 QIDP 地位和 5 年獨家經營權延長。根據 FDA 既定的慣例，相同的獨佔期應適用於新化學實體沃諾拉讚的所有形式。不幸的是，FDA 的決定和時間表不在我們的控制範圍內。

I'm certainly aware of the uncertainty and concern that this pending decision has caused and the importance with which this topic is viewed by our investors. I am confident that we have a correct interpretation of the FDA policy and solid arguments that should prevail.

我當然意識到這個未決決定所引起的不確定性和擔憂，以及我們的投資者對這個主題的重視。我相信我們對 FDA 政策的解讀是正確的，並且有充分的論點可以採納。

And I am also confident that no matter which exclusivity period ultimately results, we have a meaningful path to creating significant shareholder value. Our initiatives today to continue ramping sales and to managing expenses to reach profitability next year are a first step on that path to creating significant value.

而我也相信，無論最終的獨佔期是怎樣的，我們都擁有一條為股東創造重大價值的有效途徑。我們今天採取的舉措是繼續提高銷售額並控制費用以實現明年的盈利，這是創造重大價值的第一步。

As for our first quarter 2025 results, we reported net revenues of $28.5 million and ended with $212 million in cash. Our target is for this balance to be able to support our restructured operations without the need for additional financing through the point of reaching profitability next year. Molly will share further details on these results in our commercial KPIs shortly.

至於我們的 2025 年第一季業績，我們報告的淨收入為 2850 萬美元，最終現金為 2.12 億美元。我們的目標是，這種平衡能夠支持我們重組後的運營，而無需額外融資，直到明年實現盈利。Molly 很快就會在我們的商業 KPI 中分享有關這些結果的更多詳細資訊。

Lastly, one note on the manufacturing front that does not affect our core of VOQUEZNA tablet product, but does impact one of our H. pylori combination packs. We've been informed of a possible future disruption in the supply of the VOQUEZNA TRIPLE PAKs. We are monitoring that situation closely and have not experienced any commercial disruption to-date. But given the possibility that we could experience such, we wanted to inform our investors to avoid any possible future strides.

最後，製造方面的一點需要注意，這不會影響我們的 VOQUEZNA 片劑產品的核心，但會影響我們的一款 H. pylori 組合包。我們已獲悉，VOQUEZNA TRIPLE PAK 的供應未來可能會中斷。我們正在密切關注這一情況，迄今為止尚未遇到任何商業中斷。但考慮到我們可能遇到這種情況，我們想告知我們的投資者，以避免任何可能的未來進展。

Given the limited sales contribution of the TRIPLE PAK and the fact that the DUAL PAK availability will not be affected, we do not anticipate any material impact on our revenues or operations if the supply disruption to the TRIPLE PAK occurs.

鑑於三重包裝 (TRIPLE PAK) 的銷售貢獻有限，且雙重包裝 (DUAL PAK) 的供應不會受到影響，因此，如果三重包裝 (TRIPLE PAK) 的供應中斷，我們預計不會對我們的收入或營運產生任何重大影響。

We could also switch our HP marketing emphasis quickly to the available DUAL PAK if this develops. We are at an inflection point for Phathom transitioning from an early stage company to a stable, profitable organization. We have only just begun to see VOQUEZNA's market potential. The launch has been going well. And there is so much growth ahead for this extraordinary product.

如果這種情況發生，我們也可以迅速將 HP 行銷重點轉向可用的 DUAL PAK。我們正處於 Phathom 從早期公司轉型為穩定、獲利的組織的轉折點。我們才剛開始看到VOQUEZNA的市場潛力。此次發布會進展順利。這款非凡的產品未來將擁有龐大的發展空間。

In all of my meetings so far, a consistent theme is that patients and doctors love this drug. It really has a profound impact. VOQUEZNA's benefit is a rapid, potent and durable asset suppression profile. We are starting to make internal decisions with both the top line and bottom line focus. This will make us a stronger company and will help us drive VOQUEZNA to reach its blockbuster potential.

到目前為止，在我參加的所有會議中，一個一致的主題是病人和醫生都喜歡這種藥物。它確實影響深遠。VOQUEZNA 的優勢在於其快速、強大且持久的資產抑制能力。我們開始製定既關注收入又關注收入的內部決策。這將使我們成為一家更強大的公司，並幫助我們推動 VOQUEZNA 發揮其巨大潛力。

I will now turn the call over to Molly to provide further details on our recent commercial progress and financial results. Molly?

現在我將把電話轉給 Molly，讓她提供有關我們最近的商業進展和財務業績的更多詳細資訊。莫莉？

Thanks, Steve and hello everyone. Today, I will be sharing updates on our key performance metrics since our last earnings report 8 weeks ago and outlining our financial results for the first quarter of 2025. Starting with the latest VOQUEZNA prescriptions, we have now surpassed 390,000 scripts filled by patients from launch through April 18. Over the 8 weeks since our last earnings report, this figure has grown approximately 30%. In the first quarter specifically, we recorded approximately 127,000 filled VOQUESNA prescriptions, equating to growth of about 8% over the fourth quarter.

謝謝，史蒂夫，大家好。今天，我將分享自 8 週前發布上一份收益報告以來我們的關鍵績效指標的最新情況，並概述 2025 年第一季的財務表現。從最新的 VOQUEZNA 處方開始，截至 4 月 18 日，患者開出的處方已超過 39 萬份。自我們上次發布收益報告以來的 8 週內，這一數字增長了約 30%。具體來說，在第一季度，我們記錄了約 127,000 份 VOQUESNA 處方，相當於第四季度增加了約 8%。

Among the scripts filled this quarter, we observed roughly 75% being filled by repeat patients on VOQUESNA. These results include the typical seasonal Q1 softness and also account for an anticipated downward adjustment by our data provider, IQVIA. IQVIA has informed us that a retroactive projection adjustment will be made in June, impacting data for the weeks ending January 10 through April 4 of this year. This is due to an overstatement in their mail channel volumes.

在本季開出的處方中，我們發現大約 75% 是由 VOQUESNA 的回頭客開出的。這些結果包括典型的季節性第一季疲軟，也解釋了我們的資料提供者 IQVIA 預期的下調。IQVIA 已通知我們，將於 6 月進行追溯預測調整，影響今年 1 月 10 日至 4 月 4 日期間的數據。這是由於他們的郵件頻道數量被誇大了。

As a result, we have incorporated an estimated 5% impact for this adjustment per IQVIA's guidance in the Q1 filled prescription metric we reported today. As of April 11, this has been adjusted in their weekly script data. Despite all of this, we have still demonstrated prescription growth, and we are pleased to see continued momentum with these KPIs.

因此，我們根據 IQVIA 的指導，在今天報告的第一季處方填寫量指標中納入了此次調整預計 5% 的影響。截至 4 月 11 日，他們的每週劇本數據已進行了調整。儘管如此，我們的處方量仍然在增長，我們很高興看到這些 KPI 繼續保持成長勢頭。

During the first quarter, access to VOQUEZNA through our primary patient support program partner, BlinkRx, helped to offset some of the seasonality by offering patients a cash pay option, which can be a beneficial alternative for those affected by health plan changes and high deductible resets.

在第一季度，透過我們的主要患者支援計劃合作夥伴 BlinkRx 獲得 VOQUEZNA，透過為患者提供現金支付選項，幫助抵消了部分季節性因素的影響，這對於那些受到健康計劃變更和高免賠額重置影響的人來說是一個有益的替代方案。

As a result, the proportion of scripts in the first quarter which flowed through retail pharmacies and were captured by IQVIA changed to approximately 70% from 75% in the fourth quarter, thereby representing a 70% to 30% split between retail and cash pay. In parallel, the number of prescribers who have written a filled script has increased to over 23,600 as of April 11 compared to over 20,000 as of our last report demonstrating steady adoption over these last 8 weeks.

因此，第一季流經零售藥局並被 IQVIA 取得的處方比例從第四季的 75% 變為約 70%，即零售和現金支付的比例為 70% 比 30%。同時，截至 4 月 11 日，開立處方的處方人數已增至 23,600 多人，而我們上次報告時該人數為 20,000 多人，表明過去 8 週內採用率穩步上升。

Additionally, through the end of Q1, about 22,800 cumulative prescribers have written the filled VOQUEZNA prescription, up nearly 30% compared to the fourth quarter. Among this group, primary care prescribers continue to represent the majority of writers.

此外，截至第一季末，累計約有 22,800 名處方者開出了 VOQUEZNA 處方，與第四季度相比增長了近 30%。在這群人中，初級保健處方者仍然佔作者的大多數。

On the access front, our commercial coverage remains consistent with over 120 million lives covered, representing above 80% of the total commercially insured market. And beginning in April, we rolled out a new cash pay consignment program through BlinkRx that allows government patients whose insurance does not cover VOQUEZNA to access the products outside of their insurance benefits.

在覆蓋面方面，我們的商業保險覆蓋範圍保持不變，覆蓋人數超過 1.2 億，佔商業保險市場總量的 80% 以上。從四月開始，我們透過 BlinkRx 推出了一項新的現金支付寄售計劃，允許保險不涵蓋 VOQUEZNA 的政府患者使用其保險福利以外的產品。

This program functions in a similar way to our existing commercial cash pay consignment program while requiring additional enrollment criteria. We are pleased to be able to make VOQUEZNA more accessible to this group of patients who make up approximately 50% of the GERD market.

該計劃的運作方式與我們現有的商業現金支付寄售計劃類似，但需要額外的註冊標準。我們很高興能夠讓佔 GERD 市場約 50% 的患者群體更容易獲得 VOQUEZNA。

Before I begin discussing our financials, I'd like to share that today marks my final earnings call with Phathom. With the company entering a new phase under Steve's leadership, we felt this was the right time to also transition our financial leadership.Over the next couple of weeks, I'll be working closely with Robert Breedlove, who has been involved with Phathom since its inception and will assume the role of Principal Accounting Officer. I remain proud of what we have accomplished during my time at Phathom and believe the company is well positioned for continued success.

在我開始討論我們的財務狀況之前，我想告訴大家，今天是我與 Phathom 的最後一次收益電話會議。隨著公司在史蒂夫的領導下進入新階段，我們認為這也是轉變財務領導的正確時機。在接下來的幾週內，我將與羅伯特·布里德洛夫 (Robert Breedlove) 密切合作，他自 Phathom 成立以來一直參與其中，並將擔任首席會計官一職。我仍然為我們在 Phathom 任職期間所取得的成就感到自豪，並相信公司已準備好繼續取得成功。

Now turning to the financials. Note that similar to prior quarters, I will be commenting on both GAAP and non-GAAP financial measures. Supporting schedules with detailed reconciliations between non-GAAP measures and their most directly comparable GAAP measures will be discussed later in my section. It can be found in this morning's press release.

現在談談財務。請注意，與前幾個季度類似，我將對 GAAP 和非 GAAP 財務指標進行評論。我將在本部分後面討論非 GAAP 指標與其最直接可比較的 GAAP 指標之間的詳細對帳支援時間表。您可以在今天早上的新聞稿中找到它。

For the first quarter 2025, we reported net revenues of $28.5 million, down slightly on a sequential quarterly basis. Despite the increase in prescriptions filled, revenues were impacted by a shift in volume toward cash pay and elevated stocking at the end of 2024.

2025 年第一季度，我們報告的淨收入為 2,850 萬美元，比上一季略有下降。儘管配藥量有所增加，但到 2024 年底，由於支付方式轉向現金以及庫存增加，收入受到了影響。

Specifically, recall that we noted wholesalers increased their inventory on hand by approximately one extra week at the end of last year and those extra shipments were then earned through in the first quarter. We estimate this resulted in approximately $2 million in additional stocking revenue in the fourth quarter of 2024.

具體來說，回想一下，我們注意到批發商在去年年底增加了大約一周的庫存，而這些額外的發貨量在第一季就完成了。我們估計這將導致 2024 年第四季庫存收入增加約 200 萬美元。

As of the end of March, wholesaler inventory levels have now returned to previous averages, approximating 2 weeks. Our gross to net discount rate this quarter was 53%, a slight improvement compared to the guidance we provided last quarter. We continue to expect our gross to net discount rate to range between 55% and 65% on average for the remainder of 2025.

截至 3 月底，批發商庫存水準已恢復到先前的平均水平，約為 2 週。本季我們的毛利率與淨利率折現率為 53%，與上個季度提供的預期相比略有改善。我們預計，2025 年剩餘時間內的毛利率與淨利率折現率平均將在 55% 至 65% 之間。

Moving down the P&L to our operating expenses, we reported non-GAAP R&D expenses of $7.9 million and non-GAAP SG&A expenses of $90.3 million for the first quarter of 2025, which represents a 4% decrease and 57% increase respectively compared to this period in 2024.

將損益表移至我們的營運費用，我們報告 2025 年第一季的非 GAAP 研發費用為 790 萬美元，非 GAAP 銷售、一般及行政費用為 9030 萬美元，與 2024 年同期相比分別下降 4% 和增長 57%。

As part of our SG&A expenses, we incurred advertising costs of $28.3 million in connection with their new celebrity endorsed direct-to-consumer initiatives, representing a 40% increase compared to the fourth quarter of 2024.

作為銷售、一般及行政費用 (SG&A) 的一部分，我們因新的名人代言直接面向消費者的計劃而產生了 2830 萬美元的廣告費用，與 2024 年第四季度相比增長了 40%。

This change in spending levels was primarily driven by the timing and nature of our clinical operating activities on the R&D side and the expansion of commercial investment in support of VOQUEZNA launch on the SG&A side.

支出水準的變化主要是由我們在研發方面的臨床營運活動的時間和性質，以及在銷售、一般和行政費用方面為支持 VOQUEZNA 推出而擴大的商業投資所驅動。

With regard to cost saving efforts described by Steve, Q2 expenses are expected to be relatively consistent with Q1 and we expect a more material reduction in operating spend beginning in the third quarter of this year.

關於史蒂夫所描述的成本節約措施，預計第二季度的支出將與第一季相對一致，並且我們預計從今年第三季開始營運支出將進一步大幅減少。

As a result, we are reducing our previous non-GAAP full year 2025 operating expense range by $60 million to $70 million to $290 million to $320 million.

因此，我們將先前的非 GAAP 2025 年全年營運費用範圍下調了 6,000 萬美元至 7,000 萬美元，降至 2.9 億美元至 3.2 億美元。

For the quarter ended March 31, 2025, we reported gross profit of $24.8 million, which equates to a gross margin of 87%, similar to last quarter. After accounting for quarterly cash expenses, we reported a loss from operations of $73.3 million, excluding stock-based compensation.

截至 2025 年 3 月 31 日的季度，我們報告的毛利為 2,480 萬美元，相當於毛利率為 87%，與上一季持平。扣除季度現金支出後，我們報告的營業虧損為 7,330 萬美元（不含股票薪酬）。

Non-GAAP adjusted net loss for the first quarter of 2025 was $77.1 million or $1.07 loss per share compared to $64.8 million or $1.11 loss per share for the same period in 2024. Consistent with past earnings reports, the most significant reconciling item between GAAP and non-GAAP operating expenses was non-cash stock-based compensation. Other non-GAAP reconciling items include non-cash interest on our revenue interest financing liability and non-cash interest expense related to amortization of debt discount.

2025 年第一季非公認會計準則調整後淨虧損為 7,710 萬美元，即每股虧損 1.07 美元，而 2024 年同期為 6,480 萬美元，即每股虧損 1.11 美元。與過去的收益報告一致，GAAP 和非 GAAP 營運費用之間最重要的調節項目是非現金股票薪酬。其他非公認會計準則調節項目包括我們的收入利息融資負債的非現金利息和與債務折扣攤銷相關的非現金利息費用。

Lastly, as of March 31, 2025, cash and cash equivalents were $212 million. Based on recent script trends, we have initiated discussions with our debt lender to lower the revenue triggers for the remaining debt tranches.

最後，截至 2025 年 3 月 31 日，現金和現金等價物為 2.12 億美元。根據最近的劇本趨勢，我們已經開始與債務人進行討論，以降低剩餘債務部分的收入觸發條件。

That being said, based on our current revenue forecast and revised spend goals, our target is for current cash balances to be able to support operations through the point of reaching profitability in 2026, excluding stock-based compensation and without the need for further debt or equity financing.

話雖如此，根據我們目前的收入預測和修訂後的支出目標，我們的目標是當前現金餘額能夠支持運營，直至 2026 年實現盈利，不包括股票薪酬，也不需要進一步的債務或股權融資。

With that, I'll turn the call back over to Steve for closing remarks. Steve?

說完這些，我將把電話轉回給史蒂夫，請他做最後發言。史蒂夫？

Thank you, Molly and thank you again to everyone joining us on today's call. It's my pleasure to be joining Phathom at such a crucial point in the company's journey. We are fortunate to be able to build a business around a game-changing product that has the potential to improve the lives of millions of people. My goal is to deliver on that opportunity.

謝謝你，莫莉，再次感謝參加今天電話會議的所有人。我很高興能夠在公司發展的關鍵時刻加入 Phathom。我們很幸運能夠圍繞著一款具有改變遊戲規則的產品來建立業務，該產品有可能改善數百萬人的生活。我的目標是抓住這個機會。

Throughout the call today, you've heard how we are fundamentally shifting the way we do business. Going forward, our strategic decisions will be driven by dual objectives: first, driving revenue growth; and second, being able to reach profitable operations in 2026 without requiring additional financing.

在今天的整個電話會議中，你們已經聽到了我們如何從根本上改變我們的經營方式。展望未來，我們的策略決策將由雙重目標驅動：首先，推動收入成長；其次，能夠在 2026 年實現盈利運營，而無需額外融資。

Staying true to these pillars will put us on a path to success and will enable us to grow the business even further in the years to come. My promise to you is that in all our actions, my priorities will always be to serve our patients, our team, and our investors. And to our investors specifically, we are dedicated to being good stewards of your funds. And we are committed to rewarding your confidence in our mission.

堅持這些支柱將使我們走上成功之路，並使我們在未來幾年進一步發展業務。我向你們保證，在我們的一切行動中，我的首要任務始終是服務我們的病人、我們的團隊和我們的投資者。特別是對於我們的投資者，我們致力於做好您資金的管理。我們致力於回報您對我們使命的信任。

Thank you again for joining us today. We appreciate your continued interest and support. I will now turn it over to the operator to facilitate a Q&A session. Operator?

再次感謝您今天加入我們。我們感謝您一直以來的關注與支持。現在我將把時間交給操作員，以便進行問答環節。操作員？

(Operator Instructions)

（操作員指示）

Joseph Stringer, Needham & Company.

約瑟夫·斯特林格，Needham & Company。

Hi, good morning. Thanks for taking our questions. Just curious if you could provide some more color on the timing of the C-suite changes here. Why now just ahead of the CP decision and what impact, if any, do you think these changes will have on the entire CP process? And I guess as a follow-up to that, regarding the CP decision, in the scenarios where FDA says either yes or no, it seems pretty clear what next steps are. But I suppose in the scenario where FDA says they need more time, can you walk us through what that scenario looks like in terms of timelines and potential next steps? Thank you.

嗨，早安。感謝您回答我們的問題。我只是好奇您是否可以提供一些有關高階主管變動時間的更多資訊。為什麼現在就在 CP 決策之前，您認為這些變更會對整個 CP 流程產生什麼影響（如果有的話）？我想作為對此的後續行動，關於 CP 決定，在 FDA 表示是或否的情況下，下一步該怎麼做似乎非常清楚。但我想，如果 FDA 表示他們需要更多時間，您能否向我們介紹一下這種情況的時間表和可能的後續步驟？謝謝。

Certainly, just thanks so much for jumping in with the question. In terms of the management changes, there is going to be no interruption on our CP activities. We've got a team that is working with FDA that will continue those conversations. Azmi, on the management team, has been the key point person leading that along with a couple of colleagues, other colleagues internally and with external advisors.

當然，非常感謝您提出這個問題。就管理層變動而言，我們的 CP 活動不會中斷。我們有一個團隊正在與 FDA 合作，並將繼續進行這些對話。管理團隊中的阿茲米 (Azmi) 是領導這項工作的關鍵人物，他與其他幾位同事、內部其他同事以及外部顧問一起領導這項工作。

He is going to continue to work in that effort as we communicated in the release, he is going to retain an advisory role. So he is going to be actively engaged in that. There is going to be no interruption in our prosecution activities related to the conversations with FDA.

正如我們在新聞稿中所說的那樣，他將繼續致力於這項工作，他將繼續擔任顧問。所以他將積極參與其中。我們與 FDA 對話相關的起訴活動不會中斷。

And the second half of your question is sort of what happens if we get a positive, negative or a need more time kind of response, you are right, if we get a positive response, really simple, then we've got the extra exclusivity runway. A negative response, we clearly will need to take action. Likely in the need more time scenario, we will also need to take action, because we can't just sit in limbo and be on hold for a protracted period of time.

而你問題的後半部是，如果我們得到肯定的、否定的或需要更多時間的回應，會發生什麼，你是對的，如果我們得到肯定的回應，很簡單，那麼我們就有了額外的獨家經營權。如果答案是否定的，我們顯然需要採取行動。在可能需要更多時間的情況下，我們還需要採取行動，因為我們不能只是坐在那裡，長時間處於等待狀態。

But I say that with a qualification that it depends upon the nature of conversations that we have with FDA, depends on what their response is, follow-up conversations that we have with them to determine exactly what the next steps in action are. So I don't want to presume a certain action sequence in that process. We are in the midst of evaluating that, but likely we would need to take the initiative to actually define our exclusivity period more formally.

但我要說的是，這取決於我們與 FDA 對話的性質，取決於他們的反應，以及我們與他們進行的後續對話，以確定下一步的行動。所以我不想假設過程中的某個動作順序。我們正在對此進行評估，但可能需要主動更正式地定義我們的獨佔期。

Great. Thank you for taking our questions.

偉大的。感謝您回答我們的問題。

Annabel Samimy, Stifel.

安娜貝爾·薩米 (Annabel Samimy)，Stifel。

Hi, thanks for taking my questions. And just really going on a couple of things, just while we are talking about the CP, to be clear, are you speaking to the same individuals at the FDA that you were speaking to previously? So, that's the first question. Then on the strategic reductions, just drilling down here and specifically on the decision to cut DTC, we all know it's a pretty promotion-sensitive market.

你好，謝謝你回答我的問題。實際上，當我們談論 CP 時，我想問一下，您剛才和 FDA 的人員交談的還是之前和您交談過的同一批人嗎？這是第一個問題。然後關於策略性削減，深入研究這裡，特別是關於削減 DTC 的決定，我們都知道這是一個對促銷非常敏感的市場。

So, I understand you are pulling back digitally, but I guess it was also an effort to potentially expand from the 50,000 target audience to 100,000 target audience. So, should we take this as a signal that you are on enough of a trajectory with sufficient awareness that it's kind of on a flywheel and it can sort of build itself? How are you going to, I guess target this next batch of physicians or are you pulling back on that target audience? Thanks.

所以，我知道你們在數位化方面有所退縮，但我想這也是為了將目標受眾從 50,000 人擴大到 100,000 人。那麼，我們是否應該將此視為一個信號，表明您已經走在了足夠的軌道上，並且充分意識到它就像一個飛輪，可以自行構建？我想，您打算如何瞄準下一批醫生，還是會減少對目標受眾的關注？謝謝。

So, if we think about the promotion sensitivity of this market to jump into that context and how we grow our physician audience. We have had an opportunity over the past weeks to take a look at what aspects of our operations are actually driving the growth in prescribers and driving the ongoing growth in our business. And so the key thing that is working is our sales activities.

因此，如果我們考慮這個市場的促銷敏感性，進入這個背景，以及我們如何擴大我們的醫生受眾。在過去幾週，我們有機會了解我們的哪些營運方面真正推動了處方數量的成長以及業務的持續成長。因此，起作用的關鍵是我們的銷售活動。

So, the key thing that drives new adoption is field sales calls and working through the individual physician conversions to starting to write scripts and then individual physician conversations that drive growth. The broader DTC initiatives were not converting customers in terms of the broadcast spend. Weren't converting new writers at the same rate, and so that spend is simply providing a lower ROI, as we described. So, we are focusing on the thing that works.

因此，推動新採用的關鍵因素是現場銷售電話以及透過與個別醫生的轉換來開始編寫腳本，然後與個別醫生進行對話以推動成長。就廣播支出而言，更廣泛的 DTC 措施並沒有轉換客戶。沒有以相同的速度轉換新作家，因此，正如我們所描述的，支出只是提供了較低的投資報酬率。因此，我們專注於有效的事情。

Now, that doesn't limit the total potential universe of physicians at all that would ultimately be prescribing, but the path to get there is really through the field sales activities to continue expanding the prescriber base. I don't think it limits in any way the overall potential, and there is also sort of a question of timing of DTC and maturity of the product at the time that you implement DTC.

現在，這並沒有限制最終開處方的潛在醫生總數，但實現這一目標的途徑實際上是透過現場銷售活動來繼續擴大處方者基礎。我認為它不會以任何方式限制整體潛力，而且還存在 DTC 時機和實施 DTC 時產品成熟度的問題。

So we would not in any way indicate that DTC is ultimately not going to be effective. It may just be that we are a bit early in this process and we need a more established base of awareness regarding the product. The other element of your questions over the first part was related to conversations with FDA. And there is both, some consistency in staff at FDA and some changes.

因此，我們不會以任何方式表明 DTC 最終不會有效。也許我們只是處於這個過程的早期階段，我們需要對產品有一個更成熟的認知基礎。您第一部分的問題的另一個內容與與 FDA 的對話有關。FDA 的人員組成既有一致性，也有變化。

Obviously, the senior folks at FDA have all changed. So, the senior people at FDA that are going to be driving the policy decision, that's new with the new administration and working through that process. But a lot of the folks within the legal office, we understand that there is some meaningful continuity in that process of folks that had previously been looking at this.

顯然，FDA 的高層人員都已經改變了。因此，FDA 的高層人員將推動政策決策，這是新政府的新舉措，並將透過此流程開展工作。但是，我們法律辦公室裡的許多人都明白，之前關注過這個問題的人在這過程中存在著一些有意義的連續性。

So, you will get internal advice to the senior team that comes from folks who are already well familiar with our program and our issues, but the senior policy decisions, obviously, that staffing comes in with the new administration.

因此，您將獲得來自那些已經熟悉我們的計劃和問題的人員的高級團隊的內部建議，但高級政策決策顯然是由新政府人員配備的。

Got it. Thank you.

知道了。謝謝。

Chase Knickerbocker, Craig-Hallum.

蔡斯·尼克博克、克雷格·哈勒姆。

Good morning. Thanks for taking the questions. Maybe for Steve, just on how should investors be thinking about the potential impact on overall scripts, script growth, from the discontinuation of a lot of the DTC TV spend here? I mean do you have a good survey data to determine kind of what portion of scripts are coming, being driven from there? You kind of just mentioned it.

早安.感謝您回答這些問題。也許對史蒂夫來說，投資者應該如何看待大量 DTC 電視支出停止對整體劇本、劇本成長的潛在影響？我的意思是，您是否有良好的調查數據來確定哪些部分的腳本來自那裡？您剛才提到了這一點。

I know that can be difficult to determine, but just I guess how should we be thinking about that? And along those same lines, management had previously noted comfortability around $165 million net revenue consensus at the time in 2025. Can you just give us a sense overall for kind of what your model says for 2025 as it relates to how we should be maybe moderating or changing our expectations?

我知道這可能很難確定，但我想我們應該如何考慮這個問題？同樣，管理層先前也曾表示，2025 年的淨收入預期約為 1.65 億美元。您能否從整體上向我們介紹您的模型對 2025 年的預測，以及我們應該如何調整或改變我們的預期？

Chase, thanks for the impact of that. We are not actually indicating you should be changing our expectations on revenue. I think that the range of revenues that the various analysts have in their projections are a reasonable range for the year. There is not an indication here that we think that you ought to be adjusting that in any way.

蔡斯，謝謝你帶來的影響。我們實際上並不是在暗示您應該改變我們對收入的預期。我認為各位分析師預測的今年的營收範圍是合理的。這裡沒有跡象表明我們認為您應該以任何方式進行調整。

I don't think that the changes that we are making are going to adversely impact our revenue ramp in any way. We simply weren't seeing a big uptick associated with the broad DTC program. So, we are continuing the thing that is actually working to drive the revenue, which is our field sales activity. That's the core thing.

我認為我們所做的改變不會以任何方式對我們的收入成長產生不利影響。我們只是沒有看到與廣泛的 DTC 計劃相關的大幅上漲。因此，我們正在繼續進行真正能夠推動收入成長的活動，即我們的現場銷售活動。這是核心問題。

And we are going to be focusing sales force time on the activities that drive greatest volume. In some cases that may be bringing on new prescribers. And in some cases that may be going deeper with existing prescribers.

我們將把銷售人員的時間集中在能帶來最大銷售的活動上。在某些情況下，這可能會帶來新的開藥者。在某些情況下，這可能會與現有的處方人員進行更深入的合作。

Where I think potentially we had been broadening the push to try to get lots of new prescribers around the DTC initiative, but there may be more leverage associated with depth. I am not trying to signal a change in ramp of new prescribers. This is all work that Jonathan is going to be doing, but today literally is his first day starting on in conversations with the sales team.

我認為，我們一直在努力擴大推動範圍，嘗試吸引大量新的處方人員加入 DTC 計劃，但深度可能會帶來更大的影響力。我並不是想暗示新開處方者的數量會改變。這些都是喬納森要做的工作，但今天實際上是他開始與銷售團隊交談的第一天。

So, I am going to give him time to get his feet under him and sort of think about how do we optimize the sales force activity, the sales force targeting, the time and effort within GI and primary care to optimize revenue. But the thing that is working to grow our revenue is that field sales call on a physician.

因此，我會給他時間讓他適應，並思考如何優化銷售團隊的活動、銷售團隊的目標、以及在 GI 和初級保健方面的時間和精力，以優化收入。但有助於增加我們收入的方法是現場銷售拜訪醫生。

The most important thing that happens at Phathom is when a sales rep walks into a physician's office and is having that conversation to convert a new prescriber or to grow someone's business or someone's activity pattern from their first one or two scripts to now starting to adopt this for their patients that are inadequately served with PPIs. That process works and that's what's driving our revenue and that process is unchanged.

Phathom 最重要​​的事情是當銷售代表走進醫生辦公室並進行交談以轉換新的處方者或發展某人的業務或某人的活動模式時，從最初的一兩個處方到現在開始為無法充分使用 PPI 的患者採用這種方式。這個過程是有效的，也是我們收入的驅動力，而且這個過程沒有改變。

We just weren't seeing a big effect from the broad DTC spend. We were spending a lot of money that was not converting people. And I think part of it is that we might be activating patients to go into physicians who are not yet familiar with the product. And so we were getting a lower return and not as many scripts being converted from that spend. So, I don't think by shutting off that spend on the broadcast DTC, we are going to adversely impact our ramp.

我們只是沒有看到廣泛的 DTC 支出帶來巨大影響。我們花了很多錢，但並沒有改變人們的觀念。我認為部分原因是我們可能會鼓勵患者去找那些還不熟悉產品的醫生。因此，我們獲得的回報較低，而且透過這些支出轉換的劇本數量也不多。因此，我認為，透過停止對廣播 DTC 的支出，我們不會對我們的成長產生不利影響。

And I am fully noting that it's Jonathan's first day. But no plans on any sort of sales force reduction, sales force size will remain the same. And then second point on that, any change in focus from a standpoint of primary care versus specialist GI?

我完全注意到這是喬納森的第一天。但沒有計劃削減任何銷售隊伍，銷售隊伍規模將保持不變。第二點，從初級保健和專科胃腸病的角度來看，重點有什麼變化嗎？

So, we have not made any change to the sales force. So, the cost reduction actions have not impacted the sales force in any way. And they are going to be continuing at full strength in that process. The – as to the focus of GI versus primary care that's the thing that we are going to be carefully evaluating what's the allocation of sales force time.

因此，我們沒有對銷售人員做出任何變更。因此，降低成本的措施並未對銷售團隊產生任何影響。他們將全力繼續推進這項進程。至於胃腸道保健與初級保健的重點，我們將仔細評估銷售人員時間的分配。

It's not going to be exclusively one or the other, but there may be a shifted emphasis of the amount of time within a specialty call point versus a primary care call point or the frequency of calls on GIs, how do we grow them. Now, in fact, the majority of GIs are already writing scripts for VOQUEZNA.

這不會是唯一的一個或另一個，但可能會有關於專業呼叫點與初級保健呼叫點內的時間量或對 GI 的呼叫頻率的重點轉移，我們如何增加它們。事實上，現在大多數美國大兵都已經在為《VOQUEZNA》編寫劇本了。

So, we have actually converted more than 50% of them to writing, but there is an opportunity also to go deeper. So, we may shift timing a little bit, but I don't want to get ahead of the assessment that he is going to do with the sales leadership team to figure out how we optimize our time to get the optimal revenue ramp.

因此，我們實際上已經將其中超過 50% 的內容轉化為書面形式，但也有機會進行更深入的研究。因此，我們可能會稍微調整一下時間，但我不想搶在他與銷售領導團隊進行的評估之前，弄清楚如何優化我們的時間以獲得最佳的收入成長。

That's work that we are going to be doing on an ongoing basis in the coming months. And I am sure in the next one quarter or two quarters, we are going to be giving you more of an update on how that evaluation is evolving. But, again, it's still early days since I joined. So, we are working through that exercise.

這是我們在未來幾個月內將持續進行的工作。我相信在接下來的一兩個季度裡，我們將向您提供更多有關評估進展的最新資訊。但是，我加入的時間還為時過早。所以，我們正在進行這項練習。

Got it. And then just last confirmation question. Just to confirm, you plan to be cash flow from operations breakeven on a full year basis in 2026 or in a quarter within 2026?

知道了。然後是最後一個確認問題。只是為了確認一下，您計劃在 2026 年全年或 2026 年某個季度實現經營現金流收支平衡嗎？

So, we understand that our comment on that guidance was a little bit vague in that regard, and partly that's just preserving a little bit of flexibility. I mean 2026 is still a year away. We could be operating profit. We could be showing an operating profit for the full year. We could show an operating profit for part of the year.

因此，我們理解我們對該指南的評論在這方面有點模糊，部分原因只是為了保留一點靈活性。我的意思是 2026 年還有一年的時間。我們可以獲得營業利潤。我們可能會實現全年營業利潤。我們可以在一年中的部分時間實現營業利潤。

It will depend upon the timing of various investments, and I don't want to get too far ahead of a commitment. The broader commitment you should absolutely take from this conversation is a commitment to bring our spend rate down. That's why we have given the very precise number of, look, we are going to be below $55 million in terms of operating expenses on a quarterly basis by Q4.

這將取決於各種投資的時機，我不想在承諾之前走得太遠。您絕對應該從這次談話中做出的更廣泛的承諾是降低我們的支出率。這就是為什麼我們給出了非常精確的數字，看，到第四季度，我們的季度營運費用將低於 5500 萬美元。

We are going to be vigilant about maintaining discipline in our spend rate and partly when we go profitable depends on what the revenue ramp into 2026 is, and we are not forecasting exactly which quarter that we might cross over in that process.

我們將密切關注支出率的維持紀律，何時實現盈利部分取決於 2026 年的收入成長情況，而我們無法準確預測在此過程中可能跨越哪個季度。

Thank you.

謝謝。

Yatin Suneja, Guggenheim.

古根漢美術館的亞廷·蘇內賈（Yatin Suneja）。

Hey guys, good morning.

大家好，早安。

Thank you for taking my question. I mean just a question particularly on what you are seeing in the market dynamics currently. Like if you look at the script for the last, let's say, four weeks or five weeks, it seems to be relatively flat. So, anything particular that is happening where you are not seeing a growth in Q2, which generally happens even for seasonal products. So, that's one. If you could also comment on where you are on gross to net and how any changes to gross to net we should anticipate for the better half of 2025.

感謝您回答我的問題。我只是想問一個問題，特別是關於您目前看到的市場動態。如果你看一下過去四周或五週的劇本，你會發現它似乎相對平淡。因此，如果發生任何特殊情況，您將不會看到第二季度出現成長，這種情況通常也會發生在季節性產品中。所以，這是一個。如果您能評論一下您的毛利率與淨利率的比率情況，以及我們預計 2025 年上半年毛利率與淨利率將如何變化，那該如何預測呢？

Thank you.

謝謝。

Yes. And I will do the first half of that regarding sort of the last few weeks, and then I will let Molly take the gross to net question and work through that. Well, in the first half of it, we are simply not going to get into the pattern of trying to sort of speculate on a week to week IQVIA reported data and sort of week-to-week changes.

是的。我將處理過去幾週的前半部分，然後讓 Molly 處理總額到淨額的問題並進行解決。好吧，在前半部分，我們根本不會陷入試圖推測每週 IQVIA 報告的數據和每週變化的模式。

As you see in the numbers and you go through it, there will be up weeks and flat weeks. And that's just the natural variability that happens in those kinds of numbers. Nothing that we are seeing Q2 or that we have seen in the last couple of weeks is impacting any of these decisions. This is basically looking at our long-term spend pattern and the expense discipline comes from the fact that the revenue is tracking along the lines that I think all of the analysts estimates have been indicating.

正如您在數字中看到並經歷的那樣，會有上漲的幾周和持平的幾週。這只是這些數字中自然發生的變化。我們在第二季度看到的情況以及過去幾週看到的情況都不會影響任何這些決定。這基本上是對我們的長期支出模式的觀察，而支出紀律源於這樣一個事實：收入正沿著我認為所有分析師估計都表明的路線進行。

And so we have communicated that we are comfortable with those. We continue to be comfortable with the range of analyst estimates on revenue. There is nothing that we are seeing that departs from that on the revenue side, but our spend rate was simply too high. And to finance that spend rate at a $4 per share stock price would have been too highly dilutive.

因此，我們已經表示我們對此感到滿意。我們仍然對分析師對收入的估計範圍感到滿意。從收入方面來看，我們沒有看到任何變化，但我們的支出率實在太高了。而以每股 4 美元的股價來為這一支出率提供資金，其稀釋性太強。

And so we are taking the prudent step of reducing expenses. But it doesn't in any way indicate that we have concerns about anything we are seeing or any of the last one week or two weeks. You get one week or two weeks of variability in that process.

因此，我們採取謹慎的措施來削減開支。但這絕不表明我們對所看到的任何事情或過去一周或兩週的任何情況感到擔憂。在這個過程中，你會遇到一週或兩週的變化。

Overall on gross to net, I am going to let Molly jump in on that.

總體而言，就總收入和淨收入而言，我將讓 Molly 參與其中。

Yes. So, yes, as it relates to gross to net, we did see a bit of an improvement in the first quarter. It came in at 53%. As you remember, we signaled on average between 55% and 65% for the full year. We still remain and/or keeps our guidance on the 55% to 65% of the year.

是的。所以，是的，就總額與淨額而言，我們確實看到第一季有所改善。其比例達 53%。正如您所記得的，我們預計全年平均成長率在 55% 至 65% 之間。我們仍然維持和/或保持對今年 55% 至 65% 的預期。

So just as you know, the economics between payers are different. So, depending on which claims are coming through, through which payer, it can have an impact on that gross to net. But on average, we still feel comfortable with that 55% to 65% to use as a guide for the year.

如您所知，付款人之間的經濟狀況是不同的。因此，根據提出索賠的具體情況和付款人，這可能會對總額與淨額產生影響。但平均而言，我們仍然認為 55% 到 65% 可以作為今年的指導。

Thank you.

謝謝。

Paul Choi, Goldman Sachs.

高盛的保羅·崔（Paul Choi）。

Hi, thank you. Good morning everyone and thanks for taking our questions. I have a few. First, for Steve, can you maybe just comment on how many of these changes, like, for instance, the pullback in DTC had been considered prior to you taking the CEO seat, just maybe some color on that would be helpful.

你好，謝謝。大家早安，感謝您回答我們的問題。我有幾個。首先，對於史蒂夫，您能否評論一下這些變化有多少，例如，在您擔任執行長之前，已經考慮過 DTC 的撤回，也許對此進行一些說明會有所幫助。

Second, just can you maybe comment on your level of conviction that the CP response will be on time in the June timeframe that you mentioned here, just given that we are starting to see FDA miss PDUFA deadlines and other delayed regulatory actions that should statutorily be on time?

其次，鑑於我們開始看到 FDA 錯過 PDUFA 期限以及其他應按法定時間進行的監管行動延遲，您能否評論一下您對 CP 響應將在您在此處提到的 6 月時間範圍內按時完成的信心程度？

And third, can you comment, given the expense pullback, are there still plans to continue the pediatric studies, given how important they are for the sort of IP and exclusivity management for request out here? Thank you very much.

第三，您能否評論一下，考慮到費用的減少，是否仍有計劃繼續進行兒科研究，因為它們對於此類請求的知識產權和排他性管理有多麼重要？非常感謝。

Paul, Thank you for that. So, let me just jump in on each of the three points. First in terms of the changes that we are implementing today, how many of these were considered prior to my taking the seat. I don't think any of the changes that we are implementing today were on the table prior to my taking the seat. This is an evaluation that we have done over the last 30 days.

保羅，謝謝你。那麼，讓我簡單談談這三個要點。首先，就我們今天實施的變革而言，其中有多少是在我就任之前就考慮過的。我認為，我們今天實施的任何變革在我就任之前都不存在。這是我們在過去 30 天內所做的評估。

One of the first things that I did when I joined is spend first two weeks, literally meeting with every group in the company to ask what's working, what's not working question and try to understand what parts of our organization are getting leverage, what parts of our organization and what things are having a significant impact. And in the context of those reviews and reviewing the DTC programs in some detail, we saw that, we are getting a positive return on our digital DTC.

我加入後做的第一件事就是花兩週時間與公司的每個小組會面，詢問哪些有效，哪些無效，並試圖了解我們組織的哪些部分正在獲得槓桿作用，我們組織的哪些部分以及哪些事情正在產生重大影響。在這些審查和詳細審查 DTC 計劃的背景下，我們發現，我們的數位 DTC 獲得了積極的回報。

So, I don't want to indicate that DTC doesn't work at all, but the high dollar spend on some of our broadcast wasn't providing near-term return. Now, it might actually be building brand value that might accrue to us in future years. So, I don't want to eliminate the possibility that we ever do DTC in that process, but it wasn't having the near-term impact that we needed to have. So, that was an insight that came through some of those conversations.

所以，我並不是想表明 DTC 根本不起作用，而是我們在一些廣播上花費的高額資金並沒有帶來短期回報。現在，它可能實際上正在建立未來幾年可能為我們帶來的品牌價值。因此，我不想排除我們在過程中進行 DTC 的可能性，但它並沒有產生我們需要的短期影響。所以，這是透過一些對話得出的見解。

But the other thing that happens is we routinely re-forecast on a quarterly basis. And as Molly and I were meeting in the first few days after I joined to review because I literally joined on April 1. So, we were just getting through the March 31st date. We were reviewing the three plus nine forecast internally around what we experienced in the first quarter and what our expected spend would be for the remaining quarter.

但另一件事是，我們每季都會定期重新預測。由於我是 4 月 1 日加入的，因此在我加入後的頭幾天，我和 Molly 進行了會面並進行了審查。所以，我們剛剛度過了 3 月 31 日。我們正在內部審查三加九預測，包括第一季的經驗以及剩餘季度的預期支出。

And my assessment in looking at that, and I think others have sort of internally come to the same conclusion is, that with our current market capitalization, it would be too highly dilutive for us to raise money to continue spending at that rate. And we needed to pare back expenses pretty significantly. And so we have taken significant steps in the past few weeks to evaluate how do we bring our spend rate down.

我認為，從我的評估來看，並且我認為其他人也得出了同樣的結論，那就是，以我們目前的市值，如果我們籌集資金並繼續以這樣的速度支出，那麼我們的股權稀釋性太強了。我們需要大幅削減開支。因此，我們在過去幾週採取了重大措施來評估如何降低支出率。

And again, when the stock price was at much higher level last year, it would have been a reasonable decision to say we can finance a very aggressive spend rate with the stock price at $4 a share. It just doesn't make sense to finance a very aggressive spend rate. And so we have taken the steps to pare back pretty significantly to spending in a number of areas.

再說一次，當去年股價處於高位時，我們可以以每股 4 美元的股價為非常激進的支出率提供資金，這是一個合理的決定。為非常激進的支出率提供資金是沒有意義的。因此，我們已採取措施大幅削減多個領域的開支。

Second question that you have got is much harder for me to answer on what's our level of conviction on CP timing. There has been lots of turnover at FDA. We have not seen or heard anything that indicates that the CP timing of the decision is not on the timeframe.

您的第二個問題對我來說更難回答，即我們對 CP 時機的確信程度。FDA 的人員流動率很高。我們沒有看到或聽到任何跡象表明 CP 的決策時機不符合時間表。

They could come, they should come back to us by early June, but given the turnover at FDA, it is possible that they don't respond on that target date and they take some time longer, or it's possible that they respond indicating that they need more time, because obviously there has been a significant amount of turnover in the organization and it's really out of our control in that process.

他們可能會來，他們應該在六月初回复我們，但考慮到 FDA 的人員流動情況，他們有可能無法在目標日期回复，而是需要更長的時間，或者他們可能會回复說他們需要更多時間，因為顯然該組織已經有大量人員流動，而這確實超出了我們的控制範圍。

So, we have not heard anything from them that indicates that the timing is going to be different. I don't want to send any signals in that regard. We fully expect that it's still coming in in June, but it's hard for us to confirm that our regulatory body is actually going to respond on the date they are supposed to, given that they have had some turnover within the organization.

因此，我們還沒有聽到他們任何表示時間會有所不同的消息。我不想就此發出任何信號。我們完全預期它仍會在六月到來，但考慮到組織內部已經發生了一些流動，我們很難確認我們的監管機構是否會在預定日期做出回應。

And then lastly, on plans to continue the pediatric studies, one of the pediatric extension strategies was related to the EoE study. We are deferring the EoE study to reevaluate it after the CP decision. So, we have paused that study. That is one of the paths to getting that pediatric extension. There may be other paths to getting the pediatric extension, and we are going to be evaluating all of the alternatives that may be available to us to get to the extended six months of exclusivity.

最後，關於繼續兒科研究的計劃，其中一項兒科延伸策略與 EoE 研究有關。我們將推遲 EoE 研究，以便在 CP 決定之後重新評估它。因此，我們暫停了這項研究。這是獲得兒科延長的途徑之一。可能還有其他途徑可以獲得兒科延長，我們將評估所有可用的替代方案，以獲得延長六個月的獨佔權。

Right now, the priority is on how do we get our financials in line to be able to get to break even and mitigate financing risk just because of the current market dynamics. That's a short-term need to bring down our spending, that doesn't eliminate the possibility of doing additional studies in 2026 or 2027 to be able to get to that extension.

現在，我們的首要任務是如何使我們的財務狀況趨於平衡，並降低當前市場動態下的融資風險。這是短期內降低支出的需要，但這並不排除在 2026 年或 2027 年進行額外研究以實現延期的可能性。

We are going to be doing that evaluation on what the alternatives are, what studies are possible, and what's the best path for doing that. We still want to get that extension, but we may ramp down spend for the remainder of this year.

我們將對有哪些替代方案、哪些研究是可行的以及實現這些目標的最佳途徑進行評估。我們仍然希望獲得延期，但我們可能會減少今年剩餘時間的支出。

Got it. Thank you very much.

知道了。非常感謝。

Kristen Kluska, Cantor Fitzgerald.

克里斯汀·克魯斯卡，坎托·費茲傑拉。

Good morning. This is Ayan on the on the line for Kristen here.

早安.我是 Ayan，接聽 Kristen 的電話。

Thank you for taking our questions. First, of the prescriptions filled to-date, do you have a sense of the contribution from the non-erosive? And then second, could you speak to the split of the 30-day and 60-day scripts? Is there a change in this pattern that could be attributed to physicians' conflict with the VOQUEZNA?

感謝您回答我們的問題。首先，在迄今為止開出的處方中，您是否了解非侵蝕性藥物的貢獻？其次，您能談談 30 天和 60 天腳本的分割嗎？這種模式的變化是否可歸因於醫生與 VOQUEZNA 的衝突？

Thank you very much.

非常感謝。

I am not certain that I heard the second half of your question clearly regarding 30 to 60 days. I might ask you to repeat that just because it wasn't entirely clear. But on the last comment that you made around physician confidence in this product, we have heard absolutely nothing in any way that implies that physicians don't have enormous confidence in this product.

我不確定我是否聽清楚了你的問題的後半部分，即 30 到 60 天。我可能會請你重複一遍，因為這不是完全清楚的。但是，關於您最後提到的醫生對該產品的信心，我們完全沒有聽到任何暗示醫生對該產品沒有太大信心的聲音。

I couldn't possibly be more clear in the understanding from every conversation I have had with every one of our team members about discussions that they have had with physicians and the conversations with physicians who are using the product that they love this product.

我與團隊中的每一位成員進行了多次交談，了解他們與醫生的討論，以及與使用該產品的醫生的交談，我非常清楚地了解到他們非常喜歡這款產品。

They find this product provides immediate benefit for patients the magnitude of the pain reduction for patients is really quite significant, the rapid onset of heartburn relief and acid reduction in the stomach is really quite significant. This is a better treatment than PPIs for patients, particularly for patients who aren't adequately treated by PPIs.

他們發現該產品能為患者帶來即時的效果，患者的疼痛減輕程度確實非常顯著，胃灼熱緩解和胃酸減少的快速效果也確實非常顯著。對於患者來說，這是一種比 PPI 更好的治療方法，特別是對於那些無法透過 PPI 充分治療的患者。

So a patient who may be adequately treated by PPIs may not need to switch, but a patient who is still having heartburn or has breakthrough episodes or has an erosive condition or has nighttime GERD. For any number of reasons, the patient may not be adequately treated with PPIs.

因此，可以透過 PPI 充分治療的患者可能不需要更換藥物，但仍有胃灼熱或突破性發作或有糜爛性疾病或有夜間 GERD 的患者則需要更換藥物。由於多種原因，患者可能無法得到 PPI 的充分治療。

They ought to be switching to our product, and physicians really like the effects that it has on their patients. As to the percentage of patients that are non-erosive versus erosive, Molly, I am going to let you comment on breakdowns and what we know in that process. And she has been looking more closely at the number of these numbers historically.

他們應該轉用我們的產品，而醫生也確實喜歡它對病人產生的效果。至於非糜爛性和糜爛性患者的百分比，莫莉，我將讓您對故障情況以及我們在過程中所了解的情況進行評論。她一直在從歷史上更仔細地觀察這些數字。

Yes. And I think as we mentioned in the past, it's difficult to necessarily discern between the non-erosive and erosive based on claims data because it can be somewhat muddied. But what we have seen as somewhat of an indirect proxy is the number of scripts between 10 milligrams and 20 milligrams. But keep in mind that the 10s can also be used as maintenance after the 20 are used for erosive. But that being said, we are seeing continued strong momentum in the script data and you see that in IQVIA every week of the 10 milligrams, so we do believe that, a lot of the new scripts are coming from the non-erosive indication.

是的。我認為，正如我們過去提到的那樣，根據索賠數據很難辨別非侵蝕性和侵蝕性，因為它可能有些混亂。但我們看到的間接代理是 10 毫克到 20 毫克之間的腳本數量。但請記住，在 20 用於侵蝕後，10s 也可以用作維護。但話雖如此，我們看到處方數據持續保持強勁勢頭，而且 IQVIA 每週都會發布 10 毫克的數據，因此我們確實相信，許多新處方都來自非侵蝕性適應症。

Got it. Thank you. That's very helpful.

知道了。謝謝。這非常有幫助。

Umer Raffat, Evercore.

烏默·拉法特（Umer Raffat），Evercore。

Hey, good morning. This is Chengxiang on for Umer. Thanks for taking our questions. I guess my first question is regarding manufacturing. I think you commented there will be a very limited impact. But for VOQUEZNA tablets, can you confirm are both API and finished products are manufactured in the US? And second question, I think [Sebela] just announced their top-line data. There is probably still some time before their potential launch of the product, but just from your perspective, what the competitive landscape will look like and what might be the factors that could differentiate VOQUEZNA from Sebela?

嘿，早安。我是程祥，代表烏默爾發言。感謝您回答我們的問題。我想我的第一個問題是關於製造業的。我認為您評論說影響會非常有限。但對於 VOQUEZNA 片劑，您能確認 API 和成品都是在美國生產的嗎？第二個問題，我認為 [Sebela] 剛剛公佈了他們的頂線數據。距離他們可能推出的產品可能還有一段時間，但從您的角度來看，競爭格局將會是什麼樣的，以及哪些因素可能會使 VOQUEZNA 與 Sebela 有所區別？

Thank you.

謝謝。

So, just on manufacturing, if I understood your question clearly, it's around the tariff impact on manufacturing of our product. And so there should be no near-term impact. We have got a significant inventory of the API already in place, and the final tablet manufacturing occurs in the US, and so there is no tariff impact associated with importing our final product. Our API is made internationally.

因此，僅就製造業而言，如果我理解清楚了您的問題，那就是關稅對我們產品製造的影響。因此短期內不會產生影響。我們已經擁有大量的 API 庫存，最終的藥片製造在美國進行，因此進口我們的最終產品不會受到關稅影響。我們的 API 是國際化的。

So beyond the current inventory of API, if we have to make future purchases, if tariffs are continuing next year, the year after, it's possible that there is some impact. But our API cost is a very small percentage. So, even a significant tariff on top of it would not have a material impact on our business. And if there is any part of that that I missed, Molly, I would ask you to jump in.

因此，除了目前的 API 庫存之外，如果我們必須進行未來的採購，如果明年、後年關稅繼續存在，可能會產生一些影響。但我們的 API 成本只佔很小的比例。因此，即使徵收高額關稅也不會對我們的業務產生重大影響。莫莉，如果我遺漏了任何部分，我請你補充。

So the other element of your question is sort of the competitive landscape with Sebela's data. And certainly, we have not seen full data. We have only seen the same thing everybody else has seen, which is their press release with p-values and so on. It looks like their product also works and works well. And we would fully expect that this class works well.

所以你的問題的另一個要素是 Sebela 數據的競爭格局。當然，我們還沒有看到完整的數據。我們所看到的只是和其他人看到的一樣的東西，也就是他們的新聞稿，其中包含 p 值等等。看起來他們的產品也有效，而且效果很好。我們完全期望這個課程能夠順利進行。

And so having another PCAB launch, I think has the advantage from a physician perception that we are suddenly not a product in the broader GERD treatment landscape, but rather there is a new category of products of PCABs. And so, yes, there is always the competitive dynamic of having a second entrant, but often there is a market growth dynamic associated with having a second entrant that the category grows, physician awareness of the category grows.

因此，我認為推出另一款 PCAB 的優勢在於，從醫生的角度來看，我們突然不再是更廣泛的 GERD 治療領域中的一種產品，而是出現了一種新的 PCAB 產品類別。因此，是的，第二個進入者的出現總是存在競爭動態，但第二個進入者的出現往往也伴隨著市場成長動態，即該類別的成長，醫生對該類別的認識也會增強。

There may be a second sales organization that is educating physicians about this category, and that grows the entire category and shifts patients to using the new class of therapy. So, there could be an updraft as well as a competitive dynamic with a second entrant. Obviously, we have the first to market status, and that becomes a very important consideration.

可能有第二個銷售組織正在對醫生進行有關此類別的教育，並擴大整個類別並讓患者轉而使用新類別的治療方法。因此，第二個進入者的出現可能會帶來上升勢頭，同時也帶來競爭態勢。顯然，我們擁有市場先發優勢，這是一個非常重要的考慮因素。

So, by the time they launch, physicians will have had a significant amount of experience with VOQUEZNA and significant confidence in the product. And we are carefully looking at a number of variables regarding the two products. But we do expect that they are both going to work. There may be some differences in the molecule. There may be differences in half-life or other variables that could be important. But that analysis will be ongoing over the coming months as to exactly how to reposition for the competitive entry of that product.

因此，當產品上市時，醫生將對 VOQUEZNA 有豐富的使用經驗，並對產品充滿信心。我們正在仔細研究這兩種產品的許多變數。但我們確實希望它們都能發揮作用。分子上可能存在一些差異。半衰期或其他重要變數可能存在差異。但在接下來的幾個月裡，我們將持續進行分析，以確定如何重新定位該產品的競爭力。

Thank you so much.

太感謝了。

Thank you. I'm showing no further questions at this time. This concludes today's conference call. Thank you for participating. You may now disconnect.

謝謝。我目前沒有其他問題。今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。